Enhanced Patient information Sheets (EPIS)
Ethics committees rightly want to ensure that participants receive appropriate information and are able to provide fully informed consent.
However, long and complex information sheets may impact negatively on recruitment if they are unattractive, confusing or raise inappropriate levels of anxiety.
This is especially critical when patients are initially approached by a letter from their health professional, which occurs in a significant proportion of trials in primary care and community settings, especially in patients with long-term conditions.
To test the effects of enhanced information sheets, we will develop new versions of study materials, and enhance readability via expertise in writing for patients and its presentation via graphic design.
The revision would then be tested using the principles of user testing, where the ability of patients to locate and understand key pieces of information is evaluated objectively to provide an assessment of the ability of the sheet to inform.
Patients in each trial would then be randomised to either the original or modified information sheet.
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Knapp P, Raynor D, Silcock J, Parkinson B. Performance-based readability testing of participant information for a Phase 3 IVF trial. Trials 2009;10:
Knapp P, Raynor D, Silcock J, Parkinson B. Performance-based readability testing of participant materials for a phase I trial: TGN1412. Journal of Medical Ethics 2009;35:573-578.