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Range and Consistency of Outcomes Reported in Randomized Trials Conducted in Kidney Transplant Recipients

A Systematic Review

Sautenet, Bénédicte, MD, PhD1,2,3,4,5; Tong, Allison, PhD1,2; Chapman, Jeremy R.6; Warrens, Anthony N., MD, PhD7; Rosenbloom, David8; Wong, Germaine, PhD1,2,6; Gill, John, MD, PhD9; Budde, Klemens, MD, PhD10; Rostaing, Lionel, MD, PhD11; Marson, Lorna, MD, FRCS12; Josephson, Michelle A, MD, PhD13; Reese, Peter P.14; Pruett, Timothy L., MD, PhD15; Evangelidis, Nicole1,2; Craig, Jonathan C., PhD1,2

doi: 10.1097/TP.0000000000002278
Original Clinical Science—General

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, 9-42) 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.

Conclusions Mortality- and graft-related outcome domains were frequently reported and assessed with a multiplicity of measures. Most 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.

This review confirms that while mortality and graft related outcomes are frequently reported in trials in kidney transplantation, surrogate outcomes, life-threatening complications and patient-reported outcome are uncommon, suggesting the need to establish core outcomes to improve clinical decision-making.

1 Sydney School of Public Health, The University of Sydney, Sydney, Australia.

2 Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.

3 University Francois Rabelais, Tours, France.

4 Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France.

5 INSERM, U1246, Tours, France.

6 Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.

7 Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.

8 ESRD Network 18, Los Angeles, CA.

9 Division of Nephrology, University of British Columbia, Vancouver, Canada.

10 Department of Nephrology, Charité-Universitäts Medizin, Berlin, Germany.

11 Department of Nephrology and Renal Transplantation, CHU Grenoble-Alpes, Grenoble, France.

12 Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom.

13 Department of Medicine, The University of Chicago, Chicago, IL.

14 Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.

15 Department of Surgery, University of Minnesota, Minneapolis, MN.

Received 22 November 2017. Revision received 13 March 2018.

Accepted 8 April 2018.

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).

The authors declare no conflicts of interest.

B.S. participated in the research design, data collection, data analysis, and drafted the article. A.T. participated in the research design, data collection, data analysis, and drafted the article. J.R.C. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. A.W. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. D.R. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. G.W. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. J.G. participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to article writing. K.B. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. L.R. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. L.M. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. M.A.J. participated in the research design, data analysis, and provided intellectual input on the manuscript and contributed to article writing. P.R. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. T.P. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. N.E. participated in the research design, data analysis, and provided intellectual input on the article and contributed to article writing. J.C.C. participated in the research design, data collection, data analysis, and drafted the article.

Correspondence: Benedicte Sautenet, MD, PhD, Nephrology and Clinical Immunology Department, Hospital Bretonneau, 2 Boulevard Tonnellé, 37000 Tours, France. (benedicte.sautenet@univ-tours.fr).

Supplemental digital content (SDC) is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.transplantjournal.com).

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