Dataset Information

A cost-effectiveness comparison of the NICE 2015 and WHO 2013 diagnostic criteria for women with gestational diabetes with and without risk factors.

ABSTRACT:

Objectives

To compare the cost-effectiveness (CE) of the National Institute for Health and Care Excellence (NICE) 2015 and the WHO 2013 diagnostic thresholds for gestational diabetes mellitus (GDM).

Setting

The analysis was from the perspective of the National Health Service in England and Wales.

Participants

6221 patients from four of the Hyperglycaemia and Adverse Pregnancy Outcomes (HAPO) study centres (two UK, two Australian), 6308 patients from the Atlantic Diabetes in Pregnancy study and 12?755 patients from UK clinical practice.

Primary and secondary outcome measures planned

The incremental cost per quality-adjusted life year (QALY), net monetary benefit (NMB) and the probability of being cost-effective at CE thresholds of £20?000 and £30?000 per QALY.

Results

In a population of pregnant women from the four HAPO study centres and using NICE-defined risk factors for GDM, diagnosing GDM using NICE 2015 criteria had an NMB of £239?902 (relative to no treatment) at a CE threshold of £30?000 per QALY compared with WHO 2013 criteria, which had an NMB of £186?675. NICE 2015 criteria had a 51.5% probability of being cost-effective compared with the WHO 2013 diagnostic criteria, which had a 27.6% probability of being cost-effective (no treatment had a 21.0% probability of being cost-effective). For women without NICE risk factors in this population, the NMBs for NICE 2015 and WHO 2013 criteria were both negative relative to no treatment and no treatment had a 78.1% probability of being cost-effective.

Conclusion

The NICE 2015 diagnostic criteria for GDM can be considered cost-effective relative to the WHO 2013 alternative at a CE threshold of £30?000 per QALY. Universal screening for GDM was not found to be cost-effective relative to screening based on NICE risk factors.

SUBMITTER: Jacklin PB

PROVIDER: S-EPMC5629715 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Publications

A cost-effectiveness comparison of the NICE 2015 and WHO 2013 diagnostic criteria for women with gestational diabetes with and without risk factors.

Jacklin Paul Brian PB Maresh Michael Ja MJ Patterson Chris C CC Stanley Katharine P KP Dornhorst Anne A Burman-Roy Shona S Bilous Rudy W RW

BMJ open 20170811 8

<h4>Objectives</h4>To compare the cost-effectiveness (CE) of the National Institute for Health and Care Excellence (NICE) 2015 and the WHO 2013 diagnostic thresholds for gestational diabetes mellitus (GDM).<h4>Setting</h4>The analysis was from the perspective of the National Health Service in England and Wales.<h4>Participants</h4>6221 patients from four of the Hyperglycaemia and Adverse Pregnancy Outcomes (HAPO) study centres (two UK, two Australian), 6308 patients from the Atlantic Diabetes in ...[more]

PMID: 28801424

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Project description:BACKGROUND:In response to concerns that the International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria labeled too many women with gestational diabetes mellitus (GDM) without evidence of clinical or economic benefit, NICE recommended a change in diagnostic criteria in 2015. AIM:To compare diabetes associated maternal and neonatal complications in pregnancies complicated by GDM diagnosed using IADPSG criteria only, to those with GDM diagnosed using both IADPSG and NICE 2015 criteria. GDM screening was risk factor based. METHODS:This was a secondary analysis of a trial of women with GDM diagnosed by the IADPSG criteria (fasting blood glucose (BG) ? 5.1 mmol/L, 1 h ? 10.0 mmol/L and 2 h ? 8.5 mmol/L). Outcomes were compared for two groups: NICE + IADPSG defined as those with GDM diagnosed by both the NICE 2015 and IADPSG criteria (fasting BG ? 5.6 mmol/L, 2 h ? 8.5 mmol/L); and IADPSG-ONLY (fasting BG 5.1 mmol/L to 5.5 mmol/L, and/or 1-hour ?10.0 mmol/L, and 2 h ? 8.5 mmol/L). We were not able to obtain data for women with a 2-h value between BG 7.8?8.4 mmol/L (i.e., NICE-ONLY; NICE 2015 positive and IADPSG negative). All women were treated for GDM using targets of fasting BG < 5.3 mmol/L and 1-h post prandial BG < 7.8 mmol/L respectively. RESULTS:Of 159 women, 65 (40.9%) were NICE + IADPSG and 94 (59.1%) IADPSG-ONLY. Hypoglycaemic medication use was similar in both groups: 52.3% NICE + IADPSG, 46.8% IADPSG-ONLY, OR 1.0 (0.5?1.9). The IADPSG-ONLY group delivered later than the NICE + IADPSG group; 39.0 weeks (sd 1.4) compared to 38.2 weeks (sd 2.5), p value 0.02. Fewer caesarean sections occurred in IADPSG-ONLY group 30.9% vs. 52.3%, OR 0.4 (0.2?0.9). Birthweight, large for gestational age, and other neonatal complications were not significantly different between groups. CONCLUSIONS:Gestational diabetes-associated perinatal complications were similar in both groups. The IADPSG criteria detect women with evidence of ongoing hyperglycaemia who may benefit from treatment during pregnancy.

