The cost implications of continuous glucose monitoring in pregnant women with type 1 diabetes in 3 Canadian provinces: a posthoc cost analysis of the CONCEPTT trial.

BACKGROUND: The Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial (CONCEPTT) found improved health outcomes for mothers and their infants among those randomized to self-monitoring of blood glucose (SMBG) with continuous glucose monitoring (CGM) compared with SMBG alone. In this study, we evaluated whether CGM or standard SMBG was more or less costly from the perspective of a third-party payer. METHODS: We conducted a posthoc analysis of data from the CONCEPTT trial (Mar. 25, 2013, to Mar. 22, 2016). Health care resource data from 215 pregnant women, randomized to CGM or SMBG, were collected from 31 hospitals in 7 countries. We determined resource costs posthoc based on prices from hospitals in 3 Canadian provinces (Ontario, British Columbia, Alberta). The primary outcome was the difference between groups in the mean total cost of care for mother and infant dyads, paid by each government (i.e., the third-party payer) from randomization to hospital discharge (time horizon). The secondary outcome included CGM and SMBG costs not paid by governments (e.g., glucose monitoring devices and supplies). RESULTS: The mean total cost of care was lower in the CGM group compared with the SMBG group in each province (Ontario: $13 270.25 v. $18 465.21, difference in mean total cost [DMT] -$5194.96, 95% confidence interval [CI] -$9841 to -$1395; BC: $13 480.57 v. $18 762.17, DMT -$5281.60, 95% CI -$9964 to -$1382; Alberta: $13 294.39 v. $18 674.45, DMT -$5380.06, 95% CI -$10 216 to -$1490). There was no difference in the secondary outcome. INTERPRETATION: Government health care costs are lower when CGM is paid by the patient, driven by lower costs from reduced use of the neonatal intensive care unit in the CGM group; however, when governments pay for CGM equipment, there is no overall cost difference between CGM and SMBG. Governments should consider paying for CGM, as it results in improved maternal and neonatal outcomes with no added overall cost. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01788527.

Resident Attitudes Towards Caesarean Delivery in Canadian Obstetrics and Gynaecology Residency Programs.

OBJECTIVE: This study aimed to explore the attitudes of obstetrics and gynaecology residents in Canada towards interventions that influence caesarean section rates. The study looked at residents' attitudes towards four guidelines that support vaginal and assisted delivery (vaginal birth after caesarean section, induction of labour, operative vaginal birth, and fetal health surveillance in labour) and towards Society of Obstetricians and Gynaecologists of Canada (SOGC) guidelines in general. The study also sought to investigate whether these attitudes vary by residency training location. METHODS: An online survey of obstetrics and gynaecology residents across Canada was conducted. Residents responded to statements derived from guidelines using a five-point attitudinal scale and to an optional long-answer question about how residency has prepared them to make decisions around interventions. Descriptive summary statistics are used to present the findings (Canadian Task Force Classification III). RESULTS: A total of 27% of residents completed the survey. The majority demonstrated attitudes congruent with guidelines and favourable towards SOGC guidelines in general. Residents attitudes were least favourable towards electronic fetal monitoring, with 67.4% of responses congruent with the guideline. Attitudes were most aligned with the operative vaginal birth guideline, with 87.9% of responses congruent with the guideline. This sample was underpowered to detect statistically significant differences among residency programs, although there was some variation in attitudes across programs, with the most congruent scoring program at 81.8% congruent responses and the lowest at 66.7%. CONCLUSION: Obstetrics and gynaecology residents in Canada have favourable attitudes towards interventions that support vaginal and assisted delivery. There was variability in observed attitudes across programs, although this was not statistically significant.

Birth Outcomes for Midwifery Clients Who Begin Postdates Induction of Labour Under Midwifery Care Compared With Those Who Are Transferred to Obstetrical Care.

OBJECTIVE: This study sought to compare clinical outcomes of midwifery clients who had postdates induction of labour with oxytocin under midwifery care with those transferred to obstetrical care. METHODS: This was a retrospective cohort study using 2006-2009 Ontario Midwifery Program data. All low-risk Ontario midwifery clients who had postdates oxytocin induction were included. Groups were established according to the planned care provider at onset of induction. The primary outcome was Cesarean section (CS). The secondary outcome was a composite of stillbirth, neonatal death, or serious morbidity. Other outcomes included assisted vaginal delivery, pharmaceutical pain relief, and use of episiotomy. We stratified by parity and used logistic regression to conduct analyses controlling for maternal age (Canadian Task Force Classification II-2). RESULTS: For nulliparas, postdates induction with oxytocin under midwifery care decreased the odds of interventions including assisted vaginal delivery (OR 0.68; 95% CI 0.48-0.97), episiotomy (OR 0.49; 95% CI 0.34-0.70), and pharmaceutical pain relief (OR 0.57; 95% CI 0.36-0.90), with no difference in odds of neonatal morbidity or mortality (OR 0.71; 95% CI 0.25-2.04) when compared with induction under obstetrical care. For multiparas, the use of pharmaceutical pain relief was significantly lower in the midwifery group (OR 0.65; 95% CI 0.44-0.96). CONCLUSION: For low-risk midwifery clients at 41 weeks or more gestation, the odds of Caesarean section and neonatal morbidity and mortality are similar when induction of labour with oxytocin under the care of a midwife is compared with induction of labour under obstetrical care, and rates of intervention are decreased.

