Lin 2005.
Study characteristics | |||
Patient sampling |
Primary objective: to investigate the role of interleukin‐16 (IL‐16) in the pathogenesis of endometriosis Participants: women with suspected endometriosis who underwent laparoscopy Selection criteria: exclusion criteria: autoimmune diseases, no steroid treatment or immunosuppressant treatment 6 months prior to surgery Study design: cross‐sectional, single‐gate design, prospective collection of samples |
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Patient characteristics and setting |
Clinical presentation: not specified Age: mean age 37 ± 10.3 years (endometriosis group), 36.8 ± 12.1 years (controls) Number of participants enrolled: 44 participants Number of participants available for analysis: 44 participants (cycle phase not reported) Setting: Department of O&G, College of Medicine, Zhejiang University Place of study: Hangzhou, China Period of study: September 2001 ‐ June 2002 Language: Chinese |
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Index tests |
Index test: IL‐16 Details of the index test procedure as stated: serum IL‐16 was measured with enzyme‐linked immunosorbent assay (ELISA) (human IL‐16 BMS 248, Bender Medsystems, Vienna, Austria); no working ranges were reported; sample handling described Threshold for positive result: not provided Examiners: no information provided; unclear if blinded to the result of reference standard Interobserver variability: CV < 10% |
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Target condition and reference standard(s) |
Target condition: endometriosis Prevalence of target condition in the sample: n = 22/44 (50%): stage I‐II 8, stage III‐IV 14; controls n = 22 Reference standard: laparoscopy/laparotomy N = 44 (100%) + histology Description of positive case definition by reference standard test as reported: visual inspection confirmed by histopathology; staging according to the rASRM classification Examiners: no information provided |
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Flow and timing |
Time interval between index test and reference standard: blood samples were collected on the day of surgery Withdrawals: none |
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Comparative | |||
Key conclusions by the authors | Reduced levels of IL‐16 in peritoneal fluid and serum of women with advanced stage endometriosis may imply a role of IL‐16 in the development and progression of endometriosis. | ||
Conflict of interest | Not reported | ||
Notes | The data for markers measured in peritoneal fluid are not reported in this review For IL‐16 there was no statistically significant difference between the groups ‐ no data available for meta‐analysis |
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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 cycle phase considered in interpretation of the result of 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 |