Is a larger patient benefit always better in healthcare priority setting?

When considering the introduction of a new intervention in a budget constrained healthcare system, priority setting based on fair principles is fundamental. In many jurisdictions, a multi-criteria approach with several different considerations is employed, including severity and cost-effectiveness. Such multi-criteria approaches raise questions about how to balance different considerations against each other, and how to understand the logical or normative relations between them. For example, some jurisdictions make explicit reference to a large patient benefit as such a consideration. However, since patient benefit is part of a cost-effectiveness assessment it is not clear how to balance considerations of greater patient benefit against considerations of severity and cost-effectiveness. The aim of this paper is to explore the role of a large patient benefit as an independent criterion for priority setting in a healthcare system also considering severity and cost-effectiveness. By taking the opportunity cost of new interventions (i.e., the health forgone in patients already receiving treatment) into account, we argue that patient benefit has a complex relationship to priority setting. More specifically, it cannot be reasonably concluded that large patient benefits should be given priority if severity, cost-effectiveness, and opportunity costs are held constant. Since we cannot find general support for taking patient benefit into account as an independent criterion from any of the most discussed theories about distributive justice: utilitarianism, prioritarianism, telic egalitarianism and sufficientarianism, it is reasonable to avoid doing so. Hence, given the complexity of the role of patient benefit, we conclude that in priority practice, a large patient benefit should not be considered as an independent criterion, on top of considerations of severity and cost-effectiveness.

Ethical Challenges for Plastic Surgery in Treating Internationally Adopted Children With Cleft Lip and Palate.

A large number of children with cleft lip and palate (CLP) were adopted to Sweden in the last decade, mainly from China. Most of the children arrived with unoperated palates and at later ages than earlier years. This article aims to present an overview of ethical challenges within the practice of international adoption of children with CLP from the perspective of plastic surgery in a welfare health care system. An overview of CLP treatment is presented, followed by a normative discussion and ethical analysis using the 4 principles of Beauchamp and Childress: non-maleficence, beneficence, autonomy, and justice. The following themes and subthemes were analyzed: the search for normality and the potential challenge of being adopted and having CLP-treatment autonomy of the child and future preferences, adoptive parents' expectations of plastic surgery, the journey of the adoptee and the adoptive parents; and general issues-reconstructive possibilities and consequences of CLP in the country of origin, information to the adoptive parents, health care needs, and reconstructive possibilities for children with CLP in the receiving country. Clinical implications are discussed, and suggestions for future research are provided.

Consolidating political leadership in healthcare: a mediating institution for priority-setting as a political strategy in a local health system.

The allocation of resources is a crucial part of political decision-making in healthcare, but explicit priorities are rarely set when resources are distributed. Two areas that have received some attention in research about legitimacy and priority-setting decisions in healthcare are the role of technical expert agencies as mediating institutions and the role of elected politicians. This paper investigates a political priority-setting advisory committee within a regional authority in Sweden. The aim is to explore how a political body can serve as a mediating institution for priority-setting in healthcare by disentangling the arrangements of its work in terms of what role it performs in the organisation and what it should do. The findings illustrate that promoting the notion of explicit priority-setting and the political aspects inherent in priority-setting in political healthcare management can contribute to consolidating political governance and leadership. There is, however, a complex tension between stability and conflicting values which has implications for the role of politicians as citizens' democratic representatives. This paper enhances our understanding of the role of mediating institutions and political properties of healthcare priority-setting, as well as our understanding of political and democratic healthcare governance in local self-government.

Nurses' priority-setting for older nursing home residents during COVID-19.

BACKGROUND: Ethical principles behind prioritization in healthcare are continuously relevant. However, applying ethical principles during times of increased need, such as during the COVID-19 pandemic, is challenging. Also, little is known about nursing home nurses' prioritizations in their work to achieve well-being and health for nursing home residents. AIM: The aim of this study was to explore nursing home nurses' priority-setting for older nursing home residents in Sweden during the COVID-19 pandemic. RESEARCH DESIGN, PARTICIPANTS, AND RESEARCH CONTEXT: We conducted a qualitative interview study. Data were collected through in-depth interviews (retrospective self-reports) between February and May 2021 with 21 nursing home nurses. To help respondents to recall their memories, we used the critical incident technique (CIT). We analyzed data within the theoretical framework and the methodological orientation of content analysis. ETHICAL CONSIDERATIONS: Written and verbal consent was obtained before the interviews, and information was given to participants informing them that participation was entirely voluntary. The Swedish Ethical Review Agency gave an advisory opinion stating that there were no ethical objections to the research project (Dnr. 2020-05649). FINDINGS: We identified an overarching theme-nursing home nurses struggling on multiple fronts, "just do it"-and seven categories: striving for survival and caring about a dignified death; responding sensitively to relatives' expectations; ranking the urgency of needed care; responding to input from different actors; combating the spread of infection in unconventional ways; taking the lead and doing what is required; and following the ideals of person-centered nursing. CONCLUSIONS: Nurses' priority-setting for older nursing homes residents during the COVID-19 pandemic meant strain and struggle. In some cases, nurses had taken responsibility for priorities falling outside their statutory powers. Different demands and interests affected nurses' priorities. Nursing home nurses need organizational and managerial support to prioritize.

