Protocol for cost-effectiveness analysis of a randomised trial of mHealth coaching (Bump2Baby and Me) compared with usual care for healthy gestational weight gain and postnatal outcomes in at-risk women and their offspring in the UK, Australia, Ireland and Spain.

INTRODUCTION: Gestational diabetes mellitus and overweight are associated with an increased likelihood of complications during birth and for the newborn baby. These complications lead to increased immediate and long-term healthcare costs as well as reduced health and well-being in women and infants. This protocol presents the health economic evaluation to investigate the cost-effectiveness of Bump2Baby and Me (B2B&Me), which is a health coaching intervention delivered via smartphone to women at risk of gestational diabetes. METHODS AND ANALYSIS: Using data from the B2B&Me randomised controlled trial, this economic evaluation compares costs and health effects between the intervention and control group as an incremental cost-effectiveness ratio. Direct healthcare costs, costs of pharmaceuticals and intervention costs will be included in the analysis, body weight and quality-adjusted life-years for the mother will serve as the effect outcomes. To investigate the long-term cost-effectiveness of the trial, a Markov model will be employed. Deterministic and probabilistic sensitivity analysis will be employed. ETHICS AND DISSEMINATION: The National Maternity Hospital Human Research and Ethics Committee was the primary approval site (EC18.2020) with approvals from University College Dublin HREC-Sciences (LS-E-20-150-OReilly), Junta de Andalucia CEIM/CEI Provincial de Granada (2087-M1-22), Monash Health HREC (RES-20-0000-892A) and National Health Service Health Research Authority and Health and Care Research Wales (HCRW) (21/WA/0022). The results from the analysis will be disseminated in scientific papers, through conference presentations and through different channels for communication within the project. TRIAL REGISTRATION NUMBER: ACTRN12620001240932.

Cost-effectiveness analysis of metformin versus insulin in the treatment of gestational diabetes mellitus.

OBJECTIVE: Although there have been many studies on gestational diabetes mellitus (GDM) treatment, there is still a knowledge gap regarding the comparative cost-effectiveness of metformin and insulin in the treatment phase. Existing studies have focused on treatment efficacy and drug safety, but relatively little has been explored regarding cost-effectiveness analysis. In particular, no comprehensive study has evaluated the cost-effectiveness of metformin and insulin for GDM treatment. Therefore, this study aimed to fill this knowledge gap by conducting a cost-effectiveness analysis of these two treatments for GDM. METHODS: A decision-analytic model was used to compare the cost-effectiveness of metformin and insulin in China. Probabilities, costs, and utilities were derived from the literature. The cost and quality-adjusted life years (QALYs) were calculated using the roll-back method. The strategy was considered cost-effective if the incremental cost-effectiveness ratio (ICER) was below the willingness-to-pay (WTP) threshold of ¥242,938 per QALY. Sensitivity analyses were also conducted to assess the robustness of the results. RESULTS: The roll-back analysis indicated that insulin was not cost-effective compared to metformin, resulting in increased costs and decreased QALYs, with a negative ICER. These findings suggested that metformin is a cost-effective option than insulin. Furthermore, the sensitivity analysis showed that the model was robust. CONCLUSIONS: Compared with insulin, metformin is a cost-effective treatment option for GDM.

Exploring Structural Uncertainty in Cost-Effectiveness Modeling of Gestational Diabetes Screening: An Application Example from Norway.

