Core Outcome Measures in Effectiveness Trials

Development of a core outcome set for clinical trials in primary dysmenorrhea:study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

General Information

Summary:
Background: Primary dysmenorrhea is the most common gynecological disease, accounting for more than 90% of dysmenorrhea, which have caused a certain impact on women's work and life.At present, there are a large number of clinical trials on primary dysmenorrhea, but the lack of unified and standardized methods for selecting clinical outcomes leads to low comparability in similar clinical trials, which reduces the value of the studies.This study aims to develop the core outcomet set of primary dysmenorrhea and provide reliable evidence for clinical trials.
Methods:(1) original list of outcomes: systematic review and semi-structured interview;(2) two rounds of Delphi surveys :collect opinions from different stakeholders, including patients, clinical experts, health system decision makers and methodologists;(3) consensus meeting : form the core outcome set according to the results of Delphi surveys.
Discussion:This study aims to develop a core outcome set to guide assessment in clinical trials of primary dysmenorrhea. The end goal is to improve the consistency of the selection of outcomes and the reliability of outcome reporting,thereby providing a higher level of evidence for clinical practice and patient satisfaction.

Contributors:
Guihua Tian(principal investigator), Hongcai Shang, Songjie Han, Tianmai He, Ruijin Qiu
Dongzhimen Hospital, Beijing University of Chinese Medicine

Further Study Information

Current Stage:
Ongoing
Date:
November 2018 - 2019
Funding source(s):
The national natural science foundation of China:Electrical regulation of Wnt/ ß-catenin signaling pathway mediated by CPSP rat astrocytes(serial number:81674050)

Health Area

Disease Category
Gynaecology

Disease Name
Dysmenorrhea

Target Population

Age Range
18 - 50

Sex
Female


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Semi structured discussion
Systematic review

(1) original list of outcomes: systematic review and semi-structured interview;(2) two rounds of Delphi surveys :collect opinions from different stakeholders, including patients, clinical experts, health system decision makers and methodologists;(3) consensus meeting : form the core outcome set according to the results of Delphi surveys.


Stakeholders Involved

Clinical experts
Consumers (patients)
Methodologists
Patient/ support group representatives
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research

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