1,670
Views
2
CrossRef citations to date
0
Altmetric
Reproductive Medicine

Clinical and economic evaluation of a proteomic biomarker preterm birth risk predictor: cost-effectiveness modeling of prenatal interventions applied to predicted higher-risk pregnancies within a large and diverse cohort

ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, , ORCID Icon, , ORCID Icon, , ORCID Icon, ORCID Icon, , , , ORCID Icon, , , ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, & ORCID Icon show all
Pages 1255-1266 | Received 30 Sep 2022, Accepted 11 Nov 2022, Published online: 02 Dec 2022

References

  • Blencowe H, Vos T, Lee AC, et al. Estimates of neonatal morbidities and disabilities at regional and global levels for 2010: introduction, methods overview, and relevant findings from the Global Burden of Disease study. Pediatr Res. 2013;74(Suppl 1):4–16.
  • Osterman MJK, Hamilton BE, Martin JA, et al. Births: final data for 2020 (National Vital Statistics Reports Volume 70, Number 17). Centers for Disease Control and Prevention; 2022. [updated 2022 Feb 7; cited 2022 Feb 9]. Available from: https://www.cdc.gov/nchs/nvss/births.htm
  • American College of Obstetricians and Gynecologists, Gynecologists’ Committee on practice; Bulletins-Obstetrics. Prediction and prevention of spontaneous preterm birth: ACOG practice bulletin, number 234. Obstet Gynecol. 2021;138(2):e65–e90.
  • Petrini JR, Callaghan WM, Klebanoff M, et al. Estimated effect of 17 alpha-hydroxyprogesterone caproate on preterm birth in the United States. Obstet Gynecol. 2005;105(2):267–272.
  • Laughon SK, Albert PS, Leishear K, et al. The NICHD consecutive pregnancies study: recurrent preterm delivery by subtype. Am J Obstet Gynecol. 2014;210(2):131 e1–8.
  • Hassan SS, Romero R, Vidyadhari D, et al. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011;38(1):18–31.
  • McIntosh J, Feltovich H, Berghella V, et al. The role of routine cervical length screening in selected high- and low-risk women for preterm birth prevention. Am J Obstet Gynecol. 2016;215(3):B2–7.
  • Gyamfi-Bannerman C, Ananth CV. Trends in spontaneous and indicated preterm delivery among singleton gestations in the United States, 2005–2012. Obstet Gynecol. 2014;124(6):1069–1074.
  • Saade GR, Boggess KA, Sullivan SA, et al. Development and validation of a spontaneous preterm delivery predictor in asymptomatic women. Am J Obstet Gynecol. 2016 May;214(5):633.e1-633–e24.
  • Bradford C, Severinsen R, Pugmire T, et al. Analytical validation of protein biomarkers for risk of spontaneous preterm birth. Clin Mass Spectrom. 2017;3:25–38.
  • Boggess K, Saade GR, Sullivan SA, et al. Use of a second trimester serum-based proteomic risk classifier for prediction of spontaneous and medically-indicated preterm birth. Presented at the 37th Annual Meeting of the Society for Maternal Fetal Medicine 23–28 January 2017, Poster #336. Am J Obstet Gynecol. 2017;216(1):S204–S205.
  • Branch DW, VanBuren JM, Porter TF, et al. Prediction and prevention of preterm birth: a prospective, randomized intervention trial. Am J Perinatol. 2021. DOI:10.1055/s-0041-1732339
  • Burchard J, Polpitiya AD, Fox AC, et al. Clinical validation of a proteomic biomarker threshold for increased risk of spontaneous preterm birth and associated clinical outcomes: a replication study. J Clin Med. 2021;10(21):5088.
  • Markenson GR, Saade GR, Laurent LC, et al. Performance of a proteomic preterm delivery predictor in a large independent prospective cohort. Am J Obstet Gynecol MFM. 2020;2(3):100140.
  • Burchard J, Saade GR, Boggess KA, et al. Better estimation of spontaneous preterm birth prediction performance through improved gestational age dating. J Clin Med. 2022;11:2885.
  • Stankaitis JA, Brill HR, Walker DM. Reduction in neonatal intensive care unit admission rates in a medicaid managed care program. Am J Manag Care. 2005;11(3):166–172.
  • Newman RB, Sullivan SA, Menard MK, et al. South Carolina partners for preterm birth prevention: a regional perinatal initiative for the reduction of premature birth in a Medicaid population. Am J Obstet Gynecol. 2008;199(4):393.e1–393.e8.
