Screening for Gestational Diabetes Mellitus: Are the Criteria Proposed by the International Association of Diabetes and Pregnancy Study Groups Cost-Effective?
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Epidemiology/Health Services Research ORIGINAL ARTICLE Screening for Gestational Diabetes Mellitus: Are the Criteria Proposed by the International Association of Diabetes and Pregnancy Study Groups Cost-Effective? 1 3 ERIKA F. WERNER, MD, MS EDMUND F. FUNAI, MD The current screening criteria for 2 1 CHRISTIAN M. PETTKER, MD JANICE HENDERSON, MD 2 3 GDM were initially chosen to identify LISA ZUCKERWISE, MD STEPHEN F. THUNG, MD 2 patients at risk for developing diabetes MICHAEL REEL, MD, MBA after pregnancy and therefore identify a population that has a subsequent 50% d risk (1). However, the current application OBJECTIVE The International Association of Diabetes and Pregnancy Study Group of screening during pregnancy is princi- (IADPSG) recently recommended new criteria for diagnosing gestational diabetes mellitus pally used to identify pregnant women at (GDM). This study was undertaken to determine whether adopting the IADPSG criteria would be cost-effective, compared with the current standard of care. risk for adverse perinatal outcomes. Some groups have demonstrated that current RESEARCH DESIGN AND METHODSdWe developed a decision analysis model com- screening protocols fail to identify many paring the cost-utility of three strategies to identify GDM: 1) no screening, 2) current screening at-risk pregnancies (2,3). practice (1-h 50-g glucose challenge test between 24 and 28 weeks followed by 3-h 100-g glucose The Hyperglycemia and Adverse 3 tolerance test when indicated), or ) screening practice proposed by the IADPSG. Assumptions Pregnancy (HAPO) group sought to iden- included that 1) women diagnosed with GDM received additional prenatal monitoring, mitigating 2 tify new screening values that would the risks of preeclampsia, shoulder dystocia, and birth injury; and ) GDM women had opportunity better identify pregnancies at risk for for intensive postdelivery counseling and behavior modification to reduce future diabetes risks. The primary outcome measure was the incremental cost-effectiveness ratio (ICER). perinatal complications. The HAPO study demonstrated a positive linear relation- RESULTSdOur model demonstrates that the IADPSG recommendations are cost-effective ship between screening glucose values only when postdelivery care reduces diabetes incidence. For every 100,000 women screened, and adverse perinatal outcomes. Moreover, 6,178 quality adjusted life-years (QALYs) are gained, at a cost of $125,633,826. The ICER for the the study authors found that perinatal risks IADPSG strategy compared with the current standard was $20,336 per QALY gained. When began to increase in women with glucose postdelivery care was not accomplished, the IADPSG strategy was no longer cost-effective. These values previously considered ‘normal’ (2). results were robust in sensitivity analyses. Similar findings have been demonstrated CONCLUSIONSdThe IADPSG recommendation for glucose screening in pregnancy is cost- by others (3,7). As a result, the Interna- effective. The model is most sensitive to the likelihood of preventing future diabetes in patients tional Association of Diabetes and Preg- identified with GDM using postdelivery counseling and intervention. nancy Study Group (IADPSG) have recommended a new screening strategy for GDM incorporating the data provided by the HAPO study and others. However, estational diabetes mellitus (GDM) delivery, neonatal hyperbilirubinemia, such a modification of screening criteria re- Gaffects 2–5% of pregnant women in shoulder dystocia, and birth injury (2–5). mains controversial because there is no ran- the U.S., a prevalence that is increas- Recent studies have demonstrated that domized controlled trial to support the ing rapidly in the face of an obesity epi- screening for and managing GDM miti- change and the predicted prevalence of an demic (1). These pregnancies are at risk gates many of these pregnancy complica- “abnormal test” would increase from 2–5% for a host of obstetric complications includ- tions and improves perinatal outcomes in the U.S. to beyond 16% (1,10). As such, ing preeclampsia, preterm labor, cesarean (6–9). there is significant discordance in the adoption of the IADPSG recommendation ccccccccccccccccccccccccccccccccccccccccccccccccc between the American Diabetes Associa- tion, which has embraced these recom- 1 From the Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine, Baltimore, Mary- mendations, and the American College of land; the 2Department of Obstetrics, Gynecology, and Reproductive Science, Yale University, New Haven, Connecticut; and the 3Department of Obstetrics and Gynecology, The Ohio State University College of