Body

In the ongoing arms race between humans and the parasite that causes malaria, Taane Clark and colleagues at the London School of Hygiene and Tropical Medicine (LSHTM) report that new mutations that enhance resistance to a drug used to prevent malaria in pregnant women and children are already common in countries fighting the disease. The new results are published December 31 in PLOS Genetics.

Malaria causes about 435,000 deaths each year, primarily in young children in sub-Saharan Africa. Despite a long-term global response, efforts to control the disease are hampered by the rise of drug-resistant strains of the parasite species that cause malaria. Sulfadoxine-pyrimethamine (SP), for example, was once a first-line anti-malaria treatment, but now primarily is used to prevent infection in pregnant women and children. Mutations in two genes in the parasite Plasmodium falciparum offer resistance to SP, but recently, mutations related to resistance were discovered in a third gene, pfgch1. To understand the extent and spread of these new mutations, Clark and colleagues analyzed genome sequences from 4,134 blood samples collected from 29 countries where malaria is endemic. They discovered at least ten different versions of pfgch1, which occur in about one quarter of the samples from Southeast Asia and in one third of the samples from Africa, where strains carrying the mutations may be on the rise.

The growth in the number of malaria parasites with pfgch1 mutations is concerning, because the mutations enhance resistance to SP and may encourage the evolution of new resistant strains. As a result, their growth may threaten efforts to use SP to prevent malaria in vulnerable groups. With the identification of these pfgch1 mutations through the new study, however, scientists can monitor their presence in parasite populations, to understand where SP can be used effectively, and where rates of drug-resistance are already too high.

"We need to understand how these mutations work and monitor them as part of malaria surveillance programs," says Clark.

Colin Sutherland, an author and co-Director of the LSHTM Malaria Centre, says, "SP is an established drug for malaria prevention and treatment in vulnerable groups such as pregnant women and children. We may have underestimated its vulnerability to parasite resistance, as these new data show."

BOSTON - Reports of possible allergic reactions to the COVID-19 vaccines produced by Pfizer-BioNTech and Moderna, both recently approved for emergency use by the U.S. Food and Drug Administration (FDA), have raised public concern. A team of experts led by allergists at Massachusetts General Hospital (MGH) has now examined all relevant information to offer reassurance that the vaccines can be administered safely even to people with food or medication allergies. The group's review is published in the Journal of Allergy and Clinical Immunology: In Practice.

In response to accounts of potential allergic reactions in some people following COVID-19 vaccination in the United Kingdom, that country's medical regulatory agency advised that individuals with a history of anaphylaxis to a medicine or food should avoid COVID-19 vaccination. After closer review of the data related to allergic reactions, however, the FDA recommended that the vaccines be withheld only from individuals with a history of severe allergic reactions to any component of the COVID-19 vaccine, and the Centers for Disease Control and Prevention advised that all patients be observed for 15 minutes post-vaccination by staff who can identify and manage such reactions. The U.S. agencies do not recommend that people with food or medication allergies avoid vaccination.

To provide insights from allergists' perspectives, Aleena Banerji, MD, clinical director of the Allergy and Clinical Immunology Unit at MGH and associate professor at Harvard Medical School, and her colleagues have summarized what's currently known about allergic reactions to vaccines like those developed against COVID-19, and they have proposed detailed advice so that individuals with different allergy histories can safely receive their first COVID-19 vaccine. They also outline steps on safely receiving the second dose in individuals who develop a reaction to their first dose of COVID-19 vaccine.

"As allergists, we want to encourage vaccination by reassuring the public that both FDA-approved COVID-19 vaccines are safe. Our guidelines are built upon the recommendations of U.S. regulatory agencies and provide clear steps to the medical community on how to safely administer both doses of the vaccine in individuals with allergic histories," says Banerji.

The experts note that allergic reactions to vaccines are rare, with a rate of about 1.3 per 1 million people. They also determined that the Pfizer-BioNTech and Moderna COVID-19 vaccine allergic reactions will have a similarly low rate of occurrence. They stress that vaccine clinics will be monitoring all patients for 15 to 30 minutes and can manage any allergic reactions that occur. Banerji and her co-authors recommend that individuals with a history of anaphylaxis to an injectable drug or vaccine containing polyethylene glycol or polysorbate speak with their allergists before being vaccinated. They stress that patients with severe allergies to foods, oral drugs, latex, or venom can safely receive the COVID-19 vaccines.

COLUMBUS, Ohio -- When using social media to nudge people toward safe and healthy behaviors, it's critical to make sure the words match the pictures, according to a new study.

