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  • 1.
    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, ISSN 1471-2458, 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.

  • 2.
    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.

  • 3.
    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)
  • 4.
    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....

  • 5.
    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.

  • 6.
    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.
  • 7.
    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: Studentlitteratur, 2013, 1:1, p. 89-99Chapter in book (Other academic)
    Abstract [sv]

    Hälso- och sjukvårdens resurser räcker inte till alla behov och önskemål från patienter och medborgare, vilket gör att personal och beslutsfattare hamnar i svåra situationer. Hur ska vi veta att det är rätt patienter som tvingas stå tillbaka? Att välja rättvist tar upp centrala begrepp och etiska principer kring prioriteringar. Boken beskriver även metoder för att göra prioriteringar på ett systematiskt sätt och erfarenheter av såväl nationella som internationella prioriteringar.

    Prioriteringsbeslut fattas på alla nivåer och kan gälla fördelning av resurser till olika verksamheter, behandlingsbeslut av enskilda patienter eller investeringar i nya medicinska metoder. Boken ger förslag på hur beslutsunderlagen kan förbättras. Här ges anvisningar om hur man mäter behov och nytta hos patientgrupper och i befolkningen, hur kostnadseffektivitet beräknas och hur man skapar ett kunskapsunderlag. På så sätt får läsaren inte bara ta del av prioriteringarnas teori utan även av deras praktik, inte minst genom konkreta exempel på hur öppna prioriteringar i dag tillämpas i svensk hälso- och sjukvård.

    Boken är avsedd för dig som arbetar kliniskt eller planerar att arbeta med prioriteringar – nationellt, i landsting eller i kommuner. Boken ger även en värdefull inblick för dig som vill lära mer om hur vårdens svåra val ska kunna hanteras i framtiden.

  • 8.
    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.

  • 9.
    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.

  • 10.
    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.

  • 11.
    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.

  • 12.
    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.

  • 13.
    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: Studentlitteratur, 2013, 1, p. 49-64Chapter in book (Other academic)
    Abstract [sv]

    Hälso- och sjukvårdens resurser räcker inte till alla behov och önskemål från patienter och medborgare, vilket gör att personal och beslutsfattare hamnar i svåra situationer. Hur ska vi veta att det är rätt patienter som tvingas stå tillbaka? Att välja rättvist tar upp centrala begrepp och etiska principer kring prioriteringar. Boken beskriver även metoder för att göra prioriteringar på ett systematiskt sätt och erfarenheter av såväl nationella som internationella prioriteringar.

    Prioriteringsbeslut fattas på alla nivåer och kan gälla fördelning av resurser till olika verksamheter, behandlingsbeslut av enskilda patienter eller investeringar i nya medicinska metoder. Boken ger förslag på hur beslutsunderlagen kan förbättras. Här ges anvisningar om hur man mäter behov och nytta hos patientgrupper och i befolkningen, hur kostnadseffektivitet beräknas och hur man skapar ett kunskapsunderlag. På så sätt får läsaren inte bara ta del av prioriteringarnas teori utan även av deras praktik, inte minst genom konkreta exempel på hur öppna prioriteringar i dag tillämpas i svensk hälso- och sjukvård.

    Boken är avsedd för dig som arbetar kliniskt eller planerar att arbeta med prioriteringar – nationellt, i landsting eller i kommuner. Boken ger även en värdefull inblick för dig som vill lära mer om hur vårdens svåra val ska kunna hanteras i framtiden.

  • 14.
    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 Medical and Health Sciences, Division of Health Care Analysis. 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 analysis2019In: Scandinavian Journal of Plastic and Reconstructive Surgery and Hand Surgery, ISSN 2000-656X, E-ISSN 2000-6764Article 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.

  • 15.
    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.

  • 16.
    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.

  • 17.
    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, ISSN 1179-3201, 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.

  • 18.
    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.

  • 19.
    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.))
  • 20.
    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 (Print), 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.

  • 21.
    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.

  • 22.
    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.

  • 23.
    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.))
  • 24.
    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)
  • 25.
    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)
  • 26.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Ethics in Quality Improvement with in Health Care: Focusing on the Improvement2017In: Open Medicine Journal, ISSN 1874-2203, Vol. 04, p. 48-56Article, review/survey (Refereed)
    Abstract [en]

    Background:

    Health-care is permeated with ethical values and norms and so there are ethical implications to all interventions which changes practice, and this includes quality improvement (QI). The interest for ethics in QI so far has not had an explicit focus on the ethics of the actual improvement. Contrasting this with health technology assessment (HTA), we there find an almost exclusive interest in the ethics of the developed technology, and less regard for the other ethical aspects related to development, evaluation and implementation of the technology.

    Method:

    We identify how a research ethics perspective on QI differs from the ethics of the actual improvement or change. It will be argued that the field of ethics in QI can benefit from the development of ethics within HTA by raising awareness of the need to ethically assess the actual improvement or change, and by using models for this found within HTA. For an ethical analysis of quality improvement, elderly care in the Swedish context will be given as a tentative example.