BACKGROUND: Screening pregnant women for gestational diabetes mellitus (GDM) has recently been expanded in Norway, although screening eligibility criteria continue to be debated. We aimed to compare the cost-effectiveness of alternative GDM screening strategies and explored structural uncertainty and the value of future research in determining the most cost-effective eligibility criteria for GDM screening in Norway. DESIGN: We developed a probabilistic decision tree to estimate the total costs and health benefits (i.e., quality-adjusted life-years; QALYs) associated with 4 GDM screening strategies (universal, current guidelines, high-risk, and no screening). We identified the most cost-effective strategy as the strategy with the highest incremental cost-effectiveness ratio below a Norwegian benchmark for cost-effectiveness ($28,400/QALY). We excluded inconclusive evidence on the effects of screening on later maternal type 2 diabetes mellitus (T2DM) in the primary analysis but included this outcome in a secondary analysis using 2 different sources of evidence (i.e., Cochrane or US Preventive Services Task Force). To quantify decision uncertainty, we conducted scenario analysis and value-of-information analyses. RESULTS: Current screening recommendations were considered inefficient in all analyses, while universal screening was most cost-effective in our primary analysis ($26,014/QALY gained) and remained most cost-effective when we assumed a preventive effect of GDM treatment on T2DM. When we assumed no preventive effect, high-risk screening was preferred ($19,115/QALY gained). When we assumed GDM screening does not prevent perinatal death in scenario analysis, all strategies except no screening exceeded the cost-effectiveness benchmark. In most analyses, decision uncertainty was high. CONCLUSIONS: The most cost-effective screening strategy, ranging from no screening to universal screening, depended on the source and inclusion of GDM treatment effects on perinatal death and T2DM. Further research on these long-term outcomes could reduce decision uncertainty. HIGHLIGHTS: This article analyses the cost-effectiveness of 4 alternative gestational diabetes mellitus (GDM) screening strategies in Norway: universal screening, current (broad) screening, high-risk screening, and no screening.The current Norwegian screening recommendations were considered inefficient under all analyses.The most cost-effective screening strategy ranged from no screening to universal screening depending on the source and inclusion of GDM treatment effects on later maternal diabetes and perinatal death.The parameters related to later maternal diabetes and perinatal death accounted for most of the decision uncertainty.

Health service use and health system costs associated with diabetes during pregnancy in Australia.

BACKGROUND AND AIMS: In the context of the rising rate of diabetes in pregnancy in Australia, this study aims to examine the health service and resource use associated with diabetes during pregnancy. METHODS AND RESULTS: This project utilised a linked administrative dataset containing health and cost data for all mothers who gave birth in Queensland, Australia between 2012 and 2015 (n = 186,789, plus their babies, n = 189,909). The association between maternal characteristics and diabetes status were compared with chi-square analyses. Multiple logistic regression produced the odds ratio of having different outcomes for women who had diabetes compared to women who did not. A two-sample t-test compared the mean number of health services accessed. Generalised linear regression produced the mean costs associated with health service use. Mothers who had diabetes during pregnancy were more likely to have their labour induced at <38 weeks gestation (OR:1.39, 95% CI:1.29-1.50); have a cesarean section (OR: 1.26, 95% CI:1.22-1.31); have a preterm birth (OR:1.24, 95%: 1.18-1.32); have their baby admitted to a Special Care Nursery (OR: 2.34, 95% CI:2.26-2.43) and a Neonatal Intensive Care Unit (OR:1.25, 95%CI: 1.14-1.37). On average, mothers with diabetes access health services on more occasions during pregnancy (54.4) compared to mothers without (50.5). Total government expenditure on mothers with diabetes over the first 1000 days of the perinatal journey was significantly higher than in mothers without diabetes ($12,757 and $11,332). CONCLUSION: Overall, mothers that have diabetes in pregnancy require greater health care and resource use than mothers without diabetes in pregnancy.

Economic Evaluations of Gestational Diabetes Mellitus Screening: A Systematic Review.

