• Guillaume Lonjon, Isabelle Boutron, Ludovic Trinquart, Nizar Ahmad, Florence Aim, Rémy Nizard, and Philippe Ravaud.
• *Unité INSERM U738 †Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Service d'orthopédie et traumatologie ‡Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, Centre d'Epidémiologie Clinique §Université Paris Descartes-Sorbonne Paris Cité ¶French Cochrane Centre, Paris, France; and ‖Columbia University, Mailman School of Public Health, NY.
• Ann. Surg. 2014 Jan 1; 259 (1): 182518-25.

ObjectiveWe aimed to compare treatment effect estimates from NRSs with PS analysis and RCTs of surgery.BackgroundEvaluating a surgical procedure in randomized controlled trials (RCTs) is challenging. Nonrandomized studies (NRSs) involving use of propensity score (PS) analysis to limit bias are of increasing interest.DesignMeta-epidemiological study.MethodsWe systematically searched MEDLINE via PubMed for all prospective NRSs with PS analysis evaluating a surgical procedure. Related RCTs, addressing the same clinical questions, were systematically retrieved. Our primary outcome of interest was all-cause mortality. We also selected 1 subjective outcome. We calculated the summary odds ratios (OR) for each study design, the ratio of OR (ROR) between the designs and the summary ROR across clinical questions. An ROR<1 indicated that the experimental intervention is more favorable in NRSs with PS analysis than RCTs.ResultsWe retrieved 70 reports of NRSs with PS analysis and 94 related RCTs evaluating 31 clinical questions, of which 22 assessed all-cause mortality and 26 a subjective outcome. The combined ROR for all-cause mortality was 0.83 (95% confidence interval: 0.65-1.04). For subjective outcomes, the combined ROR was 1.07 (0.87-1.33).ConclusionsThere was no statistically significant difference in treatment effect between NRSs with PS analysis and RCTs. Prospective NRSs with suitable and careful PS analysis can be relied upon as evidence when RCTs are not possible.

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