Trial Outcomes & Findings for Validation of the Hospital Asthma Severity Score (HASS) (NCT NCT02782065)
NCT ID: NCT02782065
Last Updated: 2021-03-23
Results Overview
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
COMPLETED
58 participants
4 years and 9 months
2021-03-23
Participant Flow
Participant milestones
| Measure |
Pediatric Patients With Asthma
34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years
Not an interventional study
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Pediatric Patients With Asthma
n=58 Participants
34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years
Not an interventional study
|
|---|---|
|
Age, Categorical
<=18 years
|
58 Participants
n=58 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=58 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=58 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
17 participants
n=57 Participants • 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.
|
|
Race/Ethnicity, Customized
Black/African American
|
24 participants
n=57 Participants • 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.
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=57 Participants • 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.
|
|
Race/Ethnicity, Customized
Dominican
|
3 participants
n=57 Participants • 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.
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=57 Participants • 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.
|
|
Race/Ethnicity, Customized
Unknown
|
9 participants
n=57 Participants • 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.
|
|
Region of Enrollment
United States
|
58 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pediatric Patients With Asthma
n=58 Participants
34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years
Not an interventional study
|
|---|---|
|
Inter-rater Reliability for the Hospital Asthma Severity Score (HASS)
|
29 percentage of agreement between raters
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pediatric Patients With Asthma
n=58 Participants
34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years
Not an interventional study
|
|---|---|
|
Inter-rater Reliability for the Pediatric Respiratory Assessment Measure (PRAM)
|
28 percentage of agreement between raters
|
PRIMARY outcome
Timeframe: 4 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.
Outcome measures
| Measure |
Pediatric Patients With Asthma
n=58 Participants
34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years
Not an interventional study
|
|---|---|
|
Intra-rater Reliability Between HASS and PRAM
Rater 1
|
71 percentage of agreement between raters
|
|
Intra-rater Reliability Between HASS and PRAM
Rater 2
|
64 percentage of agreement between raters
|
PRIMARY outcome
Timeframe: 4 years, 9 monthsPopulation: There were 29 patients out of 58 that performed spirometry and therefore were able to be analyzed for this data.
The correlation coefficient between the HASS tool and FEV1 measurements.
Outcome measures
| Measure |
Pediatric Patients With Asthma
n=29 Participants
34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years
Not an interventional study
|
|---|---|
|
Correlation Between the HASS and Forced Expiratory Volume in 1 Second (FEV1)
|
-.31 correlation coefficient
|
PRIMARY outcome
Timeframe: 4 years 9 monthsPopulation: There were 29 patients out of 58 that performed spirometry and therefore were able to be analyzed for this data.
The correlation between the PRAM and FEV1
Outcome measures
| Measure |
Pediatric Patients With Asthma
n=29 Participants
34 patients aged 7 to 18 years, and 24 patients aged 2 to 6 years
Not an interventional study
|
|---|---|
|
Correlation Between the PRAM and FEV1
|
-.30 correlation coefficient
|
Adverse Events
Pediatric Patients With Asthma
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place