@article{ref1,
title="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",
journal="Physiotherapy theory and practice",
year="2023",
author="Clark, Teresa and Lewko, Agnieszka and Calestani, Melania",
volume="ePub",
number="ePub",
pages="ePub-ePub",
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). <br><br>PURPOSE: Identify factors affecting the inclusion of PSBI and reduced CTC in a PS RCT and methodologies more capable of generating condition-specific outcomes. <br><br>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. <br><br>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. <br><br>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 &quot;evidence-biased medicine.&quot; 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.<p /> <p>Language: en</p>",
language="en",
issn="0959-3985",
doi="10.1080/09593985.2023.2236194",
url="http://dx.doi.org/10.1080/09593985.2023.2236194"
}