Admissions and Emergency Visits by Late Preterm Singletons and Twins in the First 5 Years: A Population-Based Cohort Study.

OBJECTIVE: To compare admission and emergency visits of late preterm (340/7-366/7 weeks) versus term infants (370/7-416/7 weeks) in the first 5 years. STUDY DESIGN: This population-based cohort study included all singletons and twins born alive at 340/7 to 416/7 weeks' gestation registered in a health administrative database in Ontario, Canada, between April 1, 2002 and December 31, 2012. Admissions and emergency visits from initial postnatal discharge to 5 years were compared between late preterm and term infants adjusting for maternal and infant characteristics. RESULTS: A total of 1,316,931 infants (75,364 late preterm infants) were included. Late preterm infants had more frequent admissions than term infants in the first 5 years in both singletons (adjusted incidence rate ratio [95% confidence interval] = 1.46 [1.42-1.49]) and twins (1.21 [1.11-1.31]). The difference in admissions between late preterm and term infants were smaller in twins than singletons and decreased with children's ages. Twins had less frequent admissions than singletons for late preterm infants, but not for term infants. The emergency visits were more frequent in late preterm than term infants in all the periods. CONCLUSION: Admissions and emergency visits were more frequent in late preterm than term infants through the first 5 years. Admissions were less frequent in late preterm twins than singletons.

Hospital Care Cost and Resource Use of Early Discharge of Healthy Late Preterm and Term Singletons: A Population-based Cohort Study and Cost Analysis.

OBJECTIVE: To assess the hospital care cost and resource use associated with discharge timings after late preterm and term births. STUDY DESIGN: This population-based cohort study and cost analysis included all healthy singleton late preterm (35-36 weeks gestational age) and term infants (37-41 weeks gestational age) born vaginally in hospitals in Ontario, Canada, from 2003 to 2012. Early, late, and very late discharge (<48, 48-71, and 72-95 hours after birth, respectively) were compared using generalized linear models. The primary outcome was the total hospital care cost (hospitalizations and emergency department visits) per infant within 28 days of birth. RESULTS: Among 860 693 singletons (3.7% late preterm), early discharge increased significantly over 10 years for term infants (from 69% to 82%; P < .001), but not late preterm infants (from 32% to 35%; P = .75). The mean total cost within 28 days after birth was not significantly different for late preterm infants between early discharge and late discharge after adjustment. However, for term infants, the adjusted cost was higher with early discharge than late discharge (aMCD $311 [95% CI, $211-$412] per infant; $366 [95% CI, $355-$377] per mother-infant dyad). The neonatal readmission rates were higher after early than late discharge for late preterm and term infants. CONCLUSIONS: Early discharge was not associated with cost savings for vaginally born healthy singleton late preterm infants, and instead was associated with a cost increase for term infants. Early discharge was associated with higher neonatal readmission rates. Individualized approach balancing the risk and benefit is appropriate to determine the discharge timings.

Unilateral and bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression: a meta-analysis of randomized controlled trials over 2 decades

Background: Approximately 35% of people with depression do not respond to 2 courses of antidepressant medications of adequate dosage, and treatment-resistant depression (TRD) is still a major clinical concern with a great impact on patients, their families, society and the health system. The present meta-analysis evaluates antidepressant efficacy of unilateral and bilateral repetitive transcranial magnetic stimulation (rTMS) in patients with unipolar TRD. Methods: We searched for randomized controlled trials that compared rTMS with sham treatment and were published by Apr. 3, 2017. The primary outcome was improvement in depression scores measured using the Hamilton Rating Scale for Depression. The secondary outcomes were remission and response rates. Two independent review authors screened the studies and extracted the data. Results: Twenty-three studies met the inclusion criteria. Meta-analysis of the depression scores showed a weighted mean difference (WMD) of 3.36 (95% confidence interval [CI] 1.85­4.88) between unilateral rTMS and sham treatment. Stratified data showed that the effect was relatively higher when rTMS was used as an add-on to antidepressant medications (WMD 3.64, 95% CI 1.52­5.76) than when it was used as a stand-alone treatment (WMD 2.47, 95% CI 0.90­4.05). The WMD between bilateral rTMS and sham was 2.67 (95% CI 0.83­4.51), and all studies that contributed to this outcome used rTMS while participants were taking antidepressant medications. The pooled remission and response rates for unilateral rTMS versus sham treatment were 16.0% and 25.1% for rTMS and 5.7% and 11.0% for sham treatment, respectively. The pooled remission and response rates for bilateral rTMS versus sham treatment were 16.6% and 25.4% for rTMS and 2.0% and 6.8% for sham treatment, respectively. Conclusion: This study suggests that rTMS has moderate antidepressant effects and appears to be promising in the short-term treatment of patients with unipolar TRD.

