Adding epitope compatibility to deceased donor kidney allocation criteria: recommendations from a pan-Canadian online public deliberation.

BACKGROUND: The widening supply-demand imbalance for kidneys necessitates finding ways to reduce rejection and improve transplant outcomes. Human leukocyte antigen (HLA) epitope compatibility between donor and recipient may minimize premature graft loss and prolong survival, but incorporating this strategy to deceased donor allocation criteria prioritizes transplant outcomes over wait times. An online public deliberation was held to identify acceptable trade-offs when implementing epitope compatibility to guide Canadian policymakers and health professionals in deciding how best to allocate kidneys fairly. METHODS: Invitations were mailed to 35,000 randomly-selected Canadian households, with over-sampling of rural/remote locations. Participants were selected for socio-demographic diversity and geographic representation. Five two-hour online sessions were held from November-December 2021. Participants received an information booklet and heard from expert speakers prior to deliberating on how to fairly implement epitope compatibility for transplant candidates and governance issues. Participants collectively generated and voted on recommendations. In the final session, kidney donation and allocation policymakers engaged with participants. Sessions were recorded and transcribed. RESULTS: Thirty-two individuals participated and generated nine recommendations. There was consensus on adding epitope compatibility to the existing deceased donor kidney allocation criteria. However, participants recommended including safeguards/flexibility around this (e.g., mitigating declining health). They called for a transition period to epitope compatibility, including an ongoing comprehensive public education program. Participants unanimously recommended regular monitoring and public sharing of epitope-based transplant outcomes. CONCLUSIONS: Participants supported adding epitope compatibility to kidney allocation criteria, but advised safeguards and flexibility around implementation. These recommendations provide guidance to policymakers about incorporating epitope-based deceased donor allocation criteria.

Conducting clinical trials-costs, impacts, and the value of clinical trials networks: A scoping review.

BACKGROUND: A significant barrier to conducting clinical trials is their high cost, which is driven primarily by the time and resources required to activate trials and reach accrual targets. The high cost of running trials has a substantial impact on their long-term feasibility and the type of clinical research undertaken. METHODS: A scoping review of the empirical literature on the costs associated with conducting clinical trials was undertaken for the years 2001-2015. Five reference databases were consulted to elicit how trials costs are presented in the literature. A review instrument was developed to extract the content of in-scope papers. Findings were characterized by date and place of publication, clinical disease area, and network/cooperative group designation, when specified. Costs were captured and grouped by patient accrual and management, infrastructure, and the opportunity costs associated with industry funding for trials research. Cost impacts on translational research and health systems were also captured, as were recommendations to reduce trial expenditures. Since articles often cited multiple costs, multiple cost coding was used during data extraction to capture the range and frequency of costs. RESULTS: A total of 288 empirical articles were included. The distribution of reported costs was: patient management and accrual costs (132 articles), infrastructure costs (118 articles) and the opportunity costs of industry sponsorship (72 articles). 221 articles reported on the impact of undertaking costly trials on translational research and health systems; of these, the most frequently reported consequences were to research integrity (52% of articles), research capacity (36% of articles) and running low-value trials (34% of articles). 254 articles provided recommendations to reduce trial costs; of these, the most frequently reported recommendations related to improvements in: operational efficiencies (33% of articles); patient accrual (24% of articles); funding for trials and transparency in trials reporting (18% of articles, each). CONCLUSION: Key findings from the review are: 1) delayed trial activation has costs to budgets and research; 2) poor accrual leads to low-value trials and wasted resources; 3) the pharmaceutical industry can be a pragmatic, if problematic, partner in clinical research; 4) organizational know-how and successful research collaboration are benefits of network/cooperative groups; and 5) there are spillover benefits of clinical trials to healthcare systems, including better health outcomes, enhanced research capacity, and drug cost avoidance. There is a need for more economic evaluations of the benefits of clinical research, such as health system use (or avoidance) and health outcomes in cities and health authorities with institutions that conduct clinical research, to demonstrate the affordability of clinical trials, despite their high cost.