BACKGROUND: This study aims to find evidence of the cost-effectiveness of gestational diabetes mellitus (GDM) screening and assess the quality of current economic evaluations, which have shown different conclusions with a variation in screening methods, data sources, outcome indicators, and implementation in diverse organizational contexts. METHODS: Embase, Medline, Web of Science, Health Technology Assessment, database, and National Health Service Economic Evaluation Database databases were searched through June 2019. Studies on economic evaluation reporting both cost and health outcomes of GDM screening programs in English language were selected, and the quality of the studies was assessed using Drummond's checklist. The general characteristics, main assumptions, and results of the economic evaluations were summarized. RESULTS: Our search yielded 10 eligible economic evaluations with different screening strategies compared in different settings and perspectives. The selected papers scored 81% (68-97%) on the items in Drummond's checklist on average. In general, a screening program is cost-effective or even dominant over no screening. The one-step screening, with more cases detected, is more likely to be cost-effective than the two-step screening. Universal screening is more likely to be cost-effective than screening targeting the high-risk population. Parameters affecting cost-effectiveness include: diagnosis criteria, epidemiological characteristics of the population, efficacy of screening and treatment, and costs. CONCLUSIONS: Most studies found GDM screening to be cost-effective, though uncertainties remain due to many factors. The quality assessment identified weaknesses in the economic evaluations in terms of integrating existing data, measuring costs and consequences, analyzing perspectives, and adjusting for uncertainties.

Within-trial cost-effectiveness of lifestyle intervention using a 3-tier shared care approach for pregnancy outcomes in Chinese women with gestational diabetes.

This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM). SC consisted of an individualized dietary advice and physical activity counseling program. The UC was a one-time group education program. The effectiveness was measured by number needed to treat (NNT) to prevent one macrosomia/large for gestational age (LGA) infant. The cost-effectiveness was measured by incremental cost-effectiveness ratio in terms of cost (2012 Chinese Yuan/US dollar) per case of macrosomia and LGA prevented. The study took both a health care system and a societal perspective. This study found that the NNT was 16/14 for macrosomia/LGA. The incremental cost for treating a pregnant woman was ¥1,877 ($298) from a health care system perspective and ¥2,056 ($327) from a societal perspective. The cost of preventing a case of macrosomia/LGA from the two corresponding perspectives were ¥30,032/¥26,278 ($4,775/$4,178) and ¥32,896/¥28,784 ($5,230/$4,577), respectively. Considering the potential severe adverse health and economic consequences of a macrosomia/LGA infant, our findings suggest that implementing this lifestyle intervention for women with GDM is an efficient use of health care resources.

Barriers and facilitating factors in the prevention of diabetes type 2 and gestational diabetes in vulnerable groups: A scoping review.

AIMS: Type 2 diabetes mellitus (T2DM) and gestational diabetes (GDM) are globally on the rise, accompanied by comorbidities and associated health costs. Increased physical activity, healthy nutrition, and weight loss have shown the potential to prevent T2DM/GDM. Despite this, reaching vulnerable groups remains a key challenge. The aim of this scoping review was to identify barriers and facilitating factors in the prevention of T2DM/GDM in vulnerable groups. METHODS: We conducted a systematic literature search in May 2018, updated in September 2019, in several databases (e.g. PubMed, Embase) to identify barriers and facilitating factors in the prevention of T2DM/GDM in vulnerable groups. Two reviewers independently screened the results. Extracted data was charted, categorized, and summarized. RESULTS: We included 125 articles. Ninety-eight studies were extracted, and eight categories of barriers and facilitating factors were formed. The most common categories of barriers were limited knowledge, family/friends, and economic factors, and the most common categories of facilitating factors were family/friends, social support, and knowledge. CONCLUSION: This scoping review identified various barriers and facilitating factors in vulnerable groups. Preventive interventions should consider these barriers and facilitating factors in developing preventive interventions or in adapting existing ones.

Are Lifestyle Interventions to Reduce Excessive Gestational Weight Gain Cost Effective? A Systematic Review.

