Dementia means a continuous deterioration of abilities and has a large impact on the persons affected as well as on family members and others close to the persons with dementia. Interventions aimed at this population in order to support and alleviate the often straining situation may be of great importance. There is a need to increase the knowledge and understanding of the impact and consequences of these interventions, both at an individual level and at a societal level. The demand for information concerning, e.g., economic and medical impact of technologies and interventions within health care is increasing. Assessment of technologies and interventions in dementia is related to certain methodological issues. The overall aim of this thesis is to contribute to the development of methodological knowledge concerning assessment studies and understanding of support interventions in dementia.

This thesis work includes four studies that examine methodological aspects of assessment of support interventions in dementia and also report empirical research on the perception of support interventions from the perspectives of family caregivers of persons with dementia. In study I, an assessment model for assistive technology (AT) interventions in dementia was developed. In study II, part of the assessment model is applied, and a process evaluation of the AT intervention is presented. Study III examines family caregivers’ perception of the importance of different types of support and services. In the final study, study IV, a well‐acknowledged methodological challenge within the field of assessment in dementia is addressed: measuring health‐related quality of life (HRQoL). The studies are based on different data materials.

An assessment model of AT interventions was developed that includes health economic evaluation from a societal perspective as well as evaluation of the intervention process. The perspectives of both persons with dementia and their relatives were incorporated in the model. The process evaluation was applied in study II in order to study the relatives’ perception of an AT intervention process. Assistive technology interventions in dementia may be of great significance for the relatives. By performing the process evaluation, several important aspects that need to be acknowledged in AT intervention processes in dementia were identified.

Family caregivers of persons with dementia perceived different types of support/services within the comprehensive areas of counselling, relief and information as very important. Knowledge of the caregivers’ preferences is significant so that more directed support interventions may be provided.

One specific methodological issue was addressed in study IV. The results of study IV showed that there were large differences in the results of cost‐effectiveness analyses depending on whether patient self‐ratings or proxy ratings (ratings of persons close to the patient) of patient HRQoL were used for the same analysis. These differences in the results could ultimately have an important impact on decision making and resource allocation.

Support interventions aimed at persons with dementia and their relatives may be of great value. Conducting assessment studies of technologies and interventions within health care is important in order to increase the knowledge concerning, e.g., economic and medical impact. Assessment studies of support interventions dementia entails methodological issues that need to be addressed. There is a need for increased knowledge within this field and suggestions on methodology are made.

Purpose: The aim of this study was to examine relatives' perception of an assistive technology intervention aimed at persons with dementia (PwDs) and their relatives, and to examine whether, and how, experiences of the intervention process differed between relatives valuing the intervention to be of high, and relatives perceiving it to be of low significance. Method: A total of 47 relatives of PwDs within the Swedish Technology and Dementia project were interviewed telephonically using a modified version of the Patient perspective on Care and Rehabilitation process instrument. A total of 46 participants were divided into two groups depending on whether they valued the intervention to be of great significance (GS group; N = 33) or of some/no significance (SNS group; N = 13). Results: Several aspects of the intervention were perceived as highly important, e.g. being shown consideration and respect, and having somewhere to turn. The results indicate that relatives in the GS group perceived certain aspects of the intervention process as highly fulfilled to a larger extent than did relatives in the SNS group. Conclusions: This study illustrates how process evaluations can be used to increase the understanding and to identify improvement aspects of interventions.

The overall aim of this study was to study costs and effects of an assistive technology intervention that included assistive technology, support and strategies for persons with dementia and their relatives. Further, the aim was to study the quality of the intervention process and how it was perceived by the participants in the project.

This assessment study was performed within a project called “Technology and Dementia – development work, create methods and increase competence”. This project was coordinated by the Swedish Institute of Assistive Technology in collaboration with the Alzheimer Society in Sweden and the Dementia Association and was funded by the Swedish Inheritance Fund, Linköping University and the County Council of Östergötland. Two national resource centres were appointed within the project. These developed the assistive technology intervention.

The study was designed as a pre/post study. Data was collected at three different occasions of measurement: baseline, first follow-up (four weeks after the intervention) and second follow-up (twelve weeks after the intervention). Different outcome measures were used to study the effect of the intervention: health related quality of life (HRQoL), support/caregiving situation, quality of sleep, perception of time and ability to perform everyday life activities. The costs in the study had a societal perspective. A process oriented instrument was used to study the quality of the intervention process. Persons with dementia as well as their relatives answered questionnaires and interviews in the study.

Data was collected via interviews at the resource centres, via self ratings and through telephone interviews from the research team. The total population included in the analyses was 48 persons with dementia and 47 relatives.

The results showed that there were no significant differences in effects between baseline and the two follow-ups, except for ability to perform everyday activities where data indicated deterioration during the study period. In one dimension of HRQoL for the relatives there was also a significant difference; the relatives rated greater difficulties at the second follow-up. Cognitive ability was used as a measure for disease stability during the study, and showed no significant differences. There was, however, a rather large drop-out at the second follow-up (15 %) in data on cognitive ability, therefore this result should be interpreted with caution; the persons with dementia may have deteriorated during the study period. This could be reflected in the deterioration in the ability to perform everyday life activities measure.

The persons with dementia rated their HRQoL higher than the relatives’ proxy ratings (i.e. relatives’ ratings of the HRQoL of the persons with dementia), the differences between the proxy ratings and the persons’ own ratings were significant at all three occasions of measurement. The relatives rated their own HRQoL somewhat higher than the persons with dementia rated their own HRQoL. There were no significant differences between baseline and the followups.

The intervention included many different types of assistive technologies. The cost of the intervention was 16 000 SEK/person with dementia and relative. There were no significant differences in costs of formal care during the study period. Many relatives performed informal care many hours of the day. Even though the differences in informal caregiving between baseline and the second follow-up were not significant there was a tendency of a slight increase in informal care time of everyday life activities and there was also a decrease in time spent supervising, a little less than one hour per day.

An evaluation of the quality of the intervention process and how it was perceived was performed. Most relatives perceived that their needs were well fulfilled during the intervention process. Some aspects were brought forward where the intervention process could be improved. Seventy-two percent of the relatives rated the intervention as of great importance, 28 percent rated the intervention as of some importance or of no importance. The persons with dementia had higher expectations on the intervention than the relatives and most persons with dementia perceived the intervention as of great importance.

Technology and Dementia was a trial project where potential effects and costs were studied. The study was explorative and contributes to increasing the knowledge on use of assistive technology in dementia and also on assessment methodology within this field. There were limitations in the study regarding size of the study population and lack of a comparison group.

Assessing assistive technology for persons with dementia and their relatives from a socioeconomic perspective entails certain methodological challenges. A model for assessment of assistive technology interventions was developed and tried in this study. Results and methodology are discussed in relation to the assessment model. From this assessment study, areas have been identified for future studies. Future studies will be performed through subgroup analyses to identify groups where the intervention was successful and groups where the intervention was not successful.

Conclusion: The results from this study suggest that there is almost no difference between groups of caregivers experiencing higher and lower NI regarding their perception of what are important types of support/services. The caregivers rated different types of support/services within the areas of information, relief and counselling as very important.

During the 1990s most western European and Organization of Economic Cooperation and Development (OECD) countries experienced financial difficulties and were forced to cut back on or restrain health care expenditures. Home rehabilitation has received attention in recent years because of its potential for cost containment. Often forgotten, however, is the redistribution of costs from one caregiver to another. The aim of this study was to analyse whether a redistribution of costs occurs between health care providers (the County councils) and social welfare providers (the municipalities) in a comparison of home-based rehabilitation and hospital-based rehabilitation after stroke. The study population included 123 patients, 53 in the home-based rehabilitation group and 68 in the hospital-based rehabilitation group. The patients were followed up at 6 and 12 months after onset of stroke. Resource use over a 12-month period included acute hospital care, in-hospital rehabilitation, home rehabilitation and use of home-help service as well as nursing home living. The hospital-based rehabilitation group had significantly fewer hospitalization days after a decision was made about rehabilitation at the acute care ward and consequently the cost for the acute care period was significantly lower. The cost for the rehabilitation period was significantly lower in the home-based rehabilitation group. However, the cost for home help service was significantly higher in the home-based rehabilitation group. The total costs for the care episode did not differ between the two groups. The main finding of this study is that there seems to occur a redistribution of costs between health care providers and social welfare providers in home rehabilitation after stroke in a group of patients with mixed degree of impairment.

Vitamin A deficiency (VAD) is a huge public health burden among preschool-aged children in sub-Saharan Africa, and is associated with a high level of susceptibility to infectious diseases and pediatric blindness. We examined the Nigerian national vitamin A capsule (VAC) supplementation program, a short-term cost-effective intervention for prevention of VAD-associated morbidity for equity in terms of socioeconomic and geographic coverage. Using the most current, nationally representative data from the 2008 Nigerian Demographic and Health Survey, we applied multilevel regression analysis on 19,555 children nested within 888 communities across the six regions of Nigeria. The results indicate that there was variability in uptake of VAC supplement among the children, which could be attributed to several characteristics at individual, household, and community levels. Individual-level characteristics, such as maternal occupation, were shown to be associated with receipt of VAC supplement. The results also reveal that household wealth status is the only household-level characteristic that is significantly associated with receipt of VAC, while neighborhood socioeconomic disadvantage and geographic location were the community-level characteristics that determined receipt of VAC. The findings from this study have shown that both individual and contextual socioeconomic status, together with geographic location, is important for uptake of VAC. These findings underscore the need to accord the VAC supplementation program the much needed priority with focus on characteristics of neighborhoods (communities), in addition to individual-level characteristics.

