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Difference in surgical outcomes of rectal cancer by study design: meta-analyses of randomized clinical trials, case-matched studies, and cohort studies.

ABSTRACT: RCTs are considered the standard in surgical research, whereas case-matched studies and propensity score matching studies are conducted as an alternative option. Both study designs have been used to investigate the potential superiority of robotic surgery over laparoscopic surgery for rectal cancer. However, no conclusion has been reached regarding whether there are differences in findings according to study design. This study aimed to examine similarities and differences in findings relating to robotic surgery for rectal cancer by study design. A comprehensive literature search was conducted using PubMed, Scopus, and Cochrane CENTRAL to identify RCTs, case-matched studies, and cohort studies that compared robotic versus laparoscopic surgery for rectal cancer. Primary outcomes were incidence of postoperative overall complications, incidence of anastomotic leakage, and postoperative mortality. Meta-analyses were performed for each study design using a random-effects model. Fifty-nine articles were identified and reviewed. No differences were observed in incidence of anastomotic leakage, mortality, rate of positive circumferential resection margins, conversion rate, and duration of operation by study design. With respect to the incidence of postoperative overall complications and duration of hospital stay, the superiority of robotic surgery was most evident in cohort studies (risk ratio (RR) 0.83, 95 per cent c.i. 0.74 to 0.92, P < 0.001; mean difference (MD) -1.11 (95 per cent c.i. -1.86 to -0.36) days, P = 0.004; respectively), and least evident in RCTs (RR 1.12, 0.91 to 1.38, P = 0.27; MD -0.28 (-1.44 to 0.88) days, P = 0.64; respectively). Results of case-matched studies were often similar to those of RCTs in terms of outcomes of robotic surgery for rectal cancer. However, case-matched studies occasionally overestimated the effects of interventions compared with RCTs.

SUBMITTER: Hoshino N

PROVIDER: S-EPMC7962725 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background/aims Non-inferiority trials with time-to-event outcomes are becoming increasingly common. Designing non-inferiority trials is challenging, in particular, they require very large sample sizes. We hypothesized that the difference in restricted mean survival time, an alternative to the hazard ratio, could lead to smaller required sample sizes. Methods We show how to convert a margin for the hazard ratio into a margin for the difference in restricted mean survival time and how to calculate the required sample size under a Weibull survival distribution. We systematically selected non-inferiority trials published between 2013 and 2016 in seven major journals. Based on the protocol and article of each trial, we determined the clinically relevant time horizon of interest. We reconstructed individual patient data for the primary outcome and fit a Weibull distribution to the comparator arm. We converted the margin for the hazard ratio into the margin for the difference in restricted mean survival time. We tested for non-inferiority using the difference in restricted mean survival time and hazard ratio. We determined the required sample size based on both measures, using the type I error risk and power from the original trial design. Results We included 35 trials. We found evidence of non-proportional hazards in five (14%) trials. The hazard ratio and the difference in restricted mean survival time were consistent regarding non-inferiority testing, except in one trial where the difference in restricted mean survival time led to evidence of non-inferiority while the hazard ratio did not. The median hazard ratio margin was 1.43 (Q1-Q3, 1.29-1.75). The median of the corresponding margins for the difference in restricted mean survival time was -21?days (Q1-Q3, -36 to -8) for a median time horizon of 2.0?years (Q1-Q3, 1-3?years). The required sample size according to the difference in restricted mean survival time was smaller in 71% of trials, with a median relative decrease of 8.5% (Q1-Q3, 0.4%-38.0%). Across all 35 trials, about 25,000 participants would have been spared from enrollment using the difference in restricted mean survival time compared to hazard ratio for trial design. Conclusion The margins for the hazard ratio may seem large but translate to relatively small differences in restricted mean survival time. The difference in restricted mean survival time offers meaningful interpretation and can result in considerable reductions in sample size. Restricted mean survival time-based measures should be considered more widely in the design and analysis of non-inferiority trials with time-to-event outcomes.

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Difference in surgical outcomes of rectal cancer by study design: meta-analyses of randomized clinical trials, case-matched studies, and cohort studies.

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