Body

What The Study Did: This community-engaged qualitative study describing Black and Latinx participants' experiences during the COVID-19 pandemic found that fear, illness and loss experienced during the pandemic motivated information seeking and mitigation behaviors, while vaccine skepticism was high, as was the demand for clearer information. Among Black participants, racism and medical experimentation were associated with distrust.

Authors: Manuel E. Jimenez, M.D., M.S., of the Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, is the corresponding author.

To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/

(doi:10.1001/jamanetworkopen.2021.17074)

Editor's Note: The article includes conflict of interest and funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

Study is most comprehensive of its kind and included more than 70,000 adults in the UK hospitalised with severe COVID-19 disease. Of these, half (36,367 of 73,197) developed one or more health complication during their hospitalisation.

Most common complications included renal, complex respiratory, and systemic complications, but cardiovascular, neurological, and gastrointestinal and liver complications were also reported.

The study found high rates of complications across all age groups. Men and those aged older than 60 years were most likely affected, but complications and poor functional outcomes were common, even in younger, previously healthy adults.

The authors note that complication rates following COVID-19 are high, and these complications often affect people's ability to look after themselves. They warn that this may cause a substantial strain on health and social care in the coming years.

An observational study of more than 70,000 people in 302 UK hospitals finds that one in two people hospitalised with COVID-19 developed at least one complication. The new study, published in The Lancet, is the first to systematically assess a range of in-hospital complications, and their associations with age, sex and ethnicity, and their outcomes for the patients.

The authors say these complications are likely to have important short- and long-term impacts for patients, healthcare utilisation, healthcare system preparedness, and society amidst the ongoing COVID-19 pandemic. They also note that these complications are different to long COVID symptoms in patients with COVID-19 who were not hospitalised.

The authors say that complications in patients admitted to hospital with COVID-19 are high, even in young, previously healthy individuals - with 27% of 19-29 year olds and 37% of 30-39 year olds experiencing a complication. They also note that acute complications are associated with reduced ability to self-care at discharge - with 13% of 19-29 year olds and 17% of 30-39 year olds unable to look after themselves once discharged from hospital.

The study looked at cases between 17 January and 4 August 2020 before vaccines were widely available, and new variants of the virus had not arisen. However, the authors note that their findings remain relevant in dispelling suggestions that COVID-19 presents no risk to younger healthy adults, many of whom remain unvaccinated.

The authors warn that policymakers must consider the risk of complications for those who survive COVID-19, not just mortality, when making decisions around easing restrictions. The authors predict that COVID-19 complications are likely to cause significant challenges for individuals and for the health and social care system in the coming years. Policy makers and health-care planners should anticipate that large amounts of health and social care resources will be required to support those who survive COVID-19.

Chief Investigator and joint senior author of the study, Professor Calum Semple, University of Liverpool, UK, says: "This work contradicts current narratives that COVID-19 is only dangerous in people with existing comorbidities and the elderly. Dispelling and contributing to the scientific debate around such narratives has become increasingly important. Disease severity at admission is a predictor of complications even in younger adults, so prevention of complications requires a primary prevention strategy, meaning vaccination." [1]

Joint senior author Professor Ewen Harrison from the University of Edinburgh, UK, says: "Patients in hospital with COVID-19 frequently had complications of the disease, even those in younger age groups and without pre-existing health conditions. These complications could affect any organ, but particularly the kidney, heart and lungs. Those with complications had poorer health on discharge from hospital, and some will have long-term consequences. We now have a more detailed understanding of COVID-19 and the risks posed, even to younger otherwise healthy people."

He adds: "Our review highlights some insightful patterns and trends that can inform healthcare systems and policy maker responses to the impacts of COVID-19. Our results can also inform public health messaging on the risk COVID-19 poses to younger otherwise healthy people at a population level, particularly in terms of the importance of vaccination for this group." [1]

Previous research on the impact of COVID-19 on patients has focussed on the numbers of deaths or on outcomes related to one specific organ system or health condition.

The new study assessed in-hospital complications in adults aged 19 years or over with confirmed or highly suspected SARS-CoV-2 infection leading to COVID-19 disease. Data were collected by nurses and medical students, and included the participants' age, sex at birth, health measures when hospitalised, and comorbidities (such as asthma, chronic cardiac disease, chronic haematological disease, chronic kidney disease, chronic neurological disease, chronic pulmonary disease, HIV/AIDS, cancer, liver disease, obesity, rheumatological disorders, and smoking).

In addition, they collected data on the respiratory, neurological, cardiovascular, renal, gastrointestinal and systemic complications participants experienced while in hospital [2]. Complications were assessed at multiple timepoints until discharge or, if the patient was not discharged, 28 days after hospitalisation [3]. The study also investigated the ability of patients to look after themselves when discharged from hospital.

80,388 patients were included in the study, but 7,191 were excluded due to duplicated medical records, as they were not eligible for the study, or because no data was collected on the compilations they experienced while in hospital.

Of the remaining 73,197 patients, 56% were men, 81% had an underlying health condition, 74% were of white ethnicity, and the average age of the cohort was 71 years. Almost one in three participants (32%, 23,092 of 73,197) in the study died.

Overall, complications occurred in 50% of all participants, including in 44% (21,784 of 50,105) of participants who survived.

