Translating the HAPO Study Results & IADPSG Recommendations into a National Health Policy

Transcription

1 Translating the HAPO Study Results & IADPSG Recommendations into a National Health Policy March 14, 2013 Moshe Hod MD Rabin Medical Center Sackler School of Medicine Tel Aviv University Israel

2 First Definition of GDM O Sullivan JB et al, Diabetes 1964 Those meeting criteria had an increased risk of Type-2 diabetes when followed up to 8 years after the index pregnancy No correlation with Pregnancy Outcome Diagnosis : Two steps GCT 50gr. >140mg% Fasting 90 1h 165 2h 145 3h 125 Whole blood Mean ± 2SD

3 March 4-6, 2013 Based on the above considerations, the panel believes that there are benefits from standardization within the United States and between the United States and the world with regard to the diagnostic approach to GDM. Nevertheless, at present, the panel believes that there is not sufficient evidence to adopt a one-step approach, such as that proposed by the IADPSG. The panel is particularly concerned about the adoption of new criteria that would increase the prevalence of GDM, and the corresponding costs and interventions, without clear demonstration of improvements in the most clinically important health and patient-centered outcomes. Thus, the panel recommends that the two-step approach be continued. However, given the potential benefits of a one-step approach, resolution of the uncertainties associated with its use would warrant reconsideration of this conclusion

4 Maternal Fetal Medicine Challenges The Unmet Need Diagnosis of GDM Worldwide Controversy No Consensus 49 Years without a consensus

5 March 14, 2013 How do we change a National Health Care Policy?

6 Changing a National Health Policy Policy Change Consensus Evidence Hypothesis

7 The Hypothesis Overt diabetes clearly increases the risk of adverse pregnancy outcome What level of glucose intolerance during pregnancy, short of diabetes, is associated with the risk of Adverse Perinatal Outcome?

8 The Evidence Hyperglycemia and Adverse Pregnancy Outcome NIH Multicentral Multinational Study

9 Frequency (%) Frequency (%) Frequency (%) Frequency (%) Evidence Birth Weight > 90th Percentile Primary C-Section Glucose Categories Fasting One Hour Two Hour Glucose Categories Fasting One Hour Two Hour Clinical Hypoglycemia Cord C-Peptide >90th Percentile Glucose Categories Fasting One Hour Two Hour Glucose Categories Fasting One Hour Two Hour

10 Evidence May Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: Neonatal Anthropometrics Feb Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: Associations with Maternal BMI March 2010 Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: Preeclampsia Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: Neonatal Glycemia International Association of Diabetes and Pregnancy Study Groups (IADPSG) Recommendations on the Diagnosis and Classification of Hyperglycemia in Pregnancy

11 The new Diagnostic Criteria

12 The Consensus the DIABETES CARE, VOLUME 33, NUMBER 3, MARCH 2010 Controversy 12

13 The Israeli approach

14 HAPO Blinded Participants At Each Field Center Bellflower Chicago Providence Cleveland Toronto Belfast Manchester Barbados Petah-Tiqva Beersheba Israel - 3,345 Bangkok 2426 Brisbane Newcastle Singapore Hong Kong

15 HAPO Study: Frequency of Gestational Diabetes Mellitus (GDM) at Collaborating Centers Based on IADPSG Consensus Panel Recommended Criteria Field Center Age-adjusted Frequency of GDM (%) Field Center Age-adjusted Frequency of GDM (%) Bellflower, USA 23.2 Petah Tiqva, Israel 10.4 Chicago, USA 13.2 Beersheba, Israel 10.1 Providence, USA 17.7 Bangkok, Thailand 22.3 Cleveland, USA 25.0 Brisbane, Australia 11.9 Toronto, Canada 10.6 Newcastle, Australia 13.5 Belfast, UK 15.1 Singapore, Singapore 20.5 Manchester, UK 20.4 Hong Kong, China 12.1 Barbados, West Indies 13.2 HAPO Overall 16.1% Total Israel - 3,345

