Informative for Decision-making? The Spectrum and Consistency of Outcomes Following Living Kidney Donation Reported in Trials and Observational Studies

Background Evidence about outcomes following living kidney donation is needed both to inform donor acceptance criteria, and to guide the decisions of potential donors and their healthcare providers about donation. However, the scope and heterogeneity of outcomes reported in research and their relevance to decision-making is uncertain. To determine the spectrum and consistency of outcomes reported in randomized trials and observational studies in living kidney donors aged 18 years or over. Methods Electronic databases were searched for randomized trials and observational studies reporting outcomes in adult living kidney donors published from January 2011 to May 2017. All outcome domains and measurements were extracted, and their frequency and characteristics were evaluated. Results Of the 268 eligible studies, 14 (5%) were randomized and 254 (95%) observational. Overall, 136 studies (51%) were short-term (≤1 year follow up) and reported 109 outcome domains, of which 51 (47%) were classified as clinical, 35 (32%) were surrogate and 23 (21%) were donor-reported. The five most commonly reported domains were kidney function (154, 58%), time to discharge (96, 36%), blood loss (85, 32%), operative time (79, 30%) and blood pressure (74, 28%). Quality of life (13%), mortality (16%), end-stage kidney disease (ESKD) (10%) and cardiovascular events (9%) were reported infrequently. Conclusions The outcomes of living kidney donation reported in contemporary trials and observational studies are numerous, heterogeneous, and often focused on short-term surgical complications. Consistent reporting of outcomes relevant to decision making is needed to better inform and prepare donors for outcomes after donation. Corresponding author: Camilla Sara Hanson, Centre for Kidney Research, The Children's Hospital at Westmead, Westmead NSW 2145, Sydney, Australia, Tel: +61 2 9845 1466 Fax: +61 2 9845 1491 Email: camilla.hanson@sydney.edu.au Authorship: CSH participated in the research design, writing of the paper, performance of the research and participated in data analysis. BS participated in the research design, writing of the paper, performance of the research and participated in data analysis. JCC participated in the research design, writing of the paper and participated in data analysis. JRC participated in the research design and writing of the paper. GK participated in the research design, writing of the paper and participated in data analysis. PRR participated in the research design, writing of the paper and participated in data analysis. AT participated in the research design, writing of the paper and participated in data analysis. Disclosures and conflict of interest The authors declare no conflicts of interest. CSH is supported by a National Health and Medical Research Council (NHMRC) Postgraduate Scholarship (GNT1092741) and a Program Grant (APP1092579). AT is supported by a NHMRC Fellowship (APP1106716). The funding organization had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval or the manuscript. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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