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. 2012 Oct 17;2012(10):CD009175. doi: 10.1002/14651858.CD009175.pub2

Kumar 2011.

Clinical features and settings Hospital setting (Lok Nayak Hospital, India)
Clinical features for study inclusion: cough and fever with breathlessness of less than 30 days duration, increased respiratory rate on examination, signs of consolidation or bronchopneumonia with or without wheeze on auscultation, radiological findings suggestive of consolidation, bronchopneumonia or interstitial infiltrates with or without hyperinflation
Participants Children aged 2 months to 12 years admitted to hospital with lower respiratory tract infections
Number of participants: 200
Male participants: 127 (63.5%)
Number of participants with M. pneumoniae: 71 (35.5%)
Study design Prospective observational cohort study
Target condition and reference standard(s) M. pneumoniae detected using:
  1. serological testing of acute and convalescent blood samples (ELISA for IgM and IgG antibodies to M. pneumoniae). Serological evidence of M. pneumoniae infection was defined as presence of M. pneumoniae‐specific IgM or IgG or fourfold rise in IgG titre between acute and convalescent sera

  2. PCR analysis of nasopharyngeal aspirates


Presence of M. pneumoniae infection was defined as M. pneumoniae detected using either or both laboratory methods
Index and comparator tests Symptoms: cough, coryza, afebrile
Signs: wheeze audible on auscultation
Follow‐up Duration of follow‐up not reported
Notes  
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Unclear Co‐morbidities in study population were not reported. Did not state whether or not children with co‐morbidities were excluded
Acceptable reference standard? 
 All tests Yes Children with positive PCR results but negative serology results were still diagnosed with M. pneumoniae. However, there was good agreement between PCR and serology results; 20 children had positive PCR results of whom only 3 did not also have serological evidence of M. pneumoniae infection
Acceptable delay between tests? 
 All tests Unclear Timing of nasopharyngeal aspirate and acute blood sample collection in relation to recording of clinical features was not reported
Partial verification avoided? 
 All tests Yes All study participants were subjected to the same laboratory tests
Differential verification avoided? 
 All tests Yes All study participants were subjected to the same laboratory tests
Incorporation avoided? 
 All tests Yes The diagnosis of M. pneumoniae was based on laboratory test results only
Reference standard results blinded? 
 All tests Yes Clinical symptoms and signs were recorded during the acute community‐acquired pneumonia illness episode, when the results of convalescent serum samples would not have been available
Index test results blinded? 
 All tests Unclear Laboratory criteria/thresholds for serological diagnosis of M. pneumoniae detection were not reported
Relevant clinical information? 
 All tests Unclear Baseline data on participant age and sex were collected. However, unclear whether data on duration of illness were collected at the time of study entry
Uninterpretable results reported? 
 All tests Yes Three children had positive PCR results without serological evidence of M. pneumoniae infection
Withdrawals explained? 
 All tests Yes Data reported for all 200 participants; no withdrawals reported