IP153. Methodological Quality of Randomized Control Trials in Vascular Surgery

Abstract

This study evaluated methodological quality of published vascular surgery randomized control trials (RCTs) to determine whether specific study characteristics were predictors of trial quality and to compare results to other surgical specialties. RCTs published from 2012 to 2015 in the top five vascular surgery journals by impact factor were scored using the Detsky Quality Scale. Trials were evaluated for number and degree of authors, epidemiology affiliation, centers of collaboration, number of subjects, and study type. The associations between quality scores and multiple independent parameters were explored. A total of 5606 articles were screened, and 181 met eligibility criteria. The mean Detsky score was 79.9% ± 1.7%. Drug trials had statistically higher mean scores than surgical trials (87.6% v s78.1%; P < .05). A priori sample size calculation was only performed in 42.2% of studies. Regression analysis determined that studies conducted with the aid of epidemiology departments, registered RCTs, non-USA trials, and nonsurgical trials were associated with higher scores (P < .05). Lack of randomization concealment and unblinded outcome assessors were associated with significantly lower-quality scores (P < .05). Among specialties, vascular surgery trials had similar quality scores as compared to neurosurgery (79.4% vs 80.9%; P = .8), with both specialties having higher scores than plastic surgery and orthopedic surgery (68.4% and 68.1%; P < .05). Factors associated with higher quality of RCTs include involvement of statistician, registered RCTs, and non-USA nonsurgical trials. An assessment of RCTs in vascular surgery reveals that the quality of literature is on par with other specialties. However, the greatest deficits include failure of randomization concealment and failure of blinding outcome assessors. Increased awareness of standardized guidelines for performing and reporting RCTs in vascular surgery is required to improve the quality of clinical trials.