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Quality of surgical randomized controlled trials for acute cholecystitis: assessment based on CONSORT and additional check items
Author(s) -
Shikata Satoru,
Nakayama Takeo,
Yamagishi Hisakazu
Publication year - 2008
Publication title -
journal of hepato‐biliary‐pancreatic surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.63
H-Index - 60
eISSN - 1868-6982
pISSN - 0944-1166
DOI - 10.1007/s00534-007-1268-8
Subject(s) - acute cholecystitis , randomized controlled trial , consolidated standards of reporting trials , medicine , quality (philosophy) , medical physics , general surgery , cholecystectomy , surgery , philosophy , epistemology
Background/Purpose In this study, we conducted a limited survey of reports of surgical randomized controlled trials, using the consolidated standards of reporting trials (CONSORT) statement and additional check items to clarify problems in the evaluation of surgical reports. Methods A total of 13 randomized trials were selected from two latest review articles on biliary surgery. Each randomized trial was evaluated according to 28 quality measures that comprised items from the CONSORT statement plus additional items. Analysis focused on relationships between the quality of each study and the estimated effect gap (“pooled estimate in meta‐analysis” — “estimated effect of each study”). Results No definite relationships were found between individual study quality and the estimated effect gap. The following items could have been described but were not provided in almost all the surgical RCT reports: “clearly defined outcomes”; “details of randomization”; “participant flow charts”; “intention‐to‐treat analysis”; “ancillary analyses”; and “financial conflicts of interest”. The item, “participation of a trial methodologist in the study” was not found in any of the reports. Conclusions Although the quality of reporting trials is not always related to a biased estimation of treatment effect, the items used for quality measures must be described to enable readers to evaluate the quality and applicability of the reporting. Further development of an assessment tool is needed for items specific to surgical randomized controlled trials.