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Amsterdam, July 13, 2021 - Cerebral palsy (CP) is one of the most common developmental movement disorders in children. It is associated with complex healthcare needs and impacts development and function. In this special issue of the Journal of Pediatric Rehabilitation Medicine: An Interdisciplinary Approach Throughout the Lifespan (JPRM), experts review disparities of care and limitations of access and provide practical recommendations and insights to help resolve these issues.

"Healthcare disparity and opportunity inequities are a reality and exist for many children and adults with CP," explained Guest Editors Deborah Gaebler-Spira, MD, Feinberg Northwestern University School of Medicine and Shirley Ryan Ability Lab/Lurie Children's Hospital, Chicago, IL; and Michael M. Green, DO, Clinical Pediatric Rehabilitation Medicine Attending at Primary Children's Hospital, University of Utah Health, Salt Lake City, UT. "Their challenges are our challenges as we strive for optimizing enablement, functioning, and participation for the whole population. This issue provides some ideas and insights into the problem to motivate all caregivers to be better allies, advocates, and partners with our families."

"There are significant health and social disparities in the care of people with CP," said Dr. Gaebler-Spira. "An important focus of this issue is on ways to recognize and react to challenges of healthcare disparity, embedded racism, and the continued problems of exclusion of disadvantaged populations.

"Another theme is maximizing equity through education and use of learning health systems to improve healthcare for children, adolescents, and adults with CP," added Dr. Green. "Finding the most current and relevant resources is critical to shared decision making. There are regional and practitioner differences in how we manage children with CP, and we can all learn from each other to optimize outcomes."

Recognizing health disparities among children with CP is necessary for understanding potential risk factors for CP and for implementing early and effective preventative and intervention treatments," wrote Michael E. Msall, MD, University of Chicago Comer Children's Hospital, Section of Developmental and Behavioral Pediatrics, Chicago, IL, and colleagues, noting that there is currently little and conflicting evidence about impact of factors such as socioeconomic status for children in the US.

"We need a greater understanding of population groups at increased risk, comprehensive assessment and care for young children with motor delays, and systematic population counts of children and adults with CP using registries and systems of neurodevelopmental surveillance across health, education, and community rehabilitation," commented Dr. Msall. "These efforts also require sensitivity to structural and persistent racism, stigma, trauma-informed care, and culturally sensitive community engagement."

In the first of two "Needle Tips" articles, Matthew McLaughlin, MD, University of Missouri Kansas City, Kansas City, MO, and Didem Inanoglu, MD, University of Texas Southwestern Medical Center, Dallas, TX, review decreased clinical response to therapy in pediatric patients with CP, emphasizing a precision medicine perspective in the context of current rehabilitation practice. They discuss treatment options in a thorough and detailed discussion of a young boy who was reviewed at seven and eight years old and whose family reported that botulinum toxin injections did not last as long as previously.

"A significant challenge in treating pediatric patients with CP is ensuring we are optimizing the right dose of the right medication at the right time for the right patient," noted Dr. McLaughlin. "Future research needs to focus on better longer-term strategies to successfully prevent worsening of gait and function in this group of children," added. Dr Inanoglu.

In the second "Needle Tips" article, Edward Wright, MD, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, and Lauren Fetsko, DO, Baylor College of Medicine, reviewed the litigation that has occurred following Botulinum Toxin Type A injections for pediatric spasticity. They encourage practitioners to be aware of potential liability pitfalls and offer suggestions for content sharing during the consent process to keep patients informed about potential adverse events. "If a serious adverse event occurs, clear documentation of information sharing and informed consent, as well as the provider-patient relationship, are critical to minimizing litigation risks," they advised.

Other topics covered in this issue include:

Experiences with sexual and reproductive health
education and services in women with CP

Health literacy and shared decision making

Studies on balance games, foot and ankle
somatosensory deficits, and hip surgery and radiology
reporting for children with CP

Family needs of children with CP

Mentoring adolescents with physical disabilities
attending a therapeutic camp

Building a learning health network

A review of the American TV sitcom centered on the DiMeo family, whose oldest teen has CP and uses a power wheelchair and communication board, concludes the issue. "'Speechless' gives us hope that attitudes are changing!" commented Dr. Gaebler-Spira.

"Looking forward, one of the challenges we face is regional limitations and unwillingness to break out of the status quo mindset," concluded the Guest Editors. "This past year upended so much of our in-person contact at work and in meetings along with affecting time with family. However, we see the emergence of many virtual communities forming to support professional education, research, clinical care, and stakeholder engagement. Now as we round the corner of isolation to vaccination against COVID-19, there is light at the end of the tunnel. This is an era of cooperation and collaboration!"

"Dr. Gaebler and Dr. Green have continued to brilliantly expand the yearly special cerebral palsy issue and develop its depth and relevance to our present-day practice by addressing community and global concerns. Health literacy impacts everyone and is readily apparent in our worldwide interventions for those with CP and other health conditions including the handling of the COVID-19 pandemic," stated Editor-in-Chief of JPRM Elaine L. Pico, MD, UCSF Benioff Children's Hospital Oakland, CA. She noted that because JPRM provides an interdisciplinary approach throughout the lifespan, as evidenced by its new subtitle, the article on sexual and reproductive health in women with CP is particularly timely.

CP occurs in about 1.5 to more than 4 per 1,000 live births, and individuals with CP benefit from ongoing rehabilitation throughout childhood and into adulthood. The symptoms of CP vary over the lifespan. Commonly the first symptoms are gross motor delay due to abnormal muscle tone and decreased motor control and coordination. As children age, their muscles can become stiff and weak with subsequent orthopedic problems. Other systems affected may include vision, hearing, swallowing, speaking, bowel and bladder, and sensation. Although there is no cure, management and treatments such as medications and surgery can ameliorate complications and assist people with CP to live a full life.

YorkU pain research finds what you say in the first minute after a vaccine can be key in reducing a child's future distress

New study finds it's not just what say, but when you say it that can keep preschoolers calmer during vaccinations

TORONTO, July 13, 2021 - As we look forward to a fall with hopefully one of the most important vaccination uptakes of children in a generation, a new study provides insights to help parents with reducing post-vaccination distress in younger kids. The study, published in PAIN, looked at preschool children who were at least four-to-five years old and what their parents said that could help reduce distress during their vaccination. This study is part of the largest study in the world looking at caregivers and children during vaccinations from birth to the age of five -- coined the OUCH Cohort. The OUCH Cohort originally followed 760 caregiver-child dyads from three pediatric clinics in the Greater Toronto Area and were observed during vaccinations during the first five years of a child's life.

"What we found is that in the first minute after the needle, the more parents said coping-promoting statements, such as 'you can do this' and 'it will be over soon' or tried to distract them with talking about something else, the higher distressed the children were. This really surprised us," said Rebecca Pillai Riddell, senior author, professor in the department of psychology, Faculty of Health and Director at the OUCH Lab at York University. "We found however, during the second minute after the vaccine, when the child was calmer, these same coping promoting statements resulted in them calming down faster. On the other hand, distress-promoting statements, such as criticizing the child, or reassuring them they were fine, had no relationship with child distress in minute-one but and in minute-two, the distress-promoting comments were strongly predictive of higher distress in kids. We also showed with preschoolers that the more distressed they were prior to the needle, the more distressed they were after the needle -- like a domino effect of previous pain."

"Previous research has shown that the vast majority of preschoolers calm down within two minutes after a vaccination, however, about 25 per cent of children did not. We wanted to determine what parents were saying before or during the vaccination appointment that could be leading to these children feeling distressed during and after a vaccination," said Ilana Shiff, first author and master's student in Pillai Riddell's lab.

Based on their findings, the researchers recommend that in first minute after a vaccine parents should not start encouraging coping right away, but rather keep them calm by using physical strategies such as hugging, cuddling or hand-holding. This should be done instead of trying to give a child verbal direction on how to cope when they are in peak distress. Once children get over that initial minute of high distress, Pillai Riddell says, they think children are more able to get benefit from parents' coping-promoting statements. The findings also provide insight for health-care providers and caregivers on how to support children during immunization appointments.

Researchers say because preschool children show the prior pain 'domino-effect,' it is critical for health-care providers to try to vaccinate calm preschoolers. Routinely adopting techniques that allow the child to be approached without distressing them prior to the needle (e.g., allowing a child to stay close to their caregiver while viewing a video on a smartphone as a distraction) will help minimize the pain 'domino effect' these findings suggest. Moreover, for both groups, supporting caregivers to avoid distress-promoting behaviours before and during the vaccination will be critical.

"This type of data has never been found in preschoolers before. It's important to understand post-needle reactions at this age because needle phobia and phobias in general start coming on at five to 10 years of age, so understanding how children can be coached and how parents can have a really powerful role in reducing stress post a vaccination is key," said Pillai Riddell.

Google searches related to infertility and coronavirus (COVID-19) vaccines increased by 34,900% after a pair of physicians submitted a petition questioning the safety and efficacy data of the COVID-19 Pfizer vaccine. Referencing the petition, anti-vaccine activists circulated claims that misconstrued the information regarding the possibility that the vaccine could impact fertility in women.

The inaccurately represented information spread rapidly on social media channels, potentially influencing public perception and decision-making among pregnant patients or those seeking to become pregnant, according to research published in the Journal of Osteopathic Medicine. This happened despite the fact that the European Medicines Agency (EMA) and the US Food and Drug Administration issued emergency use authorization for the vaccine, deeming the concerns in the petition insignificant.

"Misinformation is a significant threat to healthcare today and a main driver of vaccine hesitancy," said Nicholas Sajjadi, a study researcher and third-year osteopathic medical student at Oklahoma State University College of Osteopathic Medicine. "We're seeing well-intentioned research and concerns taken out of context to stoke fear and anxiety about vaccination."

The making of a misinformation campaign

On December 1, 2020, Drs. Wolfgang Wodarg and Michael Yeadon petitioned to withhold emergency use authorization of the BNT162b2 mRNA vaccine for COVID-19 manufactured by BioNTech and Pfizer. The petitioners raised unfounded concerns that female infertility could arise from vaccine-induced antibodies. It is important to note that the petitioners acknowledged the absence of any evidence associating female infertility risks with COVID-19 vaccines.

Anti-vaccine advocates seized on this concern to create a misinformation claim misrepresenting the EMA petition, and the public turned to Google to understand if the information was legitimate. At peak interest, the Google search terms "infertility," "infertility AND vaccine," and "infertility AND COVID vaccine" experienced increases of 119.9%, 11,251%, and 34,900%, respectively, when compared with forecasted values.

"I'm disappointed this misinformation occurred, but I am pleased to see spikes in searches because it reflects genuine interest and suggests that people are doing their research and trying to make informed decisions," said J. Martin Beal, DO, an OB-GYN with Tulsa OB-GYN Associates. "What I'd like to emphasize to patients is that your doctor would love to have this conversation with you to help clarify any questions or concerns you may have. Additionally, I highly encourage getting vaccinated--it will protect you and the baby."