PURPOSE OF REVIEW: Lifestyle interventions (such as diet and physical activity) successfully limit excessive gestational weight gain and can reduce some adverse maternal events; however, benefit is variable and cost-effectiveness remains unclear. We aimed to review published cost-effectiveness analyses of lifestyle interventions compared with usual care on clinically relevant outcome measures. Five international and six grey-literature databases were searched from 2007 to 2018. Articles were assessed for quality of reporting. Data were extracted from healthcare and societal perspectives. Costs were adapted to the common currencies of Australia and the United Kingdom by adjusting for resource utilization, healthcare purchase price and changes in costs over time. Included studies were economic analyses of lifestyle interventions aiming to limit weight-gain during pregnancy and/or reduce risk of gestational diabetes, for women with a BMI of 25 or greater in pre- or early-pregnancy. RECENT FINDINGS: Of the 538 articles identified, six were retained for review: one modelling study and five studies in which an economic analysis was performed alongside a randomized-controlled trial. Outcome measures included infant birth-weight, fasting glucose, insulin resistance, gestational weight-gain, infant respiratory distress syndrome, perceived health, cost per case of adverse outcome avoided and quality-adjusted life years (QALYs). Interventions were cost-effective in only one study. Although many studies have investigated the efficacy of lifestyle interventions in pregnancy, few have included cost-effectiveness analyses. Where cost-effectiveness studies were undertaken, results were inconsistent. Secondary meta-analysis, taxonomy and framework research is now required to determine the effective components of lifestyle interventions and to guide future cost-effectiveness analyses.

Demonstrated Cost-Effectiveness of a Telehomecare Program for Gestational Diabetes Mellitus Management.

Background: Prevalence of gestational diabetes mellitus (GDM) has increased steadily in recent years. Pregnant women with GDM are at risk for obstetrical and neonatal complications and require close multidisciplinary follow-up, which implies a significant use of hospital resources. Methods: A prospective noninferiority and controlled clinical trial was designed. The telehomecare (THCa) initiative is a clinical remote patient management project in women with GDM. The main objective was to evaluate the cost-effectiveness of THCa by assessing the direct costs, including the related reduction in medical visits. Secondary outcomes were to evaluate the impact of THCa on diabetes control, GDM-related complications, and patient satisfaction. Results: A total of 161 women were assigned to either an intervention group provided with a THCa system for transmission and online analysis of capillary glucose data (n = 80) or a control group receiving usual care in the clinic (n = 81). A decrease in medical visits by 56% (P < 0.001) in the THCa group was observed. There was no difference between the two groups in diabetes control or maternal and fetal complications. However, results showed a 10-fold increase in nursing interventions in THCa group (mainly by phone calls and e-mails). Satisfaction with care was high. Direct cost analysis revealed savings of 16% in patients followed by THCa compared with the control group. Conclusion: THCa monitoring significantly decreases medical visits and direct costs in GDM women without compromising pregnancy outcomes, quality of care, or patient satisfaction. THCa was shown to be cost-effective despite placing an additional burden on nursing time.

Diagnostic Strategies for Gestational Diabetes Mellitus: Review of Current Evidence.

PURPOSE OF REVIEW: Currently, the diagnosis of gestational diabetes mellitus (GDM) lacks uniformity. Several controversies are still under debate, especially on the method of screening and diagnosis. This review focuses on recent literature and provides current evidence for the screening and diagnosis of GDM. RECENT FINDINGS: Selective screening would miss a significant number of women with GDM. In contrast, universal screening has been shown to be cost-effective, compared with selective screening, and is recommended by many medical societies. For the diagnostic methods for GDM, most observational cohort studies reported that the one-step method is associated with improved pregnancy outcomes and is cost-saving or cost-effective, compared with the two-step method, although these findings should be confirmed in the upcoming randomized controlled trials which compare the performance of one-step and two-step methods. On the other hand, the methods of early screening or diagnosis of GDM are varied, and current evidence does not justify their use during early pregnancy. In conclusion, current evidence favors universal screening for GDM using the one-step method. Early screening for GDM is not favorably supported by the literature.

Short-term health and economic burden of gestational diabetes mellitus in Mexico: A modeling study.