Objective: To compare bilateral and unilateral speech recognition in quiet and in multi-source noise, and horizontal sound localization of low and high frequency sounds in children with bilateral cochlear implants. Design: Bilateral performance was compared to performance of the implanted side with the best monaural speech recognition in quiet result. Parental reports were collected in a questionnaire. Results from the CI children were compared to binaural and monaural performance of normal-hearing peers. Study sample: Sixty-four children aged 5.1-11.9 years who were daily users of bilateral cochlear implants. Thirty normal-hearing children aged 4.8-9.0 years were recruited as controls. Results and Conclusions : Group data showed a statistically significant bilateral speech recognition and sound localization benefit, both behaviorally and in parental reports. The bilateral speech recognition benefit was smaller in quiet than in noise. The majority of subjects localized high and low frequency sounds significantly better than chance using bilateral implants, while localization accuracy was close to chance using unilateral implants. Binaural normal-hearing performance was better than bilateral performance in implanted children across tests, while bilaterally implanted children showed better localization than normal-hearing children under acute monaural conditions.

SSI:s vetenskapliga UV-råd skall ge myndigheten råd om det vetenskapliga underlaget beträffande sambandet UV-strålning och biologiska effekter. Vidare ligger i uppdraget att ge vägledning inför SSI:s ställningstagande i frågor av policykaraktär. Rådet har under året haft följande ledamöter: docent Harry Beitner, docent Yvonne Brandberg, meteorolog Weine Josefsson, professor Olle Larkö, professor Ulrik Ringborg (ordförande), docent Bernt Lindelöf, professor Per Söderberg, professor Rune Toftgård, docent Johan Hansson och docent Johan Westerdahl. Till rådet har adjungerats myndighetsspecialist Lars-Erik Paulsson.

Alla tre hudcancerformer - malignt melanom, skivepitelcancer och basalcellscancer – ökar i Sverige och internationellt. Gemensamt för alla tre formerna är att ökningen sammanhänger med exposition av solens UV-strålning, den viktigaste yttre riskfaktorn. Av detta följer att modifiering av UV-exposition, framför allt genom ändrade solvanor i befolkningen, bör kunna leda till en minskning av förekomsten av hudcancer. Primär prevention genom förebyggande insatser med syfte minskad UV-exposition, bedöms vara ett betydelsefullt sätt att motverka uppkomsten av alla tre formerna av hudcancer.

Ett annat gemensamt drag hos dessa tre tumörformer är nyttan av tidig diagnostik. Ett tidigt avlägsnande av en hudcancer innebär mindre sjukvårdsinsatser och, för framför allt malignt melanom, minskad risk för tumörspridning. Tumörutvecklingen sker ofta via förstadier och ökad kunskap om dessa leder till möjligheter att avlägsna förstadier innan dessa har hunnit bli elakartade tumörer. Denna form av tidigdiagnostik gränsar till den primära preventionen.

Av de tre formerna hudcancer är det i första hand malignt melanom som kan förorsaka död i sjukdomen. Ett väsentligt mål med förebyggande insatser är därför att minska dödligheten. För alla tre formerna kan insjuknande förorsaka betydande besvär för patienten. På grund av den rikliga förekomsten av maligna hudtumörer är sjukvårdskostnader betydande. Därför är mål för förebyggande insatser också minskad morbiditet och sjukvårdskostnader. Förutom hudcancer orsakar solens UV-strålning betydande problem i form av ögonskador.

I årets rapport redovisas (1) epidemiologiska aspekter av malignt hudmelanom, som under senare år uppvisar en stegrad ökningstakt; (2) maligna melanom hos barn och ungdomar; (3) förslag till studier av skivepitelcancer och yrke; (4) förekomst och kostnader för medicinsk handläggning av patienter med basalcellscancer, som visar höga incidenssiffror och höga kostnader; (5) lymfom och UV-strålning; (6) UV-strålning och katarakt, betydelsefullt med förebyggande åtgärder; (7) förslag till workshop om cellulära effekter av UV-strålning; (8) rekommendation att använda den uppgraderade versionen av European Code Against Cancer; (9) UV-strålning och vitamin D, viss UV-dos är av nytta; (10) dosrat och fraktioner av UV-strålning i relation till utveckling av hudcancer och hos möss, påverkar ej preventiva strategier; (11) debatt om ökad solexposition eventuellt skulle leda till förbättrad överlevnad för melanompatienter ändrar ej preventiva strategier; (12) synpunkter på primär prevention från 6th World Conference on Melanoma, Vancouver, 2005.

Gapet mellan behov och resurser inom hälso- och sjukvården gör tillsammans med det faktum att marknaden inte fungerar för att fördela vårdens tjänster att beslut om prioriteringar måste fattas genom planering. Sådana beslut bör för att vinna acceptans och legitimitet vara genomtänkta och baserade på värdegrunder med bred förankring i befolkningen. De värdegrunder som i detta sammanhang främst bör beaktas är de som kommer till uttryck i medicin- och vårdetik, prioriteringsutredningens riktlinjer samt hälso- och sjukvårdslagen. Resonemang om prioriteringsgrunder leder oftast fram till principerna rättvisa eller effektivitet. Rättvisa i prioriteringen av hälso- och sjukvård avser rimligast en fördelning efter behov medan effektivitet bör tolkas i termer av kostnadseffektivitet. De båda prioriteringskriterierna behovsrättvisa och kostnadseffektivitet anses ofta som oförenliga, något som inte minst visas av prioriteringsutredningens strikta rangordning i vilken behovsprincipen ges absolut företräde framför kostnadseffektivitetsprincipen.

I denna rapport utmanas uppfattningen om en absolut konflikt mellan dessa begrepp, och därmed det nödvändiga i en strikt rangordning, mellan behov och kostnadseffektivitet. För att skapa en förståelse för de båda prioriteringskriterierna redogörs i rapporten för dess bakomliggande teorier samt för rimliga innebörder av olika centrala begrepp.

När det gäller rättvisa tas utgångspunkten i Rawls teori om rättvisa som närmast är att betrakta som inriktad på jämlikhet. Den rimligaste tolkningen av Rawls teori tillämpad på den svenska sjukvården är att vårdens resurser skulle fördelas efter behov så att den person som har störst behov kommer i första hand. Behovsbegreppet relateras i prioriteringsutredningen till hälsa och livskvalitet där graden av inskränkning i dessa variabler styr behovets storlek. Behov kan dock definieras på olika sätt och i denna rapport har en teleologisk tolkning ansetts som rimligast. Enligt en sådan tolkning anses behov existera av något om detta är nödvändigt för ett visst ändamål. Inom hälso- och sjukvården är det rimligt att tolka behov som ett gap mellan det tillstånd som råder och ett mål som satts upp. Behovet avser rimligen vård(resurser) och målet borde vara att uppnå en förbättrad hälsa eller ett ökat välbefinnande. Gapet skulle alltså kunna utgöras av skillnaden mellan det rådande hälsotillståndet och ett hälsotillstånd som satts upp som mål. För att kunna tillämpa en sådan behovsprincip är det nödvändigt att på en och samma hälsoskala kunna mäta och fastställa såväl det rådande tillståndet som målet. För att behov av en vårdinsats ska existera krävs dessutom att insatsen är verksam, d.v.s. har en gynnsam effekt på hälsan.

Kostnadseffektivitet har sin grund i välfärdsekonomisk teori, för vilken utilitaristisk moralteori utgör en viktig värdegrund. Den välfärdsekonomiska teorin och utilitarismen är viktiga influenser för den hälsoekonomiska disciplinen och dess utvärderingar. Syftet med sådana utvärderingar är att finna den lösning som maximerar den hälsorelaterade nyttan.

Rättvisa och kostnadseffektivitet som begrepp tycks alltså fokusera på olika saker, hälsa respektive nytta, vilket gör det i högsta grad relevant att närmare studera olika begrepp som är kopplade till sjukvårdens resultat. Det finns två huvudinriktningar när det gäller hälsobegreppet, dels en biologisk/biostatistisk och dels en holistisk. Ett biologiskt synsätt har traditionellt dominerat inom den medicinska professionen. Boorses biostatistiska hälsobegrepp där hälsa jämställs med statistisk normalitet i biologiska funktioner har erhållit mycket uppmärksamhet och ligger ganska nära den traditionella medicinska uppfattningen. På senare år har dock en mer omfattande syn på hälsa blivit allt mer framträdande. Denna holistiska syn på hälsa inkluderar mer än bara biologiska funktioner då även människors förmåga att fungera i olika avseenden, socialt, fysiskt, psykiskt, arbetsmässigt etc, vägs in. Nyttobegreppet betraktas i termer av subjektiva autonoma preferenser, d.v.s. att det är människors egna önskemål och värderingar som avgör värdet av t.ex. en vårdinsats.

