A systematic review of the methodological and practical challenges of undertaking randomised-controlled trials with...

Approximately 10% of the world's population have a cognitive disability. Cognitive disabilities can have a profound impact on a person's social, cognitive or mental functioning, requiring high levels of costly health and social support. Therefore, it is imperative that interventions and services received are based upon a sound evidence-base. For many interventions for this population, this evidence-base does not yet exist and there is a need for more Randomised Controlled Trials (RCTs). The process of conducting RCTs with disabled populations is fraught with methodological challenges. We need a better understanding of these methodological barriers if the evidence-bases are to be developed. The purpose of this study was to explore the methodological and practical barriers to conducting trials with adults with cognitive disabilities. As a case example, the literature regarding RCTs for people with intellectual disabilities (ID) was used to highlight these pertinent issues. A systematic literature review was conducted of RCTs with adults with ID, published from 2000 to 2017. A total of 53 papers met the inclusion criteria and were reviewed. Some of the barriers reported were specific to the RCT methodology and others specific to people with disabilities. Notable barriers included; difficulties recruiting; obtaining consent; resistance to the use of control groups; engaging with carers, staff and stakeholders; the need to adapt interventions and resources to be disability-accessible; and staff turnover. Conducting RCTs with people with cognitive disabilities can be challenging, however with reasonable adjustments, many of these barriers can be overcome. Researchers are not maximising the sharing of their experience-base. As a result, the development of evidence-bases remains slow and the health inequities of people with disabilities will continue to grow. The importance of the MRC guidelines on process evaluations, together with implications for the dissemination of 'evidence-base' and 'experience-base' are discussed.