The COS-AECOPD study
Research type
Research Study
Full title
Development of a core outcome set (COS) for the management of Acute Exacerbations of Chronic Obstructive Pulmonary Disease. The COS-AECOPD study.
IRAS ID
261896
Contact name
Jørgen Vestbo
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
1325, COMET Initiative
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Research Summary
Introduction: Acute exacerbations of COPD are symptom flare-ups which can cause poor health, hospitalisation or death. Numerous research studies aim to improve the treatment of exacerbations. However, researchers use different strategies to look at the effects of treatments. This results in the conduct of studies that are not similar and cannot be compared to evaluate which treatments are more effective. The effect treatments have on patients are usually measured by one or more outcomes (e.g. how long the symptoms of the exacerbation last).
Objectives: The aim of this study is to identify which are considered the most important outcomes of flare-ups, by patients and other stakeholders. Based on this information, we will prioritise a set of main outcomes (a “core outcome set”) that all future studies will assess as a minimum.
Methods: We have developed a list of outcomes that have been measured in trials evaluating the management of COPD exacerbations. Next, we will conduct semi-structured interviews and group discussions with patients diagnosed with COPD and their caregivers, aiming to identify additional outcomes that may be important to patients. Next, we will launch an extensive online survey, designed to facilitate prioritisation of the most important outcomes to be included in the core outcome set. We will invite patients and relevant stakeholders to respond to this survey. The responses will be collated, summarised and presented to the participants, who will be asked to re-rate the outcomes taking into account the previous responses. While the aim of this survey is to facilitate participants to reach agreement, no-one will be under any pressure to change their rating if they don’t want to. Overall, participants will be asked to rate the outcomes up to three successive times. The core outcome set will be finalised through consensus, during a meeting of international stakeholders.Summary of Results
Chronic obstructive pulmonary disease (COPD) is a long-term condition causing burdensome chest symptoms that limit patients’ quality of life and ability to function. COPD is often complicated by symptom flare-ups (so called exacerbations), that often lead to hospital admission, or even death. Moreover, they can cause permanent worsening of a patient’s symptoms. Over one in three patients with COPD suffer from exacerbations every year.
Unfortunately, the treatment of COPD exacerbations has remained unchanged for decades, and it could be improved. One of the reasons for this is that testing whether a new drug is effective for patients with COPD exacerbations is challenging. One of the challenges researchers face is to select the most important “outcomes” to test new treatments against, in controlled clinical trials. An outcome is how a trial assesses if a new treatment works, and is safe. For example, one trial may test whether a medication can prevent hospital admission by improving symptoms, whether it can prevent future exacerbations, whether it is associated with side effects, or whether it impacts the inflammation in people lungs. Some of these outcomes are more important to patients and health professionals and need to be tested in all trials, in the same way. However, this has not been the case. As a result, the findings of some trials were not informative for clinicians. Moreover, clinicians are not able to compare the results of different trials, if they do not test the same outcomes. As a result, clinical trials testing effective new treatments, often fail to persuade clinicians about the benefits of the treatment.
For this reason, the European Respiratory Society (ERS) set up a task force involving health professionals, researchers, COPD patients and other stakeholders from around the world, to solve this problem. The group created a list of “core outcomes” which are the most critical outcomes of COPD exacerbations and should be tested in all future clinical trials of COPD exacerbations treatments. In addition, the group provided guidance about how to test each of these core outcomes. These will improve the quality of future trials and will allow health professionals and researchers to compare the results of the trials.
The group developed a list of all different outcomes of COPD exacerbations by searching the literature and by interviewing patients with COPD from all over the world. Then, over 1,000 health professionals, researchers, COPD patients and other stakeholders from around the world were surveyed about which outcomes they think are most important. In two broad international meetings, that involved members of the group and patients, the results of the survey were discussed and the core outcome set was finalized.
The most critical outcomes of COPD exacerbations, that were included in the core outcome set are summarized below. It is strongly recommended that all future trials will use these outcomes, to help health professionals interpret their results and use them in clinical practice. It is expected that this work will improve the quality and comparability of future clinical trials.Core Outcome Set for Clinical Trials Evaluating the Management of COPD Exacerbations.
1. Death
a. Death from any cause*
b. Death from a COPD exacerbation
2. Treatment success
3. Need for a higher level of care
a. Need for hospital admission for the presenting exacerbation
b. Need for admission to the intensive care unit for the exacerbation
4. Levels of oxygen and carbon dioxide in the blood (arterial blood gases)
5. Outcomes reported by patients
a. Breathlessness
b. Health-related quality of life (how a patient rates their current physical health)
c. Effect on activities of daily living (such as dressing and moving around the house)
d. Worsening of symptoms after the initial treatment
6. Future Impact
a. Disease progression (permanent change in the patient’s COPD severity after the exacerbation resolves)
b. Future exacerbations
c. Future hospital admissions
7. Safety
a. Serious adverse events of treatments*
b. Development of resistant bacteria
c. Development of pneumonia*
8. Treatment adherence*REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0477
Date of REC Opinion
28 Aug 2019
REC opinion
Favourable Opinion