Core Outcome Measures in Effectiveness Trials

Core Outcome Set in Trials on Renal and Ureteric sTones: the COSTRUT project

General Information

Summary:
Renal (or kidney) stone is among the most prevalent urological diseases.
Literature regarding treatments outcomes is very heterogeneous and so far does not allow for comparison or meta-analysis.
As a consequence, the amount of information from the moltitude publications remains fragmented and robust recommendations seldomly can be done by panelists of relevant international guidelines.
The COSTRUT project has been promoted with the purpose to identify a core set of outcomes to be included consistently in all the trials regarding adult patients affected by upper tract urinary stones.
This project is in accordance to the WHO recommendation regarding the need of standardising the reporting of treatment outcomes in a specific area of health or disease.
The Steering Committee of the COSTRUT project includes members of the European Association of Urology (EAU).
The project has been presented and approved during the proceeding of the 4th Meeting of the EAU Section of Urolithiasis (5-7th October 2017).
The project includes two phases: a first one will be focused on the performance of a systematic review to identify which outcomes have been included in randomised clinical trials and how they have been reported.
A Delphi process will be afterwards set up to select the COS after intervention (including observation) in renal stones.
The same methodology will be applied in a second project focused on ureteric stones only, as interventions are different in this setting of patients.


Contributors:
Francesco Sanguedolce, Panagiotis Kallidonis and Kemal Sarica on behalf of the EULIS (EAU Section of Urolithiasis) in collaboration with ESUT (EAU Section of Urotechnology).

Further Study Information

Current Stage:
Ongoing
Date:
December 2017 - January 2019
Funding source(s):
Funding from EULIS (EAU Section in Urolithiasis) has been agreed by the Chairman (Prof Sarica).

Health Area

Disease Category
Urology

Disease Name
Urolithiasis

Target Population

Age Range
18 - 99

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Systematic review

A systematic review will be performed to identify different types and modality on reporting outcomes in kidney stones trials.
According to the results, a number of items -grouped in domains- will be identified and drafted for a Delphi process.
A pool of stakeholders will be surveyed in order to refine and score the list of items.
Two or 3 rounds of surveys will be performed.
A final list of items, including those deemed as potentially needed but where full agreement was not found, will be reviewed and approved in a consensus meeting.


Stakeholders Involved

Clinical experts
Consumers (patients)
Device manufacturers
Epidemiologists
Methodologists
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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