Denna rapport är framtagen i ett samarbete mellan CMT, Reumakliniken i Östergötland och Avdelningen för Reumatologi vid IKE, Hälsouniversitetet i Linköping och har finansierats med hjälp av Landstinget i Östergötland och Forskningsrådet i Sydvästra Sjukvårdsregionen (FORSS).

Det övergripande syftet med TIRA-projektet (Tidiga Insatser vid Reumatoid Artrit) var att ställa diagnos tidigt och starta multiprofessionell behandling på specialistenhet. Modern handläggning av RA (ledgångsreumatism) innebär snabbt ställd diagnos, snabbt insatt potent bromsmedicin och strukturerad uppföljning. Detta arbetssätt utvecklades i TIRA-studien och har haft stor betydelse för omhändertagandet av nyinsjuknade patienter med reumatisk sjukdom. TIRA studien har också skapat ett nätverk för kunskapsutveckling inom hela sydvästra sjukvårdsregionen samt Södermanlands och Örebro län. En stor databas för forskning har skapats och arbetet har resulterat i 16 originalartiklar i vetenskapliga tidskrifter. Fem avhandlingar har hittills skrivits med utgångspunkt från TIRA-data. Data har också exporterats till det nationella Svenska RA-registret.

Sedan TIRA-studien startade, har behandlingsstrategierna ändrats avsevärt. I början av 2000-talet introducerades s.k. biologiska läkemedel, framför allt TNFblockerare och 10 år efter start av TIRA-1 har nu TIRA-2 studien startat.

Upplägget är i allt väsentligt detsamma och TIRA-1 kohorten kommer därvid att utgöra ett unikt referensmaterial, såväl till hälsoekonomiska data som till sjukdomsutveckling för patienter i den nya studien. Denna rapport omfattar TIRA-1 studien och redovisar sjukdomsförlopp och hälsoekonomiska konsekvenser av sjukdomen och dess behandling. Många personer har varit delaktiga i studien och vi vill främst tacka Thomas Skogh, Reumakliniken Universitetssjukhuset i Linköping och alla medarbetare på de 10 medverkande reumatologenheterna. Vi vill också tacka Jan Persson som är medarbetare i TIRA projektet och har bidragit med värdefulla synpunkter. Ett extra varmt tack riktas till alla 320 patienter som deltagit i undersökningar och noggrant fyllt i enkäter under flera år.

Linköping november 2007-11-27

Eva Hallert, Magnus Husberg, Andrea Schmidt, Dick Jonsson

Rheumatoid  arthritis  (RA)  is  a  chronic  progressive  inflammatory   disease, associated with tissue destruction and functional disability. The yearly incidence of RA in Sweden is 25/100 000 and the prevalence is 0.5-0.7%, with women being more often affected than men. The economic consequences of the disease are substantial  for the  individual  and  their  families  and  for the society  as a whole.   Previous   studies   have   reported   that   early   treatment   limits   joint destruction and improves functional outcome.

In 1996 a multicenter study TIRA was started in Linköping in cooperation with 10 rheumatology units and Center for Medical Technology Assessment (CMT) TIRA is the Swedish acronym for ‘early intervention  in rheumatoid  arthritis’. The   main   goal   was   to   obtain   early   diagnosis,   rapid   multiprofessional intervention  and  a  regular  follow-up.  Further,  the  TIRA  project  aimed  at forming  a research  database  and health economic  evaluation  in patients  with recent-onset RA.

This study describes disease activity, functional ability, direct and indirect costs as well as self-reported health and quality of life (QoL) in patients with recent- onset RA, during the first 3 years after diagnosis.

320 subjects were enrolled in the study from January 1996 through April 1998, 2/3  being  women.  At  inclusion  most  patients  had  high  disease  activity  and impaired functional capacity. More than half of patients < 65 were on sick leave and a few were already early retired.

Highly significant improvements were seen within the first 3 months regarding disease  activity  and functional  ability,  but 15% of the patients  had sustained high or moderate disease activity throughout the study period, despite traditional treatment. The scores of ‘Health Assessment Questionnaire’ (HAQ) were similar for men and women at baseline, but had a less favourable course in women, who also had DMARDs  more frequently prescribed,  suggesting  that women might have a more severe disease.

At inclusion QoL did not differ between groups concerning different housing, marital   status,   income   or  other  socio-demographic   factors.   Most  patients experienced their health as worse compared with others of the same age. During the first 2 years QoL was improved as well as general mobility and ability to perform activities of daily living. During year 3 a slight deterioration was noted.

The average direct costs per patient during the first year was SEK 36 000 and indirect costs SEK 89 000 (price level of 2001). All direct costs decreased from year 1 to 3, except costs of drugs and surgery which on the contrary increased. Indirect costs were substantially unchanged over the years. Sick-leave decreased but was offset by an increase in early retirement. Indirect costs were 2-3 times higher than direct costs.

