Moving from intervention management to disease management: a qualitative study exploring a systems approach to health technology assessment in Canada.

OBJECTIVES: Health technology assessment (HTA) traditionally informs decision making for single health technologies, which could lead to ill-informed decisions, suboptimal care, and system inefficiencies. We explored opportunities for conceptualizing the decision space in HTA as a disease management question versus an intervention management question. METHODS: Semistructured interviews were conducted between April 2022 and October 2022 with purposefully selected individuals from national and provincial HTA agencies and related organizations in Canada. We conducted manual line by line coding of data informed by our interview guide and sensitizing concepts from the literature. One author coded the data, and findings were independently verified by a second author who coded a subset of transcripts. RESULTS: Twenty-four invitations were distributed, and eighteen individuals agreed to participate. A disease management approach to HTA was differentiated from traditional approaches as being disease-based, multi-interventional, and dynamic. There was general support for an explicit care pathway approach to HTA by informing discussions around patient choice and suboptimal care, creating a space where decision makers can collaborate on shared objectives, and in setting up a platform for open dialogue about managing high-cost and high-severity diseases. There are opportunities for a care pathway approach to be implemented that build on the strengths of the existing HTA system in Canada. CONCLUSIONS: A disease management approach may enhance the impact of HTA by supporting dynamic decision making that could better inform a proactive, resilient, and sustainable healthcare system in Canada.

Outsourcing practice-based education: The role of industry representatives and implications for clinical expertise.

In an era of significant human and fiscal constraints, hospitals increasingly rely on industry representatives to fill gaps related to practice-based education. Given their dual sales and support functions, the extent to which education and support functions are, or ought to be, fulfilled by industry representatives is unclear. We conducted an interpretive qualitative study at a large, academic medical centre in Ontario, Canada, during 2021-2022, interviewing 36 participants across the organization with direct and varied experiences with industry-delivered education. We found that ongoing fiscal and human resource challenges prompted hospital leaders to outsource practice-based education to industry representatives, which created an expanded role for industry beyond initial product rollouts. Outsourcing, however, generated downstream costs to the organization and undermined the goals of practice-based education. To attract and retain clinicians, participants advocated for re-investment in practice-based education in-house, with a limited and supervised role for industry representatives.

Reusable personal protective equipment in Canadian healthcare: Safe, secure, and sustainable.

Personal Protective Equipment (PPE) that was intentionally designed and manufactured as reusable, including gowns, goggles, face shields, and elastomeric respirators, took on a heightened role during the pandemic. Healthcare workers who had access to these products and infrastructure for cleaning and sterilizing them had a greater sense of confidence to undertake their jobs due to an increased sense of personal safety. Using multiple data sources, including a literature review, roundtables, interviews, surveys, and Internet-based research, the project team investigated the impact of disposable PPE and role of reusable PPE during the pandemic in Canada. This research supports the claim that adopting and supporting reusable PPE systems throughout the health sector can, if used appropriately on an ongoing basis, provide continuous access to reusable PPE while also contributing many co-benefits, including lower costs, domestic jobs, and improved environmental performance such as reduced waste and greenhouse gas emissions.

Industry involvement in evidence production for genomic medicine: A bibliometric and funding analysis of decision impact studies.

BACKGROUND: Decision impact studies have become increasingly prevalent in genomic medicine, particularly in cancer research. Such studies are designed to provide evidence of clinical utility for genomic tests by evaluating their impact on clinical decision-making. This paper offers insights into understanding of the origins and intentions of these studies through an analysis of the actors and institutions responsible for the production of this new type of evidence. METHODS: We conducted bibliometric and funding analyses of decision impact studies in genomic medicine research. We searched databases from inception to June 2022. The datasets used were primarily from Web of Science. Biblioshiny, additional R-based applications, and Microsoft Excel were used for publication, co-authorship and co-word analyses. RESULTS: 163 publications were included for the bibliometric analysis; a subset of 125 studies were included for the funding analysis. Included publications started in 2010 and increased steadily over time. Decision impact studies were primarily produced for proprietary genomic assays for use in cancer care. The author and affiliate analyses reveal that these studies were produced by 'invisible colleges' of researchers and industry actors with collaborations focused on producing evidence for proprietary assays. Most authors had an industry affiliation, and the majority of studies were funded by industry. While studies were conducted in 22 countries, the majority had at least one author from the USA. DISCUSSION: This study is a critical step in understanding the role of industry in the production of new types of research. Based on the data collected, we conclude that decision impact studies are industry-conceived and -produced evidence. The findings of this study demonstrate the depth of industry involvement and highlight a need for further research into the use of these studies in decision-making for coverage and reimbursement.

Decision impact studies, evidence of clinical utility for genomic assays in cancer: A scoping review.

BACKGROUND: Decision impact studies have become increasingly prevalent in cancer prognostic research in recent years. These studies aim to evaluate the impact of a genomic test on decision-making and appear to be a new form of evidence of clinical utility. The objectives of this review were to identify and characterize decision impact studies in genomic medicine in cancer care and categorize the types of clinical utility outcomes reported. METHODS: We conducted a search of four databases, Medline, Embase, Scopus and Web of Science, from inception to June 2022. Empirical studies that reported a "decision impact" assessment of a genomic assay on treatment decisions or recommendations for cancer patients were included. We followed scoping review methodology and adapted the Fryback and Thornbury Model to collect and analyze data on clinical utility. The database searches identified 1803 unique articles for title/abstract screening; 269 articles moved to full-text review. RESULTS: 87 studies met inclusion criteria. All studies were published in the last 12 years with the majority for breast cancer (72%); followed by other cancers (28%) (lung, prostate, colon). Studies reported on the impact of 19 different proprietary (18) and generic (1) assays. Across all four levels of clinical utility, outcomes were reported for 22 discrete measures, including the impact on provider/team decision-making (100%), provider confidence (31%); change in treatment received (46%); patient psychological impacts (17%); and costing or savings impacts (21%). Based on the data synthesis, we created a comprehensive table of outcomes reported for clinical utility. CONCLUSIONS: This scoping review is a first step in understanding the evolution and uses of decision impact studies and their influence on the integration of emerging genomic technologies in cancer care. The results imply that DIS are positioned to provide evidence of clinical utility and impact clinical practice and reimbursement decision-making in cancer care. Systematic review registration: Open Science Framework osf.io/hm3jr.

A comparative analysis of non-invasive prenatal testing in Ontario and Quebec: the role of governing style in health technology innovation & adoption.

BACKGROUND: While processes of adoption and the impacts of various health technologies have been extensively studied by health services and policy researchers, the influence of policy makers' governing styles on these processes have been largely neglected. Through a comparative analysis of non-invasive prenatal testing (NIPT) in the Canadian provinces of Ontario and Quebec, this article examines how decisions about this technology were shaped by contrasting political ideologies, resulting in vastly different innovation and adoption strategies and outcomes. METHODS: A comparative qualitative investigation comprising of a document analysis followed by semi-structured interviews with key informants. Interview participants were researchers, clinicians, and private sector medical laboratory employees based in Ontario and Quebec, Canada. Interviews were conducted both in person and virtually- owing partly to the COVID-19 pandemic - to garner perspectives regarding the adoption and innovation processes surrounding non-invasive prenatal testing in both provinces. All interviews were recorded and transcribed verbatim and data were analyzed using thematic analysis. RESULTS: Through an analysis of 21 in-depth interview transcripts and key documents, the research team identified three central themes: 1) health officials in each province demonstrated a unique approach to using the existing scholarly literature on NIPT; 2) each provincial government demonstrated its own preference for service delivery, with Ontario preferring private and Quebec preferring public; and finally, 3) both Ontario and Quebec's strategies to NIPT adoption and innovation was contextualized within each province's unique financial positioning and concerns. These findings illustrate how both Quebec's nationalist focus and use of industrial policy and Ontario's 'New Public Management' style had implications for how this emerging healthcare technology was made available within each province's publicly-financed health system. CONCLUSIONS: Our study reveals how these governments' differing approaches to using data and research, public versus private service delivery, and financial goals and concerns resulted in distinct testing technologies, access, and timelines for NIPT adoption. Our analysis demonstrates the need for health policy researchers, policy makers, and others to move beyond analyses solely considering clinical and health economic evidence to understand the impact of political ideologies and governing styles.

How can entrepreneurs experience inform responsible health innovation policies? A longitudinal case study in Canada and Brazil.

