Progress toward Health System Readiness for Genome-Based Testing in Canada.

(1) Background: Genomic medicine harbors the real potential to improve the health and healthcare journey of patients, care provider experiences, and improve the health system efficiency-even reducing healthcare costs. There is expected to be an exponential growth in medically necessary new genome-based tests and test approaches in the coming years. Testing can also create scientific research and commercial opportunities beyond healthcare decision making. The purpose of this research is to generate a better understanding of Canada's state of readiness for genomic medicine, and to provide some insights for other healthcare systems. (2) Methods: A mixed-methods approach of a review of the literature and key informant interviews with a purposive sample of experts was used. The health system readiness was assessed using a previously published set of conditions. (3) Results: Canada has created some of the established conditions, but further action needs to be taken to improve the state of readiness for genome-based medicine. The important gaps to be filled are the need for linked information systems and data integration; evaluative processes that are timely and transparent; navigational tools for care providers; dedicated funding to facilitate rapid onboarding and support test development and proficiency testing; and broader engagement with innovation stakeholders beyond care providers and patients. These findings highlight the role of the organizational context, social influence, and other factors that are known to affect the diffusion of innovation within health systems.

Return on investment from service transformation for young people experiencing mental health problems: Approach to economic evaluations in ACCESS Open Minds (Esprits ouverts), a multi-site pan-Canadian youth mental health project.

Introduction: Mental health problems are common globally, and typically have their onset in adolescence and early adulthood-making youth (aged 11-25) an optimal target for prevention and early intervention efforts. While increasing numbers of youth mental health (YMH) initiatives are now underway, thus far few have been subject to economic evaluations. Here we describe an approach to determining the return on investment of YMH service transformation via the pan-Canadian ACCESS Open Minds (AOM) project, for which a key focus is on improving access to mental health care and reducing unmet need in community settings. Approach: As a complex intervention package, it is hoped that the AOM transformation will: (i) enable early intervention through accessible, community-based services; (ii) shift care away toward these primary/community settings and away from acute hospital and emergency services; and (iii) offset at least some of the increased costs of primary care/community-based mental health services with reductions in the volume of more resource-intensive acute, emergency, hospital or specialist services utilized. Co-designed with three diverse sites that represent different Canadian contexts, a return on investment analysis will (separately at each site) compare the costs generated by the intervention, including volumes and expenditures associated with the AOM service transformation and any contemporaneous changes in acute, emergency, hospital or service utilization (vs. historical or parallel comparators). Available data from health system partners are being mobilized to assess these hypotheses. Anticipated results: Across urban, semi-urban and Indigenous sites, the additional costs of the AOM transformation and its implementation in community settings are expected to be at least partially offset by a reduction in the need for acute, emergency, hospital or specialist care. Discussion: Complex interventions such as AOM aim to shift care "upstream": away from acute, emergency, hospital and specialist services and toward community-based programming which is more easily accessible, often more appropriate for early-stage presentations, and more resource-efficient. Carrying out economic evaluations of such interventions is challenging given the constraints of available data and health system organization. Nonetheless, such analyses can advance knowledge, strengthen stakeholder engagement, and further implementation of this public health priority.

Effective and Efficient Delivery of Genome-Based Testing-What Conditions Are Necessary for Health System Readiness?

Health systems internationally must prepare for a future of genetic/genomic testing to inform healthcare decision-making while creating research opportunities. High functioning testing services will require additional considerations and health system conditions beyond traditional diagnostic testing. Based on a literature review of good practices, key informant interviews, and expert discussion, this article attempts to synthesize what conditions are necessary, and what good practice may look like. It is intended to aid policymakers and others designing future systems of genome-based care and care prevention. These conditions include creating communities of practice and healthcare system networks; resource planning; across-region informatics; having a clear entry/exit point for innovation; evaluative function(s); concentrated or coordinated service models; mechanisms for awareness and care navigation; integrating innovation and healthcare delivery functions; and revisiting approaches to financing, education and training, regulation, and data privacy and security. The list of conditions we propose was developed with an emphasis on describing conditions that would be applicable to any healthcare system, regardless of capacity, organizational structure, financing, population characteristics, standardization of care processes, or underlying culture.