    Conclusion:

    The existing frameworks for ethical assessment within HTA need further development for use within QI. In essence, the introduction of new technologies within health-care could be viewed as a quality improvement, where considerations generally acknowledged within QI are relevant to consider in relation to all potential technologies to be used within health-care.

  • 27.
    Sandman, Lars
    Högskolan i Borås, Sweden.
    Invited commentary to the discussion paper Ethics dilemmas of early detection of obesity2016In: Scandinavian Journal of Public Health, ISSN 1403-4948, E-ISSN 1651-1905, Vol. 44, no 6, p. 546-548Article in journal (Other academic)
    Abstract [en]

    n/a

  • 28.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Kronologisk ålder: några reflektioner utifrån den etiska plattformen för prioriteringar2016In: Perspektiv på utvärdering, prioritering, implementering och hälsoekonomi. En hyllningsskrift till Per Carlsson / [ed] Martin Henriksson, Linköping: Linköpings universitet , 2016, p. 87-96Chapter in book (Other academic)
  • 29.
    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.
    Patient involvement in HTA - ethical rationales and implications2017Conference paper (Refereed)
  • 30.
    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.
    Prioritising, Ranking and Resource Implementation: A Normative Analysis2018In: International Journal of Health Policy and Management, ISSN 2322-5939, E-ISSN 2322-5939, Vol. 7, no 6, p. 532-541Article in journal (Refereed)
    Abstract [en]

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

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

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

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

  • 31.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    The importance of being pregnant: On the healthcare need for uterus transplantation2018In: Bioethics, ISSN 0269-9702, E-ISSN 1467-8519, Vol. 32, no 8, p. 519-526Article in journal (Refereed)
    Abstract [en]

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

    The full text will be freely available from 2020-10-15 11:32
  • 32.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    The surge in value framworks and their use in decision-making: Ethical (and philisophical) perspectives2017Conference paper (Refereed)
  • 33.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Vilken vägledning ger den etiska plattformen för prioriteringar i konkreta prioriteringssituationer?: En översikt av tolknings- och tillämpningssvårigheter : Reviderad version2015Report (Other academic)
    Abstract [en]

    What guidance does the ethical platform offer for setting priorities in specific situations? A review of problems in interpretation and implementation.

    This report addresses several problems of interpreting and implementing the ethical platform for priority setting. One reason for raising these problems is to stimulate debate concerning the potential need for a new parliamentary commission to address interpretation issues and development of a platform for managing the priority setting situations facing health services. Another reason is to stimulate more public debate, discussion, and research concerning how the ethical platform can and should be interpreted. The report begins with chapters presenting the interpretation problems previously identified in the 2007 report, Resolving Health Care’s Difficult Choices, by the National Centre for Priority Setting in Health Care and the points raised in the directives for a white paper commissioned by the Norwegian parliament. This is followed by a systematic presentation of the ethical platform and an analysis of several interpretation and implementation problems related to the various principles: the human dignity principle, the needs and solidarity principle, the cost-effectiveness principle; to the alternative principles that were rejected; to other guidelines; and in relation to special areas of implementation. The final chapter presents a list of the areas that appear to be most urgent to address (all points are presented in an appendix to the report):

    • Views towards social conditions and how these should or should not influence priority setting.
    • Views towards chronological age and its relationship to biological age, and how this should or should not influence priority setting.
    • The potential for co- or self-financing for health services.
    • How we should view and judge severity in prioritised areas.
    • How documentation on equal opportunities and equal outcomes should be interpreted and applied in decisions on priorities.
    • The role of the cost-effectiveness principle in relation to the other principles.
    • How the standpoints in the human dignity principle should influence the calculation of cost effectiveness.
    • The role of patients’ self-determination and demands.
    • Views on aggregation.
    • The existence (or absence) and position of the priority groups.
    • Views towards self care within the framework of the ethical platform.
    • The platform’s relation to other legislation and other initiatives in the field of health services.
  • 34.
    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.
    Why we should not meet unmet needs!2017Conference paper (Refereed)
  • 35.
    Sandman, Lars
    et al.
    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.
    Bond, Ken
    Canadian Agency for Drugs and Technologies in Health, Canada.
    Hofmann, Björn
    The Norwegian University for Science and Technology Gjovik, Centre for Medical Ethics, University of Oslo, Oslo Norway.
    Exploring ethical rationales2017In: Patient invovlement in Health Technology Assessment / [ed] Karen Facey, Helle Ploug Hansen and Ann Single, Singapore: Springer Nature , 2017, p. 17-29Chapter in book (Other academic)
    Abstract [en]

    This chapter presents and analyses six ethical rationales for patient involvement in HTA. We have identified three instrumental and three substantive rationales, namely, (1) relevance to healthcare goals and healthcare needs, (2) legitimacy leading to adherence to decisions, (3) capacity building via patient empowerment, (4) fairness and legitimacy through democratic participation, (5) fairness through respect for autonomy and (6) equity. Our ethical analysis finds that these rationales support patient involvement in HTA under specific premises. For example, relevance to healthcare goals and needs mainly support the use of patient-based evidence, while the other rationales require patient participation in some form. That is, for HTA to be legitimate enough to increase adherence, patients probably need to participate in the process and the same goes for equity. Likewise, when the rationales are democratic participation, empowerment and autonomy. Importantly, in order to achieve strong ethical support for patient involvement in HTA, it is crucial to ensure that these premises and their preconditions are fulfilled. On the other hand, all rationales raise issues of representation, i.e. which patient group should be represented through evidence or participation.

