Range and consistency of outcomes reported in randomized trials conducted in kidney transplant recipients: a systematic review

Background The potential for clinical trials to impact patient care may be limited if the outcomes reported vary by trial and lack direct relevance to patients. Despite the many trials conducted in kidney transplantation, premature death due to cardiovascular disease, infection and malignancy remains high. We aimed to assess the range and consistency of outcomes reported in trials in kidney transplantation. Methods We searched for randomized trials conducted in kidney transplantation. We extracted the outcome measures, classified them into outcome domains, and into categories (clinical, surrogate or patient-reported outcome [PRO]). We assessed the measures used for the top 4 domains. Results Overall, 397 trials reported 12 047 outcomes measures and time points (median 19 per trial, interquartile range 9 to 42) across 106 different domains, of which 55 (52%) were surrogate, 35 (33%) clinical and 16 (15%) PRO. The 4 most frequently reported were graft function (322 (81%) trials, 118 outcome measures), acute rejection (234 [59%], 93 measures), graft loss (215 [54%], 48 measures) and mortality (204 [51%], 51 measures). The remaining 102 domains were reported in less than 50% of trials. Conclusion Mortality and graft related outcome domains were frequently reported, and assessed with a multiplicity of measures. The majority of outcome domains were surrogate outcomes, and the reporting of relevant life-threatening complications and PRO were uncommon. Establishing core outcomes based on the shared priorities of patients/caregivers and health professionals in kidney transplantation may improve the relevance and consistency of outcome reporting in trials to better inform clinical decision-making. Corresponding author: Benedicte Sautenet, Nephrology and Clinical Immunology department, Hospital Bretonneau, 2 boulevard Tonnellé, 37000 Tours, France, Email: benedicte.sautenet@univ-tours.fr Authors' specific contributions: BS participated in the research design, data collection, data analysis, and drafted the manuscript. AT participated in the research design, data collection, data analysis, and drafted the manuscript. JRC participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. AW participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. DR participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. GW participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. JG participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. KB participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. LR participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. LM participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. MAJ participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. PR participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. TP participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. NE participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to manuscript writing. JCC participated in the research design, data collection, data analysis, and drafted the manuscript. Disclosure: The authors declare no conflicts of interest. Funding: The project is funded by a National Health and Medical Research Council Project Grant (APP1128564) and a National Health and Medical Research Council Program Grant (APP109279). Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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