Van der Linden 1995.
Study characteristics | |||
Patient sampling | Primary objective: to examine the immunohistochemical properties of epithelial cells in peritoneal fluid and to compare the staining characteristics with cells of endometrium, menstrual effluent, peritoneum, and endometriotic lesions Participants: women who underwent a diagnostic laparoscopy as part of a subfertility work‐up Selection criteria: inclusion criteria: regular ovulatory cycles Study design: observational single‐gate, prospective sample collection |
||
Patient characteristics and setting | Clinical presentation: infertility Age: reproductive age, not specified Number enrolled: 16 women Number available for analysis: 16 women (all in early proliferative cycle phase) Setting: tertiary care university medical centre ‐ the University of Limburg Place of study: Maastricht, the Netherlands Period of study: not reported Language: English |
||
Index tests | Index test: vimentin, cytokeratin 18, cytokeratin 19 and endometrial epithelial marker BW 495/36 in menstrual fluid and endometrium Description of positive case definition by index test as reported: positive IHC staining; laboratory technique described Examiners: none stated; unclear if blinded to the result of reference standard Interobserver variability: not reported |
||
Target condition and reference standard(s) | Target condition: endometriosis Prevalence of target condition in the sample: n/N = 8/16 (50%): all stage I; controls 8 Reference standard: laparoscopy + histology Description of positive case definition by reference test as reported: visual inspection confirmed by histopathology, staging according to rAFS Examiners: none stated |
||
Flow and timing | Time interval between index test and reference standard: samples were collected at surgery Withdrawals: none reported |
||
Comparative | |||
Notes | Conclusion: These results support the contention of transport of menstrual detritus to the peritoneal cavity in women with patent fallopian tubes. Comment: For vimentin, cytokeratin 18, cytokeratin 19 and endometrial epithelial marker BW 495/36, there was no statistically significant difference between the groups ‐ no data available for meta‐analysis (Appendix 7) |
||
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? | 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? | Yes | ||
Was a menstrual cycle phase considered in interpreting the index test | Yes | ||
Unclear | 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 |