AIM: To estimate the annual burden of gestational diabetes mellitus (GDM) in Mexico. METHODS: A model was built to conduct estimates from a healthcare system perspective, namely, the incremental costs of GDM pregnancy compared with non-GDM pregnancy from the first trimester until childbirth. The model used probabilities from the literature and surveys, and costs obtained from the Ministry of Health and national healthcare institutions. Scenario analyses were performed to estimate the GDM burden at different levels of incidence. RESULTS: Although a non-GDM pregnancy cost on average USD 1880.6 (low risk was USD 1043.9 and high risk was USD 1673.5), a pregnancy with GDM cost USD 2934.9. Therefore, the total additional cost was USD 1576.2 per case. Given the considerable variability of the GDM incidence in Mexico, the total burden could range from USD 86.8 to USD 827.4 million per year. CONCLUSIONS: GDM is one of the most frequent complications of pregnancy, but research has been insufficient regarding its epidemiological and economic burden in Latin America. This paper shows that the GDM economic burden in Mexico is substantial despite only accounting for short-term medical costs. Further research to assess the GDM incidence and evaluate its long-term consequences from a broader societal perspective in Mexico is recommended.

Influence of different diagnostic criteria on gestational diabetes mellitus incidence and medical expenditures in China.

AIMS/INTRODUCTION: To summarize the development of the criteria for diagnosing gestational diabetes mellitus (GDM) in China, and investigate how different GDM diagnostic criteria influence the national prevalence of GDM, the national health system and the economic burden of GDM in China. MATERIALS AND METHODS: Retrospectively using data from women undergoing a 2-h, 75-g oral glucose tolerance test at 24-28 gestational weeks in the First Affiliated Hospital of Jinan University (Guangzhou, Guangdong, China) from January 2011 to December 2017, the prevalence rate of GDM and its impacts on the national health system were evaluated using different criteria (the 7th edition textbook criteria, National Diabetes Data Group 1979, World Health Organization 1985, European Association for the Study of Diabetes 1996, Japan 2002, American Diabetes Association [ADA] 2011 [International Association of the Diabetes and Pregnancy Study Groups], and National Institute for Heath and Care Excellence 2015). RESULTS: The incidence rates of GDM based on the ADA 2011 and National Institute for Heath and Care Excellence 2015 were, respectively, 22.94% (P < 0.01) and 21.72% (P < 0.01), over threefold higher than implementing the 7th edition textbook criteria (P < 0.001). On the contrary, the incidence rates of GDM diagnosed with the National Diabetes Data Group 1979 and World Health Organization 1985 guidelines were significantly less than the 7th edition textbook criteria (P < 0.001). From 2001 to 2016, the estimated national cost of treating GDM rose from ¥3.9 billion to ¥27.4 billion after implementing the ADA 2011 guidelines. CONCLUSIONS: With the implementation of ADA 2011 (International Association of the Diabetes and Pregnancy Study Groups) guidelines, there are fewer adverse perinatal outcomes and cases of type 2 diabetes mellitus in the long term, but the medical costs increased significantly, and the cost-effectiveness of diagnostic criteria in China is still yet to be confirmed.

Implications of the introduction of new criteria for the diagnosis of gestational diabetes: a health outcome and cost of care analysis.

OBJECTIVE: To identify effects on health outcomes from implementing new criteria diagnosing gestational diabetes mellitus(GDM) and to analyse costs-of-care associated with this change. DESIGN: Quasi-experimental study comparing data from the calendar year before (2014) and after (2016) the change. SETTING: Single, tertiary-level, university-affiliated, maternity hospital. PARTICIPANTS: All women giving birth in the hospital, excluding those with pre-existing diabetes or multiple pregnancy. MAIN OUTCOME MEASURES: Primary outcomes were caesarean section, birth weight >90th percentile for gestation, hypertensive disorder of pregnancy and preterm birth less than 37 weeks. A number of secondary outcomes reported to be associated with GDM were also analysed.Care packages were derived for those without GDM, diet-controlled GDM and GDM requiring insulin. The institutional Business Reporting Unit data for average occasions of service, pharmacy schedule for the costs of consumables and medications, and Medicare Benefits Schedule ultrasound services were used for costing each package. All costs were estimated in figures from the end of 2016 negating the need to adjust for Consumer Price Index increases. RESULTS: There was an increase in annual incidence of GDM of 74% without overall improvements in primary health outcomes. This incurred a net cost increase of AUD$560 093. Babies of women with GDM had lower rates of neonatal hypoglycaemia and special care nursery admissions after the change, suggesting a milder spectrum of disease. CONCLUSION: New criteria for the diagnosis of GDM have increased the incidence of GDM and the overall cost of GDM care. Without obvious changes in short-term outcomes, validation over other systems of diagnosis may require longer term studies in cohorts using universal screening and treatment under these criteria.