  • Newnham JP, White SW, Meharry S, et al. Reducing preterm birth by a statewide multifaceted program: an implementation study. Am J Obstet Gynecol. 2017;216(5):434–442.
  • Husereau D, Drummond M, Augustovski F, et al. Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. Value Health. 2022;25(1):3–9.
  • Husereau D, Drummond M, Augustovski F, et al. Consolidated health economic evaluation reporting standards (CHEERS) 2022 explanation and elaboration: a report of the ISPOR CHEERS II good practices task force. Value Health. 2022;25(1):10–31.
  • Martin JA, Hamilton BE, Osterman MJK, et al. Births: final data for 2019. Natl Vital Stat Rep. 2021;70(2):1–51.
  • Phibbs CS, Schmitt SK, Cooper M, et al. Birth hospitalization costs and days of care for mothers and neonates in California, 2009–2011. J Pediatr. 2019;204:118–125 e14.
  • Beam AL, Fried I, Palmer N, et al. Estimates of healthcare spending for preterm and low-birthweight infants in a commercially insured population: 2008–2016. J Perinatol. 2020;40(7):1091–1099.
  • Federal Reserve Bank of St. Louis. FRED economic data: producer Price Index by Industry: selected Health Care Industries (PCUASHCASHC) 2022. [cited 2022 Feb 26]. Available from: https://fred.stlouisfed.org/series/PCUASHCASHC
  • Fried I, Beam AL, Kohane IS, et al. Utilization, cost, and outcome of branded vs compounded 17-alpha hydroxyprogesterone caproate in prevention of preterm birth. JAMA Intern Med. 2017;177(11):1689–1690.
  • Cohen AW, Copel JA, Macones GA, et al. Unjustified increase in cost of care resulting from U.S. Food and Drug Administration approval of Makena (17alpha-hydroxyprogesterone caproate). Obstet Gynecol. 2011;117(6):1408–1412.
  • Cahill AG, Odibo AO, Caughey AB, et al. Universal cervical length screening and treatment with vaginal progesterone to prevent preterm birth: a decision and economic analysis. Am J Obstet Gynecol. 2010;202(6):548 e1–548 e8.
  • Kowalski JT. A guide to the cost of progesterone for prevention of preterm labor. Proc Obstet Gynecol. 2011;1(3):9. Available from: http://ir.uiowa.edu/pog/
  • Viechtbauer W. Conducting meta-analyses in R with the metafor package. J Stat Soft. 2010;36(3):1–48.
  • Eddy DM, Hollingworth W, Caro JJ, et al. Model transparency and validation: a report of the ISPOR-SMDM modeling good research practices task force-7. Med Decis Making. 2012;32(5):733–743.
  • Grabner M, Burchard J, Nguyen C, et al. Cost-effectiveness of a proteomic test for preterm birth prediction. Clinicoecon Outcomes Res. 2021;13:809–820.
  • Microsoft R Application Network [cited 2022 Aug 1]. Available from: https://mran.microsoft.com/open
  • Berger ML, Sox H, Willke RJ, et al. Good practices for real-world data studies of treatment and/or comparative effectiveness: recommendations from the joint ISPOR-ISPE special task force on real-world evidence in health care decision making. Value Health. 2017;20(8):1003–1008.
  • Garite TJ, Combs CA. Obstetric interventions beneficial to prematurely delivering newborn babies: antenatal corticostetroids, progesterone, magnesium sulfate. Clin Perinatol. 2012;39(1):33–45.
  • Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003;348(24):2379–2385.
  • Romero R, Conde-Agudelo A, Da Fonseca E, et al. Vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in singleton gestations with a short cervix: a meta-analysis of individual patient data. Am J Obstet Gynecol. 2018;218(2):161–180.
  • Manuck TA, Henry E, Gibson J, et al. Pregnancy outcomes in a recurrent preterm birth prevention clinic. Am J Obstet Gynecol. 2011;204(4):320 e1–320 e6.
  • Behrman RE ,Butler AS. Institute of Medicine (US) Committee on understanding premature birth and assuring healthy outcomes. In: Behrman RE, Butler AS, editors. Societal costs of preterm birth. Preterm birth: causes, consequences, and prevention. Washington (DC): National Academies Press (US); 2007.
  • Hillemeier MM, Domino ME, Wells R, et al. Effects of maternity care coordination on pregnancy outcomes: propensity-weighted analyses. Matern Child Health J. 2015;19(1):121–127.