AIM: To foster equity and make health systems economically and environmentally more sustainable, Responsible Innovation in Health (RIH) calls for policy changes advocated by mission-oriented innovation policies. These policies focus, however, on instruments to foster the supply of innovations and neglect health policies that affect their uptake. Our study's aim is to inform policies that can support RIH by gaining insights into RIH-oriented entrepreneurs' experience with the policies that influence both the supply of, and the demand for their innovations. METHODS: We recruited 16 for-profit and not-for-profit organisations engaged in the production of RIH in Brazil and Canada in a longitudinal multiple case study. Our dataset includes three rounds of interviews (n = 48), self-reported data, and fieldnotes. We performed qualitative thematic analyses to identify across-cases patterns. FINDINGS: RIH-oriented entrepreneurs interact with supply side policies that support technology-led solutions because of their economic potential but that are misaligned with societal challenge-led solutions. They navigate demand side policies where market approval and physician incentives largely condition the uptake of technology-led solutions and where emerging policies bring some support to societal challenge-led solutions. Academic intermediaries that bridge supply and demand side policies may facilitate RIH, but our findings point to an overall lack of policy directionality that limits RIH. CONCLUSION: As mission-oriented innovation policies aim to steer innovation towards the tackling of societal challenges, they call for a major shift in the public sector's role. A comprehensive mission-oriented policy approach to RIH requires policy instruments that can align, orchestrate, and reconcile health priorities with a renewed understanding of innovation-led economic development.

An urgent call for the environmental sustainability of health systems: A 'sextuple aim' to care for patients, costs, providers, population equity and the planet.

Health systems have a duty to protect the health and well-being of individuals and populations. Yet, healthcare contributes about 4.6% of global greenhouse gas emissions. Health systems need to question and improve established practices, assume strong environmental leadership, and aim for ambitious, sometimes radical, actions in favour of the climate. In this paper, we interrogate the suitability and feasibility of integrating the aim of 'environmental sustainability' to form the 'Sextuple Aim.' Environmental sustainability may be in tension with, but also a potential lever to meet the other cardinal aims: (1) quality and experience of patient care; (2) population health; (3) quality of work and satisfaction of healthcare providers; (4) equity and inclusion; and (5) cost reduction. We propose policy and practical avenues to help move towards the Sextuple Aim.

A qualitative study of what motivates and enables climate-engaged physicians in Canada to engage in health-care sustainability, advocacy, and action.

Increasing numbers of health-care professionals are aware of the need to deliver low-carbon sustainable health systems. We aimed to explore how physicians can be motivated and supported to pursue this ambition by conducting an exploratory qualitative descriptive study that involved individual in-depth interviews with climate-engaged Canadian physicians participating in health-care sustainability advocacy and action. Interview transcripts were analysed to identify themes related to the actions that physicians can take to promote sustainable health care, and the motivators and enablers of physician engagement in sustainable health care. Participants (n=19) engaged in a spectrum of health-care sustainability initiatives ranging from reducing health-care waste to lobbying and political action. They were motivated to advance health-care sustainability by their concern about the health implications of climate change, frustration with health-care waste, and recognition of their locus of influence as physicians. Participants articulated that policy and system, organisational and team, and knowledge generation and translation supports are required to strengthen their capacity to advance health-care sustainability. These findings can provide inspiration for engagement opportunities in health-care sustainability, guide service delivery and educational innovations to promote health-care professionals' interest in becoming sustainability champions, and extend the capacity of health-care professionals to reduce the climate impact of health care.

Antibias Efforts in United States Maternity Care: A Scoping Review of the Publicly Funded Health Equity Intervention Pipeline.

Antibias training is increasingly identified as a strategy to reduce maternal health disparities. Evidence to guide this work is limited. We conducted a community-guided scoping review to characterize new antibias research. Four of 508 projects met our criteria: US-based, publicly funded, initiated from January 1, 2018 to June 30, 2022, and featuring an intervention to reduce bias or racism in maternal health care providers. Training was embedded in multicomponent interventions in 3 projects, limiting its evaluation as a stand-alone intervention. Major public funders have sponsored few projects to advance antibias training research in maternal health. More support is needed to develop a rigorous and scalable evidence base.

The Market in Noninvasive Prenatal Tests and the Message to Consumers: Exploring Responsibility.

