Body

"It is wise to consider all non-surgical treatment options before resorting to an artificial hip or knee joint implant," said EULAR President Professor Iain B. McInnes, University of Glasgow, Scotland. Yet in many cases, doctors and patients fail to exhaust the full range of conservative therapy options. A Norwegian study has now shown how many patients with osteoarthritis (OA) can benefit from a qualified, conservative therapy programme.

The study design, a so-called cluster-randomised trial (CRT), comprised a programme developed based on international treatment recommendations for hip and knee osteoarthritis (OA). It included an initial three-hour patient education programme, among other things. This was followed by 8-12 weeks of individually tailored exercises supervised by physiotherapists. The programme was facilitated by general practitioners, primary care physicians and physiotherapists, who also received prior training. A total of 393 patients participated in the study; 284 were included in the special osteoarthritis programme and 109 (control group) continued their usual care. The participants were at least 45 years old and presented with clinical OA symptoms such as reduced mobility or pain. They were re-examined 12 months after the beginning of the programme. The study parameters included but were not limited to quality of care, satisfaction with care, physical activity, and referrals to physiotherapy or orthopaedic surgeons. The researchers also recorded whether joint replacement surgery was performed.

92 percent of the patients participated in the patient education programme and 64 percent completed a minimum participation period of at least eight weeks of exercise. Twelve months later, the intervention group reported a significantly higher quality of care (score of 58, versus 41 for the control group). The study participants also reported significantly higher satisfaction with care (Odds ratio (OR) 7.8; 95% CI 3.55, 17.27). A significantly larger proportion (OR: 4.0; 95% CI 1.27, 12.63) also met the recommendations for physical activity compared to the control group. A smaller proportion was referred to orthopaedic surgeons (OR 0.5; 95% CI 0.29, 1.00) and an even smaller proportion (4%) received joint replacement surgery during the observation period, compared to the control group (11%, OR 0.3; 95% CI 0.14, 0.74).

"The implementation of a structured model for OA care led to an improved quality of care, higher patient satisfaction and increased physical activity, despite OA," stated co-author of the study Tuva Moseng, Diakonhjemmet Hospital, Oslo, Norway. There is also some evidence to suggest that a structured OA programme including patient education and exercise may delay or even reduce the need for surgery after 12 months.

Professor John Isaacs from Newcastle University, UK, and Chair of the EULAR 2020 Scientific Programme Committee summarised: "Once again, we see just how important and effective consistent, conservative therapy is for our OA patients." He urged that "conservative care based on the international recommendations for OA treatment should become the standard for all patients."

In 2018 and 2019, the German Institute for Quality and Efficiency in Health Care (IQWiG) already investigated whether the drug enzalutamide has an advantage in comparison with the appropriate comparator therapy, i.e. in comparison with watchful waiting while maintaining ongoing conventional androgen deprivation therapy (ADT), for adult men with high-risk non-metastatic castration-resistant prostate cancer. On the basis of the first and the second data cut-offs of the PROSPER study, an added benefit was not proven. Since the study was not yet completed, the Federal Joint Committee (G-BA) limited its corresponding decision. After expiry of the decision, IQWiG reassessed the drug on the basis of the third data cut-off of the study, which had been completed in the meantime. There is now a hint of considerable added benefit - in particular due to the longer overall survival under treatment with enzalutamide.

New data for the assessment of mortality and side effects

Regarding the outcome categories of morbidity and health-related quality, there were no new findings in comparison with the first assessment, so that the result of the assessment for these outcomes has not changed: In each case, an added benefit is not proven.

In the outcome category of mortality, there was now a hint of considerable added benefit on the basis of the third data cut-off: On average, patients in the enzalutamide arm of the study survived notably longer than in the comparator arm.

In the last outcome category, the side effects, the picture is mixed: There was a hint of a major advantage of enzalutamide for renal and urinary disorders, but it is not completely clear whether these really were side effects of treatment or symptoms of the disease. Furthermore, there were hints of disadvantages of the drug in comparison with watchful waiting while maintaining ongoing ADT for four further specific side effects; their extents were minor to considerable. However, these disadvantages did not raise doubts about the advantages, particularly the longer overall survival, so that the overall assessment resulted in a hint of considerable added benefit of enzalutamide in comparison with the appropriate comparator therapy.

Direct comparison of the treatment options makes sense

There are two further drugs for the same therapeutic indication, i.e. the treatment of men with non-metastatic castration-resistant prostate cancer at high risk of developing metastasis: Similar to enzalutamide, IQWiG recently reassessed apalutamide due to a limitation of the first G-BA decision. This assessment showed an indication of considerable added benefit in comparison with watchful waiting while maintaining ongoing conventional ADT. The recently conducted first assessment of darolutamide also found an indication of considerable added benefit. Thus, at this point at the latest, it would make sense to conduct a study comparing these drugs directly with one another rather than comparing them with watchful waiting while maintaining ADT. However, there is no such study yet.

G BA decides on the extent of added benefit

The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.

19 August 2020, Cambridge - Researchers have investigated the function of a complex mesh of muscle fibres that line the inner surface of the heart. The study, published in the journal Nature, sheds light on questions asked by Leonardo da Vinci 500 years ago, and shows how the shape of these muscles impacts heart performance and heart failure.

