Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol

Abstract

Randomised controlled trials (RCTs) on the management of COPD exacerbations evaluate heterogeneous outcomes, often omitting those that are clinically important and patient relevant. This limits their usability and comparability. A core outcome set (COS) is a consensus-based minimum set of clinically important outcomes that should be evaluated in all RCTs in specific areas of health care. We present the study protocol of the COS-AECOPD ERS Task Force, aiming to develop a COS for COPD exacerbation management, that could remedy these limitations.For the development of this COS we follow standard methodology recommended by the COMET initiative. A comprehensive list of outcomes is assembled through a methodological systematic review of the outcomes reported in relevant RCTs. Qualitative research with patients with COPD will also be conducted, aiming to identify additional outcomes that may be important to patients, but are not currently addressed in clinical research studies. Prioritisation of the core outcomes will be facilitated through an extensive, multi-stakeholder Delphi survey with a global reach. Selection will be finalised in an international, multi-stakeholder meeting. For every core outcome, we will recommend a specific measurement instrument and standardised time points for evaluation. Selection of instruments will be based on evidence-informed consensus.Our work will improve the quality, usability and comparability of future RCTs on the management of COPD exacerbations and, ultimately, the care of patients with COPD. Multi-stakeholder engagement and societal support by the European Respiratory Society will raise awareness and promote implementation of the COS.

Protocol for the development of a core outcome set for stillbirth care research (iCHOOSE Study)

“…It will also be used to refine the long-list of outcomes. The think-aloud method has been used by other core outcome set developers to improve their questionnaire design 45–49. We will examine how parents and other stakeholders interpret the outcome labels and definitions, check they understand how to complete the nine-point Likert rating scale and identify problems 23.…”

“…The think-aloud method has been used by other core outcome set developers to improve their questionnaire design. [45][46][47][48][49] We will examine how parents and other stakeholders interpret the outcome labels and definitions, check they understand how to complete the nine-point Likert rating scale and identify problems. 23 Participants will think aloud as they work through the draft Delphi and provide a running commentary on their thoughts on rating of outcomes.…”

Assessing Treatment Success or Failure as an Outcome in Randomised Clinical Trials of COPD Exacerbations. A Meta-Epidemiological Study

“…It is crucial that trials evaluating the management of a disease entity assess the same outcomes, those important to patients and health professionals, to facilitate decision making and improve the comparability of the trial results [ 10 ]. For this reason, the European Respiratory Society (ERS) launched a task force that developed a core outcome set for RCTs on the management of COPD exacerbations [ 11 , 12 ]. A core outcome set is an agreed standardised set of critically important outcomes that should be measured and reported as a minimum in all clinical trials in specific areas of health and health care [ 10 ].…”

Inspiring stories: the impact that being part of ERS activities can have on a professional career

“…Most importantly, I had the privilege to work more closely with the ERS Guidelines Working Group and, besides my contribution to the ERS Guidelines on the management of sarcoidosis [12], I was also able to co-lead two other important task forces. One of these task forces developed a core outcome set for the management of COPD exacerbation [13][14][15][16], and the second assessed factors impacting adherence to international asthma guidelines [17]. Finally, systematic reviews and clinical trials are strongly interlinked, and, during my PhD, I was able to develop further skills in clinical trials methods.…”