Thursday, August 18, 2022

FOR PROFIT HEALTHCARE U$A

Current insurer calculation of qualified payment amount for out-of-network (OON) care may violate No Surprises Act


Skewing data when calculating key rate for OON care weakens community anesthesiology, emergency and radiology practices, and can be used to narrow provider networks and reduce patient access to care

Reports and Proceedings

AMERICAN SOCIETY OF ANESTHESIOLOGISTS

CHICAGO – In possible violation of the No Surprises Act, health insurance company calculations of Qualified Payment Amounts (QPA) for anesthesiology, emergency medicine and radiology services (and possibly other specialty services) likely include rates from primary care provider (PCP) contracts. A new study conducted by Avalere Health and commissioned by three national physician organizations examined a subpopulation of PCPs and determined that contracting practices may directly impact the QPA.   

Despite the law’s directive that QPA calculation be based on payment data from the “same or similar specialty” in the same geographic region, insurers may be calculating median in-network rates for specialty services using PCP contracted rates for services that were never negotiated, may never be provided by those physicians and may never be paid. This method may violate the law and produce insurer-calculated QPAs that do not represent typical payments for these services.

Insurers have already attempted to use the new law to raise profits by artificially lowering the QPA. Further, they have cancelled contracts of providers who declined large reimbursement cuts. Using such erroneous data in QPA calculation may further narrow medical networks, deny patients their choice of providers and could delay diagnosis and treatment of illness and injury.

“This new research raises significant questions about the accuracy of insurer calculated QPAs,” said American Society of Anesthesiologists (ASA) President Randall M. Clark, M.D., FASA. “We have received reports of extremely low QPAs that bear absolutely no resemblance to actual in-network rates in the geographic area; yet these same rates are being used by insurers as their initial payment.”

In the study, 75 primary care practice employees who have a role in contracting with insurers were surveyed regarding whether they contract with insurers for services they rarely or never provide, as well as negotiation practices related to these services. The survey found that 68% of respondents had services that they rarely provide (fewer than twice a year) included in their contracts, and 57% of respondents had services that they never provide included in their contract.

Congress debated including a benchmark for determining payment rates for out-of-network providers in the No Surprises Act but decided not to dictate a specific rate. Such a rate, Congress argued, could not adequately reflect the different specialties and regions care is provided in across the country. Instead, the law directed insurance companies to calculate their own QPAs and directed independent arbiters to take these QPAs into consideration when settling payment disputes. The QPA is intended to reflect a health insurer’s median contracted rate to providers based on the region in which they practice and for providers in the “same or similar specialty.”

Unfortunately, insurance companies may be incorporating contracted rates for services like those included in the PCP contracts that will never be provided by those physicians and for which insurers will never pay. Additionally, the inclusion of rates not actively negotiated by such providers will likely artificially lower the QPA, effectively reducing payments for the anesthesiologists, emergency physicians and radiologists, who actually do provide those services.

“On behalf of our all our members, the American College of Emergency Physicians (ACEP), the American College of Radiology® (ACR®) and ASA call on policymakers to eliminate the QPA as the sole/primary factor in arbitration and ensure the integrity of the QPA, by insisting they be calculated based on “same or similar specialty” in network rates, thus mitigating the unintended consequences of relying on health insurers’  median in-network rates based partially on data from providers who don’t actively negotiate those rates,” said Gillian Schmitz, M.D., FACEP, president of ACEP. “Physicians rely on fair reimbursement to keep their doors open and continue providing lifesaving medical care to their patients.”

“This study demonstrates yet another reason why policymakers cannot make the QPA the primary factor in such arbitration nor base important regulations solely on insurer-produced and defined data,” said Jacqueline Bello, M.D., FACR, Chair of the American College of Radiology Board of Chancellors. “Decisionmakers should work with healthcare providers and insurers to consider relevant and verifiable data, ensure that patients have adequate provider networks, and protect access to care by ensuring sensible, sustainable reimbursement.”     

About the American Society of Anesthesiologists
Founded in 1905, the American Society of Anesthesiologists (ASA) is an educational, research and scientific society with more than 55,000 members organized to raise and maintain the standards of the medical practice of anesthesiology. ASA is committed to ensuring physician anesthesiologists evaluate and supervise the medical care of patients before, during and after surgery to provide the highest quality and safest care every patient deserves.

