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  • 1.
    Arvidsson, Eva
    et al.
    Linköping University, Faculty of Medicine and Health Sciences.
    Broqvist, Mari
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health.
    Bäckman, Karin
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health.
    Carlsson, Per
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health.
    Garpenby, Peter
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health.
    Gustavsson, Erik
    Linköping University, Faculty of Arts and Sciences. Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Culture and Society, Division of Philosophy, History, Arts and Religion.
    Lindholm, Lars
    Umeå universitet.
    Nedlund, Ann-Charlotte
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Sandman, Lars
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health.
    Tinghög, Gustav
    Linköping University, Department of Management and Engineering, Economics. Linköping University, Faculty of Arts and Sciences.
    Waldau, Susanne
    Umeå universitet.
    Wiss, Johanna
    Linköping University, Faculty of Medicine and Health Sciences.
    Vägen framåt2013In: Att välja rättvist: om prioriteringar i hälso- och sjukvården / [ed] Per Carlsson, Susanne Waldau, Lund: Studentlitteratur AB, 2013, Vol. Sidorna 207-214, p. 207-214Chapter in book (Other academic)
    Abstract [sv]

    Som vi visat har utvecklingen av metoder och strukturer för öppna prioriteringar i Sverige kommit långt. Många frågor återstår likväl. Under vårt arbete med denna bok har vi identifierat ett antal förbättringsområden och utmaningar som vi avslutningsvis vill lyfta fram. Det rör sig om vilka som ska delta i prioriteringarna, tydliggörande av värdegrunden, behov av bättre kunskap, baserad på både vetenskaplig metod och erfarenhet, och fortsatt utveckling av prioriteringsprocesser på olika nivåer och i olika sammanhang. Även om vi i Sverige skulle nå en god enighet kring principer och kriterier för prioriteringar så kommer vi alltid finna många olika sätt att praktiskt lösa specifika prioriteringsproblem.

  • 2.
    Barra, Mathias
    et al.
    Akershus Universitetssykehus HF, Lørenskog, Norway.
    Broqvist, Mari
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Gustavsson, Erik
    Linköping University, Department of Culture and Society, Division of Philosophy, History, Arts and Religion. Linköping University, Faculty of Arts and Sciences.
    Henriksson, Martin
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Juth, Niklas
    Karolinska Institute, Stockholm, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Solberg, Carl Tollef
    Universitetet i Bergen Det medisinsk-odontologiske fakultet, Bergen, Norway.
    Do not despair about severity—yet2020In: Journal of Medical Ethics, ISSN 0306-6800, E-ISSN 1473-4257, Vol. 46, no 8, p. 557-558Article in journal (Other academic)
    Abstract [en]

    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.

  • 3.
    Barra, Mathias
    et al.
    Akershus Universitetssykehus HF, Lørenskog, Norway.
    Broqvist, Mari
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Gustavsson, Erik
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Culture and Society, Division of Philosophy, History, Arts and Religion. Linköping University, Faculty of Arts and Sciences.
    Henriksson, Martin
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Juth, Niklas
    Karolinska Institute, Stockholm, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Solberg, Carl Tollef
    Universitetet i Bergen Det medisinsk-odontologiske fakultet, Bergen, Norway.
    Do not despair about severity—yet2020In: Journal of Medical Ethics, ISSN 0306-6800, E-ISSN 1473-4257, Vol. 46, no 8, p. 557-558Article in journal (Other academic)
    Abstract [en]

    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.

  • 4.
    Barra, Mathias
    et al.
    Akershus Univ Hosp, Norway.
    Broqvist, Mari
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Gustavsson, Erik
    Linköping University, Department of Culture and Society, Division of Philosophy, History, Arts and Religion. Linköping University, Faculty of Arts and Sciences. Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Henriksson, Martin
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Juth, Niklas
    Karolinska Inst, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Solberg, Carl Tollef
    Akershus Univ Hosp, Norway; Univ Bergen, Norway.
    Severity as a Priority Setting Criterion: Setting a Challenging Research Agenda2020In: Health Care Analysis, ISSN 1065-3058, E-ISSN 1573-3394, Vol. 28, no 1, p. 25-44Article in journal (Refereed)
    Abstract [en]

    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.

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  • 5.
    Björk Bramberg, Elisabeth
    et al.
    Karolinska Inst, Sweden.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Hellman, Therese
    Uppsala Univ, Sweden.
    Kwak, Lydia
    Karolinska Inst, Sweden.
    Facilitators, barriers and ethical values related to the coordination of return-to-work among employees on sick leave due to common mental disorders: a protocol for a qualitative study (the CORE-project)2019In: BMJ Open, E-ISSN 2044-6055, Vol. 9, no 9, article id e032463Article in journal (Refereed)
    Abstract [en]

    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.

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  • 6.
    Björk Brämberg, Elisabeth
    et al.
    Karolinska Inst, Sweden; Univ Gothenburg, Sweden; Narhalsan, Sweden.
    Holmgren, Kristina
    Narhalsan, Sweden; Univ Gothenburg, Sweden.
    Bultmann, Ute
    Univ Med Ctr Groningen, Netherlands.
    Gyllensten, Hanna
    Karolinska Inst, Sweden; Univ Gothenburg, Sweden.
    Hagberg, Jan
    Karolinska Inst, Sweden.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Bergstrom, Gunnar
    Karolinska Inst, Sweden; Univ Gavle, Sweden.
    Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA)2018In: BMC Public Health, E-ISSN 1471-2458, Vol. 18, article id 889Article in journal (Refereed)
    Abstract [en]

    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.

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  • 7.
    Broqvist, Mari
    et al.
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health.
    Sandman, Lars
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health.
    Reaktioner på nätet: ett axplock av reaktioner på riktlinjer för prioriteringar av intensivvård under covid-19 pandemin2021Report (Other academic)
    Abstract [en]

    Who will have access to intensive care if the situation becomes strained? Will the access to respirators be sufficient, and if not, how will the shortage be handled? Ever since the covid-19 pandemic hit Sweden, the media, through daily reporting, has put priority setting in healthcare on the agenda for the public. But it is not just the media that communicates to the citizens, the reactions from the public have also been intense in the newspapers' commenting fields. Studying reactions to priority setting is often a challenge, as the subject is perceived as sensitive. Using netnography, has provided an opportunity to gain insight into reactions to prioritization in healthcare that could be found in social media during covid-19. The comments studied are taken from 18 articles in our largest dailies and relate to the National Board of Health and Welfare's national principles for intensive care. The result is based on 1096 comments, posted by 645 people, and analyzed both qualitative and quantitative.

    The comments can be divided into positive and negative reactions to the prioritization principles. Among the negative comments are those that say that principles would not be needed if healthcare had not been disarmed or if people followed the Public Health Agency's restrictions. Concerns are also expressed that priorities will be based primarily on chronological age, or that older people would be given a lower priority solely for financial reasons. However, positive comments regarding biological age as a basis for prioritization are about as common. A positive reaction also applies to the transparency about which priorities should prevail, a transparency that can provide an important reminder of the seriousness of the situation.

    Another purpose with this study has been to explore the interaction online when discussing the principles. The posters interact by lecturing each other on their interpretations of the principles and by trying to explain the “correct” interpretation.

    They criticize each other´s standpoints, both calming and challenging each other with prioritization dilemmas and discuss these in terms of "we-and-them".