The most common complications were renal (affecting almost one in four people, 24%, 17,752), respiratory (affecting around one in five people, 18%, 13,486), and systemic (affecting one in six, 16%, 11,895). However, cardiovascular complications were reported in around one in eight participants (12%, 8,973), and neurological (less than one in 20, 4%, 3,115), and gastrointestinal or liver (11%, 7,901) complications were also reported. Specifically, acute kidney injury, probable acute respiratory distress syndrome, liver injury, anaemia, and cardiac arrhythmia were the most common complications.

The incidence of complications rose with increasing age, occurring in 39% (3,596 of 9,249) of 19-49 year olds, compared to 51% (32,771 of 63,948) of people aged 50 and older. Going up the age ranges, 27% of 19-29 year olds hospitalised with COVID-19 developed a complication, 37% of 30-39 year olds, 43% of 40-49 year olds, 49% of 50-59 year olds, 54% of 60-69 year olds, 52% of 70-79 year olds, 51% of 80-89 year olds, and 50% of people aged 90 or over (see Table 1).

Complications were more common in men compared with females, with males aged older than 60 years the most likely group to have at least one complication (women aged under 60 years: 37% [2,814 of 7,689] and men 49% [5,179 of 10,609]; women aged 60 years and over: 48% [11,707 of 24,288] and men 55% [16,579 of 30,416]).

People of white, South Asian, and East Asian ethnicities had similar rates of complications, but rates were highest in Black people (58% [1,433 of 2,480] in Black patients vs 49% [26,431 of 53,780] in white patients - see Table 1).

Following hospitalisation, 27% (13,309 of 50,105) of patients were less able to look after themselves than before COVID-19, and this was more common with older age, being male, and in people who received critical care. The association between having a complication and worse ability for self-care remained irrespective of age, sex, socioeconomic status, and which hospital someone received treatment in. Neurological complications were associated with the biggest impact on ability for self-care.

Based on these rates, the authors say that policymakers and health-care planners should anticipate that large amounts of health and social care resources will be required to support those who survive COVID-19. This includes adequate provision of staffing and equipment - for example, provision of follow-up clinics for those who have sustained in-hospital complications such as acute kidney injury or respiratory tract infection.

Dr Thomas Drake, co-author from the University of Edinburgh, UK, says: "Our research looked at a wide range of complications, and found that short-term damage to several organs is extremely common in those treated in hospital for COVID-19. These complications were common in all age groups, not just in older people or those with pre-existing health conditions. People who have complications will often need expert care and extra help to recover from their initial hospital admission. Our study shows it is important to consider not just death from COVID-19, but other complications as well. This should provide policy makers with data to help them make decisions about tackling the pandemic and planning for the future. We are still studying the participants in our study to understand what the long-term effects of COVID-19 on their health. The results from these ongoing studies will be particularly useful, as we found many people who survive COVID-19 and develop complications are from economically active age groups." [1]

Aya Riad, joint co-author from the University of Edinburgh, UK, says: "It is important that with the high risk of complications and the impact these have on people, that complications of COVID-19, not just death, are considered when making decisions on how best to tackle the pandemic. Just focussing on death from COVID-19 is likely to underestimate the true impact, particularly in younger people who are more likely to survive severe COVID-19." [1]

The authors note that around 85% of participants had a positive SARS-CoV-2 RT-PCR test, and patients who did not have a positive test recorded similar or slightly lower rates of in-hospital complications.

They also note some limitations, including that the data does not provide a long-term picture, and that the timings of complications and patients quality of life were not studied. In addition, the complications in the study were predefined and not specific to COVID-19, so may underestimate some areas as these were added later. In addition, as it was inappropriate to subject patients to numerous tests, patients did not undergo additional tests for complications, and the authors say that the true burden of complications is likely to be higher.

Co-author Professor Jonathan Van Tam "The ISARIC/CO-CIN study was set up at very short notice in March 2020. Ever since it has delivered a steady stream of high-quality data to the UK's SAGE committee and the Department for Health and Social Care on patients hospitalised with SARS-CoV-2 infection. The project has also produced a series of highly important peer-reviewed science papers which have been heavily cited and are of benefit to scientists worldwide. This is another example of how with support from the UK's National Institute for Health Research, the NHS has delivered high quality clinical science studies at pace." [1]

Writing in a linked Comment, Professor Bin Cao, China-Japan Friendship Hospital, China, (who was not involved in the study) says: "The public health effect of post-acute COVID-19 is substantial considering the large number of people infected by SARS-CoV-2 globally.8 In addition to delineating the diverse manifestation across the full clinical spectrum of post-acute COVID-19, the pathophysiological mechanisms attributable to post-acute COVID-19, especially long COVID-19, need to be further elucidated among people with different demographic and clinical characteristics. Furthermore, research on the effects of the serological features, together with immunological aberrations and inflammatory damage resulting from acute SARS-CoV-2 infection, on post-acute or long COVID-19 is needed."

Black and Latinx people intensely sought information on COVID-19 and engaged in public health measures such as mask-wearing and testing due to devastating experiences during the pandemic but are still skeptical about vaccines, according to a Rutgers study.

The findings, which appear in JAMA Network Open, offer insight into what motivates people in Black and Latinx communities - which have been disproportionately affected by the pandemic - to embrace COVID-19 safety precautions but to hesitate about vaccines. The findings may also help to develop appropriate public health messages and strategies.