After looking at social media posts, parents of young children were better able to recall safety messages such as how to put a baby safely to sleep when the images in the posts aligned with the messages in the text, the researchers found.

The study appears in the Journal of Health Communication.

"Many times, scientists and safety experts aren't involved in decisions about social media for health agencies and other organizations, and we end up seeing images that have nothing to do with the safety message or, worse, images that contradict the guidance," said lead author Liz Klein, an associate professor of public health at The Ohio State University.

Take the safe sleep example, for instance. The researchers found posts that advocated a bumper-free crib for baby but used an image of an infant in a crib with bumpers. They saw posts about preventing head injury with bike helmets illustrated by pictures of kids without bike helmets.

"In this study, we were trying to understand how much those mismatches matter -- do people understand the message even if the picture isn't right? Does the picture really matter?" Klein said.

Their answers came from research using eye-tracking technology to gauge the attention young parents paid to various posts, and subsequent tests to see what they recalled about the safety messages.

When the 150 parents in the study were shown a trio of posts with matched imagery and text and three other posts with mismatched visual and written messages, they spent far longer on the matched posts -- 5.3 seconds, compared to the 3.3 seconds their eyes lingered on the mismatched posts.

Further, the matched messages appeared to make a difference in understanding and recall of safety messages. After accounting for differences in health literacy and social media use among participants, the researchers found that each second of viewing time on matched posts was associated with a 2.8% increase in a safety knowledge score.

"With nearly 70% of adults reporting use of social media, and many parents using social media and other internet sources to keep current on injury prevention strategies, social media is a great opportunity to broadcast safety and injury prevention messages," said study co-author Lara McKenzie, a principal investigator in the Center for Injury Research and Policy at Nationwide Children's Hospital in Columbus.

"As more health organizations and public health agencies use social media to share health information with the public, the findings of our study underscore the need to ensure that the imagery and text in social media posts are aligned."

Klein said she understands that those managing social media accounts may be drawn to images that are the most attention-grabbing. But when it comes to health and safety, this study suggests that making sure the image and the text are sending the same message is more important.

"If you want people to put their medicine up and out of reach of children, kids to wear their bike helmets or new parents to remember that babies should always go to sleep on their backs, alone and in a crib -- that's where matching matters. Maybe save the eye-grabbing stuff and the humorous posts for different purposes."

Klein said the findings in this study likely extend beyond child safety messaging to any number of health and safety campaigns, but that there's more work to be done to understand how best to harness the power of social media for different types of public health communication.

"We need to pay more attention to how we communicate with the people we're trying to influence with health and safety guidance. All of us can do a better job of thinking about how we use our social media accounts to contribute to better public health," she said.

WHAT:

The investigational vaccine known as mRNA-1273 was 94.1% efficacious in preventing symptomatic coronavirus disease 2019 (COVID-19), according to preliminary results from a Phase 3 clinical trial reported in the New England Journal of Medicine. The vaccine also demonstrated efficacy in preventing severe COVID-19. Investigators identified no safety concerns and no evidence of vaccine-associated enhanced respiratory disease (VAERD).

The vaccine was co-developed by Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Moderna and NIAID previously shared initial results from the COVE trial. On Dec. 18, 2020, the FDA issued an Emergency Use Authorization allowing Moderna to make the vaccine available for the prevention of COVID-19 in adults in the United States.

The trial was led by principal investigators Lindsey R. Baden, M.D. of Brigham and Women's Hospital in Boston, Hana M. El-Sahly, M.D. of Baylor College of Medicine in Houston, and Brandon Essink, M.D., of Meridian Clinical Research. The trial was implemented under the U.S. government's Operation Warp Speed program and supported by NIAID and the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response.

The trial began on July 27, 2020, and enrolled 30,420 adult volunteers at clinical research sites across the United States. Volunteers were randomly assigned 1:1 to receive either two 100 microgram (mcg) doses of the investigational vaccine or two shots of saline placebo 28 days apart. The average age of volunteers is 51 years. Approximately 47% are female, 25% are 65 years or older and 17% are under the age of 65 with medical conditions placing them at higher risk for severe COVID-19. Approximately 79% of participants are white, 10% are Black or African American, 5% are Asian, 0.8% are American Indian or Alaska Native, 0.2% are Native Hawaiian or Other Pacific Islander, 2% are multiracial, and 21% (of any race) are Hispanic or Latino.

From the start of the trial through Nov. 25, 2020, investigators recorded 196 cases of symptomatic COVID-19 occurring among participants at least 14 days after they received their second shot. One hundred and eighty-five cases (30 of which were classified as severe COVID-19) occurred in the placebo group and 11 cases (0 of which were classified as severe COVID-19) occurred in the group receiving mRNA-1273. The incidence of symptomatic COVID-19 was 94.1% lower in those participants who received mRNA-1273 as compared to those receiving placebo.

Investigators observed 236 cases of symptomatic COVID-19 among participants at least 14 days after they received their first shot, with 225 cases in the placebo group and 11 cases in the group receiving mRNA-1273. The vaccine efficacy was 95.2% for this secondary analysis.

There were no concerning safety issues with vaccination, according to the authors. Local reactions to the vaccine were generally mild. About 50% of participants receiving mRNA-1273 experienced moderate-to-severe side effects--such as fatigue, muscle aches, joint pain and headache--after the second dose, which resolved in most volunteers within two days.

Investigators also observed no evidence of VAERD among those who received mRNA-1273. This rare complication was seen in individuals vaccinated with a whole-inactivated respiratory syncytial virus (RSV) vaccine in the 1960s, before there was a capacity to define protein structures and measure immune responses with precision. VAERD can occur when a vaccine induces an immune response that is not strong enough to protect against infection.

Although mRNA-1273 is highly efficacious in preventing symptomatic COVID-19, there is not yet enough available data to draw conclusions as to whether the vaccine can impact SARS-CoV-2 transmission. Preliminary trial data suggests there may be some degree of prevention of asymptomatic infection after a single dose. Additional analyses are underway of the incidence of asymptomatic infection and viral shedding post-infection to understand the vaccine's impact on infectiousness.

The authors concluded by discussing the unprecedented efficiency of the candidate vaccine's development, noting, "this process demonstrates what is possible in the context of motivated collaboration among key sectors of society including academia, government, industry, regulators and the larger community."

December 30, 2020 - As the COVID-19 pandemic emerged, trauma centers faced unprecedented obstacles to providing care for injured patients. A look at steps taken by trauma centers in response to COVID-19 is provided by a survey in the January/February Journal for Healthcare Quality (JHQ), the peer-reviewed journal of the National Association for Healthcare Quality (NAHQ). The journal is published in the Lippincott portfolio by Wolters Kluwer.

Trauma centers introduced new processes to optimize use of personal protective equipment (PPE), ICU beds, ventilators, and other limited resources, according to the report by David Bar-Or, MD, of ION Research, Englewood, Colo., and colleagues. "This information will be of value as trauma centers continue to respond and adapt to the pandemic, focusing on meeting the need for critical trauma services while protecting the health of trauma care teams," Dr. Bar-Or comments.

New processes to provide care at U.S. trauma centers, despite scarce resources

As the pandemic took hold in the spring of 2020, hospitals struggled to provide care not only for patients with COVID-19, but also for other groups of patients in need of care that couldn't be delayed. While the American College of Surgeons Committee on Trauma provided initial guidance on maintaining trauma center access, it was up to individual trauma centers to work out detailed processes for providing patient care.

"Trauma centers have a unique situation in that admissions for traumatic injuries are not scheduled and therefore cannot be cancelled or postponed," Dr. Bar-Or and colleagues point out. "Accordingly, they must prepare for an influx of patients with acute respiratory symptoms and continue care for patients with traumatic injuries."

To gain insights into how they met these challenges, Dr. Bar-Or and colleagues surveyed directors of six level I trauma centers in four states: Colorado, Kansas, Missouri, and Texas. The responses provided insights into changes in key areas, including:

N-95 respirators. Trauma centers faced shortages of essential N-95 respirator masks. Four of the six trauma centers surveyed reported reusing respirators after employing various methods of sanitization or sterilization. At some centers, trauma team members received only one mask per day or per week.

PPE. Most trauma centers clustered patient contacts, with the aim of minimizing need for personal protective equipment (masks, gowns, respirators, etc). Four hospitals increased PPE use for all patients on arrival, while two provided PPE to symptomatic patients. One hospital had to request PPE from local government due to regional shortages.

ICU beds. Five hospitals added ICU beds, while three designated a specific ICU for COVID-19 patients. All hospitals isolated COVID-19 patients in negative pressure rooms. In some cases, rooms or entire floors were converted to negative pressure.

Mechanical ventilation. Two trauma centers created ventilator allocation protocols. Three centers reported daily tracking of ventilator use, while three requested additional ventilators in anticipation of a surge. The trauma centers reported varying changes to intubation protocols, and in the use of noninvasive ventilation approaches (CPAP or BiPAP).

