Body

Parents, caregivers and health care professionals are increasingly concerned about childhood obesity. Compounding their concern are fears of inadvertently provoking disordered eating, such as unhelpful dieting, when discussing a child’s weight status (i.e. normal weight, overweight or obese). Given the complexity of these concerns, major health advocacy groups have independently published guidelines for having conversations with children about weight status – all at the fingertips of parents, caregivers and health care professionals with a quick internet search.

To help sort it all out, researchers from the Center for Weight, Eating and Lifestyle Science (WELL Center) in the College of Arts and Sciences at Drexel University systematically reviewed numerous independently published guidelines for having conversations with children about weight status to analyze their content, consistency, actionability and scientific support.

“It’s important that parents and health care professionals be critical consumers of guidelines on talking to kids about overweight and obesity because guidelines have a lot of variability between them on the question of whether or not to talk about a kid’s weight directly,” said Elizabeth Lampe, graduate student in the College of Arts and Sciences and lead author. “Parents and health care professionals should read several different guidelines and make sure that they are making the best decision for their kid, since every situation can be unique.”

Researchers performed web-based searches that identified 59 independently published guidelines on childhood obesity by major health advocacy groups. Only 13 provided explicit direction on how the caregiver or health care professional should approach a conversation about overweight or obesity with a child.

Throughout the 13 guidelines, nine topics were identified within the advice provided: attitude modeling (covered by 31% of guidelines), behavior modeling (61%), dietary recommendations (54%), physical activity (46%), body acceptance and self-esteem (69%), conversation advice (92%), contact with health care professionals (46%), talking about “weight” versus “overall health” (54%) and external factors, such as bullying and/or media (54%).

Lampe noted that although all guidelines presented similar content, several inconsistencies in recommendations emerged. Only three of the 13 guidelines referenced any scholarly sources and only a small minority of advice was easily applied to everyday situations by caregivers or health care professionals.

“We call for future guidelines to unify their messages for caregivers and health care professionals and be better supported by scholarly data,” said Lampe.

She added that parents and caregivers are not the only consumers of these guidelines.

“Policy makers may be using these guidelines to influence their decisions or practitioners might use these guidelines to inform their practice,” said Lampe. “Some important implications of this could be a lack of health behavior change and potential perpetuation of weight stigma.”

The report, “Guidelines for Caregivers and Healthcare Professionals on Speaking to Children About Overweight and Obesity: A Systematic Review of the Gray Literature,” was recently published in Translational Behavioral Medicine. Authors include Sophie Abber, graduate student; Evan Forman, PhD and Stephanie Manasse, PhD of Drexel University.

Although this study has concluded, the WELL Center continues to recruit for other weight management studies, including a teen healthy lifestyle study through the Child and Adolescent Program called Project REACH.

DOI

10.1093/tbm/ibaa012

BOSTON - A first-of-its-kind intervention integrating palliative care early in the course of cancer therapy for patients with advanced acute myeloid leukemia (AML), a highly aggressive cancer of the blood and bone marrow, resulted in substantial improvements in patients' quality of life, mood and end-of-life care, a team of investigators has found.

"We know from the literature that patients with acute myeloid leukemia have high rates of post-traumatic stress disorder," says co-investigator Areej El-Jawahri, MD, a hematologist-oncologist at Massachusetts General Hospital (MGH) Cancer Center.

El-Jawahri and colleagues at Duke University Medical Center in Durham, North Carolina, the University of Pennsylvania in Philadelphia and Ohio State University in Columbus, conducted a randomized clinical trial demonstrating the benefits of early integration of palliative care into oncology care for patients with high-risk AML.

They report their results in JAMA Oncology.

The World Health Organization defines palliative care as "an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual."

Previous studies have shown that specialty palliative care improves quality of life, reduces symptom severity and psychological stresses, and enhances end-of-life care for patients with solid tumors.

"A lot of work has been done on integration of palliative care for patients with solid tumors, but there has been less attention paid to the integration of palliative care for patients with blood cancers," El-Jawahri says. "There have been multiple barriers to palliative care integration in this population, including the misperception equating palliative care with end-of-life care, and not understanding the potential benefit of palliative care beyond enhancing end-of-life outcomes."

Palliative care has been shown to improve quality of life and reduce psychological stress for patients who undergo bone marrow transplants to treat blood cancers, but "oncologists rarely consult palliative care for patients with AML, in part due to the lack of evidence for the role of early palliative care in this population," El-Jawahri and colleagues write.

In the trial, 160 adults treated at the four comprehensive cancer centers for advanced AML were randomly assigned to the intervention or to usual care.

"This is the first multi-site randomized trial of an integrated palliative care intervention in patients with any blood cancer," says co-investigator Thomas W. LeBlanc, MD, a medical oncologist and palliative care physician at Duke.

Patients assigned to the integrated palliative and oncology care (IPC) intervention met with palliative care specialists who focused on establishing a relationship with each patient, assessing their needs, treating their symptoms, understanding their goals and expectations for treatment, and helping make decisions about their therapy.

Patients assigned to usual care received supportive measures from their oncology team and were permitted to receive palliative care if they or their oncologist requested it. Only six of the 74 patients assigned to usual care received palliative care early in the course of their illness.

Patients who received IPC reported significantly better quality of life and lower levels of depression, anxiety and PTSD at two weeks, and the benefits of palliative care on all these measures continued through 24 weeks.

Of the patients who died, significantly more who had been assigned to IPC had discussed end-of-life care preferences with their clinicians, and significantly fewer underwent chemotherapy in the last few weeks of life. Chemotherapy at the end of life is not curative and is associated with significant side effects that can severely impair quality of life.

