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A UC San Francisco study has found that the antibiotic azithromycin was no more effective than a placebo in preventing symptoms of COVID-19 among non-hospitalized patients, and may increase their chance of hospitalization, despite widespread prescription of the antibiotic for the disease.

"These findings do not support the routine use of azithromycin for outpatient SARS-CoV-2 infection," said lead author Catherine E. Oldenburg, ScD, MPH, an assistant professor with the UCSF Proctor Foundation. SARS-CoV-2 is the virus that causes COVID-19.

Azithromycin, a broad-spectrum antibiotic, is widely prescribed as a treatment for COVID-19 in the United States and the rest of the world. "The hypothesis is that it has anti-inflammatory properties that may help prevent progression if treated early in the disease," said Oldenburg. "We did not find this to be the case."

The study, which was conducted in collaboration with Stanford University, appears July 16, 2021, in the Journal of the American Medical Association.

The study included 263 participants who all tested positive for SARS-CoV-2 within seven days before entering the study. None were hospitalized at the time of enrollment. In a random selection process, 171 participants received a single, 1.2 gram oral dose of azithromycin and 92 received an identical placebo.

At day 14 of the study, 50 percent of the participants remained symptom free in both groups. By day 21, five of the participants who received azithromycin had been hospitalized with severe symptoms of COVID-19 and none of the placebo group had been hospitalized.

The researchers concluded that treatment with a single dose of azithromycin compared to placebo did not result in greater likelihood of being symptom-free.

"Most of the trials done so far with azithromycin have focused on hospitalized patients with pretty severe disease," said Oldenburg. "Our paper is one of the first placebo-controlled studies showing no role for azithromycin in outpatients."

The COVID-19 pandemic knocked many women off schedule for important health appointments, a new study finds, and many didn't get back on schedule even after clinics reopened. The effect may have been greatest in areas where such care is already likely falling behind experts' recommendations.

The study, by health care researchers in the University of Michigan Institute for Healthcare Policy and Innovation, looks at screenings for breast cancer, cervical cancer and sexually transmitted infections (STI), as well as two types of birth control care: prescriptions for oral contraceptives and insertions of longer-acting devices.

For all of 2020, adult women covered by Michigan's largest private health insurer were 20% to 30% less likely to receive these services than they were in 2019, according to the findings reported in JAMA Health Forum.

As expected, there was a sharp drop in most such care during Michigan's first pandemic peak in March and April 2020. That includes the weeks when the state's public health orders paused all non-essential health care, and many health clinics closed, to reduce the risk of coronavirus transmission and free up health providers for the surge of a brand-new disease caused by a little-understood virus.

But even after clinics reopened, there was no added increase in these services during the rest of the year to make up for lost time.

From July 2020 to the end of the year, women got most of these kinds of care at pre-pandemic levels, but not at higher levels that would catch up on missed care.

"This recovery to baseline levels, but not above them, means a group of women missed these services all year. The question is, what will that mean for them over the longer term?" says Nora Becker, M.D., Ph.D., the lead author of the study and a primary care doctor at Michigan Medicine, U-M's academic medical center. "We don't know yet whether they have caught up in 2021, but we will need to keep looking at the data as they become available."

Signs of disparity

The study also suggests that disparities in preventive care could have been made worse by the pandemic. Women with lower incomes or less English-speaking ability, and those who are Black or Latina, were already known before the pandemic to be less likely to receive these services as recommended.

Although the anonymous data used in the study didn't include information about the race, ethnicity, income or English proficiency of the individual patients, it does include ZIP code information. Becker used data from the American Community Survey run by the US Census Bureau to match ZIP codes to information about average income, percentage of nonwhite residents and percentage of non-English speakers.

In general, lower use of preventive care in 2020 was seen in women from ZIP codes that have lower average income levels, more non-white residents or more non-proficient English speakers.

"While these data don't allow us to know for sure that disparities worsened, it's concerning that a lot of these comparisons were moving in the direction of worsening the disparities that we know already existed," said Becker.

"This study demonstrates the wide-ranging effects that the COVID-19 pandemic has had on other important health care services," said senior author John Z. Ayanian, M.D., M.P.P., director of IHPI. A longtime researcher on health disparities in preventive care, Ayanian is the Alice Hamilton Distinguished University Professor of Medicine and Healthcare Policy in the U-M Medical School, as well as professor of health management and policy in the School of Public Health, and professor of public policy in the Gerald R. Ford School of Public Policy. He is also editor of JAMA Health Forum but recused himself from the editorial decision process for the study.

Getting back on track

Becker, an assistant professor of internal medicine at the U-M Medical School and member of IHPI, recommends that women should contact their providers if they skipped care in 2020, or had appointments canceled but not rescheduled by their providers during the spring of that year.

Similarly, she encourages providers to identify and reach out to the highest-risk individuals who could benefit most from preventive care - for example, those who were already overdue for a screening test when the pandemic arrived, or those who have other health or lifestyle factors that put them at higher risk of breast cancer, cervical cancer, STIs or unplanned pregnancy.

The study points to a bigger question of whose responsibility it is to remind women that they are due for a mammogram, Pap smear, STI screening or new long-acting birth control implant to replace one that has reached the end of its life.

Health insurers may send reminders, but clinicians most likely review what types of services are needed after the patient has arrived for an appointment. If the patient doesn't come for an appointment, in person or via telemedicine, the clinician won't necessarily notice that they're due or overdue for a particular service.

While a single late or missed mammogram or Pap smear might not have a major impact on an individual woman's life as long as it is quickly rescheduled, a missed birth control pill refill, STI test or LARC insertion could, Becker noted.

The reduction in social interaction during the pandemic, including reduced sexual activity among those not in relationships, may offset some of the risk of sexually transmitted infection or unplanned pregnancy, she added. Birth control pill refills at pharmacies were lower for all of 2020, compared with 2019.

The study is based on data from 685,000 Michigan women between the ages of 18 and 74 who were enrolled in an employer-based or Medigap plan offered by Blue Cross Blue Shield of Michigan between January 2019 and January 2021. However, if a woman received a preventive service without using her insurance, or was not covered by a BCBSM plan for the entire study period and received coverage for a service through a different plan, the data would not reflect that.

Vaccine negativity and reluctance didn't just emerge during the COVID-19 pandemic. In a recent study published in the Disaster Medicine and Public Health Preparedness journal, authors from Loyola University Maryland and Johns Hopkins Bloomberg School of Public Health explored the appearance of negative dominance - a concept in which negative messages outweigh positive, solution-oriented messages in audiences' perceptions - in the context of COVID-19 vaccine-related information and activity online.

