Validation Study of the Speedy Meyer Fall Scale for Determining the Fall Risk of the Paediatric Patient
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 332
- 试验地点
- 3
- 主要终点
- validation of the SMFS t
研究概览
简要总结
Fall prevention is an essential element in ensuring safe care for paediatric patients. The first step in building a risk reduction programme is the adoption of an assessment tool to identify those most at risk at an early stage. From October 2014 to date, a study has been conducted for the linguistic-cultural validation of the Humpty Dumpty Fall Scale (HDFS) in the Italian context, through a multicentre survey with the help of the Clinical Risk Management Group of the Region of Tuscany.
The objective of this study is the validation of the new Humpty Dumpty Fall Scale defined as Speedy Meyer-Fall Scale (SMFS) by assessing the comprehension and validity of the scale and items via Content Validity Index (SCVI and ICVI) estimation of inter-item reliability (Crombach's alpha), inter-rater reliability (Cohen's K), sensitivity, specificity, PPV, NPV and ROC curve.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children admitted as in-patients for whom the parents have given consent to the study, aged between 12 months and 16 years, of any gender, pathology and reason for admission.
排除标准
- •not signed consent form
结局指标
主要结局
validation of the SMFS t
时间窗: through study completion, an average of 1 year
validation of the SMFS through the assessment of the comprehensibility of the SMFS, the validity of the SMFS through Content Validity Index at item (ICVI) and scale (SCVI) level, and the reliability of the SMFS through inter-item reliability (Cronbach's alpha) and Inter-rater Reliability (Cohen's K)
次要结局
- identification of patients high risk of falls(through study completion, an average of 1 year)
研究者
Daniele Ciofi
Princiapl Investigator
Meyer Children's Hospital IRCCS