Core Outcome Measures in Effectiveness Trials

Establishing core outcome sets for pediatric ureteropelvic junction obstruction (UPJO) in children: study protocol for systematic reviews and Delphi surveys

General Information

Summary:
Uretero-pelvic junction obstruction (UPJO) is the most common cause of obstructive uropathy in children and may lead to loss of renal function or development of symptoms such as urinary tract infection, kidney stones, hematuria or pain. There are limitations with the current diagnostic approach with renal imaging that cannot reliably determine which newborns and children have a significant obstruction and if left untreated are at risk of development of symptoms, or permanent renal injury. Currently, there is heterogeneity in the published literature regarding which diagnostic criteria define a pediatric UPJO as well as the outcomes are assessed in studies. This variation contributes to an inability to compare, contrast and combine the results of individual studies. This protocol outlines a study that will establish COS for pediatric UPJO in children.

Contributors:
Pediatric Urologists of Canada Consortium for Research (PUCCR)
Melise A. Keays MD, CHEO, University of Ottawa
Dawn MacLellan MD, IWK, Dalhousie University
Luis Braga MD, Hamilton Children’s Hospital, McMaster University

Further Study Information

Current Stage:
Ongoing
Date:
May 2019 - May 2020
Funding source(s):
CHEO Department of Surgery

Health Area

Disease Category
Urology

Disease Name
Ureteropelvic junction obstruction

Target Population

Age Range
0 - 18

Sex
Either


Nature / type of Intervention
Observation
Surgery

Method(s)

Consensus meeting
Delphi process
Systematic review

This two-part study includes a systematic review of studies of children with UPJO where their diagnostic criteria or reported outcomes are clearly defined. The review follows established methods for knowledge synthesis, including a comprehensive search strategy, two stages of screening citations against inclusion/exclusion criteria by at least 2 independent reviewers working independently, and extraction of important data elements from the eligible studies including details of the diagnostic criteria for UPJO, the outcomes collected and outcome measurement instruments. The review findings will inform part 2 of our study, a set of Delphi surveys to establish consensus on the highest priority diagnostic criteria and outcomes for UPJO. All practicing pediatric urologists in Canada will be invited to participate in two to three rounds of the Delphi surveys. A final consensus conference with relevant stakeholders will be held to review findings and achieve consensus.


Stakeholders Involved

Clinical experts
Epidemiologists
Methodologists
Researchers
Service providers

Study Type

COS for clinical trials or clinical research
COS for practice

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