This project included collaborators at EMBL's European Bioinformatics Institute (EMBL-EBI), Cold Spring Harbor Laboratory, the MRC London Institute of Medical Sciences, Heidelberg University, and the Politecnico di Milano.

In humans, the heart is the first functional organ to develop and starts beating spontaneously only four weeks after conception. Early in development, the heart grows an intricate network of muscle fibres - called trabeculae - that form geometric patterns on the heart's inner surface. These are thought to help oxygenate the developing heart, but their function in adults has remained an unsolved puzzle since the 16th century.

To understand the roles and development of trabeculae, an international team of researchers used artificial intelligence to analyse 25 000 magnetic resonance imaging (MRI) scans of the heart, along with associated heart morphology and genetic data. The study reveals how trabeculae work and develop, and how their shape can influence heart disease. UK Biobank has made the study data openly available.

Solutions to da Vinci's biological enigma

Leonardo da Vinci was the first to sketch trabeculae and their snowflake-like fractal patterns in the 16th century. He speculated that they warm the blood as it flows through the heart, but their true importance has not been recognised until now.

"Our findings answer very old questions in basic human biology. As large-scale genetic analyses and artificial intelligence progress, we're rebooting our understanding of physiology to an unprecedented scale," says Ewan Birney, Deputy Director General of EMBL.

The research suggests that the rough surface of the heart ventricles allows blood to flow more efficiently during each heartbeat, just like the dimples on a golf ball reduce air resistance and help the ball travel further.

The study also highlights six regions in human DNA that affect how the fractal patterns in these muscle fibres develop. Intriguingly, the researchers found that two of these regions also regulate branching of nerve cells, suggesting a similar mechanism may be at work in the developing brain.

"Our work significantly advanced our understanding of the importance of myocardial trabeculae," explains Hannah Meyer, Principal Investigator at Cold Spring Harbor Laboratory. "Perhaps even more importantly, we also showed the value of a truly multidisciplinary team of researchers. Only the combination of genetics, clinical research, and bioengineering led us to discover the unexpected role of myocardial trabeculae in the function of the adult heart."

Trabeculae and the risk of heart failure

The researchers discovered that the shape of trabeculae affects the performance of the heart, suggesting a potential link to heart disease. To confirm this, they analysed genetic data from 50 000 patients and found that different fractal patterns in these muscle fibres affected the risk of developing heart failure.

Further research on trabeculae may help scientists better understand how common heart diseases develop and explore new approaches to treatment.

"Leonardo da Vinci sketched these intricate muscles inside the heart 500 years ago, and it's only now that we're beginning to understand how important they are to human health. This work offers an exciting new direction for research into heart failure, which affects the lives of nearly 1 million people in the UK," says Declan O'Regan, Clinical Scientist and Consultant Radiologist at the MRC London Institute of Medical Sciences.

Clinical and sociodemographic features of early COVID-19 patients in Massachusetts: MGH study suggests vulnerable populations are hardest hit

BOSTON - Data from the first COVID-19 patients treated at three large Massachusetts hospitals reveal important trends, including disproportionate representation of vulnerable populations, high rates of disease-related complications, and the need for post-discharge, post-acute care and monitoring.

"Our medium follow-up revealed that many of these patients are very sick even after leaving the hospital," says senior author Jason H. Wasfy, MD, MPhil, director of Quality and Outcomes Research at the Massachusetts General Hospital (MGH) Heart Center. The study was published today in EClinicalMedicine.

For the study, the group created a detailed registry based on physician review of 247 patient charts for demographics, baseline characteristics, symptoms, home medications, laboratory data, electrocardiogram (EKG) data, imaging, and treatment.

Patients were included if they were admitted from March 7 through 30, 2020, with confirmed SARS-CoV-2 infection, to one of three Mass General Brigham (formerly Partners HealthCare) system's hospitals -- MGH, Brigham and Women's Hospital (BWH), and Newton-Wellesley Hospital (NWH). These represent three of the largest hospitals in New England's largest integrated health care system. MGH and BWH are both academic medical centers, and Newton-Wellesley is a community hospital.

"I'm glad we got that mix because we need data from across different kinds of settings," says Wasfy, who is also an assistant professor of Medicine at Harvard Medical School (HMS).

Most of the study patients were initially treated with hydroxychloroquine (72 percent) and statins (76 percent, with 34 percent of those newly initiated), a practice that has since changed. "We don't use either of those treatments at our institutions anymore, which highlights the dynamic nature of COVID-19 patient care," says study lead author Cian P. McCarthy, MD, investigator in the Division of Cardiology at MGH.

Another trend that stood out was the ethnic and socio-economic mix: 30 percent of patients were Hispanic, 21 percent were enrolled in Medicaid, and 12 percent were dual-enrolled Medicare/Medicaid. "This strongly suggests that there are some built in disadvantages that fall on these populations' shoulders," says Wasfy. "They may have more family members living in one home, have greater difficulty accessing care, or other circumstances making them more likely to become infected and sick."