The survey was conducted in the latter half of May 2020, as U.S. Coronavirus deaths passed the 100,000 mark. At that time, none of the trauma centers had experienced an overwhelming surge of COVID-19 patients. "This could be due to the actions taken to allow for additional treatment beds," the researchers write.

The survey provides a snapshot of how trauma teams and hospitals met the need for essential trauma care through the first months of the Coronavirus crisis. "This study summarized the processes that participating trauma centers developed to protect the trauma patient and trauma care providers while providing optimal trauma care for patients--without specific guidance from professional organizations," Dr. Bar-Or and colleagues conclude. "This was possible even when faced with scarce resources."

What The Study Did: Severe COVID-19 is characterized by the intense formation of neutrophil extracellular traps (NETs), leading to the blockage of microvessels, as shown in pulmonary samples. The occurrence of ST-elevated myocardial infarction (STEMI) is a serious cardiac manifestation of COVID-19; the intrinsic mechanism of coronary thrombosis appears to still be unknown. This case series report of five patients sought to determine the role of NETs in coronary thrombosis in patients with COVID-19.

Authors: Ana Blasco, M.D., Ph.D., of the Hospital Universitario Puerta de Hierro-Majadahonda in Madrid, Spain, 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/jamacardio.2020.7308)

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

Small studies have suggested that a group of medications called RAS inhibitors may be harmful in persons with advanced chronic kidney disease, and physicians therefore often stop the treatment in such patients. Researchers at Karolinska Institutet now show that although stopping the treatment is linked to a lower risk of requiring dialysis, it is also linked to a higher risk of cardiovascular events and death. The results are published in The Journal of the American Society of Nephrology.

Chronic kidney disease (CKD) affects approximately ten percent of the global population. Hypertension is the most common comorbidity. Patients with CKD have an increased risk of cardiovascular disease and death.

Advanced chronic kidney disease is classified as 'severely decreased kidney function' and is defined as the kidney's ability to clean the blood being less than approximately 30 percent of normal for a young adult. In some patients, CKD progresses to the point that dialysis or transplantation is required as a kidney replacement therapy to prolong life.

Renin-angiotensin system inhibitors (RAS inhibitors), including both ACE inhibitors (ending in 'pril') and ARBs (ending in 'sartan'), are common medications for the treatment of hypertension, cardiovascular disease, heart failure and CKD. However, not enough is known about their efficacy and safety in patients with advanced CKD, since this population was underrepresented in the landmark randomised trials.

"Small-scale studies have suggested that stopping RAS inhibitors in these patients may improve kidney function and delay the need for kidney replacement therapy," says Edouard Fu, MD and PhD Candidate at the Department of Clinical Epidemiology, Leiden University Medical Center and the study's first author. "However, stopping these medications may also increase the risk of heart attacks, stroke and death. We wanted to help practitioners by evaluating the risks and benefits of this decision, and Swedish Quality Registers are uniquely suited to answer this question."

Researchers at Karolinska Institutet and collaborators have conducted an epidemiological study using data from the Swedish Renal Registry to evaluate over 10,000 patients with advanced CKD who received RAS inhibitors over the past decade.

Comparing morbidity and mortality rates in patients whose treatment was discontinued with those who continued the drug regimen, the researchers found that discontinuing these medications was associated with an eight percent lower risk of requiring kidney replacement therapy.

However, discontinuing was also linked to a thirteen percent higher risk of death at five years, and a twelve percent higher risk of suffering a heart attack or stroke.

"The use of RAS inhibitors in patients with advanced CKD is controversial, and many doctors deprescribe them," says principal investigator Juan Jesus Carrero, professor at the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet in Sweden. "Rather than routinely discontinuing treatment, our results show that the issue is a complex one and that doctors must carefully weigh the protective effects of RAS inhibitors on the cardiovascular system against the potential harms on the kidneys. Until clinical trials are performed, this evidence supports continued use of this lifesaving therapy in patients with advanced CKD who are doing well on the medications."

He points out that sometimes these medications may have to be stopped for other reasons, for example, if patients have persistently high blood potassium levels that don't respond to management.

Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.

1. Despite recommendations, patients with treatment-resistant hypertension rarely tested for primary aldosteronism
Abstract: https://www.acpjournals.org/doi/10.7326/M20-4873
URL goes live when the embargo lifts

A retrospective cohort study found that testing for primary aldosteronism in patients with treatment-resistent hypertension was rare and also associated with higher rates of evidence-based treatment and better longitudinal blood pressure control. The findings are published in Annals of Internal Medicine.

