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 |
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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 |
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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 |
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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 |
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Flow and timing |
Time interval between index test and reference standard: within 2 weeks Withdrawals: no withdrawals reported |
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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 |
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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? | 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 |