Designing a system for patients controlling providers' access to their electronic health records: organizational and technical challenges.

BACKGROUND: Electronic health records (EHRs) are proliferating, and financial incentives encourage their use. Applying Fair Information Practice principles to EHRs necessitates balancing patients' rights to control their personal information with providers' data needs to deliver safe, high-quality care. We describe the technical and organizational challenges faced in capturing patients' preferences for patient-controlled EHR access and applying those preferences to an existing EHR. METHODS: We established an online system for capturing patients' preferences for who could view their EHRs (listing all participating clinic providers individually and categorically-physicians, nurses, other staff) and what data to redact (none, all, or by specific categories of sensitive data or patient age). We then modified existing data-viewing software serving a state-wide health information exchange and a large urban health system and its primary care clinics to allow patients' preferences to guide data displays to providers. RESULTS: Patients could allow or restrict data displays to all clinicians and staff in a demonstration primary care clinic, categories of providers (physicians, nurses, others), or individual providers. They could also restrict access to all EHR data or any or all of five categories of sensitive data (mental and reproductive health, sexually transmitted diseases, HIV/AIDS, and substance abuse) and for specific patient ages. The EHR viewer displayed data via reports, data flowsheets, and coded and free text data displayed by Google-like searches. Unless patients recorded restrictions, by default all requested data were displayed to all providers. Data patients wanted restricted were not displayed, with no indication they were redacted. Technical barriers prevented redacting restricted information in free textnotes. The program allowed providers to hit a "Break the Glass" button to override patients' restrictions, recording the date, time, and next screen viewed. Establishing patient-control over EHR data displays was complex and required ethical, clinical, database, and programming expertise and difficult choices to overcome technical and health system constraints. CONCLUSIONS: Assessing patients' preferences for access to their EHRs and applying them in clinical practice requires wide-ranging technical, clinical, and bioethical expertise, to make tough choices to overcome significant technical and organization challenges.

Top ten biotechnologies for improving health in developing countries.

Most research into genomics and other related biotechnologies is concerned with the priorities of industrialized nations, and yet a limited number of projects have shown that these technologies could help improve health in developing countries. To encourage the successful application of biotechnology to global health, we carried out a study in which we asked an international group of eminent scientists with expertise in global health issues to identify the top ten biotechnologies for improving health in developing countries. The results offer concrete guidance to those in a position to influence the direction of research and development, and challenge common assumptions about the relevance and affordability of biotechnology for developing countries.

Implementation of Lung Cancer Screening in Primary Care and Pulmonary Clinics: Pragmatic Clinical Trial of Electronic Health Record-Integrated Everyday Shared Decision-Making Tool and Clinician-Facing Prompts.

BACKGROUND: Although low-dose CT (LDCT) scan imaging lung cancer screening (LCS) can reduce lung cancer mortality, it remains underused. Shared decision-making (SDM) is recommended to assess the balance of benefits and harms for each patient. RESEARCH QUESTION: Do clinician-facing electronic health record (EHR) prompts and an EHR-integrated everyday SDM tool designed to support routine incorporation of SDM into primary care improve LDCT scan imaging ordering and completion? STUDY DESIGN AND METHODS: A preintervention and postintervention analysis was conducted in 30 primary care and four pulmonary clinics for visits with patients who met United States Preventive Services Task Force criteria for LCS. Propensity scores were used to adjust for covariates. Subgroup analyses were conducted based on the expected benefit from screening (high benefit vs intermediate benefit), pulmonologist involvement (ie, whether the patient was seen in a pulmonary clinic in addition to a primary care clinic), sex, and race and ethnicity. RESULTS: In the 12-month preintervention phase among 1,090 eligible patients, 77 patients (7.1%) had LDCT scan imaging orders and 48 patients (4.4%) completed screenings. In the 9-month intervention phase among 1,026 eligible patients, 280 patients (27.3%) had LDCT scan imaging orders and 182 patients (17.7%) completed screenings. Adjusted ORs were 4.9 (95% CI, 3.4-6.9; P < .001) and 4.7 (95% CI, 3.1-7.1; P < .001) for LDCT imaging ordering and completion, respectively. Subgroup analyses showed increases in ordering and completion for all patient subgroups. In the intervention phase, the SDM tool was used by 23 of 102 ordering providers (22.5%) and for 69 of 274 patients (25.2%) for whom LDCT scan imaging was ordered and who needed SDM at the time of ordering. INTERPRETATION: Clinician-facing EHR prompts and an EHR-integrated everyday SDM tool are promising approaches to improving LCS in the primary care setting. However, room for improvement remains. As such, further research is warranted. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT04498052; URL: www. CLINICALTRIALS: gov.

