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The first COVID-19 vaccines could be authorised as early as the start of 2021. However, in all likelihood, there will not be sufficient vaccine doses in the beginning for all the people willing to undergo vaccination. This is why prioritisation will be necessary. In the position paper published today, medical-epidemiological aspects of infection prevention are presented alongside ethical, legal and practical considerations. On this basis, the authors develop a framework for action for the initial prioritisation of vaccination measures against COVID-19.

Prioritisation helps with decisions on who should receive which vaccine first. However, prioritisation should not be based on medical-epidemiological findings alone. It is rather the case that ethical and legal considerations should play a decisive role, too.

According to the experts, decisive results on the characteristics of the vaccines from the ongoing clinical trials (phase 3) are not yet available. Consequently, a detailed recommendation by STIKO concerning priority groups for vaccination is still not possible at the present time. However, the ethical and legal principles according to which prioritisation is to be undertaken have already been established. In addition to self-determination, they are non-maleficence and protection of integrity, justice, fundamental equality of rights, solidarity and urgency.

These ethical and legal principles are reflected in concrete vaccination goals: prevention of severe courses of COVID-19 (hospitalisation) and deaths; protection of persons with an especially high work-related risk of exposure to SARS-CoV-2 (occupational indication); prevention of transmission and protection in environments with a high proportion of vulnerable individuals and in those with a high outbreak potential; maintenance of essential state functions and public life.

The paper points out that the distribution of the initially scarce vaccines touches on relevant ethical values and values pertaining to basic rights, and therefore necessitates clear legal regulation. Furthermore, vaccine distribution is to be organised in such a way as to ensure that the vaccination goals are achieved. This requires suitable new structures. Uniform, transparent distribution is needed that inspires confidence and ensures acceptance. This argues in favour of a vaccination strategy that relies not on individual general practitioners but on vaccination centres mandated by the state.

In principle, informed, voluntary consent is required for vaccination. Therefore, prioritisation criteria must be presented to the population in a comprehensible way. Furthermore, the authors of this position paper also rule out undifferentiated, general compulsory vaccination.

Experts are of the opinion that a self-determined decision about vaccination is dependent on ongoing, transparent information and education of the population regarding both the efficacy of vaccination and the associated risks. In order to identify and minimise vaccination risks at an early stage, the timely nationwide recording of all vaccinations and an evaluation of adverse events must be established in parallel to vaccination. To this end, the authors call for the product-based recording of COVID-19 vaccinations in a central database, also for the purpose of exactly determining vaccination coverage rates.

Many environmental and lifestyle factors have been implicated in the decline of sperm quality, with diet being one of the most plausible factors identified in recent years. Moreover, several studies have reported a close association between the alteration of specific sperm DNA methylation signatures and semen quality. To date, however, no randomized clinical trials (RCT) have been published that assess the effects of diet on these changes in the function of sperm DNA.

Researchers from the Human Nutrition Unit of the Universitat Rovira i Virgili, the Pere Virgili Institute of Health and CIBERobn (led by Dr Jordi Salas-Salvadó), and researchers from the University of Utah (led by Dr Douglas T. Carrell) have evaluated for the first time the effect of a short/middle-term consumption of a mixture of tree nuts (almonds, hazelnuts and walnuts) on sperm DNA methylation patterns in healthy individuals reporting eating a Western-style diet. The analysis was done within the framework of the FERTINUTS trial, an RCT led by Dr Mónica Bulló; and Dr Albert Salas-Huetos, the results of which were published in 2018. The research revealed that the inclusion of a mix of nuts for 14 weeks significantly improved the sperm count, viability, motility, and morphology.

This new study was conducted in 72 healthy, non-smoking, young participants from the FERTINUTS trial (nut group, n=48; control group, n=24) and has recently been published in the scientific journal Andrology. The researchers observed that the methylation of 36 genomic regions was significantly different between baseline and the end of the trial only in the group that consumed nuts, and 97.2% of the regions displayed hypermethylation.

According to the researchers, these findings provide the first evidence that adding nuts to a regular Western-style diet impacts sperm DNA methylation in specific regions.

Albert Salas-Huetos (who is now working at Harvard University, USA), the first author of the article states, that "This work demonstrates that there are some sensitive regions of the sperm epigenome that respond to diet, and which can result in changes in sperm and in its ability to fertilize". Researchers also point out that the potential health benefits of the findings warrant further study to verify the results found in other populations.

November 9, 2020 - Men undergoing active surveillance for prostate cancer have very low rates - one percent or less - of cancer spread (metastases) or death from prostate cancer, according to a recent study published in The Journal of Urology®, an Official Journal of the American Urological Association (AUA). The journal is published in the Lippincott portfolio by Wolters Kluwer.

"In the long-term, active surveillance is a safe and viable option for men with low-risk and carefully selected intermediate-risk prostate cancer," according to the report by senior author Peter R. Carroll, MD, MPH, of University of California, San Francisco (UCSF) and colleagues.

During active surveillance, prostate cancer is carefully monitored for signs of progression through regular prostate-specific antigen (PSA) screening, prostate exams, imaging and repeat biopsies. If symptoms develop, or if tests indicate the cancer is more aggressive, active treatment such as surgery or radiation may be warranted.

New data on outcomes of active surveillance

The goal of active surveillance is to avoid or delay the side effects of treatment in men with favorable-risk disease without compromising such long-term outcomes as survival or metastasis. Dr. Carroll and his team set out to assess the long-term outcomes of men on active surveillance for prostate cancer to determine which, if any, prognostic factors could predict the risk of metastases.