    This study is a snapshot of reactions on social media in an early phase of the pandemic. In line with the World Health Organization's guidelines for risk communication, the results underline the value for decision-makers of being aware of the debate on social media. It can inform about misunderstandings that need to be clarified, but also raise relevant concerns about how prioritization principles can be applied incorrectly in practice. Assuming that social media is only a forum for the dissatisfied is an oversimplification. Instead, it can be seen as a platform where arguments are sharpened in dialogues about what are the fair bases for resource allocation in care.

     

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  • 8.
    Broqvist, Mari
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Garpenby, Peter
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Krevers, Barbro
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    The meaning of severity - do citizenś views correspond to a severity framework based on ethical principles for priority setting?2018In: Health Policy, ISSN 0168-8510, E-ISSN 1872-6054, Vol. 122, no 6, p. 630-637, article id S0168-8510(18)30081-2Article in journal (Refereed)
    Abstract [en]

    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.

  • 9.
    Carlsson, Per
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Garpenby, Peter
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Nedlund, Ann-Charlotte
    Linköping University, Department of Social and Welfare Studies, NISAL - National Institute for the Study of Ageing and Later Life. Linköping University, Faculty of Arts and Sciences.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences. Högskolan i Borås, Institutionen för vårdvetenskap.
    Öppna prioriteringar inom vård och omsorg - var står vi idag och hur ska vi komma vidare?2014In: Vägval för välfärden: En antologi om finansieringsgap, prioriteringar och försäkring som kompletterande lösning / [ed] Kristina Ström Olsson, Stockholm: Svensk Försäkring , 2014, p. 31-61Chapter in book (Other academic)
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    Öppna prioriteringar inom vård och omsorg - var står vi idag och hur ska vi komma vidare?
  • 10.
    Carlsson, Per
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Hoffman, Mikael
    Linköping University, Department of Medical and Health Sciences, Division of Drug Research. Linköping University, Faculty of Health Sciences. Nätverk för läkemedelsepidemiologi (NEPI).
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences. Högskolan i Borås, Institutionen för vårdvetenskap.
    Wiss, Johanna
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Prioritering av läkemedel för behandling av patienter med sällsynta sjukdomar2014In: Läkemedel för djur, maskinell dos och sällsynta tillstånd: hantering och prissättning. Slutbetänkande av Läkemedels- och apoteksutredningen, Stockholm: Fritzes, 2014, p. 639-699Chapter in book (Other academic)
    Abstract [sv]

    I vilken utsträckning kan särskilda hänsyn tas vid prioritering av särläkemedel och läkemedel för behandling av sällsynta tillstånd? Bör man i vissa speciella situationer kunna acceptera sämre kostnadseffektivitet och lägre krav på vetenskapligt underlag? Om så, vad är det för villkor/kriterier som då bör vara uppfyllda? Hur stämmer ett sådant undantag med den etiska plattformen för prioriteringar? Finns det andra argument som talar för eller mot en särbehandling av sällsynta tillstånd? Detta är frågor som vi diskuterar i denna rapport som tagits fram på uppdrag av Läkemedels- och apoteksutredningen.

    I rapporten konstaterar vi att särläkemedel är en relativt heterogen grupp av läkemedel och att det finns andra läkemedel med motsvarande egenskaper som inte ansökt eller kunnat ansöka om status som särläkemedel. Ur prioriteringssynpunkt är det därför mer relevant att fokusera på alla typer av läkemedel, som används för sällsynta tillstånd, när vi diskuterar vilka principer för prioriteringar som bör gälla.

    Utifrån litteratur och erfarenheter i andra länder, som formulerat kriterier för en särskild hantering av läkemedel vid sällsynta sjukdomar, drar vi den preliminära slutsatsen att samhället bör kunna betala mer per hälsovinst (kostnad per kvalitetsjusterat levnadsår (QALY)) och acceptera lägre krav på vetenskapligt underlag vid prioritering av läkemedel för behandling av sällsynta sjukdomar om samtliga följande villkor är uppfyllda:

    • att behandlingen har en hög kostnad per hälsovinst som en konsekvens av att den omfattar endast få patienter,
    • att det rör sig om ett tillstånd med mycket stor svårighetsgrad,
    • att det behandlingsalternativ som övervägs på goda grunder ska antas ha en väsentlig effekt,
    • att det inte finns någon alternativ behandling med en väsentlig effekt som förväntas förebygga, bota, fördröja försämring eller lindra det aktuella tillståndet.

    Om dessa kriterier anses uppfyllda kan läkemedlet bedömas i relation till ett förhöjt tröskelvärde för kostnadseffektivitet. Hur högt detta värde kan vara för att anses rimligt tar vi inte ställning till i rapporten, men en viktig ståndpunkt är att det måste finnas en övre gräns för hur hög kostnad per QALY samhället kan acceptera. Detta bör gälla även om ovanstående kriterier är uppfyllda, annars riskerar det uppstå oacceptabla undanträngningseffekter av andra prioriterade åtgärder. Även lägre krav på vetenskapligt underlag skakunna accepteras....

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    Prioritering av läkemedel för behandling av patienter med sällsynta sjukdomar
  • 11.
    Carlsson, Per
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Hoffmann, Mikael
    Nätverk för läkemedelsepidemiologi, NEPI.
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Wiss, Johanna
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Prioritering och finansiering av läkemedel för behandling av patienter med sällsynta sjukdomar: Reviderad version2015Report (Other academic)
    Abstract [en]

    To what extent can special consideration be given towards prioritising orphan drugs and drugs for treating rare conditions? In certain special situations should we accept lower cost effectiveness and lower standards for scientific evidence? If so, what are the conditions/criteria that should be fulfilled? How would such exceptions fit in with the ethical platform for priority setting? Are there other arguments that speak for or against special handling of rare conditions? These are questions we discuss in this report commissioned by the Committee on Pharmaceuticals and Pharmacies.

    In this report we describe orphan drugs as a relatively heterogeneous group of pharmaceuticals, and discuss that other drugs with similar characteristics have not applied for, or were able to apply for, status as orphan drugs. Hence, from a priority setting perspective it is more relevant to focus on all types of drugs used for rare conditions when we discuss the principles that should apply when setting priorities.

    Based on literature and experiences from other countries that have formulated criteria for special handling of drugs for rare diseases, we have drawn the preliminary conclusion that society should be able to pay more per health gain (cost per quality-adjusted life year [QALY]) and accept lower standards for scientific evidence when prioritising drugs for treating rare diseases if all of the following conditions are met:

    • that treatment has a high cost per health gain as a consequence treating only a few patients
    • that it involves a health condition with a very high level of severity
    • that the treatment option being considered is assumed, based on firm grounds, to have a substantial effect
    • that no alternative treatment having a substantial effect is available that can be expected to prevent, cure, delay, or ameliorate the health condition in question.

    If these criteria are met, the drug can be evaluated in relation to an elevated threshold value for cost effectiveness. In this report we do not address how high this value should be to be considered reasonable, but an important point is that there must be an upper limit regarding how high of a cost per QALY society can accept. This should apply even if the above criteria are met to avoid the risk of unacceptable displacement of other prioritised interventions. Even lower standards for scientific evidence could be acceptable.

    These preliminary conclusions were tested against the Swedish ethical platform and from a perspective of welfare economics.

    Our conclusions from the ethical analysis are:

    The human dignity principle allows for special handling of rare conditions that can generate high treatment costs. Hence, our first criterion is acceptable based on the ethical platform. When a higher threshold value (cost per health gain achieved) for treating rare conditions is accepted, these patients are given greater equity in access to health compared to other patients (assuming that the other criteria are also met). However, this does not automatically mean that all rare conditions generating high treatment costs should receive special handling.

    According to the needs and solidarity principle society should strive, to the extent possible, to give all citizens equal opportunities for care; but also enable them to achieve a level of health that is as equitable as possible. The latter assumes that we primarily prioritise those who are furthest from such an equitable level, i.e. those with the greatest needs. To be able to influence the opportunities and outcomes regarding health, it is essential that the interventions used can actually help people approach more equitable outcomes, i.e. that these interventions have a substantial effect on health.

    The cost-effectiveness principle states that a reasonable relationship between costs and effects should be pursued in choosing between different interventions or areas of activity. Very severe conditions should take precedence over minor conditions, even if the interventions, in contrast to the former, are associated with relatively higher costs per health gain. When the above criteria are met in treating a rare condition it only means that the treatment can be subject to evaluation of whether a higher threshold value can be accepted. Hence, this does not automatically mean that the treatment should be offered or that a drug, for example, should be included among the pharmaceutical benefits. Even when these criteria are met, and hence there is reason for special handling of the treatment, decisions makers in this context should decide what constitutes a reasonable relationship between costs and effects, i.e. what is an acceptable threshold value in a particular decision-making situation.

    In conclusion, we believe that the current ethical platform along with the modification of the cost effectiveness principle, which appears in more recent legislation, offers the opportunity to give special consideration when prioritising drugs targeted at rare and very severe conditions. For a drug to be considered for special handling, it should have a substantial effect on the condition in question. There is a difference between treatments that have poor cost effectiveness due to minor effects and those that have poor cost effectiveness due to high costs. The difference arises since the effect size of the treatment influences its potential to contribute to an outcome in line with the health and quality of life of the rest of the population, where a greater effect size approaches this in a better way. Our interpretation is that if there are two interventions with the same cost effectiveness ratio and the same severity level, but where one has greater effects on the condition than the other, it is the one with the greatest effects that should be given priority.

    We also studied whether there are any arguments from a socioeconomic efficiency standpoint that speak in favour of or against special handling of rare conditions. This has been done based on theoretical and empirical literature on the subject and preliminary data from a Swedish study. Some studies suggest there is a social value: first in the knowledge that people receive care regardless of the situation, which creates greater security and confidence in society based on self interest since everyone in society is at risk for severe conditions; and second, based on more altruistic motivation where people in general can be influenced in a positive way knowing that they live in a compassionate society.

    However, purely empirical studies do not offer any evidence that people in general think that treatment of rare diseases should receive special handling, everything else being equal. In other words, no empirical studies show that rarity per se is a relevant criterion in priority setting – this was also the conclusion of our previous ethical argument in this context (see Carlsson et al 2012). Preliminary data from an ongoing Swedish study support this conclusion to some extent. When complementing the analysis in the same study with attitude questions and focus group interviews, a more detailed picture emerges – namely, support can be found for special handling if the condition is rare, has a high level of severity, and is the only treatment option.

    After deciding that special consideration can be given in prioritising drugs for severe and rare conditions, based on the ethical platform and from a welfare economy perspective, positions must be taken on a series of practical considerations in designing procedures for priority setting, namely:

    • Based on the goal to reduce differences and guarantee care on equal terms for rare conditions, it would be preferable to use a model involving national decision making. The same principles for prioritising drugs for rare and severe conditions should apply regardless of how the drug reaches the patient, i.e. regardless of whether it involves prescribed or requisitioned drugs. Whether one or more bodies set priorities is an organisational issue that we do not address in this report.
    • From a priority setting standpoint there should be no difference between orphan drugs and other drugs used for rare conditions. When it comes to decisions on whether orphan drugs in general should be included under the pharmaceutical benefits system, they should be assessed and approved by the Dental and Pharmaceutical Benefits Agency in usual fashion, while drugs targeted at conditions that are both very rare and very severe may need special consideration and handled according to a modified procedure. This should include the cost per health gain and dealing with uncertainty of the scientific evidence, and should apply whether or not the drug has orphan status.
    • In some situations where the scientific evidence is uncertain, problems arise in deciding on general use of expensive drugs for severe diseases on a group level. In this context it seems reasonable to initially allow some exceptions in the evidence for cost effectiveness related to severe diseases when, for various reasons, practical factors stand in the way of producing such evidence. However, a conflict can arise in both accepting a higher willingness to pay and accepting greater uncertainty in the scientific evidence. In such cases it is particularly important to pursue adequate follow-up and try to reduce uncertainty as quickly as possible and reassess the decision.
    • Various principles are available to define patient groups with very severe and rare conditions. Groups may be defined based on the prevalence of the condition in the population or on the number of patients with a given condition that the drug in question will be used to treat (in other words, the number of patients who are potential candidates for treatment). The latter method appears to be advantageous when the particular problem we address here relates to the fact that few patients are candidates for treatment, not how usual/unusual the condition/disease is. In the report we do not take a definitive position on what constitutes a suitable limit. This needs further study. However, we believe that such a limit should be set much lower than the usual definition for orphan drugs. In Sweden’s case, a reasonable starting point for discussion could be that the expected estimated size of the patient group should not exceed 200 patients (1 in 50 000 inhabitants) during 5 years. Experience from England, for instance, supports this definition.
    • One way to arrive at a reasonable threshold for cost effectiveness in different situations involving rare conditions is to designate some entity to make decisions transparently. Such decisions could then be discussed broadly and possibly be subject to reassessment. By comparing with other situations in health care and society where decisions are made on interventions for severe conditions and small patient groups, the development of accepted practice can be accelerated. Even comparisons with decisions in other countries can give an indication of reasonable threshold values in various situations.
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  • 12.
    Carlsson, Per
    et al.
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Hoffmann, Mikael
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Sandman, Lars
    Högskolan i Borås.
    Wiss, Johanna
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Prioritering och finansiering av läkemedel för behandling av patienter med sällsynta sjukdomar: Reviderad version2012Report (Other academic)
    Abstract [en]

    An addendum to the terms of reference for the inquiry on certain issues regarding pricing, accessibility, and market conditions in the pharmaceutical and pharmacy sector (Dir. 2011:82) calls for an analysis of the need for special solutions in decisions on subsidising orphan drugs. An orphan drug is a drug that fulfils certain conditions and is thereby covered by special stimulus measures prior to approval by agencies that evaluate medical products. Orphan drugs also have the possibility, but not the right, to hold sole rights in the marketplace for 10 years.

    The report includes an analysis of the ethics platform and the Pharmaceutical Benefits Act, which serve as the Dental and Pharmaceutical Benefits Agency’s base for making decisions on subsidies. One conclusion drawn is that the current ethics platform, along with the modification of the cost-effectiveness principle that appears in the Pharmaceutical Benefits Act, offers the option to determine that society is prepared to pay more per health benefit for drugs targeted at very rare and severe diseases/conditions.

    The human dignity principle indicates that irrelevant group affiliation or group characteristics should not affect equality in a patient group’s opportunities and outcomes regarding health. Whether a patient group is small or large is an irrelevant group characteristic, and the size of the group or the rarity of the condition should not affect the group’s opportunities for treatment, or the possibility to achieve an equitable health outcome compared to other larger groups or groups with more common diseases. However, the consequence of higher costs for intervention that can result from rarity could be grounds for special treatment.

    The needs and solidarity principle indicates that all citizens should be given equal opportunities to achieve good health and that we should achieve health outcomes that are as equitable as possible for citizens. If we allow the development costs for orphan drugs to influence the possibility to access these drugs, then the citizens are not given equal opportunities to achieve good health. Hence, we draw the conclusion that people with rare and severe conditions should be given opportunities to achieve good health that are equal to those given to people with common and serious conditions.

    The cost-effectiveness principle. When lower cost effectiveness is primarily due to high costs connected with the size of the patient group, i.e. the market size for a drug, and not poor effects from the intervention, there is just cause, on the grounds of equity, to try to influence the cost aspects of the drug and in some cases accept a lower level of cost effectiveness. The cost can be influenced, for example, by pricing based on special agreements with the company marketing the drug.

    There is value in knowing that we live in a compassionate society that cares for and attempts to help people that find themselves in life-threatening or other difficult situations. This value stems partly from the assertion that knowledge creates greater security and trust in the community (based on self interest since we are all at risk of contracting a severe condition) and partly from a more altruistic motivation stemming from the assertion that we are affected positively by knowing that we live in a compassionate society. This is a factor that should also be considered in cost-effectiveness analyses. The size of this value is uncertain.

    Orphan drugs are a relatively heterogeneous group, and there are other drugs with corresponding characteristics that have not applied for status as orphan drugs. From a standpoint of priority setting, it is more relevant to focus instead on drugs that are used for rare and severe diseases. Drugs for very rare and severe conditions, particularly when no other treatment is available, should therefore be processed in a special manner regardless of whether or not they are classified as an orphan drug. To assure equitable access, transparent decisions, and appropriate care it is preferable to use a model involving national decision- making for such drugs. Three alternative principles for decisions and financing can be discussed: 1) the state as the principal authority, 2) collaboration between the state and the county councils, and 3) collaboration among the county councils.

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  • 13.
    Carlsson, Per
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences. Högskolan i Borås, Institutionen för vårdvetenskap.
    Att skapa ett kunskapsunderlag2013In: Att välja rättvist: om prioriteringar i hälso- och sjukvården / [ed] Per Carlsson och Susanne Waldau, Lund, 2013, 1:1, p. 89-99Chapter in book (Other academic)
    Abstract [sv]

    En viktig del i ett välgrundat prioriteringsbeslut i hälso- och sjukvården är fakta om olika undersökningar och behandlingars effekter, kostnadseffektivitet, etiska och andra relevanta konsekvenser. Fakta kan vara av olika karaktär. Vanligtvis tänker vi på vetenskapliga artiklar och rapporter men i prioriteringsbeslut behöver även erfarenhetsbaserad kunskap vägas in. Sverige är i hög grad beroende av klinisk forskning och kunskapssammanställningar som görs i andra länder. Under de senaste två decennierna har både metodiken och arbetsformerna för systematiska översikter utvecklats och blivit mer enhetliga ur metodsynpunkt, vilket underlättar användning av underlag från andra länder. Även organiserat samarbete mellan länder har ökat, inte minst inom den Europeiska unionen.

  • 14.
    Carlsson, Per
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    "Dags att utveckla den etiska plattformen för prioriteringar"2015In: Dagens Medicin, ISSN 1104-7488Article in journal (Other (popular science, discussion, etc.))
    Abstract [sv]

    Hälso- och sjukvården har under senare år ställts inför en rad utmaningar när det gäller användningen av de begränsade resurserna. Exempelvis har nya effektiva men mycket dyra läke­medel som Zytiga, Soliris eller läkemedel mot hepatit C lett till prioriteringsbeslut som har kritiserats men också blottlagt brister i den etiska plattform som ska vägleda beslutsfattare. Därför menar vi att plattformen behöver en parlamentarisk översyn.

  • 15.
    Davidson, Thomas
    et al.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Ekberg, Jana
    Univ Gothenburg, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Brannstrom, Mats
    Univ Gothenburg, Sweden; Stockholm IVF EUGIN, Sweden.
    The costs of human uterus transplantation: a study based on the nine cases of the initial Swedish live donor trial2021In: Human Reproduction, ISSN 0268-1161, E-ISSN 1460-2350, Vol. 36, no 2, p. 358-366Article in journal (Refereed)
    Abstract [en]

    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.

  • 16.
    Eklund Saksberg, My
    et al.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Nursing Sciences and Reproductive Health. Linköping University, Faculty of Medicine and Health Sciences.
    Bielsten, Therese
    Jonkoping Univ, Sweden.
    Cahill, Suzanne
    Jaarsma, Tiny
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Nursing Sciences and Reproductive Health. Linköping University, Faculty of Medicine and Health Sciences. Trinity Coll Dublin, Ireland.
    Nedlund, Ann-Charlotte
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Jaarsma, Pier
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Nurses' priority-setting for older nursing home residents during COVID-192024In: Nursing Ethics, ISSN 0969-7330, E-ISSN 1477-0989Article in journal (Refereed)
    Abstract [en]

    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.

  • 17.
    El-Alti, Leila
    et al.
    Edinburgh Napier Univ, Scotland; Univ Gothenburg, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Munthe, Christian
    Univ Gothenburg, Sweden.
    Caregiver perspectives on patient capacities and institutional pathways to person centered forensic psychiatric care2022In: PLOS ONE, E-ISSN 1932-6203, Vol. 17, no 9, article id e0275205Article in journal (Refereed)
    Abstract [en]

    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.

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  • 18.
    El-Alti, Leila
    et al.
    Univ Gothenburg, Sweden.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Munthe, Christian
    Univ Gothenburg, Sweden.
    Person Centered Care and Personalized Medicine: Irreconcilable Opposites or Potential Companions?2019In: Health Care Analysis, ISSN 1065-3058, E-ISSN 1573-3394, Vol. 27, no 1, p. 45-59Article in journal (Refereed)
    Abstract [en]

    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.

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  • 19.
    Grin, John
    et al.
    Univ Amsterdam, Netherlands.
    Bloemen, Bart
    Radboud Univ Nijmegen Med Ctr, Netherlands.
    Gutierrez-Ibarluzea, Inaki
    Basque Fdn Hlth Innovat & Res, Spain.
    Hofmann, Bjorn
    Norwegian Univ Sci & Technol, Norway; Univ Oslo, Norway.
    Oortwijn, Wija
    Radboud Univ Nijmegen Med Ctr, Netherlands.
    Refolo, Pietro
    Univ Cattolica Sacro Cuore, Italy.
    Sacchini, Dario
    Univ Cattolica Sacro Cuore, Italy.
    Sampietro-Colom, Laura
    Hosp Clin Barcelona, Spain.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    van der Wilt, Gert Jan
    Radboud Univ Nijmegen Med Ctr, Netherlands.
    Learning and practicing more value-reflective, problem-setting health technology assessment: experiences and lessons from the VALIDATE project2022In: International Journal of Technology Assessment in Health Care, ISSN 0266-4623, E-ISSN 1471-6348, Vol. 38, no 1, article id e63Article in journal (Refereed)
    Abstract [en]

    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.

  • 20.
    Gustavsson, Erik
    et al.
    Linköping University, Department of Culture and Society, Division of Philosophy and Applied Ethics. Linköping University, Faculty of Arts and Sciences. Linköping University, Department of Health, Medicine and Caring Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Juth, Niklas
    Uppsala Univ, Sweden.
    Larfars, Gerd
    Reg Stockholm, Sweden.
    Raaschou, Pauline
    Karolinska Inst, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Should relational effects be considered in health care priority setting?2023In: Bioethics, ISSN 0269-9702, E-ISSN 1467-8519, Vol. 37, no 7, p. 668-673Article in journal (Refereed)
    Abstract [en]

    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.

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  • 21.
    Gustavsson, Erik
    et al.
    Linköping University, Department of Culture and Society, Division of Philosophy, History, Arts and Religion. Linköping University, Faculty of Arts and Sciences.
    Juth, Niklas
    Karolinska institutet, Sverige.
    Lärfars, Gerd
    Region Stockholms läkemedelskommitté, Sverige.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Nya läkemedel vid Alzheimers sjukdom: Håll huvudet kallt2020In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, Vol. 117, no 48, p. 1576-1577Article in journal (Other academic)
  • 22.
    Gustavsson, Erik
    et al.
    Linköping University, Department of Culture and Communication, Arts and Humanities. Linköping University, Faculty of Arts and Sciences.
    Juth, Niklas
    Centre for healthcare ethics, Karolinska institutet, Solna, Sverige.
    Munthe, Christian
    Institutionen för filosofi, lingvistik och vetenskapsteori, Göteborgs universitet, Sverige.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. Institutionen för vårdvetenskap, Högskolan i Borås, Sverige.
    Etiska och praktiska utmaningar med ökat patientinflytande2015In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, Vol. 112, article id DD3XArticle in journal (Other academic)
    Abstract [sv]

    Det finns ett ökat intresse för patientinflytande i vården. Ett sådant fokus kan dock komma i konflikt med ett antal värden/praktiker inom vården. I denna artikel identifierar vi att följande värden/praktiker kan påverkas: 

    Idén om patientens vårdbehov förefaller tappa sin moraliska och politiska ställning. 

    Prioriteringar på gruppnivå kan bli svårare att tillämpa på individnivå. 

    Det kan bli svårare att bedöma nyttan med behandlingar. 

    Det kan bli svårare att få fram evidens för behandlingar. 

    Det tycks komplicera idén om den följsamme patienten. 

    Det kan innebära vissa implikationer för resursanvändning. 

    Det kan ge ett nytt perspektiv på idén om att prioritera efter en ansvarsprincip.

  • 23.
    Gustavsson, Erik
    et al.
    Linköping University, Faculty of Arts and Sciences. Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Culture and Society, Division of Philosophy, History, Arts and Religion.
    Juth, Niklas
    Raaschou, Pauline
    Bonnard, Alexandre
    Davidson, Thomas
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Lärfars, Gerd
    Sandman, Lars
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health.
    Sjukdomsmodifierande läkemedel mot Alzheimers sjukdom: etiska aspekter av prioriteringar och screening2020Report (Other academic)
    Abstract [en]

    Intensive research is carried out by several pharmaceutical companies in order to develop a disease modifying drug for Alzheimer’s disease (AD). The development of drug candidates which reduce Aß and tau in the brain seems particularly promising. These drugs and the characteristics of AD raise a number of ethical challenges. In this report we analyze these challenges in relation to priority setting and the diagnostic measures associated with these drugs. The former analysis draws primarily on the Swedish ethical platform for health care priority setting, whereas the latter draws on the guidelines for screening developed by the National Board of Health and Welfare.

    Although the effect of the new drugs is likely to have an impact on relatives of people with AD, it is our interpretation that the Swedish ethical platform leaves no room for such considerations.

    In relation to the effect of the drugs there is also reason to pay special attention to the extent to which the surrogate measures used in the clinical studies are of clinical relevance.

    When it comes to aggregating benefits across individuals, it is our interpretation that the platform does not allow aggregation of patient benefits in such a way. This means that the fact that people with AD constitute a large group of patients does not in itself constitute a reason for giving this group a higher priority. The ethical platform rather seems to prescribe that the effect must be assessed with regard to how it accrues to each individual. In a scenario where the budgetary impact becomes so great that decision makers need to prioritize within the group, it seems that there are no relevant criteria for these priorities.

    AD is a condition with a very high degree of severity. However, as the new drugs are targeting the preclinical or Mild Cognitive Impairment (MCI) phase, the severity of the condition should be decreased with respect to the likelihood of actually developing AD. The severity of the condition thus becomes different for drugs that aim at the preclinical phase, those that aim at the MCI phase and those that aim at clinical stages of AD.

    Solidarity considerations in the platform prescribes that people with AD may be less able than other patient groups to communicate their needs, they should therefore be given special consideration. However, this does not mean a higher priority but to stress that people with AD have the same right to health care as other groups with similar needs.

    Population screening for AD is associated with several problems. There are general problems with screening from, for example, an autonomy point of view. But there are also problems related to the fact that current methods of risk stratification are so unreliable, which in turn results in false negatives (with risk of undertreatment) and false positives (with risk of overtreatment).

    Screening in the MCI phase has (in addition to the problems that come with population screening) problems with inequality and arbitrariness. When the clinical phase begins, there is no longer any point with screening: the later the identification, the less potential treatment benefits compared to standard diagnostics.

    It is our overall assessment that the new drugs must generate large health benefits for people at risk of developing AD in order to be eligible for general funding and to justify the ethical costs that come with current diagnostic methods.

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  • 24.
    Gustavsson, Erik
    et al.
    Linköping University, Department of Culture and Society, Division of Philosophy, History, Arts and Religion. Linköping University, Faculty of Arts and Sciences. Linköping University, Department of Health, Medicine and Caring Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Raaschou, Pauline
    Clinical Pharmacology Unit, Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
    Larfars, Gerd
    Health and Medical Care Administration, Stockholm, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Juth, Niklas
    Stockholm Centre of Healthcare Ethics, LIME, Karolinska Institute, Stockholm, Sweden.
    Comments: The ethics of disease-modifying drugs targeting Alzheimer disease: response to our commentators (vol.47, issue 9, page :608–614)2022In: Journal of Medical Ethics, ISSN 0306-6800, E-ISSN 1473-4257, Vol. 48, no 3, article id 108157Article in journal (Other academic)
  • 25.
    Gustavsson, Erik
    et al.
    Linköping University, Department of Culture and Society, Division of Philosophy, History, Arts and Religion. Linköping University, Faculty of Arts and Sciences.
    Raaschou, Pauline
    Karolinska Inst, Sweden.
    Larfars, Gerd
    Reg Stockholm, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Juth, Niklas
    Karolinska Inst, Sweden.
    Novel drug candidates targeting Alzheimers disease: ethical challenges with identifying the relevant patient population2021In: Journal of Medical Ethics, ISSN 0306-6800, E-ISSN 1473-4257, Vol. 47, no 9, p. 608-614Article in journal (Refereed)
    Abstract [en]

    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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  • 26.
    Gustavsson, Erik
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Etisk analys av pre-expositionsprofylax (PrEP) för hiv2018Report (Other academic)
    Abstract [sv]

    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.