Prior research has looked at media coverage to identify vaccine concerns among the public and its impact on vaccine-related beliefs and behaviors, the spread of misinformation and fake news on the Internet, and the role of social media in aiding vaccine hesitancy, among others. Surprisingly, however, research to date has yet to explicitly explore negative dominance of vaccine-related information online using more recently developed tools for analyzing big data.

In the context of COVID-19, one of the greatest challenges for health and risk communicators has been dealing with the accompanying infodemic. The World Health Organization has defined the term as an overabundance of information, including false and misleading information, that causes confusion and can further threaten public health. In June 2020, 132 member states of the World Health Organization signed a cross-regional statement in which they declared the infodemic "as dangerous to human health and security as the pandemic itself." (Cross-Regional Statement) Social media platforms were used to spread mis- and disinformation, further exacerbating the infodemic. Adverse events related to the vaccine, such as reports of anaphylaxis and Bell's Palsy, gave fodder to those pushing anti-vaccination messages and promoting conspiracy theories. According to the study's lead-author, Dr. Paola Pascual-Ferrá of Loyola University Maryland, "While we did not find evidence of negative dominance of adverse events in the context of COVID-19 vaccine discourse on social media, that does not mean that there was no negative content circulating in social media platforms during the time we studied. What our study showed is that, compared to all other content, the number of posts focused on the adverse effects of COVID-19 vaccines, and levels of engagement for those posts, pale in comparison to all other content related to COVID-19 vaccines during the same time frame.

There are several potential explanations for this, which would require further research, but some of those explanations include the effectiveness of moderation efforts by the social media platforms to counter mis- and dis-information, as well as perhaps the emergence of new social norms that discourage people from promoting negative content."

Co-author Dr. Neil Alperstein of Loyola University Maryland reports that "After extracting posts from Facebook, Instagram and Reddit, with the Crowdtangle tool, we analyzed the data using Communalytic, a tool that, based on Google's Perspective API, measures the use of toxic language in online conversations."

Dr. Daniel Barnett, co-author, at Johns Hopkins Bloomberg School of Public Health notes that "This examination of online negative dominance during COVID-19 provides evidence-based insights that public health agencies can apply toward their crisis risk communication efforts in pandemic contexts. More broadly, this study also highlights the relevance of research on gauging online public sentiment during public health emergencies and the need for further examination of the degree of online negative dominance in current and future public health crises."

New research from the RIKEN Center for Brain Science (CBS) in Japan shows that a deficit in histone methylation could lead to the development of autism spectrum disorders (ASD). A human variant of the SUV39H2 gene led researchers to examine its absence in mice. Published in Molecular Psychiatry, the study found that when absent, adult mice exhibited cognitive inflexibility similar to what occurs in autism, and embryonic mice showed misregulated expression of genes related to brain development. These findings represent the first direct link between the SUV39H2 gene and ASD.

Genes are turned on and off throughout our development. But genetic variation means that what is turned off in some people remains turned on in others. This is why, for example, some adults can digest dairy products and others are lactose intolerant; the gene for making the enzyme lactase is turned off when some people become adults, but not others. One way that genes can be turned on and off is through a process called histone methylation in which special enzymes transfer methyl groups to histone proteins that are wrapped around DNA.

Variations in genes related to methylation during brain development can lead to serious problems. One such variation occurs in a rare disorder called Kleefstra Syndrome, in which a mutation prevents methylation of H3K9--a specific location on histone H3. Because Kleefstra Syndrome resembles autism in some ways, RIKEN CBS researchers led by Takeo Yoshikawa looked for autism-specific variations in genes that can modify H3K9. Among nine such genes, they found one variant in an H3K9 methyltransferase gene--SUV39H2--that was present in autism, and the mutated SUV39H2 prevented methylation when tested in the lab. Similar loss-of-function results were found for the mouse version of the variant.

The next step was to see what happens in mice that lack the Suv39h2 gene. Behaviorally, the researchers found that the mice could learn a simple cognitive task, but had difficultly when the task required cognitive flexibility. In the simple task, mice learned to get a reward by poking a door at alternating diagonal corners of a cage. After they could do this well, the possible reward locations switched to the other two diagonal corners. The genetically modified mice did this as well as wild-type mice. In another task, after learning to alternate between the two diagonal corners, only the location of one reward was switched. When the mice were challenged to alternate randomly between these two tasks, wild-type mice could adapt quickly, but the Suv39h2-deficient mice took much longer. "This serial reversal-learning task was essential," says first author Shabeesh Balan. "Cognitive inflexibility is a core symptom of ASD, and our new task was able to address this behavioral feature in ways that previous mouse studies could not."

When the researchers examined what happened in the mouse brain when H3K9 methylation failed to occur, they found that important genes that are usually silenced in early development were turned on in the experimental mice. "Suv39h2 is known to be expressed in early neurodevelopment and to methylate H3K9," explains Yoshikawa. "This keeps a check on genes that should be switched-off. But without it, genes in the protocadherin β cluster were abnormally expressed at high levels in embryonic mice." Because protocadherins are critical for the formation of neural circuits, the researchers believe they have found an important biological pathway that could be central to several neurodevelopmental disorders.

The team then verified the importance of SUV39H2 in human ASD by finding that its expression was lower in the postmortem brains of people with ASD than of controls. "What began with a loss-of-function mutation in only one person with ASD," says Yoshikawa, "has led to a general causal landscape for ASD that culminates in brain circuit abnormality."

Protocadherins have already been proposed to be related to a broad range of mental disorders. This study shows that activating the SUV39H2 gene is a potential therapy for mental disorders--including ASD--that should be investigated more thoroughly in future studies.

New research published in Nature Medicine reveals willingness to get a COVID-19 vaccine was considerably higher in developing countries (80% of respondents) than in the United States (65%) and Russia (30%).

The study provides one of the first insights into vaccine acceptance and hesitancy in a broad selection of low- and-middle income countries (LMIC), covering over 20,000 survey respondents and bringing together researchers from over 30 institutions including the International Growth Centre (IGC), Innovations for Poverty Action (IPA), WZB Berlin Social Science Center, the Yale Institute for Global Health, the Yale Research Initiative on Innovation and Scale (Y-RISE), and HSE University (Moscow, Russia).

Personal protection against COVID-19 was the main reason given for vaccine acceptance among LMIC respondents (91%), and concern about side effects (44%) was the most common reason for vaccine hesitancy. Health workers were considered the most trusted sources of information about COVID-19 vaccines.

The study comes at a critical juncture when vaccine shipments are still slow to arrive to the majority of the world's population, and COVID-19 cases are surging in many parts of Africa, Asia, and Latin America. The findings suggest that prioritizing vaccine distribution to low- and middle -income countries should yield high returns in expanding global immunization coverage.

