To measure and standardize 30-day complication rates across study sites, a two-stage process can be utilized. First, coordinators may gather adverse events from chart reviews and patient interviews in the following categories:
In the second stage each identified complication can be graded accorded to the Clavien-Dindo classification of surgical complications. [1, 2] The Clavien-Dindo classification is a validated scale that grades severity of surgical complications according to the type of therapy provided to address the complication and is increasingly used and recommended for clinical trials whose outcomes include medical and surgical complications. The use of the Dindo-Clavien scale standardizes complication definition and grading across the sites of a study. According to this classification, grades I-II will be considered minor complications and grades III-V will be considered major complications. Clinical scenarios describing the surgical complications and grades are available on a website for training coordinators (http://www.surgicalcomplication.info/templates_download.html). The data used to assign Clavien-Dindo grades are usually well documented and easily verifiable, and therefore, the Scale minimizes errors and bias, and improves consistency across sites.
1. Clavien, P.A., et al., The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg, 2009. 250(2): p. 187-96.
2. Dindo, D., N. Demartines, and P.A. Clavien, Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg, 2004. 240(2): p. 205-13.