First‐trimester trisomy screening: nuchal translucency measurement training and quality assurance to correct and unify technique

Snijders, R. J. M.; Thom, Elizabeth; Zachary, Julia; Platt, Lawrence D.; Greene, Naomi; Jackson, Laird G.; Sabbagha, Rudy E.; Filkins, Karen; Silver, Richard K.; Hogge, W. Allen; Ginsberg, Norman; Beverly, S.; Morgan, Pam; Blum, K. U.; Chilis, P.; Hill, Lyndon M.; Hecker, Julie; Wapner, Ronald J.

doi:10.1046/j.1469-0705.2002.00637.x

Cited by 145 publications

(148 citation statements)

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“…For example, should the quality score be high if all criteria but caliper placement were to be met, even though the result might be poor? 7 These systems have been found too cumbersome to be used for routine quality assessment. They might be of more value during the initial training period, or when quantitative assessment indicates the need for further scrutiny.…”

Section: Discussionmentioning

confidence: 99%

“…5,6 Acquiring the skill to properly measure NT requires specialized training and oversight. 7 Recognizing this, several national and international programs have been established to train and qualify sonographers, and also to assess their ability to consistently and accurately quantify the NT thickness. 8 -11 The hands-on performance training is usually evaluated through still images submitted to one, or a panel of, expert sonographers.…”

mentioning

confidence: 99%

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Quality assessment of routine nuchal translucency measurements: a North American laboratory perspective

Palomaki

Neveux

Donnenfeld³

et al. 2008

Genetics in Medicine

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Purpose: To assess nuchal translucency measurements that were performed as part of routine prenatal screening for Down syndrome. Methods: Collect ultrasound measurements of nuchal translucency and crown rump length provided by individual sonographers over a 6-month period to six North American prenatal screening laboratories, along with the laboratory's nuchal translucency interpretation in multiples of the median. For sonographers with 50 or more observations, compute three nuchal translucency quality measures (medians, standard deviations, and slopes), based on epidemiological monitoring. Results: Altogether, 23,462 nuchal translucency measurements were submitted by 850 sonographers. Among the 140 sonographers (16%) who submitted more than 50 observations, 76 (54%) were found to have all three quality measures in the target range. These 140 sonographers collectively accounted for 14,210 nuchal translucency measurements (61%). The most common single measure to be out of range was nuchal translucency multiples of the median, found for 29 of the 140 sonographers (21%). Nuchal translucency (NT) is defined as the collection of fluid behind the fetal neck occurring in the first trimester of pregnancy. 1-3 When measured and interpreted correctly, it is the most discriminatory marker for Down syndrome that has been reported in a routine setting. Univariately, NT measurements can identify about 60% of Down syndrome pregnancies in the first trimester at a 5% false-positive rate. 4 Detection increases to between 80% and 85%, when NT is combined with first trimester biochemical measurements of pregnancyassociated plasma protein-A (PAPP-A) and human chorionic gonadotropin (the intact, total, or free-␤ subunit forms). 4 When NT measurements are incorporated into the integrated test (NT and PAPP-A measurements in the first trimester) and the quadruple test (␣-fetoprotein, unconjugated estriol, human chorionic gonadotropin and dimeric inhibin-A in the second trimester), 85-90% detection is achievable at a false-positive rate of 2% or less. 5,6 Acquiring the skill to properly measure NT requires specialized training and oversight. 7 Recognizing this, several national and international programs have been established to train and qualify sonographers, and also to assess their ability to consistently and accurately quantify the NT thickness. 8 -11 The hands-on performance training is usually evaluated through still images submitted to one, or a panel of, expert sonographers. Several research trials using NT measurements have shown that such training, although necessary, is not sufficient to assure reproducibility of absolute measurements among sonographers. For example, both the Serum, Urine and Ultrasound Screening Study (SURUSS) 5 and First and Second Trimester Evaluation of Risk (FASTER) study 12 found that use of sonographer-specific reference data (medians) resulted in improved screening performance.In the current study, information was sought from screening laboratories regarding how they deal with NT measurements

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Quality assessment of routine nuchal translucency measurements: a North American laboratory perspective

