The Severe Asthma Questionnaire: sensitivity to change and minimal clinically important difference

Masoli, Matthew; Lanario, Joseph W.; Hyland, Michael E.; Menzies‐Gow, Andrew; Mansur, Adel; Allen, David J.; Dodd, James; Hayes, Gemma; Valderas, José M; Lamb, Sarah E; Jones, Rupert

doi:10.1183/13993003.00300-2021

Cited by 8 publications

(15 citation statements)

References 10 publications

(22 reference statements)

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“…Patients were discussed in a multi-disciplinary team (MDT) meeting to determine if they were considered a super-responder and eligible to take part in the study. Criteria for making this judgement included all the following: significant improvements in quality of life (as measured by the Severe Asthma Questionnaire (SAQ) [ 16 ] (≥ 2xMCID of 0.5) [ 17 ], an improvement on the Global rating of change (GRoC) scale of a ‘good’ or ‘great’ deal better [ 17 ] and > 50% reduction in OCS usage. If eligible to take part, patients were provided with information about the study and told that a significant other person (e.g., partner) was invited to take part simultaneously.…”

Section: Methodsmentioning

confidence: 99%

“Life-changing”: the experience of super-responders to biologics in severe asthma

et al. 2022

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Background There is limited information on the patient’s perspective of how biologic treatments impact their lives. We conducted a qualitative study to explore the patient’s experience of being considered a super-responder from a quality of life perspective. Methods Patients with severe asthma identified as super-responders were invited to semi-structured interviews conducted online. Participants could bring a family member/friend to the interview. The interviews explored experiences of biologic treatment, were transcribed and underwent thematic analysis. Results Twenty-five participants took part in this study. Themes emerged on the impact of biologic treatment for participants and for their friends/family: (i) Words used to describe their often life-changing experiences and (ii) the positive changes noted. Biologic treatment stopped the disruption of family life and social life caused by exacerbations. Improvements in mental health were also noted. Marked individual variations in the way it affected their lives were noted. Most participants noticed improvements 2–3 months after starting their biologic, but some noticed improvement within a few days and others after 6 months. Conclusions Super-responders reported profound but heterogeneous improvements following biologic treatment beyond asthma symptoms and exacerbations including important benefits to social and family life. Improvements may be underestimated as social and family benefits are not reliably measured in current studies with implications for health economic evaluations. Not all patients are super-responders, and excellent responses may be lost in group mean data in trials. Individual time course and response patterns need further elucidation to identify who will respond best to biologics.

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Section: Methodsmentioning

confidence: 99%

“Life-changing”: the experience of super-responders to biologics in severe asthma

et al. 2022

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“…The full text of 35 papers were assessed for eligibility, including 20 articles identified through review of citations. Thirteen papers were included in the systematic review of which three were about development of the outcome measures [44][45][46] , five were validation papers [47][48][49][50][51] and five [52][53][54][55][56] reported development and validation data in the same manuscript. (Figure 1)…”

Section: Description Of Studiesmentioning

confidence: 99%

“…Definitions were developed for three composite asthma outcome measures [51][52][53] , three asthma symptoms measures 49,50 , one asthma control 55 , and one quality of life (QoL) measure. 48 The following methods of development were used: consensus 53,55 , anchor-based [48][49][50][51] and distribution-based 52 methods. Ten definitions measured response based on MCID 48,49,51 or MID 50,52 and seven 50,55 based on responder/non-responder levels.…”

Section: Development and Quality Of Definitions Of Non-response And R...mentioning

confidence: 99%

“…48 The following methods of development were used: consensus 53,55 , anchor-based [48][49][50][51] and distribution-based 52 methods. Ten definitions measured response based on MCID 48,49,51 or MID 50,52 and seven 50,55 based on responder/non-responder levels. Omalizumab 48,51,52,55 , brodalumab 50 , benralizumab 48,53 , reslizumab 48,53 and mepolizumab 48,49,53 were predominantly used in these studies.…”