Cost-effectiveness of controlling gestational diabetes mellitus: a systematic review.

OBJECTIVE: Timely screening for hyperglycaemia in pregnancy using a simple glucose test enhances early detection and control of gestational diabetes mellitus (GDM). The aim of this study was to provide an overview of the evidence on the cost-effectiveness of identification and/or treatment of GDM. METHODS: We conducted a systematic review using three electronic databases (PubMed, EMBASE, and Cochrane) of cost-effectiveness studies of GDM screening and treatment published during 2000-2017. RESULTS: The initial search discovered 287 references (PubMed 86, EMBASE 195, Cochrane library 6) of which six full articles were included in the review. Two articles were model-based analysis and the remaining four were trial based. Two studies demonstrated favorable cost-effectiveness of intensified management of mild GDM. In the other included studies, neither screening nor treatment of GDM was shown to be cost effective, although results varied with the particular outcome measures used and the assumptions that where applied. CONCLUSION: Neither screening nor treating GDM seems to be convincingly cost-effective from the studies reviewed. However, all studies were done in high-income countries with obviously different health systems than low-/middle-income countries (LMIC) have. Since detection of GDM may be relatively poor in LMIC, screening might be more worthwhile in these countries. Comprehensive research is necessary in LMIC, including the potential outcomes of assessing its cost-effectiveness. Favorable cost-effectiveness could help in bridging the need for and access to increased diabetes screening in early pregnancy in these countries.

Impact of maternal income on the risk of gestational diabetes mellitus in primiparous women.

AIMS: Findings concerning the impact of socio-economic status on the risk of gestational diabetes mellitus (GDM) are inconclusive and little is known about the simultaneous impact of income and educational attainment on the risk of GDM. This study aims to assess the impact of maternal prepregnancy income in combination with traditional GDM risk factors on the incidence of GDM in primiparous women. METHODS: This is an observational cohort study including 5962 Finnish women aged ≥ 20 years from the city of Vantaa, Finland, who delivered for the first time between 2009 and 2015, excluding women with pre-existing diabetes mellitus. The Finnish Medical Birth Register, Finnish Tax Administration, Statistics Finland, Social Insurance Institution of Finland and patient healthcare records provided data for the study. We divided the study population according to five maternal income levels and four educational attainment levels. RESULTS: Incidence of GDM decreased with increasing income level in primiparous women (P < 0.001 for linearity, adjusted for smoking, age, BMI and cohabiting status). In an adjusted two-way model, the relationship was significant for both income (P = 0.007) and education (P = 0.039), but there was no interaction between income and education (P = 0.52). CONCLUSIONS: There was an inverse relationship between both maternal prepregnancy taxable income and educational attainment, and the risk of GDM in primiparous Finnish women.

A systematic review on costs and cost-effectiveness of screening and prevention of type 2 diabetes in women with prior gestational diabetes: Exploring uncharted territory.