The researchers analyzed 1,450 men with early-stage disease (median age 62 years) who were managed using active surveillance at UCSF between 1990 and 2018. Average follow-up was approximately 6.5 years; however, nearly one-fourth of patients were followed up for 10 years or longer.

Results showed risk of metastases during long-term active surveillance was affected by three factors:

Gleason grade (GG), a standard measure of prostate cancer grade. On initial biopsies, 90 percent of men had low-grade prostate cancers (GG1) and 10 percent had intermediate-grade (GG2) cancers. Overall, 99 percent of patients were alive and without metastases at seven years. For those with GG2 cancers, this figure was slightly, but significantly lower: 96 percent.

PSA velocity, or rate of change on this prostate cancer risk marker. Patients with faster increases in PSA had a higher risk of metastases.

Multiparametric MRI. A new imaging technique called multiparametric MRI was performed in about half of patients. Men with a high likelihood of clinically significant cancer on multiparametric MRI were at higher risk of metastases.

"At seven years, one percent of men in our cohort developed metastatic disease and less than one percent died from prostate cancer," lead author Martina Maggi, MD, and coauthors write. Overall survival rates varied according to GG and PSA velocity: from 98 percent for men with GG1 cancers and slower PSA velocity to 87 percent for those with GG2 cancers.

The study provides new evidence on the benefits of active surveillance, with longer-term follow-up than most previous reports. It also provide insights into risk factors for metastases during follow-up: GG, PSA velocity, and possibly multiparametric MRI. Dr. Maggi and colleagues conclude: "These characteristics should be taken into account when selecting, following, and counseling patients for active surveillance."

Online consumer reviews play an important role in almost every consumer industry -- from dining and shopping to travel and technology. But what do online reviews of physicians tell consumers?

In a new study, researchers from The University of Texas at Dallas investigated whether patient-generated online reviews of physicians accurately reflect the quality of care.

"Many patients use online reviews of physicians for deciding which physicians to see and which to avoid," said Dr. Atanu Lahiri, associate professor of information systems in the Naveen Jindal School of Management. "At the same time, though, some physicians have become quite wary of these websites, and they have even filed defamation lawsuits over negative patient reviews. In short, while patients seem to trust the reviews, the physicians don't."

In their study, published online Sept. 23 in Information Systems Research, Lahiri and his colleagues examined the relationship between online reviews of physicians and their patients' actual clinical outcomes. They wanted to know how much consumers can rely on the reviews, specifically in regard to chronic-disease care.

Prior research on online reviews of physicians is rather limited and does not cover chronic diseases in general, Lahiri said. According to the Centers for Disease Control and Prevention, 90% of the $3.5 trillion that the U.S. spends annually on health care goes toward patients with chronic conditions such as chronic obstructive pulmonary disease (COPD), diabetes and long-term mental-health issues.

"Any chronic disease, by definition, is treatable but not curable," Lahiri said. "Think of a diabetic patient who needs continuous care and whose disease will never fully subside. Contrast this with an acute-care service, such as surgery to fix a broken leg. If the patient can walk soon after the surgery, the patient would know the surgery went well and could write an online review of the surgeon. However, when there is no visible recovery cue, as with chronic diseases, how can patients possibly know how well doctors treated them?"

Add the fact that a person with a chronic disease may see several physicians over years, and that various social and economic factors oftentimes influence chronic-disease treatment outcomes, it becomes apparent that writing accurate reviews is even more challenging for a patient, Lahiri said.

"Naturally, one ought to ask, 'Are chronic-disease patients capable of writing reviews that can inform prospective patients about the true care quality provided by a physician?'" Lahiri said. "In other words, should we trust the reviews that we see on websites such as Vitals, Healthgrades and Yelp?"

For the study, the researchers examined 10 years of COPD patient admission-discharge data for hospitals in North Texas, tracking each patient's clinical journey spanning multiple physicians. They also studied online reviews of physicians on one of the ranking websites and scored the overall sentiments expressed in the text of each review in addition to considering the accompanying star ratings.

For chronic diseases, the study found that online reviews do not reliably indicate the quality of care provided by a physician, as measured in terms of readmission risk and other similar broadly accepted clinical outcomes. Both the star ratings and textual reviews were found to be equally uninformative of the actual quality of care, Lahiri said.

"The result was indeed a surprise," he said. "Since prior research on online reviews is mostly based on search goods and experience goods, it typically finds that online reviews are useful to prospective consumers. A key takeaway is that the efficacy of online reviews of search and experience goods does not extend to credence goods, such as chronic-disease care.

"Given that credence goods are inherently different from search or experience goods, it is important to study them separately, which is precisely what we set out to do in this research."

Lahiri recommends that consumers reduce their overreliance on physician-review sites. While reviews may provide some information, such as whether the staff is courteous, they are not necessarily reliable indicators of the quality of care.

The study also has implications for health care administrators. Some hospitals link physicians' compensation to the quality of patient care, Lahiri said.

"Our message to hospitals would be that online reviews of physicians do not necessarily provide the best proxy for quality, especially in the case of physicians treating chronic-disease patients," he said. "Also, patient surveys administered by hospitals may have similar issues, so hospitals should be very careful when evaluating physicians treating chronic-disease patients."

Dr. Zhiqiang Zheng, Ashbel Smith Professor of information systems and finance at UT Dallas; Danish H. Saifee PhD'18, assistant professor of management information systems at the University of Alabama; and Dr. Indranil R. Bardhan, the Foster Parker Centennial Professor in Information Technology at UT Austin, also contributed to the research.

During Saifee's doctoral studies at UT Dallas, Lahiri was his advisor, and Bardhan, who was then at UT Dallas, and Zheng served on his dissertation committee. An earlier version of the paper won a Best Student Paper award at the Conference on Health IT and Analytics in 2017.

Receiving an initial antibiotic prescription for a viral acute respiratory infection--the type of infection that doesn't respond to antibiotics--increases the likelihood that a patient or their spouse will seek care for future such infections and will receive subsequent antibiotic prescriptions, according to the findings of a study from Harvard Medical School and the Harvard T.H. Chan School of Public Health.

The analysis, published online August 10 in Clinical Infectious Diseases, is believed to be the first to measure how variation in clinicians' antibiotic-prescribing patterns impacts patients' care-seeking behavior and antibiotic use in the long term.

The findings are alarming because they suggest that once such prescriptions are given improperly for a viral infection they could become a gateway to more antibiotic use, the researchers said. Overuse of antibiotics is common. Previous studies have shown that nearly a quarter of antibiotics prescribed in an outpatient setting are given inappropriately for a diagnosis that does not warrant antibiotic treatment.

"The choices physicians make about prescribing antibiotics can have long-term effects on when individual patients choose to obtain care," said lead study author Zhuo Shi, an HMS student in the Harvard-MIT Program in Health Sciences and Technology program. "A physician who prescribes an antibiotic inappropriately needs to understand that it's not just one little prescription of a harmless antibiotic but a potential gateway to a much bigger problem."

The researchers used encounter data from a national insurer to analyze more than 200,000 initial visits for acute respiratory infections (ARIs) at 736 urgent care centers across the United States. At those centers, the researchers found that antibiotic prescribing rates for ARIs varied greatly among clinicians. In the highest quartile of prescribers, 80 percent of clinicians prescribed antibiotics for viral respiratory infections, and in the lowest, 42 percent did. To understand the impact of greater antibiotic prescribing, the researchers exploited the fact that patients do not choose their urgent care clinician. They are essentially randomly assigned to a clinician.

In the year after an initial ARI visit, patients seen by clinicians in the highest-prescribing group received 14.6 percent more antibiotics for ARI--an additional three antibiotic prescriptions filled per 100 patients--compared with patients seen by the lowest-antibiotic-prescribing clinicians. The increase in patient ARI antibiotic prescriptions was largely driven by an increased number of ARI visits, an increase of 5.6 ARI visits per 100 patients, rather than a higher antibiotic prescribing rate during those subsequent ARI visits, the analysis showed.

It's not that they were more likely to get antibiotics on repeat visits, the researchers found, simply that each return visit provided another opportunity to receive antibiotics.

Why? In the case of a viral illness, patients wrongly attribute improvement in symptoms to the antibiotics. Naturally, next time they have similar symptoms they believe they need more antibiotics, the researchers said.

"You'll hear lots of people say, 'Every winter I need antibiotics for bronchitis,'" said study senior author Ateev Mehrotra, an associate professor of health care policy in the Blavatnik Institute at Harvard Medical School and a hospitalist at Beth Israel Deaconess Medical Center. "The antibiotics don't actually help, but patients tend to perceive a benefit. The fancy term for this psychological phenomenon is 'illusionary correlation.'"

"They get antibiotics and they feel better, not because the antibiotics have worked but because the infection has run its course," Mehrotra said. "The next time they become ill with similar symptoms they go back to the doctor to get another prescription."

And the lesson isn't just learned by the patients themselves. Their spouses showed similar increases in visits and use of antibiotics for ARIs.

The inappropriate use of antibiotics is a serious problem, the researchers said, noting that the practice increases spending unnecessarily, exposes patients to the risk of side effects for no medical reason and helps to drive the rise of antibiotic-resistant strains of bacteria.

Using encounter data from a national insurer, the researchers categorized clinicians within each urgent care center based on their ARI antibiotic prescribing rate. The fact that urgent care patients are randomly assigned to a clinician ruled out the possibility that patients might be choosing a physician they knew would likely give them antibiotics for their viral infection, enabling the researchers to examine the impact of physician behavior on future patient behavior. The researchers examined the association between the clinician's antibiotic prescribing rate and the patients' rates of ARI antibiotic receipt as well as their spouses' rate of antibiotic receipt in the subsequent year. Several members of the research team first applied this method to examine pattens of opioid prescribing.

While there is plenty of anecdotal evidence that some physicians say they give antibiotics to patients who request them to improve patient satisfaction, the researchers wanted to see whether and how physician prescribing behavior might be fueling the effect. They set out to answer the question: Could an initial prescription from a high-prescribing physician drive future antibiotic-seeking behavior among patients?

It does, the analysis showed, and the study, the researchers said, underscores the ongoing need to educate clinicians and patients on judicious prescribing practices to reduce inappropriate prescribing, as well as the overall overuse of antibiotics and its associate risks.

November 9, 2020 - The recently FDA-authorized alpha-defensin lateral flow test is a highly accurate, ten-minute test for diagnosis of periprosthetic joint infection (PJI) - a serious and costly complication of total joint replacement, reports a study in The Journal of Bone & Joint Surgery. The journal is published in the Lippincott portfolio in partnership with Wolters Kluwer.

The study shows "solid diagnostic performance" of the alpha-defensin lateral flow test, according to the report by Carl Deirmengian, MD, of The Rothman Orthopedic Institute, Wynnewood, Pa., and colleagues. The data led to US Food and Drug Administration authorization of the new test: the first rapid test for specifically designed and validated to aid in the diagnosis of PJI. The alpha-defensin test also represents the first diagnostic test specifically designed for use in orthopedics.

