Validity of a French Version of the Severe Asthma Questionnaire
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

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.

      However, just like oral steroids sparing, improving quality of life is of concern for
      physicians.

      The development of Patient Reported Outcome (PRO) instruments follows rigorous scientific
      methodology. The Severe Asthma Questionnaire (SAQ) is a specific instrument for measuring
      quality of life in severe asthma. It was developed and validated in English by the University
      of Plymouth in 2018, according to the current recommendations, in an attempt to respond to
      the lack of specificity of the former quality of life tests.

      It has gone through forward and backward translation process into French thanks to the Mappy
      Trust organization. It seems important to validate, in its French translation, the
      psychometric properties of the SAQ questionnaire, a specific instrument measuring quality of
      life for severe asthmatics.

      Practical considerations:

        -  Useful data cf primary and secondary objectives will be collected at the first and the
           6th month.

        -  Standard Operating Procedures: Patient recruitment will only take place in Bichat
           Hospital. Questionnaires and forms will be lend to the severe asthmatics coming to
           consultation and day hospital thanks to clinical research associate. Data will be
           anonymized and collected by a clinical research associate (fulfilled forms and
           questionnaire and medical file). Data management, data analysis will be ensured by
           Clinical Research Unit of Bichat Hospital.

        -  Sample size assessment : estimated on FALISSARD assumption: 320 patients.

        -  Plan for missing data: usual way for each quality of life questionnaire, enlarged 6th
           month visit period to collect 6th month reevaluation.

        -  Statistical analysis plan: cf section primary and secondary objectives.

        -  Quality assurance plan: Data validation and registry procedures, including any plans for
           site monitoring and auditing will be ensured by the Clinical Research Unit of Bichat
           Hospital.

        -  Data checks: Predefined rules for range will be pre-configure in the eCase Report Form
           (CRF) computed in REDCap. The data dictionary that contains detailed descriptions of
           each variable used by the registry (cf inclusion/exclusion criteria, primary and
           secondary outcome), including the source of the variable, and normal ranges is described
           in a specific document based on which the eCRF will be built. "
    

Intervention name(s): biologic initiation
Intervention type(s): Other
Intervention description(s): introduction or modification of biotherapy at M0
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with severe asthma
      
Keywords: severe asthma; quality of life questionnaire