Optimizing the delivery of genetic and advanced diagnostic testing in the province of Ontario: challenges and implications for laboratory technology assessment and management in decentralized healthcare systems.

AIMS: The Canadian province of Ontario provides full coverage for its residents (pop.14.8 M) for hospital-based diagnostic testing. Historical governance of the healthcare system and a legacy scheme of health technology assessment (HTA) and financing has led to a suboptimal approach of adopting advanced diagnostic technology (i.e. protein expression, cytogenetic, and molecular/genetic) for guiding therapeutic decisions. The aim of this research is to explore systemic barriers and provide guidance to improve patient and care provider experiences by reducing delays and inequity of access to testing, while benefitting laboratory innovators and maximizing system efficiency. MATERIALS AND METHODS: A mixed-methods approach including literature review, semi-structured interviews, and a multi-stakeholder forum involving patient representatives (n = 1), laboratory leaders (n = 6), physicians (n = 5), Ministry personnel (n = 4), administrators (n = 3), extra-provincial experts, and researchers (n = 7), as well as pharmaceutical (n = 5) and diagnostic companies (n = 2). The forum considered evidence of good practices in adoption, implementation, and financing laboratory services and identified barriers as well as feasible options for improving advanced diagnostic testing in Ontario. RESULTS: Overarching challenges identified included: barriers to define what is needed; need for a clear approach to adoption; and the need for more oversight and coordination. Recommendations to address these included a shift to an anticipatory system of test adoption, creating a fit-for-purpose system of health technology management that consolidates existing evaluation processes, and modernizing the governance and financing of testing so that it is managed at a care-delivery level. CONCLUSIONS: The proposals for change in Ontario highlight the role that HTA, governance, and financing of health technology play along the continuum of a health technology life cycle within a healthcare system where decision-making is highly decentralized. Resource availability and capacity were not a concern - instead, solutions require higher levels of coordination and system integration along with innovative approaches to HTA.

Three-dimensional quantitative measurements of atrophy and fat infiltration in sub-regions of the supraspinatus muscle show heterogeneous distributions: a cadaveric study.

INTRODUCTION: Rotator cuff tears are common in the older population. Atrophy and fat infiltration develop un-evenly in torn supraspinatus (SSP) muscles leading to pre- and post-surgical complications. The purpose of the current study was twofold: first, to implement a volumetric and quantitative magnetic resonance imaging (MRI) approach to quantify the degree of muscle atrophy and fat infiltration within the SSP muscle and its four sub-regions (AS, PS, AD, and PD); second to compare 3-D MRI outcomes to the standard 2-D assessment and investigate their relationship with tear size. MATERIALS AND METHODS: Fifteen cadaveric shoulders were obtained and MRI performed. Quantitative 3-D outcomes included SSP muscle volume, fossa volume, fat-free muscle volume, and fat fraction for the whole SSP muscle and its four sub-regions. 2-D and qualitative measurements included tear size, 2-D fat infiltration using the Goutallier classification, tangent sign, and occupation ratio. RESULTS: Linear regression outcomes with tear size were not significant for both cross-sectional area (r = - 0.494, p = 0.061) and occupation ratio (r = - 0.011, p = 0.969). Tear size negatively correlated with fat-free muscle volume for both AS and PS sub-regions (AS: r = - 0.78, p < 0.001; PS: r = - 0.68, p = 0.005, respectively) while showing no significant correlation with fat fraction outcomes. AD and PD sub-regions positively correlated with tear size and fat fraction outcomes (AD: r = 0.70, p = 0.017; PD: r = 0.52, p = 0.045, respectively), while no significant correlation was observed between tear size and fat-free muscle volumes. CONCLUSION: Quantitative 3-D volumetric assessment of muscle degeneration resulted in better outcomes compared to the standard 2-D evaluation. The superficial supraspinatus muscle sub-regions primarily presented muscle atrophy, while the deep sub-regions were mainly affected by fat infiltration. 3-D assessments could be used pre-surgically to determine the best course of treatment and to estimate the muscles' regenerative capacity and function.

Can you afford to keep practising? Family medicine finances transformed by COVID-19 in Alberta.

OBJECTIVE: To estimate the impact of the coronavirus disease 2019 (COVID-19) pandemic on FP finances in Alberta. DESIGN: A financial model that included fees, visits per day, number of days of practice, and overhead costs. SETTING: Alberta before, during, and after the COVID-19 pandemic. PARTICIPANTS: Hypothetical fee-for-service FP practices. INTERVENTIONS: Changes in practice modes caused by the pandemic and changes to fees set by the Government of Alberta (no interventions were controlled by the researchers). MAIN OUTCOME MEASURES: Annual average FP billings and annual average FP income after overhead expenses. RESULTS: Practice changes related to COVID-19 could result in a reduction in average FP income (billings after expenses) of 27% to 78%. CONCLUSION: Practice pattern changes, including the rapid adoption of telemedicine owing to the COVID-19 pandemic, will reduce incomes for fee-for-service community FP practices in Alberta. Fees at current levels could make some practices unsustainable.

Dataset: local government mask orders preceding statewide orders by US states.

We present a database listing local government mask orders for COVID-19 that were enacted between April and September, 2020, prior to the date that the governors issued statewide mask wearing mandates. We obtained data from a Google search of web pages of local and national commercial and public broadcasters and newspapers, and of the orders themselves.  In the database, we present data identifying the county, municipality or tribal council, date of the order, and the source's internet address. In the 34 states with statewide orders, local governments in 21 of these states issued mandates in 218 municipalities, 155 counties, and 1 tribal council.  The dataset can be accessed from https://doi.org/10.7939/DVN/NDFEHK.

Stiffness of the infraspinatus and the teres minor muscles during shoulder external rotation: An in-vitro and in-vivo shear wave elastography study.

BACKGROUND: A better understanding of the morphological and functional differences in the anatomical sub-regions of the rotator cuff muscles is critical so that appropriate surgical and rehabilitation methodologies can be implemented in patients with shoulder-related injuries. The purpose of the current study was to develop a comprehensive imaging protocol using shear-wave elastography for the infraspinatus and teres minor muscles, and investigate differences in elastic properties of three distinct infraspinatus muscle sub-regions and of the teres minor muscle. METHODS: First, we developed a protocol for probe positioning for both muscles using three cadaveric shoulders. Second, we evaluated in-vivo elastic properties [passive and active stiffness (kPa)] and excursion (mm) outcomes from these muscles during shoulder external rotation. FINDINGS: Elastic properties were significantly different among the infraspinatus muscle sub-regions and teres minor muscle. Passive stiffness decreased with increasing rotation angles except for the middle sub-region of the infraspinatus muscle which showed a decreased up to mid-range followed by an increment towards the end-range. Overall, active stiffness of the infraspinatus muscle and teres minor muscle decreased with increasing rotation angles, while that of the middle sub-region increased up to mid-range, and decreased at the end-range. INTERPRETATION: Distinct characteristics of the infraspinatus and teres minor muscles, and more importantly, of the individual sub-regions within the infraspinatus muscle call for an in-depth analysis of their morphological and functional differences. Special attention should be put into these sub-regions when performing surgical and rehabilitation procedures for patients with shoulder-related injuries.

Self-Report Measures of Presenteeism Are Not Strongly Correlated With Health Workers' Logged Activity.

OBJECTIVE: Low productivity while at work (presenteeism) has been reported to produce significant cost excesses for organizations and economies. However, many of these reports have been based on estimates drawn from self-report instruments that are not supported by evidence showing their efficacy. Thus, the aim of this study was to assess associations between responses to leading self-report tests of presenteeism and self-recorded on-the-job productivity. METHODS: Health care worker self-ratings of productivity were taken from a questionnaire that contained the key item from each presenteeism instrument. Productivity levels were drawn from employee reported daily work activity logs. RESULTS: Test-based productivity estimates did not show strong associations with daily recordings of work activity. CONCLUSIONS: Associations were too low to recommend any test as a proxy measure for reported productivity. It is suggested that objective measures of work output be explored.

