TY - JOUR
T1 - Discordant diagnostic criteria for pneumonia in COPD trials
T2 - a review
AU - Wise, Robert A.
AU - Bafadhel, Mona
AU - Crim, Courtney
AU - Criner, Gerard J.
AU - Day, Nicola C.
AU - Halpin, David M.G.
AU - Han, Mei Lan K.
AU - Lange, Peter
AU - Lipson, David A.
AU - Martinez, Fernando J.
AU - Maselli, Diego J.
AU - Midwinter, Dawn
AU - Singh, Dave
AU - Zysman, Maeva
AU - Dransfield, Mark T.
AU - Russell, Richard E.K.
N1 - Publisher Copyright:
Copyright ©The authors 2021.
PY - 2021/12/31
Y1 - 2021/12/31
N2 - Inhaled corticosteroids (ICS) have a class effect of increasing pneumonia risk in patients with COPD. However, pneumonia incidence varies widely across clinical trials of ICS use in COPD. This review clarifies methodological differences in defining and recording pneumonia events in these trials and discusses factors that could contribute to the varying pneumonia incidence. Literature searches and screening yielded 40 relevant references for inclusion. Methods used to capture pneumonia events in these studies included investigator-reported pneumonia adverse events, standardised list of signs or symptoms, radiographic confirmation of suspected cases and/or confirmation by an independent clinical end-point committee. In general, more stringent pneumonia diagnosis criteria led to lower reported pneumonia incidence rates. In addition, studies varied in design and population characteristics, including exacerbation history and lung function, factors that probably contribute to the varying pneumonia incidence. As such, cross-trial comparisons are problematic. A minimal set of standardised criteria for diagnosis and reporting of pneumonia should be used in COPD studies, as well as reporting of patients' pneumonia history at baseline, to allow comparison of pneumonia rates between trials. Currently, within-trial comparison of ICS-containing versus non-ICS-containing treatments is the appropriate method to assess the influence of ICS on pneumonia incidence.
AB - Inhaled corticosteroids (ICS) have a class effect of increasing pneumonia risk in patients with COPD. However, pneumonia incidence varies widely across clinical trials of ICS use in COPD. This review clarifies methodological differences in defining and recording pneumonia events in these trials and discusses factors that could contribute to the varying pneumonia incidence. Literature searches and screening yielded 40 relevant references for inclusion. Methods used to capture pneumonia events in these studies included investigator-reported pneumonia adverse events, standardised list of signs or symptoms, radiographic confirmation of suspected cases and/or confirmation by an independent clinical end-point committee. In general, more stringent pneumonia diagnosis criteria led to lower reported pneumonia incidence rates. In addition, studies varied in design and population characteristics, including exacerbation history and lung function, factors that probably contribute to the varying pneumonia incidence. As such, cross-trial comparisons are problematic. A minimal set of standardised criteria for diagnosis and reporting of pneumonia should be used in COPD studies, as well as reporting of patients' pneumonia history at baseline, to allow comparison of pneumonia rates between trials. Currently, within-trial comparison of ICS-containing versus non-ICS-containing treatments is the appropriate method to assess the influence of ICS on pneumonia incidence.
KW - Administration, Inhalation
KW - Adrenal Cortex Hormones/adverse effects
KW - Humans
KW - Pneumonia/diagnosis
KW - Pulmonary Disease, Chronic Obstructive/diagnosis
UR - http://www.scopus.com/inward/record.url?scp=85121993742&partnerID=8YFLogxK
U2 - 10.1183/16000617.0124-2021
DO - 10.1183/16000617.0124-2021
M3 - Review
C2 - 34789465
AN - SCOPUS:85121993742
SN - 1600-0617
VL - 30
JO - European respiratory review : an official journal of the European Respiratory Society
JF - European respiratory review : an official journal of the European Respiratory Society
IS - 162
M1 - 210124
ER -