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

Visnovsky 2008.

Study characteristics
Patient sampling Primary objective: to determine clinical benefits of mRNA aromatase expression in entopic endometrium as a diagnostic marker of endometriosis
Participants: women undergoing laparoscopy or laparotomy for pelvic pain, infertility of benign pelvic tumours
Selection criteria: inclusion criteria: confirmed benign pelvic condition by pre‐operative ultrasound
Study design: observational single‐gate, prospective sample collection
Patient characteristics and setting Clinical presentation: endometriosis: pelvic pain, infertility, pelvic mass
Age: mean age 39.7; SD and range not reported
Number enrolled: 23 women
Number available for analysis: 23 women (menstrual cycle phase not specified)
Setting: university hospital ‐ O&G Department Jessenius Medical Faculty and Martin University Hospital
Place of study: Martin, Czech Republic
Period of study: May 2006 to August 2007
Language: English
Index tests Index test: aromatase mRNA
Description of positive case definition by index test as reported: mRNA expression by RT‐PCR, semi‐quantitative expression scored 0‐3: 0 ‐ no expression; 1 ‐ low; 2 ‐ medium; 3 ‐ high expression; technique not described; threshold ‐ low expression (score 1 and above, not pre‐specified)
Examiners: not reported; unclear if were blinded to the results 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 = 12/23 (52%); stage not specified; controls 11
Reference standard: laparoscopy n = 17/laparotomy n = 6 + histology
Description of positive case definition by reference test as reported: visual inspection confirmed by histology, rAFS staging
Examiners: none stated
Flow and timing Time interval between index test and reference standard: endometrial samples were collected at surgery
Withdrawals: none reported
Comparative  
Notes Conclusion: Aromatase expression in eutopic endometrium is a good diagnostic marker 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? Unclear    
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? Unclear    
If a threshold was used, was it pre‐specified? No    
Was a menstrual cycle phase considered in interpreting the index test No    
    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