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National Validation and Sensitivity to Change of the SAQ

  • Research type

    Research Study

  • Full title

    National Validation and Sensitivity to Change of a scale to measure quality of life in patients with severe asthma

  • IRAS ID

    250167

  • Contact name

    Matthew Masoli

  • Contact email

    matthew.masoli@nhs.net

  • Sponsor organisation

    University Hospitals Plymouth HNS Trusy Research and Development Department

  • Duration of Study in the UK

    1 years, 6 months, 27 days

  • Research summary

    “Is the Severe Asthma Questionnaire a better measure of quality of life in patients with severe asthma compared to established scales?” \nUnlike mild/moderate asthma which can usually be controlled using inhaled medication, patients with severe asthma often require oral corticosteroids (OCS) to keep their asthma symptoms under control. OCS use is associated with side effects. Of major concern to patients are changes in facial and body appearance, weight gain, gastro-oesophageal reflux, mood changes and sleep disruption. \n\nFor patients with severe asthma, the impact of OCS can to be far greater than the impact of other asthma treatments, and therefore, severe patients, i.e. those exposed to high doses of OCS, are likely to have a greater treatment burden than other patients. Despite experiencing very different health related quality of life burdens compared to patients with mil/moderate asthma, patients with severe asthma are still asked to complete the same quality of life questionnaires. \n\nA new questionnaire, the Severe Asthma questionnaire was drafted with the aim of capturing the experience of patients with severe asthma including their asthma symptoms and medication side effects. This experiential information was gained from 23 semi-structured interviews with patients with severe asthma. The wording and concepts in this draft were amending based on the feedback from 16 patients across 4 focus groups. The SAQ was then field tested in 160 patients and compared to other questionnaires. \n\nThis further study is to provide additional validating data from multiple centres around the UK for the Severe Asthma Questionnaire as the prior study was in a relatively small dataset (160) and in one geographical location. Data to determine the Minimum Clinically Important Difference (MCID) of the SAQ will also be collected. The MCID of the SAQ is required if the questionnaire is to be useful in clinical practice and trials. \n\nFor patients with severe asthma, the impact of OCS can to be far greater than the impact of other asthma treatments, and therefore, severe patients, i.e. those exposed to high doses of OCS, are likely to have a greater treatment burden than other patients. Despite experiencing very different health related quality of life burdens compared to patients with mil/moderate asthma, patients with severe asthma are still asked to complete the same quality of life questionnaires. \n\nA new questionnaire, the Severe Asthma questionnaire was drafted with the aim of capturing the experience of patients with severe asthma including their asthma symptoms and medication side effects. This experiential information was gained from 23 semi-structured interviews with patients with severe asthma. The wording and concepts in this draft were amending based on the feedback from 16 patients across 4 focus groups. The SAQ was then field tested in 160 patients and compared to other questionnaires. \n\nThis further study is to provide additional validating data from multiple centres around the UK for the Severe Asthma Questionnaire as the prior study was in a relatively small dataset (160) and in one geographical location. Data to determine the Minimum Clinically Important Difference (MCID) of the SAQ will also be collected. The MCID of the SAQ is required if the questionnaire is to be useful in clinical practice and trials. \n

  • REC name

    Wales REC 3

  • REC reference

    19/WA/0011

  • Date of REC Opinion

    24 Jan 2019

  • REC opinion

    Further Information Favourable Opinion