16 Diabetic Pregnancy 2013 The Numbers Deliveries Australia - 200,000 Diabetic Pregnancies Pre-GDM GDM Rate Can we cope with it US - 5,000,000 Europe - 5,000, ,000 = 20, ,000??? 14,800 = ,000 Israel 170,000 from 10,000 to China = 18,000,000 2,600,000 = 460, ,800,000 India 30,000,000 4,000,000 = 0.5mil mil COST??? 50% Increase by IADPSG Screening & Diagnosis, Management, Follow up 8% 7% 6% 9% 10% 12%

17 Translating the HAPO Study Results into a National Health Policy GDM Diagnosis National Committee Chairman : Prof. Moshe Hod Israel Ministry of Health National Councils : Diabetes, Obst & Gynecol National Societies : Diabetes, Obst & Gynecol National Institute for Epidemiology & Health Policy Research Sackler Faculty of Medicine, Tel-Aviv University Clalit Health Services Maccabi Health Services Perinatal Division, Rabin Medical Center 17

18 GDM Diagnosis Israel Policy Change IADPSG Consensus Evidence Hypothesis National Committee on GDM Diagnosis Pending Ministry of Health

19 GDM Diagnosis Israel B. Changing a Health Care Policy- From a Study to a National Policy Diagnosis of GDM facing a new challenge Chairman, National committee on GDM diagnosis, Moshe Hod, Israel Analysis of the Israeli HAPO-Study data for making locally-relevant health policy decisions The National Institute of Research, Ofra Kalter, Israel The National Implications Assessment of Medical Benefits President of the Israeli Society of Ob&Gyn, Yariv Yogev, Israel Cost Effectiveness - Mathematical Model Evaluation of the HMO's Cohort The HMO management (Clalit Health Services), Nicky Liberman, Israel The Ministry of Health Evaluation Director General - Ministry of Health Israel, Roni Gamzu, Israel

20 Based on the above considerations, the panel believes that there are benefits from standardization within the United States and between the United States and the world with regard to the diagnostic approach to GDM. Nevertheless, at present, the panel believes that there is not sufficient evidence to adopt a one-step approach, such as that proposed by the IADPSG. The panel is particularly concerned about the adoption of new criteria that would increase the prevalence of GDM, and the corresponding costs and interventions, without clear demonstration of improvements in the most clinically important health and patient-centered outcomes. Thus, the panel recommends that the two-step approach be continued. However, given the potential benefits of a one-step approach, resolution of the uncertainties associated with its use would warrant reconsideration of this conclusion

21 GDM Diagnosis Universal A. Changing a Health Care Policy Towards a Consensus of Consensuses Highlights from the NIH Consensus Conference: Diagnosing GDM Chairperson: Donald Coustan, USA Overview of the consensus process, background of the topic and the key questions Catherine Spong, USA IADPSG perspective David McIntyre, Australia WHO perspective Gojka Roglic, Switzerland NICHD perspective Mark Landon, USA IDF perspective Stephen Colagiuri, Australia WDF perspective (Developing World) Anil Kapur, Denmark Wrap up - The panel statement Catherine Spong, USA

22 On your marks..

23 The Israeli approach Epidemiologic evaluation The National Institute of Research Ofra Kalter

24 Ofra Kalter-Leibovici, DIP-2013; Firenze Diabetes Care Sep;35(9): Making health policy decisions that are locally-relevant: Analysis of the Israeli HAPO-Study data Ofra Kalter Leibovici*, Laurence S. Freedman, Liraz Olmer, Nicky Liebermann, Anthony Heymann, Orna Tal, Liat Lerner-Geva, Nir Melamed and Moshe Hod. 24 * The Gertner Institute for Epidemiology & Health Policy Research

