Szymanowski 2003.
Study characteristics | |||
Patient sampling | Primary objective: to describe the expression of α3β1, α4β1 and β1 integrin chain in endometrial biopsy in women suffering from endometriosis Participants: women with infertility, pelvic pain or both undergoing laparoscopy and hysteroscopy Selection criteria: inclusion criteria: regular cycles, no hormonal treatment at least 1/12 month prior surgery; exclusion criteria: pregnancy, non‐peritoneal endometriosis Study design: observational single‐gate, prospective sample collection |
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Patient characteristics and setting | Clinical presentation: infertility ‐ 23/32, pelvic pain ‐ 11/32 Age: mean age 29.2 ± 4.19 years Number enrolled: 32 women Number available for analysis: 32 women (all in secretory phase) Setting: university hospital ‐ Division of Reproduction, K. Marcinkowski University of Medical Sciences Place of study: Poznan, Poland Period of study: January 1998 to June 2000 Language: English |
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Index tests | Index test: α3β1, α4β1 and β1 Integrin chain Description of positive case definition by index test as reported: Positive IHC staining (staining intensity was defined as weak +, moderate ++, strong +++; not defined in glandular and stromal cells); threshold not pre‐specified Examiners: blinded observer Interobserver variability: not provided |
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Target condition and reference standard(s) | Target condition: peritoneal endometriosis Prevalence of target condition in the sample: n/N = 17/32 (53%): stage not specified; controls 15 Reference standard: laparoscopy + histology Description of positive case definition by reference test as reported: direct visualisation of endometrial foci with histological confirmation; rAFS classification Examiners: not stated |
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Flow and timing | Time interval between reference test and index test: tissue sample was obtained at surgery Withdrawals: none reported |
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Comparative | |||
Notes | Conclusion: The selected integrins do not yet allow identification of a pattern characteristic for endometriosis. | ||
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? | Yes | ||
High | Unclear | ||
DOMAIN 2: Index Test All tests | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
If a threshold was used, was it pre‐specified? | No | ||
Was a menstrual cycle phase considered in interpreting the 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 |