The study patients also showed a surprising range of symptoms and outcomes. More than 100 patients (42 percent) required intensive care during their stay. At the end of the data collection period, 213 patients (86.2 percent) were discharged alive, 2 patients (0.8 percent) were still in the hospital, and 32 patients (13 percent) had died. Among those discharged alive, 70 (32.9 percent) were discharged to a post-acute facility, 31 (14.6 percent) newly required supplemental oxygen, 19 (8.9 percent) newly required tube feeding, and 34 (16 percent) required new prescriptions for antipsychotics, benzodiazepines, methadone or opioids. About 10 percent of the study patients were readmitted when followed for an average of 80 days after discharge.

"Our data demonstrates that the road to recovery extends far beyond the hospital and we must ensure we are supporting our patients physical and emotional needs after discharge," says McCarthy.

Leesburg, VA, August 19, 2020--According to ARRS' American Journal of Roentgenology (AJR), electronic consultation not only offered primary care providers (PCPs) easy access to expert opinions by radiologists, it promoted collaboration between physicians that improved patient care, including avoiding unnecessary imaging tests.

"The eConsult (Champlain BASE) electronic consultation platform was developed to provide a secure method for PCPs to ask a specialist patient-specific questions supported by relevant clinical information," explained first author Daniel Walker at the University of Ottawa.

Of the 20,678 eConsults completed through the service to all participating specialists from September 2012 to January 2017, 307 (1.48%) were sent to radiologists--classified by subspecialty (neuroradiology, thoracic, abdominal, musculoskeletal, or pediatric radiology), question type (workup, surveillance, education, specialist referral query, discharge, or other), anatomy, and pathology.

To evaluate timeliness, value, and impact on patient care, Walker and team had PCPs complete feedback surveys after each consultation.

The Canadian researchers excluded five eConsults from their analysis due to insufficient clinical information, so of the 302 total consultations they reviewed, the subspecialties broke down accordingly:

abdominal (94/302 [31%]),

neuroradiology (74/302 [25%]),

musculoskeletal (61/302 [20%]),

Leesburg, VA, August 19, 2020--According to ARRS' American Journal of Roentgenology (AJR), electronic consultation not only offered primary care providers (PCPs) easy access to expert opinions by radiologists, it promoted collaboration between physicians that improved patient care, including avoiding unnecessary imaging tests.

"The eConsult (Champlain BASE) electronic consultation platform was developed to provide a secure method for PCPs to ask a specialist patient-specific questions supported by relevant clinical information," explained first author Daniel Walker at the University of Ottawa.

Of the 20,678 eConsults completed through the service to all participating specialists from September 2012 to January 2017, 307 (1.48%) were sent to radiologists--classified by subspecialty (neuroradiology, thoracic, abdominal, musculoskeletal, or pediatric radiology), question type (workup, surveillance, education, specialist referral query, discharge, or other), anatomy, and pathology.

To evaluate timeliness, value, and impact on patient care, Walker and team had PCPs complete feedback surveys after each consultation.

The Canadian researchers excluded five eConsults from their analysis due to insufficient clinical information, so of the 302 total consultations they reviewed, the subspecialties broke down accordingly:

abdominal (94/302 [31%]),

neuroradiology (74/302 [25%]),

musculoskeletal (61/302 [20%]),

thoracic (56/302 [19%]),

pediatric (17/302 [6%]).

With regard to anatomic subclassification, eConsults most often pertained to the brain (47/302 [16%]), lungs (30/302 [10%]), spine (29/302 [10%]), and liver (27/302 [9%]).

Further subclassification revealed the most common conditions were cystic lesions (38/302 [13%]), pain (24/302 [8%]), bone lesions (21/302 [7%]), and nodules (18/302 [6%]).

The majority of consultations pertained to patient workup (112/302 [37%]), surveillance of imaging findings (95/302 [31%]), and provider education (48/302 [16%]).

Patient management was altered in 167 cases (55%), and unnecessary testing was avoided in 84 cases (28%). Meanwhile, in 227 cases (75%), PCPs rated the perceived value of the eConsult platform as "excellent."

"It may be helpful for radiologists to alter their reporting style to include clear follow-up guidelines for incidental findings," Walker et al. concluded, adding that PCPs may also benefit from continuing medical education on cystic lesion imaging, as well as imaging's role in the workup of patient pain.

Irvine, Calif., Aug. 19, 2020 -- A robust, low-cost imaging platform utilizing lab-on-a-chip technology created by University of California, Irvine scientists may be available for rapid coronavirus diagnostic and antibody testing throughout the nation by the end of the year.

The UCI system can go a long way toward the deployment of a vaccine for COVID-19 and toward reopening the economy, as both require widespread testing for the virus and its antibodies. So far, antibody testing in the U.S. has been too inaccurate or expensive to reach the necessary numbers.

But UCI investigators Weian Zhao, Per Niklas Hedde, Enrico Gratton and Philip Felgner believe that their new technology can help accelerate the testing process quickly and affordably. Their discovery appears in the journal Lab on a Chip, which is published by the Royal Society of Chemistry.

