RT Journal Article
SR Electronic
T1 Meta-analytic comparison of randomized and nonrandomized studies of breast cancer surgery
JF Canadian Journal of Surgery
JO CAN J SURG
FD Canadian Medical Association
SP 155
OP 162
DO 10.1503/cjs.023410
VO 55
IS 3
A1 Janet P. Edwards
A1 Elizabeth J. Kelly
A1 Yongtao Lin
A1 Taryn Lenders
A1 William A. Ghali
A1 Andrew J. Graham
YR 2012
UL http://canjsurg.ca/content/55/3/155.abstract
AB Background: Randomized controlled trials (RCTs) are thought to provide the most accurate estimation of “true” treatment effect. The relative quality of effect estimates derived from nonrandomized studies (nRCTs) remains unclear, particularly in surgery, where the obstacles to performing high-quality RCTs are compounded. We performed a meta-analysis of effect estimates of RCTs comparing surgical procedures for breast cancer relative to those of corresponding nRCTs.Methods: English-language RCTs of breast cancer treatment in human patients published from 2003 to 2008 were identified in MEDLINE, EMBASE and Cochrane databases. We identified nRCTs using the National Library of Medicine’s “related articles” function and reference lists. Two reviewers conducted all steps of study selection. We included studies comparing 2 surgical arms for the treatment of breast cancer. Information on treatment efficacy estimates, expressed as relative risk (RR) for outcomes of interest in both the RCTs and nRCTs was extracted.Results: We identified 12 RCTs representing 10 topic/outcome combinations with comparable nRCTs. On visual inspection, 4 of 10 outcomes showed substantial differences in summary RR. The pooled RR estimates for RCTs versus nRCTs differed more than 2-fold in 2 of 10 outcomes and failed to demonstrate consistency of statistical differences in 3 of 10 cases. A statistically significant difference, as assessed by the z score, was not detected for any of the outcomes.Conclusion: Randomized controlled trials comparing surgical procedures for breast cancer may demonstrate clinically relevant differences in effect estimates in 20%–40% of cases relative to those generated by nRCTs, depending on which metric is used.