Comparative effectiveness research in the "real" world: lessons learned in a study of treatment-resistant hypertension.

Comparative effectiveness research (CER) is vital to translate new efficacious diagnostic and therapeutic approaches into effectiveness in usual clinical practice settings. Studying the practice environment in which effectiveness protocols are implemented is necessary to identify the complex challenges that can limit translation of evidence. These issues were addressed in our National Heart, Lung, and Blood Institute-funded R34, "Controlling Blood Pressure in Treatment-Resistant Hypertension (TRH): A Pilot Study." Qualitative methods were used in this cluster (clinic)-randomized, four-arm pilot study of TRH in eight diverse, community-based practices including: (i) focus group discussions with practice staff and physicians; (ii) conference calls with physicians; and (iii) discussions with research coordinators. Sources were summarized and analyzed by content analysis. Results include data segregated into categories representing facilitators of and barriers to research. Key facilitators included: (i) early success in controlling challenging TRH patients (ii) improved management of TRH, and (iii) reimbursement for study time and expenses. Barriers included: (i) time-consuming regulatory requirements; (ii) limited training and research experience of some study coordinators; and (iii) reluctance of some physicians to refer to Hypertension Specialists. Qualitative assessment is valuable for identifying facilitators and barriers to CER. This information is important in designing and implementing CER to accelerate translation of clinical efficacy into effectiveness.