Publications by authors named "Douglas K Martin"

60 Publications

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

JAMIA Open 2021 Jul 31;4(3):ooab041. Epub 2021 Jul 31.

Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA.

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.
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http://dx.doi.org/10.1093/jamiaopen/ooab041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8325485PMC
July 2021

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

J Am Med Inform Assoc 2020 08;27(8):1225-1234

Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA.

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.
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http://dx.doi.org/10.1093/jamia/ocaa099DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7481023PMC
August 2020

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

AMIA Jt Summits Transl Sci Proc 2019 6;2019:656-664. Epub 2019 May 6.

Regenstrief Institute, Indianapolis, IN.

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.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6568135PMC
May 2019

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

J Gen Intern Med 2015 Jan;30 Suppl 1:S17-24

Regenstrief Institute, Inc., 401 West Tenth Street, Suite HS2000, Indianapolis, IN, 46202, USA.

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.
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http://dx.doi.org/10.1007/s11606-014-3055-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4265219PMC
January 2015

Regenstrief Institute's Medical Gopher: a next-generation homegrown electronic medical record system.

Int J Med Inform 2014 Mar 14;83(3):170-9. Epub 2013 Dec 14.

Regenstrief Institute Inc., Indianapolis, IN, USA; Indiana University School of Medicine, Indianapolis, IN, USA; Wishard/Eskenazi Health Services, Indianapolis, IN, USA.

Objective: Regenstrief Institute developed one of the seminal computerized order entry systems, the Medical Gopher, for implementation at Wishard Hospital nearly three decades ago. Wishard Hospital and Regenstrief remain committed to homegrown software development, and over the past 4 years we have fully rebuilt Gopher with an emphasis on usability, safety, leveraging open source technologies, and the advancement of biomedical informatics research. Our objective in this paper is to summarize the functionality of this new system and highlight its novel features.

Materials And Methods: Applying a user-centered design process, the new Gopher was built upon a rich-internet application framework using an agile development process. The system incorporates order entry, clinical documentation, result viewing, decision support, and clinical workflow. We have customized its use for the outpatient, inpatient, and emergency department settings.

Results: The new Gopher is now in use by over 1100 users a day, including an average of 433 physicians caring for over 3600 patients daily. The system includes a wizard-like clinical workflow, dynamic multimedia alerts, and a familiar 'e-commerce'-based interface for order entry. Clinical documentation is enhanced by real-time natural language processing and data review is supported by a rapid chart search feature.

Discussion: As one of the few remaining academically developed order entry systems, the Gopher has been designed both to improve patient care and to support next-generation informatics research. It has achieved rapid adoption within our health system and suggests continued viability for homegrown systems in settings of close collaboration between developers and providers.
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http://dx.doi.org/10.1016/j.ijmedinf.2013.11.004DOI Listing
March 2014

Stakeholder involvement in expensive drug recommendation decisions: an international perspective.

Health Policy 2012 May 5;105(2-3):226-35. Epub 2012 Jan 5.

Department of Pediatrics, McMaster University, Canada.

Objectives: To describe stakeholder involvement in the priority setting and appeals processes across five drug reimbursement recommendation committees.

Methods: We conducted qualitative case studies of how five independent drug advisory committees from Canada, Israel, England and Wales, Australia, and the USA made funding decisions for six expensive drugs. Interviews with 48 informants were conducted with committee members, patient groups, and industry representatives.

Results: Different stakeholders were allowed, in varying degrees, to participate in the formal mechanisms for revisions and appeals of decisions. Participants identified a number of stakeholder groups who were already involved in the process, as well as stakeholders whom they believed should be included in the decision-making process.

Conclusions: A central component of a legitimate and fair priority setting process is to make priority setting explicit and to involve both pertinent values and stakeholders in decision-making. Study participants believed that the involvement of multiple stakeholder groups within the deliberative and appeals/revisions processes would contribute to a fair and legitimate drug reimbursement process.
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http://dx.doi.org/10.1016/j.healthpol.2011.12.002DOI Listing
May 2012

Priority setting for orphan drugs: an international comparison.

Health Policy 2011 Apr 18;100(1):25-34. Epub 2010 Oct 18.

Department of Pediatrics, McMaster Children's Hospital Hamilton Health Sciences, Hamilton, ON Canada.

Objectives: To describe the process of priority setting for two orphan drugs - Cerezyme and Fabrazyme - in Canada, Australia and Israel, in order to understand and improve the process based on stakeholder perspectives.