The Community Health Assessment Program in the Philippines (CHAP-P) diabetes health promotion program for low- to middle-income countries: study protocol for a cluster randomized controlled trial.

BACKGROUND: Type 2 diabetes is increasing globally, with the highest burden in low- to middle-income countries (LMICs) such as the Philippines. Developing effective interventions could improve detection, prevention, and treatment of diabetes. The Cardiovascular Health Awareness Program (CHAP), an evidence-based Canadian intervention, may be an appropriate model for LMICs due to its low cost, ease of implementation, and focus on health promotion and disease prevention. The primary aim of this study is to adapt the CHAP model to a Philippine context as the Community Health Assessment Program in the Philippines (CHAP-P) and evaluate the effect of CHAP-P on glycated hemoglobin (HbA1c) compared to a random sample of community residents in control communities. METHODS: Six-month, 26-community (13 intervention, 13 control) parallel cluster randomized controlled trial in Zamboanga Peninsula, an Administrative Region in the southern Philippines. Criteria for community selection include: adequate political stability, connection with local champions, travel feasibility, and refrigerated space for materials. The community-based intervention, CHAP-P sessions, are volunteer-led group sessions with chronic condition assessment, blood pressure monitoring, and health education. Three participant groups will be involved: 1) Random sample of community participants aged 40 or older, 100 per community (1300 control, 1300 intervention participants total); 2) Community members aged 40 years or older who attended at least one CHAP-P session; 3) Community health workers and staff facilitating sessions. PRIMARY OUTCOME: mean difference in HbA1c at 6 months in intervention group individuals compared to control. SECONDARY OUTCOMES: modifiable risk factors, health utilization and access (individual); diabetes detection and management (cluster). Evaluation also includes community process evaluation and cost-effectiveness analysis. DISCUSSION: CHAP has been shown to be effective in a Canadian setting. Individual components of CHAP-P have been piloted locally and shown to be acceptable and feasible. This study will improve understanding of how best to adapt this model to an LMIC setting, in order to maximize prevention, detection, and management of diabetes. Results may inform policy and practice in the Philippines and have the potential to be applied to other LMICs. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT03481335 ), registered March 29, 2018.

Health Technology Agency insights: informing modification of a qualitative benefit risk framework for Health Technology Reassessment of prescription medications.

OBJECTIVES: This study's intent was to determine if a qualitative benefit risk framework could be used or modified to further enable Health Technology Reassessment (HTR) of prescription medicine recommendations. The purpose of this research was to understand Canadian Health Technology Agency assessors past experiences and insights to inform any modifications to the Universal Methodology for Benefit-Risk Assessment (UMBRA) qualitative framework. The UMBRA framework consists of an eight-step process, used during the assessment phase, to aid in decision making and dissemination. METHODS: A qualitative descriptive study was conducted and included a purposeful, criterion-based sample of eight assessors who had participated in Health Technology Assessment (HTA) or HTR for prescription medicines or in qualitative decision-making frameworks. RESULTS: Participant interviews lead to four common themes: "adoption of a qualitative benefit risk framework," "data (either too much or not enough)," "importance of incorporating stakeholder values," and "feasibility of the UMBRA framework." Methodological challenges with HTR were highlighted including the lack of clinical outcome data and the ability to compare clinically relevant meaningful differences. The implementation of a ranking or weighing process found within the UMBRA framework was not favored by half of the participants. CONCLUSIONS: Research participants did not consider all steps of the UMBRA framework to be transferable to the assessment phase of HTR given the need for simplicity, resource efficiency, and stakeholder input throughout the process. The assessor experiences and insights and the resultant key themes can be used in future research to aid in the development of a qualitative recommendation framework for HTR.

