Behovet av omdiagnostisering av patienter med olika tillstånd väcker etiska frågeställningar. I denna korta etiska analys som genomförts på uppdrag av Nationellt programområde för psykisk hälsa lyfts ett antal etiska frågeställningar kopplade till omdiagnostisering. Analysen går inte i på detaljer kring vem som ska genomföra en sådan, inte heller var i hälso- och sjukvårdssystemet det bäst sker – eftersom detta beror på vilket specifikt diagnosområde det handlar om.

Analysen landar i följande övergripande slutsatser:

• Generellt är diagnossättande förknippat med etiska principer om att göra gott(genom att ge underlag för att patienten får rätt insatser) och icke-skada(genom att förhindra uppkomst av risker och vårdskada).
• Vårdgivaren har ett etiskt ansvar för att patienten får rätt diagnos (ellerdiagnoser). I detta ansvar ingår att också överväga vilka konsekvenserdiagnostisering och omdiagnostisering får ur ett vidare perspektiv –exempelvis om det kan innebära risker för andra individer.
• Patientens önskemål om omdiagnostisering kan vara en utgångspunkt, meninte avgöra frågan om huruvida en omdiagnostisering bör ske – eller resultatetav en sådan omdiagnostisering.
• Det finns skäl att skilja mellan situationer där skälet för omdiagnostisering äratt patienten i nuläget har en diagnos som negativt påverkar tillgången tillbehovsbaserade insatser eller riskerar att leda till vårdskada – och de fall därskälet för omdiagnostisering snarare drivs av att diagnosen inte längre äraktuell och snarare har påverkan på patientens upplevelse eller innebär hinderi patientens övriga liv.
• I det första fallet finns det generellt skäl att prioritera omdiagnostisering högreän i det andra fallet – beroende på hur stora det potentiella konsekvensernaför patienten är. I det andra fallet beror det på hur livet i stort påverkas men vidmindre allvarlig påverkan finns det generellt skäl att prioritera diagnostiseringhögre än omdiagnostisering.

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.

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 persons 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.

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 patients 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 Alzheimers 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.

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 T-0 as the relevant population, this supports the risk argument. If we instead focus on the population of as-yet (at T-0) unidentified individuals who will develop the condition at T-1, 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.

One way to compare health care needs and outcomes on common scales is by estimating the strength of preferences or willingness-to-pay (WTP). The aim of this study was to review directly measured preference values and WTP estimates for health states treated by plastic surgery. The included articles had to meet the criteria defined in the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research type). Relevant databases were searched using predetermined strings. Data were extracted in a standardised manner. Included studies were appraised according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach for rating the importance of outcomes. In total, 213 abstracts were retrieved. Of these, 179 did not meet the inclusion criteria and were excluded, leaving 34 studies in the review. The risk of bias was considered moderate in four studies and serious in the rest. The overall certainty of evidence for directly measured preference values and WTP estimates for health states treated by plastic surgery is low (Grade circle minus circle minus OO). The lowest preference scores were generally elicited for facial defects/anomalies and the highest for excess skin after massive weight loss. Scientific knowledge about preferences and the resulting health gains might play an essential role in deciding which procedures should be considered for public funding or rather rationed within the system. Better quality studies are required to allow for such applications.

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 countrys 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.

The ethical discourse surrounding patients agential capacities, vis-a-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.

Purpose To identify facilitators of and barriers to the coordination of return-to-work between the primary care services, the employee, and the employers from the perspective of coordinators and employees on sick leave due to common mental disorders (CMDs). Material and methods Descriptive qualitative study. Semi-structured interviews were conducted with eighteen coordinators and nine employees on sick leave due to CMDs. The Consolidated Framework for Implementation Research (CFIR) was used as a starting point for the interview guides and in the thematic analysis of data. Results The results show facilitators and barriers related to the CFIR domains "intervention characteristics," "outer setting," "inner setting," and "characteristics of individuals." Positive attitudes, an open dialogue in a three-party meeting, and a common ground for the sick leave process at the primary care centre facilitated coordination, while an unclear packaging, conflicts at the employees workplace, and a lack of team-based work were examples of barriers. Conclusion The results indicate a need for the detailed packaging of coordination; formalization of coordinators qualifications and levels of training; and acknowledgement of the role of organizational factors in the implementation of coordination. This is important to further develop and evaluate the efficacy of coordination.

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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.

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.

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 coordinators professional role, and facilitate ongoing boundary work between stakeholders.

Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (ORourke 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 technologys 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 Unions 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 projects website www.validatehta.eu.

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.

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.

Prioritization of COVID-19 vaccines is one of the most relevant topics in the current pandemic emergency. Prioritization decisions are political decisions that are value-laden, and as such of ethical nature. Despite the clear political and ethical nature of this topic, prioritization decisions are often interpreted and presented as scientific decisions. The aim of this article is twofold. First, we aim to show critical points that characterize certain pandemic vaccination plans from the ethical viewpoint using four dimensions (problem definitions, incorporation of different perspectives, context, and specification). The four dimensions were drawn from findings of the European project "VALIDATE" (VALues In Doing Assessments of healthcare TEchnologies", https://validatehta.eu). Second, we aim to reframe the issue about prioritization itself in the light of the four dimensions mentioned. Our conclusion is that policy-problem definitions, incorporation of different perspectives, contextual considerations and specification of moral principles seem to be common critical points of some vaccination plan documents. The European project "VALIDATE" seems to be able to provide a useful and profitable approach to address many of these critical points.