Researchers interviewed 111 Black and Latinx people from New Jersey low-income counties with high rates of COVID-19 infections and deaths during the initial surge in 2020. They also interviewed health care workers in these communities to understand their views.

"Fear, illness and loss experienced during the pandemic motivated them to intensely seek information and take safety precautions like wearing a mask, social distancing and washing hands to protect themselves and loved ones," said co-author Manuel Jimenez, an assistant professor of pediatrics, family medicine and community health at Rutgers Robert Wood Johnson Medical School. "However, participants did not trust the vaccine development process and wanted clearer information."

The study found that:

Latinx participants, in particular, reported difficulty finding testing sites, transportation issues and language barriers. This was more pronounced for undocumented people who were told to pay for testing if they are ineligible for unemployment benefits and other assistance programs.

Some participants did not feel safe inside or outside their homes, and described uncertainty about who among them had the virus. Crowded living conditions resulted in contact with neighbors and housemates who had COVID-19.

Participants questioned how a vaccine for a new virus could be developed so rapidly when other diseases have been around for decades without successful vaccines. They also expressed concerns that the vaccine development process, including that clinical trials had been "rushed," and worried about the short- and long-term side effects.

They questioned whether vaccines would work against variants and wanted clear and transparent information on vaccine effectiveness. Many wanted to see how others would respond to vaccination first.

Black participants mentioned distrust of health care systems and government, citing experience of racism, discriminatory interventions and medical experimentation.

"We need to reduce logistical barriers and improve access to testing within underserved communities, regardless of documentation status," said co-principal investigator Shawna Hudson, professor and research division chief in the Department of Family Medicine and Community Health at Rutgers Robert Wood Johnson Medical School. "Health care providers should offer convenient testing options, accessible sites within walking distance, translated information and transparency about free testing to address these barriers."

Logistical barriers to testing must be addressed and vaccine skepticism needs to be taken seriously, the report concluded, the researchers said.

"The remaining unknowns about new vaccines need to be acknowledged and described for these communities to make informed decisions," Jimenez said. "Scientists and public officials need to work collaboratively with trusted community leaders and health professionals to provide transparent information, including remaining unknowns, so that these communities can make informed decisions rather than focusing on marketing campaigns to eliminate vaccine hesitancy."

The presence of more than five symptoms of COVID-19 in the first week of infection is significantly associated with the development of long COVID, irrespective of age or gender, according to a new review published by the Journal of the Royal Society of Medicine.

The review by the University of Birmingham-led Therapies for Long COVID (TLC) Study Group, summarises current research on symptom prevalence, complications and management of long COVID. Pooled prevalence data in the review highlights the ten most common symptoms of long COVID. These are fatigue, shortness of breath, muscle pain, cough, headache, joint pain, chest pain, altered smell, diarrhoea and altered taste.

The researchers identified two main symptom clusters of long COVID: those comprising exclusively of fatigue, headache and upper respiratory complaints; and those with multi-system complaints including ongoing fever and gastroenterological symptoms.

Lead author Dr Olalekan Lee Aiyegbusi, Deputy Director at the University of Birmingham's Centre for Patient Reported Outcomes Research (CPROR), said: "There is evidence that the impact of acute COVID-19 on patients, regardless of severity, extends beyond hospitalisation in the most severe cases, to ongoing impaired quality of life, mental health and employment issues. People living with long COVID generally feel abandoned and dismissed by healthcare providers and receive limited or conflicting advice. More than one-third of the patients in one of the studies included in the review reported they still felt ill or in a worse clinical condition at eight weeks than at the onset of COVID-19."

Dr Shamil Haroon, Clinical Lecturer in Primary Care and co-Principal Investigator of the University of Birmingham NIHR/UKRI funded TLC Study, further commented: "Neither the biological or immunological mechanisms of long COVID, nor the rationale for why certain people are more susceptible to these effects, are yet clear, limiting development of therapies. It is essential we act quickly to address these issues."

In a comparison with other coronaviruses, the researchers suggest that in the longer term, patients with long COVID may also experience a similar disease trajectory to that of patients who had SARS or MERS, pointing to analysis showing that six months after hospital discharge, approximately 25% of patients hospitalised with SARS and MERS had reduced lung function and exercise capacity.

TLC Study's Co-Principal Investigator Melanie Calvert, Professor of Outcomes Methodology at the University of Birmingham and NIHR Senior Investigator, said: "The wide range of potential symptoms and complications patients with long COVID may experience highlights the need for a deeper understanding of the clinical course of the condition. There is an urgent need for better, more integrated care models to support and manage patients with long COVID to improve clinical outcomes."

New research presented at The Physiological Society's Annual Conference Physiology 2021 shows that molecules released into the bloodstream during exercise (such as small proteins) can act directly on bowel cancer cells to slow down their growth.

Previous research has shown that regular physical activity reduces the risk of developing bowel cancer. This is mainly thought to happen because physical activity can help individuals to maintain a healthy body weight.

This new research shows that being physically active may reduce the risk of getting bowel cancer, even if the physical activity does not lead to weight loss.

These are preliminary findings, but having a better understanding of the mechanisms linking physical activity and cancer risk will help develop the most effective exercise programmes for preventing cancer development.

It could also help develop drugs that can mimic some of the benefits of exercise.

Furthermore, this research could ultimately lead to exercise being part of standard care as part of bowel cancer screening programmes, which could reduce the number of people who develop cancer. ?

The study was done on 16 male participants who had lifestyle risk factors for bowel cancer (all participants were 50 years or older, had overweight or obesity, and did not regularly exercise).

The researchers collected blood samples from participants before and after 45 minutes of 'moderate' intensity indoor cycling, and before and after a non-exercise 'control' experiment.

They assessed whether exercise altered the concentration of specific proteins in the blood.

Finally, they then added the liquid portion of each blood sample that contains the proteins (known as serum) to bowel cancer cells in a laboratory and monitored cancer cell growth over 48 hours.

The main limitation of this research is that the cancer cells were grown in a dish under tightly-controlled laboratory conditions. Cancer tumours in humans are more complex and interact with the environment around them, such as surrounding blood vessels and immune cells. This means that the findings may not necessarily apply to real-life cancer tumours - this is something the researchers will investigate in the future.

Dr Sam Orange, the presenter and lead author of this research said: Following on from this research, we want to understand a few more things, including which specific molecules in the blood are responsible for reducing the growth of the bowel cancer cells, and whether exercise performed at a high-intensity has a more pronounced effect on bowel cancer cell growth than exercise performed at a moderate-intensity.

Patients with advanced chronic kidney disease (CKD) typically suffer from impaired bone quality and quantity, with a non-vertebral fracture risk which is 4-to 6-fold higher than the fracture risk of matched controls. However, despite their high risk of fragility fractures, the vast majority of patients with chronic CKD stages 4 to 5D, are not receiving osteoporosis therapy.

A newly published review by the International Osteoporosis Foundation (IOF) and European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) CKD-MBD working group now provides concise recommendations, with a clear management algorithm, to support clinicians' knowledge and confidence in managing osteoporosis in their patients1. The review summarises the recent 'European Consensus Statement on the Diagnosis and Management of Osteoporosis in Chronic CKD Stages G4-G5D'2. It outlines essential information on the diagnosis of osteoporosis; risk factors for fragility fractures; assessment of fracture risk; intervention thresholds for pharmacological intervention; non-pharmacological and pharmacological intervention; monitoring; and systems of care. The review also points to key research questions and future perspectives, and recommends that fracture liaison services integrate systematic identification and management of CKD patients with fragility fractures, in close collaboration with nephrologists as part of the multidisciplinary team.

Lead author, Dr Pieter Evenepoel, Department of Nephrology of the University Hospitals Leuven, Leuven, Belgium stated:

"Clinicians treating chronic kidney disease patients are often unsure about how to optimally manage bone health, resulting in inaction and a 'wait and see' approach in regard to preventative osteoporosis care. Now that recent studies suggest a similar efficacy of common osteoporosis drugs in patients with CKD stages G4-G5D as in the general patient population, it is time to foster a paradigm shift with regard to osteoporosis care in these patients. We hope that this succinct new review will serve to boost physicians' knowledge and confidence in managing osteoporosis in their patients."

Professor Serge Ferrari, co-author and Vice-Chair of the IOF Committee of Scientific Advisors, added:

"The number of people with advanced chronic kidney disease (CKD) and undergoing maintenance dialysis is rapidly increasing around the world. We expect that these pragmatic recommendations, which result from a successful collaboration between European societies, will help to stimulate a proactive and cohesive approach to the management of osteoporosis in this growing subset of patients at high risk of debilitating fragility fractures."

A new study by the University of Malta and Staffordshire University highlights an urgent need for change in the curriculum and demonstrates how introducing longer, more frequent and more physically intense PE lessons can significantly improve children's weight and overall health.

Malta currently has one of the highest rates of obesity worldwide with 40% of primary and 42.6% of secondary school children being overweight or obese.

The World Health Organization (WHO) recommends that children engage in at least 60 minutes of age-appropriate moderate-to-vigorous physical activity (MVPA) daily, however Maltese children are among the lowest to achieve this.

Dr Alfred Gatt, Associate Professor at the University of Malta said: "Widespread obesity in Malta has physical, psychological and social implications, as well as crippling health costs for Malta of around 70 million euros each year for the treatment of complications of obesity. Childhood intervention is crucial, and we believe the school environment to be the best outreach system."

Dr Amanda Fenech, a paediatric doctor at Mater Dei Hospital, who led the study said, "Currently Malta has both an insufficient number of PE lessons - with only 31 hours in secondary schools annually compared to 108 hours in France - and low activity rates during those lessons. Our study investigates whether adopting an alternative, evidence-based PE education program alongside biomechanical testing could be used as a cost-effective way to address this."

120 children aged 9 to 10, attending state primary schools, participated in the study over one school year. While a control group was taught the national PE curriculum, an intervention group took part in the Sports, Play and Active Recreation for Kids (SPARK) PE education program, which is specifically designed to achieve the recommended 50% of MPVA per PE lesson.

The impact of increased MPVA on BMI, waist circumference, and resting heart rate were measured alongside biomechanical tests to assess vertical jump height and postural stability.

Vertical jumps executed on a force platform measured sports performance by evaluating the explosive strength of the lower limbs, while the postural stability tests looked at gait pattern and balance which are often affected by being overweight.

Professor Nachi Chockalingam, from Staffordshire University's Centre for Biomechanics and Rehabilitation Technologies, explained: "The concept of biomechanical fitness testing is still relatively new and mainly performed by elite athletes. However, it is important to understand that biomechanical tests can also be used as educational tools for youths. Additionally, biomechanical assessments can objectively pinpoint those students who have the potential to become gifted athletes, as well as identify those students who might have structural or positional problems with their body and can therefore be picked up early in life and managed accordingly."

