Asthma
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 HASS and Forced Expiratory Volume in 1 Second (FEV1) | 4 years, 9 months | The correlation coefficient between the HASS tool and FEV1 measurements. |
| Correlation Between the PRAM and FEV1 | 4 years 9 months | The correlation between the PRAM and FEV1 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pediatric Patients With Asthma 34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years
Not an interventional study | 58 |
| Total | 58 |
Baseline characteristics
| Characteristic | Pediatric 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 type | EG000 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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric Patients With Asthma | Correlation Between the HASS and Forced Expiratory Volume in 1 Second (FEV1) | -.31 correlation coefficient |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric Patients With Asthma | Correlation Between the PRAM and FEV1 | -.30 correlation coefficient |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric Patients With Asthma | Inter-rater Reliability for the Hospital Asthma Severity Score (HASS) | 29 percentage of agreement between raters |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric Patients With Asthma | Inter-rater Reliability for the Pediatric Respiratory Assessment Measure (PRAM) | 28 percentage of agreement between raters |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pediatric Patients With Asthma | Intra-rater Reliability Between HASS and PRAM | Rater 1 | 71 percentage of agreement between raters |
| Pediatric Patients With Asthma | Intra-rater Reliability Between HASS and PRAM | Rater 2 | 64 percentage of agreement between raters |