Primary aldosteronism is a common cause of secondary hypertension and is highly prevalent among patients with treatment-resistant hypertension. Primary aldosteronism is associated with a 4- to 12-fold increased risk for adverse cardiovascular events compared with primary hypertension and can be effectively treated with MRAs or surgery. Although clinical practice guidelines recommend aldosteronism screening for such patients, they may not be followed.

Researchers from the University of Pennsylvania Perelman School of Medicine, Stanford University, and University of Michigan reviewed data from the Veterans Health Administration (VHA) for more than 269,000 veterans with incident apparent treatment-resistant hypertension to evaluate testing rates for primary aldosteronism (plasma aldosterone-renin) and evidence-based hypertension management. Treatment-resistant hypertension was defined as either 2 blood pressures of at least 140 mm Hg (systolic) or 90 mm Hg (diastolic) at least 1 month apart during use of at least 3 antihypertensive agents (including a diuretic), or hypertension requiring at least 4 antihypertensive classes.

The data showed that fewer than 2% of patients with incident apparent treatment-resistant hypertension underwent guideline-recommended testing for primary aldosteronism. Testing rates ranged from 0% to 6% across medical centers and did not correlate to population size of patients with apparent treatment-resistant hypertension. Testing also was associated with higher rates of evidence-based treatment with mineralocorticoid receptor antagonist (MRAs) and better longitudinal blood pressure control. Testing rates also did not change meaningfully over nearly 2 decades of follow-up despite an increasing number of guidelines recommending testing for primary aldosteronism in this population. According to the researchers, these findings suggest an opportunity for the VHA to introduce innovative practices to educate providers about the importance of testing high-risk patients.

Media contacts: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To reach the corresponding author, Jordana B. Cohen, MD, MSCE, please contact Lauren Ingeno at Lauren.Ingeno@Pennmedicine.upenn.edu.

2. A stepped exercise program may improve symptoms of knee osteoarthritis
Abstract: https://www.acpjournals.org/doi/10.7326/M20-4447
Summaries for Patients (Free): https://www.acpjournals.org/doi/10.7326/P20-0013
URL goes live when the embargo lifts

An adaptive stepped approach to delivering exercise and physical therapy interventions for knee osteoarthritis improved pain and physical function compared with arthritis education alone in a randomized controlled trial. The findings are published in Annals of Internal Medicine.

Knee osteoarthritis is a common condition that may be painful and limit a person's activity level. Exercise with or without a physical therapist can help, but many patients do not exercise. A stepped care model that moves from exercises a patient can do on their own to in-person physical therapy might be an effective way to meet patients' needs.

Researchers from the Veterans Administration (VA) Health Care System randomly assigned 345 patients with painful knee osteoarthritis at two VA health care sites to an exercise program called STEP-KOA (stepped exercise program for patients with knee osteoarthritis) or to arthritis education. The STEP-KOA program consists of a 3-level intervention that progresses based on patient needs. If the internet-based exercise program in step 1 was not effective, the patient moved to step 2, 3 months of physical activity coaching calls twice per month. If pain still did not approve, the patient advanced to step 3, in-person physical therapy visits. The arthritis education group received educational materials via mail every 2 weeks. After 9 months, the researchers found that of the patients in the stepped exercise program, 65% progressed to step 2 and 35% went on to step 3. The stepped care group also showed greater improvement in pain and function levels compared with the group that received arthritis education only.

According to the researchers, this type of stepped care strategy could preserve health care resources and tailor programs to patients' needs. However, more work would be needed to increase patient engagement in such programs.

Media contacts: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To reach the corresponding author, Kelli D. Allen, PhD, please contact James Shahron at Shahron.James@va.gov.

What The Study Did: The likelihood of having obesity or eating disorders was compared between sexual and gender minority children ages 9 to 10 and other children in this study.

Authors: Natasha A. Schvey, Ph.D., of the Uniformed Services University of the Health Sciences in Bethesda, Maryland, is the corresponding author.

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

(doi:10.1001/jamapediatrics.2020.5152)

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

December 28, 2020 - Platelet-rich plasma (PRP) treatment, which involves injecting a small amount of a patient's own blood to release various growth factors from platelets, continues to increase in popularity. The American Society of Plastic Surgeons has tracked the procedure since 2015 and reports a 25 percent increase in cosmetic PRP use in the last four years.

