TY - JOUR
T1 - Clinical trials of pneumonia management assess heterogeneous outcomes and measurement instruments
AU - Mathioudakis, Alexander G
AU - Fally, Markus
AU - Hansel, Jan
AU - Robey, Rebecca C
AU - Haseeb, Faiuna
AU - Williams, Thomas
AU - Kouta, Ahmed
AU - Welte, Tobias
AU - Wootton, Dan G
AU - Clarke, Mike
AU - Waterer, Grant
AU - Dark, Paul
AU - Williamson, Paula R
AU - Vestbo, Jørgen
AU - Felton, Timothy W
AU - Pneumonia Outcomes Group
PY - 2023/10/27
Y1 - 2023/10/27
N2 - To inform clinical practice guidelines, randomised 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. 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. We found 280 eligible RCTs of which 115 (41.1%) enrolled critically ill patients and 165 (58.9%) predominantly non-critically ill patients. We identified 43 distinct outcomes and 108 measurement instruments, excluding non-validated 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.
AB - To inform clinical practice guidelines, randomised 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. 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. We found 280 eligible RCTs of which 115 (41.1%) enrolled critically ill patients and 165 (58.9%) predominantly non-critically ill patients. We identified 43 distinct outcomes and 108 measurement instruments, excluding non-validated 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.
KW - Pneumonia
KW - outcomes
KW - clinical trials
KW - hospital-acquired pneumonia
KW - ventilator-associated pneumonia
KW - endpoints
KW - systematic reviews
KW - evidence-based medicine
KW - core outcome set
KW - Community-acquired pneumonia
U2 - 10.1016/j.jclinepi.2023.10.011
DO - 10.1016/j.jclinepi.2023.10.011
M3 - Article
C2 - 37898460
SN - 0895-4356
VL - 164
SP - 88
EP - 95
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -