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. 2016 Feb 26;2016(2):CD009591. doi: 10.1002/14651858.CD009591.pub2

Sugimura 1993.

Study characteristics
Patient sampling Primary objectives: to analyse the value of magnetic resonance imaging (MRI) in detection and characterisation of pelvic endometriosis; to assess the usefulness of fat‐saturated MRI for detection of endometrial cysts, with laparoscopy or laparotomy as the standard reference
Study population: women with clinically suspected endometriosis
Selection criteria: not specified
Study design: prospective, observational; consecutive enrolment
Patient characteristics and setting Clinical presentation: not specified
Age: mean 36 years, range 24 to 48 years
Number enrolled: 35 women
Number available for analysis: 35 women
Setting: university hospital, Shimane Medical University
Place of study: Izumo, Japan
Period of study: March 1991 to August 1992
Language: English
Index tests Index test:MRI (T1/T2‐w)
Description of positive case definition by index test as reported: assessed sites included surface of the uterus, adnexa, POD, peritoneum, ovaries; recorded details included location of lesion, size, shape; thickness, regularity and signal intensity of lesion margins; distinctness of interface of the lesion with adjacent organs; and appearance of the lesion. Criteria provided only for ovarian endometrioma and referenced to a primary source
Examiners: MRI images prospectively read by 2 study authors who were aware that patients had a clinical history of suspected endometriosis; level of expertise not reported
Interobserver variability: not provided
Target condition and reference standard(s) Target condition: pelvic endometriosis
Prevalence of target condition in the sample: pelvic endometriosis 26/35 (74.3%)
Reference standard: laparoscopy 13/35 (37%), laparotomy 22/35 (63%) + histopathology
Description of positive case definition by reference test as reported: diagnostic criteria not mentioned; surgical procedure not described
Examiners: 'laparoscopy and laparotomy procedure reports and photographs and histologic slides (when available) were reviewed by 2 gynaecologists from our university' ‐ additional information not provided; unclear whether blinded to results of the index test
Flow and timing Time interval between index test and reference standard: within 2 weeks
Withdrawals: no withdrawals reported
Comparative  
Key conclusions by the authors Diagnostic accuracy improved with addition of fat‐saturated images, so their use together with conventional images is recommended in assessment of endometriosis
Conflict of interests Not reported
Notes Reported accuracy estimates for conventional MRI for diagnosis of pelvic endometriosis confirmed as accurate
Data for endometrioma reported separately for large and small endometriomas; this does not allow construction of 2 × 2 tables ‐ not presented in this review
Likely overlap with data for fat‐saturated MRI for another larger study from the same group ‐ Okada 1995 (study period August 1991 to December 1993) ‐ not able to clarify with study authors; therefore these data have been removed from the index study
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Did the study avoid inappropriate exclusions? Unclear    
Was a 'two‐gate' design avoided? Yes    
    Unclear Low
DOMAIN 2: Index Test Any test
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
Did the study provide a clear pre‐specified definition of what was considered to be a “positive” result of index test? No    
Was the index test performed by a single operator or interpreted by consensus in a joint session? No    
Were the same clinical data available when the index test results were interpreted as would be available when the test is used in practice?   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? Unclear    
    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