Attitudes of patients and surgeons towards sham surgery trials: a protocol for a scoping review of attributes to inform a discrete choice experiment
Laura Wall, Madeleine Hinwood, Danielle Lang, Angela Smith, Samantha Bunzli, Philip Clarke, Peter FM Choong, Michelle M Dowsey, Francesco Paolucci
BMJ OPEN | BMJ PUBLISHING GROUP | Published : 2020
INTRODUCTION: In order to properly evaluate the efficacy of orthopaedic procedures, rigorous, randomised controlled sham surgery trial designs are necessary. However, randomised controlled trials (RCTs) for surgery involving a placebo are ethically debated and difficult to conduct with many failing to reach their desired sample size and power. A review of the literature on barriers and enablers to recruitment, and patient and surgeon attitudes and preferences towards sham surgery trials, will help to determine the characteristics necessary for successful recruitment. METHODS AND ANALYSIS: This review will scope the diverse literature surrounding sham surgery trials with the aim of informing ..View full abstract
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THE PRETEND TRIAL: A MIXED METHODS STUDY EVALUATING PREFERENCES, FEASIBILITY, AND COSTS OF PERFORMING SHAM SURGERY TRIALS INVOLVING MAJOR SURGICAL PROCEDURES
Randomising patients to receive either an 'active' or a 'sham' (pretend) surgery and comparing the outcomes is the best way to test how effe..
Awarded by NHMRC
This review is part of project supported by an NHMRC Project Grant (APP1163613); MMD holds an NHMRC Career Development Fellowship (APP1122526); PFMC holds an NHMRC Practitioner Fellowship (APP1154203).