Group recruitment sessions enhance patient understanding in a small multi-centre phase III clinical trial

Monson, Kathryn, Parlour, Louise, Simcock, Richard, Fallowfield, Lesley and Jenkins, Valerie (2012) Group recruitment sessions enhance patient understanding in a small multi-centre phase III clinical trial. Contemporary Clinical Trials, 33 (2). pp. 286-290. ISSN 1551-7144

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Introduction. There is continuing concern that patient information leaflets, tailored to current regulatory requirements, fail to meet patients' needs. Provision of comprehensible information is vital if patients are to provide valid informed consent. The design of the ARIX (acupuncture for radiation induced xerostomia) trial provided an opportunity to deliver researcher led, enhanced patient information to groups of potential participants.

Methods. Between November 2009 and September 2010, 149 patients attended a trial introduction meeting at their local site. All meetings followed the same format. The study coordinator delivered a PowerPoint presentation containing standard trial information together with customised local details. This was followed by group questions and answers. Patients could sign a consent form immediately afterwards or with local staff at a later date. Participants who completed the study were invited to feedback their views on these meetings.

Results. One hundred and forty nine patients attended a meeting of whom 116 ultimately participated in ARIX and provided feedback. Eighty four (72%) reported that the meeting helped their understanding of the trial ‘very much’. Fourteen attendees reported feeling uncomfortable at having the information presented in a group setting but of these, only one felt under pressure to join the trial. Eighty three patients (71%) felt ‘not at all’ uncomfortable and 111 (95%) ‘not at all’ under pressure to participate.

Conclusion. Trial introduction meetings involving researcher led presentation of information, followed by group discussion, can help enhance the information provided in the patient information leaflet in a useful and non coercive manner.

Item Type: Article
Keywords: Informed consent, patient information, recruitment, clinical trial, cancer
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Subjects: R Medicine > R Medicine (General) > R727 Medical personnel and the public. Physician and the public
R Medicine > RA Public aspects of medicine > RA0001 Medicine and the state. Including medical statistics, medical economics, provisions for medical care, medical sociology > RA0418 Medicine and society. Social medicine. Medical sociology
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens
Depositing User: Tracy Woodcock
Date Deposited: 16 Jul 2012 11:10
Last Modified: 16 Jul 2012 11:10
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