A methodological review of clinical outcomes reported in liver transplantation trials Author links open overlay panel

Abstract
Background
Liver Transplantation (LT) is a life-saving treatment for end-stage liver disease, for which various outcomes are measured in randomized clinical trials (RCT). The aim of this methodological review is to evaluate and classify outcomes reported in RCT in LT.

Methods
PubMed and ClinicalTrials.gov were searched in July 2018 for published and ongoing RCTs on LT in the last 5 years. Studies were eligible if focusing on first LT in adult patients, with interventions during the perioperative period. Data extracted concerned LT characteristics, type of intervention, methodological characteristics and outcomes assessed.

Results
Of 2685 references, 55 were included with a median of 78 (40–120) patients for published trials and planned to include 117 (55–218) patients for ongoing trials. Morbidity was the most frequently used as primary outcome in 37 published (67%) and 13 ongoing trials (54%). We identified 10 different definitions for graft dysfunction, 9 for recovery outcomes and 12 different time-points for mortality. For published trials, among the 397 outcomes specified in the method section, results were reported for 283 (71%).

Conclusion
Outcomes reported in LT trials are very heterogeneous. A consensus approach to develop a core outcome set (COS) should be considered allowing for comparisons of results across trials.

Contributors

Raffaele Brustia, Agnès Dechartres. Olivier Scatton

Publication

Journal: HPB
Volume: 22
Issue: 6
Pages: 833 - 844
Year: 2020
DOI: 10.1016/j.hpb.2019.12.010

Further Study Information

Current Stage: Completed
Date:
Funding source(s):


Health Area

Disease Category: Gastroenterology

Disease Name: Liver Transplant

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

Study Type

- Systematic review of outcomes measured in trials

Method(s)

- Systematic review

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