Public perspectives on disinvestments in drug funding: results from a Canadian deliberative public engagement event on cancer drugs.

BACKGROUND: Decisions relating to the funding of new drugs are becoming increasingly challenging due to a combination of aging populations, rapidly increasing list prices, and greater numbers of drug-indication pairs being brought to market. This is especially true in cancer, where rapid list price inflation is coupled with steeply rising numbers of incident cancer cases. Within a publicly funded health care system, there is increasing recognition that resource allocation decisions should consider the reassessment of, and potential disinvestment from, currently funded interventions alongside new investments. Public input into the decision-making process can help legitimize the outcomes and ensure priority-setting processes are aligned with public priorities. METHODS: In September 2014, a public deliberation event was held in Vancouver, Canada, to obtain public input on the topic of cancer drug funding. Twenty-four members of the general public were tasked with making collective recommendations for policy-makers about the principles that should guide funding decisions for cancer drugs in the province of British Columbia. Deliberative questions and decision aids were used to elicit individuals' willingness to make trade-offs between expenditures and health outcomes. RESULTS: Participants discussed the implications of disinvestment decisions from cancer drugs in terms of its impact on patient choice, fairness and quality of life. Their discussions indicate that in order for a decision to disinvest from currently-funded cancer drugs to be acceptable, it must align with three main principles: the decision must be accompanied by significant gains, described both in terms of cost savings and opportunities to re-invest elsewhere in the health care system; those who are currently prescribed a cancer drug should be allowed to continue their course of treatment (referred to as a continuance clause, or "grandfathering" approach); and it must consider how access to care for specialized populations is impacted. CONCLUSIONS: The results from this deliberation event provide insight into what is acceptable to British Columbians with respect to disinvestment decisions for cancer drugs. These recommendations can be considered within wider health system decision-making frameworks for funding decisions relating to all drugs, as well as for cancer drugs.

Addressing the affordability of cancer drugs: using deliberative public engagement to inform health policy.

BACKGROUND: Health system expenditure on cancer drugs is rising rapidly in many OECD countries given the costly new treatments and increased rates of use due to a growing and ageing population. These factors put considerable strain on the sustainability of health systems worldwide, sparking public debate among clinicians, pharmaceutical companies, policy-makers and citizens on issues of affordability and equity. We engaged Canadians through a series of deliberative public engagement events to determine their priorities for making cancer drug funding decisions fair and sustainable in Canada's publicly financed health system. METHODS: An approach to deliberation was developed based on the McMaster Health Forum's citizen panels and the established Burgess and O'Doherty model of deliberative public engagement. Six deliberations were held across Canada in 2016. Transcripts were coded in NVivo and analysed to determine where participants' views converged and diverged. Recommendations were grouped thematically. RESULTS: A total of 115 Canadians participated in the deliberative events and developed 86 recommendations. Recommendations included the review and regular re-review of approved drugs using 'real-world' evidence on effectiveness and cost-effectiveness; prioritisation of treatments that restore patients' independence, mental health and general well-being; ensuring that decision processes, results and their rationales are transparent; and commitment to people with similar needs receiving the same care regardless of where in Canada they live. CONCLUSIONS: The next steps for policy-makers should be to develop mechanisms for (1) re-reviewing effectiveness and cost-effectiveness data for all cancer drugs; (2) making disinvestments in cancer drugs that satisfy requirements relating to grandfathering and compassionate access; (3) ensuring fair and equitable access to cancer drugs for all Canadians; and (4) fostering a pan-Canadian approach to cancer drug funding decisions.

Long-term effects of cancer on earnings of childhood, adolescent and young adult cancer survivors - a population-based study from British Columbia, Canada.

