Validation of the Hospital Asthma Severity Score (HASS)

Completed

• Conditions: Asthma
• Interventions: Other: Not an interventional study

• Registration Number: NCT02782065
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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.

Detailed Description

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.

Primary Aim 2. To evaluate construct validity of the HASS tool in a cohort of patients' ages 7 to18 years old as compared to forced expiratory volume through spirometry

Data Analysis 2. Treating the outcomes as continuous, a correlation coefficient will be computed for HASS and %Forced Expiratory Volume 1. Sub-analyses will also be performed by age group and by %Forced Expiratory Volume1 severity level to see whether the correlation of HASS and %Forced Expiratory Volume1 is consistent across age and asthma severity strata. Treating the outcomes as categorical, if the HASS and %Forced Expiratory Volume1 are each categorized into three levels (mild, moderate, severe), then the investigator could classify each of the nine cells of a 3 by 3 table (HASS X %Forced Expiratory Volume1) as either:

1. concordant (three cells; complete agreement: both tests say 'Severe', for instance),

2. discordant (four cells; e.g. one test says Moderate while the other say Mild) and

3. grossly discordant (two cells; one test says Severe when the other says Mild). For the Receiver Operating Curve analysis, the Forced Expiratory Volume will be dichotomized as Severe (%Forced Expiratory Volume1\<60% predicted) versus Less Severe (%Forced Expiratory Volume1≥60% predicted). In analyzing these data, the correlation (continuous), 3 by 3 table (categorical), and Receiver Operating Curve (dichotomous %Forced Expiratory Volume1) treatments will be presented, with the continuous result considered primary. A high level of agreement is expected between the HASS and the spirometry severity score to make the case that the HASS can be used in place of the %Forced Expiratory Volume1 test.

Secondary Aim 3. To evaluate construct validity of the HASS tool in a cohort of patients' ages 2 to 6 years old as compared to forced expiratory volume through spirometry.

Data Analysis 3. Treating the outcomes as continuous, a correlation coefficient will be computed for HASS and %Forced Expiratory Volume1. Treating the outcomes as categorical, if the HASS and %Forced Expiratory Volume1 are each categorized into three levels (mild, moderate, severe), then the investigator could classify each of the nine cells of a 3 by 3 table (HASS X %Forced Expiratory Volume1) as concordant, discordant or grossly discordant (as described in Data Analysis 2). An adequate level of observed agreement would be 80% of observations in agreement cells, 18% discordant, and 2% in grossly discordant cells. In analyzing these data, both the correlation (continuous) and 3 by 3 table (categorical) treatments will be presented, with the continuous result considered primary. A high level of agreement is expected between the HASS and the spirometry severity score to make the case that the HASS can be used in place of the spirometry.

Secondary Aim 4. To evaluate construct validity of the HASS tool in a cohort of patients' ages 2 to 6 years old as compared to the Preschool Respiratory Assessment Measure (PRAM) Data Analysis 4. Treating the outcomes as continuous, a correlation coefficient will be computed for HASS and PRAM. If the HASS and PRAM are each categorized into three levels (mild, moderate, severe), then the investigator could classify each of the nine cells of a 3 by 3 table (HASS X PRAM) as either concordant, discordant, or grossly discordant (as described in Data Analysis 2). An adequate level of observed agreement would be 80% of observations in agreement cells, 18% discordant, and 2% in grossly discordant cells.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-25
• Study Start: 2016-09-29
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Results First Submitted: 2020-12-16
• Results First Submitted QC: 2021-01-27
• Results First Posted: 2021-02-16
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• asthma exacerbation

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric patients with Asthma	Not an interventional study	165 patients aged 7 to 18 years, and 30 patients aged 2 to 6 years

Primary Outcome Measures

Name	Time	Method
Intra-rater Reliability Between HASS and PRAM	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	4 years 9 months	The correlation between the PRAM and FEV1
Inter-rater Reliability for the Hospital Asthma Severity Score (HASS)	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)	4 years, 9 months	The correlation coefficient between the HASS tool and FEV1 measurements.
Inter-rater Reliability for the Pediatric Respiratory Assessment Measure (PRAM)	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.

Trial Locations

Locations (1)

Boston Childrens Hospital; 🇺🇸 Boston, Massachusetts, United States