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Informative for Decision Making? The Spectrum and Consistency of Outcomes After Living Kidney Donation Reported in Trials and Observational Studies

Hanson, Camilla S., PhD1,2; Sautenet, Benedicte, PhD1,2,3,4,5; Craig, Jonathan C., PhD1,2; Chapman, Jeremy R., FRCP6; Knoll, Greg, MD7,8,9; Reese, Peter P., MD10,11; Tong, Allison, PhD12

doi: 10.1097/TP.0000000000002489
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Background Evidence about outcomes after 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 18 years or older.

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 (51%) studies 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 5 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 (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.

This study examines the spectrum and consistency of outcomes for living kidney donors reported in recent randomized trials and observational studies and reports that most outcomes studies are observational, heterogeneous, and focused on short-term surgical complications.

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

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

7 Division of Nephrology, Department of Medicine, University of Ottawa, Ottawa, Canada.

8 Kidney Research Centre, University of Ottawa, Ottawa, Canada.

9 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.

10 Renal-Electroylte and Hypertension Division, University of Pennsylvania, Philadelphia, PA.

11 Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA.

12 Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA.

Received 27 June 2018. Revision received 6 September 2018.

Accepted 9 October 2018.

C.S.H. is supported by a National Health and Medical Research Council (NHMRC) Postgraduate Scholarship (GNT1092741) and a Program Grant (APP1092579). A.T. 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 of the article.

The authors declare no conflicts of interest.

C.S.H. participated in the research design, writing of the article, performance of the research and participated in data analysis. B.S. participated in the research design, writing of the article, performance of the research and participated in data analysis. J.C.C. participated in the research design, writing of the article and participated in data analysis. J.R.C. participated in the research design and writing of the article. G.K. participated in the research design, writing of the article, and participated in data analysis. P.R.R. participated in the research design, writing of the article and participated in data analysis. A.T. participated in the research design, writing of the article, and participated in data analysis.

Correspondence: Camilla Sara Hanson, Centre for Kidney Research, The Children's Hospital at Westmead, Westmead NSW 2145, Sydney, Australia. (camilla.hanson@sydney.edu.au).

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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