Lima 2006.
Study characteristics | |||
Patient sampling |
Primary objective: to determine FSH, LH, E2, progesterone, and Hi concentrations in serum, PF and FF of women with and without endometriosis Participants: women undergoing laparoscopy for infertility and/or pelvic pain (cases) and tubal sterilisation (controls) Selection criteria: inclusion criteria: secretory cycle phase, no medical treatment for at least three months preceding surgery, absence of other gynaecological diseases, absence of pelvic pain, age between 18 and 40 years Study design: cross‐sectional, two‐gate design, prospective collection of samples |
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Patient characteristics and setting |
Clinical presentation: pelvic pain, infertility (cases); asymptomatic fertile women requesting sterilisation (controls) Age: mean age 33.9 ± 7.8 years (endometriosis group), 36.8 ± 7.4 years (controls) Number of participants enrolled: 49 women Number of participants available for analysis: 49 women (all in luteal cycle phase) Setting: Department of O&G, Hospital das Clinicas, Faculty of Medicine of Ribeirão Preto, University of São Paulo Place of study: São Paulo, Brazil Period of study: 2002‐2004 Language: Portuguese |
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Index tests |
Index test: FSH , LH, E2, progesterone Details of the index test procedure as stated: serum concentrations of FSH, LH, E2 and progesterone were measured using a commercial kit (DPC Imm Sys, California) by chemiluminescence; sample processing 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 were for FSH 7.9% and 6.5%, for LH 8.8% and 11.3%, for E2 8.4% and 9.3%, for P 5.8% and 10.3% |
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Target condition and reference standard(s) |
Target condition: endometriosis Prevalence of target condition in the sample: n = 28/49 (57%): stage I‐II 18, stage III‐IV 10; controls n = 21 Reference standard: laparoscopy n = 49 (100%) Description of positive case definition by reference standard as reported: visual inspection; 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 before anaesthesia Withdrawals: none |
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Comparative | |||
Key conclusions by the authors | Ovary dysfunction in women with endometriosis, with reduction on E, P and Hi concentrations, which may contribute to the subfertility often associated with the disease | ||
Conflict of interest | Not reported | ||
Notes | For LH and FSH there was no statistically significant difference between the groups ‐ no data available for meta‐analysis For E2 and progesterone there was statistically significant difference between the groups, but there was insufficient data to construct 2 x 2 tables ‐ not included in this review The data for markers measured in peritoneal fluid are not presented in this review |
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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? | No | ||
Did the study avoid inappropriate exclusions? | Yes | ||
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? | 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? | Unclear | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Yes | ||
Unclear | 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 |