Ethical challenges from a problem-solving intervention with workplace involvement: a qualitative study among employees with common mental disorders, first-line managers, and rehabilitation coordinators.

PURPOSE: This study aims to explore ethical challenges potentially arising from a problem-solving intervention with workplace involvement (PSI-WPI) in primary health care (with first-line manager involvement) for employees on sickness absence due to common mental disorders. METHODS: A qualitative design guided by the theoretical framework for systematic identification of ethical aspects of healthcare technologies. Semi-structured interviews were performed with coordinators (n = 6), employees (n = 13), and first-line managers (n = 8). Reflexive thematic analysis was used to analyse and interpret themes. RESULTS: A main theme was identified "the workplace and healthcare hold different organizational value logics" and four sub-themes: "the PSI-WPI challenged the organizational goals and values of the workplace and healthcare", "the PSI-WPI challenged organizational values on fairness", "the PSI-WPI challenged the professional roles of first-line managers and rehabilitation coordinators" and "the PSI-WPI introduced a need for the employee to juggle the employee and patient roles". CONCLUSION: Different organizational value logics, values, and goals can introduce ethical challenges. We advise clarifying stakeholders' roles and preparing employees and managers for the return to work process by providing sufficient information. The ethical challenges and suggested measures to minimize them, should be considered when planning return to work interventions that involve several stakeholders.

How did European countries set health priorities in response to the COVID-19 threat? A comparative document analysis of 24 pandemic preparedness plans across the EURO region.

The COVID-19 pandemic has forced governments across the world to consider how to prioritise the allocation of scarce resources. There are many tools and frameworks that have been designed to assist with the challenges of priority setting in health care. The purpose of this study was to examine the extent to which formal priority setting was evident in the pandemic plans produced by countries in the World Health Organisation's EURO region, during the first wave of the COVID-19 pandemic. This compliments analysis of similar plans produced in other regions of the world. Twenty four pandemic preparedness plans were obtained that had been published between March and September 2020. For data extraction, we applied a framework for identifying and assessing the elements of good priority setting to each plan, before conducting comparative analysis across the sample. Our findings suggest that while some pre-requisites for effective priority setting were present in many cases - including political commitment and a recognition of the need for allocation decisions - many other hallmarks were less evident, such as explicit ethical criteria, decision making frameworks, and engagement processes. This study provides a unique insight into the role of priority setting in the European response to the onset of the COVID-19 pandemic.

Should Severity Assessments in Healthcare Priority Setting be Risk- and Time-Sensitive?

BACKGROUND: Severity plays an essential role in healthcare priority setting. Still, severity is an under-theorised concept. One controversy concerns whether severity should be risk- and/or time-sensitive. The aim of this article is to provide a normative analysis of this question. METHODS: A reflective equilibrium approach is used, where judgements and arguments concerning severity in preventive situations are related to overall normative judgements and background theories in priority-setting, aiming for consistency. Analysis, discussion, and conclusions: There is an argument for taking the risk of developing a condition into account, and we do this when we consider the risk of dying in the severity assessment. If severity is discounted according to risk, this will 'dilute' severity, depending on how well we are able to delineate the population, which is dependent on the current level of knowledge. This will potentially have a more far-reaching effect when considering primary prevention, potentially the de-prioritisation of effective preventive treatments in relation to acute, less-effective treatments. The risk arguments are dependent on which population is being assessed. If we focus on the whole population at risk, with T0 as the relevant population, this supports the risk argument. If we instead focus on the population of as-yet (at T0) unidentified individuals who will develop the condition at T1, risk will become irrelevant, and severity will not be risk sensitive. The strongest argument for time-sensitive severity (or for discounting future severity) is the future development of technology. On a short timescale, this will differ between different diagnoses, supporting individualised discounting. On a large timescale, a more general discounting might be acceptable. However, we need to also consider the systemic effects of allowing severity to be risk- and time-sensitive.