25 Ofra Kalter-Leibovici, DIP-2013; Firenze Results Currently, about 6% of pregnant women in Israel are diagnosed with GDM (~10,000 women/year) Under the new IADPSG criteria, this rate will increase by 1.5-fold (additional 5,000 women/year) The expected yield of adoption of the IADPSG criteria: Rate (%) Relative Risk* Fetal macrosomia NNS (95% CI) 145 (90, 232) NNT (95% CI) 12 (7.5, 19) Preeclampsia ,242 (431, 3,584) 103 (36, 292) NNS= number needed to screen NNT= number needed to treat *-Landon MB et al. N Engl J Med, 2009; 361:

26 Ofra Kalter-Leibovici, DIP-2013; Firenze Risk Stratification Objective: to define among women diagnosed with GDM under the IADPSG criteria, a subset at low risk for pregnancy adverse outcome (fetal macrosomia) Method: development of a risk score based on maternal BMI*, height and parity Risk score=bmi (kg/m 2 ) x parity x height (cm) High risk: score >166 IADPSG- IADPSG+ IADPSG+ ; RISK SCORE >166 IADPSG+ ; RISK SCORE <166 Fetal macrosomia% * at the time of GDM screening 26

27 Algorithm for GDM Management- Ofra Kalter-Leibovici, DIP-2013; Firenze IADPSG Criteria and Risk Score Pregnant women: weeks of gestation Screen according to IADPDG recommendations, using 75-gr OGTT; diagnose GDM according to IADPSG glucose thresholds IADPSG negative IADPSG positive Use FM Management Risk Score Score >166: treat in a careintensive setup Score <166: treat in a less care-intensive community setup *- FM Management Risk Score = BMI (kg/m 2 ) x height (cm) x parity 27

28 Ofra Kalter-Leibovici, DIP-2013; Firenze Comparison with Other Screening Methods We calculated the FPG threshold and BMI which provide a rate of positive cases similar to the rate of positive cases expected under the IADPSG criteria Thresholds: FPG: 89 mg/dl BMI: 33.5 kg/m 2 IADPSG- N=2,930 IADPSG+ N=277 FPG >89 mg/dl N=277 BMI > 33.5 kg/m 2 N=278 Fetal macrosomia % Preeclampsia %

29 A Two-Step Strategy, Using FPG and OGTT: Screening Algorithm Pregnant women: weeks of gestation Screen for GDM with FPG; threshold for GDM diagnosis: FPG > 89 mg/dl FPG >89 mg/dl FPG <89 mg/dl Use FM Diagnosis Risk Score* Diagnose GDM >200: <200: Give an OGTT and employ IADPSG GDM negative post-load glucose thresholds Post-load glucose levels equal to or higher than thresholds Post-load glucose levels lower than thresholds: GDM negative *FM Diagnosis Risk Score = 0.87 x BMI (kg/m 2 ) x height (cm) x parity x FPG (mg/dl) Score 200 signifies high risk for fetal macrosomia.

30 Ofra Kalter-Leibovici, DIP-2013; Firenze Summary and Conclusions The adoption of the IADPSG diagnostic criteria will create a 1.5-fold increase in the number of women diagnosed with GDM in Israel and will require appropriate allocation of resources for screening and management. Among women diagnosed with GDM under the new IADPSG criteria, there is a subgroup (~⅓) at relatively low risk for adverse pregnancy outcomes. These women may benefit from a less care-intensive setup, focused on lifestyle modification. FPG is a reasonable alternative method to GDM screening that avoids universal screening with OGTT Reduction of maternal overweight is important for risk reduction of adverse pregnancy outcome, regardless of the level of glycemia. To assess the benefit and cost/benefit of changing the diagnostic criteria of GDM, there is a need for careful monitoring of pregnancy outcomes before and after a change is made. 30

31 Ofra Kalter-Leibovici, DIP-2013; Firenze 31

32 The Israeli approach The professional evaluation The Israeli Association of Obstetrics & Gynecology Society of Perinatal Medicine Yariv Yogev

33 Changing a Health Care Policy- From a Study to a National Policy The National Implications Assessment of Medical Benefits Yariv Yogev, MD Sackler School of Medicine Tel Aviv University Israel

