A randomized comparison of two-stage versus traditional one-stage consent for a low-stakes randomized trial.

ABSTRACT:

Background/aims

It has been proposed that informed consent for randomized trials should be split into two stages, with the purported advantage of decreased information overload and patient anxiety. We compared patient understanding, anxiety and decisional quality between two-stage and traditional one-stage consent.

Methods

We approached patients at an academic cancer center for a low-stakes trial of a mind-body intervention for procedural distress during prostate biopsy. Patients were randomized to hear about the trial by either one- or two-stage consent (n = 66 vs n = 59). Patient-reported outcomes included Quality of Informed Consent (0-100); general and consent-specific anxiety and decisional conflict, burden, and regret.

Results

Quality of Informed Consent scores

SUBMITTER: Vickers AJ 

PROVIDER: S-EPMC10764653 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature