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Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study. | LitMetric

AI Article Synopsis

  • * Researchers conducted a mixed-methods analysis involving surveys and interviews with ICU patients, relatives, and healthcare practitioners across 14 English ICUs, finding a general agreement on the role of relatives as SDMs, but some skepticism about doctors' involvement.
  • * Results indicate that while most support current consent practices, opinions vary based on specific study details, highlighting the need for improved communication and decision-making processes, ultimately guiding better consent practices in future research.

Article Abstract

Objectives: Obtaining informed consent from patients in intensive care units (ICUs) prior to enrolment in a study is practically and ethically complex. Decisions about the participation of critically ill patients in research often involve substitute decision makers (SDMs), such as a patient's relatives or doctors. We explored the perspectives of different stakeholder groups towards these consent procedures.

Design And Methods: Mixed-methods study comprising surveys completed by ICU patients, their relatives and healthcare practitioners in 14 English ICUs, followed by qualitative interviews with a subset of survey participants. Empirical bioethics informed the analysis and synthesis of the data. Survey data were analysed using descriptive statistics of Likert responses, and analysis of interview data was informed by thematic reflective approaches.

Results: Analysis included 1409 survey responses (ICU patients n=333, relatives n=488, healthcare practitioners n=588) and 60 interviews (ICU patients n=13, relatives n=30, healthcare practitioners n=17). Most agreed with relatives acting as SDMs based on the perception that relatives often know the patient well enough to reflect their views. While the practice of doctors serving as SDMs was supported by most survey respondents, a quarter (25%) disagreed. Views were more positive at interview and shifted markedly depending on particularities of the study. Participants also wanted reassurance that patient care was prioritised over research recruitment. Findings lend support for adaptations to consent procedures, including collaborative decision-making to correct misunderstandings of the implications of research for that patient. This empirical evidence is used to develop good practice guidance that is to be published separately.

Conclusions: Participants largely supported existing consent procedures, but their perspectives on these consent procedures depended on their perceptions of what the research involved and the safeguards in place. Findings point to the importance of explaining clearly what safeguards are in place to protect the patient.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9664286PMC
http://dx.doi.org/10.1136/bmjopen-2022-066149DOI Listing

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