The new Health of Women program, under the auspices of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), was launched June 24–25. The program brings together clinicians, researchers, academia, industry, and others to discuss ways to improve the health of women.

Specifically, the program will address the availability and consistency of sex-specific information for the safe and effective use of medical devices in women. Additionally, the program hopes to address identified gaps and unmet needs by targeting resources and fostering the development of innovative strategies, technology, and clinical study paradigms.

The impact of sex
As explained by CDRH Health Advisor Kathryn O’Callaghan, being a man or woman has a significant impact on health, as a result of both biological (sex) and psychosocial (gender) differences. Women-specific considerations for CDRH include the following:

• the unique risks and needs of pregnant females
• risks and needs related to research involving women of child-bearing potential
• effects of hormones through life stages
• baseline differences in anatomy
• potential differences in health communication and health-seeking behavior, which may affect how benefits and risk are communicated to this target population

Ms. O’Callaghan also noted that limited data analysis and historical underrepresentation of women in clinical trials contribute to uncertainty about how medical devices perform in women.

To address some of these unique issues and secure commitments from key stakeholders, the FDA sponsored a 2-day workshop, focused on the following three primary areas: highlighting device-specific recruitment and retention strategies; improving analysis and communication of sex-specific findings to providers and patients; and developing a priority research road map based on identified gaps and needs.

In each area, panels examined major themes using data-driven case studies with a focus on practical strategies relevant to the particular challenges in the medical device arena. Additionally, participants rotated through breakout sessions, collectively building an action plan for each activity area.

Recruiting and retention strategies
During the session on device-specific recruitment and retention strategies, participants examined reasons for the underrepresentation of women in medical device clinical studies. They also identified high-priority areas for increased recruitment and retention of women.

According to Stephen Thomas, PhD, director of the University of Maryland Center for Health Equity, health inequality exists because of race and ethnicity, which intersect with other social determinants of health, such as sex and gender. Several panelists—including Kimberly Wong Oleson, vice president of global clinical operations for the Medtronic Clinical Research Institute, and Brooke Allocco, MD, vice president, cardiac rhythm management clinical communications and education, Boston Scientific Corporation—presented device-specific case studies.

Panelists posed questions on how to increase the recruitment and retention of women in medical device clinical studies and what actions can be taken to address leading drivers of underrepresentation of women in medical device clinical studies. Audience participants recorded their responses, discussed them during small group breakout sessions, and were challenged to turn the most promising strategies into action plans.

Improving communication
During the session on improving analysis and communication of sex-specific findings to providers and patients, panelists examined when and how much clinical data in women is needed, along with how this information can be communicated and used by various audiences.

In his presentation on “Gender Expression in Patient-Reported Outcomes and the Minimum Important Difference in Orthopedic Medical Devices,” Manuel Bayona, MD, MS, PhD, an epidemiologist at CDRH, evaluated how sex affects patient-reported outcomes and how this translates into effects on the minimum important difference in device-related orthopaedic surgery.

Lilly Yue, PhD, deputy director of the division of biostatistics at CDRH, called for the performance, interpretation, and reporting of sex-difference analyses for any completed study. Dr. Yue also insisted that a strategy for assessing consistency and heterogeneity across sexes should be included in the protocol and design of medical device studies. In comparative studies, she noted that treatment by sex interaction hypothesis testing should be prespecified.

Developing a road map
AAOS members Mary I. O’Connor, MD, and Amy L. Ladd, MD, were among the presenters on the final topic area, which focused on developing a priority research road map for the Health of Women Device Ecosystem. Dr. O’Connor, professor and chair of the department of orthopaedic surgery at the Mayo Clinic in Jacksonville, Fla., discussed sex disparity in the rates of use of total joint arthroplasty (TJA) surgery. She noted that TJA is recommended equally to male and female patients with severe osteoarthritis of the knee, but studies have shown that when patients have moderate osteoarthritis of the knee, TJA is more frequently recommended to men than to women.

Dr. Ladd, current president of the Ruth Jackson Orthopaedic Society and chief of the Robert A. Chase Hand and Upper Limb Center, Stanford University School of Medicine, gave a presentation on wrist fragility fractures. Often the orthopaedic surgeon is first to recognize the fragility fracture and thus the first to make the diagnosis of osteopenia and osteoporosis.

“Wrist fractures are important because they are a strong predictor for another, more dramatic fracture, such as a hip fracture, that has higher morbidity and mortality,” explained Dr. Ladd. “As orthopaedists, we are the best advocates for improving examination of sex and gender by applying for grants, getting the word out, and increasing awareness among our patients and our colleagues.”

Elizabeth Fassbender is the communications specialist in the AAOS office of government relations. She can be reached at fassbender@aaos.org

Additional Information
Health of Women workshop materials