GARDE: a standards-based clinical decision support platform for identifying population health management cohorts.

Population health management (PHM) is an important approach to promote wellness and deliver health care to targeted individuals who meet criteria for preventive measures or treatment. A critical component for any PHM program is a data analytics platform that can target those eligible individuals. OBJECTIVE: The aim of this study was to design and implement a scalable standards-based clinical decision support (CDS) approach to identify patient cohorts for PHM and maximize opportunities for multi-site dissemination. MATERIALS AND METHODS: An architecture was established to support bidirectional data exchanges between heterogeneous electronic health record (EHR) data sources, PHM systems, and CDS components. HL7 Fast Healthcare Interoperability Resources and CDS Hooks were used to facilitate interoperability and dissemination. The approach was validated by deploying the platform at multiple sites to identify patients who meet the criteria for genetic evaluation of familial cancer. RESULTS: The Genetic Cancer Risk Detector (GARDE) platform was created and is comprised of four components: (1) an open-source CDS Hooks server for computing patient eligibility for PHM cohorts, (2) an open-source Population Coordinator that processes GARDE requests and communicates results to a PHM system, (3) an EHR Patient Data Repository, and (4) EHR PHM Tools to manage patients and perform outreach functions. Site-specific deployments were performed on onsite virtual machines and cloud-based Amazon Web Services. DISCUSSION: GARDE's component architecture establishes generalizable standards-based methods for computing PHM cohorts. Replicating deployments using one of the established deployment methods requires minimal local customization. Most of the deployment effort was related to obtaining site-specific information technology governance approvals.

Establishing a multidisciplinary initiative for interoperable electronic health record innovations at an academic medical center.

OBJECTIVE: To establish an enterprise initiative for improving health and health care through interoperable electronic health record (EHR) innovations. MATERIALS AND METHODS: We developed a unifying mission and vision, established multidisciplinary governance, and formulated a strategic plan. Key elements of our strategy include establishing a world-class team; creating shared infrastructure to support individual innovations; developing and implementing innovations with high anticipated impact and a clear path to adoption; incorporating best practices such as the use of Fast Healthcare Interoperability Resources (FHIR) and related interoperability standards; and maximizing synergies across research and operations and with partner organizations. RESULTS: University of Utah Health launched the ReImagine EHR initiative in 2016. Supportive infrastructure developed by the initiative include various FHIR-related tooling and a systematic evaluation framework. More than 10 EHR-integrated digital innovations have been implemented to support preventive care, shared decision-making, chronic disease management, and acute clinical care. Initial evaluations of these innovations have demonstrated positive impact on user satisfaction, provider efficiency, and compliance with evidence-based guidelines. Return on investment has included improvements in care; over $35 million in external grant funding; commercial opportunities; and increased ability to adapt to a changing healthcare landscape. DISCUSSION: Key lessons learned include the value of investing in digital innovation initiatives leveraging FHIR; the importance of supportive infrastructure for accelerating innovation; and the critical role of user-centered design, implementation science, and evaluation. CONCLUSION: EHR-integrated digital innovation initiatives can be key assets for enhancing the EHR user experience, improving patient care, and reducing provider burnout.

Public views on a wait time management initiative: a matter of communication.

