Evaluating the impact of a SIMPlified LaYered consent process on recruitment of potential participants to the <i>Staphylococcus aureus</i> Network Adaptive Platform trial: study protocol for a multicentre pragmatic nested randomised clinical trial (SIMPLY-SNAP trial).

ABSTRACT:

Introduction

Informed 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. In turn, this can influence trial recruitment, completion and external validity.

Methods and analysis

SIMPLY-SNAP is a pragmatic, multicentre, open-label, two-arm parallel-group superiority RCT, nested within a larger trial, the Staphylococcus aureus Network Ada

SUBMITTER: Ong SWX 

PROVIDER: S-EPMC10806654 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature