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

Kim 2007.

Study characteristics
Patient sampling Primary objective: to evaluate the replication potential of the endometrium in patients with endometriosis by examining hTERT mRNA expression and telomerase activity.
Participants: women undergoing laparotomy or operative laparoscopy at the authors institution
Selection criteria: exclusion criteria: postmenopausal women, previous hormone or GnRH agonist users, and patients with adenomyosis or endometrial cancer/hyperplasia/polyps
Study design: observational, unclear if single‐ or two‐gate, prospective sample collection
Patient characteristics and setting Clinical presentation: not specified
Age: mean age 32.7 ± 6.8 years, endometriosis; 34.6 ± 6.7 years, controls
Number enrolled: 60 women
Number available for analysis: 60 women (26 in proliferative and 34 in secretory cycle phase)
Setting: University hospital ‐ Yongdong Severance Hospital, Yonsei University College of Medicine
Place of study: Seoul, South Korea
Period of study: September 2005 to March 2006
Language: English
Index tests Index test: hTERT mRNA, telomerase activity
Description of positive case definition by index test as reported: hTERT mRNA expression level as measured by RT–PCR (TaqMan methodology, normalised to the endogenous control GAPDH and compared to the calibrator as per 2‐ΔΔCt method); telomerase ‐ relative telomerase activity (RTA), defined as the activity equivalent to that in 100 molecules of TSR (determined by the telomerase repeat amplification protocol assay, referenced to primary source (Kim et al.,1994); laboratory techniques described; no thresholds provided
Examiners: no information provided
Interobserver variability: no information provided
Target condition and reference standard(s) Target condition: endometriosis
Prevalence of target condition in the sample: n/N = 30/60 (50%): stage I‐II 8, stage III‐IV 22; controls 30
Reference standard: laparoscopy/laparotomy
Description of positive case definition by reference test as reported: disease stages established by rASRM
Examiners: no information provided
Flow and timing Time interval between index test and reference standard: biopsies were performed at surgery
Withdrawals: none reported
Comparative  
Notes Conclusion: The demonstrated overexpression of hTERT mRNA and telomerase activity in the endometrium of endometriosis patients suggests that replication potential of endometrial cells may have an important role in the pathogenesis of endometriosis.
Comments:
For hTERT there was a statistically significant difference between the groups, but there were insufficient data to construct 2 × 2 tables; not included in this review
For telomerase activity 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? Yes    
Was a 'two‐gate' design avoided? Unclear    
    High Unclear
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard? No    
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? Unclear    
Were the reference standard results interpreted without knowledge of the results of the index tests? Yes    
    Unclear 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