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    Etisk analys av pre-expositionsprofylax (PrEP) för hiv
  • 27.
    Gustavsson, Erik
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. University of Boras, Sweden.
    Health-care needs and shared decision-making in priority-setting2015In: Medicine, Health care and Philosophy, ISSN 1386-7423, E-ISSN 1572-8633, Vol. 18, no 1, p. 13-22Article in journal (Refereed)
    Abstract [en]

    In this paper we explore the relation between health-care needs and patients desires within shared decision-making (SDM) in a context of priority setting in health care. We begin by outlining some general characteristics of the concept of health-care need as well as the notions of SDM and desire. Secondly we will discuss how to distinguish between needs and desires for health care. Thirdly we present three cases which all aim to bring out and discuss a number of queries which seem to arise due to the double focus on a patients need and what that patient desires. These queries regard the following themes: the objectivity and moral force of needs, the prediction about what kind of patients which will appear on a micro level, implications for ranking in priority setting, difficulties regarding assessing and comparing benefits, and implications for evidence-based medicine.

  • 28.
    Gustavsson, Erik
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health and Society. Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences. Högskolan i Borås, Institutionen för vårdvetenskap.
    Wiss, Johanna
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Rättviseteorier och prioriteringar2013In: Att välja rättvist: om prioriteringar i hälso- och sjukvården / [ed] Per Carlsson och Susanne Waldau, Lund, 2013, 1, p. 49-64Chapter in book (Other academic)
    Abstract [sv]

    Detta kapitel presenterar de rättviseteorier som brukar diskuteras i samband med prioriteringar inom hälso- och sjukvården. Målet med prioriteringar är i grund och botten att uppnå en större rättvisa i fördelningen av knappa hälso- och sjukvårdsresurser. Men hur ska man egentligen förstå rättvisa? Det är ett normativt begrepp som kan diskuteras utifrån ett antal teorier som också presenteras här. Den svenska etiska plattformen presenteras närmare liksom dess koppling till etablerade rättviseteorier. Slutligen redovisas några etiska principer som den svenska riksdagen tagit avstånd från.

  • 29.
    Hansson, Emma
    et al.
    Gothenburg Univ, Sweden; Lund Univ, Sweden.
    Elander, Anna
    Gothenburg Univ, Sweden.
    Hallberg, Hakan
    Gothenburg Univ, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. Vastra Gotaland Reg, Sweden; Boras Univ, Sweden.
    Should immediate breast reconstruction be performed in the setting of radiotherapy? An ethical analysis2020In: Journal of Plastic Surgery and Hand Surgery, ISSN 2000-656X, E-ISSN 2000-6764, Vol. 54, no 2, p. 83-88Article in journal (Refereed)
    Abstract [en]

    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.

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  • 30.
    Hansson, Emma
    et al.
    Sahlgrens Univ Hosp, Sweden; Gothenburg Univ, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. Vastra Gotaland Reg, Sweden; Boras Univ, Sweden.
    Davidson, Thomas
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    A systematic review of direct preference measurements in health states treated with plastic surgery2022In: Journal of Plastic Surgery and Hand Surgery, ISSN 2000-656X, E-ISSN 2000-6764, Vol. 56, no 3, p. 180-190Article, review/survey (Refereed)
    Abstract [en]

    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.

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  • 31.
    Heintz, Emelie
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. Swedish Council Health Technology Assessment SBU, Sweden.
    Lintamo, Laura
    Swedish Council Health Technology Assessment SBU, Sweden.
    Hultcrantz, Monica
    Swedish Council Health Technology Assessment SBU, Sweden; Karolinska Institute, Sweden.
    Jacobson, Stella
    Swedish Council Health Technology Assessment SBU, Sweden; Karolinska Institute, Sweden.
    Levi, Ragnar
    Swedish Council Health Technology Assessment SBU, Sweden.
    Munthe, Christian
    University of Gothenburg, Sweden.
    Tranaeus, Sofia
    Swedish Council Health Technology Assessment SBU, Sweden; Malmö University, Sweden; Karolinska Institute, Sweden.
    Ostlund, Pernilla
    Swedish Council Health Technology Assessment SBU, Sweden; Malmö University, Sweden.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. University of Boras, Sweden.
    FRAMEWORK FOR SYSTEMATIC IDENTIFICATION OF ETHICAL ASPECTS OF HEALTHCARE TECHNOLOGIES: THE SBU APPROACH2015In: International Journal of Technology Assessment in Health Care, ISSN 0266-4623, E-ISSN 1471-6348, Vol. 31, no 3, p. 124-130Article in journal (Refereed)
    Abstract [en]

    Objectives: Assessment of ethical aspects of a technology is an important component of health technology assessment (HTA). Nevertheless, how the implementation of ethical assessment in HTA is to be organized and adapted to specific regulatory and organizational settings remains unclear. The objective of this study is to present a framework for systematic identification of ethical aspects of health technologies. Furthermore, the process of developing and adapting the framework to a specific setting is described. Methods: The framework was developed based on an inventory of existing approaches to identification and assessment of ethical aspects in HTA. In addition, the framework was adapted to the Swedish legal and organizational healthcare context, to the role of the HTA agency and to the use of non-ethicists. The framework was reviewed by a group of ethicists working in the field as well as by a wider set of interested parties including industry, interest groups, and other potential users. Results: The framework consists of twelve items with sub-questions, short explanations, and a concluding overall summary. The items are organized into four different themes: the effects of the intervention on health, its compatibility with ethical norms, structural factors with ethical implications, and long term ethical consequences of using the intervention. Conclusions: In this study, a framework for identifying ethical aspects of health technologies is proposed. The general considerations and methodological approach to this venture will hopefully inspire and present important insights to organizations in other national contexts interested in making similar adaptations.

  • 32.
    Hofmann, Bjorn
    et al.
    Norwegian Univ Sci and Technol NTNU, Norway; Univ Oslo, Norway.
    Bond, Ken
    CADTH, Canada.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Evaluating facts and facting evaluations: On the fact-value relationship in HTA2018In: Journal of Evaluation In Clinical Practice, ISSN 1356-1294, E-ISSN 1365-2753, Vol. 24, no 5, p. 957-965Article in journal (Refereed)
    Abstract [en]

    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.

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  • 33.
    Holmlund, Lisa
    et al.
    Karolinska Inst, Sweden.
    Hellman, Therese
    Karolinska Inst, Sweden; Uppsala Univ, Sweden.
    Engblom, Monika
    Karolinska Inst, Sweden; Acad Primary Hlth Care Ctr, Sweden.
    Kwak, Lydia
    Karolinska Inst, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Tornkvist, Lena
    Karolinska Inst, Sweden; Acad Primary Hlth Care Ctr, Sweden.
    Bjork Bramberg, Elisabeth
    Karolinska Inst, Sweden; Univ Gothenburg, Sweden.
    Coordination of return-to-work for employees on sick leave due to common mental disorders: facilitators and barriers2022In: Disability and Rehabilitation, ISSN 0963-8288, E-ISSN 1464-5165, Vol. 44, no 13, p. 3113-3121Article in journal (Refereed)
    Abstract [en]

    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.

