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. 2016 May 1;2016(5):CD012179. doi: 10.1002/14651858.CD012179

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
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
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%
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
Flow and timing Time interval between index test and reference standard: blood samples were collected on the day of surgery
Withdrawals: none
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
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