"This is not just about end-of-life care, but how do we help patients live in the best way possible for as long as possible?" says El-Jawahri.

Researchers at the University of Ottawa have found the mental health effects of the COVID-19 pandemic have particularly impacted healthcare professionals and their sleep, putting these frontline workers at risk of severe future mental health problems.

Jude Mary Cénat, an Assistant Professor in the Faculty of Social Sciences' School of Psychology, and his team conducted a systematic review and meta-analysis of 55 global studies involving nearly 190,000 participants for 'Prevalence of symptoms of depression, anxiety, insomnia, posttraumatic stress disorder, and psychological distress among populations affected by the COVID-19 pandemic: A systematic review and meta-analysis', which is published in Psychiatry Research.

Dr. Cénat's team found when assessing COVID-19 affected populations that mental health problems such as depression, anxiety and post-traumatic stress disorder (PTSD) had significantly climbed throughout the pandemic. Strikingly, healthcare workers who have been on the front lines without relent since the emergence of the novel coronavirus at the start of 2020, have seen their mental health significantly impacted, with concern about their future should the proper mental health support not be provided.

Dr. Cénat, Director of the Vulnerability, Trauma, Resilience and Culture Research Laboratory (V-TRaC Lab), was happy to discuss some of the key findings from the study.

Why did you decide to conduct this study?
JMC: "Conducted in a global mental health perspective, the main objective of this systematic review and meta-analysis was to analyze the impacts of the COVID-19 pandemic on the mental health of affected populations to help develop and implement mental health programs based on initial evidence."

What did you find?
"We found an increased prevalence of depression (up 15.97 percent), anxiety (+15.15%), insomnia (+23,87%), PTSD (+21.94%), and psychological distress (+13.29%) among COVID-19 affected populations. These findings are important because the rates of symptoms and disorders we found are higher than the usual prevalence reported by the World Health Organization; depression was three times higher; anxiety was four times higher, and PTSD was five times higher in our study."

What was the case with healthcare workers?
"Healthcare workers (HCWs) had reported significantly more insomnia than the general population while presenting similar rates to the general population for other symptoms. These results are consistent with previous studies that have shown that during epidemics and crises (such as SARS or Ebola), HCWs generally have the same level - or fewer - mental health problems than community members. However, longitudinal studies need to be conducted to determine whether this non-differentiation between HCWs and the general population is related to temporary coping strategies associated with being on the front lines.

Did findings vary at all depending on the origin of the study you reviewed?
"There were no significant differences observed for gender, geographical regions, and healthcare workers, except for insomnia being more prevalent in this latter group. The short-term mental health consequences are equally high across affected countries."

What is the long-term worry?
"After the pandemic ends, HCWs may develop more severe mental health problems. For example, the prevalence of insomnia that is more than two times higher among HCW is a predictor of depression and suicidal ideation."

Why are these findings so important?
"This is the largest and most comprehensive systematic review of this matter since the beginning of the COVID-19 pandemic. Our study will help guide research and the development of better mental health programs during and after the pandemic."

Hearing loss and diabetes are major public health problems, with Latinos at higher risk than other demographic groups. In a new study published December 17, 2020 in the online issue of JAMA Otolaryngology-Head & Neck Surgery, researchers at University of California San Diego School of Medicine with colleagues elsewhere, report that hearing loss and high blood sugar are associated with poor cognitive performance among middle-aged and older Latinos.

Diabetes is a risk factor for Alzheimer's disease (AD) and related dementias. More recently, hearing loss has also been linked to increased risk for AD. However, few studies have investigated the combined relationships between cardiovascular disease risk, hearing loss and cognition.

As part of the Hispanic Community Health Study/Study of Latinos, more than 9,000 middle age and older Latinos (ages 45 to 74 years) underwent hearing examinations, extensive cardiovascular and diabetes testing and cognitive assessments. Participants include Central Americans, Cubans, Dominicans, Mexicans, Puerto Ricans and South Americans residing in the Bronx, NY; Chicago, IL; Miami, FL and San Diego, CA.

Those who displayed hearing loss also included individuals with mild to severe levels of cognitive impairment.

"Initially, we thought that the relationships between hearing loss and cognition would be overshadowed by high cardiovascular disease risk, but this was not the case," said first author Ariana M. Stickel, PhD, a postdoctoral scholar in the Department of Neurosciences at UC San Diego School of Medicine.

"This opens up promising avenues for interventions to reduce Alzheimer's disease risk. Evidence suggests that hearing aid use may be protective against cognitive declines for individuals with hearing loss, yet we also see that fewer than 5 percent of Latinos with hearing loss report using hearing aids. This is something we can change to help prevent cognitive declines, but it is going to take awareness on the part of health care providers and their patients."

The study also found that high cardiovascular disease risk is associated with poorer cognition.

"We were surprised to find that individuals with high blood sugar and otherwise average cardiovascular health are susceptible to poorer learning and memory, but only if they also had hearing loss," said senior author Hector M. González, PhD, professor in the Department of Neurosciences at UC San Diego School of Medicine and a member of the UC San Diego Shiley-Marcos Alzheimer's Disease Research Center.

Impairments in learning and memory occur in the preclinical stages of AD. González said the next step is to investigate what is happening within the brain.

"Is there a particular region or network in the brain that is susceptible to damage from both hearing loss and high blood sugar? Does this overlap with early brain changes due to Alzheimer's disease, and how might it be related to learning and memory," González said.

According to a new report by the Lancet Commission, there would be an 8 percent reduction in dementia prevalence globally if hearing loss alone is eliminated.

"Both hearing loss and diabetes can be modified," said Stickel. "Latinos are projected to have the highest increase in Alzheimer's disease and related dementia cases in the U.S. by 2060. Connecting our findings to public health solutions that work for Latinos can help mitigate the impending public health crisis."

In a new study published in the Journal of Medical Entomology, researchers at the University of Maryland (UMD) found higher rates of West Nile virus-infected mosquitoes in lower-income neighborhoods in urban areas of Baltimore, Maryland. Continuing a collaboration with the Cary Institute of Ecosystem Studies and building on previous work finding larger mosquitoes (which may be more likely to transmit disease) in lower-income neighborhoods, this preliminary data provides another piece of the puzzle pointing to higher risks of mosquito-transmitted diseases like West Nile virus in these neighborhoods already struggling with environmental injustices and poorer health outcomes. This paper points to a need for more research in lower-income communities to inform policy and programs that can protect the health of those most at risk.

"In order to effectively address environmental injustices, we have to understand where they occur and why," says Sarah Rothman, doctoral student in Environmental Science & Technology at UMD and lead author of this paper. "Urban mosquito sampling often takes place in city parks or other areas where traps are easily accessible to personnel, but we need to ensure we are sampling for mosquitoes in neighborhoods that are diverse in socioeconomic status. Representative surveillance is the first step. Only after identifying where disease risk is actually greatest can we direct public health resources to communities that need them most."

This study acts as a first step in addressing environmental justice, providing another important connection between lower-income neighborhoods and risky mosquito populations, according to Paul Leisnham, associate professor in Environmental Science & Technology at UMD. "A higher infection rate was shown in two species of mosquito, the invasive tiger mosquito and the northern house mosquito. In previous studies, we have shown that mosquito abundances and female body sizes, two other ecological parameters that promote virus transmission, are also larger in lower-income neighborhoods. Now we have introduced another piece of the puzzle pointing to higher risks in lower-income areas."

Leisnham spends time interacting with locals in urban Baltimore through his research and Extension efforts, highlighting an important point for mosquito population growth that isn't exactly intuitive: "Less trash, fewer mosquitoes." Mosquitoes can surprisingly breed in an amount of water as small as what gathers in a bottle cap left outside in a shady area for four or five days. If the water gathers in a shaded container and isn't infiltrating into the ground through managed stormwater practices, it can easily become a mosquito breeding ground that can produce hundreds of biting adults.

Cary Institute disease ecologist Shannon LaDeau, collaborator on the study, explains, "More people are living in cities. At the same time, many other species are also adapting to city living. Invasive species like the tiger mosquito increasingly thrive in temperate urban areas, living among us and fundamentally altering the risk of local disease emergence. People living in neighborhoods with abandoned infrastructure are more at risk, because tiger mosquitoes flourish in less managed landscapes."

While the connection between vacant lots, more trash, and more mosquitoes is established, more research is needed to further connect these environmental injustices to higher infection rates in humans. "West Nile virus incidence in the human population is often underestimated," says Rothman. "Most cases are asymptomatic, and mild symptomatic cases are easily confused with other illnesses that present similarly, like the flu. We are likely especially missing cases in underserved populations with reduced access to quality medical care. Since it's hard to track the prevalence of West Nile virus in people, we suggest additional sampling of the virus in mosquitoes. Additional research could also help us figure out why we're seeing patterns of higher mosquito infection rates in lower-income neighborhoods and how these patterns are affected by environmental factors such as weather."

"It's important, especially in populations from lower-income areas since they are often immunocompromised with other infections, including HIV and likely COVID-19," adds Leisnham. "The CDC [Centers for Disease Control and Prevention] has reported that the U.S. is not prepared for mosquito and tick-borne risks based on local health agencies' surveys."

Rothman stresses the need for this work to improve environmental justice in lower-income areas of cities like Baltimore. "Our research supports the notion that residents in these neighborhoods are disproportionately at risk for mosquito-borne illness," says Rothman. "We need additional research to understand and address the underlying factors, and ultimately protect urban residents."

Researchers at the Center for Health Outcomes and Policy Research (CHOPR) at the University of Pennsylvania School of Nursing, conducting independent research on whether pending nurse staffing legislation in New York state is in the public's interest, found that the wide variation in patient-to-nurse ratios across hospitals in New York is contributing to avoidable deaths for patients with sepsis, a common, high mortality condition.

New York state is a national leader in sepsis care through legislation known as Rory's Regulations named after a child that unexpectedly died in a New York hospital from sepsis. The new study finds avoided sepsis deaths associated with better hospital nurse staffing are much greater than adherence to mandated sepsis care bundles.

The new study shows each additional patient added to a nurse's workload is associated with 12% higher in-hospital mortality from sepsis compared with only a 5% improvement in mortality associated with improved adherence to mandated care bundles.

The study concluded that while Rory's Regulations and sepsis care bundles helped reduce deaths from sepsis, implementing proposed patient-to-nurse ratios in NY state holds promise for much greater reductions in sepsis deaths.

Lead author Karen Lasater, PhD, RN, an assistant professor and CHOPR researcher said, "Results show that improving nurse staffing in New York hospitals could substantially reduce deaths from sepsis over and above the benefits of mandated care bundles."

Additionally, the study showed that while hospital adherence to mandated sepsis care bundles is associated with shorter length of hospital stays, improved nurse staffing at the levels in the pending legislation had more than twice as large an effect on reducing length of stay than the care bundles.