"As COVID-19 vaccine supplies trickle into developing countries, the next few months will be key for governments and international organizations to focus on designing and implementing effective vaccine uptake programs," said Niccoló Meriggi, Country Economist for IGC Sierra Leone and study co-author. "Governments can use this evidence to develop communications campaigns and systems to ensure that those who intend to get a vaccine actually follow through."

The researchers, who conducted the surveys between June 2020 and January 2021, point out that vaccine acceptance may vary with time and with the information that people have available to them. While the evidence on the safety and efficacy of available COVID-19 vaccines has become more clear in the last six months, severe, but rare, side effects may have undermined public confidence.

Saad Omer, Director of the Yale Institute of Global Health and study co-author, said: "What we've seen in Europe, the US, and other countries suggests that vaccine hesitancy can complicate policy decisions, thereby hindering rapid and widespread vaccine uptake. Governments in developing countries can start engaging trusted people like health workers now to deliver vaccine messaging about side effects that is accurate, balanced, and easily available to the public."

"Across countries, we observe that acceptance of COVID-19 vaccines is generally somewhat lower than for other vaccines, perhaps because of their novelty. However, the consistently pro-vaccine attitudes we see in low and middle income countries give us reason to be optimistic about uptake," said Alexandra Scacco, Senior Research Fellow at the WZB and study co-author. "We hope that evidence from our study can help inform strategies to expand global COVID-19 vaccination."

Researchers from National University of Singapore and Stanford University published a new paper in the Journal of Marketing that investigates how rural consumers in India shift their expenditures towards branded consumption when they migrate to urban areas.

The study, forthcoming in the Journal of Marketing, is titled "The Economic and Social Impacts of Migration on Brand Expenditure: Evidence from Rural India" and is authored by Vishal Narayan and Shreya Kankanhalli.

With Covid-19 disrupting work patterns and increased investment in rural employment, many of India's 450 million internal migrants are returning to their villages. Consumer goods companies view this as an opportunity to grow their presence in rural markets, with migrants serving as unofficial brand ambassadors to home communities. This new study investigates how rural consumers in India shift their expenditures towards branded consumption when they migrate to urban areas.

In many developing economies like India, the majority of rural consumer spending goes to unbranded products that are affordable, albeit less flashy. However, once migrants gain exposure to brands in cities, "they are likely to seek the same brands even when they return to rural areas," Suresh Narayanan, chairman at Nestle India, told The Economic Times.

In line with these insights, the researchers suggest that migration can affect brand expenditures through two major pathways. First, migrants who obtain better economic opportunities might send money or goods in-kind to the sending household. These "economic remittances" can increase the rural families' ability to consume more expensive products that increase their social status in their village.

Second, as migrants become more settled in their new destinations, they can share information on urban lifestyles, aspirations, and behaviors with their families back home. This form of information diffusion, termed "social remittances," can be powerful in overcoming rural households' uncertainty and persuading them towards brands.

The researchers conducted a large-scale field survey of 434 rural families across 30 villages in India and found quantitative evidence supporting both of these pathways. They discovered that economic remittances have a positive and significant impact on household consumption of branded products. This impact is greater for poorer households, for whom brands may be one of the only means of increasing social status.

Moreover, consistent with the idea of social remittances, results show that migration has a significantly greater impact for households that own mobile phones--devices that enable regular communication with the migrant. On the other hand, migration has a much smaller impact for households that own televisions (which substitute for social remittances in exposing households to brands) and those that sent migrants more recently.

A final discovery is that migration has a significantly greater impact on households located in more populous villages where the retail infrastructure is better developed and branded products are available.

These findings have practical implications for brand marketers allocating marketing resources in large developing economies, such as across the 650,000 villages of India.

Conversations with several marketing managers who focus on rural Indian markets confirmed that resource allocation is usually based just on village population and household income. Both of these statistics are available at the village level from census reports. Narayan says that "We demonstrate if managers used migration data for predicting brand expenditure, this would lead to a large improvement in salesforce effort allocation, even when primary data on other household descriptors, such as TV ownership, is available."

The research also applies to the resource allocation problem for door-to-door sales agents in rural communities--a business model that has received attention for increasing female empowerment. Results suggest that when selling to households within a village with similar income levels, these agents can be more successful if they target households who have sent migrants in the distant past and own a TV. Shreya Kankanhalli adds, "To expand on this idea, we create a dashboard that estimates migration effects for 20 identifiable consumer segments in rural India. The dashboard illustrates substantial heterogeneity across households in their propensity to consume brands, implying that the 20 identifiable segments require differing levels and types of sales efforts."

Finally, the research provides insights to stakeholders interested in increasing adoption of branded services in rural areas, such as higher-quality private schools. Managers of rural private schools should consider investing in areas with a high incidence of long-term migration (i.e., migrants who left the village over a year ago) and high levels of remittance receipts. This could mean opening more schools in such areas and/or allocating more teaching and monetary resources to existing schools in such areas.

Meanwhile, for greater inclusion, policymakers could target education subsidies at households not sending migrants or those who have recently sent migrants. Such households are much less likely to send their children to higher-quality private schools.

Migration is a major phenomenon across developing economies. Marketers and policymakers should harness the power of migrants' remittances--both economic and social.

BOSTON - Resistance to antibiotics is common and often deadly among children with pneumonia in Bangladesh, according to a new study coauthored by researchers from Massachusetts General Hospital (MGH) with colleagues at the International Centre for Diarrhoeal Disease Research, Bangladesh (abbreviated as icddr,b). This study, which appears in the journal Open Forum Infectious Diseases, offers an early warning that a pandemic of potentially deadly antibiotic resistance is under way and could spread around the globe.

The study was led by Mohammod Jobayer Chisti, MD, PhD, a senior scientist in icddr,b's Nutrition and Clinical Services Division. Chisti was inspired to conduct the research when he observed that the hospital affiliated with icddr,b was admitting more and more young children with pneumonia who were highly resistant to treatment with standard antibiotics. "At our hospital, dozens of kids died of pneumonia between 2014 and 2017, despite receiving the World Health Organization's recommended antibiotics and enhanced respiratory support," says Chisti.

Pneumonia is an infection of the lungs that causes fluid and pus to fill air sacs, producing cough, fever, trouble breathing, and other symptoms. Without effective treatment, the infection can be fatal; pneumonia is the most common cause of death in young children, according to the World Health Organization. In small children, pneumonia can be caused by viruses, but certain types of bacteria are common sources of infection, too. In the United States and other high-income countries, Staphylococcus ("staph"), Streptococcus ("strep"), and Haemophilus influenzae are the most common bacterial causes of pneumonia, which usually respond well to antibiotic therapy. Vaccines for the latter two have saved countless lives worldwide.

