A randomized trial comparing concise and standard consent forms in the START trial

Christine Grady, Giota Touloumi, A Sarah Walker, Mary Smolskis, Shweta Sharma, Abdel G Babiker, Nikos Pantazis, Jorge Tavel, Eric Florence, Adriana Sanchez, Fleur Hudson, Antonios Papadopoulos, Ezekiel Emanuel, Megan Clewett, David Munroe, Eileen Denning, INSIGHT START Informed Consent Substudy Group, Christine Grady, Giota Touloumi, A Sarah Walker, Mary Smolskis, Shweta Sharma, Abdel G Babiker, Nikos Pantazis, Jorge Tavel, Eric Florence, Adriana Sanchez, Fleur Hudson, Antonios Papadopoulos, Ezekiel Emanuel, Megan Clewett, David Munroe, Eileen Denning, INSIGHT START Informed Consent Substudy Group

Abstract

Background: Improving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed.

Methods: We conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin).

Results: 77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups.

Conclusions: An easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient.

Trial registration: Informed consent substudy was registered as part of START study in clinicaltrials.gov #NCT00867048, and EudraCT # 2008-006439-12.

Conflict of interest statement

Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: CG, FH, JT, ED, NP, AP, AS, GT, MS declare no competing interests. AB, SS, SW report receipt of grants. EE reports stock ownership, paid consultancies, Board memberships, and speaking honoraria. There are no commercial or other interests that alter our adherence to PLOS One policies on sharing data and materials.

Figures

Fig 1. START informed consent substudy participants.
Fig 1. START informed consent substudy participants.

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