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. 2015 Mar 11;2015(3):CD009579. doi: 10.1002/14651858.CD009579.pub2

Shane2011_Colley2013.

Study characteristics
Patient sampling Cross‐sectional design; consecutive sampling
Patient characteristics and setting Species: S. mansoni
Country: Kenya
Sample size: 1845 (updated from Colley 2013)
Age range: 1 to 15 years
Participants: children from a village in Western Kenya
Setting: field study
Praziquantel status before study: reported that there had been no treatment in the area
Index tests CCA POC cassette (Rapid Medical Diagnostics, Pretoria, South Africa)
Target condition and reference standard(s) S. mansoni infection measured by stool microscopy (Kato‐Katz smears)
Flow and timing  
Comparative  
Notes This article was part of a multi‐centre study (Colley 2013). In this article, 2‐by‐2 tables of the CCA POC measured against the first daily stool specimen (duplicate KK smears on 1 stool sample) were presented
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
    Unclear Low
DOMAIN 2: Index Test CCA POC
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
If a threshold was used, was it pre‐specified? Yes    
Was quality control done? Yes    
    Low Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? No    
Were the reference standard results interpreted without knowledge of the results of the index tests? Yes    
Was quality control done? Yes    
    High Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
    Low