BACKGROUND: Many countries have tried to reduce waiting times for health care through formal wait time reduction strategies. Our paper describes views of members of the public about a wait time management initiative--the Ontario Wait Time Strategy (OWTS) (Canada). Scholars and governmental reports have advocated for increased public involvement in wait time management. We provide empirically derived recommendations for public engagement in a wait time management initiative. METHODS: Two qualitative studies: 1) an analysis of all emails sent by the public to the (OWTS) email address; and 2) in-depth interviews with members of the Ontario public. RESULTS: Email correspondents and interview participants supported the intent of the OWTS. However they wanted more information about the Strategy and its actions. Interview participants did not feel they were sufficiently made aware of the Strategy and email correspondents requested additional information beyond what was offered on the Strategy's website. Moreover, the email correspondents believed that some of the information that was provided on the Strategy's website and through the media was inaccurate, misleading, and even dishonest. Interview participants strongly supported public involvement in the OWTS priority setting. CONCLUSIONS: Findings suggest the public wanted increased communication from and with the OWTS. Effective communication can facilitate successful public engagement, and in turn fair and legitimate priority setting. Based on the study's findings we developed concrete recommendations for improving public involvement in wait time management.

Evaluating priority setting success in healthcare: a pilot study.

BACKGROUND: In healthcare today, decisions are made in the face of serious resource constraints. Healthcare managers are struggling to provide high quality care, manage resources effectively, and meet changing patient needs. Healthcare managers who are constantly making difficult resource decisions desire a way to improve their priority setting processes. Despite the wealth of existing priority setting literature (for example, program budgeting and marginal analysis, accountability for reasonableness, the 'describe-evaluate-improve' strategy) there are still no tools to evaluate how healthcare resources are prioritised. This paper describes the development and piloting of a process to evaluate priority setting in health institutions. The evaluation process was designed to examine the procedural and substantive dimensions of priority setting using a multi-methods approach, including a staff survey, decision-maker interviews, and document analysis. METHODS: The evaluation process was piloted in a mid-size community hospital in Ontario, Canada while its leaders worked through their annual budgeting process. Both qualitative and quantitative methods were used to analyze the data. RESULTS: The evaluation process was both applicable to the context and it captured the budgeting process. In general, the pilot test provided support for our evaluation process and our definition of success, (i.e., our conceptual framework). CONCLUSIONS: The purpose of the evaluation process is to provide a simple, practical way for an organization to better understand what it means to achieve success in its priority setting activities and identify areas for improvement. In order for the process to be used by healthcare managers today, modification and contextualization of the process are anticipated. As the evaluation process is applied in more health care organizations or applied repeatedly in an organization, it may become more streamlined.

Successful priority setting in low and middle income countries: a framework for evaluation.

Priority setting remains a big challenge for health managers and planners, yet there is paucity of literature on evaluating priority setting. The purpose of this paper is to present a framework for evaluating priority setting in low and middle income countries. We conducted a qualitative study involving a review of literature and Delphi interviews with respondents knowledgeable of priority setting in low and middle income countries. Respondents were asked to identify the measures of successful priority setting in low and middle income countries. Responses were grouped as: immediate internal or external/delayed internal or external. We also identified some pre-requisites for successful priority setting. The immediate internal measures included increased efficiency in decision making, improved quality of decisions and fairer priority setting. Immediate External measures included-improved public understanding and acceptance of decisions, increased public participation, increased trust. Delayed Internal measures included increased satisfaction, understanding, compliance, balanced budget, achievement of organization goals, and improved internal accountability. Delayed External measures include impact on policy and practice, improved population health and reduction of health inequalities, achievement of health system goals and strengthening of health care systems. Identified pre-requisites for successful priority setting included; the presence of credible priority setting institutions, incentives for participation and implementation and resources, capacity and political will to implement. These would be augmented in a conducive political, social and economic context. This framework, although not exhaustive, provides a practical basis for planning and evaluating priority setting in low and middle income countries.

Public perceptions of ethical issues regarding adult predictive genetic testing.

The purpose of this study was to explore the views of members of the general public regarding ethical issues in adult predictive genetic testing. The literature pertaining to ethical issues regarding to adult predictive genetic testing is largely restricted to the views of 'experts' who have emphasized informed consent, patent issues, and insurance discrimination. Occasionally the views of patients who have undergone genetic counselling and testing have been elicited, adding psychosocial and family issues. However, the general public has not had the opportunity to contribute. In order to explore theatre as a health policy research tool, 1,200 audience members attended the play 'Sarah's Daughters' in seven Canadian cities, following which audience discussions were audiotaped. This study performed a secondary qualitative analysis of the data to identify the ethical issues of adult predictive genetic testing important to members of the general public. The identified issues were: (1) need for public education; (2) choice to undergo genetic counselling and testing; (3) access to genetic counselling and testing; and (4) obligations regarding the handling of genetic information. Audience members emphasized public education and access to information regarding potential choices, which was different from the emphasis on informed consent and other ethical issues prominent in the literature. Members of the general public emphasized ethical issues that were different than those identified by experts and patients. It is essential that members of the public be included in complex and controversial public policy decisions.

Integrated displays to improve chronic disease management in ambulatory care: A SMART on FHIR application informed by mixed-methods user testing.

OBJECTIVE: The study sought to evaluate a novel electronic health record (EHR) add-on application for chronic disease management that uses an integrated display to decrease user cognitive load, improve efficiency, and support clinical decision making. MATERIALS AND METHODS: We designed a chronic disease management application using the technology framework known as SMART on FHIR (Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources). We used mixed methods to obtain user feedback on a prototype to support ambulatory providers managing chronic obstructive pulmonary disease. Each participant managed 2 patient scenarios using the regular EHR with and without access to our prototype in block-randomized order. The primary outcome was the percentage of expert-recommended ideal care tasks completed. Timing, keyboard and mouse use, and participant surveys were also collected. User experiences were captured using a retrospective think-aloud interview analyzed by concept coding. RESULTS: With our prototype, the 13 participants completed more recommended care (81% vs 48%; P < .001) and recommended tasks per minute (0.8 vs 0.6; P = .03) over longer sessions (7.0 minutes vs 5.4 minutes; P = .006). Keystrokes per task were lower with the prototype (6 vs 18; P < .001). Qualitative themes elicited included the desire for reliable presentation of information which matches participants' mental models of disease and for intuitive navigation in order to decrease cognitive load. DISCUSSION: Participants completed more recommended care by taking more time when using our prototype. Interviews identified a tension between using the inefficient but familiar EHR vs learning to use our novel prototype. Concept coding of user feedback generated actionable insights. CONCLUSIONS: Mixed methods can support the design and evaluation of SMART on FHIR EHR add-on applications by enhancing understanding of the user experience.

Fairness and accountability for reasonableness. Do the views of priority setting decision makers differ across health systems and levels of decision making?

Accountability for reasonableness is an ethical framework for fair priority setting process. This framework has been used to evaluate fairness in several contexts, and a few studies have evaluated its acceptability to decision makers. However, no studies have compared the acceptability of the four conditions of the framework to decision makers across health systems and levels of priority setting. This paper reports the elements of fairness described by 184 decision makers involved in priority setting at the macro-, meso- and micro-levels of priority setting in the Canadian (Ontario), Norwegian and Ugandan health care systems and compares them against the four conditions of 'Accountability for Reasonableness' and across levels of decision making, and health care systems. Our respondents identified 23 elements of fair priority setting. Most of these (17) were well aligned with the four conditions of Accountability for Reasonableness; six were not. Comparisons across health care system and levels of decision making revealed that four elements (transparency, participatory and among the criteria-need based and objective) were common to all and the rest were common to only the health care systems (but not at all levels), or only the levels of decision making (but not to all health are systems). Perceptions varied remarkably across levels of decision making. The overlap between the elements of fairness found in this study and the conditions of Accountability for Reasonableness demonstrates that the four conditions are recognizable and applicable across health care systems and levels of decision making. However, the framework should be used with flexibility to allow for identification of elements and relevant explicit criteria (such as those identified in this study) - that may not directly fit under any of the four conditions.

Responding to trust: surgeons' perspective on informed consent.

BACKGROUND: Every day thousands of surgeons and patients negotiate their way through the complex process of decision-making about operative treatments. We conducted a series of qualitative studies, asking patients and surgeons to describe their experience and beliefs about informed decision-making and consent. This study focuses on surgeons' views. METHODS: Open-ended interviews and focus group discussions were conducted with thoracic surgeons who treated esophageal cancer patients by esophagectomy, and general surgeons who routinely performed laparoscopic cholecystectomy. Their views were analyzed using a qualitative approach, grounded in the perspectives of the participants. RESULTS: Five dominant themes emerged from the analysis: (1) making informed decisions; (2) communicating information and confidence; (3) managing expectations and fears; (4) consent as a decision to trust; (5) commitment inspired by trust. These themes are illustrated by verbatim quotes from the surgeon interviews. CONCLUSIONS: Surgeons carefully assess the risks and benefits of treatment before consenting to perform operative interventions. They are influenced by objective findings and by affective factors such as courage and the determination to survive expressed by their patients. They manage risks, doubts, and fears-both their patients' and their own-relying on trust and commitment on both sides to ensure the success of the surgical mission. The trust of their patients has a strong influence on the surgeons' decisions and actions.