Should relational effects be considered in health care priority setting?

It is uncontroversial to claim that the extent to which health care interventions benefit patients is a relevant consideration for health care priority setting. However, when effects accrue to the individual patient, effects of a more indirect kind may accrue to other individuals as well, such as the patient's children, friends, or partner. If, and if so how, such relational effects should be considered relevant in priority setting is contentious. In this paper, we illustrate this question by using disease-modifying drugs for Alzheimer's disease as a case in point. The ethical analysis begins by sketching the so-called prima facie case for ascribing moral weight to relational effects and then moves on to consider a number of objections to it. We argue that, whereas one set of objections may be dismissed, there is another set of arguments that poses more serious challenges for including relational effects in priority setting.

Severity as a moral qualifier of malady.

The overarching aim of this article is to scrutinize how severity can work as a qualifier for the moral impetus of malady. While there is agreement that malady is of negative value, there is disagreement about precisely how this is so. Nevertheless, alleviating disease, injury, and associated suffering is almost universally considered good. Furthermore, the strength of a diseased person's moral claims for our attention and efforts will inevitably vary. This article starts by reflecting on what kind of moral impetus malady incites. We then analyze how severity may qualify this impetus. We do so by discussing the relationship between severity and need, well-being and disvalue, death, urgency, rule of rescue, and distributive justice. We then summarize our thoughts about severity as a moral qualifier. We conclude that severity is, and should continue to be seen, as a morally significant concept that deserves continued attention in the future.

Patient experience of implant loss after immediate breast reconstruction: An interpretative phenomenological analysis.

Immediate breast reconstruction (IBR) is an integral part of modern breast cancer treatment. Our aim was to investigate patient experience with implant loss after IBR by using interpretative phenomenological analysis (IPA). We conducted semi-structured interviews with eight informants. We analyzed data according to the IPA flexible seven-stage process and four main themes were developed: immediate breast reconstruction as the indisputable choice, a difficult experience, an altered body: redefining normality, and trying to cope. The experience of implant loss appears to affect women for many years and might overshadow some of the benefits of IBR.

Ethical aspects of the coordination of return-to-work among employees on sick leave due to common mental disorders: a qualitative study.

PURPOSE: Identify ethical issues that arise in the coordination of return-to-work (RTW) among employees on sick leave due to common mental disorders (CMDs). MATERIAL AND METHODS: 41 semi-structured individual interviews and one focus group interview with stakeholders (n = 46) involved in RTW: employees on sick leave due to CMDs, coordinators and physicians at primary health care centres, managers, representatives of the Swedish social insurance agency and occupational health services. A six-step thematic analysis focused on the ethical values and norms related to autonomy, privacy, resources and organization, and professional values. RESULTS: Five themes were identified: (1) autonomous decision-making versus the risk of taking over, (2) employee rights versus restrictions to self-determination, (3) respect for employee privacy versus stakeholders' interests, (4) risk of unequal inclusion due to insufficient organizational structure and resources, (5) risk of unequal support due to unclear professional roles and responsibilities. CONCLUSION: The main ethical issues are the risks of unequal access to and unequal support for the coordination of RTW. For the fair and equal provision of coordination, it is necessary to be transparent on how to prioritize the coordination of RTW for different patient groups, provide clarity about the coordinator's professional role, and facilitate ongoing boundary work between stakeholders. IMPLICATIONS FOR REHABILITATIONUnfair and arbitrary criteria for inclusion to the coordination of RTW implicate risks of unequal access for the employee on sick leave due to CMDs.Unclear professional roles and responsibilities among stakeholders in the coordination of RTW implicate risks of unequal support for the employee on sick leave due to CMDs.Coordination of RTW should be transparently prioritized on policy and organisational levels to secure fair and equal inclusion.The coordinator's professional role should be clearly defined to facilitate boundary work between stakeholders and improve the competence around the coordination of RTW.

Caregiver perspectives on patient capacities and institutional pathways to person centered forensic psychiatric care.

The ethical discourse surrounding patients' agential capacities, vis-à-vis their active participation in shared decision-making (SDM) in forensic psychiatric (FP) contexts, is an unexplored area of inquiry. The aim of this paper is to explore caregivers' perceptions of patient agential capacities and institutional pathways and barriers to person centered care (PCC) in the context of FP. Following an exploratory qualitative design, we conducted eight semi-structured interviews with hands-on caregivers at an in-patient FP facility in Sweden. A deductive framework method of analysis was employed, and four themes emerged: "Fundamental Variability in Patient Capacity", "Patient Participation: Narration or Compliance?", "Antagonism Rooted in Power Struggles", and "System Structure Thwarts Patient Release". While the results generally paint a bleak picture for the possibility of a person-centered FP care, we describe a constrained version of PCC with high-level SDM dynamics which promotes a certain degree of patient empowerment while allowing care strategies, within set restrictions, to promote patient adherence and treatment progress.

