Abstract
Clinical trials evaluating the management of acute exacerbations of COPD assess heterogeneous outcomes, often omitting those that are clinically relevant or more important to patients. We have developed a core outcome set, a consensus-based minimum set of important outcomes that we recommend are evaluated in all future clinical trials on exacerbations management, to improve their quality and comparability. COPD exacerbations outcomes were identified through methodological systematic reviews and qualitative interviews with 86 patients from 11 countries globally. The most critical outcomes were prioritized for inclusion in the core outcome set through a two-round Delphi survey that was completed by 1,063 participants (256 patients, 488 health professionals and 319 clinical academics) from 88 countries in 5 continents. Two global, multi-stakeholder, virtual consensus meetings were conducted to (i) finalize the core outcome set and (ii) prioritize a single measurement instrument to be used for evaluating each of the prioritized outcomes. Consensus was informed by rigorous methodological systematic reviews. The views of patients with COPD were accounted for in all stages of the project. Survival, treatment success, breathlessness, quality of life, activities of daily living, need for higher level of care, arterial blood gases, disease progression, future exacerbations and hospital admissions, treatment safety and adherence were all included in the core outcome set. Focused methodological research was recommended to further validate and optimize some of the selected measurement instruments. The panel did not consider the prioritized set of outcomes and associated measurement instruments burdensome for patients and health professionals to use.
Footnotes
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Conflict of interest: Dr. Mathioudakis reports grants from Boehringer Ingelheim, outside the submitted work.
Conflict of interest: Dr. Abroug has nothing to disclose.
Conflict of interest: Dr. Agusti reports grants and personal fees from GSK, grants and personal fees from Menarini, grants and personal fees from Chiesi, grants and personal fees from AZ, outside the submitted work; .
Conflict of interest: Dr. Ananth has nothing to disclose.
Conflict of interest: Dr. Bakke reports personal fees from AstraZeneca, personal fees from Novartis, personal fees from GlaxoSmithKline, outside the submitted work; .
Conflict of interest: Dr. Bartziokas has nothing to disclose.
Bianca Beghe
Conflict of interest: Dr. Bikov has nothing to disclose.
Conflict of interest: Mr. Bradbury reports receiving an academic scholarship funded by GlaxoSmithKline outside the submitted work.
Conflict of interest: Dr. Brusselle reports personal fees from Astra Zeneca, personal fees from Boehringer-Ingelheim, personal fees from Chiesi, personal fees from GlaxoSmithKline, personal fees from Novartis, personal fees from Sanofi, personal fees from Teva, outside the submitted work; .
Conflict of interest: Dr. Cadus reports personal fees from Mundipharma, personal fees from AstraZeneca outside the submitted work; .
Conflict of interest: Ms. Coleman has nothing to disclose.
Conflict of interest: Dr. Contoli reports grants, personal fees and non-financial support from Chiesi, personal fees and non-financial support from AstraZeneca, personal fees and non-financial support from Boehringer Ingelheim, personal fees and non-financial support from Alk-Abello, grants, personal fees and non-financial support from GlaxoSmithKline, personal fees and non-financial support from Novartis, personal fees and non-financial support from Zambon, grants from University of Ferrara - Italy, outside the submitted work; .
Conflict of interest: Dr. A Corlateanu has nothing to disclose.
Olga Corlateanu
Conflict of interest: Dr. Criner reports grants and personal fees from Galaxo Smith Kline, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Chiesi, grants and personal fees from Mereo, personal fees from Verona, grants and personal fees from Astra Zeneca, grants and personal fees from Pulmonx, grants and personal fees from Pneumrx, personal fees from BTG, grants and personal fees from Olympus, grants and personal fees from Broncus, personal fees from EOLO, personal fees from NGM, grants and personal fees from Lungpacer, grants from Alung, grants and personal fees from Nuvaira, grants and personal fees from ResMed, grants and personal fees from Respironics, grants from Fisher Paykel, grants and personal fees from Patara, grants from Galapgos, outside the submitted work; .
Conflict of interest: Dr. Csoma has nothing to disclose.
