Adherence to Behavioral and Pharmacological Interventions in Clinical Research on Older Adults

Abstract

Although adherence in clinical research tends to be better than that in nonresearch settings, poor adherence or overadherence to an experimental regimen can adversely affect the validity of research outcomes. In the case of large prevention trials in which much time and money have been invested, poor adherence can be quite costly. Participants’ adherence to therapeutic regimens is a critical issue in clinical research, and resolutions to the challenges of imposing adherence can enhance the conduct of ongoing clinical research. In May 1998, investigators who work daily to meet the challenges of adherence in clinical research with older adults convened to discuss the issues and problems they encounter and to consider solutions. This conference, “Adherence to Behavioral and Pharmacological Interventions in Clinical Research on Older Adults,” was hosted by the Women’s Health Center of Excellence and the Claude D. Pepper Older Americans Independence Center and was held at the Wake Forest University School of Medicine in Winston-Salem, North Carolina. Funding was provided by the National Institutes on Aging, the National Institutes of Health (NIH) Office of Research on Women’s Health, the NIH Office of Behavioral and Social Sciences Research, Wyeth-Ayerst Laboratories, Merck & Co., Inc., and the Wake Forest University Department of Health and Exercise Science. The conference organizers asked presenters and participants to re-examine the conventional, nontheoretical conceptualization of adherence and to consider the larger context in which adherence does or does not occur. We also asked them to look at a range of possible interventions, including dietary, pharmacological, and physical activity. From this small working conference emerged this collection of papers, covering the use and continued need for theory to orient adherence research, the methodological sophistication required to improve adherence and its study, the special issues encountered in clinical research with older adults, and the elements unique to the three intervention types. Finally, all consider the social and ethical issues we touch upon when conducting adherence research within clinical trials, the broader implications of attempting to enhance adherence to any intervention, and the meanings assigned to adherence.