"We need to test millions of people a day, and we're very far from that," said Hedde, a project scientist in pharmaceutical sciences and the study's lead author. "This accurate testing platform enables public health officers to implement individualized mitigation strategies that are needed to safely reopen the country and economy."

How it works

Using blood from a finger prick, the UCI test probes hundreds of antibody responses to 14 respiratory viruses, including SARS-CoV-2, in a mere two to four hours. Identifying responses to viral infections with symptoms similar to those of COVID-19 will keep hospitals clear of patients with standard colds and flus.

The results are printed on a low-cost imaging platform. The TinyArray imager combines a 3D-printed prototype with an off-the-shelf LED and a small 5-megapixel camera to find markers for many antibodies simultaneously. This ensures accuracy equal to that of expensive imaging systems but makes the platform portable enough to deploy anywhere - at a cost of only $200.

The same device can also process the results of commonly used nose swab tests for SARS-CoV-2 so that patients can be tested for COVID-19 and its antibodies on a single platform.

Currently, most antibody tests only check for one or two antigens, the foreign substances that cause the body to produce antibodies.

"A month or two ago, testing was kind of regarded as the Wild West," said Zhao, a professor of pharmaceutical sciences, adding that most SARS-CoV-2 antibody tests are "just not accurate."

Systems that test for the full range of antibodies necessary for reliable results require imaging machines that cost $10,000 to $100,000 and are too bulky for widespread use. Areas without the resources to acquire one of these machines have to send their samples to external labs for testing, meaning that results take days instead of hours.

Big impact

Large-scale testing will determine what percentage of the population had COVID-19 but never showed symptoms, which will have a big impact on public health and reopening decisions.

"What if it turns out that a larger percentage of the people in a community have already contracted the virus?" Zhao said. "This means you are closer to accomplishing herd immunity."

And understanding what antibodies are produced and how long they last will be key in developing an effective vaccine and administering the right dosage. This may be critical for years to come if the virus mutates, requiring updates much like yearly flu vaccinations.

The UCI team has already completed 5,000 tests in Orange County, and the final goal is to test 20,000 samples per unit a day. The researchers are partnering with UCI startups Velox Biosystems Inc. and Nanommune Inc. to scale up production. They expect that the TinyArray imager will be ready to deploy across the U.S. by the end of 2020 and are working with scientists in Uruguay, Russia and Thailand to develop similar systems for their nations.

"This would be great for a low-income country," Hedde said. "Because the device's materials are cheap and easy to obtain, the platform is easy to manufacture and use in low-resource areas, making testing accessible on a world scale."

Research Highlights:

For children with Kawasaki disease with higher risk of developing blood vessel complications, adding corticosteroids to standard intravenous immunoglobulin treatment could boost initial treatment response and prevent complications.

Researchers used real-world data from large, nationwide Japanese Kawasaki disease surveys to compare combination therapy with the standard treatment.

Kawasaki disease causes blood vessels throughout the body to become inflamed and is a leading cause of heart disease in children born without heart defects.

DALLAS, August 19, 2020 -- Adding corticosteroids to standard intravenous (IV) immunoglobulin treatment for children with Kawasaki disease judged to be at higher risk of developing blood vessel complications made initial treatment more successful and prevented these complications, according to new research published today in the Journal of the American Heart Association, an open access journal of the American Heart Association.

"Early diagnosis and prompt treatment are important for children with Kawasaki disease to prevent the development of cardiac complications," said lead author Ryusuke Ae, M.D., Ph.D., an assistant professor in the department of public health at the Center for Community Medicine at Jichi Medical University in Shimotsuke, Japan. The study was conducted during 2018-2019 when Dr. Ae was a guest researcher at the U.S. Centers for Disease Control and Prevention (CDC) and is a collaboration between the CDC and Jichi Medical University.

Kawasaki disease, which occurs most often in children younger than 5 years old, causes inflammation of the blood vessels, particularly the coronary arteries that supply fresh blood to the heart muscle. In developed countries, Kawasaki disease is a leading cause of heart disease in children born without heart defects and the cause is unknown. The criteria for diagnosis is when a child has a fever for five days or longer (unless interrupted by treatment) along with multiple other defining symptoms that can include a rash over the abdomen, swollen and red hands and feet, bloodshot eyes, swollen lymph glands, and redness and swelling of the mouth, lips, throat and tongue. Kawasaki disease occurs in children of all races and ethnicities; however, it is more common among Asian children regardless of where they live.

"As the blood vessel wall becomes enlarged, the inside of the vessel may narrow. Blood clots may form, blocking the artery and potentially leading to a heart attack. Children who have such vessel wall complications may require long-term follow-up after the onset of Kawasaki disease," said Ae.

Standard treatment for Kawasaki disease includes IV immunoglobulin with aspirin. However, for an estimated 17% of Kawasaki disease patients, initial IV immunoglobulin treatment is not effective, increasing their risk of cardiac complications. In recent years, it has become more common to add corticosteroids to the initial treatment approach; however, researchers have reached different conclusions about which approach is best.

In this study, the largest of its kind to-date, researchers analyzed real-world data on children with Kawasaki disease in Japan to determine whether the more intensive combination approach could heal children faster and prevent cardiac complications among those considered more vulnerable to treatment failure and long-term complications. In this study, patients were deemed at higher risk if initial treatment was predicted to be ineffective based on standing scoring systems, if the child was less than one year old or had elevated blood test results.

Researchers identified 1,593 Kawasaki disease patients under the age of 18 who were first treated with standard IV immunoglobulin with aspirin. Outcomes were compared with another set of 1,593 Kawasaki disease patients who were likely to have been initially treated with corticosteroids in combination with the standard therapy. Patients were matched for age, sex and how quickly treatment was started after symptoms appeared, with care taken to account for other factors that could bias results.

Compared with standard IV immunoglobulin treatment, the researchers found:

Initial combination treatment (immunoglobulin plus aspirin and corticosteroids) reduced the need for a second course of therapy by 35%.

Initial combination treatment reduced the risk of coronary artery abnormalities by 47%.

Delivering a low-dosage of corticosteroids over many days was more beneficial than a high-dose pulse over fewer days or typically just one day.

"It was surprising to see the dramatic results of our analysis. Clinicians should consider initial combination treatment with multiple-dose corticosteroids for high-risk Kawasaki disease patients," Ae said.

Limitations of the study included that researchers did not have precise information on the type, dose and duration of corticosteroid therapy because of the way initial data was recorded.

The same combination treatment of immunoglobulin and corticosteroids has been recently used to treat children with multisystem inflammatory syndrome (MIS-C), a new condition associated with COVID-19 infection that has some symptoms like Kawasaki disease. While MIS-C is seen in children with COVID-19, it is rare.

JACKSONVILLE, Fla. -- Women with a history of high blood pressure disorders during pregnancy are more likely to experience bothersome menopausal symptoms such as hot flashes and night sweats, according to a study published Wednesday, Aug. 19, in Menopause: The Journal of the North American Menopause Society.

"We already know that women with high blood pressure during pregnancy or those who experience menopause symptoms such as hot flashes and night sweats have a higher risk of developing heart disease. Our research discovered that women who experienced high blood pressure during pregnancy were much more likely to experience bothersome menopausal symptoms, including hot flashes and night sweats during menopause," says Stephanie Faubion, M.D., the study's lead author. Dr. Faubion is the Penny and Bill George Director for Mayo Clinic's Center for Women's Health.

Researchers analyzed the medical records of 2,684 women ages 40 to 65 who were seen for specialty menopause or sexual health consultations at women's health clinics at Mayo Clinic in Rochester, Minnesota, and Mayo Clinic in Scottsdale, Arizona, between May 2015 and September 2019. All study participants completed a questionnaire in which they self-reported their menopause symptoms and effects of these symptoms on their quality of life. Study participants also completed questionnaires that documented whether they experienced high blood pressure disorders during pregnancy, such as preeclampsia or gestational hypertension.

Researchers discovered a significant association between women with a history of high blood pressure disorders during pregnancy who reported more bothersome menopausal symptoms. Women with this high blood pressure history using hormone therapy also reported more menopausal symptoms, compared to women with no history of high blood pressure disorders during pregnancy.

Dr. Faubion says more research is needed to understand why there is a link between high blood pressure disorders during pregnancy and more severe menopausal symptoms. But one thing is clear: Physicians need to do a better job monitoring women who experience high blood pressuring during pregnancy after they give birth.

"We know medical providers have historically done a lousy job identifying and following women with histories of high blood pressure disorders during pregnancy, despite knowing that they have a higher heart disease risk," says Dr. Faubion. "This study is another reminder that these women are different. It is important that they not only receive education with regard to what they may experience during menopause, but also that they undergo routine screenings and counseling on how they can reduce their risk for heart disease."

CLEVELAND, Ohio (August 19, 2020)--Women with high blood pressure during pregnancy are at an increased risk for chronic hypertension, diabetes, coronary artery disease, stroke, and early cardiovascular death. A new study suggests that they may also be at risk for more bothersome menopause symptoms, including hot flashes. Study results are published online today in Menopause, the journal of The North American Menopause Society (NAMS).

Hypertensive disorders of pregnancy (HDP), such as gestational hypertension and preeclampsia, are well recognized as female-specific predictors of cardiovascular disease, the leading cause of death in women. Similarly, certain menopause symptoms, such as hot flashes, are known to be indicators of cardiovascular risk, although the exact link is unknown. Despite the fact that HDP and hot flashes are both tied to heart disease, there has been little research to link the two.

Researchers in this new study involving nearly 2,700 women theorized that by understanding the connection between HDP and hot flashes, they may help clinicians better identify women at higher risk for cardiovascular disease so that they can intervene with effective treatment strategies. The purpose of the study was to investigate the association between a history of HDP and menopause symptoms. In the end, it was concluded that women with a history of HDP experienced more severe menopause symptoms compared with women without a history of HDP or with women without a pregnancy. On more detailed analysis, the researchers additionally found that women with HDP using hormone therapy had significantly higher total menopause symptoms than women with no such history.

Results are published in the study "Hypertensive disorders of pregnancy and menopausal symptoms: a cross-sectional study from the data registry on experiences of aging, menopause and sexuality."