The Cost Implications of Less Tight Versus Tight Control of Hypertension in Pregnancy (CHIPS Trial).

UNLABELLED: The CHIPS randomized controlled trial (Control of Hypertension in Pregnancy Study) found no difference in the primary perinatal or secondary maternal outcomes between planned "less tight" (target diastolic 100 mm Hg) and "tight" (target diastolic 85 mm Hg) blood pressure management strategies among women with chronic or gestational hypertension. This study examined which of these management strategies is more or less costly from a third-party payer perspective. A total of 981 women with singleton pregnancies and nonsevere, nonproteinuric chronic or gestational hypertension were randomized at 14 to 33 weeks to less tight or tight control. Resources used were collected from 94 centers in 15 countries and costed as if the trial took place in each of 3 Canadian provinces as a cost-sensitivity analysis. Eleven hospital ward and 24 health service costs were obtained from a similar trial and provincial government health insurance schedules of medical benefits. The mean total cost per woman-infant dyad was higher in less tight versus tight control, but the difference in mean total cost (DM) was not statistically significant in any province: Ontario ($30 191.62 versus $24 469.06; DM $5723, 95% confidence interval, -$296 to $12 272; P=0.0725); British Columbia ($30 593.69 versus $24 776.51; DM $5817; 95% confidence interval, -$385 to $12 349; P=0.0725); or Alberta ($31 510.72 versus $25 510.49; DM $6000.23; 95% confidence interval, -$154 to $12 781; P=0.0637). Tight control may benefit women without increasing risk to neonates (as shown in the main CHIPS trial), without additional (and possibly lower) cost to the healthcare system. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01192412.

The Cost Implications in Ontario, Alberta, and British Columbia of Early Versus Delayed External Cephalic Version in the Early External Cephalic Version 2 (EECV2) Trial.

OBJECTIVE: According to the Early External Cephalic Version (EECV2) Trial, planning external cephalic version (ECV) early in pregnancy results in fewer breech presentations at delivery compared with delayed external cephalic version. A Cochrane review conducted after the EECV2 Trial identified an increase in preterm birth associated with early ECV. We examined whether a policy of routine early ECV (i.e., before 37 weeks' gestation) is more or less costly than a policy of delayed ECV. METHODS: We undertook this analysis from the perspective of a third-party payer (Ministry of Health). We applied data, using resources reported in the EECV2 Trial, to the Canadian context using 10 hospital unit costs and 17 physician service/procedure unit costs. The data were derived from the provincial health insurance plan schedule of medical benefits in three Canadian provinces (Ontario, Alberta, and British Columbia). The difference in mean total costs between study groups was tested for each province separately. RESULTS: We found that planning early ECV results in higher costs than planning delayed ECV. The mean costs of all physician services/procedures and hospital units for planned ECV compared with delayed ECV were $7997.32 versus $7263.04 in Ontario (P < 0.001), $8162.82 versus $7410.55 in Alberta (P < 0.001), and $8178.92 versus $7417.04 in British Columbia (P < 0.001), respectively. CONCLUSION: From the perspective of overall cost, our analyses do not support a policy of routinely planning ECV before 37 weeks' gestation.

Outcomes associated with planned place of birth among women with low-risk pregnancies.

BACKGROUND: Previous studies have shown that planned home birth is associated with a decreased likelihood of intrapartum intervention with no difference in neonatal outcomes compared with planned hospital birth. The purpose of our study was to evaluate different birth settings by comparing neonatal mortality, morbidity and rates of birth interventions between planned home and planned hospital births in Ontario, Canada. METHODS: We used a provincial database of all midwifery-booked pregnancies between 2006 and 2009 to compare women who planned home birth at the onset of labour to a matched cohort of women with low-risk pregnancies who had planned hospital births attended by midwives. We conducted subgroup analyses by parity. Our primary outcome was stillbirth, neonatal death (< 28 d) or serious morbidity (Apgar score < 4 at 5 min or resuscitation with positive pressure ventilation and cardiac compressions). RESULTS: We compared 11 493 planned home births and 11 493 planned hospital births. The risk of our primary outcome did not differ significantly by planned place of birth (relative risk [RR] 1.03, 95% confidence interval [CI] 0.68-1.55). These findings held true for both nulliparous (RR 1.04, 95% CI 0.62-1.73) and multiparous women (RR 1.00, 95% CI 0.49-2.05). All intrapartum interventions were lower among planned home births. INTERPRETATION: Compared with planned hospital birth, planned home birth attended by midwives in a jurisdiction where home birth is well-integrated into the health care system was not associated with a difference in serious adverse neonatal outcomes but was associated with fewer intrapartum interventions.

