Abstract
BACKGROUND: The decision to conduct a randomized controlled trial (RCT) in a field raises ethical as well as scientific issues. From the clinical equipoise literature, future trials are justifiable if there is "honest, professional disagreement in the community of expert practitioners as to the preferred treatment". Empirical data are sparse about how clinicians apply the principles of equipoise to the justification of future RCTs. For example, selective decontamination of the digestive tract (SDD) is not widely used in critical care practice despite the strength of the evidence base and therefore provides a unique opportunity to learn how clinicians think about the ethics of further RCTs in critical care.
METHODS: In an international interview study of views of healthcare professionals about SDD, we undertook a secondary analysis of qualitative data collected using a Theoretical Domains Framework of clinical behaviour. We adopted a general descriptive approach to explore how physicians determined whether another RCT of SDD is ethical. Following a constant comparison approach, three investigators reviewed 54 purposively chosen transcripts from three international regions. We interpreted the data using thematic analysis.
RESULTS: We grouped participants' responses into four inter-related themes: 1) cultural norms about evidence and practice within healthcare; 2) personal views about what evidence is current or applicable; 3) the interpersonal and relational nature of professional decision making locally; and 4) an a priori commitment to future trials. The analysis also identified several unresolved tensions regarding when a future RCT should be pursued. These tensions focused on a clash between potential benefits to current individual patients and potential future harms to patients more broadly.
CONCLUSIONS: Our study suggests that ethical decision making about future RCTs in the field of SDD does not rely strongly on appeals to evidence, even when the quality of the evidence is reasonably high. Rather, "extra-evidential" reasons, including social, professional, and relational factors, seem to influence opinions regarding the ethics of future trials. Further work is required to see if these conclusions are applicable to other clinical topics and settings.
| Original language | English |
|---|---|
| Article number | 12 |
| Pages (from-to) | 1-8 |
| Number of pages | 8 |
| Journal | Trials |
| Volume | 17 |
| DOIs | |
| Publication status | Published - 6 Jan 2016 |
Bibliographical note
AcknowledgementsThe SuDDICU collaboration is a collaboration of the Canadian Critical Care Trials Group (CCCTG), the UK Critical Care Research Forum, and the Australia and New Zealand Clinical Trials Group (ANZICS CTG) and is supported by all three organizations. The Health Services Research Unit at the University of Aberdeen is core funded by the Chief Scientist Office of the Scottish Government Health Directorates. Views expressed are those of the authors and do not necessarily reflect the view of the Chief Scientist Office. We acknowledge the support of a Canadian Institutes of Health Research operating grant. The UK arm of this project was funded in the UK by the NIHR Health Technology Assessment programme and is published in full in the Health Technology Assessment journal series at http://www.journalslibrary.nihr.ac.uk/hta/volume-18/issue-25. Visit the HTA Programme website for more details at www.hta.ac.uk/2299. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the UK Department of Health. We acknowledge the support of the UK Intensive Care Foundation. We acknowledge the support of an Australian Intensive Care Foundation grant and an Australian and New Zealand College of Anaesthetists grant.
Keywords
- ethics
- clinical equipoise
- harm-benefit analysis
- critical care
- evidence-based medicine
- qualitative research
- randomized controlled trials