  • 34.
    Holmlund, Lisa
    et al.
    Karolinska Inst, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Hellman, Therese
    Karolinska Inst, Sweden; Uppsala Univ, Sweden.
    Kwak, Lydia
    Karolinska Inst, Sweden.
    Bramberg, Elisabeth Bjork
    Karolinska Inst, Sweden.
    Ethical aspects of the coordination of return-to-work among employees on sick leave due to common mental disorders: a qualitative study2023In: Disability and Rehabilitation, ISSN 0963-8288, E-ISSN 1464-5165, Vol. 45, no 13, p. 2118-2127Article in journal (Refereed)
    Abstract [en]

    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.

  • 35.
    Jonasson, Lise-Lotte
    et al.
    Univ Boras, Sweden.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. Univ Boras, Sweden.
    Bremer, Anders
    Univ Boras, Sweden; Linnaeus Univ, Sweden.
    Managers experiences of ethical problems in municipal elderly care: a qualitative study of written reflections as part of leadership training2019In: Journal of Healthcare Leadership, E-ISSN 1179-3201, Vol. 11, p. 63-74Article in journal (Refereed)
    Abstract [en]

    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.

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  • 36.
    Juth, Niklas
    et al.
    Karolinska Inst, Sweden.
    Henriksson, Martin
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Gustavsson, Erik
    Linköping University, Department of Culture and Society, Division of Philosophy, History, Arts and Religion. Linköping University, Faculty of Arts and Sciences.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Should we accept a higher cost per health improvement for orphan drugs? A review and analysis of egalitarian arguments2021In: Bioethics, ISSN 0269-9702, E-ISSN 1467-8519, Vol. 35, no 4, p. 307-314Article, review/survey (Refereed)
    Abstract [en]

    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.

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  • 37.
    Kapiriri, Lydia
    et al.
    McMaster Univ, Canada.
    Kiwanuka, Suzanne
    Makerere Univ, Uganda.
    Biemba, Godfrey
    Natl Hlth Res Author, Zambia.
    Velez, Claudia
    McMaster Univ, Canada.
    Razavi, S. Donya
    McMaster Univ, Canada.
    Abelson, Julia
    McMaster Univ, Canada.
    Essue, Beverly
    St Michaels Hosp, Canada.
    Danis, Marion
    NIH, MD 20812 USA.
    Goold, Susan
    Univ Michigan, MI 48109 USA.
    Noorulhuda, Mariam
    NIH, MD 20812 USA.
    Nouvet, Elysee
    Western Univ, Canada.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Williams, Ieystn
    Univ Birmingham, England.
    Priority setting and equity in COVID-19 pandemic plans: a comparative analysis of 18 African countries2022In: Health Policy and Planning, ISSN 0268-1080, E-ISSN 1460-2237, Vol. 37, no 3, p. 297-309Article in journal (Refereed)
    Abstract [en]

    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.

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  • 38.
    Karlsson, Ida
    et al.
    Karolinska Inst, Sweden.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Axen, Iben
    Karolinska Inst, Sweden.
    Kwak, Lydia
    Karolinska Inst, Sweden.
    Sernbo, Elisabet
    Univ Gothenburg, Sweden.
    Braemberg, Elisabeth Bjork
    Karolinska Inst, Sweden.
    Ethical challenges from a problem-solving intervention with workplace involvement: a qualitative study among employees with common mental disorders, first-line managers, and rehabilitation coordinators2024In: International Journal of Qualitative Studies on Health and Well-being, ISSN 1748-2623, E-ISSN 1748-2631, Vol. 19, no 1, article id 2308674Article in journal (Refereed)
    Abstract [en]

    PurposeThis 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.MethodsA 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.ResultsA 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".ConclusionDifferent 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.

  • 39.
    Lundberg, Kristina
    et al.
    Jonkoping Univ, Sweden; Univ Boras, Sweden.
    Kjellstrom, Sofia
    Jonkoping Univ, Sweden.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. Univ Boras, Sweden.
    Dual loyalties: Everyday ethical problems of registered nurses and physicians in combat zones2019In: Nursing Ethics, ISSN 0969-7330, E-ISSN 1477-0989, Vol. 26, no 2, p. 480-495Article in journal (Refereed)
    Abstract [en]

    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.

  • 40.
    Lärfars, Gerd
    et al.
    NT-rådet.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. University of Boras, Sweden.
    Därför måste vi ibland säga nej till dyra läkemedel2017In: Göteborgs PostenArticle in journal (Other (popular science, discussion, etc.))
  • 41.
    Malmqvist, Erik
    et al.
    Linköping University, Department of Culture and Communication, Culture and Aesthetics. Linköping University, Faculty of Arts and Sciences.
    Furberg, Elisabeth
    Centre for Research Ethics and Bioethics, Department of Public Health and Caring Sciences, Uppsala University, Uppsala Sweden.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. University of Boras, Sweden.
    Ethical aspects of medical age assessment in the asylum process: a Swedish perspective.2018In: International journal of legal medicine, ISSN 0937-9827, E-ISSN 1437-1596, Vol. 132, no 3, p. 815-823Article in journal (Refereed)
    Abstract [en]

    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.

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  • 42.
    Munthe, Christian
    et al.
    Göteborgs universitet.
    Broström, Linus
    Lunds universitet.
    Brülde, Bengt
    Göteborgs universitet.
    Cutas, Daniela
    Umeå och Göteborgs universitet.
    Eriksson, Stefan
    Uppsala universitet.
    Helgeson, Gert
    Karolinska institutet.
    Juth, Niklas
    Karolinska institutet.
    Kihlbom, Ulrik
    Uppsala universitet.
    Malmqvist, Erik
    Linköping University, Department of Thematic Studies, Technology and Social Change. Linköping University, Faculty of Arts and Sciences. Göteborg och Borås.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. University of Borås, Sweden.
    Zeiler, Kristin
    Linköping University, Department of Thematic Studies, Technology and Social Change. Linköping University, Faculty of Arts and Sciences.
    Johansson, Mats
    Lunds universitet.
    Efter skandalen: ”Gråzoner sätt att blanda bort korten”2016In: Svenska Dagbladet, ISSN 1101-2412Article in journal (Other (popular science, discussion, etc.))
    Abstract [sv]

    Efter skandalen kring kirurgen på Karolinska Institutet som gjorde experimentella operationer, talas det om gråzoner i lagen. Men detta stämmer inte, utan är ett sätt att blanda bort korten, skriver en rad professorer från sex olika universitet gemensamt.

  • 43.
    Oortwijn, Wija
    et al.
    Radboud Univ Nijmegen Med Ctr, Netherlands.
    Husereau, Don
    Univ Ottawa, Canada.
    Abelson, Julia
    McMaster Univ, Canada.
    Barasa, Edwine
    Hlth Econ Res Unit HERU, Kenya.
    Bayani, Diana Dana
    Natl Univ Singapore, Singapore.
    Santos, Vania Canuto
    Minist Hlth, Brazil.
    Culyer, Anthony
    Univ York, England.
    Facey, Karen
    Evidence Based Health Policy Consultant, Drymen, Scotland.
    Grainger, David
    Biointelect, Australia.
    Kieslich, Katharina
    Univ Vienna, Austria.
    Ollendorf, Daniel
    Tufts Univ, MA, USA.
    Pichon-Riviere, Andres
    Univ Buenos Aires, Argentina.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Strammiello, Valentina
    European Patients Forum, Belgium.
    Teerawattananon, Yot
    Minist Hlth, Thailand.
    Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force2022In: International Journal of Technology Assessment in Health Care, ISSN 0266-4623, E-ISSN 1471-6348, Vol. 38, no 1, p. 1-16, article id e37Article in journal (Refereed)
    Abstract [en]

    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.

