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. 2016 Apr 20;2016(4):CD012165. doi: 10.1002/14651858.CD012165

Van der Linden 1995.

Study characteristics
Patient sampling Primary objective: to examine the immunohistochemical properties of epithelial cells in peritoneal fluid and to compare the staining characteristics with cells of endometrium, menstrual effluent, peritoneum, and endometriotic lesions
Participants: women who underwent a diagnostic laparoscopy as part of a subfertility work‐up
Selection criteria: inclusion criteria: regular ovulatory cycles
Study design: observational single‐gate, prospective sample collection
Patient characteristics and setting Clinical presentation: infertility
Age: reproductive age, not specified
Number enrolled: 16 women
Number available for analysis: 16 women (all in early proliferative cycle phase)
Setting: tertiary care university medical centre ‐ the University of Limburg
Place of study: Maastricht, the Netherlands
Period of study: not reported
Language: English
Index tests Index test: vimentin, cytokeratin 18, cytokeratin 19 and endometrial epithelial marker BW 495/36 in menstrual fluid and endometrium
Description of positive case definition by index test as reported: positive IHC staining; laboratory technique described
Examiners: none stated; unclear if blinded to the result of reference standard
Interobserver variability: not reported
Target condition and reference standard(s) Target condition: endometriosis
Prevalence of target condition in the sample: n/N = 8/16 (50%): all stage I; controls 8
Reference standard: laparoscopy + histology
Description of positive case definition by reference test as reported: visual inspection confirmed by histopathology, staging according to rAFS
Examiners: none stated
Flow and timing Time interval between index test and reference standard: samples were collected at surgery
Withdrawals: none reported
Comparative  
Notes Conclusion: These results support the contention of transport of menstrual detritus to the peritoneal cavity in women with patent fallopian tubes.
Comment:
For vimentin, cytokeratin 18, cytokeratin 19 and endometrial epithelial marker BW 495/36, there was no statistically significant difference between the groups ‐ no data available for meta‐analysis (Appendix 7)
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? No    
Did the study avoid inappropriate exclusions? Unclear    
Was a 'two‐gate' design avoided? No    
    High High
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard? Unclear    
If a threshold was used, was it pre‐specified? Yes    
Was a menstrual cycle phase considered in interpreting the index test Yes    
    Unclear Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? Yes    
    Low 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