Résumé
Background: Accurate knowledge of adverse events is critical for evaluation of the safety of interventions. Historically, adverse events in surgical trials have been poorly reported. The objective of this study was to systematically evaluate the reporting of adverse events in randomized controlled trials in the plastic surgery literature. Methods: Two independent reviewers conducted a systematic search using MEDLINE, Embase, and Scopus of the top seven plastic surgery journals with the highest impact factors. Randomized controlled trials describing a potentially invasive treatment, published between January of 2012 and December of 2016, were included. Results: One hundred forty-five randomized controlled trials involving 10,266 patients were included, of which 30 percent were registered. Anticipated adverse events were clearly defined in 15 percent of trials, and in 70 percent it was not clear who would be documenting adverse events. Furthermore, 72 percent of randomized controlled trials reported the occurrence of adverse events, of which 61 percent failed to report events occurring in the intrainterventional period. Binary logistic regression revealed that funded randomized controlled trials were 4.04 times more likely to report adverse events compared with nonfunded randomized controlled trials (95 percent CI, 1.41 to 10.83; p = 0.009). Conclusions: The authors' findings suggest the need for reporting standards for adverse events in the plastic surgery literature, as such reporting remains heterogeneous and is lacking rigor. Improved quality and transparency are needed to strengthen evidence-based practice and permit a balanced intervention assessment. This study provides a set of recommendations aimed at improving adverse event reporting.
| Langue d'origine | English |
|---|---|
| Pages (de-à) | 199E-208E |
| Journal | Plastic and Reconstructive Surgery |
| Volume | 143 |
| Numéro de publication | 1 |
| DOI | |
| Statut de publication | Published - janv. 2019 |
Note bibliographique
Funding Information:Year of publication 2016 2015 2014 2013 2012 Journal Plastic and Reconstructive Surgery Aesthetic Surgery Journal Journal of Hand Surgery Burns Journal of Plastic, Reconstructive and Aesthetic Surgery Annals of Plastic Surgery Journal of Hand Surgery, European Volume Domain of plastic surgery Hand/upper extremity Aesthetic Breast surgery Burns Craniofacial Head and neck reconstruction Lower extremities Miscellaneous Trunk Intervention type Surgical Drug Other Funding source Not funded Not declared Nonindustry Industry Conflict of interest No conflict Conflict reported
Funding Information:
We speculate that funding bodies may demand more stringent and transparent reporting of adverse events by authors. This may especially be true for non–industry-funding sources, as we found that these studies were more likely to report their adverse events in comparison to industry-funded trials. Federally funded studies are overseen by a data safety monitoring board, and the National Institutes of Health conducts site visits to assess whether adverse events are being collected. These studies also usually have oversight by an officer who requires immediate adverse event reporting to the National Institutes of Health and local institutional research ethics board. In contrast, industry-sponsored or unfunded trials do not have the same oversight and reporting procedures.
Publisher Copyright:
Copyright © 2018 by the American Society of Plastic Surgeons.
ASJC Scopus Subject Areas
- Surgery