For more information on the field of anesthesiology, visit the American Society of Anesthesiologists online at asahq.org. To learn more about the role physician anesthesiologists play in ensuring patient safety, visit asahq.org/madeforthismoment. Like ASA on Facebook and follow ASALifeline on Twitter.

About the American College of Emergency Physicians
The American College of Emergency Physicians (ACEP) is the national medical society representing emergency medicine. Through continuing education, research, public education, and advocacy, ACEP advances emergency care on behalf of its 40,000 emergency physician members, and the more than 150 million Americans they treat on an annual basis. For more information, visit http://www.acep.org and www.emergencyphysicians.org.

About the American College of Radiology
The American College of Radiology (ACR), founded in 1924, is a professional medical society dedicated to serving patients and society by empowering radiology professionals to advance the practice, science and professions of radiological care.

 

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MY BREAKFAST FOR THIRTY YEARS

Coffee and cigarettes: Research sheds new light on nicotine and morning brew

Peer-Reviewed Publication

UNIVERSITY OF FLORIDA

For some smokers, the first cigarette of the day is just not as satisfying without a cup of coffee. That could be more than just a morning habit: Chemical compounds in roasted coffee beans may help lighten the effects of morning nicotine cravings, University of Florida researchers have found.

In a cell-based study, the researchers identified two compounds in coffee that directly affect certain high-sensitivity nicotine receptors in the brain. In smokers, these brain receptors can be hypersensitive after a night of nicotine withdrawal.

The recently published findings have yet to be tested in humans but are an important step toward better understanding how coffee and cigarettes affect nicotine receptors in the brain, said Roger L. Papke, Ph.D., a pharmacology professor in the UF College of Medicine. Caffeine is coffee’s feel-good ingredient for most people but smokers may get another kind of boost.

“Many people like caffeine in the morning but there are other molecules in coffee that may explain why cigarette smokers want their coffee,” Papke said.

The researchers applied a dark-roasted coffee solution to cells that express a particular human nicotine receptor. An organic chemical compound in coffee may help restore the nicotine receptor dysfunction that leads to nicotine cravings in smokers, the researchers concluded.

The findings have led Papke to a broader hypothesis: One of the compounds in brewed coffee, known as n-MP, may help to quell morning nicotine cravings.

Papke said he was intrigued by the idea that nicotine-dependent smokers associate tobacco use with coffee in the morning and alcohol in the evening. While alcohol’s effect on nicotine receptors in the brain has been thoroughly researched, the receptors’ interaction with coffee has been studied less.

“Many people look for coffee in the morning because of the caffeine. But was the coffee doing anything else to smokers? We wanted to know if there were other things in coffee that were affecting the brain’s nicotine receptors,” Papke said.

The findings, he said, provide a good foundation for behavioral scientists who could further study nicotine withdrawal in animal models. 

Funding for the research was provided by the National Institutes of Health.

University of Houston professor working to heal homelessness, fix broken aid industry

Dr. David Buck’s passion for helping underserved populations inspired by encounter with Mother Teresa

Peer-Reviewed Publication

UNIVERSITY OF HOUSTON

While volunteering at an Indian orphanage in 1984, Dr. David Buck found his passion for helping those most in need during an encounter with the greatest humanitarian in human history – Mother Teresa. That unforgettable experience put him on a decades-long path to reshaping how communities care for the underserved.

“Mother Teresa asked us ‘Who among you wants to change the world?’” recalled Buck. “Internally I was screaming ‘Me, I do!’”

But Buck, now a professor and associate dean for community health at the University of Houston Tilman J. Fertitta Family College of Medicine, didn’t raise his hand.

“She said ‘For all of you who want to do that, there’s the door. Our task is much greater. Our task is to love one person at a time,’” he said. “So, I came back to the U.S. and knew I wanted to make a difference here at home.”

Buck recently reflected on his nearly 40 years of tackling the homelessness epidemic, repairing a fragmented aid industry, and challenging the status quo in medicine in a first-person account published in the Journal of Social Distress and Homelessness.

