Methodological Issues in Pharmacotherapy Research in Older Adults

Background: The shifting of demographics to an aging society with multiple chronic illnesses and increased heterogeneity has created an undeniable imperative regarding the knowledge about pharmacotherapy in older patients, especially because older adults have a higher rate of medication use compared with the general population. More research on pharmacotherapy in older adults is needed to maximize not only the appropriate use of medications but also the benefits of available treatments in this historically underrepresented group. Investigators face many challenges that may greatly affect the outcomes of research on pharmacotherapy in older adults. Objective: This commentary discusses the common challenges of research on pharmacotherapy in older adults and provides strategies to overcome such challenges. Methods: The following databases were searched for examples of concepts (dates: 1976 September 14, 2010; key terms: research [in the title], aged, elderly, older adult, and geriatric): PubMed, Cumulative Index to Nursing and Allied Health Literature Database (CINAHL), Family & Societal Studies Worldwide, Women's Studies International, Academic Search Premier, Health Source: Academic/Nursing Edition, ISI Web of Knowledge, International Pharmaceutical Abstracts, PsycInfo, and Social Work Abstracts. Results: There are several methodological challenges related to study design, including the measurement of outcomes and the analytical plan; study implementation, such as the recruitment of sites and individuals; the informed-consent process; retention; and other practical considerations. A crucial area to consider is the measurement of medication adherence, both as an independent factor and as a confounder. Many challenges of research in older patients reflect the complexities of the aging process, including psychosocial consequences, and the resultant effects on study participation and outcomes. Conclusion: It is hoped that the recommendations provided will help researchers and clinicians overcome the methodological challenges of conducting research on pharmacotherapy in older adults, thereby fostering more studies that critically evaluate pharmacotherapy and medication-management services and maximizing treatment outcomes in older adults. (Am J Geriatr Pharmacother. 2011;9:173-189) (C) 2011 Elsevier HS Journals, Inc. All rights reserved.