Table 3 The barriers and facilitators mapped to the risk vs benefit assessment theme
From: Barriers and facilitators to the recruitment of disabled people to clinical trials: a scoping review
Risk vs benefits assessment | |
|---|---|
Barriers | Facilitators |
Safety risk posed by trial interventions, practices. For example, medication washout was considered by both patients and health professionals to potentially worsen individual’s health experience of their disability during the trial As disabled people were believed to be more vulnerable to complications and side effects of invasive procedures, there was decreased willingness for recruitment [15,16,17,18,19] | Targeted additional protections informed by an analysis of needs was proposed by Hsiao et al. [28]. For example, people living with fibrodysplasia ossificans progressiva (FOP) were identified for being particularly vulnerable to repeated blood draw complications. To address this, Hsiao et al. suggests the procedures to be conducted by experienced phlebotomists with special directions |
Disabled groups had increased perception of risks to health, privacy and mental wellbeing for taking part. For example, worries that recruitment would mean detachment from routine care that the person benefitted from [20], discomfort from trial procedures [21], confidentiality breaches [22], discrimination by staff [23], and placebo randomisation [24, 25] | Using open communication strategies that involved all stakeholders were found to be reassuring and successful at clarifying perceived threats [29]. This helped individuals to have realistic expectation and make informed decisions to enrol |
Disabled groups had low expectations of therapeutic benefit. Due to disabled groups having often exhausted available medical options and research opportunities for resolving their impairment to little avail [26, 27] | Detailed information was found to be particularly appreciated by families and carers who showed preference for direct communication [24, 27] |
Clinicians with long term contact with disabled patients worried about loss of trust from patient and their family [19]. Families and carers perceived a risk of increased workload if patient deteriorated from trial [21] | |