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In Praise of Participants

Chiarello, Cynthia, M., PT, PhD; Editor-in-Chief

Journal of Women's Health Physical Therapy: May/August 2018 - Volume 42 - Issue 2 - p 63–64
doi: 10.1097/JWH.0000000000000104

The author declares no conflicts of interest.

The #me too and #times up movements have certainly caused many of us to stop and reflect. It seems those of us who have been kicking around the planet for a bit got used to norms of behavior often overlooking and ignoring improper conduct. That is until now, when women with a fresh perspective said, “Wait a minute, this isn't right.” Once someone broke the ice, more women participated in this public outcry and changed the zeitgeist. Ideas and behaviors once tolerated, perhaps even endorsed, are being recognized as inappropriate. As we ponder our own lives for how this profound shift in thinking has impacted all of us, we must pay homage to those women who participated in our enlightenment.

We can see the impact of accepted behavioral norms in all aspects of society including health care and medical research. I remembered from my physical therapy school days, women were not usually studied and issues regarding women's health were considered inconsequential. Wanting to get more factual information, I started looking into government policies regarding women as participants and was surprised to learn that it was considered normal to exclude women as clinical research subjects. Allegedly for protection, it's now hard to imagine that we had limited knowledge about conditions that specifically affect women or affect women differently from men simply because their physiology was considered to confound results. It was just assumed that the findings of medical research on men could be generalized to women. In 1977, women were actually prohibited from participating in phase I and II trials by the Food and Drug Administration because of the possibility that women might be pregnant, a ruling that was not reversed for 17 years.1 To encourage the inclusion of women in clinical trials, the National Institutes of Health (NIH) issued guidelines in the 1980s and 1990s.2 By the turn of the century, the General Accounting Office (GAO) found that the NIH had made progress in research that conducted acceptable analysis by sex that informed whether interventions affected men and women differently.3 The GAO found that studying women research participants decreased deaths and diminished disease morbidity for some, yet many gaps remained.3

Underrepresentation of women participants in biomedical research investigations might seem like ancient history to some, as there has been steady progress in some areas of health-related concerns of women such as breast and cervical cancer and heart disease. Progress is still lacking in understanding the prevention, diagnosis, and treatment of conditions that disproportionately affect women including unintended pregnancy, maternal morbidity and mortality, autoimmune diseases, alcohol and drug addition, lung cancer, gynecological cancers and other cervical cancers, and Alzheimer disease.2 To this day, the NIH is still issuing guidelines to ensure that research provides analysis of how interventions differentially affect women.4

As more evidence regarding conditions affecting women's health becomes accessible, behavioral norms change. I am gratified to edit a journal that can contribute to this knowledge base. In this issue, 4 articles illustrate some of the benefits owing to women research participants. In a preliminary randomized controlled clinical trial (RCT), a group led by Dr Tuttle, using ultrasound imaging, demonstrates the role of transverse abdominis exercises in reducing the size of a diastasis rectus abdominis. Dr Brizzolara's group presents an RCT examining lumbopelvic stabilization exercises and pelvic compression belts on muscle behavior in women with sacroiliac joint dysfunction with ultrasound imaging. Also using ultrasound imaging, Dr Maher compared volitional pelvic floor muscle contractions with those elicited by 2 neuromuscular electrical stimulation methods in 2 positions. Finally, I am pleased to announce that a systematic review by Dr Tremback-Ball and colleagues evaluating the efficacy of kinesiology taping in the treatment of women with breast cancer–related postmastectomy lymphedema is our first article published ahead of print. Journal of Women's Health Physical Therapy readers can now access important research online as it becomes available before the next issue of the journal appears in print.

As a researcher, I often forget the important role the women who volunteer as subjects play in the successful outcomes of our efforts. In paraphrasing the words of one participant, a pregnant woman with back pain, “I am glad to participate if it will help other women with my condition.”

—Cynthia M. Chiarello, PT, PhD


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1. National Institutes of Health Office of Research on Women's Health. History of women's participation in clinical research. Assessed March 20, 2018.
2. Institute of Medicine. Women's Health Research: Progress, Pitfalls, and Promise. Washington, DC: The National Academies Press; 2010. doi:10.17226/12908.
3. GAO (US General Accounting Office). Women's Health: NIH Has Increased Its Efforts to Include Women in Research; Report to Congressional Requesters. Washington, DC: GAO; 2000. Assessed March 27, 2018.
4. National Institutes of Health. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. Published 2017. Assessed March 24, 2018.
Copyright © 2018 by the Section on Women's Health, American Physical Therapy Association.