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"Lies, damned lies ..." and observational studies in comparative effectiveness research
1Denver Health and University of Colorado, Denver, CO 80204, USA. ralbert@dhha.org
Summary
While observational studies are proposed for comparative effectiveness research, this analysis questions their validity. Concerns exist that these studies may increase healthcare costs and potentially harm patients.
Area of Science:
- Health Services Research
- Clinical Epidemiology
Background:
- Federal funding supports comparative effectiveness research (CER).
- Observational studies are proposed as a key component of CER.
- Randomized controlled trials (RCTs) face limitations in real-world applicability and feasibility.
Purpose of the Study:
- To critically evaluate the proposed benefits of using observational studies in CER.
- To examine the validity of criticisms leveled against RCTs for CER.
- To highlight potential drawbacks of observational studies in CER.
Main Methods:
- Literature review and critical analysis of existing arguments.
- Examination of proposed limitations of RCTs.
- Review of concerns regarding the accuracy of observational studies.
Main Results:
- Challenges the "real-world" limitations attributed to RCTs.
- Summarizes concerns about the accuracy of observational study findings.
- Presents examples of discrepancies between RCTs and observational studies in pulmonary and critical care.
Conclusions:
- The utility of observational studies for CER is questioned.
- Using observational studies may not be cost-effective.
- Potential for patient harm exists with reliance on observational studies for CER.
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