Methods: We conducted qualitative case studies of how three independent drug advisory committees made decisions relating to the funding of Cerezyme and Fabrazyme. Interviews were conducted with 22 informants, including committee members, patient groups and industry representatives.

Results: (1) DESCRIPTION: Orphan drugs reimbursement recommendations by expert panels were based on clinical evidence, cost and cost-effectiveness analysis. (2) EVALUATION: Committee members expressed an overall preference for the current drug review process used by their own committee, but were concerned with the fairness of the process particularly for orphan drugs. Other informants suggested the inclusion of other relevant values (e.g. lack of alternative treatments) in order to improve the priority setting process. Some patient groups suggested the use of an alternative funding mechanism for orphan drugs.

Conclusions: Priority setting for drugs is not solely a technical process (involving cost-effective analysis, evidence-based medicine, etc.). Understanding the process by which reimbursement decisions are made for orphan drugs may help improve the system for future orphan drugs.
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http://dx.doi.org/10.1016/j.healthpol.2010.09.008DOI Listing
April 2011

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

BMC Health Serv Res 2010 Aug 5;10:228. Epub 2010 Aug 5.

Joint Centre for Bioethics, University of Toronto, Toronto, Canada.

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.
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http://dx.doi.org/10.1186/1472-6963-10-228DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2922208PMC
August 2010

Evaluating priority setting success in healthcare: a pilot study.

BMC Health Serv Res 2010 May 19;10:131. Epub 2010 May 19.

School of Health Studies The University of Western Ontario London, Ontario, N6A 5B9, Canada.

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.
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http://dx.doi.org/10.1186/1472-6963-10-131DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2890637PMC
May 2010

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

Health Res Policy Syst 2009 Oct 24;7:23. Epub 2009 Oct 24.

DBL - Centre for Health Research and Development, Faculty of Life Sciences, University of Copenhagen, Frederiksberg, Denmark.

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.
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http://dx.doi.org/10.1186/1478-4505-7-23DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2777144PMC
October 2009

Responding to trust: surgeons' perspective on informed consent.

World J Surg 2009 Jul;33(7):1341-7

Toronto General Hospital, University of Toronto, Department of Surgery and Joint Centre for Bioethics, Toronto, ON, Canada.

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.
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http://dx.doi.org/10.1007/s00268-009-0021-7DOI Listing
July 2009

Public perceptions of ethical issues regarding adult predictive genetic testing.

Health Care Anal 2010 Jun 14;18(2):103-12. Epub 2009 Mar 14.

Department of Health Policy, Management and Evaluation and the Joint Centre for Bioethics, University of Toronto, 88 College St., Toronto, ON, M5G 1L4, Canada.

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.
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http://dx.doi.org/10.1007/s10728-009-0113-4DOI Listing
June 2010

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

Health Care Anal 2010 Jun 14;18(2):129-47. Epub 2009 Mar 14.

Health, Aging & Society, Mcmaster University, 1280 Main St. W.KTH 236, Hamilton, ON, L8S 4M4, Canada.

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.
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http://dx.doi.org/10.1007/s10728-009-0115-2DOI Listing
June 2010

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

BMC Health Serv Res 2009 Mar 5;9:43. Epub 2009 Mar 5.

Department of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.

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.
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http://dx.doi.org/10.1186/1472-6963-9-43DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2655292PMC
March 2009

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

Soc Sci Med 2009 Feb 11;68(4):766-73. Epub 2008 Dec 11.

McMaster University, Hamilton, Ontario, Canada.

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.
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http://dx.doi.org/10.1016/j.socscimed.2008.11.011DOI Listing
February 2009

Public engagement in setting priorities in health care.

CMAJ 2008 Jul;179(1):15-8

University of Toronto Joint Centre for Bioethics, Toronto, Ontario, Canada.

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http://dx.doi.org/10.1503/cmaj.071656DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2464477PMC
July 2008

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

Health Policy 2008 Sep 20;87(3):359-68. Epub 2008 Mar 20.

Department of Health Policy Management and Evaluation and the Joint Centre for Bioethics, University of Toronto, 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.
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http://dx.doi.org/10.1016/j.healthpol.2008.02.004DOI Listing
September 2008

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

BMC Health Serv Res 2007 Nov 28;7:193. Epub 2007 Nov 28.

Division of Medical Oncology/Hematology, Sunnybrook Health Sciences Centre, Department of Medicine, University of Toronto, Toronto, Canada.

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.
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http://dx.doi.org/10.1186/1472-6963-7-193DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2148046PMC
November 2007

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

BMC Health Serv Res 2007 Nov 16;7:186. Epub 2007 Nov 16.

Joint Centre for Bioethics, University of Toronto, Toronto, Canada.

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.
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http://dx.doi.org/10.1186/1472-6963-7-186DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2238747PMC
November 2007

Adoption of an innovation to repair aortic aneurysms at a Canadian hospital: a qualitative case study and evaluation.

BMC Health Serv Res 2007 Nov 15;7:182. Epub 2007 Nov 15.

Department of Health, Policy, Management and Evaluation, University of Toronto, Toronto, Canada.

Background: Priority setting in health care is a challenge because demand for services exceeds available resources. The increasing demand for less invasive surgical procedures by patients, health care institutions and industry, places added pressure on surgeons to acquire the appropriate skills to adopt innovative procedures. Such innovations are often initiated and introduced by surgeons in the hospital setting. Decision-making processes for the adoption of surgical innovations in hospitals have not been well studied and a standard process for their introduction does not exist. The purpose of this study is to describe and evaluate the decision-making process for the adoption of a new technology for repair of abdominal aortic aneurysms (endovascular aneurysm repair [EVAR]) in an academic health sciences centre to better understand how decisions are made for the introduction of surgical innovations at the hospital level.

Methods: A qualitative case study of the decision to adopt EVAR was conducted using a modified thematic analysis of documents and semi-structured interviews. Accountability for Reasonableness was used as a conceptual framework for fairness in priority setting processes in health care organizations.

Results: There were two key decisions regarding EVAR: the decision to adopt the new technology in the hospital and the decision to stop hospital funding. The decision to adopt EVAR was based on perceived improved patient outcomes, safety, and the surgeons' desire to innovate. This decision involved very few stakeholders. The decision to stop funding of EVAR involved all key players and was based on criteria apparent to all those involved, including cost, evidence and hospital priorities. Limited internal communications were made prior to adopting the technology. There was no formal means to appeal the decisions made.

Conclusion: The analysis yielded recommendations for improving future decisions about the adoption of surgical innovations. ese empirical findings will be used with other case studies to help develop guidelines to help decision-makers adopt surgical innovations in Canadian hospitals.
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http://dx.doi.org/10.1186/1472-6963-7-182DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2194685PMC
November 2007

What do district health planners in Tanzania think about improving priority setting using 'Accountability for reasonableness'?

BMC Health Serv Res 2007 Nov 12;7:180. Epub 2007 Nov 12.

Department of Health Policy, Management and Evaluation and the Joint Centre for Bioethics, University of Toronto, Toronto, Canada.

Background: Priority setting in every health system is complex and difficult. In less wealthy countries the dominant approach to priority setting has been Burden of Disease (BOD) and cost-effectiveness analysis (CEA), which is helpful, but insufficient because it focuses on a narrow range of values - need and efficiency - and not the full range of relevant values, including legitimacy and fairness. 'Accountability for reasonableness' is a conceptual framework for legitimate and fair priority setting and is empirically based and ethically justified. It connects priority setting to broader, more fundamental, democratic deliberative processes that have an impact on social justice and equity. Can 'accountability for reasonableness' be helpful for improving priority setting in less wealthy countries?

Methods: In 2005, Tanzanian scholars from the Primary Health Care Institute (PHCI) conducted 6 capacity building workshops with senior health staff, district planners and managers, and representatives of the Tanzanian Ministry of Health to discussion improving priority setting in Tanzania using 'accountability for reasonableness'. The purpose of this paper is to describe this initiative and the participants' views about the approach.

Results: The approach to improving priority setting using 'accountability for reasonableness' was viewed by district decision makers with enthusiastic favour because it was the first framework that directly addressed their priority setting concerns. High level Ministry of Health participants were also very supportive of the approach.

Conclusion: Both Tanzanian district and governmental health planners viewed the 'accountability for reasonableness' approach with enthusiastic favour because it was the first framework that directly addressed their concerns.
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http://dx.doi.org/10.1186/1472-6963-7-180DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2151948PMC
November 2007

A strategy to improve priority setting in developing countries.

Health Care Anal 2007 Sep;15(3):159-67

University of Toronto Joint Centre for Bioethics, 88 College Street, Toronto, Ontario, Canada, M5G 1L4.

Because the demand for health services outstrips the available resources, priority setting is one of the most difficult issues faced by health policy makers, particularly those in developing countries. Priority setting in developing countries is fraught with uncertainty due to lack of credible information, weak priority setting institutions, and unclear priority setting processes. Efforts to improve priority setting in these contexts have focused on providing information and tools. In this paper we argue that priority setting is a value laden and political process, and although important, the available information and tools are not sufficient to address the priority setting challenges in developing countries. Additional complementary efforts are required. Hence, a strategy to improve priority setting in developing countries should also include: (i) capturing current priority setting practices, (ii) improving the legitimacy and capacity of institutions that set priorities, and (iii) developing fair priority setting processes.
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http://dx.doi.org/10.1007/s10728-006-0037-1DOI Listing
September 2007

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

Med Decis Making 2007 Jan-Feb;27(1):44-52

Joint Centre for Bioethics, University of Toronto, Toronto, Ontario, Canada.

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.
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http://dx.doi.org/10.1177/0272989X06297397DOI Listing
March 2007

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

Health Policy 2007 Jun 10;82(1):78-94. Epub 2006 Oct 10.

University of Toronto Joint Centre for Bioethics, Toronto, Ontario, Canada.

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.
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http://dx.doi.org/10.1016/j.healthpol.2006.09.001DOI Listing
June 2007

Priority setting in developing countries health care institutions: the case of a Ugandan hospital.

BMC Health Serv Res 2006 Oct 6;6:127. Epub 2006 Oct 6.

Joint Centre for Bioethics, University of Toronto, 88 College Street, Toronto, Ontario, M5G 1L4, Canada.

Background: Because the demand for health services outstrips the available resources, priority setting is one of the most difficult issues faced by health policy makers, particularly those in developing countries. However, there is lack of literature that describes and evaluates priority setting in these contexts. The objective of this paper is to describe priority setting in a teaching hospital in Uganda and evaluate the description against an ethical framework for fair priority setting processes--Accountability for Reasonableness.

Methods: A case study in a 1,500 bed national referral hospital receiving 1,320 out patients per day and an average budget of 13.5 million US dollars per year. We reviewed documents and carried out 70 in-depth interviews (14 health planners, 40 doctors, and 16 nurses working at the hospital). Interviews were recorded and transcribed. Data analysis employed the modified thematic approach to describe priority setting, and the description was evaluated using the four conditions of Accountability for Reasonableness: relevance, publicity, revisions and enforcement.

Results: Senior managers, guided by the hospital strategic plan make the hospital budget allocation decisions. Frontline practitioners expressed lack of knowledge of the process.

Relevance: Priority is given according to a cluster of factors including need, emergencies and patient volume. However, surgical departments and departments whose leaders "make a lot of noise" are also prioritized. Publicity: Decisions, but not reasons, are publicized through general meetings and circulars, but this information does not always reach the frontline practitioners. Publicity to the general public was through ad hoc radio programs and to patients who directly ask. Revisions: There were no formal mechanisms for challenging the reasoning. Enforcement: There were no mechanisms to ensure adherence to the four conditions of a fair process.

Conclusion: Priority setting decisions at this hospital do not satisfy the conditions of fairness. To improve, the hospital should: (i) engage frontline practitioners, (ii) publicize the reasons for decisions both within the hospital and to the general public, and (iii) develop formal mechanisms for challenging the reasoning. In addition, capacity strengthening is required for senior managers who must accept responsibility for ensuring that the above three conditions are met.
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http://dx.doi.org/10.1186/1472-6963-6-127DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1609114PMC
October 2006

The Global Fund Secretariat's suspension of funding to Uganda: how could this have been avoided?

Bull World Health Organ 2006 Jul;84(7):576-80

Joint Centre for Bioethics, University of Toronto, Toronto, Ontario, Canada.

In August 2005, the Global Fund to fight AIDS, Tuberculosis and Malaria (the Global Fund) Secretariat suspended its five grants to Uganda following a PricewaterhouseCoopers audit report that exposed gross mismanagement in the Project Management Unit. How could this have been avoided? How can other countries avoid a similar pitfall? We argue that if a legitimate and fair decision-making process were used, the suspension of funding to Uganda could have been avoided, and that this lesson should be applied to other countries. The "accountability for reasonableness" framework of relevance, publicity, revisions and enforcement would help in implementing legitimate and fair decision-making processes, which would improve effectiveness, accountability and transparency in the implementation of Global Fund programmes, preventing future suspension of funding to any Global Fund projects.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2627384PMC
http://dx.doi.org/10.2471/blt.06.030718DOI Listing
July 2006

Priority setting and cardiac surgery: a qualitative case study.

