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AURORA, Colo low cost lasix official statement. €” John Letson had seen too many apocalyptic movies to feel comfortable getting a hypertension medications treatment initially. “I was completely against it,” the 40-year-old low cost lasix movie buff said, referencing “I Am Legend” and “Children of Men,” in which humanity is in jeopardy, as examples of what could go wrong. €œI think an untested thing during a lasix has later effects that we don’t know yet.” After discussing with a doctor the various myths that have arisen about the treatments, his opposition softened. On the way to get pizza in late June, he happened upon a mobile vaccination clinic behind a bus stop on Colfax Avenue in this Denver suburb and got his first dose.

€œI was here low cost lasix. They were here,” he explained, as a nurse gave him a shot of the Pfizer-BioNTech treatment. The mobile clinic in the East Colfax neighborhood is part of a new push by Denver-area public health officials to find the neighborhoods where vaccinations lag behind state or county averages. Using detailed low cost lasix maps that show treatments given by ZIP code or census tract, the health departments highlight underperforming areas being masked by a county’s overall vaccination rate. They then partner with community organizations with intimate knowledge of those neighborhoods to determine strategies to address the specific barriers keeping residents from being inoculated.

As the Biden administration seeks to boost the nation’s treatment rate by going “neighborhood by neighborhood,” in the president’s words, the approach taken on Colfax Avenue could become a model for the rest of the country. According to the National Association of County and City Health low cost lasix Officials, such efforts depend on the accuracy of the data and the willingness of jurisdictions to work together, which can be difficult for some regions to accomplish. The Denver-area effort has managed to use granular data across seven counties to help raise the vaccination rate by an estimated 4 percentage points in one troubled Colfax area in about a month. €œWe have to do the dirty work to be with the community and listen to what their actual concerns are,” Nicole Steffens, a program manager with the nonprofit Colorado Health Institute, said in a presentation on the mapping tool. €œWe can take all the data that we want based on large, mass groups of people on surveys with treatment hesitancy or why people aren’t getting vaccinations, but that might not actually apply to that very specific location.” The public low cost lasix health agencies cooperating in the Denver region represent 3 million Coloradans, about 60% of the state’s population.

They overlay data from the state treatment database with the hypertension medications caseload, poverty rates and racial demographics to highlight areas of concern. €œWe weren’t very surprised to see the areas that lit up,” said Meghan Prentiss, with the Tri-County Health Department, which serves Adams, Arapahoe and Douglas counties east and south of Denver. €œThey all kind low cost lasix of followed those common trends of other health indicators.” East Colfax topped the department’s priority list. The neighborhood, which spans the border between Denver and Aurora, is one of the more impoverished in the metro area, with large numbers of immigrants and minorities, many of whom speak neither English nor Spanish. Two-thirds of the city of Denver’s eligible residents were fully vaccinated by the end of June, compared with just above 30% in the East Colfax neighborhood.

In the 80010 and 80011 ZIP codes, which include the Colfax low cost lasix corridor, fewer than half of those ages 30 to 39 were vaccinated, compared with more than 75% in more affluent Washington Park or City Park. Part of the problem, people in the community told health officials, was transportation. A mobile treatment clinic run by Denver Public Health provides hypertension medications treatments behind a bus low cost lasix stop in Aurora, Colorado, on June 23. The clinic was a collaboration between health and transit officials to improve access to treatments in a neighborhood where many low-income residents don’t own cars. (Markian Hawryluk / KHN) Initially, the state had set up mass vaccination clinics in the center of Denver.

But many East Colfax residents have no low cost lasix car, relying primarily on public transit. It’s about a 50-minute ride one way on the Route 15 bus to the Ball Arena treatment site. For many, that was too far to venture. €œIt looks great low cost lasix on TV to have these mass clinics where people drive through,” said Judy Shlay, an associate director who runs the immunization program for Denver Public Health, which operates the mobile treatment clinic. €œBut we have to be more agile and flexible for people who are maybe more hesitant to go downtown, or because they have to take three buses to get there.” Moreover, people in the East Colfax area often work hourly jobs as independent contractors or gig workers and get no time off to get vaccinated.

And if they fall ill after getting vaccinated, they might miss another day’s pay. So public health officials worked with transit authorities to identify where high-ridership bus lines intersected in the corridor, settling on a location by a Walmart, a Sprouts grocery store low cost lasix and the Little Caesars restaurant where Letson had gone to buy pizza. On two days in late June, the mobile clinic vaccinated a total of 150 people, most receiving their first shots. Among them was Marley Sosa, 18, whose sister is a nurse who worked at the clinic. €œShe made me feel safe about it,” he low cost lasix said.

€œPeople are just hesitant because it’s a new treatment.” Ira Milhouse, 40, who is homeless, said he got vaccinated so he could receive a $50 grocery gift card provided as an incentive. Stephanie Aguilar, 18, came after clinic staffers walked through the shopping plaza where the van was parked, informing everyone they could get vaccinated that day. Ira Milhouse, a homeless man, says the offer of a $50 grocery card enticed him low cost lasix to get vaccinated at the Denver Public Health mobile treatment clinic June 23. The East Colfax corridor where the clinic was held has a high number of homeless and low-income people, and one of the lowest vaccination rates in the Denver area. (Markian Hawryluk / KHN) Others inquired about the incentives but walked away unvaccinated.

Janice Robinson, 53, had come to the bus stop, part of her low cost lasix daily routine of “taking a ride” with no particular destination. €œI don’t want the treatment,” she said. €œI don’t think I need low cost lasix it. I don’t really go anywhere.” Desiree Mister, 45, had just finished a shift at Sprouts. She was tired of wearing a mask and wanted to get vaccinated.

But she wasn’t sure if she could low cost lasix sell her plasma if she got vaccinated. She decided she’d come back the following week after a plasma draw. (The Food and Drug Administration says people who have received hypertension medications treatments can continue to donate blood or sell plasma without a waiting period, although rules at plasma collection sites can vary.) Early data, Shlay said, showed that treatment access was highly correlated with income, and those able to connect digitally had an easier time tracking down shots. It proved much more difficult for East Colfax residents with low cost lasix language barriers. That meant the treatment had to come to East Colfax, which has few police or fire stations, libraries or rec centers that could host treatment clinics.

€œWe couldn’t anchor something in there,” Shlay said. €œSo we had to use small organizations that maybe aren’t reaching everybody.” One of those was the Village Exchange Center, low cost lasix a nonprofit just a block off Colfax Avenue. The center offers benefits to immigrants, including a food bank that serves 4,000 people a day. Workers there inserted flyers about the treatments into the bags of food they distributed and held information sessions. €œWe have several pastors that have just said, ‘This is evil, and we’re not going low cost lasix to do it,’” said Amanda Blaurock, the center’s executive director.

€œAnd we respect that. We don’t go around decisions that community members have made. We just say, ‘We’re hosting it, and if you want it, we’re trying to make it low cost lasix as accessible as possible.’” One census tract in the area has a recorded population of 4,389, and as of mid-June, slightly more than 1,300, or about 30%, were fully vaccinated. Health officials would need to get roughly 1,700 more vaccinated to reach their 70% goal. A month later, the rate had climbed to 34%, and health officials expect more dramatic gains in the coming weeks after people receive their second doses.

The initial success has buoyed interest low cost lasix in more transit-based treatment clinics. Shontel Lewis, who represents the East Colfax area on the Regional Transportation District mass transit agency’s board of directors and spearheaded its involvement, said future clinics might be held at park-and-ride locations and other bus stops in underserved areas. €œThe approach is often cookie-cutter low cost lasix. We tend to go with the same strategies, and then, when no one comes, we just throw our hands up,” Lewis said. If the goal is to get everybody vaccinated, she said, the interventions need to be tailored to specific communities.

€œOur approach might be different,” she said, “but our goal is the same.” Squeeze-toy buses provided by the Denver transit authority were just one of the incentives provided to encourage people to get vaccinated at a mobile clinic arranged by public health and transit officials June 23 in Aurora, Colorado low cost lasix. (Markian Hawryluk / KHN) Markian Hawryluk. MarkianH@kff.org, @MarkianHawryluk Related Topics Contact Us Submit a Story TipThe long list of side effects that follow ads for the newer expensive drugs to treat Type 2 diabetes sometimes include an unusual warning. They might cause weight low cost lasix loss. That side effect is one that many people — especially those with Type 2 diabetes, which is associated with obesity — may desperately want.

So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for Type 2 diabetes, which affects about 10% of Americans, they join the far low cost lasix smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit. One that recently hit the market — winning Food and Drug Administration approval in June — is Novo Nordisk’s Wegovy, a higher-dose version of the company’s injectable diabetes drug, Ozempic. Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer. That it “is not a weight loss drug.” low cost lasix Now — with a new name — it is.

And clinical trials showed using it leads to significant weight loss for many patients. €œPeople who go on this medication lose more weight than with any drug we’ve seen, ever,” said Dr. Fatima Cody Stanford, low cost lasix an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School who was not involved with any of the clinical trials. But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it. Wegovy’s monthly wholesale price tag — set at $1,349 — is about 58% more than Ozempic’s, although, the company points out, the drug’s injector pens contain more than twice as much of the active ingredient.

Studies so low cost lasix far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight loss treatments are not universally covered by insurance policies. The arrival of this new class of weight loss drugs — one from Lilly may soon follow low cost lasix — has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price. €œThe metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, or ERIC, which represents large, self-insured employers.

€œIf we pay for this drug, how much is this going to cost and how much value will it provide to the low cost lasix beneficiaries?. € Weight loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems. New drugs like Wegovy, more effective low cost lasix but also pricier than previous weight loss treatments, will add more fuel to that debate. Past treatments were shown to prompt weight loss in the range of 5% to 10% of body weight.

But many had relatively serious or unpleasant side effects. Wegovy, however, helped patients lose an low cost lasix average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and low cost lasix exercise.

Side effects, generally considered mild, included nausea, diarrhea, vomiting and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of low cost lasix thyroid cancer. Weight loss in those taking Wegovy puts it close to the 20% to 25% losses seen with bariatric surgery, said Stanford at Mass General, and well above the 3% to 4% seen with diet and other lifestyle changes alone. Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Dr.

Sean Wharton, low cost lasix an internal medicine specialist and adjunct professor at York University in Toronto who was among the co-authors of the report outlining the results of the first clinical trial on Wegovy. Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?. Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs low cost lasix for “anorexia, weight loss or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.

Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, low cost lasix either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013. €œEmployers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy. The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Maryland, woman low cost lasix who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped.

Only after the trial ended did she find out she was in the treatment group the entire time. Her weight fell slowly at first, then low cost lasix ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased. She felt better all around. €œI definitely feel the drug was it for me,” said Pannell, who also low cost lasix followed the trial’s guidance on diet and exercise.

The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%. After the low cost lasix trial ended, and the hypertension medications lasix hit, Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it. Many employers do cover obesity drugs.

For example, low cost lasix about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations. He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective. Still, that low cost lasix is more than the $851 monthly wholesale price of Ozempic. But, he points out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.

€œThere’s more drug in the pen,” Bachner low cost lasix said. €œThat drives the price up.” He added. €œThis is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different low cost lasix clinical program,” which required new trials. Now scientists, employers, physicians and patients will have to decide whether the new drugs are worth it.

Earlier estimates — some commissioned by Novo Nordisk — of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in. Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a low cost lasix month to more than $300, a small fraction of Wegovy’s cost. Julie Appleby. jappleby@kff.org, @Julie_Appleby Related Topics Contact Us Submit a Story TipWest Virginia raced ahead of the country last winter to get people in nursing homes vaccinated against hypertension medications, but with cases and hospitalizations on the rise again, state officials want to know whether immunity levels are falling for residents who had their shots. Starting in August, the state plans to begin low cost lasix measuring the levels of disease-fighting antibodies in the blood of vaccinated nursing home residents, which could help indicate whether they need a booster shot.

The process will be voluntary and the data will be shared with federal health agencies evaluating the need for boosters. Some experts question the strategy, particularly since the federal government has not yet authorized the extra shots. hypertension medications cases in low cost lasix West Virginia and nationally have more than tripled in the past month. Much of that surge is blamed on the delta variant, a highly contagious form of the lasix sweeping the country. In June, about 10% of hospitalized hypertension medications patients in West Virginia and 12% of hypertension medications deaths were among fully vaccinated people, said Dr.

Clay Marsh, executive dean for health sciences low cost lasix at West Virginia University and the state’s hypertension response coordinator. Nationally, about 3% of hospitalizations and 1% of deaths in July have been among people vaccinated for hypertension medications. Still, deaths attributed to hypertension medications remain very rare in West Virginia, which is averaging two fatalities low cost lasix a day. Hospitalizations have risen from 65 hypertension medications patients on July 1 to 133 as of July 28, according to state data. €œIn West Virginia, we were very aggressive in vaccinating our long-term care population, but we now worry and are paying more attention about whether we have sufficient immunity in those fully vaccinated,” said Marsh, often referred to as the state’s hypertension czar.

The question of the need for a low cost lasix booster has gained much attention lately. On Thursday, Israel announced plans to start providing booster shots this weekend to adults over 60 years old who have received their second shot at least five months earlier. The decision comes a day after the release of a paper by executives at Pfizer, one of the companies producing a treatment, that shows a slight dip in efficacy against any symptomatic cases of hypertension medications four months after immunization is completed. The paper, which has not been peer-reviewed, predicted that a third shot could boost disease-fighting antibodies many times higher than the level achieved low cost lasix from a two-shot regimen. Pfizer said it plans to seek Food and Drug Administration authorization for a booster shot by mid-August.

Some health experts cautioned that information on antibody levels may not be helpful. Dr. Michael Wasserman, a California geriatrician and member of the California treatment advisory committee, said lower antibody levels don’t automatically mean less immunity. €œThe fact that antibodies are going down is normal and it doesn’t mean that those people are not immune to the lasix,” he said. Antibodies do decrease over time, “but that doesn’t tell us if you’re exposed to hypertension medications whether your body will move into gear and produce more.

€¦ The question of whether antibodies are a marker of adequate immunity is one we have not answered yet,” Wasserman said. West Virginia officials say their nursing home antibody testing could help FDA and other regulators evaluate the need for boosters. €œWe want to gather this information and, pending what we find, work with Centers for Disease Control and Prevention and the Food and Drug Administration on an appropriate response,” said Marsh. €œThis is a complicated issue as antibodies are not the only defense against hypertension medications.” An antibody test will be used to measure levels against what was expected after immunization and whether it is a high-enough level to neutralize the delta variant, he said. The state will also look at breakthrough s and how many vaccinated people have ended up hospitalized or dead.

The state’s nursing home industry supports the initiative, although officials say they’ve seen no increase in vaccinated hypertension medications residents getting sick. €œOur goal is to advance knowledge and information that exists about the treatments,” said Marty Wright, CEO of the West Virginia Health Care Association, which represents nursing homes. He said antibody testing will offer one indicator of how well treatments are still working. Dr. David Wohl, professor of medicine and director of the treatment clinics at the University of North Carolina School of Medicine, pointed out that even if the West Virginia initiative shows antibody levels have dropped, states can’t provide booster shots until the federal government authorizes them.

€œYou do not do a test unless there is something you can do with the information that you get from the test,” he said. Wohl said he anticipates that booster shots are likely to be needed eventually and that higher-risk populations — such as those who are immunocompromised or those in nursing homes — would likely be first to get them. Dr. Mark Roberts, professor and former chair of the health policy and management department at the University of Pittsburgh Graduate School of Public Health, said immunity protection is much more complicated than just the level of antibodies. €œIt looks like protection from the treatment wanes, but we don’t know exactly how fast, and if protection wanes it may still protect people from getting sick and dying,” he said.

Wasserman said a bigger question is whether officials are seeing more breakthrough s in nursing homes and whether unvaccinated staff members are to blame. €œI argued strongly against treatment mandates when the treatment came out, but I am in favor of them now” for nursing home workers, Wasserman said. California requires unvaccinated nursing home staffers to be tested regularly, requiring them to wear N95s. West Virginia requires all nursing home employees to get vaccinated or face twice-a-week testing. In a joint statement in July, the FDA, the CDC and the National Institutes of Health said the government is analyzing laboratory data, clinical trial data and other data — which can include data from specific pharmaceutical companies — as they evaluate the need for booster shots.

€œWe continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.” In a press call with reporters, state health officials in Maine, Louisiana and Delaware on Thursday said they are paying attention to the booster shot issue and waiting for CDC guidance, but it’s not their top priority. €œRight now our focus is getting folks first doses, not third doses,” said Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention. €œThere will be a time for booster shots, but there are still folks who do not have a first dose and that is where our team is focused,” said Shah, also president of the Association of State and Territorial Health Officials.

KHN senior correspondents Jenny Gold and Markian Hawryluk contributed to this story. Phil Galewitz. pgalewitz@kff.org, @philgalewitz Related Topics Contact Us Submit a Story Tip.

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Rules Kamagra oral jelly price what do you need to buy lasix and Household Size 3. The Three MSP Programs - What are they and how are they Different?. 4. FOUR Special Benefits what do you need to buy lasix of MSP Programs.

Back Door to Extra Help with Part D MSPs Automatically Waive Late Enrollment Penalties for Part B - and allow enrollment in Part B year-round outside of the short Annual Enrollment Period No Medicaid Lien on Estate to Recover Payment of Expenses Paid by MSP Food Stamps/SNAP not reduced by Decreased Medical Expenses when Enroll in MSP - at least temporarily 5. Enrolling in an MSP - Automatic Enrollment &. Applications for People who what do you need to buy lasix Have Medicare What is Application Process?. 6.

Enrolling in an MSP for People age 65+ who Do Not Qualify for Free Medicare Part A - the "Part A Buy-In Program" 7. What Happens After MSP Approved - How what do you need to buy lasix Part B Premium is Paid 8 Special Rules for QMBs - How Medicare Cost-Sharing Works 1. NO ASSET LIMIT!. Since April 1, 2008, none of the three MSP programs have resource limits in New York -- which means many Medicare beneficiaries who might not qualify for Medicaid because of excess resources can qualify for an MSP.

1.A what do you need to buy lasix. SUMMARY CHART OF MSP BENEFITS QMB SLIMB QI-1 Eligibility ASSET LIMIT NO LIMIT IN NEW YORK STATE INCOME LIMIT (2021) Single Couple Single Couple Single Couple $1,094 $1,472 $1,308 $1,762 $1,469 $1,980 Federal Poverty Level 100% FPL 100 – 120% FPL 120 – 135% FPL Benefits Pays Monthly Part B premium?. YES, and also Part A premium if did not have enough work quarters and meets citizenship requirement. See “Part what do you need to buy lasix A Buy-In” YES YES Pays Part A &.

B deductibles &. Co-insurance YES - with limitations NO NO Retroactive to Filing of Application?. Yes what do you need to buy lasix - Benefits begin the month after the month of the MSP application. 18 NYCRR §360-7.8(b)(5) Yes – Retroactive to 3rd month before month of application, if eligible in prior months Yes – may be retroactive to 3rd month before month of applica-tion, but only within the current calendar year.

(No retro for January application). See GIS 07 MA 027 what do you need to buy lasix. Can Enroll in MSP and Medicaid at Same Time?. YES YES NO!.

Must choose between QI-1 and Medicaid what do you need to buy lasix. Cannot have both, not even Medicaid with a spend-down. 2. INCOME LIMITS and RULES Each of the three MSP programs has different income eligibility requirements and provides what do you need to buy lasix different benefits.

The income limits are tied to the Federal Poverty Level (FPL). 2021 FPL levels were released by NYS DOH in GIS 21 MA/06 - 2021 Federal Poverty Levels Attachment II NOTE. There is usually a lag in time of several weeks, or even months, from January 1st of each year until the new FPLs are release, and then before the new MSP income what do you need to buy lasix limits are officially implemented. During this lag period, local Medicaid offices should continue to use the previous year's FPLs AND count the person's Social Security benefit amount from the previous year - do NOT factor in the Social Security COLA (cost of living adjustment).

Once the updated guidelines are released, districts will use the new FPLs and go ahead and factor in any COLA. See 2021 Fact Sheet on MSP in NYS by Medicare Rights Center ENGLISH SPANISH Income is determined by the what do you need to buy lasix same methodology as is used for determining in eligibility for SSI The rules for counting income for SSI-related (Aged 65+, Blind, or Disabled) Medicaid recipients, borrowed from the SSI program, apply to the MSP program, except for the new rules about counting household size for married couples. N.Y. Soc.

Serv. L. 367-a(3)(c)(2), NYS DOH 2000-ADM-7, 89-ADM-7 p.7. Gross income is counted, although there are certain types of income that are disregarded.

The most common income disregards, also known as deductions, include. (a) The first $20 of your &. Your spouse's monthly income, earned or unearned ($20 per couple max). (b) SSI EARNED INCOME DISREGARDS.

* The first $65 of monthly wages of you and your spouse, * One-half of the remaining monthly wages (after the $65 is deducted). * Other work incentives including PASS plans, impairment related work expenses (IRWEs), blind work expenses, etc. For information on these deductions, see The Medicaid Buy-In for Working People with Disabilities (MBI-WPD) and other guides in this article -- though written for the MBI-WPD, the work incentives apply to all Medicaid programs, including MSP, for people age 65+, disabled or blind. (c) monthly cost of any health insurance premiums but NOT the Part B premium, since Medicaid will now pay this premium (may deduct Medigap supplemental policies, vision, dental, or long term care insurance premiums, and the Part D premium but only to the extent the premium exceeds the Extra Help benchmark amount) (d) Food stamps not counted.

You can get a more comprehensive listing of the SSI-related income disregards on the Medicaid income disregards chart. As for all benefit programs based on financial need, it is usually advantageous to be considered a larger household, because the income limit is higher. The above chart shows that Households of TWO have a higher income limit than households of ONE. The MSP programs use the same rules as Medicaid does for the Disabled, Aged and Blind (DAB) which are borrowed from the SSI program for Medicaid recipients in the “SSI-related category.” Under these rules, a household can be only ONE or TWO.

18 NYCRR 360-4.2. See DAB Household Size Chart. Married persons can sometimes be ONE or TWO depending on arcane rules, which can force a Medicare beneficiary to be limited to the income limit for ONE person even though his spouse who is under 65 and not disabled has no income, and is supported by the client applying for an MSP. EXAMPLE.

Bob's Social Security is $1300/month. He is age 67 and has Medicare. His wife, Nancy, is age 62 and is not disabled and does not work. Under the old rule, Bob was not eligible for an MSP because his income was above the Income limit for One, even though it was well under the Couple limit.

In 2010, NYS DOH modified its rules so that all married individuals will be considered a household size of TWO. DOH GIS 10 MA 10 Medicare Savings Program Household Size, June 4, 2010. This rule for household size is an exception to the rule applying SSI budgeting rules to the MSP program. Under these rules, Bob is now eligible for an MSP.

When is One Better than Two?. Of course, there may be couples where the non-applying spouse's income is too high, and disqualifies the applying spouse from an MSP. In such cases, "spousal refusal" may be used SSL 366.3(a). (Link is to NYC HRA form, can be adapted for other counties).

In NYC, if you have a Medicaid case with HRA, instead of submitting an MSP application, you only need to complete and submit MAP-751W (check off "Medicare Savings Program Evaluation") and fax to (917) 639-0837. (The MAP-751W is also posted in languages other than English in this link. (Updated 4/14/2021.)) 3. The Three Medicare Savings Programs - what are they and how are they different?.

1. Qualified Medicare Beneficiary (QMB). The QMB program provides the most comprehensive benefits. Available to those with incomes at or below 100% of the Federal Poverty Level (FPL), the QMB program covers virtually all Medicare cost-sharing obligations.

Part B premiums, Part A premiums, if there are any, and any and all deductibles and co-insurance. QMB coverage is not retroactive. The program’s benefits will begin the month after the month in which your client is found eligible. ** See special rules about cost-sharing for QMBs below - updated with new CMS directive issued January 2012 ** See NYC HRA QMB Recertification form ** Even if you do not have Part A automatically, because you did not have enough wages, you may be able to enroll in the Part A Buy-In Program, in which people eligible for QMB who do not otherwise have Medicare Part A may enroll, with Medicaid paying the Part A premium (Materials by the Medicare Rights Center).

2. Specifiedl Low-Income Medicare Beneficiary (SLMB). For those with incomes between 100% and 120% FPL, the SLMB program will cover Part B premiums only. SLMB is retroactive, however, providing coverage for three months prior to the month of application, as long as your client was eligible during those months.

3. Qualified Individual (QI-1). For those with incomes between 120% and 135% FPL, and not receiving Medicaid, the QI-1 program will cover Medicare Part B premiums only. QI-1 is also retroactive, providing coverage for three months prior to the month of application, as long as your client was eligible during those months.

However, QI-1 retroactive coverage can only be provided within the current calendar year. (GIS 07 MA 027) So if you apply in January, you get no retroactive coverage. Q-I-1 recipients would be eligible for Medicaid with a spend-down, but if they want the Part B premium paid, they must choose between enrolling in QI-1 or Medicaid. They cannot be in both.

It is their choice. DOH MRG p. 19. In contrast, one may receive Medicaid and either QMB or SLIMB.

4. Four Special Benefits of MSPs (in addition to NO ASSET TEST). Benefit 1. Back Door to Medicare Part D "Extra Help" or Low Income Subsidy -- All MSP recipients are automatically enrolled in Extra Help, the subsidy that makes Part D affordable.

They have no Part D deductible or doughnut hole, the premium is subsidized, and they pay very low copayments. Once they are enrolled in Extra Help by virtue of enrollment in an MSP, they retain Extra Help for the entire calendar year, even if they lose MSP eligibility during that year. The "Full" Extra Help subsidy has the same income limit as QI-1 - 135% FPL. However, many people may be eligible for QI-1 but not Extra Help because QI-1 and the other MSPs have no asset limit.

People applying to the Social Security Administration for Extra Help might be rejected for this reason. Recent (2009-10) changes to federal law called "MIPPA" requires the Social Security Administration (SSA) to share eligibility data with NYSDOH on all persons who apply for Extra Help/ the Low Income Subsidy. Data sent to NYSDOH from SSA will enable NYSDOH to open MSP cases on many clients. The effective date of the MSP application must be the same date as the Extra Help application.

Signatures will not be required from clients. In cases where the SSA data is incomplete, NYSDOH will forward what is collected to the local district for completion of an MSP application. The State implementing procedures are in DOH 2010 ADM-03. Also see CMS "Dear State Medicaid Director" letter dated Feb.

18, 2010 Benefit 2. MSPs Automatically Waive Late Enrollment Penalties for Part B Generally one must enroll in Part B within the strict enrollment periods after turning age 65 or after 24 months of Social Security Disability. An exception is if you or your spouse are still working and insured under an employer sponsored group health plan, or if you have End Stage Renal Disease, and other factors, see this from Medicare Rights Center. If you fail to enroll within those short periods, you might have to pay higher Part B premiums for life as a Late Enrollment Penalty (LEP).

Also, you may only enroll in Part B during the Annual Enrollment Period from January 1 - March 31st each year, with Part B not effective until the following July. Enrollment in an MSP automatically eliminates such penalties... For life.. Even if one later ceases to be eligible for the MSP.

AND enrolling in an MSP will automatically result in becoming enrolled in Part B if you didn't already have it and only had Part A. See Medicare Rights Center flyer. Benefit 3. No Medicaid Lien on Estate to Recover MSP Benefits Paid Generally speaking, states may place liens on the Estates of deceased Medicaid recipients to recover the cost of Medicaid services that were provided after the recipient reached the age of 55.

Since 2002, states have not been allowed to recover the cost of Medicare premiums paid under MSPs. In 2010, Congress expanded protection for MSP benefits. Beginning on January 1, 2010, states may not place liens on the Estates of Medicaid recipients who died after January 1, 2010 to recover costs for co-insurance paid under the QMB MSP program for services rendered after January 1, 2010. The federal government made this change in order to eliminate barriers to enrollment in MSPs.

See NYS DOH GIS 10-MA-008 - Medicare Savings Program Changes in Estate Recovery The GIS clarifies that a client who receives both QMB and full Medicaid is exempt from estate recovery for these Medicare cost-sharing expenses. Benefit 4. SNAP (Food Stamp) benefits not reduced despite increased income from MSP - at least temporarily Many people receive both SNAP (Food Stamp) benefits and MSP. Income for purposes of SNAP/Food Stamps is reduced by a deduction for medical expenses, which includes payment of the Part B premium.

Since approval for an MSP means that the client no longer pays for the Part B premium, his/her SNAP/Food Stamps income goes up, so their SNAP/Food Stamps go down. Here are some protections. Do these individuals have to report to their SNAP worker that their out of pocket medical costs have decreased?. And will the household see a reduction in their SNAP benefits, since the decrease in medical expenses will increase their countable income?.

The good news is that MSP households do NOT have to report the decrease in their medical expenses to the SNAP/Food Stamp office until their next SNAP/Food Stamp recertification. Even if they do report the change, or the local district finds out because the same worker is handling both the MSP and SNAP case, there should be no reduction in the household’s benefit until the next recertification. New York’s SNAP policy per administrative directive 02 ADM-07 is to “freeze” the deduction for medical expenses between certification periods. Increases in medical expenses can be budgeted at the household’s request, but NYS never decreases a household’s medical expense deduction until the next recertification.

Most elderly and disabled households have 24-month SNAP certification periods. Eventually, though, the decrease in medical expenses will need to be reported when the household recertifies for SNAP, and the household should expect to see a decrease in their monthly SNAP benefit. It is really important to stress that the loss in SNAP benefits is NOT dollar for dollar. A $100 decrease in out of pocket medical expenses would translate roughly into a $30 drop in SNAP benefits.

See more info on SNAP/Food Stamp benefits by the Empire Justice Center, and on the State OTDA website. Some clients will be automatically enrolled in an MSP by the New York State Department of Health (NYSDOH) shortly after attaining eligibility for Medicare. Others need to apply. The 2010 "MIPPA" law introduced some improvements to increase MSP enrollment.

See 3rd bullet below. Also, some people who had Medicaid through the Affordable Care Act before they became eligible for Medicare have special procedures to have their Part B premium paid before they enroll in an MSP. See below. WHO IS AUTOMATICALLY ENROLLED IN AN MSP.

Clients receiving even $1.00 of Supplemental Security Income should be automatically enrolled into a Medicare Savings Program (most often QMB) under New York State’s Medicare Savings Program Buy-in Agreement with the federal government once they become eligible for Medicare. They should receive Medicare Parts A and B. Clients who are already eligible for Medicare when they apply for Medicaid should be automatically assessed for MSP eligibility when they apply for Medicaid. (NYS DOH 2000-ADM-7 and GIS 05 MA 033).

Clients who apply to the Social Security Administration for Extra Help, but are rejected, should be contacted &. Enrolled into an MSP by the Medicaid program directly under new MIPPA procedures that require data sharing. Strategy TIP. Since the Extra Help filing date will be assigned to the MSP application, it may help the client to apply online for Extra Help with the SSA, even knowing that this application will be rejected because of excess assets or other reason.

SSA processes these requests quickly, and it will be routed to the State for MSP processing. Since MSP applications take a while, at least the filing date will be retroactive. Note. The above strategy does not work as well for QMB, because the effective date of QMB is the month after the month of application.

As a result, the retroactive effective date of Extra Help will be the month after the failed Extra Help application for those with QMB rather than SLMB/QI-1. Applying for MSP Directly with Local Medicaid Program. Those who do not have Medicaid already must apply for an MSP through their local social services district. (See more in Section D.

Below re those who already have Medicaid through the Affordable Care Act before they became eligible for Medicare. If you are applying for MSP only (not also Medicaid), you can use the simplified MSP application form (theDOH-4328(Rev. 8/2017-- English) (2017 Spanish version not yet available). Either application form can be mailed in -- there is no interview requirement anymore for MSP or Medicaid.

See 10 ADM-04. Applicants will need to submit proof of income, a copy of their Medicare card (front &. Back), and proof of residency/address. See the application form for other instructions.

One who is only eligible for QI-1 because of higher income may ONLY apply for an MSP, not for Medicaid too. One may not receive Medicaid and QI-1 at the same time. If someone only eligible for QI-1 wants Medicaid, s/he may enroll in and deposit excess income into a pooled Supplemental Needs Trust, to bring her countable income down to the Medicaid level, which also qualifies him or her for SLIMB or QMB instead of QI-1. Advocates in NYC can sign up for a half-day "Deputization Training" conducted by the Medicare Rights Center, at which you'll be trained and authorized to complete an MSP application and to submit it via the Medicare Rights Center, which submits it to HRA without the client having to apply in person.

Enrolling in an MSP if you already have Medicaid, but just become eligible for Medicare Those who, prior to becoming enrolled in Medicare, had Medicaid through Affordable Care Act are eligible to have their Part B premiums paid by Medicaid (or the cost reimbursed) during the time it takes for them to transition to a Medicare Savings Program. In 2018, DOH clarified that reimbursement of the Part B premium will be made regardless of whether the individual is still in a Medicaid managed care (MMC) plan. GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare ( PDF) provides, "Due to efforts to transition individuals who gain Medicare eligibility and who require LTSS, individuals may not be disenrolled from MMC upon receipt of Medicare. To facilitate the transition and not disadvantage the recipient, the Medicaid program is approving reimbursement of Part B premiums for enrollees in MMC." The procedure for getting the Part B premium paid is different for those whose Medicaid was administered by the NYS of Health Exchange (Marketplace), as opposed to their local social services district.

The procedure is also different for those who obtain Medicare because they turn 65, as opposed to obtaining Medicare based on disability. Either way, Medicaid recipients who transition onto Medicare should be automatically evaluated for MSP eligibility at their next Medicaid recertification. NYS DOH 2000-ADM-7 Individuals can also affirmatively ask to be enrolled in MSP in between recertification periods. IF CLIENT HAD MEDICAID ON THE MARKETPLACE (NYS of Health Exchange) before obtaining Medicare.

IF they obtain Medicare because they turn age 65, they will receive a letter from their local district asking them to "renew" Medicaid through their local district. See 2014 LCM-02. Now, their Medicaid income limit will be lower than the MAGI limits ($842/ mo reduced from $1387/month) and they now will have an asset test. For this reason, some individuals may lose full Medicaid eligibility when they begin receiving Medicare.

People over age 65 who obtain Medicare do NOT keep "Marketplace Medicaid" for 12 months (continuous eligibility) See GIS 15 MA/022 - Continuous Coverage for MAGI Individuals. Since MSP has NO ASSET limit. Some individuals may be enrolled in the MSP even if they lose Medicaid, or if they now have a Medicaid spend-down. If a Medicare/Medicaid recipient reports income that exceeds the Medicaid level, districts must evaluate the person’s eligibility for MSP.

08 OHIP/ADM-4 ​If you became eligible for Medicare based on disability and you are UNDER AGE 65, you are entitled to keep MAGI Medicaid for 12 months from the month it was last authorized, even if you now have income normally above the MAGI limit, and even though you now have Medicare. This is called Continuous Eligibility. EXAMPLE. Sam, age 60, was last authorized for Medicaid on the Marketplace in June 2016.

He became enrolled in Medicare based on disability in August 2016, and started receiving Social Security in the same month (he won a hearing approving Social Security disability benefits retroactively, after first being denied disability). Even though his Social Security is too high, he can keep Medicaid for 12 months beginning June 2016. Sam has to pay for his Part B premium - it is deducted from his Social Security check. He may call the Marketplace and request a refund.

This will continue until the end of his 12 months of continues MAGI Medicaid eligibility. He will be reimbursed regardless of whether he is in a Medicaid managed care plan. See GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare (PDF) When that ends, he will renew Medicaid and apply for MSP with his local district. Individuals who are eligible for Medicaid with a spenddown can opt whether or not to receive MSP.

(Medicaid Reference Guide (MRG) p. 19). Obtaining MSP may increase their spenddown. MIPPA - Outreach by Social Security Administration -- Under MIPPA, the SSA sends a form letter to people who may be eligible for a Medicare Savings Program or Extra Help (Low Income Subsidy - LIS) that they may apply.

The letters are. · Beneficiary has Extra Help (LIS), but not MSP · Beneficiary has no Extra Help (LIS) or MSP 6. Enrolling in MSP for People Age 65+ who do Not have Free Medicare Part A - the "Part A Buy-In Program" Seniors WITHOUT MEDICARE PART A or B -- They may be able to enroll in the Part A Buy-In program, in which people eligible for QMB who are age 65+ who do not otherwise have Medicare Part A may enroll in Part A, with Medicaid paying the Part A premium. See Step-by-Step Guide by the Medicare Rights Center).

This guide explains the various steps in "conditionally enrolling" in Part A at the SSA office, which must be done before applying for QMB at the Medicaid office, which will then pay the Part A premium. See also GIS 04 MA/013. In June, 2018, the SSA revised the POMS manual procedures for the Part A Buy-In to to address inconsistencies and confusion in SSA field offices and help smooth the path for QMB enrollment. The procedures are in the POMS Section HI 00801.140 "Premium-Free Part A Enrollments for Qualified Medicare BenefiIaries." It includes important clarifications, such as.

SSA Field Offices should explain the QMB program and conditional enrollment process if an individual lacks premium-free Part A and appears to meet QMB requirements. SSA field offices can add notes to the “Remarks” section of the application and provide a screen shot to the individual so the individual can provide proof of conditional Part A enrollment when applying for QMB through the state Medicaid program. Beneficiaries are allowed to complete the conditional application even if they owe Medicare premiums. In Part A Buy-in states like NYS, SSA should process conditional applications on a rolling basis (without regard to enrollment periods), even if the application coincides with the General Enrollment Period.

(The General Enrollment Period is from Jan 1 to March 31st every year, in which anyone eligible may enroll in Medicare Part A or Part B to be effective on July 1st). 7. What happens after the MSP approval - How is Part B premium paid For all three MSP programs, the Medicaid program is now responsible for paying the Part B premiums, even though the MSP enrollee is not necessarily a recipient of Medicaid. The local Medicaid office (DSS/HRA) transmits the MSP approval to the NYS Department of Health – that information gets shared w/ SSA and CMS SSA stops deducting the Part B premiums out of the beneficiary’s Social Security check.

SSA also refunds any amounts owed to the recipient. (Note. This process can take awhile!. !.

!. ) CMS “deems” the MSP recipient eligible for Part D Extra Help/ Low Income Subsidy (LIS). ​Can the MSP be retroactive like Medicaid, back to 3 months before the application?. ​The answer is different for the 3 MSP programs.

QMB -No Retroactive Eligibility – Benefits begin the month after the month of the MSP application. 18 NYCRR § 360-7.8(b)(5) SLIMB - YES - Retroactive Eligibility up to 3 months before the application, if was eligible This means applicant may be reimbursed for the 3 months of Part B benefits prior to the month of application. QI-1 - YES up to 3 months but only in the same calendar year. No retroactive eligibility to the previous year.

7. QMBs -Special Rules on Cost-Sharing. QMB is the only MSP program which pays not only the Part B premium, but also the Medicare co-insurance.

Some consumers may be eligible for the Medicare Insurance Premium Payment (MIPP) Program, Kamagra oral jelly price instead of low cost lasix MSP. See this article for more info. TOPICS COVERED IN THIS ARTICLE 1. No Asset low cost lasix Limit 1A.

Summary Chart of MSP Programs 2. Income Limits &. Rules low cost lasix and Household Size 3. The Three MSP Programs - What are they and how are they Different?.

4. FOUR Special low cost lasix Benefits of MSP Programs. Back Door to Extra Help with Part D MSPs Automatically Waive Late Enrollment Penalties for Part B - and allow enrollment in Part B year-round outside of the short Annual Enrollment Period No Medicaid Lien on Estate to Recover Payment of Expenses Paid by MSP Food Stamps/SNAP not reduced by Decreased Medical Expenses when Enroll in MSP - at least temporarily 5. Enrolling in an MSP - Automatic Enrollment &.

Applications for low cost lasix People who Have Medicare What is Application Process?. 6. Enrolling in an MSP for People age 65+ who Do Not Qualify for Free Medicare Part A - the "Part A Buy-In Program" 7. What Happens After MSP Approved - How low cost lasix Part B Premium is Paid 8 Special Rules for QMBs - How Medicare Cost-Sharing Works 1.

NO ASSET LIMIT!. Since April 1, 2008, none of the three MSP programs have resource limits in New York -- which means many Medicare beneficiaries who might not qualify for Medicaid because of excess resources can qualify for an MSP. 1.A low cost lasix. SUMMARY CHART OF MSP BENEFITS QMB SLIMB QI-1 Eligibility ASSET LIMIT NO LIMIT IN NEW YORK STATE INCOME LIMIT (2021) Single Couple Single Couple Single Couple $1,094 $1,472 $1,308 $1,762 $1,469 $1,980 Federal Poverty Level 100% FPL 100 – 120% FPL 120 – 135% FPL Benefits Pays Monthly Part B premium?.

YES, and also Part A premium if did not have enough work quarters and meets citizenship requirement. See “Part A Buy-In” YES YES Pays Part low cost lasix A &. B deductibles &. Co-insurance YES - with limitations NO NO Retroactive to Filing of Application?.

Yes - Benefits begin the month after the month low cost lasix of the MSP application. 18 NYCRR §360-7.8(b)(5) Yes – Retroactive to 3rd month before month of application, if eligible in prior months Yes – may be retroactive to 3rd month before month of applica-tion, but only within the current calendar year. (No retro for January application). See GIS 07 MA 027 low cost lasix.

Can Enroll in MSP and Medicaid at Same Time?. YES YES NO!. Must choose between QI-1 low cost lasix and Medicaid. Cannot have both, not even Medicaid with a spend-down.

2. INCOME LIMITS low cost lasix and RULES Each of the three MSP programs has different income eligibility requirements and provides different benefits. The income limits are tied to the Federal Poverty Level (FPL). 2021 FPL levels were released by NYS DOH in GIS 21 MA/06 - 2021 Federal Poverty Levels Attachment II NOTE.

There is usually a lag in time of several weeks, or even months, from January 1st of each year until the new FPLs are low cost lasix release, and then before the new MSP income limits are officially implemented. During this lag period, local Medicaid offices should continue to use the previous year's FPLs AND count the person's Social Security benefit amount from the previous year - do NOT factor in the Social Security COLA (cost of living adjustment). Once the updated guidelines are released, districts will use the new FPLs and go ahead and factor in any COLA. See 2021 Fact Sheet on MSP in NYS by Medicare Rights Center ENGLISH SPANISH Income is determined by the same methodology as is used for determining in eligibility for SSI The rules for counting income for SSI-related (Aged 65+, Blind, or Disabled) Medicaid recipients, borrowed from low cost lasix the SSI program, apply to the MSP program, except for the new rules about counting household size for married couples.

367-a(3)(c)(2), NYS DOH 2000-ADM-7, 89-ADM-7 p.7. Gross income is counted, although there are certain types of income that are disregarded. The most common income disregards, also known as deductions, include. (a) The first $20 of your &.

Your spouse's monthly income, earned or unearned ($20 per couple max). (b) SSI EARNED INCOME DISREGARDS. * The first $65 of monthly wages of you and your spouse, * One-half of the remaining monthly wages (after the $65 is deducted). * Other work incentives including PASS plans, impairment related work expenses (IRWEs), blind work expenses, etc.

For information on these deductions, see The Medicaid Buy-In for Working People with Disabilities (MBI-WPD) and other guides in this article -- though written for the MBI-WPD, the work incentives apply to all Medicaid programs, including MSP, for people age 65+, disabled or blind. (c) monthly cost of any health insurance premiums but NOT the Part B premium, since Medicaid will now pay this premium (may deduct Medigap supplemental policies, vision, dental, or long term care insurance premiums, and the Part D premium but only to the extent the premium exceeds the Extra Help benchmark amount) (d) Food stamps not counted. You can get a more comprehensive listing of the SSI-related income disregards on the Medicaid income disregards chart. As for all benefit programs based on financial need, it is usually advantageous to be considered a larger household, because the income limit is higher.

The above chart shows that Households of TWO have a higher income limit than households of ONE. The MSP programs use the same rules as Medicaid does for the Disabled, Aged and Blind (DAB) which are borrowed from the SSI program for Medicaid recipients in the “SSI-related category.” Under these rules, a household can be only ONE or TWO. 18 NYCRR 360-4.2. See DAB Household Size Chart.

Married persons can sometimes be ONE or TWO depending on arcane rules, which can force a Medicare beneficiary to be limited to the income limit for ONE person even though his spouse who is under 65 and not disabled has no income, and is supported by the client applying for an MSP. EXAMPLE. Bob's Social Security is $1300/month. He is age 67 and has Medicare.

His wife, Nancy, is age 62 and is not disabled and does not work. Under the old rule, Bob was not eligible for an MSP because his income was above the Income limit for One, even though it was well under the Couple limit. In 2010, NYS DOH modified its rules so that all married individuals will be considered a household size of TWO. DOH GIS 10 MA 10 Medicare Savings Program Household Size, June 4, 2010.

This rule for household size is an exception to the rule applying SSI budgeting rules to the MSP program. Under these rules, Bob is now eligible for an MSP. When is One Better than Two?. Of course, there may be couples where the non-applying spouse's income is too high, and disqualifies the applying spouse from an MSP.

In such cases, "spousal refusal" may be used SSL 366.3(a). (Link is to NYC HRA form, can be adapted for other counties). In NYC, if you have a Medicaid case with HRA, instead of submitting an MSP application, you only need to complete and submit MAP-751W (check off "Medicare Savings Program Evaluation") and fax to (917) 639-0837. (The MAP-751W is also posted in languages other than English in this link.

(Updated 4/14/2021.)) 3. The Three Medicare Savings Programs - what are they and how are they different?. 1. Qualified Medicare Beneficiary (QMB).

The QMB program provides the most comprehensive benefits. Available to those with incomes at or below 100% of the Federal Poverty Level (FPL), the QMB program covers virtually all Medicare cost-sharing obligations. Part B premiums, Part A premiums, if there are any, and any and all deductibles and co-insurance. QMB coverage is not retroactive.

The program’s benefits will begin the month after the month in which your client is found eligible. ** See special rules about cost-sharing for QMBs below - updated with new CMS directive issued January 2012 ** See NYC HRA QMB Recertification form ** Even if you do not have Part A automatically, because you did not have enough wages, you may be able to enroll in the Part A Buy-In Program, in which people eligible for QMB who do not otherwise have Medicare Part A may enroll, with Medicaid paying the Part A premium (Materials by the Medicare Rights Center). 2. Specifiedl Low-Income Medicare Beneficiary (SLMB).

For those with incomes between 100% and 120% FPL, the SLMB program will cover Part B premiums only. SLMB is retroactive, however, providing coverage for three months prior to the month of application, as long as your client was eligible during those months. 3. Qualified Individual (QI-1).

For those with incomes between 120% and 135% FPL, and not receiving Medicaid, the QI-1 program will cover Medicare Part B premiums only. QI-1 is also retroactive, providing coverage for three months prior to the month of application, as long as your client was eligible during those months. However, QI-1 retroactive coverage can only be provided within the current calendar year. (GIS 07 MA 027) So if you apply in January, you get no retroactive coverage.

Q-I-1 recipients would be eligible for Medicaid with a spend-down, but if they want the Part B premium paid, they must choose between enrolling in QI-1 or Medicaid. They cannot be in both. It is their choice. DOH MRG p.

19. In contrast, one may receive Medicaid and either QMB or SLIMB. 4. Four Special Benefits of MSPs (in addition to NO ASSET TEST).

Benefit 1. Back Door to Medicare Part D "Extra Help" or Low Income Subsidy -- All MSP recipients are automatically enrolled in Extra Help, the subsidy that makes Part D affordable. They have no Part D deductible or doughnut hole, the premium is subsidized, and they pay very low copayments. Once they are enrolled in Extra Help by virtue of enrollment in an MSP, they retain Extra Help for the entire calendar year, even if they lose MSP eligibility during that year.

The "Full" Extra Help subsidy has the same income limit as QI-1 - 135% FPL. However, many people may be eligible for QI-1 but not Extra Help because QI-1 and the other MSPs have no asset limit. People applying to the Social Security Administration for Extra Help might be rejected for this reason. Recent (2009-10) changes to federal law called "MIPPA" requires the Social Security Administration (SSA) to share eligibility data with NYSDOH on all persons who apply for Extra Help/ the Low Income Subsidy.

Data sent to NYSDOH from SSA will enable NYSDOH to open MSP cases on many clients. The effective date of the MSP application must be the same date as the Extra Help application. Signatures will not be required from clients. In cases where the SSA data is incomplete, NYSDOH will forward what is collected to the local district for completion of an MSP application.

The State implementing procedures are in DOH 2010 ADM-03. Also see CMS "Dear State Medicaid Director" letter dated Feb. 18, 2010 Benefit 2. MSPs Automatically Waive Late Enrollment Penalties for Part B Generally one must enroll in Part B within the strict enrollment periods after turning age 65 or after 24 months of Social Security Disability.

An exception is if you or your spouse are still working and insured under an employer sponsored group health plan, or if you have End Stage Renal Disease, and other factors, see this from Medicare Rights Center. If you fail to enroll within those short periods, you might have to pay higher Part B premiums for life as a Late Enrollment Penalty (LEP). Also, you may only enroll in Part B during the Annual Enrollment Period from January 1 - March 31st each year, with Part B not effective until the following July. Enrollment in an MSP automatically eliminates such penalties...

For life.. Even if one later ceases to be eligible for the MSP. AND enrolling in an MSP will automatically result in becoming enrolled in Part B if you didn't already have it and only had Part A. See Medicare Rights Center flyer.

Benefit 3. No Medicaid Lien on Estate to Recover MSP Benefits Paid Generally speaking, states may place liens on the Estates of deceased Medicaid recipients to recover the cost of Medicaid services that were provided after the recipient reached the age of 55. Since 2002, states have not been allowed to recover the cost of Medicare premiums paid under MSPs. In 2010, Congress expanded protection for MSP benefits.

Beginning on January 1, 2010, states may not place liens on the Estates of Medicaid recipients who died after January 1, 2010 to recover costs for co-insurance paid under the QMB MSP program for services rendered after January 1, 2010. The federal government made this change in order to eliminate barriers to enrollment in MSPs. See NYS DOH GIS 10-MA-008 - Medicare Savings Program Changes in Estate Recovery The GIS clarifies that a client who receives both QMB and full Medicaid is exempt from estate recovery for these Medicare cost-sharing expenses. Benefit 4.

SNAP (Food Stamp) benefits not reduced despite increased income from MSP - at least temporarily Many people receive both SNAP (Food Stamp) benefits and MSP. Income for purposes of SNAP/Food Stamps is reduced by a deduction for medical expenses, which includes payment of the Part B premium. Since approval for an MSP means that the client no longer pays for the Part B premium, his/her SNAP/Food Stamps income goes up, so their SNAP/Food Stamps go down. Here are some protections.

Do these individuals have to report to their SNAP worker that their out of pocket medical costs have decreased?. And will the household see a reduction in their SNAP benefits, since the decrease in medical expenses will increase their countable income?. The good news is that MSP households do NOT have to report the decrease in their medical expenses to the SNAP/Food Stamp office until their next SNAP/Food Stamp recertification. Even if they do report the change, or the local district finds out because the same worker is handling both the MSP and SNAP case, there should be no reduction in the household’s benefit until the next recertification.

New York’s SNAP policy per administrative directive 02 ADM-07 is to “freeze” the deduction for medical expenses between certification periods. Increases in medical expenses can be budgeted at the household’s request, but NYS never decreases a household’s medical expense deduction until the next recertification. Most elderly and disabled households have 24-month SNAP certification periods. Eventually, though, the decrease in medical expenses will need to be reported when the household recertifies for SNAP, and the household should expect to see a decrease in their monthly SNAP benefit.

It is really important to stress that the loss in SNAP benefits is NOT dollar for dollar. A $100 decrease in out of pocket medical expenses would translate roughly into a $30 drop in SNAP benefits. See more info on SNAP/Food Stamp benefits by the Empire Justice Center, and on the State OTDA website. Some clients will be automatically enrolled in an MSP by the New York State Department of Health (NYSDOH) shortly after attaining eligibility for Medicare.

Others need to apply. The 2010 "MIPPA" law introduced some improvements to increase MSP enrollment. See 3rd bullet below. Also, some people who had Medicaid through the Affordable Care Act before they became eligible for Medicare have special procedures to have their Part B premium paid before they enroll in an MSP.

See below. WHO IS AUTOMATICALLY ENROLLED IN AN MSP. Clients receiving even $1.00 of Supplemental Security Income should be automatically enrolled into a Medicare Savings Program (most often QMB) under New York State’s Medicare Savings Program Buy-in Agreement with the federal government once they become eligible for Medicare. They should receive Medicare Parts A and B.

Clients who are already eligible for Medicare when they apply for Medicaid should be automatically assessed for MSP eligibility when they apply for Medicaid. (NYS DOH 2000-ADM-7 and GIS 05 MA 033). Clients who apply to the Social Security Administration for Extra Help, but are rejected, should be contacted &. Enrolled into an MSP by the Medicaid program directly under new MIPPA procedures that require data sharing.

Strategy TIP. Since the Extra Help filing date will be assigned to the MSP application, it may help the client to apply online for Extra Help with the SSA, even knowing that this application will be rejected because of excess assets or other reason. SSA processes these requests quickly, and it will be routed to the State for MSP processing. Since MSP applications take a while, at least the filing date will be retroactive.

Note. The above strategy does not work as well for QMB, because the effective date of QMB is the month after the month of application. As a result, the retroactive effective date of Extra Help will be the month after the failed Extra Help application for those with QMB rather than SLMB/QI-1. Applying for MSP Directly with Local Medicaid Program.

Those who do not have Medicaid already must apply for an MSP through their local social services district. (See more in Section D. Below re those who already have Medicaid through the Affordable Care Act before they became eligible for Medicare. If you are applying for MSP only (not also Medicaid), you can use the simplified MSP application form (theDOH-4328(Rev.

8/2017-- English) (2017 Spanish version not yet available). Either application form can be mailed in -- there is no interview requirement anymore for MSP or Medicaid. See 10 ADM-04. Applicants will need to submit proof of income, a copy of their Medicare card (front &.

Back), and proof of residency/address. See the application form for other instructions. One who is only eligible for QI-1 because of higher income may ONLY apply for an MSP, not for Medicaid too. One may not receive Medicaid and QI-1 at the same time.

If someone only eligible for QI-1 wants Medicaid, s/he may enroll in and deposit excess income into a pooled Supplemental Needs Trust, to bring her countable income down to the Medicaid level, which also qualifies him or her for SLIMB or QMB instead of QI-1. Advocates in NYC can sign up for a half-day "Deputization Training" conducted by the Medicare Rights Center, at which you'll be trained and authorized to complete an MSP application and to submit it via the Medicare Rights Center, which submits it to HRA without the client having to apply in person. Enrolling in an MSP if you already have Medicaid, but just become eligible for Medicare Those who, prior to becoming enrolled in Medicare, had Medicaid through Affordable Care Act are eligible to have their Part B premiums paid by Medicaid (or the cost reimbursed) during the time it takes for them to transition to a Medicare Savings Program. In 2018, DOH clarified that reimbursement of the Part B premium will be made regardless of whether the individual is still in a Medicaid managed care (MMC) plan.

GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare ( PDF) provides, "Due to efforts to transition individuals who gain Medicare eligibility and who require LTSS, individuals may not be disenrolled from MMC upon receipt of Medicare. To facilitate the transition and not disadvantage the recipient, the Medicaid program is approving reimbursement of Part B premiums for enrollees in MMC." The procedure for getting the Part B premium paid is different for those whose Medicaid was administered by the NYS of Health Exchange (Marketplace), as opposed to their local social services district. The procedure is also different for those who obtain Medicare because they turn 65, as opposed to obtaining Medicare based on disability. Either way, Medicaid recipients who transition onto Medicare should be automatically evaluated for MSP eligibility at their next Medicaid recertification.

NYS DOH 2000-ADM-7 Individuals can also affirmatively ask to be enrolled in MSP in between recertification periods. IF CLIENT HAD MEDICAID ON THE MARKETPLACE (NYS of Health Exchange) before obtaining Medicare. IF they obtain Medicare because they turn age 65, they will receive a letter from their local district asking them to "renew" Medicaid through their local district. See 2014 LCM-02.

Now, their Medicaid income limit will be lower than the MAGI limits ($842/ mo reduced from $1387/month) and they now will have an asset test. For this reason, some individuals may lose full Medicaid eligibility when they begin receiving Medicare. People over age 65 who obtain Medicare do NOT keep "Marketplace Medicaid" for 12 months (continuous eligibility) See GIS 15 MA/022 - Continuous Coverage for MAGI Individuals. Since MSP has NO ASSET limit.

Some individuals may be enrolled in the MSP even if they lose Medicaid, or if they now have a Medicaid spend-down. If a Medicare/Medicaid recipient reports income that exceeds the Medicaid level, districts must evaluate the person’s eligibility for MSP. 08 OHIP/ADM-4 ​If you became eligible for Medicare based on disability and you are UNDER AGE 65, you are entitled to keep MAGI Medicaid for 12 months from the month it was last authorized, even if you now have income normally above the MAGI limit, and even though you now have Medicare. This is called Continuous Eligibility.

EXAMPLE. Sam, age 60, was last authorized for Medicaid on the Marketplace in June 2016. He became enrolled in Medicare based on disability in August 2016, and started receiving Social Security in the same month (he won a hearing approving Social Security disability benefits retroactively, after first being denied disability). Even though his Social Security is too high, he can keep Medicaid for 12 months beginning June 2016.

Sam has to pay for his Part B premium - it is deducted from his Social Security check. He may call the Marketplace and request a refund. This will continue until the end of his 12 months of continues MAGI Medicaid eligibility. He will be reimbursed regardless of whether he is in a Medicaid managed care plan.

See GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare (PDF) When that ends, he will renew Medicaid and apply for MSP with his local district. Individuals who are eligible for Medicaid with a spenddown can opt whether or not to receive MSP. (Medicaid Reference Guide (MRG) p. 19).

Obtaining MSP may increase their spenddown. MIPPA - Outreach by Social Security Administration -- Under MIPPA, the SSA sends a form letter to people who may be eligible for a Medicare Savings Program or Extra Help (Low Income Subsidy - LIS) that they may apply. The letters are. · Beneficiary has Extra Help (LIS), but not MSP · Beneficiary has no Extra Help (LIS) or MSP 6.

Enrolling in MSP for People Age 65+ who do Not have Free Medicare Part A - the "Part A Buy-In Program" Seniors WITHOUT MEDICARE PART A or B -- They may be able to enroll in the Part A Buy-In program, in which people eligible for QMB who are age 65+ who do not otherwise have Medicare Part A may enroll in Part A, with Medicaid paying the Part A premium. See Step-by-Step Guide by the Medicare Rights Center). This guide explains the various steps in "conditionally enrolling" in Part A at the SSA office, which must be done before applying for QMB at the Medicaid office, which will then pay the Part A premium. See also GIS 04 MA/013.

In June, 2018, the SSA revised the POMS manual procedures for the Part A Buy-In to to address inconsistencies and confusion in SSA field offices and help smooth the path for QMB enrollment. The procedures are in the POMS Section HI 00801.140 "Premium-Free Part A Enrollments for Qualified Medicare BenefiIaries." It includes important clarifications, such as. SSA Field Offices should explain the QMB program and conditional enrollment process if an individual lacks premium-free Part A and appears to meet QMB requirements. SSA field offices can add notes to the “Remarks” section of the application and provide a screen shot to the individual so the individual can provide proof of conditional Part A enrollment when applying for QMB through the state Medicaid program.

Beneficiaries are allowed to complete the conditional application even if they owe Medicare premiums. In Part A Buy-in states like NYS, SSA should process conditional applications on a rolling basis (without regard to enrollment periods), even if the application coincides with the General Enrollment Period. (The General Enrollment Period is from Jan 1 to March 31st every year, in which anyone eligible may enroll in Medicare Part A or Part B to be effective on July 1st). 7.

What happens after the MSP approval - How is Part B premium paid For all three MSP programs, the Medicaid program is now responsible for paying the Part B premiums, even though the MSP enrollee is not necessarily a recipient of Medicaid. The local Medicaid office (DSS/HRA) transmits the MSP approval to the NYS Department of Health – that information gets shared w/ SSA and CMS SSA stops deducting the Part B premiums out of the beneficiary’s Social Security check. SSA also refunds any amounts owed to the recipient. (Note.

This process can take awhile!. !. !. ) CMS “deems” the MSP recipient eligible for Part D Extra Help/ Low Income Subsidy (LIS).

​Can the MSP be retroactive like Medicaid, back to 3 months before the application?. ​The answer is different for the 3 MSP programs. QMB -No Retroactive Eligibility – Benefits begin the month after the month of the MSP application.

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Notes1 https://www.sgrsports.com/buy-lasix-pill/ lasix 20mg uses. R. C Keller lasix 20mg uses (2006). "Geographies of power, legacies of mistrust. Colonial medicine in the global present." Historical Geography no.

34:26-48.2. Bridget Pratt et al. (2018). "Exploring the ethics of global health research priority-setting." BMC Medical Ethics no. 19 (94).

Doi. 10.1186/s12910-018-0333-y3. Richard Horton (2013). "Offline. Is global health neocolonialist?.

" The Lancet no. 382 (9906):1690. Doi. 10.1016/S0140-6736(13)62379-X4. Anonymous (2019).

"Editorial. Break with tradition. The World Health Organization’s decision about traditional Chinese medicine could backfire." Nature no. 570:5.5. S.

S Amrith (2006). Decolonizing international health. India and Southeast Asia, 1930–65. London. Palgrave Macmillan.6.

Arturo Escobar and A Escobar (1984). "Discourse and power in development. Michel Foucault and the relevance of his work to the third world." Alternatives no. 10 (3):377-400. Doi.

10.1177/0304375484010003047. UNDG (2013). A million voices. The world we want. A sustainable future with dignity for all.

New York, NY. United Nations Development Group.8. WHO (2019). Speech by the Director-General. Transforming for impact 2019 (cited 10 March 2019).

Available from. Https://www.who.int/dg/speeches/detail/transforming-for-impact.9. R. C Keller (2006). Geographies of power, legacies of mistrust.

Colonial medicine in the global present.10. Mishal S Khan et al. (2019). Durrance-Bagale, H. Legido-Quigley "‘LMICs as reservoirs of AMR’.

A comparative analysis of policy discourse on antimicrobial resistance with reference to Pakistan." Health Policy and Planning no. 34 (3):178–187. Doi. 10.1093/heapol/czz02211. Clare I R Chandler (2019).

"Current accounts of antimicrobial resistance. Stabilisation, individualisation and antibiotics as infrastructure." Palgrave Communications no. 5 (1):53. Doi. 10.1057/s41599-019-0263-412.

In the area of antimicrobial use for human health, other problem areas include, for example, public hygiene and disease prevention, regulated access to medicines, disease diagnosis, or market conditions for the development of new antimicrobials. The Review on Antimicrobial Resistance (2016). Tackling drug-resistant s globally. Final report and recommendations. London.

The UK Prime Minister, WHO (2015b). Global action plan on antimicrobial resistance. Geneva. World Health Organization, Conan MacDougall and Ron E Polk (2005). "Antimicrobial stewardship programs in health care systems." Clinical Microbiology Reviews no.

18 (4):638-656. Doi. 10.1128/CMR.18.4.638-656.2005.13. The Review on Antimicrobial Resistance. Tackling drug-resistant s globally.

Final report and recommendations.14. WHO, Global action plan on antimicrobial resistance.15. Maria R Gualano et al. (2015). "General population's knowledge and attitudes about antibiotics.

A systematic review and meta-analysis." Pharmacoepidemiology and Drug Safety no. 24 (1):2-10. Doi. 10.1002/pds.371616. H Haak and A.

Radyowijati (2010). "Determinants of antimicrobial use. Poorly understood, poorly researched." In Antimicrobial resistance in developing countries, edited by Sosa, Byarugaba, Amábile-Cuevas, Hsueh, Kariuki and Okeke, 283-300. New York, NY. Springer.17.

These problems persist despite encouraging trends. For example, the field is becoming increasingly multidisciplinary through the involvement of several United Nations agencies alongside WHO in governing AMR, and AMR policy narratives are slowly broadening the hitherto hyper-individualised and behaviour change focus of global action plans. Connor Rochford et al. (2018). "Global governance of antimicrobial resistance." The Lancet no.

391 (10134):1976-1978. Doi. 10.1016/S0140-6736(18)31117-6, WHO, FAO, and OIE (2018). Monitoring global progress on addressing antimicrobial resistance. Analysis report of the second round of results of AMR country self-assessment survey 2018.

Geneva. World Health Organization, Food and Agriculture Organization of the United Nations and World Organisation for Animal Health (OIE), WHO (2017). Antimicrobial Resistance Behaviour Change first informal technical consultation, 6-7 November, 2017 Château de Penthes, Geneva. Meeting Report. Geneva.

World Health Organization, Elise Klein and China Mills (2017). "Psy-expertise, therapeutic culture and the politics of the personal in development." Third World Quarterly no. 38 (9):1990-2008. Doi. 10.1080/01436597.2017.131927718.

Emma R M Cohen et al. (2008). "Public engagement on global health challenges." BMC Public Health no. 8 (168). Doi.

10.1186/1471-2458-8-16819. B Hamlyn et al. (2015).Factors affecting public engagement by researchers. A study on behalf of a consortium of UK public research funders. London.

TNS20. Research Councils UK (2011) Concordat for engaging the public with research. Research Councils UK. Swindon.21. C Wilson, P.

Manners, and S. Duncan (2014). Building an engaged future for UK higher education. Full report from the Engaged Futures consultation. Bristol.

National Co-ordinating Centre for Public Engagement.22. Also referred to as ‘community engagement’, ‘patient and public involvement’ (PPI) in research, or in some instances also as participatory research. S. Staniszewska et al. (2017).

"GRIPP2 reporting checklists. Tools to improve reporting of patient and public involvement in research." Research Involvement and Engagement no. 3 (13). Doi. 10.1186/s40900-017-0062-2, Jo Brett et al.

(2014). "Mapping the impact of patient and public involvement on health and social care research. A systematic review." Health Expectations no. 17 (5):637-650. Doi.

10.1111/j.1369-7625.2012.00795.x, Paulina O Tindana et al. (2007). "Grand challenges in global health. Community engagement in research in developing countries." PLOS Medicine no. 4 (e273).

Doi. 10.1371/journal.pmed.0040273, F Darroch and A. Giles (2014). "Decolonizing health research. Community-based participatory research and postcolonial feminist theory." Canadian Journal of Action Research no.

15 (3):22-36.23. J Redfern et al. (2018). "Spreading the message of antimicrobial resistance. A detailed account of a successful public engagement event." FEMS Microbiology Letters no.

365 (16). Doi. 10.1093/femsle/fny17524. Victoria Jane Hume et al. (2018).

"Biomedicine and the humanities. Growing pains." Medical Humanities no. 44 (4):230-238. Doi. 10.1136/medhum-2018-01148125.

Astrid Treffry-Goatley et al. (2018). Ibid. "Community engagement with HIV drug adherence in rural South Africa. A transdisciplinary approach." 239-246.

Doi. 10.1136/medhum-2018-01147426. L Jordanova (2014). "Medicine and the visual arts." In Medicine, health and the arts. Approaches to medical humanities, edited by Bates, Bleakley and Goodman, 41-63.

Abingdon. Routledge.27. Angela Ross Perfetti (2018). "Fate and the clinic. A multidisciplinary consideration of fatalism in health behaviour." Medical Humanities no.

44 (1):59-62. Doi. 10.1136/medhum-2017-01131928. Devan Stahl et al. (2016).

