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

Borkowski 2008.

Study characteristics
Patient sampling Primary objective: to evaluate total serum and peritoneal concentrations of vitamin D‐binding protein in women with endometriosis, known as an inflammation‐associated disease
Participants: women undergoing surgical visualisation because of pain, infertility or both
Selection criteria: inclusion criteria: pre‐menopausal age, regular cycle (25‐32 days)
Study design: cross‐sectional, single‐gate design, prospective collection of samples
Patient characteristics and setting Clinical presentation: pelvic pain, infertility or both
Age: range 21‐50 years
Number of participants enrolled: 43 women
Number of participants available for analysis: 43 women (all in follicular phase of the menstrual cycle)
Setting: Department of O&G, Wrocław Medical University; Laboratory of Reproductive Immunology, Institute of Immunology and Experimental Therapy, Polish Academy of Sciences
Place of study: Wrocław, Poland
Period of study: not stated
Language: English
Index tests Index test: vitamin D‐binding protein
Details of the index test procedure as stated: serum vitamin D‐binding protein was measured by using ELISA (using goat polyclonal antibody against human Gc globulin; absorbance at 490 nm was read by using a Bio‐Tek 340 EL spectrophotometer; data analysed with KC3 software (Bio‐Tek Instruments; Winooski, USA); concentration were calculated by interpolation from a six‐point logarithmic standard curve); sample processing and experiments described
Threshold for positive result: not provided
Examiners: no information provided; unclear if blinded to the result of reference standard
Interobserver variability: intra‐ and interassay CV < 10% and < 15%
Target condition and reference standard(s) Target condition: endometriosis
Prevalence of target condition in the sample: n = 26/43 (61%): stage I‐II 11, stage III‐IV 15; controls n = 17
Reference standard: laparoscopy N = 43 (100%) + histology
Description of positive case definition by reference standard 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: venous blood was collected before the induction of anaesthesia
Withdrawals: none
Comparative  
Key conclusions by the authors Serum and peritoneal DBP concentrations are not affected in women with endometriosis; however, based on the latest published data, it is possible that both the serum and peritoneal concentrations of vitamin D‐binding protein may be dependent on Gc genotype, which results in differential modulation of monocyte/macrophage activity
Conflict of interest Not reported; supported by grant No. 3P05E 077 24 from the Polish Ministry for Scientific Research and Information Technology
Notes For vitamin D‐binding protein 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? Yes    
    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