Health Policy 2007 Mar 6;80(3):444-58. Epub 2006 Jun 6.

Faculty of Community Services, The School of Nursing, Ryerson University, 350 Victoria Street, Toronto, Ont., Canada M5B 2K3.

Purpose: The purpose of this study is to describe priority setting in cardiac surgery and evaluate it using an ethical framework, "accountability for reasonableness".

Introduction: Cardiac surgery is an expensive part of hospital budgets. Priority setting decisions are made daily regarding ever increasing volumes of patients. While much attention has been paid to the management of cardiac surgery waiting lists, little empirical research exists into the way actual decision makers deliberate upon and resolve priority setting decisions on a daily basis. A key goal of priority setting, in cardiac surgical areas as well as others, is fairness. "Accountability for reasonableness" is a leading ethical framework for fair priority setting, and can be used to identify opportunities for improvement (i.e. make it fairer) and highlight good practices.

Methods: A case study was conducted to examine the process of priority setting processes at three University of Toronto affiliated cardiac surgery centres. Relevant documents were examined, weekly triage rounds were observed for 27 months, and interviews were carried out with 23 key participants including cardiac surgeons, cardiologists, and triage nurses. In data analysis, the conditions of "accountability for reasonableness" (relevance, publicity, appeals and enforcement) were used as an analytic lens.

Results:

Relevance: While decisions may appear to be based strictly upon clinical criteria (e.g. coronary anatomy); non-clinical criteria also have an impact upon decision-making (e.g. patients' lifestyle choices, type of surgical practice and departmental constraints on resource use). Participants stated that these factors influence their decision-making and can result in unfair and inconsistent decisions. PUBLICITY: Non-clinical reasons are not publicly accessible, nor are they clearly acknowledged in discussions between cardiac clinicians. APPEALS: There are mechanisms for challenging decisions however without access to the non-clinical reasons, this can be problematic. Enforcement: Participants cite little departmental or institutional support to engage in fairer priority setting.

Conclusions: To our knowledge, this is the first study to describe actual priority setting practices for cardiac surgery practices and evaluate them using an ethical framework, in this case, "accountability for reasonableness". Priority setting decision making in cardiac surgery has been described and evaluated with lessons learned include specific findings regarding the contextual and dynamic nature of decision making in cardiac surgery. The approach of combining a descriptive case study with the ethical framework of "accountability for reasonableness" is a useful tool for identifying good practices and highlighting areas for improvement. The good practices (including surgeons strongly facilitating patients seeking second opinions and approaching patients from a holistic perspective in consideration for surgery) and areas for improvement (including lack of transparency and lack of institutional support for "fair" decision making) that we have identified in this case study can be used to reflect upon the present tool used in priority setting and improve the fairness and legitimacy of priority setting decision making in cardiac surgery.
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http://dx.doi.org/10.1016/j.healthpol.2006.05.004DOI Listing
March 2007

Leadership and priority setting: the perspective of hospital CEOs.

Health Policy 2006 Nov 27;79(1):24-34. Epub 2005 Dec 27.

Department of Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto, Health Sciences Building, 155 College Street, Suite 425, Toronto, Ont., Canada M5T 3M6.

The role of leadership in health care priority setting remains largely unexplored. While the management leadership literature has grown rapidly, the growing literature on priority setting in health care has looked in other directions to improve priority setting practices--to health economics and ethical approaches. Consequently, potential for improvement in hospital priority setting practices may be overlooked. A qualitative study involving interviews with 46 Ontario hospital CEOs was done to describe the role of leadership in priority setting through the perspective of hospital leaders. For the first time, we report a framework of leadership domains including vision, alignment, relationships, values and process to facilitate priority setting practices in health services' organizations. We believe this fledgling framework forms the basis for the sharing of good leadership practices for health reform. It also provides a leadership guide for decision makers to improve the quality of their leadership, and in so doing, we believe, the fairness of their priority setting.
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http://dx.doi.org/10.1016/j.healthpol.2005.11.009DOI Listing
November 2006

Concerns about ethical review of health research in India.

Indian J Med Ethics 2004 Oct-Dec;1(4):119-20

General Hospital, Thiruvananthapuram, Kerala 695011, India.

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http://dx.doi.org/10.20529/IJME.2004.056DOI Listing
April 2006
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