Support for COVID-19 vaccination during pregnancy

The American College of Obstetricians and Gynecologists currently recommends that COVID-19 vaccines not be withheld from pregnant patients who meet criteria for vaccination based on priority groups recommended by the Advisory Committee on Immunization Practices and those at increased risk for COVID-19 acquisition, such as women healthcare workers.

"Dispelling misinformation and informing patients about the risks and benefits of COVID-19 vaccination, or other misrepresented claims, can save lives and slow the spread of disease," said Sajjadi. "In the battle to fight misinformation, Google Trends can be an effective tool to help physicians recognize and proactively address false claims with patients."

A new study from researchers at the University of Liverpool shows that decreasing local government funding over recent years probably contributed to declines in life expectancy in some areas of England, which was stalling even prior to the COVID-19 pandemic.

Local government funding and life expectancy in England, a longitudinal ecological study published in The Lancet Public Health, linked annual local government funding data from the Ministry of Housing, Communities, and Local Government with life expectancy and mortality data from Public Health England between 2013 and 2017.

Corresponding author Dr Alexandros Alexiou said: "Since 2010, large reductions in funding for local government services have been introduced in England, which led to reduced provision of health-promoting public services. We wanted to investigate whether areas that showed a greater decline in funding also had more adverse trends in life expectancy and premature mortality.

"Prior to the COVID-19 pandemic, stalling life expectancy in England was a major public health concern, and the causes were unclear.

"Our research shows that cuts to local government over recent years have probably cost lives. We found that, during a period of large reductions in funding for local government in England, areas that experienced the greatest cuts also experienced slower improvements or a decline in life expectancy. As funding for the most deprived areas decreased to a greater extent, they experienced the most adverse impact - widening health inequalities.

"This has important implications for current policy and for recovery from the COVID-19 pandemic."

On average between 2013 and 2017 central funding to local governments decreased by 33% or £168 per person in total. Each £100 reduction in funding per person was associated with an decrease in 1.3 months in male life expectancy and 1.2 months in female life expectancy.

As funding reductions were greater in more deprived areas, these places were more severely affected, increasing the gap in life expectancy between those places and more affluent areas. Researchers estimated that cuts in funding increased the gap in life expectancy between the most and least deprived areas by 3% for men and 4% for women. Overall reductions in funding during this period were associated with an additional 9600 deaths in people younger than 75 years old.

Dr Alexiou added: "Our study suggests that reduced funding for local services that disproportionally affected deprived areas have had a significant impact on health. The UK government has declared that austerity is over and has committed to investing more to 'level up' those places that have previously been 'left behind'. Fair and equitable investment in local government services can redress these inequalities, enabling the country to 'build back better'."

A USC analysis of deaths among individuals in U.S. Immigration and Customs Enforcement custody found that ICE violated its own internal medical care standards in 78% of cases, potentially contributing to deaths in relatively young and healthy men.

The study appears in JAMA Network Open.

Researchers found many of the deaths were preceded by delayed or inappropriate care and/or inadequate or absent responses to markedly abnormal vital signs. In multiple cases, detention facility staff or other detained persons raised concerns about an individual's health to a superior or staff member before that individual's death.

"The ICE medical care team minimized or dismissed signs and symptoms of critical illness," said first author Molly Grassini, a physician in the Department of Emergency Medicine at the Keck School of Medicine of USC and the Los Angeles County+USC Medical Center. "It is possible that these deaths might have been avoided if these concerns had been addressed."

ICE detention centers have both medical personnel onsite and the ability to transfer patients to nearby hospitals.

Seventy-one individuals died while in ICE detention between 2011 and 2018. The study team analyzed ICE death investigation reports for 55 deaths available for review at the time of study completion. The death investigation reports consist of a narrative developed from medical record reviews and interviews with medical and security staff as well as other detained individuals. Reviews of video footage and security logs are included when available.

In analyzing the reports, the researchers found 47 deaths were due to medical causes and eight due to suicide. The average age at death was 42.7 years. The individuals -- 85.5% of which were men -- had lived in the U.S. an average of 15.8 years prior to detention and spent a median of 39 days in custody before they died.

Markedly abnormal vital signs, such as abnormal heart rate and blood pressure, were documented preceding 29 of the 47 deaths from medical causes. These warning signs were often ignored. In one case, a man with flu-like symptoms grew increasingly ill as medical personnel documented grossly abnormal blood oxygen levels of 78%, 80% and 82% -- but supplied supplemental oxygen only intermittently and not as directed by the advising physician. The resulting death investigation report noted concerns regarding multiple instances where oxygen levels were not documented, nurses had not notified a physician of low oxygen levels and oxygen levels had not been adequately monitored following administration of supplemental oxygen.

Of note, the mean age at death among individuals who died in ICE detention facilities -- 42.7 years -- is substantially younger than the typical life expectancy for individuals not born in the US (81.2 years for men, 85.1 years for women). Individuals who died had low burdens of preexisting disease, and more than half had expected 10-year survival rates between 90% and 98% based upon a formula that considers age and preexisting medical conditions to estimate 10-year mortality.

The authors said they were aware of cases of individuals who died within days of being released but added that these cases do not undergo the mandatory death review process, potentially leading to an undercount of mortality in ICE detention facilities nationwide.

Suggested corrective actions were mentioned in several of the reports; a forthcoming research project will focus on systemic issues associated with these deaths and steps needed to improve care.

The researchers recommend that the Department of Homeland Security officials ensure timely, public and transparent reporting, along with independent medical reviews, of all deaths in ICE detention facilities as well as those that occur within one week of release.

"Facilities with recurrent violations should undergo targeted rehabilitation and close monitoring. Those that are unable to meet predetermined benchmarks and fail to implement acceptable corrective action should be faced with penalties including possible closure," said senior and corresponding author Parveen Parmar, an associate professor of clinical emergency medicine at the Keck School of Medicine. "These processes are vital to ensuring that the dignity and health of the detained population are respected."

As of July 8, ICE held 27,217 people in detention, according to Syracuse University's Transactional Research Access Clearinghouse, which tracks immigration statistics. Of those, 79.6% have no criminal record.

A single dose of the Sputnik V vaccine may elicit significant antibody responses against SARS-CoV-2, finds a study published July 13 in the journal Cell Reports Medicine.

"Due to limited vaccine supply and uneven vaccine distribution in many regions of the world, health authorities urgently need data on the immune response to vaccines to optimize vaccination strategies," says senior author Andrea Gamarnik (@GamarnikLab) of the Fundación Instituto Leloir-CONICET in Buenos Aires, Argentina. "The peer-reviewed data we present provide information for guiding public health decisions in light of the current global health emergency."

Past research has shown that two doses of Sputnik V results in 92% efficacy against coronavirus disease 2019 (COVID-19), which is caused by SARS-CoV-2. An important question is whether a single dose would achieve greater public health benefit than two doses by allowing protection of a larger population more quickly.

Evidence from other vaccines offers support for the one-shot approach. The AstraZeneca vaccine shows 76% efficacy after a single dose, and the Moderna and Pfizer vaccines may induce sufficient immunity in previously infected individuals after one dose, with no apparent benefit of an additional dose.

In the Cell Reports Medicine study, Gamarnik and her colleagues compared the effects of one and two shots of Sputnik V on SARS-CoV-2-specific antibody responses in 289 healthcare workers in Argentina. Three weeks after the second dose, all volunteers with no prior infection generated virus-specific immunoglobulin G (IgG) antibodies - the most common type of antibody found in blood.

But even within three weeks of receiving the first dose, 94% of these participants developed IgG antibodies against the virus, and 90% showed evidence of neutralizing antibodies, which interfere with the ability of viruses to infect cells.

Additional results showed that IgG and neutralizing antibody levels in previously infected participants were significantly higher after one dose than those in fully vaccinated volunteers with no history of infection. A second dose did not increase the production of neutralizing antibodies in previously infected volunteers.

"This highlights the robust response to vaccination of previously infected individuals, suggesting that naturally acquired immunity might be enhanced sufficiently by a single dose, in agreement with recent studies using mRNA vaccines," Gamarnik says.

Further studies are needed to evaluate the duration of the immune response and to assess how antibody levels relate to vaccine protection against COVID-19. "Evidence based on quantitative information will guide vaccine deployment strategies in the face of worldwide vaccine supply restriction," Gamarnik says.

Bacterial vaginosis is the most common and recurrent gynecological condition affecting nearly 30% of women between the ages of 15 and 44, according to the U.S. Centers for Disease Control and Prevention. A University of Arizona Health Sciences-led study recently identified a specific bacteria family and uncovered how it contributes to bacterial vaginosis, paving the way for new insights into disease prevention and treatment.

Led by Melissa Herbst-Kralovetz, PhD, a member of the BIO5 Institute and associate professor of basic medical sciences at the College of Medicine - Phoenix, researchers found that members of the Veillonellaceae bacteria family contribute to an increase in inflammation and cell death, and alter the acidity of the cervical microenvironment. These changes support bacterial vaginosis and create favorable conditions for subsequent gynecological diseases, such as sexually transmitted infections and cancer.

"Bacterial vaginosis is an enigma," said Dr. Herbst-Kralovetz, who is also director of the Women's Health Research Program. "We know many factors contribute to this disease, but little is known about the functional impact of the major players and how they're changing the local landscape."

The paper, "Veillonellaceae family members uniquely alter the cervical metabolic microenvironment in a human three-dimensional epithelial model," published July 6 in the journal npj Biofilms and Microbiomes, found that Veillonellaceae family members contribute to disease by altering inflammation and metabolism in the cervicovaginal region.

The female reproductive tract is typically colonized by bacteria that promote health, such as Lactobacillus. While these bacteria are considered friendly, an imbalance can lead to the creation of a biofilm - a consortium of many different harmful microbes - that promotes disease.

Last year, Dr. Herbst-Kralovetz and colleagues described a hypothetical model in which the interactions between microbes and human cells alter the vaginal microenvironment and ultimately influence the balance between health and disease. This study is the first to define a definitive role for this bacterial family in bacterial vaginosis.

Using a 3D human model, Dr. Herbst-Kralovetz's group evaluated the effects of three bacterium - Veillonella atypica, Veillonella montpellierensis, and Megasphaera micronuciformis - on the cervical microenvironment.

They found that two species - V. atypica and V. montpellierensis - decreased lactate, an acid typically produced by beneficial bacteria that provides protection from harmful infections. These two species also increased substances that play a role in bacterial vaginosis-associated vaginal odor.

They also found that M. micronuciformis further drives disease progression by increasing inflammation and promoting cell death through the production of certain fat molecules.

Insights from this study lay the foundation for polymicrobial, or "multi-bug" studies, which can determine the complex interaction effects of multiple bacterial species on female reproductive health.

"Using this study and our 3D model as a foundation, we hope to determine if and how other species are altering the environment to contribute to bacterial vaginosis," Dr. Herbst-Kralovetz said. "We have found that different species have distinct contributions, so we also hope to categorize a variety of bacterial vaginosis -associated microbes based on their unique effects on the female reproductive tract."

Ultimately, Dr. Herbst-Kralovetz says this study and others like it can help to inform treatment and intervention strategies.

"It is important to know who the major players are, but also how they're influencing physiological processes and disease, so we can develop targeted strategies to treat bacterial vaginosis and prevent subsequent gynecological infections and cancer," she said.

COVID-19 is marked by heightened inflammation and abnormal clotting in the blood vessels, particularly in the lungs, and is believed to contribute to progression to severe disease and death. New trial results show that administering a full dose of a standard blood thinner early to moderately ill hospitalized patients with COVID-19 could halt the thrombo-inflammation process and reduce the risk of severe disease and death.

The study, led by investigators at St. Michael's Hospital, a site of Unity Health Toronto, and the University of Vermont Larner College of Medicine, is available as a preprint on MedRxiv.

Heparin - a blood thinner given regularly at low dose to hospitalized patients - stops clots from forming and reduces inflammation. "This study was designed to detect a difference in the primary outcome that included ICU transfer, mechanical ventilation or death," says Mary Cushman, M.D., M.Sc., study co-principal investigator and a professor of medicine at the University of Vermont's Larner College of Medicine.

The open-label randomized international multi-center RAPID Trial (also known as the RAPID COVID COAG - RAPID Trial) examined the benefits of administering a therapeutic full dose of heparin versus a prophylactic low dose to moderately ill patients admitted to hospital wards with COVID-19.

The primary outcome was a composite of ICU admission, mechanical ventilation, or death up to 28 days. Safety outcomes included major bleeding. Primary outcome occurred in 37 of 228 patients (16.2%) with therapeutic full dose heparin, and 52 of 237 (21.9%) with low dose heparin (odds ratio [OR], 0.69; 95% confidence interval [CI], 0.43-1.10; p=0.12). Four patients (1.8%) with therapeutic heparin died vs. 18 (7.6%) with prophylactic heparin (OR, 0.22; 95% CI, 0.07-0.65).

"While we found that therapeutic heparin didn't statistically significantly lower incidence of the primary composite of death, mechanical ventilation or ICU admission compared with low dose heparin, the odds of all-cause death were significantly reduced by 78 percent with therapeutic heparin," says first author and co-principal investigator Michelle Sholzberg, M.D.C.M., M.Sc., Head of Division of Hematology-Oncology, medical director of the Coagulation Laboratory at St. Michael's Hospital of Unity Health Toronto, and assistant professor at the University of Toronto.

Peter Jüni, M.D., co-principal investigator, director of the Applied Health Research Centre (AHRC)?at St. Michael's, and professor of medicine at the University of Toronto, says that the researchers also presented a meta-analysis of randomized evidence (including data from a large multiplatform trial of ATTACC, ACTIV-4a and REMAP-CAP), which clearly indicated that therapeutic heparin is beneficial in moderately ill hospitalized COVID-19 patients. He adds that an additional meta-analysis presented in the preprint showed that therapeutic heparin is beneficial in moderately ill hospitalized patients but not in severely ill ICU patients.

Another unique aspect of the RAPID Trial was its funding mechanism - a sort of grassroots effort in which support was gathered via Defence Research Development Canada, St. Michael's Hospital Foundation, St. Joseph's Healthcare Foundation, participating institutional grants, and even a GoFundMe campaign, among other sources.

"We called this trial 'The Little Engine that Could,' because of the sheer will of investigators around the world to conduct it," says Cushman.

Sholzberg says, "We believe that the findings of our trial and the multiplatform trial taken together should result in a change in clinical practice for moderately ill ward patients with COVID-19."

The burden of hospital admission rates due to heart attacks (myocardial infarctions) in England rose between 2012 and 2016, despite decades of falling rates, suggests new research published in the Journal of Epidemiology & Community Health.

Researchers also found that after 2010-2011, rates increased in most age groups and young women aged 35 to 49 and even younger men aged 15 to 34 were the groups that showed the sharpest increases in hospitalisation rates for heart attacks in the last five years of the study.

Death rates from coronary heart disease and heart attacks have been declining in England and other countries since the 1980s. Despite this, coronary heart disease is still a large cause of illness and costs the NHS in England more than £950 million annually.

In other countries, hospital admission rates for heart attacks have also fallen since the 1980s, but little is known about these long-term admission rates in England in terms of the age and sex of the patients involved.

Therefore an international team of researchers led by Dr Lucy Wright from University of Oxford's Nuffield Department of Population Health and Big Data Institute set out to analyse the timing and scale of changes in rates of hospitalised myocardial infarction in England by age and sex over the past five decades.

They used official electronic hospital data for adults aged 15 to 84 between 1968 and 2016 and included 3.5 million hospital admissions for heart attacks in their analysis.

Of these admissions, around two thirds (68%) were male. About half (48%) of the admissions in men and 71% in women were for people aged 65 years or older.

Rates of hospital admissions increased in the early years of the study in both men and women, peaked in the mid-1980s (355 per 100,000 population in men and 127 per 100,000 in women) and declined by 38.8% in men and 37.4% in women from 1990 to 2011.

However, from 2012, there were "modest increases" in admissions for both sexes.

Analysis showed that long-term trends in rates over the study period varied by age and sex, with those aged 70 years and older having the greatest and most sustained increases in the early years (1968-1985).