Hälsa och nytta ses ibland som väldigt likartade, nästan som olika benämningar på samma sak. Av denna rapport framgår att man inte bör blanda samman dessa båda begrepp då de inte kan anses spegla samma aspekter av sjukvårdens resultat. Det finns också ett antal olika sätt att mäta resultaten – kliniska riskindikatorer för biologiskt orienterad hälsa, psykometriska instrument som kan anses indikera holistisk hälsa, metoder för fastställande av QALY-vikter som motsvarar hälsorelaterade preferenser.

Ovanstående metoder har i annat sammanhang jämförts för att få åtminstone en preliminär bild av relationen mellan de båda begreppen hälsa och nytta. Resultatet av denna analys visade att marginalnyttan av hälsa är avtagande, d.v.s. att ju bättre hälsa desto mindre blir nyttotillskottet av en given hälsoförbättring. Detta innebär i sin tur att den antagna konflikten mellan rättvisa (hälsorelaterat behov) och kostnadseffektivitet (nyttomaximering) mildras. Slutsatsen i denna rapport är att de etiska principerna rättvisa uttryckt som behov och kostnadseffektivitet inte står i direkt motsatsställning till varandra så att rangordning krävs. Då båda principerna är både viktiga och önskvärda att inkludera i prioriteringsarbetet är det förmodligen bättre att söka en rimlig avvägning mellan dem än att välja att helt följa en princip på bekostnad av den andra.

Because cost-effectiveness of different cervical cytology screening strategies with and without human papillomavirus (HPV) DNA testing is unclear, we used a Markov model to estimate life expectancy and health care cost per woman during the remaining lifetime for 4 screening strategies: (i) cervical cytology screening at age 32, 35, 38, 41, 44, 47, 50, 55 and 60, (ii) same strategy with addition of testing for HPV DNA persistence at age 32, (iii) screening with combined cytology and testing for HPV DNA persistence at age 32, 41 and 50, iv) no screening. Input data were derived from population-based screening registries, health-service costs and from a population-based HPV screening trial. Impact of parameter uncertainty was addressed using probabilistic multivariate sensitivity analysis. Cytology screening between 32 and 60 years of age in 3-5 year intervals increased life expectancy and life-time costs were reduced from 533 to 248 US Dollars per woman compared to no screening. Addition of HPV DNA testing, at age 32 increased costs from 248 to 284 US Dollars without benefit on life expectancy. Screening with both cytology and HPV DNA testing, at ages 32, 41 and 50 reduced costs from 248 to 210 US Dollars with slightly increased life expectancy. In conclusion, population-based, organized cervical cytology screening between ages 32 to 60 is highly cost-efficient for cervical cancer prevention. If screening intervals are increased to at least 9 years, combined cytology and HPV DNA screening appeared to be still more effective and less costly. © 2007 Wiley-Liss, Inc.

Title: A modelling study of the cost-effectiveness of primary cytology and HPV DNA cervical cancer screening (En hälsoekonomisk modellstudie av primärscreening mot livmoderhalscancer med cellprov och HPV DNA-test)

Organisation: Center for Medical Technology Assessment, Department of Medical and Health Sciences, Linköping university, S- 581 83 Linköping, Sweden.

Contact person: Peter Bistoletti, peterbistoletti@yahoo.com.

Language: Swedish

Publication type: Health Technology Assessment report

Technology type: Screening

Objectives: The general objective of this report was to assess the costeffectiveness of different cervical cytology screening strategies with and without HPV DNA-testing in primary cervical cancer screening. Four strategies were compared: 1) cervical cytology screening at age 32, 35, 38, 41, 44, 47, 50, 55 and 60, 2) same strategy with addition of testing for HPV DNA persistence at age 32, 3) screening with combined cytology and HPV DNA-testing at age 32, 41 and 50, 4) no screening

Methods: Input data were derived from a population-based HPV screening trial, from population-based screening registries and health service costs. A probabilistic Markov model was used to estimate life expectancy and health-care costs per woman during the remaining lifetime.

Results: Cytology screening between 32-60 years of age in 3-5 year intervals increased life expectancy and life time costs were reduced from 533 to 248 US Dollars per women compared with no screening. Addition of HPV DNA-testing at age 32 increased costs from 248 to 284 US Dollars without benefit on life expectancy. Screening with both cytology and HPV DNA testing at ages 32, 41 and 50 reduced costs from 248 to 210 US Dollars with slightly increased life expectancy.

Recommendations: Population-based, organized cervical cytology screening between age 32 to 60 in this setting is an effective health care policy which both prevents cervical cancer and can produce overall health care cost savings. If screening intervals are increased to nine years, combined cytology and HPV DNA screening appeared to be at least equally effective and less costly.

INTRODUCTION: Violence and injuries are under-reported in developing countries, especially during natural disasters such as floods. Compounding this, affected areas are isolated from the rest of the country. During 2007 Bangladesh experienced two consecutive floods which affected almost one-third of the country. The objective of this study was to examine unintentional injuries to children in rural Bangladesh and parental violence against them during floods, and also to explore the association of socioeconomic characteristics. METHODS: A cross-sectional rural household survey was conducted in the worst flood-affected areas. A group of 638 randomly selected married women of reproductive age with at least one child at home were interviewed face-to-face using pre-tested structured questionnaires. The chi2 test and logistic regression were used for data analysis. RESULTS: The majority of families (90%) were affected by the flood and were struggling to find food and shelter, resulting in the parents becoming violent towards their children and other family members in the home. Cuts (38%), falls (22%) and near drowning (21%) comprised the majority of unintentional injuries affecting children during the floods. A large number of children were abused by their parents during the floods (70% by mothers and 40% by fathers). The incidence of child injuries and parental violence against children was higher among families living in poor socio-economic conditions, whose parents were of low occupational status and had micro-credit loans during the floods. CONCLUSIONS: Floods can have significant effects on childhood injury and parental violence against children. The improvement of socio-economic conditions would assist in preventing child injuries and parental violence.

Given the increasing pressures on health care budgets, economic evaluation is used in many countries to assist decision-making regarding the optimal use of competing health care technologies. Although the standard methods of estimating cost-effectiveness underpinning these decisions have gained widespread acceptance, concerns have been raised that many technologies would not be considered for funding, due to scarcity of evidence. However, as long as the amount and quality of evidence used for the analysis are properly characterized, scarce evidence per se should not be seen as a hindrance to perform cost-effectiveness analyses. Characterizing uncertainty appropriately, though, may pose a challenge even when there is a large body of evidence available, and even more so when evidence is scarce. The aims of this thesis are to apply a methodological framework of cost-effectiveness analysis and explore methods for characterising uncertainty when evidence is scarce. Three case studies associated with limited evidence provide economic evaluations on current decision problems, investigate the feasibility of using the framework, and explore methods for characterizing uncertainty when evidence is scarce.

The results of the case studies showed that, given current information, providing transfemoral amputees with C-Leg and Airsonett Airshower to patients with perennial allergic asthma could be considered cost-effective whereas screening for hyperthrophic cardiomyopathy among young athletes is unlikely to be cost-effective. In the cases of C-Leg and Airsonett Airshower conducting further research is likely to be cost-effective. The case studies indicate that it is feasible to apply methods of cost-effectiveness in health care for technologies not commonly evaluated due to lack of evidence. The analysis showed that failing to account for individual experts’ might have a substantial effect on the interpretation of the results of cost-effectiveness analysis. Formal expert elicitation is a promising method of characterizing uncertainty when evidence is missing, and thus enable cost-effectiveness and value of further research to be appropriately estimated in such situations.

In conclusion, this thesis shows that scarcity of evidence should not preclude the use of cost-effectiveness analysis. On the contrary, in such cases it is probably more important than ever to use a framework that enable us to define key parameters for a decision problem and identify available evidence in order to determine cost-effectiveness given current information and provide guidance on further data collection.

Background: Expert opinions are often used in decision models when evidence is scarce. This study describes the details of a formal elicitation exercise to estimate parameter values and their associated uncertainty and compares the results in term of cost-effectiveness and value of information with results from only eliciting mean values from experts.

Methods: Elicited distributions for 11 unknown parameters where incorporated into a previously developed cost-effectiveness model for prosthetic knees for amputees. The original model included elicited mean values for the missing values, thus ignoring any uncertainty across experts’ beliefs.

Results: The incremental cost-effective ratio (ICER) for the analysis based on the current elicited distributions was substantially higher (€13 625) than the ICER in the original analysis (€3 258). Even decision uncertainty, at a €35 000 threshold, increased significantly, increasing the value of further research from €355 100 in the original analysis, to €5 987 444 for the current elicited values.

Conclusions: Failing to account for the individual expert’s uncertainty might have a considerable impact on the result of cost-effectiveness analyses. Formal expert elicitation offers a plausible method to generate prior distributions representing the experts’ uncertainty and thereby more appropriately account for the true uncertainty of the decision.

Objective: To estimate the costs and health outcomes of C-Leg and non–microprocessor-controlled (NMC) knees using a decision-analytic model.

