Inter-Rater Reliability of Air/Saline HyCoSy, HyFoSy and HyFoSy Combined With Power Doppler for Screening Tubal Patency

Abstract

Purpose To estimate the inter-observer reliability and agreement of offline analyses of three different ultrasound techniques for assessing tubal patency.

Methods 100 tubes (n = 100) in 50 women were evaluated for tubal patency between November 2013 and July 2015 using ultrasound as index tests and laparoscopy as the reference standard. Three different ultrasound techniques were applied: two-dimensional grayscale ultrasound using air + saline as the contrast media (2D-HyCoSy); two- and three-dimensional grayscale ultrasound using foam as the contrast media (2 D/3D-HyFoSy); and the same technique but adding bi-directional power Doppler (2 D/3D-Doppler-HyFoSy). The videos containing full standardized exams using these three techniques were split into three parts, anonymized, encoded, randomized and reassessed in Nov. 2015 by two observers who assessed tubal patency using standardized criteria. These observers were blinded to any clinical information and each other’s results. Proportions of observed agreement (po) and Cohen's Kappa (κ) including the 95 % confidence intervals (CI) were calculated.

Results The inter-observer reliability/agreement in 2 D/3D-Doppler-HyFoSy (po = 0.99, κ = 0.95, 95 % CI: 0.93 – 0.97) was higher compared to 2D-air/saline-HyCoSy (po = 0.83, κ = 0.55, 95 % CI: 0.40 – 0.68) and 2 D/3D-HyFoSy (po = 0.92, κ = 0.67, 95 % CI: 0.54 – 0.76).

Conclusion The inter-observer reliability and agreement of the diagnosis of tubal patency evaluating stored videos are improved when foam and power Doppler are used during acquisition. Therefore, this technique may be preferred to minimize misclassification and misdiagnosis.

Zusammenfassung

Ziel Messung der Interrater Reliabilität und Übereinstimmung von Offline Aufnahmen von drei unterschiedlichen Ultraschalltechniken zur Untersuchung der Durchgängigkeit der Tuba uterina.

Methoden Zwischen November 2013 und Juli 2015 wurde die Durchgängigkeit von n = 100 Tuben von 50 Frauen mit Ultraschall als Indextest und Laparoskopie als Referenzstandard untersucht. Dabei kamen drei verschiedene Ultraschalltechniken zum Einsatz: Zweidimensionaler Schwarz-Weiß-Ultraschall mit Luft und Salzlösung als Kontrastmittel (2D-HyCoSy), Zwei- und Dreidimensionaler Schwarz-Weiß-Ultraschall mit Schaum als Kontrastmittel (2 D/3D-HyFoSy) und die gleiche Technik mit zusätzlichem bi-direktionalem Powerdoppler (2 D/3D-Doppler-HyFoSy). Die Videos enthielten die vollständigen standardisierten Untersuchungen, wurden drei Gruppen zugeordnet, randomisiert und im November 2015 beurteilten zwei Rater die Durchgängigkeit der Tuben anhand standardisierter Kriterien. Die Rater waren gegenüber anderen klinischen Informationen und gegenüber einander verblindet. Anteile von Übereinstimmungen (po), Cohen’s kappa (κ) und 95 % Konfidenz Intervalle (KI) wurden berechnet.

Ergebnisse Die Interrater Reliabilität und Übereinstimmung des 2 D/3D-Doppler-HyFoSy (po = 0,99, κ = 0,95, 95 % KI: 0,93 – 0,97) war höher als der 2D-Air/saline-HyCoSy (po = 0,83, κ = 0,55, 95 % KI: 0,40 – 0,68) und der 2 D/3D-HyFoSy (po = 0,92, κ = 0,67, 95 % KI: 0,54 – 0,76).

Schlussfolgerungen Die Interrater Reliabilität und Überstimmung zur Bestimmung der Durchgängigkeit der Tuba uterina bei aufgezeichneten Videos ist verbessert wenn Schaum und Power Doppler während der Aufzeichnung verwendet wird. Deshalb sollte dieser Technik bevorzugt werden um Fehlklassifikationen und Fehldiagnosen zu minimieren.

Key words

gynecology - infertility - fallopian tube patency test - reproducibility - specificity

• References

• 1 Deichert U, Schleif R, van de Sandt M. et al. Transvaginal hysterosalpingo-contrast-sonography (Hy-Co-Sy) compared with conventional tubal diagnostics. Hum Reprod 1989; 4: 418-424
• 2 Saunders RD, Shwayder JM, Nakajima ST. Current methods of tubal patency assessment. Fertil Steril 2011; 95: 2171-2179 DOI: 10.1016/j.fertnstert.2011.02.054
• 3 Boudghene FP, Bazot M, Robert Y. et al. Assessment of Fallopian tube patency by HyCoSy: comparison of a positive contrast agent with saline solution. Ultrasound Obstet Gynecol 2001; 18: 525-530 DOI: 10.1046/j.0960–7692.2001.00513.x
• 4 Sladkevicius P, Zannoni L, Valentin L. B-flow ultrasound facilitates visualization of contrast medium during hysterosalpingo-contrast sonography. Ultrasound Obstet Gynecol 2014; 44: 221-227 DOI: 10.1002/uog.13290
• 5 Ludwin A, Pitynski K, Ludwin I. et al. Two- and three-dimensional ultrasonography and sonohysterography versus hysteroscopy with laparoscopy in the differential diagnosis of septate, bicornuate, and arcuate uteri. J Minim Invasive Gynecol 2013; 20: 90-99 DOI: 10.1016/j.jmig.2012.09.011
• 6 Ludwin I, Ludwin A, Wiechec M. et al. Accuracy of hysterosalpingo-foam sonography in comparison to hysterosalpingo-contrast sonography with air/saline and to laparoscopy with dye. Hum Reprod 2017; 32: 758-769 DOI: 10.1093/humrep/dex013
• 7 Robertshaw IM, Sroga JM, Batcheller AE. et al. Hysterosalpingo-Contrast Sonography With a Saline-Air Device Is Equivalent to Hysterosalpingography Only in the Presence of Tubal Patency. J Ultrasound Med 2016; 35: 1215-1222 DOI: 10.7863/ultra.15.08008
• 8 Ludwin A, Ludwin I, Martins WP. Venous intravasation during evaluation of tubal patency by ultrasound contrast imaging. Ultrasound Obstet Gynecol 2017; In press DOI: 10.1002/uog.17405.
• 9 Emanuel MH, Exalto N. Hysterosalpingo-foam sonography (HyFoSy): a new technique to visualize tubal patency. Ultrasound Obstet Gynecol 2011; 37: 498-499 DOI: 10.1002/uog.8912
• 10 Exacoustos C, Di Giovanni A, Szabolcs B. et al. Automated three-dimensional coded contrast imaging hysterosalpingo-contrast sonography: feasibility in office tubal patency testing. Ultrasound Obstet Gynecol 2013; 41: 328-335 DOI: 10.1002/uog.11200
• 11 Maheux-Lacroix S, Boutin A, Moore L. et al. Hysterosalpingosonography for diagnosing tubal occlusion in subfertile women: a systematic review with meta-analysis. Hum Reprod 2014; 29: 953-963 DOI: 10.1093/humrep/deu024
• 12 Ludwin A, Nastri CO, Ludwin I. et al. The “flaming tube” sign at hysterosalpingo-lidocaine-foam sonography combined with Power Doppler imaging (HyLiFoSy-PD): description of the technique. Ultrasound Obstet Gynecol 2017; DOI: 10.1002/uog.17420. : In press
• 13 Alcazar JL, Martinez-Astorquiza CT, Orozco R. et al. Three-Dimensional Hysterosalpingo-Contrast-Sonography for the Assessment of Tubal Patency in Women with Infertility: A Systematic Review with Meta-Analysis. Gynecol Obstet Invest 2016; 81: 289-295 DOI: 10.1159/000443955
• 14 Coelho Neto MA, Roncato P, Nastri CO. et al. True Reproducibility of UltraSound Techniques (TRUST): systematic review of reliability studies in obstetrics and gynecology. Ultrasound Obstet Gynecol 2015; 46: 14-20 DOI: 10.1002/uog.14654
• 15 Kottner J, Audige L, Brorson S. et al. Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were proposed. J Clin Epidemiol 2011; 64: 96-106 DOI: 10.1016/j.jclinepi.2010.03.002
• 16 Ludwin A, Ludwin I, Kudla M. et al. Diagnostic accuracy of three-dimensional sonohysterography compared with office hysteroscopy and its interrater/intrarater agreement in uterine cavity assessment after hysteroscopic metroplasty. Fertil Steril 2014; 101: 1392-1399 DOI: 10.1016/j.fertnstert.2014.01.039
• 17 Ludwin A, Martins WP, Ludwin I. Uterine cavity imaging, volume estimation, and quantification of deformity degree using automatic volume calculation: description of the technique. Ultrasound Obstet Gynecol 2017; DOI: 10.1002/uog.15890.
• 18 Streiner DL, Kottner J. Recommendations for reporting the results of studies of instrument and scale development and testing. J Adv Nurs 2014; 70: 1970-1979 DOI: 10.1111/jan.12402
• 19 Hernaez R. Reliability and agreement studies: a guide for clinical investigators. Gut 2015; 64: 1018-1027 DOI: 10.1136/gutjnl-2014–308619
• 20 Practice Committee of the American Society for Reproductive M. Diagnostic evaluation of the infertile female: a committee opinion. Fertil Steril 2015; 103: e44-50 DOI: 10.1016/j.fertnstert.2015.03.019
• 21 Kottner J, Streiner DL. The difference between reliability and agreement. J Clin Epidemiol 2011; 64: 701-702 author reply 702 DOI: 10.1016/j.jclinepi.2010.12.001
• 22 Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33: 159-174
• 23 Fleiss JLCJ, Everitt BS. Large sample standard errors of kappa and weighted kappa. Psychological Bulletin 1969; 72: 323-327 DOI: 10.1037/h0028106
• 24 Ludwin I, Martins WP, Nastri CO. et al. Pain Intensity During Ultrasound Assessment of Uterine Cavity and Tubal Patency With and Without Painkillers: Prospective Observational Study. J Minim Invasive Gynecol 2017; 24: 599-608 DOI: 10.1016/j.jmig.2017.01.015
• 25 Mohiyiddeen L, Hardiman A, Fitzgerald C. et al. Tubal flushing for subfertility. Cochrane Database Syst Rev 2015; CD003718 DOI: 10.1002/14651858.CD003718.pub4.
• 26 Groszmann YS, Benacerraf BR. Complete evaluation of anatomy and morphology of the infertile patient in a single visit; the modern infertility pelvic ultrasound examination. Fertil Steril 2016; 105: 1381-1393 DOI: 10.1016/j.fertnstert.2016.03.026
• 27 Mol BW, Swart P, Bossuyt PM. et al. Reproducibility of the interpretation of hysterosalpingography in the diagnosis of tubal pathology. Hum Reprod 1996; 11: 1204-1208
• 28 Renbaum L, Ufberg D, Sammel M. et al. Reliability of clinicians versus radiologists for detecting abnormalities on hysterosalpingogram films. Fertil Steril 2002; 78: 614-618
• 29 Lim SL, Jung JJ, Yu SL. et al. A comparison of hysterosalpingo-foam sonography (HyFoSy) and hysterosalpingo-contrast sonography with saline medium (HyCoSy) in the assessment of tubal patency. Eur J Obstet Gynecol Reprod Biol 2015; 195: 168-172 DOI: 10.1016/j.ejogrb.2015.10.008
• 30 Emanuel MH, Exalto N. Hysterosalpingo-foam sonography (HyFoSy): a new technique to visualize tubal patency. Ultrasound Obstet Gynecol 2011; 37: 498-499 DOI: 10.1002/uog.8912