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Validation of the Hospital Asthma Severity Score (HASS)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02782065
Acronym
HASS
Enrollment
58
Registered
2016-05-25
Start date
2016-09-29
Completion date
2020-01-31
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

validation, pediatrics, asthma severity

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.

Interventions

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* asthma exacerbation

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

Design outcomes

Primary

MeasureTime frameDescription
Inter-rater Reliability for the Hospital Asthma Severity Score (HASS)4 years and 9 monthsThe 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
Inter-rater Reliability for the Pediatric Respiratory Assessment Measure (PRAM)4 years and 9 monthsThe 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.
Intra-rater Reliability Between HASS and PRAM4 years and 9 monthsThe 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 HASS and Forced Expiratory Volume in 1 Second (FEV1)4 years, 9 monthsThe correlation coefficient between the HASS tool and FEV1 measurements.
Correlation Between the PRAM and FEV14 years 9 monthsThe correlation between the PRAM and FEV1

Countries

United States

Participant flow

Participants by arm

ArmCount
Pediatric Patients With Asthma
34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years Not an interventional study
58
Total58

Baseline characteristics

CharacteristicPediatric Patients With Asthma
Age, Categorical
<=18 years
58 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
36 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
9 Participants
Race/Ethnicity, Customized
Asian
2 participants
Race/Ethnicity, Customized
Black/African American
24 participants
Race/Ethnicity, Customized
Caucasian
17 participants
Race/Ethnicity, Customized
Dominican
3 participants
Race/Ethnicity, Customized
Other
4 participants
Race/Ethnicity, Customized
Unknown
9 participants
Region of Enrollment
United States
58 Participants
Sex: Female, Male
Female
30 Participants
Sex: Female, Male
Male
28 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 58
other
Total, other adverse events
0 / 58
serious
Total, serious adverse events
0 / 58

Outcome results

Primary

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

The correlation coefficient between the HASS tool and FEV1 measurements.

Time frame: 4 years, 9 months

Population: There were 29 patients out of 58 that performed spirometry and therefore were able to be analyzed for this data.

ArmMeasureValue (NUMBER)
Pediatric Patients With AsthmaCorrelation Between the HASS and Forced Expiratory Volume in 1 Second (FEV1)-.31 correlation coefficient
Primary

Correlation Between the PRAM and FEV1

The correlation between the PRAM and FEV1

Time frame: 4 years 9 months

Population: There were 29 patients out of 58 that performed spirometry and therefore were able to be analyzed for this data.

ArmMeasureValue (NUMBER)
Pediatric Patients With AsthmaCorrelation Between the PRAM and FEV1-.30 correlation coefficient
Primary

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

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

Time frame: 4 years and 9 months

ArmMeasureValue (NUMBER)
Pediatric Patients With AsthmaInter-rater Reliability for the Hospital Asthma Severity Score (HASS)29 percentage of agreement between raters
Primary

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

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.

Time frame: 4 years and 9 months

ArmMeasureValue (NUMBER)
Pediatric Patients With AsthmaInter-rater Reliability for the Pediatric Respiratory Assessment Measure (PRAM)28 percentage of agreement between raters
Primary

Intra-rater Reliability Between HASS and PRAM

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.

Time frame: 4 years and 9 months

ArmMeasureGroupValue (NUMBER)
Pediatric Patients With AsthmaIntra-rater Reliability Between HASS and PRAMRater 171 percentage of agreement between raters
Pediatric Patients With AsthmaIntra-rater Reliability Between HASS and PRAMRater 264 percentage of agreement between raters

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026