Design: Data on costs, rates and duration of problems, knee survival, and health-related quality of life were obtained from interviews with patients and prosthetists with experience of both C-Leg and NMC knees. Interview data were assessed in a decision-analytic Markov model to estimate cost-effectiveness from a health care perspective.

Setting: Outpatient.

Participants: A population sample of 20 patients currently using the C-Leg and prior experience of nonmicroprocessor knees, and 5 prosthetists.

Interventions: Not applicable.

Main Outcome Measure: Incremental cost per quality-adjusted life year (QALY).

Results: The mean incremental cost (in 2006 Euros) and QALYs for the C-Leg was €7657 and 2.38, respectively, yielding a cost per QALY gained of €3218.

Conclusions: It is important to provide decision-makers with relevant information on costs and health outcomes of different treatment strategies on actual decision problems despite limited evidence. The results of the study, taking into account both costs and a broadly defined health outcome in terms of QALY, show that given existing albeit limited evidence the C-Leg appears to yield positive health outcomes at an acceptable cost.

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Background: Screening to prevent sudden cardiac death among young athletes has been debated for some time and several countries have already introduced pre-participation cardiovascular screening to identify sports active individuals at risk. Although, hypertrophic cardiomyopathy (HCM) is the most common underlying disease that is documented to be detectable by screening the cost-effectiveness of such a screening strategy is still unclear.

Methods: A screening program to detect HCM in young athletes was compared to a non screening strategy. Prevalence of HCM, mortality risks and test characteristics were estimated from published sources and formal expert elicitation. These estimates were incorporated in a decision analytic model to estimate costs and health outcomes, expressed in life years and quality adjusted life years (QALYs), over a lifetime perspective.

Results: The screening strategy was associated with a mean incremental cost of €93 and a mean incremental gain of 0.0005 life years, yielding a cost per life year gained of €196 205. Taking quality of life into account, the screening strategy was associated with a loss of 0.034 QALY.

Conclusions: The study shows that screening young athletes for hypertrophic cardiomyopathy is not likely to yield survival benefits at a cost normally considered to be cost-effective and if quality of life is considered in the analysis screening is associated with higher costs and a loss of QALYs. Thus, based on the present findings a strategy of screening young athletes for hypertrophic cardiomyopathy is unlikely to be cost effective.

The need for a national system to evaluate medical technologies other than pharmaceuticals is being considered. Several proposals advocate establishing a type of “Treatment Benefits Board”. To highlight problems and analyse the conditions for national assessments in this context, the National Board of Health and Welfare, the Medical Products Agency, the Swedish Council on Technology Assessment in Health Care (SBU), and the Dental and Pharmaceutical Benefits Agency (TLV) jointly appointed the Centre for Medical Technology Assessment (CMT) at Linköping University to conduct a preliminary study. The preliminary study should provide a foundation for the agencies to decide whether or not the issue needs to be investigated further.

The preliminary study aims to develop background information concerning how Sweden and other countries currently assess, prioritise, and implement decisions involving new nonpharmaceutical health technologies. The basic questions addressed are:

1. How can nonpharmaceutical technologies be defined and categorised for the purpose of setting parameters for an approval process?
2. How is the current process of assessment, prioritisation, and approval in Sweden structured, focusing on SBU, the Medical Products Agency, the National Board of Health and Welfare, and TLV?
3. How have other countries organised their systems for assessment, prioritisation, and approval of nonpharmaceutical technologies?

Within the framework of the project it was not possible to conduct detailed, onsite studies of the healthcare systems in other countries. Hence, we relied on descriptions of other countries’ systems as reported in scientific articles, reports, and official documents available from various organisations and other sources via the Internet. In some instances the information was complemented by interviewing key individuals. The same applies to the descriptions of Swedish agencies. Information concerning the prevalence of various technologies was collected from official reports/reviews and registry data. We present information from six countries where we found sufficient information to preliminarily answer the questions we formulated in advance. The countries are Australia, New Zealand, England, Spain, Italy, Canada, and the USA.

We draw the following conclusions from the preliminary study: It is relatively complicated to define nonpharmaceutical technologies and delineate the technologies that potentially could be subject to regulation. Our practical attempts to describe the technologies that SBU Alert has assessed show that:

surgical and medical interventions dominate, but a relatively high number of screening programmes have also been assessed;

• medical equipment and pharmaceuticals are the predominant input factors. Active implants and biological products are also relatively common. Assistive devices and dental products are seldom considered to be primary input factors;
• most technologies are used primarily for treatment purposes. Diagnostic technologies are also relatively common.

By removing pharmaceuticals from the equation and combining interventions and input factors, SBU Alert arrived at 18 different categories of health technologies that it assesses. The predominant combination is surgical intervention and biomedical equipment. This is followed by surgical intervention and insertion of active implants. In the report, we propose a way to define and classify technologies that we found to be appropriate for the purpose. This does not exclude pharmaceuticals. Rather, pharmaceuticals are included as one input factor among others.

Another aim was to produce background information describing how Sweden and other countries currently assess, prioritise, and approve new nonpharmaceutical technologies. We identified several key components that we believe are worth considering in designing a national system for assessing, prioritising, and approving new nonpharmaceutical health technologies. These components are:

• Organisational level – At what organisational level should the approval of nonpharmaceutical health technologies take place?
• Scope – Should an all-inclusive or selective approach be taken towards inclusion/selection of health technologies for assessment?
• Base package – Should there be a basic list showing what is financed with public funds, or is it sufficient to present only new decisions on the margin?
• Diversity of actors – Should a single actor, or many actors, be responsible for assessment, prioritisation, and decisions regarding financing?
• Fact producer – Who would be most appropriate to manage the factual information base?
• Transparency – How transparent should one be in presenting the decisionmaking process and its results?
• Political involvement – How politically independent should the decisions be?
• Budgetary responsibility – Should the unit that recommends or decides on approval have a budgetary responsibility?
• New and old – Should the decisions apply both to introducing new technology and phasing out old technology?
• Fundamental values – Should there be an explicit set of fundamental values for prioritisation, and how should it be formulated?
• Appeals – Should there be a mechanism to appeal decisions?

To summarise, we see a trend in other countries towards an increasing level of assessment and prioritisation in decisions regarding the introduction of nonpharmaceutical health technologies. Our preliminary impression is that nearly every system that we studied continues to develop and remains “a work in progress”. For instance, in Australia and New Zealand official inquiries are under way to suggest or present proposals for improvement.

Our studies of systems in different countries, although limited, indicate there is no perfect system to copy directly. The way in which the various systems are organised is somewhat related to how health care is organised in the respective countries and how many resources they have decided to dedicate to this purpose. The results from our preliminary study show, however, that several countries have more experience in “approving” nonpharmaceutical-based technologies than what we have in Sweden. The most interesting countries are England, New Zealand, Canada, and Australia. Spain could also be of interest. Hence, there is good reason to consider what might be the best way to analyse these countries’ systems in detail and complement this information with data from other nations that we were unable to include in the preliminary study, e.g. the Netherlands and Israel.

To more rigorously analyse other systems, if this project is continued, investigators should probably start from one or more models for a Swedish mechanism. To arrive at one or more tentative models in this context, the county councils should be involved in the project. The format could be a workshop that engages representatives from public agencies, county councils, and professional associations, where they jointly outline conceivable models that could then be analysed and discussed in light of the experiences of other nations.

The aim of this study was to identify the social and organizational requirements for a decision support system (DSS) to be implemented in a clinical rheumatology setting, utilizing data-mining techniques. Field observations and focus group interviews were used for data collection. The decision-making was found to be situated, patient-focused, and long-term in nature. At the same time, the main part of peer-to-peer communication was informal. Patient records were involved in almost every decision. The conclusion is that the main challenges, when introducing a DSS at a rheumatology unit, are adapting the system to informal communication structures and integrating it with patient records. Considering incentive structures, understanding workflow and incorporating awareness are relevant issues when addressing these issues in future studies.

Identification of prognostic subgroups is of key clinical interest at the early stages of chronic disease. The aim of this study is to examine whether representation of physicians' expert knowledge in a simple heuristic model can improve data mining methods in prognostic assessments of patients with rheumatoid arthritis (RA). Five rheumatology consultants' experiences of clinical data patterns among RA patients, as distinguished from healthy reference populations, were formally represented in a simple heuristic model. The model was used in K-mean-clustering to determine prognostic subgroups. Cross-sectional validation using physician's global assessment scores indicated that the simple heuristic model performed better than crude data made in identification of prognostic subgroups of RA patients. A simple heuristic model of experts' knowledge was found useful for semi-automatic data mining in the chronic disease setting. Further studies using categorical baseline data and prospective outcome variables are warranted and will be examined in the Swedish TIRA-program.

