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.

Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial.

BACKGROUND: Polypharmacy in older adults can be associated with negative outcomes including falls, impaired cognition, reduced quality of life, and general and functional decline. It is not clear to what extent these are reversible if the number of medications is reduced. Primary care does not have a systematic approach for reducing inappropriate polypharmacy, and there are few, if any, approaches that account for the patient's priorities and preferences. The primary objective of this study is to test the effect of TAPER (Team Approach to Polypharmacy Evaluation and Reduction), a structured operationalized clinical pathway focused on reducing inappropriate polypharmacy. TAPER integrates evidence tools for identifying potentially inappropriate medications, tapering, and monitoring guidance and explicit elicitation of patient priorities and preferences. We aim to determine the effect of TAPER on the number of medications (primary outcome) and health-related outcomes associated with polypharmacy in older adults. METHODS: We designed a multi-center randomized controlled trial, with the lead implementation site in Hamilton, Ontario. Older adults aged 70 years or older who are on five or more medications will be eligible to participate. A total of 360 participants will be recruited. Participants will be assigned to either the control or intervention arm. The intervention involves a comprehensive multidisciplinary medication review by pharmacists and physicians in partnership with patients. This review will be focused on reducing medication burden, with the assumption that this will reduce the risks and harms of polypharmacy. The control group is a wait list, and control patients will be given appointments for the TAPER intervention at a date after the final outcome assessment. All patients will be followed up and outcomes measured in both groups at baseline and 6 months. DISCUSSION: Our trial is unique in its design in that it aims to introduce an operationalized structured clinical pathway aimed to reduce polypharmacy in a primary care setting while at the same time recording patient's goals and priorities for treatment. TRIAL REGISTRATION: Clinical Trials.gov NCT02942927. First registered on October 24, 2016.

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.

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.

Cost-effectiveness analysis of a community paramedicine programme for low-income seniors living in subsidised housing: the community paramedicine at clinic programme (CP@clinic).

OBJECTIVES: To evaluate the cost-effectiveness of the Community Paramedicine at Clinic (CP@clinic) programme compared with usual care in seniors residing in subsidised housing. DESIGN: A cost-utility analysis was conducted within a large pragmatic cluster randomised controlled trial (RCT). Subsidised housing buildings were matched by sociodemographics and location (rural/urban), and allocated to intervention (CP@clinic for 1 year) or control (usual care) via computer-assisted paired randomisation. SETTING: Thirty-two subsidised seniors' housing buildings in Ontario. PARTICIPANTS: Building residents 55 years and older. INTERVENTION: CP@clinic is a weekly community paramedic-led, chronic disease prevention and health promotion programme in the building common areas. CP@clinic is free to residents and includes risk assessments, referrals to resources, and reports back to family physicians. OUTCOME MEASURES: Quality-adjusted life years (QALYs) gained, measured with EQ-5D-3L. QALYs were estimated using area-under-the curve over the 1-year intervention, controlling for preintervention utility scores and building pairings. Programme cost data were collected before and during implementation. Costs associated with emergency medical services (EMS) use were estimated. An incremental cost effectiveness ratio (ICER) based on incremental costs and health outcomes between groups was calculated. Probabilistic sensitivity analysis using bootstrapping was performed. RESULTS: The RCT included 1461 residents; 146 and 125 seniors completed the EQ-5D-3L in intervention and control buildings, respectively. There was a significant adjusted mean QALY gain of 0.03 (95% CI 0.01 to 0.05) for the intervention group. Total programme cost for implementing in five communities was $C128 462 and the reduction in EMS calls avoided an estimated $C256 583. The ICER was $C2933/QALY (bootstrapped mean ICER with Fieller's 95% CI was $4850 ($2246 to $12 396)) but could be even more cost effective after accounting for the EMS call reduction. CONCLUSION: The CP@clinic ICER was well below the commonly used Canadian cost-utility threshold of $C50 000. CP@clinic scale-up across subsidised housing is feasible and could result in better health-related quality-of-life and reduced EMS use in low-income seniors. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov, NCT02152891.

Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study.

INTRODUCTION: This protocol is describing a multicentre, single-blind randomised controlled trial. The objective is to compare the efficacy of MyndMove therapy versus conventional therapy (CT) in improving upper extremity function in individuals with C4-C7 traumatic, incomplete spinal cord injury (SCI). It is being conducted in two US and two Canadian SCI rehabilitation centres. METHODS AND ANALYSIS: Sixty people aged 18 years or older with a C4-C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury are randomised to receive 40 sessions of MyndMove neuromodulation therapy or CT within a 14-week period of time. Therapy sessions are 1 hour in duration with a dose of 3-5 sessions per week. Assessments occur prior to randomisation, after 20 sessions, after 40 sessions and 10 weeks after the last session. The primary outcome measure is the efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore after 40 sessions. Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation. ETHICS AND DISSEMINATION: All ethical approvals were obtained prior to enrolling any participants. Dissemination of the results of the study will be made at peer-reviewed academic meetings and through peer-reviewed medical journals TRIAL REGISTRATION NUMBER: NCT03439319.

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.

Pilot randomized controlled trial of a complex intervention for diabetes self-management supported by volunteers, technology, and interprofessional primary health care teams.

BACKGROUND: Most health care for people with diabetes occurs in family practice, yet balancing the time and resources to help these patients can be difficult. An intervention empowering patients, leveraging community resources, and assisting self-management could benefit patients and providers. Thus, the feasibility and potential for effectiveness of "Health Teams Advancing Patient Experience, Strengthening Quality through Health Connectors for Diabetes Management" (Health TAPESTRY-HC-DM) as an approach supporting diabetes self-management was explored to inform development of a future large-scale trial. METHODS: Four-month pilot randomized controlled trial (RCT), sequential explanatory qualitative component. Participants-patients of an interprofessional primary care team-were over age 18 years, diagnosed with diabetes and hypertension, and had Internet access and one of the following: uncontrolled HbA1c, recent diabetes diagnosis, end-stage/secondary organ damage, or provider referral. The Health TAPESTRY-HC-DM intervention focused on patient health goals/needs, integrating community volunteers, eHealth technologies, interprofessional primary care teams, and system navigation. Pilot outcomes included process measures (recruitment, retention, program participation), perceived program feasibility, benefits and areas for improvement, and risks or safety issues. The primary trial outcome was self-efficacy for managing diabetes. There were a number of secondary trial outcomes. RESULTS: Of 425 eligible patients invited, 50 signed consent (11.8%) and 35 completed the program (15 intervention, 20 control). Volunteers (n = 20) met 28 clients in 234 client encounters (home visits, phone calls, electronic messages); 27 reports were sent to the interprofessional team. At 4 months, controlling for baseline, most outcomes were better in the intervention compared to control group; physical activity notably better. The most common goal domains set were physical activity, diet/nutrition, and social connection. Clients felt the biggest impact was motivation toward goal achievement. They struggled with some of the technologies. Several participants perceived that the program was not a good fit, mostly those that felt they were already well-managing their diabetes. CONCLUSIONS: Health TAPESTRY-HC-DM was feasible; a large-scale randomized controlled trial seems possible. However, further attention needs to be paid to improving recruitment and retention. The intervention was well received, though was a better fit for some participants than others. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02715791. Registered 22 March 2016-retrospectively registered.

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.

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.

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 Diabetes Health Coaching Randomized Controlled Trial: Rationale, Design and Baseline Characteristics of Adults Living With Type 2 Diabetes.

