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  • 1.
    Andersson, Ulrika
    et al.
    Lund Univ, Sweden.
    Nilsson, Peter M.
    Lund Univ, Sweden.
    Kjellgren, Karin
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Nursing Sciences and Reproductive Health. Linköping University, Faculty of Medicine and Health Sciences. Univ Gothenburg, Sweden.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Wennersten, Andre
    Lund Univ, Sweden; Skane Univ Healthcare, Sweden.
    Midloev, Patrik
    Lund Univ, Sweden.
    PERson-centredness in Hypertension management using Information Technology: a randomized controlled trial in primary care2023In: Journal of Hypertension, ISSN 0263-6352, E-ISSN 1473-5598, Vol. 41, no 2, p. 246-253Article in journal (Refereed)
    Abstract [en]

    Objectives:To increase the proportion of individuals with hypertension obtaining a blood pressure (BP) of less than 140/90 mmHg by improving the management of hypertension in daily life from a person-centred perspective.Methods:In this unblinded randomized controlled trial, we tested an interactive web-based self-management system for hypertension. A total of 949 patients with hypertension from 31 primary healthcare centres (PHCCs) in Sweden were randomized 1 : 1 to either the intervention or usual care group. The intervention included daily measurement - via the participants mobile phone - of BP and pulse and reports of well being, symptoms, lifestyle, medication intake and side effects for eight consecutive weeks. It also included reminders and optional motivational messages. The primary outcome was the proportion of participants obtaining BP of less than 140/90 mmHg at 8 weeks and 12 months. Significance was tested by Pearsons chi(2)-test.Results:A total of 862 patients completed the trial, 442 in the intervention group and 420 in the control group. The primary outcome (BP <140/90 mmHg) at 8 weeks was achieved by 48.8% in the intervention group and 39.9% in the control group (P = 0.006). At 12 months, 47.1% (intervention) and 41.0% (control group) had a BP less than 140/90 mmHg (P = 0.071).Conclusion:The proportion of participants with a controlled BP of less than 140/90 mmHg increased after using the interactive system for self-management of hypertension for 8 weeks compared with usual care. Although the trend continued, there was no significant difference after 12 months. The results indicate that the effect of the intervention is significant, but the long-term effect is uncertain.

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  • 2.
    Andersson, Ulrika
    et al.
    Lund Univ, Sweden.
    Nilsson, Peter M.
    Lund Univ, Sweden.
    Kjellgren, Karin
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Nursing Sciences and Reproductive Health. Linköping University, Faculty of Medicine and Health Sciences. Univ Gothenburg, Sweden.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Wennersten, Andre
    Lund Univ, Sweden; Skane Univ Hlth Care, Sweden.
    Midlov, Patrik
    Lund Univ, Sweden.
    Examining the impact of E-health management on hypertension2023In: Journal of Hypertension, ISSN 0263-6352, E-ISSN 1473-5598, Vol. 41, no 11, article id 1864Article in journal (Other academic)
  • 3.
    Bäckryd, Emmanuel
    et al.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Pain and Rehabilitation Center.
    Heilig, Markus
    Linköping University, Department of Biomedical and Clinical Sciences, Center for Social and Affective Neuroscience. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Psykiatricentrum, Psykiatriska kliniken i Linköping.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Comment on Hauser et al.: Medical use of opioids in Europe - Methodological concerns about data from the International Narcotics Control Board2022In: European Journal of Pain, ISSN 1090-3801, E-ISSN 1532-2149, Vol. 26, no 4, p. 937-938Article in journal (Other academic)
    Abstract [en]

    n/a

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  • 4.
    Bäckryd, Emmanuel
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Pain and Rehabilitation Center.
    Heilig, Markus
    Linköping University, Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Local Health Care Services in Central Östergötland, Department of Psychiatry.
    Hoffmann, Mikael
    Stiftelsen NEPI - nätverk för läkmedelsepidemiologi - Linköping, Sweden .
    Dynamiken i förskrivningen av opioider i Sverige 2000–2015 - Markanta omfördelningar inom opioidgruppen, men ingen »epidemi«2017In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, Vol. 114Article in journal (Refereed)
    Abstract [en]

    Opioid prescription changes in Sweden 2000-2015 In contrast to the well-established »opioid epidemic« in the US, very little is known about how the prescription of opioids in Sweden has developed during the last decade. Aggregated data from the open Statistical database of the Swedish Board of Health and Welfare were analyzed descriptively. The yearly prevalence of opioid prescription did not change 2006-2015, but there were dramatic shifts in the choice of opioids. During this period, dextropropoxyphene was pulled off the market. Tramadol was used by fewer individuals (-54 % over the decade), but dosages expressed as Defined Daily Dose/patient/year (DDD/pat/y) increased (+41 %). In contrast, oxycodone and morphine were used by more individuals (+465 % and +137 %, respectively), but DDD/pat/y decreased during the period (-56% and -54%). Studies on non-aggregated data from available registries are needed to further elucidate the circumstances and possible consequences of these shifts in opioid prescription patterns.

  • 5.
    Bäckryd, Emmanuel
    et al.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Pain and Rehabilitation Center.
    Heilig, Markus
    Linköping University, Department of Biomedical and Clinical Sciences, Center for Social and Affective Neuroscience. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Psykiatricentrum, Psykiatriska kliniken i Linköping.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Opioid availability statistics from the International Narcotics Control Board do not reflect the medical use of opioids: comparison with sales data from Scandinavia2021In: Scandinavian Journal of Pain, ISSN 1877-8860, E-ISSN 1877-8879, Vol. 21, no 4, p. 696-706Article in journal (Refereed)
    Abstract [en]

    Objectives: Opioid analgesics are essential in clinical practice, but their excessive use is associated with addiction risk. Increases in opioid prescription rates have fuelled an epidemic of opioid addiction in the USA, making statistics on medical opioid use a critical warning signal. A dramatic 150% increase in Swedish opioid access 2001-2013 was recently reported based on data from the International Narcotics Control Board (INCB; Berterame et al. 2016) in conflict with other studies of opioid use in the Nordic countries. This article aims to analyse to what degree published INCB statistics on opioids in Scandinavia (Denmark, Norway and Sweden) reflect actual medical use and study the methodological reasons for putative discrepancies. Methods: Data on aggregated total national sales of opioids for the whole population, including hospitals, were collected from the Swedish e-Health Authority. Total sales data for Denmark and drugs dispensed at pharmacies in Norway are publicly available through the relevant authorities websites. Results: INCB opioid statistics during the period 2001-2013 were markedly inconsistent with sales data from Scandinavia, calling the reliability of INCB data into question. INCB-data were flawed by (a) over-representing the volume of fentanyl, (b) under-reporting of codeine, and (c) by not including tramadol. Conclusions: Opioid availability, as expressed by INCB statistics, does not reflect medical opioid use. It is crucial to underline that INCB statistics are based on the manual compilation of national production, import and export data from manufacturers and drug companies. This is not the same amount that is prescribed and consumed within the health care system. Moreover, there are methodological problems in the INCB reports, in particular concerning fentanyl, codeine and tramadol. We suggest that INCB should carefully review the quality of their data on medical opioids.

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  • 6.
    Bäckryd, Emmanuel
    et al.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Pain and Rehabilitation Center.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Många fallgropar i opioidstatistik2021In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, Vol. 36/37Article in journal (Other academic)
  • 7.
    Carlsson, Per
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Hoffman, Mikael
    Linköping University, Department of Medical and Health Sciences, Division of Drug Research. Linköping University, Faculty of Health Sciences. Nätverk för läkemedelsepidemiologi (NEPI).
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences. Högskolan i Borås, Institutionen för vårdvetenskap.
    Wiss, Johanna
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Prioritering av läkemedel för behandling av patienter med sällsynta sjukdomar2014In: Läkemedel för djur, maskinell dos och sällsynta tillstånd: hantering och prissättning. Slutbetänkande av Läkemedels- och apoteksutredningen, Stockholm: Fritzes, 2014, p. 639-699Chapter in book (Other academic)
    Abstract [sv]

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

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

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

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

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

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    Prioritering av läkemedel för behandling av patienter med sällsynta sjukdomar
  • 8.
    Carlsson, Per
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Hoffmann, Mikael
    Nätverk för läkemedelsepidemiologi, NEPI.
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Sandman, Lars
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Wiss, Johanna
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Prioritering och finansiering av läkemedel för behandling av patienter med sällsynta sjukdomar: Reviderad version2015Report (Other academic)
    Abstract [en]

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

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

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

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

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

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

    Our conclusions from the ethical analysis are:

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

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

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

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

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

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

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

    • Based on the goal to reduce differences and guarantee care on equal terms for rare conditions, it would be preferable to use a model involving national decision making. The same principles for prioritising drugs for rare and severe conditions should apply regardless of how the drug reaches the patient, i.e. regardless of whether it involves prescribed or requisitioned drugs. Whether one or more bodies set priorities is an organisational issue that we do not address in this report.
    • From a priority setting standpoint there should be no difference between orphan drugs and other drugs used for rare conditions. When it comes to decisions on whether orphan drugs in general should be included under the pharmaceutical benefits system, they should be assessed and approved by the Dental and Pharmaceutical Benefits Agency in usual fashion, while drugs targeted at conditions that are both very rare and very severe may need special consideration and handled according to a modified procedure. This should include the cost per health gain and dealing with uncertainty of the scientific evidence, and should apply whether or not the drug has orphan status.
    • In some situations where the scientific evidence is uncertain, problems arise in deciding on general use of expensive drugs for severe diseases on a group level. In this context it seems reasonable to initially allow some exceptions in the evidence for cost effectiveness related to severe diseases when, for various reasons, practical factors stand in the way of producing such evidence. However, a conflict can arise in both accepting a higher willingness to pay and accepting greater uncertainty in the scientific evidence. In such cases it is particularly important to pursue adequate follow-up and try to reduce uncertainty as quickly as possible and reassess the decision.
    • Various principles are available to define patient groups with very severe and rare conditions. Groups may be defined based on the prevalence of the condition in the population or on the number of patients with a given condition that the drug in question will be used to treat (in other words, the number of patients who are potential candidates for treatment). The latter method appears to be advantageous when the particular problem we address here relates to the fact that few patients are candidates for treatment, not how usual/unusual the condition/disease is. In the report we do not take a definitive position on what constitutes a suitable limit. This needs further study. However, we believe that such a limit should be set much lower than the usual definition for orphan drugs. In Sweden’s case, a reasonable starting point for discussion could be that the expected estimated size of the patient group should not exceed 200 patients (1 in 50 000 inhabitants) during 5 years. Experience from England, for instance, supports this definition.
    • One way to arrive at a reasonable threshold for cost effectiveness in different situations involving rare conditions is to designate some entity to make decisions transparently. Such decisions could then be discussed broadly and possibly be subject to reassessment. By comparing with other situations in health care and society where decisions are made on interventions for severe conditions and small patient groups, the development of accepted practice can be accelerated. Even comparisons with decisions in other countries can give an indication of reasonable threshold values in various situations.
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  • 9.
    Carlsson, Per
    et al.
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Hoffmann, Mikael
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Sandman, Lars
    Högskolan i Borås.
    Wiss, Johanna
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Prioritering och finansiering av läkemedel för behandling av patienter med sällsynta sjukdomar: Reviderad version2012Report (Other academic)
    Abstract [en]

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

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

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

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

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

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

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

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    Prioritering och finansiering av läkemedel för behandling av patienter med sällsynta sjukdomar: Reviderad version
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  • 10.
    Erlandsson, Marcus
    et al.
    Linköping University, Department of Clinical and Experimental Medicine. Linköping University, Faculty of Health Sciences.
    Hanberger, Håkan
    Linköping University, Department of Clinical and Experimental Medicine, Infectious Diseases . Linköping University, Faculty of Health Sciences.
    Hoffmann, Mikael
    Isaksson, Barbro
    Linköping University, Department of Clinical and Experimental Medicine, Clinical Microbiology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Laboratory Medicine, Department of Clinical Microbiology.
    Lindgren, Sune
    Sörén, L.
    Department of Clinical Microbiology, County Hospital, Jönköping .
    Walther, Sten
    Linköping University, Department of Medicine and Health Sciences, Physiology . Linköping University, Faculty of Health Sciences.
    Surveillance of Antibiotic Resistance in ICUs in Southeastern Sweden1999In: Acta Anaesthesiol Scand, Vol. 43, no 8, p. 815-820Article in journal (Refereed)
    Abstract [en]

    Background: A study was designed to assess a computer-based program for continuous registration of antibiotic resistance, statistics concerning severity of illness, and consumption of antibacterial drugs.

    Methods: The frequency of antibiotic resistance among bacteria in eight ICUs in southeastern Sweden was investigated yearly from 1995 through 1997. The antibiotic consumption in the ICUs was registered as defined daily doses (DDD) and compared to severity of illness (APACHE-II scores).

