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

Maheshwari 2011.

Clinical features and settings Hospital setting (Maulana Azad Medical College, India)
Clinical features for study inclusion: presence of cough and fever with breathlessness of less than 30 days duration, tachypnoea and presence of radiological features of lower respiratory tract infections
Participants Children aged 6 months to 12 years with clinically suspected lower respiratory tract infections
Number of participants: 75
Male participants: 42, (56.0%)
Number of participants with M. pneumoniae: 23, (30.7%)
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)

  2. PCR analysis of throat swabs


Presence of M. pneumoniae infection was defined as M. pneumoniae detected using either or both laboratory methods
Index and comparator tests Symptoms: rhinorrhoea, wheezing, dry cough
Signs: rales, rhonchi
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; 5 children had positive PCR results of whom only 1 did not also have serological evidence of M. pneumoniae infection
Acceptable delay between tests? 
 All tests Unclear Timing of throat swab and acute blood sample collection in relation to recording of clinical features was not reported
Partial verification avoided? 
 All tests Yes Tried to obtain convalescent blood samples from all 75 children, but only managed to obtain samples in 45 children
Differential verification avoided? 
 All tests Yes Tried to obtain convalescent blood samples from all 75 children, but only managed to obtain samples in 45 children
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 Yes A detailed history and clinical examination were performed for all participants
Uninterpretable results reported? 
 All tests Yes One child had a positive PCR result without serological evidence of M. pneumoniae infection
Withdrawals explained? 
 All tests Yes Data were presented for all 75 participants. Reported that only managed to obtain convalescent serum samples from 45/75 participants