Co-author, CHOPR Director Linda H Aiken, PhD, RN, a senior researcher and professor at the University of Pennsylvania said, "This independent scientific study shows that improvement of hospital nurse staffing holds the best promise for significantly reducing deaths from sepsis which often strikes when it is least expected. Moreover, improving nurse staffing results in cost savings in sepsis care due to shorter hospital stays that can be reinvested in improved nurse staffing."

Background

The study is of 116 hospitals in New York state and more than 52,000 hospitalized patients with a diagnosis of sepsis. On average in these hospitals, nurses cared for 6.3 patients each and staffing varied substantially by hospital from 4.3 patients-per-nurse in the best staffed hospitals to 10.5 patients per nurse in the worst staffed hospitals. There is currently no requirement in New York that hospitals meet a minimum safe nurse staffing standard.

The Safe Staffing for Quality Care Act (A2954/S51032) currently pending action in the NY Legislature sets a minimum nurse staffing requirement for all New York state hospitals that would serve to bring hospitals with poor staffing to an evidence-based minimum standard.

A 2020 Harris Poll sponsored by NursesEverywhere.com found that 90% of the public surveyed believed that hospitals should be required to meet safe nurse staffing standards.

Sepsis is a life-threatening acute condition that results from an infection that might seem harmless initially but can escalate rapidly to death for children and adults. Each year, at least 1.7 million adults develop sepsis and nearly 270,000 die.

Rory's Regulations were enacted by New York state in 2013 after the highly publicized death of a 12-year-old boy with sepsis. The Regulations require hospitals to implement protocols for screening, early diagnosis, and timely treatment of patients with sepsis. More recently, the Centers for Medicare and Medicaid Services (CMS) began mandating the public reporting of hospital adherence to evidence-based sepsis care protocols via HospitalCompare. Nurses are responsible for implementing these protocols although no previous research has been done on the impact of nurse staffing on adherence to the protocols. This new study shows the effect of improving hospital nurse staffing on avoided deaths from sepsis is much greater than the care bundles mandated under Rory's Regulations.

Another recent publication on the adverse on patient outcomes on variation in nurse staffing across New York hospitals is:

Lasater KB, Aiken LH, Sloane DM, French R, Martin B, Reneau K, Alexander M, McHugh MD. 2020. Chronic hospital nurse understaffing meets COVID-19. BMJ Quality & Safety. Epub ahead of print 18 August 2020. doi:10:1136/bmjqs-2020-011512. Open Access.

The study was carried out by the Center for Health Outcomes and Policy Research, University of Pennsylvania School of Nursing in partnership with the National Council of State Boards of Nursing. Funding for the study was from the National Council of State Boards of Nursing, the National Institute of Nursing Research/NIH, and the Leonard Davis Institute of Health Economics at the University of Pennsylvania.

December 17, 2020 -- An opinion piece published today online in BMJ by Nina Schwalbe in the Heilbrunn Department of Population and Family Health at Columbia Mailman School of Public Health, calls for a national vaccine strategy now that COVID-19 vaccines are available. Schwalbe writes that a lack of clarity on a distribution plan sets unrealistic expectations among the public and could undermine public trust. But even with a clearly defined strategy in place, vaccinating hundreds of millions of Americans will not be easy. Read the full article here.

Vaccines don't deliver themselves," notes Schwalbe, who is also a Principal Visiting Fellow at the United Nations University International Institute of Global Health. "Vaccines require a safe, trusted and accessible immunization system."

To address the high covid-19 death rates in the medium to long term, Schwalbe recommends the following:

Set realistic expectations on the role of vaccines in the COVID-19 response and communicate those clearly. For example, given limited supply, the immediate focus seem to be to reduce mortality of individuals in high-risk groups and transmission in health care settings. It is not to reach herd immunity.

Call upon the Biden administration to enact a parallel commitment to universal health coverage to help protect those people vulnerable to underlying conditions, like diabetes and heart disease, that put them at risk of severe covid-19 disease in the first place.

Work directly with communities to devise a plan that addresses their fears, and engages them to figure out the logistical challenges.

(Boston)--Obesity is associated with poor COVID-19 outcomes but a new study suggests this is not due to increased inflammation, but instead may be driven by respiratory issues or other factors.

Multiple studies suggest those who are overweight or have obesity are more likely to experience invasive mechanical ventilation, intensive care unit (ICU) admission or death. Population-level studies also suggest a higher COVID-19 mortality rate in countries with greater prevalence of obesity. What was not known before was whether patients with obesity had more inflammation, the so-called cytokine storm of COVID.

According to the researchers, additional factors may explain the unexpected finding of lower inflammatory markers in patients with obesity. "Though definitive reasons for poor COVID-19 outcomes in obesity remain uncertain, patients with obesity are uniquely vulnerable. They may have independent risk factors (type-2 diabetes, hypertension and coronary artery disease) for poor outcomes in COVID-19, conditions that are inflammatory and immune-mediated," explained Ana Mostaghim, MD, the lead author for the study who conducted the work while an internal medicine resident at Boston Medical Center (BMC).

In an effort to better understand these potential factors, the researchers compared outcomes and inflammatory markers in patients with and without obesity who were hospitalized with COVID-19 at BMC, a safety-net hospital. They found that body mass index (BMI) greater or equal to 35 was associated with a two-fold increased risk of ICU transfer and a four-fold risk of all-cause mortality; BMI in the 30-34.9 range (Class I obesity) was also associated with increased risk of ICU transfer, but not significantly associated with increased mortality. They also found that patients with obesity had mostly lower inflammatory markers on the first and second hospital days compared to those without obesity.