  • 36.
    Sandman, Lars
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Broqvist, Mari
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Gustavsson, Erik
    Linköping University, Department of Medical and Health Sciences, Division of Health and Society. Linköping University, Faculty of Arts and Sciences.
    Arvidsson, Eva
    Linköping University, Department of Medical and Health Sciences. Linköping University, Faculty of Health Sciences.
    Ekerstad, Niklas
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Carlsson, Per
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Vård som inte kan anstå: Tolkning i relation till den etiska plattformen och nationella modellen för öppna prioriteringar2014Report (Other academic)
    Abstract [en]

    Method

    The assignment from the National Board of Health and Welfare consists of three related parts. Part one presents different interpretations of the concept “care that cannot be deferred” based on an analysis of how the concept is used in the government bill and the wording of the Act. Several criteria are used to specify these interpretations. Part two analyses the interpretations of the concept “care that cannot be deferred” discussed in part one. The analysis is based on the ethics platform for priority setting. Part three aims to analyse how the concept “care that cannot be deferred” relates to the National Model for Transparent Prioritisation in Swedish Health Care and discuss whether it can be used to support prioritisation and rationing. The theoretical analysis is complemented by several examples of practical decision-making situations, as described by clinicians, that involve the care of non-registered individuals.

    Analysis

    In this report we have formulated several criteria that the concept “care that cannot be deferred” must fulfil according to the law (2012/13:407).

    These criteria address: Care need: The individual has a care need – i.e. a discrepancy exists between the desired and actual condition, which can be influenced by a care intervention.

    Limitations: The provider may place limitations on “care that cannot be deferred” delivered to non-registered individuals in Sweden and who are 18 years of age or older. Such limitations should be based on considerations involving:

    • Severity of the condition (current ill health, risk for future ill health, or special needs arising from previous assault and trauma).
    • Effect of the intervention if it is provided now compared to deferred intervention.
    • Cost-effectiveness of the intervention if it is provided now compared to deferred intervention.

    Limited responsibility: When applying the concept “care that cannot be deferred” the provider should assume that the individual is expected to be in Sweden for a limited time, but it is not necessary to consider the person’s opportunities to receive care once he/she is no longer in Sweden.

    Expanded responsibility: When applying the concept “care that cannot be deferred” the provider should assume that the individual is expected to be in Sweden a limited time, but should also consider the person’s opportunities to receive care once he/she is no longer in Sweden.

    Conclusions

    Based on the care need criterion, we conclude that non-registered individuals who seek care should be adequately evaluated in each case so the provider can determine whether a care need exists.

    We conclude that the limited responsibility criterion conflicts with the human dignity principle when it comes to limiting care based on chronological age and national registration. Further we conclude that the rationing of care implied by the limited responsibility criterion does not appear to be based on limited resources, but that the non-registered individual does not have the same right to health services as the nationally registered population does.

    We conclude that in choosing between the limited and the expanded responsibility criteria, the latter is preferable in light of the ethical platform since, to a greater extent, the expanded responsibility criterion allows consideration of relevant aspects (e.g. severity level, effect of intervention, and cost effectiveness) similar to the way the registered population is treated. Further, we conclude that the time limitation of the responsibility criteria is difficult to address since in many cases it is highly uncertain how long a person can remain in Sweden without necessary authorisation.

    We conclude that the factors presented for determining how to define “care that cannot be deferred” are basically the same as those in the national model for priority setting – i.e. severity of the condition (current and potential), effect of the intervention (and how it changes over time), and cost effectiveness. Concurrently we point to several contradictions in defining the definition, and in the law generally, that conflict with the ethical platform and the national model for priority setting. This includes the cases where specific diagnostic or treatment areas are explicitly noted, regardless of severity level, effect of intervention, or cost effectiveness.

    Further, we conclude that it is possible to point to several general combinations of severity level, effect of intervention, and cost effectiveness that can define “care that cannot be deferred” – so these combinations are very difficult to apply at the individual level. The reason is that it is difficult to determine individual risks and effects. As regards the registered population, a normal way to determine risks or effects would be either to provide treatment “for safety’s sake” or to wait, thus providing the opportunity for the patient to return if the  condition deteriorates or for the provider to call the patient for a return visit. If the provider decides that care can be deferred, usually there is an opportunity for a new evaluation at the initiative of the patient or provider. Since it is less certain that patients in the non-registered population can return for a new evaluation, it might seem reasonable to offer treatment more often for safety’s sake. Concurrently, this must be balanced against the risks associated with treatment and the opportunities to follow up on these risks wherever the individual resides.

