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Background
Participant Information Leaflets (PILs) are often lengthy and increasingly complex—regularly eight pages long [1]—despite the current UK Health Research Authority (HRA) guidance in England advising a proportionate approach. They recommend that PILs should not provide too much detail but rather ensure that a clear and concise picture of the research is given, explaining the purpose of and background to the research and invitation, what taking part would involve, and the benefits and disadvantages of participating [2]. Perhaps longer PILs have become habit, or are a result of researchers wanting to cover all bases and not leave anything out, but it has previously been argued that lengthy participant information deters people from reading it [3] and may act as a barrier to otherwise interested and eligible participants partaking in research [4].
An RCT comparing an interactive electronic PIL (where participants could choose both the type and level of detail accessed) with a standard-length electronic PDF copy of the PIL identified that only 9% of participants in the interactive arm accessed the available, more detailed information presented [5]. A shortened PIL may be more appealing to participants as it likely provides a more manageable volume of information to efficiently process and comprehend, which may encourage eligible participants to subsequently enrol in a trial [4]. Alternatively, written PILs may not be the best method for conveying information and alternative approaches, such as staging information [6] and/or using multimedia [7], might be more effective.
A Cochrane review of recruitment interventions in 2018 identified two trials that have evaluated two postal PILs—one short and one full-length [4, 8, 9]—and concluded moderate grade evidence that a shortened postal PIL makes little-to-no difference to recruitment outcomes compared with a full PIL (RD = 0%, 95% CI = − 2% to 2%). In an online setting previous research has found that, when presented with three levels of study information to read (the first containing less than might be found on a standard PIL, the second corresponding to a standard PIL, and the third containing more information than a standard PIL) that most eligible participants chose to read the minimum (i.e. only the first of three levels of) information provided [10].
Decentralised clinical trials (DCTs) delivered remotely are an increasingly common and acceptable form of...