"This large cross-sectional study shows a link between hypertensive disorders of pregnancy and menopause symptoms, both unique to women and predictive of future cardiovascular disease risk. Future studies are needed to determine whether these risks are additive to better inform development of more accurate models for cardiovascular risk prediction in women and strategies for risk reduction," says Dr. Stephanie Faubion, lead author of the study and NAMS medical director.

More than a decade ago, electronic medical records were all the rage, promising to transform health care and help guide clinical decisions and public health response.

With the arrival of COVID-19, researchers quickly realized that electronic medical records (EMRs) had not lived up to their full potential--largely due to widespread decentralization of records and clinical systems that cannot "talk" to one another.

Now, in an effort to circumvent these impediments, an international group of researchers has successfully created a centralized medical records repository that, in addition to rapid data collection, can perform data analysis and visualization.

The platform, described Aug.19 in Nature Digital Medicine, contains data from 96 hospitals in five countries and has yielded intriguing, albeit preliminary, clinical clues about how the disease presents, evolves and affects different organ systems across different categories of patients COVID-19.

For now, the platform represents more of a proof-of-concept than a fully evolved tool, the research team cautions, adding that the initial observations enabled by the data raise more questions than they answer.

However, as data collection grows and more institutions begin to contribute such information, the utility of the platform will evolve accordingly, the team said.

"COVID-19 caught the world off guard and has exposed important deficiencies in our ability to use electronic medical records to glean telltale insights that could inform response during a shapeshifting pandemic," said Isaac Kohane, senior author on the research and chair of the Department of Biomedical Informatics in the Blavatnik Institute at Harvard Medical School. "The new platform we have created shows that we can, in fact, overcome some of these challenges and rapidly collect critical data that can help us confront the disease at the bedside and beyond."

In its report, the Harvard Medical School-led multi-institutional research team provides insights from early analysis of records from 27,584 patients and 187,802 lab tests collected in the early days of epidemic, from Jan. 1 to April 11. The data came from 96 hospitals in the United States, France, Italy, Germany and Singapore, as part of the 4CE Consortium, an international research repository of electronic medical records used to inform studies of the COVID-19 pandemic.

"Our work demonstrates that hospital systems can organize quickly to collaborate across borders, languages and different coding systems," said study first author Gabriel Brat, HMS assistant professor of surgery at Beth Israel Deaconess Medical Center and a member of the Department of Biomedical Informatics. "I hope that our ongoing efforts to generate insights about COVID-19 and improve treatment will encourage others from around the world to join in and share data."

The new platform underscores the value of such agile analytics in the rapid generation of knowledge, particularly during a pandemic that places extra urgency on answering key questions, but such tools must also be approached with caution and be subject to scientific rigor, according to an accompanying editorial penned by leading experts in biomedical data science.

"The bar for this work needs to be set high, but we must also be able to move quickly. Examples such as the 4CE Collaborative show that both can be achieved," writes Harlan Krumholz, senior author on the accompanying editorial and professor of medicine and cardiology and director of the Center for Outcomes Research and Evaluation at Yale-New Haven Hospital.

What kind of intel can EMRs provide?

In a pandemic, particularly one involving a new pathogen, rapid assessment of clinical records can provide information not only about the rate of new infections and the prevalence of disease, but also about key clinical features that can portend good or bad outcomes, disease severity and the need for further testing or certain interventions.

These data can also yield clues about differences in disease course across various demographic groups and indicative fluctuations in biomarkers associated with the function of the heart, kidney, liver, immune system and more. Such insights are especially critical in the early weeks and months after a novel disease emerges and public health experts, physicians and policymakers are flying blind. Such data could prove critical later: Indicative patterns can tell researchers how to design clinical trials to better understand the underlying drivers that influence observed outcomes. For example, if records are showing consistent changes in the footprints of a protein that heralds aberrant blood clotting, the researchers can choose to focus their monitoring, treatments on organ systems whose dysfunction is associated with these abnormalities or focus on organs that could be damaged by clots, notably the brain, heart and lungs.

The analysis of the data collected in March demonstrates that it is possible to quickly create a clinical sketch of the disease that can later be filled in as more granular details emerge, the researchers said.

In the current study, researchers tracked the following data:

Total number of COVID-19 patients

Number of intensive care unit admissions and discharges

Seven-day average of new cases per 100,000 people by country

Daily death toll

Demographic breakdown of patients

Laboratory tests to assess cardiac, immune and kidney and liver function, measure red and white blood cell counts, inflammatory markers such as C-reactive protein, as well as two proteins related to blood clotting (D-dimer) and cardiac muscle injury (troponin)

Telltale patterns

The report's observations included:

Demographic analyses by country showed variations in the age of hospitalized patients, with Italy having the largest proportion of elderly patients (over 70 years) diagnosed with COVID-19.

At initial presentation to the hospital, patients showed remarkable consistency in lab tests measuring cardiac, immune, blood-clotting and kidney and liver function.

On day one of admission, most patients had relatively moderate disease as measured by lab tests, with initial tests showing moderate abnormalities but no indication of organ failure.