BACKGROUND: To examine women’s attitude towards discontinuation of female genital mutilation (FGM) in association with their access to information, knowledge of health effects and cultural beliefs concerning FGM in Egypt. METHODS: A cross-sectional study of 9159 women, using data from the household survey in Egypt by Demographic and Health survey 2003. A comprehensive questionnaire covering attitudes towards FGM, demographics, and access to information was used. Chi-square analysis and logistic regression were applied to investigate how demographics, level of education, access to information, knowledge of health consequences and cultural beliefs influence women’s attitudes towards FGM. RESULTS: Among the demographic variables, discontinuation of FGM was independently associated with urban residency and post-secondary education. Moreover, women who were informed by the media, and those who had attended community meetings, church, or mosque where FGM was discussed, as well as women who were aware of the negative health consequences of FGM, were more likely to support discontinuation of FGM. By contrast, women with positive cultural conceptions of FGM were less likely to favour its discontinuation. CONCLUSIONS: Public education and information dissemination aiming to change current cultural notions favouring FGM practice – through community and religious leaders, and radio and television programs – may play an important role in modifying women’s attitudes towards FGM. These findings have some implications for intervention and policy.

BACKGROUND: This paper scrutinizes the association between maternal practices to correct child behavior and the mothers’ exposure to and attitudes towards intimate partner violence (IPV). METHODS: Nationally representative data comprising 14016 married women were retrieved from the Egyptian Demographic and Health Survey, 2005. Data on practices used to correct child behavior, exposure to IPV, attitudes towards IPV were our primary interest. Data were analyzed using Chi-square test and logistic regression. RESULTS: The majority of the mothers reported use of violent methods, like shouting (90.6%), striking (69.1%) and slapping (39.3%) to correct child behavior. Seven percent of the mothers used only the explanation option. Exposure to physical IPV and tolerant attitudes towards IPV were associated with an augmented risk of using violent methods (shouting, striking or slapping) to correct child behavior. On the other hand non-tolerant attitudes towards IPV were associated with increased likelihood of sole use of the explanation method. CONCLUSIONS: We thus recommend the implementation of local parental education programs focusing on communicative skills to reduce IPV and related child abuse. 

Self-directed learning denotes that the individual is in command of what should be learned and why it is important. In this study, guidelines for the design of Web 2.0 systems for supporting diabetic adolescents every day learning needs are examined in light of theories about information behaviour and social learning. A Web 2.0 system was developed to support a community of practice and social learning structures were created to support building of relations between members on several levels in the community. The features of the system included access to participation in the culture of diabetes management practice, entry to information about the community and about what needs to be learned to be a full practitioner or respected member in the community, and free sharing of information, narratives and experience-based knowledge. After integration with the key elements derived from theories of information behaviour, a preliminary design guideline document was formulated.

Aim: The study aims to identify characteristics associated with long-term expectations of professional stability or mobility among recently sick-listed workers, and to study whether expectations of professional mobility and turnover intentions were associated with duration of sick leave.

Methods: A cross-sectional study was performed on baseline measures in a prospective cohort study of patients who were granted sick leave due to musculoskeletal (MSD) or mental (MD) disorders. A total of 1,375 individuals fulfilled the inclusion criteria. A baseline questionnaire was sent by mail within 3 weeks of their first day of certified medical sickness; 962 individuals responded (70%). The main diagnosis was MSD in 595 (62%) individuals and MD in 367 (38%).

Results: Expectations of ability to remain in the present profession in 2 years was associated with better health and health-related resources, younger age, higher education, and better effort-reward balance. Effort-reward imbalance, MD, high burnout scores, and better educational and occupational position were associated with turnover intentions. Low expectations of ability to remain in the present profession defined two vulnerable groups with regard to RTW, those with no turnover intentions were older, had lower personal resources, more often had MSD, and slower RTW rate. Those with turnover intentions had a clear effort-reward imbalance and high burnout scores.

Conclusions: The results of this explorative study underline the importance of differentiating RTW-interventions based on knowledge about the sick-listed person's resources in relation to the labor market and the work place, and their expectations of future employment and employability.

Demographic trends and other factors are expected to continue widening the gap between health care demands and available resources, especially in elder services. This growing imbalance signals a need for priority setting in health care. The literature has previously described problems in constructing useable means of priority setting, particularly when evidence is sparse, when patient groups are not satisfactorily defined, when interpretation of the term patient need is unclear, and when uncertainty prevails on how to weigh different ethical values. The chosen study object illustrates these problems. Moreover, the Swedish Government recently stated that care for elderly persons with complex health care needs remains underfunded. The general aim of this thesis is: to study micro-level priority setting for elderly heart patients with complex needs, as illustrated by those with non-ST-elevation myocardial infarction (NSTEMI); to relate the findings to evidence-based priority setting, e.g. guidelines for heart disease; and to analyse how complex needs could be appropriately categorised from a perspective of evidence-based priority setting.

Paper I presents a register study that uses data from the Patient Register to describe inpatient care utilization, costs, and characteristics of elderly patients with multiple diseases. Paper II presents a confidential survey study from a random sample of 400 Swedish cardiologists. Paper III presents a prospective, clinical, observational multicentre-study of elderly patients with myocardial infarction (NSTEMI). Paper IV presents a questionnaire study from a purposeful, stratified sample of Swedish cardiologists.

The results from Paper I show that elderly patients with multiple diseases have extensive and complex needs, frequently manifesting chronic and intermittently acute disease and consuming health care at various levels. A large majority have manifested cardiovascular disease. Results from Paper II indicate that although 81% of cardiologists reported extensive use of national guidelines in their clinical decision-making generally, the individual clinician’s personal clinical experience and the patient’s views were used to a greater extent than national guidelines, when making decisions about elderly multiple-diseased patients. Many elderly heart disease patients with complex needs manifest severe, acute or chronic, comorbid conditions that constitute exclusion criteria in evidence-generating studies, thereby limiting the generalisability of evidence and applicability of guidelines for these patients. This was indicated in papers I-IV. Paper III reports that frailty is a strong independent risk factor for adverse, short-term, clinical outcomes, e.g. one-month mortality for elderly NSTEMI patients. Particularly frail patients with a high comorbidity burden manifested a markedly increased risk.

In the future, prospective clinical studies and registries with few exclusion criteria should be conducted. Consensus-based judgments based on a framework for priority setting as regards elderly patients with complex needs may offer an alternative, estimating the benefitrisk ratio of an intervention and the time-frame of expected benefits in relation to expected life-time. Such a framework, which is tentatively outlined in this thesis, should take into account comorbidity, frailty, and disease-specific risk.

Study Design. A cost-effectiveness study was performed from the societal and health care perspectives. Objective. To evaluate the costs-effectiveness of lumbar fusion for chronic low back pain (CLBP) during a 2-year follow-up. Summary of Background Data. A full economic evaluation comparing costs related to treatment effects in patients with CLBP is lacking. Patients and Methods. A total of 284 of 294 patients with CLBP for at least 2 years were randomized to either lumbar fusion or a nonsurgical control group. Costs for the health care sector ( direct costs), and costs associated with production losses ( indirect costs) were calculated. Societal total costs were identified as the sum of direct and indirect costs. Treatment effects were measured using patient global assessment of improvement, back pain ( VAS), functional disability (Owestry), and return to work. Results. The societal total cost per patient ( standard deviations) in the surgical group was significantly higher than in the nonsurgical group: Swedish kroner (SEK) 704,000 ( 254,000) vs. SEK 636,000 ( 208,000). The cost per patient for the health care sector was significantly higher for the surgical group, SEK 123,000 ( 60,100) vs. 65,200 ( 38,400) for the control group. All treatment effects were significantly better after surgery. The incremental cost-effectiveness ratio ( ICER), illustrating the extra cost per extra effect unit gained by using fusion instead of nonsurgical treatment, were for improvement: SEK 2,600 ( 600 - 5,900), for back pain: SEK 5,200 ( 1,100 - 11,500), for Oswestry: SEK 11,300 ( 1,200 - 48,000), and for return to work: SEK 4,100 ( 100 21,400). Conclusion. For both the society and the health care sectors, the 2-year costs for lumbar fusion was significantly higher compared with nonsurgical treatment but all treatment effects were significantly in favor of surgery. The probability of lumbar fusion being cost-effective increased with the value put on extra effect units gained by using surgery.

Att låta individuellt ansvar för sin egen hälsa påverka hälso- och sjukvårdens prioriteringar är ett förslag som är välkänt och ofta diskuterat i prioriteringsdebatten, men också ett förslag som sällan får bifall. Varken i Norge eller i Sverige ansåg prioriteringsutredningarna att en ansvarsprincip vore lämplig i prioriteringssammanhang och hittills har förslaget om en ansvarsprincip inte realiserats.

En anledning både till frågans fortsatta aktualitet och till utredningarnas tveksamhet är troligtvis dess bredd och komplexitet. En princip som den ovan föreslagna måste förstås i relation till redan existerande moraliska värderingar och uppfattningar, och frågan om en ansvarsprincip berör många olika värderingar och uppfattningar både när det gäller personligt ansvar och vilken roll detta ansvar bör ha inom hälso- och sjukvården. Syftet med föreliggande rapport är att belysa några av de problem (och möjligheter) som idén om en ansvarsprincip ställer oss inför.

