Evolution of methodological standards in surgical trials

Abstract

The results of surgical trials need to be interpreted with care.

CONSORT Compliance in Surgical Randomized Trials

“…Studies were specialty specific, 25,26 were not conducted systematically, 27 or assessed trials of nonsurgical interventions. 6,28 The extent to which recently published surgical trials comply with CONSORT, which may be regarded as the current standard of trial reporting, is therefore unknown. We completed a systematic review to identify randomized trials assessing any surgical intervention, to assess the extent of compliance with the CONSORT statement.…”

“…Previous reviews have assessed the reporting quality of trials, but these were often limited to a specific specialty, 25,26 were not approached systematically, 27 and may not reflect the current published evidence base. 28 Furthermore, most trials with a "surgical" subject matter may not have assessed a surgical or procedural intervention. 6,26,28 This study was performed to address these deficits.…”

“…28 Furthermore, most trials with a "surgical" subject matter may not have assessed a surgical or procedural intervention. 6,26,28 This study was performed to address these deficits.…”

How to dissect surgical journals: XIV - Clinical trials*

“…These criteria have been evaluated in surveys of surgical trials 4–8 . Although there has been a slow but progressive improvement in the reporting of methodological standards in surgical trials, there are still some special problems.…”

Quality of reporting in surgical randomized clinical trials

“…A number of reasons have been suggested. Methodological issues such as difficulty with randomization, feasibility of blinding, surgeons' preference for procedures, and learning curves can inhibit the completion and publication of a successful surgical trial. The value of a trial report often depends on the adequacy of reporting.…”