National Validation and Sensitivity to Change of the SAQ
National Validation and Sensitivity to Change of the SAQ
DESIGN A multi-centre mixed methods study of a new asthma specific quality of life
 questionnaire including limited clinic data.

 AIMS To collect further quantitative data to validate a new asthma quality of life scale, the
 Severe Asthma Questionnaire (SAQ).

 To determine the Minimum Clinically Important Difference (MCID) of the SAQ

 OUTCOME MEASURES

 Questionnaires:

 1. The Severe Asthma Questionnaire (SAQ)

 2. The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)

 3. The EQ-5D-5L

 4. The Asthma Control Test (ACT)/ Asthma Control Questionnaire (ACQ)

 5. Global Rating of Change Questionnaire (GRCQ)

 Clinical data comprises:

 6. Spirometry

 7. BMI

 8. Asthma severity

 9. Health care utilisation: ED attendance in the last 12 months, Hospital admissions in the
 last 12 months;

 10. Number of exacerbations in the last 12 months requiring OCS Prednisolone dose mg/day (if
 oral steroid dependent).

 POPULATION All patients aged 16 years or over, who have attended one of three participating
 UK specialist asthma centres for the validation study and with data also collected from
 Derriford Hospital's Chest Clinic (DHCC) for use in determining Minimum clinically Important
 difference.

 ELIGIBILITY Over 16 years of age Diagnosis of Severe Asthma

 DURATION 18 months
Part 1: National Validation

 Inclusion Criteria:

 -  All patients must have a diagnosis of severe asthma, be taking high dose inhaled
 corticosteroids (GINA step 4 & 5), and be aged 16 years or over.

 Exclusion Criteria:

 -  Patients that are unwilling to participate will be excluded from the study.

 -  In the opinion of the physician responsible for the care of the patient, the patient
 has a condition, other than asthma, which is significantly contributing to their
 respiratory symptoms, e.g. lung cancer, heart failure or severe Chronic Obstructive
 Pulmonary Disease (COPD).

 -  The SAQ is currently only translated into British English. Therefore, if the
 participant is unable to read in English, they will be unable to participate.

 Part 2: Sensitivity to change

 Inclusion Criteria

 -  Patients commencing a biologic treatment for their severe asthma (GINA step 4 & 5), as
 per NICE guidelines.

 Exclusion Criteria

 -  Patients will be excluded from the study if they are unwilling to participate

 -  In the opinion of the physician responsible for the care of the patient, the patient
 has a condition, other than asthma which is significantly contributing to their
 respiratory symptoms, e.g. lung cancer, heart failure or severe COPD.