Palomaki

Neveux

Donnenfeld³

et al. 2008

Genetics in Medicine

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“…The fetal medicine foundation has established a process of training and quality assurance for the appropriate introduction of NT screening into clinical practice, 1,2 and several studies have demonstrated that an ongoing regular audit of images and the distribution of measurements of NT are essential for the assessment of the quality of a center. [24][25][26][27] A similar process of training, certification and quality assurance oriented to fetal medicine units in DV flow can be suggested after our experience.…”

Section: Discussionmentioning

confidence: 99%

Impact of Ductus Venosus Assessment in Screening Down Syndrome Protocols: An Improved Strategy in a Fetal Medicine Unit

Echevarría¹,

Comas²,

Rodríguez³

et al. 2009

Donald School Journal of Ultrasound in Obstetrics and Gynecology

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Objective: To estimate the improvement in screening efficiency when ductus venosus (DV) Doppler studies are added to existing Down syndrome (DS) screening protocols.Methods: First-trimester combined screening for trisomy 21 was prospectively carried out, from October 2003 to March 2008, in 8842 consecutive singleton pregnancies attended in our tertiary reference center. The nuchal translucency (NT) and the pulsatility index for veins for DV were calculated. The maternal serum biochemistry was measured using the Kryptor analyzer, at the same time of the scan (one step strategy) or before it (two step strategy). The detection rate (DR) and false-positive rates for standard screening strategy (maternal age, NT and biochemistry) and the same strategy but including DV assessment were calculated.Results: Successful DV assessment was possible in the 95.3% of cases, representing a total of 8426 cases. Down syndrome was identified in 34 pregnancies (prevalence of DS 1:250). For a fixed screen positive rate of 5%, the addition of the DV assessment improves the DR from 85 to 94% and, for a fixed DR of 85%, it reduces the number of unnecessary invasive tests from 3.7 to 3.2%. Conclusion:Early evaluation of DV can be introduced to standard DS screening strategies in experienced centers as a first level test to reduce invasive test rate derived from the existing protocols.

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“…Die vorgeburtliche Risikoabklärung insgesamt sowie jede einzelne ihrer Komponenten (Ultraschall, laboratoriumsmedizinische Untersuchungen, Algorithmus) müssen einer kontinuierlichen Qualitätssicherung unterzogen werden. Durch eine kontinuierliche Qualitätssicherung kann das Problem der Unterschätzung der Nackentransparenz deutlich verringert und so die Entdeckungsrate erhöht werden [17,18,19]. Eine externe Qualitätssicherung ist insbesondere für den Bereich Ultraschall wesentlich, weil es sich bei der fetalen Nackentransparenz um eine Messung im Bereich um 0,1 mm handelt und deren Genauigkeit direkt von der Qualifikation des Anwenders abhängt [17].…”

Section: Begründungunclassified

“…Durch eine kontinuierliche Qualitätssicherung kann das Problem der Unterschätzung der Nackentransparenz deutlich verringert und so die Entdeckungsrate erhöht werden [17,18,19]. Eine externe Qualitätssicherung ist insbesondere für den Bereich Ultraschall wesentlich, weil es sich bei der fetalen Nackentransparenz um eine Messung im Bereich um 0,1 mm handelt und deren Genauigkeit direkt von der Qualifikation des Anwenders abhängt [17]. Eine regelmäßige jährliche Überprüfung der Messergebnisse und der Ultraschallbilder dient dem Absichern präziser Ergebnisse.…”

Section: Begründungunclassified

Richtlinie der Gendiagnostik-Kommission (GEKO) für die Anforderungen an die Durchführung der vorgeburtlichen Risikoabklärung sowie an die insoweit erforderlichen Maßnahmen zur Qualitätssicherung gemäß 23 Abs. 2 Nr. 5 GenDG

2013

Bundesgesundheitsbl.

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First‐trimester trisomy screening: nuchal translucency measurement training and quality assurance to correct and unify technique

Cited by 145 publications

References 10 publications

Quality assessment of routine nuchal translucency measurements: a North American laboratory perspective

Quality assessment of routine nuchal translucency measurements: a North American laboratory perspective

Impact of Ductus Venosus Assessment in Screening Down Syndrome Protocols: An Improved Strategy in a Fetal Medicine Unit

Richtlinie der Gendiagnostik-Kommission (GEKO) für die Anforderungen an die Durchführung der vorgeburtlichen Risikoabklärung sowie an die insoweit erforderlichen Maßnahmen zur Qualitätssicherung gemäß 23 Abs. 2 Nr. 5 GenDG

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