"Seeing illness in art and medicine. A patient and printmaker collaboration." Ibid. No. 42 (3):155-159. Doi.

10.1136/medhum-2015-01083829. Jonatan Wistrand and J Wistrand (2017). "When doctors are patients. A narrative study of help-seeking behaviour among addicted physicians." Ibid. No.

43 (1):19-23. Doi. 10.1136/medhum-2016-01100230. T. R Cole, N.

S. Carlin, and R. A. Carson (2015). Medical humanities.

An introduction. New York, NY. Cambridge University Press.31. Daniel Holman and Erica Borgstrom (2016). "Applying social theory to understand health-related behaviours." Medical Humanities no.

42 (2):143-145. Doi. 10.1136/medhum-2015-01068832. Hume, et al., Biomedicine and the humanities. Growing pains.33.

A Carusi (2016). "Modelling systems biomedicine. Intertwinement and the 'real'." In The Edinburgh companion to the critical medical humanities, edited by Whitehead, Woods, Atkinson, Macnaughton and Richards, 50-65. Edinburgh. Edinburgh University Press.34.

Jordanova, Medicine and the visual arts.35. Stahl and Stahl, Seeing illness in art and medicine. A patient and printmaker collaboration.36. William Viney et al. (2015).

"Critical medical humanities. Embracing entanglement, taking risks." Ibid. No. 41 (1):2-7. Doi.

10.1136/medhum-2015-01069237. J Cole and S. Gallagher (2016). "Narrative and clinical neuroscience. Can phenomenologically informed approaches and empirical work cross-fertilise?.

" In The Edinburgh companion to the critical medical humanities, edited by Whitehead, Woods, Atkinson, Macnaughton and Richards, 377-394. Edinburgh. Edinburgh University Press.38. J Macnaughton and H. Carel (2016).

Ibid."Breathing and breathlessness in clinic and culture. Using critical medical humanities to bridge an epistemic gap." In, 294-309.39. P J Pelto and G H Pelto (1997). 1997. "Studying knowledge, culture, and behavior in applied medical anthropology." Medical Anthropology Quarterly no.

11 (2):147-163.40. Lindsay Prior (2003) "Belief, knowledge and expertise. The emergence of the lay expert in medical sociology." Sociology of Health &. Illness no. 25 (3):41-57.

Doi. 10.1111/1467-9566.0033941. E Oliveira and J. Vearey (2018). "Making research and building knowledge with communities.

Examining three participatory visual and narrative projects with migrants who sell sex in South Africa." In Creating social change through creativity. Anti-oppressive arts-based research methodologies, edited by Capous-Desyllas and Morgaine, 265-287. Cham. Springer.42. Komatra Chuengsatiansup and Wirun Limsawart (2019).

"Tuberculosis in the borderlands. Migrants, microbes and more-than-human borders." Palgrave Communications no. 5 (1):31. Doi. 10.1057/s41599-019-0239-443.

R Garden (2014). "Social studies. The humanities, narrative, and the social context of the patient-professional relationship." In Health humanities reader, edited by Jones, Wear, Friedman and Pachucki, 127-137. New Brunswick, NJ. Rutgers University Press.44.

Holman and Borgstrom, Applying social theory to understand health-related behaviours.45. Claas Kirchhelle (2018). "Pharming animals. A global history of antibiotics in food production (1935–2017)." Palgrave Communications no. 4 (96).

Doi. 10.1057/s41599-018-0152-246. Hannah Landecker (2019). "Antimicrobials before antibiotics. War, peace, and disinfectants." Ibid.

No. 5 (1):45. Doi. 10.1057/s41599-019-0251-847. Sue Walker (2019).

Ibid."Effective antimicrobial resistance communication. The role of information design." 24. Doi. 10.1057/s41599-019-0231-z48. Pelto and Pelto, Studying knowledge, culture, and behavior in applied medical anthropology.49.

May Sudhinaraset et al. (2013). "What is the role of informal healthcare providers in developing countries?. A systematic review." PLoS ONE no. 8 (2):e54978.

Doi. 10.1371/journal.pone.005497850. Viroj Tangcharoensathien, Sunicha Chanvatik, and Angkana Sommanustweechai (2018). "Complex determinants of inappropriate use of antibiotics." Bulletin of the World Health Organization no. 96 (2):141-144.

Doi. 10.2471/BLT.17.19968751. WHO (2015a). Antibiotic resistance. Multi-country public awareness survey.

Geneva. World Health Organization.52. WHO, Antibiotic resistance. Multi-country public awareness survey, 42.53. Gualano, et al.

General population's knowledge and attitudes about antibiotics. A systematic review and meta-analysis.54. Edward A Belongia et al. (2002). "Antibiotic use and upper respiratory s.

A survey of knowledge, attitudes, and experience in Wisconsin and Minnesota." Preventive Medicine no. 34 (3):346-352. Doi. 10.1006/pmed.2001.099255. Miao Yu et al.

(2014). "Knowledge, attitudes, and practices of parents in rural China on the use of antibiotics in children. A cross-sectional study." BMC Infectious Diseases no. 14 (112). Doi.

10.1186/1471-2334-14-11256. Abdelmoneim Ismail Awad and Esraa Abdulwahid Aboud (2015). "Knowledge, attitude and practice towards antibiotic use among the public in Kuwait." PLoS ONE no. 10 (2):e0117910. Doi.

10.1371/journal.pone.011791057. Chandler, Current accounts of antimicrobial resistance. Stabilisation, individualisation and antibiotics as infrastructure.58. Jie Chang et al. (2018).

"Non-prescription use of antibiotics among children in urban China. A cross-sectional survey of knowledge, attitudes, and practices." Expert Review of Anti-infective Therapy no. 16 (2):163-172. Doi. 10.1080/14787210.2018.142561659.

Gualano, et al. General population's knowledge and attitudes about antibiotics. A systematic review and meta-analysis.60. A R McCullough et al. (2016).

"A systematic review of the public's knowledge and beliefs about antibiotic resistance." Journal of Antimicrobial Chemotherapy no. 71 (1):27-33. Doi. 10.1093/jac/dkv31061. Abel Santiago Muri-Gama, Albert Figueras, and Silvia Regina Secoli (2018).

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A transdisciplinary approach.96. R. J Hester (2016). "Culture in medicine. An argument against competence." In The Edinburgh companion to the critical medical humanities, edited by Whitehead, Woods, Atkinson, Macnaughton and Richards, 541-558.

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Illness and image. Case studies in the medical humanities. New York, NY. Taylor &. Francis.107.

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10.1136/medhum-2018-011517111. Suze M P J Jans et al. (2012). "A case study of haemoglobinopathy screening in the Netherlands. Witnessing the past, lessons for the future." Ethnicity &.

Health no. 17 (3):217-239. Doi. 10.1080/13557858.2011.604126112. Hume, et al., Biomedicine and the humanities.

Growing pains.113. Cole and Gallagher, Narrative and clinical neuroscience. Can phenomenologically informed approaches and empirical work cross-fertilise?. 114. Macnaughton and Carel, Breathing and breathlessness in clinic and culture.

Using critical medical humanities to bridge an epistemic gap.115. Pelto and Pelto, Studying knowledge, culture, and behavior in applied medical anthropology.116. Prior, Belief, knowledge and expertise. The emergence of the lay expert in medical sociology.117. Gilman, Illness and image.

Case studies in the medical humanities.118. Cole and Gallagher, Narrative and clinical neuroscience. Can phenomenologically informed approaches and empirical work cross-fertilise?. 119. Macnaughton and Carel, Breathing and breathlessness in clinic and culture.

Using critical medical humanities to bridge an epistemic gap.120. C Teddlie and A. Tashakkori (2009). Foundations of mixed methods research. Integrating quantitative and qualitative approaches in the social and behavioral sciences.

Thousand Oaks, CA. Sage.121. Macnaughton and Carel, Breathing and breathlessness in clinic and culture. Using critical medical humanities to bridge an epistemic gap.122. Gian Luca Barbieri et al.

(2016). "Imagination in narrative medicine." Journal of Child Health Care no. 20 (4):419-427. Doi. 10.1177/1367493515625134123.

Treffry-Goatley, et al. Community engagement with HIV drug adherence in rural South Africa. A transdisciplinary approach.124. WHO (2016). World Antibiotic Awareness Week.

2016 campaign toolkit. Geneva. World Health Organization.125. Across the three villages, 67% of the workshop attendees were female and the average age of the attendees was 44 years (range. 18 to 81 years.

Based on subsequently collected survey data).126. Nutcha Charoenboon et al. (2019)127. We thank an anonymous reviewer for highlighting the potential hazards of reproducing hierarchies through methods intended to challenge them in the first place.128. The research was reviewed and approved by the University of Oxford Tropical Research Ethics Committee (Ref.

OxTREC 528-17), and it received local ethical approval in Thailand from the Mae Fah Luang University Research Ethics Committee on Human Research (Ref. REH 60099). The service evaluation of the photo exhibition involved anonymised data collection and received a waiver for ethical approval from the University of Warwick Humanities &. Social Sciences Research Ethics Committee (HSSREC). However, all evaluation form respondents explicitly consented to the data being reported in research publications.129.

Marco J Haenssgen et al. (2018)130. National Statistical Office (2012). The 2010 population and housing census. Changwat Chiang Rai.

Bangkok. National Statistical Office.131. Data on the individual level would entail duplication of observations should both census survey rounds be included. Step-level data were aggregated on the illness level for analysis.132. Claire Charlotte McKechnie (2014).

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Carusi, Modelling systems biomedicine. Intertwinement and the 'real'.134. Garden, Social studies. The humanities, narrative, and the social context of the patient-professional relationship.135. Emma Sacks et al.

(2018). "Beyond the building blocks. Integrating community roles into health systems frameworks to achieve health for all." BMJ Global Health no. 3 (Suppl. 3):e001384.

Doi. 10.1136/bmjgh-2018-001384136. Sudhinaraset, et al. What is the role of informal healthcare providers in developing countries?. A systematic review.137.

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Jordanova, Medicine and the visual arts.140. Macnaughton and Carel, Breathing and breathlessness in clinic and culture. Using critical medical humanities to bridge an epistemic gap.141. A Bleakley (2014). Ibid.

"Towards a 'critical medical humanities'." In, 17-26.142. Hume, et al., Biomedicine and the humanities. Growing pains.143. Nutcha Charoenboon et al. (2019)144.

Marco Haenssgen et al. (2018)145. WHO, World Antibiotic Awareness Week. 2016 campaign toolkit.146. The questionnaire did so by showing all survey respondents three images of common antibiotic capsules being used in Chiang Rai (green-blue.

Amoxicillin. Red-black. Cloxacillin. White-blue. Azithromycin—see questionnaire page 10 in the online supplementary material).

Respondents were asked to name what they saw, and all their answers were recorded (field-coded and as free text).147. The ‘desirability’ of the responses was field coded by the survey team. Sample responses (as instructed through the survey manual) for ‘desirable’ answers included, for example, “Only if the doctor says that I should”. Sample responses for ‘undesirable’ answers included “Yes, you can buy it in the shop over there!. € The variable should be interpreted as ‘the fraction of respondents who uttered a ‘desirable’ response’—the inverse is the fraction of responses that could not be deemed ‘desirable’ (eg, ‘do not know’ or ‘no opinion’).148.

Because recalled descriptions of medicine tend to be ambiguous, we limited our analysis to medicines where we had a high degree of certainty that they were an antibiotic. This was specifically the case if survey respondents mentioned common antibiotic descriptions such as ‘anti-inflammatory’, ‘amoxi’ or ‘colem’, if they indicated explicitly that they know what ‘anti-inflammatory medicine’ is (noting that the term describes antibiotics unambiguously in Thai), and if they subsequently mentioned any of the previously mentioned antibiotics during their description of an illness episode (conversely, we excluded cases were the medicine could not be confirmed as either antibiotic or non-antibiotic, including descriptions like ‘white powder’ or ‘green capsule’).149. Aristotle (1954). Rhetoric. Translated by Roberts.

New York, NY. Modern Library. Original edition, 350 BC.150. Arya Nielsen et al. (2007).

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Nithima Sumpradit et al. (2012). "Antibiotics Smart Use. A workable model for promoting the rational use of medicines in Thailand." Bulletin of the World Health Organization no. 90 (12):905-913.

Doi. 10.2471/BLT.12.105445152. C Muksong and K. Chuengsatiansup (2020). Forthcoming.

"Medicine and public health in Thai historiography. From an elitist view to counter-hegemonic discourse." In Health, pluralism and globalisation. A modern history of medicine in South-East Asia, edited by Monnais and Cook. London. The Wellcome Trust Centre for the History.153.

L Sringernyuang (2000). Availability and use of medicines in rural Thailand. Amsterdam. Amsterdam Institute for Social Science Research.154. Although this was not the focus of the current paper, we note for full disclosure that the workshops, too, had mixed behavioural impacts.

The poster making sessions in Chiang Rai demonstrated for instance how our conversations about drug resistance and the introduction of messages from the World Health Organization entailed at times problematic interpretations like, “You shouldn’t take medicines that you have never seen before”—the research team responded to such interpretations directly in order to avoid misunderstandings. In addition, previous behavioural analyses documented that, while workshop participants demonstrated higher levels of awareness of drug resistance, alignment of antibiotic use with global health recommendations was mixed, and in one case, a villager started selling antibiotics after the workshop. For more details on the behavioural analysis, see Nutcha Charoenboon et al. (2019) and Marco Haenssgen et al. (2018).155.

For example, Redfern, et al., Spreading the message of antimicrobial resistance. A detailed account of a successful public engagement event.156. Antoine Boivin et al. (2018). 2018.

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GRIPP2 reporting checklists. Tools to improve reporting of patient and public involvement in research.158. Jerke, et al. Smoking cessation in mental health communities. A living newspaper applied theatre project.159.

Switzer, What’s in an image?. Towards a critical and interdisciplinary reading of participatory visual methods.160. R. C Barfield and L. Selman (2014).

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Reframing community engagement in LMICs (epub ahead of print), 1.162. Marco J Haenssgen et al. (2019)163. Marc Mendelson et al. (2017).

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Poorly understood, poorly researched.165. S Harbarth and D. L. Monnet (2008). "Cultural and socioeconomic determinants of antibiotic use." In Antibiotic Policies.

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10.1177/1468794112446104IntroductionIn Australia, the USA and the UK, the number of hospital beds required for forensic mental health treatment doubled between 1996 and 2016.1 Current trends and future predictions suggest this demand will continue to grow. But, in an age where evidence-based practice is highly valued, the demand for new facilities already outpaces the availability of credible evidence to guide designers. This article reports findings from a desktop survey of current design practice across 31 psychiatric hospitals (24 forensic, 7 non-forensic) constructed or scheduled for completion between 2006 and 2022. Desktop surveys, as a form of research, are heavily relied on in architectural practice. Photographs and architectural drawings are analysed to understand both typical and innovative approaches to designing a particular building type.

While desktop surveys are sometimes supplemented by visits to exemplar projects (which might also be termed ‘fieldwork’), time pressures and budgetary constraints often preclude this. As the result of an academic–industry partnership, the research reported herein embraced practice-based research methods in conjunction with an academic approach. The data set available for the desktop survey was rich but incomplete. Security requirements restrict the public availability of complete floor plans and postoccupancy evaluations. To mitigate these limitations, knowledge was integrated from other disciplines, including environmental psychology, architectural history and professional practice.

With regard to the latter, knowledge is specifically around the design and consultation processes that guide the construction of these facilities. This knowledge was used to identify three contemporary hospitals that challenge accepted design practice and, we argue, in doing so have the potential to act as change-agents in the delivery of forensic mental healthcare. We define innovation as variation/s to common, or typical, architectural solutions that can positively improve patients’2 experience of these facilities in ways that directly support one, or a number, of key values underpinning forensic mental healthcare. While this article does not provide postoccupancy data to quantify the value of these innovations, we hope to encourage both designers and researchers to more closely consider these projects—particularly the way that spaces have been designed to benefit patient well-being—and the questions these designs raise for the future of forensic mental healthcare delivery.Now regarded as naïve is the 19th-century belief that architecture and landscape, if appropriately designed, can restore sanity.3 Yet contemporary research from the field of evidence-based design confirms that the built environment does play a role in the therapeutic process, even if that role does not determine therapeutic outcomes.4 Research regarding the design of forensic mental healthcare facilities remains limited. An article by Ulrich et al recommended that to reduce aggression patients should be accommodated in single rooms.

Communal areas should have movable furniture. Wards should be designed for low social densities. And accessible gardens should be provided.5 An earlier study by Tyson et al showed that lower ward densities can also positively improve patient–staff interactions.6 Commonly, however, the studies referenced above compared older-style mental health units with their contemporary replacements.7 There is little comparative research available that examines contemporary facilities for forensic mental healthcare, with the exception of one article that provided a comparative analysis of nine Swedish facilities, designed between 1990 and 2008.8 However, this article merely described the design aspirations and physical composition of each hospital without investigating the link between design aspiration, patient well-being and the resulting physical environment.There are two further limitations to evidence-based design research. The first is the extent to which data do not provide directly applicable design tactics. Systematic literature reviews typically provide a set of design recommendations but without suggesting to designers what the corresponding physical design tactics to achieve those recommendations might actually be.9 This is consistent for general hospital design.

For example, architects have been advised to provide spaces that are ‘psychosocially supportive’ since 2000, yet it was 2016 before a spatially focused definition of this term was provided, offering designers a more tangible understanding of what they should be aiming for.10 The second limitation is the breadth of research currently available. While rigorous and valuable, evidence-based design often overlooks the fact that architects must design across scales, from the master-planning scale—deciding where to place buildings of various functions within a site, and how to manage the safe movement of staff and patients between those buildings—to the scale of a bathroom door. How do you design a bathroom door to meet antiligature and surveillance requirements, to maintain patient safety, while still communicating dignity and respect for patients?. The available literature provides much to contemplate, but in terms of credible evidence much of this research is based on a single study, typically conducted within a single hospital context and often focused on a single aspect of design. This raises the question, is there really a compelling basis for regarding evidence-based design knowledge as more credible than knowledge generated about this building type from other disciplines?.

In light of the small amount of evidence available in this field, is there not a responsibility to use all the available knowledge?. While the discipline of evidence-based design has existed for three decades,11 purpose-designed buildings for the treatment of mental illness have been constructed for over three centuries. Researchers working within the field of architectural history also understand that patient experience is partially determined—for better or worse—by the decisions that designers make, and that models of care have been used to drive design outcomes since the establishment of the York Retreat in 1796. With their focus on moral treatment, the York Retreat influenced a shift in the way asylum design was approached, from the provision of safe custody to finding architectural solutions to support the restoration of sanity.12 Architectural historians also bring evidence to bear in respect of this design challenge, specifically knowledge of how the best architectural intentions can result in unanticipated (sometimes devastating) outcomes—and of the conditions that gave rise to those outcomes.13 There is a third, rich source of knowledge available to guide designers that, broadly speaking, academic researchers have yet to tap into. It is the knowledge produced by practitioners themselves.

Architects learn through experience, across multiple projects and through practice-based forms of enquiry that include desktop surveys (also referred to as precedent studies), user group consultations and gathering (often informal) postoccupancy data from their clients. Architects have already offered a range of tangible solutions to meet particular aspirations related to patient care. There is value in examining these existing design solutions to identify those capable of providing direct benefits to patients that might justify implementation across multiple projects. In understanding how the physical design of forensic psychiatric hospitals can best support the therapeutic journey of patients, all available knowledge should be valued and integrated.Methodology. Embracing ‘mode two’ researchThis research was conducted within the context of a master­-planning and feasibility study, commissioned by a state government department, to investigate various international design solutions to inform future planning around forensic mental health service provisions in Victoria, Australia.

The industry-led nature of this project demanded a less conventional and more inclusive methodological approach. Tight timeframes precluded employing research methods that required ethics approvals (interviewing patients was not possible), while the timeframe and budget precluded the research team from conducting fieldwork. The following obstacles further limited a conventional approach:Postoccupancy evaluations of forensic psychiatric hospital facilities are seldom conducted and/or not made publicly available.14Published floor plans that would enable researchers to derive an understanding of the functional layouts and corresponding habits of occupancy within these facilities are limited owing to the security needs surrounding forensic psychiatric hospital sites.Available literature relevant to the design of forensic psychiatric hospital facilities provides few direct architectural recommendations to offer tactics for how the built environment might support the delivery of treatment.The team had to find a way to navigate these challenges in order to address the important question of how the physical design of forensic psychiatric hospitals can best support the therapeutic journey of patients.‘Mode two’ is a methodological approach that draws on the strength of collaborations between academia and industry to produce ‘socially robust knowledge’ whose reliability extends ‘beyond the laboratory’ to real-world contexts.15 It shares commonalities with a phenomenological approach that attributes value to the prolonged, firsthand exposure of the researcher with the phenomenon in question.16 The inclusion of practising architects and academic researchers within the research team provided considerable expertise in the design, consultation and documentation of these facilities, alongside an understanding of the kinds of challenges that arise following the occupation of this building type. Mode two, as a research approach, also recognises that, while architects reference evidence-based design literature, this will not replace the processes through which practitioners have traditionally assembled knowledge about particular building types, predominantly desktop surveys.A desktop survey was undertaken to understand contemporary design practice within this building type. Forty-four projects were identified as relevant for the period 2006–2022 (31 forensic and 13 non-forensic psychiatric hospitals).

These included facilities from the UK, the USA, Canada, Denmark, Norway, Sweden, the United Arab Emirates and Ireland (online supplementary appendix 1). Sufficient architectural information was not available for 13 of these projects and they were excluded from the study. For the remaining 31 facilities, 24 accommodated forensic patients and 7 did not. Non-forensic facilities were included to enable an awareness of any significant programmatic or functional differences in the design responses created for forensic versus non-forensic mental health patients. Architectural drawings and photographs were analysed to identify general trends, alongside points of departure from common practice.

Borrowing methods from architectural history, the desktop survey was supplemented by other available information, including a mix of hospital-authored guidebooks (as provided to patients and visitors), architects’ statements, newspaper articles and literature from the field of evidence-based design. Available data varied for each of the 31 hospitals. Adopting a method from architectural theorist Thomas Markus, the materiality and placement of external and internal boundary lines were closely studied (assisted by Google Earth).17 When read in conjunction with the architectural drawings, boundary placement revealed information regarding patient access to adjacent landscape spaces.Supplemental materialA desktop survey has limitations. It cannot provide a conclusive understanding of how these spaces operate when occupied by patients and staff. While efforts were made to contact individual practices and healthcare providers to obtain missing details, such requests typically went unanswered.

This is likely owing to concerns of security, alongside the realities of commercial practice, concerns around intellectual property, and complex client and stakeholder arrangements that can act to prohibit the sharing of this information. To deepen the team’s understanding, a 2-day workshop was hosted to which two international architectural practices were invited to attend, one from the UK and one from the USA. Both practices had recently completed a significant forensic psychiatric hospital project. While neither of these facilities had been occupied at the time of the workshops, the architects were able to share their experiences relative to the research, design, and client and patient consultation processes undertaken. The Australian architects who led the research team also brought extensive experience in acute mental healthcare settings, which assisted in data analysis.To further mitigate the limitations of the desktop survey, understandings developed by the team were used as a basis for advisory panel discussions with staff.

Feedback was sought from five 60 min long, advisory panel sessions, each including four to six clinical/facilities staff (who attended voluntarily during work hours) from a forensic psychiatric hospital in Australia, where several participants recounted professional experience in both the Australian and British contexts. Each advisory panel session was themed relative to various aspects of contemporary design. (1) site/hospital layout, (2) inpatient accommodation, (3) landscape design and access, (4) staff amenities, and (5) treatment hubs (referred to as ‘treatment malls’ in the American context). These sessions enabled the research team to double-check our analysis of the plans and photographs, particularly our assumptions regarding the likely use, practicality and therapeutic value of particular spaces.Model for analysisWithin general hospital design, a range of indicators are used to measure the contribution of architecture to healing, such as the optimisation of lighting to support sleep, the minimisation of patient falls, or whether the use of single patient rooms assists with control.18 In mental health, however, where the therapeutic journey is based more on psychology than physiology, what metrics should be employed to evaluate the success of one design response over another in supporting patient care?. We suggest the first step is to acknowledge the values that underpin contemporary approaches to mental healthcare.

The second step is to translate those treatment values into corresponding spatial values using a value-led spatial framework.19 This provides a checklist for relating particular spatial conditions to specific values around patient care. For example, if the design intent is to optimise privacy and dignity for patients, then the design of bathrooms, relaxation and de-esculation spaces are all important spaces in respect of that therapeutic value. Highlighting this relationship can assist decision makers to more closely interrogate areas that matter most relative to achieving these values. To put this in context, optimising a bathroom design to prioritise a direct line of sight for staff might improve safety but also obstruct privacy and dignity for patients. While such decisions will always need to be carefully balanced, a value-led spatial framework can provide a touchstone for designers and stakeholders to revisit throughout the design process.To analyse the 31 projects examined within this project, we developed a framework (Table 1).

It recognises that a common approach to patient care can be identified across contemporary Australian, British and Canadian models:View this table:Table 1 Value-led spatial framework. Correlating treatment values with corresponding spaces within the hospital’s physical environmentThat patients be extended privacy and dignity to the broadest degree possible without impacting their personal safety or that of other patients or staff.That patients be treated within the least restrictive environment possible relative to the severity of their illness and the legal (or security) requirements attached to their care.That patients be afforded choice and independence relative to freedom of movement within the hospital campus (as appropriate to the individual), extending to a choice of social, recreational and treatment spaces.That patients’ progression through their treatment journey is reflected in the way the architecture communicates to hospital users.That opportunities for peer-led therapeutic processes and involvement of family and community-based care providers be optimised within a hospital campus. 20Table 1 assigns a range of architectural spaces and features that are relevant to each of the five treatment values listed. Architectural decisions related to these values operate across three scales. Context, hospital and individual.

Context decisions are those made in respect of a hospital’s location, including proximity to allied services, connections to public transport and distances to major metropolitan hubs. Decisions of this type are important relative to staffing recruitment and retention, and opportunities for research relative to the psychiatric hospital’s proximity to general (teaching) hospitals or university precincts. Architectural decisions operating at the hospital scale include considerations of how secure site boundaries are provided. How buildings are laid out on a site. And how spatial and functional links are set up between those buildings.

This is important relative to the movement of patients and staff across a site, including the location and functionality of therapeutic hubs. But it can also impact patient and community psychology. The design of external fences, in particular, can compound feelings of confinement for patients. Focus community attention on the custodial role of a facility over and above its therapeutic function. And influence perceptions of safety and security for the community immediately surrounding the hospital.

Architectural decisions operating at the ‘individual’ scale are those that more closely impact the daily experience of a hospital for patients and staff. These include the various arrangements for inpatient accommodation. Tactics for providing patients with landscape access and views. And the question of staff spaces relative to safety, ease of communication and collaboration. Approaches to landscape, inpatient accommodation and concerns of staff supervision are closely intertwined.Findings.

What we learnt from 31 contemporary psychiatric hospital projectsForensic psychiatric hospitals treat patients who require mental health treatment in addition to a history of criminal offending or who are at risk of committing a criminal offence. Primarily, these include patients who are unfit to stand trial and those found not guilty on account of their illness.21 Accommodation is typically arranged according to low, medium or high security needs, alongside clinical need, and whether an acute, subacute, extended or translational rehabilitation setting is required. Security needs are determined based on the risk a patient presents to themselves and/or others, alongside their risk of absconding from the facility. The challenge that has proven intractable for centuries is how can architects balance privacy and dignity for patients, while maintaining supervision for their own safety, alongside that of their fellow patients, the staff providing care and, in some cases, the community beyond.22 In this section we present overall trends regarding the layout of buildings within hospital sites, including the placement of treatment hubs and the design of inpatient wards. Access to landscape is not explicitly addressed in this section but is implicit in decisions around site layout and inpatient accommodation.Design approaches to site layoutWe identified two approaches to site layout—the ‘village’ (4 from 31 hospitals) and the ‘campus’ (27 from 31 hospitals) (figure 1).

Similar in their functional arrangement, these are differentiated according to the degree of exterior circulation required to move between patient-occupied spaces. Village hospitals comprise a number of buildings sitting within the landscape, while campus hospitals have interconnected buildings with access provided by internal corridors that prevent the need to go outside. Neither approach is new. Both follow the models first used within the 19th century. The village hospital follows the model designed by Dr Albrecht Paetz in 1878 (Alt Scherbitz, Germany), which included detached cottages accommodating patients in groups of between 24 and 100, set within gardens.23 Paetz created this design in response to his belief that upwards of 1000 patients should not be accommodated in a single building, with security measures determined in relation to those patients whose behaviour was the least predictable.24 The resulting monotony of the daily routine and restrictions on patient movement were believed to ‘cripple the intelligence and depress the spirit’.25 Paetz’s model allowed doctors to classify patients into smaller groups and unlock doors to allow patients with predictable behaviour to wander freely within the secure outer boundaries of the hospital.26 This remained the preferred approach to patient accommodation for over a century, as endorsed by the WHO in their report of 1953.27 Broadmoor Hospital (UK, 2019) provides an example of the village model.The Broadmoor Hospital (left) follows a ‘village’ arrangement and includes an ‘internal’ treatment hub.

The Worcester Recovery Center and Hospital (right) follows a ‘campus’ arrangement and includes an ‘on-edge’ treatment hub." data-icon-position data-hide-link-title="0">Figure 1 The Broadmoor Hospital (left) follows a ‘village’ arrangement and includes an ‘internal’ treatment hub. The Worcester Recovery Center and Hospital (right) follows a ‘campus’ arrangement and includes an ‘on-edge’ treatment hub.The campus model is not dissimilar to the approach propagated by Dr Henry Thomas Kirkbride, a 19th-century psychiatrist who was active in the design of asylums and whose influence saw this planning arrangement dominate asylum constructions in the USA for many decades.28 Asylums of the ‘Kirkbride plan’ arranged patient accommodation in a series of pavilions linked by corridors. While corridors can be heavily glazed, where this action is not taken, the campus approach can compromise patient and staff connections to landscape views. Examples of campus hospitals include the Worcester Recovery Center and Hospital (USA, 2012) and the Nixon Forensic Center (USA, under construction).Treatment hubs are a contemporary addition to forensic psychiatric hospitals. These cluster a range of shared patient spaces, including recreational, treatment and vocational training facilities, and thus drive patient movement around or through a hospital site.

Two different treatment hub arrangements are in use. €˜internal’ and ‘on-edge’. Those arranged internally typically place these functions at the heart of the campus and at a significant distance from the secure boundary line. Those arranged on-edge are placed at the far end of campus-model hospitals and, in the most extreme cases, occur adjacent to one of the site’s external boundaries (refer to Figure 1). Both arrangements aspire to make life within the hospital resemble life beyond the hospital as closely as possible, as the daily practice of walking from an accommodation area to a treatment hub mimics the practice of travelling from home to a place of work or study.With evidence mounting regarding the psychological benefits to patients of landscape access, it should not be assumed that the current preference for campus hospitals over the village model indicates ‘best practice’.

A campus arrangement offers security benefits for the movement of patients across a hospital site, while avoiding the associated risks of contraband concealed within landscaped spaces. However, the existence of village hospitals for forensic cohorts suggests it is possible to successfully manage these challenges. Why then do we see such a strong persistence of the campus hospital?. This preference may be driven by cultural expectations. From 24 forensic psychiatric hospitals surveyed, 10 were located within the USA and all employed the campus model.

Yet nine of those hospitals occupied rural sites where the village model could have been used, suggesting the influence of the Kirkbride plan prevails. The four village hospitals within the broader sample of 31, spanning forensic and non-forensic settings, all occurred within the UK3 and Ireland1. Paetz’s villa model had been the preferred approach to new constructions in these countries since its introduction at close of the 19th century.29 However, a look at UK hospitals in isolation revealed a more even spread of village and campus arrangements, with two of the four UK-based campus hospitals occupying constrained urban sites that required multi-story solutions. The village model would be inappropriate for achieving this as it does not lend well to urban locations where land availability is scarce.Design approaches to inpatient accommodationThree approaches to inpatient accommodation were identified. €˜peninsula’, ‘race-track’ and ‘courtyard’ (Figure 2).

The peninsula model is characterised by rows of inpatient wings, along a single-loaded or double-loaded corridor that stretches into the surrounding landscape. This typically enables an exterior view from all patient bedrooms and is not dissimilar to the traditional ‘pavilion’ model that emerged within 19th-century hospital design.30 In the racetrack model bedrooms are arranged around a cluster of staff-only (or service) spaces, still enabling exterior views from all patient bedrooms. The courtyard model is similar to the racetrack but includes a central landscape space. Information on the design of inpatient room layouts was available for 24 of the 31 projects analysed (15 of these 24 were forensic).Common inpatient accommodation configurations. (1) Peninsula.

Single-loaded version shown (patient rooms on one side only. Double-loaded versions have patient rooms on two sides of the corridor). (2) racetrack and (3) courtyard (landscaped). Staff-occupied spaces and support spaces (social space and so on) shown in grey." data-icon-position data-hide-link-title="0">Figure 2 Common inpatient accommodation configurations. (1) Peninsula.

Single-loaded version shown (patient rooms on one side only. Double-loaded versions have patient rooms on two sides of the corridor). (2) racetrack and (3) courtyard (landscaped). Staff-occupied spaces and support spaces (social space and so on) shown in grey.Ten forensic hospitals employed a peninsula plan and five employed a courtyard plan. Of the non-forensic psychiatric hospitals five employed the courtyard, three the racetrack and only one the peninsula plan.

While the sample size is too small to generalise, the peninsula plan appears to be favoured for a forensic cohort. However, cultural trends again emerge. Of the 10 peninsula plan hospitals, 6 were located within the USA, and among the broader sample of 24 (including the non-forensic facilities) none of the courtyard hospitals were located there. Courtyard layouts for forensic patients occurred within the UK, Ireland, Denmark and Sweden. However, within these countries, a mix of courtyard and peninsula plans were used, suggesting no clear preference for one plan over the other.Each plan type has advantages and disadvantages (Table 2).