Lateral flow test enables faster, simpler diagnosis of PJI

Periprosthetic joint infection is a devastating complication of failed total hip or knee replacement, and one that can be challenging for orthopedic surgeons to diagnose. Accounting for 25 percent of total knee replacement failures and 16 percent of total hip replacement failures, PJI has a major impact on patients' lives and health-care costs.

Alpha defensins are peptides produced by the immune system specifically in response to an infection. The new test measures alpha-defensin levels in samples of synovial fluid from the joint. The new alpha-defensin lateral flow test is a simple test kit that provides results in 10 to 20 minutes. An alpha-defensin enzyme-linked immunosorbent assay (ELISA) is also available. With the ELISA, the sample must be sent to a laboratory, providing results in 24 to 48 hours.

Dr. Deirmengian and colleagues designed a formal study to evaluate the performance of the alpha-defensin lateral flow test in diagnosing PJI. The study included synovial fluid samples from 305 patients with knee (203 patients) or hip (102 patients) arthroplasties. Of these, 57 patients had PJI, based on expert review.

The alpha-defensin lateral flow test was highly accurate in distinguishing between patients with and without PJI. The sensitivity and specificity of the alpha-defensin lateral flow test was 94.3 percent and 94.5 percent, respectively, when excluding rare poor-quality synovial fluid samples that were composed of substantial blood (greater than 1M RBCs/μL). Including even the poor-quality samples, the test had a sensitivity of 89.5 percent and specificity of 94.8 percent.

Another important finding was that the diagnostic performance of the rapid lateral flow assay matched the accuracy of the laboratory-based test for alpha-defensin. Both tests demonstrated a diagnostic performance that closely matched the standard approach to PJI diagnosis, based on a combination of clinical findings and laboratory tests (Musculoskeletal Infection Society criteria).

"Our study enhances the literature by extending the evaluation of alpha defensin to a formal diagnostic trial, thus confirming the solid diagnostic performance demonstrated by previous studies using other methods." Dr. Deirmengian and coauthors write. They emphasize the need for further studies to compare different approaches to diagnosis in patients with suspected PJI.

New research reveals a perceived lack of support from family and friends affects a patient's ability to manage type 2 diabetes, according to a study published in The Journal of the American Osteopathic Association. Among vulnerable populations, the necessary modifications to daily lifestyle can be difficult to maintain without adequate social support, leading to diabetes-related distress that derails treatment.

Researchers found that as perceived social support increased, diabetes-related distress decreased. The scales used are established clinical tools that measure perceived social support and perceived distress related to diabetes.

"Too often diabetes treatment is understood as a simple process of taking medications and monitoring blood sugar," says Clipper Young, PharmD, MPH, associate professor and a clinical pharmacist at Touro University California College of Osteopathic Medicine. "In reality, diabetes is a chronic condition that requires a great deal of mental and emotional energy, which when depleted, can impair care."

Diabetes-related mortality and morbidity are highest among people with lower socioeconomic status. Yet, few previous studies have investigated the nature of diabetes distress and social support pertaining to underserved, diverse populations with type 2 diabetes.

The study was conducted at Solano County Family Health Services Clinics in Vallejo and Fairfield, California. Nearly 75% of the 101 study participants, who were between 40 and 80 years of age, reported an annual income of less than $20,000.

Integrate the family and support system into diabetes management

"Strong social support supplements effective diabetes self-management behaviors which, in turn, may reduce the risks of diabetes-related hospitalization and death," says Young.

Given the significant role that social support has on diabetes-related distress, clinicians are highly encouraged to focus not only on providing medical care for people with diabetes but also on learning about their support system to optimize diabetes management outcomes and reduce the risk of diabetes-related complications.

"This research signals that our opening conversation with patients should include a robust assessment of diabetes-related distress and perceived social support," says Young. "If that support is inadequate, we must think about how we can build it into their diabetes care plan."

DALLAS - Nov. 9, 2020 - Reducing the level of body fat and waist size are linked to a lower risk of heart failure in patients with type 2 diabetes, a study led by UT Southwestern researchers indicates. The findings, reported today in Circulation, suggest that all weight loss isn't equal when it comes to mitigating the risk of heart disease.

The burden of diabetes is increasing, with an estimated 700 million adults worldwide predicted to have this disease by 2045. The vast majority of cases are type 2 diabetes, characterized by insulin resistance, an inability for cells to respond to insulin. Type 2 diabetes doubles the risk of cardiovascular events such as heart failure and heart attacks.

Being overweight and obese are strong risk factors for both type 2 diabetes and heart disease, and patients are often counseled to lose weight to reduce the likelihood of developing both conditions. However, not all weight loss is the same, explains Ambarish Pandey, M.D., senior author of the study and assistant professor of internal medicine at UTSW.

"We have long counseled patients to lower their body-mass index into the 'healthy' range. But that doesn't tell us whether a patient has lost 'fat mass' or 'lean mass,' or where the weight came off," Pandey says. "We didn't know how each of these factors might affect patients' risk of heart disease."

Fat mass accounts for fat in different parts of the body while lean mass is mostly muscle.

Understanding the relationship between heart disease and body composition has proven especially challenging, Pandey explains, because there hasn't been an easy and inexpensive way to evaluate body composition. The gold standard of determining fat mass and lean mass is to measure it directly with tools like dual-energy X-ray absorptiometry (DXA), a scan that's cumbersome, expensive, and exposes patients to radiation.

