Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02782065 |
| Other study ID # |
P00022204 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 29, 2016 |
| Est. completion date |
January 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Boston Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