Over a period of eight months, the intervention group reported improvements in BMI, resting heart rate, jump height and balance parameters while overweight and obesity prevalence decreased by 15.7% compared to 3.2% in the control group.

Although the waist circumference increased in both groups, which is expected in a population of growing children, the prevalence of children with a waist circumference above the 90th centile decreased by 6.6% in the intervention group and increased by 6.8% in the control group.

Professor Chockalingam added: "These results prove that inexpensive methods can be adopted to raise the proportion of physical activity during PE lessons, leading to significant health benefits. The study also demonstrates the potential application of biomechanical tests, currently only used in professional athletes, as objective tools to assess children's fitness in schools."

Dr Cynthia Formosa, Associate Professor and Head of Podiatry at the University of Malta said: "Going forward, we hope that these findings can be used to integrate an evidence-based PE curriculum as a public health initiative against childhood obesity in Malta."

In a new study from University of California San Diego School of Medicine, researchers have confirmed that patients taking statin medications had a 41 percent lower risk of in-hospital death from COVID-19. The findings were published July 15, 2021 in PLOS ONE and expand upon prior research conducted at UC San Diego Health in 2020.

Statins are commonly used to reduce blood cholesterol levels by blocking liver enzymes responsible for making cholesterol. They are widely prescribed: The Centers for Disease Control estimates that 93 percent of patients who use a cholesterol-lowering drug use a statin.

"When faced with this virus at the beginning of the pandemic, there was a lot of speculation surrounding certain medications that affect the body's ACE2 receptor, including statins, and whether they may influence COVID-19 risk," said Lori Daniels, MD, lead study author, professor and director of the Cardiovascular Intensive Care Unit at UC San Diego Health.

"At the time, we thought that statins may inhibit SARS-CoV-2 infection through their known anti-inflammatory effects and binding capabilities, which could potentially stop progression of the virus."

Using data from the American Heart Association's COVID-19 Cardiovascular Disease Registry, the research team at UC San Diego applied their original findings to a much larger cohort: more than 10,000 hospitalized COVID-19 patients across the United States.

Specifically, researchers analyzed anonymized medical records of 10,541 patients admitted for COVID-19 over a nine-month period, January through September 2020, at 104 different hospitals.

"From this data, we performed more advanced analyses as we attempted to control for coexisting medical conditions, socioeconomic status and hospital factors," said Daniels. "In doing so, we confirmed our prior findings that statins are associated with a reduced risk of death from COVID-19 among patients hospitalized for COVID-19."

Daniels said it appears most of the benefit is among patients with good medical reasons to be taking statins, such as a history of cardiovascular disease or high blood pressure. According to the research team, the use of statins or an anti-hypertension medication was associated with a 32 percent lower risk of death among COVID-19 inpatients with a history of cardiovascular disease or hypertension.

In the study, statistical matching techniques were used to compare outcomes for patients who used statins or an anti-hypertension medication with similar patients who did not.

"We matched each patient to one or more similar patients, using hospital site, month of admission, age, race, ethnicity, gender, and a list of pre-existing conditions, in order to make the two groups as comparable as possible" said Karen Messer, PhD, study co-author and professor of biostatistics at UC San Diego School of Medicine.

The ACE2 receptor -- the regulatory target of statins -- helps control blood pressure. In 2020, it was discovered that SARS-CoV-2 virus primarily uses the same receptor to enter lung cells.

According to researchers, statins and anti-hypertension medications stabilize the underlying diseases for which they are prescribed, making patients more likely to recover from COVID-19.

"As with any observational study, we cannot say for certain that the associations we describe between statin use and reduced severity of COVID-19 infection are definitely due to the statins themselves; however, we can now say with very strong evidence that they may play a role in substantially lowering a patient's risk of death from COVID-19," said Daniels. "We hope that our research findings are an incentive for patients to continue with their medication."

The initial study included 170 anonymized medical records from patients receiving care at UC San Diego Health. Researchers found that statin use prior to hospital admission for COVID-19 resulted in a more than 50 percent reduction in risk of developing severe infection.

The American Heart Association's COVID-19 Cardiovascular Disease Registry contains de-identified health data on patients treated for COVID-19 at more than 140 participating hospitals across the country. As of July 2021, data from more than 49,000 patient records had been contributed into the platform.

Increases in maternal opioid use have led to an almost doubling in the number of babies born with neonatal abstinence syndrome (NAS) in the U.S. in the past 10 years. This statistic led the Centers for Disease Control and Prevention and American Academy of Pediatrics to call for stepped-up efforts to reduce opioid use during pregnancy, such as ensuring access to contraception to prevent unintended pregnancies among women who use opioids. More than 75% of women with Opioid Use Disorder (OUD) report having had an unintended pregnancy, but they are less likely to use effective contraception compared to women who do not use drugs. Results from a multi-year trial found that a two-part intervention featuring co-located contraceptive services in opioid treatment programs and financial incentives could offer an effective solution.

The results of this National Institutes of Health-funded study were published as a JAMA Psychiatry Online First article July 14.

