Measurement Properties Validity of the French Traduction of the Severe Asthma Questionnaire: a Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- Construct validity of french traduction of SAQ
Study Overview
Brief Summary
"Severe asthma affects only 5% of asthmatics, but has a considerable impact on patients owing to the respiratory disability linked to asthma but also complications from oral corticosteroid (OCS) therapy.
Biologics have recently been made available, and improve quality of life (QoL)severe asthma patients. Having a reproducible and reliable measuring tool of QoL for severe asthmatics would be useful for assessing the impact of the various interventions proposed.
QoL questionnaires currently used in respiratory diseases are not specific to severe asthma. They are very focused on respiratory disability, but for example do not take into account the impact of treatments, especially oral steroids.
The Severe Asthma Questionnaire (SAQ) is the very first tool specifically designed to assess the health related quality of life of severe asthma population. The development of its use goes through the validation of this questionnaire in its French translation available since September 2019. "
Detailed Description
"Difficult to treat asthma affects about 17% of the asthma population, among which 5% have severe asthma.
For these patients, the disease is often a burden to their professional, family and personal life, significantly altering their quality of life.
Current recommendations on medical management aim at asthma control and reduction of exacerbations. While there are now biologics that effectively address these objectives, they are still struggling to demonstrate their effectiveness in term of quality of life improvement.
Although in real life, patients well responding to biologics often report ""a changing life"", this is not well demonstrated in clinical trials, which only bring out modest variations in quality of life (mainly AQLQ) and asthma control scores. This may be due to the fact that currently used scores, measure either the quality of life in a generic way, or asthma control (dyspnea, use of rescue treatments) rather than asthma specific quality of life, and do not take into account the burden of oral steroids.
For this specific population of asthmatics, even the dedicated scores (11 scales in the adult population and 6 in the pediatric population) have trouble measuring variations in quality of life. They hardly ever manage to demonstrate a difference in quality of life between mild asthma and severe asthma.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Construct validity of french traduction of SAQ
Time Frame: 1 month
Construct validity (strength of correlation testing a priori hypotheses (discriminant and convergent validity) and degree to which the PRO instrument can distinguish among groups hypothesized a priori to be different (known groups validity)): Spearman correlation between SAQ and ACT\*, ACQ\*, miniAQLQ\*, SGRQ\*, SF36\*, EQ 5D 5L\*, EQ 5D VAS\*, OCS dose, Forced expiratory volume in 1s (FEV1)) * ACT: Asthma Control Test i * ACQ: Asthma Control Questionnaire * MiniAQLQ: Mini Asthma Quality of Life Questionnaire * SGRQ: Saint Georges Respiratory Questionnaire * SF36: 36-item Short-Form Health Survey * EQ 5D 5L: 5Level-EuroQualityoflife Instrument 5 Dimension * EQ 5D VAS: EuroQol Visual Analogue Scale
Factorial validity of french traduction of SAQ (Severe Asthma Questionnaire )
Time Frame: 1 month
Factorial validity (evidence that the instrument measures a single concept): principal component analysis of all items
Internal consistency of french traduction of SAQ
Time Frame: 1 month
Internal consistency (intercorrelation of items that contribute to a score): Item total correlation and Cronbach's alpha coefficient
Secondary Outcomes
- Test-retest reliability(6 months)
- Usability testing(6 months)
- Ability to detect change(6 months)
- Minimal Clinically Important Difference (MCID)(6 months)