Abstract
BackgroundClinical research methodology is evolving with the advent of pragmatic randomised controlled trials (PRCTs). Novel approaches for informed consent in PRCTs are needed.ObjectiveTo explore public opinion about different ways of giving informed consent for PRCTs.DesignWeb-based survey assessing acceptability of three PRCT consent scenarios for statin use.SettingCommunity-based study.Participants678 (12%) adults responded to an open-access web-based survey.MeasurementsParticipant-rated acceptability of three different options for giving informed consent for a PRCT testing two commonly prescribed, effective treatments: statins for hyperlipidaemia. Option A was written informed consent given a priori for a specific study, with verbal confirmation of consent at time of randomisation. Option B was written informed, general consent a priori for multiple comparative effectiveness studies, with verbal confirmation for a specific study at time of randomisation. Option C was written informed consent for a specific study at time of randomisation.ResultsAcceptability was higher for option A (475/529 (89.9%)) and B (441/487 (90.6%)) compared with C (339/481 (70.5%)). The estimates of differences in paired proportions were A versus C, 19.4% (95% CI 14.4 to 24.5), p<0.001; B versus C, 20.1% (95% CI 15.2 to 25.0), p<0.001.LimitationsThe study design may have been subject to cognitive biases such as framing and anchoring effects. The anonymised web-based survey allowed no follow-up or verification for missing data. The sampling frame used an institutional database and social media and selection bias and halo effects may have been present. The 12.3% response rate may represent poor generalisability.ConclusionThe concept of giving a priori consent, with subsequent confirmation at time of randomisation in a PRCT, was more favourable than the traditional model of consent in a general-practice-based study of statin use.