During subsequent years, rates fell in most age groups until 2010-2011. The exception was younger women (35-49 years) and men (15-34 years) who experienced significant increases from the mid-1990s to 2007 (a range of 2.1% per year increase to 4.7% per year increase).

From 2012 onwards, rates increased in all age groups except the oldest, with the most marked increases in men aged 15-34 years (7.2% per year) and women aged 40-49 (6.9%-7.3% per year).

The authors said a possible explanation for the rise in admissions was that a more sensitive diagnostic test was introduced in English hospitals around that time, which identified less severe heart attacks.

However, this is an observational study, and as such, can't establish cause. The study had some limitations, said the authors, such as not being able to identify changes in hospital admission rates that were due to changes in patients' healthcare-seeking behaviour and referral practices.

Nevertheless, the study used a large dataset, which they argued allowed the detailed examination of rates by sex and age of the hospitalised heart attack patients over five decades.

They conclude: "Despite substantial declines in hospital admission rates for myocardial infarction in England since 1990, the burden of annual admissions remains high. Continued surveillance of trends and coronary disease preventive strategies are warranted."

The authors added: "The rise in myocardial infarction hospitalisation rates in younger women and men is of concern and has implications for clinicians and policy makers. Primary prevention guidelines and public awareness campaigns should continue to include the message that coronary disease is not just a disease of men and the elderly."

PITTSBURGH, July 12, 2021 - States that legalize recreational marijuana experience a short-term decline in opioid-related emergency department visits, particularly among 25- to 44-year-olds and men, according to an analysis led by the University of Pittsburgh Graduate School of Public Health.

Published today in the journal Health Economics, the study shows that even after the temporary decline wears off, recreational cannabis laws are not associated with increases in opioid-related emergency department visits.

"This isn't trivial--a decline in opioid-related emergency department visits, even if only for six months, is a welcome public health development," said lead author Coleman Drake, Ph.D., assistant professor in Pitt Public Health's Department of Health Policy and Management. "But that being said, while cannabis liberalization may offer some help in curbing the opioid epidemic, it's likely not a panacea."

The opioid epidemic in the U.S. has accelerated in recent years, with more than 81,000 drug overdose deaths between June 2019 and May 2020--the highest ever recorded in a one-year period, according to the U.S. Centers for Disease Control and Prevention. So far, 19 states have legalized recreational cannabis, meaning that nearly half of the U.S. population lives in a state with a recreational cannabis law.

Drake and his colleagues analyzed data on emergency department visits involving opioids from 29 states between 2011 and 2017. The study included four states that legalized recreational marijuana during that time frame: California, Maine, Massachusetts and Nevada. The remaining 25 states acted as controls.

The four states with recreational cannabis laws experienced a 7.6% reduction in opioid-related emergency department visits for six months after the law went into effect, compared to the states that didn't implement such laws. On closer inspection, the team found that men and adults aged 25 through 44 primarily drove the reduction. Because previous studies have shown that men and young adults account for the majority of people using cannabis, it makes sense that they'd be the ones most affected by the recreational laws, the researchers say.

Although the downturn in emergency department visits for opioids doesn't persist past six months, Drake said that it is encouraging that visits also don't increase above baseline after recreational marijuana laws are adopted. This indicates that recreational marijuana is not serving as a "gateway" to opioids.

"We can't definitively conclude from the data why these laws are associated with a temporary downturn in opioid-related emergency department visits but, based on our findings and previous literature, we suspect that people who use opioids for pain relief are substituting with cannabis, at least temporarily," Drake said. "Cannabis can provide pain relief for persons using opioids, but cannabis ultimately is not a treatment for opioid use disorder. Still, this is good news for state policymakers. States can fight the opioid epidemic by expanding access to opioid use disorder treatment and by decreasing opioid use with recreational cannabis laws. These policies aren't mutually exclusive; rather, they're both a step in the right direction."

MRI-guided focused ultrasound combined with microbubbles can open the blood-brain barrier (BBB) and allow therapeutic drugs to reach the diseased brain location under the guidance of MRI. It is a promising technique that has been shown safe in patients with various brain diseases, such as Alzheimer's diseases, Parkinson's disease, ALS, and glioblastoma. While MRI has been commonly used for treatment guidance and assessment in preclinical research and clinical studies, until now, researchers did not know the impact of the static magnetic field generated by the MRI scanner on the BBB opening size and drug delivery efficiency.

In new research published in Radiology, Hong Chen and her lab at Washington University in St. Louis have found for the first time that the magnetic field of the MRI scanner decreased the BBB opening volume by 3.3-fold to 11.7-fold, depending on the strength of the magnetic field, in a mouse model.

Chen, associate professor of biomedical engineering in the McKelvey School of Engineering and of radiation oncology in the School of Medicine, and her lab conducted the study on 30 mice divided into four groups. After the mice received the injection of the microbubbles, three groups received focused-ultrasound sonication at different strengths of the magnetic field: 1.5 T (teslas), 3 T and 4.7 T, while one group never entered the magnetic field.

They found that the activity of the microbubble cavitation, or the expansion, contraction and collapse of the microbubbles, decreased by 2.1 decibels at 1.5 T; 2.9 decibels at 3 T; and 3 decibels at 4.7 T, compared with those that had received the dose outside of the magnetic field. In addition, the magnetic field decreased the BBB opening volume by 3.3-fold at 1.5 T; 4.4-fold at 3 T; and 11.7-fold at 4.7 T. None of the mice showed any tissue damage from the procedure.

Following focused-ultrasound sonication, the team injected a model drug, Evans blue, to test whether the static magnetic field affects trans-BBB drug delivery efficiency. The images showed that the fluorescence intensity of the Evans blue was lower in mice that received the treatment in one of the three strengths of magnetic fields compared with mice treated outside the magnetic field. The Evans blue trans-BBB delivery was decreased by 1.4-fold at1.5 T, 1.6-fold at 3.0 T and 1.9-fold at 4.7 T when compared with those treated outside of the magnetic field.

"The dampening effect of the magnetic field on the microbubble is likely caused by the loss of bubble kinetic energy due to the Lorentz force acting on the moving charged lipid molecules on the microbubble shell and dipolar water molecules surrounding the microbubbles," said Yaoheng (Mack) Yang, a doctoral student in Chen's lab and the lead author of the study.

"Findings from this study suggest that the impact of the magnetic field needs to be considered in the clinical applications of focused ultrasound in brain drug delivery," Chen said.

In addition to brain drug delivery, cavitation is also the fundamental physical mechanism for several other therapeutic techniques, such as histotripsy, the use of cavitation to mechanically destroy regions of tissue, and sonothrombolysis, a therapy used after acute ischemic stroke. The dampening effect induced by the magnetic field on cavitation is expected to affect the treatment outcomes of other cavitation-mediated techniques when MRI-guided focused-ultrasound systems are used.

(Boston)--Despite the availability of numerous effective birth control methods, more than 40 percent of pregnancies worldwide are unintended. In addition to contributing significantly to population growth, unintended pregnancies can have pronounced adverse effects on maternal physical, mental and economic wellbeing.

Researchers from Boston University School of Medicine (BUSM) and ZabBio (San Diego, CA) have developed an anti-sperm monoclonal antibody, the Human Contraception Antibody (HCA), which they found to be safe and possess potent sperm agglutination (clumping) and immobilization activity in laboratory tests.

"HCA appears to be suitable for contraceptive use and could be administered vaginally in a dissolvable film for a woman-controlled, on-demand method birth control method," explains senior author Deborah Anderson, PhD, Professor of Medicine at BUSM.

To evaluate its suitability as a topical contraceptive, the researchers tested HCA over a wide range of concentrations and under different physiologically relevant conditions in vitro. Specifically, HCA was mixed with sperm from normal, healthy volunteers and then tested. Within 15 seconds, sperm became immobilized and firmly stuck together. The researchers also found that HCA did not to cause vaginal inflammation in lab tissue culture tests.

Due to its effectiveness and safety profile, HCA may address current gaps in the contraception field. "HCA could be used by women who do not use currently available contraception methods and may have a significant impact on global health," said Anderson. To that end, HCA is currently being tested in a Phase I Clinical Trial.

The researchers also believe HCA could also be combined with other antibodies such as anti-HIV and anti-HSV antibodies for a multipurpose prevention technology, a product that would both serve as a contraceptive and prevent sexually transmitted infections.

Highlights

Patients with kidney failure did not report better experience with care from more frequent face-to-face visits with kidney specialists at dialysis facilities.

In fact, more frequent visits were linked with slightly lower patient-reported experiences with kidney-related care.

Washington, DC (July 12, 2021) -- In a recent analysis, more frequent kidney specialists' visits to clinics where patients with kidney failure undergo outpatient hemodialysis were not associated with more favorable patient-reported experiences with care. In fact, more frequent visits were associated with slightly lower patient-reported experiences. The findings will appear in an upcoming issue of CJASN.

Previous research has examined whether patients with kidney failure gain health benefits from more frequent visits with kidney specialists, with mixed findings about the potential benefits of more frequent visits regarding mortality, transplantation, hospitalizations, and other outcomes. In this new study, a team led by Kevin Erickson, MD, MS (Baylor College of Medicine) focused on patients-reported experience of care and assessed whether patients who receive more face-to-face dialysis visits from their physician are more satisfied with their kidney-related care.

The investigators linked patient records from a national kidney failure registry to patient experience data from the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH-CAHPS) survey. Among 243,324 patients who received care in 2015 at more than 5,000 U.S. dialysis facilities, 71% had 4 or more face-to-face visits per month with kidney specialists, 17% had 2 to 3 visits, 4% had 1 visit, and 8% had no visits.

Each 10% absolute higher proportion of patients seen by a kidney specialist 4 or more times per month was associated with a modestly but statistically significant lower score of patient experience with kidney-related care.

"Findings from this study provide evidence that more isn't always better in dialysis, and that patients at facilities where physicians provide more face-to-face dialysis visits do not report better experiences with their nephrology care," said Dr. Erickson. "The finding that more frequent face-to-face visits are not associated with better patient-reported experiences suggests an opportunity for nephrologists to improve the care they deliver by focusing more of their time and effort towards activities that patients benefit from rather than focusing on seeing all patients 4 times per month."

Men over 60 with low-risk prostate cancer could spend ten years with no active treatment, have a better sex life as a result, yet still be very unlikely to die from the disease, new research has found.

The findings come from two new studies looking at 'active surveillance' of prostate cancer - when the disease is closely monitored but not treated - presented at the European Association of Urology congress, EAU21, today.

The first uses data from Sweden's National Prostate Cancer Register, which has information on virtually every man diagnosed with the disease in that country since 1998 - 23,649 of whom went on active surveillance.

Active surveillance was introduced between 15 and 20 years ago for men with low-risk prostate cancer, so as yet, there is no data on the risks and benefits over a longer time period. The researchers, from Uppsala University and the University of Gothenburg, devised a new statistical technique to fill this gap.