Conflict of interest: Dr. Emelyanov has nothing to disclose.
Conflict of interest: Dr. Faner reports grants and other from GSK, grants from Menarini, grants from AstraZeneca, other from Chiesi, outside the submitted work; .
Conflict of interest: Dr. Fernandez Romero has nothing to disclose.
Conflict of interest: Dr. Hammouda has nothing to disclose.
Conflict of interest: Dr. Horváth has nothing to disclose.
Conflict of interest: Dr. Huerta has nothing to disclose.
Conflict of interest: Dr. Jacobs has nothing to disclose.
Conflict of interest: Dr. JENKINS reports personal fees from ASTRAZENECA, grants and personal fees from GLAXOSMITHKLINE, personal fees from BOEHRINGER INGELHEIM, personal fees from NOVARTIS, outside the submitted work; .
Conflict of interest: Dr. Joos reports grants, personal fees and non-financial support from AstraZeneca, grants from Chiesi, grants, personal fees and non-financial support from GlaxoSmithKline, personal fees from Novartis, personal fees from Lapharcon, outside the submitted work; all fees were paid to his department.
Conflict of interest: Dr. Kharevich has nothing to disclose.
Conflict of interest: Dr. Kostikas reports and He was an employee and shareholder of Novartis Pharma AG until 31.10.2018. He has received honoraria for presentations and consultancy fees from AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, ELPEN, GSK, Menarini, Novartis, Sanofi Genzyme and WebMD. His department has received funding and grants from AstraZeneca, Boehringer Ingelheim, Chiesi, Innovis, ELPEN, GSK, Menarini, Novartis and NuvoAir. He is a member of the GOLD Assembly
Conflict of interest: Dr. Lapteva has nothing to disclose.
Conflict of interest: Dr. Lazar has nothing to disclose.
Conflict of interest: JDL is supported by grants from the Swiss National Science Foundation (SNF 160072 and 185592) as well as by Swiss Personalised Health Network (SPHN 2018DR108).JDL has also received unrestricted grants from AstraZeneca AG Switzerland, Boehringer Ingelheim GmbH Switzerland, GSK AG Switzerland, and Novartis AG Switzerland.
Conflict of interest: Dr. Liddle has nothing to disclose.
Conflict of interest: Dr. Linnell has nothing to disclose.
Conflict of interest: Dr. López Giraldo has nothing to disclose.
Conflict of interest: Dr. McDonald reports grants and personal fees from GSK, grants and personal fees from AZ, personal fees from Novartis, outside the submitted work; .
Conflict of interest: Dr. Nielsen reports grants from GlaxoSmithKline Norway, grants and personal fees from AstraZeneca, grants from Boehringer Ingelheim, outside the submitted work; .
Conflict of interest: Alberto Papi report grants, personal fees, non-financial support, and other interests at AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Mundipharma, and Teva; personal fees and non-financial support from Menarini, Novartis, and Zambon; and grants from Sanofi.
Conflict of interest: Dr. Saraiva has nothing to disclose.
Conflict of interest: Dr. Sergeeva has nothing to disclose.
Conflict of interest: Dr. Sioutkou has nothing to disclose.
Conflict of interest: Dr. Sivapalan reports personal fees from Boehringer Ingelheim, personal fees from AstraZeneca, personal fees from GSK, outside the submitted work; .
Conflict of interest: Ms Stovold has nothing to disclose.
Conflict of interest: Dr. Wang has nothing to disclose.
Conflict of interest: Dr. Wen has nothing to disclose.
Conflict of interest: Dr. Yorke has nothing to disclose.
Conflict of interest: Dr. Williamson reports personal fees from European Respiratory Society, during the conduct of the study; .
Conflict of interest: Dr. Vestbo reports personal fees from AstraZeneca, grants and personal fees from Boehringer-Ingelheim, personal fees from Chiesi, personal fees from GSK, personal fees from Novartis, outside the submitted work; and My son works for Chiesi.
Conflict of interest: Dr. Jensen has nothing to disclose.
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- Received July 19, 2021.
- Accepted September 3, 2021.
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