OBJECTIVES: The Diabetes Health Coaching Trial was a single-blind, randomized controlled trial designed to evaluate the effect of a 1-year telephone-based diabetes health-coaching intervention for community-dwelling adults living with type 2 diabetes mellitus. It concerned glycated hemoglobin levels, self-care behaviours and cost-effectiveness. The purpose of this article is to describe the rationale, design and participants' characteristics. METHODS: The eligibility criteria were: 1) adults ≥18 years of age; 2) a diagnosis of type 2 diabetes; 3) glycated hemoglobin levels of ≥7.5% 6 months before randomization; 4) the ability to read, write and understand English; and 5) having telephone access. Participants were randomized to either usual diabetes education or diabetes education plus diabetes health coaching. RESULTS: From May 2016 to December 2017, 365 participants were randomized into the trial. At baseline, the mean age was 57.9 (11.78) years, the mean duration of diabetes was 8.69 (8.54) years, the mean glycated hemoglobin level was 8.98 (1.58) %, and the mean body mass index was 35.03 (8.07) kg/m2. CONCLUSIONS: The baseline characteristics of the participants were equally distributed across the intervention and control groups. The Diabetes Health Coaching Trial is in a position to evaluate a potential treatment alternative and approach for type 2 diabetes and examined the effect of the intervention on clinical outcomes, self-care behaviours and cost-effectiveness.

Economic analysis of pharmacist-administered influenza vaccines in Ontario, Canada.

OBJECTIVE: The aim of this study was to evaluate the impact of pharmacist administration of influenza vaccine in Ontario on: 1) vaccination-associated costs related to the number of people vaccinated; 2) annual influenza-related outcomes and costs; and 3) change in productivity costs. METHODS: Using available data for Ontario, the total number of vaccinations given by providers in the 2011/12 influenza season (pre) was compared to the 2013/14 influenza season (post). Vaccine costs and provider fees for administration were assigned for both periods. An economic model was created to estimate the impact of the change in influenza vaccination volume on influenza-related outcomes and on the health care costs associated with treating influenza-related outcomes. Productivity costs due to both time off work due to getting vaccinated and influenza illness were considered. One-way sensitivity analysis was used to assess parameter uncertainty. RESULTS: The number of vaccinations received by Ontarians increased by 448,000 (3% of the population), with pharmacists vaccinating approximately 765,000 people/year. The increased cost to the Ontario Ministry of Health and Long-term Care was $6.3 million, while the money saved due to reduced influenza-related outcome costs was $763,158. Productivity losses were reduced by $4.5 million and $3.4 million for the time invested to get vaccinated and time off work due to influenza illness, respectively. CONCLUSION: After two influenza seasons, following the introduction of pharmacist-administered influenza vaccinations, there was a net immunization increase of almost 450,000, which potentially saved $2.3 million in direct health care costs and lost productivity in the province.

Direct Health-Care Costs and Productivity Costs Associated With Hypoglycemia in Adults With Type 1 and Type 2 Diabetes Mellitus That Participated in the Canadian Hypoglycemia Assessment Tool Program.

OBJECTIVES: There is a paucity of information concerning the cost of hypoglycemia events in Canadians with type 1 or type 2 diabetes. The objective of this study was to estimate the direct health-care costs and indirect costs associated with hypoglycemia based on a Canadian cohort of 498 patients from the global Hypoglycemia Assessment Tool (HAT) study. METHODS: A costing model was developed to estimate the direct costs related to experiencing hypoglycemia by using health-care resources associated with hospital admissions and additional clinical appointments that were prospectively reported 1 month after baseline in the HAT study. Data collected retrospectively on work absenteeism in the year prior to baseline were used to estimate the indirect costs of hypoglycemia events. All costs were annualized and reported in 2016 Canadian dollars. RESULTS: Of the 403 patients with diabetes who experienced hypoglycemia events in the first month after baseline (81%), 10 (2.5%) patients required hospitalization or clinical appointments. Over 1 year, the mean direct health-care costs were estimated to be C$90,300 (C$1,777 per patient) for hospitalizations and C$14,695 (C$204 per person) for additional clinical appointments. Work absenteeism resulted in a total annual indirect cost of C$20,937 for time off due to sick leave (C$500 per patient), arriving late (C$187 per patient) or leaving work early (C$128 per patient). The annual direct and indirect costs of hypoglycemia events total C$125,932. CONCLUSIONS: The impact of hypoglycemia events on health-care resource utilization and work productivity leads to substantial direct and indirect costs in Canadian patients with diabetes.

