Gurgan 1990.
Study characteristics | |||
Patient sampling |
Primary objective: to evaluate possible value of peritoneal fluid CA‐125 levels as a more sensitive marker of minimal (stage I) endometriosis when compared to serum levels measured simultaneously Participants: women undergoing laparoscopy as part of infertility work‐up or tubal sterilisation Selection criteria: exclusion criteria: patients with more advanced endometriosis (> stage I) or other pathological findings Study design: cross‐sectional study of two‐gate design, prospective recruitment |
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Patient characteristics and setting |
Clinical presentation: not specified Age: mean age 30.1 ± 2.6 years (endometriosis), 27.9 ± 2.6 years (controls) Number of participants enrolled: 38 women Number of participants available for analysis: 38 women (all in mid‐secretory phase of menstrual cycle) Setting: Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Hacettepe Place of study: Sihiye‐Ankara, Turkey Period of study: October 1988 ‐ June 1989 Language: English |
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Index tests |
Index test: CA‐125 Details of the index test procedure as stated: CA‐125 in serum and PF was measured in duplicates using an immunoradiometric assay assay (ELISA CA‐125, Compagnie ORIS Industrie, France); assay sensitivity 2.4 U/ml; sample handling and laboratory procedure described Threshold for positive result: > 16 U/ml, not pre‐specified Examiners: no information provided; unclear if were blinded to the result of reference standard Interobserver variability: Inter‐ and intra‐assay CV 5.7%‐8.1% and 2%‐10% |
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Target condition and reference standard(s) |
Target condition: endometriosis Prevalence of target condition in the sample: n = 17/38 (45%) all stage I; controls n = 21 Reference standard: laparoscopy N = 38 (100%) Description of positive case definition by reference standard test as reported: classification according to the ASRM classification Examiners: no information provided |
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Flow and timing |
Time interval between index test and reference standard: blood samples were collected immediately surgery Withdrawals: none |
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Comparative | |||
Key conclusions by the authors | CA‐125 levels have been found to be mildly, but not significantly elevated in sera of patients with minimal endometriosis; laparoscopic evaluation remains the most reliable method of diagnosis of minimal endometriosis | ||
Conflict of interest | Not reported | ||
Notes | The data for markers measured in peritoneal fluid are not presented in this review | ||
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? | No | ||
High | High | ||
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 cycle phase considered in interpretation of the result of 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 |