- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02782065
Validation of the Hospital Asthma Severity Score (HASS) (HASS)
Validation Of The Hospital Asthma Severity Score (HASS) In Children Ages 2-18 Years Old
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Childrens Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric patients with Asthma
165 patients aged 7 to 18 years, and 30 patients aged 2 to 6 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 years and 9 months
|
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.
|
4 years and 9 months
|
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.
|
4 years and 9 months
|
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.
|
4 years, 9 months
|
Correlation Between the PRAM and FEV1
Time Frame: 4 years 9 months
|
The correlation between the PRAM and FEV1
|
4 years 9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leah Abecassis, MSN, Boston Children's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00022204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on Not an interventional study
-
Guy's and St Thomas' NHS Foundation TrustUnknownRespiratory Tract Infections | Healthy | Lung Infection | Droplet Spread
-
University of British ColumbiaActive, not recruitingMyocardial Injury | Chronic Kidney Diseases | SurgeryCanada
-
University of British ColumbiaActive, not recruitingMyocardial Injury | Complication,Postoperative | Non-cardiac Surgery | High-sensitivity TroponinCanada
-
University of Texas Southwestern Medical CenterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Recruiting
-
University of California, RiversideUniversity of South FloridaUnknownAging | Hiv | IncentivesUnited States
-
University of OxfordImanova Centre for Imaging SciencesCompleted
-
Queen Mary University of LondonActive, not recruiting
-
University of British ColumbiaCompletedPain | Pain, Postoperative | Surgery | Orthopedic Procedures | Ambulatory Surgical Procedures | Nerve BlockCanada
-
Danone Asia Pacific Holdings Pte, Ltd.CompletedImmunologic Activity Alteration
-
University of AthensKing's College Hospital NHS Trust; Charite University, Berlin, Germany; University...Not yet recruiting