Gross profits of Canadian pharmacies: A changing policy regime.

Recently, both the Canadian and provincial governments have instituted policies to reduce manufacturers' prices for generic ($250 million sales annually) and brand name ($1,300 million sales annually) drugs. Both government groups made estimates of the financial magnitude of changes in drug prices, but neither has estimated the impact on retail pharmacies. We used a Cost-Volume-Profit model combined with operational data collected nationally to estimate the national impact of the pricing policy changes on pharmacy gross profits. Results show the average value of gross profits per pharmacy per year was approximately $440,000. It is estimated that the policy changes will lead to a 6.8% reduction in gross profits. Adding reductions in rebates for generic drugs, the pharmacies' reductions in gross profits will be 7.2%. In conclusion, policy-makers often ignore how their pricing changes influence the financial position of pharmacies, even though the impact can be substantial.

The Costs of Industry-Sponsored Drug Trials in Canada.

OBJECTIVE: The objective of this study was to estimate the provincial and nationwide costs of industry-sponsored drug clinical trials (CTs) in Canada. METHODS: We used the Aggregate Analysis of ClinicalTrials.gov (AACT) database, and included all industry-sponsored drug CTs that were conducted in Canada and completed in 2016. We estimated the costs of the study drugs using the market price. Estimates of the costs of management and patient services were based on industry contracts. RESULTS: The sample included 394 CTs that were conducted in 2039 facilities in Canada and provided services for 20,126 Canadian enrollees. Two-thirds of the CTs (277 of 394) were in the non-cancer category. On average, the drug costs per patient were 89,680 Canadian dollars ($Can) during the lifespan of the CTs, and were higher in cancer CTs than in non-cancer CTs ($Can216,876 vs. $Can65,274). The total costs of industry-sponsored drug CTs completed in 2016 was $Can2093.7 million. Drug costs accounted for the majority of this total ($Can1804.9 million). Ontario ($Can781.2 million) and Quebec ($Can757.5 million) had the highest costs. CONCLUSION: The costs of industry-sponsored drug CTs completed in 2016 when measured in terms of market prices in Canada were valued at $Can2.1 billion.

The enforcement of statewide mask wearing mandates to prevent COVID-19 in the US: an overview.

Face masks have become the bulwark of COVID-19 prevention in the US.  Between 10 April and 1 August, 2020, 33 state governors issued orders requiring businesses to require their customers and employees to wear face masks, and persons outdoors who could not social distance  to do the same. We documented the policies and enforcement actions for these policies in each of the states.  We used governors' orders and journalists' news reports as our sources. Our results show that the states used a variety of state and local (county and municipality) agencies to enforce business prevention behaviors and primarily local  law enforcement agencies to enforce outside mask-wearing behaviours. In particular, law enforcement officers demonstrated a strong preference for educating non-mask wearers, and indicated a reluctance to resort to civil penalties that were enacted in the state orders.  Businesses expressed a preference to have government agencies enforce non-mask wearing behaviours.  But there was also a widespread reluctance on the part of local law enforcement  to resort to legal remedies.

Dataset: percent of population covered by local government mask orders in the US.

We present a dataset covering the extent of local mask orders between April and August 2020, in states which did not have statewide orders (and hence 100% coverage).  We obtained data from national and regional newspaper and broadcaster web-based articles, and city and county web pages. The information that we abstracted included: city or county of ordinance, date that the ordinance took effect, and the population of the city or county. In 14 states, city or county governments issued mask-wearing orders, and from our dataset it can been seen that the median population covered in the states was 37.5%; the coverage ranged from 1.6% (New Hampshire) to 77.1% (Arizona).  The dataset can be accessed from: https://doi.org/10.7939/DVN/A9C1UU.

Temporal Trends Of Pharmacologic Therapies For Patients With Chronic Obstructive Pulmonary Disease In Alberta, Canada.

Objectives: To describe the trends in pharmacologic treatment for patients newly diagnosed with chronic obstructive pulmonary disease (COPD) in Alberta, Canada. Methods: We linked Alberta health databases to identify patients aged ≥35 years with incident COPD between April 2010 and March 2017. Incident cases were defined as those who did not have a hospitalization or outpatient visit with COPD in the previous 2 years. Patients were categorized into two groups: 1) incident cases at a hospital and 2) incident cases at an outpatient clinic, and both were followed until death or being censored by 31 March 2018. Utilization of COPD medication for 30 days following incident event and adherence in maintenance therapy over time were reported. Results: The study included 33,169 patients with incident COPD (hospital: 9,089; outpatient: 24,080). In 18,666 (56.3%) patients starting medication within 30 days of the incident event (2010: 52.7%; 2016: 56.6%; p=0.002), SABA (60.5%) and LABA/ICS (41.6%) were most commonly used. ICS (without LABA) was used in 14.2% and was used as monotherapy in 4.5% of patients. The proportion of patients who initiated any ICS was similar (hospital: 56.7%; outpatient: 55.7%; p=0.194) and decreased in both settings over time (p<0.001). Drug adherence during the first year after the incident event was 54.3%, higher among hospital patients (66.5% vs 48.9%; p<0.001), and improved over time (2010: 53.4%; 2016: 57.4%; p<0.001). Conclusion: The initiation of and adherence to pharmacologic therapy for patients with COPD is low but improves over time. While SABA and LABA/ICS are most commonly used, ICS utilization decreases over time.

Publicly funded clinical research in Canada.

Clinical research is funded by industry, governments, charities, and hospitals. It is important to know the economic commitment of the various funding bodies, but until now there has been no national source available which provides these data. We surveyed the major funders to provide such a measure. There is evidence that government and charity funding of medical research is a trigger for private sector research investment; therefore, tracking all sources of funding for clinical research will provide policy-makers with an overall picture of health research funding. These data support policy decision-making related to clinical research in Canada.

Corrigendum to "Cost-Effectiveness of the Aerobika® Oscillating Positive Expiratory Pressure Device in the Management of Chronic Obstructive Pulmonary Disease Exacerbations in Canada".

[This corrects the article DOI: 10.1155/2019/9176504.].

Use of Real-World Data Sources for Canadian Drug Pricing and Reimbursement Decisions: Stakeholder Views and Lessons for Other Countries.

BACKGROUND: Canada has a long history of the use of clinical evidence to support healthcare decision making. Given improvements in data holdings and analytic capacity in Canada and stakeholder interest, the purpose of this study is to reflect on perceptions of the value of real-world evidence in pricing and reimbursement decisions, barriers to its optimal use in pricing and reimbursement, current initiatives that may lead to its increased use, and what role the pharmaceutical industry may play in this.Methods/ResultsTo capture stakeholder perceptions, ninety-one participants identified as key stakeholders were identified according to background roles and geography and invited to participate in four round table discussions conducted under Chatham House rule. Important themes emerging from these discussions included: (i) the need to understand what "real world" evidence means; (ii) barriers to using real world evidence from differences in access, governance, inter-operability, system structures, expertise, and quality across Canadian health systems; (iii) differing views on industry's role. CONCLUSIONS: The use of real-world data in Canada to inform pricing and reimbursement decisions is far from routine but nascent and slowly increasing. Barriers, including interoperability concerns, may also apply to other federated health systems that need to focus on the networking of healthcare administrative data across provincial jurisdictional boundaries. There also appears to be a desire to see better use of pragmatic trials linked to these administrative data sets. Emerging initiatives are under way to use real world evidence more broadly, and include identification of common data elements and approaches to networking data.

The Costs of Industry-Sponsored Medical Device Clinical Trials in Alberta.

OBJECTIVE: Our objective was to describe the costs of industry-sponsored clinical trials for medical devices in Northern Alberta, Canada. METHODS: We used centralized data to identify all industry-sponsored medical device clinical trials initiated in Northern Alberta from 2012 to 2016. For each arm of each trial, we calculated the price of devices provided by the sponsor and the cost of clinical and administrative services that were incurred to clinically operationalize the treatment. RESULTS: Our sample consisted of 18 device trials initiated between January 2012 and January 2016. The overall cost (Canadian dollars [$Can], year 2018 values) per enrolee was $Can18,243 for the experimental arm and $Can13,827 for the control arm. Devices were the highest cost component, at $Can13,446 per enrollee in the experimental arm. Clinical costs in the control arms were higher on average ($Can7202 vs. 2504) than those in the experimental arms. CONCLUSION: Data from industry-sponsored clinical trials can provide important information on the full costs of device-related interventions. As device costs rise, and as policy makers require more evidence on device-related treatments, the cost of medical device-driven interventions should be documented along with their effectiveness.

Cost-Effectiveness of the Aerobika® Oscillating Positive Expiratory Pressure Device in the Management of Chronic Obstructive Pulmonary Disease Exacerbations in Canada.

Background: The Aerobika® oscillating positive expiratory pressure (OPEP) device is a hand-held, drug-free medical device that has been shown to improve lung function and improve health-related quality of life in patients with chronic obstructive pulmonary disease (COPD). We estimated the cost-effectiveness of this device among postexacerbation COPD patients in the Canadian healthcare system. Methods: We performed a cost-utility analysis using a Markov model to compare both costs and outcome of patients with COPD who had recently experienced an exacerbation between 2 treatment arms: patients who used the Aerobika® device and patients who did not use the Aerobika® device. This cost-utility analysis included costs based on the Alberta healthcare system perspective as these represent Canadian experience. A one-year horizon with 12 monthly cycles was used. Results: For a patient after 1 year, the use of the Aerobika® device would save $694 in healthcare costs and produce 0.04 more in quality-adjusted life years (QALYs) in comparison with no positive expiratory pressure (PEP)/OPEP therapy. In other words, the economic outcome of the device was dominant (i.e., more effective and less costly). The probability for this device to be the dominant strategy was 72%. With a willingness to pay (WTP) threshold of $50,000 per QALY gained, the probability for the Aerobika® device to be cost-effective was 77%. Conclusions: Given one of the major treatment goals in the GOLD guidelines is to minimize the negative impact of exacerbations and prevent re-exacerbations, the Aerobika® OPEP device should be viewed as a potential component of a treatment strategy to improve symptom control and reduce the risk of re-exacerbations in patients with COPD.

The Public Cost of Mental Health- and Addiction-Related Services for Youth (Ages 12-17) in Alberta.

OBJECTIVE: To measure the provincial government cost of mental health-related activities for youth ages 12 to 17 in Alberta in 2014 to 2015. METHODS: The target population was Alberta youth ages 12 to 17 (the federal justice definition) who received or were funded for mental health-related or complementary services from Alberta Health Services, Alberta Health, Alberta Human Services, Alberta Justice and Solicitor General, and Alberta Education (public schools). Data on services and expenditures were obtained from each source for the target youth population. RESULTS: Costs for mental health-related services for all ministries were $175 million for 27,169 youth who used mental health services as defined by Policy Wise, $6460 per youth. Public school special education supplements for youth with emotional problems was the largest group, amounting to 30% of all costs. Other prominent sources of expenditures were hospital inpatient mental health services (18%), community mental health services (11%), physician mental health services (10%), and secure services with treatment requiring judicial approval (9%). CONCLUSION: Economists in several countries have developed countrywide measures of mental health expenditures and have used these to generate national benchmarks for mental health spending. We have estimated spending for Alberta provincial mental health and addiction services for a distinct and highly vulnerable group. This measure can be used to develop measures and benchmarks for other provinces, which will be valuable policy indicators.