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  • 44.
    Oortwijn, Wija
    et al.
    Radboud Univ Nijmegen Med Ctr, Netherlands.
    Husereau, Don
    Univ Ottawa, Canada.
    Abelson, Julia
    McMaster Univ, Canada.
    Barasa, Edwine
    KEMRI Wellcome Trust Res Programme, Kenya.
    Bayani, Diana (Dana)
    Natl Univ Singapore, Singapore.
    Santos, Vania Canuto
    Minist Hlth, Brazil.
    Culyer, Anthony
    Univ York, England.
    Facey, Karen
    Evidence Based Health Policy Consultant, Drymen, Scotland.
    Grainger, David
    Biointelect, Australia.
    Kieslich, Katharina
    Univ Vienna, Austria.
    Ollendorf, Daniel
    Tufts Univ, MA USA.
    Pichon-Riviere, Andres
    Univ Buenos Aires, Argentina.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Strammiello, Valentina
    European Patients Forum, Belgium.
    Teerawattananon, Yot
    Minist Hlth, Thailand.
    Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force2022In: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733, Vol. 25, no 6, p. 869-886Article in journal (Refereed)
    Abstract [en]

    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.

  • 45.
    Refolo, Pietro
    et al.
    Fdn Policlin Univ A Gemelli IRCCS, Italy; Univ Cattolica Sacro Cuore, Italy.
    Bloemen, Bart
    Radboud Univ Nijmegen, Netherlands.
    Corsano, Barbara
    Fdn Policlin Univ A Gemelli IRCCS, Italy; Univ Cattolica Sacro Cuore, Italy.
    Grin, John
    Univ Amsterdam, Netherlands.
    Gutierrez-Ibarluzea, Inaki
    Basque Fdn Hlth Innovat & Res BIOEF, Spain; Basque Off HTA Osteba, Spain.
    Hofmann, Bjorn
    Norwegian Univ Sci & Technol, Norway.
    Oortwijn, Wija
    Radboud Univ Nijmegen, Netherlands.
    Sampietro-Colom, Laura
    Univ Barcelona, Spain.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    van der Wilt, Gert Jan
    Radboud Univ Nijmegen, Netherlands.
    Sacchini, Dario
    Fdn Policlin Univ A Gemelli IRCCS, Italy; Univ Cattolica Sacro Cuore, Italy.
    Prioritization of COVID-19 vaccination. The added value of the "VALIDATE" approach2022In: Health Policy, ISSN 0168-8510, E-ISSN 1872-6054, Vol. 126, no 8, p. 770-776Article in journal (Refereed)
    Abstract [en]

    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.

  • 46.
    Refolo, Pietro
    et al.
    Univ Cattolica Sacro Cuore, Italy; Fdn Policlin Univ A Gemeiii IRCCS, Italy.
    Bond, Kenneth
    Inst Hlth Econ, Canada.
    Bloemen, Bart
    Radboud Univ Nijmegen, Netherlands.
    Autti-Ramo, Ilona
    Minist Social Affairs & Hlth, Finland; Minist Social Affairs & Hlth, Finland.
    Hofmann, Bjorn
    Norwegian Univ Sci & Technol, Norway.
    Mischke, Claudia
    Inst Qual & Efficiency Hlth Care, Germany.
    Mueller, Debjani
    Charlotte Maxeke Res Mister, South Africa.
    Nabukenya, Sylvia
    Makerere Univ, Uganda.
    Oortwijn, Wija
    Radboud Univ Nijmegen, Netherlands.
    Sandman, Lars
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Stanak, Michal
    Austrian Inst Hlth Technol Assessment, Austria.
    Steele, Duncan
    Ailderta Hlth Serv, Canada.
    van der Wilt, Gert Jan
    Radboud Univ Nijmegen, Netherlands.
    Sacchini, Dario
    Univ Cattolica Sacro Cuore, Italy; Fdn Policlin Univ A Gemeiii IRCCS, Italy.
    Core competencies for ethics experts in health technology assessment2020In: International Journal of Technology Assessment in Health Care, ISSN 0266-4623, E-ISSN 1471-6348, Vol. 36, no 6, p. 534-539Article in journal (Refereed)
    Abstract [en]

    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.

  • 47.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Att prioritera mellan olika värden: en modell för avvägningar mellan patientintegritet, patientsäkerhet och andra etiska värden inom hälso- och sjukvården2013Report (Other academic)
    Abstract [en]

    This report is the result of an assignment from the Inquiry on Appropriate Information in Health Care and Social Services. One of the questions addressed by the inquiry concerns how to deal with balancing patient integrity on one hand against patient security (and other relevant values) on the other. To identify the need for changes in legislation or practice, the report presents a structured model addressing issues that should be considered in light of the current Patient Data Act. Moreover, by providing guidance on the scope of the Patient Data Act for addressing central ethical values in health services, the model is intended to help resolve problematic choices that arise amongst care providers.

    The report discusses two typical cases. The first case addresses the situation where limitations in access to information potentially threaten other values. The second case addresses the situation where access to information potentially threatens other values. The premise for the model is that patient integrity is of primary, instrumental value in Swedish legislation, i.e. integrity is important to uphold since mainly it safeguards other values. The values that integrity is intended to protect (but at times might even obstruct) are health and quality of life, autonomy, dignity, and equality and justice. Upholding integrity, but also failing to fully safeguard integrity, can thereby lead in different ways towards value losses. We have designed a matrix for the model that can illustrate value losses that could arise in relation to different parties, according to a given integrity problem (the appendix includes several different examples of integrity problems in relation to the Patient Data Act). Using the matrix as a foundation, two variations of the model have been developed, depending on the case type being addressed. The model is structured as two different decision trees, reflecting a discussion of the various questions and choices that can arise in analysing the two typical integrity problems. In the decision trees, the Patient Data Act forms a basis for relevant questions to be answered, leading onward through the decision tree towards ultimately identifying the points where the Act does not provide guidance, or where a potential conflict between different values still remains.

    It is important to emphasise that the model should be viewed as a basis for analysis and discussion and is not intended to give definitive answers on how to achieve the necessary balance.

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    Att prioritera mellan olika värden: En modell för avvägningar mellan patientintegritet, patientsäkerhet och andra etiska värden inom hälso- och sjukvården
  • 48.
    Sandman, Lars
    Högskolan i Borås, Sweden.
    Den palliativa vårdens etik2016In: Palliativ vård ur ett tvärprofessionellt perspektiv / [ed] Inger Benkel, Ulla Molander, Helle Wijk, Liber, 2016, p. 141-166Chapter in book (Other (popular science, discussion, etc.))
  • 49.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. University of Boras, Sweden.
    Ethical analysis of medical age-assessment in the Swedish context2017Conference paper (Refereed)
  • 50.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. University of Boras, Sweden.
    Ethical values and norms - just a matter of social preferences?2017Conference paper (Refereed)
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