Skip to main content
. 2018 Sep 26;154(1):90–92. doi: 10.1001/jamasurg.2018.3222

Table. Categorization of the Interpretation of the ACOSOG Z6051 and ALaCaRT Trials2,3 and Examples.

Category No. of Studies Type of Studies Example Explanation
Incorrect interpretation 20 6 Overviews (30.0%), 8 observational studies (40.0%), 6 commentaries/editorials (30.0%) “…these findings confirm concerns that laparoscopic surgery may lead to more cancer recurrences and shorter survival. …ACOSOG Z6051 currently providing data that laparoscopy does not provide the same quality of resection as open surgery for rectal cancer”5 Suggests that laparoscopy met criteria for inferiority (ie, not noninferior)
Ambiguous wording 39 12 Overviews (30.8%), 16 observational studies (41.0%), 2 commentaries/editorials (5.1%), 3 systematic reviews and meta-analyses (7.7%), 2 clinical practice guidelines (5.1%), 4 other (10.3%) “Some have concerns that oncologic outcomes may be compromised with the laparoscopic approach, especially for rectal cancer. Two recent randomized clinical trials failed to show that laparoscopy was noninferior to open surgery in a composite score of immediate oncologic outcomes”6 Does not convey to the reader whether laparoscopy was not noninferior or whether results were inconclusive
Acknowledges inconclusive nature of results 12 2 Overviews (16.6%), 3 observational studies (25.0%), 4 commentaries/editorials (33.3%), 1 systematic review and meta-analysis (8.3%), 1 clinical practice guideline (8.3%), 1 trial (8.3%) “Overall, both trials were unable to establish noninferiority for pathological outcomes in comparison of laparoscopic and open resection for rectal cancer…these results have been used by some commentators to suggest that laparoscopy has had its day when it comes to treating rectal cancer. However, it is important to realize that failure to show non-inferiority cannot be used to imply inferiority…”7 Correctly acknowledges that trial results are inconclusive and thus conclusions regarding the noninferiority of laparoscopic to open surgery cannot be drawn