An exploration of the methodological and practical challenges in undertaking randomised controlled trials with adults with intellectual disabilities

Abstract

Background: There are significant gaps in the evidence base for many interventions provided to people with intellectual disabilities (ID). Few randomised controlled trials (RCTs) are conducted specifically for people with ID and this population is routinely excluded from mainstream trials. If more ID-RCTs are to be conducted, and gaps in the evidence base are to be addressed, then a better understanding of the challenges, and solutions, in conducting ID-RCTs are required.

Aims: This study had two aims: 1) to collate the challenges inherent in conducting ID-RCTs, and 2) to develop a toolkit for ID-RCT researchers.

Methods: A four stage, mixed-methods, exploratory sequential design was used. A systematic review ascertained the most commonly reported ID-RCT challenges and barriers (Stage 1). Semi-structured interviews (n=12) were then conducted with international ID-RCT researchers (Stage 2). The findings from stages 1 and 2 contributed to a modified Delphi survey (Stage 3), conducted with an international panel of ID-RCT researchers (n=22) to reach a consensus regarding which challenges should be included in a toolkit for researchers. The toolkit was developed in Stage 4.

Findings: The systematic review identified twenty-five challenges across three core themes (Randomisation, Control, Trial). The interviews identified four core themes: the uniqueness of the participants; the systems within which the research occurs; ethics and consent; and attitudes and perceptions. In the modified Delphi survey, sixty-four items (challenges), across twelve categories, achieved 70+% consensus, many of which had not been previously cited in the IDRCT literature.

Discussion: ID-RCT researchers experience more challenges than are commonly reported. In meeting these challenges, ID-RCT researchers are both developing the ‘evidence-base’ and gathering an important ‘experience-base’. However, opportunities to share this knowledge base are not currently being maximised. The on-line resource toolkit is an innovative means for sharing this ‘experience-base’, and useful resources, amongst the wider research community.

Date of Award	May 2019
Original language	English
Sponsors	DEL
Supervisor	Laurence Taggart (Supervisor), Vivien Coates (Supervisor) & Toni McAloon (Supervisor)