Discordant diagnostic criteria for pneumonia in COPD trials: a review

Robert A. Wise; Mona Bafadhel; Courtney Crim; Gerard J. Criner; Nicola C. Day; David M.G. Halpin; Meilan K. Han; Peter Lange; David A. Lipson; Fernando J. Martinez; Diego J. Maselli; Dawn Midwinter; Dave Singh; Maeva Zysman; Mark T. Dransfield; Richard E.K. Russell

doi:10.1183/16000617.0124-2021

Discordant diagnostic criteria for pneumonia in COPD trials: a review

Robert A. Wise, Mona Bafadhel, Courtney Crim, Gerard J. Criner, Nicola C. Day, David M.G. Halpin, Meilan K. Han, Peter Lange, David A. Lipson, Fernando J. Martinez, Diego J. Maselli, Dawn Midwinter, Dave Singh, Maeva Zysman, Mark T. Dransfield, Richard E.K. Russell^*

^*Corresponding author for this work

Peter Gorer Department of Immunobiology

Research output: Contribution to journal › Review article › peer-review

9 Citations (Scopus)

Abstract

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.

Original language	English
Article number	210124
Journal	European Respiratory Review
Volume	30
Issue number	162
DOIs	https://doi.org/10.1183/16000617.0124-2021
Publication status	Published - 31 Dec 2021

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10.1183/16000617.0124-2021

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Wise, R. A., Bafadhel, M., Crim, C., Criner, G. J., Day, N. C., Halpin, D. M. G., Han, M. K., Lange, P., Lipson, D. A., Martinez, F. J., Maselli, D. J., Midwinter, D., Singh, D., Zysman, M., Dransfield, M. T., & Russell, R. E. K. (2021). Discordant diagnostic criteria for pneumonia in COPD trials: a review. European Respiratory Review, 30(162), Article 210124. https://doi.org/10.1183/16000617.0124-2021

@article{31ece9a269614df3bcd64354f3ab9a0f,

title = "Discordant diagnostic criteria for pneumonia in COPD trials: a review",

abstract = "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{\textquoteright} 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.",

author = "Wise, {Robert A.} and Mona Bafadhel and Courtney Crim and Criner, {Gerard J.} and Day, {Nicola C.} and Halpin, {David M.G.} and Han, {Meilan K.} and Peter Lange and Lipson, {David A.} and Martinez, {Fernando J.} and Maselli, {Diego J.} and Dawn Midwinter and Dave Singh and Maeva Zysman and Dransfield, {Mark T.} and Russell, {Richard E.K.}",

note = "Funding Information: Acknowledgements: Editorial support in the form of collating search results, writing assistance, assembling figures, collating author comments, grammatical editing and referencing was provided by Anne Errichelli, Fishawack Indicia Ltd, UK, part of Fishawack Health, and was funded by GlaxoSmithKline (GSK). Dave Singh is supported by the National Institute for Health Research Manchester Biomedical Research Centre. Publisher Copyright: {\textcopyright} The authors 2021.",

year = "2021",

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doi = "10.1183/16000617.0124-2021",

language = "English",

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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, Meilan 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 - Funding Information: Acknowledgements: Editorial support in the form of collating search results, writing assistance, assembling figures, collating author comments, grammatical editing and referencing was provided by Anne Errichelli, Fishawack Indicia Ltd, UK, part of Fishawack Health, and was funded by GlaxoSmithKline (GSK). Dave Singh is supported by the National Institute for Health Research Manchester Biomedical Research Centre. Publisher 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.

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 article

C2 - 34789465

AN - SCOPUS:85121993742

SN - 0905-9180

VL - 30

JO - European Respiratory Review

JF - European Respiratory Review

IS - 162

M1 - 210124

ER -

Discordant diagnostic criteria for pneumonia in COPD trials: a review

Abstract

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