Mathioudakis, AG 
ORCID: 0000-0002-4675-9616, Fally, M ORCID: 0000-0002-1339-2918, Hansel, J, Robey, RC ORCID: 0000-0001-8862-4923, Haseeb, F, Williams, T, Kouta, A ORCID: 0000-0003-1027-2213, Welte, T ORCID: 0000-0002-9947-7356, Wootton, DG ORCID: 0000-0002-5903-3881, Clarke, M ORCID: 0000-0002-2926-7257 et al (show 17 more authors)
(2023)
Clinical trials of pneumonia management assess heterogeneous outcomes and measurement instruments
Journal of Clinical Epidemiology, 164.
pp. 88-95.
ISSN 0895-4356, 1878-5921
Abstract
Objectives: To inform clinical practice guidelines, randomized controlled trials (RCTs) of the management of pneumonia need to address the outcomes that are most important to patients and health professionals using consistent instruments, to enable results to be compared, contrasted, and combined as appropriate. This systematic review describes the outcomes reported in clinical trials of pneumonia management and the instruments used to measure these outcomes. Study Design and Setting: Based on a prospective protocol, we searched MEDLINE/PubMed, Cochrane CENTRAL and clinical trial registries for ongoing or completed clinical trials evaluating pneumonia management in adults in any clinical setting. We grouped reported outcomes thematically and classified them following the COMET Initiative's taxonomy. We describe instruments used for assessing each outcome. Results: We found 280 eligible RCTs of which 115 (41.1%) enrolled critically ill patients and 165 (58.9%) predominantly noncritically ill patients. We identified 43 distinct outcomes and 108 measurement instruments, excluding nonvalidated scores and questionnaires. Almost all trials reported clinical/physiological outcomes (97.5%). Safety (63.2%), mortality (56.4%), resource use (48.6%) and life impact (11.8%) outcomes were less frequently addressed. The most frequently reported outcomes were treatment success (60.7%), mortality (56.4%) and adverse events (41.1%). There was significant variation in the selection of measurement instruments, with approximately two-thirds used in less than 10 of the 280 RCTs. None of the patient-reported outcomes were used in 10 or more RCTs. Conclusion: This review reveals significant variation in outcomes and measurement instruments reported in clinical trials of pneumonia management. Outcomes that are important to patients and health professionals are often omitted. Our findings support the need for a rigorous core outcome set, such as that being developed by the European Respiratory Society.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Pneumonia Outcomes Group, Humans, Pneumonia, Treatment Outcome, Adult, Clinical Trials as Topic |
| Divisions: | Faculty of Health & Life Sciences Faculty of Health & Life Sciences > Inst. Infection, Vet & Ecological Sciences Faculty of Health & Life Sciences > Inst. Population Health |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 10 Jun 2024 10:58 |
| Last Modified: | 24 Jan 2026 04:38 |
| DOI: | 10.1016/j.jclinepi.2023.10.011 |
| Open Access URL: | https://doi.org/10.1016/j.jclinepi.2023.10.011 |
| Related Websites: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3182134 |
| Disclaimer: | The University of Liverpool is not responsible for content contained on other websites from links within repository metadata. Please contact us if you notice anything that appears incorrect or inappropriate. |
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