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ORIGINAL RESEARCH |
From the 1University of Utah and Intermountain HealthCare, Salt Lake City, Utah; 2University of California, San Francisco, San Francisco, California; 3Columbia University College of Physicians and Surgeons, New York, New York; 4Royal College of Surgeons in Ireland, Dublin, Ireland; 5Swedish Medical Center, Seattle, Washington; 6William Beaumont Hospital, Royal Oak, Michigan; 7University of Texas Medical Branch, Galveston, Texas; 8Mount Sinai School of Medicine, New York, New York; 9Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York; 10University of Colorado Health Sciences Center, Denver, Colorado; 11Tufts University School of Medicine, Boston, Massachusetts; 12New York University School of Medicine, New York, New York; 13Brown University School of Medicine, Providence, Rhode Island; 14University of North Carolina Medical Center, Chapel Hill, North Carolina; and 15DM-STAT, Boston, Massachusetts.
OBJECTIVE: To investigate the differences in costs and outcomes of Down syndrome screening using data from the First and Second Trimester Evaluation of Risk (FASTER) Trial.
METHODS: Seven possible screening options for Down syndrome were compared: 1) Triple Screen—maternal serum alpha fetoprotein, estriol, and hCG; 2) Quad—maternal serum alpha fetoprotein, estriol, hCG, and Inhibin A; 3) Combined First—nuchal translucency, pregnancy-associated plasma protein A (PAPP-A), free ß-hCG; 4) Integrated—nuchal translucency, PAPP-A, plus Quad; 5) Serum Integrated—PAPP-A, plus Quad; 6) Stepwise Sequential—Combined First plus Quad with results given after each test; and 7) Contingent Sequential—Combined First and only those with risk between 1:30 and 1:1,500 have Quad screen. The detection rates for each option were used given a 5% false-positive rate except for Contingent Sequential with a 4.3% false-positive rate. Outcomes included societal costs of each screening regimen (screening tests, amniocentesis, management of complications, and cost of care of Down syndrome live births), Down syndrome fetuses identified and born, the associated quality-adjusted life years, and the incremental cost-utility ratio.
RESULTS: Based on the screening results derived from the 38,033 women evaluated in the FASTER trial, the Contingent Sequential screen dominated (lower costs with better outcomes) all other screens. For example, the Contingent Sequential cost 32.3 million dollars whereas the other screens ranged from 32.8 to 37.5 million dollars. The Sequential strategy led to the identification of the most Down syndrome fetuses of all of the screens, but at a higher cost per Down syndrome case diagnosed ($719,675 compared with $690,427) as compared with the Contingent Sequential. Because of the lower overall false-positive rate leading to fewer procedure-related miscarriages, the Contingent Sequential resulted in the highest quality-adjusted life years as well. The Contingent Sequential remained the most cost-effective option throughout sensitivity analysis of inputs, including amniocentesis rate after positive screen, rate of therapeutic abortion after Down syndrome diagnosis, and rate of procedure-related miscarriages.
CONCLUSION: Analysis of this actual data from the FASTER Trial demonstrates that the Contingent Sequential test is the most cost-effective. This information can help shape future policy regarding Down syndrome screening.
This article has been cited by other articles:
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  B. G. Skotko First- and Second-Trimester Evaluation of Risk for Down Syndrome Obstet. Gynecol., December 1, 2007; 110(6): 1426 - 1426. [Full Text] [PDF]
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U. M. Reddy The Evolving Prenatal Screening Scene Obstet. Gynecol., July 1, 2007; 110(1): 2 - 4. [Full Text] [PDF]
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