AIMS: Women with gestational diabetes mellitus (GDM) are more likely to develop type 2 diabetes mellitus (T2DM) as compared to women with normoglycemic pregnancies. This study aims to explore the literature on cost(-effectiveness) of screening and prevention of T2DM in women with prior GDM. METHODS: Five databases were systematically searched, inclusion criteria were: (1) women with (prior) GDM; (2) post-partum screening or prevention of T2DM; and (3) health-economic evaluations. No year limits were applied. English, Dutch, French or German publications were included. Quality was assessed using the Consensus Health Economic Criteria checklist. RESULTS: Two cost-effectiveness analyses and two cost analyses were found. One study evaluated nine screening strategies. Three studies evaluated one prevention strategy each: intensive diet and behavioural modification; annual counseling; and an annual dietary consultation. Methodological quality was poor. Perspectives were unclear, time horizons were too short, and no incremental analyses were performed. CONCLUSION: An oral glucose tolerance test per three years leads to the lowest cost per case detected, and prevention is potentially cost-effective or cost-saving. More health economic evaluations are needed that compare all relevant alternatives, including 'doing nothing'.

Optimal Obstetric Management for Women with Diabetes: the Benefits and Costs of Fetal Surveillance.

PURPOSE OF REVIEW: To elaborate on the risks and benefits associated with antenatal fetal surveillance for stillbirth prevention in women with diabetes. RECENT FINDINGS: Women with pregestational diabetes have a 3- to 5-fold increased odds of stillbirth compared to women without diabetes. The stillbirth risk in women with gestational diabetes (GDM) is more controversial; while recent data suggest the odds for stillbirth are approximately 50% higher in women with GDM at term (37 weeks and beyond) than in those without GDM, it is unclear if this risk is seen in women with optimal glycemic control. Current professional society guidelines are broad with respect to fetal testing strategies and delivery timing in women with diabetes. The data supporting strategies to reduce the risk of stillbirth in women with diabetes are limited. Antepartum fetal surveillance should be performed to reduce stillbirth rates; however, the optimal test, frequency of testing, and delivery timing are not yet clear. Future studies of obstetric management for women with diabetes should consider not just individual but also system level costs and benefits associated with antenatal surveillance.

Cost-effectiveness of healthy eating and/or physical activity promotion in pregnant women at increased risk of gestational diabetes mellitus: economic evaluation alongside the DALI study, a European multicenter randomized controlled trial.

BACKGROUND: Gestational diabetes mellitus (GDM) is associated with perinatal health risks to both mother and offspring, and represents a large economic burden. The DALI study is a multicenter randomized controlled trial, undertaken to add to the knowledge base on the effectiveness of interventions for pregnant women at increased risk for GDM. The purpose of this study was to evaluate the cost-effectiveness of the healthy eating and/or physical activity promotion intervention compared to usual care among pregnant women at increased risk of GDM from a societal perspective. METHODS: An economic evaluation was performed alongside a European multicenter-randomized controlled trial. A total of 435 pregnant women at increased risk of GDM in primary and secondary care settings in nine European countries, were recruited and randomly allocated to a healthy eating and physical activity promotion intervention (HE + PA intervention), a healthy eating promotion intervention (HE intervention), or a physical activity promotion intervention (PA intervention). Main outcome measures were gestational weight gain, fasting glucose, insulin resistance (HOMA-IR), quality adjusted life years (QALYs), and societal costs. RESULTS: Between-group total cost and effect differences were not significant, besides significantly less gestational weight gain in the HE + PA group compared with the usual care group at 35-37 weeks (-2.3;95%CI:-3.7;-0.9). Cost-effectiveness acceptability curves indicated that the HE + PA intervention was the preferred intervention strategy. At 35-37 weeks, it depends on the decision-makers' willingness to pay per kilogram reduction in gestational weight gain whether the HE + PA intervention is cost-effective for gestational weight gain, whereas it was not cost-effective for fasting glucose and HOMA-IR. After delivery, the HE + PA intervention was cost-effective for QALYs, which was predominantly caused by a large reduction in delivery-related costs. CONCLUSIONS: Healthy eating and physical activity promotion was found to be the preferred strategy for limiting gestational weight gain. As this intervention was cost-effective for QALYs after delivery, this study lends support for broad implementation. TRIAL REGISTRATION: ISRCTN ISRCTN70595832 . Registered 2 December 2011.

The short-term economic burden of gestational diabetes mellitus in Italy.