    Results: There was a statistically significant increase in ampicillin resistance among Enterococcus spp. between 1996 and 1997, which was due to a shift from Enterococcus faecalis to Enterococcus faecium. A high prevalence of resistance among coagulase-negative staphylococci to oxacillin (≈ 70%), ciprofloxacin (≈ 50%), fucidic acid (≈ 50%) and netilmicin (≈ 30%) was seen in all ICUs during the whole study period. There was a statistically significant increase in ciprofloxacin resistance among Escherichia coli and Enterococcus spp. The resistance among Enterobacter spp. to cefotaxime decreased but this change was not statistically significant. Efforts were made to avoid betalactam antibiotics, except carbapenems, for treatment of infections caused by Enterobacter spp. and the consumption of cephalosporins decreased whereas the consumption of carbapenems increased. The total antibiotic consumption decreased by 2.5% during the study period. There was no correlation between APACHE II scores and antibiotic consumption.

    Conclusions: Each ICU within a hospital ought to have a program for "on-line" antibiotic resistance surveillance of drugs used in that unit so that changes in empirical treatment can be made when there is an increase in antibiotic-resistant isolates within that unit.

  • 11.
    Godman, B.
    et al.
    Institute for Pharmacological Research, Mario Negri, Milan.
    Wettermark, B.
    Stockholm County Council.
    Hoffmann, M.
    Linköping University, Department of Medicine and Health Sciences, Pharmacology . Linköping University, Faculty of Health Sciences.
    Andersson, K.
    Nordic School of Public Health.
    Haycox, A.
    University of Liverpool Management School.
    Gustafsson, L.L.
    Stockholm County Council.
    Multifaceted national and regional drug reforms and initiatives in ambulatory care in Sweden: Global relevance2009In: Expert Review of Pharmacoeconomics and Outcomes Research, ISSN 1473-7167, Vol. 9, no 1, p. 65-83Article in journal (Refereed)
    Abstract [en]

    It is a continual challenge trying to improve the quality of prescribing while concurrently trying to address increasing pharmaceutical development, utilization and expenditure. National and regional reforms and initiatives in Sweden have moderated growth in ambulatory drug expenditure to 2.7% per annum in recent years despite increasing volumes. National reforms include mandatory generic substitution and value-based pricing alongside devolution of drug budgets to the regions. Regional initiatives include strengthening the role of the regional Drug and Therapeutic Committees, further budget devolution as well as strategies incorporating prescribing guidance and monitoring coupled with financial incentives. The extent and nature of the regional initiatives vary depending on their characteristics. In this article, we compare initiatives undertaken in two major counties, Stockholm and Östergötland, and their outcomes. Outcomes include annual drug budget savings while achieving agreed quality as well as increased adherence to prescribing targets and guidance; the latter associated with savings. Appraising these multifaceted reforms can provide guidance to other countries and regions in view of their diversity. Future steps must incorporate measures to improve the utilization of new expensive drugs, which should include horizon scanning and forecasting activities as well as post-launch activities involving monitoring of prescribing and registries. This may well require cooperation with other European countries.

  • 12.
    Hallberg, Inger
    et al.
    Institutionen för vårdvetenskap och hälsa, Göteborgs Universitet, Centrum för personcentrerad vård, Sahlgrenska akademin, Göteborgs Universitet.
    Taft, Charles
    Institutionen för vårdvetenskap och hälsa, Göteborgs Universitet, Centrum för personcentrerad vård, Sahlgrenska akademin, Göteborgs Universitet.
    Ranerup, Agneta
    Avdelningen för informatik, Göteborgs Universitet, Centrum för personcentrerad vård, Sahlgrenska akademin, Göteborgs Universitet.
    Bengtsson, Ulrika
    Institutionen för vårdvetenskap och hälsa, Göteborgs Universitet, Centrum för personcentrerad vård, Sahlgrenska akademin, Göteborgs Universitet.
    Hoffman, Mikael
    Linköping University, Department of Medical and Health Sciences. Linköping University, Faculty of Health Sciences. Stiftelsen NEPI, Linköping .
    Höfer, Stefan
    Department of Medical Psychology, Innsbruck Medical University, Innsbruck, Austria.
    Kasperowski, Dick
    Institutionen för filosofi, lingvistik och vetenskapsteori, Göteborgs Universitet.
    Mäkitalo, Åsa
    Institutionen för pedagogik, kommunikation och lärande, Göteborgs Universitet.
    Lundin, Mona
    Institutionen för pedagogik, kommunikation och lärande, Göteborgs Universitet.
    Ring, Lena
    Centrum för forsknings- och bioetik, Uppsala Universitet, Enheten för läkemedelsanvändning, Läkemedelsverket, Uppsala.
    Rosenqvist, Ulf
    Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Local Health Care Services in West Östergötland, Department of Medical Specialist in Motala.
    Kjellgren, Karin I
    Linköping University, Department of Medical and Health Sciences, Division of Nursing Science. Linköping University, Faculty of Health Sciences. Institutionen för vårdvetenskap och hälsa, Göteborgs Universitet, Centrum för personcentrerad vård, Sahlgrenska akademin, Göteborgs Universitet.
    Phases in development of an interactive mobile phone-based system to support self-management of hypertension2014In: Integrated Blood Pressure Control, E-ISSN 1178-7104, Vol. 7, p. 19-28Article in journal (Refereed)
    Abstract [en]

    Hypertension is a significant risk factor for heart disease and stroke worldwide. Effective treatment regimens exist; however, treatment adherence rates are poor (30%–50%). Improving self-management may be a way to increase adherence to treatment. The purpose of this paper is to describe the phases in the development and preliminary evaluation of an interactive mobile phone-based system aimed at supporting patients in self-managing their hypertension. A person-centered and participatory framework emphasizing patient involvement was used. An interdisciplinary group of researchers, patients with hypertension, and health care professionals who were specialized in hypertension care designed and developed a set of questions and motivational messages for use in an interactive mobile phone-based system. Guided by the US Food and Drug Administration framework for the development of patient-reported outcome measures, the development and evaluation process comprised three major development phases (1, defining; 2, adjusting; 3, confirming the conceptual framework and delivery system) and two evaluation and refinement phases (4, collecting, analyzing, interpreting data; 5, evaluating the self-management system in clinical practice). Evaluation of new mobile health systems in a structured manner is important to understand how various factors affect the development process from both a technical and human perspective. Forthcoming analyses will evaluate the effectiveness and utility of the mobile phone-based system in supporting the self-management of hypertension.

    Download full text (pdf)
    fulltext
  • 13. Order onlineBuy this publication >>
    Hoffmann, Mikael
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Risk Talk: On Communicating Benefits and Harms in Health Care2006Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    One of the most critical elements in empowering the patient, and ensuring concordance, is communication of the possible benefits and harms of different actions in health care. Risk assessment is a complex task due both to the different interpretations of the concept of risk, and the common lack of hard facts. Hormone, or hormone replacement, therapy (HT) is used by many women in, and after, the menopause. The benefits and possible harms associated with short and long term treatment with HT have been extensively discussed the last decade and the use of HT has decreased dramatically internationally the last few years.

    The aims of this thesis were to study the interaction between patient and physician when discussing risks and benefits of different treatment alternatives, and to suggest strategies to improve risk communication in clinical practice. The studies have focused on how risks and benefits with HT were communicated between women and physicians during firsttime consultations in 1999- 2000 on this subject (20 women, 5 gynaecologists), and through questionnaires how attitudes towards HT have changed between 1999 (n=1,760) and 2003 (n=1,733) among women entering the menopause (53-54 years).

    Through a qualitative analysis of the risk communication in the consultations a system was constructed to classify how risk is communicated in relation to benefits. This was used to assess and present differences in risk communication in the consultations. Different rhetorical strategies by the physicians were identified and the dominating tendency was a move from the woman’s current problems to the long-term effects of HT.

    The questionnaires showed a marked difference in attitudes towards HT between the years. In 2003 women perceived HT to be associated with higher risk and less benefits than in 1999. This correlated to a drastic reduction in the use of HT over the same period. Media was the most frequent source of information about HT during the last twelve months before the questionnaire in 2003.

    Possible explanations for the different attitudes towards HT between women entering the menopause and gynaecologist; how this difference might have influenced the results; and how they may have implications for future communication strategies are discussed. This thesis illustrates the importance of a deeper understanding in health care of the concept of risk in order to achieve an adequate communication of risk. This is important both in consultations and in campaigns to educate and inform the public.

    List of papers
    1. Hormone replacement therapy in the menopause - structure and content of risk talk
    Open this publication in new window or tab >>Hormone replacement therapy in the menopause - structure and content of risk talk
    Show others...
    2005 (English)In: Maturitas, ISSN 0378-5122, E-ISSN 1873-4111, Vol. 50, no 1, p. 8-18Article in journal (Refereed) Published
    Abstract [en]

    Objective: To investigate how risks and benefits of hormone replacement therapy (HRT) are communicated to women in clinical practice. To evaluate the usefulness of a risk classification based on context framing, i.e. whether the risk is discussed for one or several alternative treatments, and/or in the same context as possible benefits.

    Design: Analysis of structure and content of transcribed consultations (n=20) from first-time visits for discussion of climacteric discomfort and/or HRT with five physicians at three different out-patient clinics of gynecology.

    Results: All women received a prescription of HRT. An alternative to HRT was discussed in seven of the consultations. No decision aids were used. Risk discussion was dominated by the physicians giving information about long-time risk and benefits. The decision to prescribe was made either before the risk discussion was initiated, or before it was finished, in 8 of the 18 consultations where risk discussion was present. Risk classification according to context framing was performed and indicated use of different communication strategies by the physicians.

    Conclusions: The perspective of the physicians was mainly on prevention while the women were more focused on symptom alleviation. Each physician had a strategy of his/her own for the risk discussion. Thus, the major differences found between the consultations were between physicians, and not between the women. Risk discussion seemed to be aimed at motivating the woman to follow the physician’s decision rather than to help her participate in the decision-making process.

    Keywords
    Hormone replacement therapy, Risk, Communication, Patient participation, Patient compliance, Concordance
    National Category
    Medical and Health Sciences
    Identifiers
    urn:nbn:se:liu:diva-13970 (URN)10.1016/j.maturitas.2004.03.014 (DOI)
    Available from: 2006-09-19 Created: 2006-09-19 Last updated: 2021-12-28Bibliographically approved
    2. Risk communication in consultations about hormone therapy in the menopause – concordance in risk assessment and framing due to the context
    Open this publication in new window or tab >>Risk communication in consultations about hormone therapy in the menopause – concordance in risk assessment and framing due to the context
    Show others...
    2006 (English)In: Climacteric, ISSN 1369-7137, E-ISSN 1473-0804, Vol. 9, no 5, p. 347-354Article in journal (Refereed) Published
    Abstract [en]

    Background

    It is important for the physician and the patient to have a mutual understanding of the possible consequences of different treatment alternatives in order to achieve a partnership in decision making.

    Objective

    The aim of this study was to explore to which degree first-time consultations for discussion of climacteric discomfort achieved shared understanding of the risks and benefits associated with hormone therapy in the menopausal transition (HT).

    Methods

    Analysis of structure and content of transcribed consultations (n=20), and follow-up interviews of the women (n=19 pairs of consultations and interviews), from first-time visits for discussion of climacteric discomfort and/or HT with five physicians at three different out-patient clinics of gynaecology in Sweden.

    Results

    Four distinctively different interpretations of risk, depending on whether or not benefits were discussed in the same context, emerged from the analysis. On average 5 advantages (range 0-11) and 2 (0-3) disadvantages were mentioned during the consultations. In the interviews the women expressed on average 4 advantages (0-7) and 1 disadvantage (0-3). There were major variations between advantages and disadvantages expressed in the consultation and the following interview.

    Conclusion

    Even though the consultations scored high in patient involvement, the information in most consultations was not structured in a way that made it possible to achieve a shared or an informed decision making.

    Keywords
    Risk, Risk assessment, Communication, Physician-Patient Relations, Professional-Patient Relations
    National Category
    Medical and Health Sciences
    Identifiers
    urn:nbn:se:liu:diva-11692 (URN)10.1080/13697130600870220 (DOI)17000583 (PubMedID)
    Note

    Original publication: Hoffmann M, Hammar M, Kjellgren K I, Lindh-Åstrand L and Ahlner J, Risk communication in consultations about hormone therapy in the menopause – concordance in risk assessment and framing due to the context, 2006, Climacteric, (9), 5, 347-354. http://dx.doi.org/10.1080/13697130600870220. Copyright © Taylor & Francis Group, an informa business

    Available from: 2008-10-13 Created: 2008-10-13 Last updated: 2024-01-05Bibliographically approved
    3. Risk talk: rhetorical strategies in consultations on hormone replacement therap
    Open this publication in new window or tab >>Risk talk: rhetorical strategies in consultations on hormone replacement therap
    2005 (English)In: Health, Risk and Society, ISSN 1369-8575, E-ISSN 1469-8331, Vol. 5, no 2, p. 139-154Article in journal (Refereed) Published
    Abstract [en]

    When analysing risk discussions in medical settings it is important to consider the specific activity type. In this qualitative study 20 first-time consultations by healthy women regarding hormone replacement therapy (HRT) in the menopause the risk discussion is asymmetrical with the doctors dominating. Despite being set up as a specific opportunity for women in the menopause to discuss problems and risks, it comes forth as a decision-making activity in a traditional medical setting. The consultations fulfil to a high extent the demands for informed decision making, but the risk discussions are recontextualised into a cost-benefit discourse with a typical implicit quantitative bias. The doctors use several different rhetorical strategies such as positive introduction of HRT, embedding drawbacks in positive introductions and/or exits thereby diminishing them. The word risk is avoided to a considerable extent and the term 'drawbacks' is used instead. The most obvious strategy is to move from the woman's symptoms to aspects of prevention, thus changing the discussion from the menopause and different strategies to cope with menopausal problems into a medically oriented discussion of pharmacological treatment alternatives. The 'change of life' in these talks is entirely conceptualised within a 'medical model'.

