Still crazy curious after all these years (with apologies to Paul Simon)

Stephen Joel Coons, PhD
Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, AZ, USA

Through pharmacy school at the University of Connecticut and graduate school at the University of Arizona, I was very interested in drug-taking behavior (interpret this as you wish). My PhD dissertation research addressed self-care behaviors, including the use of nonprescription drugs.
After completing my PhD in 1986 and joining the faculty at the University of Kentucky, I was fortunate to become involved in research exploring social factors in medication and alcohol by older adults that was funded by the National Institutes of Health (NIH). At that point in time, people 65 years of age and older in the US represented just over 12 percent of the population yet it was estimated they consumed over a third of all prescription medications dispensed. Some observers referred to this as “the nation’s other drug problem.” Our research findings confirmed that many older adults were taking a substantial number of prescription and nonprescription drugs, some of which were duplicative or potentially contraindicated. This stimulated my interest in the outcomes of medication use from the consumer’s perspective. It led me to wonder whether the multiple drugs, on balance, were enhancing or maintaining health and well-being or were they decreasing health and well-being due to the consequences of inappropriate use or overmedication.
However, since I had no experience in assessing the outcomes associated with drug use, I decided to pursue additional training in the measurement of self-reported health and well-being, or health-related quality of life. Hence, after 3½ years on the University of Kentucky faculty, I accepted a post-doctoral fellowship funded through the cancer center at the University of California, San Diego (UCSD). Although to some it may have seemed like a step backward, this was a profoundly significant and positive career move.

My mentor was Robert M. Kaplan, PhD, one of the developers of the Quality of Well-Being Scale and a true pioneer in health outcome measurement. Through this fellowship, I became a true believer in the importance of asking individuals about how they feel and function as a result of a medical condition and/or its treatment. During a project involving administration of the SF-36 to patients undergoing adjuvant chemotherapy for breast cancer, a study participant stated “Thank you for asking me about these issues; no one has asked me about them before.” To this day, that woman’s heartfelt expression of appreciation continues to move me profoundly and motivate my work.

Upon completion of the fellowship, I joined the faculty of the University of Arizona in the summer of 1991 to build a research program around what would become known as patient-reported outcome assessment. I was particularly focused on the measurement and valuation of self-reported health status. This was at the same time that Mapi introduced the Quality of Life Newsletter (#1, June-September 1991). ISOQOL had not yet been established, so Mapi’s trailblazing newsletter was a unique and rich source of timely and topical information for this rapidly expanding area of research. Also, this was prior to a readily and universally accessible Internet and I still have hard copies of the Quality of Life Newsletter starting with issue 4 in 1992. (Yes, as my wife will attest, I am a hoarder.) Although there were a few bumps in the road (e.g., an oncologist with whom I had hoped to collaborate told me that the impact of adjuvant chemotherapy on how breast cancer patients feel and function was not worth assessing), the University of Arizona proved to be an excellent setting for my research program.

The 1990s were an incredibly exhilarating and momentous time for me and for my newly chosen field. The Drug Information Association hosted meetings on quality of life evaluation at which I was able to interact with and learn from scientists representing a range of stakeholders (e.g., academia, pharma, regulatory agencies, and consulting firms) engaged in advancing the measurement of patient-centered outcomes. The International Society for Quality of Life Research (ISOQOL) was founded in 1993 and held its inaugural conference in Brussels in February 1994, which was an excellent opportunity for me to network with the international community of outcomes scientists. In addition, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) was founded in 1995 and, in that same year, what would become the Patient-Reported Outcomes Guidance Development Working Group was formed within the US Food and Drug Administration (FDA) and chaired by Laurie Beth Burke, MPH, RPh. (At that time, I had no idea that Laurie and the resulting “PRO Guidance” would have such a significant impact on what I now do on a daily basis.)

I was involved in a few PRO instrument development projects while at the University of Arizona, but most of my research involved applying existing PRO measures in a variety of patient populations. My affiliation with the EuroQol Group began during this period and, in 1997, I became its first North American member. This led to a number of EQ-5D-related projects, including the development of the set of EQ-5D health-state valuations for the US general population funded by the Agency for Healthcare Research and Quality. However, discussion of my academic career would be incomplete without acknowledgment of the graduate students that I advised, but from whom I also learned so much. My CV is a reflection of the hard work and dedication of numerous scientists that I was privileged to mentor.

After over 22 years in academia, I left the University of Arizona in 2009 to become the Director of the Patient-Reported Outcome (PRO) Consortium at the Critical Path Institute (C-Path). C-Path is a private, nonprofit organization created by the University of Arizona and the FDA to support the Critical Path Initiative, which is the FDA’s strategy for transforming the way FDA-regulated products are developed, evaluated, manufactured, and used. The PRO Consortium’s mission is to provide a pre- competitive, collaborative venue for generating and/or assembling empirical evidence to support the FDA qualification of PRO instruments for use as clinical trial endpoints to support medical product labeling claims. The PRO Consortium is a public-private partnership that engages scientists from industry, academia, consulting firms, and the FDA. I am truly honored to be a part of this worthwhile endeavor, which is aimed at more effectively incorporating the patient’s voice in the assessment of treatment benefit.

On the occasion of their 40th anniversary, I congratulate the Mapi family on their past achievements and continuing success. In addition, I sincerely thank Dr. Acquadro and her Mapi colleagues for the opportunity to be a part of this celebration.