Priority setting: what constitutes success? A conceptual framework for successful priority setting.

BACKGROUND: The sustainability of healthcare systems worldwide is threatened by a growing demand for services and expensive innovative technologies. Decision makers struggle in this environment to set priorities appropriately, particularly because they lack consensus about which values should guide their decisions. One way to approach this problem is to determine what all relevant stakeholders understand successful priority setting to mean. The goal of this research was to develop a conceptual framework for successful priority setting. METHODS: Three separate empirical studies were completed using qualitative data collection methods (one-on-one interviews with healthcare decision makers from across Canada; focus groups with representation of patients, caregivers and policy makers; and Delphi study including scholars and decision makers from five countries). RESULTS: This paper synthesizes the findings from three studies into a framework of ten separate but interconnected elements germane to successful priority setting: stakeholder understanding, shifted priorities/reallocation of resources, decision making quality, stakeholder acceptance and satisfaction, positive externalities, stakeholder engagement, use of explicit process, information management, consideration of values and context, and revision or appeals mechanism. CONCLUSION: The ten elements specify both quantitative and qualitative dimensions of priority setting and relate to both process and outcome components. To our knowledge, this is the first framework that describes successful priority setting. The ten elements identified in this research provide guidance for decision makers and a common language to discuss priority setting success and work toward improving priority setting efforts.

Accountable priority setting for trust in health systems--the need for research into a new approach for strengthening sustainable health action in developing countries.

Despite multiple efforts to strengthen health systems in low and middle income countries, intended sustainable improvements in health outcomes have not been shown. To date most priority setting initiatives in health systems have mainly focused on technical approaches involving information derived from burden of disease statistics, cost effectiveness analysis, and published clinical trials. However, priority setting involves value-laden choices and these technical approaches do not equip decision-makers to address a broader range of relevant values - such as trust, equity, accountability and fairness - that are of concern to other partners and, not least, the populations concerned. A new focus for priority setting is needed.Accountability for Reasonableness (AFR) is an explicit ethical framework for legitimate and fair priority setting that provides guidance for decision-makers who must identify and consider the full range of relevant values. AFR consists of four conditions: i) relevance to the local setting, decided by agreed criteria; ii) publicizing priority-setting decisions and the reasons behind them; iii) the establishment of revisions/appeal mechanisms for challenging and revising decisions; iv) the provision of leadership to ensure that the first three conditions are met.REACT - "REsponse to ACcountable priority setting for Trust in health systems" is an EU-funded five-year intervention study started in 2006, which is testing the application and effects of the AFR approach in one district each in Kenya, Tanzania and Zambia. The objectives of REACT are to describe and evaluate district-level priority setting, to develop and implement improvement strategies guided by AFR and to measure their effect on quality, equity and trust indicators. Effects are monitored within selected disease and programme interventions and services and within human resources and health systems management. Qualitative and quantitative methods are being applied in an action research framework to examine the potential of AFR to support sustainable improvements to health systems performance.This paper reports on the project design and progress and argues that there is a high need for research into legitimate and fair priority setting to improve the knowledge base for achieving sustainable improvements in health outcomes.

Preliminary evaluation of the Chest Pain Dashboard, a FHIR-based approach for integrating health information exchange information directly into the clinical workflow.

Despite efforts aimed at improving the integration of clinical data from health information exchanges (HIE) and electronic health records (EHR), interoperability remains limited. Barriers due to inefficiencies and workflow interruptions make using HIE data during care delivery difficult. Capitalizing on the development of the Fast Healthcare Interoperability Resource (FHIR) specification, we designed and developed a Chest Pain Dashboard that integrates HIE data into EHRs. This Dashboard was implemented in one emergency department (ED) of Indiana University Health in Indiana. In this paper, we present the preliminary findings from a mixed-methods evaluation of the Dashboard. A difference-in-difference analysis suggests that the ED with the Dashboard implementation resulted in a significant increase in HIE use compared to EDs without. This finding was supported by qualitative interviews. While these results are encouraging, we also identified areas for improvement. FHIR-based solutions may offer promising approaches to encourage greater accessibility and use of HIE data.

