摘要
Objective:Lactation mastitis is a kind of disease with high incidence during puerperium.In the early stage,breast massage can effectively eliminate the symptoms.However,the value of breast massage is not fully known to the public,which restricts its promotion and popularization.One important reason is the absence of a multi-dimensional and overall evaluation of outcome.COS is strongly advocated internationally as the outcome in clinical research to promote the transformation of clinical evidence into practice.At present,there is no systematic review of the existing outcome.This protocol aims to provide a set of outcomes and outcome evaluation schemes for developing COS of breast massage in lactation mastitis early stage.Methods:We will search PubMed,Embase,Web of Science,CNKI,Wan-fang,VIP,SinoMed,Grey literature databases(master and doctoral thesis databases and conference literature databases of CNKI,Wan-fang and SinoMed),Clinical Trials Registry Platform portal,the Clinical Trials Registry,Australian,New Zealand Clinical Trials Registry,the Center Watch Registry,before March 1,2021.We will include randomized controlled trials and non-randomized trials,cohort studies,case series,case reports.We will assess the quality of outcome reporting according to the MOMENT,classify all outcomes using the OMERACT Filter 2.0 conceptual framework.Descriptive analysis will be performed for all categorical variables using frequency and mean.Result:This protocol aims to help guide the design of systematic review to summarize the existing outcomes,and comprehensively evaluate existing outcomes,classify outcomes and provide schemes of outcome evaluation for developing COS of breast massage in the early stage of lactation mastitis.Percentage and mean will be used to describe the extracted data.Conclusion:This is the first systematic review protocol to summarize outcomes,measurement instruments,assessment times,measurement frequencies,measurers about breast massage in the early stage of lactational mastitis.
基金
This work is supported by Education Science Research Project of Beijing University of Chinese Medicine(XJYB2029)
Fundamental Research Funds for the Central Universities(2020-JYB-ZDGG-082).