That increase in popularity could in part trace back to celebrities extolling the procedure's cosmetic benefits. Yet with so much information coming from so many different sources about the treatment's myriad uses, it's difficult to understand the full extent of its advantages and limitations.

"Treatments using PRP show great promise for harnessing the body's own natural tissue repair processes to help our patients achieve improved form and function," said Edward Chamata, MD, of Baylor College of Medicine, Houston, lead author of a review and update on the science behind PRP and its evolving role in plastic surgery. The review is published in the January issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS).

Platelet-rich plasma has many characteristics that make it very attractive for use in plastic surgery: it's easy and inexpensively produced using the patient's own cells, with little or no risk of adverse effects. However, particularly for cosmetic procedures, treatments can be time consuming and may require multiple sessions.

Platelets are blood cells that play a critical role in blood clotting. When tissue damage occurs, platelets rush to the area, initiating a cascade of events to stop bleeding and start the wound-healing process. Platelets have been shown to release over 30 growth factors and other biologically active proteins, with effects including new blood vessel formation and tissue growth.

This "cocktail" of natural growth factors likely explains the wide range of therapeutic benefits reported with PRP. Platelet-rich plasma is prepared by various methods of centrifugation, spinning a small sample of the patient's blood into separate components. The red blood cells are removed, leaving the liquid component of blood (plasma) with a high concentration of platelets, sometimes with leukocytes (white blood cells).

Initially used for treatment of skin conditions and to promote bone grafting, PRP has found a growing number of uses in several surgical specialties - including plastic surgery. In the US alone, plastic surgeons performed more than 130,000 cosmetic minimally invasive procedures in 2019. Dr. Chamata and colleagues reviewed the evidence on promising applications of PRP in four key areas:

Skin rejuvenation - Historically, PRP was injected underneath the skin to improve skin texture, color and reduce wrinkle depth; however, more recently, there's been high interest in the so-called "vampire facial," consisting of nonsurgical microneedling followed by topical application of PRP. Current evidence suggests microneedling can increase collagen production, skin tightening and rejuvenation. Microneedling in conjunction with PRP has also emerged for treatment of atrophic acne scars and skin pigmentation disorders.

Hair regrowth - Used alone or in combination with hair transplants, and effective for both men and women, PRP increases proliferation rates of human dermal papilla cells that regulate hair follicle growth. According to the study, through binding of growth factors as well as interactions between dermal papilla cells and primitive stem cells, activation of the proliferative phase of the hair cycle begins, leading to hair follicle formation and maintenance.

PRP with laser treatment - Approaches combing PRP with laser resurfacing therapy have shown good results in facial rejuvenation and for treatment of acne scars. In addition to promoting healing, the growth factors provided by PRP may help to reduce redness and inflammation caused by laser treatments.

PRP with fat grafting - Fat grafting is another expanding technique in plastic surgery, transferring the patient's own fat cells for a wide range of cosmetic and reconstructive procedures. Some studies have reported dramatic improvements in skin contour and volume with PRP, compared to fat grafting alone.

"PRP has emerged as one of the most desired non-surgical treatments for a range of different cosmetic procedures - although in some cases the claims may exceed the available evidence," Dr. Chamata adds. "Plastic surgeons are on the leading edge of identifying promising uses for PRP - including developing standardized procedures and building a body of evidence for good patient outcomes."

A landmark paper published today in the New England Journal of Medicine describes the results from a global trial across 148 sites in 23 countries, showing a 30 per cent improvement in survival in patients with acute myeloid leukemia (AML). 

The Phase 3 clinical trial called QUAZAR, showed that a drug, called CC-486, significantly improved survival in older patients, over the age of 55, with the disease.  AML is the most acute blood cancer in adults and its incidence increases with age, with a poor prognosis. With current treatments, the majority of older patients will die of their disease within 2 years of diagnosis.

Around 20,000 people in the United States are diagnosed with AML every year.

The global trial, led by Professor Andrew Wei from Monash University's Australian Centre for Blood Diseases and a haematologist at Alfred Health, focused on people with AML over 55 years of age, "because of an unmet need to identify new agents able to improve outcome in patients after completing chemotherapy," he said.

"After intensive chemotherapy, the risk of AML relapse is high. Many older patients are not eligible to receive a stem cell transplant and so a less toxic option to reduce disease recurrence is desirable, rather than just being monitored and waiting for the disease to come back," he said.

"Based on the results of the QUAZAR study, it is very exciting to think that, by taking a tablet that is relatively well-tolerated, we can help reduce relapse risk and improve survival."