Courtyard accommodation provides the following benefits. Greater opportunity for patient access to landscape since these are easier for staff to maintain surveillance over. Additional safety for staff owing to continuous circulation (staff cannot get caught in ‘dead-ends’. However, the presence of corners which are difficult to see around is a drawback). Natural light is more easily available.

And ‘swing bedrooms’ can be supported (this is the ability to reconfigure the number of observable bedrooms on a nursing ward by opening and closing doors at different points within a corridor). However, courtyard accommodation requires a larger site area so is better suited to rural locations than urban and is not well suited to multi-story facilities. Peninsula accommodation enables geographical separation, giving medical teams greater opportunity to manage which patients are housed together (‘cohorting’). Blind corners can be avoided to assist safety and surveillance. Travel distances can be minimised.

Finally, the absence of continuous circulation provides greater flexibility for creating social spaces for patients with graduated degrees of (semi-)privacy.View this table:Table 2 Advantages and disadvantages of peninsula versus courtyard accommodationAnother important consideration related to inpatient accommodation is ward size. The number of bedrooms clustered together, alongside the amount of dedicated living space associated with these bedrooms. Ward size can influence patient agitation and aggression, alongside ease of supervision, staff anxiety and safety.31 The most common ward sizes were 24 or 32 beds, further subdivided into subclusters of 8 beds. Typically, each ward was provided with one large living space that all 24 or 32 patients used together. More advanced approaches gave patients a choice of living spaces.

For example, at Coalinga Hospital, patients could occupy a small living space available to only 8 patients, or a larger space that all 24 patients had access to. We describe this approach as more advanced since both 19th-century understandings alongside recent research by Ulrich et al confirm that social density (the number of persons per room) is ‘the most consistently important variable for predicting crowding stress and aggressive behaviour’.32 Only six hospitals had plans detailed enough to calculate the square-metre provision of living space per patient, and this varied between 5 and 8 square metres.Limitations of the desktop surveyData from a desktop survey are insufficient to obtain a comprehensive understanding of how design contributes to patient experience. To overcome this limitation, the following sections combine knowledge about how people use space from environmental psychology, knowledge about the design and consultation processes that guide the construction of these facilities, and understandings from architectural history. History suggests that seemingly small changes to typical design practice can effect significant change in the delivery of mental healthcare, the daily experience of hospitalised patients and more broadly public perceptions of mental illness. This integrated approach is used to identify three forensic psychiatric hospitals that challenge accepted design practice to varying degrees and, in doing so, have the potential to act as change-agents in the delivery of forensic mental healthcare.

But first it is important to understand the context in which architectural innovation is able, or unable, to emerge relative to forensic mental healthcare.Accepting the challenge. Using history to help us see beyond the roadblocks to innovationArchitects tasked with designing forensic mental health facilities respond to what is called a ‘functional brief’. This documents the specific performance requirements of the hospital in question. Much consultation goes into formulating and refining a functional brief through the initial and developed design stages. Consultation is typically undertaken with a variety of different user groups, and in a sequential fashion that includes a greater cross-section of users as the design progresses, including patients, families, and clinical and security staff.

Despite the focus on patient experience within contemporary models of care, functional briefs tend to prioritise safety and security, making them the basis on which most major architectural decisions are made.33 In large part this is simply the reality of accommodating a patient cohort who pose a risk of harm towards themselves and/or others. A comment from Tom Brooks-Pilling, a member of the design team for the Nixon Forensic Center (Fulton, Missouri), provides insight into this approach and the concerns that drive it. He explained that borrowing a ‘spoked wheel’ arrangement from prison design eliminated blind spots and hiding places to enable a centrally located staff member to:see everything that’s going on in that unit…[they are] basically watching the other staff’s back [sic] to make sure that they can focus on treatment and not worry about who might be sneaking up on them or what activities might be going on behind their backs.34Advisory panel feedback confirmed that when the architectural design of a facility heightens staff anxiety this has direct ramifications for the therapeutic process. For example, in spaces where staff could become isolated from one another, and where clear lines of sight were obstructed, such as ill-designed elevators or stairwells, this can lead to movement being reduced across the patient cohort to avoid putting staff in those spaces where they feel unsafe.The architects consulted during the course of this research, including those who were part of the research team, articulated how the necessary prioritisation of safety, in turn, leads to compromises in the attainment of an ideal environment to support treatment. In the various forensic and acute psychiatric hospital projects they had been involved with, all observed a sincere commitment on the part of those engaged in project briefing to upholding ideals around privacy, dignity, autonomy and freedom of movement for patients.

They reported, however, that the commitment to these ideals was increasingly obstructed as the design process progressed by the more pressing concerns of safety. Examples of the kinds of architectural implications of this prioritisation are things like spatially separated nursing stations (enclosed, often fully glazed), when a desire for less-hierarchical interactions between patients and staff had been expressed at the beginning of the briefing process. Or the substitution of harder-wearing materials, with a more ‘institutional’ feel when a ‘home-like’ atmosphere had been prioritised initially. There is nothing surprising or unusual about this process since design is, by its nature, a process of seeking improvements on accepted practice while systematically checking the suitability of proposed solutions against a set of performance requirements. In the context of forensic psychiatric hospitals, safety is the performance requirement that most often frustrates the implementation of innovative design.

Thus, amid the complexities of design and procurement relative to forensic psychiatric hospitals, innovation, however humble, and particularly where it can be seen to contribute positively to the patient experience, is worth a closer look.In the historical development of the psychiatric hospital as a building type, two significant departures from accepted design practice facilitated positive change in the treatment of mental illness. The first was Paetz’s development of the village hospital which sought to replace high fences, locked doors and barred windows with ‘humane but stringent supervision’.35 While this planning approach may not have significantly altered models of care, it was regarded as ‘an essential, vital development’, providing architectural support to the prevailing approach to treatment of the time—that of moral treatment—which aimed to extend kindness and respect to patients, in an environment that was as unrestrictive as possible. The York Retreat is worthy of acknowledgement here as a leading proponent of moral treatment whose influence shifted approaches to asylum design, from focusing on the provision of safe custody to supporting the restoration of sanity. Architecturally, however, the differences in the York Retreat’s approach were mainly focused on interior details that encouraged patients to maintain civil habits. Dining rooms had white tablecloths and flower vases adorned mantelpieces, door locks were custom-made to close quietly, and window bars fashioned to look like domestic window frames.36 The York Retreat was originally a small institution, in line with Samuel Tuke’s preference for a maximum asylum size of 30 patients.

History confirms the extent to which this approach was not scalable and thus unable to be replicated widely for asylum construction. For these reasons, it has not been considered here as a significant departure from accepted design practice.The second significant departure from accepted design practice was the development of acute treatment hospitals, located within cities, adjacent to general hospitals and medical research facilities. The first hospital of this type was the Maudsley Hospital, led by doctors Henry Maudsley and Frederick Mott, in London. The design intent for this hospital was announced in 1908 but it was not opened until 1923.37 In proposing this hospital, Maudsley and Mott were motivated to bring psychiatry ‘into line with the other branches of medical science’.38 This 100-bed facility, located directly across the road from the King’s College (Teaching) Hospital, emulated the general hospital typology in offering both outpatient and short-duration inpatient care, specifically targeted at patients with recent-onset illnesses. The aspirations were threefold.

To avoid the stigma associated with large public asylums. To advance the medical understanding of mental illness through research collaborations with general hospitals and medical schools and via improved teaching programmes. And to both enable and encourage patients to access early, voluntary treatment on an outpatient basis.38 Today the Maudsley appears unremarkable, an unassuming three-storied building on a busy London street. But the significance of what this building communicated at the time it was constructed, and the extent to which it challenged accepted practice, should not be underestimated. The Maudsley sent a clear message to the public that mental illness was no longer to be regarded as different from any other illness treated within a general hospital setting.

That it was no longer okay to isolate those suffering from mental illness from their families or the neighbourhoods in which they lived.39 Following the announcement of the Maudsley, the ‘psychopathic hospital’ rose to prominence within the USA with Johns Hopkins University Hospital opening the Phipps Psychiatric Clinic, in Baltimore, in 1913. The psychopathic hospital similarly promoted urban locations and closer connections to teaching and research. The Maudsley can be seen to have played a significant role in the shift to treating acute mental illness within general hospital settings.In any discussion of the history of institutional care, there is a responsibility to acknowledge that the aspiration to provide buildings that support care and recovery have not always manifested in ways that improved daily life for patients. The five treatment values that underpinned the analysis framework for this project are not new values. The extension of privacy and dignity to patients and the delivery of care within the least restrictive environment possible were both firmly embedded in the 19th-century approach of moral treatment.

Yet the rapid growth of asylum care frustrated the delivery of those values to patients.40 Choice and independence for patients, the desire for a patient’s recovery progress to be reflected in their environment, and opportunities for peer support and family involvement have been present in approaches to mental health treatment since the formal endorsement of the ‘therapeutic community’ approach to hospital construction and administration in the WHO’s report of 1953.41 History reminds us, therefore, that differences can arise between the stated values on which an institution is designed and those which it is constructed and operated. The three hospitals discussed in the following section include innovative solutions that hold the promise of positive benefits for patients. Yet we acknowledge this a theoretical analysis. For concrete evidence of a positive relationship between these design outcomes and patient well-being, postoccupancy evaluations are required.Three hospitals contributing to positive change in forensic mental healthcareBroadmoor Hospital. Optimising the value of the village model for patientsNineteenth-century beliefs and contemporary research are in accord regarding the importance of greenspace in reducing agitation within forensic psychiatric hospital environments and in promoting positive patterns of socialisation.42 It is surprising, therefore, that enshrining daily landscape access for patients is not widespread within current design practice.

The Irish National Forensic Mental Hospital and the State Hospital at Carstairs (Scotland) both follow the model of the village hospital, but only in that they comprise a number of accommodation buildings set within the landscape, enclosed by an external boundary fence. At the Irish National Forensic Mental Hospital, the scale of the landscape—the distance between buildings and the lack of intermediate boundaries within the landscape—suggests it is highly unlikely that patients are allowed to navigate this landscape on a regular basis. By comparison, the architectural response developed for Broadmoor Hospital (2019) shows an exemplary commitment to patient views and access to landscape (Figure 3).Likely extent of landscape occupation by patients as indicated by the position of inner and outer secure boundary lines. (1) Broadmoor Hospital (rural site, UK), (2) Irish National Forensic Mental Hospital (rural site) and (3) Roseberry Hospital (suburban site, UK)." data-icon-position data-hide-link-title="0">Figure 3 Likely extent of landscape occupation by patients as indicated by the position of inner and outer secure boundary lines. (1) Broadmoor Hospital (rural site, UK), (2) Irish National Forensic Mental Hospital (rural site) and (3) Roseberry Hospital (suburban site, UK).Five contemporary hospitals follow the logic of a traditional villa hospital, yet Broadmoor is the only one that optimises the benefits offered by this spatial configuration.

Comprising a gateway building and a central treatment hub, with a series of patient accommodation buildings positioned around it, the landscape becomes the only available circulation route for patients travelling off-ward to the shared therapy, recreation and vocational training spaces. Most patients will thus engage with the outdoors at least twice daily on their way to and return from these shared spaces. But in addition to accessing this central landscape, landscape views from patient rooms have been prioritised, and each ward is allocated its own large greenspace. Multiple, internal boundary fences enable patient access to the adjacent landscape to the greatest possible degree (refer to Figure 3). This approach provides patients with a diversity of landscape experiences.

This is important given the patterns of landscape use between forensic and non-forensic hospitals. In non-forensic facilities, patients are likely to have the choice of accessing multiple landscape spaces, whereas in forensic facilities access to a particular space is often restricted to one cohort, for example, a single ward group. This highlights a limitation of the courtyard model for forensic patients. Roseberry Park Hospital (2012) provides an example of how a high degree of landscape access can be similarly achieved for patients on constrained urban site, using a courtyard layout (refer to Figure 3).Providing patients with daily landscape access provides challenges to maintaining safety and security. Trees with low branches can be used as weapons, while tall branches can be used for self-harm, and ground cover landscaping increases opportunities to conceal contraband.

At the Australian hospital where advisory panel sessions were conducted (constructed in 2000), the landscape is occupied in a similar way and staff conveyed the constant effort required to ensure safe patient access to this greenspace. Significant costs are incurred annually by facilities staff in keeping the greenspace free from contraband and from several varieties of wild mushroom that grow seasonally on the site. Despite this cost, staff reported that both they and the patients value the opportunity to circulate through the landscaped grounds (even in inclement weather). Hence, the benefits to well-being are perceived as significant enough to justify this cost. These examples make evident that placing a hospital within a landscape is not enough to ensure patients are extended the well-being benefits of ongoing access.

Instead this requires that hospitals factor in the additional supervisory and maintenance requirements to maintain landscape access for patients.Worcester Recovery Center and Hospital. Spaces to support choice and a sense of controlResearch in environmental psychology, conducted within residential and hospital settings, confirms that the ability to regulate social contact can have a dramatic impact on well-being. The physical layout of spaces has been linked to both the likelihood of developing socially supportive relationships and impeding this development, with direct implications for communication, concentration, aggression and a person’s resilience to irritation.43 These problems can be more pronounced in a forensic psychiatric hospital as there is an over-representation of patients who have suffered trauma. Architects working in forensic psychiatric hospital design acknowledge that patients need space to withdraw from the busy hospital environment, spaces where they can ‘observe everything that is going on around them until they feel ready to join in’.44 It is surprising, therefore, that many contemporary forensic psychiatric hospitals still continue to provide a single social space for all 24 or 32 patients occupying a ward. The Worcester Recovery Center, by comparison, provides patients with a choice of social spaces that are designed to enable graduated degrees of social engagement.

This can support a sense of control to limit socially induced stress.Worcester is conceptualised as three distinct zones designed to resemble life beyond the hospital. The ‘house’, ‘neighbourhood’ and ‘downtown’ (Figure 4). The house zones include patient accommodation, employing a peninsula model. Each comprises 26 patient rooms, clustered into groups of 6 or 10 single bedrooms that face a collection of shared spaces dedicated to that cluster, including sitting areas, lounges and therapeutic spaces. A shared kitchen and dining room is provided for each house.

Three houses feed into a neighbourhood zone that includes shared spaces for therapy and vocational training, while the downtown zone serves a total of 14 houses. The downtown zone can be accessed by patients based on a merit system and includes a café, bank and retail spaces, music room, health club, chapel, green house, library and art rooms, alongside large interior public spaces. This array of amenities does not seem distinctly different from other contemporary facilities, where therapy and vocational training happen in a mix of on-ward and off-ward (often within a central treatment hub). The difference lies in the sensitivity of how these spaces are articulated.Details of the social spaces provided on each ward at the Worcester Recovery Center and the proximity of the ‘house’ (or ward) to the ‘neighbourhood’ and ‘downtown’." data-icon-position data-hide-link-title="0">Figure 4 Details of the social spaces provided on each ward at the Worcester Recovery Center and the proximity of the ‘house’ (or ward) to the ‘neighbourhood’ and ‘downtown’.The generosity of providing separate living spaces for every 6–10 patients and locating these directly across the corridor from the patient rooms supports a sense of control and choice for patients. Frank Pitts, an architect who worked on the Worcester project, has written that this was done to enable patients to ‘decide whether they are ready to step out and socialise or return to the privacy of their room’.45 This approach filters throughout the facility, providing a slow graduation of social engagement opportunities for patients, from opportunities to socialise with their cluster of 6–10 individuals, to their house of 26, to their neighbourhood of 78 people, to the full downtown experience.

According to the architects, the neighbourhood thus provides an intermediary zone between the quiet house and the active downtown, which can be overwhelming for some patients.46 Importantly the scale of the architecture responds to this transition from personal to public space, providing visual indicators to reflect patients’ movement through their treatment journey. Spaces become larger as they move further from the ward. This occurs because instead of providing a single, large shared living space, patients are provided a choice of smaller spaces to occupy—these are not much bigger than a patient bedroom. Dining spaces are slightly larger, while downtown spaces have a civic quality. These are double-height, providing a greater sense of light and airiness.

These are arranged in a semicircle, opening onto a large veranda and greenspace. The sensitive articulation of these spaces, with regard to both their graduated physical scale and the proximity of the social spaces to the patient bedrooms, provides spatial support to these social transitions while empowering patients to control their own level of social interaction.Margaret and Charles Juravinski Centre for Integrated Healthcare. Creating opportunities for greater public engagement and supporting readjustment to the world beyond the hospitalOne of the most significant barriers to mental health treatment is the stigma associated with admission to a psychiatric hospital. We know that discrimination poses an obstacle to recovery and that the media fuels public fears related to forensic mental health patients.47 Two further challenges to mental health delivery include the disconnection patients can experience from the community, including from family and educational opportunities, and the risk of readmission in the period immediately following discharge.48 If architecture is capable of acting as a change-agent in the delivery of mental healthcare, then it needs to show leadership, not only in the provision of a better experience for patients but more broadly in taking steps to help shift public perceptions around mental illness. The Margaret and Charles Juravinski Centre for Integrated Healthcare (MCJC) (Canada) displays several similarities with the approach taken to the Maudsley Hospital.

Its appearance communicates a modern, cutting-edge healthcare facility. It does not hide on a rural site or behind walls. At five stories, and extensively glazed, MCJC communicates a strong civic presence. Its proximity to McMaster University (6 km) and to neighbouring general hospitals, including Juravinski Hospital (4 km) and Hamilton General Hospital (4 km), positions it well for research collaborations to occur, while its proximity to the Mohawk Community College, across the road, can enable patients with leave privileges to access vocational training. More importantly, it employs three innovative design tactics to target the challenges of contemporary forensic mental healthcare, providing an example for how architecture might broker positive change.The first innovative design strategy is the co-location of support services for outpatient mental healthcare.

The risk of readmission is highest immediately following discharge. A lack of collaboration between outpatient support services can result in fragmented care when patients are most vulnerable to the stresses associated with readjustment to the world beyond.49 MCJC includes outpatient facilities allowing patients to use the hospital as a stable base, or touchstone, in adjusting to life after discharge. Bringing these services onto the same physical site can also improve opportunities for coordination between inpatient and outpatient support services which can support continuity of care. The second design strategy is the co-location of a medical ambulatory care centre which includes diagnostic imaging, educational and research facilities. This creates reasons for the general public to visit this facility, setting up the opportunity for greater public interaction.

This could potentially advance understandings of the role of this facility and the patients it treats.The third innovative design strategy was to optimise the on-edge treatment hub for public engagement. While adopted across a number of hospitals, including Hawaii State Hospital, Helix Forensic Psychiatry Clinic (Sweden) and the Worcester Recovery Center, the on-edge treatment hubs at these hospitals are buried deep inside the secure outer boundary. At MCJC, the treatment hub is placed adjacent to the public zones of the hospital—although on the second floor—and this can be viewed as extension of the public realm and enables the potential for the public to be brought right up to the secure boundary line (which occurs within the building). MCJC is divided into four zones. The public zone, the galleria (the name given to the treatment hub), the clinical corridor and inpatient accommodation (Figure 5).

The galleria functions similarly to the downtown at the Worcester Recovery Center. Patients are given graduated access to a series of spaces that support their recovery journey. These include a gym, wellness centre, spiritual centre, library, café, beauty salon, and retail and financial services, alongside patient and family support services. While the galleria was initially intended to be accessible by the general public, this was not immediately implemented on the facilities’ opening and it is unclear whether this has now occurred.50 Nonetheless, the potential for movement of patients outwards, and families inwards, has been built into the physical fabric of this building, meaning opportunities for social interaction and fostering greater public understanding are possible. If understanding is the antidote to discrimination, then exposing the public to the role of this facility and the patients it treats is an important step in the right direction.Zoning configuration at the Margaret and Charles Juravinski Centre for Integrated Healthcare.

The galleria zone is on the second floor (shown in black). The arrows indicate main access points to the galleria. Lifts (L) and stairwell (S) positions are indicated." data-icon-position data-hide-link-title="0">Figure 5 Zoning configuration at the Margaret and Charles Juravinski Centre for Integrated Healthcare. The galleria zone is on the second floor (shown in black). The arrows indicate main access points to the galleria.

Lifts (L) and stairwell (S) positions are indicated.ConclusionThe question of how architecture can support the therapeutic journey of forensic mental health patients is a critical one. Yet the availability of evidence-based design literature to guide designers cannot keep pace with growing global demand for new forensic psychiatric hospital facilities, while limitations remain relative to the breadth and usability of this research. A narrow view of what constitutes credible evidence can overlook the value of knowledge embedded in architectural practice, alongside that held by architectural historians and lessons from environmental psychology. In respect of such a pressing and important problem, there is a responsibility to integrate knowledge from across these disciplines. Accepting the limitations of a theoretical analysis and of the desktop survey method, we also argue for its value.

Architects learn through experience, across multiple projects. This gives weight to the value of examining existing, contemporary design solutions to identify architectural innovations capable of providing benefits to patients and thus perhaps worthy of implementation across multiple projects. History gives us reason to believe that small changes to typical design practice can improve the delivery of mental healthcare, the daily experience of hospitalised patients and more broadly public perceptions of mental illness. Architecture has the capacity to contribute to positive change.Here, we have provided a nuanced way for architects and decision makers to think about the relationship between architectural space and treatment values. An institution’s model of care and the therapeutic values that underpin that model of care should be placed at the centre of architectural decision making.

A survey of contemporary architectural solutions confirms that, generally speaking, innovation is lacking in this field. There will always be real obstacles to innovation, and the argument presented here does not suggest it is necessarily practical to prioritise therapeutic values at the cost of patient, staff and community safety. Instead, it challenges architects and decision makers to properly interrogate any architectural decision that compromises an initial commitment to supporting a patient’s treatment journey—to be more idealistic in the pursuit of positive change.Tangible examples exist of architectural innovations capable of positively improving patient experience by supporting key values that underpin contemporary treatment approaches. The Broadmoor Hospital optimises the value of the village model for patients, prioritising patient needs for frequent landscape engagement to support their therapeutic journey. The Worcester Recovery Center provides a generous choice and graduation of social spaces to support the social reintegration of patients at their own pace.

MCJC co-located facilities to support a patient’s readjustment to daily life postdischarge, while creating opportunities for public engagement that has the potential to foster greater public understanding of the role of these institutions and the patients they treat. In identifying these three innovative design approaches, we provide architects with tangible design tactics, while encouraging researchers to look more closely at these examples with targeted, postoccupancy studies. These projects provide hope that with a shared vision and commitment, innovation is possible in forensic psychiatric hospital design, with tangible benefits for patients.Data availability statementAll data relevant to the study are included in the article or uploaded as supplementary information. The primary method undertaken for this research relied on data publicly available on the internet.Ethics statementsPatient consent for publicationNot required.AcknowledgmentsThe opportunity to conduct this project arose out of a multidisciplinary master-planning and feasibility study, commissioned by the Victorian Health and Human Services Building Authority, to investigate various international solutions to inform future planning and design around forensic mental health service provision. The following people contributed their time and expertise in shaping the research process that enabled this article.

Neel Charitra, Stefano Scalzo, Les Potter, Margaret Grigg, Lousie Bawden, Matthew Balaam, Martin Gilbert, John MacAllister, Crystal James, Jo Ryan, Julie Anderson, Jo Wasley, Sophie Patitsas, Meagan Thompson, Judith Hemsworth, James Watson, Viviana Lazzarini, Krysti Henderson, Nadia Jaworski, Jack Kerlin and Jan Merchant.Notes1. Jamie O'Donahoo and Janette Graetz Simmonds (2016), “Forensic Patients and Forensic Mental Health in Victoria. Legal Context, Clinical Pathways, and Practice Challenges,” Australian Social Work 69, no. 2. 169–80.2.

The challenge of which terminology to select when writing about psychiatric hospital design remains difficult relative to the stigmas that surround this field. The term ‘patient’ has been used throughout, instead of ‘consumer’, as this article spans both historical and contemporary developments. In the context of this timespan, consumer is a relatively recent term, introduced around 1985.3. B Edginton (1994), “The Well-Ordered Body. The Quest for Sanity through Nineteenth-Century Asylum Architecture,” Canadian Bulletin of Medical History 11, no.

2. 375–86. Clare Hickman (2009), “Cheerful Prospects and Tranquil Restoration. The Visual Experience of Landscape as Part of the Therapeutic Regime of the British Asylum, 1800-60,” History of Psychiatry 20, no. 4 Pt 4.

425–41. Rebecca McLaughlan, 2012), “Post-Rationalisation and Misunderstanding. Mental Hospital Architecture in the New Zealand Media,” Fabrications 22, no. 2. 232–56.4.

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(2015), “Evaluating a Major Innovation in Hospital Design. Workforce Implications and Impact on Patient and Staff Experiences of All Single Room Hospital Accommodation,” Health Services and Delivery Research 3. 1–304. Penny Curtis and Andy Northcott (2017), “The Impact of Single and Shared Rooms on Family-Centred Care in Children’s Hospitals,” Journal of Clinical Nursing 26, no. 11–12.

1584–96.5. Roger S. Ulrich et al. (2018), “Psychiatric Ward Design Can Reduce Aggressive Behavior,” Journal of Environmental Psychology 57. 53–66.6.

Graham A Tyson, Gordon Lambert, and Lyn Beattie (2002), “The Impact of Ward Design on the Behaviour, Occupational Satisfaction and Well-Being of Psychiatric Nurses,” International Journal of Mental Health Nursing 11, no. 2. 94–102.7. For further examples of this see Jon E. Eggert et al.

(2014), “Person-Environment Interaction in a New Secure Forensic State Psychiatric Hospital,” Behavioral Sciences &. The Law 32, no. 4. 527–38. C.C.

Whitehead et al. (1984), “Objective and Subjective Evaluation of Psychiatric Ward Redesign,” The American Journal of Psychiatry 141, no. 5. 639–44. Gabriela Novotná et al.

(2011), “Client-Centered Design of Residential Addiction and Mental Health Care Facilities. Staff Perceptions of Their Work Environment,” Qualitative Health Research 21, no. 11. 1527–38.8. Morgan Andersson et al.

(2013), “New Swedish Forensic Psychiatric Facilities. Visions and Outcomes,” Facilities 31, no 1/2. 24–88.9. For examples see Kathleen Connellan et al. (2013), “Stressed Spaces.

Mental Health and Architecture,” HERD. Health Environments Research &. Design Journal 6, no. 4. 127–168.

Constantina Papoulias et al. (2014), “The Psychiatric Ward as a Therapeutic Space. Systematic Review,” British Journal of Psychiatry 205, no. 3. 171–6.10.

R. Allen and R.G. Nairn, 1997. Alan Dilani, 2000, “Psychosocially Supportive Design - Scandinavian Health Care Design,” World Hospitals and Health Services 37. 20–4.

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Exclusions and Opportunities within Health Care Environments Research,” Design for Health 1. 210–28.12. B Edginton (1997), “Moral Architecture. The Influence of the York Retreat on Asylum Design,” Health &. Place 3, no.

2. 91–9. Jeremy Taylor (1991), Hospital and Asylum Architecture in England 1849–1914. Building for Health Care (London. Mansell Publishing Limited).

Anne Digby (1985), Madness, Morality and Medicine. A Study of the York Retreat 1796–1914 (New York. Cambridge University Press).13. Digby, Madness, Morality and Medicine. Erving Goffman (1961), Asylums.

Essays on the Social Situation of Mental Patients and Other Inmates (New York. Doubleday). Ivan Belknap (1956), Human Problems of a State Mental Hospital (New York. Blakiston Division, McGraw-Hill). Andrew Scull (1979), Museums of Madness.

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Rebecca McLaughlan (2014), “One Dose of Architecture, Taken Daily. Building for Mental Health in New Zealand” (PhD diss., Victoria University of Wellington, New Zealand).14. Although not fitting a strict definition of postoccupancy evaluation, the following articles were notable exceptions to this finding. Eggert et al., “Person-Environment Interaction,” 527–38. Roger S.

Ulrich et al. (2018), “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66. Catherine Clark Ahern et al. (2016), “A Recovery-Oriented Care Approach. Weighing the Pros and Cons of a Newly Built Mental Health Facility,” Journal of Psychosocial Nursing and Mental Health Services 54, no.

2. 39–48.15. M Gibbons (2000), “Mode 2 Society and the Emergence of Context-Sensitive Science,” Science and Public Policy 27. 161.16. D Seamon, 2000, “A Way of Seeing People and Place,” in Theoretical Perspectives in Environment-Behavior Research, ed.

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Plenum), 157–78.17. Thomas A Markus (1982), Order in Space and Society. Architectural Form and Its Context in the Scottish Enlightenment (Edinburgh. Mainstream Publishing Company).18. Ulrich et al., “A Review of the Research Literature,” 61–125.19.

This was first created by first author for use for historical analysis during her PhD and is applied here to a contemporary setting. Refer to McLaughlan, “One Dose of Architecture, Taken Daily.”20. The following documents were referenced in compiling this list. Joint Commission Panel for Mental Health, NHS, UK (2013), “Guidance for Commissioners of Forensic Mental Health Services,” May, https://www.jcpmh.info/resource/guidance-for-commissioners-of-forensic-mental-health-services/. Cannon Design (2014), “St Joseph’s Integrated Healthcare Hamilton, Margaret and Charles Juravinski Centre for Integrated Healthcare,” Healthcare Design Showcase, September.

Health Nexus Group, 2017, “Forensicare Model of Care Report,” April, Australia (access provided by the Victorian Health and Human Services Building Authority). Donald Cant Watts Corke (2014), “Service Plan for Forensic Mental Health Services,” July, Australia (access provided by the Victorian Health and Human Services Building Authority).21. Sometimes this includes patients with no history of criminal behaviour but who are unable to be treated safely in a general hospital environment.22. W.A.F Browne (1991), "What Asylums Were, Are and Ought to Be (1837),” reprinted in The Asylum as Utopia. W.A.F.

Browne and the Mid-Nineteenth Century Consolidation of Psychiatry, ed. Andrew Scull (London. Tavistock). Morgan Andersson et al. (2013), “New Swedish Forensic Psychiatric Facilities,” 24–38.

Eggert et al., “Person-Environment Interaction.”23. Anon (1895), “Review. The Colonization of the Insane in Connection with the Open-Door System. Its Historical Development and the Mode in Which It Is Carried Out at Alt Scherbitz Manor. By Dr.

Albrecht Paetz, Director of the Provincial Institution for the Insane (Berlin. Springer, 1983),” The Journal of Mental Science 41. 697–703.24. Theodore Gray (1958), The Very Error of the Moon (Ilfracombe &. Devon.

Arthur H. Stockwell Ltd), 64.25. John Galt (1854), “The Farm of St. Anne,” American Journal of Insanity II (1854). 352.26.

Galt, “The Farm of St. Anne,” 352.27. Martin James (1948), “Diagnostic Measures,” in Modern Trends in Psychological Medicine, ed. Noel Haris (London. Buttefwork &.

Co. Ltd), 146. World Health Organization (1953), The Community Mental Hospital. Third Report of the Expert Committee on Mental Health (Geneva. WHO).28.

Carla Yanni (2007), The Architecture of Madness. Insane Asylums in the United States. Minneapolis (London. University of Minnesota Press).29. Key British examples included the 1923 rebuild of London’s Bethlem Hospital which followed the villa model, alongside Shenley Park Mental Hospital (Middlesex County) and Barrow Mental Hospital (Somerset), both constructed in the early 1930s.30.

Taylor, Hospital and Asylum Architecture in England.31. Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66. O. Jenkins, S. Dye and C.

Foy (2015) (Oliver Jenkins et al., 2015), “A Study of Agitation, Conflict and Containment in Association With Change in Ward Physical Environment,” Journal of Psychiatric Intensive Care 11, no. 01. 27–35. M. Daffern, M.M.

Mayer, and T. Martin (2004), “Environmental Contributors to Aggression in Two Forensic Psychiatric Hospitals,” International Journal of Forensic Mental Health 3 no. 1. 105–114. Kathryn L.

Brooks et al. (1994), “Patient Overcrowding in Psychiatric Hospital Units. Effects on Seclusion and Restraint,” Administration and Policy in Mental Health 22, no. 2. 133–44.

T. T Palmstierna, B Huitfeldt, and B Wistedt (1991), “The Relationship of Crowding and Aggressive Behavior on a Psychiatric Intensive Care Unit,” Psychiatric Services 42, no. 12. 1237–40.32. Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 57.

Charles Mercier (1894), Lunatic Asylums. Their Organisation and Management (London. Charles Griffin and Company), 135.33. Morgan Andersson et al. (2013), “New Swedish Forensic Psychiatric Facilities,” 24–38.

Joel A Dvoskin et al. (2002), “Architectural Design of a Secure Forensic State Psychiatric Hospital,” Behavioral Scients &. The Law, 20, no. 3. 481-493.

J. Enser and D. Maclnnes (1999), “The Relationship between Building Design and Escapes from Secure Units,” Journal of the Royal Society for the Promotion of Health 119, no. 3. 170–4.

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Leslie Topp (2007), “The Modern Mental Hospital in Late Nineteenth-Century Germany and Austria. Psychiatric Space and Images of Freedom and Control,” in Madness, Architecture and the Built Environment. Psychiatric Spaces in Historical Context, ed. Leslie Topp, James Moran and Jonathan Andrews (London and New York. Routledge), 244.36.

McLaughlan, “One Dose of Architecture, Taken Daily,” 35. Digby, Madness, Morality and Medicine.37. Anon (1908), “Proposed New Hospital for Mental Diseases,” The Lancet 171, no. 4410. 728–9.38.

Anon, “Proposed New Hospital for Mental Diseases.”39. McLaughlan, “One Dose of Architecture, Taken Daily.”40. Samuel Tuke (1964), “Description of the Retreat (1813),” reprinted in Description of the Retreat With an Introduction by Richard Hunter and Ida Macalpine (London. Dawsons of Paul Mall). Scull, Museums of Madness.