Priority setting represents an even bigger challenge during public health emergencies than routine times. This is because such emergencies compete with routine programmes for the available health resources, strain health systems and shift health-care attention and resources towards containing the spread of the epidemic and treating those that fall seriously ill. This paper is part of a larger global study, the aim of which is to evaluate the degree to which national COVID-19 preparedness and response plans incorporated priority setting concepts. It provides important insights into what and how priority decisions were made in the context of a pandemic. Specifically, with a focus on a sample of 18 African countries pandemic plans, the paper aims to: (1) explore the degree to which the documented priority setting processes adhere to established quality indicators of effective priority setting and (2) examine if there is a relationship between the number of quality indicators present in the pandemic plans and the countrys economic context, health system and prior experiences with disease outbreaks. All the reviewed plans contained some aspects of expected priority setting processes but none of the national plans addressed all quality parameters. Most of the parameters were mentioned by less than 10 of the 18 country plans reviewed, and several plans identified one or two aspects of fair priority setting processes. Very few plans identified equity as a criterion for priority setting. Since the parameters are relevant to the quality of priority setting that is implemented during public health emergencies and most of the countries have pre-existing pandemic plans; it would be advisable that, for the future (if not already happening), countries consider priority setting as a critical part of their routine health emergency and disease outbreak plans. Such an approach would ensure that priority setting is integral to pandemic planning, response and recovery.

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 treatments effectiveness and the patients 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 treatments effect, and to provide guidelines on a national level.

Intensive research is carried out to develop a disease-modifying drug for Alzheimers disease (AD). The development of drug candidates that reduce Ass or tau in the brain seems particularly promising. However, these drugs target people at risk for AD, who must be identified before they have any, or only moderate, symptoms associated with the disease. There are different strategies that may be used to identify these individuals (eg, population screening, cascade screening, etc). Each of these strategies raises different ethical challenges. In this paper, we analyse these challenges in relation to the risk stratification for AD necessary for using these drugs. We conclude that the new drugs must generate large health benefits for people at risk of developing AD to justify the ethical costs associated with current risk stratification methods, benefits much larger than current drug candidates have. This conclusion raises a new set of ethical questions that should be further discussed.

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Vem ska få tillgång till intensivvård om platssituationen blir ansträngd? Kommer respiratorerna att räcka till, och om inte, hur ska bristen hanteras? Allt sedan covid-19 pandemin drabbade Sverige har media, genom daglig rapportering, satt prioriteringar inom hälso- och sjukvården på agendan för allmänheten. Men det är inte bara media som kommunicerar till medborgarna, reaktionerna från allmänheten har också varit intensiva i tidningarnas kommentarsfält på sociala medier. Att studera uppfattningar om prioriteringar är inte sällan en utmaning, då ämnet upplevs som känsligt. Att göra studier av nätet, i form av netnografi, har gett en möjlighet att få inblick i vilka reaktioner på prioritering i vården under covid-19 som kan finnas där. De kommentarer som studerats är hämtade från 18 artiklar i våra största dagstidningar, artiklar som relaterar till Socialstyrelsens nationella principer för intensivvård under pandemin. Resultatet bygger på 1096 kommentarer, som postats av 645 användare, och som analyserats såväl kvalitativt som kvantitativt.

Kommentarerna kan delas in i positiva respektive negativa reaktioner på Socialstyrelsens prioriteringsprinciper för intensivvård. Här finns kommentarer som handlar om att principer inte skulle behövas om inte vården nedrustats eller om människor följde Folkhälsomyndighetens restriktioner. Oro uttrycks för att prioriteringar enbart kommer att baseras på kronologisk ålder, eller att äldre skulle få en lägre prioritet enbart av samhällsekonomiska skäl. Ungefär lika stor del av materialet består av positiva kommentarer, t ex när det gäller biologisk ålder som prioriteringsgrund. En positiv reaktion gäller också öppenheten kring vilka prioriteringar som ska råda, vilket anses ge en viktig påminnelse om allvaret i situationen.

Ett annat syfte har varit att studera interaktionen på nätet när principerna diskuteras. De som har kommenterat interagerar genom att förklara för varandra vad som uppfattas som missuppfattningar. De kritiserar varandras inlägg men uppmuntrar också varandra genom att försöka skapa lugn, de utmanar varandra med prioriteringsdilemman samt diskuterar känslan av ett ställningskrig gällande prioriteringar i form av ”vi-och-dem”.

Denna studie är ett axplock av reaktioner i sociala medier i en tidig fas av pandemin. I enlighet med vad som anges i Världshälsoorganisationens riktlinjer för kriskommunikation understryker resultatet värdet för beslutsfattare av att vara medvetna om debatten i sociala medier. En sådan debatt kan informera om missförstånd som behöver förtydligas, men också lyfta fram relevanta farhågor om hur prioriteringsprinciper kan tillämpas felaktigt i praktiken. Att anta att sociala medier bara är ett forum för missnöje är en alltför grov förenkling. De kan likväl ses som plattformar där åsikter utmanas och argument formas om vad som är rättvisa grunder för resursfördelning i vården.