    Place, publisher, year, edition, pages
    Hants, UK: Carfax Publishing, 2005
    Keywords
    Risk, Communication, Menopause, Hormone Replacement Therapy, Physician-patient Relations
    National Category
    Medical and Health Sciences
    Identifiers
    urn:nbn:se:liu:diva-13972 (URN)10.1080/1369857031000123920 (DOI)000184127500003 ()
    Available from: 2006-09-19 Created: 2006-09-19 Last updated: 2021-12-28
    4. Changes in women’s attitudes towards and use of hormone therapy after HERS and WHI
    Open this publication in new window or tab >>Changes in women’s attitudes towards and use of hormone therapy after HERS and WHI
    Show others...
    2005 (English)In: Maturitas, ISSN 0378-5122, E-ISSN 1873-4111, Vol. 52, no 1, p. 11-17Article in journal (Refereed) Published
    Abstract [en]

    Objectives:

    To assess changes in women's attitudes towards risk and benefits of, and use of hormone treatment in the menopausal transition (HT) before and after Heart and Estrogen/Progestin Replacement Study (HERS) and the oestrogen and progestin trial of Women's Health Initiative (WHI).

    Methods:

    Postal questionnaires to all women 53 and 54 years of age in a Swedish community in 1999 (n = 1.760) and 2003 (n = 1.733). Data on sales of HT were collected from the database of the National Corporation of Swedish Pharmacies.

    Results:

    The fraction of women reporting current use of HT fell from 40.5 to 25.3% (p < 0.001, χ2-test) both by fewer women starting and more women discontinuing treatment. This corresponded to a decrease in dispensation of HT in Linköping and nationwide for the same age group. The fraction of women who had tried complementary treatment for climacteric discomfort, increased from 9.6 to 18.1% for natural remedies (p < 0.001, χ2-test).

    Women perceived HT as more risky and less beneficial in 2003 as compared with 1999 (both p < 0.001, χ2-test). The most frequent source of information about HT during the last year before the 2003 questionnaire were newspaper or magazines (43.8%) and television or radio (31.7%).

    Conclusions:

    The decreased use of HT in the community correlated with pronounced changes in the attitudes towards HT. Media were a more frequent source of information than health care personnel. This indicates that media reports about major clinical studies might have influenced the use of HT among women.

    Place, publisher, year, edition, pages
    Elsevier, 2005
    Keywords
    Hormone replacement therapy, Risk, Communication, Communications media/mass media, Concordance (patient compliance)
    National Category
    Medical and Health Sciences
    Identifiers
    urn:nbn:se:liu:diva-13973 (URN)10.1016/j.maturitas.2005.06.003 (DOI)
    Available from: 2006-09-19 Created: 2006-09-19 Last updated: 2021-12-28Bibliographically approved
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  • 14.
    Hoffmann, Mikael
    Stiftelsen NEPI Linköping, Sweden.
    Slutreplik angående virtuell vård: Dags att skynda på införandet av telemedicin i all offentlig vård2017In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, Vol. 114Article in journal (Other (popular science, discussion, etc.))
  • 15.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. NEPI Fdn, Sweden; Swedish Soc Med, Sweden.
    Timeline of and Expectations for the National Medication List in Sweden2023In: CARING IS SHARING-EXPLOITING THE VALUE IN DATA FOR HEALTH AND INNOVATION-PROCEEDINGS OF MIE 2023, IOS PRESS , 2023, Vol. 302, p. 327-331Conference paper (Refereed)
    Abstract [en]

    It is important to separate the continuous chains of medications orders (or decisions by the prescriber) in modern electronic health records from the one-way communication of prescriptions from healthcare to pharmacies. To support the self-administration of prescribed drugs the patient needs a continuously updated list of medication orders. For the NLL to function as a safe resource for the patient, it is necessary to have the information updated, curated, and documented by prescribers in a one-step process within the electronic health record. Four of the Nordic countries have chosen separate ways trying to achieve this. The experiences and obstacles during the introduction of the mandatory National Medication List (NLL) in Sweden and the resulting delays are described. The planned integration for 2022 is now delayed to 2025 and will probably only be achieved in 2028 or even 2030 in some regions.

  • 16.
    Hoffmann, Mikael
    et al.
    Stiftelsen NEPI, Sverige.
    Böttiger, Ylva
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Drug Research. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Diagnostics, Department of Clinical Pharmacology.
    Nationell process för värdering av off label-användning behövs2020In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, Vol. 117Article in journal (Refereed)
    Abstract [sv]

    Läkemedelsverket rapporterar att man inte, utifrån sitt etablerade arbetssätt, kan genomföra nytta–riskvärdering av läkemedel utanför godkänd indikation. 

    Sjukvården har ett behov av en nationell process för värdering av off label-användning av vissa läkemedel. 

    Sjukvården behöver också fler och innovativa akademiskt drivna läkemedelsstudier.

  • 17.
    Hoffmann, Mikael
    et al.
    Linköping University, Department of Medicine and Care, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Hammar, Mats
    Linköping University, Department of Molecular and Clinical Medicine, Obstetrics and gynecology. Linköping University, Faculty of Health Sciences.
    Kjellgren, K. I.
    Faculty of Health and Caring Sciences, Institute of Nursing, The Sahlgrenska Academy at Göteborg University, Sweden.
    Lindh-Åstrand, Lotta
    Linköping University, Department of Molecular and Clinical Medicine, Obstetrics and gynecology. Linköping University, Faculty of Health Sciences.
    Ahlner, Johan
    Department of Forensic Chemistry, National Board of Forensic Medicine, Linköping, Sweden.
    Risk communication in consultations about hormone therapy in the menopause – concordance in risk assessment and framing due to the context2006In: Climacteric, ISSN 1369-7137, E-ISSN 1473-0804, Vol. 9, no 5, p. 347-354Article in journal (Refereed)
    Abstract [en]

    Background

    It is important for the physician and the patient to have a mutual understanding of the possible consequences of different treatment alternatives in order to achieve a partnership in decision making.

    Objective

    The aim of this study was to explore to which degree first-time consultations for discussion of climacteric discomfort achieved shared understanding of the risks and benefits associated with hormone therapy in the menopausal transition (HT).

    Methods

    Analysis of structure and content of transcribed consultations (n=20), and follow-up interviews of the women (n=19 pairs of consultations and interviews), from first-time visits for discussion of climacteric discomfort and/or HT with five physicians at three different out-patient clinics of gynaecology in Sweden.

    Results

    Four distinctively different interpretations of risk, depending on whether or not benefits were discussed in the same context, emerged from the analysis. On average 5 advantages (range 0-11) and 2 (0-3) disadvantages were mentioned during the consultations. In the interviews the women expressed on average 4 advantages (0-7) and 1 disadvantage (0-3). There were major variations between advantages and disadvantages expressed in the consultation and the following interview.

    Conclusion

    Even though the consultations scored high in patient involvement, the information in most consultations was not structured in a way that made it possible to achieve a shared or an informed decision making.

    Download full text (pdf)
    fulltext
  • 18.
    Hoffmann, Mikael
    et al.
    Linköping University, Department of Medicine and Care, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Hammar, Mats
    Linköping University, Department of Molecular and Clinical Medicine, Obstetrics and gynecology. Linköping University, Faculty of Health Sciences.
    Kjellgren, Karin I.
    Faculty of Health and Caring Sciences, Institute of Nursing, The Sahlgrenska Academy at Göteborg University, Göteborg, Sweden.
    Lindh-Åstrand, Lotta
    Linköping University, Department of Molecular and Clinical Medicine, Obstetrics and gynecology. Linköping University, Faculty of Health Sciences.
    Brynhildsen, Jan
    Linköping University, Department of Molecular and Clinical Medicine, Obstetrics and gynecology. Linköping University, Faculty of Health Sciences.
    Changes in women’s attitudes towards and use of hormone therapy after HERS and WHI2005In: Maturitas, ISSN 0378-5122, E-ISSN 1873-4111, Vol. 52, no 1, p. 11-17Article in journal (Refereed)
    Abstract [en]

    Objectives:

    To assess changes in women's attitudes towards risk and benefits of, and use of hormone treatment in the menopausal transition (HT) before and after Heart and Estrogen/Progestin Replacement Study (HERS) and the oestrogen and progestin trial of Women's Health Initiative (WHI).

    Methods:

    Postal questionnaires to all women 53 and 54 years of age in a Swedish community in 1999 (n = 1.760) and 2003 (n = 1.733). Data on sales of HT were collected from the database of the National Corporation of Swedish Pharmacies.

    Results:

    The fraction of women reporting current use of HT fell from 40.5 to 25.3% (p < 0.001, χ2-test) both by fewer women starting and more women discontinuing treatment. This corresponded to a decrease in dispensation of HT in Linköping and nationwide for the same age group. The fraction of women who had tried complementary treatment for climacteric discomfort, increased from 9.6 to 18.1% for natural remedies (p < 0.001, χ2-test).

    Women perceived HT as more risky and less beneficial in 2003 as compared with 1999 (both p < 0.001, χ2-test). The most frequent source of information about HT during the last year before the 2003 questionnaire were newspaper or magazines (43.8%) and television or radio (31.7%).

    Conclusions:

    The decreased use of HT in the community correlated with pronounced changes in the attitudes towards HT. Media were a more frequent source of information than health care personnel. This indicates that media reports about major clinical studies might have influenced the use of HT among women.

  • 19.
    Hoffmann, Mikael
    et al.
    Linköping University, Department of Medicine and Care, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Lindh-Åstrand, Lotta
    Linköping University, Department of Molecular and Clinical Medicine, Obstetrics and gynecology. Linköping University, Faculty of Health Sciences.
    Ahlner, Johan
    National Board of Forensic Medicine, Linköping, Sweden.
    Hammar, Mats
    Linköping University, Department of Molecular and Clinical Medicine, Obstetrics and gynecology. Linköping University, Faculty of Health Sciences.
    Kjellgren, Karin I.
    Faculty of Health and Caring Sciences, Institute of Nursing, The Sahlgrenska Academy at Göteborg University, Göteborg, Sweden.
    Hormone replacement therapy in the menopause - structure and content of risk talk2005In: Maturitas, ISSN 0378-5122, E-ISSN 1873-4111, Vol. 50, no 1, p. 8-18Article in journal (Refereed)
    Abstract [en]

    Objective: To investigate how risks and benefits of hormone replacement therapy (HRT) are communicated to women in clinical practice. To evaluate the usefulness of a risk classification based on context framing, i.e. whether the risk is discussed for one or several alternative treatments, and/or in the same context as possible benefits.

    Design: Analysis of structure and content of transcribed consultations (n=20) from first-time visits for discussion of climacteric discomfort and/or HRT with five physicians at three different out-patient clinics of gynecology.

    Results: All women received a prescription of HRT. An alternative to HRT was discussed in seven of the consultations. No decision aids were used. Risk discussion was dominated by the physicians giving information about long-time risk and benefits. The decision to prescribe was made either before the risk discussion was initiated, or before it was finished, in 8 of the 18 consultations where risk discussion was present. Risk classification according to context framing was performed and indicated use of different communication strategies by the physicians.

    Conclusions: The perspective of the physicians was mainly on prevention while the women were more focused on symptom alleviation. Each physician had a strategy of his/her own for the risk discussion. Thus, the major differences found between the consultations were between physicians, and not between the women. Risk discussion seemed to be aimed at motivating the woman to follow the physician’s decision rather than to help her participate in the decision-making process.

  • 20.
    Hoffmann, Mikael
    et al.
    Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
    Linell, Per
    Linköping University, Department of Culture and Communication. Linköping University, Faculty of Arts and Sciences.
    Lindh-Åstrand, Lotta
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology. Linköping University, Faculty of Health Sciences.
    Kjellgren, Karin I.
    Faculty of Health and Caring Sciences, Institute of Nursing, The Sahlgrenska Academy at Göteborg University, Göteborg, Sweden.
    Risk talk: rhetorical strategies in consultations on hormone replacement therap2005In: Health, Risk and Society, ISSN 1369-8575, E-ISSN 1469-8331, Vol. 5, no 2, p. 139-154Article in journal (Refereed)
    Abstract [en]

    When analysing risk discussions in medical settings it is important to consider the specific activity type. In this qualitative study 20 first-time consultations by healthy women regarding hormone replacement therapy (HRT) in the menopause the risk discussion is asymmetrical with the doctors dominating. Despite being set up as a specific opportunity for women in the menopause to discuss problems and risks, it comes forth as a decision-making activity in a traditional medical setting. The consultations fulfil to a high extent the demands for informed decision making, but the risk discussions are recontextualised into a cost-benefit discourse with a typical implicit quantitative bias. The doctors use several different rhetorical strategies such as positive introduction of HRT, embedding drawbacks in positive introductions and/or exits thereby diminishing them. The word risk is avoided to a considerable extent and the term 'drawbacks' is used instead. The most obvious strategy is to move from the woman's symptoms to aspects of prevention, thus changing the discussion from the menopause and different strategies to cope with menopausal problems into a medically oriented discussion of pharmacological treatment alternatives. The 'change of life' in these talks is entirely conceptualised within a 'medical model'.