34 Making Health Policy Change- How We Start? Ministry of Health Suggested Medical Change National committee on GDM diagnosis Israel Society of Obstetrics &Gynecology Israel Society for Maternal Fetal Medicine Authorization Suggested New Guideline Economic issue of less importance Medical Merit NNT/NNS Improved prenatal care? Feasible to apply

35 Making Health Policy Change- How We Start? Suggested Medical Change Israel Society of Obstetrics &Gynecology Medical Merit Israel Society for Maternal Fetal Medicine Suggested New Guideline

36 Is GDM a clinical entity? Jarrett GDM is a non-entity (BMJ 93) Hunter GDM is a diagnosis still looking for a disease (AJOG 85) Green Questioned if GDM is a disease (NEJM 02) ACOG GDM is one of the most common issues facing the obstetrician A lack of data from well-designed studies has contributed to the controversy surrounding the diagnosis and management. (Practice Bulletin #30,2001) Cochrane Collaboration (1993) It is unethical to involve pregnant women in interventions based on this diagnosis

37 Changing point of view

38 Treating GDM Langer et al. (AJOG 2005) Crowther et al. (NEJM 2005) Landon et al. (NEJM 2009) Retrospective 555 vs X 2 RCT 490 vs. 510 RCT 485 vs gr. OGTT> 37 weeks 1100 Non diabetics 1100 Treated 1 0 outcome: IUFD, LGA, Met. Complications 2 0 outcome: PI, PET, SHD, C/S 75 gr 2-h OGTT 1 0 outcome (composite): IUFD, SHD, C/S, nerve palsy, NICU 2 0 outcome: PET, Induction, LGA, Mat. Anxiety OGTT- Normal fasting(<95) (2 Abn values) Treatment vs. Standard OB care 1 0 outcome: IUFD, Met compl, Birth trauma, Insulinemia 2 0 outcome: LGA, C/S, PET, SHD

39 Treating GDM Langer et al. (AJOG 2005) Untreated (n = 555) Treated (n = 1110) SHD BW (g) p = 0.01 Macrosomia 17% 7% OR = 2.66 Metabolic Comp. LGA 29% 11% OR = 3.28 C/S Composite Morbidity 59% 18% OR = PET

40 Treating GDM Crowther et al. (NEJM 2005) C/S rate PET LGA/Macrosomia Induction (In Rx)

41 Landon et al. (NEJM 2009) Study Design Mild GDM Fasting <95 mg/dl 1 hour >180 mg/dl 2 hour >155 mg/dl 3 hour >140 mg/dl Randomized to: 2 abnormal Treatment SBGM Nutrition counseling Pharmacological Rx- Insulin No Treatment Standard OB care Physicians and patients blinded to OGTT results

42 Treating GDM Landon et al. (NEJM 2009) No difference in: Hypoglycemia Hyperbilirubinemia Cord C-Peptide Stillbirth/NND Birth Trauma C/S rate PET SHD LGA/Macrosomia

43 Outcome Frequency of Outcomes: May Oct HAPO HAPO FPG <95/5.3 (All Others) vs. HAPO FPG <95/5.3 1-hr >180; 2hr >155 MFMU Treated NICHD RCT Not treated BW >90 th percentile C-peptide >90 th percentile NICU admission Shoulder Dystocia Pre-eclampsia

44 Making Health Policy Change- How We Start? Suggested Medical Change Israel Society of Obstetrics &Gynecology Israel Society for Maternal Fetal Medicine Suggested New Guideline NNT/NNS

45 Cumulative proportion of GDM cases under IADPSG recommended cut-offs Plasma Glucose Fasting 1 hr 2hr Unblinded Cut-off (mg/dl) >105 FPG, >200 2hr Total HAPO Centers Israel

46 Expected yield of screening and treatment using the IADPSG criteria Outcome Rate (%) RR* NNT (95% CI) NNS (95% CI) LGA (7.5, 19) 145 (90, 232) Eclampsia/ pre-eclampsia (36, 292) 1,242 (431, 3,584) *-Landon MB et al. N Engl J Med, 2009; 361:

47 NNT/NNS- General Obstetrics Progesterone Indication Prevention of PTB Progesterone Short cervix MgSo4 Neuroprotection MgSo4 Eclampsia Aspirin PET Aspirin IUGR Aspirin PTL NNT NNS NA NA NA NA NA

48 NNT/NNS-GDM Vs General Obstetrics Indication NNT NNS Progesterone Prevention of PTB LGA 12 (7.5, 19) 145 (90, 232) Eclampsia/pre-eclampsia 103 (36, 292) 1,242 (431, 3,584) Progesterone Short cervix MgSo4 Neuroprotection MgSo4 Eclampsia Aspirin PET Aspirin IUGR Aspirin PTL NA NA NA NA NA

49 Making Health Policy Change- How We Start? Suggested Medical Change Israel Society of Obstetrics &Gynecology Israel Society for Maternal Fetal Medicine Suggested New Guideline Improved prenatal care? Feasible to apply

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55 Summary Suggested Medical Change Israel Society of Obstetrics &Gynecology Medical Merit Israel Society for Maternal Fetal Medicine Suggested New Guideline NNT/NNS Improved prenatal care?? Feasible to apply

56 The Israeli approach Cost effectiveness evaluation The HMO management (Clalit Health Services) Nicky Liberman

57 HMO & HAPO Why should a public system adopt the HAPO conclusions The HMO s P.o.V. Considerations of DM Cost Effectiveness Nicky Liberman, Israel Clalit Health Services

58 Life Expectancy Israel s Health System 8 million inhabitants (wide diversity of ethnicities) National obligatory Health Insurance to all (1995) Must be member in 1 of 4 health plans (insurer/provider) HP funding by capitation (age, sex and periphery) <1% move annually between health plans 90% happy or very happy with their health plan 95.9% 75.1% Israel OECD Bed Occupancy - general beds Average LOS* - general beds Nurses/1000 Physicians/1000 General Beds/1000

59 Some facts about Clalit 2 nd Largest HMO in the world 54% Market Share in Israel (>4M members) Overrepresentation of the sick, poor and elderly >40 Regional Women Health Centers 14 hospitals General, Children, Psychiatric, Rehabilitation & Geriatric Electronic information since 1980 s today a fully computerized system with a comprehensive EHR 59

60 Clalit s Diabetes Program special achievements Started in 1997; Updating guidelines every 2-3 years Being the 1 st in the word to write special comprehensive guidelines for the treatment of diabetic and chronic wounds and later to introduce new wound therapy technologies (VAC, Macrophages) & a telecare nurse home unit for chronic wounds (2012) Nationwide ethnic adaptation of programs st to start insulin at the level of the primary physician st to start a nationwide program of identifying&treating pre-diabetes st to adopt Bariatric surgery as treatment for T2DM in high risk patients.

61 Diabetes control according to HbA1c HbA1c>9 HbA1c<7 60% 50% 40% 30% 20% 10% 0% LDL cholesterol control % 60.00% 50.00% 40.00% 30.00% 20.00% 100 mg%>= LDL 130 mg%< LDL 10.00% 0.00%

62 The financial impact Cost of diabetic patient (median) 3500 DM:nonDM From 3.5:1 to 1.8:1!!!! The most important results of Clalit s DM program were QUALITY OF CARE and FINANCIAL GAIN

63 GDM & Pre-Diabetes Conversion Rate to DM GDM = source of pre-diabetes patients 50-70% of GDM patients T2DM Conversion from pre-diabetes to full blown disease is today 5-10 % per-year. No intervention =>3.5 million patients in Israel by the year 2020!!!

