Patients' Views Concerning Research on Medical Practices: Implications for Consent.

Journal Article (Journal Article;Multicenter Study)

BACKGROUND: Comparative effectiveness research (CER) and pragmatic clinical trials commonly test interventions that are in routine use and pose minimal incremental risk or burdens to patients who participate in this research. The objective of this study was to elicit the range of patients' views and opinions regarding a variety of different types of research on usual medical practices, especially notification and authorization for them. METHODS: We conducted twelve focus groups with adults in five U.S. cities-six focus groups addressing CER ("CER groups") and six groups addressing research involving hospital operations and clinician interventions ("Operations groups"). Participants discussed hypothetical research studies and potential methods of notifying patients and obtaining their authorization to participate. Group discussions were recorded, transcribed, and coded to identify patients' views related to research on standard medical practice. RESULTS: A total of ninety six people participated. Twelve key themes emerged from participants' discussions of the hypothetical research studies; these themes were then grouped into four general categories: clinical care; notification and authorization; communication; and conduct and design of research. The desire to be actively notified and asked was more prominent with regard to CER studies than with regard to Operations studies. CONCLUSIONS: Our data suggest that effective policy and guidance will involve balancing different patients' interests and potentially different sets of interests for different types of research studies on usual medical practices.

Full Text

Duke Authors

Cited Authors

  • Weinfurt, KP; Bollinger, JM; Brelsford, KM; Crayton, TJ; Topazian, RJ; Kass, NE; Beskow, LM; Sugarman, J

Published Date

  • 2016

Published In

Volume / Issue

  • 7 / 2

Start / End Page

  • 76 - 91

PubMed ID

  • 27800531

Pubmed Central ID

  • PMC5085261

International Standard Serial Number (ISSN)

  • 2329-4515

Digital Object Identifier (DOI)

  • 10.1080/23294515.2015.1117536


  • eng

Conference Location

  • United States