  • 21.
    Hoffmann, Mikael
    et al.
    Stiftelsen NEPI - nätverk för läkmedelsepidemiologi - Linköping, Sweden - Stiftelsen NEPI Linköping, Sweden.
    Lövström, Rikard
    Sweden.
    Nordgren, Håkan
    Sweden.
    Vårdpersonal bör vara öppna för att dra nytta av e-hälsa2018In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, Vol. 115Article in journal (Other academic)
    Abstract [en]

    n/a

  • 22.
    Hoffmann, Mikael
    et al.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Nilsson, Peter M.
    Lund Univ, Sweden.
    Ahlner, Johan
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Drug Research. Linköping University, Faculty of Medicine and Health Sciences.
    Dahllof, Bjorn
    Univ Gothenburg, Sweden.
    Fredrikson, Mats
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Inflammation and Infection. Linköping University, Faculty of Medicine and Health Sciences.
    Saljo, Roger
    Univ Gothenburg, Sweden.
    Kjellgren, Karin
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Nursing Sciences and Reproductive Health. Linköping University, Faculty of Medicine and Health Sciences.
    Do patients or their physicians more accurately assess long-term risk associated with hypertension? A population-based study2020In: Scandinavian Journal of Primary Health Care, ISSN 0281-3432, E-ISSN 1502-7724, Vol. 38, no 2, p. 166-175Article in journal (Refereed)
    Abstract [en]

    Objective: To compare the assessments of 10-year probability by patients and their physicians of cardiovascular complications of hypertension with actual outcomes. Design: Patients with uncomplicated hypertension treated with at least one antihypertensive drug at inclusion were followed for 10 years through mandatory national health registers. Setting: 55 primary health care centres, 11 hospital outpatient clinics in Sweden Patients: 848 patient, 212 physicians. Main outcome measures: Patients and physicians estimated the probability of hypertension-related complications with treatment (death, heart failure, acute myocardial infarction/AMI, and stroke) for each patient in 848 pairs. Estimates were compared with the clinical outcomes 10 years later using data from the Mortality Register and the National Patient Register. Results: Patients were significantly better (p &lt; 0.001) than their physicians in estimating the average probability of heart failure compared with actual outcome data (14% vs. 24%, outcome 15%), AMI (16% vs. 26%, outcome 8%), and stroke (15% vs. 25%, outcome 11%). Patients were significantly worse (p &lt; 0.001) at estimating the average probability of death (10% vs. 18%, actual outcome 20%). Neither the patients nor the physicians were able to distinguish reliably between low-risk and high-risk patients after adjustment for age and sex. Conclusions: Patients were better than their physicians in estimating the average probability of morbidity due to hypertension. Both the patients and their attending physicians had difficulty in estimating the individual patients risk of complications. The results support the use of evidence-based tools in consultations for assessing the risk of cardiovascular complications associated with hypertension.

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  • 23.
    Hoffmann, Mikael
    et al.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. NEPI Fdn, Sweden.
    Stovring, Henrik
    Univ Southern Denmark, Denmark.
    Incidence in pharmacoepidemiology - Basic definitions and types of misclassification2022In: Basic & Clinical Pharmacology & Toxicology, ISSN 1742-7835, E-ISSN 1742-7843, Vol. 130, no 6, p. 632-643Article in journal (Refereed)
    Abstract [en]

    The definition of a new case is a vital step in incidence studies in both epidemiology and pharmacoepidemiology, although with significant differences in methodology between the fields. We define and apply a framework for two different types of new cases of drug use, first-ever and recurrent, and show how the associated misclassifications related to length of run-in period can be expressed by the positive predictive value (PPV). In the study, we consider individual-level dispensations of statins 2006-2019 for 1,017,058 individuals with at least one dispensation in 2019 in Sweden. The incidence proportion for statins for both sexes of all ages in Sweden 2019 varied from 17.4/1000 with a run-in of 8 months, 9.45/1000 with 5 years and 8.4/1000 with 10 years. The PPV was 49% with 8 months and 89% for 5 years using 10 years as gold standard. We conclude that the interpretation of incidence and thus the selection of an appropriate run-in period, in pharmacoepidemiology, depends on whether first-ever use, recurrent treatment or both together (new cases) is the focus of the research question studied. At least five different misclassifications can be introduced depending on how incidence is defined.

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  • 24.
    Hoffmann, Mikael
    et al.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. NEPI Fdn, Sweden.
    Støvring, Henrik
    Univ Southern Denmark, Denmark.
    Incidence in pharmacoepidemiology: A conceptual framework for incidence of a single substance or group of substances with statins as an example2023In: Basic & Clinical Pharmacology & Toxicology, ISSN 1742-7835, E-ISSN 1742-7843, Vol. 132, no 2, p. 171-179Article in journal (Refereed)
    Abstract [en]

    A framework for analysing incidence in pharmacoepidemiology and drug statistics is suggested using statins as an example. A new case of statin use (first-ever use or recurrence of treatment) can be defined as new on the group (NoG), new on substance whether new on the group or not (NoS), new on substance and new on the group (NoS_and_NoG), new on substance and not new on the group (NoS_not_NoG). MethodIndividual-level dispensations of statins 2006-2019 for 1 017 058 individuals with at least one dispensation 2019 in Sweden. ResultsWith 12-month run-in, corresponding to at least 8 months without treatment, the incidence proportion of NoG was 13.39 new cases per 1000 inhabitants and 8.40 with 10-year run-in. Thus, 37% had first been treated with any statin between 12 months and 10 years before the index date.For atorvastatin, NoS was 10.69, NoS_and_NoG 9.99, and NoS_not_NoG 0.70 per 1000 inhabitants. 0.70 per 1000 inhabitants or 6.6% of new cases of atorvastatin represented a change from another statin during the run-in. ConclusionIt is essential to separate new cases that are new both on the substance and on the group from those that represent a change of therapy during the run-in.

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  • 25.
    Hoffmann, Mikael
    et al.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Vander Stichele, Robert
    Univ Ghent, Belgium.
    Bates, David W.
    Brigham & Womens Hosp, MA 02115 USA; Harvard Med Sch, MA 02115 USA.
    Bjorklund, Johanna
    Umea Univ, Sweden.
    Alexander, Steve
    Univ Nottingham, England.
    Andersson, Marine L.
    Karolinska Inst, Sweden.
    Auraaen, Ane
    Org Econ Cooperat & Dev OECD, France.
    Bennie, Marion
    Univ Strathclyde, Scotland.
    Dahl, Marja-Liisa
    Karolinska Inst, Sweden.
    Eiermann, Birgit
    Karolinska Inst, Sweden.
    Hackl, Werner
    UMIT Private Univ Hlth Sci Med Informat & Technol, Austria.
    Hammar, Tora
    Linnaeus Univ, Sweden.
    Hjemdahl, Paul
    Karolinska Inst, Sweden.
    Koch, Sabine
    Karolinska Inst, Sweden.
    Kunnamo, Ilkka
    Finnish Med Soc Duodecim, Finland.
    Le Louet, Herve
    Council Int Org Med Sci CIOMS, Switzerland.
    Panagiotis, Papapetrou
    Stockholm Univ, Sweden.
    Raego, Lembit
    Council Int Org Med Sci CIOMS, Switzerland.
    Spedding, Michael
    Int Union Basic & Clin Pharmacol IUPHAR, France.
    Seidling, Hanna M.
    Heidelberg Univ, Germany.
    Demner-Fushman, Dina
    NIH, MD USA.
    Gustafsson, Lars L.
    Karolinska Inst, Sweden; Swedish Inst Drug Informat SIDI, Sweden.
    Guiding principles for the use of knowledge bases and real-world data in clinical decision support systems: report by an international expert workshop at Karolinska Institutet2020In: Expert Review of Clinical Pharmacology, ISSN 1751-2433, E-ISSN 1751-2441, Vol. 13, no 9, p. 925-934Article in journal (Refereed)
    Abstract [en]

    Introduction Technical and logical breakthroughs have provided new opportunities in medicine to use knowledge bases and large-scale clinical data (real-world) at point-of-care as part of a learning healthcare system to diminish the knowledge-practice gap. Areas covered The article is based on presentations, discussions and recommendations from an international scientific workshop. Value, research needs and funding avenues of knowledge bases and access to real-world data as well as transparency and incorporation of patient perspectives are discussed. Expert opinion Evidence-based, publicly funded, well-structured and curated knowledge bases are of global importance. They ought to be considered as a public responsibility requiring transparency and handling of conflicts of interest. Information has to be made accessible for clinical decision support systems (CDSS) for healthcare staff and patients. Access to rich and real-world data is essential for a learning health care ecosystem and can be augmented by data on patient-reported outcomes and preferences. This field can progress by the establishment of an international policy group for developing a best practice guideline on the development, maintenance, governance, evaluation principles and financing of open-source knowledge bases and handling of real-world data.

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  • 26.
    Holmbom, Martin
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Division of Microbiology and Molecular Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Urology in Östergötland.
    Giske, Christian G.
    Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.; Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden..
    Fredrikson, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Division of Neuro and Inflammation Science. Linköping University, Faculty of Medicine and Health Sciences.
    Östholm Balkhed, Åse
    Linköping University, Department of Clinical and Experimental Medicine, Division of Microbiology and Molecular Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Infectious Diseases.
    Claesson, Carina
    Linköping University, Department of Clinical and Experimental Medicine, Division of Microbiology and Molecular Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Nilsson, Lennart E
    Linköping University, Department of Clinical and Experimental Medicine, Division of Microbiology and Molecular Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Hoffmann, Mikael
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Hanberger, Håkan
    Linköping University, Department of Clinical and Experimental Medicine, Division of Microbiology and Molecular Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Infectious Diseases.
    14-Year Survey in a Swedish County Reveals a Pronounced Increase in Bloodstream Infections (BSI). Comorbidity: An Independent Risk Factor for Both BSI and Mortality2016In: PLOS ONE, E-ISSN 1932-6203, Vol. 11, no 11Article in journal (Refereed)
    Abstract [en]

    Objectives: we assessed the incidence, risk factors and outcome of BSI over a 14-year period (2000-2013) in a Swedish county.

    Methods: retrospective cohort study on culture confirmed BSI among patients in the county of Östergötland, Sweden, with approximately 440,000 inhabitants. A BSI was defined as either community-onset BSI (CO-BSI) or hospital-acquired BSI (HA-BSI).

    Results: of a total of 11,480 BSIs, 67% were CO-BSI and 33% HA-BSI. The incidence of BSI increased by 64% from 945 to 1,546 per 100,000 hospital admissions per year during the study period. The most prominent increase, 83% was observed within the CO-BSI cohort whilst HA-BSI increased by 32%. Prescriptions of antibiotics in outpatient care decreased with 24% from 422 to 322 prescriptions dispensed/1,000 inhabitants/year, whereas antibiotics prescribed in hospital increased by 67% (from 424 to 709 DDD per 1,000 days of care). The overall 30-day mortality for HA-BSIs was 17.2%, compared to 10.6% for CO-BSIs, with an average yearly increase per 100,000 hospital admissions of 2 and 5% respectively. The proportion of patients with one or more comorbidities, increased from 20.8 to 55.3%. In multivariate analyses, risk factors for mortality within 30 days were: HA-BSI (2.22); two or more comorbidities (1.89); single comorbidity (1.56); CO-BSI (1.21); male (1.05); and high age (1.04).

    Conclusion: this survey revealed an alarming increase in the incidence of BSI over the 14-year study period. Interventions to decrease BSI in general should be considered together with robust antibiotic stewardship programmes to avoid both over- and underuse of antibiotics.

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  • 27.
    Jacobs, Maartje S.
    et al.
    Univ Groningen, Netherlands; Martini Hosp, Netherlands.
    Schouten, Jeroen F.
    Univ Groningen, Netherlands.
    de Boer, Pieter T.
    Univ Groningen, Netherlands.
    Hoffmann, Mikael
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Levin, Lars-Åke
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Postma, Maarten J.
    Univ Groningen, Netherlands; Univ Med Ctr Groningen, Netherlands; Univ Med Ctr Groningen, Netherlands.
    Secondary adherence to non-vitamin-K antagonist oral anticoagulants in patients with atrial fibrillation in Sweden and the Netherlands2018In: Current Medical Research and Opinion, ISSN 0300-7995, E-ISSN 1473-4877, Vol. 34, no 10, p. 1839-1847Article in journal (Refereed)
    Abstract [en]

    Objective: There is limited evidence on patients adherence and the impact of the prescribed dosing regimen in non-vitamin-K oral anticoagulants (NOACs). We aimed to assess secondary adherence to NOACs and to determine the impact of the dosing regimen in patients with atrial fibrillation. Methods: Patients using a NOAC between 2009 and 2013 were identified from the nation-wide Swedish Prescribed Drug Register and the Dutch regional IADB.nl database. Patients using a consistent dosage for at least 180 consecutive days were included. Adherence was calculated using the medication possession ratio (MPR) and adjusted for overlapping dates. Adherence was defined as a MPR amp;gt;= 0.8. Sensitivity analyses were performed using a MPR amp;gt;= 0.9. Logistic regression was performed to compare secondary adherence and to explore the influence of the dosing regimen. Results: A total of 5254 Swedish and 430 Dutch NOAC users were included. The mean MPR was 96.0% (SD 7.8%) in Sweden and 95.1% (SD 10.1%) in the Netherlands. Multivariable logistic regression analysis showed that a twice daily regimen had a lower likelihood of being secondary adherent compared to a once daily regimen in Sweden (odds ratio [OR] 0.21 [95% CI 0.12-0.35]). Limitations: The influence of selection bias introduced by the inclusion criterion of amp;gt;= 2 dispensations covering at least 180 days could not be excluded. Conclusions: This study demonstrated that secondary adherence was high in this specific setting among patients with at least two initial dispensations of a NOAC covering a minimum of 180 days. The use of NOACs in a once daily regimen showed higher adherence compared to a twice daily regimen.

