Laparoscopic vs Open Surgery for Low Rectal Cancer

To the Editor We read with great interest the Original Investigation by Jiang et al, so-called the LASRE randomized clinical trial, demonstrating that laparoscopic surgery provided similar pathologic outcomes compared with open approach for low rectal cancer, with an increased sphincter preservation rate and improved postoperative convalescence. Despite the excellent design and conduct of the trial, we have a few apprehensions to arouse discussions on this flourishing and fadeless research topic.

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Maggio 2023

Laparoscopic vs Open Surgery for Low Rectal Cancer—Reply

In Reply We appreciate the comments by Yuan et al regarding our recent Original Investigation. During the surgical operation, we strictly followed the study design of at least 10 cm for proximal resection margin (PRM). The fact that one-fourth of patients in the laparoscopic group had a PRM of 9 cm or less most likely reflects the contraction of resected specimen from the time of resection to the time of measurement (typically at the end of surgery). A similar phenomenon (PRM at

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Maggio 2023

Randomized Trials vs Real-World Evidence

Noting that randomized clinical trials (RCTs) “generally yield the strongest inferences about the effects of medical treatments,”(p984) the AMA Manual of Style instructs that “randomized trials may use terms such as effect and causal relationship,”(p983) In contrast, the manual claims that observational studies “cannot lead to causal inferences”(p994) and thus “should be described in terms of association or correlation and should avoid cause-and-effect wording.”(p983) Nevertheless, analyses of observational data—often consisting of real-world evidence from databases of medical claims and electronic health records—play an increasingly prominent role in health care. Given the well-recognized limitations of observational studies, their growing use to estimate treatment effects is the subject of considerable controversy. Should real-world evidence have a meaningful role in decision-making? In this issue of JAMA, investigators from the RCT DUPLICATE Initiative address this controversy by directly comparing the results of published RCTs to analyses of 3 national claims databases that are carefully designed to emulate the original RCTs. The results of their productive line of research warrant careful consideration.

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Aprile 2023