Abstract
BACKGROUND: Randomized controlled trials (RCTs) of surgical interventions are often more difficult to conduct, and their quality may lag behind other trials. OBJECTIVES: To compare quality domains in trials of surgical interventions, to a previously reported control sample of general medical trials from December 2006. DATA SOURCES: MEDLINE, EMBASE and CENTRAL were searched in May 2009. STUDY ELIGIBILITY: English language, full text RCTs, performed on humans that compared a surgical intervention to any other intervention. STUDY APPRAISAL AND SYNTHESIS: Records were ordered according to their date of publication. The most recently published trials were assessed first, until the required sample of 400 trials was obtained. The search and data collection were piloted by three authors, and was thereafter collected by one author. Data was checked. RESULTS: Although most quality domains were poorly reported, surgical trials compared favourably to general medical trials. Surgical trials were 24% more likely to have an adequate method of random sequence generation, and 71% more likely to have an adequate method of allocation concealment. However, blinding was 40% less likely to be adequate in surgical trials, and sources of funding were 33% less likely to be reported. LIMITATIONS: A single author collected most data. Data was checked and this resulted in few changes. CONCLUSIONS: Reporting of most quality domains in surgical intervention trials was better than general medical trials. Blinding was less likely due to the difficulty in conducting sham surgical trials, and reporting of sources of support should improve with adherence to reporting guidelines.