Comparative Efficacy of Angiotensin II Antagonists in Essential Hypertension: Systematic Review and Network Meta-Analysis of Randomised Controlled Trials.

BACKGROUND: Evidence on the long-term clinical benefits of individual members of angiotensin II receptor blockers is limited given the lack of head-to-head studies. We conducted a network meta-analysis to determine the comparative efficacy of different members within this drug class with respect to outcomes of (i) blood pressure reduction (at 24 and 52 weeks) and (ii) prevention of cardiovascular disease (>104 weeks). METHODS: A systematic literature review was conducted - Protocol registration: (PROSPERO - CRD42014007067) - to identify relevant literature from the following databases: Cochrane Library, PubMed, Medline and EMBASE; searched from inception to July 2016. Randomised controlled trials (RCTs) were included if they reported long-term effectiveness relating to blood pressure, mortality, myocardial infarction or stroke. Eligible studies included those with placebo or specific active-treatment comparators (either another angiotensin II receptor blockers or hydrochlorothiazide). A Bayesian random-effects network model was used to combine direct within-trial comparisons between treatment groups with indirect evidence from other trials. RESULTS: Thirty-six studies were identified, representing 28 unique trials. Blood pressure reduction, based on 12 studies (n=807) with fixed dosing regimen, was found to be similar amongst members of the angiotensin receptor blocker drug class at both 24 and 52 weeks. A network meta-analysis of five studies (n=16,716) with a treat-to-target approach found that prevention of all-cause mortality, stroke and myocardial infarction was similar across the angiotensin-receptor blockers therapies initiated. CONCLUSIONS: Current evidence is insufficient to show differences in any members within the angiotensin II receptor blocker drug class with respect to blood pressuring lowering effects or a reduction in cardiovascular diseases.

DRUG DISINVESTMENT FRAMEWORKS: COMPONENTS, CHALLENGES, AND SOLUTIONS.

OBJECTIVES: Value assessments of marketed drug technologies have been developed through disinvestment frameworks. Components of these frameworks are varied and implementation challenges are prevalent. The objective of this systematic literature review was to describe disinvestment framework process components for drugs and to report on framework components, challenges, and solutions. METHODS: A systematic literature search was conducted using the terms: reassessment, reallocation, reinvestment, disinvestment, delist, decommission or obsolescence in MEDLINE, EMBASE, NLM PubMed, the Cochrane Library, and CINAHL from January 1, 2000, until November 14, 2015. Additional citations were identified through a gray literature search of Health Technology Assessment international (HTAi) and the International Network of Agencies for Health Technology Assessment (INAHTA) member Web sites and from bibliographies of full-text reviewed manuscripts. RESULTS: Sixty-three articles underwent full text review and forty were included in the qualitative analysis. Framework components including disinvestment terms and definitions, identification and prioritization criteria and methods, assessment processes, stakeholders and dissemination strategies, challenges, and solutions were compiled. This review finds that stakeholders lack the political, administrative, and clinical will to support disinvestment and that there is not one disinvestment framework that is considered best practice. CONCLUSIONS: Drug technology disinvestment components and processes vary and challenges are numerous. Future research should focus on lessening value assessment challenges. This could include adopting more neutral framework terminology, setting fixed reassessment timelines, conducting therapeutic reviews, and modifying current qualitative decision-making assessment frameworks.