The potential for bias in industry-developed information about noninvasive prenatal testing (NIPT), in addition to the lack of regulatory oversight for this type of product, raises questions about clinical communication and adoption. We identify NIPTs marketed globally and analyze their English-language consumer-oriented brochures to determine whether they meet existing policy and ethical guidance from the Nuffield Council on Bioethics on NIPT marketing, how they establish the legitimacy of the test given the lack of regulatory oversight for NIPT, and whether content differs between the brochures from for-profit and nonprofit entities. In many of these brochures, NIPTs are misrepresented as diagnostic tests, claims lack supporting evidence, regulatory bodies that do not evaluate the test itself are referenced, and clinicians are invoked as authorities on specific NIPTs. Our findings substantiate concerns about the extent to which commercial imperatives operating in the absence of market-access regulation could exacerbate problems of misrepresentation and inaccuracy in marketing materials.

The Consultant's intermediary role in the regulation of molecular diagnostics in the US.

Molecular diagnostics are fast becoming a big business, with the promise of personalized medicine fueling the growth of "blockbuster" tests with high expectations for health system impact and commercial success. We investigate the polycentric regulatory regime for molecular diagnostics in the US, drawing attention to the prominent role of coverage and reimbursement systems in setting regulatory standards for this industry. We hone in on the private consultants who assist molecular diagnostics companies to gain broad clinical uptake of their products. Through a web-based search of consulting companies, analysis of their online materials, and 13 qualitative interviews with consultants, we describe the role of these actors in the coverage and reimbursement of novel diagnostics and highlight the production of evidence as a critical part of the process. We argue that consultants operate as regulatory intermediaries, helping to develop the evidentiary standards for payment decisions that ultimately benefit their clients, the manufacturers. We suggest that public policy discussions over how best to realize the promise of personalized medicine should be re-oriented to consider whose interests are represented in the regulatory regime governing access to these technologies.

Comparison of outpatient coverage in Canada: Assistive and medical devices.

Outpatient technologies are important for maintaining health and overall quality of life, yet the degree of access and coverage of these technologies remains variable within and across jurisdictions. In Canada, assistive technologies are not included in universal health coverage, and are not subject to the Canada Health Act's criteria and conditions that provinces and territories must fulfill to receive the full federal cash contribution under the Canada Health Transfer. As such, the thirteen Canadian provincial and territorial governments make separate decisions on programs and coverage. Drawing on the WHO Universal Coverage Cube we compare who gets access, the types of technologies that can be accessed, and the level of coverage (total costs covered) in Canada. Overall, each Canadian jurisdiction had at least one publicly supported program. All relied on a 'health assessment' of an individual's need to determine eligibility. Income and eligibility for social assistance was used as eligibility criteria in 6 of the 13 jurisdictions. Mobility aids as well as audio, visual, and communication aids were included in all jurisdictions. While some programs offered full financial support for some technologies, forms of cost sharing were common. The results are discussed in the context of international experiences, demographic changes, and health system trends to highlight areas for policy learning.

Anticipating the primary care role in genomic medicine: expectations of genetics health professionals.

Our purpose was to explore genetics health professionals' (GHPs) expectations of primary care providers' (PCPs) role in genomic medicine now and in the future. Focus groups/interviews were conducted with GHPs in Ontario, Canada. Recordings were transcribed and analysed using qualitative descriptive analysis. Five focus groups (6 clinical geneticists, 24 genetic counselors, 1 nurse, 4 laboratory staff, 3 genetics program administrators) and 3 interviews (nurses) were conducted. GHPs described a key role for PCPs in genomic medicine that could be enhanced if GHPs and PCPs worked together more effectively, making better use of GHPs as a scarce specialist resource, improving PCP knowledge and awareness of genomics, and increasing GHPs' understanding of primary care practice and how to provide PCPs meaningful education and support. Health system change is needed to facilitate the GHP/PCP relationship and improve care. This might include: PCPs ordering more genetic tests independently or with GHP guidance prior to GHP consultations, genomic expertise in primary care clinics or GHPs being accessible through buddy systems or virtually through telemedicine or electronic consultation, and developing educational materials and electronic decision support for PCPs. Our findings highlight need for change in delivering genomic medicine, which requires building the relationship between GHPs and PCPs, and creating new service delivery models to meet future needs.