64 Model Structure Testing strategy True disease state Post-test classification Antenatal (& perinatal) intervention Perinatal outcomes related to GDM (AE = Adverse Events) (Details: DALYs worksheet) Postpartum intervention Incidence of T2DM (Details: DALYs worksheet) True + GDM Pregnant OGCT; OGTT False - A women B B Intervene No intervene Perinatal AE death - mother C No Perinatal AE death - mother C D Perinatal AE death - baby D E No Perinatal AE death - baby E Intervene No Intervene F F T2DM in mother No T2DM in mother T2DM in child G No T2DM in child G No GDM True - False + B B

65 Model accounts for variable timing of T2DM

66 Outcomes of cost effectiveness comparison at 2.6% GDM prevalence - low-end estimate for Clalit cohort and at 9.0% GDM prevalence - high-end estimate for Clalit cohort Very favorable results. Not just CE, but cost saving 75 OGTT superior to 50g/100g Monte Carlo multivariate sensitivity analysis At both 2.6% prevalence and 9% prevalence = resulted as highly CE, and even cost saving

67 Sensitivity analyses: Effect of variation in key inputs and cost-effectiveness (GDM = 2.6%) The cost of treating T2DM has largest effect on CE.

68 Summarizing GDM The HAPO Study ; diagnosis of GDM based on evidence based criteria. Prevention of: 1. Adverse perinatal outcome 2. Later T2DM in the mother 3. Metabolic syndrome and DM in the offspring. The Israeli participants HAPO Study DATA = about 50% more GDM cases Economical modeling = Intervention will be cost efficient. Validation process = Starting mid 2013 will test with 75 gr., IADPSG criteria, all population in order to validate in real life setting the concept. Newly diagnosed women will be classified according to risk Low risk treatment by dietician, nurse, GP & Ob.Gyn, community Med risk treatment by dietician, nurse & WHC in the community High risk referral to specialist clinics in Hospitals We expect 50% more identification of GDM women Validation of the concept & it s feasibility in 1 year Lifestyle change of the next generation!!! Better Medical & Financial results

69 National Committee on GDM Diagnosis The Recommendation Chairman, National committee on GDM diagnosis Moshe Hod

70 Making Health Policy Change- Summarizing the Evidence Authorization Suggested Policy Change Ministry of Health Recommendation Epidemiologic evaluation Medical Merit National Committee on GDM Diagnosis Evaluation NNT/NNS Improved prenatal care?? Feasible to apply Cost effectiveness evaluation

71 Making Health Policy Change- Algorithm for GDM Recommendation 1 st Trimester Management Prediction Pregnant women: weeks of gestation IADPSG Criteria IADPSG negative IADPSG positive Use FM Management Risk Score Score >166: treat in a careintensive setup Validation Validation Clalit Perinatal Project Score <166: treat in a less care-intensive community setup Clalit Perinatal Project *- FM Management Risk Score = BMI (kg/m 2 ) x height (cm) x parity Ofra Kalter-Leibovici, DIP-2013; Firenze 71

72 Making Health Policy Change- For evaluation Recommendation Pregnant women: weeks of gestation Screen for GDM with FPG; threshold for GDM diagnosis: FPG > 89 mg/dl FPG >89 mg/dl FPG <89 mg/dl Use FM Diagnosis Risk Score* Diagnose GDM >200: <200: Give an OGTT and employ IADPSG GDM negative post-load glucose thresholds Post-load glucose levels equal to or higher than thresholds Validation Clalit Perinatal Project Post-load glucose levels lower than thresholds: GDM negative *FM Diagnosis Risk Score = 0.87 x BMI (kg/m 2 ) x height (cm) x parity x FPG (mg/dl) Score 200 signifies high risk for fetal macrosomia.

73 March 14, 2013 Authorization The Ministry of Health Ronni Gamzu 1

74 The Issue in question To use or avoid a screening test in order to improve detection rate o o o o o The value of the screening/diagnostic test (FP, FN) The prevalence of the disease (PPV) The cost and accessible resources Compliance Side effects of overuse diagnoses one step -Very high PPV, better compliance, cheap & simple, acceptable NNS & NNT 2

75 Let's kill a scarecrow Diagnosis : Two steps GCT 50gr. >140mg% Fasting 90 1h 165 2h 145 3h Whole blood 125 GCT is a screening test and OGTT is the diagnostic test. You use a screening test before the DIAGNOSTIC whenever the DIAGNOSTIC is costly or inconvenient or you don t have the resources You do not do that in order to reduce the number of the true positives!! 3

