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 .

Psychological and emotional needs, assessment, and support post-stroke: a multi-perspective qualitative study

“…Patients' understanding was 6 established using a consent support tool to determine whether they could comprehend three information carrying words in a sentence. 19 If the patients had an informal carer they were also invited to take part.…”

Behavioural Activation Therapy for Depression after Stroke (BEADS): a study protocol for a feasibility randomised controlled pilot trial of a psychological intervention for post-stroke depression

“…Participants will be excluded from the study if theyHad a diagnosis of dementia prior to the stroke (based on self-report by patient/carer)Were receiving medical or psychological treatment for depression at the time at which they had their stroke (based on self-report by patient/carer)Are currently receiving psychological interventionHave communication difficulties that would impact on their capacity to take part in the intervention (based on assessment with the Consent Support Tool [41] for people with aphasia)Have visual or hearing impairments that would impact on their capacity to take part in the intervention (based on the therapist’s discretion at baseline assessment)Were unable to communicate in English prior to the stroke or do not have mental capacity to consent to take part in the trial. …”

“…Have communication difficulties that would impact on their capacity to take part in the intervention (based on assessment with the Consent Support Tool [41] for people with aphasia)…”

Post-stroke self-management interventions: a systematic review of effectiveness and investigation of the inclusion of stroke survivors with aphasia

“…The systematic exclusion of this population of stroke survivors is not only discriminatory but may also lead to health inequalities due to a lack of evidence regarding the effectiveness of selfmanagement interventions with this population [24]. A number of well-established strategies have been advocated to promote the inclusion of stroke survivors with aphasia in research, [26,89,90] for example, the adaptation of consent procedures and written information.…”

“…The systematic exclusion of stroke survivors with aphasia from research may stem from the assumption that this population lack the capacity to consent to research procedures, however, the view that all stroke survivors with aphasia lack capacity is outdated [24]. Novel methods have been developed to facilitate the inclusion of stroke survivors with aphasia in research, however, it is unclear whether this has translated to the more frequent inclusion of this population [26]. The systematic exclusion of this sub-group of stroke survivors from research examining the efficacy and acceptability of these approaches is a cause for concern.…”