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
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Published in |
Trials, February 2014
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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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 8 | 25% |
Spain | 5 | 16% |
Canada | 1 | 3% |
Saudi Arabia | 1 | 3% |
Colombia | 1 | 3% |
Norway | 1 | 3% |
Unknown | 15 | 47% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 20 | 63% |
Scientists | 8 | 25% |
Practitioners (doctors, other healthcare professionals) | 4 | 13% |
Mendeley readers
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% |