通过Delphi共识方法开发哺乳期和母乳/母乳养不良事件术语 (LaBAET)
Katarzyna M Maksym1, Kinga Kalita-Kurzyńska2, Diane Spatz3
1Institute for Women's Health, University College London, London, United Kingdom.
International breastfeeding journal
|July 4, 2025
概括
开发了乳房和母乳养中不良事件的新定义和分级. 这旨在提高对药物安全性的理解,并鼓励在临床试验中纳入产后治疗.
科学领域:
- 哺乳期和母乳养研究
- 临床试验方法论 临床试验方法论
- 药物监督 药物监督 药物监督
背景情况:
- 许多母乳养妇女在产后使用处方药,但关于婴儿安全的数据有限.
- 对于哺乳期不良事件 (AE) 缺乏标准化的术语,阻碍了对治疗危害的理解.
- 哺乳期患者经常被排除在临床试验之外,导致治疗机会不平等.
研究的目的:
- 制定对哺乳期和母乳养中不良事件 (AE) 的标准化定义和分级.
- 解决与哺乳相关的副作用术语上的差距.
- 为了促进产后个体纳入临床试验.
主要方法:
- 与国际哺乳和母乳养专家进行了德尔菲共识过程.
- 定义和分级是基于"关于不良事件的共同监管标准" (CTCAE) 的结构.
- 患者代表和专家参与了两轮修改后的Delphi调查.
主要成果:
- 开发了三个新的定义:延迟的分泌激活,初级哺乳不足和二次哺乳不足.
- 现有的监管活动医学词典 (MedDRA) 术语被绘制为供应过剩和养模式变化.
- 对于所有五种已识别的与哺乳期相关的副作用的分级达成共识.
结论:
- 开发的框架为哺乳期AEs提供了标准化的定义和分级.
- 这些进步填补了现有分类中的关键缺口.
- 预计这一举措将促进将产后患者纳入临床试验.
相关概念视频
Pharmacovigilance
999
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
999
Documentation of Nursing Diagnosis
1.3K
The nurse documents nursing diagnoses and enters them into the patient record. The identified patient's nursing diagnosis is either written out with a plan of care or entered into the electronic health record.
In some settings, data-driven computerized decision support systems are in place, allowing for more accurate nursing diagnoses. The database within one of these systems includes diagnostic labels defining characteristics, activities, and indicators for nursing. A nurse enters...
In some settings, data-driven computerized decision support systems are in place, allowing for more accurate nursing diagnoses. The database within one of these systems includes diagnostic labels defining characteristics, activities, and indicators for nursing. A nurse enters...
1.3K
Formulating and Validating Nursing Diagnosis II
3.0K
Nursing diagnoses represent a problem validated by major defining characteristics. There are four categories of nursing diagnoses: problem-focused, risk, health promotion or wellness, and syndrome. The anatomy of a nursing diagnosis includes three components: problem statement or diagnostic label, defining characteristics, and related factors.
Risk nursing diagnoses represent clinical judgments of an individual, family, or community more vulnerable to developing the health problem than others...
Risk nursing diagnoses represent clinical judgments of an individual, family, or community more vulnerable to developing the health problem than others...
3.0K
Formulating and Validating Nursing Diagnosis I
2.9K
A nursing diagnosis is written when the nurse recognizes a cluster of essential patient data indicating health problems treated with independent nursing interventions. The standardized terminologies of a nursing diagnosis help nurses identify and treat patients' problems. Every electronic health record that uses nursing diagnosis must employ standard diagnostic terminology. Developing an efficient, individualized care plan begins with accurate nursing diagnoses.
There are thirteen domains...
There are thirteen domains...
2.9K
Nursing Diagnosis
2.9K
Following assessment, a nursing diagnosis is the next step in the nursing process. It begins after the nurse has collected and recorded the patient data. The purpose of diagnosing is to identify how the client responds to actual or potential health processes, identify factors that bestow or that cause health problems, the etiologies, and identify resources or strengths the individual, group, or community can draw on to prevent or resolve problems.
The nursing diagnosis focuses on evidence-based...
The nursing diagnosis focuses on evidence-based...
2.9K
Teratogenicity
2.8K
The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...
2.8K


