Maiorana 2007.

Study characteristics
Patient sampling	Primary objective: to evaluate if serum CA‐125 levels correlate with rAFS and whether serum CA‐125 measurement should be performed in the routine work‐up of dysmenorrhoea and dyspareunia Participants: women who underwent laparoscopy for infertility, ovarian cyst or suspected endometriosis (endometriosis group) and women operated for ovarian cysts and confirmed not to have endometriosis (controls) Selection criteria: exclusion criteria: patients with malignant tumours or inflammatory disease Study design: cross‐sectional two‐gate, prospective collection of samples
Patient characteristics and setting	Clinical presentation: In endometriosis group: dysmenorrhoea ‐ 52%, dyspareunia ‐ 26%, asymptomatic ‐ 22%; controls ‐ ovarian cysts Age: mean age 33.6 ± 7.3 years, range 21‐54 years Number of participants enrolled: 86 women Number of participants available for analysis: 86 women (in follicular phase of menstrual cycle) Setting: obstetrics and gynaecology units, Civic Hospital Place of study: Paleromo, Italy Period of study: not stated Language: English
Index tests	Index test: CA‐125 Details of the index test procedure as stated: serum CA‐125 levels were measured by enzyme immunoassay and were expressed in arbitrary units based on a primary reference standard; no other information provided Threshold for positive result: > 35 U/ml, pre‐specified Examiners: no information provided; unclear if were blinded to the result of reference standard Interobserver variability: not provided
Target condition and reference standard(s)	Target condition: endometriosis Prevalence of target condition in the sample: n = 69/86 (79%): stage I‐II 14, stage III‐IV 55; controls n = 17 Reference standard: laparoscopy N = 86 (100%) Description of positive case definition by reference standard test as reported: surgical diagnosis, rASRM classification Examiners: no information provided
Flow and timing	Time interval between index test and reference standard: not specified, but statement 'preoperative blood sample' implies short time before surgery Withdrawals: none
Comparative
Key conclusions by the authors	CA‐125 levels are related to endometriosis and rAFS score in the evaluated patient series; no correlation was found between CA‐125 and pelvic pain with endometriosis
Conflict of interest	Not reported
Notes	The presented diagnostic estimates according to severity of endometriosis are not included in this review
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?	Yes
Was a cycle phase considered in interpretation of the result of index test?	Yes
		Unclear	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