In recent years, the issue of accepting a higher cost per health improvement for orphan drugs has been the subject of discussion in health care policy agencies and the academic literature. This article aims to provide an analysis of broadly egalitarian arguments for and against accepting higher costs per health improvement. More specifically, we aim to investigate which arguments one should agree upon putting aside and where further explorations are needed. We identify three kinds of arguments in the literature: considerations of substantial equality, formal equality, and opportunity cost. We argue that considerations of substantial equality do not support higher costs per health improvement orphan drugs, even if such considerations are considered valid. On the contrary, arguments of formal equality may support accepting a higher cost per health improvement for orphan drugs. However, in order to do so, a number of both normative and empirical issues must be resolved; these issues are identified in the article. For instance, it must be settled to what extent the opportunity cost in terms of foregone health for other patients is acceptable in order to uphold formal equality. We conclude that certain arguments can be set aside, and future focus should be put on the unresolved normative and empirical issues related to formal equality and opportunity cost.

STUDY QUESTION: What are the costs of live donor uterus transplantation in a European setting? SUMMARY ANSWER: The total costs for preoperative investigations, including IVF, and live donor uterus transplantation including postoperative costs for 2 months, were calculated to be (sic) 74 564 (mean), with the costs of recipient being somewhat higher than for donor and the cost components of total costs distributed between sick leave (25.7%), postoperative hospitalization (17.8%), surgery (17.1%), preoperative investigations (15.7%), anaesthesia (9.7%), drugs (7.8%), tests after surgery (4.0%) and for re-hospitalization (2.2%). WHAT IS KNOWN ALREADY: Uterus transplantation has proved to be successful by demonstrations of live births, both after live donor and deceased donor procedures. The transplantation is considered as a complex and expensive infertility treatment. There exist no analyses of costs involved in uterus transplantation. STUDY DESIGN, SIZE, DURATION: This prospective cohort study included nine uterus transplantations procedures, performed in Sweden in 2013. Study duration of this health economic study included 6-12 months of pre-transplantation investigations and the time interval from transplantation to 2 months after. PARTICIPANTS/MATERIALS, SETTING, METHODS: Nine triads of uterus recipient, partner of recipient and uterus donor participated. All prospective recipients were in stable relationships and performed IVF with their partners before transplantation. The nine donors were relatives or family friends. The recipients and donors underwent pre-transplantation investigations with imaging, laboratory tests and psychological/medical screening prior to transplantation. Transplantation was by laparotomy in both donor and recipient. Standard immunosuppression and postoperative medication were used. After discharge from the hospital, the recipients were followed frequently with laboratory tests and examinations. MAIN RESULTS AND THE ROLE OF CHANCE: The mean costs for preoperative investigations, including IVF, and live donor uterus transplantation with postoperative costs for 2 months, were calculated to be (sic)74 564 (range (sic) 50 960-(sic)99 658), from a societal perspective. The four largest components were cost of sick leave (sic) 19 164), cost of postoperative hospitalization (sic)13 246), surgery cost (sic)12 779) and costs for preoperative investigations, including IVF (sic) 11 739). Smaller components were costs for anaesthesia (sic) 7207), costs for drugs (sic) 5821), costs for post-surgical tests (sic) 2985) and costs for re-hospitalization (sic)1623). The costs of the recipient (sic) 42 984) were somewhat higher than the costs of the donor (sic) 31 580), but in terms of costs, they should be viewed as one entity. By using a health care perspective, excluding cost for productivity loss, the total costs would be reduced by 26%. LIMITATIONS, REASONS FOR CAUTION: A limitation is the restricted sample size and that this is in the experimental, clinical stage of development. WIDER IMPLICATIONS OF THE FINDINGS: The results provide the first information concerning the costs for pre-transplantation investigations and uterus transplantation procedures with postoperative follow-up. We consider the total estimate to be in the higher interval, because of the extensive research protocol. It is likely that the cost of live donor uterus transplantation will vary between countries and that the costs will be lower in a future clinical setting.

Background Healthcare systems are increasingly struggling with resource constraints, given demographic changes, technological development, and citizen expectations. The aim of this article is to normatively analyze different suggestions regarding how publicly financed plastic surgery should be delineated in order to identify a well-considered, normative rationale. The scope of the article is to discuss general principles and not define specific conditions or domains of plastic surgery that should be treated within the publicly financed system. Methods This analysis uses a reflective equilibrium approach, according to which considered normative judgements in one area should be logically and argumentatively coherent with considered normative judgements and background theories at large within a system. Results and conclusions In exploring functional versus non-function conditions, we argue that it is difficult to find a principled reason for anabsolutepriority of functional conditions over non-functional conditions. Nevertheless, functional conditions are relatively easier to establish objectively, and surgical intervention has a clear causal effect on treating a functional condition. Considering non-functional conditions that require plastic surgery [i.e., those related to appearance or symptomatic conditions (not affecting function)], we argue that the patient needs to experience some degree of suffering (and not only a preference for plastic surgery), which must be validated in some form by the healthcare system. This validation is required for both functional and non-functional conditions. Functional conditions are validated by distinguishing between statistically normal and abnormal functioning. Similarly, for non-functional conditions, statistical normality represents a potential method for distinguishing between what should and should not be publicly funded. However, we acknowledge that such a concept requires further development.

