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

Y1 - 2021

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.

U2 - 10.1183/16000617.0124-2021

DO - 10.1183/16000617.0124-2021

M3 - Review

C2 - 34789465

AN - SCOPUS:85121993742

VL - 30

JO - European Respiratory Review

JF - European Respiratory Review

SN - 0905-9180

IS - 162

M1 - 210124

ER -