Congenital Uterine Malformation by Experts (CUME): diagnostic criteria for T-shaped uterus
Por:
Ludwin, A, Neto, M, Ludwin, I, Nastri, C, Costa, W, Acien, M, Alcazar, J, Benacerraf, B, Condous, G, DeCherney, A, De Wilde, R, Diamond, M, Emanuel, M, Guerriero, S, Hurd, W, Levine, D, Lindheim, S, Pellicer, A, Petraglia, F, Saridogan, E and Martins, W
Publicada:
1 jun 2020
Ahead of Print:
1 may 2020
Resumen:
Objectives To identify uterine measurements that are reliable and accurate to distinguish between T-shaped and normal/arcuate uterus, and define T-shaped uterus, using Congenital Uterine Malformation by Experts (CUME) methodology, which uses as reference standard the decision made most often by several independent experts.
Methods This was a prospectively planned multirater reliability/agreement and diagnostic accuracy study, performed between November 2017 and December 2018, using a sample of 100 three-dimensional (3D) datasets of different uteri with lateral uterine cavity indentations, acquired from consecutive women between 2014 and 2016. Fifteen representative experts (five clinicians, five surgeons and five sonologists), blinded to each others' opinions, examined anonymized images of the coronal plane of each uterus and provided their independent opinion as to whether it was T-shaped or normal/arcuate; this formed the basis of the CUME reference standard, with the decision made most often (i.e. that chosen by eight or more of the 15 experts) for each uterus being considered the correct diagnosis for that uterus. Two other experienced observers, also blinded to the opinions of the other experts, then performed independently 15 sonographic measurements, using the original 3D datasets of each uterus. Agreement between the diagnoses made by the 15 experts was assessed using kappa and percent agreement. The interobserver reliability of measurements was assessed using the concordance correlation coefficient (CCC). The diagnostic test accuracy was assessed using the area under the receiver-operating-characteristics curve (AUC) and the best cut-off value was assessed by calculating Youden's index, according to the CUME reference standard. Sensitivity, specificity, negative and positive likelihood ratios (LR- and LR+) and post-test probability were calculated.
Results According to the CUME reference standard, there were 20 T-shaped and 80 normal/arcuate uteri. Individual experts recognized between 5 and 35 (median, 19) T-shaped uteri on subjective judgment. The agreement among experts was 82% (kappa = 0.43). Three of the 15 sonographic measurements were identified as having good diagnostic test accuracy, according to the CUME reference standard: lateral indentation angle (AUC = 0.95), lateral internal indentation depth (AUC = 0.92) and T-angle (AUC = 0.87). Of these, T-angle had the best interobserver reproducibility (CCC = 0.87 vs 0.82 vs 0.62 for T-angle vs lateral indentation depth vs lateral indentation angle). The best cut-off values for these measurements were: lateral indentation angle <= 130 degrees (sensitivity, 80%; specificity, 96%; LR+, 21.3; LR-, 0.21), lateral indentation depth >= 7 mm (sensitivity, 95%; specificity, 77.5%; LR+, 4.2; LR-, 0.06) and T-angle <= 40 degrees (sensitivity, 80%; specificity, 87.5%; LR+, 6.4; LR-, 0.23). Most of the experts diagnosed the uterus as being T-shaped in 0% (0/56) of cases when none of these three criteria was met, in 10% (2/20) of cases when only one criterion was met, in 50% (5/10) of cases when two of the three criteria were met, and in 93% (13/14) of cases when all three criteria were met.
Conclusions The diagnosis of T-shaped uterus is not easy; the agreement among experts was only moderate and the judgement of individual experts was commonly insufficient for accurate diagnosis.