Feasibility of an altruistic sperm donation program in Canada: results from a population-based model.

BACKGROUND: Stringent donor-screening criteria and legislation prohibiting payment for donor gametes have contributed to the radical decline of donor insemination (DI) using sperm provided by Canadian men. Thus, many individuals rely on imported sperm. This paper examines the feasibility of an altruistic sperm donation (ASD) program to meet the needs of Canadians. METHODS: Using Canadian census data, published literature and expert opinions, two population-based, top-down mathematical models were developed to estimate the supply and demand for donor sperm and the feasibility of an ASD program. RESULTS: It was estimated that 63 donors would pass Canadian screening criteria, which would provide 1,575 donations. The demand for DI by women was 7,866 samples (4,319 same sex couples, 1,287 single women and 2,260 heterosexual couples). CONCLUSION: Considerable effort would be necessary to create the required increase in awareness of the program and change in societal behaviour towards sperm donation for an ASD program to be feasible in Canada.

Steps toward improving ethical evaluation in health technology assessment: a proposed framework.

BACKGROUND: While evaluation of ethical aspects in health technology assessment (HTA) has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response to the increasing demand for expansion of health technology assessment (HTA) methodology to include ethical issues more systematically, this article reports on a multi-stage study that aimed at construction of a framework for improving the integration of ethics in HTA. METHODS: The framework was developed through the following phases: 1) a systematic review and content analysis of guidance documents for ethics in HTA; 2) identification of factors influencing the integration of ethical considerations in HTA; 3) preparation of an action-oriented framework based on the key elements of the existing guidance documents and identified barriers to and facilitators of their implementation; and 4) expert consultation and revision of the framework. RESULTS: The proposed framework consists of three main components: an algorithmic flowchart, which exhibits the different steps of an ethical inquiry throughout the HTA process, including: defining the objectives and scope of the evaluation, stakeholder analysis, assessing organizational capacity, framing ethical evaluation questions, ethical analysis, deliberation, and knowledge translation; a stepwise guide, which focuses on the task objectives and potential questions that are required to be addressed at each step; and a list of some commonly recommended or used tools to help facilitate the evaluation process. CONCLUSIONS: The proposed framework can be used to support and promote good practice in integration of ethics into HTA. However, further validation of the framework through case studies and expert consultation is required to establish its utility for HTA practice.

Barriers and facilitators influencing ethical evaluation in health technology assessment.

OBJECTIVES: The objective of this study was to explore barriers and facilitators influencing the integration of ethical considerations in health technology assessment (HTA). METHODS: The study consisted of two complementary approaches: (a) a systematic review of the literature; and (b) an eighteen-item online survey that was distributed to fifty-six HTA agencies affiliated with the International Network of Agencies for Health Technology Assessment. RESULTS: The review identified twenty-six relevant articles. The most often cited barriers in the literature were: scarcity, heterogeneity and complexity of ethical analysis methods; challenges in translating ethical analysis results into knowledge that is useful for decision makers; and lack of organizational support in terms of required expertise, time and financial resources. The most frequently cited facilitators included: usage of value-based appraisal methods, stakeholder and public engagement, enhancement of practice guidelines, ethical expertise, and educational interventions. Representatives of twenty-six (46.5 percent) agencies from nineteen countries completed the survey. A median of 10 percent (interquartile range, 5 percent to 50 percent) of the HTA products produced by the agencies was reported to include an assessment of ethical aspects. The most commonly perceived barriers were: limited ethical knowledge and expertise, insufficient time and resources, and difficulties in finding ethical evidence or using ethical guidelines. Educational interventions, demand by policy makers, and involvement of ethicists in HTA were the most commonly perceived facilitators. CONCLUSIONS: Our results emphasize the importance of simplification of ethics methodology and development of good practice guidelines in HTA, as well as capacity building for engaging HTA practitioners in ethical analyses.