76 Acceptable NNS & NNT future DM (rate 33% in 5-10 years) NNS of 30 Do we have resources to treat 10% of our pregnant women? Do we have the resources to keep follow-up post pregnancy? 4

77 What are the key objectives? Reduce GDM complications o o o LGA/Macrosomy PET Shoulder dystocia/cs Improve subsequent prenatal care (in GDM/DM) Reduce DM probability and its complications Reduce CVS complications Better record of familial DM 5

78 The chronology of GDM Hanna- Diabet Med 2002; Women with GDM have a 17 63% risk of Type 2 diabetes within 5 16 years 6

79 Conclusions Apparently there is no excuse to do screening before the diagnostic test (OGTT) The threshold values of OGTT must be determined by reasonable sensitivity and specificity In order to reduce NNT d/t short resources we can reinforce the criteria for intervention by adding risk factors Preparing and confronting the DM-NCD epidemics do not allow us to avoid a simple diagnostic test from all pregnant women 7

80 Israeli approach Adoption of the IADPSG recommendation Adding clinical criteria to reduce the NNT Giving time to adopt by means of resources and clear clinical guidelines Consensus statement by the National Councils Approval by the ministry All by 1/1/14 8

81 March 4-6, 2013 Based on the above considerations, the panel believes that there are benefits from standardization within the United States and between the United States and the world with regard to the diagnostic approach to GDM. Nevertheless, at present, the panel believes that there is not sufficient evidence to adopt a one-step approach, such as that proposed by the IADPSG. The panel is particularly concerned about the adoption of new criteria that would increase the prevalence of GDM, and the corresponding costs and interventions, without clear demonstration of improvements in the most clinically important health and patient-centered outcomes. Thus, the panel recommends that the two-step approach be continued. However, given the potential benefits of a one-step approach, resolution of the uncertainties associated with its use would warrant reconsideration of this conclusion

82 March 14, 2013 B. Changing a Health Care Policy- From a Study to a National Policy Diagnosis of GDM facing a new challenge Chairman, National committee on GDM diagnosis, Moshe Hod, Israel Analysis of the Israeli HAPO-Study data for making locally-relevant health policy decisions The National Institute of Research, Ofra Kalter, Israel The National Implications Assessment of Medical Benefits President of the Israeli Society of Ob&Gyn, Yariv Yogev, Israel Cost Effectiveness - Mathematical Model Evaluation of the HMO's Cohort The HMO management (Clalit Health Services), Nicky Liberman, Israel The Ministry of Health Evaluation Director General - Ministry of Health Israel, Roni Gamzu, Israel

83 World Health Organization 2013 March 20, 2013 Diagnostic Criteria and Classification of Hyperglycaemia First Detected in Pregnancy Hyperglycaemia first detected at any time during pregnancy should be classified as either : Diabetes Mellitus in Pregnancy Gestational Diabetes Mellitus Quality of evidence: not graded Strength of recommendation: not evaluated

84 Diabetes Mellitus in Pregnancy March 20, 2013 Diabetes in pregnancy should be diagnosed by the 2006 WHO criteria for diabetes if one or more of the following criteria are met: Following a 75g oral glucose load Fasting plasma glucose 7.0 mmol/l (126 mg/ dl) 2-hour plasma glucose 11.1 mmol/l (200 mg/dl) Random plasma glucose 11.1 mmol/l (200 mg/ dl) in the presence of diabetes symptoms. Quality of evidence: not graded Strength of recommendation: not evaluated

85 Gestational Diabetes Mellitus March 20, 2013 Gestational diabetes mellitus should be diagnosed at any time in pregnancy if one or more of the following criteria are met: Fasting plasma glucose mmol/l ( mg/dl) 1-hour plasma glucose 10.0 mmol/l (180 mg/dl) 2-hour plasma glucose mmol/l ( mg/dl) Quality of evidence: very low Strength of recommendation: weak

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87 April 3, 2013