Decoding community-acquired pneumonia: a systematic review and analysis of diagnostic criteria and definitions used in clinical trials

Markus Fally; Jan Hansel; Rebecca C Robey; Faiuna Haseeb; Ahmed Kouta; Thomas Williams; Timothy Felton; Alexander G Mathioudakis

doi:10.1016/j.cmi.2024.12.028

Decoding community-acquired pneumonia: a systematic review and analysis of diagnostic criteria and definitions used in clinical trials

Markus Fally^*, Jan Hansel, Rebecca C Robey, Faiuna Haseeb, Ahmed Kouta, Thomas Williams, Timothy Felton, Alexander G Mathioudakis

^*Corresponding author for this work

Department of Respiratory Medicine

1 Citation (Scopus)

Abstract

BACKGROUND: Community-acquired pneumonia (CAP) is a frequent and potentially life-threatening condition. Even though the disease is common, evidence on CAP management is often of variable quality. This may be reinforced by the lack of a systematic and homogeneous way of defining the disease in randomized controlled trials (RCTs).

OBJECTIVES: This study aims to assess the diagnostic criteria and definitions of the term 'community-acquired' used in RCTs on CAP management.

DATA SOURCES: On the basis of the protocol (PROSPERO 2019 CRD42019147411), we conducted a systematic search of Medline/PubMed and the Cochrane Register of Controlled Trials for RCTs published or registered between 2010 and 2024.

STUDY ELIGIBILITY CRITERIA: Study eligibility criteria included completed and ongoing RCTs.

PARTICIPANTS: Participants included adults hospitalized with CAP.

METHODS OF DATA SYNTHESIS: Data were collected using a tested extraction sheet, as endorsed by the Cochrane Collaboration. After cross-checking, data were synthesized in a narrative and tabular form.

RESULTS: In total, 7173 records were identified through our searches. After removing records that did not fulfil the eligibility criteria, 170 studies were included. Diagnostic criteria were provided in 69.4% of studies, and the term 'community-acquired' was defined in 55.3% of studies. The most frequently included diagnostic criteria were pulmonary infiltrates (94.1%), cough (78.8%), fever (77.1%), dyspnoea (62.7%), sputum (57.6%), auscultation/percussion abnormalities (55.9%), and chest pain/discomfort (52.5%). The different criteria were used in 87 different sets across the studies. The term 'community-acquired' was defined in 57 different ways.

CONCLUSIONS: The diagnostic criteria and definitions of CAP in RCTs exhibit significant heterogeneity. Standardizing these criteria in clinical trials is crucial to ensure comparability across studies.

Original language	English
Journal	Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
Volume	31
Issue number	5
Pages (from-to)	724-730
Number of pages	7
ISSN	1198-743X
DOIs	https://doi.org/10.1016/j.cmi.2024.12.028
Publication status	Published - May 2025

Keywords

Humans
Community-Acquired Infections/diagnosis
Pneumonia/diagnosis
Randomized Controlled Trials as Topic
Community-Acquired Pneumonia
Inclusion criteria
Eligibility criteria
Community-acquired pneumonia
Randomized controlled trials
CAP
Diagnostic criteria
Systematic
Clinical trial

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Fally, M., Hansel, J., Robey, R. C., Haseeb, F., Kouta, A., Williams, T., Felton, T., & Mathioudakis, A. G. (2025). Decoding community-acquired pneumonia: a systematic review and analysis of diagnostic criteria and definitions used in clinical trials. Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 31(5), 724-730. https://doi.org/10.1016/j.cmi.2024.12.028

Decoding community-acquired pneumonia: a systematic review and analysis of diagnostic criteria and definitions used in clinical trials. / Fally, Markus; Hansel, Jan; Robey, Rebecca C et al.
In: Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, Vol. 31, No. 5, 05.2025, p. 724-730.

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

Fally, M, Hansel, J, Robey, RC, Haseeb, F, Kouta, A, Williams, T, Felton, T & Mathioudakis, AG 2025, 'Decoding community-acquired pneumonia: a systematic review and analysis of diagnostic criteria and definitions used in clinical trials', Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, vol. 31, no. 5, pp. 724-730. https://doi.org/10.1016/j.cmi.2024.12.028

Fally M, Hansel J, Robey RC, Haseeb F, Kouta A, Williams T et al. Decoding community-acquired pneumonia: a systematic review and analysis of diagnostic criteria and definitions used in clinical trials. Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases. 2025 May;31(5):724-730. doi: 10.1016/j.cmi.2024.12.028

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title = "Decoding community-acquired pneumonia: a systematic review and analysis of diagnostic criteria and definitions used in clinical trials",

abstract = "BACKGROUND: Community-acquired pneumonia (CAP) is a frequent and potentially life-threatening condition. Even though the disease is common, evidence on CAP management is often of variable quality. This may be reinforced by the lack of a systematic and homogeneous way of defining the disease in randomized controlled trials (RCTs).OBJECTIVES: This study aims to assess the diagnostic criteria and definitions of the term 'community-acquired' used in RCTs on CAP management.DATA SOURCES: On the basis of the protocol (PROSPERO 2019 CRD42019147411), we conducted a systematic search of Medline/PubMed and the Cochrane Register of Controlled Trials for RCTs published or registered between 2010 and 2024.STUDY ELIGIBILITY CRITERIA: Study eligibility criteria included completed and ongoing RCTs.PARTICIPANTS: Participants included adults hospitalized with CAP.METHODS OF DATA SYNTHESIS: Data were collected using a tested extraction sheet, as endorsed by the Cochrane Collaboration. After cross-checking, data were synthesized in a narrative and tabular form.RESULTS: In total, 7173 records were identified through our searches. After removing records that did not fulfil the eligibility criteria, 170 studies were included. Diagnostic criteria were provided in 69.4\% of studies, and the term 'community-acquired' was defined in 55.3\% of studies. The most frequently included diagnostic criteria were pulmonary infiltrates (94.1\%), cough (78.8\%), fever (77.1\%), dyspnoea (62.7\%), sputum (57.6\%), auscultation/percussion abnormalities (55.9\%), and chest pain/discomfort (52.5\%). The different criteria were used in 87 different sets across the studies. The term 'community-acquired' was defined in 57 different ways.CONCLUSIONS: The diagnostic criteria and definitions of CAP in RCTs exhibit significant heterogeneity. Standardizing these criteria in clinical trials is crucial to ensure comparability across studies.",

