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

Hatok 2011.

Study characteristics
Patient sampling Primary objective: to prospectively evaluate whether detection of CYP19 mRNA in eutopic endometrium could be used as specific screening tool for endometriosis as well as reflect its severity
Participants: women with regular menstrual period undergoing laparoscopic surgery for pelvic pain
Selection criteria: exclusion criteria: irregular menstrual cycle, secretory phase, menopause, history of hormonal treatment before surgery, previous abdominal surgery, pregnancy, history of IVF prior to laparoscopy
Study design: observational single‐gate, prospective recruitment and sample collection
Patient characteristics and setting Clinical presentation: pelvic pain
Age: mean age 43.02 ± 6.8 years (range 25‐55)
Number enrolled: 105 women
Number available for analysis: 101 women (all in early proliferative phase)
Setting: University hospital ‐ Jessenius Faculty of Medicine, Comenius University
Place of study: Bratislava, Slovak Republic
Period of study: not provided
Language: English
Index tests Index test: Aromatase P450 (CYP19) mRNA expression
Description of positive case definition by index test as reported: "[i]ncreased aromatase mRNA expression" ‐ not specified (detection by RT‐PCR; analysis by gel electrophoresis with GeneTools software; quantified by relative quantification: expression of target relative to housekeeping gene (β‐actin); laboratory technique described; diagnostic threshold not provided
Examiners: no information provided
Interobserver variability: not provided
Target condition and reference standard(s) Target condition: endometriosis
Prevalence of target condition in the sample: n/N = 30/101 (30%): stage I‐II 15, stage III‐IV 15; adenomyosis ‐ 25, healthy controls ‐ 46, total non‐endometriosis controls 71
Reference standard: laparoscopy + histology
Description of positive case definition by reference test as reported: surgical inspection confirmed by histological examination; rAFS classification
Examiners: no information provided
Flow and timing Time interval between index test and reference standard: tissue samples were obtained at surgery
Withdrawals: 4 participants were excluded for low sample quality
Comparative  
Notes Conclusion: Significantly increased level of CYP19 mRNA was detected in patients, and this expression was significantly dependent on disease severity. These findings provide direct evidence that screening for endometrial aromatase could be beneficial in the prediction of oestrogen dependent disease.
Comment:
For the purpose of this review diagnostic estimates were calculated for endometriosis versus non‐endometriosis (controls included women with adenomyosis)
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear    
Did the study avoid inappropriate exclusions? Yes    
Was a 'two‐gate' design avoided? Yes    
    Unclear Low
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 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