Quality and Consistency of Outcome Reporting in Clinical Trials of Immunosuppression in Renal Transplantation

Journal article

Interpretation, comparison and combination of results of clinical trials is reliant on accurate and complete reporting of outcomes. This study aims to assess the quality and variability in outcome reporting in immunosuppression trials following renal transplantation. All randomised controlled trials comparing immunosuppressive interventions in renal transplant recipients published over a 5-year period were included. Outcomes reported in these studies were extracted, along with data regarding completeness of reporting and whether a clear definition of the method used to measure the outcome was provided. 4760 outcomes were identified from 182 studies. Overall, 90.3% outcomes were completely reported; the remainder had missing data that would preclude use in meta-analysis. 31.5% manuscripts did not define a primary endpoint. Efficacy outcomes were more likely to be clearly defined than safety outcomes (OR 0.022, p<0.001) or patient reported outcomes (PROMs) (OR 0.014, p<0.001). PROMs were reported in less than half of manuscripts and only 5 reported quality of life data using a validated tool. There was significant variability in the way that common efficacy and safety outcomes were defined. Variability in the way that endpoints are selected and reported in trials in renal transplantation makes interpretation and comparison between studies difficult. This article is protected by copyright. All rights reserved.

Authors: Hussain, S; Knight, S

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: Wiley
• Journal: Clinical Transplantation
• Volume: 30
• Issue: 11
• Pages: 1440–1448
• Publication date: 2016-09-01
• Acceptance date: 2016-08-25
• DOI: 10.1111/ctr.12837
• EISSN: 1399-0012
• ISSN: 0902-0063
• Pmid: 27582408
• Language: English
• Keywords: Immunosuppression; renal transplant; quality; clinical trials; bias