Integrating Empirical Analysis and Normative Inquiry in Health Technology Assessment: The Values in Doing Assessments of Health Technologies Approach.

Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (O'Rourke et al. [2020, International Journal of Technology Assessment in Health Care 36, 187-90]). HTA is, then, where facts and values meet. But how, where, and when do facts and values meet in HTA? Currently, HTA is usually portrayed as a sequential process, starting with empirical analysis (assessment), followed by a deliberation on the implications of the findings for a judgment of a health technology's value (appraisal). In this paper, we will argue that in HTA, empirical analysis and normative inquiry are much more closely entwined. In fact, as we hope to show, normative commitments act as an indispensable guide for the collection and interpretation of empirical evidence. Drawing on policy sciences, we will suggest a concrete methodology that can help HTA practitioners to integrate empirical analysis and normative inquiry in a transparent way. The proposed methodology can be conceived as a concrete means for conducting a scoping exercise in HTA. Moreover, it offers a distinct way of giving stakeholders a structural and constructive role in HTA. This paper outlines the approach developed by the values in doing assessments of health technologies project, a project funded by the Erasmus+ program (contract number 2018-1-NL01-KA203-038960), which is the European Union's program to support education, training, youth, and sport in Europe. The project has resulted in an E-learning course, an accompanying handbook, and a consensus statement, all freely available from the project's website www.validatehta.eu.

Moral and exhausting distress working in the frontline of COVID-19: a Swedish survey during the first wave in four healthcare settings.

OBJECTIVES: To describe the prevalence and sources of experienced moral stress and anxiety by Swedish frontline healthcare staff in the early phase of COVID-19. DESIGN: Cross-sectional survey, quantitative and qualitative. PARTICIPANTS AND SETTING: 1074 healthcare professionals (75% nurses) in intensive, ward-based, primary and municipal care in one Swedish county. MEASURES: A study-specific closed-ended and an open-ended questionnaire about moral stress and the Generalised Anxiety Disorder 7-item scale measuring anxiety, followed by an open question about anxiety. FINDINGS: Moral stress was experienced by 52% of respondents and anxiety by 40%. Moral stress in concern for others attributed to institutional constraints comprised experiences of being deprived of possibilities to respond to humane and professional responsibility. Staff experienced being restricted in fulfilling patients' and families' need for closeness and security as well as being compelled to provide substandard and inhumane care. Uncertainty about right and good, without blame, was also described. However, a burdensome guilt also emerged as a moral distress, blaming oneself. This comprised feeling complicit in the spread of COVID-19, inadequacy in care and carrying patients' suffering. Staff also experienced an exhausting distress as a self-concern in an uncontrollable work situation. This comprised a taxing insecurity by being in limbo, being alone and fear of failing, despair of being deprived control by not being heard; unable to influence; distrusting management; as well as an excessive workload. CONCLUSIONS: We have not only contributed with knowledge about experiences of being in the frontline of COVID-19, but also with an understanding of a demarcation between moral stress/distress as a concern for patients and family, and exhausting distress in work situation as self-concern. A lesson for management is that ethics support should first include acknowledgement of self-concern and mitigation of guilt before any structured ethical reflection. Preventive measures for major events should focus on connectedness between all parties concerned, preventing inhumane care and burn-out.

Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force.

OBJECTIVES: Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR-The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap. METHODS: The joint Task Force consisted of 15 members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to 2 rounds of peer review. RESULTS: A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation. CONCLUSIONS: The guidance and the checklist contain a series of questions, grouped by 6 phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.

An analysis of how health systems integrated priority-setting in the pandemic planning in a sample of Latin America and the Caribbean countries.

