Satisfaction with medication: an overview of conceptual, methodologic, and regulatory issues.

OBJECTIVE: Patients' satisfaction with their medication or medical device has been of increasing interest over the past decade. This is reflective of the rise of the patient as consumer and the desire of pharmaceutical and device manufacturers to obtain feedback from the consumers about their products. Satisfaction with medication is more narrowly focused and should be distinguished from other aspects of satisfaction. The purpose of this article is to place the concept of patient satisfaction with medication in an appropriate theoretical context, to explore the challenges of performing this research, and to offer recommendations for the basis of satisfaction claims.
METHODS: We reviewed the literature on satisfaction with medication or medical devices. We summarize and discuss the background, conceptual issues, and theoretical justification for studying satisfaction with medication. We offer examples of domains to be included and suggestions on how to develop a psychometrically sound satisfaction measure. We also address additional issues for consideration.
RESULTS: Medication satisfaction is a type of patient-reported outcome, but is distinguished from other patient-reported outcomes-specifically health-related quality of life (HRQL) and self-reports of symptoms. The Theory of Reasoned Action provides one theoretical justification for the concept. The heuristic value of this theory leads to implications regarding the relation between satisfaction and adherence. In addition, the theory is consistent with the need to focus on the patient's beliefs and values concerning the impact of taking his/her medication. Although the beliefs will differ according to the specific drug-disease combination, the beliefs can often be categorized in several domains of satisfaction: symptom relief/efficacy, side effects, ease and convenience, impact on HRQL, general satisfaction, and additional domains specific to the given research question.
CONCLUSION: Patient satisfaction instruments should be subjected to the same psychometrically rigorous standards and procedures as any other patient-reported outcome and should also be subject to the same regulatory standards as other patient-reported outcomes with respect to advertising and promotion.