Major abnormalities were evident on day one of diagnosis for C-reactive protein--a measure of inflammation--and D-dimer protein, a chemical that measures blood clotting with test results progressively worsening in patients who went on to develop more severe disease or died.

Levels of the liver enzyme bilirubin, which indicate liver function, were initially normal across hospitals but worsened among persistently hospitalized patients, a finding suggesting that most patients did not have liver impairment on initial presentation.

Creatinine levels--which measure how well the kidneys are filtering waste--showed wide variations across hospitals, a finding that may reflect cross-country variations in testing, in the use of fluids to manage kidney function or differences in timing of patient presentation at various stages of the disease.

On average, white blood cell counts--a measure of immune response--were within normal ranges for most patients but showed elevations among those who had severe disease and remained hospitalized longer.

Even though the findings of the report are observations and cannot be used to draw conclusions, the trends they point to could provide a foundation for more focused and in-depth studies that get to the root of these observations, the team said.

"It's clear that amid an emerging pathogen, uncertainty far outstrips knowledge," Kohane said. "Our efforts establish a framework to monitor the trajectory of COVID-19 across different categories of patients and help us understand response to different clinical interventions."

DUARTE, Calif. -- Physicians at City of Hope, working in collaboration with scientists at Translational Genomics Research Institute (TGen), have found that greater gut microbial diversity in patients with metastatic kidney cancer is associated with better treatment outcomes on Food and Drug Administration-approved immunotherapy regimens. Their findings are outlined in a study published today in the journal European Urology.

"We also reported the changes over time in the gut microbiome that occur during the course of therapy -- the cumulative findings from our report open the door to therapies directed at the microbiome," said Sumanta Pal, M.D., one of the study's senior authors and co-director of the Kidney Cancer Program at City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases.

The gut microbiome is composed of microbes like bacteria and viruses that reside in the gastrointestinal tract. In recent years, an increase in knowledge about the microbiome in relation to general health has led to deeper explorations of its role in disease states, as well as how the organisms may interact with treatments.

"Previous studies have suggested a relationship between the gut microbiome and response to immunotherapy in solid tumors, including metastatic kidney cancer," said Nicholas Salgia, B.Sc., a clinical research assistant at City of Hope and the paper's lead author. "The results from our study build on earlier findings and reaffirm that the diversity and composition of patients' microbiomes are associated with clinical responses to anti-cancer therapies."

The study, which collected data from 31 people with metastatic kidney cancer, features the first reports of comparing microbiome sequencing at different time points in cancer patients. Participants were asked to provide up to three stool samples: at baseline, four weeks into therapy and 12 weeks into therapy.

Using the clinical trial results, the team was able to identify changes in the microbiome over time in kidney cancer patients receiving immunotherapy. The findings found that a greater variety of organisms was associated with a benefit to the patients, and also suggested that modulating the gut microbiome during the course of treatment may impact responses to therapy.

"The patients with the highest benefit from cancer treatment were those with more microbial diversity, but also those with a higher abundance of a specific bacterium known as Akkermansia muciniphila," said Sarah Highlander, Ph.D., a research professor in TGen's Pathogen and Microbiome Division and one of the study's senior authors. "This organism has been associated with benefit in other immunotherapy studies."

Highlander says one potential takeaway is that oncologists might encourage patients to pay attention to their gut microbiome by eating a high-fiber diet, including fruits and vegetables high in fructo-oligosaccharides such as bananas, dried fruit, onions, leeks, garlic, asparagus and artichokes, as well as grains with resistant starches such as barley or uncooked potato starch, for example.

Highlander says that next steps should include expanding the relatively small study to a much larger group of patients that are followed over a longer time period. At City of Hope, researchers have already embarked on a clinical trial to further explore the idea that modulating the microbiome during therapy could have an impact on clinical outcomes.

"We have randomized patients with metastatic kidney cancer to receive a probiotic supplement in addition to an FDA-approved immunotherapy regimen or the immunotherapy alone," explained Salgia. "This work provided a strong framework for such a study."

The collaborations between clinical experts at City of Hope and basic science colleagues at TGen have contributed to advancements in the understanding of not just the microbiome, but also in cancer biology and clinical outcomes at large.

"Our strong relationship with the microbiome team at TGen has fruitfully produced novel insights into the clinical implications of the microbiome in kidney cancer, among other cancer types," said Pal, who is an internationally recognized leader in the area of genitourinary cancers.

Just last month, City of Hope and TGen launched a project to use one of the world's most comprehensive genomic analysis tools to map out personalized treatment plans for metastatic kidney cancer patients.

"This current study is a further testament to the collaborative research structure we've developed between the affiliate institutions," said Pal. "Through these collaborations we can implement both a bench-to-bedside and bedside-to-bench research model that will lead to better patient care at City of Hope through access to clinical trials and precision medicine approaches."

Bottom Line: The U.S. Preventive Services Task Force (USPSTF) recommends behavioral counseling to prevent sexually transmitted infections (STIs) for all sexually active adolescents and for adults at increased risk. Sexually transmitted infections are on the rise across the United States, with approximately 20 million new cases each year. If untreated, STIs can lead to serious health complications including infertility, AIDS and cancer. The USPSTF routinely makes recommendations about the effectiveness of preventive care services and this statement is consistent with its 2014 recommendation but differs by offering a broader range of effective counseling approaches.