"While patients with obesity had worse clinical outcomes than those without obesity in our study, this effect does not appear to be mediated by a higher degree of inflammation," added Natasha Hochberg, MD, associate professor of medicine at Boston University School of Medicine and an infectious disease physician at BMC. "Patients with obesity are at higher risk of fatty liver disease and greater viral invasion with organ dysfunction may contribute to the increased mortality seen in these patients. Alternately, patients with obesity may have reduced respiratory reserve."

The researchers believe further studies are needed to determine whether this decreased inflammatory response persists during hospitalization, whether pro-inflammatory complications are seen less commonly among patients with obesity and whether anti-inflammatory therapy should be utilized differently in patients with obesity.

Pregnant women are among those most in need of safe and effective therapies against COVID-19, but they are routinely excluded from the majority of clinical treatment trials, according to authors of an opinion piece based on a review of international trial registry data, published in The Lancet Global Health journal.

Strikingly, three-quarters of COVID-19 trials reviewed specifically excluded expectant mothers, even though they were investigating medications and vitamins that already have a relatively favourable safety profile during pregnancy, or that are already used in pregnant women.

In the Viewpoint, authors raise concerns that the ongoing exclusion of pregnant women will result in lost opportunities to ensure the effectiveness and safety of treatments in expectant mothers who may be at increased risk of severe outcomes from COVID-19 illness. They argue that given the scale of the pandemic and those that will inevitably follow, there is a public health obligation to include pregnant women in treatment trials to identify and provide appropriate management and care.

"Without explicit and proactive efforts to recruit and retain pregnant women in therapeutic trials for COVID-19, expectant mothers will suffer from having fewer medical options available to them, because we are not including them in clinical trials", says author Dr Melanie Taylor from WHO in Switzerland and the US Centers for Disease Control and Prevention. "There is a very real possibility that treatment could become approved for treatment of COVID-19 without evidence-based guidance for use in pregnant women." [1]

As co-author Dr Loulou Kobeissi from WHO and HRP in Switzerland explains: "The systematic exclusion of pregnant women cannot be justified on the basis of safety as many of the medications being evaluated are either not harmful in pregnancy, or their risks are minimal. We are concerned that the resulting evidence gaps and delays will limit our understanding of the effects of treatment, dosing, and side effects in this important population, which can be vastly different from other groups due to the physiological changes that come with pregnancy."[1]

The call echoes growing appeals from leading medical societies for pregnant women to be included in COVID-19 vaccine and treatment trials, including the American Academy of Obstetrics and Gynecologists, the Society of Fetal Medicine, and 17 US medical societies [2]. While available evidence is limited, pregnant women with COVID-19 appear more likely to need intensive care and mechanical ventilation than non-pregnant women, although the reasons for this increased risk remain unclear.

Despite the surge in clinical treatment trials for COVID-19, the proportion excluding pregnant women remains consistently high. The Viewpoint, based on a review of data from 10 WHO-recognised international clinical trial registries, determined that 80% (124) of 155 clinical treatment trials of COVID-19 registered in April 2020, and 75% (538) of 722 trials in July 2020, specifically excluded pregnant women.

Crucially, the authors note, expectant mothers were excluded in three-quarters (130/176) of trials investigating six key drug treatments (lopinavir/ritonavir, chloroquine and hydroxychloroquine, remdesivir, interferon beta, ivermectin, and corticosteroids) previously used as treatments in pregnant women (see panel), as well as most (77%; 27/35) trials evaluating high-dose vitamins (ie, A B-complex, C, D, E, and zinc) for which safety data show no, or minimal risk, of adverse pregnancy or birth outcomes.

The authors also investigated the inclusion eligibility criteria for these trials and found that the principle researchers of these trials did not include an explanation for why pregnant women were excluded. They believe that pregnant women's exclusion from COVID-19 trials is likely happening due to perceived risks around use in expectant mothers and medication exposure to foetuses or neonates.

But in 2016, the Council of International Organizations of Medical Sciences (CIOMS) issued international ethical guidelines proposing that expectant mothers should not be considered vulnerable in clinical research, and provided detailed guidance on how to safely include pregnant and breastfeeding women in clinical trials [3]. Since then, numerous medical societies have recommended their inclusion in COVID-19 treatment trials [2].

The Viewpoint authors argue that pregnant women should be given the right to make their own informed decision to participate in clinical studies, based on understanding the associated potential benefits and harms of treatment.

"Pregnant women are among the least likely to have robust, timely evidence to inform decisions around their care", says Dr Caron Kim, one of the authors from WHO and HRP in Switzerland. "Categorising women as members of a vulnerable group on the basis of pregnancy status alone, rather than as individuals who are pregnant at the time of the trial, limits their individual choice, and access to potentially life-saving treatment." [1]

According to Dr Kobeissi, "With the emergence of the COVID-19 crisis and future epidemics to come, we have a public health obligation to promote inclusion of pregnant women's interests in research and reduce their vulnerability. Pregnant women should be provided with clear messaging in lay language on the potential benefits and risks of exposure to candidate medications for treatment through their participation in clinical research and should have facilitated access to obtain the needed health information, so that they can make an informed decision as soon as they perceive the need to." [1]

PROVIDENCE, R.I. [Brown University] -- For people living with opioid use disorder, the path to treatment is not always clear-cut. Sometimes, there's no path at all.

The gap between those recommended for medications for opioid use disorder -- with methadone, buprenorphine or other medications prescribed -- and those who ultimately receive it is wide and persisting. At the epicenter, accounting for more than one third of individuals with an opioid use disorder, are Medicaid recipients.

In an effort to gather information that might help to close that gap, researchers at the Brown University School of Public Health analyzed Medicaid databases to identify predictors of timely enrollment in treatment for those who experienced an opioid overdose or were diagnosed with opioid use disorder.

