Definitions of non-response and response to biological therapy for severe asthma : a systematic review
Copyright ©The authors 2023..
Background: Biologics 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.
Methods: We searched four bibliographic databases from inception to 15 March 2021. Two reviewers screened references, extracted data, and 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). A modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach and narrative synthesis were undertaken.
Results: 13 studies reported three composite outcome measures, three asthma symptoms measures, one asthma control measure and one quality of life measure. Only four measures were developed with patient input; none were composite measures. Studies utilised 17 definitions of response: 10 out of 17 (58.8%) were based on minimal clinically important difference (MCID) or minimal important difference (MID) and 16 out of 17 (94.1%) had high-quality evidence. Results were limited by poor methodology for the 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.
Conclusions: This is the first review to synthesise 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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
|---|---|
| Enthalten in: |
ERJ open research - 9(2023), 3 vom: 03. Juli |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Khaleva, Ekaterina [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
|---|
| Anmerkungen: |
Date Revised 13.03.2024 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.1183/23120541.00444-2022 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM35647089X |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM35647089X | ||
| 003 | DE-627 | ||
| 005 | 20240313233426.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1183/23120541.00444-2022 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1326.xml |
| 035 | |a (DE-627)NLM35647089X | ||
| 035 | |a (NLM)37143849 | ||
| 035 | |a (PII)00444-2022 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Khaleva, Ekaterina |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Definitions of non-response and response to biological therapy for severe asthma |b a systematic review |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 13.03.2024 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a Copyright ©The authors 2023. | ||
| 520 | |a Background: Biologics 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 | ||
| 520 | |a Methods: We searched four bibliographic databases from inception to 15 March 2021. Two reviewers screened references, extracted data, and 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). A modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach and narrative synthesis were undertaken | ||
| 520 | |a Results: 13 studies reported three composite outcome measures, three asthma symptoms measures, one asthma control measure and one quality of life measure. Only four measures were developed with patient input; none were composite measures. Studies utilised 17 definitions of response: 10 out of 17 (58.8%) were based on minimal clinically important difference (MCID) or minimal important difference (MID) and 16 out of 17 (94.1%) had high-quality evidence. Results were limited by poor methodology for the 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 | ||
| 520 | |a Conclusions: This is the first review to synthesise 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Review | |
| 700 | 1 | |a Rattu, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a Brightling, Chris |e verfasserin |4 aut | |
| 700 | 1 | |a Bush, Andrew |e verfasserin |4 aut | |
| 700 | 1 | |a Bourdin, Arnaud |e verfasserin |4 aut | |
| 700 | 1 | |a Bossios, Apostolos |e verfasserin |4 aut | |
| 700 | 1 | |a Chung, Kian Fan |e verfasserin |4 aut | |
| 700 | 1 | |a Chaudhuri, Rekha |e verfasserin |4 aut | |
| 700 | 1 | |a Coleman, Courtney |e verfasserin |4 aut | |
| 700 | 1 | |a Djukanovic, Ratko |e verfasserin |4 aut | |
| 700 | 1 | |a Dahlén, Sven-Erik |e verfasserin |4 aut | |
| 700 | 1 | |a Exley, Andrew |e verfasserin |4 aut | |
| 700 | 1 | |a Fleming, Louise |e verfasserin |4 aut | |
| 700 | 1 | |a Fowler, Stephen J |e verfasserin |4 aut | |
| 700 | 1 | |a Gupta, Atul |e verfasserin |4 aut | |
| 700 | 1 | |a Hamelmann, Eckard |e verfasserin |4 aut | |
| 700 | 1 | |a Koppelman, Gerard H |e verfasserin |4 aut | |
| 700 | 1 | |a Melén, Erik |e verfasserin |4 aut | |
| 700 | 1 | |a Mahler, Vera |e verfasserin |4 aut | |
| 700 | 1 | |a Seddon, Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Singer, Florian |e verfasserin |4 aut | |
| 700 | 1 | |a Porsbjerg, Celeste |e verfasserin |4 aut | |
| 700 | 1 | |a Ramiconi, Valeria |e verfasserin |4 aut | |
| 700 | 1 | |a Rusconi, Franca |e verfasserin |4 aut | |
| 700 | 1 | |a Yasinska, Valentyna |e verfasserin |4 aut | |
| 700 | 1 | |a Roberts, Graham |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t ERJ open research |d 2015 |g 9(2023), 3 vom: 03. Juli |w (DE-627)NLM255762003 |x 2312-0541 |7 nnns |
| 773 | 1 | 8 | |g volume:9 |g year:2023 |g number:3 |g day:03 |g month:07 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1183/23120541.00444-2022 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 9 |j 2023 |e 3 |b 03 |c 07 | ||