To help answer how different types of weight loss can affect cardiovascular disease, Pandey and his colleagues used data from the Look AHEAD (Action for Health in Diabetes) Trial, which investigated the effects of either an intense lifestyle intervention focused on weight loss and physical activity or diabetes support and education in more than 5,000 overweight or obese adults with type 2 diabetes. The study collected information on the volunteers' weight, body composition, and waist circumference at the baseline and again one and four years later. It also tracked the incidence of heart failure in this group over a 12-year period.

The Look AHEAD Trial determined body composition with DXA. But Pandey and his colleagues used a new equation that incorporates age, sex, race/ethnicity, height, body weight, and waist circumference to estimate fat and lean mass - producing results that closely matched those from DXA scans.

Among the 5,103 participants in the Look AHEAD Trial, 257 developed heart failure over the follow-up period. Pandey and his colleagues found that the more these volunteers lowered their fat mass and waist circumference, the lower were their chances of developing heart failure. Just a 10 percent reduction in fat mass led to a 22 percent lower risk of heart failure with preserved ejection fraction and a 24 percent lower risk of heart failure with reduced ejection fraction, two subtypes of this condition. A decline in waist circumference significantly lowered the risk of heart failure with preserved injection fraction but not heart failure with reduced ejection fraction. However, a decline in lean mass didn't change the risk of heart failure at all.

These findings provide important insights, says Kershaw Patel, M.D., study author and former UTSW cardiology fellow who is now a cardiologist at Houston Methodist Hospital. "We showed that reductions in specific, not all, body composition parameters are linked to heart failure," Patel says.

More studies are needed to determine if reducing fat and retaining or increasing muscle may be more effective at decreasing the risk of heart failure, research that's facilitated with the new equation to estimate body composition, Pandey adds. In the meantime, he says, patients may benefit from incorporating strategies toward this goal - such as resistance training - into their weight loss efforts.

"Our study suggests that simply losing weight is not enough," Pandey says. "We may need to prioritize fat loss to truly reduce the risk of heart failure."

More than 1.2 million people in the US prevented facing death following a cancer diagnosis, between the year 2000 and 2016, thanks to ever improving treatment options - a large new national study shows.

Published in the peer-reviewed Journal of Medical Economics, the new findings highlight how new drugs commissioned during this period to target the 15 most common cancer types helped to reduce mortality by 24% per 100,000 people in the States.

The study, carried out by experts at PRECISIONheor and Pfizer, also show that 106 new treatments were approved across these 15 most common tumours - including colorectal cancer, lung cancer, breast cancer, non-Hodgkin's lymphoma, leukemia, melanoma, gastric cancer, and renal cancer.

These new cancer drug approvals were associated with significant decreases in deaths - as measured by treatment stocks. In 2016 alone, the team estimate that new treatments were associated with 156,749 fewer cancer deaths for the 15 most common tumor types.

Across the 16 years this mortality figure was down by 1,291,769, whilst the following cancers were also reduced significantly:

Breast cancer - 127,874

Colorectal - 46,705

Lung - 375,256

Prostate - 476,210

Non-Hodgkin lymphoma -48,836

Delivering the good news, lead author Dr Joanna MacEwan, from PRECISIONheor, says: "These findings can help contribute to a better understanding of whether increased spending on cancer drugs are worth the investment. While we do not answer this question directly, our results demonstrate that the result of successful investment--i.e., new cancer therapy approvals--generates significant benefits to patients.

"The efficacy of each treatment is estimated from clinical trial results, but this study provides evidence that the gains in survival measured in clinical trials are translating into health benefits for patients in the real world and confirms previous research that has also shown that new pharmaceutical treatments are associated with improved survival outcomes for patients."

Whilst mortality rates were down across many cancers, estimated deaths were up by 825 in people with thyroid cancer, and 7,768 for those with bladder cancer. The study explains these rises are likely due to the result of sparse drug approvals during this period: five for thyroid cancer and three for bladder cancer.

Co-author Rebecca Kee states more can still be done.

"There were no approvals in liver or uterine cancer from 2000 to 2016, and few approvals in pancreatic and oral cancer. Seven in 10 of the drug approvals came after 2008, in the latter half of the study time period. Thus, we haven't yet observed the full effect of their introductions in terms of reduced mortality," she added.

The study - funded by Pfizer - used a series of national data sets from sources including the Centers for Disease Control and Prevention, the US Mortality Files by the National Center of Health Statistics, Survival, Epidemiology and End Results program (SEER), and United States Cancer Statistics data.

The team calculated age-adjusted cancer mortality rates per year by the 15 most common tumor types.

They also looked at incident cases of cancer by tumor type - represented as per 100,000 population for all ages, races, and genders.

They then translated the change in cancer mortality in the USA from 2000 to 2016 associated with treatment stocks in each year into deaths averted per year from 2000 to 2016.

The treatment stock for each year was calculated as the weighted sum of new indication approvals since 1976 (which is a standard measure in this field of research).

The findings highlight how drugs prescribed are having a huge effect; with the mortality changes largest in prevalent tumor types with relatively more drug approvals: lung cancer, breast cancer, melanoma, lymphoma and leukemia.

"When interpreting these results, however, one must carefully evaluate whether there are alternative explanations for observed mortality reductions that may be correlated over time with new treatments," Dr MacEwan says.

Therefore, in order to control external factors - such as smoking rates, age distribution of the population, and cancer screening practices - and differentiate them from the impact of drug approvals, the team controlled for tumor-specific cancer incidence, driven by these underlying population level trends.

"Improved screening could partially explain the decline in mortality in some tumor types," Dr MacEwan explained, however.

"For instance, uptake of screening programs for breast, cervical, and colorectal cancer remained relatively high at >50% in 2015, all of which have been associated with mortality declines."