However, when Chisti and his colleagues examined health records of more than 4,000 children under age five with pneumonia admitted to their hospital between 2014 and 2017, they found that a very different pattern of bacterial infections was occurring. The usual staph and strep infections that commonly cause pneumonia in the United States and elsewhere were relatively rare. Among the children who had a positive culture, gram-negative bacteria were responsible for 77 percent of the infections, including Pseudomonas, E. coli, Salmonella and Klebsiella.

"That's totally different than what I'm used to in my practice in Boston," says Jason Harris, MD, MPH, co-first author of the study and chief of the division of Pediatric Global Health at the Massachusetts General Hospital for Children. Unfortunately, he adds, "the gram-negative bacteria we saw in these kids are notorious for being antibiotic resistant." To wit: Some 40 percent of the gram-negative bacterial infections in this study resisted treatment with first- and second-line antibiotics that are routinely used to treat pneumonia. More alarming, children who had antibiotic-resistant bacterial infections were 17 times more likely than others without bacterial infections to die.

Harris believes that these results are clear evidence that longstanding concerns that antibiotic resistance will become a deadly menace are no longer theoretical--the problem has taken root. "These kids are already dying early because of antibiotic-resistant bacteria, from what would be a routine infection in other parts of the world," says Harris. "And this was at one hospital in Bangladesh. Extrapolate these findings across a country of 163 million people, and then to a larger region where antibiotic resistance is emerging, and the overall numbers are probably huge."

There is an urgent need to address factors that are promoting antibiotic resistance in Bangladesh, says Tahmeed Ahmed, PhD, executive director of icddr,b and senior author of the study. For starters, antibiotics can be purchased without a prescription in the country and many people use them to self-treat conditions such as dysentery, cold, cough and fever. Misuse of antibiotics promotes the spread of bacteria that resist the medications. "We may be able to reduce this emerging bacterial resistance by improving antibiotic stewardship, particularly in the outpatient setting," says Ahmed. Lab testing for diagnosis of bacterial infections is also inadequate in the country. "What's more, lack of access to clean water and adequate sanitation helps spread bacteria that are resistant to antibiotics," adds Ahmed. Improvements in health care infrastructure and policy changes to rein in the misuse of antibiotics are essential, he argues, though Ahmed notes that Bangladesh's health care system also needs better access to more advanced antibiotic therapies for resistant infections.

If these and other steps aren't taken now, it's only a matter of time before the problem of widespread deadly antibiotic resistance spreads around the world, notes Harris. "We know that acquisition of antibiotic resistance is very common in travelers, and that when highly resistant bacteria crop up in one part of the world, they ultimately crop up everywhere," he says, comparing the problem to another current global health care crisis. "If COVID-19 was a tsunami, then emerging antibiotic resistance is like a rising flood water. And it's kids in Bangladesh who are already going under."

NEW YORK, NY (July 15, 2021)--Heart problems in children hospitalized with multisystem inflammatory syndrome (MIS-C)--an inflammatory condition triggered by COVID--were mostly gone within a few months, a new study by researchers at Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian has found.

The study published in Pediatrics about 45 MIS-C patients is the first in North America to report on longitudinal cardiac and immunologic outcomes in children hospitalized with MIS-C.

"We've learned that COVID causes a spectrum of illness in children. Some are asymptomatic or mildly symptomatic and a small number of kids who develop MIS-C become critically ill, requiring admission to the ICU," says Kanwal M. Farooqi, MD, assistant professor of pediatrics at Columbia University Vagelos College of Physicians and Surgeons and first author of the study. "It is a relief that this study shows that most of the severe heart and immunologic manifestations we saw in kids with MIS-C resolved rapidly."

MIS-C is a rare condition triggered by SARS-CoV-2 infection that causes widespread inflammation throughout the body. Many children with MIS-C were asymptomatic or had mild COVID symptoms at first but weeks later developed a variety of nonrespiratory symptoms including abdominal pain, skin rashes, heart abnormalities, and, in some cases, vasodilatory shock (extremely low blood pressure).

Some of the first MIS-C cases in the United States were seen in spring 2020 by Columbia pediatricians at NewYork-Presbyterian Morgan Stanley Children's Hospital.

"It was both challenging and scary, because we didn't know how these patients would do long term, especially in terms of cardiac and immunologic abnormalities, which were the most prominent issues at the time," says Farooqi, who is also a pediatric cardiologist at NewYork-Presbyterian Morgan Stanley Children's Hospital.

When first admitted to the hospital, most of the 45 children (median age 9 years old) in the study were critically ill and required intensive care. Nearly 80% of the children had some type of cardiac dysfunction, and almost half had moderate to severe cardiac abnormalities, including decreased ability of the heart to pump properly, coronary artery dilation, and leaking heart valves. Two-thirds of the children experienced a temporary decrease in the number of white blood cells during their hospital stay. The majority had an increase in inflammatory markers, and more than half also had elevated cardiac-specific markers indicating heart injury.

To ease the inflammatory response, doctors treated the children with steroids, and most received intravenous immunoglobulin and immunomodulators. One-third received respiratory support, though none required ECMO (an external life-support machine). More than half received therapies to increase and maintain blood pressure.

"These kids were quite sick, but at our hospital, where we began using steroids and other treatments routinely for MIS-C, most of the patients responded rapidly and were discharged by about five days," Farooqi says.

The researchers found that immunologic abnormalities and markers for heart injury returned to normal within a few weeks after the children left the hospital. By four months, most of the heart abnormalities had resolved, including all of the coronary artery abnormalities.

"It's reassuring that our cardiac and immunologic outcomes were similar to those reported in a recent retrospective study of children hospitalized in the United Kingdom with MIS-C," Farooqi says.

Most of the children continued to do well several months after being hospitalized with MIS-C.

"Nevertheless, given the absence of long-term data, we are recommending that children who had more than mild dysfunction on cardiac ultrasound should get a cardiac MRI at six months and see a pediatrician before being cleared for competitive sports," Farooqi says.

Cases of MIS-C are now far below the peak last year, but they are still trickling in.

"For parents, it's reasonable to have children evaluated by a pediatrician or a cardiologist if they complain of nonspecific cardiac symptoms like chest pain or palpitations," she continues. "They can then be screened so that the need for further testing can be better assessed. Our team remains focused on the longer-term outcomes of these children with MIS-C and other potential long-term manifestations of SARS-CoV-2 infection."

VANCOUVER, Wash. - The psychological toll of losing a job due to COVID-19 caused many young hotel and restaurant workers to consider changing careers, according to a Washington State University study.

In the study, the laid-off and fully furloughed hospitality employees reported being financially strained, depressed, socially isolated and panic stricken over the pandemic's effects, leading to increased intention to leave the industry all together. The intention to leave was particularly strong among women and younger workers.

