Assessing treatment success or failure as an outcome in randomised clinical trials of COPD exacerbations. A meta-epidemiological study
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A recently published ERS core outcome set recommends that all trials of COPD exacerbation management should assess the treatment success (or “cure” of the exacerbation), defined as a dichotomous measure of the overall outcome of an exacerbation. This methodological systematic review describes and compares the instruments that were used to assess treatment success or failure in 54 such RCTs, published between 2006–2020. Twenty-three RCTs used composite measures consisting of several undesirable outcomes of an exacerbation, together defining an overall unfavourable outcome, to define treatment failure. Thirty-four RCTs used descriptive instruments that used qualitative or semi-quantitative descriptions to define cure, marked improvement, improvement of the exacerbation, or treatment failure. Treatment success and failure rates among patients receiving guidelines-directed treatments at different settings and timepoints are described and could be used to inform power calculations in future trials. Descriptive instruments appeared more sensitive to treatment effects compared to composite instruments. Further methodological studies are needed to optimise the evaluation of treatment success/failure. In the meantime, based on the findings of this systematic review, the ERS core outcome set recommends that cure should be defined as sufficient improvement of the signs and symptoms of the exacerbation such that no additional systemic treatments are required.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 1837 |
| Tidsskrift | Biomedicines |
| Vol/bind | 9 |
| Udgave nummer | 12 |
| ISSN | 2227-9059 |
| DOI | |
| Status | Udgivet - dec. 2021 |
Bibliografisk note
Funding Information:
Acknowledgments: A.G.M. and J.V. were supported by the National Institute for Health Research Manchester Biomedical Research Centre (NIHR Manchester BRC).
Funding Information:
Conflicts of Interest: This study received no external funding. The authors declare no conflict of interest related to this work. S.A., B.C., E.S., G.F.-R., Z.L., G.J.C., and J.-U.J. do not report any conflicts of interest outside this work either. A.G.M. reports grants from Boehringer Ingelheim and shares in Healthy Networks. T.B. reports a scholarship funded by GlaxoSmithKline, outside the submitted work. P.S. reports honoraria from AstraZeneca, Boehringer Ingelheim, and GSK, outside the submitted work. A.P. reports grants from Chiesi, AstraZeneca, GSK, Boehringer Ingelheim, Pfizer, Teva, and Sanofi; consulting fees from Chiesi, AstraZeneca, GSK, Novartis, Sanofi, Iqvia, Avillion, and Elpen Pharmaceuticals; and honoraria from Chiesi, AstraZeneca, GSK., Boehringer Ingelheim, Menarini, Novartis, Zambon, Mundipharma, Teva, Sanofi, Edmond Pharma, Iqvia, MSD, Avillion, and Elpen Pharmaceuticals, outside this work. C.J. reports grants from GlaxoSmithKline; consulting fees from AstraZeneca and Novartis; honoraria from AstraZeneca, Boehringer Ingelheim, Cipla, GlaxoSmithKline, Novartis, Sanofi; payment for expert testimony from Novartis; support for attending meetings from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Sanofi; participation on advisory boards with AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Sanofi, outside the submitted work. J.V. reports grants from Boehringer-Ingelheim; consulting fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Teva, ALK-Abello; honoraria from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK; support for attending meetings from ALK-Abello; and participation in an advisory board from AstraZeneca, outside the submitted work.
Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
ID: 290256476