ABSTRACT
Aims
To develop the core outcome set and identify unique outcomes for the three stages and five types of nursing interventions, respectively, in lactational mastitis.
Design
A mixed methods study.
Methods
A systematic literature search, four semi-structured interviews for key stakeholders, two rounds of Delphi surveys and two online consensus meetings were conducted.
Results
Thirty-one nursing outcomes were derived from the systematic review (literature research from January 2019 to December 2021) and semi-structured interviews in 2022. Six A-category nursing outcomes and 19 B-category nursing outcomes were determined after Dephi survey and provided in consensus meeting in 2023. The consensus meetings resulted in the agreement on seven core outcomes: Pain Level, Breast Establishment: infant, Breast Establishment: maternal, Breast Maintenance, Client satisfaction: care, Sleep, and Family Support during Treatment. Specifically, the unique outcomes for the three stages were identified as Breastfeeding Maintenance, Infection Severity and Wound Healing: Primary Intention, respectively. The unique outcomes for the five interventions included Pain level, Infection Severity, Wound Healing: Primary Intention, Comfort and Knowledge: breastfeeding, respectively.
Conclusion
Based on an evidence-based, consensus-driven approach, the core outcome set incorporates the perspectives of key stakeholders. It is recommended that all core outcomes be reported in both lactational mastitis nursing research and clinical quality control and audit. Unique outcomes should be reported based on the stages of lactational mastitis and types of interventions.
Impact
The core outcome set and unique outcomes developed by our study could provide nursing researchers and clinical practitioners with sensitive outcomes for lactational mastitis, while also promoting standardisation. Utilising these outcomes could enhance comparability among studies, reduce reporting bias and promote standardised evaluation of practice effectiveness.
Reporting Method
Findings are reported per Core Outcome Set-STAndards for Reporting: COS-STAR Statement.
Patient or Public Contribution
None.
Trial Registration
https://www.comet-initiative.org/Studies/Details/1650
To develop the core outcome set and identify unique outcomes for the three stages and five types of nursing interventions, respectively, in lactational mastitis.
ContributorsYun-Peng Lv, Ke-Ke Lin, Fen Zhou, Ying-Yi Fan, Xiao-Ying Mu, Ting Yuan, Yu-Xi Wang
Disease Category: Gynaecology
Disease Name: Lactational mastitis
Age Range: 18 - 60
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Consensus meeting
- Delphi process
- Interview
- 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.