Objectives. There is no consensus on who might be qualified to conduct ethical analysis in the field of health technology assessment (HTA). Is there a specific expertise or skill set for doing this work? The aim of this article is to (i) clarify the concept of ethics expertise and, based on this, (ii) describe and specify the characteristics of ethics expertise in HTA. Methods. Based on the current literature and experiences in conducting ethical analysis in HTA, a group of members of the Health Technology Assessment International (HTAi) Interest Group on Ethical Issues in HTA critically analyzed the collected information during two ace-to-face workshops. On the basis of the analysis, working definitions of "ethics expertise" and "core competencies" of ethics experts in HTA were developed. This paper reports the output of the workshop and subsequent revisions and discussions online among the authors. Results. Expertise in a domain consists of both explicit and tacit knowledge and is acquired by formal training and social learning. There is a ubiquitous ethical expertise shared by most people in society; nevertheless, some people acquire specialist ethical expertise. To become an ethics expert in the field of HTA, one needs to acquire general knowledge about ethical issues as well as specific knowledge of the ethical domain in HTA. The core competencies of ethics experts in HTA consist of three fundamental elements: knowledge, skills, and attitudes. Conclusions. The competencies described here can be used by HTA agencies and others involved in HTA to call attention to and strengthen ethical analysis in HTA.

In a recent extended essay, philosopher Daniel Hausman goes a long way towards dismissing severity as a morally relevant attribute in the context of priority setting in healthcare. In this response, we argue that although Hausman certainly points to real problems with how severity is often interpreted and operationalised within the priority setting context, the conclusion that severity does not contain plausible ethical content is too hasty. Rather than abandonment, our proposal is to take severity seriously by carefully mapping the possibly multiple underlying accounts to well-established ethical theories, in a way that is both morally defensible and aligned with the term’s colloquial uses.

In a recent extended essay, philosopher Daniel Hausman goes a long way towards dismissing severity as a morally relevant attribute in the context of priority setting in healthcare. In this response, we argue that although Hausman certainly points to real problems with how severity is often interpreted and operationalised within the priority setting context, the conclusion that severity does not contain plausible ethical content is too hasty. Rather than abandonment, our proposal is to take severity seriously by carefully mapping the possibly multiple underlying accounts to well-established ethical theories, in a way that is both morally defensible and aligned with the term’s colloquial uses.

Den etiska analys som presenteras i rapporten rör sänkt åldersgräns för underlivskirurgi vid könsbekräftande vård från 18 till 15 år och har skett på uppdrag av Socialstyrelsen. I analysen berörs denna fråga från följande perspektiv: risk/nytta, autonomi och rättvisa/jämlikhet. Analysen landar i en försiktighetsprincip med att erbjuda patienter från 15 år underlivskirurgi baserat på följande huvudargument.

Det rör sig om irreversibla ingrepp med stora konsekvenser för den person som genomgår dessa, där ett svagt evidensläge för en äldre population ska överföras till en yngre population. Utfallets är starkt beroende av personens upplevda könsidentitet vilket skapar större osäkerhet för en population som är under kognitiv och emotionell utveckling. Vårdbehovets karaktär, där ett nödvändigt (men inte tillräckligt) villkor är att de fysiologiska ingreppen görs i den mån personen önskar sig dessa och inte ges på rekommendation av vårdpersonalen – skapar en större osäkerhet. Det lidande och de problem som uppkommer på grund av fördröjd behandling förefaller i många fall vara reversibelt (förutom när det gäller suicid), och det finns osäkerheter kring om suicid på grund av fördröjd behandling (som förefaller vara ett av huvudargumenten för tidigarelagd behandling) förekommer och i så fall i vilken utsträckning. Skulle det visa sig att det finns en sådan koppling bör det övervägas om försiktighetsprincipen snarare talar för att erbjuda behandling. Det saknas studier kring om risken för ånger efter underlivskirurgi skulle skilja sig för en yngre åldersgrupp, men det kan finnas faktorer som skulle kunna tala för det.

Detta utesluter inte att det i individuella fall kan anses berättigat att erbjuda underlivskirurgi i undantagsfall, särskilt om personerna fysiologiskt och mognadsmässigt närmar sig vad som generellt gäller för personer som är 18 år.

Eftersom det är ett oavvisligt krav för underlivskirurgi i detta fall att personen kan ge sitt informerade samtycke, finns det skäl att ha en lägsta åldersgräns från vilket personer generellt kan anses har tillräcklig förmåga att kunna ge ett sådant samtycke. Trots att det är svårt att sätta upp generella åldersgränser för autonom förmåga, så förefaller 15 år vara en rimlig gräns givet att det är den ålder i vilken personer tillåts självständigt ge sitt informerade samtycke till att delta i forskningsprojekt. Restriktivitet med att erbjuda personer under 18 år tillgång till underlivskirurgi utifrån ovanstående risk/nytta-bedömning, implicerar att det bör ställas höga krav på autonom förmåga för att tillåta det i individuella fall för personer under 18 år. Utifrån behovet att stärka evidensen för behandling av den yngre populationen och som en kontrollfunktion finns det skäl att sådan behandling endast ges inom ramen för kliniska studier som genomgått etikprövning vid Etikprövningsmyndigheten.

Generellt gäller att försiktighetsprincipen implicerar en större försiktighet ju yngre personerna är för att gradvis kunna minska ju mer personerna närmar sig 18-årsgränsen.

With healthcare systems under pressure from scarcity of resources and ever-increasing demand for services, difficult priority setting choices need to be made. At the same time, increased attention to patient involvement in a wide range of settings has given rise to the idea that those who are eventually affected by priority setting decisions should have a say in those decisions. In this paper, we investigate arguments for the inclusion of patient representatives in priority setting bodies at the policy level. We find that the standard justifications for patient representation, such as to achieve patient-relevant decisions, empowerment of patients, securing legitimacy of decisions, and the analogy with democracy, all fall short of supporting patient representation in this context. We conclude by briefly outlining an alternative proposal for patient participation that involves patient consultants.