  • 28.
    Järvstråt, Lotta
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Spetz, Anna-Clara
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Lindh-Åstrand, Lotta
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Hoffmann, Mikael
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis.
    Fredrikson, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Division of Neuro and Inflammation Science. Linköping University, Faculty of Health Sciences.
    Hammar, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Use of hormone therapy in Swedish women aged 80 years or older2015In: Menopause: The Journal of the North American Menopause, ISSN 1072-3714, E-ISSN 1530-0374, Vol. 22, no 3, p. 275-278Article in journal (Refereed)
    Abstract [en]

    Objective: Menopausal symptoms such as hot flashes and night sweats may persist for 10 to 20 years or even longer. Information about the extent to which older women use hormone therapy is limited. The aim of this study was to determine the use of hormone therapy in Swedish women aged 80 years or older.Methods: The study is based on national register data on dispensed drug prescriptions (ie, prescribed therapy that has been provided to individuals by pharmacies) for hormone therapy and local low-dose estrogens.Results: Of 310,923 Swedish women who were aged at least 80 years, 609 (0.2%) were new users of hormone therapy. A total of 2,361 women (0.8%) were current users of hormone therapy. The median duration of hormone therapy use in new users was 257 days (25th to 75th percentiles, 611-120 d). About one in six women aged 80 years or older had used local vaginal estrogen therapy for at least four 3-month periods. The drugs were mainly prescribed by gynecologists and general practitioners.Conclusions: Our results show that a number of women aged 80 years or older still use hormone therapy and that most women who started a new treatment period had only one or two dispensations despite the median duration of treatment being more than half a year. Because at least some of the women aged 80 years or older who used hormone therapy probably did so owing to persistent climacteric symptoms, vasomotor symptoms and hormone therapy are still relevant issues that need to be discussed when counseling women around and after age 80.

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  • 29.
    Levin, Lars-Åke
    et al.
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Andersson, David
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Anell, Anders
    Lunds universitet.
    Heintz, Emelie
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Hoffman, Mikael
    Östergötlands Läns Landsting. Linköping University, Department of Medical and Health Sciences. Linköping University, Faculty of Health Sciences.
    Schmidt, Andrea
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Carlsson, Per
    Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics. Linköping University, Faculty of Health Sciences.
    Styrformer för effektiv läkemedelsanvändning2010Report (Other academic)
    Abstract [sv]

    Rapporten Styrformer för effektiv läkemedelsanvändning har tagits fram av Institutionen för medicin och hälsa vid Linköpings universitet. Utgångspunkten var ett uppdrag som givits av Socialdepartementet och Sveriges kommuner och landsting inom arbetet med Handlingsplan för effektivare läkemedelsanvändning. Handlingsplanen presenterades av en arbetsgrupp i mars 2009. Rapportens resultat kommer att integreras i arbetet med en nationell läkemedelsstrategi.

    Syftet med rapporten är att kartlägga olika styrformer för läkemedelsanvändning i landstingen och analysera deras betydelse för rättvisa och effektivitet i läkemedelsanvändningen. Ett delsyfte med studien, som görs för första gången, är att starta utvecklingen av metodik för den här typen av analys.

    Studien består av tre delar. Den första delen är en kartläggning av landstingens styrning av läkemedelsförmånerna. I del två redovisas mått (indikatorer) som beskriver utfallet i form av läkemedelsanvändningen i olika landsting. I del tre analyseras skillnader i kunskaps- och ekonomistyrning i relation till skillnader i läkemedelsanvändning i form av de utfallsmått som beskrivits i del två.

    Material till kartläggningen har insamlats via enkät till samtliga 21 landsting och enkätsvaren har sedan följts upp per telefon. I enkäten efterfrågades hur styrningen fungerade år 2008 och år 2005.

    • Decentraliseringsgraden i landstingen har ökat. Kostnadsansvaret låg på klinik- och vårdcentralsnivå i tolv landsting (9 landsting år 2005), på en mellannivå i fem landsting (7 landsting år 2005) och centralt i fyra landsting år 2008 (5 landsting år 2005).
    • Fler landsting valde en förskrivarbaserad modell (9 landsting) istället för en befolkningsbaserad modell (8 landsting) 2008. Tre år tidigare var det istället något fler som hade valt den befolkningsbaserade modellen (10 landsting respektive 6 landsting med förskrivarbaserad modell).
    • Tio landsting hade en integrerad hälso- och sjukvårdsbudget år 2008 (8 landsting 2005). Sju landsting hade en separat läkemedelsbudget (8 landsting 2005).
    • Oavsett om landstingen hade en separat läkemedelsbudget eller en integrerad hälso- och sjukvårdsbudget var det vanligast att över- och underskott på lokal nivå hanterades inom den totala budgetramen för hälso- och sjukvård. Några landsting hade utvecklat olika incitamentsmodeller där det fanns möjlighet att ta del av hela eller delar av eventuellt överskott om vissa förskrivningsmål/produktionsmål/ kvalitetsmål uppfylldes.
    • Frågan om hur under- och överskott hanteras i praktiken upplevdes som svår att besvara av kontaktpersonerna. Det finns en osäkerhet om vilka formella regler som egentligen gäller, vilket påverkat svaren.
    • Kunskapsstöd i form av läkemedelskommitténs rekommendationslista och producentobunden information fanns i alla landsting. Representanter för ansåg generellt att deras olika former av förskrivarstöd fungerade minst lika bra som motsvarande stöd i övriga landsting. Ett undantag var IT-baserat förskrivarstöd inom privat vård där många landsting ansåg att det egna stödet fungerade sämre än i andra landsting.
    • Vid en rangordning av de tre viktigaste stödformerna anses IT-baserat förskrivarstöd vid sjukhus som allra viktigast följt av läkemedelskommitténs rekommendationslista samt producentobundeninformation.
    • Tidigare kartläggningar visar att landstingen över tiden hanterat kostnadsansvaret för öppenvårdsläkemedel på olika sätt. Jämfört med en tidigare undersökning från 2002 har decentraliseringsgraden inomlandstingen år 2008 ökat markant[1, 2].

    Analysdelen – med sammanvägning av enkätresultat och utfall av indikatorer i skilda dimensioner – visar att:

    • Landstingens struktur i form av förekomst av universitet och landstingets storlek är den faktor som påverkar läkemedelsanvändningen mest.
    • Landsting som infört ett decentraliserat kostnadsansvar jämfört med övriga landsting:
    1. har inte mindre volym (DDD/invånare) men lägre kostnad per invånare.
    2. har bättre följsamhet till läkemedel som rekommenderas av läkemedelskommittéer.
    3. avvek däremot inte från övriga landsting vad gällde andel patienter som fick kostnadseffektiv behandling, olämplig förskrivning inklusive polyfarmaci, användning av nya läkemedel med stor innovationshöjd samt jämlikhet. Detta kan eventuellt förklaras av otillräcklig statistisk styrka för att finna skillnader mellan grupperna.
    • Kunskapsstyrning har i denna studie en liten påverkan på  läkemedelsanvändningen. Det beror bland annat på att:
    1. kunskapsstyrning är starkt korrelerad med struktur vilket gör analysen svårtolkad.
    2. kunskapsstyrning är svår att operationalisera och mäta.
    3. kunskapsvariablernas variation är dessutom liten mellan landstingen.
    • IT-stöd i form av gemensam läkemedelslista samvarierar emellertid med kvalitetsvariabeln ”färre interaktioner”.

    Ett huvudresultat är att landsting med ett decentraliserat kostnadsansvar för läkemedel samtidigt hade lägre kostnader för läkemedel i öppen vård per invånare och högre följsamhet till rekommendationer utan att volymen läkemedel avvek från övriga landsting.

    Då detta är en epidemiologisk studie kan samvariationer beskrivas. Däremot kan studien inte visa om samvariationerna också är uttryck för orsakssamband, eller i vilken riktning ett eventuellt orsakssamband skulle gå. Inte heller kan studien kontrollera för okända faktorer som kan tänkas påverka båda de variabler som samvarierar. Inventeringen och analysen av existerande indikatorer på effektiv och jämlik läkemedelsanvändning visar på en mängd metodproblem som försvårar studier av samband mellan styrformer och utfall. Det är därför angeläget att arbetet med att utveckla valida effektivitetsindikatorer fortsätter.

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    Styrformer för effektiv läkemedelsanvändning
  • 30.
    Lindh Åstrand, Lotta
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Division of Children's and Women's health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Hoffmann, Mikael
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Fredrikson, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Division of Neuro and Inflammation Science. Linköping University, Faculty of Medicine and Health Sciences.
    Hammar, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Division of Children's and Women's health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Spetz Holm, Anna-Clara
    Linköping University, Department of Clinical and Experimental Medicine, Division of Children's and Women's health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Use of hormone therapy (HT) among Swedish women with contraindications - A pharmacoepidemiological cohort study2019In: Maturitas, ISSN 0378-5122, E-ISSN 1873-4111, Vol. 123, p. 55-60Article in journal (Refereed)
    Abstract [en]

    Objectives: To assess how women in Sweden with breast cancer (BC), endometrial cancer (EC), and/or pulmonary embolism (PE) were dispensed menopausal hormone therapy (HT). Study design: A retrospective study of Swedish women aged 40 years or more on 31 December 2005 (n = 2,863,643), followed through to December 2011. The study analysed three mandatory national healthcare registries: the Swedish Prescribed Drug Register, the National Inpatient Register and the Cancer Register. New users were defined as having a first dispensation after at least a 9-month break, and thus were possible to identify from April 2006. New users with at least one of the diagnoses BC, EC or PE before the first dispensation were classified as having a relative or absolute contraindication for HT. Main outcome measures: The relative risks of having HT dispensed after being diagnosed with BC, EC and/or PE. Results: In total, 171,714 women had at least one of the diagnoses BC, EC or PE. The relative risk of having hormone therapy dispensed (current and new users) after being diagnosed with any of the diagnoses was significantly lower (PE, IRR 0.11, 95% CI 0.10-0.12;/ BC, IRR 0.12, 95% CI 0.11-0.13; EC, IRR 0.43, CI 0.40-0.46) than for women without these diagnoses. Conclusions: One in about 250 women started treatment with HT after being diagnosed with BC, PE or EC. Swedish prescribers seem to be well aware of the recommendations for HT use in women with contraindications. A few women, however, are prescribed HT despite having BC, EC or PE, possibly after careful evaluation of the risks and benefits and giving informed consent. Women with a history of PE were prescribed transdermal HT to a larger extent than women in general, in line with results from observational studies.

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  • 31.
    Lindh-Åstrand, Lotta
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Brynhildsen, Jan
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Hoffman, Mikael
    Linköping University, Department of Medicine and Health Sciences, Clinical Pharmacology . Linköping University, Faculty of Health Sciences.
    Hammar, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Vasomotor symptoms usually reappear after cessation of postmenopausal hormone therapy: a Swedish population-based study.2009In: Menopause (New York, N.Y.), ISSN 1530-0374Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE:: The purpose of this study was to investigate the extent of reappearance of vasomotor symptoms after cessation of postmenopausal hormone therapy (HT) in women who started HT because of hot flashes. METHODS:: A cross-sectional postal survey was conducted. A validated questionnaire was sent to all women 53 to 54 years old living in Linköping, Sweden (n = 1,733), including questions about menopause, HT, and vasomotor symptoms. Pearson's chi test and logistic regression were used for statistical analyses. RESULTS:: Response rate after one reminder was 77.3%. After omitting incomplete answers, 72.9% remained for analysis. In all women, 319 (25.3%) were current users of HT, 242 (19.2%) were previous users, and 702 (55.6%) were never-users. Of the 242 previous users, 165 (69%) women stated that they had vasomotor symptoms before starting HT. Vasomotor symptoms recurred after cessation of HT in 143 (87%) of these 165 women. We found no significant difference in symptom recurrence in comparisons of the three groups based on usage of HT for 0 to 1, 2 to 4, or 5 years or more. CONCLUSIONS:: Most women who had vasomotor symptoms when they initiated HT reported recurrence of symptoms after cessation of HT (87%), although the flashes were usually reported to be less frequent and bothersome than they were before HT. Effective and safe treatment approaches for women with recurrence of vasomotor symptoms are needed.