Digby, Madness, Morality and Medicine. Smith, Cure, Comfort and Safe Custody.41. World Health Organization (1953), The Community Mental Hospital. Also refer to T.F Main (1946), “The Hospital as a Therapeutic Institution”, Bulletin of the Menninger Clinic 10, no. 3.

66–71. David Clark (1965), “The Therapeutic Community Concept, Practice and Future,” The Journal of Mental Science 111. 947–54.42. Jolanda Maas et al. (2009), “Social Contacts as a Possible Mechanism behind the Relation between Green Space and Health,” Health &.

Place 15, no. 2. 586–95. Gayle Souter-Brown (2015), Landscape and Urban Design for Health and Well-Being. Using Healing, Sensory and Therapeutic Gardens (Oxon &.

New York. Routledge). Ulrich et al., “A Review of the Research Literature,” 61–125.43. Leon Festinger et al. (1950), Social Pressures in Informal Groups.

A Study of Human Factors in Housing, vol. 11 (New York. Harper Bros). David Halpern (1995), Mental Health and the Built Environment. More than Bricks and Mortar?.

(London. Taylor and Francis). A. Baum and G.E. Davis (1980), “Reducing the Stress of High-Density Living.

An Architectural Intervention,” Journal of Personality and Social Psychology 38, no. 3. 471–81. I. Altman and M.M.

Chemers (1984), Culture and Environment (Monterey, CA. Brooks &. Cole Publishing). Gary W Evans (2003), “The Built Environment and Mental Health,” Journal of Urban Health. Bulletin of the New York Academy of Medicine 80 no.

4. 536–55. Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66.44. Stence Guldager cited in Troldtekt, “Innovative Architecture is Good for Mental Health,” https://www.troldtekt.com/News/Themes/Healing_architecture/Innovative_architecture_is_good_for_mental_health (accessed June 30, 2019). Clare Hickman and “Cheerful Prospects (2009).45.

Frank Pitts cited in Patricia Wen (2012), “For Mentally Ill, A Design Departure,” B News, August 16, https://www.boston.com/news/local-news/2012/08/16/for-mentally-ill-a-design-departure46. Ellenzweig with Architecture Plus, “Massachusetts Department of Mental Health, Worcester Recovery Center and Hospital – Worcester, MA,” Healthcare Design (2013), July 30, https://www.healthcaredesignmagazine.com/architecture/massachusetts-department-mental-health-worcester-recovery-center-and-hospital-worcester-ma/47. Sane Australia (2003), “A Life Without Stigma,” July 25, http://apo.org.au/resource/life-without-stigma. Otto F Wahl (2012), “Stigma as a Barrier to Recovery from Mental Illness,” Trends in Cognitive Sciences 16, no. 1.

9–10. New Zealand Ministry of Health and Health Promotion Agency (2014), “Like Minds, Like Mine National Plan 2014–2019. Programme to Increase Social Inclusion and Reduce Stigma and Discrimination for People with Experience of Mental Illness,” May 20, https://www.likeminds.org.nz/assets/National-Plans/like-minds-like-mine-national-plan-2014-2019-may14.pdf. G Moon (2000), “Risk and Protection. The Discourse of Confinement in Contemporary Mental Health Policy," Health &.

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A transdisciplinary approach.124. WHO (2016). World Antibiotic Awareness Week. 2016 campaign toolkit.

Geneva. World Health Organization.125. Across the three villages, 67% of the workshop attendees were female and the average age of the attendees was 44 years (range. 18 to 81 years.

Based on subsequently collected survey data).126. Nutcha Charoenboon et al. (2019)127. We thank an anonymous reviewer for highlighting the potential hazards of reproducing hierarchies through methods intended to challenge them in the first place.128.

The research was reviewed and approved by the University of Oxford Tropical Research Ethics Committee (Ref. OxTREC 528-17), and it received local ethical approval in Thailand from the Mae Fah Luang University Research Ethics Committee on Human Research (Ref. REH 60099). The service evaluation of the photo exhibition involved anonymised data collection and received a waiver for ethical approval from the University of Warwick Humanities &.

Social Sciences Research Ethics Committee (HSSREC). However, all evaluation form respondents explicitly consented to the data being reported in research publications.129. Marco J Haenssgen et al. (2018)130.

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National Statistical Office.131. Data on the individual level would entail duplication of observations should both census survey rounds be included. Step-level data were aggregated on the illness level for analysis.132. Claire Charlotte McKechnie (2014).

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The humanities, narrative, and the social context of the patient-professional relationship.135. Emma Sacks et al. (2018). "Beyond the building blocks.

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University of Sussex138. WHO (2007). Strengthening health systems to improve health outcomes. WHO’s framework for action.

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Using critical medical humanities to bridge an epistemic gap.141. A Bleakley (2014). Ibid. "Towards a 'critical medical humanities'." In, 17-26.142.

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The questionnaire did so by showing all survey respondents three images of common antibiotic capsules being used in Chiang Rai (green-blue. Amoxicillin. Red-black. Cloxacillin.

White-blue. Azithromycin—see questionnaire page 10 in the online supplementary material). Respondents were asked to name what they saw, and all their answers were recorded (field-coded and as free text).147. The ‘desirability’ of the responses was field coded by the survey team.

Sample responses (as instructed through the survey manual) for ‘desirable’ answers included, for example, “Only if the doctor says that I should”. Sample responses for ‘undesirable’ answers included “Yes, you can buy it in the shop over there!. € The variable should be interpreted as ‘the fraction of respondents who uttered a ‘desirable’ response’—the inverse is the fraction of responses that could not be deemed ‘desirable’ (eg, ‘do not know’ or ‘no opinion’).148. Because recalled descriptions of medicine tend to be ambiguous, we limited our analysis to medicines where we had a high degree of certainty that they were an antibiotic.

This was specifically the case if survey respondents mentioned common antibiotic descriptions such as ‘anti-inflammatory’, ‘amoxi’ or ‘colem’, if they indicated explicitly that they know what ‘anti-inflammatory medicine’ is (noting that the term describes antibiotics unambiguously in Thai), and if they subsequently mentioned any of the previously mentioned antibiotics during their description of an illness episode (conversely, we excluded cases were the medicine could not be confirmed as either antibiotic or non-antibiotic, including descriptions like ‘white powder’ or ‘green capsule’).149. Aristotle (1954). Rhetoric. Translated by Roberts.

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Amsterdam Institute for Social Science Research.154. Although this was not the focus of the current paper, we note for full disclosure that the workshops, too, had mixed behavioural impacts. The poster making sessions in Chiang Rai demonstrated for instance how our conversations about drug resistance and the introduction of messages from the World Health Organization entailed at times problematic interpretations like, “You shouldn’t take medicines that you have never seen before”—the research team responded to such interpretations directly in order to avoid misunderstandings. In addition, previous behavioural analyses documented that, while workshop participants demonstrated higher levels of awareness of drug resistance, alignment of antibiotic use with global health recommendations was mixed, and in one case, a villager started selling antibiotics after the workshop.

For more details on the behavioural analysis, see Nutcha Charoenboon et al. (2019) and Marco Haenssgen et al. (2018).155. For example, Redfern, et al., Spreading the message of antimicrobial resistance.

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10.1177/1468794112446104IntroductionIn Australia, the USA and the UK, the number of hospital beds required for forensic mental health treatment doubled between 1996 and 2016.1 Current trends and future predictions suggest this demand will continue to grow. But, in an age where evidence-based practice is highly valued, the demand for new facilities already outpaces the availability of credible evidence to guide designers. This article reports findings from a desktop survey of current design practice across 31 psychiatric hospitals (24 forensic, 7 non-forensic) constructed or scheduled for completion between 2006 and 2022. Desktop surveys, as a form of research, are heavily relied on in architectural practice.

Photographs and architectural drawings are analysed to understand both typical and innovative approaches to designing a particular building type. While desktop surveys are sometimes supplemented by visits to exemplar projects (which might also be termed ‘fieldwork’), time pressures and budgetary constraints often preclude this. As the result of an academic–industry partnership, the research reported herein embraced practice-based research methods in conjunction with an academic approach. The data set available for the desktop survey was rich but incomplete.

Security requirements restrict the public availability of complete floor plans and postoccupancy evaluations. To mitigate these limitations, knowledge was integrated from other disciplines, including environmental psychology, architectural history and professional practice. With regard to the latter, knowledge is specifically around the design and consultation processes that guide the construction of these facilities. This knowledge was used to identify three contemporary hospitals that challenge accepted design practice and, we argue, in doing so have the potential to act as change-agents in the delivery of forensic mental healthcare.

We define innovation as variation/s to common, or typical, architectural solutions that can positively improve patients’2 experience of these facilities in ways that directly support one, or a number, of key values underpinning forensic mental healthcare. While this article does not provide postoccupancy data to quantify the value of these innovations, we hope to encourage both designers and researchers to more closely consider these projects—particularly the way that spaces have been designed to benefit patient well-being—and the questions these designs raise for the future of forensic mental healthcare delivery.Now regarded as naïve is the 19th-century belief that architecture and landscape, if appropriately designed, can restore sanity.3 Yet contemporary research from the field of evidence-based design confirms that the built environment does play a role in the therapeutic process, even if that role does not determine therapeutic outcomes.4 Research regarding the design of forensic mental healthcare facilities remains limited. An article by Ulrich et al recommended that to reduce aggression patients should be accommodated in single rooms. Communal areas should have movable furniture.

Wards should be designed for low social densities. And accessible gardens should be provided.5 An earlier study by Tyson et al showed that lower ward densities can also positively improve patient–staff interactions.6 Commonly, however, the studies referenced above compared older-style mental health units with their contemporary replacements.7 There is little comparative research available that examines contemporary facilities for forensic mental healthcare, with the exception of one article that provided a comparative analysis of nine Swedish facilities, designed between 1990 and 2008.8 However, this article merely described the design aspirations and physical composition of each hospital without investigating the link between design aspiration, patient well-being and the resulting physical environment.There are two further limitations to evidence-based design research. The first is the extent to which data do not provide directly applicable design tactics. Systematic literature reviews typically provide a set of design recommendations but without suggesting to designers what the corresponding physical design tactics to achieve those recommendations might actually be.9 This is consistent for general hospital design.

For example, architects have been advised to provide spaces that are ‘psychosocially supportive’ since 2000, yet it was 2016 before a spatially focused definition of this term was provided, offering designers a more tangible understanding of what they should be aiming for.10 The second limitation is the breadth of research currently available. While rigorous and valuable, evidence-based design often overlooks the fact that architects must design across scales, from the master-planning scale—deciding where to place buildings of various functions within a site, and how to manage the safe movement of staff and patients between those buildings—to the scale of a bathroom door. How do you design a bathroom door to meet antiligature and surveillance requirements, to maintain patient safety, while still communicating dignity and respect for patients?. The available literature provides much to contemplate, but in terms of credible evidence much of this research is based on a single study, typically conducted within a single hospital context and often focused on a single aspect of design.

This raises the question, is there really a compelling basis for regarding evidence-based design knowledge as more credible than knowledge generated about this building type from other disciplines?. In light of the small amount of evidence available in this field, is there not a responsibility to use all the available knowledge?. While the discipline of evidence-based design has existed for three decades,11 purpose-designed buildings for the treatment of mental illness have been constructed for over three centuries. Researchers working within the field of architectural history also understand that patient experience is partially determined—for better or worse—by the decisions that designers make, and that models of care have been used to drive design outcomes since the establishment of the York Retreat in 1796.

With their focus on moral treatment, the York Retreat influenced a shift in the way asylum design was approached, from the provision of safe custody to finding architectural solutions to support the restoration of sanity.12 Architectural historians also bring evidence to bear in respect of this design challenge, specifically knowledge of how the best architectural intentions can result in unanticipated (sometimes devastating) outcomes—and of the conditions that gave rise to those outcomes.13 There is a third, rich source of knowledge available to guide designers that, broadly speaking, academic researchers have yet to tap into. It is the knowledge produced by practitioners themselves. Architects learn through experience, across multiple projects and through practice-based forms of enquiry that include desktop surveys (also referred to as precedent studies), user group consultations and gathering (often informal) postoccupancy data from their clients. Architects have already offered a range of tangible solutions to meet particular aspirations related to patient care.

There is value in examining these existing design solutions to identify those capable of providing direct benefits to patients that might justify implementation across multiple projects. In understanding how the physical design of forensic psychiatric hospitals can best support the therapeutic journey of patients, all available knowledge should be valued and integrated.Methodology. Embracing ‘mode two’ researchThis research was conducted within the context of a master­-planning and feasibility study, commissioned by a state government department, to investigate various international design solutions to inform future planning around forensic mental health service provisions in Victoria, Australia. The industry-led nature of this project demanded a less conventional and more inclusive methodological approach.

Tight timeframes precluded employing research methods that required ethics approvals (interviewing patients was not possible), while the timeframe and budget precluded the research team from conducting fieldwork. The following obstacles further limited a conventional approach:Postoccupancy evaluations of forensic psychiatric hospital facilities are seldom conducted and/or not made publicly available.14Published floor plans that would enable researchers to derive an understanding of the functional layouts and corresponding habits of occupancy within these facilities are limited owing to the security needs surrounding forensic psychiatric hospital sites.Available literature relevant to the design of forensic psychiatric hospital facilities provides few direct architectural recommendations to offer tactics for how the built environment might support the delivery of treatment.The team had to find a way to navigate these challenges in order to address the important question of how the physical design of forensic psychiatric hospitals can best support the therapeutic journey of patients.‘Mode two’ is a methodological approach that draws on the strength of collaborations between academia and industry to produce ‘socially robust knowledge’ whose reliability extends ‘beyond the laboratory’ to real-world contexts.15 It shares commonalities with a phenomenological approach that attributes value to the prolonged, firsthand exposure of the researcher with the phenomenon in question.16 The inclusion of practising architects and academic researchers within the research team provided considerable expertise in the design, consultation and documentation of these facilities, alongside an understanding of the kinds of challenges that arise following the occupation of this building type. Mode two, as a research approach, also recognises that, while architects reference evidence-based design literature, this will not replace the processes through which practitioners have traditionally assembled knowledge about particular building types, predominantly desktop surveys.A desktop survey was undertaken to understand contemporary design practice within this building type. Forty-four projects were identified as relevant for the period 2006–2022 (31 forensic and 13 non-forensic psychiatric hospitals).

These included facilities from the UK, the USA, Canada, Denmark, Norway, Sweden, the United Arab Emirates and Ireland (online supplementary appendix 1). Sufficient architectural information was not available for 13 of these projects and they were excluded from the study. For the remaining 31 facilities, 24 accommodated forensic patients and 7 did not. Non-forensic facilities were included to enable an awareness of any significant programmatic or functional differences in the design responses created for forensic versus non-forensic mental health patients.

Architectural drawings and photographs were analysed to identify general trends, alongside points of departure from common practice. Borrowing methods from architectural history, the desktop survey was supplemented by other available information, including a mix of hospital-authored guidebooks (as provided to patients and visitors), architects’ statements, newspaper articles and literature from the field of evidence-based design. Available data varied for each of the 31 hospitals. Adopting a method from architectural theorist Thomas Markus, the materiality and placement of external and internal boundary lines were closely studied (assisted by Google Earth).17 When read in conjunction with the architectural drawings, boundary placement revealed information regarding patient access to adjacent landscape spaces.Supplemental materialA desktop survey has limitations.

It cannot provide a conclusive understanding of how these spaces operate when occupied by patients and staff. While efforts were made to contact individual practices and healthcare providers to obtain missing details, such requests typically went unanswered. This is likely owing to concerns of security, alongside the realities of commercial practice, concerns around intellectual property, and complex client and stakeholder arrangements that can act to prohibit the sharing of this information. To deepen the team’s understanding, a 2-day workshop was hosted to which two international architectural practices were invited to attend, one from the UK and one from the USA.

Both practices had recently completed a significant forensic psychiatric hospital project. While neither of these facilities had been occupied at the time of the workshops, the architects were able to share their experiences relative to the research, design, and client and patient consultation processes undertaken. The Australian architects who led the research team also brought extensive experience in acute mental healthcare settings, which assisted in data analysis.To further mitigate the limitations of the desktop survey, understandings developed by the team were used as a basis for advisory panel discussions with staff. Feedback was sought from five 60 min long, advisory panel sessions, each including four to six clinical/facilities staff (who attended voluntarily during work hours) from a forensic psychiatric hospital in Australia, where several participants recounted professional experience in both the Australian and British contexts.

Each advisory panel session was themed relative to various aspects of contemporary design. (1) site/hospital layout, (2) inpatient accommodation, (3) landscape design and access, (4) staff amenities, and (5) treatment hubs (referred to as ‘treatment malls’ in the American context). These sessions enabled the research team to double-check our analysis of the plans and photographs, particularly our assumptions regarding the likely use, practicality and therapeutic value of particular spaces.Model for analysisWithin general hospital design, a range of indicators are used to measure the contribution of architecture to healing, such as the optimisation of lighting to support sleep, the minimisation of patient falls, or whether the use of single patient rooms assists with control.18 In mental health, however, where the therapeutic journey is based more on psychology than physiology, what metrics should be employed to evaluate the success of one design response over another in supporting patient care?. We suggest the first step is to acknowledge the values that underpin contemporary approaches to mental healthcare.

The second step is to translate those treatment values into corresponding spatial values using a value-led spatial framework.19 This provides a checklist for relating particular spatial conditions to specific values around patient care. For example, if the design intent is to optimise privacy and dignity for patients, then the design of bathrooms, relaxation and de-esculation spaces are all important spaces in respect of that therapeutic value. Highlighting this relationship can assist decision makers to more closely interrogate areas that matter most relative to achieving these values. To put this in context, optimising a bathroom design to prioritise a direct line of sight for staff might improve safety but also obstruct privacy and dignity for patients.

While such decisions will always need to be carefully balanced, a value-led spatial framework can provide a touchstone for designers and stakeholders to revisit throughout the design process.To analyse the 31 projects examined within this project, we developed a framework (Table 1). It recognises that a common approach to patient care can be identified across contemporary Australian, British and Canadian models:View this table:Table 1 Value-led spatial framework. Correlating treatment values with corresponding spaces within the hospital’s physical environmentThat patients be extended privacy and dignity to the broadest degree possible without impacting their personal safety or that of other patients or staff.That patients be treated within the least restrictive environment possible relative to the severity of their illness and the legal (or security) requirements attached to their care.That patients be afforded choice and independence relative to freedom of movement within the hospital campus (as appropriate to the individual), extending to a choice of social, recreational and treatment spaces.That patients’ progression through their treatment journey is reflected in the way the architecture communicates to hospital users.That opportunities for peer-led therapeutic processes and involvement of family and community-based care providers be optimised within a hospital campus. 20Table 1 assigns a range of architectural spaces and features that are relevant to each of the five treatment values listed.

Architectural decisions related to these values operate across three scales. Context, hospital and individual. Context decisions are those made in respect of a hospital’s location, including proximity to allied services, connections to public transport and distances to major metropolitan hubs. Decisions of this type are important relative to staffing recruitment and retention, and opportunities for research relative to the psychiatric hospital’s proximity to general (teaching) hospitals or university precincts.

Architectural decisions operating at the hospital scale include considerations of how secure site boundaries are provided. How buildings are laid out on a site. And how spatial and functional links are set up between those buildings. This is important relative to the movement of patients and staff across a site, including the location and functionality of therapeutic hubs.

But it can also impact patient and community psychology. The design of external fences, in particular, can compound feelings of confinement for patients. Focus community attention on the custodial role of a facility over and above its therapeutic function. And influence perceptions of safety and security for the community immediately surrounding the hospital.

Architectural decisions operating at the ‘individual’ scale are those that more closely impact the daily experience of a hospital for patients and staff. These include the various arrangements for inpatient accommodation. Tactics for providing patients with landscape access and views. And the question of staff spaces relative to safety, ease of communication and collaboration.

Approaches to landscape, inpatient accommodation and concerns of staff supervision are closely intertwined.Findings. What we learnt from 31 contemporary psychiatric hospital projectsForensic psychiatric hospitals treat patients who require mental health treatment in addition to a history of criminal offending or who are at risk of committing a criminal offence. Primarily, these include patients who are unfit to stand trial and those found not guilty on account of their illness.21 Accommodation is typically arranged according to low, medium or high security needs, alongside clinical need, and whether an acute, subacute, extended or translational rehabilitation setting is required. Security needs are determined based on the risk a patient presents to themselves and/or others, alongside their risk of absconding from the facility.

The challenge that has proven intractable for centuries is how can architects balance privacy and dignity for patients, while maintaining supervision for their own safety, alongside that of their fellow patients, the staff providing care and, in some cases, the community beyond.22 In this section we present overall trends regarding the layout of buildings within hospital sites, including the placement of treatment hubs and the design of inpatient wards. Access to landscape is not explicitly addressed in this section but is implicit in decisions around site layout and inpatient accommodation.Design approaches to site layoutWe identified two approaches to site layout—the ‘village’ (4 from 31 hospitals) and the ‘campus’ (27 from 31 hospitals) (figure 1). Similar in their functional arrangement, these are differentiated according to the degree of exterior circulation required to move between patient-occupied spaces. Village hospitals comprise a number of buildings sitting within the landscape, while campus hospitals have interconnected buildings with access provided by internal corridors that prevent the need to go outside.

Neither approach is new. Both follow the models first used within the 19th century. The village hospital follows the model designed by Dr Albrecht Paetz in 1878 (Alt Scherbitz, Germany), which included detached cottages accommodating patients in groups of between 24 and 100, set within gardens.23 Paetz created this design in response to his belief that upwards of 1000 patients should not be accommodated in a single building, with security measures determined in relation to those patients whose behaviour was the least predictable.24 The resulting monotony of the daily routine and restrictions on patient movement were believed to ‘cripple the intelligence and depress the spirit’.25 Paetz’s model allowed doctors to classify patients into smaller groups and unlock doors to allow patients with predictable behaviour to wander freely within the secure outer boundaries of the hospital.26 This remained the preferred approach to patient accommodation for over a century, as endorsed by the WHO in their report of 1953.27 Broadmoor Hospital (UK, 2019) provides an example of the village model.The Broadmoor Hospital (left) follows a ‘village’ arrangement and includes an ‘internal’ treatment hub. The Worcester Recovery Center and Hospital (right) follows a ‘campus’ arrangement and includes an ‘on-edge’ treatment hub." data-icon-position data-hide-link-title="0">Figure 1 The Broadmoor Hospital (left) follows a ‘village’ arrangement and includes an ‘internal’ treatment hub.

The Worcester Recovery Center and Hospital (right) follows a ‘campus’ arrangement and includes an ‘on-edge’ treatment hub.The campus model is not dissimilar to the approach propagated by Dr Henry Thomas Kirkbride, a 19th-century psychiatrist who was active in the design of asylums and whose influence saw this planning arrangement dominate asylum constructions in the USA for many decades.28 Asylums of the ‘Kirkbride plan’ arranged patient accommodation in a series of pavilions linked by corridors. While corridors can be heavily glazed, where this action is not taken, the campus approach can compromise patient and staff connections to landscape views. Examples of campus hospitals include the Worcester Recovery Center and Hospital (USA, 2012) and the Nixon Forensic Center (USA, under construction).Treatment hubs are a contemporary addition to forensic psychiatric hospitals. These cluster a range of shared patient spaces, including recreational, treatment and vocational training facilities, and thus drive patient movement around or through a hospital site.

Two different treatment hub arrangements are in use. €˜internal’ and ‘on-edge’. Those arranged internally typically place these functions at the heart of the campus and at a significant distance from the secure boundary line. Those arranged on-edge are placed at the far end of campus-model hospitals and, in the most extreme cases, occur adjacent to one of the site’s external boundaries (refer to Figure 1).

Both arrangements aspire to make life within the hospital resemble life beyond the hospital as closely as possible, as the daily practice of walking from an accommodation area to a treatment hub mimics the practice of travelling from home to a place of work or study.With evidence mounting regarding the psychological benefits to patients of landscape access, it should not be assumed that the current preference for campus hospitals over the village model indicates ‘best practice’. A campus arrangement offers security benefits for the movement of patients across a hospital site, while avoiding the associated risks of contraband concealed within landscaped spaces. However, the existence of village hospitals for forensic cohorts suggests it is possible to successfully manage these challenges. Why then do we see such a strong persistence of the campus hospital?.

This preference may be driven by cultural expectations. From 24 forensic psychiatric hospitals surveyed, 10 were located within the USA and all employed the campus model. Yet nine of those hospitals occupied rural sites where the village model could have been used, suggesting the influence of the Kirkbride plan prevails. The four village hospitals within the broader sample of 31, spanning forensic and non-forensic settings, all occurred within the UK3 and Ireland1.

Paetz’s villa model had been the preferred approach to new constructions in these countries since its introduction at close of the 19th century.29 However, a look at UK hospitals in isolation revealed a more even spread of village and campus arrangements, with two of the four UK-based campus hospitals occupying constrained urban sites that required multi-story solutions. The village model would be inappropriate for achieving this as it does not lend well to urban locations where land availability is scarce.Design approaches to inpatient accommodationThree approaches to inpatient accommodation were identified. €˜peninsula’, ‘race-track’ and ‘courtyard’ (Figure 2). The peninsula model is characterised by rows of inpatient wings, along a single-loaded or double-loaded corridor that stretches into the surrounding landscape.

This typically enables an exterior view from all patient bedrooms and is not dissimilar to the traditional ‘pavilion’ model that emerged within 19th-century hospital design.30 In the racetrack model bedrooms are arranged around a cluster of staff-only (or service) spaces, still enabling exterior views from all patient bedrooms. The courtyard model is similar to the racetrack but includes a central landscape space. Information on the design of inpatient room layouts was available for 24 of the 31 projects analysed (15 of these 24 were forensic).Common inpatient accommodation configurations. (1) Peninsula.

Single-loaded version shown (patient rooms on one side only. Double-loaded versions have patient rooms on two sides of the corridor). (2) racetrack and (3) courtyard (landscaped). Staff-occupied spaces and support spaces (social space and so on) shown in grey." data-icon-position data-hide-link-title="0">Figure 2 Common inpatient accommodation configurations.

(1) Peninsula. Single-loaded version shown (patient rooms on one side only. Double-loaded versions have patient rooms on two sides of the corridor). (2) racetrack and (3) courtyard (landscaped).

Staff-occupied spaces and support spaces (social space and so on) shown in grey.Ten forensic hospitals employed a peninsula plan and five employed a courtyard plan. Of the non-forensic psychiatric hospitals five employed the courtyard, three the racetrack and only one the peninsula plan. While the sample size is too small to generalise, the peninsula plan appears to be favoured for a forensic cohort. However, cultural trends again emerge.

Of the 10 peninsula plan hospitals, 6 were located within the USA, and among the broader sample of 24 (including the non-forensic facilities) none of the courtyard hospitals were located there. Courtyard layouts for forensic patients occurred within the UK, Ireland, Denmark and Sweden. However, within these countries, a mix of courtyard and peninsula plans were used, suggesting no clear preference for one plan over the other.Each plan type has advantages and disadvantages (Table 2). Courtyard accommodation provides the following benefits.

Greater opportunity for patient access to landscape since these are easier for staff to maintain surveillance over. Additional safety for staff owing to continuous circulation (staff cannot get caught in ‘dead-ends’. However, the presence of corners which are difficult to see around is a drawback). Natural light is more easily available.

And ‘swing bedrooms’ can be supported (this is the ability to reconfigure the number of observable bedrooms on a nursing ward by opening and closing doors at different points within a corridor). However, courtyard accommodation requires a larger site area so is better suited to rural locations than urban and is not well suited to multi-story facilities. Peninsula accommodation enables geographical separation, giving medical teams greater opportunity to manage which patients are housed together (‘cohorting’). Blind corners can be avoided to assist safety and surveillance.

Travel distances can be minimised. Finally, the absence of continuous circulation provides greater flexibility for creating social spaces for patients with graduated degrees of (semi-)privacy.View this table:Table 2 Advantages and disadvantages of peninsula versus courtyard accommodationAnother important consideration related to inpatient accommodation is ward size. The number of bedrooms clustered together, alongside the amount of dedicated living space associated with these bedrooms. Ward size can influence patient agitation and aggression, alongside ease of supervision, staff anxiety and safety.31 The most common ward sizes were 24 or 32 beds, further subdivided into subclusters of 8 beds.

Typically, each ward was provided with one large living space that all 24 or 32 patients used together. More advanced approaches gave patients a choice of living spaces. For example, at Coalinga Hospital, patients could occupy a small living space available to only 8 patients, or a larger space that all 24 patients had access to. We describe this approach as more advanced since both 19th-century understandings alongside recent research by Ulrich et al confirm that social density (the number of persons per room) is ‘the most consistently important variable for predicting crowding stress and aggressive behaviour’.32 Only six hospitals had plans detailed enough to calculate the square-metre provision of living space per patient, and this varied between 5 and 8 square metres.Limitations of the desktop surveyData from a desktop survey are insufficient to obtain a comprehensive understanding of how design contributes to patient experience.

To overcome this limitation, the following sections combine knowledge about how people use space from environmental psychology, knowledge about the design and consultation processes that guide the construction of these facilities, and understandings from architectural history. History suggests that seemingly small changes to typical design practice can effect significant change in the delivery of mental healthcare, the daily experience of hospitalised patients and more broadly public perceptions of mental illness. This integrated approach is used to identify three forensic psychiatric hospitals that challenge accepted design practice to varying degrees and, in doing so, have the potential to act as change-agents in the delivery of forensic mental healthcare. But first it is important to understand the context in which architectural innovation is able, or unable, to emerge relative to forensic mental healthcare.Accepting the challenge.

Using history to help us see beyond the roadblocks to innovationArchitects tasked with designing forensic mental health facilities respond to what is called a ‘functional brief’. This documents the specific performance requirements of the hospital in question. Much consultation goes into formulating and refining a functional brief through the initial and developed design stages. Consultation is typically undertaken with a variety of different user groups, and in a sequential fashion that includes a greater cross-section of users as the design progresses, including patients, families, and clinical and security staff.

Despite the focus on patient experience within contemporary models of care, functional briefs tend to prioritise safety and security, making them the basis on which most major architectural decisions are made.33 In large part this is simply the reality of accommodating a patient cohort who pose a risk of harm towards themselves and/or others. A comment from Tom Brooks-Pilling, a member of the design team for the Nixon Forensic Center (Fulton, Missouri), provides insight into this approach and the concerns that drive it. He explained that borrowing a ‘spoked wheel’ arrangement from prison design eliminated blind spots and hiding places to enable a centrally located staff member to:see everything that’s going on in that unit…[they are] basically watching the other staff’s back [sic] to make sure that they can focus on treatment and not worry about who might be sneaking up on them or what activities might be going on behind their backs.34Advisory panel feedback confirmed that when the architectural design of a facility heightens staff anxiety this has direct ramifications for the therapeutic process. For example, in spaces where staff could become isolated from one another, and where clear lines of sight were obstructed, such as ill-designed elevators or stairwells, this can lead to movement being reduced across the patient cohort to avoid putting staff in those spaces where they feel unsafe.The architects consulted during the course of this research, including those who were part of the research team, articulated how the necessary prioritisation of safety, in turn, leads to compromises in the attainment of an ideal environment to support treatment.

In the various forensic and acute psychiatric hospital projects they had been involved with, all observed a sincere commitment on the part of those engaged in project briefing to upholding ideals around privacy, dignity, autonomy and freedom of movement for patients. They reported, however, that the commitment to these ideals was increasingly obstructed as the design process progressed by the more pressing concerns of safety. Examples of the kinds of architectural implications of this prioritisation are things like spatially separated nursing stations (enclosed, often fully glazed), when a desire for less-hierarchical interactions between patients and staff had been expressed at the beginning of the briefing process. Or the substitution of harder-wearing materials, with a more ‘institutional’ feel when a ‘home-like’ atmosphere had been prioritised initially.

There is nothing surprising or unusual about this process since design is, by its nature, a process of seeking improvements on accepted practice while systematically checking the suitability of proposed solutions against a set of performance requirements. In the context of forensic psychiatric hospitals, safety is the performance requirement that most often frustrates the implementation of innovative design. Thus, amid the complexities of design and procurement relative to forensic psychiatric hospitals, innovation, however humble, and particularly where it can be seen to contribute positively to the patient experience, is worth a closer look.In the historical development of the psychiatric hospital as a building type, two significant departures from accepted design practice facilitated positive change in the treatment of mental illness. The first was Paetz’s development of the village hospital which sought to replace high fences, locked doors and barred windows with ‘humane but stringent supervision’.35 While this planning approach may not have significantly altered models of care, it was regarded as ‘an essential, vital development’, providing architectural support to the prevailing approach to treatment of the time—that of moral treatment—which aimed to extend kindness and respect to patients, in an environment that was as unrestrictive as possible.

The York Retreat is worthy of acknowledgement here as a leading proponent of moral treatment whose influence shifted approaches to asylum design, from focusing on the provision of safe custody to supporting the restoration of sanity. Architecturally, however, the differences in the York Retreat’s approach were mainly focused on interior details that encouraged patients to maintain civil habits. Dining rooms had white tablecloths and flower vases adorned mantelpieces, door locks were custom-made to close quietly, and window bars fashioned to look like domestic window frames.36 The York Retreat was originally a small institution, in line with Samuel Tuke’s preference for a maximum asylum size of 30 patients. History confirms the extent to which this approach was not scalable and thus unable to be replicated widely for asylum construction.

For these reasons, it has not been considered here as a significant departure from accepted design practice.The second significant departure from accepted design practice was the development of acute treatment hospitals, located within cities, adjacent to general hospitals and medical research facilities. The first hospital of this type was the Maudsley Hospital, led by doctors Henry Maudsley and Frederick Mott, in London. The design intent for this hospital was announced in 1908 but it was not opened until 1923.37 In proposing this hospital, Maudsley and Mott were motivated to bring psychiatry ‘into line with the other branches of medical science’.38 This 100-bed facility, located directly across the road from the King’s College (Teaching) Hospital, emulated the general hospital typology in offering both outpatient and short-duration inpatient care, specifically targeted at patients with recent-onset illnesses. The aspirations were threefold.