The overall figures uncovered likely understate the impact of new drugs approved between 2000 and 2016, the study suggests. This is because many drugs were approved later during the study period, meaning the bulk of mortality reductions are likely to be realized after the end of the study period.

Other limitations of the study include that new treatment interventions were limited to cancer pharmaceutical interventions and did not account for non-pharmaceutical innovations, such as robotic surgery, advances in radiotherapy and other surgical techniques, which may also affect cancer mortality.

The authors now call for future research to evaluate the relationship between drug approvals and cancer mortality post 2016.

DALLAS, Nov. 9, 2020 -- The new, investigational heart medication mavacamten may improve key structural abnormalities of obstructive hypertrophic cardiomyopathy, a condition characterized by thickened heart muscle that obstructs pumping of blood through the heart, according to research from the Phase 3 EXPLORER-HCM trial, to be presented at the American Heart Association's Scientific Sessions 2020. The meeting will be held virtually, Friday, November 13 - Tuesday, November 17, 2020, and is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care worldwide.

Hypertrophic cardiomyopathy affects 1 in 500 people and is caused by genes expressed in the heart muscle that trigger the walls of the heart chamber (the left ventricle) to contract harder and thicken more than normal. In obstructive hypertrophic cardiomyopathy, the wall between the two bottom chambers of the heart thicken, and the walls of the chamber that pumps blood can also become stiff. This may block or reduce the flow of blood from the left ventricle of the heart to the aorta. Current treatments for hypertrophic cardiomyopathy focus on relieving symptoms, such as chest pain and shortness of breath - especially with physical exertion, fatigue, abnormal heart rhythms, dizziness, fainting (syncope) and/or swelling in the ankles, feet, legs, abdomen and veins in the neck.

The EXPLORER-HCM clinical trial is an international, double-blind, placebo-controlled, phase three trial to evaluate the efficacy of mavacamten for adults with symptomatic obstructive hypertrophic cardiomyopathy. Recently, the primary results of the trial were announced, and mavacamten was shown to improve symptoms among those with obstructive hypertrophic cardiomyopathy. Among 244 patients (average age 58) who completed the trial, mavacamten led to significant improvement in reducing obstruction to flow through the heart, improving exercise capacity and symptoms.

This study is an additional analysis of data from the EXPLORER-HCM trial. Researchers found that mavacamten also reduces the size of the enlarged left atrium of the heart, decreases elevated filling pressures (reduces measures of stiffness) and restores normal mitral valve motion.

Participants with obstructive hypertrophic cardiomyopathy were randomly assigned to receive either mavacamten (in doses ranging from 2.5 to 15 mg) or a placebo daily for 30 weeks. Cardiac testing and patient evaluation were conducted every two-to-four weeks during the study period.

In this study, analyses of serial echocardiograms (ultrasounds of the heart) were reviewed to investigate the effect mavacamten had on additional specific measures of the heart's structure and function. Data from the analyses indicates 30-weeks of treatment with mavacamten led to improvement in measurements of the left ventricle's wall thickness and markers of blood flow through the heart. Additionally, abnormal motion of the mitral valve, which often leads to obstructive blood flow, and mitral valve regurgitation were resolved in most patients.

"Improvement in the key echocardiographic features of hypertrophic cardiomyopathy supports the hypothesis that mavacamten can be used as a disease-specific therapy, which would be a significant advance in therapy for this population," said Sheila M. Hegde, M.D., M.P.H., lead author of the study, a cardiovascular medicine specialist at Brigham and Women's Hospital and an instructor in medicine at Harvard Medical School, both in Boston. "These findings reinforced and extended data from prior open label trials. Additional changes in measures of cardiac structure and function were also observed including reduction in the size of the left atrium. Together, these results reflect this medication's impact on the underlying pathophysiology of hypertrophic cardiomyopathy. A long-term extension trial is ongoing and will provide additional insight on the long term-impact on cardiac structure and function."

DALLAS, Nov. 9, 2020 -- Nearly twice as many pregnancies were complicated by high blood pressure in 2018 than in 2007, and women living in rural areas continue to have higher rates of high blood pressure compared to their urban counterparts, according to preliminary research to be presented at the American Heart Association's Scientific Sessions 2020. The meeting will be held virtually, Friday, November 13 - Tuesday, November 17, 2020, and is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care.

Pre-pregnancy hypertension is a well-established risk to the health of both mothers and infants, and mortality rates of mothers are increasing in the U.S. with significant rural-urban disparities. The goal of the study, "Trends and Disparities in Pre-pregnancy Essential Hypertension Among Women in Rural and Urban United States, 2007-2018," was to detail trends in maternal pre-pregnancy high blood pressure so geographically targeted prevention and policy strategies can be developed.

"We were surprised to see the dramatic increase in the percentage over the last 10 years of women entering pregnancy with hypertension. It was also shocking to see women as young as 15 to 24 years old with high blood pressure, and the statistics were worse in rural areas, leading us to be concerned these numbers may, in part, be driven by hospital closures and difficulty accessing care," said the study's lead author Natalie A. Cameron, M.D., a resident in the department of medicine at Northwestern University's Feinberg School of Medicine in Chicago.

Researchers collected maternal data from almost 50 million live births in women ages 15 to 44, between 2007 and 2018, from the national CDC Natality Database. They calculated rates of pre-pregnancy hypertension per 1,000 live births overall and by the type of community the women lived in (rural or urban). The annual percentage change was calculated to compare yearly rates between rural and urban settings.

