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.

Abstract

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 randomized 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-method feasibility studies, 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 two focus groups and two interviews. Four themes were identified: 1) complexity of contracture management; 2) burden of decision making; 3) lack of evidence and uncertainty; and 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 generalized healthcare and "evidence-biased medicine." Due to the complexity of their condition, simply including PSBI in randomized research is unlikely to create meaningful health outcomes. Improving their care requires a paradigm shift toward pluralistic methods of knowledge generation.