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Comparative effectiveness research in critically ill patients: risks associated with mischaracterising usual care
Willard N Applefeld1, Jeffrey Wang1, Harvey G Klein2
1Critical Care Medicine Department; Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Summary
Comparative effectiveness research (CER) trials must accurately reflect usual care to ensure patient safety. Inadequate oversight risks patient harm and invalidates informed consent when unusual care deviates from standard practices.
Area of Science:
- Clinical Research
- Medical Ethics
- Patient Safety
Background:
- Comparative effectiveness research (CER) aims to inform common medical practice.
- CER trials require accurate representation of current practices for safety and validity.
- Deviations from usual care in CER can pose risks, especially to critically ill patients.
Purpose of the Study:
- To highlight the critical need for accurate representation of usual care in comparative effectiveness research.
- To address the potential safety and ethical concerns arising from unrecognized deviations from standard practices in clinical trials.
- To advocate for improved oversight mechanisms to ensure the integrity of comparative effectiveness research.
Main Methods:
- Analysis of the assumptions and potential risks associated with comparative effectiveness research.
- Examination of the impact of deviations from usual care on patient safety and informed consent.
- Review of current oversight measures for clinical trials.
Main Results:
- Unrecognized deviations from usual care in CER can increase patient risk, including mortality and injury.
- Such deviations compromise the validity of informed consent by masking underappreciated risks.
- Existing oversight mechanisms are insufficient to guarantee that participants receive usual care.
Conclusions:
- Enhanced oversight is crucial to ensure that comparative effectiveness trials accurately reflect current clinical practices.
- Specialized governmental and non-governmental entities should be empowered to verify the representation of usual care.
- Preventing unusual care from masquerading as usual care is essential for the safety and ethical conduct of clinical trials.
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