Qualitative and Mixed Methods Provide Unique Contributions to Outcomes Research

Outcomes research examines the effects of medical care interventions and policies on the health outcomes of individuals and society.1 Investigators conducting outcomes research seek to inform the development of clinical practice guidelines, to evaluate the quality of medical care, and to foster effective interventions to improve the quality of care.2 Outcomes research has traditionally used quantitative sciences to examine the utilization, cost, and clinical effectiveness of medical care through randomized and nonrandomized experimental designs. Quantitative methods are not as well suited to measure other complex aspects of the healthcare delivery system, such as organizational change, clinical leadership in implementing evidence-based guidelines, and patient perceptions of quality of care, which are also critical issues in outcomes research.3–7 These more nuanced aspects of healthcare delivery may be most appropriately examined with qualitative research methods.8–10 Qualitative approaches are becoming more common in clinical medicine and health services research.5,11–15 Federal encouragement of qualitative research is regularly reflected in funding program announcements issued by the National Institutes of Health.16 For more than a decade, federal agencies and foundations such as the National Science Foundation have demonstrated a commitment to supporting qualitative research through funding scientific conferences, workshops, and monographs on this field of inquiry.17–20 Despite this steady growth in qualitative research, outcomes investigators in cardiology have relatively little guidance on when and how best to implement these methods in their investigations. The purpose of the present report is to introduce qualitative methods as providing unique and critical contributions to outcomes research. This report will describe the situations in which qualitative approaches are most helpful; summarize the primary principles and practices in study design, sampling, data collection, and data analysis for qualitative studies; present representative examples of cardiovascular outcomes research that uses qualitative methods; and synthesize current standards for …