title: Differences in reporting of acute rejections between American and European publications of large immunosuppressive trials impair comparability of study results.
abstract: This study examined the use of different definitions for acute rejection in recent large multicenter trials performed in America and Europe in order to assess whether systematic differences exist between both scientific cultures. We systematically selected recent publications on multicenter randomized controlled trials, investigating immunosuppressive regimens in de novo kidney transplant recipients. Publications included were classified according to the type of acute rejection reported: group 1 reported no or only one type of rejection rate (biopsy-proven or treated); group 2 reported information on both treated and biopsy-proven rates. Other potential factors (journal's impact-factor, study size) were compared within the subgroups. To determine the rates of treated but not biopsy-proven acute rejections, additional analyses were performed within subgroup 2. The reviewed publications were 24/44 (54.5%) European (E) and 20/44 (45.5%) American (A) origin. Eighteen of 44 publications reported no or only one type of rejection rate (group 1); 26 publications reported treated as well as biopsy-proven rates (group 2). Significantly more European publications reported both treated and biopsy-proven rates (E: 18/24 [75.0%] vs A: 8/20 [40.0%]; P = .019). Group 1 American papers were published in higher-ranked journals than European ones. The rate of blindly treated rejections did not differ significantly (A: 6.13% [range 0% to 12.8%] vs E: 8.43% [range 0% to 16.9%]) and the proportion of blindly treated rejections was slightly lower in American studies (A: 18.5% vs E: 26.5%). Our systematic review showed large discrepancies with a trend to report biopsy-proven rejection rates only in recent years.
authors.affiliation: Department of Nephrology, University Hospital Charité, Campus Mitte, Schumannstrasse 20/21, 10098 Berlin, Germany. f.fleiner@gmx.net
authors.forename: F
authors.initials: F
authors.lastname: Fleiner
authors.forename: K
authors.initials: K
authors.lastname: Budde
authors.forename: D
authors.initials: D
authors.lastname: Dragun
authors.forename: M
authors.initials: M
authors.lastname: Hartmann
authors.forename: H H
authors.initials: HH
authors.lastname: Neumayer
authors.forename: L
authors.initials: L
authors.lastname: Fritsche
mesh_terms: D000208:Acute Disease; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D005060:Europe; D006084:Graft Rejection / Q000453:epidemiology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D010506:Periodicals as Topic; D011643:Publishing; D015203:Reproducibility of Results; D014481:United States
chemical_list: D007166:Immunosuppressive Agents