The findings, published in the journal
Drug and Alcohol Dependence, show that 58% of Medicaid recipients did not enroll in treatment within six months of an overdose, and that prior overdose, alcohol use disorder and back problems were predictors of non-enrollment. Conversely, frequent visits to the emergency room or a primary care provider were associated with timely enrollment.

The researchers used multiple linked, state-level databases available through the Rhode Island Executive Office of Health and Human Services to conduct the study of 17,449 Medicaid recipients in Rhode Island.

"These findings underscore the need to enhance pathways to treatment, and we provide several recommendations to that end," said Alexandria Macmadu, study author and a Brown doctoral candidate in epidemiology.

By pinpointing predictors of enrollment, and non-enrollment, researchers and physicians can get a clearer sense of where they need to connect with people to encourage treatment: in settings that provide mental health care, emergency departments, treatment programs for other substance use disorders, and even pain clinics.

Based on the findings, the researchers generated a two-tiered approach to enhance existing systems of care and ensure maximum exposure to pathways to treatment for OUD at the state level.

Interventions in these high-impact settings to improve screening for OUD and referrals to treatment are among the first steps in stemming the opioid epidemic, the researchers say.

"When it comes to treatment for opioid use disorder, we need to meet people where they are," said Brandon Marshall, an associate professor of epidemiology at Brown and corresponding author of the study. "We can have the best treatment options out there, but they won't do any good if we can't deliver these options in a timely, accessible and non-judgmental way to everyone who might benefit."

Because frequent visits to a primary care provider or emergency department were closely tied to receiving timely treatment, Macmadu said that's a great place to start -- and Rhode Island is already a national leader in that regard, she noted. Compared to other states, medications for OUD are easy to access, available when needed and covered by insurance. There are no waiting lists for the treatment, and enrollment has been growing steadily for several years, according to data from multiple state health agencies.

"Emergency department-based initiation is an incredible approach to use," Macmadu said. "These findings have tremendous implications for other states that wish to replicate the increased engagement in treatment we've been able to achieve in Rhode Island."

In addition to screenings and early interventions, Macmadu said that establishing on-demand buprenorphine induction -- in which patients receive their first dose of the medication -- at key facilities and incorporating peer recovery specialists -- individuals who are in recovery themselves and can help to engage and support peers in the early stages of recovery -- into overdose response are key to mitigating barriers to treatment.

Not all solutions are health care-based, however. Medicaid recipients tend to be lower-income than the broader population, and enhancing transportation support would have a remarkable impact their ability to receive the care they need.

"If you would like to engage in treatment, but you don't have transportation, or you have to navigate the logistical issues of childcare, it can be incredibly difficult," Macmadu said.

Above all, the researchers agree that the simplest, most impactful step toward stemming the tide of overdose is removing the stigma associated with medications for OUD.

Despite years of research that show medications for OUD are the most effective, evidence-based treatment, there is an enduring misconception among patients, physicians and the public that if a person is a patient at a methadone clinic, they're still addicted to something, and that it's not "real recovery," Macmadu explained.

Kimberly Paull, director of data and analytics at EOHHS and one of the co-authors of the paper, said one of the most critical findings of the study was uncovered during focus group conversations with participants -- that no improvement is possible if negative beliefs about medications for OUD persist.

"If we have bias, fear and discrimination about treating a disease with a medication, we are hurting people," Paull said. "We are not showing up to save lives."

Positive results from additional analyses of PRIDE-HD and Open-HART trials with pridopidine published in peer-reviewed journal, The Journal of Huntington’s Disease.

Exploratory additional efficacy data show pridopidine (45 mg bid) to be the first drug to exert a significant and clinically meaningful beneficial effect on Total Functional Capacity (TFC).

Results from Open-HART trial demonstrate potential durability of the effect of pridopidine with less TFC decline over 5 years compared to historical placebo group, as well as positive safety and tolerability data.

Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announces the publication of two articles in the peer-reviewed journal, The Journal of Huntington's Disease, highlighting positive efficacy and safety data for pridopidine, as demonstrated by new additional analyses of the Phase 2 PRIDE-HD and Open-HART trials.

Pridopidine is a first-in-class small molecule in development for the treatment of Huntington's disease (HD) and Amyotrophic Lateral Sclerosis (ALS). It is the most selective, high-affinity Sigma-1-receptor (S1R) agonist in clinical development. Activation of the S1R by pridopidine exerts neuroprotective effects in preclinical models of HD and other in neurodegenerative diseases.

Highlights from the published articles include the following:

Effects of Pridopidine on Functional Capacity in Early-Stage Participants from the PRIDE-HD Study

Pridopidine 45 mg bid is the first drug to demonstrate a beneficial effect on TFC at 52 weeks in HD patients (?TFC vs placebo 0.87, p=0.0032). The effect was more pronounced in early-stage HD patients (?TFC vs placebo 1.16, p=0.0003).

The effect remains nominally significant using the most conservative, worst-case scenario Missing Not at Random (MNAR) sensitivity analysis.

Responder analysis demonstrates that treatment with pridopidine 45 mg bid reduces the probability to decline in TFC by approximately 80%.

Additional Safety and Exploratory Efficacy Data at 48 and 60 Months from Open-HART, an Open-Label Extension Study of Pridopidine in Huntington Disease

Pridopidine 45 mg bid demonstrates a durable effect on slowing the decline in TFC versus a historical placebo group over 5 years. Pridopidine remained safe and tolerable over 60 months.

Early HD patients treated with pridopidine 45 mg bid show less decline in TFC at 60 months (-1.8 points/5 years) compared to historical placebo group demonstrating the expected decline in TFC (-5.0/5 years) (nominal pThis effect remains nominally significant after sensitivity analysis with mixed model repeated measures to account for missing data.

Andrew McGarry, MD, Director, Clinical Development, Clintrex and lead author of the PRIDE-HD and Open-HART publications, commented: "Pridopidine has demonstrated an excellent long-term safety profile and suggestion of improvement in clinical trials, as well as in exploratory analyses, where early HD populations appear to particularly benefit. In view of these promising data, the newly initiated Phase 3 study in HD will be of great interest to the entire HD community."

Pridopidine is an orally administered drug currently being assessed in a Phase 3 randomized, double-blind, placebo-controlled study (PROOF-HD), evaluating the effect of pridopidine 45 mg bid on Total Functional Capacity (TFC) in patients with early stage HD. The first patients in this trial were dosed in October 2020. TFC is the standard widely used clinical scale for tracking the progression of HD with respect to functional capacity. In addition, TFC is accepted by the FDA and EMA as a single primary endpoint in HD trials.

Pridopidine is also being assessed in the first ever platform trial for ALS in collaboration with the Healey Center for ALS at Mass General Hospital.

Ralf Reilmann, MD, Founding Director of the George Huntington Institute and Principal Investigator of the PROOF-HD Phase 3 clinical trial in Europe, commented: "These are critical results. At the 45 mg bid dosage used in the Phase 2 Pride-HD and Open-HART trials, pridopidine is the first drug to show a significant clinical effect on the functional decline caused by Huntington's disease progression, as well as long-term safety data. The PROOF-HD Phase 3 trial will be an important next step to see if pridopidine can offer an effective and safe treatment that allows patients to better maintain their functional and motor abilities, and quality of life."

Michael R. Hayden, MD, PhD, CEO of Prilenia and world-renowned expert in Huntington's Disease research, commented: "Pridopidine is showing strong scientific and clinical data in support of its use for Huntington's disease and other neurodegenerative diseases, such as ALS. By understanding the mechanism of action clearly, we are now delighted about the reported positive data in terms of efficacy and safety."

BOSTON -- Understanding the body's immune response to SARS-CoV-2, the virus that causes COVID-19, is key to developing effective treatments and long-lasting vaccines. Of particular interest are neutralizing antibodies, which can block the virus from entering and infecting human cells, helping the immune system clear the virus and prevent future infections.

Scientists at the Ragon Institute of MGH, MIT and Harvard, publishing in the journal Cell, show that the potency of neutralizing antibodies which developed in COVID-19 patients was significantly reduced in those with severe or fatal disease compared to patients with milder infections.

"Potent neutralizing antibodies were associated with a positive outcome," says Alejandro Balazs, PhD, Ragon Core Member and lead author of the study. "We found that if a person made antibodies that were more effective at neutralizing the virus, they seemed to have better clinical outcomes."

Balazs's group developed an automated assay that could measure the potency of neutralizing antibodies in hundreds of COVID-19 patient samples at a time. They used this technology to examine samples from 113 COVID-19 patients, comparing milder cases to severe and fatal ones to understand the nuances of the antibody response.

They discovered that patients with severe or fatal COVID-19 had significantly less effective neutralizing antibodies than patients with milder cases. In fact, a model they built suggested that measuring the potency of these neutralizing antibodies could predict patient outcomes.

"By measuring the neutralization potency of a patient's antibodies," says Wilfredo Garcia-Beltran, MD, PhD, co-first author of the study, "we may be able to identify patients at risk of severe disease or death and use that to guide treatment options."

The neutralizing antibodies were also effective against the recently identified and widespread SARS-CoV-2 mutation known as D614G, indicating that the antibody responses that develop in most patients may provide protection even as the virus mutates. However, by modifying their assay to look at neutralization potency against a similar, pre-emergent coronavirus identified in bats, they found the antibody responses were largely ineffective, suggesting that this coronavirus strain may pose a threat if it ever crosses into humans.

"Though the ability to protect against mutated forms of the virus is promising," says Evan Lam, also a co-first author of the study, "these results suggest that, to prepare for potential future pandemics, we need to look towards developing vaccines capable of providing a broadly protective response."

DES PLAINES, IL -- The LOOP technique for incision and drainage (I&D) of abscesses in adults is a safe and effective alternative to the traditional I & D with packing and may offer an alternative to the standard regimen in the treatment of uncomplicated skin abscesses in pediatric patients. That is the conclusion of a study to be published in the December 2020 issue of Academic Emergency Medicine (AEM), a journal of the Society for Academic Emergency Medicine (SAEM).

The lead author of the study is Dr. Jay Ladde, an academic emergency physician working at Orlando Regional Medical Center serving as core faculty and senior associate program director. Dr. Ladde also has the rank professor of emergency medicine for University of Central Florida College of Medicine.

The clinical trial compared the failure rate of incision and drainage (I&D) with LOOP technique, versus I&D with standard packing technique, in adults and children presenting to the emergency department (ED) with subcutaneous abscess. In conclusion, the LOOP and packing techniques were found to have similar failure rates for treatment of subcutaneous abscesses in adults, but the LOOP technique had significantly fewer failures in children. Overall, pain and patient satisfaction were significantly better in patients treated using the LOOP technique.

The authors suggest that with further study, this technique may offer an alternative to this standard regimen in the treatment of uncomplicated skin abscesses in pediatric patients.

Companies worldwide are facing unprecedented challenges due to the COVID-19 pandemic, from modifying operations to keeping employees safe and informed. But not all businesses have followed the recommended safety protocols set by the Centers for Disease Control and Prevention. This mixed messaging could have a significant impact on employee trust, loyalty and overall commitment, according to a study led by the University of Houston Conrad N. Hilton College of Hotel and Restaurant Management and Missouri State University's Hospitality Leadership Department.

The survey of 240 food, beverage and lodging employees examined the role emotions play in developing organizational trust amid a crisis. The results show mangers whose communications followed CDC guidelines made employees feel grateful, where communications that ignored CDC recommendations enhanced fear and anger toward the organization. The results are published in the International Journal of Hospitality Management.

"If I feel angry toward you, I'm not going to trust you. And if I don't trust you, I'm not going to be committed to you. I may want to work somewhere else," said study co-author Juan Madera, UH professor. "Employees are more grateful when their employer tells them to do the obvious, which is what scientists are telling them to do. Wear a mask, wash your hands and social distance. Social norms dictate that there's safety in numbers."

As the pandemic emerged and worsened last spring, some companies faced a backlash for putting the health of their workers at risk. A lawsuit against an Iowa food processing plant accused the company of endangering employees by downplaying virus concerns and ordering employees - many of whom eventually tested positive, with some deaths reported - to come to work. One manager referred to the virus as a "glorified flu" that "everyone is going to get," according to the lawsuit.

"After seeing some companies making the headlines for not following the CDC and international health safety guidelines, we started to discuss the emotional consequences for employees and how that in turn would affect the company. That's where we found inspiration for this study," said lead author Renata Guzzo, a former UH PhD student and lecturer and now an assistant professor at Missouri State University. Other authors are Xingyu Wang, Hong Kong Polytechnic University, and JéAnna Abbott from UH.

E-commerce giant Amazon made headlines when warehouse employees spoke out about working conditions, accusing the company of not taking sufficient precautions to reduce their risk of exposure to the virus. Some restaurants and bars, especially early in the outbreak, ignored CDC health and safety guidelines, such as not requiring masks or social distancing.

Those and similar actions can have profound long-term negative consequences, not only for employees but also for the organization itself, according to the researchers.

"The stakes are very high. Workers can get sick or develop severe mental health issues while the companies have to deal with loss of production from sick leave and a bad reputation. Accurate and consistent messaging can mitigate some of those risks," said Madera. "How employees are treated today will affect how they feel about the organization years from now, long after the pandemic is over."

While this study focused on hospitality employees amid a pandemic, the researchers say the findings have implications for a variety of crises, such as terrorist attacks or natural disasters. Each event can disrupt services, close businesses and change the productions of service, creating a crisis for organizations.

"During crises, and especially during a global crisis such as the COVID-19, establishing and maintaining trust among employees in times of crisis is critical to the survival and success for hospitality organizations," the researchers wrote.

WASHINGTON, DC - DEC. 16, 2020 -- As the biggest vaccination effort in U.S. history gets underway, several states may not have a sufficient number of facilities in some areas to administer the COVID-19 vaccine to all residents who want it, according to a new analysis from the University of Pittsburgh School of Pharmacy and the nonprofit West Health Policy Center.

In what is believed to be the first county-level analysis of the nation's potential COVID-19 vaccine facilities, which include community pharmacies, federally qualified health centers, hospital outpatient departments and rural health clinics, the researchers found that more than a third (35%) of U.S. counties have two or fewer of these facilities and nearly 1 in 10 counties have fewer than one facility per 10,000 residents.

The analysis, including an interactive, open-access map, titled VaxMap, and white paper, was published online today by West Health.

"The U.S. has large geographic variation in population access to potential COVID-19 vaccine administration facilities, particularly at the county level," said Inmaculada Hernandez, Pharm.D., Ph.D., Assistant Professor at the Pitt School of Pharmacy and senior author of the study.

"This highlights the need for state and local public health officials to tailor their vaccine distribution and administration plans to their specific populations and the current limitations of their state's existing healthcare infrastructure," said Lucas Berenbrok, Pharm.D., Assistant Professor at the Pitt School of Pharmacy and first author of the study.

Researchers used geographic information system (GIS) software to map more than 70,000 potential COVID-19 vaccine administration facilities and calculate the average driving distance to the closest facility for simulated citizens, including high-risk populations such as people age 65 or older.

The counties with the fewest vaccination facilities relative to the size of their populations are located in Texas, Kansas, Nebraska, Montana and Virginia. When it comes to driving distance, residents of North Dakota, South Dakota, Montana, Wyoming, Nebraska, and Kansas face the longest drives, with over 10% living more than 10 miles away from the closest facility.

For older adults it's even worse. In 12% of counties, at least half of the older population have a more than 10-mile drive. In North and South Dakota, 25% of older adults are more than 10 miles away from a facility.

"We did the analysis to help states and counties throughout the U.S. identify potential problem areas for vaccine administration and enact effective strategies and take measures to overcome them," said Tim Lash, President of the West Health Policy Center. "Clearly there are certain spots throughout the country that need more help and support than others."

The researchers suggest that state and local authorities in areas with short driving distances and low facility density may consider adding mass vaccination clinics to increase capacity and reduce the time to vaccinate. Conversely, areas with high driving distances may benefit from mobile vaccination clinics to reduce travel-related barriers, and vaccines that require only one dose instead of two may be more effective in ensuring sufficient vaccine uptake.

"Facility density and distance metrics can guide state officials not only in identifying the most appropriate strategy to increase capacity and convenience in each locality, but also in vaccine selection," said paper co-author Sean Dickson, Director of Health Policy, West Health Policy Center. "When large populations are served by only a few vaccine administration points, additional support to store and dispense vaccine will be needed."