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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric patients with Asthma | 165 patients aged 7 to 18 years, and 30 patients aged 2 to 6 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not an interventional study | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 years and 9 months |
| 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. | 4 years and 9 months |
| 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. | 4 years and 9 months |
| Correlation Between the HASS and Forced Expiratory Volume in 1 Second (FEV1) | The correlation coefficient between the HASS tool and FEV1 measurements. | 4 years, 9 months |
| Correlation Between the PRAM and FEV1 | The correlation between the PRAM and FEV1 | 4 years 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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Children with asthma exacerbation in the emergency room, inpatient medical units, and medicine intensive care unit
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| Name | Affiliation | Role |
|---|---|---|
| Leah Abecassis, MSN | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Childrens Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33198536 | Derived | Abecassis L, Gaffin JM, Forbes PW, Schenkel SR, McBride S, DeGrazia M. Validation of the Hospital Asthma Severity Score (HASS) in children ages 2-18 years old. J Asthma. 2022 Feb;59(2):315-324. doi: 10.1080/02770903.2020.1852414. Epub 2020 Dec 2. |
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To ensure anonymity and confidentiality of participants, the investigators will not be sharing individual data. A summary report will be provided to participants upon request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pediatric Patients With Asthma | 34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years Not an interventional study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pediatric Patients With Asthma | 34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years Not an interventional study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | percentage of agreement between raters | 4 years and 9 months |
|
|
Adverse event data was collected at a single point in time during the data collection (approximately 30 minutes).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pediatric Patients With Asthma | 34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years Not an interventional study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leah Abecassis | Boston Children's Hospital | 6173552299 | leah.abecassis@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2020 | Jan 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | There were two participants classified as two different races, and one participant had missing data for that question. With those extra 2 added and 1 not included, it would bring the total number in the race table to be 59. | Number | participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| 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. | Posted | Number | percentage of agreement between raters | 4 years and 9 months |
|
|
|
| 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. | Posted | Number | percentage of agreement between raters | 4 years and 9 months |
|
|
|
| Primary | Correlation Between the HASS and Forced Expiratory Volume in 1 Second (FEV1) | The correlation coefficient between the HASS tool and FEV1 measurements. | There were 29 patients out of 58 that performed spirometry and therefore were able to be analyzed for this data. | Posted | Number | correlation coefficient | 4 years, 9 months |
|
|
|
| Primary | Correlation Between the PRAM and FEV1 | The correlation between the PRAM and FEV1 | There were 29 patients out of 58 that performed spirometry and therefore were able to be analyzed for this data. | Posted | Number | correlation coefficient | 4 years 9 months |
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|
| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |