QUALITY OF REPORTING IN SURGICAL RANDOMIZED CLINICAL TRIALS
Author(s)
Yu J1, Sun X2, LI Y1, Li X3
1West China Hospital of Sichuan University, Chengdu, China, 2West China Hospital, Sichuan University, Chengdu, China, 3Chengdu Military General Hospital, Chengdu, China
OBJECTIVES: Randomized controlled trials testing surgical interventions have drawn increasing attention. The adequate reporting of surgical trials represents one of important issues. We conducted a cross-sectional survey to assess the reporting quality of surgical trials and explored associated factors. METHODS: We searched PubMed for 2-arm parallel randomized trials assessing surgical interventions published in 2003 or 2013. Quality of reporting was evaluated against the CONSORT checklist containing 29 items (standard CONSORT plus CONSORT Extension for Nonpharmacological Treatments). Univariate and multivariate linear regression was undertaken to explore factors associated with quality of reporting measured with CONSORT scores. RESULTS: Some 120 trials were identified and included. The mean (s.d.) CONSORT score was 12.7 (4.0). Trials published in 2013 achieved a higher CONSORT score than those in 2003 (mean 14.5 (3.8) versus 10.8 (3.4) respectively, P<0.001). The extent to which those trials met the requirement for CONSORT reporting differed substantially across items: four of 29 items were adequately reported across trials, and seven were reported adequately in less than 20% of trials. Less than 40% of the trials described the details on surgical interventions and care providers (such as nursing care and anesthetics management). In multivariate regression analysis, trials published in 2013 (coefficient 3.0, 95%CI, 1.9 to 4.2) and multicenter studies (coefficient 2.1, 95%CI, 0.8 to 3.4) were associated with statistically higher quality of reporting. CONCLUSIONS: The quality of reporting in surgical trials improved in the past decade. Overall quality, however, remains suboptimal, particularly in those important details regarding surgical interventions and management. Journal editors and trials investigators should consider more rigorous standards in the reporting of surgical trials.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PRM163
Topic
Study Approaches
Disease
Multiple Diseases