The trial, led by Sarah Heil, Ph.D., professor of psychiatry at the Vermont Center on Behavior and Health at the University of Vermont's Larner College of Medicine, tested a novel two-component intervention informed by behavioral economics--combining contraceptive services co-located with an opioid treatment program with financial incentives for attending follow-up visits. The goal of the study was to determine whether co-locating services could effectively remove barriers to initiating contraceptive use (defined as pills, patch, ring, injection, intrauterine device/IUD, and implant), as well as examine the benefits of adding incentives to help ease the burden associated with coming to follow-up visits. Incentives were earned solely for attending follow-up visits and were not dependent on contraceptive use.

"Women with OUD have the same right to decide whether and when to have children as other women, but their persistently high rate of unintended pregnancy suggests that the way contraceptive services are provided does not work for most of them," said Heil.

A total of 138 women aged 20-44 who were receiving medication for OUD and were at high risk for unintended pregnancy were enrolled between 2015 and 2018. Participants were randomly assigned to one of three conditions: usual care, contraceptive services, or contraceptive services plus financial incentives. The trial's results showed graded increases in verified prescription contraceptive use at the end of the six-month intervention period (usual care was 10.4%; contraceptive services was 29.2%; and contraceptive plus incentives was 54.8%) and was sustained through the 12-month final assessment, which showed contraceptive adherence at 6.3% with usual care vs. 25% with co-located contraceptive services vs. 42.9% with co-located contraceptive services plus incentives. These numbers also coincided with a graded decrease in unintended pregnancy rates across the 12-month trial (usual care at 22.2% vs. contraceptive services at 16.7% vs. contraceptive services plus incentives at 4.9%). Further, an economic analysis found that each dollar invested yielded a societal cost-benefit of $5.59 for contraceptive services vs. usual care, $6.14 for contraceptive services plus incentives vs. usual care, and $6.96 for contraceptive services vs. contraceptive services plus incentives.

"For women with OUD who do not want to become pregnant, the two interventions we tested provide contraceptive services that better meet their needs and do so in a cost-beneficial way," said Heil.

While both interventions yielded benefits, the combination of onsite contraceptive services and financial incentives was the more efficacious and cost-beneficial intervention. These results provide promising solutions to help increase access to prescription contraception to prevent unintended pregnancies among women who use opioids.

University of Otago scientists have opened the door to improved treatment of brain dysfunction which causes psychosis.

Dr Ryan Ward, of the Department of Psychology, says he and a team of researchers have been working on ways to model schizophrenia symptoms in animal models.

"Psychosis is a debilitating aspect of schizophrenia and, while current drugs treat it well, they have horrendous side effects which lead to poor quality of life for patients. Research which can identify specific mechanisms of the dysfunction can provide more precise drug targets for treatment, improving patient outcomes and quality of life.
"We have been particularly interested in modelling symptoms which have historically been difficult. One that is particularly difficult to model in non-humans is psychosis, because of the challenge of assessing subjective internal state.

"We have recently broken new ground, thanks to the Masters thesis work of Wayne Meighan, by combining a rat model of schizophrenia risk with a procedure which allows a very sensitive screening for subjective internal state," he says.

In a study published in the Journal of Psychopharmacology, researchers measured the ability of rats which model a risk factor for schizophrenia to tell the difference between a drug (ketamine) and saline.

Dr Ward says the critical aspect is that the dose of ketamine used causes schizophrenia-like psychosis in humans.

"We found that our model was impaired at discriminating the drug from saline only at doses that cause psychosis in humans. We believe this means that the subjective internal state of these models is similar to the state induced in human psychosis.

"This opens up a way to model in non-humans symptoms that were previously thought to be only measurable in humans, such as psychosis. The finding may greatly enhance our ability to pinpoint brain mechanisms of these symptoms and lead to more effective treatments," he says.

Dr Ward says figuring out how to model psychiatric disease is often about being able to ask the question in the right way.

"In our case, we demonstrated that it is possible to ask an animal how it 'feels' in a rigorous way.

"These types of studies open the door for further work in which we may be able to identify specific brain dysfunction that produces psychosis, improving future treatments."

Statins are associated with a small increased risk of side effects in patients without a history of heart disease, but these effects are mild compared with the potential benefits of treatment in preventing major cardiovascular events, say researchers in The BMJ today.

They say their findings suggest that the benefit-to-harm balance of statins for adults without heart disease is generally favourable.

Statins are widely used to prevent heart disease, and severe side effects are rare, but many people are reluctant to take them because of the potential for milder effects such as muscle weakness and stiffness.

For people with existing heart disease, the benefits of statins far outweigh the risk of these effects, but when statins are used by people without a history of heart disease (known as primary prevention) the benefit-to-harm balance of treatment might be less favourable.

Yet recent guidelines have recommended wider use of statins for primary prevention.

So, a team of UK and US researchers set out to examine the associations between statins and adverse events in adults without a history of heart disease, and how they vary by type and dose of statins.

They analysed the results of 62 randomised controlled trials with 120,456 participants (average age 61; 40% women) followed up for an average of 3.9 years. The trials were designed differently, and were of varying quality, but the researchers were able to allow for that in their analysis.

Statins were associated with a slightly increased risk of self-reported muscle pain, liver and kidney problems, and certain eye conditions such as cataracts, but were not associated with clinically confirmed muscle disorders or diabetes.

These risks equated to 15 more instances of muscle symptoms, eight more liver events, 12 more kidney events, and 14 more eye conditions per 10,000 patients treated for a year.

