Patients' views concerning research on medical practices: Implications for consent

Abstract

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.

Comparison of Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices

“…Similar types of misunderstandings have been documented in prior work 6 and highlight the challenges in helping people to understand research that so closely resembles regular medical care. It was also noteworthy and somewhat paradoxical that better understanding was not demonstrated consistently by participants who were randomly assigned to a scenario that included a written informed consent process.…”

“…The study scenarios were drafted based on prior focus group findings 6 and input from the principal investigators involved with the NIH Health Care Systems Research Collaboratory, a national effort to conduct a series of major pragmatic clinical trials (https://www.nihcollaboratory.org/Pages/default.aspx), who reviewed the scenarios for clinical relevance and authenticity. The study team created posters, information sheets, and consent forms corresponding to notification and authorization approaches to accompany the hypothetical research scenarios, using samples of actual study documents as models.…”

Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research

“…By contrast, our earlier DES study of disclosure/consent preferences among patients found no difference in support for streamlined approaches for randomized studies as compared with observational designs . These findings are consistent with those of Kraft et al, who found that, while patients generally had similar consent preferences for both observational and randomized studies, IRB professionals distinguished between different study designs when expressing preferences regarding approaches for disclosure/consent . One explanation for this difference, suggested by prior qualitative work, is that IRB professionals may view observational research as less risky than randomized trials .…”

A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent

“…Prior qualitative studies have identified widespread misunderstanding about research on medical practices, particularly when participants compare it to the well-known archetype of a placebo-controlled clinical trial of new treatments. 16–17 Our study suggests that at least some aspects of research on medical practices are difficult for people to understand without explicit and direct teaching. This is an important point for researchers who are interested in developing informed consent materials about topics that are unfamiliar to prospective participants, and it highlights the need for a clear approach to teaching key learning goals.…”