Det finns många olika typer av ansvar men jag menar att det ansvar vi rimligen tillskriver vissa personer för deras (dåliga) hälsotillstånd främst handlar om dessa personers onödigt stora risktagande med sin hälsa. Det vi vänder oss emot både när det gäller extremsportaren, rökaren eller en person som reser utomlands utan att ta de rekommenderade vaccinationerna (för att nämna några exempel) är att de alla tar risker med sin hälsa. Risktagande kan delas upp i direkta risker och kumulativa risker. Handlande som utgör en direkI relation till en ansvarsprincip verkar Shaver och Drowns femte variabel rimligast att förstå som ett ansvar att inte i onödan utnyttja hälso- och sjukvårdens resurser eftersom andra personer kan ha ett större behov av dessa. Detta är kanske också den främsta anledningen att ta en ansvarsprincip i beaktande vid fördelning av resurser.

t risk är sådant som utgör en risk vid varje tillfälle handlingen utförs. Kumulativ risk är sådant handlande som sammantaget utgör en hälsorisk, men som inte nödvändigtvis är en risk vid det enskilda handlandet.

Enligt psykologerna Shaver och Drown (Shaver, Drown 1986) tillskriver vi individer ansvar (och klander) efter att ha gjort en bedömning av fem olika variabler. Dessa variabler är orsakande, kännedom om sina handlingars konsekvenser, avsiktlighet, frivillighet och det moraliskt felaktiga i handlingen som man utfört. Trots att orsakande spelar viss roll när vi tillskriver ansvar verkar orsakande (i snäv bemärkelse) varken vara en nödvändig eller tillräcklig förutsättning för tillskrivande av ansvar. Om det ansvar man har för sin hälsa/ohälsa innebär just att man inte bör ta alltför stora risker med sin hälsa verkar orsakssambanden spela en än mindre roll. Detta skulle förklara varför vi till exempel anser att en skadad bergsklättrare till viss del kan vara ansvarig för sin skada trots att han eller hon inte har orsakat den i någon strikt bemärkelse. Däremot är det viktigt för tillskrivande av ansvar att individen faktiskt kände till vilka risker hans eller hennes handlande innebar.

Medan en bergsklättrare troligtvis känner till de risker han eller hon tar är det kanske inte självklart att en rökare för några decennier sedan kände till de hälsorisker rökning innebär.

En skillnad mellan kumulativa risker och direkta risker är att man i en bemärkelse kan säga att de senare är avsedda till högre grad. När det gäller ansvar i förhållande till just ohälsa är det tydligt att avsikten med handlingen eller vanan sällan är skada eller sjukdom. När det gäller de direkta riskerna kan man emellertid tänka sig att de möjliga negativa konsekvenserna under normala omständigheter tas i beräknande till högre grad vilket i sin tur kan förstås som en högre grad av avsiktlighet. Det kumulativa risktagandet, å andra sidan, är troligtvis avsiktligt till lägre grad eftersom riskerna här ofta ligger längre fram i tiden och inte har en lika tydlig koppling till beteendet.

När det gäller frivillighet och avsaknad av tvång verkar det faktum att det ofta är vanor eller beroende som ligger till grund för det kumulativa risktagandet tala för att det finns en viss skillnad i vårt tillskrivande av ansvar även här, men frågan hur stort tvång olika beroenden eller de faktorer som gör att vi grundlägger vissa vanor är svår att besvara. Dessutom kan man tänka sig att även de personer som tar direkta risker påverkas av behov av andra kemiska substanser som t ex adrenalin. Vad som är en ursäktande grad av tvång i förhållande till en ansvarsprincip borde dock inte vara annorlunda än den grad av tvång vi anser frånta en person ansvar i andra sammanhang som till exempel inom rättssystemet.

Ett av de huvudsakliga problemen med en ansvarsprincip i allmänhet och ansvar för hälsa i termer av risk i synnerhet är att det är svårt att dra en gräns för vilken typ av risker en ansvarsprincip ska tillämpas på. Vi tar alla risker med vår hälsa och frågan är hur man på ett rimligt sätt ska kunna avgöra vilken typ av risker som är för stora. Vid en sådan bedömning löper man stor risk att valet av grupper en ansvarsprincip skulle kunna tillämpas på är redan utsatta grupper eller patientgrupper ur en lägre socioekonomisk samhällsklass. Detta är i synnerhet ett problem om hälsa ses som en av de resurser många av oss anser att samhället bör fördela rättvist. Vidare måste man vara uppmärksam på andra tillämpningsproblem som till exempel vem som ska göra bedömningen av den enskilde individens ansvar för sitt hälsotillstånd och om denna bedömning främst ska göras på vissa typer av patientgrupper eller på individen.

Om man trots detta problem skulle lägga en ansvarsprincip till den etiska plattformen återstår problemen med ansvarsprincipens relation till de övriga principerna i den etiska plattformen. Här finns emellertid också en möjlighet. En ansvarsprincip och dess påverkan på resursfördelningen inom hälso- och sjukvården skulle kunna begränsas genom just dess relation till exempel människovärdesprincipen eller behovs- eller solidaritetsprincipen. Vidare kan man tänka sig att en ansvarsprincip (tillsammans med andra principer) kunde vara en riktlinje för vad som ska ingå i det offentliga åtagandet.

Chronic obstructive pulmonary disease (COPD) is an increasing public health problem, generating considerable costs. The objective of this study was to identify factors affecting COPD-related costs. A cohort of 179 subjects with COPD was interviewed over the telephone on four occasions about their annual use of COPD-related resources. The data set and explanatory variables were analysed by means of multivariate regression techniques for six different types of cost: societal (or total), direct (health care) and indirect (productivity), and three subcomponents of direct costs-hospitalisation, outpatient and medication. Poor lung function, dyspnoea and asthma were independently associated with higher costs. Poor lung function (severity of COPD) significantly increased all six examined cost types. Dyspnoea (breathing problems) also increased costs, though to a varying extent. The presence of reported asthma increased total, direct, outpatient and medication costs. Poor lung function and, to a lesser extent, extent of dyspnoea and concomitant asthma, were all strongly associated with higher COPD-related costs. Strong efforts should be made to prevent the progression of COPD and its symptoms.

Objective: To describe the course of recent onset rheumatoidarthritis (RA) and to compare consequences of the disease inmen and women.

Methods: 284 patients with recent onset RA were followed upprospectively for two years from the time of diagnosis. Measuresof disease activity (for example, 28 joint disease activityscore (DAS28), C reactive protein, morning stiffness, physician’sglobal assessment) and function outcome (for example, rangeof movement, hand function, walking time) were determined. Thepatients’ self reported assessment of functional capacity(Health Assessment Questionnaire (HAQ)) and grading of wellbeingand pain (visual analogue scale) were registered. Changes overtime and differences between men and women were evaluated.

Results: Improvements were seen for all variables within thefirst three months. Disease activity then remained unchanged.Function variables followed the same pattern during the firstyear, but then tended to worsen. HAQ scores were similar atbaseline, but significantly worse in women than in men at theone and two year follow ups.

Conclusions: Disease activity was well managed and had improvedsubstantially after two years, whereas function seemed slowlyto deteriorate. Although disease variables were similar formen and women, functional ability (HAQ) had a less favourablecourse in women.

This study aimed to analyse the impact of the disease and treatment on health-related quality of life (HRQOL) in intensively treated young patients with diabetes. Our main hypothesis was that metabolic control, gender, age and socio-economic status predict HRQOL. All children and adolescents (n = 400, 191 girls) and parents in a geographic population of two paediatric clinics in Sweden [mean age 13.2 yr, ±SD 3.9, range 2.6-19.6; mean duration of diabetes 5.1 yr, ± SD 3.8, range 0.3-17.6; yr mean haemoglobin A1c (HbA1c) 7.1%, ±SD 1.2, range 4.0-10.7] received the DISABKIDS questionnaire, a validated combined chronic generic and condition-specific HRQOL measure for children, and the EuroQol-5D questionnaire. Parents as proxy perceived HRQOL lower than their children. Adolescents with separated parents reported lower generic HRQOL (GeHRQOL) and diabetes-specific HRQOL (DiHRQOL) than those with parents living together (p = 0.027 and p = 0.043, respectively). Adolescent girls reported lower GeHRQOL (p = 0.041) and DiHRQOL (p = 0.001) than boys did. Parents of girls less than8 yr of age reported lower DiHRQOL (p = 0.047) than did parents of boys less than8 yr. In addition, a difference was found in HRQOL between centres. Intensive insulin therapy did not seem to lower HRQOL. If anything, along with better metabolic control, it increased HRQOL. A correlation between DiHRQOL and HbA1c was found in adolescents (r = -0.16, p=0.046) and boys aged 8-12 yr (r = -0.28, p = 0.045). We conclude that the diabetes team can influence the HRQOL of the patients as there was a centre difference and because HRQOL is influenced by glycaemic control and insulin regimen. Girls seem to need extra support.