BACKGROUND: The incidence of Gestational Diabetes Mellitus (GDM) is rising in all developed countries. This study aimed at assessing the short-term economic burden of GDM from the Italian healthcare system perspective. METHODS: A model was built over the last pregnancy trimester (i.e., from the 28th gestational week until childbirth included). The National Hospital Discharge Database (2014) was accessed to estimate delivery outcome probabilities and inpatient costs in GDM and normal pregnancies (i.e., euglycemia). International Classification of Disease-9th Revision-Clinical Modification (ICD9-CM) diagnostic codes and Diagnosis-Related Group (DRG) codes were used to identify GDM cases and different types of delivery (i.e., vaginal or cesarean) within the database. Neonatal outcomes probabilities were estimated from the literature and included macrosomia, hypoglycemia, hyperbilirubinemia, shoulder dystocia, respiratory distress, and brachial plexus injury. Additional data sources such as regional documents, official price and tariff lists, national statistics and expert opinion were used to populate the model. The average cost per case was calculated at national level to estimate the annual economic burden of GDM. One-way sensitivity analyses and Monte Carlo simulations were performed to quantify the uncertainty around base case results. RESULTS: The amount of pregnancies complicated by GDM in Italy was assessed at 54,783 in 2014 using a prevalence rate of 10.9%. The antenatal outpatient cost per case was estimated at €43.7 in normal pregnancies compared to €370.6 in GDM patients, which is equivalent to a weighted sum of insulin- (14%; €1034.6) and diet- (86%; €262.5) treated women's costs. Inpatient delivery costs were assessed at €1601.6 and €1150.3 for euglycemic women and their infants, and at €1835.0 and €1407.7 for GDM women and their infants, respectively. Thus, the overall cost per case difference between GDM and normal pregnancies was equal to €817.8 (+ 29.2%), resulting in an economic burden of about €44.8 million in 2014 at national level. Probabilistic sensitivity analysis yielded a cost per case difference ranging between €464.9 and €1164.8 in 80% of simulations. CONCLUSIONS: The economic burden of GDM in Italy is substantial even accounting for short-term medical costs only. Future research also addressing long-term consequences from a broader societal perspective is recommended.

The short-term health and economic burden of gestational diabetes mellitus in China: a modelling study.

OBJECTIVES: Gestational diabetes mellitus (GDM) is associated with a higher risk for adverse health outcomes during pregnancy and delivery for both mothers and babies. This study aims to assess the short-term health and economic burden of GDM in China in 2015. DESIGN: Using TreeAge Pro, an analytical decision model was built to estimate the incremental costs and quality-of-life loss due to GDM, in comparison with pregnancy without GDM from the 28th gestational week until and including childbirth. The model was populated with probabilities and costs based on current literature, clinical guidelines, price lists and expert interviews. Deterministic and probabilistic sensitivity analyses were performed to test the robustness of the results. PARTICIPANTS: Chinese population who gave birth in 2015. RESULTS: On average, the cost of a pregnancy with GDM was ¥6677.37 (in 2015 international $1929.87) more (+95%) than a pregnancy without GDM, due to additional expenses during both the pregnancy and delivery: ¥4421.49 for GDM diagnosis and treatment, ¥1340.94 (+26%) for the mother's complications and ¥914.94 (+52%) for neonatal complications. In China, 16.5 million babies were born in 2015. Given a GDM prevalence of 17.5%, the number of pregnancies affected by GDM was estimated at 2.90 million in 2015. Therefore, the annual societal economic burden of GDM was estimated to be ¥19.36 billion (international $5.59 billion). Sensitivity analyses were used to confirm the robustness of the results. Incremental health losses were estimated to be approximately 260 000 quality-adjusted life years. CONCLUSION: In China, the GDM economic burden is significant, even in the short-term perspective and deserves more attention and awareness. Our findings indicate a clear need to implement GDM prevention and treatment strategies at a national level in order to reduce the economic and health burden at both the population and individual levels.