The three sonographic measurements with cut-offs that we identified (lateral internal indentation depth >= 7 mm, lateral indentation angle <= 130 degrees and T-angle <= 40 degrees) had good diagnostic test accuracy and fair-to-moderate reliability and, when applied in combination, they provided high post-test probability for T-shaped uterus. In the absence of other anomalies, we suggest considering a uterus to be normal when none or only one criterion is met, borderline when two criteria are met, and T-shaped when all three criteria are met. These three CUME criteria for defining T-shaped uterus may aid in determination of its prevalence, clinical implications and best management and in the assessment of post-surgical morphologic outcome. The CUME definition of T-shaped uterus may help in the development of interventional randomized controlled trials and observational studies and in the diagnosis of uterine morphology in everyday practice, and could be adopted by guidelines on uterine anomalies to enrich their classification systems. Copyright (c) 2019 ISUOG. Published by John Wiley & Sons Ltd.
Filiaciones:
Ludwin, A:
Jagiellonian Univ, Dept Gynecol & Oncol, Kopernika 23, PL-31501 Krakow, Poland
Private Med Ctr, Ludwin Ludwin Gynecol, Krakow, Poland
Neto, M:
SEMEAR Fertilidade, Reprod Med, Ribeirao Preto, Brazil
Univ Sao Paulo DGO FRMP USP, Fac Med Ribeirao Preto, Dept Obstet & Gynaecol, Ribeirao Preto, Brazil
Ludwin, I:
Jagiellonian Univ, Dept Gynecol & Oncol, Kopernika 23, PL-31501 Krakow, Poland
Private Med Ctr, Ludwin Ludwin Gynecol, Krakow, Poland
Nastri, C:
SEMEAR Fertilidade, Reprod Med, Ribeirao Preto, Brazil
Costa, W:
SEMEAR Fertilidade, Reprod Med, Ribeirao Preto, Brazil
Univ Sao Paulo DGO FRMP USP, Fac Med Ribeirao Preto, Dept Obstet & Gynaecol, Ribeirao Preto, Brazil
:
Miguel Hernandez Univ, San Juan Univ Hosp, Alicante, Spain
Alcazar, J:
Univ Navarra, Dept Obstet & Gynecol, Pamplona, Spain
Benacerraf, B:
Harvard Med Sch, Boston, MA 02115 USA
Condous, G:
Univ Sydney, Sydney Med Sch Nepean, Acute Gynaecol Early Pregnancy & Adv Endosurg Uni, Nepean Hosp, Sydney, NSW, Australia
DeCherney, A:
Eunice Kennedy Shriver Natl Inst Child Hlth & Hum, Bethesda, MD USA
De Wilde, R:
Carl von Ossietzky Univ Oldenburg, Oldenburg, Germany
Diamond, M:
Augusta Univ, Dept Obstet & Gynecol, Augusta, GA USA
Emanuel, M:
Univ Med Ctr Utrecht, Dept Gynaecol & Reprod Med, Utrecht, Netherlands
Univ Hosp Ghent, Dept Gynaecol, Ghent, Belgium
Guerriero, S:
Univ Cagliari, Dept Obstet & Gynecol, Cagliari, Italy
Hurd, W:
Duke Univ, Med Ctr, Dept Obstet & Gynecol, Div Reprod Endocrinol & Infertil, Durham, NC 27710 USA
Levine, D:
Beth Israel Deaconess Med Ctr, Dept Radiol, 330 Brookline Ave, Boston, MA 02215 USA
Lindheim, S:
Wright State Univ, Boonshoft Sch Med, Dept Obstet & Gynecol, Dayton, OH 45435 USA
Pellicer, A:
Inst Valenciano Infertilidad, Valencia, Spain
Petraglia, F:
Univ Florence, Florence, Italy
Saridogan, E:
Univ Coll London Hosp, London, England
Martins, W:
SEMEAR Fertilidade, Reprod Med, Ribeirao Preto, Brazil
Univ Sao Paulo DGO FRMP USP, Fac Med Ribeirao Preto, Dept Obstet & Gynaecol, Ribeirao Preto, Brazil
Bronze, Green Published
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