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We also want you to continue having access to the latest Johns Hopkins Medicine research achievements and clinical advances, so we are issuing a second tip sheet every Thursday, covering topics not related to COVID-19 or the SARS-CoV-2 virus.

Stories associated with journal publications provide a link to the paper. Interviews with the researchers featured may be arranged by contacting the media representatives listed.


Media Contact: Vanessa McMains, Ph.D.

VIDEO: Women Underrepresented in Clinical Trials | Dr. Erin Michos

Although heart disease is the leading cause of death in women, and older adults are more likely to have heart and vascular disease than young people, randomized clinical trials testing medications to lower cholesterol have historically underenrolled both groups. Randomized clinical trials generate the best evidence regarding the benefits or harms of given drug, and their results are used to shape guidelines for patient management in clinical practice. Due to a push from the U.S. National Institutes of Health and the U.S. Food and Drug Administration, the pharmaceutical industry had begun efforts to enroll more women and seniors into their trials.

However, after analyzing the trends in the types of 485,409 people enrolled in 60 studies from 1990 to 2018, Johns Hopkins Medicine researchers report that ¾ although some progress has been made — women and older adults are still vastly underrepresented in lipid lowering therapy trials compared with their disease burden. The findings, published on May 21, 2020, in the journal JAMA Network Open, suggest that trials still aren’t reflecting real-world patient populations.

We want to ensure that the types of patients who will be using these drugs are the ones included in the clinical trials, so that we can determine if these medications are safe and effective for the people who are prescribed them,” says senior author Erin Michos, M.D., M.H.S., associate professor of medicine at the Johns Hopkins University School of Medicine. “Although we did see an improvement over the years in representation of women and older adults, that progress was rather modest. Clearly more still needs to be done to shift the balance to represent our patient demographics.”

For their study, the researchers reported an increase in the number of women participants from about 20% in the early 1990s to about 33% in the most recent trials analyzed. However, many trials included only women who were past menopause or who were unable to have children, particularly excluding people who were pregnant or breastfeeding. Only slightly more than half of the 60 trials reported results based on effectiveness by gender.

“Heart diseases have been increasingly on the rise among younger women,” says lead author Safi U. Khan, M.D., an assistant professor of medicine at West Virginia University. “The exclusion of women of childbearing age into these lipid-lowering trials results in missed opportunities to understand about important cardiovascular disease prevention measures in this group.”

In the report on these studies, the percentage of trial participants 65 or older increased from 32% from the early 1990s, compared with 42% in the most recent trials examined. As with gender, only slightly more than half of the 60 studies reported their findings specifically for older adults.

The researchers say older Americans must be included in trials because as people age over time, the way they metabolize drugs may change, or they may develop other health conditions that could alter the effectiveness of the treatment.



Media Contact: Waun’Shae Blount

There are an estimated 2 million older adults who are homebound or unable to leave their homes due to multiple chronic conditions and functional impairment. Home-based primary care provides access to care for these patients and has been shown to save costs for the Medicare program. The federal government’s Centers for Medicare and Medicaid Services (CMS) is currently moving from volume-based reimbursement — where health care providers are paid based on the quantity of care supplied — to value-based reimbursement — where providers are rewarded with incentive payments for the quality of care their patients receive. To successfully achieve the shift, it’s critical that CMS quality measures include ones focused on medical care provided in the home by physicians.

In a report published in the May 19, 2020, issue of the Annals of Internal Medicine, researchers at Johns Hopkins Medicine and four other U.S. medical institutions examined the performance quality measures used by the CMS Merit-based Incentive Payment System (MIPS) to determine if they appropriately addressed home-based medical care.

In their review of 257 overall quality measures on the CMS 2019 MIPS list, the researchers found that of the 78 potentially appropriate quality measures for home-based care, only 50% (39) included certain codes that enable physicians to report they provided services in a patient’s home. These codes indicate that the services are eligible for quality-based incentives.

“This is unfortunate, because strong evidence exists that improving care for frail older adults, particularly those who are homebound, can help improve care and reduce health care costs,” says lead author Bruce Leff, M.D., director of the Center for Transformative Geriatric Research and professor of medicine at the Johns Hopkins University School of Medicine. “Currently,” he adds, “only 12% of homebound patients receive their medical care at home.”

Based on their findings, the researchers recommend that (1) the CMS add home visit codes to all MIPS quality measures relevant to such care; (2) that quality measure developers consider home-based primary care when designing new standards; and (3) that research initiatives foster this development. They also support the establishment of a national learning collaborative and practice-based research network focused on home-based medical care.



Media Contact: Ayanna Tucker

Join science writers, journalists, bloggers and public information officers on Monday, June 8, 2020, from 9 a.m. until 5 p.m. Eastern Daylight Time, for a free webinar to learn about the latest advances in research and clinical care from Johns Hopkins experts.

The 12th annual Johns Hopkins Medicine Science Writers’ Boot Camp, “If the Medicine Fits: The Promise of Precision Medicine in Action,” will be a daylong immersion in science, medicine and health care, featuring presentations from researchers and clinicians making new discoveries and advances in the field of precision medicine.

Topics include:

  • The Origin of the Promise: Basic as the Foundation of Precision Medicine
  • The Basic Biology of Why Certain Medications Don’t Work Well for Some African Americans
  • Eye Care for All
  • Imaging for Precision Medicine: From Surgery to COVID-19
  • How the Body’s Postal System Informs Disease Diagnosis and Treatment
  • Right Medications: Right Dose and Time
  • Panel Discussion: COVID-19 – Moving from the Bench to the Bedside

Science Writers' Boot Camp is open to science communicators of all types by registering at


Journal Link: Annals of Internal Medicine Journal Link: Jama Network Open