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Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation

Overview of attention for article published in Trials, February 2014
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Title
Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation
Published in
Trials, February 2014
DOI 10.1186/1745-6215-15-62
Pubmed ID
Authors

Katie Gillies, Wan Huang, Zoë Skea, Jamie Brehaut, Seonaidh Cotton

Abstract

Informed consent is regarded as a cornerstone of ethical healthcare research and is a requirement for most clinical research studies. Guidelines suggest that prospective randomised controlled trial (RCT) participants should understand a basic amount of key information about the RCTs they are being asked to enrol in in order to provide valid informed consent. This information is usually provided to potential participants in a patient information leaflet (PIL). There is evidence that some trial participants fail to understand key components of trial processes or rationale. As such, the existing approach to information provision for potential RCT participants may not be optimal. Decision aids have been used for a variety of treatment and screening decisions to improve knowledge, but focus more on overall decision quality, and may be helpful to those making decisions about participating in an RCT. We investigated the feasibility of using a tool to identify which items recommended for good quality decision making are present in UK PILs.

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Mendeley readers

The data shown below were compiled from readership statistics for 123 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United Kingdom 2 2%
Netherlands 1 <1%
Unknown 120 98%

Demographic breakdown

Readers by professional status Count As %
Student > Master 24 20%
Student > Ph. D. Student 16 13%
Student > Bachelor 14 11%
Researcher 12 10%
Student > Doctoral Student 12 10%
Other 25 20%
Unknown 20 16%
Readers by discipline Count As %
Medicine and Dentistry 38 31%
Psychology 15 12%
Pharmacology, Toxicology and Pharmaceutical Science 11 9%
Nursing and Health Professions 9 7%
Social Sciences 4 3%
Other 19 15%
Unknown 27 22%