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Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA)
Ekaterina Khaleva1, Anna Rattu1, Chris Brightling2
1Clinical and Experimental Sciences and Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
Insights
Standardized outcome measures for severe asthma biologics are needed. The COMSA group developed Core Outcome Measures (COM) sets for children and adults to improve clinical trial data synthesis and biologic appraisal.
Area of Science:
- Pulmonology
- Clinical Pharmacology
- Health Outcomes Research
Background:
- Effectiveness studies for biological therapies in severe asthma often lack standardized outcome measures.
- This hinders data synthesis and the appraisal of biologic treatments in clinical studies.
- The COMSA Working Group aimed to address this gap by developing standardized Core Outcome Measures (COM) sets.
Conclusions:
- Two patient-centred COM sets for paediatric and adult severe asthma have been established.
- These sets are expected to standardize future clinical trial methodology and improve comparability of biologic therapy evaluations.
- The COM sets will aid in assessing the socioeconomic value of biologics and defining response criteria for severe asthma treatments.
Background:
Effectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe Asthma) Working Group sought to develop Core Outcome Measures (COM) sets to facilitate better synthesis of data and appraisal of biologics in paediatric and adult asthma clinical studies.
Methods:
COMSA utilised a multi-stakeholder consensus process among patients with severe asthma, adult and paediatric clinicians, pharmaceutical representatives, and health regulators from across Europe. Evidence included a systematic review of development, validity and reliability of selected outcome measures plus a narrative review and a pan-European survey to better understand patients' and carers' views about outcome measures. It was discussed using a modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision framework. Anonymous voting was conducted using predefined consensus criteria.
Results:
Both adult and paediatric COM sets include forced expiratory volume in 1 s (FEV1) as z-scores, annual frequency of severe exacerbations and maintenance oral corticosteroid use. Additionally, the paediatric COM set includes the Paediatric Asthma Quality of Life Questionnaire and Asthma Control Test or Childhood Asthma Control Test, while the adult COM set includes the Severe Asthma Questionnaire and Asthma Control Questionnaire-6 (symptoms and rescue medication use reported separately).
Conclusions:
This patient-centred collaboration has produced two COM sets for paediatric and adult severe asthma. It is expected that they will inform the methodology of future clinical trials, enhance comparability of efficacy and effectiveness of biological therapies, and help assess their socioeconomic value. COMSA will inform definitions of non-response and response to biological therapy for severe asthma.
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