BACKGROUND: The patterns and determinants of long-term income among young people surviving cancer, and differences compared to peers, have not yet been fully explored. The objectives of this paper are to describe long-term income among young survivors of cancer, the impact of socio-demographic, disease, and treatment factors on long-term income, and income relative to the general population. METHODS: Retrospective cohort study with comparison group from the general population, using linked population-based registries, clinical data, and tax-records. Multivariate random effects regression models were used to determine survivor income, compare long-term income between survivors and comparators, and assess income determinants. Subjects included all residents of British Columbia (BC), Canada, diagnosed with cancer before 25 years of age and surviving 5 years or more. Comparators were selected from the BC general population matched by gender and birth year. RESULTS: Young cancer survivors earned significantly less than the general population. In addition, survivors of central nervous system tumors have significantly lower incomes than lymphoma survivors. Survivors who received radiation therapy have significantly lower income. Results should be interpreted with caution as the comparator group was matched by gender and date of birth. CONCLUSIONS: Depending on original diagnosis, treatment, and other characteristics, survivors face significantly lower income than peers and may require supports to gain and retain paid employment. Lower income will affect their opportunity for independent living, and will reduce productivity in the labour force.

Trade-offs, fairness, and funding for cancer drugs: key findings from a deliberative public engagement event in British Columbia, Canada.

BACKGROUND: Spending on cancer drugs has risen dramatically in recent years compared to other areas of health care, due in part to higher prices associated with newly approved drugs and increased demand for these drugs. Addressing this situation requires making difficult trade-offs between cost, harms, and ability to benefit when using public resources, making it important for policy makers to have input from many people affected by the issue, including citizens. METHODS: In September 2014, a deliberative public engagement event was conducted in Vancouver, British Columbia (BC), on the topic of priority setting and costly cancer drugs. The aim of the study was to gain citizens' input on the topic and have them generate recommendations that could inform cancer drug funding decisions in BC. A market research company was engaged to recruit members of the BC general public to deliberate over two weekends (four days) on how best to allocate resources for expensive cancer treatments. Participants were stratified based on the 2006 census data for BC. Participants were asked to discuss disinvestment, intravenous versus oral chemotherapy delivery, and decision governance. All sessions were audio recorded and transcribed. Transcripts were analyzed using NVivo 11 software. RESULTS: Twenty-four individuals participated in the event and generated 30 recommendations. Participants accepted the principle of resource scarcity and the need of governments to make difficult trade-offs when allocating health-care resources. They supported the view that cost-benefit thresholds must be set for high-cost drugs. They also expected reasonable health benefits in return for large expenditures, and supported the view that some drugs do not merit funding. Participants also wanted drug funding decisions to be made in a non-partisan and transparent way. CONCLUSION: The recommendations from the Vancouver deliberation can provide guidance to policy makers in BC and may be useful in challenging pricing by pharmaceutical companies.

Qualitative Research Informing a Preference Study on Selecting Cannabis for Cancer Survivor Symptom Management: Design of a Discrete Choice Experiment.

INTRODUCTION: The legalization of recreational cannabis use can enable cancer survivors to manage aspects of their care with cannabinoids without medical authorization or stigmatization. However, the absence of medical guidance-from the scientific literature or the healthcare system-makes it difficult for survivors to reach informed decisions about their care. OBJECTIVE: This article outlines the qualitative research undertaken to design a discrete choice experiment (DCE) aimed at understanding Canadian cancer survivors' preferences for managing their cancer symptoms with cannabis in this complex socio-medical context. METHODS: In this study, we drew on previously published qualitative research (a literature review and interviews with cancer survivors) and the theory of planned behavior, holding weekly team meetings to review the qualitative data and identify initial attributes associated with medicinal cannabis consumption to inform the DCE design. The initial attributes were further assessed to determine whether they were sensitive to the Canadian context, modifiable to produce levels and trade-offs, and amenable to policy intervention, in order to form the DCE choice sets. The choice sets were tested via think-aloud exercises with members of the general population and included debriefing interviews. Think-aloud participants were recruited from patient groups and previous studies. RESULTS: Based on our review of the interview study, we identified the following attributes associated with selecting medicinal cannabis: effectiveness; chance of side effects; support from family, friends, and/or physicians; cost; and availability. Ability to perform everyday activities was added and monthly out-of-pocket cost was refined to render the DCE realistic to cancer survivors in the Canadian context. Revisions to the DCE instructions, terminology, and cost levels were made based on results from the think-aloud exercises (n = 10). CONCLUSIONS: This qualitative study outlines the preference evidence collected regarding Canadian cancer survivors' decisions to manage their symptoms with cannabis to inform a DCE quantitative survey. It contributes to transparent reporting of qualitative work in DCE development and to understanding cancer survivors' preferences regarding medicinal cannabis consumption under legalization.

