Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI,Wanfang,VIP,S...Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI,Wanfang,VIP,Sino Med,Pub Med,Web of Science,Embase,Cochrane library,JBI,CINAHL,Psyc INFO,Clinical Trials Registry Platform portal,Clinical Trials Registry,Australian New Zealand Clinical Trials Registry,Center Watch Registry from inception to May 15,2022 to find randomized controlled trials,non-randomized controlled trials,case series and cohort studies which reported the outcomes of stasis acute mastitis managed with Traditional Chinese Medicine breast massage,with search terms of mastitis,acute mastitis,lactation mastitis,puerperal mastitis,breast problem,breast engorgement,milk stasis,blocked ducked,breast pain,breast massage,and acupoint massage.Outcomes and the measurement schemes(measurement methods,timing of assessing outcome,frequency of assessing outcome,measurers)were extracted from the included studies.We used the Management of Otitis Media with Effusion in Children with Cleft Palate(MOMENT)to assess the quality of each study,then categorized outcomes derived from the included studies into different domains according to the Outcome Measures in Rheumatology Arthritis Clinic Trials(OMERACT)Filter 2.1 framework.Results We identified 85 clinical trials,in which 54 different outcomes were reported.A total of 81.2%(69/85)of studies were assessed as medium quality with a mean score of 2.6,and 18.8%(16/85)as low quality with a mean score of 0.9.These outcomes were organized in three core areas.Lump size(89.4%,76/85)was the most frequently reported outcome,followed by breast pain(69.4%,59/85)and milk excretion(68.2%,58/85).Five methods were used to assess lump size and four methods to assess breast pain.Conclusions The outcomes reported in clinical trials regarding stasis acute mastitis treated by Traditional Chinese Medicine breast massage are heterogeneous.Developing a core outcome set to achieve consistent standards for reporting outcomes and modalities for validation of the outcomes is clearly warranted.展开更多
Traditional Chinese medicine breast massage,also known as breast Tuina or manual expression of breast milk,is a technique of using certain manipulations to act on specific positions or acupoints of the breast to promo...Traditional Chinese medicine breast massage,also known as breast Tuina or manual expression of breast milk,is a technique of using certain manipulations to act on specific positions or acupoints of the breast to promote blood and lymphatic circulation of breast and facilitate the discharge of stagnant milk.This technique is widely used in China to treat breastfeeding problems such as breast engorgement,mastitis,and postpartum hypogalactia.In this article,we introduce the definition and standardization process of breast massage,elaborate the operating procedures of breast massage in detail,and summarize and discuss the current situation of its clinical application,so as to provide a reference for its wide application and in‑depth research.展开更多
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 t...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.展开更多
基金supported by Special Funds for Basic Research Business Expenses of Central Universities(2022-JYB-PY-004).
文摘Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI,Wanfang,VIP,Sino Med,Pub Med,Web of Science,Embase,Cochrane library,JBI,CINAHL,Psyc INFO,Clinical Trials Registry Platform portal,Clinical Trials Registry,Australian New Zealand Clinical Trials Registry,Center Watch Registry from inception to May 15,2022 to find randomized controlled trials,non-randomized controlled trials,case series and cohort studies which reported the outcomes of stasis acute mastitis managed with Traditional Chinese Medicine breast massage,with search terms of mastitis,acute mastitis,lactation mastitis,puerperal mastitis,breast problem,breast engorgement,milk stasis,blocked ducked,breast pain,breast massage,and acupoint massage.Outcomes and the measurement schemes(measurement methods,timing of assessing outcome,frequency of assessing outcome,measurers)were extracted from the included studies.We used the Management of Otitis Media with Effusion in Children with Cleft Palate(MOMENT)to assess the quality of each study,then categorized outcomes derived from the included studies into different domains according to the Outcome Measures in Rheumatology Arthritis Clinic Trials(OMERACT)Filter 2.1 framework.Results We identified 85 clinical trials,in which 54 different outcomes were reported.A total of 81.2%(69/85)of studies were assessed as medium quality with a mean score of 2.6,and 18.8%(16/85)as low quality with a mean score of 0.9.These outcomes were organized in three core areas.Lump size(89.4%,76/85)was the most frequently reported outcome,followed by breast pain(69.4%,59/85)and milk excretion(68.2%,58/85).Five methods were used to assess lump size and four methods to assess breast pain.Conclusions The outcomes reported in clinical trials regarding stasis acute mastitis treated by Traditional Chinese Medicine breast massage are heterogeneous.Developing a core outcome set to achieve consistent standards for reporting outcomes and modalities for validation of the outcomes is clearly warranted.
文摘Traditional Chinese medicine breast massage,also known as breast Tuina or manual expression of breast milk,is a technique of using certain manipulations to act on specific positions or acupoints of the breast to promote blood and lymphatic circulation of breast and facilitate the discharge of stagnant milk.This technique is widely used in China to treat breastfeeding problems such as breast engorgement,mastitis,and postpartum hypogalactia.In this article,we introduce the definition and standardization process of breast massage,elaborate the operating procedures of breast massage in detail,and summarize and discuss the current situation of its clinical application,so as to provide a reference for its wide application and in‑depth research.
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).
文摘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.