"It's a warning sign for my industry that the younger generation was really hit hard," said Chun-Chu Chen, an assistant professor in WSU's School of Hospitality Business Management and lead author on the study in the International Journal of Contemporary Hospitality Management. "We've already witnessed that as the hospitality business is recovering and trying to hire more people, they cannot find the workers they want. There are many factors for that, but one may be that because of the pandemic, people think that hospitality is no longer an industry they want to work for."

Chen added that previous research has indicated that younger workers may not have as strong of a career identity as more experienced employees, making it easier for them to change careers.

Unemployment in the hospitality industry reached 37.3% in April 2020 after many lockdown measures were put in place, according to U.S. Labor Statistics. Chen heard about the impact directly from his own hospitality students who had lost jobs and decided to find out more about how other lodging and food service employees were faring during the pandemic.

For this study, Chen and coauthor WSU Professor Ming Hsiang Chen surveyed more than 600 laid-off and fully furloughed hospitality workers in June 2020. While all the workers in the study had no income at the time, furloughed workers reported somewhat less distress than those who were laid-off, a difference the authors said employers should note for the future.

"Being furloughed is not good, but it's a little bit better than being laid-off," said Chen. "One possible explanation is that if you are furloughed, you are technically still part of the organization, so you still have a sense of community, of belonging."

That feeling of being connected is important in a profession that tends to attract people who are very social, Chen said. In fact, the researchers found that social isolation was the most important factor predicting wellbeing for these workers. But it was financial strain and the perceived impact of the pandemic that predicted whether the workers were considering a career change.

The researchers found one protecting factor for unemployed or furloughed workers' wellbeing: self-efficacy, or the belief that they had personal control over their own circumstances.

However, when it came to some of Chen's unemployed hospitality students, that sense of personal control may have meant they decided to move on.

"I've seen some of my students actually looking for really good jobs in other service industries," said Chen. "I have mixed feelings about their decisions. Our students are well-equipped to thrive in most positions in the service sector. However, as much more opportunities are available right now, I would encourage them to stay in the hospitality industry."

WASHINGTON—A new study, published by the North American Menopause Society in the journal Menopause, found a plant-based diet rich in soy reduces moderate-to-severe hot flashes by 84%, from nearly five per day to fewer than one per day. During the 12-week study, nearly 60% of women became totally free of moderate-to-severe hot flashes. Overall hot flashes (including mild ones) decreased by 79%.

The study, called the WAVS trial—the Women’s Study for the Alleviation of Vasomotor Symptoms–shows that diet changes can be much more powerful for treating hot flashes than scientists had thought. Vasomotor symptoms refer to night sweats, hot flashes, and flushes.

The study used no hormone medications or extracts. Instead, the research team tested a combination of a low-fat plant-based diet plus 1/2 cup of ordinary soybeans added to a salad or soup each day.

“This is a game changer for women aged 45 and over, most of whom we now know can get prompt relief from the most severe and troubling menopause symptoms without drugs,” says lead researcher Neal Barnard, MD, president of the Physicians Committee and adjunct professor at the George Washington University School of Medicine.

As many as 80% of postmenopausal women suffer from hot flashes. Heat wells up from the chest, causing flushing, sweating, and chills. At night, hot flashes interfere with sleep. Estrogen-based medications were once routinely used to treat hot flashes but have been shown to increase the risk of breast cancer and other serious problems. Isoflavone extracts from soybeans work only modestly, leaving women and their doctors with few effective options.

Study Details

Postmenopausal women reporting two or more hot flashes per day were randomly assigned to either an intervention group—consisting of a low-fat, vegan diet, including half a cup of cooked soybeans daily—or to a control group that made no diet changes for 12 weeks. Frequency and severity of hot flashes were recorded using a mobile application, and vasomotor, psychosocial, physical, and sexual symptoms were assessed using the Menopause Specific Quality of Life Questionnaire (MENQOL).

Each participant was given a digital self-calibrating scale to track body weight day by day, a mobile app to track hot flashes in real time, and an Instant Pot to prepare soybeans at home. Each week, the group got together with the research team via Zoom.

“Previous studies have shown that soy could be beneficial, so we decided to put a diet change to the test,” says study author Hana Kahleova, MD, PhD, director of clinical research for the Physicians Committee. “We believe that the combination is what is important. By the end of the study, the majority of women on a plant-based diet rich in soy reported that they no longer experienced moderate-to-extreme hot flashes at all and that they experienced significant improvements in their quality of life.”

Key Findings

Total hot flashes decreased by 79% and moderate-to-severe hot flashes decreased by 84% in the intervention group. At the study’s conclusion, 59% of intervention-group participants reported becoming free of moderate and severe hot flashes. There was no change in this variable in the control group.

In previous randomized trials, soy products have been shown to modestly reduce the frequency of hot flashes. The researchers theorize that the effect may be a result of soy products containing isoflavones, which can be metabolized by gut bacteria into equol—a nonsteroidal compound that has been shown in some studies to reduce the incidence and severity of hot flashes. Previous studies have also shown that those following vegetarian or vegan diets produce higher levels of equol. The new study showed a more robust response, using the combination of a plant-based diet plus soy.

Many study participants also reported improvements in sexual symptoms, mood, and overall energy.

“This was basically a lifesaver for me,” said one study participant. “I’ve got my quality of life back.” Another said, “I am sleeping better, and my hot flashes diminished tremendously.” Several participants also noticed significant weight loss and better digestion.
“Before you jump to any kind of medication, I would try this route, because it’s easy,” a study participant said. “Anybody can do it.”

The study was based on the new approach to menopausal symptoms described by Dr. Barnard in his book Your Body in Balance. After the book was released in 2020, a reader contacted Dr. Barnard to let him know that his method eliminated her hot flashes within five days. Rather than using isoflavone extracts or soy foods such as soy milk or tofu, she used whole soybeans.

Reno, Nev. (July 15, 2021) - Wildfire smoke may greatly increase susceptibility to SARS-CoV-2, the virus that causes COVID-19, according to new research from the Center for Genomic Medicine at the Desert Research Institute (DRI), Washoe County Health District (WCHD), and Renown Health (Renown) in Reno, Nev.

In a study published earlier this week in the Journal of Exposure Science and Environmental Epidemiology, the DRI-led research team set out to examine whether smoke from 2020 wildfires in the Western U.S. was associated with an increase in SARS-CoV-2 infections in Reno.

To explore this, the study team used models to analyze the relationship between fine particulate matter (PM 2.5) from wildfire smoke and SARS-CoV-2 test positivity rate data from Renown Health, a large, integrated healthcare network serving Nevada, Lake Tahoe, and northeast California.

