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

Szymanowski 2003.

Study characteristics
Patient sampling Primary objective: to describe the expression of α3β1, α4β1 and β1 integrin chain in endometrial biopsy in women suffering from endometriosis
Participants: women with infertility, pelvic pain or both undergoing laparoscopy and hysteroscopy
Selection criteria: inclusion criteria: regular cycles, no hormonal treatment at least 1/12 month prior surgery; exclusion criteria: pregnancy, non‐peritoneal endometriosis
Study design: observational single‐gate, prospective sample collection
Patient characteristics and setting Clinical presentation: infertility ‐ 23/32, pelvic pain ‐ 11/32
Age: mean age 29.2 ± 4.19 years
Number enrolled: 32 women
Number available for analysis: 32 women (all in secretory phase)
Setting: university hospital ‐ Division of Reproduction, K. Marcinkowski University of Medical Sciences
Place of study: Poznan, Poland
Period of study: January 1998 to June 2000
Language: English
Index tests Index test: α3β1, α4β1 and β1 Integrin chain
Description of positive case definition by index test as reported: Positive IHC staining (staining intensity was defined as weak +, moderate ++, strong +++; not defined in glandular and stromal cells); threshold not pre‐specified
Examiners: blinded observer
Interobserver variability: not provided
Target condition and reference standard(s) Target condition: peritoneal endometriosis
Prevalence of target condition in the sample: n/N = 17/32 (53%): stage not specified; controls 15
Reference standard: laparoscopy + histology
Description of positive case definition by reference test as reported: direct visualisation of endometrial foci with histological confirmation; rAFS classification
Examiners: not stated
Flow and timing Time interval between reference test and index test: tissue sample was obtained at surgery
Withdrawals: none reported
Comparative  
Notes Conclusion: The selected integrins do not yet allow identification of a pattern characteristic for endometriosis.
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? Yes    
Was a 'two‐gate' design avoided? Yes    
    High Unclear
DOMAIN 2: Index Test All tests
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? No    
Was a menstrual cycle phase considered in interpreting the index test Yes    
    High 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