Systematic review and meta-analysis of the benefits of out-of-hospital 12-lead ECG and advance notification in ST-segment elevation myocardial infarction patients.

STUDY OBJECTIVE: To present a review of out-of-hospital identification of ST-segment elevation myocardial infarction patients transported by emergency medical services with 12-lead ECG and advance notification versus standard or no cardiac monitoring. METHODS: EMBASE, PubMed, and the Cochrane Library were searched, using controlled vocabulary and keywords. Randomized controlled trials and observational studies were included. Outcomes included short-term mortality (≤30 days), door-to-balloon/needle time and/or first medical contact-to-balloon/needle time. Pooled estimates were determined, where appropriate. Results were stratified by percutaneous coronary intervention or fibrinolysis. RESULTS: The search yielded 1,857 citations, of which 68 full-texts were reviewed and 16 studies met the final criteria: 15 included data on percutaneous coronary intervention and 3 on fibrinolysis (2 included both). Where percutaneous coronary intervention was performed, out-of-hospital 12-lead ECG and advance notification was associated with a 39% reduction in short-term mortality (8 studies; n=6,339; risk ratio 0.61; 95% confidence interval 0.42 to 0.89; P=.01; I(2)=30%) compared with standard or no cardiac monitoring. Where fibrinolysis was performed, out-of-hospital 12-lead ECG and advance notification was associated with a 29% reduction in short-term mortality (1 study; n=17,026; risk ratio 0.71; 95% confidence interval 0.54 to 0.93; P=.01). First medical contact-to-balloon, door-to-balloon, and door-to-needle times were consistently reduced, though large heterogeneity generally precluded pooling. CONCLUSION: The present study adds to previous reviews by identifying and appraising the strength and quality of a larger body of evidence. Out-of-hospital identification with 12-lead ECG and aadvance notification was found to be associated with reductions in short-term mortality and first medical contact-to-balloon, door-to-balloon, and door-to-needle time.

The excess burden of rheumatoid arthritis in Ontario, Canada.

OBJECTIVES: The purpose of this study was to estimate the excess burden of RA in Ontario, the largest province in Canada. METHODS: The records of all adult Ontarians who participated in the Canadian Community Health Survey (CCHS) cycle 1.1 (2000/2001) and provided consent to data linkage were linked to the Ontario Health Insurance Program (OHIP) physician claims database and the Discharge Abstract Database (DAD) In-Patient (i.e. hospitalisation) and Day-Procedure databases. RA individuals (n=233) were identified using CCHS 1.1 and the physician claims database. A control group matched by age, gender and rural/urban status was created with three controls for one case (n=699). Socio-demographic variables, medical characteristics, health-related quality of life (HRQoL) and one-year physician services, hospitalizations and day procedures costs were determined for the RA and non-RA groups. Regression techniques were used to identify predictors of medical characteristics, utility and cost data. RESULTS: The mean age of the population was 59 years and 76% were female. Compared to the matched control group, individuals with RA were statistically more likely to be obese, less educated, physically inactive and have a lower income. RA individuals also reported a statistically higher number of comorbidities and a lower HRQoL. Although no statistical differences were observed between the RA and non-RA groups for the costs associated with hospitalisations, the physician ($1,015 vs. $624, respectively) and day procedure ($102 vs. $51, respectively) costs were statistically higher among RA individuals. CONCLUSIONS: These results indicate that the human and economic burden of RA in Ontario is considerable.

The excess burden of osteoarthritis in the province of Ontario, Canada.

