Evaluating the impact of a SIMPlified LaYered consent process on recruitment of potential participants to theStaphylococcus aureusNetwork Adaptive Platform trial: study protocol for a multicentre pragmatic nested randomised clinical trial (SIMPLY-SNAP trial)
Sean W X Ong,
Todd C Lee,
Robert A Fowler
et al.
Abstract:IntroductionInformed consent forms (ICFs) for randomised clinical trials (RCTs) can be onerous and lengthy. The process has the potential to overwhelm patients with information, leading them to miss elements of the study that are critical for an informed decision. Specifically, overly long and complicated ICFs have the potential to increase barriers to trial participation for patients with mild cognitive impairment, those who do not speak English as a first language or among those with lower medical literacy. … Show more
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