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

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 Children‘s Hospital, Capital Medical University; National Center for Children's Health ,Beijing, China

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

Further Study Information

Current Stage: Completed – pending publication
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 of Intervention: Drug

Stakeholders Involved

- Clinical experts
- Conference participants
- Epidemiologists
- Methodologists
- Researchers
- Statisticians

Study Type

- COS for clinical trials or clinical research

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.

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