Results from the analysis indicate:

The rate of pre-pregnancy hypertension per 1,000 births nearly doubled in both rural (13.7 to 23.7) and urban (10.5 to 20) women.

In both rural and urban areas, hypertension rates were lower among younger women (ages 15-19) than in older women (40-44), yet all age groups experienced similar rate increases between 2007 and 2018.

The greatest annual percentage change of pre-pregnancy hypertension was nearly 10% for women in rural areas and 9% for women in urban areas.

"These data demonstrate unacceptable increases in the number of women with hypertension that need to be addressed urgently," says Cameron. "Preventive care must start before pregnancy. This is especially important in rural communities where there is a far greater burden of high blood pressure and much higher risks to the health of mother and baby. We also must address the structural and systemic racism that can be barriers to high quality care."

Important limitations of this work include the lack of data on continuous blood pressure measurements, as well as other important factors that can be related to high blood pressure such as body mass index.

DALLAS, Nov. 9, 2020 -- Restricting meals to early in the day did not affect weight among overweight adults with prediabetes or diabetes, according to preliminary research to be presented at the American Heart Association's Scientific Sessions 2020. The meeting will be held virtually, Friday, November 13 - Tuesday, November 17, 2020, and is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care worldwide.

"We have wondered for a long time if when one eats during the day affects the way the body uses and stores energy," said study author Nisa M. Maruthur, M.D., M.H.S., associate professor of medicine, epidemiology and nursing at Johns Hopkins University in Baltimore. "Most prior studies have not controlled the number of calories, so it wasn't clear if people who ate earlier just ate fewer calories. In this study, the only thing we changed was the time of day of eating."

Maruthur and colleagues followed 41 overweight adults in a 12-week study. Most participants (90%) were Black women with prediabetes or diabetes, and average age of 59 years. Twenty-one of the adults followed a time-restricted eating pattern, limiting eating to specific hours of the day and ate 80% of their calories before 1 p.m. The remaining 20 participants ate at usual times during a 12-hour window, consuming half of their daily calories after 5 p.m. for the entire 12 weeks. All participants consumed the same pre-prepared, healthy meals provided for the study. Weight and blood pressure were measured at the beginning of the study; then at 4 weeks, 8 weeks and 12 weeks.

The analysis found that people in both groups lost weight and had decreased blood pressure regardless of when they ate.

"We thought that the time-restricted group would lose more weight," Maruthur said. "Yet that didn't happen. We did not see any difference in weight loss for those who ate most of their calories earlier versus later in the day. We did not see any effects on blood pressure either."

The researchers are now collecting more detailed information on blood pressure recorded over 24 hours, and they will be compiling this information with the results of a study on the effects of time-restricted feeding on blood sugar, insulin and other hormones.

"Together, these findings will help us to more fully understand the effects of time-restricted eating on cardiometabolic health," Maruthur said.

DALLAS, Nov. 9, 2020 -- Despite clear evidence of the health benefits, the vast majority of young adults with cardiovascular disease are not getting the recommended annual influenza vaccine, according to preliminary research to be presented at the American Heart Association's Scientific Sessions 2020. The meeting will be held virtually, Friday, November 13 - Tuesday, November 17, 2020, and is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care worldwide.

For people with cardiovascular disease, getting the flu vaccine helps prevent the flu and its serious complications.

"Individuals with cardiovascular disease are more likely to have flu than among those without any chronic health conditions," said study lead author Tarang Parekh, M.B.B.S, M.S., Ph.D. candidate and assistant researcher at George Mason University College of Health and Human Services in Fairfax, Virginia. "Having a flu infection can exacerbate cardiovascular diseases like heart attack and stroke and can also lead to secondary infections such as pneumonia. You are putting yourself at increased risk when you don't get the flu vaccine."

For the study, researchers analyzed information on flu vaccination and cardiovascular disease from the 2018 Behavioral Risk Factor Surveillance System. For the survey, participants were asked whether they had a flu shot within the past 12 months and have a history of heart attack, angina (chest pain), congestive heart failure or stroke.

Using data from more than 100,000 adults, ages 18 to 44 years old, researchers categorized participants into two groups: 18- to 34-year-olds and 35- to 44-year-olds. The analysis looked at the vaccination rates between the two groups, focusing on those who had any cardiovascular disease.

The study revealed that:

Only about 20% of 18- to 34-year-olds who had a history of heart attack received an annual influenza vaccination, versus about one-fourth of those free from heart attack.

Only about 22% of 35- to 44-year-olds who had a heart attack got the flu vaccine, compared to about 28% of those with no history of heart attack.

Compared to younger adults, the flu vaccination rate in those with any cardiovascular disease was lower in older adults, 28% versus 26.7%, respectively.

Surprisingly, younger stroke survivors were more likely to be vaccinated: 27% of 18- to 34-year-olds who had a history of stroke received the flu vaccine, compared to 24% who never had a stroke.

Overall, the 2018 flu vaccine rate was higher among older adults (aged 35 to 44) than younger adults (aged 18 to 34), yet it was similar among younger adults, with or without a history of cardiovascular disease.

"If we look at our Healthy People 2020 goals, one major goal is to reach 70% of the population receiving the annual flu vaccine. However, we are not even at the halfway mark, especially when you consider that the vaccine rate among those with cardiovascular disease is significantly lower," Parekh said. "It's essential that young adults with cardiovascular disease receive the flu vaccine. We need to place greater focus on patients who are not being vaccinated and push a targeted intervention to close that gap."

The authors hope their study will increase awareness among cardiologists and the public. "The next step would be for the cardiovascular community to routinely recommend the flu vaccine to their patients. Putting the current recommendations into action has the potential to prevent serious heart complications and save lives," he said.