Background: Diabetes requires extensive self-care and comprehensive knowledge, making patient education central to diabetes self-management. Web 2.0 systems have great potential to enhance health information and open new ways for patients and practitioners to communicate. less thanbrgreater than less thanbrgreater thanObjective: To develop a Web portal designed to facilitate self-management, including diabetes-related information and social networking functions, and to study its use and effects in pediatric patients with diabetes. less thanbrgreater than less thanbrgreater thanMethods: A Web 2.0 portal was developed in collaboration with patients, parents, and practitioners. It offered communication with local practitioners, interaction with peers, and access to relevant information and services. Children and adolescents with diabetes in a geographic population of two pediatric clinics in Sweden were randomized to a group receiving passwords for access to the portal or a control group with no access (n=230) for 1 year. All subjects had access during a second study year. Users activity was logged by site and page visits. Health-related quality of life (HRQOL), empowerment (DES), and quality of information (QPP) questionnaires were given at baseline and after 1 and 2 study years. Clinical data came from the Swedish pediatric diabetes quality registry SWEDIABKIDS. less thanbrgreater than less thanbrgreater thanResults: There was a continuous flow of site visits, decreasing in summer and Christmas periods. In 119/233 families (51%), someone visited the portal the first study year and 169/484 (35%) the second study year. The outcome variables did not differ between intervention and control group. No adverse treatment or self-care effects were identified. A higher proportion of mothers compared to fathers visited once or more the first year (Pandlt;.001) and the second year (Pandlt;.001). The patients who had someone in the family visiting the portal 5 times or more, had shorter diabetes duration (P=.006), were younger (P=.008), had lower HbA1c after 1 year of access (P=.010), and were more often girls (Pandlt;.001). Peer interaction seems to be a valued aspect. less thanbrgreater than less thanbrgreater thanConclusions: The Web 2.0 portal may be useful as a complement to traditional care for this target group. Widespread use of a portal would need integration in routine care and promotion by diabetes team members.

Background: Evidence suggests that an early interventional strategy for patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) can improve health outcomes but also increase costs when compared with a conservative strategy.

Objective: The aim of this study was to assess the cost-effectiveness of an early interventional strategy in different risk groups from a UK health-service perspective.

Design: Decision-analytic model based on randomised clinical trial data.

Main outcome measures: Costs in UK Sterling at 2003/2004 prices and quality-adjusted life years (QALYs) combined into an incremental cost-effectiveness ratio.

Methods: Data from the third Randomised Intervention Trial of unstable Angina (RITA 3) was employed to estimate rates of cardiovascular death and myocardial infarction, costs and health-related quality of life. Cost-effectiveness was estimated over patients’ lifetimes within the decision-analytic model.

Results: The mean incremental cost per QALY gained for an early interventional strategy was approximately £55 000, £22 000 and £12 000 for patients at low, intermediate and high risk, respectively. The early interventional strategy is approximately 1%, 35% and 95% likely to be cost-effective for patients at low, intermediate and high risk, respectively, at a threshold of £20 000 per QALY. The cost-effectiveness of early intervention in low-risk patients is sensitive to assumptions about the duration of the treatment effect.

Conclusion: An early interventional strategy in patients presenting with NSTE-ACS is likely to be considered cost-effective for patients at high and intermediate risk, but this is less likely to be the case for patients at low risk.

Background: Long-term health outcomes and costs are important when deciding whether a strategy of carotid endarterectomy in addition to best medical management should be recommended for patients with asymptomatic carotid artery stenosis. This study investigated the cost-effectiveness of such a strategy compared with a strategy of best medical management alone.

Methods: Based on data from the randomized Asymptomatic Carotid Surgery Trial (ACST), a national vascular database and other published sources, expected costs and health outcomes in terms of quality-adjusted life years (QALYs) of both treatment strategies were estimated using decision-analytical modelling. Cost-effectiveness was established for a Swedish setting from a societal perspective.

Results: Base-case analysis showed that the incremental cost per QALY of a strategy with carotid endarterectomy for 65- and 75-year-old men (women) was 34 557 (311 133) and 58 930 (779 776) respectively. Sensitivity analyses indicated that the duration of the treatment effect after 5 years of follow-up in the ACST was important for the cost-effectiveness results.

Conclusion: Carotid endarterectomy in addition to best medical management can be considered cost-effective in men aged 73 years or less but is less likely to be cost-effective in older men or in women.

We randomised 143 patients –age 75 years or older–with displaced femoral neck fracture to either internal fixation or total hip replacement (THR) and compared the socio-economic consequences. In the internal fixation group, 34 of 78 hips underwent secondary surgery. In the THR group, 12 of 68 hips dislocated, the majority in mentally impaired patients. We calculated the total hospital costs for two years after operation. When secondary surgery was included, there was no difference in costs between the internal fixation and THR groups, or between the mentally impaired and lucid subgroups. The costs to the community were calculated comparing the baseline cost before surgery with the average cost per month during the first postoperative year. No difference was found between the treatment groups. The Harris hip scores were higher in the THR group, and pain was more common in the internal fixation group. In lucid patients, THR gives a better clinical result at the same cost.

The total cost of the Swedish handicap system is estimated at US $ 10.7 billion for 1989. The cost is distributed across different authorities with separate legal and financial responsibility. The concept of technology must be extended to include consideration of both the resources spent and benefits gained in the public sector and the magnitude and distribution of transfer payments from social insurance to fulfill its function in handicap policy decision making.

Background: Social cognitive theories on behaviour change are increasingly being used to understand and predict healthcare professionals intentions and clinical behaviours. Although these theories offer important insights into how new behaviours are initiated, they provide an incomplete account of how changes in clinical practice occur by failing to consider the role of cue-contingent habits. This article contributes to better understanding of the role of habits in clinical practice and how improved effectiveness of behavioural strategies in implementation research might be achieved. Discussion: Habit is behaviour that has been repeated until it has become more or less automatic, enacted without purposeful thinking, largely without any sense of awareness. The process of forming habits occurs through a gradual shift in cognitive control from intentional to automatic processes. As behaviour is repeated in the same context, the control of behaviour gradually shifts from being internally guided (e. g., beliefs, attitudes, and intention) to being triggered by situational or contextual cues. Much clinical practice occurs in stable healthcare contexts and can be assumed to be habitual. Empirical findings in various fields suggest that behaviours that are repeated in constant contexts are difficult to change. Hence, interventions that focus on changing the context that maintains those habits have a greater probability of success. Some sort of contextual disturbance provides a window of opportunity in which a behaviour is more likely to be deliberately considered. Forming desired habits requires behaviour to be carried out repeatedly in the presence of the same contextual cues. Summary: Social cognitive theories provide insight into how humans analytically process information and carefully plan actions, but their utility is more limited when it comes to explaining repeated behaviours that do not require such an ongoing contemplative decisional process. However, despite a growing interest in applying behavioural theory in interventions to change clinical practice, the potential importance of habit has not been explored in implementation research.

Little is known about the views of young patients themselves on interactive Web portal services provided by pediatric practitioners. We aimed to explore their perceptions of a real-world diabetes portal that offers facts and contact with peers and practitioners; e.g., discussion forums, blog tools, self-care and treatment information, research updates and news from local practitioners. Twelve young patients (ages 12–21, median 15 years), one boyfriend, 7 mothers and one father each wrote an essay on their experience from use of the portal. Their essays underwent qualitative content analysis. A major theme was “Helping and facilitating daily life with diabetes”, the portal was perceived as a place where contents are interesting, inspiring and may trigger users’ curiosity. There were three subthemes; “Ease of use in my everyday life,” which includes the perception that the portal was perceived as smooth and easy to enter and navigate whenever needed; that information was easy to understand for different groups of users. “Support via an exchange of experience,” includes the ability to contact peers being regarded advantageous. Some said that just reading others’ experiences can be helpful in terms of persevering; children could find peers in the same age group. “Evidence based information,” includes the perception of the portal being a useful and trustworthy source of facts on e.g., physical activity, blood glucose, medical devices, emotional wellbeing, food and nutrition, and other aspects that impact living with diabetes. Young users expressed positive perceptions towards the interactive web portal. Such services seem to have great potential for supporting young patients and significant others - intergrading for confidence.

The aim of this study was to describe costs and other short-term effects of severe hypoglycaemia in children and adolescents with type 1 diabetes. The study comprised a geographic population of 129 patients <19 y of age with families prospectively registering detailed data after self-reported severe hypoglycaemia. In the period Jan.-Dec. 1998, 16 events were reported with unconsciousness and 95 events without unconsciousness but needing the assistance of another person. Of all events, 20-30% had effects requiring the assistance of people other than parents, school absence, parents' absence from work, extra transport and/or telephone calls. Patient (family) activities were cancelled after 10% (5%) of events. Increased worry for parents was reported after 8% and poor sleep after 7% of events. Hospital visits took place at 5% and hospitalizations at 3% of all events. Patients with severe hypoglycaemia indicated lower global quality of life (p=0.0114). The average socio-economic burden for events of severe hypoglycaemia was estimated at EURO 17,400 yearly per 100 type 1 diabetes patients. Average cost was estimated at EURO 239 per event of severe hypoglycaemia with unconsciousness or EURO 478 yearly per patient with unconsciousness, and EURO 63 per event of severe hypoglycaemia without unconsciousness but needing assistance from another person or EURO 307 yearly per patient in this category. These are conservative estimates and do not include unpaid time and other intangibles, possible road traffic accidents, disabling or premature deaths. Conclusions: The results suggest the potential for socio-economic savings and increased quality of life for patients and families from severe hypoglycaemia prevention programs.

Aims: This study considers how a local diabetes team can develop a system for patient data registration and follow-up to enhance quality control and health economic analysis, and how a high response rate for patient data can be achieved.

