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 randomized controlled trials (RCTs). Purpose: Identify factors affect...

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Publicado en:Physiotherapy Theory & Practice Vol. 40; no. 10; pp. 2196 - 2213
Autores principales: Clark, Teresa, Lewko, Agnieszka, Calestani, Melania
Formato: research tables/charts Journal Article
Publicado: Taylor & Francis Ltd Oct2024
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Oct2024
      vid: 40
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      pub: Taylor & Francis Ltd
      place: Philadelphia, Pennsylvania
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        10.1080/09593985.2023.2236194
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        atl: 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.
      aug:
        au:
          Clark, Teresa
          Lewko, Agnieszka
          Calestani, Melania
        affil: Physiotherapy, Royal Hospital for Neurodisability, London, UK
      sug:
        subj:
          Brain Injuries
          Severity of Injury
          Randomized Controlled Trials
          Decision Making
          Competence (Legal)
          Research Subject Recruitment
          Consent
          Human
          Adult
          Middle Age
          Multimethod Studies
          Pilot Studies
          Focus Groups
          Interviews
          Thematic Analysis
          Safety
          Purposive Sample
          Scales
          Adult: 19-44 years
          Middle Aged: 45-64 years
      ab: 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.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Unknown
    language: English
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