Priority setting in health care is ubiquitous and health authorities are increasingly recognising the need for priority setting guidelines to ensure efficient, fair, and equitable resource allocation. While cost-effectiveness concerns seem to dominate many policies, the tension between utilitarian and deontological concerns is salient to many, and various severity criteria appear to fill this gap. Severity, then, must be subjected to rigorous ethical and philosophical analysis. Here we first give a brief history of the path to todays severity criteria in Norway and Sweden. The Scandinavian perspective on severity might be conducive to the international discussion, given its long-standing use as a priority setting criterion, despite having reached rather different conclusions so far. We then argue that severity can be viewed as a multidimensional concept, drawing on accounts of need, urgency, fairness, duty to save lives, and human dignity. Such concerns will often be relative to local mores, and the weighting placed on the various dimensions cannot be expected to be fixed. Thirdly, we present what we think are the most pertinent questions to answer about severity in order to facilitate decision making in the coming years of increased scarcity, and to further the understanding of underlying assumptions and values that go into these decisions. We conclude that severity is poorly understood, and that the topic needs substantial further inquiry; thus we hope this article may set a challenging and important research agenda.

Immediate breast reconstruction (IBR) combined with post-mastectomy radiotherapy (PMRT) is associated with an increased risk for complications. Here, we analyse whether IBR combined with PMRT is ethically acceptable. We employ normative analysis following reflective equilibrium and the principles of Beauchamp and Childress: non-maleficence, beneficence, autonomy, and justice. From the perspective of beneficence and non-maleficence, we can choose either IBR or PMRT according to documented risks and complications, delayed autologous breast reconstruction with corresponding benefits but less risk for complications, or even no reconstruction, which for some women, might be equally beneficial. In such a situation, given the level of severity associated with lacking a breast after mastectomy, IBR violates the principles of beneficence and non-maleficence. To deny an IBR in the context of PMRT does not violate the principle of autonomy as it is normally interpreted in the healthcare system, not even when patient-centred care is taken into consideration. Moreover, there is a risk that the decision of the patient will be affected by heuristics, optimism bias, and surgeon bias. IBR in the context of PMRT could be in conflict with the principle of justice, as it could lead to displacement of care for other patient groups. Furthermore, an acceptable level of cost effectiveness should be low, given that living without a breast is a condition of moderate severity. In conclusion, given the current knowledgebase and established ethical norms within the healthcare system, we find strong ethical reasons not to offer IBR when PMRT is expected.

I skrivande stund pågår det intensiv forskning för att få fram ett sjukdomsmodifierande läkemedel mot Alzheimers sjukdom (AD). Vid introduktion av sådana läkemedel kommer en rad etiskt svåra frågor kring screening och prioriteringar av vårdens resurser, att aktualiseras. Föreliggande rapport behandlar dessa frågor.

Trots att de nya läkemedlens effekt sannolikt har en påverkan på närstående till personer med AD så är det vår bedömning att den svenska etiska plattformen inte lämnar något utrymme för sådan hänsyn. Det finns också skäl att vara särskilt uppmärksam på utsträckningen i vilken de surrogatmått som används i de kliniska studierna faktiskt är av klinisk relevans.

När det gäller att väga samman patientnytta som tillfaller olika individer är det vår bedömning att plattformen inte tillåter aggregering av patientnytta på ett sådant sätt. Det innebär att det faktum att personer med AD utgör en stor patientgrupp utgör i sig inte ett skäl för högre prioritet då effekten skall bedömas med avseende på hur den tillfaller varje enskild individ. I ett scenario där budgetpåverkan blir så stor att man behöver prioritera inom gruppen så tycks det saknas för prioriteringar relevanta kriterier.

Manifest AD är ett tillstånd med mycket stor svårighetsgrad. Men eftersom de nya läkemedlen siktar in sig på den prekliniska eller fasen i vilken patienter har en lindrig kognitiv störning så bör svårighetsgraden av tillståndet viktas ned med avseende på sannolikheten att faktiskt insjukna i AD. Tillståndets svårighetsgrad blir därmed olika för läkemedel som siktar på den prekliniska fasen, de som siktar på fasen med lindrig kognitiv störning och de som siktar på kliniska stadier av AD. Eftersom personer med AD kan ha sämre förutsättningar än andra patientgrupper att kommunicera sina behov bör de beaktas särskilt. Det innebär dock inte någon högre prioritet utan en markering att personer med AD har samma rätt till hälso- och sjukvård som andra grupper med liknande behov.

Populationsscreening för AD är förknippat med flera problem. Det finns generella problem med screening ur exempelvis autonomisynpunkt. Men det finns också problem som relaterar till att nuvarande metoder för riskstratifiering är så opålitliga vilket i sin tur resulterar i falska negativa (med risk för underbehandling) och falska positiva (med risk för överbehandling). Screening i fasen då patienten har en lindrig kognitiv störning har (förutom de problem som kommer med populationsscreening) problem med ojämlikhet och godtycke. När den kliniska fasen inträder har poängen med screening gått förlorad: ju senare identifikation, desto mindre potentiella behandlingsfördelar jämfört med vanlig diagnostik som den går till idag.

Det är vår sammantagna bedömning att de nya läkemedlen måste generera stora hälsovinster för personer som riskerar att insjukna i AD för att berättigas allmän finansiering och för att rättfärdiga de etiska kostnader som kommer med de nuvarande diagnostiska metoderna.

Background: When healthcare personnel take part in military operations in combat zones, they experience ethical problems related to dual loyalties, that is, when they find themselves torn between expectations of doing caring and military tasks, respectively. Aim: This article aims to describe how Swedish healthcare personnel reason concerning everyday ethical problems related to dual loyalties between care and military tasks when undertaking healthcare in combat zones. Design: Abductive qualitative design. Participants and research context: Individual interviews with 15 registered nurses and physicians assigned for a military operation in Mali. Ethical considerations: The participants signed up voluntarily, and requirements for informed consent and confidentiality were met. The research was approved by the Regional Ethics Review Board in Gothenburg (D no. 816-14; 24 November 2014). Findings: Three main categories emerged: reasons for not undertaking combat duties, reasons for undertaking combat duties and restricted loyalty to military duties, and 14 subcategories. Reasons for not undertaking combat duties were that it was not in their role, not according to ethical codes or humanitarian law or a breach towards patients. Reasons for undertaking combat duties were that humanitarian law does not apply or has to be treated pragmatically or that it is a case of force protection. Shortage of resources and competence were reasons for both doing and not doing military tasks. Under some circumstances, they could imagine undertaking military tasks: when under threat, if unseen or if not needed for healthcare duties. Discussion/conclusion: These discrepant views suggest a lack of a common view on what is ethically acceptable or not, and therefore we suggest further normative discussion on how these everyday ethical problems should be interpreted in the light of humanitarian law and ethical codes of healthcare personnel and following this, further training in ethical reflection before going on military operations.

Introduction Diagnoses related to common mental disorders such as anxiety, depression, adjustment disorders and stress-related disorders are one of the leading causes of long-term sick leave for both women and men in Organisation for Economic Co-operation and Development countries. To increase the rate of return-to-work workplace involvement in a coordinated return-to-work process has been included in recent best practice guidelines. This form of cooperation is a complex process, involving political structures and a wide range of stakeholders. The studys first aim is to describe facilitators and barriers to the coordination of return-to-work from the perspectives of: (A) employees on sick leave due to common mental disorders, (B) employers, (C) rehabilitation coordinators, (D) physicians and (E) other stakeholders. The second aim is to identify ethical issues that arise in the coordination of return-to-work and analyse how these can be resolved. Methods and analysis The study has a qualitative design using interviews with employees on sick leave due to common mental disorders, employers, rehabilitation coordinators, physicians and other stakeholders. The study is conducted in the Swedish primary healthcare. Employees, employers and rehabilitation coordinators are recruited via primary healthcare centres. Rehabilitation coordinators receive information about the study and those who consent to participation are asked to recruit employees and employers. Interview guides have been developed from the consolidated framework for implementation research and ethical values and norms found in Swedish healthcare, social services and workplace legislation. Data will be analysed with qualitative content analysis reflecting manifest and latent content, and ethical issues will be analysed by means of reflective equilibrium methodology. Ethics and dissemination The study was approved by the Regional Ethical Review Board in Stockholm, Sweden (Reg.no 2018/677-31/2 and 2018/2119-32). The findings will be disseminated through publication in scientific journals, social media, seminars and national and international conferences.

Background: Managers in elderly care have a complex ethical responsibility to address the needs and preferences of older persons while balancing the conflicting interests and requirements of relatives demands and nursing staffs work environment. In addition, managers must consider laws, guidelines, and organizational conditions that can cause ethical problems and dilemmas that need to be resolved. However, few studies have focused on the role of health care managers in the context of how they relate to and deal with ethical conflicts. Therefore, the aim of this study was to describe ethical problems experienced by managers in elderly care. Methods: We used a descriptive, interpretative design to analyze textual data from two examinations in leadership courses for managers in elderly care. A simple random selection of 100 out of 345 written exams was made to obtain a manageable amount of data. The data consisted of approximately 300 pages of single-spaced written text. Thematic analysis was used to evaluate the data. Results: The results show that managers perceive the central ethical conflicts relate to the older persons autonomy and values versus their needs and the values of the staff. Additionally, ethical dilemmas arise in relation to the relatives perspective of their loved ones needs and preferences. Legislations, guidelines, and a lack of resources create difficulties when managers perceive these factors as conflicting with the care needs of older persons. Conclusion: Managers in elderly care experience ethical conflicts that arise as unavoidable and perennial values conflicts, poorly substantiated values, and problematic organizational conditions. Structured approaches for identifying, reflecting on, and assessing ethical problems in the organization should therefore be implemented.

In contrast to standardized guidelines, personalized medicine and person centered care are two notions that have recently developed and are aspiring for more individualized health care for each single patient. While having a similar drive toward individualized care, their sources are markedly different. While personalized medicine stems from a biomedical framework, person centered care originates from a caring perspective, and a wish for a more holistic view of patients. It is unclear to what extent these two concepts can be combined or if they conflict at fundamental or pragmatic levels. This paper reviews existing literature in both medicine and related philosophy to analyze closer the meaning of the two notions, and to explore the extent to which they overlap or oppose each other, in theory or in practice, in particular regarding ethical assumptions and their respective practical implications.

In health care priority setting different criteria are used to reflect the relevant values that should guide decision-making. During recent years there has been a development of value frameworks implying the use of multiple criteria, a development that has not been accompanied by a structured conceptual and normative analysis of how different criteria relate to each other and to underlying normative considerations. Examples of such criteria are unmet need and severity. In this article these crucial criteria are conceptually clarified and analyzed in relation to each other. We argue that disease-severity and condition-severity should be distinguished and we find the latter concept better reflects underlying normative values. We further argue that unmet need does not fulfil an independent and relevant role in relation to condition-severity except for in some limited situations when having to distinguish between conditions of equal severity (and where other features also equals each other).