To avoid the stigma associated with large public asylums. To advance the medical understanding of mental illness through research collaborations with general hospitals and medical schools and via improved teaching programmes. And to both enable and encourage patients to access early, voluntary treatment on an outpatient basis.38 Today the Maudsley appears unremarkable, an unassuming three-storied building on a busy London street. But the significance of what this building communicated at the time it was constructed, and the extent to which it challenged accepted practice, should not be underestimated.

The Maudsley sent a clear message to the public that mental illness was no longer to be regarded as different from any other illness treated within a general hospital setting. That it was no longer okay to isolate those suffering from mental illness from their families or the neighbourhoods in which they lived.39 Following the announcement of the Maudsley, the ‘psychopathic hospital’ rose to prominence within the USA with Johns Hopkins University Hospital opening the Phipps Psychiatric Clinic, in Baltimore, in 1913. The psychopathic hospital similarly promoted urban locations and closer connections to teaching and research. The Maudsley can be seen to have played a significant role in the shift to treating acute mental illness within general hospital settings.In any discussion of the history of institutional care, there is a responsibility to acknowledge that the aspiration to provide buildings that support care and recovery have not always manifested in ways that improved daily life for patients.

The five treatment values that underpinned the analysis framework for this project are not new values. The extension of privacy and dignity to patients and the delivery of care within the least restrictive environment possible were both firmly embedded in the 19th-century approach of moral treatment. Yet the rapid growth of asylum care frustrated the delivery of those values to patients.40 Choice and independence for patients, the desire for a patient’s recovery progress to be reflected in their environment, and opportunities for peer support and family involvement have been present in approaches to mental health treatment since the formal endorsement of the ‘therapeutic community’ approach to hospital construction and administration in the WHO’s report of 1953.41 History reminds us, therefore, that differences can arise between the stated values on which an institution is designed and those which it is constructed and operated. The three hospitals discussed in the following section include innovative solutions that hold the promise of positive benefits for patients.

Yet we acknowledge this a theoretical analysis. For concrete evidence of a positive relationship between these design outcomes and patient well-being, postoccupancy evaluations are required.Three hospitals contributing to positive change in forensic mental healthcareBroadmoor Hospital. Optimising the value of the village model for patientsNineteenth-century beliefs and contemporary research are in accord regarding the importance of greenspace in reducing agitation within forensic psychiatric hospital environments and in promoting positive patterns of socialisation.42 It is surprising, therefore, that enshrining daily landscape access for patients is not widespread within current design practice. The Irish National Forensic Mental Hospital and the State Hospital at Carstairs (Scotland) both follow the model of the village hospital, but only in that they comprise a number of accommodation buildings set within the landscape, enclosed by an external boundary fence.

At the Irish National Forensic Mental Hospital, the scale of the landscape—the distance between buildings and the lack of intermediate boundaries within the landscape—suggests it is highly unlikely that patients are allowed to navigate this landscape on a regular basis. By comparison, the architectural response developed for Broadmoor Hospital (2019) shows an exemplary commitment to patient views and access to landscape (Figure 3).Likely extent of landscape occupation by patients as indicated by the position of inner and outer secure boundary lines. (1) Broadmoor Hospital (rural site, UK), (2) Irish National Forensic Mental Hospital (rural site) and (3) Roseberry Hospital (suburban site, UK)." data-icon-position data-hide-link-title="0">Figure 3 Likely extent of landscape occupation by patients as indicated by the position of inner and outer secure boundary lines. (1) Broadmoor Hospital (rural site, UK), (2) Irish National Forensic Mental Hospital (rural site) and (3) Roseberry Hospital (suburban site, UK).Five contemporary hospitals follow the logic of a traditional villa hospital, yet Broadmoor is the only one that optimises the benefits offered by this spatial configuration.

Comprising a gateway building and a central treatment hub, with a series of patient accommodation buildings positioned around it, the landscape becomes the only available circulation route for patients travelling off-ward to the shared therapy, recreation and vocational training spaces. Most patients will thus engage with the outdoors at least twice daily on their way to and return from these shared spaces. But in addition to accessing this central landscape, landscape views from patient rooms have been prioritised, and each ward is allocated its own large greenspace. Multiple, internal boundary fences enable patient access to the adjacent landscape to the greatest possible degree (refer to Figure 3).

This approach provides patients with a diversity of landscape experiences. This is important given the patterns of landscape use between forensic and non-forensic hospitals. In non-forensic facilities, patients are likely to have the choice of accessing multiple landscape spaces, whereas in forensic facilities access to a particular space is often restricted to one cohort, for example, a single ward group. This highlights a limitation of the courtyard model for forensic patients.

Roseberry Park Hospital (2012) provides an example of how a high degree of landscape access can be similarly achieved for patients on constrained urban site, using a courtyard layout (refer to Figure 3).Providing patients with daily landscape access provides challenges to maintaining safety and security. Trees with low branches can be used as weapons, while tall branches can be used for self-harm, and ground cover landscaping increases opportunities to conceal contraband. At the Australian hospital where advisory panel sessions were conducted (constructed in 2000), the landscape is occupied in a similar way and staff conveyed the constant effort required to ensure safe patient access to this greenspace. Significant costs are incurred annually by facilities staff in keeping the greenspace free from contraband and from several varieties of wild mushroom that grow seasonally on the site.

Despite this cost, staff reported that both they and the patients value the opportunity to circulate through the landscaped grounds (even in inclement weather). Hence, the benefits to well-being are perceived as significant enough to justify this cost. These examples make evident that placing a hospital within a landscape is not enough to ensure patients are extended the well-being benefits of ongoing access. Instead this requires that hospitals factor in the additional supervisory and maintenance requirements to maintain landscape access for patients.Worcester Recovery Center and Hospital.

Spaces to support choice and a sense of controlResearch in environmental psychology, conducted within residential and hospital settings, confirms that the ability to regulate social contact can have a dramatic impact on well-being. The physical layout of spaces has been linked to both the likelihood of developing socially supportive relationships and impeding this development, with direct implications for communication, concentration, aggression and a person’s resilience to irritation.43 These problems can be more pronounced in a forensic psychiatric hospital as there is an over-representation of patients who have suffered trauma. Architects working in forensic psychiatric hospital design acknowledge that patients need space to withdraw from the busy hospital environment, spaces where they can ‘observe everything that is going on around them until they feel ready to join in’.44 It is surprising, therefore, that many contemporary forensic psychiatric hospitals still continue to provide a single social space for all 24 or 32 patients occupying a ward. The Worcester Recovery Center, by comparison, provides patients with a choice of social spaces that are designed to enable graduated degrees of social engagement.

This can support a sense of control to limit socially induced stress.Worcester is conceptualised as three distinct zones designed to resemble life beyond the hospital. The ‘house’, ‘neighbourhood’ and ‘downtown’ (Figure 4). The house zones include patient accommodation, employing a peninsula model. Each comprises 26 patient rooms, clustered into groups of 6 or 10 single bedrooms that face a collection of shared spaces dedicated to that cluster, including sitting areas, lounges and therapeutic spaces.

A shared kitchen and dining room is provided for each house. Three houses feed into a neighbourhood zone that includes shared spaces for therapy and vocational training, while the downtown zone serves a total of 14 houses. The downtown zone can be accessed by patients based on a merit system and includes a café, bank and retail spaces, music room, health club, chapel, green house, library and art rooms, alongside large interior public spaces. This array of amenities does not seem distinctly different from other contemporary facilities, where therapy and vocational training happen in a mix of on-ward and off-ward (often within a central treatment hub).

The difference lies in the sensitivity of how these spaces are articulated.Details of the social spaces provided on each ward at the Worcester Recovery Center and the proximity of the ‘house’ (or ward) to the ‘neighbourhood’ and ‘downtown’." data-icon-position data-hide-link-title="0">Figure 4 Details of the social spaces provided on each ward at the Worcester Recovery Center and the proximity of the ‘house’ (or ward) to the ‘neighbourhood’ and ‘downtown’.The generosity of providing separate living spaces for every 6–10 patients and locating these directly across the corridor from the patient rooms supports a sense of control and choice for patients. Frank Pitts, an architect who worked on the Worcester project, has written that this was done to enable patients to ‘decide whether they are ready to step out and socialise or return to the privacy of their room’.45 This approach filters throughout the facility, providing a slow graduation of social engagement opportunities for patients, from opportunities to socialise with their cluster of 6–10 individuals, to their house of 26, to their neighbourhood of 78 people, to the full downtown experience. According to the architects, the neighbourhood thus provides an intermediary zone between the quiet house and the active downtown, which can be overwhelming for some patients.46 Importantly the scale of the architecture responds to this transition from personal to public space, providing visual indicators to reflect patients’ movement through their treatment journey. Spaces become larger as they move further from the ward.

This occurs because instead of providing a single, large shared living space, patients are provided a choice of smaller spaces to occupy—these are not much bigger than a patient bedroom. Dining spaces are slightly larger, while downtown spaces have a civic quality. These are double-height, providing a greater sense of light and airiness. These are arranged in a semicircle, opening onto a large veranda and greenspace.

The sensitive articulation of these spaces, with regard to both their graduated physical scale and the proximity of the social spaces to the patient bedrooms, provides spatial support to these social transitions while empowering patients to control their own level of social interaction.Margaret and Charles Juravinski Centre for Integrated Healthcare. Creating opportunities for greater public engagement and supporting readjustment to the world beyond the hospitalOne of the most significant barriers to mental health treatment is the stigma associated with admission to a psychiatric hospital. We know that discrimination poses an obstacle to recovery and that the media fuels public fears related to forensic mental health patients.47 Two further challenges to mental health delivery include the disconnection patients can experience from the community, including from family and educational opportunities, and the risk of readmission in the period immediately following discharge.48 If architecture is capable of acting as a change-agent in the delivery of mental healthcare, then it needs to show leadership, not only in the provision of a better experience for patients but more broadly in taking steps to help shift public perceptions around mental illness. The Margaret and Charles Juravinski Centre for Integrated Healthcare (MCJC) (Canada) displays several similarities with the approach taken to the Maudsley Hospital.

Its appearance communicates a modern, cutting-edge healthcare facility. It does not hide on a rural site or behind walls. At five stories, and extensively glazed, MCJC communicates a strong civic presence. Its proximity to McMaster University (6 km) and to neighbouring general hospitals, including Juravinski Hospital (4 km) and Hamilton General Hospital (4 km), positions it well for research collaborations to occur, while its proximity to the Mohawk Community College, across the road, can enable patients with leave privileges to access vocational training.

More importantly, it employs three innovative design tactics to target the challenges of contemporary forensic mental healthcare, providing an example for how architecture might broker positive change.The first innovative design strategy is the co-location of support services for outpatient mental healthcare. The risk of readmission is highest immediately following discharge. A lack of collaboration between outpatient support services can result in fragmented care when patients are most vulnerable to the stresses associated with readjustment to the world beyond.49 MCJC includes outpatient facilities allowing patients to use the hospital as a stable base, or touchstone, in adjusting to life after discharge. Bringing these services onto the same physical site can also improve opportunities for coordination between inpatient and outpatient support services which can support continuity of care.

The second design strategy is the co-location of a medical ambulatory care centre which includes diagnostic imaging, educational and research facilities. This creates reasons for the general public to visit this facility, setting up the opportunity for greater public interaction. This could potentially advance understandings of the role of this facility and the patients it treats.The third innovative design strategy was to optimise the on-edge treatment hub for public engagement. While adopted across a number of hospitals, including Hawaii State Hospital, Helix Forensic Psychiatry Clinic (Sweden) and the Worcester Recovery Center, the on-edge treatment hubs at these hospitals are buried deep inside the secure outer boundary.

At MCJC, the treatment hub is placed adjacent to the public zones of the hospital—although on the second floor—and this can be viewed as extension of the public realm and enables the potential for the public to be brought right up to the secure boundary line (which occurs within the building). MCJC is divided into four zones. The public zone, the galleria (the name given to the treatment hub), the clinical corridor and inpatient accommodation (Figure 5). The galleria functions similarly to the downtown at the Worcester Recovery Center.

Patients are given graduated access to a series of spaces that support their recovery journey. These include a gym, wellness centre, spiritual centre, library, café, beauty salon, and retail and financial services, alongside patient and family support services. While the galleria was initially intended to be accessible by the general public, this was not immediately implemented on the facilities’ opening and it is unclear whether this has now occurred.50 Nonetheless, the potential for movement of patients outwards, and families inwards, has been built into the physical fabric of this building, meaning opportunities for social interaction and fostering greater public understanding are possible. If understanding is the antidote to discrimination, then exposing the public to the role of this facility and the patients it treats is an important step in the right direction.Zoning configuration at the Margaret and Charles Juravinski Centre for Integrated Healthcare.

The galleria zone is on the second floor (shown in black). The arrows indicate main access points to the galleria. Lifts (L) and stairwell (S) positions are indicated." data-icon-position data-hide-link-title="0">Figure 5 Zoning configuration at the Margaret and Charles Juravinski Centre for Integrated Healthcare. The galleria zone is on the second floor (shown in black).

The arrows indicate main access points to the galleria. Lifts (L) and stairwell (S) positions are indicated.ConclusionThe question of how architecture can support the therapeutic journey of forensic mental health patients is a critical one. Yet the availability of evidence-based design literature to guide designers cannot keep pace with growing global demand for new forensic psychiatric hospital facilities, while limitations remain relative to the breadth and usability of this research. A narrow view of what constitutes credible evidence can overlook the value of knowledge embedded in architectural practice, alongside that held by architectural historians and lessons from environmental psychology.

In respect of such a pressing and important problem, there is a responsibility to integrate knowledge from across these disciplines. Accepting the limitations of a theoretical analysis and of the desktop survey method, we also argue for its value. Architects learn through experience, across multiple projects. This gives weight to the value of examining existing, contemporary design solutions to identify architectural innovations capable of providing benefits to patients and thus perhaps worthy of implementation across multiple projects.

History gives us reason to believe that small changes to typical design practice can improve the delivery of mental healthcare, the daily experience of hospitalised patients and more broadly public perceptions of mental illness. Architecture has the capacity to contribute to positive change.Here, we have provided a nuanced way for architects and decision makers to think about the relationship between architectural space and treatment values. An institution’s model of care and the therapeutic values that underpin that model of care should be placed at the centre of architectural decision making. A survey of contemporary architectural solutions confirms that, generally speaking, innovation is lacking in this field.

There will always be real obstacles to innovation, and the argument presented here does not suggest it is necessarily practical to prioritise therapeutic values at the cost of patient, staff and community safety. Instead, it challenges architects and decision makers to properly interrogate any architectural decision that compromises an initial commitment to supporting a patient’s treatment journey—to be more idealistic in the pursuit of positive change.Tangible examples exist of architectural innovations capable of positively improving patient experience by supporting key values that underpin contemporary treatment approaches. The Broadmoor Hospital optimises the value of the village model for patients, prioritising patient needs for frequent landscape engagement to support their therapeutic journey. The Worcester Recovery Center provides a generous choice and graduation of social spaces to support the social reintegration of patients at their own pace.

MCJC co-located facilities to support a patient’s readjustment to daily life postdischarge, while creating opportunities for public engagement that has the potential to foster greater public understanding of the role of these institutions and the patients they treat. In identifying these three innovative design approaches, we provide architects with tangible design tactics, while encouraging researchers to look more closely at these examples with targeted, postoccupancy studies. These projects provide hope that with a shared vision and commitment, innovation is possible in forensic psychiatric hospital design, with tangible benefits for patients.Data availability statementAll data relevant to the study are included in the article or uploaded as supplementary information. The primary method undertaken for this research relied on data publicly available on the internet.Ethics statementsPatient consent for publicationNot required.AcknowledgmentsThe opportunity to conduct this project arose out of a multidisciplinary master-planning and feasibility study, commissioned by the Victorian Health and Human Services Building Authority, to investigate various international solutions to inform future planning and design around forensic mental health service provision.

The following people contributed their time and expertise in shaping the research process that enabled this article. Neel Charitra, Stefano Scalzo, Les Potter, Margaret Grigg, Lousie Bawden, Matthew Balaam, Martin Gilbert, John MacAllister, Crystal James, Jo Ryan, Julie Anderson, Jo Wasley, Sophie Patitsas, Meagan Thompson, Judith Hemsworth, James Watson, Viviana Lazzarini, Krysti Henderson, Nadia Jaworski, Jack Kerlin and Jan Merchant.Notes1. Jamie O'Donahoo and Janette Graetz Simmonds (2016), “Forensic Patients and Forensic Mental Health in Victoria. Legal Context, Clinical Pathways, and Practice Challenges,” Australian Social Work 69, no.

2. 169–80.2. The challenge of which terminology to select when writing about psychiatric hospital design remains difficult relative to the stigmas that surround this field. The term ‘patient’ has been used throughout, instead of ‘consumer’, as this article spans both historical and contemporary developments.

In the context of this timespan, consumer is a relatively recent term, introduced around 1985.3. B Edginton (1994), “The Well-Ordered Body. The Quest for Sanity through Nineteenth-Century Asylum Architecture,” Canadian Bulletin of Medical History 11, no. 2.

375–86. Clare Hickman (2009), “Cheerful Prospects and Tranquil Restoration. The Visual Experience of Landscape as Part of the Therapeutic Regime of the British Asylum, 1800-60,” History of Psychiatry 20, no. 4 Pt 4.

425–41. Rebecca McLaughlan, 2012), “Post-Rationalisation and Misunderstanding. Mental Hospital Architecture in the New Zealand Media,” Fabrications 22, no. 2.

232–56.4. Roger S Ulrich et al. (2008), “A Review of the Research Literature on Evidence-Based Healthcare Design,” HERD 1, no. 3.

61–125. Jill Maben et al. (2015), “Evaluating a Major Innovation in Hospital Design. Workforce Implications and Impact on Patient and Staff Experiences of All Single Room Hospital Accommodation,” Health Services and Delivery Research 3.

1–304. Penny Curtis and Andy Northcott (2017), “The Impact of Single and Shared Rooms on Family-Centred Care in Children’s Hospitals,” Journal of Clinical Nursing 26, no. 11–12. 1584–96.5.

Roger S. Ulrich et al. (2018), “Psychiatric Ward Design Can Reduce Aggressive Behavior,” Journal of Environmental Psychology 57. 53–66.6.

Graham A Tyson, Gordon Lambert, and Lyn Beattie (2002), “The Impact of Ward Design on the Behaviour, Occupational Satisfaction and Well-Being of Psychiatric Nurses,” International Journal of Mental Health Nursing 11, no. 2. 94–102.7. For further examples of this see Jon E.

Eggert et al. (2014), “Person-Environment Interaction in a New Secure Forensic State Psychiatric Hospital,” Behavioral Sciences &. The Law 32, no. 4.

527–38. C.C. Whitehead et al. (1984), “Objective and Subjective Evaluation of Psychiatric Ward Redesign,” The American Journal of Psychiatry 141, no.

5. 639–44. Gabriela Novotná et al. (2011), “Client-Centered Design of Residential Addiction and Mental Health Care Facilities.

Staff Perceptions of Their Work Environment,” Qualitative Health Research 21, no. 11. 1527–38.8. Morgan Andersson et al.

(2013), “New Swedish Forensic Psychiatric Facilities. Visions and Outcomes,” Facilities 31, no 1/2. 24–88.9. For examples see Kathleen Connellan et al.

(2013), “Stressed Spaces. Mental Health and Architecture,” HERD. Health Environments Research &. Design Journal 6, no.

4. 127–168. Constantina Papoulias et al. (2014), “The Psychiatric Ward as a Therapeutic Space.

Systematic Review,” British Journal of Psychiatry 205, no. 3. 171–6.10. R.

Allen and R.G. Nairn, 1997. Alan Dilani, 2000, “Psychosocially Supportive Design - Scandinavian Health Care Design,” World Hospitals and Health Services 37. 20–4.

Rebecca McLaughlan (2018), “Psychosocially Supportive Design. The Case for Greater Attention to Social Space within the Pediatric Hospital," HERD 11, no. 2. 151–62.11.

Rebecca McLaughlan (2017), “Learning From Evidence-Based Medicine. Exclusions and Opportunities within Health Care Environments Research,” Design for Health 1. 210–28.12. B Edginton (1997), “Moral Architecture.

The Influence of the York Retreat on Asylum Design,” Health &. Place 3, no. 2. 91–9.

Jeremy Taylor (1991), Hospital and Asylum Architecture in England 1849–1914. Building for Health Care (London. Mansell Publishing Limited). Anne Digby (1985), Madness, Morality and Medicine.

A Study of the York Retreat 1796–1914 (New York. Cambridge University Press).13. Digby, Madness, Morality and Medicine. Erving Goffman (1961), Asylums.

Essays on the Social Situation of Mental Patients and Other Inmates (New York. Doubleday). Ivan Belknap (1956), Human Problems of a State Mental Hospital (New York. Blakiston Division, McGraw-Hill).

Andrew Scull (1979), Museums of Madness. The Social Organization of Insanity in 19th Century England (London. Allen Lane). Leonard Smith (1999), Cure, Comfort and Safe Custody.

Public Lunatic Asylums in Early Nineteenth-Century England (London. Leicester University Press). Rebecca McLaughlan (2014), “One Dose of Architecture, Taken Daily. Building for Mental Health in New Zealand” (PhD diss., Victoria University of Wellington, New Zealand).14.

Although not fitting a strict definition of postoccupancy evaluation, the following articles were notable exceptions to this finding. Eggert et al., “Person-Environment Interaction,” 527–38. Roger S. Ulrich et al.

(2018), “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66. Catherine Clark Ahern et al. (2016), “A Recovery-Oriented Care Approach. Weighing the Pros and Cons of a Newly Built Mental Health Facility,” Journal of Psychosocial Nursing and Mental Health Services 54, no.

2. 39–48.15. M Gibbons (2000), “Mode 2 Society and the Emergence of Context-Sensitive Science,” Science and Public Policy 27. 161.16.

D Seamon, 2000, “A Way of Seeing People and Place,” in Theoretical Perspectives in Environment-Behavior Research, ed. S. Wapner, J. Demick, T.

Yamamoto and H. Minami (New York. Plenum), 157–78.17. Thomas A Markus (1982), Order in Space and Society.

Architectural Form and Its Context in the Scottish Enlightenment (Edinburgh. Mainstream Publishing Company).18. Ulrich et al., “A Review of the Research Literature,” 61–125.19. This was first created by first author for use for historical analysis during her PhD and is applied here to a contemporary setting.

Refer to McLaughlan, “One Dose of Architecture, Taken Daily.”20. The following documents were referenced in compiling this list. Joint Commission Panel for Mental Health, NHS, UK (2013), “Guidance for Commissioners of Forensic Mental Health Services,” May, https://www.jcpmh.info/resource/guidance-for-commissioners-of-forensic-mental-health-services/. Cannon Design (2014), “St Joseph’s Integrated Healthcare Hamilton, Margaret and Charles Juravinski Centre for Integrated Healthcare,” Healthcare Design Showcase, September.

Health Nexus Group, 2017, “Forensicare Model of Care Report,” April, Australia (access provided by the Victorian Health and Human Services Building Authority). Donald Cant Watts Corke (2014), “Service Plan for Forensic Mental Health Services,” July, Australia (access provided by the Victorian Health and Human Services Building Authority).21. Sometimes this includes patients with no history of criminal behaviour but who are unable to be treated safely in a general hospital environment.22. W.A.F Browne (1991), "What Asylums Were, Are and Ought to Be (1837),” reprinted in The Asylum as Utopia.

W.A.F. Browne and the Mid-Nineteenth Century Consolidation of Psychiatry, ed. Andrew Scull (London. Tavistock).

Morgan Andersson et al. (2013), “New Swedish Forensic Psychiatric Facilities,” 24–38. Eggert et al., “Person-Environment Interaction.”23. Anon (1895), “Review.

The Colonization of the Insane in Connection with the Open-Door System. Its Historical Development and the Mode in Which It Is Carried Out at Alt Scherbitz Manor. By Dr. Albrecht Paetz, Director of the Provincial Institution for the Insane (Berlin.

Springer, 1983),” The Journal of Mental Science 41. 697–703.24. Theodore Gray (1958), The Very Error of the Moon (Ilfracombe &. Devon.

Arthur H. Stockwell Ltd), 64.25. John Galt (1854), “The Farm of St. Anne,” American Journal of Insanity II (1854).

352.26. Galt, “The Farm of St. Anne,” 352.27. Martin James (1948), “Diagnostic Measures,” in Modern Trends in Psychological Medicine, ed.

Noel Haris (London. Buttefwork &. Co. Ltd), 146.

World Health Organization (1953), The Community Mental Hospital. Third Report of the Expert Committee on Mental Health (Geneva. WHO).28. Carla Yanni (2007), The Architecture of Madness.

Insane Asylums in the United States. Minneapolis (London. University of Minnesota Press).29. Key British examples included the 1923 rebuild of London’s Bethlem Hospital which followed the villa model, alongside Shenley Park Mental Hospital (Middlesex County) and Barrow Mental Hospital (Somerset), both constructed in the early 1930s.30.

Taylor, Hospital and Asylum Architecture in England.31. Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66. O. Jenkins, S.

Dye and C. Foy (2015) (Oliver Jenkins et al., 2015), “A Study of Agitation, Conflict and Containment in Association With Change in Ward Physical Environment,” Journal of Psychiatric Intensive Care 11, no. 01. 27–35.

M. Daffern, M.M. Mayer, and T. Martin (2004), “Environmental Contributors to Aggression in Two Forensic Psychiatric Hospitals,” International Journal of Forensic Mental Health 3 no.

(1994), “Patient Overcrowding in Psychiatric Hospital Units. Effects on Seclusion and Restraint,” Administration and Policy in Mental Health 22, no. 2. 133–44.

T. T Palmstierna, B Huitfeldt, and B Wistedt (1991), “The Relationship of Crowding and Aggressive Behavior on a Psychiatric Intensive Care Unit,” Psychiatric Services 42, no. 12. 1237–40.32.

Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 57. Charles Mercier (1894), Lunatic Asylums. Their Organisation and Management (London. Charles Griffin and Company), 135.33.

Morgan Andersson et al. (2013), “New Swedish Forensic Psychiatric Facilities,” 24–38. Joel A Dvoskin et al. (2002), “Architectural Design of a Secure Forensic State Psychiatric Hospital,” Behavioral Scients &.

Enser and D. Maclnnes (1999), “The Relationship between Building Design and Escapes from Secure Units,” Journal of the Royal Society for the Promotion of Health 119, no. 3. 170–4.

Jon E. Eggert et al. (2014), “Person-Environment Interaction,” 527–38.34. Tom Brooks-Pilling cited in Mike Lear (2015), “Designer.

New Fulton State Hospital Will Be Better, Safer,” Missourinet, January 5, https://www.missourinet.com/2015/01/05/designer-new-fulton-state-hospital-will-be-better-safer/35. Leslie Topp (2007), “The Modern Mental Hospital in Late Nineteenth-Century Germany and Austria. Psychiatric Space and Images of Freedom and Control,” in Madness, Architecture and the Built Environment. Psychiatric Spaces in Historical Context, ed.

Leslie Topp, James Moran and Jonathan Andrews (London and New York. Routledge), 244.36. McLaughlan, “One Dose of Architecture, Taken Daily,” 35. Digby, Madness, Morality and Medicine.37.

Anon (1908), “Proposed New Hospital for Mental Diseases,” The Lancet 171, no. 4410. 728–9.38. Anon, “Proposed New Hospital for Mental Diseases.”39.

McLaughlan, “One Dose of Architecture, Taken Daily.”40. Samuel Tuke (1964), “Description of the Retreat (1813),” reprinted in Description of the Retreat With an Introduction by Richard Hunter and Ida Macalpine (London. Dawsons of Paul Mall). Scull, Museums of Madness.

Digby, Madness, Morality and Medicine. Smith, Cure, Comfort and Safe Custody.41. World Health Organization (1953), The Community Mental Hospital. Also refer to T.F Main (1946), “The Hospital as a Therapeutic Institution”, Bulletin of the Menninger Clinic 10, no.

3. 66–71. David Clark (1965), “The Therapeutic Community Concept, Practice and Future,” The Journal of Mental Science 111. 947–54.42.

Jolanda Maas et al. (2009), “Social Contacts as a Possible Mechanism behind the Relation between Green Space and Health,” Health &. Place 15, no. 2.

586–95. Gayle Souter-Brown (2015), Landscape and Urban Design for Health and Well-Being. Using Healing, Sensory and Therapeutic Gardens (Oxon &. New York.

Routledge). Ulrich et al., “A Review of the Research Literature,” 61–125.43. Leon Festinger et al. (1950), Social Pressures in Informal Groups.

A Study of Human Factors in Housing, vol. 11 (New York. Harper Bros). David Halpern (1995), Mental Health and the Built Environment.

More than Bricks and Mortar?. (London. Taylor and Francis). A.

Baum and G.E. Davis (1980), “Reducing the Stress of High-Density Living. An Architectural Intervention,” Journal of Personality and Social Psychology 38, no. 3.

471–81. I. Altman and M.M. Chemers (1984), Culture and Environment (Monterey, CA.

Brooks &. Cole Publishing). Gary W Evans (2003), “The Built Environment and Mental Health,” Journal of Urban Health. Bulletin of the New York Academy of Medicine 80 no.

4. 536–55. Ulrich et al., “Psychiatric Ward Design Can Reduce Aggressive Behavior,” 53–66.44. Stence Guldager cited in Troldtekt, “Innovative Architecture is Good for Mental Health,” https://www.troldtekt.com/News/Themes/Healing_architecture/Innovative_architecture_is_good_for_mental_health (accessed June 30, 2019).

Clare Hickman and “Cheerful Prospects (2009).45. Frank Pitts cited in Patricia Wen (2012), “For Mentally Ill, A Design Departure,” B News, August 16, https://www.boston.com/news/local-news/2012/08/16/for-mentally-ill-a-design-departure46. Ellenzweig with Architecture Plus, “Massachusetts Department of Mental Health, Worcester Recovery Center and Hospital – Worcester, MA,” Healthcare Design (2013), July 30, https://www.healthcaredesignmagazine.com/architecture/massachusetts-department-mental-health-worcester-recovery-center-and-hospital-worcester-ma/47. Sane Australia (2003), “A Life Without Stigma,” July 25, http://apo.org.au/resource/life-without-stigma.

Otto F Wahl (2012), “Stigma as a Barrier to Recovery from Mental Illness,” Trends in Cognitive Sciences 16, no. 1. 9–10. New Zealand Ministry of Health and Health Promotion Agency (2014), “Like Minds, Like Mine National Plan 2014–2019.

Programme to Increase Social Inclusion and Reduce Stigma and Discrimination for People with Experience of Mental Illness,” May 20, https://www.likeminds.org.nz/assets/National-Plans/like-minds-like-mine-national-plan-2014-2019-may14.pdf. G Moon (2000), “Risk and Protection. The Discourse of Confinement in Contemporary Mental Health Policy," Health &. Place 6, no.

Nairn (1997), “Media Depictions of Mental Illness. An Analysis of the Use of Dangerousness,” Australian &. New Zealand Journal of Psychiatry 31, no. 3.

375–81. Greg Philo et al. (1994), “The Impact of the Mass Media on Public Images of Mental Illness. Media Content and Audience Belief,” Health Education Journal 53, no.

3. 271–81.48. G Moon (2000), “Risk and Protection,” 239–50. T.F Main (1948), “Rehabilitation and the Individual,” in Modern Trends in Psychological Medicine, ed.

Noel Haris (London. Buttefwork &. Co. Ltd).

D.A Fuller, E. Sinclair, and J. Snook (2016), “Released, Relapsed, Rehospitalized. Length of Stay and Readmission Rates in State Hospitals.

A Comparative State Survey,” 2016, https://www.treatmentadvocacycenter.org/storage/documents/released-relapsed-rehospitalized.pdf. Leila Salem et al. (2015), “Supportive Housing and Forensic Patient Outcomes,” Law and Human Behavior 39, no. 3.

311.49. National Institute for Health and Clinical Excellence, Manchester (2016), “Transition between Inpatient Mental Health Settings and Community or Care Home Settings. Guideline,” August, https://www.nice.org.uk/guidance/ng53/evidence/full-guideline-pdf-260695191750. Catherine Clark Ahern et al.

(2016), “A Recovery-Oriented Care Approach,” 47..

Lasix diuretic otc

Specificity of hypertension Antibody Assays Both assays measuring pan-Ig lasix diuretic otc antibodies had low numbers of false positives among samples collected in 2017. There were 0 and 1 false positives for the two assays among 472 samples, results that compared favorably with those obtained with the single IgM anti-N and lasix diuretic otc IgG anti-N assays (Table S3). Because of the low prevalence of hypertension in Iceland, we required positive results from both pan-Ig antibody assays for a sample to be considered seropositive (see Supplementary Methods in Supplementary Appendix 1). None of the samples collected in early 2020 group were seropositive, which indicates that the lasix had not spread widely in Iceland before February 2020 lasix diuretic otc. hypertension Antibodies among qPCR-Positive Persons Figure 2.

Figure 2 lasix diuretic otc. Antibody Prevalence and Titers among qPCR-Positive Cases as lasix diuretic otc a Function of Time since Diagnosis by qPCR. Shown are the percentages of samples positive for both pan-Ig antibody assays and the antibody titers. Red denotes the count or percentage lasix diuretic otc of samples among persons during their hospitalization (249 samples from 48 persons), and blue denotes the count or percentage of samples among persons after they were declared recovered (1853 samples from 1215 persons). Vertical bars denote 95% confidence intervals.

The dashed lines indicated the thresholds for a test to lasix diuretic otc be declared positive. OD denotes lasix diuretic otc optical density, and RBD receptor binding domain.Table 1. Table 1. Prevalence of hypertension Antibodies by Sample Collection as Measured by Two Pan-Ig lasix diuretic otc Antibody Assays. Twenty-five days after diagnosis by qPCR, more than 90% of samples from recovered persons tested positive with both pan-Ig antibody assays, and the percentage of persons testing positive remained stable thereafter (Figure 2 and Fig.