  • 37.
    Sandman, Lars
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Carlsson, Per
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Är vårdsponsring förenligt med den etiska plattformen för prioriteringar i hälso- och sjukvård?: Reviderad version2016Report (Other academic)
    Abstract [sv]

    Under senare tid har det uppkommit diskussion och kritik av att specifika insatser inom hälso- och sjukvården finansieras av utomstående aktörer. "Vårdsponsring" uppfattas då som ett främmande inslag i den offentligt finansierade vården som skulle kunna komma i konflikt med gällande etiska principer för fördelning av resurser.

    Syftet med rapporten är att definiera vad som menas med "vårdsponsring" och analysera fenomenet i förhållande till den etiska plattformen för prioriteringar, andra etiska principer och regelverk inom hälso- och sjukvården.

    Vi gör ingen fullständig kartläggning av företeelsen "vårdsponsring" utan utgår från ett antal typexempel på "vårdsponsring" (i vid bemärkelse) baserade på verkliga fall som återgetts i media, register eller protokollsanteckningar. Även om vi inte gjort en fullödig kartläggning kan vi konstatera att "vårdsponsring" i nuläget har en liten praktisk betydelse men är principiellt intressant att analysera ur etiskt perspektiv för att ha beredskap för en eventuell framtida ökning.

    Vi inventerar rådande etiska regelverk och diskuterar dessa i förhållande till varandra och de typfall som vi konstruerat. Vid sidan av den etiska plattformen för prioriteringar inom hälso- och sjukvården finns det generella regelverk om sponsring och donation framtagna för den statliga sektorn, samverkansregler mellan Life Science industrin och hälso- och sjukvården och riktlinjer inom enskilda regioner och landsting. Avslutningsvis lämnar vi några förslag till åtgärder som syftar till klargöranden avseende svåra avvägningar och utveckling av regler och riktlinjer.

    Vi ser att det finns en principiellt viktig skillnad mellan sponsring och donation nämligen kravet på motprestation som ska vara uppfyllt vid sponsring men inte vid donationen. Det är istället så att donation ska utmärkas av att det inte finns krav på motprestation. I den praktiska användningen av begreppen tycks dock uppdelningen mellan sponsring och donation inte vara entydig. Vissa så kallade donationer är förenade med krav på en motprestation i form av ökad resurstillförsel t.ex. att sjukvårdshuvudmannen förutsätts ta ett driftansvar för en donerad utrustning, vilket kan ses som en problematisk form av donation eller istället betraktas som en typ av sponsring.

    Den etiska analysen pekar på ett antal risker med "vårdsponsring" av olika former:

    • Risk för att "vårdsponsringen" inte är i linje med de resursbeslut som följer av den etiska plattformen för prioriteringar och därmed strider mot dess krav på jämlikhet och rättvisa.
    • Risk för att "vårdsponsringen" driver på en utveckling mot efterfrågestyrning av vården.
    • Risk för att makten över vårdens prioriteringar förskjuts med påverkan på förtroendet för vårdgivaren.
    • Risk för att "vårdsponsring" lockar till att krav på utvärdering och etisk analys av nya vårdåtgärder inte efterlevs med påverkan på patientsäkerhet och professionellt ansvar.

    I nuläget är det svårt att bedöma omfattningen av "vårdsponsring" och vår genomlysning tillåter inte någon övergripande värdering av faktiska positiva och negativa effekter. Samtidigt innebär det att vi har ett utmärkt läge för att formulera riktlinjer för hur en vårdgivare bör förhålla sig till en framtida eventuellt ökande "vårdsponsring" av olika karaktär.

    Även om de samverkansregler och de riktlinjer som finns i enskilda landsting och regioner täcker flera av de aspekter som vi berört anser vi att det finns skäl till olika förtydliganden och tillägg. Likaså täcker dessa regler endast samverkan mellan Life Science industrin och hälso- och sjukvården, dvs. varken andra kommersiella aktörer, eller andra intressegrupper eller intressen.

    Följande aspekter bör beaktas i en utveckling av riktlinjer och regler för vårdsponsring och donationer:

    • De bör täcka in all form av "vårdsponsring" och donationer (oavsett om den är företags-, intressegruppsbaserad eller kopplad till någon annan organisation eller enskild aktör).
    • De bör på ett mer explicit sätt ta sin utgångspunkt i de etiska normer som finns reglerade i svensk hälso- och sjukvård, dvs. den etiska plattformen, normer kring patientens och professionens roll etc.
    • Frågor kring vad som avses med ordinarie vårdverksamhet behöver redas ut och eventuellt även föras till i de existerande riktlinjerna och reglerna.
    • Det kan behöva förtydligas vilka typer av motprestationer som är rimliga när externa aktörer sluter avtal kring "vårdsponsring" med hälso- och sjukvården.
    • All form av "vårdsponsring" innebär en teoretisk risk för etiska konsekvenser och ett hot mot den offentliga vårdens trovärdighet. Samtidigt finns det vinster med samverkan mellan den offentliga vården och det omgivande samhället. Därför måste storleken på risken beaktas i varje fall. Exempelvis får inte samverkan mellan hälso- och sjukvård och industrin innebära otillbörlig påverkan och äventyra eller uppfattas äventyra hälso- och sjukvårdens oberoende utan ska präglas av måttfullhet. Vad som ska anses som måttfullhet är med andra ord centralt i detta sammanhang och behöver om möjligt förtydligas även när det gäller "vårdsponsring" på motsvarande sätt som skett för sponsring av sammankomster etc. Ökade krav på utvärderingar, dokumentation och publicering kan vara en väg för att motivera ökad extern finansiering av utvecklingsprojekt. Även tidsaspekten bör beaktas i detta sammanhang, där korta tidsbegränsade projekt framstår som mindre problematiska.
    • En viktig slutsats utifrån den etiska analysen är att om enskilda sponsrings- eller donationsinitiativ underkastas en noggrann etisk analys utifrån den etiska plattformen och de andra etiska normer som vi återfinner inom hälso- och sjukvården - så kan vårdgivaren dels urskilja de sponsringsavtal som är mer i linje med dessa etiska normer, dels modifiera dessa avtal så att dessa bättre överensstämmer med normerna.

  • 38.
    Sandman, Lars
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences. Högskolan i Borås.
    Carlsson, Per
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Mikael, Hoffman
    NEPI - nätverk för läkemedelsepidemiologi.
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Liliemark, Jan
    Snäv tolkning av etisk plattform2015In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, article id 112:DH94Article in journal (Other (popular science, discussion, etc.))
    Abstract [sv]

    Etikdelegationens tolkning av den etiska plattformen innebär att nya dyra läkemedel tränger bort andra viktiga åtgärder. Författarna efterlyser en uppdatering av den etiska plattformen i en öppen process.

  • 39.
    Sandman, Lars
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Davidson, Thomas
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Helgesson, Gert
    Karolinska institutet - LIME Stockholm, Sweden.
    Juth, Niklas
    Karolinska institutet - LIME Stockholm, Sweden.
    Etiskt problematiskt att begränsa rollen för kostnadseffektivitet [The ethical problems in limiting the role for cost-effectiveness]: Begränsad roll kan leda till godtycke och strida mot andra principer för prioriteringar i vården2018In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, Vol. 115Article in journal (Other academic)
    Abstract [en]

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

  • 40.
    Sandman, Lars
    et al.
    Högskolan i Borås.
    Ekerstad, Niklas
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Lindroth, Kartrin
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Triage som prioriteringsinstrument på akutmottagning: en etisk analys av RETTS2012Report (Other academic)
    Abstract [en]

    Sweden’s emergency departments use a triage system to categorise patients for different levels of care. Triage involves the first step in the care of sick and injured patients in situations where it is not possible to care for everyone immediately, but cases must be prioritized and patient safety assured. The most common triage system used in Swedish emergency departments is called the Rapid Emergency Triage and Treatment System, RETTS (synonymous with METTS). RETTS involves a combination of evaluating the reason for seeking care and various vital parameters, i.e. critical physiological functions. The combined appraisal of the reason for seeking care and the vital parameters leads to five levels of priority, each of which involves different care. This provides guidance on where to treat emergent patients, how quickly the patient must see a physician, and the level of monitoring required.

    This study aims to investigate how the staff in Sweden’s emergency  departments described their experience with the triage system from an ethical perspective and also conduct an ethical analysis of the triage system. The interviewees responded that although there is no guarantee that the evaluations are always conducted in a similar way (which could lead to over or under triaging), the introduction of a triage system does provide some guarantee of compliance with the parliament’s guidelines on priority setting – that patients with the greatest need are first in line to receive care. Staff experience some sense of security in using the same parameters to evaluate all patients, which facilitates communication among the different functions in the emergency department. However, despite the standardised process, the system is not without shortcomings, and not all cases are appropriate for the method. Elderly with multiple disorders and people with psychiatric or substance- and alcohol-type problems problems are perceived as being difficult to evaluate and triage “correctly” for later placement in the appropriate continuum of care. The ethical analysis showed that the triage system per se adhered to the ethical platform’s emphasis on caring for those with the greatest needs first, but it does not consider the effects of the interventions that patients might receive (since such evaluation takes place later in the process). Since application of the triage method could have a negative impact on certain groups, this is problematic  from the perspective of the human dignity principle. From an ethical perspective it is important to be aware of a method’s limitations and not always assume that it can manage every case in an equitable manner. The study identifies the need for a deeper ethical analysis of triage in emergency departments that includes investigating actual implementation and its ongoing process.

  • 41.
    Sandman, Lars
    et al.
    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.
    Gustavsson, Erik
    Linköping University, Department of Culture and Communication, Arts and Humanities. Linköping University, Faculty of Arts and Sciences.
    Beyond the Black Box Approach to Ethics! Comment on "Expanded HTA: Enhancing Fairness and Legitimacy".2016In: International Journal of Health Policy and Management, ISSN 2322-5939, E-ISSN 2322-5939, Vol. 5, no 6, p. 393-394Article in journal (Refereed)
    Abstract [en]

    In the editorial published in this journal, Daniels and colleagues argue that his and Sabin's accountability for reasonableness (A4R) framework should be used to handle ethical issues in the health technology assessment (HTA)-process, especially concerning fairness. In contrast to this suggestion, it is argued that such an approach risks suffering from the irrrelevance or insufficiency they warn against. This is for a number of reasons: lack of comprehensiveness, lack of guidance for how to assess ethical issues within the "black box" of A4R as to issues covered, competence and legitimate arguments and finally seemingly accepting consensus as the final verdict on ethical issues. We argue that the HTA community is already in a position to move beyond this black box approach.

  • 42.
    Sandman, Lars
    et al.
    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.
    Gustavsson, Erik
    Linköping University, Department of Culture and Communication, Arts and Humanities. Linköping University, Faculty of Arts and Sciences.
    The (Ir)relevance of Group Size in Health Care Priority Setting: A Reply to Juth2017In: Health Care Analysis, ISSN 1065-3058, E-ISSN 1573-3394, Vol. 25, no 1, p. 21-33Article in journal (Refereed)
    Abstract [en]

    How to handle orphan drugs for rare diseases is a pressing problem in current health-care. Due to the group size of patients affecting the cost of treatment, they risk being disadvantaged in relation to existing cost-effectiveness thresholds. In an article by Niklas Juth it has been argued that it is irrelevant to take indirectly operative factors like group size into account since such a compensation would risk discounting the use of cost, a relevant factor, altogether. In this article we analyze Juths argument and observe that we already do compensate for indirectly operative factors, both outside and within cost-effectiveness evaluations, for formal equality reasons. Based on this we argue that we have reason to set cost-effectiveness thresholds to integrate equity concerns also including formal equality considerations. We find no reason not to compensate for group size to the extent we already compensate for other factors. Moreover, groups size implying a systematic disadvantage also on a global scale, i.e. taking different aspects of the health condition of patients suffering from rare diseases into account, will provide strong reason for why group size is indeed relevant to compensate for (if anything).

  • 43.
    Sandman, Lars
    et al.
    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.
    Gustavsson, Erik
    Linköping University, Department of Culture and Communication, Arts and Humanities. Linköping University, Faculty of Arts and Sciences.
    Munthe, Christian
    University of Gothenburg, Sweden.
    Individual responsibility as ground for priority setting in shared decision-making2016In: Journal of Medical Ethics, ISSN 0306-6800, E-ISSN 1473-4257, Vol. 42, no 10, p. 653-658Article in journal (Refereed)
    Abstract [en]

    Introduction Given healthcare resource constraints, voices are being raised to hold patients responsible for their health choices. In parallel, there is a growing trend towards shared decision-making, aiming to empower patients and give them more control over healthcare decisions. More power and control over decisions is usually taken to mean more responsibility for them. The trend of shared decision-making would therefore seem to strengthen the case for invoking individual responsibility in the healthcare priority setting. Objective To analyse whether the implementation of shared decision-making would strengthen the argument for invoking individual responsibility in the healthcare priority setting using normative analysis. Results and conclusions Shared decision-making does not constitute an independent argument in favour of employing individual responsibility since these notions rest on different underlying values. However, if a health system employs shared decision-making, individual responsibility may be used to limit resource implications of accommodating patient preferences outside professional standards and goals. If a healthcare system employs individual responsibility, high level dynamic shared decision-making implying a joint deliberation resulting in a decision where both parties are willing to revise initial standpoints may disarm common objections to the applicability of individual responsibility by virtue of making patients more likely to exercise adequate control of their own actions. However, if communication strategies applied in the shared decision-making are misaligned to the patients initial capacities, arguments against individual responsibility might, on the other hand, gain strength.

  • 44.
    Sandman, Lars
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Heintz, Emelie
    Linköping University, Department of Medical and Health Sciences. Linköping University, Faculty of Medicine and Health Sciences. Statens beredning för medicinska utvärderingar (SBU).
    ”Är du nyttig lille vän?”: om produktionspåverkan, konsumtionspåverkan och den svenska etiska plattformen för prioriteringar2013In: Prioriteringar i hälso- och sjukvården / [ed] Ingalill Rahm Hallberg, Lund: Region Skånes etiska råd , 2013, p. 63-93Chapter in book (Other academic)
    Abstract [sv]

    I Sverige har vi en etisk plattform som skall styra de prioriteringar som görs inom hälso- och sjukvården. Denna plattform innehåller tre principer: människovärdesprincipen, behovs-solidaritetsprincipen och kostnadseffektivitetsprincipen (se nedan). När man beräknar kostnadseffektiviteten för en viss insats inom hälso- och sjukvården så tar man dels med direkta kostnader (dvs. sådana kostnader som är direkt förknippade med sjukvården), dels väger man in indirekta kostnader (exempelvis kostnader för produktionspåverkan och framtida konsumtion) – dvs. kostnader som faller på en annan sektor i samhället än hälso- och sjukvården. Under senare år har detta väckt en del diskussion framförallt eftersom man menar att det är diskriminerande gentemot äldre eller grupper som inte kan återgå i arbete. Detta då åtgärder som riktas till dessa grupper inte kan ge samma produktionsintäkter i form av återgång till arbete som åtgärder som riktar sig till yngre arbetsföra individer. Som konsekvens blir deras framtida konsumtion endast en kostnad för samhället utan någon motsvarande vinst i form av ökad produktion. I denna uppsats analyserar vi huruvida det är etiskt försvarbart att väga in produktionspåverkan och framtida konsumtion när vi prioriterar hälso- och sjukvårdsinsatser1 utifrån den svenska etiska plattformen.

  • 45.
    Sandman, Lars
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Hofmann, Bjorn
    Norwegian Univ Sci and Technol NTNU Gjovik, Norway; Univ Oslo, Norway.
    Why We Dont Need "Unmet Needs"! On the Concepts of Unmet Need and Severity in Health-Care Priority Setting2019In: Health Care Analysis, ISSN 1065-3058, E-ISSN 1573-3394, Vol. 27, no 1, p. 26-44Article in journal (Refereed)
    Abstract [en]

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

  • 46.
    Sandman, Lars
    et al.
    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.
    Liliemark, Jan
    Swedish Agency Health Technology Assessment and Assessment, Sweden; Dent and Pharmaceut Benefits Agency, Sweden.
    From evidence-based to hope-based medicine? Ethical aspects on conditional market authorization of and early access to new cancer drugs2017In: Seminars in Cancer Biology, ISSN 1044-579X, E-ISSN 1096-3650, Vol. 45, p. 58-63Article, review/survey (Refereed)
    Abstract [en]

    There is a strong patient demand for early access to potentially beneficial cancer drugs. In line with this authorization agencies like the European Medicines Agency are providing drugs with conditional market authorisation based on positive interim analyses. This implies that drugs are used with insecure evidence of efficacy and adverse side-effects. Several authors have pointed to ethical problems with such a system but up to date no indepth ethical analysis of this system is found which is the aim of this article. Drawing of the four generally accepted principles of medical ethics: beneficence, nonmaleficence, respect for autonomy and justice the ethical pros and cons of conditional market authorisation are analysed. From the perspective of beneficence and non maleficence it is found that the main problem is not risk of adverse side-effects to patients, but rather risk of less beneficial outcomes than what can be expected which could change incentives for patients choice of treatment. This is also related to the extent to which patients might make an autonomous choice, especially taking into account problematic psychological attitudes and biases in medical decision-making. However, the main problem is related to justice and an equitable distribution of scarce health-care resources given the opportunity cost of drugs treatment. When using resources on cancer treatments which later might be found to be less efficacious than was first expected, other patients (in and outside the cancer field) are deprived of potentially more beneficial treatments even though their needs might be equally or more severe. At the same time, demanding more evidence has an ethical cost to patients in terms of depriving them of potential benefits in terms of reduced mortality and morbidity. In order to handle these ethical conflicts further research and analyses are required and it is suggested that pricing strategies and information requirements are alternatives to be further explored.

  • 47.
    Sandman, Lars
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Liliemark, Jan
    Linköping University.
    Withholding and withdrawing treatment for cost-effectiveness reasons: Are they ethically on par?2019In: Bioethics, ISSN 0269-9702, E-ISSN 1467-8519, Vol. 33, no 2, p. 278-286Article in journal (Refereed)
    Abstract [en]

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

  • 48.
    Sandman, Lars
    et al.
    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.
    Molander, Ulla
    University of Gothenburg, Sweden; Sahlgrens University Hospital, Sweden.
    Benkel, Inger
    University of Gothenburg, Sweden; Sahlgrens University Hospital, Sweden.
    Developing organisational ethics in palliative care: A three-level approach2017In: Nursing Ethics, ISSN 0969-7330, E-ISSN 1477-0989, Vol. 24, no 2, p. 138-150Article in journal (Refereed)
    Abstract [en]

    Background: Palliative carers constantly face ethical problems. There is lack of organised support for the carers to handle these ethical problems in a consistent way. Within organisational ethics, we find models for moral deliberation and for developing organisational culture; however, they are not combined in a structured way to support carers everyday work. Research objective: The aim of this study was to describe ethical problems faced by palliative carers and develop an adapted organisational set of values to support the handling of these problems. Research design: Ethical problems were mapped out using focus groups and content analysis. The organisational culture were developed using normative analysis and focus group methodology within a participatory action research approach. Main participants and research context: A total of 15 registered nurses and 10 assistant nurses at a palliative unit (with 19 patient beds) at a major University Hospital in Sweden. Ethical considerations: The study followed standard ethics guidelines concerning informed consent and confidentiality. Findings: We found six categories of ethical problems (with the main focus on problems relating to the patients loved ones) and five categories of organisational obstacles. Based on these findings, we developed a set of values in three levels: a general level, an explanatory level and a level of action strategies. Discussion: The ethical problems found corresponded to problems in other studies with a notable exception, the large focus on patient loved ones. The three-level set of values is a way to handle risks of formulating abstract values not providing guidance in concrete care voiced in other studies. Conclusion: Developing a three-level set of values adapted to the specific ethical problems in a concrete care setting is a first step towards a better handling of ethical problems.

  • 49.
    Scott, Anna Mae
    et al.
    The Dartmouth Institute for Health Policy & Clinical Practice, USA.
    Bond, Kenneth
    Canadian Agency for Drugs and Technologies in Health (CADTH).
    Gutierrez-Ibarluzea, Inaki
    Servicio de Evaluación de Tecnologías Sanitarias (OSTEBA).
    Hofmann, Björn
    University College of Gjovik, Norway.
    Sandman, Lars
    School of Health Sciences, University of Borås, Sweden.
    QUALITY ASSESSMENT OF ETHICS ANALYSES FOR HEALTH TECHNOLOGY ASSSESSMENT2016In: International Journal of Technology Assessment in Health Care, ISSN 0266-4623, E-ISSN 1471-6348, Vol. 32, no 5, p. 362-369Article in journal (Refereed)
    Abstract [en]

    Objectives: Although consideration of ethical issues is recognized as a crucial part of health technology assessment, ethics analysis for HTA is generally perceived as methodologically underdeveloped in comparison to other HTA domains. The aim of our study is (i) to verify existing tools for quality assessment of ethics analyses for HTA, (ii) to consider some arguments for and against the need for quality assessment tools for ethics analyses for HTA, and (iii) to propose a preliminary set of criteria that could be used for assessing the quality of ethics analyses for HTA.

    Methods: We systematically reviewed the literature, reviewed HTA organizations’ Web sites, and solicited views from thirty-two experts in the field of ethics for HTA.

    Results: The database and HTA agency Web site searches yielded 420 references (413 from databases, seven from HTA Web sites). No formal instruments for assessing the quality of ethics analyses for HTA purposes were identified. Thirty-two experts in the field of ethics for HTA from ten countries, who were brought together at two workshops held in Edmonton (Canada) and Cologne (Germany) confirmed the findings from the literature.

    Conclusions: Generating a quality assessment tool for ethics analyses in HTA would confer considerable benefits, including methodological alignment with other areas of HTA, increase in transparency and transferability of ethics analyses, and provision of common language between the various participants in the HTA process. We propose key characteristics of quality assessment tools for this purpose, which can be applied to ethics analyses for HTA purposes.

  • 50.
    Scott, Anna Mae
    et al.
    Centre for Research in Evidence-Based Practice (CREBP), Bond University, Gold Coast, Queensland, Australia.
    Hofmann, Björn
    Norwegian University for Science and Technology, Gjøvik, Norway; University of Oslo, Oslo, Norway.
    Gutiérrez-Ibarluzea, Iñaki
    Nursing University School Vitoria-Gasteiz, Vitoria-Gasteiz, Basque Country, Spain; Research and Innovation Directorate, Department for Health, Vitoria-Gasteiz, Basque Country, Spain .
    Bakke Lysdahl, Kristin
    University of Oslo, Oslo, Norway.
    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, Borås, Sweden.
    Bombard, Yvonne
    St. Michael's Hospital, Toronto, Canada; University of Toronto, Toronto, Canada.
    Q-SEA – a tool for quality assessment of ethics analyses conducted as part of health technology assessments2017In: GMS Health Technology Assessment, ISSN 1861-8863, E-ISSN 1861-8863, Vol. 13Article in journal (Refereed)
    Abstract [en]

    Introduction: Assessment of ethics issues is an important part of health technology assessments (HTA). However, in terms of existence of quality assessment tools, ethics for HTA is methodologically under-developed in comparison to other areas of HTA, such as clinical or cost effectiveness.Objective: To methodologically advance ethics for HTA by: (1) proposing and elaborating Q-SEA, the first instrument for quality assessment of ethics analyses, and (2) applying Q-SEA to a sample systematic review of ethics for HTA, in order to illustrate and facilitate its use. Methods: To develop a list of items for the Q-SEA instrument, we sys-tematically reviewed the literature on methodology in ethics for HTA, reviewed HTA organizations’ websites, and solicited views from 32 ex-perts in the field of ethics for HTA at two 2-day workshops. We sub-sequently refined Q-SEA through its application to an ethics analysis conducted for HTA.Results: Q-SEA instrument consists of two domains – the process do-main and the output domain. The process domain consists of 5 ele-ments: research question, literature search, inclusion/exclusion criteria, perspective, and ethics framework. The output domain consists of 5 elements: completeness, bias, implications, conceptual clarification, and conflicting values.Conclusion: Q-SEA is the first instrument for quality assessment of ethics analyses in HTA. Further refinements to the instrument to enhance its usability continue.

12 1 - 50 of 53
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