The account for provider and center effects in multicenter interventional and surgical randomized controlled trials is in need of improvement: a review

• Published in: Journal of clinical epidemiology Vol. 61; no. 5; pp. 435 - 439
• Main Authors: Biau, David J, Porcher, Raphaël, Boutron, Isabelle
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01-05-2008; Elsevier; Elsevier Limited
• Subjects: Adjustment; Biological and medical sciences; Center; Clinical trials; Epidemiology; Humans; Internal Medicine; Interventional; Medical sciences; Miscellaneous; Multicenter Studies as Topic - methods; Multicenter Studies as Topic - standards; Provider; Quality Assurance, Health Care; Random effects; Randomized controlled trial; Randomized Controlled Trials as Topic - methods; Randomized Controlled Trials as Topic - standards; Research Design; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgical; Surgical Procedures, Operative; Treatment Outcome; Center; Surgical; Interventional; Adjustment; Random effects; Randomized controlled trial; Provider; Interventional radiology; Review; Improvement; Need; Randomization; Treatment; Surgery; Clinical trial; Bibliographic review
• ISSN: 0895-4356; 1878-5921
• DOI: 10.1016/j.jclinepi.2007.10.018

Abstract Objective To systematically review the account of center and provider effects in large surgical and interventional randomized controlled trials. Study Design A systematic review of multicenter interventional randomized trials of 200+ patients. The search included Medline from 1 January 2000 through 11 October 2005 and a hand search of the bibliographies of retrieved articles. One author abstracted all data using standardized abstraction forms; a second reviewer assessed a random sample of reports as quality-assurance procedure. Results Sixty-eight reports met inclusion criteria. The trials predominantly reported on cardiology ( n = 23, 34%). The number of participating providers was reported in 11 trials (16%). Both the performed control and performed interventional procedures were described in 43 trials (63%). The use of stratified random allocation on center was reported in 26 trials (38%) and on provider in 6 trials (9%). The analysis was adjusted for center in four trials (6%) and for provider in three trials (4%). Conclusions Only few trials account for center or provider effect in the design and analysis. Authors and journal editors could play an important role in improving the reporting of trials.