According to their results, PM 2.5 from wildfire smoke was responsible for a 17.7 percent increase in the number of COVID-19 cases that occurred during a period of prolonged smoke that took place between Aug. 16 and Oct. 10, 2020.

"Our results showed a substantial increase in the COVID-19 positivity rate in Reno during a time when we were affected by heavy wildfire smoke from California wildfires," said Daniel Kiser, M.S., co-lead author of the study and assistant research scientist of data science at DRI. "This is important to be aware of as we are already confronting heavy wildfire smoke from the Beckwourth Complex fire and with COVID-19 cases again rising in Nevada and other parts of the Western U.S."

Reno, located in Washoe County (population 450,000) of northern Nevada, was exposed to higher concentrations of PM2.5 for longer periods of time in 2020 than other nearby metropolitan areas, including San Francisco. Reno experienced 43 days of elevated PM2.5 during the study period, as opposed to 26 days in the San Francisco Bay Area.

"We had a unique situation here in Reno last year where we were exposed to wildfire smoke more often than many other areas, including the Bay Area," said Gai Elhanan, M.D., co-lead author of the study and associate research scientist of computer science at DRI. "We are located in an intermountain valley that restricts the dispersion of pollutants and possibly increases the magnitude of exposure, which makes it even more important for us to understand smoke impacts on human health."

Kiser's and Elhanan's new research builds upon past work of studies in San Francisco and Orange County by controlling for additional variables such as the general prevalence of the virus, air temperature, and the number of tests administered, in a location that was heavily impacted by wildfire smoke.

"We believe that our study greatly strengthens the evidence that wildfire smoke can enhance the spread of SARS-CoV-2," said Elhanan. "We would love public health officials across the U.S. to be a lot more aware of this because there are things we can do in terms of public preparedness in the community to allow people to escape smoke during wildfire events."

A new study by Vanderbilt University Medical Center researchers of more the 400,000 Medicare patients taking medications for insomnia found that the risk of death is increased when either benzodiazepines or "z-drugs" are taken with opioids.

The study, published July 15 in PLOS Medicine and led by Wayne Ray, PhD, professor of Health Policy at VUMC, compared patients taking these drugs with opioids to comparable patients taking trazodone, another commonly prescribed sleep medication for older patients.
The researchers found that those using benzodiazepines had a 221% increase in the risk of death from any cause and those taking non-benzodiazepine hypnotics, or "z-drugs," had a 68% increased risk.

"Our findings indicate that the risks of benzodiazepine-opioid use go well beyond the recognized hazards of overdose. They also suggest that the z-drugs, thought to have better safety than the benzodiazepines, in fact are dangerous when prescribed in combination with opioid pain medications," Ray said.

Benzodiazepines, including brand names such as Restoril, Ativan, and Halcion and the "z-drugs", a type of medication known more commonly under names like Ambien, Lunesta and Sonata, are among the most frequently prescribed medications for older adults.

Trazodone, a medication initially introduced for depression, is often prescribed in low doses for insomnia. Although researchers have speculated about the relative safety of these sleep medications, there is limited relative safety data.

Ray said the study findings could help to fill this data gap and thus lead to changes in both provider behavior and policy.

"Our findings add urgency to efforts to limit concurrent prescribing of benzodiazepines and opioids. They also suggest that targeted warnings are needed to advise older patients and their providers regarding the potential risks of taking z-drugs with opioids," Ray said.

The study was supported by a grant from the National Heart, Lung and Blood Institute.

Adolescent girls and young women can and will use HIV prevention products with consistency, according to interim results of a study of two different methods: daily use of the antiretroviral (ARV) tablet Truvada® as oral pre-exposure prophylaxis (PrEP) and the monthly dapivirine vaginal ring, a new HIV prevention product currently under regulatory review in several countries.

To provide protection against HIV, both must be used consistently- daily, for oral PrEP, and for the ring, a full month at a time - which previous studies of these products found to be especially challenging for younger women.

This was not the case in an ongoing study, known as REACH (Reversing the Epidemic in Africa with Choices in HIV prevention), being conducted at four clinical research sites in Uganda, South Africa and Zimbabwe by the National Institutes of Health-funded Microbicide Trials Network (MTN). The vast majority (97 percent) of the study's 247 participants, who were between the ages of 16 and 21 when they enrolled, used the vaginal ring and daily oral PrEP some or all of the time. Fewer than three percent of participants used neither of the products, according to laboratory tests for adherence.

These and other results from the study's first two periods, during which participants were asked to use each of the products for six months, are being reported at IAS 2021 - the 11th IAS Conference on HIV Science - taking place virtually from 18-21 July, and were featured in an official IAS press conference today.

Both approaches received high marks from the study's participants: during the six months they were asked to use the monthly dapivirine ring, 88 percent said they liked it, and during the period when they were assigned to use oral PrEP, 64 percent said they liked the daily pill-taking regimen.

The research team attributes the study's findings of high product adherence and acceptability to the ongoing support measures, tailored for this population, and nonjudgmental counseling approach provided as part of the study.

"In many ways, these results exceeded even our own expectations, yet at the same time, it's not surprising to find that these young women have the capacity and desire to protect themselves against HIV. They simply need to feel empowered and have the agency to make choices based on what they feel is right for them," said Gonasagrie (Lulu) Nair, MBChB, MPH, REACH protocol chair and senior lecturer, Centre for Medical Ethics and Law, Faculty of Medicine, at Stellenbosch University in South Africa.

Globally, more than half of all people living with HIV are women, and in sub-Saharan Africa, women account for more than 60 percent of adults with HIV. Rates of infection are especially high among adolescent girls and young women. According to UNAIDS, in 2020, one in four new infections in sub-Saharan Africa were in young women ages 15-24, despite making up only 10 percent of the population.

REACH, also known as MTN-034, was designed to fill important gaps in information about the safety and acceptability of the dapivirine ring and Truvada (a tablet containing a combination of the ARV drugs tenofovir disoproxil fumarate and emtricitabine) as oral PrEP in girls younger than 18. Of the 247 participants in REACH, 86 (35 percent) were age 16 or 17 at the time of enrollment. The study is also collecting important data that will supplement existing safety and acceptability data among young women ages 18-21.

Indeed, interim results also found both Truvada as oral PrEP and the dapivirine ring were well tolerated with no safety concerns. As REACH is still an ongoing study, the safety of these products continues to be monitored by the research team.

Information about the safety of the ring among adolescent girls is especially important. The ring, which was developed by the nonprofit International Partnership for Microbicides (IPM), would be the first biomedical prevention method designed specifically for women, and the first long-acting method. However, because the product's Phase III trials were conducted among cisgender women ages 18-45, additional data would be needed to support the ring's use in women younger than 18. Pending its final results, data from REACH, as well as from the MTN-023/IPM 030 study among adolescent girls ages 15 to 17 in the United States, will be submitted to regulators so that they may consider approving the ring for adolescent girls.