According to the American Heart Association's Chief Medical Officer for Prevention Eduardo Sanchez, M.D., M.P.H., FAAFP, this study provides additional merit for the American Heart Association's ongoing collaboration with American Lung Association and the American Diabetes Association:

"We have partnered with the American Lung Association and the American Diabetes Association to collectively deliver a message to physicians and other health care professionals and to the general public that all adults and all children, by and large, should be getting influenza vaccinations year after year. In particular, for patients who have chronic diseases like high blood pressure, diabetes or emphysema, it is critically important to get the annual flu vaccine. The potentially serious complications of the flu are far, far greater for those with chronic diseases," said Sanchez.

DALLAS, Nov. 9, 2020 -- Individuals who consume chili pepper may live longer and may have a significantly reduced risk of dying from cardiovascular disease or cancer, according to preliminary research to be presented at the American Heart Association's Scientific Sessions 2020. The meeting will be held virtually, Friday, November 13-Tuesday, November 17, 2020, and is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care worldwide.

Previous studies have found eating chili pepper has an anti-inflammatory, antioxidant, anticancer and blood-glucose regulating effect due to capsaicin, which gives chili pepper its characteristic mild to intense spice when eaten. To analyze the effects of chili pepper on all-cause and cardiovascular disease mortality, researchers screened 4,729 studies from five leading global health databases (Ovid, Cochrane, Medline, Embase and Scopus). Their final analysis includes four large studies that included health outcomes for participants with data on chili pepper consumption.

The health and dietary records of more than 570,000 individuals in the United States, Italy, China and Iran were used to compare the outcomes of those who consumed chili pepper to those who rarely or never ate chili pepper. Compared to individuals who rarely or never ate chili pepper, the analysis found that people who ate chili pepper had:

a 26% relative reduction in cardiovascular mortality;

a 23% relative reduction in cancer mortality; and

a 25% relative reduction in all-cause mortality.

"We were surprised to find that in these previously published studies, regular consumption of chili pepper was associated with an overall risk-reduction of all cause, CVD and cancer mortality. It highlights that dietary factors may play an important role in overall health," said senior author Bo Xu, M.D., cardiologist at the Cleveland Clinic's Heart, Vascular & Thoracic Institute in Cleveland, Ohio. "The exact reasons and mechanisms that might explain our findings, though, are currently unknown. Therefore, it is impossible to conclusively say that eating more chili pepper can prolong life and reduce deaths, especially from cardiovascular factors or cancer. More research, especially evidence from randomized controlled studies, is needed to confirm these preliminary findings."

Dr. Xu said that there are several limitations to this type of study. The four studies reviewed included limited specific health data on individuals or other factors that may have influenced the findings. Researcher also noted that the amount and type of chili pepper consumed was variable among the studies, making it difficult to draw conclusions about exactly how much, how often and which type of chili pepper consumption may be associated with health benefits. The researchers are continuing to analyze their data and hope to publish the full paper soon.

DALLAS, Nov. 9, 2020 -- Green spaces - trees, shrubs and grasses - can improve air quality and may lower heart disease deaths, according to preliminary research to be presented at the American Heart Association's Scientific Sessions 2020. The meeting will be held virtually, Friday, November 13 - Tuesday, November 17, 2020, and is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care worldwide.

"We found that both increased greenness and increased air quality were associated with fewer deaths from heart disease," said William Aitken, M.D., a cardiology fellow with the University of Miami Miller School of Medicine and UM/Jackson Memorial Hospital in Miami, Florida.

Greenness is a measure of vegetative presence (trees, shrubs, grass) often assessed by NASA imaging of the Earth and other methods. Here, researchers used the Normalized Difference Vegetative Index (NDVI), which measures wavelengths of visible and near-infrared sunlight reflected from the Earth's surface via NASA satellite imagery. A higher index corresponds to more healthy vegetation, as chlorophyll typically absorbs visible light and reflects near-infrared light.

In this cross-sectional study conducted using national air quality, greenness, CVD and census data from 2014-2015, researchers measured greenness by county across the United States and compared it to national disease death rates from the Centers for Disease Control and Prevention's Interactive Atlas of Heart Disease. They also overlaid data from the Environmental Protection Agency's air quality measurements of particulate matter for each county and the Census Bureau's information on age, race, education and income by county.

The analysis found:

For every 0.10 unit increase in greenness, deaths from heart diseases decreased by 13 deaths per 100,000 adults. Greenness (NDVI) values ranged from 0.00 - 0.80.

For every 1 microgram increase in particulate matter per cubic meter of air, death from heart disease increased by roughly 39 deaths per 100,000 adults.

"We found that areas with better air quality have higher greenness, and that having higher greenness measures, in turn, is related to having a lower rate of deaths from heart disease," said Aitken, who collaborated on the research with University of Miami public health scientists.

"Given the potential cardiovascular benefits of higher greenness measures, it's important that dialogue about improved health and quality of life include environmental policies that support increasing greenness. Policymakers should support greenness through efforts that promote environmental justice through equitable access to green spaces, clean air and clean water, as well as minimizing exposure to environmental hazards," he added.

The researchers hope their results encourage clinical trials using built environment interventions (e.g., tree planting to increase vegetative presence and greenness) to improve cardiovascular health. "We will be performing a longitudinal study in Miami to assess if changes in neighborhood greenness over time are associated with changes in cardiovascular disease," Aitken said.

The main limitations of this study include that it was cross-sectional and used a total of combined cardiovascular disease death rates.