OBJECTIVE: Little is known about the burden of osteoarthritis (OA) in Canada. This study was undertaken to estimate the excess burden of OA in Ontario, the largest province in Canada. METHODS: The records of Ontarian respondents to the Canadian Community Health Survey (CCHS) who provided consent to data linkage were linked to the Ontario Health Insurance Program physician claims database and the Discharge Abstract Database Inpatient and Day Procedure databases. Patients with OA (n = 1,474) were identified using CCHS 1.1 and the physician claims database. To determine the excess burden of OA, a control group matched by age, sex, and rural/urban status was created, with 3 controls per case (n = 4,422). Sociodemographic and medical characteristics, health-related quality of life, and 1-year physician, day (outpatient) procedure, and hospitalization costs were compared between the 2 groups. Regression analyses were performed to identify predictors of medical characteristics, health utility, and cost. RESULTS: The mean age of the OA patients and the control subjects was 66 years, and 74% of all study subjects were women. Several differences were observed between patients with OA and subjects without OA in terms of socioeconomic and medical characteristics. On a scale of 0-1, the mean utility value associated with OA was 0.68, compared to 0.84 for the control group (P < 0.0001), representing a utility decrement of 0.16. The 1-year physician, outpatient procedure, and hospitalization costs were significantly higher in the OA group than in the non-OA group ($2,233 Canadian versus $1,033 Canadian, respectively; P < 0.0001). CONCLUSION: These results indicate that the excess burden of OA in Ontario is considerable.

Hyperbaric oxygen therapy for diabetic ulcers: systematic review and meta-analysis.

OBJECTIVES: Approximately 10-15 percent of individuals with diabetes mellitus develop foot ulcers, which precede 85 percent of amputations. Increased oxygen, through the use of hyperbaric oxygen therapy (HBOT), has been suggested to encourage ulcer healing thus reducing the risk of amputation. The objective of this systematic review is to evaluate the efficacy of systemic HBOT for nonhealing ulcers of the lower limb in diabetes patients. METHODS: A systematic search, using controlled and keyword terms focusing on "HBOT" and "lower limb diabetic ulcers," was conducted. Databases searched included Medline, EMBASE, CINAHL, PubMed, Wiley's Cochrane Library, and Biosis. Randomized controlled trials (RCTs) and observational studies were included. Pooled estimates of outcomes were determined when appropriate. RESULTS: Of the 654 citations identified, 157 articles underwent full-text review. Data were abstracted from twelve publications (six RCTs and six comparative observational studies). Pooled analysis of the RCT and observational data showed that treatment with HBOT reduced the risk of major amputation by 60 percent (p = .29) and 61 percent (p = .003) compared with standard wound care, respectively. The RCT data revealed that the relative risk of having an unhealed wound following HBOT was 0.54 (p = .10) and 0.24 (p < .0001) based on observational data. CONCLUSIONS: Due to the limited RCT evidence, it is not possible to conclusively establish the benefits and harms of treating diabetic lower limb ulcers with HBOT. No significant effects on amputation rates were found in the RCT evidence and in the high quality studies, no difference was found.

Sentinel lymph node biopsy in vulvar cancer: a health technology assessment for the canadian health care context.

OBJECTIVES: Inguinofemoral lymphadenectomy for vulvar cancer is associated with a high incidence of groin wound complications and lymphedema. Sentinel lymph node biopsy (SLNB) is a morbidity-reducing alternative to lymphadenectomy. The objective of this health technology assessment was to determine the clinical effectiveness, cost-effectiveness, and organizational feasibility of SLNB in the Canadian health care system. METHODS: A review of the English-language literature published from January 1992 to October 2011 was performed across five databases and six grey-literature sources. Predetermined eligibility criteria were used to select studies, and results in the clinical, economic, and organizational domains were summarized. Included studies were evaluated for methodologic quality using the Newcastle-Ottawa Scale. RESULTS: Of 825 reports identified, 88 observational studies met the eligibility criteria. Overall study quality was poor, with a median Newcastle-Ottawa Scale score of 2 out of 9 stars. Across all studies, the detection rate of the sentinel lymph node was 82.2% per groin and the false-negative rate was 6.3%. The groin recurrence rate after negative SLNB was 3.6% compared with 4.3% after negative lymphadenectomy, and complications were reduced after SLNB. No economic evaluations were identified comparing SLNB to lymphadenectomy. Safe implementation of SLNB requires appropriate patient selection, detection technique, and attention to the learning curve. CONCLUSIONS: Although study quality is poor, the available data suggest implementation of SLNB may be safe and feasible in Canadian centres with adequate procedural volumes, assuming that implementation includes careful patient selection, careful technique, and ongoing quality assessment. Cost-effectiveness has yet to be determined.