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  • 32.
    Lindh-Åstrand, Lotta
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Brynhildsen, Jan
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Hoffmann, Mikael
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Kjellgren, Karin I
    Sahlgrenska Academy.
    Hammar, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Knowledge of reproductive physiology and hormone therapy in 53- to 54-year-old Swedish women: a population-based study.2007In: Menopause: The Journal of the North American Menopause, ISSN 1072-3714, E-ISSN 1530-0374, Vol. 14, no 6, p. 1039-1046Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To investigate knowledge of hormone therapy (HT), reproductive physiology, and menopause in a population of 53- to 54-year-old women. Further aims were to determine whether the knowledge differed between users and nonusers of HT and between groups with different levels of education.

    DESIGN: In 2003, all 53- and 54-year-old women (N = 1,733) in Linköping, Sweden, were sent a questionnaire containing questions about reproductive physiology related to menopause and HT. Answers from 73% of the women were analyzed.

    RESULTS: Swedish women had limited knowledge of HT, reproductive physiology, and menopause irrespective of HT use or educational level. Most of the women knew that hot flashes are common around menopause and decreasing estrogen production causes the menopause. They knew little about the effects of progestagens and the effects of HT on fertility. Women with low educational level were more likely to answer the questions by stating that they were unsure than did women with high educational level. Ever-users of HT knew more than never-users about risks and benefits of HT in relation to breast cancer and osteoporosis, and ever-users thought that the risks of thrombosis and myocardial infarction were lower than did never-users.

    CONCLUSIONS: Women need improved knowledge of the risks and benefits of HT as well as education about the reproductive system around menopause. This would probably better support and empower women to manage an important period of their lives.

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  • 33.
    Lindh-Åstrand, Lotta
    et al.
    Linköping University, Department of Clinical and Experimental Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Brynhildsen, Jan
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology . Linköping University, Faculty of Health Sciences.
    Hoffmann, Mikael
    Linköping University, Department of Medicine and Health Sciences, Clinical Pharmacology . Linköping University, Faculty of Health Sciences.
    Liffner, Susanne
    Linköping University, Department of Clinical and Experimental Medicine. Linköping University, Faculty of Health Sciences.
    Hammar, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Attitudes towards the menopause and hormone therapy over the turn of the century2007In: Maturitas, ISSN 0378-5122, E-ISSN 1873-4111, Vol. 56, no 1, p. 12-20Article in journal (Refereed)
    Abstract [en]

    Objective: To assess attitudes and beliefs about the menopausal transition in a population of peri- and postmenopausal women, and if these attitudes differed before and after publication of studies on risks and benefits with hormone therapy (HT).

    Material and methods: In 1999 and 2003 all women aged 53 and 54 years in the community of Linköping, Sweden, were sent a questionnaire about use of HT, menopausal status and attitudes regarding menopause and HT.

    Results: Most women regarded menopause as a natural process characterized by both hormonal deficiency and aging and these views did not differ between 1999 and 2003. A majority of women thought that significant climacteric symptoms were a good reason to use HT, but not that women without symptoms should use HT. The fraction of women who supported HT use was, however, significantly lower in 2003 than in 1999. Most women agreed that menopause leads to increased freedom and that it is a relief not to have to think about contraception and pregnancies.

    Conclusions: Most Swedish women had a mainly biological view on menopause but nevertheless they thought that only women with climacteric symptoms should use HT. Women’s attitudes towards HT have changed after recent reports on risks from long-term use of HT whereas the attitudes towards the menopausal transition were stable. Other factors than attitudes towards menopause affect women’s actual use of HT. Probably women’s and health care provider’s apprehension of the risk-benefit balance of HT use is one such factor.

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  • 34.
    Lindh-Åstrand, Lotta
    et al.
    Linköping University, Department of Clinical and Experimental Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Hoffmann, Mikael
    Linköping University, Department of Medicine and Health Sciences, Clinical Pharmacology . Linköping University, Faculty of Health Sciences.
    Hammar, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Kjellgren, Karin I.
    Faculty of Health and Caring Sciences, Institute of Nursing, The Sahlgrenska Academy, Göteborg, Sweden.
    Women’s conception of the menopausal transition – a qualitative study2007In: Journal of Clinical Nursing, ISSN 0962-1067, E-ISSN 1365-2702, Vol. 16, no 3, p. 509-517Article in journal (Refereed)
    Abstract [en]

    Aim: To explore, with a qualitative approach, whether the conception of menopause varies between women seeking medical advice due to climacteric symptoms and, if so, to describe these different conceptions.

    Background: For many women, the menopausal transition is a troublesome period of life, often associated with decreased well-being and a number of symptoms. Besides the hormonal changes, many other factors such as psychological, sociological and lifestyle factors affect how women perceive their menopause.

    Method: Semi-structured interviews were held with 20 women after their first-time visits at outpatient clinics of gynaecology for discussion of climacteric symptoms. The interviews were audio-taped, transcribed and analysed using a phenomenographic approach.

    Results: A wide variation of conceptions was revealed. Two main categories were identified including different physical changes with varying symptoms and both positive and negative psychological changes. The menopausal transition was also described as a natural process and as a developmental phase of life.

    Conclusion and relevance to clinical practice: Women’s conceptions of the menopausal transition were individual and contained both physical and psychological symptoms but also expressed a more holistic view of the menopausal transition. The transition was described as a natural process affected by endocrine and life-style factors as well as by the psychosocial situation and by aging per se. It is important that health care providers are aware of women’s conceptions about the menopausal transition to be able to communicate optimally, support and empower middle-aged women in different health care situations and thereby optimise the result of care.

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  • 35.
    Lindh-Åstrand, Lotta
    et al.
    Östergötlands Läns Landsting, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping. Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Hoffmann, Mikael
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. The NEPI foundation.
    Hammar, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Östergötlands Läns Landsting, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping. Linköping University, Faculty of Medicine and Health Sciences.
    Spetz, Anna-Clara
    Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping. Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Hot flushes, hormone therapy and alternative treatments: 30 years of experience from Sweden2015In: Climacteric, ISSN 1369-7137, E-ISSN 1473-0804, Vol. 18, no 1, p. 53-62Article in journal (Refereed)
    Abstract [en]

    Objectives The use of hormone therapy (HT) for hot flushes has changed dramatically over the past five decades. In this cross-sectional questionnaire study, the aim was to describe the use of HT and alternative treatments and to study the frequency of hot flushes. A further aim was to compare data from the present questionnaire with data from previous studies made in the same geographic area. Method A questionnaire was sent to a random sample of 2000 women aged 47-56 years living in Ostergotland County, Sweden. The results were compared with findings from previous studies regarding use of HT, alternative treatment and hot flushes, and the number of HT prescriptions dispensed during the corresponding time using data derived from the Swedish Prescribed Drug Registry. Results The response rate was 66%. Six percent used HT, in line with prevalence data from the Swedish Prescribed Drug Registry. Alternative treatments were used by 10%. About 70% of postmenopausal women reported flushes and almost one-third of those with flushes stated that they would be positive to HT if therapy could be shown to be harmless, a view more often stated by women with severe complaints of hot flushes (67%). Conclusion The use of HT and alternative treatments is low and many women suffer from flushes that could be treated. Women considered their knowledge of the climacteric period and treatment options as insufficient. Individualized information should be given and women with significant climacteric complaints, without contraindications, should be given the opportunity to try HT.

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  • 36.
    Lindh-Åstrand, Lotta
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Hoffmann, Mikael
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Järvstråt, Lotta
    Fredrikson, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Division of Neuro and Inflammation Science. Linköping University, Faculty of Health Sciences.
    Hammar, Mats
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Spetz, Anna-Clara
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Hormone therapy might be underutilized in women with early menopause.2015In: Human Reproduction, ISSN 0268-1161, E-ISSN 1460-2350, Vol. 30, no 4, p. 848-852Article in journal (Refereed)
    Abstract [en]

    STUDY QUESTION Are Swedish women age 40–44 years with assumed early menopause ‘undertreated’ by hormone therapy (HT)?

    SUMMARY ANSWER Many women with probable early menopause discontinue their HT after a short period of time. Thus, they fail to complete the recommended replacement up to age 51–52 years, the average age of menopause.

    WHAT IS KNOWN ALREADY Spontaneous early menopause occurs in ∼5% of women age 40–45 years. Regardless of the cause, women who experience hormonal menopause due to bilateral oophorectomy before the median age of spontaneous menopause are at increased risk of cardiovascular disease, neurological disease, osteoporosis, psychiatric illness and even death.

    STUDY DESIGN, SIZE, DURATION The study is descriptive, and epidemiological and was based on the use of national registers of dispensed drug prescriptions (HT) linking registers from the National Board of Health and Welfare and Statistics Sweden from 1 July 2005 until 31 December 2011.

    PARTICIPANTS/MATERIALS, SETTING, METHODS The study population consisted of 310 404 women, 40–44 years old on 31 December 2005 who were followed from 1 July 2005 until 31 December 2011.

    MAIN RESULTS AND THE ROLE OF CHANCE Only 0.9% of women 40–44 years old started HT during the study period. A majority of these women used HT <1 year.

    LIMITATIONS, REASONS FOR CAUTION We do not know the indications that led to the prescription of HT but assume that early onset of menopause was the main reason. Because of the study design—making a retrospective study of registers—we can only speculate on the reasons for most of the women in this group discontinuing HT. Another limitation of this study is that we have a rather short observation time. However, we have up to now only been able to collect and combine the data since July 2005.

    WIDER IMPLICATIONS OF THE FINDINGS As the occurrence of spontaneous early menopause in women age 40–45 is reported to be ∼5%, the fact that <1% of Swedish women age 40–44 are prescribed HT, and can be shown also to have had the medication dispensed at a pharmacy suggests an unexpectedly low treatment rate. Some women with early menopause may have used combined contraceptives as supplementation therapy, but in Sweden HT is the recommended treatment for early menopause so any such women are not following this recommendation. Women who experience early menopause are at increased risk for overall morbidity and mortality, and can expect to benefit from HT until they have reached at least the median age of spontaneous menopause. It is therefore important to individualize the information given these women and to convey new knowledge in this area to gynaecologists and physicians in general as well as the recommendation that women in this group continue HT at least until the average age for spontaneous menopause is reached.

  • 37.
    Malmström, Rickard E.
    et al.
    Karolinska University Hospital Solna, Sweden.
    Godman, Brian B.
    Karolinska University Hospital Huddinge, Sweden; University of Liverpool, England; University of Strathclyde, Scotland.
    Diogene, Eduard
    Catalan Institute Heatlh, Spain.
    Baumgartel, Christoph
    Austrian Medical and Medical Dev Agency, Austria.
    Bennie, Marion
    University of Strathclyde, Scotland; NHS National Serv Scotland, Scotland.
    Bishop, Iain
    NHS National Serv Scotland, Scotland.
    Brzezinska, Anna
    Agency Health Technology Assessment, Poland.
    Bucsics, Anna
    Hauptverband Osterreichischen Sozialversicherung, Austria.
    Campbell, Stephen
    University of Manchester, England.
    Ferrario, Alessandra
    LSEHealth, England.
    Finlayson, Alexander E.
    Weston Educat Centre, England.
    Furst, Jurij
    Health Insurance Institute, Slovenia.
    Garuoliene, Kristina
    National Health Insurance Fund, Lithuania.
    Gomes, Miguel
    Institute Nacl Farmacia and Med, Portugal.
    Gutierrez-Ibarluzea, Inaki
    Ministry Health Basque Country, Spain.
    Haycox, Alan
    University of Liverpool, England.
    Hviding, Krystyna
    Norwegian Medical Agency, Norway.
    Herholz, Harald
    Kassenarztliche Vereinigung Hessen, Germany.
    Hoffmann, Mikael
    Linköping University, Department of Medical and Health Sciences, Division of Drug Research. Linköping University, Faculty of Medicine and Health Sciences.
    Jan, Saira
    Horizon Blue Cross Blue Shield New Jersey, NJ USA.
    Jones, Jan
    NHS Tayside, Scotland.
    Joppi, Roberta
    Local Health Unit Verona, Italy.
    Kalaba, Marija
    Republ Institute Health Insurance, Serbia.
    Kvalheim, Christina
    Norwegian Medical Agency, Norway.
    Laius, Ott
    State Agency Med, Estonia.
    Langner, Irene
    Wissenschaftliches Institute AOK, Germany.
    Lonsdale, Julie
    Lancashire Commissioning Support Unit, England.
    Lööv, Sven-Åke
    Stockholm County Council, Sweden.
    Malinowska, Kamila
    HTA Consulting, Poland; Medical Centre Postgrad Educat, Poland.
    McCullagh, Laura
    St James Hospital, Ireland.
    Paterson, Ken
    Scottish Medical Consortium, Scotland.
    Markovic-Pekovic, Vanda
    University of Banja Luka, Bosnia and Herceg; Ministry Health and Social Welfare, Bosnia and Herceg.
    Martin, Andrew
    NHS Bury, England.
    Piessnegger, Jutta
    Hauptverband Osterreichischen Sozialversicherung, Austria.
    Selke, Gisbert
    State Agency Med, Estonia.
    Sermet, Catherine
    Institute Rech and Documentat Econ St, France.
    Simoens, Steven
    Katholieke University of Leuven, Belgium.
    Tulunay, Cankat
    President Turkish Rational Drug Use Platform, Turkey.
    Tomek, Dominik
    Comenius University, Slovakia; Slovak Medical University, Slovakia.
    Voncina, Luka
    Minist Heatlh, Croatia.
    Vlahovic-Palcevski, Vera
    University Hospital Rijeka, Croatia.
    Wale, Janet
    Independent Consumer Advocate, Australia.
    Wilcock, Michael
    Royal Cornwall Hospital NHS Trust, England.
    Wladysiuk, Magdalena
    HTA Consulting, Poland.
    van Woerkom, Menno
    Dutch Institute Rational Use Med, Netherlands.
    Zara, Corrine
    Catalan Health Serv, Spain.
    Gustafsson, Lars L.
    Karolinska University Hospital Huddinge, Sweden.
    Dabigatran - a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs2013In: Frontiers in Pharmacology, E-ISSN 1663-9812, Vol. 4, article id 39Article in journal (Refereed)
    Abstract [en]

    Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use. Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups. Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. Results: There has been a plethora of activities among authorities to manage the prescribing of dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions, and monitoring of prescribing post-launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, pen-, and post-launch activities. Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

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  • 38.
    Midlov, Patrik
    et al.
    Lund Univ, Sweden.
    Nilsson, Peter M.
    Lund Univ, Sweden.
    Bengtsson, Ulrika
    Univ Gothenburg, Sweden.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Wennersten, Andre
    Skane Univ Hlth Care, Sweden.
    Andersson, Ulrika
    Lund Univ, Sweden.
    Malmqvist, Ulf
    Skane Univ Hlth Care, Sweden.
    Steen Carlsson, Katarina
    Lund Univ, Sweden.
    Ranerup, Agneta
    Univ Gothenburg, Sweden.
    Kjellgren, Karin I.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Nursing Sciences and Reproductive Health. Linköping University, Faculty of Medicine and Health Sciences. Univ Gothenburg, Sweden.
    PERson-centredness in hypertension management using information technology (PERHIT): a protocol for a randomised controlled trial in primary health care2020In: Blood Pressure, ISSN 0803-7051, E-ISSN 1651-1999, Vol. 29, no 3, p. 149-156Article in journal (Refereed)
    Abstract [en]

    Purpose: For primary health care (PHC), hypertension is the number one diagnosis for planned health care visits. The treatment of high blood pressure (BP) and its consequences constitutes a substantial economic burden. In spite of efficient antihypertensive medications, a low percentage of patients reach a well-controlled BP. The PERson-centredness in Hypertension management using Information Technology (PERHIT) Study is a multicentre randomised controlled trial. PERHIT is designed to evaluate the effect of supporting self-management on systolic blood pressure by the use of information technology in Swedish primary health care. Materials and Methods: After inclusion, 900 patients from 36 PHC centres are randomised to two groups. In the intervention group, patients are provided with a self-management support system including a home-BP monitor and further requested to perform self-reports and measure BP every evening for eight consecutive weeks. In the control group, patients receive treatment as usual. Results: The primary outcome will be the change in systolic blood pressure in patients with hypertension. In addition, person-centredness, daily life activities, awareness of risk and health care costs will also be evaluated. Conclusion: The results of this randomised controlled trial with assessment of blood pressure and same-day self-reports will provide patients a tool to understand the interplay between blood pressure and lifestyle applicable to primary health care. The self-management support system may be of importance for improved adherence to treatment and persistence to treatment recommendations.

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  • 39.
    Molander, L
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Clinical Pharmacology.
    Hansson, A
    Lunell, E
    Alainentalo, L
    Hoffman, Mikael
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Clinical Pharmacology. Östergötlands Läns Landsting, Centre for Laboratory Medicine, Department of Clinical Pharmacology.
    Larsson, Rutger
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Internal Medicine. Östergötlands Läns Landsting, Centre for Medicine, Department of Nephrology UHL.
    Pharmacokinetics of nicotine in kidney failure2000In: Clinical Pharmacology and Therapeutics, ISSN 0009-9236, E-ISSN 1532-6535, Vol. 68, no 3, p. 250-260Article in journal (Refereed)
    Abstract [en]

    Background: Smoking is an important risk factor for cardiovascular and cerebrovascular complications in patients with chronic kidney failure. Very high plasma nicotine concentrations have been reported in patients with severe kidney failure, indicating that the disposition of nicotine in these patients may be different. The purpose of this study was to assess the pharmacokinetics of intravenously administered nicotine in healthy subjects and in patients with kidney failure. Methods: Nine healthy subjects (glomerular filtration rare [GFR], 84 to 143 mL/min/1.73 m2), four patients with mild kidney failure (GFR, 63 to 73 mL/min/1.73 m2), five patients with moderate kidney failure (GFR, 18 to 36 mL/min/1.73 m2), and six patients with severe kidney failure (GFR, 1 to 10 mL/min/1.73 m2) were recruited. Three patients were treated with continuous ambulatory peritoneal dialysis. An intravenous infusion of nicotine (0.028 mg/kg) was given for 10 minutes. Nicotine and cotinine concentrations were measured in plasma, urine, and peritoneal dialysate from 0 to 24 hours after start of infusion Results: There were significant correlations between GFR and total clearance, nonrenal and renal clearance of nicotine, area under the plasma concentration-time curve extrapolated to infinity, terminal elevation half-life, and mean residence time. Nonrenal clearance was 1303 mL/min and 661 mL/min in healthy subjects and patients with severe kidney failure, respectively. Only 1% to 2% of the nicotine dose was excreted unchanged in a 24-hour collection of peritoneal dialysate. The elimination of cotinine was also decreased in patients with kidney failure. Conclusion: Progressive kidney failure is associated with a gradual decrease of renal and nonrenal elimination of nicotine.

  • 40.
    Sundell, Micaela
    et al.
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Kalmar Cty Hosp, Sweden.
    Brynhildsen, Jan
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping. Orebro Univ, Sweden.
    Fredrikson, Mats
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Inflammation and Infection. Linköping University, Faculty of Medicine and Health Sciences.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. NEPI Fdn, Sweden.
    Spetz Holm, Anna-Clara
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Insufficient use of menopausal hormone therapy in Swedish women with early or premature menopause caused by bilateral oophorectomy: a register-based study2024In: British Journal of Obstetrics and Gynecology, ISSN 1470-0328, E-ISSN 1471-0528, Vol. 131, no 4, p. 500-507Article in journal (Refereed)
    Abstract [en]

    ObjectiveTo investigate the use of menopausal hormone therapy (MHT) in premenopausal women after bilateral oophorectomy.DesignRetrospective register-based cohort study.SettingSweden.PopulationSwedish women aged 35-44 years without malignancy who underwent bilateral oophorectomy in 2005-2020 were identified using The Swedish National Quality Register of Gynaecological Surgery (GynOp).MethodsData from GynOp were cross-linked with data on dispensed drugs extracted from the Swedish Prescribed Drug Register.Main outcome measuresProportion of women dispensed MHT at least once within 1 year after surgery. Repeated treatment episodes were defined, and the proportion of person time covered by dispensations was analysed.ResultsIn total, 1231 of all women (n = 1706) were dispensed MHT at some point after surgery, with 1177 women dispensed MHT within 1 year. This proportion increased from 64% in 2005 to 84% in 2019 (p &lt; 0.001). In the total population, 4537 treatment years transpired, corresponding to 43% of the mean time covered. In women dispensed MHT within 1 year, the proportion of time covered was 63%.ConclusionsOnly 69% of all women without malignancy of any kind who underwent bilateral oophorectomy were dispensed MHT within 1 year after surgery, and the duration of treatment was limited. It is important to study further the reasons behind the low dispensation rate in this group to increase adherence to current treatment guidelines, improve quality of life, and avoid increased morbidity and mortality.

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  • 41.
    Sundell, Micaela
    et al.
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Department of Obstetrics and Gynaecology, Kalmar, County Hospital, Kalmar, Sweden.
    Brynhildsen, Jan
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping. Orebro Univ, Sweden.
    Spetz Holm, Anna-Clara
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Fredrikson, Mats
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Inflammation and Infection. Linköping University, Faculty of Medicine and Health Sciences.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. NEPI Fdn, Sweden.
    Trends in the incidence, prevalence and sales volume of menopausal hormone therapy in Sweden from 2000 to 20212023In: Maturitas, ISSN 0378-5122, E-ISSN 1873-4111, Vol. 175, article id 107787Article in journal (Refereed)
    Abstract [en]

    Objectives: To describe the trends in the prevalence of use menopausal hormone therapy (MHT) in Sweden over the period 2000-2021 and to analyse the impact of different lengths of run-in on the calculated incident use. Study design: Individual-level data on MHT dispensations for 2.5 million women aged 45-69 years for the period 2006-2021 were analysed. Aggregated sales volumes in defined daily dose (DDD) were available for the whole study period (2000-2021). Main outcome measures: One-year prevalence and one-year incidence (18-month run-in) per 1000 women and DDD per 1000 women per day of MHT were the main outcome measures. The predictive values for incidence representing first-ever use of MHT were calculated for different run-in periods, which is a defined period without dispensations. Results: Both the DDD, from 2000, and the prevalence, from 2006, decreased by over 80 % in women aged 50-54 years, until 2010, when the use of MHT stabilised. The predictive value for incident users to be first-ever users was 88 % in women aged 50-54 years, with a run-in of 18 months, in 2021. The incidence was stable between 2007 and 2016. From 2017 the incidence increased, being most pronounced for women close to menopause. Conclusions: MHT use decreased significantly after the turn of the century, but has increased since 2017. A run-in period of 18 months was found suitable and reliable for defining incident users of MHT in the age intervals closest to menopause. Incidence seems to be a more sensitive measure than prevalence or DDD for the early detection of changes in trends in prescriptions of MHT.

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  • 42.
    Sundell, Micaela
    et al.
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Kalmar Cty Hosp, Sweden.
    Spetz Holm, Anna-Clara
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Fredrikson, Mats
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Inflammation and Infection. Linköping University, Faculty of Medicine and Health Sciences.
    Hammar, Mats
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Brynhildsen, Jan
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Children's and Women's Health. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping. Orebro Univ, Sweden.
    Pulmonary embolism in menopausal hormone therapy: a population-based register study2022In: Climacteric, ISSN 1369-7137, E-ISSN 1473-0804, Vol. 25, no 6, p. 615-621Article in journal (Refereed)
    Abstract [en]

    Objective Oral but not transdermal menopausal hormone therapy (MHT) increases the risk of venous thromboembolism. There is no evidence regarding the risk of the serious complication pulmonary embolism (PE). The aim was to investigate the risk of PE in women using MHT depending on administration route, type of progestin and treatment duration. Method The population-based case-control study covered 1,771,253 women aged 40-69 years, during 2006-2015. Diagnoses of PE (n = 13,974) and drug dispensations were received from national validated registers. Results Current MHT users had a higher risk of PE than non-users (odds ratio [OR] 1.15, 95% confidence interval [CI] 1.05-1.26). First ever users had the highest risk (OR 2.07, 95% CI 1.23-3.50). Transdermal administration was not associated with increased risk of PE. The OR was slightly but non-significantly higher with estrogen combined with medroxyprogesterone acetate than with norethisterone acetate. Discussion The risk of PE was significantly increased in users of oral but not transdermal MHT, with the highest risk in first ever users of oral estrogen combined with medroxyprogesterone acetate. The risk was considerably lower in women with recurrent treatment, probably because of the healthy user effect. Conclusion PE was most common close to initiation of oral treatment. Transdermal MHT did not increase the risk of PE.

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  • 43.
    Wallerstedt, Susanna M.
    et al.
    University of Gothenburg, Sweden; Sahlgrens University Hospital, Sweden.
    Hoffmann, Mikael
    NEPI, Linköping, Sweden.
    Evaluating beneficial drug effects in a non-interventional setting: a review of effectiveness studies based on Swedish Prescribed Drug Register data2017In: British Journal of Clinical Pharmacology, ISSN 0306-5251, E-ISSN 1365-2125, Vol. 83, no 6, p. 1309-1318Article, review/survey (Refereed)
    Abstract [en]

    AIMS To describe and assess current effectiveness studies published up to 2014 using Swedish Prescribed Drug Register (SPDR) data. METHODS Study characteristics were extracted. Each study was assessed concerning the clinical relevance of the research question, the risk of bias according to a structured checklist, and as to whether its findings contributed to new knowledge. The biases encountered and ways of handling these were retrieved. RESULTS A total of 24 effectiveness studies were included in the review, the majority on cardiovascular or psychiatric disease (n=17; 71%). The articles linked data from four (interquartile range: three to four) registers, and were published in 21 different journals with an impact factor ranging from 1.58 to 51.66. All articles had a clinically relevant research question. According to the systematic quality assessments, the overall risk of bias was low in one (4%), moderate in eight (33%) and high in 15 (62%) studies. Overall, two (8%) studies were assessed as contributing to new knowledge. Frequently occurring problems were selection bias making the comparison groups incomparable, treatment bias with suboptimal handling of drug exposure and an intention-to-treat approach, and assessment bias including immortal time bias. Good examples of how to handle bias problems included propensity score matching and sensitivity analyses. CONCLUSION Although this review illustrates that effectiveness studies based on dispensed drug register data can contribute to new evidence of intended effects of drug treatment in clinical practice, the expectations of such data to provide valuable information need to be tempered due to methodological issues.