Clinical outcomes and health care utilization pre- and post-laparoscopic radiofrequency ablation of symptomatic fibroids and laparoscopic myomectomy: a randomized trial of uterine-sparing techniques (TRUST) in Canada.

OBJECTIVE: The objective of this study was to compare laparoscopic ultrasound-guided radiofrequency ablation of fibroids (Lap-RFA) and laparoscopic myomectomy in terms of 1) health care utilization and 2) serious complication rates. The secondary objectives were comparison of subject responses to validated symptom and quality-of-life questionnaires. We hypothesized that Lap-RFA health care utilization and clinical outcomes would not be worse than those of laparoscopic myomectomy in the aggregate. PATIENTS AND METHODS: Post-market, randomized, prospective, multicenter, longitudinal, non-inferiority interventional comparative evaluation of health care utilization and clinical outcomes in premenopausal women with symptomatic uterine fibroids who desired uterine conservation was conducted. Both procedures were planned as outpatient day surgeries. Health care resource utilization was measured during the procedure day and at 1 week, 1 and 3 months post-surgery. Symptom severity and quality of life were based on patients' responses to the Uterine Fibroid Symptom Severity and Quality-of-Life Questionnaire, EuroQol-5D-visual analog scale general health status and menstrual impact questionnaires, and time from work. RESULTS: Forty-five participants provided written informed consent and were enrolled (Lap-RFA, n=23; myomectomy, n=22) in Canada. Hospitalization time (primary endpoint) was 6.7±3.0 hours for the Lap-RFA group and 9.9±10.7 hours for the myomectomy group (Wilcoxon, p=0.0004). Intraoperative blood loss was lesser for Lap-RFA subjects: 25.2±21.6 versus 82.4±62.5 mL (p=0.0002). Lap-RFA procedures took lesser time than myomectomy procedures: 70.0 versus 86.5 minutes (p=0.018), and Lap-RFA required -34.9% (130 fewer) units of surgical equipment. At 3 months, both cohorts reported the same significant symptom severity reduction (-44.8%; p<0.0001). Lap-RFA subjects also took lesser time from work: 11.1±7.6 versus 18.5±10.6 days (p=0.0193). One myomectomy subject was hospitalized overnight after experiencing a 20-second asystole during the procedure. One Lap-RFA subject underwent a reintervention. The combined per patient direct and indirect costs of the two procedures were comparable: Lap-RFA (CAD $5,224.96) and myomectomy (CAD $5,321.96). CONCLUSION: Compared to myomectomy, Lap-RFA is associated with significantly lesser intraoperative blood loss, shorter procedure and hospitalization times, lesser consumption/use of disposable and reusable surgery equipment, reduced health care resource utilization, and faster return to work through 3 months posttreatment. Direct and indirect costs of Lap-RFA and myomectomy are comparable.

Clinical and economic burden of idiopathic pulmonary fibrosis in Quebec, Canada.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF), although rare, is a severe and costly disease. OBJECTIVE: To estimate the clinical and economic burden of IPF over multiple years before and after diagnosis using comprehensive administrative databases for the province of Quebec, Canada. METHODS: Several administrative databases from Quebec, providing information on hospital care, community care, and pharmaceuticals, were linked over a 5-year period ending March 31, 2011, which was before approval of antifibrotic drugs in Canada. Prevalent and incident IPF cases were defined using International Classification Disease-10-CA codes and International Classification Disease-9-CM codes. We used a broad definition that excluded cases with subsequent diagnosis of other interstitial lung diseases and a narrow definition that required further diagnostic testing to confirm IPF diagnosis. Incident cases had an IPF code in a particular year without any IPF code in the 2 previous years. Health care resource utilization before and after the index diagnosis date was determined and costs calculated. Costs were expressed in 2016 Canadian dollars. RESULTS: Over 5-years, 10,579 (mean age: 76.4; 58% male) satisfied the broad definition of IPF and 8,683 (mean age: 74.5; 57% male) satisfied the narrow definition (82% of broad). Incidences of IPF overall were 25.8 and 21.7/100,000 population for broad and narrow definitions, respectively. Three-year survival was 40% and 37% in broad and narrow cohorts, respectively. For both cohorts, health care resource utilization and costs increased several years before diagnosis ($2,721 and $7,049/patient 5 years and 2 years prior to diagnosis using a broad definition, respectively) and remained elevated for multiple years post diagnosis ($12,978 and $8,267 at 2 and 3 years postdiagnosis). CONCLUSION: Health care resource utilization and costs of IPF increase many years prior to diagnosis. Incorporating multiyear annual costs before and after diagnosis results in a higher estimate of the economic burden of IPF than previous studies using a 1-year time frame.

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.

Health Services Use by Late Preterm and Term Infants From Infancy to Adulthood: A Meta-analysis.

CONTEXT: Late-preterm infants born at 34 to 36 weeks' gestation have increased risks of various health problems. Health service utilization (HSU) of late-preterm infants has not been systematically summarized before. OBJECTIVES: To summarize the published literature on short- and long-term HSU by late-preterm infants versus term infants from infancy to adulthood after initial discharge from the hospital. DATA SOURCES: We searched Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature, and PsycINFO. STUDY SELECTION: Cohort and case-control studies that compared HSU (admissions, emergency department visits, etc) between late-preterm infants and term infants were included. DATA EXTRACTION: Data extracted included study design, setting, population, HSU, covariates, and effect estimates. RESULTS: Fifty-two articles were included (50 cohort and 2 case-control studies). Meta-analyses with random effect models that used the inverse-variance method found that late-preterm infants had higher chances of all-cause admissions than term infants during all the time periods. The magnitude of the differences decreased with age from the neonatal period through adolescence, with adjusted odds ratios from 2.34 (95% confidence intervals 1.19-4.61) to 1.09 (1.05-1.13) and adjusted incidence rate ratios from 2.62 (2.52-2.72) to 1.14 (1.11-1.18). Late-preterm infants had higher rates of various cause-specific HSU than term infants for jaundice, infection, respiratory problems, asthma, and neurologic and/or mental health problems during certain periods, including adulthood. LIMITATIONS: Considerable heterogeneity existed and was partially explained by the variations in the adjustment for multiple births and gestational age ranges of the term infants. CONCLUSIONS: Late-preterm infants had higher risks for all-cause admissions as well as for various cause-specific HSU during the neonatal period through adolescence.

Preliminary Results of the Adoption and Application of the Integrated Comprehensive Care Bundle Care Program When Treating Patients with Chronic Obstructive Pulmonary Disease.

BACKGROUND: St. Joseph's Health System has implemented an integrated comprehensive care bundle care (ICC) program with the hopes that it would improve patients' care while reducing overall costs. The aim of this analysis was to evaluate the performance of the ICC program within patients admitted with chronic pulmonary obstructive disease (COPD). METHODS: We conducted a retrospective observational cohort study comparing ICC patients to non-ICC patients admitted to St. Joseph's Healthcare Hamilton for COPD being discharged with support services between June 2012 and March 2015, using administrative data. Confounding adjustment was achieved through the use of propensity score matching. Medical resource utilizations during the initial hospitalization and within the 60 days following discharge were compared using regression models. RESULTS: All 76 patients who entered the ICC program (100.0%) were matched 1 : 1 to 76 eligible non-ICC patients (28.4%). Length of stay (6.47 [7.29] versus 9.55 [10.21] days) and resource intensity weights (1.16 [0.80] versus 1.64 [1.69]) were lower in the ICC group within the initial hospitalization but, while favoring the ICC program, healthcare resource use tended not to differ statistically following discharge. INTERPRETATION: The ICC program was able to reduce initial medical resource utilization without increasing subsequent medical resource use.