Economic Analysis of a Diabetes Health Coaching Intervention for Adults Living With Type 2 Diabetes: A Single-Centre Evaluation From a Community-Based Randomized Controlled Trial.

BACKGROUND: A recent randomized controlled trial demonstrated that a community-based, telephone-delivered diabetes health coaching intervention was effective for improving diabetes management. Our aim in this study was to determine whether this intervention is also cost-effective. METHODS: An economic evaluation, in the form of a cost-utility analysis (CUA), was used to assess the cost-effectiveness of the coaching intervention from a public payer's perspective. All direct medical costs, as well as intervention implementation, were included. The outcome measure for the CUA was quality-adjusted life-year (QALY). Uncertainty of cost-effectiveness results was estimated using nonparametric bootstraps of patient-level costs and QALYs in the coaching and control arms. A cost-effectiveness acceptability curve was used to express this uncertainty as the probability that diabetes health coaching is cost-effective across a range of values of willingness-to-pay thresholds for a QALY. RESULTS: The results show that subjects in the coaching arm incurred higher overall costs (in Canadian dollars) than subjects in the control arm ($1,581 vs $1,086, respectively) and incurred 0.02 more QALYs. The incremental cost-effectiveness ratio of the diabetes health coaching intervention compared with usual care was found to be $35,129 per QALY, with probabilities of 67% and 82% that diabetes health coaching would be cost-effective at a willingness-to-pay threshold of $50,000 per QALY and $100,000 per QALY, respectively. CONCLUSION: A community-based, telephone-delivered diabetes health coaching intervention is cost-effective.

Estimation of the impact of diabetes-related complications on health utilities for patients with type 2 diabetes in Ontario, Canada.

OBJECTIVES: The goal of this study was to analyze health-related quality of life (HRQL) data from a Canadian population with type 2 diabetes in order to estimate the disutility associated with experiencing a diabetes-related complication. METHODS: The EQ-5D, a standardized instrument for use as a measure of health outcome, was administered to 1,147 patients in Hamilton, Ontario, with type 2 diabetes. After controlling for age, gender, and duration of diabetes, changes in utility values were estimated by regressing the EQ-5D scores onto binary indicators for the presence of an event. The primary method of analysis was Ordinary Least Squares (OLS) and due to concerns over non-Normality, bootstrap standard errors (SE) were calculated. RESULTS: The analysis included 1,143 participants. Based on the OLS model, reductions in HRQL were associated with duration of diabetes (-0.0015, SE = 0.0006), experiencing a myocardial infarction (MI) (-0.059, SE = 0.017), amputation (-0.063, SE = 0.059), stroke (-0.046, SE = 0.023), and kidney failure (-0.102, SE = 0.047). CONCLUSION: This study estimated the reductions in HRQL associated with several important complications commonly experienced in patients with diabetes. The greatest impacts on HRQL were associated with kidney failure and MI. The utility values calculated here can be used to assess the outcome of interventions that reduce these diabetes-related complications and will have a useful impact on future economic evaluations of diabetes management strategies in Canada.

Prehospital evaluation and economic analysis of different coronary syndrome treatment strategies--PREDICT--rationale, development and implementation.

