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 |
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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 |
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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 |
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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 |
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Flow and timing | Time interval between index test and reference standard: endometrial samples were collected at surgery Withdrawals: none reported |
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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 |