AsthmaHASSNCT02782065
Validation of the Hospital Asthma Severity Score (HASS)
An observational study of Asthma, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Not an interventional study
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2016to Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with asthma exacerbation in the emergency room, inpatient medical units, and medicine intensive care unit
Who may be able to join
- asthma exacerbation
Who cannot join
- continuous albuterol and/or
- pneumonia, croup, varicella, cystic fibrosis, broncho-pulmonary dysplasia, cardiac or kidney disease AND
- previously approached for participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Childrens Hospital
Boston, Massachusetts, 02115
About this study
Official title: Validation Of The Hospital Asthma Severity Score (HASS) In Children Ages 2-18 Years Old
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.
Read the 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:
- concordant (three cells; complete agreement: both tests say 'Severe', for instance),
- discordant (four cells; e.g. one test says Moderate while the other say Mild) and
- 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.
- Conditions
- Asthma
- Being tested
- Not an interventional study
- Keywords
- validation, pediatrics, asthma severity
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not an interventional studyOther
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients with Asthma | 165 patients aged 7 to 18 years, and 30 patients aged 2 to 6 years Receives: Other: Not an interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 years, 9 months
Correlation Between the PRAM and FEV1
The correlation between the PRAM and FEV1
Measured: 4 years 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start29 Sep 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leah Abecassis, Boston Children's Hospital
- Investigators
- Leah Abecassis, MSN, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782065
- Sponsor's protocol ID
- P00022204
- Acronym
- HASS
- Status last verified
- Mar 2021
- First submitted
- 6 May 2016
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 33198536
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Of The Hospital Asthma Severity Score (HASS) In Children Ages 2-18 Years Old
- ClinicalTrials.gov ID
- NCT02782065
- Acronym / sponsor ID
- HASS / P00022204
- Conditions
- Asthma
- Keywords
- validation, pediatrics, asthma severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Posted 16 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- concordant (three cells; complete agreement: both tests say 'Severe', for instance),
- discordant (four cells; e.g. one test says Moderate while the other say Mild) and
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with Asthma | – | Other: Not an interventional study165 patients aged 7 to 18 years, and 30 patients aged 2 to 6 years |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with asthma exacerbation in the emergency room, inpatient medical units, and medicine intensive care unit
Key inclusion criteria (1 listed)
- asthma exacerbation
Key exclusion criteria (3 listed)
- continuous albuterol and/or
- pneumonia, croup, varicella, cystic fibrosis, broncho-pulmonary dysplasia, cardiac or kidney disease AND
- previously approached for participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not an interventional study | Other | Pediatric patients with Asthma |
Primary outcome
Inter-rater Reliability for the Hospital Asthma Severity Score (HASS)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 4 years, 9 months
The correlation coefficient between the HASS tool and FEV1 measurements.
Correlation Between the PRAM and FEV1
Time frame: 4 years 9 months
The correlation between the PRAM and FEV1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33198536Abecassis 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Abecassis, MSN principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater Reliability for the Hospital Asthma Severity Score (HASS) (time frame: 4 years and 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02782065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.