Project description:ObjectiveTo evaluate the predictability of gestational diabetes mellitus wth a 75 g oral glucose tolerance test (OGTT) in early pregnancy, based on the 2013 criteria of the World Health Organization, and to test newly proposed cut-off values.DesignInternational, prospective, multicentre cohort study.SettingSix university or cantonal departments in Austria, Germany, and Switzerland, from 1 May 2016 to 31 January 2019.ParticipantsLow risk cohort of 829 participants aged 18-45 years with singleton pregnancies attending first trimester screening and consenting to have an early 75 g OGTT at 12-15 weeks of gestation. Participants and healthcare providers were blinded to the results.Main outcome measuresFasting, one hour, and two hour plasma glucose concentrations after an early 75 g OGTT (12-15 weeks of gestation) and a late 75 g OGTT (24-28 weeks of gestation).ResultsOf 636 participants, 74 (12%) developed gestational diabetes mellitus, according to World Health Organization 2013 criteria, at 24-28 weeks of gestation. Applying WHO 2013 criteria to the early OGTT with at least one abnormal value gave a low sensitivity of 0.35 (95% confidence interval 0.24 to 0.47), high specificity of 0.96 (0.95 to 0.98), positive predictive value of 0.57 (0.41 to 0.71), negative predictive value of 0.92 (0.89 to 0.94), positive likelihood ratio of 10.46 (6.21 to 17.63), negative likelihood ratio of 0.65 (0.55 to 0.78), and diagnostic odds ratio of 15.98 (8.38 to 30.47). Lowering the postload glucose values (75 g OGTT cut-off values of 5.1, 8.9, and 7.8 mmol/L) improved the detection rate (53%, 95% confidence interval 41% to 64%) and negative predictive value (0.94, 0.91 to 0.95), but decreased the specificity (0.91, 0.88 to 0.93) and positive predictive value (0.42, 0.32 to 0.53) at a false positive rate of 9% (positive likelihood ratio 5.59, 4.0 to 7.81; negative likelihood ratio 0.64, 0.52 to 0.77; and diagnostic odds ratio 10.07, 6.26 to 18.31).ConclusionsThe results of this prospective low risk cohort study indicated that the 75 g OGTT as a screening tool in early pregnancy is not sensitive enough when applying WHO 2013 criteria. Postload glucose values were higher in early pregnancy complicated by diabetes in pregnancy. Lowering the postload cut-off values identified a high risk group for later development of gestational diabetes mellitus or those who might benefit from earlier treatment. Results from randomised controlled trials showing a beneficial effect of early intervention are unclear.Trial registrationClinicalTrials.gov NCT02035059.

Project description:Bloodstream infections are associated with considerable morbidity and health care costs. Molecular rapid diagnostic tests (mRDTs) are a promising complement to conventional laboratory methods for the diagnosis of bloodstream infections and may reduce the time to effective therapy among patients with bloodstream infections. The concurrent implementation of antimicrobial stewardship programs (ASPs) may reinforce these benefits. The aim of this study was to evaluate the cost-effectivenesses of competing strategies for the diagnosis of bloodstream infection alone or combined with an ASP. To this effect, we constructed a decision-analytic model comparing 12 strategies for the diagnosis of bloodstream infection. The main arms compared the use of mRDT and conventional laboratory methods with or without an ASP. The baseline strategy used as the standard was the use of conventional laboratory methods without an ASP, and our decision-analytic model assessed the cost-effectivenesses of 5 principal strategies: mRDT (with and without an ASP), mRDT with an ASP, mRDT without an ASP, conventional laboratory methods with an ASP, and conventional laboratory methods without an ASP. Furthermore, based on the availability of data in the literature, we assessed the cost-effectivenesses of 7 mRDT subcategories, as follows: PCR with an ASP, matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) analysis with an ASP, peptide nucleic acid fluorescent in situ hybridization (PNA-FISH) with an ASP, a blood culture nanotechnology microarray system for Gram-negative bacteria (BC-GP) with an ASP, a blood culture nanotechnology microarray system for Gram-positive bacteria (BC-GN) with an ASP, PCR without an ASP, and PNA-FISH without an ASP. Our patient population consisted of adult inpatients in U.S. hospitals with suspected bloodstream infection. The time horizon of the model was the projected life expectancy of the patients. In a base-case analysis, cost-effectiveness was determined by calculating the numbers of bloodstream infection deaths averted, the numbers of quality-adjusted life years gained, and incremental cost-effectiveness ratios (ICERs). In a probabilistic analysis, uncertainty was addressed by plotting cost-effectiveness planes and acceptability curves for various willingness-to-pay thresholds. In the base-case analysis, MALDI-TOF analysis with an ASP was the most cost-effective strategy, resulting in savings of $29,205 per quality-adjusted life year and preventing 1 death per 14 patients with suspected bloodstream infection tested compared to conventional laboratory methods without an ASP (ICER, -$29,205/quality-adjusted life year). BC-GN with an ASP (ICER, -$23,587/quality-adjusted life year), PCR with an ASP (ICER, -$19,833/quality-adjusted life year), and PCR without an ASP (ICER, -$21,039/quality-adjusted life year) were other cost-effective options. In the probabilistic analysis, mRDT was dominant and cost-effective in 85.1% of simulations. Importantly, mRDT with an ASP had an 80.0% chance of being cost-effective, while mRDT without an ASP had only a 41.1% chance. In conclusion, our findings suggest that mRDTs are cost-effective for the diagnosis of patients with suspected bloodstream infection and can reduce health care expenditures. Notably, the combination of mRDT and an ASP can result in substantial health care savings.

Project description:ObjectivesTo identify the incidence of postpartum glucose intolerance and develop a prediction model based on antenatal characteristics to predict postpartum glucose intolerance.DesignProspective cohort study.SettingGondar town public health facilities in Northwest Ethiopia.ParticipantsWomen who had gestational diabetes mellitus were advised to undergo postpartum oral glucose tolerance test at 6-12 weeks of delivery.Main outcomePostpartum glucose intolerance.Data analysisPredictors of postpartum glucose intolerance were identified using multivariable logistic regression analysis. The discriminative power of the predictor variables for postpartum glucose intolerance and the model accuracy were computed by area under the receiver operating characteristic curve and estimated by area under the curve (AUC) with 95% CI.ResultsA total of 112 (85.5%) women with gestational diabetes mellitus returned and completed the postpartum oral glucose tolerance test. The incidence of postpartum glucose intolerance was 21.4% (95% CI14.3 to 28.4), inclusive of 18.7% pre-diabetes and 2.7% diabetes. Multivariable logistic regression analysis revealed that advanced maternal age, high fasting plasma glucose level at diagnosis, overweight and/or obesity, and antenatal depression were predictors of postpartum glucose intolerance. The AUC of the final reduced model to predict postpartum glucose intolerance was 0.884 (95% CI 0.822 to 0.937). Fasting plasma glucose at diagnosis of gestational diabetes mellitus (AUC=0.736, 95% CI0.616 to 0.845) and overweight and/or obesity (AUC=0.718, 95% CI 0.614 to 0.814) were better predictors of postpartum glucose intolerance. Moreover, the AUC for the combined predictors of fasting plasma glucose at diagnosis and mid-upper arm circumference was 0.822 (95% CI 0.722 to 0.907), which was the best predictor.ConclusionsThe incidence of postpartum glucose intolerance was high among women with gestational diabetes mellitus. Antenatal predictors modestly predicted postpartum glucose intolerance. The findings suggest ongoing glucose screening is indicated for all women with gestational diabetes mellitus.

Dataset Information

A cost-effectiveness comparison of the NICE 2015 and WHO 2013 diagnostic criteria for women with gestational diabetes with and without risk factors.

Objectives

Setting

Participants

Primary and secondary outcome measures planned

Results

Conclusion

Publications

A cost-effectiveness comparison of the NICE 2015 and WHO 2013 diagnostic criteria for women with gestational diabetes with and without risk factors.

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