Obstetricians and Gynecologists, which Medicine, Columbus, Ohio. has not. Corresponding author: Erika F. Werner, [email protected]. The hesitation in accepting the Received 25 August 2011 and accepted 30 November 2011. IADPSG guidelines in the U.S. may be DOI: 10.2337/dc11-1643 because of the size of the cohort that © 2012 by the American Diabetes Association. Readers may use this article as long as the work is properly “ ” cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/ wouldnowbelabeledas at-risk for licenses/by-nc-nd/3.0/ for details. future diabetes. Health care costs would See accompanying brief report, p. XXX, and commentary, p. XXX. initially increase because these at-risk care.diabetesjournals.org DIABETES CARE 1 Diabetes Care Publish Ahead of Print, published online January 20, 2012 Cost and utility of the glucose tolerance test patients will require additional counseling RESEARCH DESIGN AND GTT between 24 and 28 weeks. In this on behavior modification and frequent METHODSdWe developed a decision strategy, only one elevated glucose value screening for progression to diabetes. tree model that compared the expected (fasting $92 mg/dL, 1 h $180 mg/dL, or However, by identifying these patients, costs and health outcomes of three possible 2h$153 mg/dL) was required to make a there may also be long-term cost savings. screening strategies for GDM in pregnant GDM diagnosis. We assumed that all Multiple studies, including several from women without a prior diagnosis of di- women identified as having GDM received the Diabetes Prevention Program Re- abetes, using TreeAge Pro 2011 (TreeAge similar interventions as strategy 2. search Group, demonstrate that intense Software, Williamstown, MA). These three The base-case estimates were chosen life-style modification can reduce the in- strategies are outlined in Fig. 1. In the first from data in the published literature. To cidence of future diabetes by as much as strategy, we assumed that all screening obtain these estimations, a bibliographic 50% in women previously diagnosed for GDM was deferred. In the second survey in PUBMED was performed using with GDM (11). strategy, a common standard of current the following search terms: gestational Given the many changes that adopt- care, women universally received a 50-g diabetes, pregestational diabetes, preg- ing a new strategy for GDM screening 1-h GCT between 24 and 28 weeks. nancy complications, preeclampsia, pre- may have on our health care system, it is Women who failed the initial screening term birth, shoulder dystocia, cesarean critical to assess the costs and effects of the GCT received a diagnostic 3-h 100-g section, diabetes reduction, cost, utility, approach, especially given the magnitude GTT. Women with at least two elevated and combinations of these terms. Point of an endeavor that would impact over values based upon the Carpenter and estimates were determined from meta- 4 million pregnant women and result in Coustan diagnostic criteria were classified analyses, randomized controlled trials, over 500,000 additional diagnoses of GDM as having GDM (cGDM) (1). GDM women and prospective cohorts when possible. annually in the U.S. alone. To explore this received interventions including nutri- Retrospective cohorts, expert opinions, problem, we developed a cost-utility model tional counseling, instruction and sup- or internal data from our institution were with three glucose screening strategies plies for home glucose monitoring, used when no other sources of informa- in pregnancy: 1) no screening, 2) current antenatal surveillance (including fetal ul- tion were available. The probability esti- screening practice (screening 1-h 50-g glu- trasound in the third trimester and non- mates and references used in support cose challenge test [GCT] between 24 stress testing), as well as insulin therapy of our model are reported in Table 1. Be- and 28 weeks followed by a 3-h 100-g glu- when needed. After pregnancy, GDM cause much of the data were garnered cose tolerance test [GTT] when indicated), women received postpartum screening from randomized controlled trials, patient or 3) screening practice proposed by the for diabetes as well as intensive exercise compliance was incorporated in the source IADPSG (first prenatal visit fasting glu- and nutrition counseling. If they were data. cose, followed by a 2-h 75-g GTT between found to not have diabetes at their initial We stratified the risk of pregnancy 24 and 28 weeks when indicated). We postpartum screening, their glycemic sta- complications by the severity of glucose chose to include a no-screening strategy tus was evaluated every 3 years. In strategy intolerance. Although all women diag- because universal GDM screening has 3, proposed by the IADPSG, clinicians nosed for the first time during pregnancy never been endorsed by U.S. Preventative