Patients and methods: A geographic population of yearly 120-130 intensively treated type 1 diabetes children. <19 years of age was studied. A prospective patient questionnaire monitored: blood glucose and urine testing, insulin doses, acute complications, medications for hypertension and epilepsy, tobacco and snuff use, and any open questions and needs of the patient. This was completed before every visit to the out-patient department and used as a database for consultation. Data were thereafter registered in regular computer software, and analysed on a yearly basis.

Results: Response rate increased with time to near 100%. There was a time gain for diabetes nurse and physician. Many patients found the questionnaire good for overviewing treatment and easy to complete, whereas some found it was irksome and boring. The total cost of the method was <160 SEK/patient year.

Conclusions: A very high patient data response rate can be achieved over years by a patientsupportive questionnaire integrated in the treatment program. Treatment and outcome analysis can then be performed locally at low costs. The combination of a patient questionnaire with regular hard- and software is easy to create, manage and develop. Benefits for diabetes team and patients exceed the total cost.

Background

Little is known about parents’ views on the use of online resources for information, education and support regarding childhood type 1 diabetes (T1DM). Considering the rapidly evolving new communication practices, parents’ perspectives need to be explored. The main purpose of this paper was to explore parents’ perceptions of their information-seeking, Internet use, and social networking online. This applied to their everyday life, including the contexts of T1DM and contact with peers. A second aim was to identify implications for future development of Internet use in this respect.

Methodology/Principal Findings

Twenty-seven parents of 24 young persons aged 10–17 with T1DM participated in eight focus group interviews during their regular visits to a county hospital. Focus group discussions were video/audio-taped, transcribed and analysed using inductive qualitative content analysis. Self-reported demographic and medical information was also collected. A main theme was Finding things out, including two sub-themes, Trust and Suitability. The latter were key factors affecting parents’ perceptions of online resources. Parents’ choice of information source was related to the situation, previous experiences and knowledge about sources and, most importantly, the level of trust in the source. A constantly present background theme was Life situation, including two sub-themes, Roles and functions and Emotions and needs. Parents’ information-seeking regarding T1DM varied greatly, and was closely associated with their life situation, the adolescents development phases and the disease trajectory.

Conclusions/Significance

Health practitioners and system developers need to focus on creating trust and suitability for users’ needs. They should understand the children’s diverse needs, which depend on their life situation, on the children’s development, and on the disease trajectory. To enhance trust in online health information and support services, the participation of local practitioners is crucial.

Background: Using the new modular socket system (MSS) to produce a prosthetic socket directly on the patient has the potential of being easier and quicker to manufacture but also incurring higher costs. less thanbrgreater than less thanbrgreater thanObjectives: The purpose of the study was to compare the costs of manufacturing a transtibial prosthetic socket using either a MSS or a standard laminated socket (PC). less thanbrgreater than less thanbrgreater thanStudy design: Concurrent controlled trial. less thanbrgreater than less thanbrgreater thanMethods: A total of 20 patients at two orthopaedic facilities were followed with regards to the cost of manufacturing a prosthetic socket using either MSS or PC. Time aspects and material costs were considered in the cost analysis. Other factors studied include delivery time and number of visits. For the cost analysis, only direct costs pertaining to the prosthetic socket were considered. less thanbrgreater than less thanbrgreater thanResults: The total cost of MSS was found to be significantly higher (p andlt; 0.01) compared to PC. However, the production and time cost was significantly lower. Delivery time to the patient was 1 day for MSS compared to 17 days for PC. less thanbrgreater than less thanbrgreater thanConclusions: Our study shows that the direct prosthetic cost of treating a patient using MSS is significantly higher than treating a patient using PC. However, the MSS prosthesis can be delivered significantly faster and with fewer visits. Further studies taking the full societal costs of MSS into account should therefore be performed.

This study aimed at investigating effectiveness and cost-effectiveness of hearing aid fitting. Especially, two types, i.e. linear one-channel AGC (simple) and nonlinear multichannel AGC (advanced), were compared. Randomised cross-over design was used, blinded through similar shells of the devices without any identifications of type. Outcome measures were “speech in noise”, problem solving ability (IPPA, PIRS) and health related quality of life (EQ-5D, HUI3). In addition, the users’ preferences with regard to final choice of hearing aid with and without information on costs were studied.

The study was a collaboration with hearing aid centres in the county councils of Östergötland, Kalmar and Jönköping in the southeast of Sweden. During 2002 and 2003, 161 users were recruited to the study, mean age was 70 years, 60 % were men and 40 % women. The intervention was fitting of hearing aids to first time applicants, bilaterally “behind the ear” model, if no contra-indication for bilateral fitting was present.

Free choice of equipment without any information on costs resulted in prescription of about 60 % of simple and and 40 % of advanced hearing aids. With information on costs the corresponding figures were 50%/50 %. The costeffectiveness, measured as cost per quality adjusted life years gained (cost/QALY) was 80 000 SEK based on EQ-5D and 17 300 SEK based on HUI3 Assumptions were an improvement of quality of life which was sustainable over five years. The costs included visit to physician, audiogram, assessment and construction of two earmolds and investment costs for the devices. Without information about costs 88% choose bilateral fitting and 12% unilateral. With information of costs these figures changed marginally to 87% and 13%, respectively.

The advanced device performed significantly better in the “speech in noise” test (p=0.004) and problem solving ability measured through IPPA (p=0.044). Quality of life showed significantly lower results (p=0.009) of the use of the advanced device.

Only a small fraction, 12 persons, changed their decision on device after cost information, 11 of these changed from advanced to simple device and one from bilateral to unilateral fitting (still advanced). The additional costs between bilateral and unilateral fitting amounted to about 8000 SEK, which seems to be an amount which the main group of users were willing to pay. No adjustment to household incomes was made.

It has been shown that hearing aid fitting for first time applicants has a high (favorable) cost-effectiveness. The advanced device yields an improved speech recognition in noise in comparison with the simple device. The measurements of quality of life indicate difficulties to discriminate between types of devices. It could be that subgroups’ value the two types differently. An hypothesis, which has not been tested, is whether people with better cognitive ability prefer the advanced device to a higher extent than do users with lower cognitive ablity.

The market for new medical devices depends on evidence on effectiveness and cost-effectiveness as well as ethical criteria based on patients needs and severity of disease. HTA is therefore increasingly used to provide appraisals for decision makers. In comparison to pharmaceuticals, medical devices face difficulties in providing studies with high evidence. There are, however, new promising developments in health economics and in the systems for valuing evidence which may improve the possibility of quicker appraisal of medical devices. This development, comprising Bayesian modeling and revision of systems for grading evidence, may be used in an iterative procedure to anticipate the market potential and to contribute to finding an optimal time when the implementation of a new device is worthwhile. In such a system, researches, developers and manufacturers, and healthcare services should gain from strengthened collaboration.

Diabetic foot complications are associated with substantial costs and loss of quality of life. This article gives an overview of available and emerging devices for the monitoring of foot temperature as a means of early detection of foot disorders in diabetes. The aim is to describe the technologies and to summarize experiences from experimental use. Studies show that regular monitoring of foot temperature may limit the incidence of disabling conditions such as foot ulcers and lower-limb amputations. Infrared thermometry and liquid crystal thermography were identified as the leading technologies in use today. Both technologies are feasible for temperature monitoring of the feet and could be used as a complement to current practices for foot examinations in diabetes.

An increased use of medical devices has been assumed to be a major cause of rising healthcare expenditures. Nations around the world are trying to keep costs down, but strong incentives still exist for the development and use of new devices. Innovation is, however, never exclusively good or bad and it is not easy to evaluate the net effect. Theories and empirical research on innovation have been produced for more than 100 years. In this, the diffusion of innovations has attracted the most interest, while other areas, such as the integration of technologies, have been less thoroughly researched.

This thesis presents a model of medical device innovation in hospitals – from the first idea and invention effort to regular use of a new technology. The suggested model is built on three fundaments: (1) academic innovation literature, (2) empirical studies, and (3) observations of on-going innovation processes. The model is a synthesis of the accumulated knowledge in different innovation research traditions, and of empirical studies of the Swedish healthcare system and the medical device industry. The aim is to give a comprehensive picture of the innovation process, and to provide a theoretical model, which can be used for studying and influencing the paths of medical device innovations into healthcare practice.

In order to achieve a balanced rate of change, with long-term societal benefits, an inter-disciplinary approach is necessary in the planning and regulation of medical device innovation. The new model combines academic views with political/entrepreneurial and healthcare views. Innovation, in this model, is suggested to occur in three integrated activity domains: invention, diffusion, and deployment. A great number of factors that influence these activities are investigated and described, and different roles and incentives are discussed. Deviations from traditional innovation theory are for example: (a) integration of invention activities as having an impact on later events; (b) inclusion of the inventor/developer as a main actor also in the diffusion and deployment domains; (c) increased focus of the concept of technology cluster innovation, and (d) the rationality of use and abandonment of knowledge as factors to be included in the estimation of consequences of innovation.

Finally, the thesis suggests a number of model and methodology improvements and policy implications for management of innovation in hospitals.