The art of quality assessment of RCTs included in systematic reviews

J Clin Epidemiol. 2001 Jul;54(7):651-4. doi: 10.1016/s0895-4356(00)00360-7.


The best evidence on the efficacy of medical interventions is provided by high-quality trials summarized in high-quality systematic reviews or meta-analyses. The methodological quality of studies included in a systematic review can have a substantial impact on the estimates of the treatment effect and therefore on the conclusions of such a review. But what is the empirical evidence to support quality assessment of randomized clinical trials (RCTs)? We elaborate on questions such as: what is the concept of quality of individual studies (RCTs), can quality be measured validly and reliably? Plans for future research on this issue are proposed.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Humans
  • Quality Assurance, Health Care*
  • Randomized Controlled Trials as Topic*
  • Reproducibility of Results