ERS Statement: A core outcome set for clinical trials evaluating the management of chronic obstructive pulmonary disease (COPD) exacerbations.

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish
JournalThe European respiratory journal
Publication statusAccepted/In press - 3 Sept 2021

Fingerprint

Dive into the research topics of 'ERS Statement: A core outcome set for clinical trials evaluating the management of chronic obstructive pulmonary disease (COPD) exacerbations.'. Together they form a unique fingerprint.

Cite this