title: Reports of large immunosuppression trials in kidney transplantation: room for improvement.
abstract: The reporting quality of publications of clinical trials can affect the quality of clinical decision-making. We systematically assessed the quality of publications of large multicenter trials evaluating immunosuppressive regimens in de novo kidney transplantation. Study quality, reporting quality and accessibility of the results of 63 publications were assessed independently by three blinded investigators using an instrument combining the Jadad scale with a list of reporting quality items. Study quality was rated with an average of only 2.3 (range 1-5) on the Jadad scale. Unblinded studies were reported in 68.3% of publications and follow-up longer than 12 months was reported for only 13 out of 50 studies. The reviewed publications fulfilled an average of 69.1% of the reporting quality criteria. Fifty-four percent of publications did not report both treated and biopsy-proven rejections. Whether reported graft survival was censored for death could not be determined for 27% of publications. Only a few publications gave confidence intervals (CIs) or stated whether additional analyses were pre-specified. Even the largest trials of immunosuppression in kidney transplantation show considerable quality deficits in their design and publication. Additional efforts are required of investigators, editors and sponsors to achieve maximum study and reporting quality.
authors.affiliation: Department Nephrology, Charité Campus Mitte, Berlin, Germany. Lutz.Fritsche@charite.de
authors.forename: Lutz
authors.initials: L
authors.lastname: Fritsche
authors.forename: Gunilla
authors.initials: G
authors.lastname: Einecke
authors.forename: Franca
authors.initials: F
authors.lastname: Fleiner
authors.forename: Duska
authors.initials: D
authors.lastname: Dragun
authors.forename: Hans-Hellmut
authors.initials: HH
authors.lastname: Neumayer
authors.forename: Klemens
authors.initials: K
authors.lastname: Budde
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology*; D016030:Kidney Transplantation
chemical_list: D007166:Immunosuppressive Agents