Effects of reviparin, a low-molecular-weight heparin, on mortality, reinfarction, and strokes in patients with acute myocardial infarction presenting with ST-segment elevation.

CONTEXT: Although reperfusion therapy, aspirin, beta-blockers, and angiotensin-converting enzyme inhibitors reduce mortality when used early in patients with acute myocardial infarction (MI), mortality and morbidity remain high. No antithrombotic or newer antiplatelet drug has been shown to reduce mortality in acute MI. OBJECTIVE: To evaluate the effects of reviparin, a low-molecular-weight heparin, when initiated early and given for 7 days in addition to usual therapy on the primary composite outcome of death, myocardial reinfarction, or strokes at 7 and 30 days. DESIGN, SETTING, AND PATIENTS: A randomized, double-blind, placebo-controlled trial (Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment Evaluation [CREATE]) of 15,570 patients with ST-segment elevation or new left bundle-branch block, presenting within 12 hours of symptom onset at 341 hospitals in India and China from July 2001 through July 2004. INTERVENTION: Reviparin or placebo subcutaneously twice daily for 7 days. MAIN OUTCOME MEASURE: Primary composite outcome of death, myocardial reinfarction, or stroke at 7 and 30 days. RESULTS: The primary composite outcome was significantly reduced from 854 (11.0%) of 7790 patients in the placebo group to 745 (9.6%) of 7780 in the reviparin group (hazard ratio [HR], 0.87; 95% CI, 0.79-0.96; P = .005). These benefits persisted at 30 days (1056 [13.6%] vs 921 [11.8%] patients; HR, 0.87; 95% CI, 0.79-0.95; P = .001) with significant reductions in 30-day mortality (877 [11.3%] vs 766 [9.8%]; HR, 0.87; 95% CI, 0.79-0.96; P = .005) and reinfarction (199 [2.6%] vs 154 [2.0%]; HR, 0.77; 95% CI, 0.62-0.95; P = .01), and no significant differences in strokes (64 [0.8%] vs 80 [1.0%]; P = .19). Reviparin treatment was significantly better when it was initiated very early after symptom onset at 7 days (<2 hours: HR, 0.70; 95% CI, 0.52-0.96; P = .03; 30/1000 events prevented; 2 to <4 hours: HR, 0.81; 95% CI, 0.67-0.98; P = .03; 21/1000 events prevented; 4 to <8 hours: HR, 0.85; 95% CI, 0.73-0.99; P = .05; 16/1000 events prevented; and > or =8 hours: HR, 1.06; 95% CI, 0.86-1.30; P = .58; P = .04 for trend). There was an increase in life-threatening bleeding at 7 days with reviparin and placebo (17 [0.2%] vs 7 [0.1%], respectively; P = .07), but the absolute excess was small (1 more per 1000) vs reductions in the primary outcome (18 fewer per 1000) or mortality (15 fewer per 1000). CONCLUSIONS: In patients with acute ST-segment elevation or new left bundle-branch block MI, reviparin reduces mortality and reinfarction, without a substantive increase in overall stroke rates. There is a small absolute excess of life-threatening bleeding but the benefits outweigh the risks.

Challenges in the conduct of large simple trials of important generic questions in resource-poor settings: the CREATE and ECLA trial program evaluating GIK (glucose, insulin and potassium) and low-molecular-weight heparin in acute myocardial infarction.

BACKGROUND: Approximately 15.5 million deaths from cardiovascular diseases occur every year. About half are due to acute myocardial infarction (AMI), and 80% occur in low- and middle-income countries. Therefore, low-cost therapies would be invaluable. Although glucose-insulin-potassium (GIK) infusion and low-molecular-weight heparin (LMWH) appear to be promising in AMI, the available trials are inconclusive and these treatments require rigorous evaluation. METHODS: The Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment and Evaluation-Estudios Clinicos Latino America (CREATE-ECLA) study is a randomized controlled trial in ST-elevation AMI patients evaluating a 24-hour infusion of Glucose-Insulin-Potassium (GIK) intravenous vs usual care (control) on 30-day mortality in 20,000 patients from 21 countries. Patients from India and China (n = 15,000) are also randomized using a factorial design to receive low-molecular-weight heparin (Reviparin) or placebo injection twice daily for 7 days to assess the impact on the composite outcomes of death, reinfarction or stroke (first co-primary outcome) or the composite + refractory ischemia (second co-primary outcome). RESULTS: Twenty thousand two hundred and one (20,201) GIK/control patients and 15,570 Reviparin/placebo patients have been included, with results expected in November 2004. CONCLUSIONS: The CREATE-ECLA trial will provide definitive answers to the role of 2 practical, promising and low-cost therapies, LMWH and GIK, in AMI patients. If effective, these therapies could be used in small medical centers in low- and middle- income countries. The experiences in this trial indicate that large trials of important questions can be successfully conducted in resource-poor settings, by academic groups without industry involvement.