Core Outcome Measures in Effectiveness Trials

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

General Information

Abstract:
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 5most 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.

Authors:
Camilla S. Hanson, Benedicte Sautenet, Jonathan C. Craig, Jeremy R. Chapman, Greg Knoll, Peter P. Reese, and Allison Tong

Publication

Journal:
Transplantation
Volume:
103
Issue:
2
Pages:
284 - 290
Year:
2019
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Other

Disease Name
Kidney Transplant

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Systematic review

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.


Stakeholders Involved

Study investigators

Study Type

Systematic review of outcomes measured in trials

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