Clinical research studies evaluating the management of pneumonia assess and report heterogeneous outcome measures. Patient important outcomes such as mortality and cure rate are sometimes omitted. This complicates comparing, synthesising, and interpreting of research results. A core outcome set (COS) is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health care and can remedy these issues.
The proposed European Respiratory Society (ERS) Task Force (TF) aims to develop globally representative COS for community-acquired pneumonia (CAP) as well as nosocomial pneumonia (hospital-acquired pneumonia, HAP, and ventilator-associated pneumonia, VAP). Following standard methodology suggested by the COMET Initiative, we have already completed a methodological systematic review (step 1). This TF will involve the conduct of qualitative interviews with 15-30 people who had recently experienced CAP, HAP or VAP (step 2), an extensive multi-stakeholder Delphi survey (step 3), and, finally, a consensus meeting, with the overall aim to evaluate how patients, clinicians, clinical researchers and other relevant stakeholders rate the importance of the outcomes in pneumonia (step 4). Based on these ratings, the TF will develop a COS with an international reach, including high- and low-income countries.
This document could improve the quality and comparability of future clinical research studies and – consequently – clinical practice guidelines on the management of pneumonia.
To develop core outcome sets for trials evaluating the management of pneumonia
ContributorsTim Felton TF Chair, Supervisor University of Manchester
Tobias Welte TF Chair, Supervisor Hannover Medical School (MHH)
Markus Fally TF Junior Chair, Principal Investigator Copenhagen University Hospital
Stefano Aliberti Panellist University of Milan
Aleksandra Barac Panellist University of Belgrade
Francesco Blasi Panellist University of Milan
Jean Chastre Panellist Assistance Publique – Hôpitaux de Paris
Catia Cilloniz Panellist Hospital Clínic de Barcelona
George Dimopoulos Panellist National and Kapodistrian University of Athens
Eva Polverino Panellist University Hospital Vall d'Hebron Barcelona
Daiana Stolz Panellist University Hospital of Basel
Grant Waterer Panellist University of Western Australia
Wouter van Geffen Panellist Medisch Centrum Leeuwarden
Dan Wooton Panellist University of Liverpool
Claire Roger Panellist Centre Hospitalier Régional Universitaire de Nîmes
Paula Williamson Methodologist University of Liverpool
Alexander Mathioudakis Methodologist University of Manchester
All contributors are also affiliated with the European Respiratory Society (ERS).
Disease Category: Infectious disease, Lungs & airways
Disease Name: Pneumonia (community-acquired), Pneumonia (hospital-acquired), Pneumonia (ventilator-associated)
Age Range: 18
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
In preparation of this TF, we have conducted a methodological systematic review to identify outcomes measured and reported in previous randomized controlled trials evaluating the management of pneumonia (completed and due to be submitted for publication). During this TF, we will conduct qualitative interviews with 5-10 patients who have recently experienced community-acquired, hospital-acquired or ventilator-associated pneumonia (total of 15-30 patient interviews), aiming to identify which pneumonia outcomes are considered important by patients and their caregivers.
Next, an online Delphi survey will be distributed to clinicians, clinical researchers, patients, caregivers and other relevant stakeholders, aiming to prioritize the most relevant and important outcomes that should be included in the COS. For recruiting participants for the Delphi survey, we will use a similar methodology as used in previous ERS TF, that successfully recruited >1,000 participants with a global and multi-stakeholder reach. All outcomes of pneumonia that will have been identified through our methodological systematic reviews and patient interviews, will be listed in plain English in the Delphi survey. We will invite patients, clinicians, clinical researchers, policy makers, regulators and industry representatives from all continents to complete the survey, using an invitation which will be compliant with GDPR and e-privacy policies. More specifically, we will circulate the survey to ERS members with a documented interest in pneumonia, patients who have experienced pneumonia, identified by the European Lung Foundation (ELF) and – possibly – other patient organisations. Members of the TF will also reach out directly to colleagues with relevant expertise.
In line with the Core Outcome Measures in Effectiveness Trials (COMET) initiative’s methodology, participants will have to respond to two iterations of the Delphi survey, prioritizing the outcome measures. The aim of this survey will be to select the most clinically important outcomes to be included in the core outcome set. After completion of the Delphi survey, we will conduct a consensus meeting, involving representatives from all relevant stakeholder groups, and aiming to finalise the COS.