In healthcare priority settings, early access to treatment before reimbursement decisions gives rise to problems of whether negative decisions for cost-effectiveness reasons should result in withdrawing treatment, already accessed by patients. Among professionals there seems to be a strong attitude to distinguish between withdrawing and withholding treatment, viewing the former as ethically worse. In this article the distinction between withdrawing and withholding treatment for reasons of cost effectiveness is explored by analysing the doing/allowing distinction, different theories of justice, consequentialist and virtue perspectives. The authors do not find any strong reasons for an intrinsic difference, but do find some reasons for a consequentialist difference, given present attitudes. However, overall, such a difference does not, all things considered, provide a convincing reason against withdrawal, given the greater consequentialist gain of using cost-effective treatment. As a result, patients should be properly informed when given early access to treatment, that such treatment can be later withdrawn following a negative reimbursement decision.

According to European regulations and the legislations of individual member states, children who seek asylum have a different set of rights than adults in a similar position. To protect these rights and ensure rule of law, migration authorities are commonly required to assess the age of asylum seekers who lack reliable documentation, including through various medical methods. However, many healthcare professionals and other commentators consider medical age assessment to be ethically problematic. This paper presents a simplified and amended account of the main findings of a recent ethical analysis of medical age assessment in the asylum process commissioned by the Swedish National Board of Health and Welfare. A number of ethical challenges related to conflicting goals, equality and fairness, autonomy and informed consent, privacy and integrity, and professional values and roles are identified and analysed. It is concluded that most of these challenges can be met, but that this requires a system where the assessment is sufficiently accurate and where adequate safeguards are in place. Two important ethical questions are found to warrant further analysis. The first is whether asylum seekers' consent to the procedure can be considered genuinely voluntary. The second is whether and how medical age assessments could affect negative public attitudes towards asylum seekers or discriminatory societal views more generally.

Föreliggande etiska analys rör pre- expositionsprofylax (PrEP) mot hiv som en hivnegativ person kan ta för att minska risken för att drabbas av en hivinfektion. Om PrEP tas som ordinerat ger det en ungefärlig skyddsgrad mot hiv på 85 % jämfört med en kontrollgrupp. Eftersom PrEP inte ger 100 % skydd och inte heller skyddar mot andra sexuellt överförbara sjukdomar så är rekommendationen att det tas i kombination med praktiserandet av säkert sex.

Den här etiska analysen har gjorts på uppdrag av NT-rådet och behandlar följande två frågeställningar: 1) finns det etiska skäl som talar emot förskrivning av PrEP; (2) hur bör PrEP prioriteras i relation till den etiska plattformen med ett särskilt fokus på huruvida PrEP bör egenfinanseras. Det finns starka skäl att minska smittspridningen av hiv utifrån såväl ett individ- som ett samhällsperspektiv vilket talar för förskrivning av PrEP. I diskussionen kring PrEP har det dock framförts att PrEP skiljer sig från annan preventiv behandling för att minska smittspridning på ett sätt som talar emot att PrEP förskrivs. Den etiska analysen diskuterar ett antal sådana argument: att friska personer utan medicinskt behov behandlas, att det handlar om ett socialt riskbeteende, att individer själva bör ta ansvar för smittspridning genom att ändra sitt beteende, samt risken för resistensproblematik. Slutsatsen är att inte något av dessa motargument är tillräckligt starkt för att tala emot förskrivningen av PrEP.

När det gäller prioritering av PrEP i relation till den etiska plattformen dras slutsatsen att PrEP hamnar i den lägre delen av prioriteringsskalan baserat på svårighetsgraden hos tillståndet som PrEP riktar sig emot. Det innebär att PrEP skulle kunna vara en kandidat för egenfinansiering.

Eftersom den etiska plattformen säger mycket lite om vilka åtgärder som bör egenfinaiseras så har analysen utgått från två ramverk presenterade i den internationella literaturen. Trots att flera aspekter av dessa ramverk talar för att PrEP skulle vara passande för egenfinansiering så väger aspekten av minskad smittspridning tungt. Dessa positiva externa effekter tillsammans med svårigheten att bedöma huruvida patientpopulationen skulle kunna egenfinansiera PrEP bidrar till bedömningen att PrEP bör finansieras inom ramen för det offentliga åtagandet.

In relation to the Swedish ethical platform for priority setting in health-care it is debated what role cost-effectiveness should play. In the article an ethical analysis is presented showing that a limited role risks leading to unequal priorities between similar needs in conflict with the human dignity and need-solidarity principles of the platform. It is also argued that resulting problems with effect comparability over different conditions and resulting equality problems with the current praxis can be mitigated through strategies like explicitly considering outcome measure and by adjusting the cost-effectiveness threshold under specific conditions.

Health technology assessment (HTA) is an evaluation of health technologies in terms of facts and evidence. However, the relationship between facts and values is still not clear in HTA. This is problematic in an era of fake facts and truth production. Accordingly, the objective of this study is to clarify the relationship between facts and values in HTA. We start with the perspectives of the traditional positivist account of evaluating facts and the social-constructivist account of facting values. Our analysis reveals diverse relationships between facts and a spectrum of values, ranging from basic human values, to the values of health professionals, and values of and in HTA, as well as for decision making. We argue for sensitivity to the relationship between facts and values on all levels of HTA, for being open and transparent about the values guiding the production of facts, and for a primacy for the values close to the principal goals of health care, ie, relieving suffering. We maintain that philosophy (in particular ethics) may have an important role in addressing the relationship between facts and values in HTA. Philosophy may help us to avoid fallacies of inferring values from facts; to disentangle the normative assumptions in the production or presentation of facts and to tease out implicit value judgements in HTA; to analyse evaluative argumentation relating to facts about technologies; to address conceptual issues of normative importance; and to promote reflection on HTAs own value system. In this we argue for a(n Aristotelian) middle way between the traditional positivist account of evaluating facts and the social-constructivist account of facting values, which we call factuation. We conclude that HTA is unique in bringing together facts and values and that being conscious and explicit about this factuation is key to making HTA valuable to both individual decision makers and society as a whole.

