Scientific Publications by FDA Staff

JAMA Netw Open 2020 May;3(5):e205435

Consensus on language for advance informed consent in health care-associated pneumonia clinical trials using a delphi process.

Corneli A, Calvert SB, Powers JH 3rd, Swezey T, Collyar D, Perry B, Farley JJ, Santiago J, Donnelly HK, De Anda C, Blanchard K, Fowler VG Jr, Holland TL

IMPORTANCE: Information to be included in advance informed consent forms for health care-associated pneumonia treatment trials remains to be determined. OBJECTIVE: To identify and determine how to describe information to be included in an advance informed consent form for an early-enrollment noninferiority hospital-acquired and/or ventilator-associated bacterial pneumonia (HABP/VABP) clinical trial. DESIGN, SETTING, AND PARTICIPANTS: A Delphi consensus process with stakeholders in HABP/VABP clinical trials was conducted using qualitative semistructured telephone interviews from June to August 2016, followed by 2 online surveys, the first from April to May 2017, and the second from September to October 2017. All stakeholders who participated in the interview were invited to participate in the first survey. Stakeholders who participated in the first survey were invited to participate in the second survey. Stakeholders were patients at risk of pneumonia, caregivers, representatives of institutional review boards, investigators, and study coordinators. MAIN OUTCOMES AND MEASURES: Description and consensus of information to be included in advance informed consent forms for early enrollment in noninferiority HABP/VABP clinical trials. RESULTS: Suggestions from 52 stakeholders about what key informed consent concepts to include and how to explain them were used to create 3 categories to be included in an advance consent form: (1) reassurances on patient health and treatment, (2) rationale for advance consent and early enrollment, and (3) an explanation of noninferiority. At the end of the Delphi process, at least 80% consensus was reached among the 40 stakeholders who participated in the second online survey on each of the statements to include in the proposed consent text. Throughout the process, however, describing and reaching consensus on statements about noninferiority was more problematic than the other categories. CONCLUSIONS AND RELEVANCE: The stakeholders endorsed consent language to be used in combination with a strategy for enrolling patients at highest risk for pneumonia before infection onset. Data-driven consent language may help potential participants make informed decisions about their involvement in clinical research and improve enrollment rates, which are necessary to evaluate new treatments and improve patient care. The proposed consent language may be adapted for other trials using an early enrollment strategy and for noninferiority trials.