Marasinghe 2014.
Study characteristics | |||
Patient sampling |
Primary objectives To compare the performance of history and examination findings combined with transvaginal ultrasound 'soft marker' evaluation of ovarian mobility, for the prediction of fixed ovaries secondary to endometriosis at laparoscopy Study population Women scheduled for laparoscopy for chronic pelvic pain and or subfertility Selection criteria Exclusion criteria: previous surgical diagnosis of endometriosis or pelvic adhesions, confirmed diagnosis of genital abnormalities, those who did not consent to vaginal examinations Study design Cross‐sectional single‐gate, prospective recruitment and collection of samples, consecutive series |
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Patient characteristics and setting |
Clinical presentation Infertility 83%, chronic pelvic pain 17%, dysmenorrhoea 46%, dyspareunia 31% Age Mean age 33.3 ± 5.1 years, range 22 ‐ 48 years Number of participants enrolled 110 women Number of participants available for analysis 106 women Setting University Gynecology unit, National Hospital of Sri Lanka, tertiary referral centre Place of study Colombo, Sri Lanka Period of study December 2009 ‐ March 2010 Language English |
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Index tests |
Index test Clinical history + examination + TVUS Details of the index test procedure as stated Clinical history ‐ interview with history of dysmenorrhoea and dyspareunia, severity was assessed using a visual analogue scale ranging 1‐10 with a score of one considered as 'no pain'; examination included pelvic bimanual examination to detect the presence of pelvic tenderness, a fixed retroverted uterus, tender uterosacral ligaments and deeply infiltrating nodules on the uterosacral ligaments or in the cul‐de‐sac; TVUS ‐ Assessment was with gentle pressure on the ovary with the transvaginal probe, fixed or mobile ovaries were diagnosed by assessing the ovaries in relation to the uterus and ipsilateral internal iliac vessels Threshold for positive result Clinical history ‐ dysmenorrhoea or dyspareunia; examination ‐ at least one of the abovementioned examination features; TVUS: at least one 'fixed' ovary Examiners Clinical history and examination: one clinician with > four years experience in gynaecology; TVUS ‐ single examiner with > four years experience in ultrasound blinded to the clinical data Interobserver variability Each tests was performed by a single operator |
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Target condition and reference standard(s) |
Target condition Endometriosis and other peri‐ovarian adhesions Prevalence of target condition in the sample n = 32/106 (30%): stage I‐II 19, stage III‐IV 13; other peri‐ovarian adhesions n = 5; controls n = 17) Reference standard Laparoscopy n = 106 (100%) ± histology Description of positive case definition by reference standard test as reported Visual inspection, endometriotic adhesions causing a fixed ovary ‐ defined as ovaries fixed to the uterus or ovarian fossa and when it could not be elevated from the ovarian fossa by using a blunt probe; histology was considered in selected cases, histological criteria provided; staging according to the rAFS classification . Examiners Single examiner with 15 years of laparoscopic experience, blinded to the results of index test |
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Flow and timing |
Time interval between index test and reference standard The tests were performed within two weeks before surgery Withdrawals In four women at least one ovary could not be visualised on transvaginal scanning and they were excluded |
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Comparative | |||
Key conclusions by the authors | A combination of clinical and transvaginal ultrasound based 'soft marker' of ovarian mobility provides a valid method for identifying fixed ovaries secondary to endometriosis | ||
Conflict of interest | Not reported | ||
Notes | The primary outcome of the study was endometriosis with fixed ovaries or other peri‐ovarian adhesions | ||
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? | Yes | ||
Was a 'two‐gate' design avoided? | Yes | ||
Low | Low | ||
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? | Yes | ||
Was a cycle phase considered in interpretation of the result of index test? | |||
Did the study provide a clear pre‐specified definition of what was considered to be a positive result of index test? | Yes | ||
Was the index test performed by a single operator or interpreted by consensus in a joint session? | Yes | ||
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 | ||
Low | 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? | No | ||
High |