Introduction: Lactational mastitis, common in the first three months of breastfeeding, is a condition in which a woman's breast becomes painful, swollen, and red. The main feature of the disease is pain, which greatly reduces the quality of life of the puerperal. Besides, puerperal usually stop breastfeeding early due to pain, which will also increase the risk of infant infection. At present, antibiotic is considered an effective treatment, but there are side effects. In traditional Chinese medicine(TCM), acupoint tuina at breast for lactational mastitis is safe and effective without any side effects. Acupoint tuina at breast refers to massage of breast through special TCM techniques, such as kneading, pushing, squeezing, grasping, etc., and finally to achieve the purpose of dredge the mammary duct, empty the milk, reduce swelling and pain. Nowadays, research on the impact of acupoint tuina at breast for lactational mastitis is growing. However, the reporting outcomes of these studies had the following problems. First, it was diverse in similar clinical trials. Meanwhile, it may exist a risk of selective outcome. Second, the definition of outcome was relatively vague, such as "significant and effective", which may reduce the repeatability of the research. Third, symptom outcomes accounted for most, while economic outcomes only accounted for few, this may result in the inability to systematically evaluate the efficacy of acupoint tuina at breast. Therefore, a core outcome set(COS) for lactational mastitis of acupoint tuina at breast is needed to compare and interpret clinical trial results and to synthesize the results data.Aim
We aim to develop a COS for lactational mastitis of acupoint tuina at breast to provide a reference for the outcome report of future research.Contributors
Fen Zhou, Supervisors, Excellence Center of JBI, School of Nursing, Beijing University of Chinese Medicine, Beijing, China
Shujun Zou, researcher,School of Nursing, Beijing University of Chinese Medicine, Beijing, China
Yunpeng Lv, researcher, School of Nursing, Beijing University of Chinese Medicine, Beijing, China
- COS for clinical trials or clinical research
- Consensus conference
- Consensus meeting
- Delphi process
- Literature review
- Semi structured discussion
The research is carried out following “the COMET Handbook: version 1.0”. The following four steps are included in the study.
(1)A literature study to identify outcomes and measurement instruments relevant for acupoint tuina of lactational mastitis.
(2)A semi-structured interview to collect opinions of stakeholders on important outcomes.
(3)A two-step Delphi study to identify an initial COS.
(4)A consensus process to discuss and agree the final COS and its definitions.
(5)A consensus meeting on measurement instruments for each outcome in the COS.