Core Outcome Measures in Effectiveness Trials

Developing a Core Outcome Set of Traditional Chinese Medicine for abdominal Henoch Schonlein purpura in Children

General Information

Summary:
Henoch Schonlein purpura (HSP) is the most common vasculitis in children. In clinical classification of western medicine, abdominal Henoch Schonlein purpura (AHSP) is characterized by abdominal pain, vomiting, gastrointestinal bleeding and other gastrointestinal symptoms. Besides western medicine, Traditional Chinese Medicine (TCM) is also used to treat AHSP in clinical practice. Many related clinical studies on the treatment of AHSP have been published. However, there is a great heterogeneous in the reporting outcomes selected among different studies, which affects the further comparison and synthesis of the results in meta-analyses. Therefore, it is necessary to develop a core outcome set (COS) of AHSP, that can be used to assess the effectiveness and safety of clinical trials of TCM in the treatment of AHSP.

Contributors:
Principle investigator: Yali Liu,
Supervisor: Yan Yang

Affiliation: Center for Clinical Epidemiology and Evidence-based Medicine; Beijing Childrenā€˜s Hospital, Capital Medical University; National Center for Children's Health ,Beijing, China

Collaborators:Yali Liu, Yan Yang, Qiang He, Chang Liu, Changhe Yu, Yanju Zhang, Yuan Ma, Ruohua Yan

Further Study Information

Current Stage:
Ongoing
Date:
January 2019 - 2021
Funding source(s):
Beijing Municipal Administration of Hospitals Incubating Program,Code:PZ2019030

Health Area

Disease Category
Child health
Rheumatology

Disease Name
Abdominal Henoch Schonlein purpura
Vasculitis (small-vessel/ ANCA-associated)

Target Population

Age Range
2 - 18

Sex
Either


Nature / type of Intervention
Drug

Method(s)

Consensus conference
Delphi process
Interview
Systematic review

We will develop a systematic review to search the clinical trials, systematic evaluation/meta-analysis, guidelines of AHSP from January 2016 to December 2018, and interview with clinical experts and patients/parents or guardians, in order to establish a preliminary list of outcome set of clinical trials. Then the COS-AHSP will be constructed by 2-3 rounds of Delphi method and consensus meeting method.


Stakeholders Involved

Clinical experts
Conference participants
Epidemiologists
Methodologists
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research

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