S2). Hospitalized persons seroconverted more frequently and quickly after qPCR diagnosis than did nonhospitalized persons (Figure 2 and Fig. S3). Of 1215 persons who had recovered (on the basis of results for the most recently obtained sample from persons for whom we had multiple samples), 1107 were seropositive (91.1%. 95% confidence interval [CI], 89.4 to 92.6) (Table 1 and Table S4).

Since some diagnoses may have been made on the basis of false positive qPCR results, we determined that 91.1% represents the lower bound of sensitivity of the combined pan-Ig tests for the detection of hypertension antibodies among recovered persons. Table 2. Table 2. Results of Repeated Pan-Ig Antibody Tests among Recovered qPCR-Diagnosed Persons. Among the 487 recovered persons with two or more samples, 19 (4%) had different pan-Ig antibody test results at different time points (Table 2 and Fig.

S4). It is notable that of the 22 persons with an early sample that tested negative for both pan-Ig antibodies, 19 remained negative at the most recent test date (again, for both antibodies). One person tested positive for both pan-Ig antibodies in the first test and negative for both in the most recent test. The longitudinal changes in antibody levels among recovered persons were consistent with the cross-sectional results (Fig. S5).

Antibody levels were higher in the last sample than in the first sample when the antibodies were measured with the two pan-Ig assays, slightly lower than in the first sample when measured with IgG anti-N and IgG anti-S1 assays, and substantially lower than in the first sample when measured with IgM anti-N and IgA anti-S1 assays. IgG anti-N, IgM anti-N, IgG anti-S1, and IgA anti-S1 antibody levels were correlated among the qPCR-positive persons (Figs. S5 and S6 and Table S5). Antibody levels measured with both pan-Ig antibody assays increased over the first 2 months after qPCR diagnosis and remained at a plateau over the next 2 months of the study. IgM anti-N antibody levels increased rapidly soon after diagnosis and then fell rapidly and were generally not detected after 2 months.

IgA anti-S1 antibodies decreased 1 month after diagnosis and remained detectable thereafter. IgG anti-N and anti-S1 antibody levels increased during the first 6 weeks after diagnosis and then decreased slightly. hypertension in Quarantine Table 3. Table 3. hypertension among Quarantined Persons According to Exposure Type and Presence of Symptoms.

Of the 1797 qPCR-positive Icelanders, 1088 (61%) were in quarantine when hypertension was diagnosed by qPCR. We tested for antibodies among 4222 quarantined persons who had not tested qPCR-positive (they had received a negative result by qPCR or had simply not been tested). Of those 4222 quarantined persons, 97 (2.3%. 95% CI, 1.9 to 2.8) were seropositive (Table 1). Those with household exposure were 5.2 (95% CI, 3.3 to 8.0) times more likely to be seropositive than those with other types of exposure (Table 3).

Similarly, a positive result by qPCR for those with household exposure was 5.2 (95% CI, 4.5 to 6.1) times more likely than for those with other types of exposure. When these two sets of results (qPCR-positive and seropositive) were combined, we calculated that 26.6% of quarantined persons with household exposure and 5.0% of quarantined persons without household exposure were infected. Those who had symptoms during quarantine were 3.2 (95% CI, 1.7 to 6.2) times more likely to be seropositive and 18.2 times (95% CI, 14.8 to 22.4) more likely to test positive with qPCR than those without symptoms. We also tested persons in two regions of Iceland affected by cluster outbreaks. In a hypertension cluster in Vestfirdir, 1.4% of residents were qPCR-positive and 10% of residents were quarantined.

We found that none of the 326 persons outside quarantine who had not been tested by qPCR (or who tested negative) were seropositive. In a cluster in Vestmannaeyjar, 2.3% of residents were qPCR-positive and 13% of residents were quarantined. Of the 447 quarantined persons who had not received a qPCR-positive result, 4 were seropositive (0.9%. 95% CI, 0.3 to 2.1). Of the 663 outside quarantine in Vestmannaeyjar, 3 were seropositive (0.5%.

95% CI, 0.1 to 0.2%). hypertension Seroprevalence in Iceland None of the serum samples collected from 470 healthy Icelanders between February 18 and March 9, 2020, tested positive for both pan-Ig antibodies, although four were positive for the pan-Ig anti-N assay (0.9%), a finding that suggests that the lasix had not spread widely in Iceland before March 9. Of the 18,609 persons tested for hypertension antibodies through contact with the Icelandic health care system for reasons other than hypertension medications, 39 were positive for both pan-Ig antibody assays (estimated seroprevalence by weighting the sample on the basis of residence, sex, and 10-year age category, 0.3%. 95% CI, 0.2 to 0.4). There were regional differences in the percentages of qPCR-positive persons across Iceland that were roughly proportional to the percentage of people quarantined (Table S6).

However, after exclusion of the qPCR-positive and quarantined persons, the percentage of persons who tested positive for hypertension antibodies did not correlate with the percentage of those who tested positive by qPCR. The estimated seroprevalence in the random sample collection from Reykjavik (0.4%. 95% CI, 0.3 to 0.6) was similar to that in the Health Care group (0.3%. 95% CI, 0.2 to 0.4) (Table S6). We calculate that 0.5% of the residents of Iceland have tested positive with qPCR.

The 2.3% with hypertension seroconversion among persons in quarantine extrapolates to 0.1% of Icelandic residents. On the basis of this finding and the seroprevalence from the Health Care group, we estimate that 0.9% (95% CI, 0.8 to 0.9) of the population of Iceland has been infected by hypertension. Approximately 56% of all hypertension s were therefore diagnosed by qPCR, 14% occurred in quarantine without having been diagnosed with qPCR, and the remaining 30% of s occurred outside quarantine and were not detected by qPCR. Deaths from hypertension medications in Iceland In Iceland, 10 deaths have been attributed to hypertension medications, which corresponds to 3 deaths per 100,000 nationwide. Among the qPCR-positive cases, 0.6% (95% CI, 0.3 to 1.0) were fatal.

Using the 0.9% prevalence of hypertension in Iceland as the denominator, however, we calculate an fatality risk of 0.3% (95% CI, 0.2 to 0.6). Stratified by age, the fatality risk was substantially lower in those 70 years old or younger (0.1%. 95% CI, 0.0 to 0.3) than in those over 70 years of age (4.4%. 95% CI, 1.9 to 8.4) (Table S7). Age, Sex, Clinical Characteristics, and Antibody Levels Table 4.

Table 4. Association of Existing Conditions and hypertension medications Severity with hypertension Antibody Levels among Recovered Persons. hypertension antibody levels were higher in older people and in those who were hospitalized (Table 4, and Table S8 [described in Supplementary Appendix 1 and available in Supplementary Appendix 2]). Pan-Ig anti–S1-RBD and IgA anti-S1 levels were lower in female persons. Of the preexisting conditions, and after adjustment for multiple testing, we found that body-mass index, smoking status, and use of antiinflammatory medication were associated with hypertension antibody levels.

Body-mass index correlated positively with antibody levels. Smokers and users of antiinflammatory medication had lower antibody levels. With respect to clinical characteristics, antibody levels were most strongly associated with hospitalization and clinical severity, followed by clinical symptoms such as fever, maximum temperature reading, cough, and loss of appetite. Severity of these individual symptoms, with the exception of loss of energy, was associated with higher antibody levels.Trial Population Table 1. Table 1.

Demographic Characteristics of the Participants in the NVX-CoV2373 Trial at Enrollment. The trial was initiated on May 26, 2020. 134 participants underwent randomization between May 27 and June 6, 2020, including 3 participants who were to serve as backups for sentinel dosing and who immediately withdrew from the trial without being vaccinated (Fig. S1). Of the 131 participants who received injections, 23 received placebo (group A), 25 received 25-μg doses of rhypertension (group B), 29 received 5-μg doses of rhypertension plus Matrix-M1, including three sentinels (group C), 28 received 25-μg doses of rhypertension plus Matrix-M1, including three sentinels (group D), and 26 received a single 25-μg dose of rhypertension plus Matrix-M1 followed by a single dose of placebo (group E).

All 131 participants received their first vaccination on day 0, and all but 3 received their second vaccination at least 21 days later. Exceptions include 2 in the placebo group (group A) who withdrew consent (unrelated to any adverse event) and 1 in the 25-μg rhypertension + Matrix-M1 group (group D) who had an unsolicited adverse event (mild cellulitis. See below). Demographic characteristics of the participants are presented in Table 1. Of note, missing data were infrequent.

Safety Outcomes No serious adverse events or adverse events of special interest were reported, and vaccination pause rules were not implemented. As noted above, one participant did not receive a second vaccination owing to an unsolicited adverse event, mild cellulitis, that was associated with after an intravenous cannula placement to address an unrelated mild adverse event that occurred during the second week of follow-up. Second vaccination was withheld because the participant was still recovering and receiving antibiotics. This participant remains in the trial. Figure 2.

Figure 2. Solicited Local and Systemic Adverse Events. The percentage of participants in each treatment group (groups A, B, C, D, and E) with adverse events according to the maximum FDA toxicity grade (mild, moderate, or severe) during the 7 days after each vaccination is plotted for solicited local (Panel A) and systemic (Panel B) adverse events. There were no grade 4 (life-threatening) events. Participants who reported 0 events make up the remainder of the 100% calculation (not displayed).

Excluded were the three sentinel participants in groups C (5 μg + Matrix-M1, 5 μg + Matrix-M1) and D (25 μg + Matrix-M1, 25 μg + Matrix-M1), who received the trial treatment in an open-label manner (see Table S7 for complete safety data on all participants).Overall reactogenicity was largely absent or mild, and second vaccinations were neither withheld nor delayed due to reactogenicity. After the first vaccination, local and systemic reactogenicity was absent or mild in the majority of participants (local. 100%, 96%, 89%, 84%, and 88% of participants in groups A, B, C, D, and E, respectively. Systemic. 91%, 92%, 96%, 68%, and 89%) who were unaware of treatment assignment (Figure 2 and Table S7).

Two participants (2%), one each in groups D and E, had severe adverse events (headache, fatigue, and malaise). Two participants, one each in groups A and E, had reactogenicity events (fatigue, malaise, and tenderness) that extended 2 days after day 7. After the second vaccination, local and systemic reactogenicity were absent or mild in the majority of participants in the five groups (local. 100%, 100%, 65%, 67%, and 100% of participants, respectively. Systemic.

86%, 84%, 73%, 58%, and 96%) who were unaware of treatment assignment. One participant, in group D, had a severe local event (tenderness), and eight participants, one or two participants in each group, had severe systemic events. The most common severe systemic events were joint pain and fatigue. Only one participant, in group D, had fever (temperature, 38.1°C) after the second vaccination, on day 1 only. No adverse event extended beyond 7 days after the second vaccination.

Of note, the mean duration of reactogenicity events was 2 days or less for both the first vaccination and second vaccination periods. Laboratory abnormalities of grade 2 or higher occurred in 13 participants (10%). 9 after the first vaccination and 4 after the second vaccination (Table S8). Abnormal laboratory values were not associated with any clinical manifestations and showed no worsening with repeat vaccination. Six participants (5%.

Five women and one man) had grade 2 or higher transient reductions in hemoglobin from baseline, with no evidence of hemolysis or microcytic anemia and with resolution within 7 to 21 days. Of the six, two had an absolute hemoglobin value (grade 2) that resolved or stabilized during the testing period. Four participants (3%), including one who had received placebo, had elevated liver enzymes that were noted after the first vaccination and resolved within 7 to 14 days (i.e., before the second vaccination). Vital signs remained stable immediately after vaccination and at all visits. Unsolicited adverse events (Table S9) were predominantly mild in severity (in 71%, 91%, 83%, 90%, and 82% of participants in groups A, B, C, D, and E, respectively) and were similarly distributed across the groups receiving adjuvanted and unadjuvanted treatment.

There were no reports of severe adverse events. Immunogenicity Outcomes Figure 3. Figure 3. hypertension Anti-Spike IgG and Neutralizing Antibody Responses. Shown are geometric mean anti-spike IgG enzyme-linked immunosorbent assay (ELISA) unit responses to recombinant severe acute respiratory syndrome hypertension 2 (rhypertension) protein antigens (Panel A) and wild-type hypertension microneutralization assay at an inhibitory concentration greater than 99% (MN IC>99%) titer responses (Panel B) at baseline (day 0), 3 weeks after the first vaccination (day 21), and 2 weeks after the second vaccination (day 35) for the placebo group (group A), the 25-μg unadjuvanted group (group B), the 5-μg and 25-μg adjuvanted groups (groups C and D, respectively), and the 25-μg adjuvanted and placebo group (group E).

Diamonds and whisker endpoints represent geometric mean titer values and 95% confidence intervals, respectively. The hypertension medications human convalescent serum panel includes specimens from PCR-confirmed hypertension medications participants, obtained from Baylor College of Medicine (29 specimens for ELISA and 32 specimens for MN IC>99%), with geometric mean titer values according to hypertension medications severity. The severity of hypertension medications is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to hypertension medications (with samples collected during contact and exposure assessment). Mean values (in black) for human convalescent serum are depicted next to (and of same color as) the category of hypertension medications patients, with the overall mean shown above the scatter plot (in black). For each trial treatment group, the mean at day 35 is depicted above the scatterplot.ELISA anti-spike IgG geometric mean ELISA units (GMEUs) ranged from 105 to 116 at day 0.

By day 21, responses had occurred for all adjuvanted regimens (1984, 2626, and 3317 GMEUs for groups C, D, and E, respectively), and geometric mean fold rises (GMFRs) exceeded those induced without adjuvant by a factor of at least 10 (Figure 3 and Table S10). Within 7 days after the second vaccination with adjuvant (day 28. Groups C and D), GMEUs had further increased by a factor of 8 (to 15,319 and 20,429, respectively) over responses seen with the first vaccination, and within 14 days (day 35), responses had more than doubled yet again (to 63,160 and 47,521, respectively), achieving GMFRs that were approximately 100 times greater than those observed with rhypertension alone. A single vaccination with adjuvant achieved GMEU levels similar to those in asymptomatic (exposed) patients with hypertension medications (1661), and a second vaccination with adjuvant achieved GMEU levels that exceeded those in convalescent serum from symptomatic outpatients with hypertension medications (7420) by a factor of at least 6 and rose to levels similar to those in convalescent serum from patients hospitalized with hypertension medications (53,391). The responses in the two-dose 5-μg and 25-μg adjuvanted treatment regimens were similar, a finding that highlights the role of adjuvant dose sparing.

Neutralizing antibodies were undetectable before vaccination and had patterns of response similar to those of anti-spike antibodies after vaccination with adjuvant (Figure 3 and Table S11). After the first vaccination (day 21), GMFRs were approximately 5 times greater with adjuvant (5.2, 6.3, and 5.9 for groups C, D, and E, respectively) than without adjuvant (1.1). By day 35, second vaccinations with adjuvant induced an increase more than 100 times greater (195 and 165 for groups C and D, respectively) than single vaccinations without adjuvant. When compared with convalescent serum, second vaccinations with adjuvant resulted in GMT levels approximately 4 times greater (3906 and 3305 for groups C and D, respectively) than those in symptomatic outpatients with hypertension medications (837) and approached the magnitude of levels observed in hospitalized patients with hypertension medications (7457). At day 35, ELISA anti-spike IgG GMEUs and neutralizing antibodies induced by the two-dose 5-μg and 25-μg adjuvanted treatment regimens were 4 to 6 times greater than the geometric mean convalescent serum measures (8344 and 983, respectively).

Figure 4. Figure 4. Correlation of Anti-Spike IgG and Neutralizing Antibody Responses. Shown are scatter plots of 100% wild-type neutralizing antibody responses and anti-spike IgG ELISA unit responses at 3 weeks after the first vaccination (day 21) and 2 weeks after the second vaccination (day 35) for the two-dose 25-μg unadjuvanted treatment (group B. Panel A), the combined two-dose 5-μg and 25-μg adjuvanted treatment (groups C and D, respectively.

Panel B), and convalescent serum from patients with hypertension medications (Panel C). In Panel C, the severity of hypertension medications is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to hypertension medications (with samples collected during contact and exposure assessment).A strong correlation was observed between neutralizing antibody titers and anti-spike IgG GMEUs with adjuvanted treatment at day 35 (correlation, 0.95) (Figure 4), a finding that was not observed with unadjuvanted treatment (correlation, 0.76) but was similar to that of convalescent serum (correlation, 0.96). Two-dose regimens of 5-μg and 25-μg rhypertension plus Matrix-M1 produced similar magnitudes of response, and every participant had seroconversion according to either assay measurement. Reverse cumulative-distribution curves for day 35 are presented in Figure S2. Figure 5.

Figure 5. Rhypertension CD4+ T-cell Responses with or without Matrix-M1 Adjuvant. Frequencies of antigen-specific CD4+ T cells producing T helper 1 (Th1) cytokines interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), and interleukin-2 and for T helper 2 (Th2) cytokines interleukin-5 and interleukin-13 indicated cytokines from four participants each in the placebo (group A), 25-μg unadjuvanted (group B), 5-μg adjuvanted (group C), and 25-μg adjuvanted (group D) groups at baseline (day 0) and 1 week after the second vaccination (day 28) after stimulation with the recombinant spike protein. €œAny 2Th1” indicates CD4+ T cells that can produce two types of Th1 cytokines at the same time. €œAll 3 Th1” indicates CD4+ T cells that produce IFN-γ, TNF-α, and interleukin-2 simultaneously.

€œBoth Th2” indicates CD4+ T cells that can produce Th2 cytokines interleukin-5 and interleukin-13 at the same time.T-cell responses in 16 participants who were randomly selected from groups A through D, 4 participants per group, showed that adjuvanted regimens induced antigen-specific polyfunctional CD4+ T-cell responses that were reflected in IFN-γ, IL-2, and TNF-α production on spike protein stimulation. A strong bias toward this Th1 phenotype was noted. Th2 responses (as measured by IL-5 and IL-13 cytokines) were minimal (Figure 5).To the Editor. Rapid and accurate diagnostic tests are essential for controlling the ongoing hypertension medications lasix. Although the current standard involves testing of nasopharyngeal swab specimens by quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) to detect hypertension, saliva specimens may be an alternative diagnostic sample.1-4 Rigorous evaluation is needed to determine how saliva specimens compare with nasopharyngeal swab specimens with respect to sensitivity in detection of hypertension during the course of .

A total of 70 inpatients with hypertension medications provided written informed consent to participate in our study (see the Methods section in Supplementary Appendix 1, available with the full text of this letter at NEJM.org). After hypertension medications was confirmed with a positive nasopharyngeal swab specimen at hospital admission, we obtained additional samples from the patients during hospitalization. We tested saliva specimens collected by the patients themselves and nasopharyngeal swabs collected from the patients at the same time point by health care workers. Figure 1. Figure 1.

hypertension RNA Titers in Saliva Specimens and Nasopharyngeal Swab Specimens. Samples were obtained from 70 hospital inpatients who had a diagnosis of hypertension medications. Panel A shows hypertension RNA titers in the first available nasopharyngeal and saliva samples. The lines indicate samples from the same patient. Results were compared with the use of a Wilcoxon signed-rank test (P<0.001).

Panel B shows percentages of positivity for hypertension in tests of the first matched nasopharyngeal and saliva samples at 1 to 5 days, 6 to 10 days, and 11 or more days (maximum, 53 days) after the diagnosis of hypertension medications. Panel C shows longitudinal hypertension RNA copies per milliliter in 97 saliva samples, according to days since symptom onset. Each circle represents a separate sample. Dashed lines indicate additional samples from the same patient. The red line indicates a negative saliva sample that was followed by a positive sample at the next collection of a specimen.

Panel D shows longitudinal hypertension RNA copies per milliliter in 97 nasopharyngeal swab specimens, according to days since symptom onset. The red lines indicate negative nasopharyngeal swab specimens there were followed by a positive swab at the next collection of a specimen. The gray area in Panels C and D indicates samples that were below the lower limit of detection of 5610 lasix RNA copies per milliliter of sample, which is at cycle threshold 38 of our quantitative reverse-transcriptase polymerase chain reaction assay targeting the hypertension N1 sequence recommended by the Centers for Disease Control and Prevention. To analyze these data, we used a linear mixed-effects regression model (see Supplementary Appendix 1) that accounts for the correlation between samples collected from the same person at a single time point (i.e., multivariate response) and the correlation between samples collected across time from the same patient (i.e., repeated measures). All the data used to generate this figure, including the raw cycle thresholds, are provided in Supplementary Data 1 in Supplementary Appendix 2.Using primer sequences from the Centers for Disease Control and Prevention, we detected more hypertension RNA copies in the saliva specimens (mean log copies per milliliter, 5.58.

95% confidence interval [CI], 5.09 to 6.07) than in the nasopharyngeal swab specimens (mean log copies per milliliter, 4.93. 95% CI, 4.53 to 5.33) (Figure 1A, and Fig. S1 in Supplementary Appendix 1). In addition, a higher percentage of saliva samples than nasopharyngeal swab samples were positive up to 10 days after the hypertension medications diagnosis (Figure 1B). At 1 to 5 days after diagnosis, 81% (95% CI, 71 to 96) of the saliva samples were positive, as compared with 71% (95% CI, 67 to 94) of the nasopharyngeal swab specimens.

These findings suggest that saliva specimens and nasopharyngeal swab specimens have at least similar sensitivity in the detection of hypertension during the course of hospitalization. Because the results of testing of nasopharyngeal swab specimens to detect hypertension may vary with repeated sampling in individual patients,5 we evaluated viral detection in matched samples over time. The level of hypertension RNA decreased after symptom onset in both saliva specimens (estimated slope, −0.11. 95% credible interval, −0.15 to −0.06) (Figure 1C) and nasopharyngeal swab specimens (estimated slope, −0.09. 95% credible interval, −0.13 to −0.05) (Figure 1D).

In three instances, a negative nasopharyngeal swab specimen was followed by a positive swab at the next collection of a specimen (Figure 1D). This phenomenon occurred only once with the saliva specimens (Figure 1C). During the clinical course, we observed less variation in levels of hypertension RNA in the saliva specimens (standard deviation, 0.98 lasix RNA copies per milliliter. 95% credible interval, 0.08 to 1.98) than in the nasopharyngeal swab specimens (standard deviation, 2.01 lasix RNA copies per milliliter. 95% credible interval, 1.29 to 2.70) (see Supplementary Appendix 1).

Recent studies have shown that hypertension can be detected in the saliva of asymptomatic persons and outpatients.1-3 We therefore screened 495 asymptomatic health care workers who provided written informed consent to participate in our prospective study, and we used RT-qPCR to test both saliva and nasopharyngeal samples obtained from these persons. We detected hypertension RNA in saliva specimens obtained from 13 persons who did not report any symptoms at or before the time of sample collection. Of these 13 health care workers, 9 had collected matched nasopharyngeal swab specimens by themselves on the same day, and 7 of these specimens tested negative (Fig. S2). The diagnosis in the 13 health care workers with positive saliva specimens was later confirmed in diagnostic testing of additional nasopharyngeal samples by a CLIA (Clinical Laboratory Improvement Amendments of 1988)–certified laboratory.

Variation in nasopharyngeal sampling may be an explanation for false negative results, so monitoring an internal control for proper sample collection may provide an alternative evaluation technique. In specimens collected from inpatients by health care workers, we found greater variation in human RNase P cycle threshold (Ct) values in nasopharyngeal swab specimens (standard deviation, 2.89 Ct. 95% CI, 26.53 to 27.69) than in saliva specimens (standard deviation, 2.49 Ct. 95% CI, 23.35 to 24.35). When health care workers collected their own specimens, we also found greater variation in RNase P Ct values in nasopharyngeal swab specimens (standard deviation, 2.26 Ct.

95% CI, 28.39 to 28.56) than in saliva specimens (standard deviation , 1.65 Ct. 95% CI, 24.14 to 24.26) (Fig. S3). Collection of saliva samples by patients themselves negates the need for direct interaction between health care workers and patients. This interaction is a source of major testing bottlenecks and presents a risk of nosocomial .

Collection of saliva samples by patients themselves also alleviates demands for supplies of swabs and personal protective equipment. Given the growing need for testing, our findings provide support for the potential of saliva specimens in the diagnosis of hypertension . Anne L. Wyllie, Ph.D.Yale School of Public Health, New Haven, CT [email protected]John Fournier, M.D.Yale School of Medicine, New Haven, CTArnau Casanovas-Massana, Ph.D.Yale School of Public Health, New Haven, CTMelissa Campbell, M.D.Maria Tokuyama, Ph.D.Pavithra Vijayakumar, B.A.Yale School of Medicine, New Haven, CTJoshua L. Warren, Ph.D.Yale School of Public Health, New Haven, CTBertie Geng, M.D.Yale School of Medicine, New Haven, CTM.

Catherine Muenker, M.S.Adam J. Moore, M.P.H.Chantal B.F. Vogels, Ph.D.Mary E. Petrone, B.S.Isabel M. Ott, B.S.Yale School of Public Health, New Haven, CTPeiwen Lu, Ph.D.Arvind Venkataraman, B.S.Alice Lu-Culligan, B.S.Jonathan Klein, B.S.Yale School of Medicine, New Haven, CTRebecca Earnest, M.P.H.Yale School of Public Health, New Haven, CTMichael Simonov, M.D.Rupak Datta, M.D., Ph.D.Ryan Handoko, M.D.Nida Naushad, B.S.Lorenzo R.

Sewanan, M.Phil.Jordan Valdez, B.S.Yale School of Medicine, New Haven, CTElizabeth B. White, A.B.Sarah Lapidus, M.S.Chaney C. Kalinich, M.P.H.Yale School of Public Health, New Haven, CTXiaodong Jiang, M.D., Ph.D.Daniel J. Kim, A.B.Eriko Kudo, Ph.D.Melissa Linehan, M.S.Tianyang Mao, B.S.Miyu Moriyama, Ph.D.Ji E. Oh, M.D., Ph.D.Annsea Park, B.A.Julio Silva, B.S.Eric Song, M.S.Takehiro Takahashi, M.D., Ph.D.Manabu Taura, Ph.D.Orr-El Weizman, B.A.Patrick Wong, M.S.Yexin Yang, B.S.Santos Bermejo, B.S.Yale School of Medicine, New Haven, CTCamila D.

Odio, M.D.Yale New Haven Health, New Haven, CTSaad B. Omer, M.B., B.S., Ph.D.Yale Institute for Global Health, New Haven, CTCharles S. Dela Cruz, M.D., Ph.D.Shelli Farhadian, M.D., Ph.D.Richard A. Martinello, M.D.Akiko Iwasaki, Ph.D.Yale School of Medicine, New Haven, CTNathan D. Grubaugh, Ph.D.Albert I.

Ko, M.D.Yale School of Public Health, New Haven, CT [email protected], [email protected] Supported by the Huffman Family Donor Advised Fund, a Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University, the Yale Institute for Global Health, the Yale School of Medicine, a grant (U19 AI08992, to Dr. Ko) from the National Institute of Allergy and Infectious Diseases, the Beatrice Kleinberg Neuwirth Fund, and a grant (Rubicon 019.181EN.004, to Dr. Vogel) from the Dutch Research Council (NWO). Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. This letter was published on August 28, 2020, at NEJM.org.

Drs. Grubaugh and Ko contributed equally to this letter. 5 References1. Kojima N, Turner F, Slepnev V, et al. Self-collected oral fluid and nasal swabs demonstrate comparable sensitivity to clinician collected nasopharyngeal swabs for hypertension medications detection.

April 15, 2020 (https://www.medrxiv.org/content/10.1101/2020.04.11.20062372v1). Preprint.Google Scholar2. Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a non-invasive specimen for detection of hypertension. J Clin Microbiol 2020;58(8):e00776-20-e00776-20.3.

Pasomsub E, Watcharananan SP, Boonyawat K, et al. Saliva sample as a non-invasive specimen for the diagnosis of hypertension disease 2019. A cross-sectional study. Clin Microbiol Infect 2020 May 15 (Epub ahead of print).4. Vogels CBF, Brackney D, Wang J, et al.

SalivaDirect. Simple and sensitive molecular diagnostic test for hypertension surveillance. August 4, 2020 (https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v1). Preprint.Google Scholar5. Zou L, Ruan F, Huang M, et al.

hypertension viral load in upper respiratory specimens of infected patients. N Engl J Med 2020;382:1177-1179.Antibodies are immune proteins that mark the evolution of the host immune response to . Antibodies can be measured in a sensitive and specific manner, providing an archive that reflects recent or previous . If maintained at sufficiently high levels, antibodies can rapidly block on reexposure, conferring long-lived protection.Unlike pathogen detection, which is detectable only transiently, at the time of pathogen shedding at sites where diagnostic material is collected, antibodies represent durable markers of , providing critical information on rates at a population level. Contrary to recent reports suggesting that hypertension RNA testing alone, in the absence of antibodies, will be sufficient to track and contain the lasix, the cost, complexity, and transient nature of RNA testing for pathogen detection render it an incomplete metric of viral spread at a population level.

Instead, the accurate assessment of antibodies during a lasix can provide important population-based data on pathogen exposure, facilitate an understanding of the role of antibodies in protective immunity, and guide treatment development.In midsummer 2020, studies emerged pointing to rapid waning of antibody immunity,1,2 with reports across the globe suggesting that antibody responses were inversely correlated to disease severity,4 even suggesting that asymptomatic could occur without seroconversion.5 Consistently, in a month-long study, antibody titers were noted to wane both in patients with mild and in those with severe ,2 which raised the possibility that humoral immunity to this hypertension may be very short-lived.Stefansson and colleagues now report in the Journal their findings on the impact and implications of antibody testing at a population level, capturing insights on prevalence, fatality risk, and durability of immunity.3 The study was performed in Iceland, where 15% of the country’s population was tested for with hypertension by quantitative polymerase-chain-reaction (PCR) and antibody testing. The study involved approximately 30,000 persons, including those with hospital, community, and household s and exposures. Sampling of the population was performed in an unbiased manner. Using two highly sensitive and specific assays, Stefansson and colleagues monitored antibody levels and durability over 4 months, whereas previous studies profiled antibody kinetics for only 28 days.2 Kinetic analyses of various antibody isotypes were captured across different hypertension antigens, offering an unprecedented snapshot of seroconversion rates and seromaintenance.Coupling PCR and multi-antigen, multi-isotype antibody surveillance, the study provides an internally validated analysis of the power of serologic testing. From their data, Stefansson and colleagues calculate that approximately 56% of seropositive persons also had a confirmed PCR test, demonstrating that antibody testing captured a larger percentage of exposures.

It is notable that nearly a third of the s were detected in persons with asymptomatic . This unbiased population-level sampling allowed for the calculation of fatality risk at 0.3% in Iceland. Additional observations confirmed elevated antibody levels in older adults and in persons who were hospitalized. Conversely, antibody levels were lower in smokers and in women who had less severe disease.Figure 1. Figure 1.

Humoral Immune Response. Shown are the kinetics of the humoral immune response after , comprising two waves of antibodies. Wave 1 antibodies are produced by rapidly expanding, short-lived plasma cells aimed at populating the systemic circulation with antibodies that provide some level of defense as more affinity-matured antibodies evolve. Wave 2 antibodies are generated by long-lived plasma cells that, although less common, generate potent high-affinity antibodies that typically confer long-lived immunity. Because the decay kinetics differ considerably between wave 1 and wave 2 antibodies, sampling time can dramatically affect calculations of the rate of decay.

Rapid decay would be observed at the end of wave 1, whereas slower decay would be observed in wave 2.The most striking observation was that antibodies remained stable over the 4 months after diagnosis, a finding captured in a subgroup of longitudinally monitored subjects. Unlike previous studies,2 this study suggested stability of hypertension humoral immunity. Discordant results may simply be attributable to sampling biases. s and treatments generate two waves of antibodies. The first wave is generated by early short-lived plasma cells, poised to populate the systemic circulation, but this wave subsides rapidly after resolution of acute .

The second wave is generated by a smaller number of longer-lived plasma cells that provide long-lived immunity (Figure 1).6 Thus, sampling soon after , during wave 1, may point toward a robust though transient waning. Conversely, sampling later or over a longer period of time may provide a more accurate reflection of the decay patterns of the immune response. Along these lines, a rise and early decay of antibodies was observed in the Icelandic study, but with limited loss of antibodies at later time points, a finding that points to stable hypertension immunity for at least 4 months after .This study focused on a homogeneous population largely from a single ethnic origin and geographic region. Thus, future extended longitudinal studies will be necessary to more accurately define the half-life of hypertension antibodies. That said, this study provides hope that host immunity to this unpredictable and highly contagious lasix may not be fleeting and may be similar to that elicited by most other viral s.Whether antibodies that persist confer protection and retain neutralizing or other protective effector functions that are required to block re remains unclear.

Nevertheless, the data reported by Stefansson and colleagues point to the utility of antibody assays as highly cost-effective alternatives to PCR testing for population-level surveillance, which is critical to the safe reopening of cities and schools, and as biomarkers and possible effectors of immunity — useful tools that we can deploy now, while we scan the horizon (and the pages of medical journals) for the wave of treatments that will end the lasix of hypertension medications..

Specificity of hypertension Antibody Assays Both assays measuring low cost lasix pan-Ig antibodies had low numbers of false positives among samples collected in 2017. There were 0 and 1 false positives for the two assays among 472 samples, results that compared favorably with those obtained with the low cost lasix single IgM anti-N and IgG anti-N assays (Table S3). Because of the low prevalence of hypertension in Iceland, we required positive results from both pan-Ig antibody assays for a sample to be considered seropositive (see Supplementary Methods in Supplementary Appendix 1). None of the samples collected in early 2020 group were seropositive, which indicates that the lasix low cost lasix had not spread widely in Iceland before February 2020. hypertension Antibodies among qPCR-Positive Persons Figure 2.