(doi:10.1001/jama.2020.13095)

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

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Note: More information about the U.S. Preventive Services Task Force, its process, and its recommendations can be found on the newsroom page of its website.

What The Study Did: Respiratory droplet spread during an ophthalmologic slitlamp exam was simulated to help establish risk of infectious disease contagion in this setting.

Authors: Efrem D. Mandelcorn, M.D., of the Toronto Western Hospital/University Health Network in Toronto, Canada, 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/jamaophthalmol.2020.3472)

Phone calls after Mohs micrographic skin surgery can address patient concerns and quickly identify complications. But what is the optimal time for dermatologists to check-in with surgical patients after surgery? A new study from the University of Missouri School of Medicine and MU Health Care provides insight into how the timing of post-operative phone calls can address pain, bleeding and overall patient satisfaction.

Researchers enrolled 400 patients into a randomized controlled trial that included four arms. The control group did not receive a call after surgery. The second arm received a call from a physician the evening of Mohs micrographic surgery. The third group received a call the day after surgery. The fourth arm received a follow-up call two days after surgery. The doctors used standardized scripts on all calls to gauge bleeding and insufficient pain control. In addition, patients on all four arms of the study received a phone call seven to 10 days after surgery from research staff to assess their satisfaction. The results from the study showed 83% of patients contacted the evening of surgery experienced active pain, compared to 67% on day two and 51% on day three.

"We found follow-up calls made the evening of surgery best identified patients with active pain," said senior author Nicholas Golda, MD, associate professor of dermatology at the MU School of Medicine. "This presents an opportunity to better coach patients through pain management and adjust medications if the calls are made on the evening of surgery rather than at other points."

While the study identified when a patient is most at-risk for active pain, no single group best identified bleeding complications or highest pain levels. In addition, a comparison of the four groups designed to evaluate different aspects of patient experience did not show any statistically significant differences.

"While surgeons may elect to make follow-up calls, these do not seem to strongly contribute to overall patient satisfaction," Golda said. "It is somewhat surprising that the control group's experience, quality of care and willingness to recommend scores matched the groups that received follow-up calls. This finding is contrary to our previously held belief that these calls directly affect patient satisfaction."

In addition to Golda, the study's lead author was MU School of Medicine micrographic surgery and dermatologic oncology fellow Robert Bednarek, MD. MU School of Medicine student Corey Jonak also contributed to the study.

PISCATAWAY, NJ - Your smartphone can tell when you've had too much to drink by detecting changes in the way you walk, according to a new study published in the Journal of Studies on Alcohol and Drugs.

Having real-time information about alcohol intoxication could be important for helping people reduce alcohol consumption, preventing drinking and driving or alerting a sponsor for someone in treatment, according to lead researcher Brian Suffoletto, M.D., who was with the University of Pittsburgh School of Medicine when the research was conducted and is now with Stanford University School of Medicine's Department of Emergency Medicine.

"We have powerful sensors we carry around with us wherever we go," Suffoletto says. "We need to learn how to use them to best serve public health."

But for Suffoletto, this research is much more than academic. "I lost a close friend to a drinking and driving crash in college," he says. "And as an emergency physician, I have taken care of scores of adults with injuries related to acute alcohol intoxication. Because of this, I have dedicated the past 10 years to testing digital interventions to prevent deaths and injury related to excessive alcohol consumption."

For the study, Suffoletto and colleagues recruited 22 adults ages 21 to 43. Volunteers came to a lab and received a mixed drink with enough vodka to produce a breath alcohol concentration of .20 percent. They had one hour to finish the alcohol.

Then hourly for seven hours, participants had their breath alcohol concentration analyzed and performed a walking task. For this task, researchers placed a smartphone on each participant's lower back, secured with an elastic belt. Participants walked a straight line for 10 steps, turned around, and walked back 10 steps.

The smartphones measured acceleration and mediolateral (side to side), vertical (up and down) and anteroposterior (forward and backward) movements while the participants walked.

About 90 percent of the time, the researchers were able to use changes in gait to identify when participants' breath alcohol concentration exceeded .08 percent, the legal limit for driving in the United States.

"This controlled lab study shows that our phones can be useful to identify 'signatures' of functional impairments related to alcohol," Suffoletto says.

Although placing the smartphone on the lower back does not reflect how people carry their cell phones in real life, the research group plans to conduct additional research while people carry phones in their hands and in their pockets.

And although it was a small investigation, the researchers write that this is a "proof-of-concept study" that "provides a foundation for future research on using smartphones to remotely detect alcohol-related impairments."

"In 5 years, I would like to imagine a world in which if people go out with friends and drink at risky levels," Suffoletto says, "they get an alert at the first sign of impairment and are sent strategies to help them stop drinking and protect them from high-risk events like driving, interpersonal violence and unprotected sexual encounters."

Going forward, Suffoletto and his colleagues plan to not only build on this research detecting real-world signatures of alcohol-related impairment but also identify the best communication and behavioral strategies to influence and support individuals during high-risk periods such as intoxication.