However, these increased risks did not outweigh the reduction in the risk of major cardiovascular events. For example, statins were estimated to prevent 19 heart attacks, nine strokes, and eight deaths from cardiovascular disease per 10,000 patients treated for a year.

This suggests that the benefit-to-harm balance of statins for primary prevention of cardiovascular disease is favourable, say the researchers.

Analyses by type of statin showed that atorvastatin, lovastatin, and rosuvastatin were associated with some adverse events, but few significant differences were seen between the statins.

A possible modest dose-response relationship was identified for the effect of atorvastatin on liver dysfunction, but the dose-response relationships for the other types of statins and adverse effects were inconclusive.

This suggests that tailoring statin doses to deal with safety concerns when starting treatment is not currently needed, the researchers add.

This was a large study that was able to accurately assess the adverse effects of treatment with statins. But the researchers point to some limitations in trial design that may have led to events being underestimated or more severe long term events being missed.

However, they say the low risk of adverse events caused by statins reported in this review "should reassure patients and physicians that the potential harms of statins are small and should not deter their use for primary prevention of cardiovascular disease."

They agree that routine monitoring of liver function during treatment is probably warranted in primary prevention, and say further studies are needed to help improve adherence to treatment and achieve more efficient monitoring.

Ultra-processed food linked to higher risk of IBD

Further studies needed to identify contributory factors in processed foods that might account for these associations

A higher intake of ultra-processed food is associated with higher risk of inflammatory bowel disease (IBD), finds a study published by The BMJ today.

Ultra-processed foods include packaged baked goods and snacks, fizzy drinks, sugary cereals, ready meals containing food additives, and reconstituted meat and fish products - often containing high levels of added sugar, fat and salt, but lacking in vitamins and fibre.

Inflammatory bowel disease (IBD) is more common in industrialised nations and it is thought that dietary factors might play a role, but data linking ultra-processed food intake with IBD are limited.

To explore this further, an international team of researchers drew on detailed dietary information from 116,087 adults aged 35-70 years living in 21 low, middle, and high income countries who were taking part in the Prospective Urban Rural Epidemiology (PURE) study.

PURE is examining the impact of societal influences on chronic diseases in different countries around the world.

Participants were enrolled in the study between 2003 and 2016 and were assessed at least every three years. Over an average follow-up of 9.7 years, new diagnoses of IBD, including Crohn's disease or ulcerative colitis, were recorded.

During this time, 467 participants developed IBD (90 with Crohn's disease and 377 with ulcerative colitis).

After taking account of other potentially influential factors, the researchers found that higher intake of ultra-processed food was associated with a higher risk of IBD.

For example, compared with less than one serving of ultra-processed food per day, they found an 82% increased risk of IBD among those who consumed five or more servings per day, and a 67% increased risk for 1-4 servings per day.

Different subgroups of ultra-processed food, including soft drinks, refined sweetened foods, salty snacks, and processed meat, each were associated with higher risks of IBD.

In contrast, intakes of white meat, red meat, dairy, starch, and fruit, vegetables, and legumes (such as peas, beans and lentils) were not associated with IBD.

Results were consistent for Crohn's disease and ulcerative colitis, and were similar after further analysis to test the risk of developing IBD based on age and region, suggesting that the findings are robust.

This is an observational study so can't establish causality. What's more, results relied on self-reported diagnoses and did not account for dietary changes over time. And the researchers cannot rule out the possibility that other unmeasured (confounding) factors may have affected their results.

Nevertheless, they say their findings "support the hypothesis that intake of ultra-processed foods could be an environmental factor that increases the risk of IBD."

As white meat, unprocessed red meat, dairy, starch, and fruit, vegetables, and legumes were not found to be associated with development of IBD, this study suggests that it might not be the food itself that confers this risk but rather the way the food is processed or ultra-processed, they explain.

"Further studies are needed to identify specific potential contributory factors among processed foods that might be responsible for the observed associations in our study," they conclude.

What The Study Did: The COVID-19 pandemic was associated with a decline in addiction treatment initiations but more research is needed to understand the cause of the decline in initiations and the extent to which it was due to reduced demand for services or reduced ability to supply treatment.

Authors: Tami L. Mark, Ph.D., M.B.A., of RTI International in Rockville, Maryland, is the corresponding author.

To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/

(doi:10.1001/jamanetworkopen.2021.17029)

Editor's Note: The article includes funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

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The COVID-19 pandemic has amplified calls to end the detention of migrant children, as cases surge among children held in crowded conditions; yet immigration detention's threats to children's fundamental rights did not begin with the current public health crisis.

Unlike nearly three-quarters of high-income countries, however, the U.S. has no laws specifically limiting the detention of accompanied migrant and asylum-seeking children, according to a new study by the UCLA Fielding School of Public Health's WORLD Policy Analysis Center (WORLD). Moreover, the U.S. offers minimal legal protection for unaccompanied minors, and for children who are detained, the U.S. has no legal guarantees of access to adequate healthcare or education.

"The U.S. lags behind when it comes to protecting the most fundamental rights of migrant children," said Dr. Jody Heymann, a UCLA distinguished professor of public health, public policy, and medicine who serves as director of WORLD. "The child detention crisis did not begin or resolve with a single administration, and these longstanding gaps in the law have left countless children vulnerable to grave health risks and human rights violations. Adopting legal protections that provide for the types of effective alternatives to detention modeled elsewhere is critical to bringing the U.S. in line with its peers and ensuring children can no longer be detained or denied access to health and education simply because of their migration status."

