Rational centre selection for RCTs with a parallel economic evaluation--the next step towards increased
Adrian Gheorghe1, Tracy Roberts, Thomas D Pinkney
1Primary Care Clinical Sciences and MRC Midland Hub for Trials Methodology Research, University of Birmingham, UK; Department of Global Health and Development, London School of Hygiene & Tropical Medicine, UK.
Health Economics
|February 14, 2014
Summary
Centre selection in randomised controlled trials (RCTs) significantly impacts economic evaluation generalisability. Future research should prioritize generalisability during RCT design, not post-hoc analysis, for better policy relevance.
Area of Science:
- Health economics
- Clinical trial methodology
- Health services research
Background:
- Generalisability of economic evaluations from randomised controlled trials (RCTs) is crucial for policy decisions.
- Current methods for assessing generalisability lack verifiable assumptions about centre representativeness.
- Centre selection in multicentre RCTs can influence cost-effectiveness estimates.
Purpose of the Study:
- To examine the impact of centre selection on the generalisability of RCT-based economic evaluations.
- To propose novel concepts for advancing generalisability research in clinical trials.
- To shift focus towards proactive generalisability assessment during trial design.
Main Methods:
- Review of current methods for addressing generalisability in economic evaluations.
- Analysis of data from a multicentre RCT to demonstrate the effect of centre sampling on cost-effectiveness.
- Introduction of the 'research space' vs. 'policy space' distinction.
- Proposal of a centre-specific generalisability index.
Main Results:
- Existing generalisability methods do not verify centre representativeness.
- Cost-effectiveness estimates are demonstrably influenced by the specific centres included in an RCT.
- Policy makers require generalisability within the 'policy space', which differs from the 'research space' addressed by current methods.
Conclusions:
- Generalisability of economic evaluations is highly dependent on the selection of recruiting centres.
- A centre-specific generalisability index should be developed and utilized at the RCT design stage.
- Future research should prioritize enhancing generalisability during the design phase of RCTs over post-hoc evaluations.
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