Impact of cancer on income, wealth and economic outcomes of adult cancer survivors: a scoping review.

OBJECTIVE: To summarise peer-reviewed evidence on the effect of a cancer diagnosis on the different sources of income of individuals diagnosed with cancer during adulthood (age ≥18 years). DESIGN: A scoping review following the Joanna Briggs Institute's methodological framework for conducting scoping reviews and reporting results following the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews checklist. DATA SOURCES: Ovid MEDLINE, PsycINFO, CINAHL, EMBASE, Econ-Lit and Evidence-based Medicine Reviews, and reference lists of evidence syntheses. Published literature of any study type in English was searched from January 2000 to December 2020. ELIGIBILITY AND CRITERIA: Study participants were individuals diagnosed with cancer during adulthood (age ≥18 years). Studies from any country and/or healthcare system were included. Primary outcomes were employment income (eg, individual or household); investment income (eg, stocks/bonds, properties, savings); government transfer payments (eg, disability income/pension); debt and bankruptcy. DATA EXTRACTION AND SYNTHESIS: Findings are summarised descriptively and in tabular form. RESULTS: From 6297 citations retrieved, 63 studies (67 articles) met our inclusion criteria. Most (51%) were published in 2016-2020; 65% were published in the USA or Scandinavia. Survivors incurred debt (24 studies), depleted savings (13 studies) and liquidated stocks/bonds (7 studies) in response to a cancer diagnosis. 41 studies reported changes to employment income; of these, 12 case-control studies reported varying results: 5 reported survivors earned less than controls, 4 reported no significant differences, 2 reported mixed results and 1 reported income increased. Initial declines in income tended to lessen over time. CONCLUSIONS: Cancer's impact on survivors' income is complex and time-varying. Longitudinal studies are needed to document the trend of initial declines in income, with declines lessening over time, and its variations. Study designs using standardised income measures and capturing treatment type and follow-up time will improve our understanding of cancer's impact on survivors' income.

Impact of a cancer diagnosis on the income of adult cancer survivors: a scoping review protocol.

INTRODUCTION: While the socioeconomic impact of a cancer diagnosis on cancer survivors has gained some attention in the literature, to our knowledge, a review of the evidence on changes in income due to cancer has yet to be undertaken. In this paper, we describe a scoping review protocol to review the evidence on the effect of a cancer diagnosis on the income of individuals diagnosed with cancer during adulthood (≥18 years). The purpose is to summarise existing evidence, identify gaps in current research and highlight priority areas for future research. METHODS AND ANALYSIS: This study will follow the methodological framework for conducting scoping reviews by the Joanna Briggs Institute In collaboration with a health science librarian, we developed a search strategy to be performed in Ovid MEDLINE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Econ-Literature and Evidence-Based Medicine Reviews. This scoping review will search the scientific literature published in English from 1 January 2000 to 31 December 2020. Studies that measured the impact of cancer on income of adults will be eligible for inclusion. Studies exclusively focused on employment outcomes (eg, return to work, unemployment, productivity loss), financial expenditures, childhood cancer survivors and/or the caregivers of cancer survivors will be excluded. Three independent reviewers will conduct screening and extract data. Descriptive information will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for Scoping Reviews. ETHICS AND DISSEMINATION: This scoping review will analyse data from publicly available materials and thus does not require ethics approval. Results from this review will be disseminated through a peer-reviewed publication and/or conference presentation with the potential to identify gaps in the literature, suggest strategies for standardised terminology and provide directions for future research.

Layperson Views about the Design and Evaluation of Decision Aids: A Public Deliberation.

PURPOSE: We carried out the first public deliberation to elicit lay input regarding guidelines for the design and evaluation of decision aids, focusing on the example of colorectal ("colon") cancer screening. METHODS: A random, demographically stratified sample of 28 laypeople convened for 4 days, during which they were informed about key issues regarding colon cancer, screening tests, risk communication, and decision aids. Participants then deliberated in small and large group sessions about the following: 1) What information should be included in all decision aids for colon screening? 2) What risk information should be in a decision aid and how should risk information be presented? 3) What makes a screening decision a good one (reasonable or legitimate)? 4) What makes a decision aid and the advice it provides trustworthy? With the help of a trained facilitator, the deliberants formulated recommendations, and a vote was held on each to identify support and alternative views. RESULTS: Twenty-one recommendations ("deliberative conclusions") were strongly supported. Some conclusions matched current recommendations, such as that decision aids should be available for use with and without providers present (conclusions 1-4) and should support informed choice (conclusion 9). Some conclusions differed from current recommendations, at least in emphasis-for example, that decision aids should disclose cost of screening (conclusion 11) and should be kept simple and understandable (conclusion 14). Deliberants recommended that decision aids should disclose the baseline risk of getting colon cancer (conclusions 15, 17). LIMITATIONS: Single location and medical decision. CONCLUSIONS: Guidelines for design of decision aids should consider putting a greater focus on disclosing cost and keeping decision aids simple, and they possibly should recommend disclosing less extensive amounts of quantitative information than currently recommended.

Understanding cancer survivors' reasons to medicate with cannabis: A qualitative study based on the theory of planned behavior.

BACKGROUND: Prior to nonmedical cannabis legalization in Canada, individuals were only able to access cannabis legally through licensed producers with medical authorization. Now with an additional legal access system designed for nonmedical purposes, it is unclear what factors influence cancer survivors' decisions to medicate or not medicate cannabis as a complementary therapy to alleviate their cancer symptoms. METHODS: We recruited cancer survivors via social media. Interested individuals were purposively sampled to ensure maximization in terms of age, sex, and province of residence. Constructs of the Theory of Planned Behavior were explored during the telephone interviews as participants described what influenced their decisions to medicate or not medicate cannabis to manage their symptoms. RESULTS: Interviews were conducted with 33 cancer survivors. All individuals believed that cannabis would manage their cancer symptoms. Those that chose to medicate with cannabis provided a variety of reasons, including that cannabis was a more natural alternative; that it reduced their overall number of prescription drugs; and that safer products had become available with the legalization of nonmedical cannabis. Some individuals also indicated that support from physicians and validation from family and friends were important in their decision to medicate with cannabis. Individuals who opted not to medicate with cannabis raised concerns about the lack of scientific evidence and/or possible dependency issues. Some also felt their physician's disapproval was a barrier to considering cannabis use. CONCLUSIONS: The findings revealed that recreational legalization made using cannabis appear safer and easier to access for some cancer survivors. However, physicians' censure of cannabis use for symptom management was a barrier for survivors considering its use.

Conceptual and practical challenges for implementing the communities of practice model on a national scale--a Canadian cancer control initiative.

BACKGROUND: Cancer program delivery, like the rest of health care in Canada, faces two ongoing challenges: to coordinate a pan-Canadian approach across complex provincial jurisdictions, and to facilitate the rapid translation of knowledge into clinical practice. Communities of practice, or CoPs, which have been described by Etienne Wenger as a collaborative learning platform, represent a promising solution to these challenges because they rely on bottom-up rather than top-down social structures for integrating knowledge and practice across regions and agencies. The communities of practice model has been realized in the corporate (e.g., Royal Dutch Shell, Xerox, IBM, etc) and development (e.g., World Bank) sectors, but its application to health care is relatively new. The Canadian Partnership Against Cancer (CPAC) is exploring the potential of Wenger's concept in the Canadian health care context. This paper provides an in-depth analysis of Wenger's concept with a focus on its applicability to the health care sector. DISCUSSION: Empirical studies and social science theory are used to examine the utility of Wenger's concept. Its value lies in emphasizing learning from peers and through practice in settings where innovation is valued. Yet the communities of practice concept lacks conceptual clarity because Wenger defines it so broadly and sidelines issues of decision making within CoPs. We consider the implications of his broad definition to establishing an informed nomenclature around this specific type of collaborative group. The CoP Project under CPAC and communities of practice in Canadian health care are discussed. SUMMARY: The use of communities of practice in Canadian health care has been shown in some instances to facilitate quality improvements, encourage buy in among participants, and generate high levels of satisfaction with clinical leadership and knowledge translation among participating physicians. Despite these individual success stories, more information is required on how group decisions are made and applied to the practice world in order to leverage the potential of Wenger's concept more fully, and advance the science of knowledge translation within an accountability framework.

