CRTs - Cluster Randomized Trials or Courting Real Troubles: the real-world challenges of running a CRT in rural Gujarat, India
Abstract
Cluster randomized trials CRTs have undeniable strengths, but also complications. This paper addresses the logistical challenges of achieving methodological 'best practice' in CRTs, drawing on the experience of implementing a CRT within a running community-based health insurance CBHI scheme in Gujarat, India.
Our CRT is seeking to improve the equity impact - i.e. reduce the differential in claims submission for hospitalization between poor and less poor - of this CBHI in rural areas.
Six main challenges are identified and discussed:
- assigning control clusters;
- blinding;
- implementing multiple interventions simultaneously across twelve sub-districts;
- minimizing leakage across intervention groups;
- piggy-backing on a continually changing scheme;
- designing interventions that are financially and administratively sustainable.
The challenges identified are not likely to be unique to low-income settings, although the last two issues are particularly likely when working with relatively small and resource-constrained programmes. While compromises to methodological best-practice may reduce internal validity, they make the intervention more 'real', and potentially more applicable, to other programmes and settings.
Citation
Canadian Journal of Public Health (2006) 97 (1) 72-75