Healthcare sustainability and the challenges of innovation to biopharmaceuticals in Canada.

Governments around the world have focused on issues of sustainability, innovations and priority setting within their health systems. Tension exists between governments' desire to increase biotechnology innovation and the need to address health system sustainability. This commentary will: (1) review government initiatives in biotechnology in health innovation; (2) discuss how innovation, specifically biopharmaceuticals, challenges health system sustainability; and (3) explore how the tension between innovation and sustainability can be addressed using fairness and legitimacy. It is evident that a uni-jurisdictional approach may not be optimal in promoting innovation while ensuring a sustainable health system. Harmonization of biotechnology policies across the federal, provincial, and territorial governments will ensure consistent policies across all branches in order to circumvent the possibility of one governmental branch refusing to reimburse the very innovations other branches are promoting.

Bedside rationing by health practitioners: a case study in a Ugandan hospital.

PURPOSE: The purpose of this study was to describe bedside rationing by health practitioners in a teaching hospital in Uganda. METHODS: This was a case study involving in-depth interviews. A modified thematic approach was used in data analysis. Types of decisions, the decision-making process, key players, and hospital-, medical-, and patient-related considerations in the process were identified. Klein's 6 forms of rationing were used to identify the forms of rationing used. The setting was a tertiary hospital in Uganda. Theoretical sampling was used to identify 40 doctors and 16 nurses from the Departments of Medicine, Surgery, Paediatrics, and Obstetric and Gynaecology. RESULTS: Four types of bedside rationing decisions were identified: 1) which patients are seen first, 2) which treatment the patients receive, 3) which patients are admitted, and 4) which patients are taken to the operating theatre first. Hospital-related considerations regarding bedside rationing included the hospital budget and number of beds; medical-related considerations included the patient's diagnosis and effectiveness of treatment; and patient-related considerations included poverty, social status, and age. All forms of rationing (denial, dilution, deflection, deterrence, delay, and termination) were practiced. CONCLUSION: Although bedside rationing decisions in the study hospital seem somewhat similar to that in developed countries, the rationing of 1st-line drugs by health practitioners in Uganda is complex, difficult, and different from what has been described in industrialized countries. The complexity and severity of the consequences of the bedside decisions necessitate the development of resource-sensitive clinical guidelines and transparent decision-making processes to foster patients' understanding of the reasons and the procedures and to ensure fair decision-making processes.

Priority setting at the micro-, meso- and macro-levels in Canada, Norway and Uganda.

UNLABELLED: The objectives of this study were (1) to describe the process of healthcare priority setting in Ontario-Canada, Norway and Uganda at the three levels of decision-making; (2) to evaluate the description using the framework for fair priority setting, accountability for reasonableness; so as to identify lessons of good practices. METHODS: We carried out case studies involving key informant interviews, with 184 health practitioners and health planners from the macro-level, meso-level and micro-level from Canada-Ontario, Norway and Uganda (selected by virtue of their varying experiences in priority setting). Interviews were audio-recorded, transcribed and analyzed using a modified thematic approach. The descriptions were evaluated against the four conditions of "accountability for reasonableness", relevance, publicity, revisions and enforcement. Areas of adherence to these conditions were identified as lessons of good practices; areas of non-adherence were identified as opportunities for improvement. RESULTS: (i) DESCRIPTION: at the macro-level, in all three countries, cabinet makes most of the macro-level resource allocation decisions and they are influenced by politics, public pressure, and advocacy. Decisions within the ministries of health are based on objective formulae and evidence. International priorities influenced decisions in Uganda. Some priority-setting reasons are publicized through circulars, printed documents and the Internet in Canada and Norway. At the meso-level, hospital priority-setting decisions were made by the hospital managers and were based on national priorities, guidelines, and evidence. Hospital departments that handle emergencies, such as surgery, were prioritized. Some of the reasons are available on the hospital intranet or presented at meetings. Micro-level practitioners considered medical and social worth criteria. These reasons are not publicized. Many practitioners lacked knowledge of the macro- and meso-level priority-setting processes. (ii) Evaluation-relevance: medical evidence and economic criteria were thought to be relevant, but lobbying was thought to be irrelevant. Publicity: all cases lacked clear and effective mechanisms for publicity. REVISIONS: formal mechanisms, following the planning hierarchy, were considered less effective, informal political mechanisms were considered more effective. Canada and Norway had patients' relations officers to deal with patients' dissensions; however, revisions were more difficult in Uganda. Enforcement: leadership for ensuring decision-making fairness was not apparent. CONCLUSIONS: The different levels of priority setting in the three countries fulfilled varying conditions of accountability for reasonableness, none satisfied all the four conditions. To improve, decision makers at the three levels in all three cases should engage frontline practitioners, develop more effectively publicized reasons, and develop formal mechanisms for challenging and revising decisions.