BACKGROUND: Latin America and the Caribbean (LAC) are among those regions most affected by the COVID-19 pandemic worldwide. The COVID-19 pandemic has strained health systems in the region. In this context of severe healthcare resource constraints, there is a need for systematic priority-setting to support decision-making which ensures the best use of resources while considering the needs of the most vulnerable groups. The aim of this paper was to provide a critical description and analysis of how health systems considered priority-setting in the COVID-19 response and preparedness plans of a sample of 14 LAC countries; and to identify the associated research gaps. METHODS: A documentary analysis of COVID-19 preparedness and response plans was performed in a sample of 14 countries in the LAC region. We assessed the degree to which the documented priority-setting processes adhered to established quality indicators of effective priority-setting included in the Kapiriri and Martin framework. We conducted a descriptive analysis of the degree to which the reports addressed the quality parameters for each individual country, as well as a cross-country comparison to explore whether parameters varied according to independent variables. RESULTS: While all plans were led and supported by the national governments, most included only a limited number of quality indicators for effective priority-setting. There was no systematic pattern between the number of quality indicators and the country's health system and political contexts; however, the countries that had the least number of quality indicators tended to be economically disadvantaged. CONCLUSION: This study adds to the literature by providing the first descriptive analysis of the inclusion of priority-setting during a pandemic, using the case of COVID-19 response and preparedness plans in the LAC region. The analysis found that despite the strong evidence of political will and stakeholder participation, none of the plans presented a clear priority-setting process, or used a formal priority-setting framework, to define interventions, populations, geographical regions, healthcare setting or resources prioritized. There is need for case studies that analyse how priority-setting actually occurred during the COVID-19 pandemic and the degree to which the implementation reflected the plans and the parameters of effective priority-setting, as well as the impact of the prioritization processes on population health, with a focus on the most vulnerable groups.

Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force.

OBJECTIVES: Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR-The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap. METHODS: The joint Task Force consisted of fifteen members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to two rounds of peer review. RESULTS: A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation. CONCLUSIONS: The guidance and the checklist contain a series of questions, grouped by six phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.

Learning and practicing more value-reflective, problem-setting health technology assessment: experiences and lessons from the VALIDATE project.

OBJECTIVES: To conduct a formative evaluation of applying the VALIDATE approach in practice by (i) assessing how students appreciated the e-learning course, (ii) exploring how, for what purposes and with what outcomes the acquired VALIDATE competences subsequently were used in internships in different institutional contexts, and how this was shaped by these contexts, and (iii) what this shows on real-world use of VALIDATE. METHODS: Comparative discussion of experiences of applying the VALIDATE approach via a semistructured survey and oral feedback from e-course students; final reports on internships in health technology assessment (HTA) practice, followed by semistructured interviews with interns and supervisors to complement and interpret results. RESULTS: All students considered the VALIDATE approach an enlightening and important addition to current HTA knowledge, especially regarding understanding the relation between empirical analysis and normative inquiry, identifying policy relevant questions and using the method of reconstructing interpretive frames for scoping. The latter appeared intellectually challenging and requiring some prior HTA knowledge. The use the VALIDATE approach in practice shows that interns productively redefined the HTA problem, based on appreciation of different stakeholders' definition of the issue; they experienced constraints from retrieving all relevant perspectives from existing literature as well as from institutional rules and routines. CONCLUSIONS: Some challenges in applying the VALIDATE approach deserve attention for its future use: currently used research approaches often assume a problem as "given"; and the data needed on different perspectives is often not reported in scientific literature. Finally, data gathering on and evaluation of value dimensions was experienced as challenging.

Withdrawing or withholding treatments in health care rationing: an interview study on ethical views and implications.

BACKGROUND: When rationing health care, a commonly held view among ethicists is that there is no ethical difference between withdrawing or withholding medical treatments. In reality, this view does not generally seem to be supported by practicians nor in legislation practices, by for example adding a 'grandfather clause' when rejecting a new treatment for lacking cost-effectiveness. Due to this discrepancy, our objective was to explore physicians' and patient organization representatives' experiences- and perceptions of withdrawing and withholding treatments in rationing situations of relative scarcity. METHODS: Fourteen semi-structured interviews were conducted in Sweden with physicians and patient organization representatives, thematic analysis was used. RESULTS: Participants commonly express internally inconsistent views regarding if withdrawing or withholding medical treatments should be deemed as ethically equivalent. Participants express that in terms of patients' need for treatment (e.g., the treatment's effectiveness and the patient's medical condition) withholding and withdrawing should be deemed ethically equivalent. However, in terms of prognostic differences, and the patient-physician relation and communication, there is a clear discrepancy which carry a moral significance and ultimately makes withdrawing psychologically difficult for both physicians and patients, and politically difficult for policy makers. CONCLUSIONS: We conclude that the distinction between withdrawing and withholding treatment as unified concepts is a simplification of a more complex situation, where different factors related differently to these two concepts. Following this, possible policy solutions are discussed for how to resolve this experienced moral difference by practitioners and ease withdrawing treatments due to health care rationing. Such solutions could be to have agreements between the physician and patient about potential future treatment withdrawals, to evaluate the treatment's effect, and to provide guidelines on a national level.