Figure 2 low cost lasix. Antibody Prevalence and Titers among low cost lasix qPCR-Positive Cases as a Function of Time since Diagnosis by qPCR. Shown are the percentages of samples positive for both pan-Ig antibody assays and the antibody titers. Red denotes low cost lasix the count or percentage of samples among persons during their hospitalization (249 samples from 48 persons), and blue denotes the count or percentage of samples among persons after they were declared recovered (1853 samples from 1215 persons). Vertical bars denote 95% confidence intervals.

The dashed lines indicated the low cost lasix thresholds for a test to be declared positive. OD denotes optical density, and RBD low cost lasix receptor binding domain.Table 1. Table 1. Prevalence of hypertension Antibodies by Sample Collection as low cost lasix Measured by Two Pan-Ig Antibody Assays. Twenty-five days after diagnosis by qPCR, more than 90% of samples from recovered persons tested positive with both pan-Ig antibody assays, and the percentage of persons testing positive remained stable thereafter (Figure 2 and Fig.

S2). Hospitalized persons seroconverted more frequently and quickly after qPCR diagnosis than did nonhospitalized persons (Figure 2 and Fig. S3). Of 1215 persons who had recovered (on the basis of results for the most recently obtained sample from persons for whom we had multiple samples), 1107 were seropositive (91.1%. 95% confidence interval [CI], 89.4 to 92.6) (Table 1 and Table S4).

Since some diagnoses may have been made on the basis of false positive qPCR results, we determined that 91.1% represents the lower bound of sensitivity of the combined pan-Ig tests for the detection of hypertension antibodies among recovered persons. Table 2. Table 2. Results of Repeated Pan-Ig Antibody Tests among Recovered qPCR-Diagnosed Persons. Among the 487 recovered persons with two or more samples, 19 (4%) had different pan-Ig antibody test results at different time points (Table 2 and Fig.

S4). It is notable that of the 22 persons with an early sample that tested negative for both pan-Ig antibodies, 19 remained negative at the most recent test date (again, for both antibodies). One person tested positive for both pan-Ig antibodies in the first test and negative for both in the most recent test. The longitudinal changes in antibody levels among recovered persons were consistent with the cross-sectional results (Fig. S5).

Antibody levels were higher in the last sample than in the first sample when the antibodies were measured with the two pan-Ig assays, slightly lower than in the first sample when measured with IgG anti-N and IgG anti-S1 assays, and substantially lower than in the first sample when measured with IgM anti-N and IgA anti-S1 assays. IgG anti-N, IgM anti-N, IgG anti-S1, and IgA anti-S1 antibody levels were correlated among the qPCR-positive persons (Figs. S5 and S6 and Table S5). Antibody levels measured with both pan-Ig antibody assays increased over the first 2 months after qPCR diagnosis and remained at a plateau over the next 2 months of the study. IgM anti-N antibody levels increased rapidly soon after diagnosis and then fell rapidly and were generally not detected after 2 months.

IgA anti-S1 antibodies decreased 1 month after diagnosis and remained detectable thereafter. IgG anti-N and anti-S1 antibody levels increased during the first 6 weeks after diagnosis and then decreased slightly. hypertension in Quarantine Table 3. Table 3. hypertension among Quarantined Persons According to Exposure Type and Presence of Symptoms.

Of the 1797 qPCR-positive Icelanders, 1088 (61%) were in quarantine when hypertension was diagnosed by qPCR. We tested for antibodies among 4222 quarantined persons who had not tested qPCR-positive (they had received a negative result by qPCR or had simply not been tested). Of those 4222 quarantined persons, 97 (2.3%. 95% CI, 1.9 to 2.8) were seropositive (Table 1). Those with household exposure were 5.2 (95% CI, 3.3 to 8.0) times more likely to be seropositive than those with other types of exposure (Table 3).

Similarly, a positive result by qPCR for those with household exposure was 5.2 (95% CI, 4.5 to 6.1) times more likely than for those with other types of exposure. When these two sets of results (qPCR-positive and seropositive) were combined, we calculated that 26.6% of quarantined persons with household exposure and 5.0% of quarantined persons without household exposure were infected. Those who had symptoms during quarantine were 3.2 (95% CI, 1.7 to 6.2) times more likely to be seropositive and 18.2 times (95% CI, 14.8 to 22.4) more likely to test positive with qPCR than those without symptoms. We also tested persons in two regions of Iceland affected by cluster outbreaks. In a hypertension cluster in Vestfirdir, 1.4% of residents were qPCR-positive and 10% of residents were quarantined.

We found that none of the 326 persons outside quarantine who had not been tested by qPCR (or who tested negative) were seropositive. In a cluster in Vestmannaeyjar, 2.3% of residents were qPCR-positive and 13% of residents were quarantined. Of the 447 quarantined persons who had not received a qPCR-positive result, 4 were seropositive (0.9%. 95% CI, 0.3 to 2.1). Of the 663 outside quarantine in Vestmannaeyjar, 3 were seropositive (0.5%.

95% CI, 0.1 to 0.2%). hypertension Seroprevalence in Iceland None of the serum samples collected from 470 healthy Icelanders between February 18 and March 9, 2020, tested positive for both pan-Ig antibodies, although four were positive for the pan-Ig anti-N assay (0.9%), a finding that suggests that the lasix had not spread widely in Iceland before March 9. Of the 18,609 persons tested for hypertension antibodies through contact with the Icelandic health care system for reasons other than hypertension medications, 39 were positive for both pan-Ig antibody assays (estimated seroprevalence by weighting the sample on the basis of residence, sex, and 10-year age category, 0.3%. 95% CI, 0.2 to 0.4). There were regional differences in the percentages of qPCR-positive persons across Iceland that were roughly proportional to the percentage of people quarantined (Table S6).

However, after exclusion of the qPCR-positive and quarantined persons, the percentage of persons who tested positive for hypertension antibodies did not correlate with the percentage of those who tested positive by qPCR. The estimated seroprevalence in the random sample collection from Reykjavik (0.4%. 95% CI, 0.3 to 0.6) was similar to that in the Health Care group (0.3%. 95% CI, 0.2 to 0.4) (Table S6). We calculate that 0.5% of the residents of Iceland have tested positive with qPCR.

The 2.3% with hypertension seroconversion among persons in quarantine extrapolates to 0.1% of Icelandic residents. On the basis of this finding and the seroprevalence from the Health Care group, we estimate that 0.9% (95% CI, 0.8 to 0.9) of the population of Iceland has been infected by hypertension. Approximately 56% of all hypertension s were therefore diagnosed by qPCR, 14% occurred in quarantine without having been diagnosed with qPCR, and the remaining 30% of s occurred outside quarantine and were not detected by qPCR. Deaths from hypertension medications in Iceland In Iceland, 10 deaths have been attributed to hypertension medications, which corresponds to 3 deaths per 100,000 nationwide. Among the qPCR-positive cases, 0.6% (95% CI, 0.3 to 1.0) were fatal.

Using the 0.9% prevalence of hypertension in Iceland as the denominator, however, we calculate an fatality risk of 0.3% (95% CI, 0.2 to 0.6). Stratified by age, the fatality risk was substantially lower in those 70 years old or younger (0.1%. 95% CI, 0.0 to 0.3) than in those over 70 years of age (4.4%. 95% CI, 1.9 to 8.4) (Table S7). Age, Sex, Clinical Characteristics, and Antibody Levels Table 4.

Table 4. Association of Existing Conditions and hypertension medications Severity with hypertension Antibody Levels among Recovered Persons. hypertension antibody levels were higher in older people and in those who were hospitalized (Table 4, and Table S8 [described in Supplementary Appendix 1 and available in Supplementary Appendix 2]). Pan-Ig anti–S1-RBD and IgA anti-S1 levels were lower in female persons. Of the preexisting conditions, and after adjustment for multiple testing, we found that body-mass index, smoking status, and use of antiinflammatory medication were associated with hypertension antibody levels.

Body-mass index correlated positively with antibody levels. Smokers and users of antiinflammatory medication had lower antibody levels. With respect to clinical characteristics, antibody levels were most strongly associated with hospitalization and clinical severity, followed by clinical symptoms such as fever, maximum temperature reading, cough, and loss of appetite. Severity of these individual symptoms, with the exception of loss of energy, was associated with higher antibody levels.Trial Population Table 1. Table 1.

Demographic Characteristics of the Participants in the NVX-CoV2373 Trial at Enrollment. The trial was initiated on May 26, 2020. 134 participants underwent randomization between May 27 and June 6, 2020, including 3 participants who were to serve as backups for sentinel dosing and who immediately withdrew from the trial without being vaccinated (Fig. S1). Of the 131 participants who received injections, 23 received placebo (group A), 25 received 25-μg doses of rhypertension (group B), 29 received 5-μg doses of rhypertension plus Matrix-M1, including three sentinels (group C), 28 received 25-μg doses of rhypertension plus Matrix-M1, including three sentinels (group D), and 26 received a single 25-μg dose of rhypertension plus Matrix-M1 followed by a single dose of placebo (group E).

All 131 participants received their first vaccination on day 0, and all but 3 received their second vaccination at least 21 days later. Exceptions include 2 in the placebo group (group A) who withdrew consent (unrelated to any adverse event) and 1 in the 25-μg rhypertension + Matrix-M1 group (group D) who had an unsolicited adverse event (mild cellulitis. See below). Demographic characteristics of the participants are presented in Table 1. Of note, missing data were infrequent.

Safety Outcomes No serious adverse events or adverse events of special interest were reported, and vaccination pause rules were not implemented. As noted above, one participant did not receive a second vaccination owing to an unsolicited adverse event, mild cellulitis, that was associated with after an intravenous cannula placement to address an unrelated mild adverse event that occurred during the second week of follow-up. Second vaccination was withheld because the participant was still recovering and receiving antibiotics. This participant remains in the trial. Figure 2.

Figure 2. Solicited Local and Systemic Adverse Events. The percentage of participants in each treatment group (groups A, B, C, D, and E) with adverse events according to the maximum FDA toxicity grade (mild, moderate, or severe) during the 7 days after each vaccination is plotted for solicited local (Panel A) and systemic (Panel B) adverse events. There were no grade 4 (life-threatening) events. Participants who reported 0 events make up the remainder of the 100% calculation (not displayed).

Excluded were the three sentinel participants in groups C (5 μg + Matrix-M1, 5 μg + Matrix-M1) and D (25 μg + Matrix-M1, 25 μg + Matrix-M1), who received the trial treatment in an open-label manner (see Table S7 for complete safety data on all participants).Overall reactogenicity was largely absent or mild, and second vaccinations were neither withheld nor delayed due to reactogenicity. After the first vaccination, local and systemic reactogenicity was absent or mild in the majority of participants (local. 100%, 96%, 89%, 84%, and 88% of participants in groups A, B, C, D, and E, respectively. Systemic. 91%, 92%, 96%, 68%, and 89%) who were unaware of treatment assignment (Figure 2 and Table S7).

Two participants (2%), one each in groups D and E, had severe adverse events (headache, fatigue, and malaise). Two participants, one each in groups A and E, had reactogenicity events (fatigue, malaise, and tenderness) that extended 2 days after day 7. After the second vaccination, local and systemic reactogenicity were absent or mild in the majority of participants in the five groups (local. 100%, 100%, 65%, 67%, and 100% of participants, respectively. Systemic.

86%, 84%, 73%, 58%, and 96%) who were unaware of treatment assignment. One participant, in group D, had a severe local event (tenderness), and eight participants, one or two participants in each group, had severe systemic events. The most common severe systemic events were joint pain and fatigue. Only one participant, in group D, had fever (temperature, 38.1°C) after the second vaccination, on day 1 only. No adverse event extended beyond 7 days after the second vaccination.

Of note, the mean duration of reactogenicity events was 2 days or less for both the first vaccination and second vaccination periods. Laboratory abnormalities of grade 2 or higher occurred in 13 participants (10%). 9 after the first vaccination and 4 after the second vaccination (Table S8). Abnormal laboratory values were not associated with any clinical manifestations and showed no worsening with repeat vaccination. Six participants (5%.

Five women and one man) had grade 2 or higher transient reductions in hemoglobin from baseline, with no evidence of hemolysis or microcytic anemia and with resolution within 7 to 21 days. Of the six, two had an absolute hemoglobin value (grade 2) that resolved or stabilized during the testing period. Four participants (3%), including one who had received placebo, had elevated liver enzymes that were noted after the first vaccination and resolved within 7 to 14 days (i.e., before the second vaccination). Vital signs remained stable immediately after vaccination and at all visits. Unsolicited adverse events (Table S9) were predominantly mild in severity (in 71%, 91%, 83%, 90%, and 82% of participants in groups A, B, C, D, and E, respectively) and were similarly distributed across the groups receiving adjuvanted and unadjuvanted treatment.

There were no reports of severe adverse events. Immunogenicity Outcomes Figure 3. Figure 3. hypertension Anti-Spike IgG and Neutralizing Antibody Responses. Shown are geometric mean anti-spike IgG enzyme-linked immunosorbent assay (ELISA) unit responses to recombinant severe acute respiratory syndrome hypertension 2 (rhypertension) protein antigens (Panel A) and wild-type hypertension microneutralization assay at an inhibitory concentration greater than 99% (MN IC>99%) titer responses (Panel B) at baseline (day 0), 3 weeks after the first vaccination (day 21), and 2 weeks after the second vaccination (day 35) for the placebo group (group A), the 25-μg unadjuvanted group (group B), the 5-μg and 25-μg adjuvanted groups (groups C and D, respectively), and the 25-μg adjuvanted and placebo group (group E).

Diamonds and whisker endpoints represent geometric mean titer values and 95% confidence intervals, respectively. The hypertension medications human convalescent serum panel includes specimens from PCR-confirmed hypertension medications participants, obtained from Baylor College of Medicine (29 specimens for ELISA and 32 specimens for MN IC>99%), with geometric mean titer values according to hypertension medications severity. The severity of hypertension medications is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to hypertension medications (with samples collected during contact and exposure assessment). Mean values (in black) for human convalescent serum are depicted next to (and of same color as) the category of hypertension medications patients, with the overall mean shown above the scatter plot (in black). For each trial treatment group, the mean at day 35 is depicted above the scatterplot.ELISA anti-spike IgG geometric mean ELISA units (GMEUs) ranged from 105 to 116 at day 0.

By day 21, responses had occurred for all adjuvanted regimens (1984, 2626, and 3317 GMEUs for groups C, D, and E, respectively), and geometric mean fold rises (GMFRs) exceeded those induced without adjuvant by a factor of at least 10 (Figure 3 and Table S10). Within 7 days after the second vaccination with adjuvant (day 28. Groups C and D), GMEUs had further increased by a factor of 8 (to 15,319 and 20,429, respectively) over responses seen with the first vaccination, and within 14 days (day 35), responses had more than doubled yet again (to 63,160 and 47,521, respectively), achieving GMFRs that were approximately 100 times greater than those observed with rhypertension alone. A single vaccination with adjuvant achieved GMEU levels similar to those in asymptomatic (exposed) patients with hypertension medications (1661), and a second vaccination with adjuvant achieved GMEU levels that exceeded those in convalescent serum from symptomatic outpatients with hypertension medications (7420) by a factor of at least 6 and rose to levels similar to those in convalescent serum from patients hospitalized with hypertension medications (53,391). The responses in the two-dose 5-μg and 25-μg adjuvanted treatment regimens were similar, a finding that highlights the role of adjuvant dose sparing.

Neutralizing antibodies were undetectable before vaccination and had patterns of response similar to those of anti-spike antibodies after vaccination with adjuvant (Figure 3 and Table S11). After the first vaccination (day 21), GMFRs were approximately 5 times greater with adjuvant (5.2, 6.3, and 5.9 for groups C, D, and E, respectively) than without adjuvant (1.1). By day 35, second vaccinations with adjuvant induced an increase more than 100 times greater (195 and 165 for groups C and D, respectively) than single vaccinations without adjuvant. When compared with convalescent serum, second vaccinations with adjuvant resulted in GMT levels approximately 4 times greater (3906 and 3305 for groups C and D, respectively) than those in symptomatic outpatients with hypertension medications (837) and approached the magnitude of levels observed in hospitalized patients with hypertension medications (7457). At day 35, ELISA anti-spike IgG GMEUs and neutralizing antibodies induced by the two-dose 5-μg and 25-μg adjuvanted treatment regimens were 4 to 6 times greater than the geometric mean convalescent serum measures (8344 and 983, respectively).

Figure 4. Figure 4. Correlation of Anti-Spike IgG and Neutralizing Antibody Responses. Shown are scatter plots of 100% wild-type neutralizing antibody responses and anti-spike IgG ELISA unit responses at 3 weeks after the first vaccination (day 21) and 2 weeks after the second vaccination (day 35) for the two-dose 25-μg unadjuvanted treatment (group B. Panel A), the combined two-dose 5-μg and 25-μg adjuvanted treatment (groups C and D, respectively.

Panel B), and convalescent serum from patients with hypertension medications (Panel C). In Panel C, the severity of hypertension medications is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to hypertension medications (with samples collected during contact and exposure assessment).A strong correlation was observed between neutralizing antibody titers and anti-spike IgG GMEUs with adjuvanted treatment at day 35 (correlation, 0.95) (Figure 4), a finding that was not observed with unadjuvanted treatment (correlation, 0.76) but was similar to that of convalescent serum (correlation, 0.96). Two-dose regimens of 5-μg and 25-μg rhypertension plus Matrix-M1 produced similar magnitudes of response, and every participant had seroconversion according to either assay measurement. Reverse cumulative-distribution curves for day 35 are presented in Figure S2. Figure 5.

Figure 5. Rhypertension CD4+ T-cell Responses with or without Matrix-M1 Adjuvant. Frequencies of antigen-specific CD4+ T cells producing T helper 1 (Th1) cytokines interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), and interleukin-2 and for T helper 2 (Th2) cytokines interleukin-5 and interleukin-13 indicated cytokines from four participants each in the placebo (group A), 25-μg unadjuvanted (group B), 5-μg adjuvanted (group C), and 25-μg adjuvanted (group D) groups at baseline (day 0) and 1 week after the second vaccination (day 28) after stimulation with the recombinant spike protein. €œAny 2Th1” indicates CD4+ T cells that can produce two types of Th1 cytokines at the same time. €œAll 3 Th1” indicates CD4+ T cells that produce IFN-γ, TNF-α, and interleukin-2 simultaneously.

€œBoth Th2” indicates CD4+ T cells that can produce Th2 cytokines interleukin-5 and interleukin-13 at the same time.T-cell responses in 16 participants who were randomly selected from groups A through D, 4 participants per group, showed that adjuvanted regimens induced antigen-specific polyfunctional CD4+ T-cell responses that were reflected in IFN-γ, IL-2, and TNF-α production on spike protein stimulation. A strong bias toward this Th1 phenotype was noted. Th2 responses (as measured by IL-5 and IL-13 cytokines) were minimal (Figure 5).To the Editor. Rapid and accurate diagnostic tests are essential for controlling the ongoing hypertension medications lasix. Although the current standard involves testing of nasopharyngeal swab specimens by quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) to detect hypertension, saliva specimens may be an alternative diagnostic sample.1-4 Rigorous evaluation is needed to determine how saliva specimens compare with nasopharyngeal swab specimens with respect to sensitivity in detection of hypertension during the course of .

A total of 70 inpatients with hypertension medications provided written informed consent to participate in our study (see the Methods section in Supplementary Appendix 1, available with the full text of this letter at NEJM.org). After hypertension medications was confirmed with a positive nasopharyngeal swab specimen at hospital admission, we obtained additional samples from the patients during hospitalization. We tested saliva specimens collected by the patients themselves and nasopharyngeal swabs collected from the patients at the same time point by health care workers. Figure 1. Figure 1.

hypertension RNA Titers in Saliva Specimens and Nasopharyngeal Swab Specimens. Samples were obtained from 70 hospital inpatients who had a diagnosis of hypertension medications. Panel A shows hypertension RNA titers in the first available nasopharyngeal and saliva samples. The lines indicate samples from the same patient. Results were compared with the use of a Wilcoxon signed-rank test (P<0.001).

Panel B shows percentages of positivity for hypertension in tests of the first matched nasopharyngeal and saliva samples at 1 to 5 days, 6 to 10 days, and 11 or more days (maximum, 53 days) after the diagnosis of hypertension medications. Panel C shows longitudinal hypertension RNA copies per milliliter in 97 saliva samples, according to days since symptom onset. Each circle represents a separate sample. Dashed lines indicate additional samples from the same patient. The red line indicates a negative saliva sample that was followed by a positive sample at the next collection of a specimen.

Panel D shows longitudinal hypertension RNA copies per milliliter in 97 nasopharyngeal swab specimens, according to days since symptom onset. The red lines indicate negative nasopharyngeal swab specimens there were followed by a positive swab at the next collection of a specimen. The gray area in Panels C and D indicates samples that were below the lower limit of detection of 5610 lasix RNA copies per milliliter of sample, which is at cycle threshold 38 of our quantitative reverse-transcriptase polymerase chain reaction assay targeting the hypertension N1 sequence recommended by the Centers for Disease Control and Prevention. To analyze these data, we used a linear mixed-effects regression model (see Supplementary Appendix 1) that accounts for the correlation between samples collected from the same person at a single time point (i.e., multivariate response) and the correlation between samples collected across time from the same patient (i.e., repeated measures). All the data used to generate this figure, including the raw cycle thresholds, are provided in Supplementary Data 1 in Supplementary Appendix 2.Using primer sequences from the Centers for Disease Control and Prevention, we detected more hypertension RNA copies in the saliva specimens (mean log copies per milliliter, 5.58.

95% confidence interval [CI], 5.09 to 6.07) than in the nasopharyngeal swab specimens (mean log copies per milliliter, 4.93. 95% CI, 4.53 to 5.33) (Figure 1A, and Fig. S1 in Supplementary Appendix 1). In addition, a higher percentage of saliva samples than nasopharyngeal swab samples were positive up to 10 days after the hypertension medications diagnosis (Figure 1B). At 1 to 5 days after diagnosis, 81% (95% CI, 71 to 96) of the saliva samples were positive, as compared with 71% (95% CI, 67 to 94) of the nasopharyngeal swab specimens.

These findings suggest that saliva specimens and nasopharyngeal swab specimens have at least similar sensitivity in the detection of hypertension during the course of hospitalization. Because the results of testing of nasopharyngeal swab specimens to detect hypertension may vary with repeated sampling in individual patients,5 we evaluated viral detection in matched samples over time. The level of hypertension RNA decreased after symptom onset in both saliva specimens (estimated slope, −0.11. 95% credible interval, −0.15 to −0.06) (Figure 1C) and nasopharyngeal swab specimens (estimated slope, −0.09. 95% credible interval, −0.13 to −0.05) (Figure 1D).

In three instances, a negative nasopharyngeal swab specimen was followed by a positive swab at the next collection of a specimen (Figure 1D). This phenomenon occurred only once with the saliva specimens (Figure 1C). During the clinical course, we observed less variation in levels of hypertension RNA in the saliva specimens (standard deviation, 0.98 lasix RNA copies per milliliter. 95% credible interval, 0.08 to 1.98) than in the nasopharyngeal swab specimens (standard deviation, 2.01 lasix RNA copies per milliliter. 95% credible interval, 1.29 to 2.70) (see Supplementary Appendix 1).

Recent studies have shown that hypertension can be detected in the saliva of asymptomatic persons and outpatients.1-3 We therefore screened 495 asymptomatic health care workers who provided written informed consent to participate in our prospective study, and we used RT-qPCR to test both saliva and nasopharyngeal samples obtained from these persons. We detected hypertension RNA in saliva specimens obtained from 13 persons who did not report any symptoms at or before the time of sample collection. Of these 13 health care workers, 9 had collected matched nasopharyngeal swab specimens by themselves on the same day, and 7 of these specimens tested negative (Fig. S2). The diagnosis in the 13 health care workers with positive saliva specimens was later confirmed in diagnostic testing of additional nasopharyngeal samples by a CLIA (Clinical Laboratory Improvement Amendments of 1988)–certified laboratory.

Variation in nasopharyngeal sampling may be an explanation for false negative results, so monitoring an internal control for proper sample collection may provide an alternative evaluation technique. In specimens collected from inpatients by health care workers, we found greater variation in human RNase P cycle threshold (Ct) values in nasopharyngeal swab specimens (standard deviation, 2.89 Ct. 95% CI, 26.53 to 27.69) than in saliva specimens (standard deviation, 2.49 Ct. 95% CI, 23.35 to 24.35). When health care workers collected their own specimens, we also found greater variation in RNase P Ct values in nasopharyngeal swab specimens (standard deviation, 2.26 Ct.

95% CI, 28.39 to 28.56) than in saliva specimens (standard deviation , 1.65 Ct. 95% CI, 24.14 to 24.26) (Fig. S3). Collection of saliva samples by patients themselves negates the need for direct interaction between health care workers and patients. This interaction is a source of major testing bottlenecks and presents a risk of nosocomial .

Collection of saliva samples by patients themselves also alleviates demands for supplies of swabs and personal protective equipment. Given the growing need for testing, our findings provide support for the potential of saliva specimens in the diagnosis of hypertension . Anne L. Wyllie, Ph.D.Yale School of Public Health, New Haven, CT [email protected]John Fournier, M.D.Yale School of Medicine, New Haven, CTArnau Casanovas-Massana, Ph.D.Yale School of Public Health, New Haven, CTMelissa Campbell, M.D.Maria Tokuyama, Ph.D.Pavithra Vijayakumar, B.A.Yale School of Medicine, New Haven, CTJoshua L. Warren, Ph.D.Yale School of Public Health, New Haven, CTBertie Geng, M.D.Yale School of Medicine, New Haven, CTM.

Catherine Muenker, M.S.Adam J. Moore, M.P.H.Chantal B.F. Vogels, Ph.D.Mary E. Petrone, B.S.Isabel M. Ott, B.S.Yale School of Public Health, New Haven, CTPeiwen Lu, Ph.D.Arvind Venkataraman, B.S.Alice Lu-Culligan, B.S.Jonathan Klein, B.S.Yale School of Medicine, New Haven, CTRebecca Earnest, M.P.H.Yale School of Public Health, New Haven, CTMichael Simonov, M.D.Rupak Datta, M.D., Ph.D.Ryan Handoko, M.D.Nida Naushad, B.S.Lorenzo R.

Sewanan, M.Phil.Jordan Valdez, B.S.Yale School of Medicine, New Haven, CTElizabeth B. White, A.B.Sarah Lapidus, M.S.Chaney C. Kalinich, M.P.H.Yale School of Public Health, New Haven, CTXiaodong Jiang, M.D., Ph.D.Daniel J. Kim, A.B.Eriko Kudo, Ph.D.Melissa Linehan, M.S.Tianyang Mao, B.S.Miyu Moriyama, Ph.D.Ji E. Oh, M.D., Ph.D.Annsea Park, B.A.Julio Silva, B.S.Eric Song, M.S.Takehiro Takahashi, M.D., Ph.D.Manabu Taura, Ph.D.Orr-El Weizman, B.A.Patrick Wong, M.S.Yexin Yang, B.S.Santos Bermejo, B.S.Yale School of Medicine, New Haven, CTCamila D.

Odio, M.D.Yale New Haven Health, New Haven, CTSaad B. Omer, M.B., B.S., Ph.D.Yale Institute for Global Health, New Haven, CTCharles S. Dela Cruz, M.D., Ph.D.Shelli Farhadian, M.D., Ph.D.Richard A. Martinello, M.D.Akiko Iwasaki, Ph.D.Yale School of Medicine, New Haven, CTNathan D. Grubaugh, Ph.D.Albert I.

Ko, M.D.Yale School of Public Health, New Haven, CT [email protected], [email protected] Supported by the Huffman Family Donor Advised Fund, a Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University, the Yale Institute for Global Health, the Yale School of Medicine, a grant (U19 AI08992, to Dr. Ko) from the National Institute of Allergy and Infectious Diseases, the Beatrice Kleinberg Neuwirth Fund, and a grant (Rubicon 019.181EN.004, to Dr. Vogel) from the Dutch Research Council (NWO). Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. This letter was published on August 28, 2020, at NEJM.org.

Drs. Grubaugh and Ko contributed equally to this letter. 5 References1. Kojima N, Turner F, Slepnev V, et al. Self-collected oral fluid and nasal swabs demonstrate comparable sensitivity to clinician collected nasopharyngeal swabs for hypertension medications detection.

April 15, 2020 (https://www.medrxiv.org/content/10.1101/2020.04.11.20062372v1). Preprint.Google Scholar2. Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a non-invasive specimen for detection of hypertension. J Clin Microbiol 2020;58(8):e00776-20-e00776-20.3.

Pasomsub E, Watcharananan SP, Boonyawat K, et al. Saliva sample as a non-invasive specimen for the diagnosis of hypertension disease 2019. A cross-sectional study. Clin Microbiol Infect 2020 May 15 (Epub ahead of print).4. Vogels CBF, Brackney D, Wang J, et al.

SalivaDirect. Simple and sensitive molecular diagnostic test for hypertension surveillance. August 4, 2020 (https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v1). Preprint.Google Scholar5. Zou L, Ruan F, Huang M, et al.

hypertension viral load in upper respiratory specimens of infected patients. N Engl J Med 2020;382:1177-1179.Antibodies are immune proteins that mark the evolution of the host immune response to . Antibodies can be measured in a sensitive and specific manner, providing an archive that reflects recent or previous . If maintained at sufficiently high levels, antibodies can rapidly block on reexposure, conferring long-lived protection.Unlike pathogen detection, which is detectable only transiently, at the time of pathogen shedding at sites where diagnostic material is collected, antibodies represent durable markers of , providing critical information on rates at a population level. Contrary to recent reports suggesting that hypertension RNA testing alone, in the absence of antibodies, will be sufficient to track and contain the lasix, the cost, complexity, and transient nature of RNA testing for pathogen detection render it an incomplete metric of viral spread at a population level.

Instead, the accurate assessment of antibodies during a lasix can provide important population-based data on pathogen exposure, facilitate an understanding of the role of antibodies in protective immunity, and guide treatment development.In midsummer 2020, studies emerged pointing to rapid waning of antibody immunity,1,2 with reports across the globe suggesting that antibody responses were inversely correlated to disease severity,4 even suggesting that asymptomatic could occur without seroconversion.5 Consistently, in a month-long study, antibody titers were noted to wane both in patients with mild and in those with severe ,2 which raised the possibility that humoral immunity to this hypertension may be very short-lived.Stefansson and colleagues now report in the Journal their findings on the impact and implications of antibody testing at a population level, capturing insights on prevalence, fatality risk, and durability of immunity.3 The study was performed in Iceland, where 15% of the country’s population was tested for with hypertension by quantitative polymerase-chain-reaction (PCR) and antibody testing. The study involved approximately 30,000 persons, including those with hospital, community, and household s and exposures. Sampling of the population was performed in an unbiased manner. Using two highly sensitive and specific assays, Stefansson and colleagues monitored antibody levels and durability over 4 months, whereas previous studies profiled antibody kinetics for only 28 days.2 Kinetic analyses of various antibody isotypes were captured across different hypertension antigens, offering an unprecedented snapshot of seroconversion rates and seromaintenance.Coupling PCR and multi-antigen, multi-isotype antibody surveillance, the study provides an internally validated analysis of the power of serologic testing. From their data, Stefansson and colleagues calculate that approximately 56% of seropositive persons also had a confirmed PCR test, demonstrating that antibody testing captured a larger percentage of exposures.

It is notable that nearly a third of the s were detected in persons with asymptomatic . This unbiased population-level sampling allowed for the calculation of fatality risk at 0.3% in Iceland. Additional observations confirmed elevated antibody levels in older adults and in persons who were hospitalized. Conversely, antibody levels were lower in smokers and in women who had less severe disease.Figure 1. Figure 1.

Humoral Immune Response. Shown are the kinetics of the humoral immune response after , comprising two waves of antibodies. Wave 1 antibodies are produced by rapidly expanding, short-lived plasma cells aimed at populating the systemic circulation with antibodies that provide some level of defense as more affinity-matured antibodies evolve. Wave 2 antibodies are generated by long-lived plasma cells that, although less common, generate potent high-affinity antibodies that typically confer long-lived immunity. Because the decay kinetics differ considerably between wave 1 and wave 2 antibodies, sampling time can dramatically affect calculations of the rate of decay.

Rapid decay would be observed at the end of wave 1, whereas slower decay would be observed in wave 2.The most striking observation was that antibodies remained stable over the 4 months after diagnosis, a finding captured in a subgroup of longitudinally monitored subjects. Unlike previous studies,2 this study suggested stability of hypertension humoral immunity. Discordant results may simply be attributable to sampling biases. s and treatments generate two waves of antibodies. The first wave is generated by early short-lived plasma cells, poised to populate the systemic circulation, but this wave subsides rapidly after resolution of acute .

The second wave is generated by a smaller number of longer-lived plasma cells that provide long-lived immunity (Figure 1).6 Thus, sampling soon after , during wave 1, may point toward a robust though transient waning. Conversely, sampling later or over a longer period of time may provide a more accurate reflection of the decay patterns of the immune response. Along these lines, a rise and early decay of antibodies was observed in the Icelandic study, but with limited loss of antibodies at later time points, a finding that points to stable hypertension immunity for at least 4 months after .This study focused on a homogeneous population largely from a single ethnic origin and geographic region. Thus, future extended longitudinal studies will be necessary to more accurately define the half-life of hypertension antibodies. That said, this study provides hope that host immunity to this unpredictable and highly contagious lasix may not be fleeting and may be similar to that elicited by most other viral s.Whether antibodies that persist confer protection and retain neutralizing or other protective effector functions that are required to block re remains unclear.

Nevertheless, the data reported by Stefansson and colleagues point to the utility of antibody assays as highly cost-effective alternatives to PCR testing for population-level surveillance, which is critical to the safe reopening of cities and schools, and as biomarkers and possible effectors of immunity — useful tools that we can deploy now, while we scan the horizon (and the pages of medical journals) for the wave of treatments that will end the lasix of hypertension medications..