REACH also seeks to understand what adolescent girls and young women need to help them to use the dapivirine ring and oral PrEP as consistently as possible, and their preferences for either or both. After having experienced using both of the products, each for six months, participants then choose which one they want to use for the remaining six months of the study, or to choose neither. Moreover, participants are free to change their minds. The choice phase of REACH is still ongoing, with approximately 50 participants still in the study.

As researchers are reporting at IAS 2021, adherence to both products was high during the first two periods of the study. Adherence to oral PrEP was based on levels of drug in blood samples taken at each monthly visit. For the ring, researchers looked at the amount of residual drug left in rings participants returned after a month of use. The ring contains 25mg of the ARV dapivirine, about 4 mg of which is released into the vagina when used continuously for 28 days.

Using these measures, researchers determined that during the six months participants were assigned to use oral PrEP, 39.9 percent of the participants had drug levels that suggested they used oral PrEP at least some of the time, meaning they took the tablets between one and three times a week; and 58.6 percent were classified as high users, whose drug levels suggested they took the tablets at least four times a week, which among men who have sex with men has been associated with 100 percent protection. The threshold for protection in cisgender women has yet to be determined. For the ring, drug levels in returned rings suggested that 45.4 percent used it at least some of the time, and that 50.2 percent used the ring for the full month. Full compliance to oral PrEP, whereby blood levels indicate taking at least six pills per week, was evident for 22 percent of the participants.

"It's important to note that our aim is not to make direct comparisons between oral PrEP and the ring, which wouldn't be feasible anyway because the methods for measuring adherence are not the same. Rather, the study aims to compare participants' adherence to the ring and oral PrEP in this study with what had been observed among young women in other trials of these products, as a way to understand whether these are feasible options for young women and whether they are willing to use either or both," explained Dr. Nair. "The answer, as these results make clear, is yes."

In the two Phase III trials of the ring, younger women used the ring least regularly, and as a group, had the lowest rates of risk reduction. In ASPIRE, for example, the ring was not shown to be effective among women ages 18-21, with levels of drug in returned rings also indicating low adherence to use. Likewise, daily pill taking was more challenging for younger women in the Phase III trials of oral PrEP (VOICE and FEM-PrEP). Moreover, results of the HPTN 082 open-label study among adolescent girls and young women in South Africa and Zimbabwe, found that 85 percent of the participants used oral PrEP with some regularity at the beginning of the study, but when clinic visits changed from monthly to every three months, there was a steep decline. Three months into the study, fewer than 25 percent were using oral PrEP, and by month 12, it was only nine percent.

"What strikes me most about REACH is that not only are we seeing high adherence, but persistence appears to be high as well. Clearly, the ongoing support and individual attention paid to participants seems to make a difference," noted Connie Celum, M.D., M.P.H., professor of global health and medicine and director of the International Clinical Research Center at the University of Washington in Seattle, who is a REACH protocol co-chair and led the HPTN 082 study. "To see this kind of high adherence - it's pretty remarkable, especially during this time of COVID-19."

As part of REACH, study participants receive extensive support and counseling focused on helping them to use their assigned (or chosen) product as best they can. Every monthly visit includes a meeting with a counselor, and participants can also choose from a menu of additional forms of support, including daily text messages or weekly check-ins by phone; having a "Peer Buddy"; and adherence support groups. At some sessions, participants receive their individual adherence test results as a way to help facilitate discussion about adherence and how it relates to HIV risk reduction. Results are presented in terms of what they may mean for level of protection they are receiving and given without judgement.

"We've tried to empower these young women by letting them take control of their own health and behaviors and to make their own decisions. If participants don't want to or cannot use either the ring or oral PrEP, we simply want to understand the reasons why, while also seeing what kind of support may help. And if they change their mind, that's okay as well, because as their circumstances change, so will their needs and preferences for HIV prevention," added Kenneth Ngure, Ph.D., MPH, chair of the department of community health at Jomo Kenyatta University of Agriculture & Technology in Nairobi, Kenya, and REACH protocol co-chair.

REACH began in February 2019 and is expected to be completed by October 2021, with final results, including outcomes from the choice period, anticipated in early-to-mid 2022.

While the study was originally designed to enroll 300 participants, 100 of whom would be 16- and 17-years old, in March 2020, in the face of the emerging COVID-19 pandemic, MTN and study leadership decided to close the study to further enrollment so that fullest attention could be paid to ensuring the safety of its current participants as well as clinic staff. By this time, REACH had already enrolled 247 participants, including 86 who were under the age of 18, such that the study would still be able to provide sufficient data about the safety of the dapivirine vaginal ring and oral PrEP in adolescent girls and young women, and to do so in less time as well.

Just four months later, in July 2020, the ring received a positive opinion from the European Medicines Agency (EMA) for its use among women ages 18 and older in developing countries, and soon after, was added to the World Health Organization's (WHO) list of pre-qualified medicines. IPM is now seeking approval of the ring in eastern and southern Africa, including in countries where REACH is being conducted. Just yesterday, the ring received its first approval, which came from the Medicines Control Authority of Zimbabwe. IPM is also seeking regulatory approval from the US Food and Drug Administration.

In anticipation of the ring's potential approval, WHO's updated guidelines for HIV prevention, published in March 2021, recommend the ring as an additional HIV prevention choice for women at substantial risk of HIV, while also acknowledging that study's like REACH will help to better understand ways to support consistent and persistent use of both PrEP and the ring in adolescent girls and young women.

The clinical research sites (CRSs) where REACH is being conducted are Makerere University-Johns Hopkins University CRS in Kampala, Uganda; the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre Spilhaus CRS, Harare; and in South Africa, the Wits Reproductive Health and HIV Institute in Johannesburg and the Emavundleni CRS of the Desmond Tutu HIV Foundation in Cape Town.

High-dose buprenorphine therapy, provided under emergency department care, is safe and well tolerated in people with opioid use disorder experiencing opioid withdrawal symptoms, according to a study supported by the National Institutes of Health's National Institute on Drug Abuse (NIDA) through the Helping to End Addiction Long-term Initiative, or the NIH HEAL Initiative.

Lower doses of buprenorphine, a medication approved by the U.S. Food and Drug Administration to treat opioid use disorder, are the current standard of care. However, elevated doses of the medication may provide a critical extended period of withdrawal relief to people after being discharged from the emergency department that may help them navigate barriers to obtaining medications as well as accessing care for the treatment of opioid use disorder. The findings appeared today in JAMA Network Open.