Rather than looking simply at the numbers of patients on active surveillance who died of prostate cancer, they identified how many moved on from active surveillance to other treatments, such as radiotherapy or surgery. As these treatments have been provided for many years, long-term follow up data on them already exists.

This allowed the researchers to model the likely outcomes for men on active surveillance up to 30 years from diagnosis, based on the numbers moving onto different treatments. They were able to show not only the percentage of men who would die from the disease over that period, but also the number of years they would spend without treatment, post diagnosis.

Eugenio Ventimiglia, a urologist at San Raffaele Hospital in Milan (Italy) and a PhD student at the Department of Surgical Sciences, Uppsala University (Sweden) explained: "We wanted to identify the real winners from active surveillance, the men who are unlikely to die from their prostate cancer but who will also spend most of their remaining years without treatment if the disease is carefully monitored.

"Obviously, the older you are and the lower risk your cancer, the greater the benefit. But we saw a real divide at age 60. Men diagnosed under 60 on active surveillance have a greater likelihood of dying of prostate cancer with very little added benefit, in terms of extra years with no other treatment. After sixty, if your cancer is low-risk, then active surveillance is really a win-win: the model showed men having ten years or more without other treatment with only a low percentage likely to die from the disease."

Low impact on sexual function

Other treatments for prostate cancer - such as radiotherapy or surgery - can result in incontinence and erectile dysfunction, whereas the physical side effects of active surveillance are minimal. Other research being presented at EAU21 today found that men on active surveillance report fewer problems with sexual function than those on other treatments.

The research draws on data from the EUPROMS study (Europa Uomo Patient Reported Outcome Study), the first prostate cancer quality of life survey conducted by patients for patients. Just under 3,000 men from 24 European countries diagnosed with prostate cancer have completed the survey at home in their own time. This allows them more time to consider their answers and report how they really feel, compared to questionnaires carried out in a clinical environment.

The survey showed that under 45 percent of men on active surveillance reported problems having an erection, compared to between 70 and 90 percent of men on other treatments.

Lionne Venderbos, Postdoctoral Researcher at Erasmus MC, Rotterdam, who analysed the survey results said: "Lack of sexual function affects patients' quality of life more than any other reported side effect. The survey shows that active surveillance has the least impact on sexual function of all possible treatment options.

"This is important for men diagnosed with prostate cancer to be aware of, before they decide which treatment option to pursue. Men who choose active surveillance as their preferred option have the same survival rates over five years as those who chose surgery or radiation, but can also maintain sexual function."

Hendrik Van Poppel, Emeritus Professor of Urology at Katholieke Universiteit Leuven, Belgium, and member of the EAU Executive, said: "When men diagnosed with prostate cancer are deciding their treatment option, quality of life is often the most important factor. As these studies show, active surveillance has the least negative impact, but that treatment option is only possible when the disease is diagnosed at an early stage. It's vital to pick up this disease early, and the option of active surveillance should encourage men to overcome their reluctance to be tested for prostate cancer. Prostate cancer can be fatal, but also the later the diagnosis, the more severe the treatments and the greater the impact on quality of life."

Care homes need to be vigilant for outbreaks of COVID-19, even after residents have received two doses of the vaccine, according to new research being presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) held online this year.

Long-term care facilities, such as care homes with elderly residents with multiple underlying conditions, are at high risk of COVID-19 outbreaks and many vaccination campaigns have initially focused on care home residents and the staff looking after them. An outbreak in a French care home, however, raises questions about how effective the vaccine is in the elderly.

Martin Martinot, of the Hopitaux Civils de Colmar, Colmar, France, and colleagues studied an outbreak of COVID-19 that began in a care home in eastern France a month after a campaign to double vaccinate residents and staff with the Pfizer-BioNTech jab had ended.

Seventy (75%) of the residents and 38 (52%) of the staff were fully vaccinated by mid-February 2021.

Tests on samples of blood taken by the researchers on April 6 showed that all but one of the fully vaccinated residents had antibodies against COVID-19.

The outbreak started on March 15 and, over the next seven weeks, 24/93 residents (26%) and 16/73 staff (22%) were infected by the SARS-CoV-2 virus. Infected residents were older, with an average age of 91, than the uninfected residents, where the average age was 87.

Twelve out of the 24 infected residents had not been fully vaccinated. None of the infected staff had been vaccinated. Analysis showed that the unvaccinated residents were three times more likely to develop COVID-19 than those who had had two doses of the vaccine.

The estimated effectiveness of the vaccine in the elderly residents was 68%. This is lower than previously reported.

Infections seem to have been milder among the vaccinated residents, with no severe cases. In contrast, there were three severe cases among the residents who had not been vaccinated.

Genetic sequencing showed that the outbreak was due to the B.1.1.7 Alpha strain, which was dominant in France at that time.

The study authors say the results show that COVID-19 can still be a threat in long-term care facilities, especially those with older residents, and high rates of vaccination are essential.

Dr Martinot adds that immunosenescence (age-related weakening of the immune system) means that the elderly may still be at risk of COVID-19, even when fully vaccinated.

He concludes: "This outbreak highlights need for high rates of vaccination of residents and healthcare workers in long-term care facilities and other centres accepting elderly patients and those with multiple underlying health conditions.

"Immunisation against COVID-19, although very protective - residents were three times less likely to develop COVID-19 when fully vaccinated - seems a bit less effective in our oldest patients. Thus, achieving the highest rate of vaccination is important to prevent outbreaks and protect residents and healthcare workers."