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Reporting of adverse events in surgical trials: critical appraisal of current practice


Rosenthal, Rachel; Hoffmann, Henry; Dwan, Kerry; Clavien, Pierre-Alain; Bucher, Heiner C (2015). Reporting of adverse events in surgical trials: critical appraisal of current practice. World Journal of Surgery, 39(1):80-87.

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.

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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8 citations in Web of Science®
1 citation in Scopus®
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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Visceral and Transplantation Surgery
Dewey Decimal Classification:610 Medicine & health
Date:January 2015
Deposited On:16 Jan 2015 12:27
Last Modified:05 Apr 2016 18:46
Publisher:Springer
ISSN:0364-2313
Publisher DOI:https://doi.org/10.1007/s00268-014-2776-8
PubMed ID:25201471

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