"Emergency departments are at the front lines of treating people with opioid use disorder and helping them overcome barriers to recovery such as withdrawal," said Nora D. Volkow, M.D., director of NIDA. "Providing buprenorphine in emergency departments presents an opportunity to expand access to treatment, especially for underserved populations, by supplementing urgent care with a bridge to outpatient services that may ultimately improve long-term outcomes."

Some emergency departments already use higher doses of buprenorphine for the treatment of withdrawal and opioid use disorder in response to the increasing potency of the illicit opioid drug supply and commonly encountered delays in access to follow-up care, but this practice has not been evaluated previously.

In this study, researchers used a retrospective chart review to analyze data from electronic health records documenting 579 emergency department visits at the Alameda Health System?Highland Hospital in Oakland, California, made by 391 adults with opioid use disorder in 2018. Many of the patients were from vulnerable populations, with 23% experiencing homelessness and 41% having a psychiatric disorder. Most patients were male (68%). Forty-four percent of patients were Black, and 15% were Hispanic or Latino.

The data analysis showed that in 63% of cases, the clinicians administered more than the standard upper limit of 12 mg of sublingual buprenorphine during emergency department induction, and in 23% of cases, patients were given 28 mg or more. Higher doses of buprenorphine were safe and tolerable, and among those given the higher doses, there were no reports of respiratory problems or drowsiness - possible side effects of the medication. The small number of serious adverse events that occurred were determined to be unrelated to high-dose buprenorphine therapy.

Studies have shown that initiating buprenorphine in emergency departments improves engagement in treatment and is cost effective, but barriers to the medication's use persist. At the time of the study, there were strict controls on buprenorphine prescribing. While clinicians could dispense the medication in the emergency department, only those who had fulfilled the federal certification requirements related to training and ancillary services needed to obtain a buprenorphine prescribing waiver could provide a prescription upon discharge. Patients discharged without a prescription for buprenorphine may experience a return of withdrawal symptoms before they have a chance to access follow-up care. Recent changes to prescribing guidelines by the U.S. Department of Health and Human Services now allow some clinicians treating up to 30 patients to prescribe buprenorphine without the previous training and services criteria.

"Once discharged, many people have difficulty linking to follow-up medical care," said study leader Andrew A. Herring, M.D., of Highland Hospital Department of Emergency Medicine. "Adjusting the timing and dosage of buprenorphine in the emergency department, along with resources and counseling aimed at facilitating the transition to outpatient services, may provide the momentum needed to access continuing care."

"This study enhances the evidence we know about emergency-department buprenorphine induction, and could be a gamechanger, particularly for vulnerable populations who would likely benefit from a rapid induction at the time of the visit," says study author Gail D'Onofrio, M.D., of Yale University, New Haven, Connecticut, who published the original studies on emergency department-initiated buprenorphine, as well as recent consensus recommendations on the treatment of opioid use disorder in the emergency department.

While the researchers note that their findings need to be prospectively confirmed in other emergency departments, this study suggests that with proper support and training, emergency medicine providers may safely and effectively initiate high-dose buprenorphine therapy.

BOSTON - The unprecedented increase in overweight and obesity in low- and middle-income countries (LMICs) has led to an alarming rise in diabetes in these regions. Of the estimated 463 million people with diabetes worldwide, 79% live in LMICs.

Until now, however, there were scant empirical data to guide clinicians and health systems in determining which individuals should be screened for diabetes based on body mass index (BMI). "There are guidelines from the World Health Organization that recommend screening individuals age 40 and older with a BMI of 25 kg/m2 and above for diabetes," says Jennifer Manne-Goehler, MD, ScD, faculty member at the Medical Practice Evaluation Center at Massachusetts General Hospital (MGH). "But it's long been suspected that these BMI and age thresholds may not be optimal for diabetes screening in all regions of the world. Our goal was to estimate the relationship between BMI and diabetes risk across many low- and middle-income countries to help resource-strapped health systems devise the most effective screening programs for their populations," says Manne-Goehler, senior author of a new study published in The Lancet.

Manne-Goehler and investigators from 57 countries spent five years compiling and leveraging existing datasets of more than 680,000 people in LMICs that included every individual's weight, height and a diabetes biomarker--either a blood glucose measurement or hemoglobin A1c.

The study, the first of its kind, found substantial regional differences in the association between BMI and diabetes risk. Across all LMICs, people with a BMI of 23 kg/m2 or greater had an increased risk of diabetes. There was, however, variability in the optimal BMI to choose for diabetes screening among regions and genders, ranging from 23.8 kg/m2 among men in East/Southeast Asia to 28.3 kg/m2 among women in the Middle East, North Africa, Latin America and the Caribbean. The investigators also found differences in the risk of diabetes across BMI categories in several regions. For example, men and women in sub-Saharan Africa and East/Southeast Asia had more than a 100% increase in the risk of diabetes between being overweight and obese. These findings, in part, reinforced a growing literature from Asian and South Asian countries that recommends using lower BMI thresholds to better characterize metabolic risk in these populations.

And while diabetes increased in middle age and beyond, the proportion of individuals with diabetes rose steeply across all regions in the 35-to-44 age group, and among men 25 to 34 years old in sub-Saharan Africa. "Diagnosing diabetes in younger adults can prevent long-term complications of the disease," says Manne-Goehler.

"Although the data aren't prescriptive, our hope is that policymakers in LMICs will find this evidence useful as they try to decide how they will spend limited resources to optimize diabetes screening for their particular populations," she adds.

The research also demonstrates the power of collaborations among countries to create important evidence to inform public health guidelines. "It's difficult to draw meaningful high-level global conclusions when individual countries are examining diabetes risk in only one country's survey," says Manne-Goehler. The World Health Organization is creating a global strategy called the Global Diabetes Compact to scale up care for people with diabetes, for example. "We believe that our collaboration of many investigators across these 57 countries can help inform best diabetes screening practices throughout the world," she says.

"LMICs now have evidence-based specific answers to the 'Who? When? and How much?' regarding diabetes prevention and screening in relation with BMI," writes Siméon Pierre Choukem, MD, dean of the faculty of Medicine and Pharmaceutical Sciences, University of Dschang, Cameroon, in a related commentary in The Lancet. "These results have major public health implications as the actual burden of diabetes in LMICs is probably underestimated because of the current screening guidelines, and it is unclear to what extent."

The global team of investigators are now studying how waist circumference might increase the accuracy of diabetes risk assessment when used with BMI, and they are also examining the relationship between behavioral factors--alcohol, smoking, physical activity and diet--and risk of diabetes across these 57 countries. In the future, the researchers also hope to create collaborations that include surveys from high-income countries to facilitate direct comparisons across a wider spectrum of global health settings. "Health systems in every country in the world have to make the best use of their resources to improve the health of their populations," says Manne-Goehler.