The trial involved 472 patients, with an average age 68 years, who were either given CC-486 or a placebo.

Those receiving the drug - which has the added advantage of being a tablet that can be taken at home - had an average survival from remission of almost 25 months compared to those who did not take the drug, whose average survival was almost 15 months.

Following Professor Wei's presentation of the results at the American Society for Hematology meeting in the United States in December 2019, the Food and Drug Administration fast-tracked approval for the use of CC-486 in the U.S in September this year.

Professor Wei says the data presented in the NEJM is likely to establish a new standard of care for older patients with AML, "because our findings show that CC-486 significantly delays recurrence of the disease, thereby prolonging survival and without impacting on quality of life".

"This is a very significant advance because the drug is easy to administer and means that adults with AML don't have to spend extra time in hospital," he said.

Professor Wei added the drug is currently not approved for use in Australia.

The use of a standardized tool for assessing the risk of serious outcomes in patients with chest pain was associated with women at high risk receiving comparable care to men, according to new research published in the Annals of Emergency Medicine. Care received by women at low and intermediate risk was consistent with current clinical recommendations. Men received more stress testing and were more likely to be hospitalized than women.

The researchers' goal in this study was to look at gender disparities after developing and implementing a standardized approach to cardiac care for patients in 2016, using the HEART score. The HEART score, which stands for history, electrocardiogram, age, risk factors, and troponin level, is used to determine risk for adults with suspected acute coronary syndrome and based on that risk informs clinical decisions and standard care recommendations.

"Historically, a lot has been published about disparities in cardiovascular care for women, including misdiagnosing them," said Adam Sharp, MD, MSc. "So, we hypothesized that our standardized approach with more objective risk stratification may reduce or eliminate disparities in care for women. "We found after implementation of the HEART score that women received more appropriate care than men with physicians less likely to recommend low-value cardiac testing for lower and intermediate risk levels, and comparable care for those at high risk."

This study used data collected from more than 34,000 emergency department visits from May 20, 2016, to December 1, 2017, at 15 emergency departments within Kaiser Permanente in Southern California. The study findings included:

Women were hospitalized or received stress tests less frequently than men even after adjusting for HEART score and comorbidities.

Women received care consistent with guidelines:

Low-risk women were less likely to be referred for stress tests or to be hospitalized than men.

High-risk women received similar care to high-risk men.

Despite less care, women still had fewer reports of heart attacks or death within 30 days of the emergency department visit than men overall, and particularly among those at low risk.

Dr. Sharp said the study showed that risk stratification by HEART score of emergency department patients with suspected heart attacks may be useful in improving the care of women, and an opportunity to avoid nonrecommended care in low-risk men.

Kaiser Permanente strives to provide the right care, at the right place and time, and to reduce the amount of nonrecommended care for heart patients and others. Unnecessary and nonrecommended care can have negative effects on patient safety, convenience, and the overall affordability of health care.

"There is always a margin of error with any testing, which requires physicians and patients to weigh the benefits against the risks," Dr. Sharp said. "More testing in low-risk patients can lead to more invasive tests, which has potential health risks as well as potential time in the hospital. No one wants to take time off to go to the hospital. Especially if it's unnecessary."

What The Viewpoint Says: This Viewpoint discusses initiatives of the U.S. Food and Drug Administration's Oncology Center of Excellence to address COVID-19-related challenges faced by patients with cancer and the health care professionals who provide cancer treatment.

Authors: Jennifer J. Gao, M.D., of the Oncology Center of Excellence at the FDA in Silver Spring, Maryland, is the corresponding author.

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

(doi:10.1001/jamaoncol.2020.6783)

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New research into this question shows that the second wave of an epidemic is very different if a population has a homogenous distribution of contacts, compared to the scenario of subpopulations with diverse number of contacts.

The research, by American authors from Oakland University, Novi High School, and California Polytechnic State University, used a simulation approach to model the progress of an epidemic in a network where the connectivity of each individual changed over time, modelling the effects of political decisions made concerning various degrees of quarantine. It was published on December 23 in Europhysics Letters.

The authors stated: "Recently, several authors incorporated quarantine into COVID-19 modeling. However, these models were not network-based. In addition, they did not address the question of the optimal strategy for easing the quarantine in order to minimize the net number of infected individuals - one of the central questions in the present paper." The benefits of a network-based model are that it more accurately accounts for a peaked distribution of individual disease durations, which is a problem for continuum models; also, it does not require the assumption of an equal number of contacts for each individual, so it more accurately models the underlying microscopic structure of the social network.

