Initial evaluation of the Consent Support Tool: A structured procedure to facilitate the inclusion and engagement of people with aphasia in the informed consent process

Abstract

This study evaluated the Consent Support Tool (CST), a procedure developed to identify the optimum format in which to present research information to people with different severities of aphasia, in order to support their understanding during the informed consent process. Participants were a convenience sample of 13 people with aphasia who had mixed comprehension ability. The CST was used to profile each participant's language ability and identify an information format that should maximize her/his understanding. Next, participants were shown information presented in three formats: standard text and two ‘aphasia-friendly’ versions providing different levels of support. Participants’ understanding of the information was measured for each format. The format recommended by the CST was compared with the format observed to maximize understanding for each participant. The CST accurately predicted the optimum format for 11/13 participants and differentiated people who could understand fully with support from those who could not in 12/13 cases. All participants interviewed (10/10) found the adapted formats helpful and 9/10 preferred them to the standard version. These findings suggest that the CST could usefully support researchers to determine whether a person with aphasia is likely to be able to provide informed consent, and which information format will maximize that individual's understanding. The CST and different information formats are available as Supplementary Appendices to be found online at http://www.informahealthcare.com/doi/abs/10.3109/17549507.2013.795999.

Keywords::

• Aphasia
• stroke
• case series

Acknowledgements

Mr Jayes undertook this research whilst in receipt of a National Institute for Health Research (NIHR) Clinical Academic Training (CAT) Masters in Clinical Research studentship award. The study was supervised by Dr Rebecca Palmer and was supported by the NIHR Collaboration for Leadership in Applied Health Research and Care for South Yorkshire (CLAHRC SY). CLAHRC SY acknowledges funding from the National Institute for Health Research. The views and opinions expressed are those of the authors, and not necessarily those of the NHS, the NIHR or the Department of Health. CLAHRC SY would also like to acknowledge the participation and resources of their partner organizations. Further details can be found at www.clahrc-sy.nihr.ac.uk.

Declaration of Interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.