Early in his career, just after returning from that life-changing experience with Mother Teresa, Buck volunteered with Houston Catholic Worker House where he learned the biggest problem facing the homeless was access to health care. Not long after, he established two free health clinics and a dental clinic, but soon realized the root problem wasn’t just access. Instead, it was a lack of integration of all the services they needed.

“There was no system of care, from primary care to subspecialty care, health care to housing, food, even identification cards to transportation. Homelessness is like a prison of these catastrophic failures at every level. Education, employment, the judicial system. It goes on and on,” said Buck, noting that there are hundreds of non-profits but no financial incentives for one service industry to work with others like housing, transportation or employment.

Recognizing what he calls a “profound lack of leadership,” Buck founded Healthcare for the Homeless Houston in 1999 to promote health, hope and dignity for those affected by homelessness through accessible and comprehensive quality care. His vision was to provide pathways for moving beyond the cycle of homelessness through integrated care and collaborative partnerships and eliminate those obstructive service silos.

“You have to go to the place that does housing, but you don’t have transportation,” he said. “You have to get I.D., but that’s a different Texas agency. You have psychiatry here, but not at your primary care doctor, and then you have to go somewhere else for your meds. It’s this endless cycle.”

To further the mission, Buck founded another non-profit, the Patient Care Intervention Center (PCIC), and partnered with United Way, among others, to build a coordinated health safety-net where stakeholders share and integrate social and medical data to help make better decisions.

In the journal article, Buck suggests three strategies that need to be adopted across the health care system to more effectively treat homeless individuals and improve health outcomes:

  • Challenge funders at all levels

Philanthropic institutions, the private sector, local, national, and international public grant agencies must implement financing strategies that incentivize and reward collaboration among service organizations.

  • Resist the temptation to add new non-profits

Further proliferation of non-profit organizations will only serve to further fragment care. Instead, regardless of whether the financial incentives are there or not, reach across the aisle and build meaningful coalitions with existing players.

  • Change starts from within

Reform professional culture to reward practices that are proven to improve key outcomes.

When asked how it’s possible to build a primary care system that is responsive to the needs of the homeless, Buck suggested providing care based on values rather than problems. It’s a strategy based on cognitive behavioral therapy that can lead to health behavior changes.

“Imagine your typical doctor’s appointment: “Hi Mr. Patient, nice to see you today for your hypertension, obesity, substance use, your mental illness, oh and did I mention your obesity?” As I go on with that statement, you become less and less motivated for the behavior change that could improve your health. Now compare that to a values-based approach. Who and what is most important to you? And then you derive goals from that,” he said in the journal interview with article authors Nicholas Peoples and Mary Fang, both medical students at Baylor College of Medicine.

Buck said challenging the status quo is what brought him into academic administration. The Fertitta Family College of Medicine was founded in 2019 on a distinct social mission to improve health and health care in underserved urban and rural communities where poor health outcomes are often more prevalent. Buck is part of the team educating medical students on how to provide compassionate, high-value care (high quality at reasonable cost), with a focus on primary care and other needed physician specialties.

In September, Fertitta Family College of Medicine students for the first time will join students from Baylor and UT medical schools in working at the HOMES (Houston Outreach Medicine, Education and Social Services) Clinic at Healthcare for the Homeless, one of the first student-run medical clinics in the country and the only one in Houston, and the first one at a Federally Qualified Health Center (FQHC).

“We know what’s wrong, and now we have the tools to fix it,” he said.

His vision goes back to that day nearly 40 years ago when Mother Teresa gave him the inspiration for what has become his life’s work. But that work is far from finished, and now he’s hoping that inspiration is passed along to his students.

“We need the next generation of doctors to implement new approaches to improve the quality of care, and that’s part of our focus at UH.”

Attitudes toward mandatory COVID-19 vaccination in Germany

DEUTSCHES AERZTEBLATT INTERNATIONAL


COLOGNE. It has become obvious that sufficiently high immunity to COVID-19 cannot be achieved in Germany through voluntary vaccination alone. On this background, Thomas Rieger and Carsten Schröder from the German Institute for Economic Research, Berlin, together with Christoph Schmidt-Petri from the Karlsruhe Institute of Technology, investigated the acceptance of a policy of general mandatory vaccination against COVID-19. The scientists also investigated the questions of which population groups are supportive of such a measure, which ones are opposed, and what their reasons are, respectively (Rieger T, Schmidt-Petri C, Schröder C: Attitudes toward mandatory COVID-19 vaccination in Germany—a representative analysis of data from the Socio-Economic Panel for the year 2021. Dtsch Arztebl Int 2022; 119: 335–41).

The authors used for their analysis representative data from the Socio-Economic Panel (SOEP). The SOEP consists of a random sample from the population resident in Germany, whose members participate in annual surveys. Because of the far-reaching consequences of the COVID-19 pandemic, the SOEP 2021 was enhanced by including a new COVID-19 survey module. In the time period from January through December 2021, 17,132 participants were interviewed regarding their attitudes regarding a policy of general mandatory vaccination against COVID-19. Furthermore, data were collected on participants’ sociodemographic characteristics, health, political attitudes, and trust in the legal and political systems. The authors used univariate, bivariate, and multivariate statistical analyses to evaluate these data.

They found that a slight majority of survey participants were supportive of mandatory general vaccination against COVID-19. The primary reason given was the attitude that otherwise, not enough people would undergo vaccination. The most important reason given by those opposed to mandatory vaccination was the desire for individual freedom of choice. The group of supporters were older, fewer of them had received tertiary education, they were less healthy, tended to have no children, had centrist political orientations, and had more trust in politics. These differences were, however, not terribly pronounced compared with the group of opponents of mandatory vaccination. The biggest difference actually consisted in the fact that notably more supporters were vaccinated against COVID-19 than opponents (90% versus 60%).

In the authors’ view, future analyses should investigate the question of how attitudes towards mandatory COVID-19 vaccination change over time and can be influenced. In this context, in addition to whether or not mandatory vaccination is introduced in Germany, it is likely to play a role how this would be implemented in detail.

https://www.aerzteblatt.de/pdf.asp?id=224864

Bruin biophysicist’s research pushes forward development of cultured meat

CNSI member Amy Rowat advances technology toward tasty new alternative protein offerings

Peer-Reviewed Publication

CALIFORNIA NANOSYSTEMS INSTITUTE

Mini burger 

IMAGE: IN DEVELOPMENT—A CULTURED MEAT “MINI-BURGER” view more 

CREDIT: IMAGE COURTESY: JEANNIE BARBER-CHOI/UCLA

After earning her undergraduate degree, Amy Rowat found herself at a fork in the road. Should she follow her love of science to graduate school for physics, or her passion for cooking to culinary school?

At the time, academia won out. But over the long term, she’s answered the “science or food” question her own way: Why not both?

Now an associate professor of integrative biology and physiology and the holder of UCLA’s Marcie H. Rothman Presidential Chair in Food Studies, Rowat has spiced up both her pedagogy and her research with her gastronomic interests. She is founding director of Science and Food, a campus-based organization that promotes knowledge of science through food and food through science. And in recent years, her research in mechanical biology — exploring how physical forces affect cells — has included studies into cultured meat that may help to eventually add labmade steaks to the grocer’s shelves.

She views that scientific endeavor, aided by the tailwind of private philanthropy, federal research grants and her membership in the California NanoSystems Institute at UCLA, as an aspect of a broader research mission.

“Very broadly, our work is driven by the desire to advance both human and planetary health,” Rowat said. “When I realized there was a gap in the field of alternative proteins, my skillset and the expertise of my lab in biophysics, engineering, cell biology and mechanical biology seemed like a strong fit.”

She points to one of many deleterious effects of the COVID-19 pandemic, disruptions to the supply chain sometimes rendering household staples hard to find, as an example of why expanding the menu of protein-rich foods would benefit society.

“Having other methods to produce animal protein can help increase the resilience of our food system,” she said.

Although there are a number of problems to be solved along the way, cultured meat has the potential to cause less greenhouse gas emission, reduce antibiotic use and occupy less land pound-for-pound than traditional meat from livestock.

“I see cultured meat as a complement to other solutions, such as regenerative agriculture,” Rowat said. “An important aspect is simply to have these alternative protein sources out there.”

Cultured chicken nuggets are already obtainable in Singapore. With similar products working their way through U.S. regulatory processes, Rowat predicts that cultured meat may be available for sale stateside in the next year and a half. Of course, it remains to be seen whether it will find widespread adoption, as plant-based meat alternatives have, or occupy a niche such as feeding people living in extreme environments.

The ability to grow cells in labs is nothing new. However, the cost and the challenges involved with production for consumption at consumer scale have been substantial obstacles. In her research, Rowat is looking for methods that add efficiency to the processes behind cultured meat.

A study she led appearing in the August 2022 edition of the journal Biomaterials signals a step forward for the effort.

Rowat and her colleagues take on a fundamental limitation, that animal cells require some sort of scaffold to grow on if they’re going to develop and function properly. But the petri dish won’t do the trick at industrial scale. Rather, the instrument for the job is a large vat called a bioreactor. To date, cultured meat has been grown on tiny beads, called microcarriers, made of inedible polymers. They must later be separated from the cells, increasing cost and cutting into efficiency.

In the paper, the UCLA team presents a process for making edible microcarriers from gelatin and a food-grade enzyme. Because muscle stem cells have been shown to grow more readily on grooved surfaces — similar to the texture of skeletal muscle — the researchers also describe a technique for patterning their microcarriers. In a proof-of-concept experiment, they cultured cow muscle cells, harvested them into a patty and cooked it with olive oil until browned.

Two resources connected to the CNSI played important roles in the study.

The team made their grooved microcarriers at the UCLA NanoLab, a cleanroom facility for the fabrication of devices that reach down into the scale of billionths of a meter. To measure the mechanical properties of the microcarriers, and confirm the 3D shapes of the grooved ones, the scientists used instruments at the Nano and Pico Characterization Laboratory, a CNSI Technology Center.

The study also benefited from private support, through the Good Food Institute as well as the Noble Family Innovation Fund, a CNSI resource that backs research with potential to launch knowledge-driven commercial enterprises and benefit society.

That philanthropic assistance has borne fruit in more ways than one. Seed funding led to progress that helped attract major grants from the National Science Foundation and the Agriculture and Food Research Initiative of the U.S. Department of Agriculture’s National Institute of Food and Agriculture. And the Noble Fund award is backing experiments at another CNSI Technology Center, the Molecular Screening Shared Resource, which allows scientists to quickly test large libraries of molecules.

Rowat has previously worked with the MSSR on investigations toward fighting cancer; for her cultured meat investigations, the facility will enable her to screen a collection of food ingredients for the ability to aid in growing fat cells. This is the key to another ambition of Rowat’s: to create the capacity for a sumptuous cut of cultured steak shot through with flecks of fat.

“The holy grail in this work is to develop a piece of meat that is more spatially patterned, like a filet mignon, and marbled with fat,” she said. “Fat is really important for mouthfeel, for texture, for flavor and for nutrition.

“That’s the next frontier we’re working on now, and we’re grateful for the Noble Family Innovation Fund support. We’re excited for the next level of findings, which we think will make cultured meat more delicious and healthful.”

After climate-linked disasters, some US animal shelters experience a spike in dog and cat numbers for up to a year

Peer-Reviewed Publication

PLOS

Burned trees in Flagstaff, Arizona, U.S.A. 

IMAGE: BURNED TREES IN FLAGSTAFF, ARIZONA, U.S.A. view more 

CREDIT: HEIDI E. BROWN, CC-BY 4.0 (HTTPS://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/)

After climate-linked disasters, some US animal shelters experience a spike in dog and cat numbers for up to a year

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Article URL: https://journals.plos.org/climate/article?id=10.1371/journal.pclm.0000066

Article Title: Disaster event effects on cat and dog populations within United States animal care facility services: A cross sectional study

Author Countries: U.S.A.

Funding: The authors received no specific funding for this work.

“Nutri-Score” label may counter misleading sugar claims on groceries

Consumer survey supports the use of Nutri-Score labeling to help boost public health

Peer-Reviewed Publication

PLOS

Product examples with the three sweet claim variations and the Nutri-Score. 

IMAGE: PRODUCT EXAMPLES WITH THE THREE SWEET CLAIM VARIATIONS AND THE NUTRI-SCORE. view more 

CREDIT: JÜRKENBECK ET AL., 2022, PLOS ONE, CC-BY 4.0 (HTTPS://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/)

A new analysis suggests that the Nutri-Score—a label indicating the overall nutritional quality of a food product—can counteract the misleading effects of sugar claims. Kristin Jürkenbeck and colleagues of the University of Göttingent, Germany, present these findings in the open-access journal PLOS ONE on August 17, 2022.