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  • 44.
    Wallerstedt, Susanna M.
    et al.
    Univ Gothenburg, Sweden; Sahlgrens Univ Hosp, Sweden.
    Hoffmann, Mikael
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Evidence synthesis based on non-randomised studies-a critical review of studies leading to conclusions on fall risk properties of loop diuretics/beta-blockers2019In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 75, no 12, p. 1731-1738Article, review/survey (Refereed)
    Abstract [en]

    Purpose To describe methodological and reporting issues in non-randomised comparative drug safety studies pooled in meta-analyses, with focus on confounding by indication. Methods All studies included in statistically significant meta-analyses in a recent publication investigating fall risk properties of cardiovascular drugs were reviewed. Study characteristics were extracted and assessed. Results Nine studies, including between 498 and 321,995 individuals, contributed data to the significant meta-analyses in which loop diuretics and beta-blockers were associated with falls, five published in 2015. Five individual studies reported a statistically significant association. In the five cohort studies, characteristics of exposed vs unexposed individuals were either not reported (n = 3) or differed substantially regarding morbidity (n = 2). Drug treatment was determined at baseline, and data on falls were collected for up to 2 years thereafter. Out of the four case-control studies, the cases and controls in only one study were matched for morbidity. Morbidity characteristics of fallers compared with non-fallers were either not reported (n = 2) or they differed (n = 1) or were reported according to the matched-for diseases (n = 1). Confounding by indication was explicitly discussed in two studies. None of the abstract conclusions considered causality issues or the possibility of confounding by indication. Conclusions Confounding by indication is a major issue in non-randomised comparative drug safety studies, a problem which may be concealed in meta-analyses. To enhance such research, compared groups need to be balanced regarding relevant factors including morbidities and characteristics adequately reported. Confounding by indication needs to be explicitly discussed and highlighted in the abstract conclusion.

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  • 45.
    Wallerstedt, Susanna M.
    et al.
    Univ Gothenburg, Sweden; Sahlgrens Univ Hosp, Sweden.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Lönnbro, Johan
    Univ Gothenburg, Sweden; Sahlgrens Univ Hosp, Sweden.
    Methodological issues in research on drug-related admissions: A meta-epidemiological review with focus on causality assessments2022In: British Journal of Clinical Pharmacology, ISSN 0306-5251, E-ISSN 1365-2125, Vol. 88, no 2, p. 541-550Article, review/survey (Refereed)
    Abstract [en]

    Aim To investigate methodological aspects potentially related to the diverging scientific literature on the prevalence of drug-related hospitalisations, focusing on causality assessments. Methods Original studies contributing data to a recent meta-analysis were reviewed. Methodological aspects, in particular those related to causality assessments, were extracted and compiled. Results Thirteen studies provided data on the prevalence of drug-related admissions. Seven studies focused on adverse drug reactions (prevalences 1.3-10%), and six studies used the broader concept of drug-related problems (prevalences 4.5-41%). In 10 out of 13 studies, causality between the drug and the specified problem was assessed. One study required a probable causal relationship; the remaining studies merely required a possible causal relationship. Five studies assessed the association between the problem assumed to be related to drug therapy and the admission, at one end requiring the former to be demonstrated as the underlying cause and, at the other, merely requiring a temporal relationship between drug intake and admission. Three out of eight studies involving multiple assessors for all/some cases reported the inter-rater agreement, ranging from none to almost perfect. Physicians were involved in the assessments in five studies, reporting prevalences of 3.2% to 4.5%, while studies without such medical input reported prevalences of 8.8% to 41%. Conclusions This review illustrates that methodological issues contribute to the diverse literature on drug-related admissions. We provide suggestions for harmonisation of research, including explicitly assessing the drug-problem-admission relationships from a medical perspective, focusing on problems where the drug treatment is the probable culprit.

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  • 46.
    Wallerstedt, Susanna M.
    et al.
    Univ Gothenburg, Sweden; Sahlgrens Univ Hosp, Sweden.
    Svensson, Staffan A.
    Univ Gothenburg, Sweden; Narhalsan Hjallbo Hlth Ctr, Sweden.
    Lönnbro, Johan
    Univ Gothenburg, Sweden; Sahlgrens Univ Hosp, Sweden.
    Hieronymus, Fredrik
    Univ Gothenburg, Sweden.
    Fastbom, Johan
    Karolinska Inst, Sweden; Stockholm Univ, Sweden.
    Hoffmann, Mikael
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Lopez, Naldy Parodi
    Univ Gothenburg, Sweden; Narhalsan Kungshojd Hlth Ctr, Sweden.
    Performance of 3 Sets of Criteria for Potentially Inappropriate Prescribing in Older People to Identify Inadequate Drug Treatment2022In: JAMA Network Open, E-ISSN 2574-3805, Vol. 5, no 10, article id e2236757Article in journal (Refereed)
    Abstract [en]

    IMPORTANCE Potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs) are used in research to reflect the quality of drug treatment in older people and have been suggested for inclusion in core outcome sets for evaluation of interventions for improved prescribing. Their validation so far, however, is primarily restricted to expert opinion-based processes. OBJECTIVE To evaluate the performance of 3 explicit PIM/PPO criteria sets as diagnostic tools to identify inadequate drug treatment in older patients. DESIGN, SETTING, AND PARTICIPANTS This diagnostic study analyzed patients aged 65 years or older consecutively included from 2 primary health care centers from October to November 2017. Data were analyzed from February to August 2022. EXPOSURES The PIMs/PPOs were concordantly identified by 2 specialist physicians (2018-2019) retrospectively after a planned physician visit, using 3 European PIM/PPO criteria sets and without knowledge of this diagnostic study. MAIN OUTCOMES AND MEASURES Area under the receiver operating characteristic (ROC) curve, reflecting the ability of PIM/PPO criteria sets to identify the reference standard of inadequate drug treatment, determined by 2 specialist physicians in consensus. Inadequate drug treatment implied that additional action related to the medication could be medically justified before the next regular visit. RESULTS A total of 302 patients were analyzed (median age, 74 [IQR, 69-81] years; 178 women [59%]; median number of drugs in the medication list, 6 [IQR, 3-9]); 98 patients (32%) had inadequate drug treatment. A total of 0 to 8 PIMs/PPOs per patient were identified using the Screening Tool of Older Persons Prescriptions (STOPP)/Screening Tool to Alert to Right Treatment (START) criteria, 0 to 6 with the European EU(7)-PIM list, and 0 to 12 with the Swedish set of indicators of prescribing quality. The areas under the ROC curve for the 3 sets to identify the reference standard for inadequate drug treatment were 0.60 (95% CI, 0.53-0.66) for the STOPP/ START criteria, 0.69 (95% CI, 0.63-0.75) for the EU(7)-PIM list, and 0.73 (95% CI, 0.67-0.80) for the Swedish set. For comparison, the area under the ROC curve was 0.71 (95% CI, 0.65-0.78) using the number of drugs in the medication list. CONCLUSIONS AND RELEVANCE In this diagnostic study, the evaluated PIM/PPO sets had poor to fair performance as diagnostic tools to identify inadequate drug treatment, comparable with a simple count of the number of drugs in the medication list. These findings suggest that use of PIMs/PPOs as indicators of drug treatment quality in core outcome sets for the evaluation of interventions for improved prescribingmay need reconsideration.

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  • 47.
    Wallerstedt, Susanna M.
    et al.
    University of Gothenburg, Sweden.
    Wettermark, Björn
    Karolinska Institute, Sweden; Stockholm County Council, Sweden.
    Hoffmann, Mikael
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis.
    The First Decade with the Swedish Prescribed Drug Register - A Systematic Review of the Output in the Scientific Literature2016In: Basic & Clinical Pharmacology & Toxicology, ISSN 1742-7835, E-ISSN 1742-7843, Vol. 119, no 5, p. 464-469Article, review/survey (Refereed)
    Abstract [en]

    The aim of this study was to quantify and characterize the scientific output from the Swedish Prescribed Drug Register (SPDR) the first decade after its establishment. A systematic literature search was performed in Medline, EMBASE and PubMed (2005-2014). Additional publications were identified by personal knowledge, reference lists, contact with active authors and a citation search in Web of Sciences. Publications using SPDR data were included in the analysis and characterized regarding study type, presence of patient-level record linkage, target population and topic. A total of 719 publications were identified in the literature search and an additional 148 by other strategies. Three hundred and thirty-eight studies fulfilled the inclusion criteria. The majority were analytic (n = 166; 49.1%) or descriptive (n = 100; 29.5%). The remaining studies focused on validation (n = 20; 5.9%), health economics (n = 16; 4.7%) or miscellaneous (n = 36; 10.7%). The analytic studies investigating effects of drug exposure focused mainly on safety (n = 46) and/or effectiveness (n = 24). The first publications appeared in 2007 (n = 6), and in 2014, 90 articles using SPDR were published. Over the years, linkage with other registers using the personal identity number increased (0-88.9% of the publications). The population was often selected by age (49.7%), condition (45.0%) and/or drug (22.8%) and concerned predominantly psychiatric (29.0%) and cardiovascular (20.4%) diseases. In conclusion, this study illustrates that the establishment of a nationwide individual-based register on dispensed prescription drugs facilitates an encouraging development of pharmacoepidemiological research, both regarding the number of publications and the scientific level of the analyses.

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  • 48.
    Walther, Sten
    et al.
    Linköping University, Department of Medicine and Health Sciences, Physiology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart Centre, Department of Thoracic and Vascular Surgery.
    Erlandsson, M.
    Linköping University, Department of Clinical and Experimental Medicine, Infectious Diseases . Linköping University, Faculty of Health Sciences.
    Olsson-Liljequist, B.
    Smittskyddsinstitutet, Solna, Sweden.
    Hanberger, Håkan
    Linköping University, Department of Clinical and Experimental Medicine, Infectious Diseases . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Medicine, Department of Infectious Diseases in Östergötland.
    The Icustrama Study Group (2002),
    Burman, L.G.
    Smittskyddsinstitutet, Solna, Sweden.
    Cars, O.
    Smittskyddsinstitutet, Solna, Sweden.
    Gill, Hans
    Linköping University, Department of Biomedical Engineering, Medical Informatics. Linköping University, The Institute of Technology.
    Hoffman, Mikael
    Linköping University, Department of Medicine and Health Sciences, Clinical Pharmacology . Linköping University, Faculty of Health Sciences.
    Isaksson, Barbro
    Linköping University, Department of Clinical and Experimental Medicine, Clinical Microbiology . Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Laboratory Medicine, Department of Clinical Microbiology.
    Kahlmeter, G.
    Department of Clinical Microbiology, Växjö lasarett.
    Lindgren, S.
    Nilsson, Lennart
    Linköping University, Department of Clinical and Experimental Medicine, Clinical Microbiology . Linköping University, Faculty of Health Sciences.
    Antibiotic prescription practices, consumption and bacterial resistance in a cross section of Swedish intensive care units2002In: Acta Anaesthesiologica Scandinavica, ISSN 0001-5172, Vol. 46, no 9, p. 1075-1081Article in journal (Refereed)
    Abstract [en]

    Background: The purpose of this work was to study usage of antibiotics, its possible determinants, and patterns of bacterial resistance in Swedish intensive care units (ICUs).

    Methods: Prospectively collected data on species and antibiotic resistance of clinical isolates and antibiotic consumption specific to each ICU in 1999 were analyzed together with answers to a questionnaire. Antibiotic usage was measured as defined daily doses per 1000 occupied bed days (DDD1000).

    Results: Data were obtained for 38 ICUs providing services to a population of approximately 6 million. The median antibiotic consumption was 1257 DDD1000 (range 584–2415) and correlated with the length of stay but not with the illness severity score or the ICU category. Antibiotic consumption was higher in the ICUs lacking bedside devices for hand disinfection (2193 vs. 1214 DDD1000, p=0.05). In the ICUs with a specialist in infectious diseases responsible for antibiotic treatment the consumption pattern was different only for use of glycopeptides (58% lower usage than in other ICUs: 26 vs. 11 DDD1000,P=0.02). Only 21% of the ICUs had a written guideline on the use of antibiotics, 57% received information on antibiotic usage at least every 3 months and 22% received aggregated resistance data annually. Clinically significant antimicrobial resistance was found among Enterbacter spp. to cephalosporins and among Enterococcus spp. to ampicillin.

    Conclusions: Availability of hand disinfection equipment at each bed and a specialist in infectious diseases responsible for antibiotic treatment were factors that correlated with lower antibiotic consumption in Swedish ICUs, whereas patient-related factors were not associated with antibiotic usage.

  • 49.
    Wårdell, Karin
    et al.
    Linköping University, The Institute of Technology. Linköping University, Department of Biomedical Engineering, Biomedical Instrumentation.
    Hoffman, Mikael
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Care, Clinical Pharmacology.
    Ilias, Michail
    Linköping University, The Institute of Technology. Linköping University, Department of Biomedical Engineering, Biomedical Instrumentation.
    Salerud, Göran
    Linköping University, The Institute of Technology. Linköping University, Department of Biomedical Engineering, Biomedical Instrumentation.
    Stücker, M.
    Karaktärisering av blodperfusionen I hudlesioner med laser Doppler perfusion imaging2000In: Svenska Läkarsällskapets Riksstämma,2000, 2000, p. 249-249Conference paper (Other academic)
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