Background: Common mental disorders affect about one-third of the European working-age population and are one of the leading causes of sick leave in Sweden and other OECD countries. Besides the individual suffering, the costs for society are high. This paper describes the design of a study to evaluate a work-related, problem-solving intervention provided at primary health care centers for employees on sick leave due to common mental disorders. Methods: The study has a two-armed cluster randomized design in which the participating rehabilitation coordinators are randomized into delivering the intervention or providing care-as-usual. Employees on sick leave due to common mental disorders will be recruited by an independent research assistant. The intervention aims to improve the employees return-to-work process by identifying problems perceived as hindering return-to-work and finding solutions. The rehabilitation coordinator facilitates a participatory approach, in which the employee and the employer together identify obstacles and solutions in relation to the work situation. The primary outcome is total number of sick leave days during the 18-month follow-up after inclusion. A long-term follow-up at 36 months is planned. Secondary outcomes are short-term sick leave (min. 2 weeks and max. 12 weeks), psychological symptoms, work ability, presenteeism and health related quality of life assessed at baseline, 6 and 12-month follow-up. Intervention fidelity, reach, dose delivered and dose received will be examined in a process evaluation. An economic evaluation will put health-related quality of life and sick leave in relation to costs from the perspectives of society and health care services. A parallel ethical evaluation will focus on the interventions consequences for patient autonomy, privacy, equality, fairness and professional ethos and integrity. Discussion: The study is a pragmatic trial which will include analyses of the interventions effectiveness, and a process evaluation in primary health care settings. Methodological strengths and challenges are discussed, such as the risk of selection bias, contamination and detection bias. If the intervention shows promising results for return-to-work, the prospects are good for implementing the intervention in routine primary health care.

Background: Priority setting in publicly financed healthcare systems should be guided by ethical norms and other considerations viewed as socially valuable, and we find several different approaches for how such norms and considerations guide priorities in healthcare decision-making. Common to many of these approaches is that interventions are ranked in relation to each other, following the application of these norms and considerations, and that this ranking list is then translated into a coverage scheme. In the literature we find at least two different views on how a ranking list should be translated into coverage schemes: (1) rationing from the bottom where everything below a certain ranking order is rationed; or (2) a relative degree of coverage, where higher ranked interventions are given a relatively larger share of resources than lower ranked interventions according to some “curve of coverage.” 

Methods: The aim of this article is to provide a normative analysis of how the background set of ethical norms and other considerations support these two views.

 Results: The result of the analysis shows that rationing from the bottom generally gets stronger support if taking background ethical norms seriously, and with regard to the extent the ranking succeeds in realising these norms. However, in non-ideal rankings and to handle variations at individual patient level, there is support for relative coverage at the borderline of what could be covered. A more general relative coverage curve could also be supported if there is a need to generate resources for the healthcare system, by getting patients back into production and getting acceptance for priority setting decisions.

 Conclusion: Hence, different types of reasons support different deviations from rationing from the bottom. And it should be noted that the two latter reasons will imply a cost in terms of not living up to the background set of ethical norms.

Researchers have recently provided proof of concept for uterus transplantation, giving rise to a discussion about priority setting. This article analyses whether absolute uterine-factor infertility (AUFI), the main indication for uterus transplantation, gives rise to a healthcare need and the extent to which such a need places justified claims on public funding in a needs-based welfare system. It is argued that, regardless of the concept of health to which one subscribes, there is a healthcare need for uterus transplantation in women with AUFI. The provision of alternative ways of addressing this need, such as surrogacy and adoption, reduces its severity. Hence, where such alternatives are publicly funded, uterus transplantation is unlikely to become cost-effective. However, where surrogacy and adoption are not publicly funded, uterus transplantation should be given a similar priority level to other assisted reproductive technologies. In these circumstances, public funding for uterus transplants may well be justified, particularly in well-funded healthcare system with relatively generous cost-effectiveness thresholds.

The importance for governments of establishing ethical principles and criteria for priority setting in line with social values, has been emphasised. The risk of such criteria not being operationalised and instead replaced by de-contextualised priority-setting tools, has been noted. The aim of this article was to compare whether citizenś views are in line with how a criterion derived from parliamentary-decided ethical principles have been interpreted into a framework for evaluating severity levels, in resource allocation situations in Sweden. Interviews were conducted with 15 citizens and analysed by directed content analysis. The results showed that the multi-factorial aspects that participants considered as relevant for evaluating severity, were similar to those used by professionals in the Severity Framework, but added some refinements on what to consider when taking these aspects into account. Findings of similarities, such as in our study, could have the potential to strengthen the internal legitimacy among professionals, to use such a priority-setting tool, and enable politicians to communicate the justifiability of how severity is decided. The study also disclosed new aspects regarding severity, of which some are ethically disputed, implying that our results also reveal the need for ongoing ethical discussions in publicly-funded healthcare systems.