According to the authors, if a population has a homogeneous distribution of the number of contacts, "the total number of infected people at the end of the epidemic is the same as if no lockdown had been decreed (saturation of the health system aside)," whereas in the case of diverse frequency of contacts, the overall number of infected individuals can be significantly smaller. The reason for this effect is simple. After the individuals with a large number of contacts (high-degree nodes) have acquired immunity, they prevent the propagation of the epidemic through them, thus, slowing-down the spread of the epidemic through the network. Therefore, the optimal timing to allow the low-degree nodes to increase connections (by lifting the lockdown) would be after the high-degree nodes have become immune; this will minimize the net number of infected individuals over the course of the epidemic.

The results suggest an optimal degree-based procedure for lifting the quarantine: "high degrees go first. In practice, when the state lifts the strict quarantine (or moves from one phase of quarantine to the next phase), there is always a choice. One can open smaller stores (where cashiers are high-degree nodes) or/and one can allow gatherings (which typically consist of low-degree nodes). The model suggests that the stores need to be opened first: this way we can save many individuals (mostly low-degree nodes) from being infected".

The authors continue: "This has two important consequences: first, it stresses the relevance of adopting lockdown measures to stop the first outbreak of an epidemic, and second, it shows that second and further waves may be milder than expected."

The results are counterintuitive, as the controversy in the media about the relevance of adopting lockdown measures reveals. This paper points to the importance of a feature that is usually overlooked in the analysis of how epidemics spread: how the heterogeneity of people's behaviours affects their ability to protect themselves from contagion.

Researchers from SWOG Cancer Research Network, a cancer clinical trials group funded by the National Cancer Institute (NCI), part of the National Institutes of Health, have shown that a triple drug combination - of irinotecan, cetuximab, and vemurafenib - is a more powerful tumor fighter and keeps people with metastatic colon cancer disease free for a significantly longer period of time compared with patients treated with irinotecan and cetuximab.

Results of the SWOG study, led by Scott Kopetz, MD, PhD, of M.D. Anderson Cancer Center, are published in the Journal of Clinical Oncology. The findings are expected to change the standard of care for patients with colorectal cancer that is metastatic - when tumors spread to other parts of the body - and includes a mutation in the BRAF gene called V600E. This mutation is found in about 10 percent of metastatic colorectal cancers and tumors with the mutation rarely responds to treatment, resulting in a poor prognosis for patients.

Kopetz is an expert in the science of BRAF-mutated colorectal cancer and has tested a variety of combination therapies to treat it, including leading the BEACON trial. This phase III trial found that two targeted drugs - cetuximab and encorafenib - significantly shrank tumors and helped patients live longer compared with those who received standard treatment. These results made a splash last year when simultaneously published in the New England Journal of Medicine and presented at the European Society of Medical Oncology annual meeting.

In his SWOG study, S1406, Kopetz and his team also pursued combination therapies to see what might work best. In this trial, they tested 106 patients whose metastatic colorectal cancer includes the deadly V600E mutation. All the patients had been previously treated with chemotherapy, and their cancer didn't respond. The team randomly assigned study participants to one of two treatment groups - those who received irinotecan and cetuximab and those who received that combination with a third drug, vemurafenib.

The SWOG team found that patients who received the triple combination had better tumor response rates to the drugs - 17 percent compared to 4 percent - and stayed cancer-free longer. On a molecular level, Kopetz said, here's how the triplet works: Irinotecan, a traditional chemotherapy drug, kills cancer cells. Cetuximab, a monoclonal antibody, is a targeted drug that blocks cancer growth by blocking the action of a protein called epidermal growth factor receptor, or EGFR. Kopetz says vemurafenib, a BRAF inhibitor and another targeted therapy, attacks the BRAF protein directly, further slowing tumor growth.

"That 1-2-3 action, that triple threat, shuts off a powerful growth pathway in these cancers," Kopetz said. "In this trial, unlike in BEACON, we added chemo and found that it makes for a more effective way to treat this aggressive form of colorectal cancer."

Another intriguing finding: An 87 percent decline in circulating tumor DNA (ctDNA) of the BRAFV600E variant allele frequency in patients receiving all three drugs, compared with no ctDNA drop in patients receiving the two-drug combination. Kopetz said this is strong evidence that measuring the presence of ctDNA can be an effective way to measure short-term response to treatment. And it could be as easy as drawing blood, using a test known as a liquid biopsy.

The SWOG study results will be accompanied by an editorial in JCO in January 2021.