The circular paradox of including people with severe brain injuries and reduced decisional capacity in research: A feasibility study exploring randomized research, consent-based recruitment biases, and the resultant health inequities

Background: People with severe brain injuries (PSBI) and reduced capacity to consent (CTC) frequently develop muscle contractures. Standard care includes prolonged stretch (PS) but there is limited condition specific evidence from randomised controlled trials (RCTs).

Purpose: Identify factors affecting the inclusion of PSBI and reduced CTC in a PS RCT and methodologies more capable of generating condition specific outcomes.

Methods: Mixed-methods feasibility study, including a pilot RCT (PSBI, adults with reduced CTC) comparing PS treatments (serial casting and splinting) and focus groups/interviews with physiotherapists involved in PS treatment. Reflexive thematic analysis developed themes.

Results: Two PSBI were included in the pilot RCT with no significant safety concerns or adverse effects. Twelve physiotherapists participated in 2 focus groups and 2 interviews. Four themes were identified: 1. the complexity of contracture management; 2. the burden of decision making; 3. lack of evidence and uncertainty; 4. challenges to RCT acceptability and feasibility.

Conclusions: Reduced CTC contributes to the exclusion of PSBI from experimental research, and a circular paradox where poor research inclusion contributes to generalised healthcare and ‘evidence-biased medicine’. Due to the complexity of their condition, simply including PSBI in randomised research is unlikely to create meaningful health outcomes. Improving their care requires a paradigm shift towards pluralistic methods of knowledge generation.