Public involvement in the priority setting activities of a wait time management initiative: a qualitative case study.

BACKGROUND: As no health system can afford to provide all possible services and treatments for the people it serves, each system must set priorities. Priority setting decision makers are increasingly involving the public in policy making. This study focuses on public engagement in a key priority setting context that plagues every health system around the world: wait list management. The purpose of this study is to describe and evaluate priority setting for the Ontario Wait Time Strategy, with special attention to public engagement. METHODS: This study was conducted at the Ontario Wait Time Strategy in Ontario, Canada which is part of a Federal-Territorial-Provincial initiative to improve access and reduce wait times in five areas: cancer, cardiac, sight restoration, joint replacements, and diagnostic imaging. There were two sources of data: (1) over 25 documents (e.g. strategic planning reports, public updates), and (2) 28 one-on-one interviews with informants (e.g. OWTS participants, MOHLTC representatives, clinicians, patient advocates). Analysis used a modified thematic technique in three phases: open coding, axial coding, and evaluation. RESULTS: The Ontario Wait Time Strategy partially meets the four conditions of 'accountability for reasonableness'. The public was not directly involved in the priority setting activities of the Ontario Wait Time Strategy. Study participants identified both benefits (supporting the initiative, experts of the lived experience, a publicly funded system and sustainability of the healthcare system) and concerns (personal biases, lack of interest to be involved, time constraints, and level of technicality) for public involvement in the Ontario Wait Time Strategy. Additionally, the participants identified concern for the consequences (sustainability, cannibalism, and a class system) resulting from the Ontario Wait Times Strategy. CONCLUSION: We described and evaluated a wait time management initiative (the Ontario Wait Time Strategy) with special attention to public engagement, and provided a concrete plan to operationalize a strategy for improving public involvement in this, and other, wait time initiatives.

The effect of priority setting decisions for new cancer drugs on medical oncologists' practice in Ontario: a qualitative study.

BACKGROUND: Health care policies, including drug-funding policies, influence physician practice. Funding policies are especially important in the area of cancer care since cancer is a leading cause of death that is responsible for a significant level of health care expenditures. Recognizing the rising cost of cancer therapies, Cancer Care Ontario (CCO) established a funding process to provide access to new, effective agents through a "New Drug Funding Program" (NDFP). The purpose of this study is to describe oncologists' perceptions of the impact of NDFP priority setting decisions on their practice. METHODS: This is a qualitative study involving semi-structured, in-depth interviews with 46 medical oncologists in Ontario. Oncologists were asked to describe the impact of CCO's NDFP drug funding decisions on their practice. Analysis of interview transcripts commenced with data collection. RESULTS: Our key finding is that many of the medical oncologists who participated in this study did not accept limits when policy decisions limit access to cancer drugs they feel would benefit their patients. Moreover, overcoming those limits had a significant impact on oncologists' practice in terms of how they spend their time and energy and their relationship with patients. CONCLUSION: When priority setting decisions limit access to cancer medications, many oncologists' efforts to overcome those limits have a significant impact on their practice. Policy makers need to seriously consider the implications of their decisions on physicians, who may go to considerable effort to circumvent their policies in the name of patient advocacy.