BACKGROUND: A standard of prehospital care for patients presenting with ST-segment elevation myocardial infarction (STEMI) includes prehospital 12-lead and advance Emergency Department notification or prehospital bypass to percutaneous coronary intervention centres. Implementation of either care strategies is variable across communities and neither may exist in some communities. The main objective is to compare prehospital care strategies for time to treatment and survival outcomes as well as cost effectiveness. METHODS/DESIGN: PREDICT is a multicentre, prospective population-based cohort study of all chest pain patients 18 years or older presenting within 30 mins to 6 hours of symptom onset and treated with nitroglycerin, transported by paramedics in a number of different urban and rural regions in Ontario. The primary objective of this study is to compare the proportion of study subjects who receive reperfusion within the target door-to-reperfusion times in subjects obtained after four prehospital strategies: 12-lead ECG and advance emergency department (ED) notification or 3-lead ECG monitoring and alert to dispatch prior to hospital arrival; either with or without the opportunity to bypass to a PCI centre. DISCUSSION: We anticipate four challenges to successful study implementation and have developed strategies for each: 1) diversity in the interpretation of the ethical and privacy issues across 47 research ethics boards/committees covering 71 hospitals, 2) remote oversight of data guardian abstraction, 3) timeliness of implementation, and 4) potential interference in the study by concurrent technological advances. Research ethics approvals from academic centres were obtained initially and submitted to non academic centre applications. Data guardians were trained by a single investigator and data entry is informed by a detailed data dictionary including variable definitions and abstraction instructions and subjected to error and logic checks. Quality oversight provided by a single investigator. The window of the trial in each community has been confirmed with the base-hospital medical director to correspond to the planned technological advances of the system of care. We hope this comparative analysis across treatment strategies for clinical outcomes and cost will provide sufficient evidence to implement the superior strategy across all communities and improve outcomes for all STEMI patients.

Evidence-Based Decision Making 3: Health Technology Assessment.

This chapter begins with a brief introduction to health technology assessment (HTA). HTA is concerned with the systematic evaluation of the consequences of the adoption and use of new health technologies and to improve the evidence on existing technologies. The objective of mainstream HTA is to support evidence-based decision- and policy-making that encourage the uptake of efficient and effective health-care technologies. This chapter provides a basic framework for conducting an HTA, as well as some fundamental concepts and challenges in assessing health technologies. Whether HTA is beneficial-supporting timely access to needed technologies-or detrimental depends on three critical issues: when the assessment is performed; how it is performed; and how the findings are used.

Effect of Diabetes Health Coaching on Glycemic Control and Quality of Life in Adults Living With Type 2 Diabetes: A Community-Based, Randomized, Controlled Trial.

OBJECTIVES: Health coaching for type 2 diabetes (T2DM) represents a promising addition toward efforts to improve clinical health outcomes and quality of life. The purpose of this study was to evaluate the effect of a 12-month telephone diabetes health coaching (DHC) intervention on glycemic control in persons living with T2DM. METHODS: In this community-based, randomized, controlled trial, adults with T2DM, glycated hemoglobin (A1C) ≥7.5% and telephone access were assigned to either usual diabetes education (DE) or DHC and access to DE. The primary outcome was change in A1C after 1 year, and secondary outcomes included score on the 19-item Audit of Diabetes-Dependent Quality of Life (ADDQoL-19) instrument and self-care behaviours. Safety was assessed in all participants (NCT02128815 at www.clinicaltrials.gov). RESULTS: Three hundred sixty-five participants (50% females; mean age, 57 years; mean A1C, 8.98%) were randomized to control (DE, n=177) or intervention (DHC, n=188) groups. The A1C level decreased by an absolute amount of 1.8% and 1.3% in the intervention and control groups, respectively. DHC plus DE reduced A1C by 0.49% more than DE alone (95% confidence interval, -0.80 to -0.18; p<0.01) and improved ADDQoL-19 scores, with between-group differences for the average weighted score of 0.28 (95% confidence interval, 0.04 to 0.52; p=0.02). There were no differences between groups for proportion of participants having an emergency department visit or hospitalization. CONCLUSIONS: Providing frequent telephone-based DHC and access to DE to adults living with T2DM for 1 year supports improvements in glycemic control and quality of life.