Heterogeneity of Outcomes Reporting in Trials Evaluating Traditional Chinese Medicine Breast Massage for Stasis Acute Mastitis: A Methodological Review

Yun-Peng Lv; Ting Yuan; Xiao-Ying Mu; Ying-Yi Fan; Ming-Yang An; Fen Zhou

doi:10.24920/004164

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Heterogeneity of Outcomes Reporting in Trials Evaluating Traditional Chinese Medicine Breast Massage for Stasis Acute Mastitis: A Methodological Review

Chinese Medical Sciences Journal Vol. 38, Issue 2, Pages: 147-158(2023)

Review | Updated：2024-06-12

- Heterogeneity of Outcomes Reporting in Trials Evaluating Traditional Chinese Medicine Breast Massage for Stasis Acute Mastitis: A Methodological Review
- Affiliations：
  
  1. 1School of Nursing, Beijing University of Chinese Medicine, Beijing 102488, China
  2. 2Galactophore Department, Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing 100029, China
  3. 3Graduate School, Medical School of Chinese People’s Liberation Army, Beijing 100039, China
- Author bio：
  
  *86-10-53912295, E-mail: zhoufen_bucm@163.com
- Funds：
- DOI：10.24920/004164
  CLC：
- Received：08 September 2022，
  
  Accepted：2023-03-01，
  
  Published Online：06 June 2023，
  
  Published：30 June 2023
- Accepted：
Scan QR Code
Yun-Peng Lv, Ting Yuan, Xiao-Ying Mu, et al. Heterogeneity of Outcomes Reporting in Trials Evaluating Traditional Chinese Medicine Breast Massage for Stasis Acute Mastitis: A Methodological Review[J]. Chinese medical sciences journal, 2023, 38(2): 147-158.
DOI：

Yun-Peng Lv, Ting Yuan, Xiao-Ying Mu, et al. Heterogeneity of Outcomes Reporting in Trials Evaluating Traditional Chinese Medicine Breast Massage for Stasis Acute Mastitis: A Methodological Review[J]. Chinese medical sciences journal, 2023, 38(2): 147-158. DOI： 10.24920/004164.

摘要

目的

分析中医手法排乳治疗郁滞期乳痈临床试验中结局指标报告的现状。

方法

以乳痈、急性乳腺炎、哺乳期乳腺炎、乳房问题、乳房肿胀、乳汁淤积、乳管阻塞、乳房疼痛、手法排乳及穴位按摩等为检索词，检索CNKI、万方、维普、SinoMed、PubMed、WOS、Embase、Cochrane library、JBI、CINAHL、PsycINFO、Clinical Trials Registry Platform portal、Clinical Trials Registry、Australian New Zealand Clinical Trials Registry、Center Watch Registry等数据库，获取关于中医手法排乳治疗郁滞期乳痈的随机对照临床试验、非随机对照临床试验、病例系列和队列研究。提取结局指标及其测量方案，如测量工具、测量时间、测量频率和测量者等指标。采用腭裂儿童中耳炎积液的管理量表（Management of Otitis Media with Effusion in Children with Cleft Palate，MOMENT）评估每项研究的质量。根据风湿病临床试验结局测量（Outcome Measures in Rheumatology Arthritis Clinic Trials，OMERACT）Filter2.1框架，对纳入研究的结局指标进行分类。

结果

纳入的85项临床试验共报告了54项结局指标。质量等级评价显示：81.2%（69/85）的研究为中等，MOMENT平均得分为2.6分；18.8%（16/85）的研究为低等，平均得分为0.9分。所有结局指标分属于OMERACT框架的3个核心领域。肿块大小（76/85）是最常用的结局指标，其次是乳房疼痛（59/85）和乳汁排泄（58/85）。5种方法被用于测定肿块大小，4种工具被用于评估乳房疼痛情况。

结论

在中医手法排乳干预郁滞期乳痈的临床试验中，结局指标存在异质性的问题。因此，应构建一套核心结局指标，以实现对此类研究结局及测量方案评价的标准化。

Abstract

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

SinoMed

PubMed

Web of Science

Embase

Cochrane library

JBI

CINAHL

PsycINFO

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 whic

h 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.

关键词

Keywords

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