High consumption of sugar has been linked to an increased risk of becoming overweight and other health issues. Some companies therefore label products with claims about sugar content, such as “without added sugar” or “less sweet.” However, consumers may interpret such claims to mean that a food product is healthier than it really is.

Another type of label, the Nutri-Score, is increasingly being used in European countries to inform consumers of the overall nutritional quality of food products. Previous research shows that the Nutri-Score can indeed guide consumers to make healthier food purchases.

Now, Jürkenbeck and colleagues have examined how the Nutri-Score might interact with sugar-content labels. In October 2020, they conducted an online survey of 1,103 German participants. The survey asked participants for their perceptions after being presented with images of the packaging of three hypothetical products—instant cappuccino, chocolate muesli, and an oat drink—with different combinations of sugar claims and Nutri-Score labels.

Statistical analysis of the survey results suggests that, when a Nutri-Score was not present, claims about reduced sugar did indeed mislead participants into believing that hypothetical products were healthier than they actually were. However, the presence of a Nutri-Score counteracted those effects, reducing misconceptions about the healthiness of less nutritional foods.

On the basis of these findings, the researchers call for restricted use of sugar content claims and similar labels, and mandatory use of the Nutri-Score by companies that do make such claims. They also call for future research to evaluate the effects of the Nutri-Score for additional food categories and in the context of other advertising claims that could mislead consumers about food healthiness.

The authors add: “Nutrition or taste claims about sugar on the front of packages can improve the health perception of foods with poor health images.”

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In your coverage please use this URL to provide access to the freely available article in PLOS ONEhttps://journals.plos.org/plosone/article?id=10.1371/journal.pone.0272220

Citation: Jürkenbeck K, Mehlhose C, Zühlsdorf A (2022) The influence of the Nutri-Score on the perceived healthiness of foods labelled with a nutrition claim of sugar. PLoS ONE 17(8): e0272220. https://doi.org/10.1371/journal.pone.0272220

Author Countries: Germany

Funding: This research was funded by the Federation of German Consumer Organizations (Verbraucherzentrale Bundesverband (vzbv). For publication we acknowledge support by the German Research Foundation and the Open Access Publication Funds of the University of Goettingen. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

To grow food on Mars, researchers find that alfalfa plants can fertilize the natural soil and marine cyanobacteria can desalinate the high salt water

Peer-Reviewed Publication

PLOS

Growth of radish plants. 

IMAGE: GROWTH OF RADISH PLANTS IN ALFALFA TREATED BASALTIC REGOLITH SIMULANT SOIL USING FRESH WATER (LEFT), UNFILTERED (MIDDLE) OR FILTERED (RIGHT) BIODESALINATED WATER. view more 

CREDIT: KASIVISWANATHAN ET AL., 2022, PLOS ONE, CC-BY 4.0 (HTTPS://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/)

To grow food on Mars, researchers find that alfalfa plants can fertilize the natural soil and marine cyanobacteria can desalinate the high salt water

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Article URL:  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0272209

Article Title: Farming on Mars: Treatment of basaltic regolith soil and briny water simulants sustains plant growth

Author Countries: U.S.A.

Funding: The authors received no specific funding for this work.
 

Isolation may affect horses' health too: Housing them alone appears to stress and hamper their immune system

Peer-Reviewed Publication

PLOS

Two horses in Germany. 

IMAGE: TWO HORSES IN GERMANY. view more 

CREDIT: IBRAHIM RIFATH, UNSPLASH, CC0 (HTTPS://CREATIVECOMMONS.ORG/PUBLICDOMAIN/ZERO/1.0/)

Isolation may affect horses' health too: housing them alone appears to stress and hamper their immune system

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Article URL:  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0272445

Article Title: Single housing but not changes in group composition causes stress-related immunomodulations in horses

Author Countries: Germany

Funding: The study was funded by the Ministry of Food, Rural Affairs and Consumer Protection of the State of Baden-Württemberg, Germany. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.