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author = "Markus Fally and Jan Hansel and Robey, \{Rebecca C\} and Faiuna Haseeb and Ahmed Kouta and Thomas Williams and Timothy Felton and Mathioudakis, \{Alexander G\}",

year = "2025",

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T1 - Decoding community-acquired pneumonia

T2 - a systematic review and analysis of diagnostic criteria and definitions used in clinical trials

AU - Fally, Markus

AU - Hansel, Jan

AU - Robey, Rebecca C

AU - Haseeb, Faiuna

AU - Kouta, Ahmed

AU - Williams, Thomas

AU - Felton, Timothy

AU - Mathioudakis, Alexander G

PY - 2025/5

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N2 - BACKGROUND: Community-acquired pneumonia (CAP) is a frequent and potentially life-threatening condition. Even though the disease is common, evidence on CAP management is often of variable quality. This may be reinforced by the lack of a systematic and homogeneous way of defining the disease in randomized controlled trials (RCTs).OBJECTIVES: This study aims to assess the diagnostic criteria and definitions of the term 'community-acquired' used in RCTs on CAP management.DATA SOURCES: On the basis of the protocol (PROSPERO 2019 CRD42019147411), we conducted a systematic search of Medline/PubMed and the Cochrane Register of Controlled Trials for RCTs published or registered between 2010 and 2024.STUDY ELIGIBILITY CRITERIA: Study eligibility criteria included completed and ongoing RCTs.PARTICIPANTS: Participants included adults hospitalized with CAP.METHODS OF DATA SYNTHESIS: Data were collected using a tested extraction sheet, as endorsed by the Cochrane Collaboration. After cross-checking, data were synthesized in a narrative and tabular form.RESULTS: In total, 7173 records were identified through our searches. After removing records that did not fulfil the eligibility criteria, 170 studies were included. Diagnostic criteria were provided in 69.4% of studies, and the term 'community-acquired' was defined in 55.3% of studies. The most frequently included diagnostic criteria were pulmonary infiltrates (94.1%), cough (78.8%), fever (77.1%), dyspnoea (62.7%), sputum (57.6%), auscultation/percussion abnormalities (55.9%), and chest pain/discomfort (52.5%). The different criteria were used in 87 different sets across the studies. The term 'community-acquired' was defined in 57 different ways.CONCLUSIONS: The diagnostic criteria and definitions of CAP in RCTs exhibit significant heterogeneity. Standardizing these criteria in clinical trials is crucial to ensure comparability across studies.

AB - BACKGROUND: Community-acquired pneumonia (CAP) is a frequent and potentially life-threatening condition. Even though the disease is common, evidence on CAP management is often of variable quality. This may be reinforced by the lack of a systematic and homogeneous way of defining the disease in randomized controlled trials (RCTs).OBJECTIVES: This study aims to assess the diagnostic criteria and definitions of the term 'community-acquired' used in RCTs on CAP management.DATA SOURCES: On the basis of the protocol (PROSPERO 2019 CRD42019147411), we conducted a systematic search of Medline/PubMed and the Cochrane Register of Controlled Trials for RCTs published or registered between 2010 and 2024.STUDY ELIGIBILITY CRITERIA: Study eligibility criteria included completed and ongoing RCTs.PARTICIPANTS: Participants included adults hospitalized with CAP.METHODS OF DATA SYNTHESIS: Data were collected using a tested extraction sheet, as endorsed by the Cochrane Collaboration. After cross-checking, data were synthesized in a narrative and tabular form.RESULTS: In total, 7173 records were identified through our searches. After removing records that did not fulfil the eligibility criteria, 170 studies were included. Diagnostic criteria were provided in 69.4% of studies, and the term 'community-acquired' was defined in 55.3% of studies. The most frequently included diagnostic criteria were pulmonary infiltrates (94.1%), cough (78.8%), fever (77.1%), dyspnoea (62.7%), sputum (57.6%), auscultation/percussion abnormalities (55.9%), and chest pain/discomfort (52.5%). The different criteria were used in 87 different sets across the studies. The term 'community-acquired' was defined in 57 different ways.CONCLUSIONS: The diagnostic criteria and definitions of CAP in RCTs exhibit significant heterogeneity. Standardizing these criteria in clinical trials is crucial to ensure comparability across studies.

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KW - Community-Acquired Infections/diagnosis

KW - Pneumonia/diagnosis

KW - Randomized Controlled Trials as Topic

KW - Community-Acquired Pneumonia

KW - Inclusion criteria

KW - Eligibility criteria

KW - Community-acquired pneumonia

KW - Randomized controlled trials

KW - CAP

KW - Diagnostic criteria

KW - Systematic

KW - Clinical trial

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U2 - 10.1016/j.cmi.2024.12.028

DO - 10.1016/j.cmi.2024.12.028

M3 - Review

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SN - 1198-743X

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JO - Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases

JF - Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases

IS - 5

ER -

Decoding community-acquired pneumonia: a systematic review and analysis of diagnostic criteria and definitions used in clinical trials

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