Barriers and facilitators to the recruitment of disabled people to clinical trials: a scoping review

Abstract

Introduction Underrepresentation of disabled groups in clinical trials results in an inadequate evidence base for their clinical care, which drives health inequalities. This study aims to review and map the potential barriers and facilitators to the recruitment of disabled people in clinical trials to identify knowledge gaps and areas for further extensive research. The review addresses the question: ‘What are the barriers and facilitators to recruitment of disabled people to clinical trials?’. Methods The Joanna Briggs Institute (JBI) Scoping review guidelines were followed to complete the current scoping review. MEDLINE and EMBASE databases were searched via Ovid. The literature search was guided by a combination of four key concepts from the research question: (1) disabled populations, (2) patient recruitment, (3) barriers and facilitators, and (4) clinical trials. Papers discussing barriers and facilitators of all types were included. Papers that did not have at least one disabled group as their population were excluded. Data on study characteristics and identified barriers and facilitators were extracted. Identified barriers and facilitators were then synthesised according to common themes. Results The review included 56 eligible papers. The evidence on barriers and facilitators was largely sourced from Short Communications from Researcher Perspectives (N = 22) and Primary Quantitative Research (N = 17). Carer perspectives were rarely represented in articles. The most common disability types for the population of interest in the literature were neurological and psychiatric disabilities. A total of five emergent themes were determined across the barriers and facilitators. These were as follows: risk vs benefit assessment, design and management of recruitment protocol, balancing internal and external validity considerations, consent and ethics, and systemic factors. Conclusions Both barriers and facilitators were often highly specific to disability type and context. Assumptions should be minimised, and study design should prioritise principles of co-design and be informed by a data-driven assessment of needs for the study population. Person-centred approaches to consent that empower disabled people to exercise their right to choose should be adopted in inclusive practice. Implementing these recommendations stands to improve inclusive practices in clinical trial research, serving to produce a well-rounded and comprehensive evidence base.

Effectiveness of multimodal participant recruitment in SPARK, a large, online longitudinal research study of autism

“…Finally, a challenge that is not unique to pediatric research is the recruitment and engagement of traditionally underrepresented groups, such as individuals with disabilities and racial and ethnic minority populations [ 27 ]. Individuals with disabilities are routinely underrepresented in research because of physical, cognitive, and economic challenges and the added resources that may be required to accommodate their needs [ 28 , 29 ]. For racial and ethnic minority communities, studies have shown that it is important to employ a range of community engagement strategies [ 30 , 31 ], as well as communicate both their unique contributions to research and the benefits conferred with their participation [ 32 – 34 ].…”

Altered tongue muscle contractile properties coincide with altered swallow function in the adult Ts65Dn mouse model of down syndrome

“…The clinical study of tongue muscle function and swallowing disorders in adults with DS has some logistical limitations. These include limited geographical availability and capacities of specialized multidisciplinary clinical care centers for DS, which creates barriers for some adults with DS to receive health care services aligned with best practices (45,46), accessibility barriers that disproportionately disenfranchise individuals with communication support needs who may require special accommodation in order to communicate with medical providers (47), which may be applicable to many individuals with DS (44,48,49), and risks for disconnects between researcher expectations and the lived experiences of some disabled study participants (50). In light of these systemic challenges, the continued use of animal models of DS for basic discovery of underlying mechanisms of dysphagia is one of many strategies that can be used to ultimately advance more equitable inclusion of people with DS in the benefits of basic dysphagia research.…”

Shining a spotlight on the inclusion of disabled participants in clinical trials: a mixed methods study

“…Another barrier to participation is the presence of ambiguous eligibility criteria, such as the lack of clearly justified criteria for individuals with conditions that may put participants at risk during the trial. This ambiguity may not adequately account for the diverse range of disabilities among participants in clinical trials [44]. This has been discussed in many previous studies and is a very complex topic that has not yet reached a consensus on the implementation of standardised practice [45][46][47].…”

“…Although the challenges faced by under-served groups participating in clinical trials have been investigated internationally, research focusing on disabled people in this context is still limited. Most of the evidence currently available is from researcher perspectives, literature reviews or primary quantitative studies [22][23][24][32][33][34]. The perspectives of carers and disabled people themselves are rarely represented in the research outputs.…”