Heymann is lead author of a study - "Preventing Immigration Detention of Children: a Comparative Study of Laws in 150 Countries" - published in the July edition of the peer-reviewed International Journal of Human Rights; it is currently available electronically. Her team systematically coded legal restrictions on detention of child migrants in the 150 most populous United Nations-member countries, as well literature on the cost/benefits of varying approaches to keeping such children safe and under responsible oversight.

Overall, the research team found that while the U.S. falls behind other high-income nations, gaps persist globally: looking across low-, middle-, and high-income countries, less than a quarter legally protect unaccompanied asylum-seekers from detention and only 11% do so for accompanied minor migrants.

"International treaties are clear that detaining children based on citizenship is a violation of human rights law," said Aleta Sprague, a senior legal analyst at WORLD. "The U.N. Convention on the Rights of the Child--signed by the U.S. and ratified by every other country globally--guarantees all children's rights to health, education, liberty, and family unity, and national legislation prohibiting child detention plays a critical role in realizing these commitments."

Researchers have consistently found that the detention of migrant and asylum-seeking children is commonly associated with anxiety, depression, and posttraumatic stress disorder (PTSD), among other conditions; all of these can have both mental and physical tolls on children's life expectancy.

"The lack of adequate legal protections for migrant children's access to health and education is a global issue," said Amy Raub, a research analyst at WORLD. "While detention on its own has grave implications for health, conditions of detention routinely exacerbate these health risks while threatening migrant children's other fundamental rights."

Among countries that permit detention in at least some circumstances, only a minority address basic rights such as separation from adult strangers, family unity, access to education, and access to health care. The U.S. is not among the 34% of high-income countries that guarantee access to education or the 44% of high-income countries that guarantee access to health care for detained accompanied minor migrants.

These outcomes are avoidable: effective and human rights-respecting alternatives to detention (ATDs) exist, and widespread evidence from both government and non-government organizations (NGOs) supports their adoption, researchers said.

For example, in Germany, Canada, and the U.S. (in pilots), ATDs that provided case management and community-based living have demonstrated 95%-98% compliance including with immigration interviews and court appearances. There are also financial savings - a short-lived social services-based ATD in the U.S., the Family Case Management Program, cost just $38.47 per participant per day compared to $318.79 per detainee, while reporting a 99% compliance rate.

"Not only can ATDs eliminate detention's grave health risks to children and their parents, but they can also dramatically lower government costs," Heymann said. "This is good public policy in terms of effectiveness and cost efficiency ... and it is also simple human decency."

Methods: To assess the quality of legislative protections for migrant and asylum-seeking children from detention, researchers created quantitatively comparable data on legal provisions across the 150 most populous U.N. member states. Primary sources for national-level laws, regulations, ministerial decisions, and executive decrees pertaining to asylum-seekers, refugees, and immigration were the United Nations High Commissioner for Refugees' (UNHCR) RefWorld catalog and ILO NATLEX legislative database. The team captured legislative provisions that were in effect as of July 31, 2018.

GALVESTON, TEXAS - A new study published in Science Translational Medicine reports on the Ebola vaccine-mediated protection of five mucosal vaccine vectors based on the human and avian paramyxoviruses. The study comprehensively characterized the antibody response to each vaccine, identifying features and functions that were elevated in survivors and that could serve as vaccine correlates of protection.

The multi-year study, led by Alexander Bukreyev, PhD, of the University of Texas Medical Branch (UTMB) Galveston National Laboratory looked at whether all the vaccines conferred protection and produced robust antibody responses. The team also explored 139 different immune and vaccine response parameters to see which ones were responsible for improving the "quality of survival."

"Testing during outbreaks is difficult because of their sporadic nature, and yet much needs to be studied in order to determine the most effective vaccine for combatting this disease. Establishing the signatures of vaccine-generated immunity remains crucial for vaccine design, assessment and application," said Bukreyev.

Research Scientist Michelle Meyer, PhD, of UTMB served as lead author of the paper, Ebola vaccine-induced protection in non-human primates correlates with antibody specificity and Fc-mediated effects, which reports the efficacy results of the vaccines in cynomolgus macaques challenged with EBOV. The five mucosal vaccines tested differed in the degree of protection against death and disease, ranging from disease-free survival to only partial protection.

Meyer notes vaccines need to do more than allow for survival, with an ideal result being to arrest virus replication and abate disease. To evaluate antibody features that are relevant and potentially predictive of protection, the team employed a survival index in the analysis which incorporated several parameters of EBOV disease to allow for correlations with improved infection outcomes.

"Through in-depth characterization of the antibody response, we found that even though all vaccines express the same antigen, they differed in multiple aspects, with the correlates of protection appearing to be unique to the vaccine platform. Our analysis defined RBD-specific antibodies and Fc-mediated immune functions as contributing factors to improved survival," said Meyer. The lack of correlation with neutralizing antibody titers suggests that the conventional means of predicting efficacy does not apply to all vaccines.

During the most recent ebola outbreaks in Sierra Leone and the Democratic Republic of Congo, more than 300,000 people were vaccinated. Deciphering the immune responses to vaccination that correlate with protection is imperative to predict efficacy of vaccines in humans, says Meyer.