Sharing linked data sets for research: results from a deliberative public engagement event in British Columbia, Canada.

INTRODUCTION: Research using linked data sets can lead to new insights and discoveries that positively impact society. However, the use of linked data raises concerns relating to illegitimate use, privacy, and security (e.g., identity theft, marginalization of some groups). It is increasingly recognized that the public needs to be consulted to develop data access systems that consider both the potential benefits and risks of research. Indeed, there are examples of data sharing projects being derailed because of backlash in the absence of adequate consultation. (e.g., care.data in the UK). OBJECTIVES AND METHODS: This paper describes the results of a public deliberation event held in April 2018 in Vancouver, British Columbia. The purpose of this event was to develop informed and civic-minded public advice regarding the use and the sharing of linked data for research with a focus on the processes and regulations employed to release data. The event brought together 23 members of the public over two weekends. RESULTS: Participants developed and voted on 19 policy-relevant statements. Voting results and the rationale behind any disagreements are reported here. Taken together, these statements provide a broad view of public support and concerns regarding the use of linked data sets for research and offer guidance on measures that can be taken to improve the trustworthiness of policies and process around data sharing and use. CONCLUSIONS: Generally, participants were supportive of research using linked data because of the value they provide to society. Participants expressed a desire to see the data access request process made more efficient to facilitate more research, as long as there are adequate protections in place around security and privacy of the data.

Understanding Contextual Factors in Cost, Quality and Priority Setting Decisions in Health Comment on "Contextual Factors Influencing Cost and Quality Decisions in Health and Care: A Structured Evidence Review and Narrative Synthesis".

There is growing recognition in the academic literature that critical decisions concerning resource allocation and resource management in health and care are influenced by a range of contextual factors. In their paper in this journal, Williams et al define these 'decisions of value' as being characterized by a significant and demonstrable impact on quality and resources in health and care. 'Decisions of value' are key functions of health and care organizations, yet relatively little is known about how contextual factors (such as different sources and types of evidence used, organizational context and decision-making structures, and the wider interests of patients, the public and politicians) influence those decisions. In this commentary we offer some reflections on our international experiences in capacity building, developing and implementing priority setting and resource allocation (PSRA) mechanisms in the health and care sectors in a range of low-, middle-, and high-income countries. We focus on the role of organizational culture, the relationship to government including political and regulatory environments, and the potential for patient and public engagement in PSRA mechanisms.

Public engagement in priority-setting: results from a pan-Canadian survey of decision-makers in cancer control.

Decision-makers are challenged to incorporate public input into priority-setting decisions. We conducted a pan-Canadian survey of decision-makers in cancer control to investigate the types of evidence, especially evidence supplied by the public, that are utilized in health care priority-setting. We further examined how normative attitudes and contextual factors influence the use of public engagement as evidence at the committee level. Administered between November and December 2012, 67 respondents from 117 invited individuals participated in the survey. The results indicated that public engagement was infrequently utilized compared to clinical effectiveness evidence or cost evidence. General positive agreement between normative attitudes towards the use of evidence and the frequency of evidence utilization was observed, but absence of correlative agreement was found for the types of evidence that are supplied by the general public and for cost-effectiveness inputs. Regression analyses suggested that public engagement was unevenly utilized between jurisdictions and that educational background and barriers to implementing public input may decrease the odds of using public engagement as evidence. We recommend that institutions establish a link between committee members' normative attitudes for using public engagement and its real-world utilization.