Section: Development and Quality Of Definitions Of Non-response And R...mentioning

confidence: 99%

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Definitions of non-response and response to biological therapy for severe asthma: a systematic review

et al. 2023

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BackgroundBiologics have proven efficacy for patients with severe asthma but there is lack of consensus on defining response. We systematically reviewed and appraised methodologically developed, defined, and evaluated definitions of non-response and response to biologics for severe asthma.MethodsWe searched four bibliographic databases from inception to 15th March 2021 (PROSPERO: CRD42021211249).Two reviewers screened references, extracted data, assessed methodological quality of development, measurement properties of outcome measures and definitions of response based on COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN). Modified GRADE approach and narrative synthesis were undertaken.ResultsThirteen studies reported three composite outcome measures, three measures of asthma symptoms, one asthma control and one quality of life. Only four were developed with patient input; none were composite measures. Studies utilised 17 definitions of response: 10/17 (58.8%) were based on Minimal Clinically Important Difference (MCID) or Minimal Important Difference (MID) and 16/17 (94.1%) had high quality evidence. Results were limited by poor methodology for development process and incomplete reporting of psychometric properties. Most measures rated “very low” to “low” for quality of measurement properties and none met all quality standards.ConclusionThis is the first review to synthesize evidence about definitions of response to biologics for severe asthma. While high quality definitions are available, most are MCIDs or MIDs which may be insufficient to justify continuation of biologics in terms of cost-effectiveness. There remains an unmet need for universally accepted, patient-centred, composite definitions to aid clinical decision making and comparability of responses to biologics.

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“…Patients were discussed in a multi-disciplinary team (MDT) meeting to determine if they were considered a super-responder and eligible to take part in the study. Criteria for making this judgement included all the following: significant improvements in quality of life (as measured by the Severe Asthma Questionnaire (SAQ) [16] (≥ 2xMCID of 0.5) [17], an improvement on the Global rating of change (GRoC) scale of a 'good' or 'great' deal better [17] and > 50% reduction in OCS usage.…”

Section: Recruitment and Selectionmentioning

confidence: 99%

“Life-changing”- the experience of super-responders to biologics in severe asthma

Lanario

Cartwright

Jones

et al. 2022

05.02 - Monitoring Airway Disease

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Background: There is limited information on the patient's perspective of how biologic treatments impact their lives. We conducted a qualitative study to explore the patient's experience of being considered a super-responder from a quality of life perspective. Methods:Patients with severe asthma identified as super-responders were invited to semi-structured interviews conducted online. Participants could bring a family member/friend to the interview. The interviews explored experiences of biologic treatment, were transcribed and underwent thematic analysis.Results: Twenty-five participants took part in this study. Themes emerged on the impact of biologic treatment for participants and for their friends/family: (i) Words used to describe their often life-changing experiences and (ii) the positive changes noted. Biologic treatment stopped the disruption of family life and social life caused by exacerbations. Improvements in mental health were also noted. Marked individual variations in the way it affected their lives were noted. Most participants noticed improvements 2-3 months after starting their biologic, but some noticed improvement within a few days and others after 6 months.Conclusions: Super-responders reported profound but heterogeneous improvements following biologic treatment beyond asthma symptoms and exacerbations including important benefits to social and family life. Improvements may be underestimated as social and family benefits are not reliably measured in current studies with implications for health economic evaluations. Not all patients are super-responders, and excellent responses may be lost in group mean data in trials. Individual time course and response patterns need further elucidation to identify who will respond best to biologics.

show abstract

The Severe Asthma Questionnaire: sensitivity to change and minimal clinically important difference

Cited by 8 publications

References 10 publications

“Life-changing”: the experience of super-responders to biologics in severe asthma

“Life-changing”: the experience of super-responders to biologics in severe asthma

Definitions of non-response and response to biological therapy for severe asthma: a systematic review

“Life-changing”- the experience of super-responders to biologics in severe asthma

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