Reporting of Adverse Events in Surgical Trials: Critical Appraisal of Current Practice

Henry Hoffmann · Kerry M. Dwan · Pierre‐Alain Clavien · Heiner C. Bucher

45 citations0/0 files storedWorld Journal of Surgery

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Meta-analysis and systematic reviews Cardiac, Anesthesia and Surgical Outcomes Delphi Technique in Research

Abstract

BACKGROUND: Reporting of surgical outcomes is important for healthcare decision making and includes the reporting of complications. Several classifications have been proposed and validated for postoperative, but not intraoperative, complications. The aim of the present study is to assess the current practice of complication reporting in surgical trials. METHODS: We evaluated the reporting of intra- and postoperative complications in all registered randomized controlled trials that included investigate surgery or invasive interventions in at least one study arm and were published in 2010 in the Annals of Surgery, JAMA Surgery, and the British Journal of Surgery. RESULTS: A total of 46 trials were identified; intra- and postoperative complications were reported separately in 42 % and pooled in 15 %. In 37 % intraoperative, in 2 % postoperative, and in 4 % both intra- and postoperative, complications were not reported at all. Exact definitions were provided in 13 % for intraoperative and in 50 % for postoperative complications. A classification was used in 9 % for intra- and in 54 % for postoperative complications, most frequently according to severity. The type of intervention (surgical vs. other) or whether the primary outcome was the assessment of complications had no significant impact on reporting definitions of adverse events. CONCLUSIONS: Intraoperative complications are frequently pooled with postoperative complications, ill-defined, or not reported at all, hampering informed decision making. As further research, we propose to develop and validate a classification of intraoperative complications. This will facilitate the evaluation of safety and the continuous quality control of surgical interventions with the ultimate goal to contribute to patient safety.

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References

2010CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials 2010CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials 2008Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration 2012Developing core outcome sets for clinical trials: issues to consider 2004Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement 2002Quality of Complication Reporting in the Surgical Literature 2001Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.1998Reporting of safety data from randomised trials

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