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临床试验/NCT02782065
NCT02782065已完成不适用

Validation Of The Hospital Asthma Severity Score (HASS) In Children Ages 2-18 Years Old

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Intra-rater Reliability Between HASS and PRAM

研究概览

简要总结

The purpose of this research will be to evaluate the reliability and validity of the HASS tool in a cohort of patients' ages 7 to18 years old against the gold standard of spirometry, and in ages 2 to 6 against spirometry, if possible, and the most similar validated tool, the PRAM.

详细描述

Children aged 7-18 years will have a HASS score obtained by two providers. After scoring is complete, a pulmonary technician will perform the spirometry test.

Children aged 2 to 6 years old will concurrently (but separately) have their asthma severity graded by 2 individual measurers using the HASS tool and the PRAM tool. If consented to perform spirometry, this test will be performed after the tool(s) scores have been obtained.

The spirometry tests will be interpreted by a board-certified pediatric pulmonologist.

Descriptive statistics will be used for preliminary analysis to describe the sample characteristics, outliers, and representativeness of the data.

Primary Aim 1. To describe the inter-rater reliability for the HASS as scored by 2 individual health care providers Data Analysis 1. Use of an overall percentage of agreement, weighted and unweighted kappa and the intraclass correlation coefficient will show the inter-rater reliability of the HASS tool. For each measure, percent agreement between raters and Cohen's kappa statistic (rater agreement adjusted for chance agreement) will be reported.

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
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • asthma exacerbation

排除标准

  • continuous albuterol and/or
  • pneumonia, croup, varicella, cystic fibrosis, broncho-pulmonary dysplasia, cardiac or kidney disease AND
  • previously approached for participation in the study

结局指标

主要结局

Intra-rater Reliability Between HASS and PRAM

时间窗: 4 years and 9 months

The intra-rater reliability between HASS and PRAM as scored by 2 individual health care providers. Intra-rater agreement refers to the with-in rater agreement between the PRAM and HASS categorical ratings. This was calculated separately for Rater 1 and Rater 2. The intra-rater agreement for Rater 2 was calculated by pooling the data from the Rater 2 clinicians.

Correlation Between the PRAM and FEV1

时间窗: 4 years 9 months

The correlation between the PRAM and FEV1

Inter-rater Reliability for the Hospital Asthma Severity Score (HASS)

时间窗: 4 years and 9 months

The inter-rater reliability (the percent of agreement among raters) for the HASS as scored by 2 individual health care providers. Inter-rater agreement refers to the agreement between the single clinician who was Rater 1 and the second clinician rating the patient (Rater 2), regardless of which clinician served as Rater 2

Correlation Between the HASS and Forced Expiratory Volume in 1 Second (FEV1)

时间窗: 4 years, 9 months

The correlation coefficient between the HASS tool and FEV1 measurements.

Inter-rater Reliability for the Pediatric Respiratory Assessment Measure (PRAM)

时间窗: 4 years and 9 months

The inter-rater reliability for the PRAM as scored by 2 individual health care providers. Inter-rater agreement refers to the agreement between the single clinician who was Rater 1 and the second clinician rating the patient (Rater 2), regardless of which clinician served as Rater 2.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leah Abecassis

Nurse Practice Specialist

Boston Children's Hospital

研究点 (1)

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