More than 90% of the patients were satisfied or very satisfied with treatment and availability and information from the medical staff in the participating hospitals.

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 aim of the study was to compare text telephone relay service and videophone relay service. The target group was people borne deaf. The following aspects were investigated: (1) socioeconomic costs, (2) costs of different actors, (3) qualitative aspects of the services, (4) outcomes (intermediate effects and quality of life). The study was longitudinal and measurements were made at three occasions. Data collection was made by post-mailed questionnaires. Of the 41 respondents, 16 persons had access to the text telephone relay service only and 25 persons had access to text telephone relay service supplemented with videophone relay service. The ratings of the quality of the services and the outcomes were significantly higher for videophone relay service than for text telephone relay service (at a 95%-level). The incremental cost was approximately SEK 40 000, or EUR 4 510 (1 EUR = 8.87 SEK, as of 31 December 2000) higher per person and year for the group with access to both text telephone relay service and videophone relay service compared with the group with access to text telephone relay service only.

The Swedish National Post and Telecom Agency provides services in the postal and telecommunication area for disabled persons. The text telephone relay service, videophone relay service, free directory enquiries and extended rural postal service are aimed for various groups of persons with disabilities. The aim of this study was to develop a socioeconomic model for assessing such telecommunication services for disabled persons. The model development included the WHO Classification ICIDH-2 and ICF, literature review, reference panel opinions, expert opinions and pilot studies. The developed model encompasses quality of the services, costs and outcomes. The quality of the services refers to quality in structure and process. Costs for different actors are included, e.g. the user, family members, county councils, local authorities and the government. Outcomes of the services refer to intermediate outcomes (direct communicative outcomes) and generic outcomes (quality of life). The socioeconomic model is general and is applicable to different rehabilitation interventions.

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.

Objective. To calculate direct and indirect costs in early rheumatoid arthritis (RA) and to characterize patients generating high and low costs respectively.

Methods. Two hundred and ninety-seven patients with recent-onset (≤12 months) RA were recruited. Clinical/laboratory data and 'health assessment questionnaire' (HAQ) were registered at inclusion and after 3, 6 and 12 months. After 6 and 12 months, the patients completed a questionnaire concerning health-care utilization and days lost from work. A cut-off point for direct costs was set at 34 000 Swedish kronor (3675) defining one-third of the patients as a high-cost group and two-thirds as low-cost group. Indirect costs were calculated for patients aged <65 yr.

Results. Two hundred and eleven patients completed the HAQ on both occasions. Indirect costs exceeded direct costs by a factor of 2.3. Sixty three per cent experienced work disability during the first year and were identified as the 'high-indirect-cost group'. Indirect costs accounted for >70% of total costs. Direct costs included ambulatory health care (76%), hospitalization (12%) and medication (9%). Men aged ≥65 yr had low costs compared with younger men and women of all ages. In multiple logistic regression tests, HAQ, high levels of IgM rheumatoid factor (IgM RF) and poor hand function increased the odds of entering the high-direct-cost group, and poor hand function and pain increased the odds of entering the high-indirect-cost group.

Conclusions. Substantial costs were incurred during the first year after diagnosis of early RA, mainly due to work disability. Indirect costs were two to three times higher than direct costs. High levels of IgM RF, high HAQ score, poor hand function and pain increased the odds of entering high-cost groups.

Objective: To study the costs and use of healthcare for patients during the first months with early joint inflammation, in a population-based prospective referral study in Southern Sweden.

Methods: Adult patients with arthritis for <3 months and with onset of symptoms between 1 May 1999 and 1 May 2000 were referred from primary health centres to rheumatologists. Four clinical assessments were performed during a 6-month follow-up period. The direct medical costs for inpatient stays, outpatient visits, visits to general practitioners, and visits to health professionals, as well as costs for medication, radiographs, and laboratory tests were recorded from the onset of the disease up to 6 months of follow-up. Indirect costs for sick leave were also recorded.

Results: Fifty-six of 71 referred patients agreed to participate. Thirteen (23%) had RA, 21 (38%) had reactive arthritis (ReA), 14 (25%) had undifferentiated arthritis, and eight (14%) had other arthritides. The median cost per patient in the entire group was USD 3362. The median cost per patient in the RA group was USD 4385, and USD 4085 in the ReA group. There was no statistically significant difference in the median costs per patient in the different diagnostic groups. Sick leave accounted for 44% of the total costs in the entire group, and 46% and 47%, respectively, in the RA and ReA groups.

Conclusion: The costs of early arthritis are already considerable during the first months of the disease following the onset of the symptoms. The indirect costs due to sick leave accounted for nearly half of the costs.

Objective. The aim of this study was to elucidate the care of patients with asthma in primary health care from medical, patient self-management, health, quality of live, and health economic perspectives.

Methods. Asthma nurse practice (ANP), an alternative asthma self-management strategy, was compared with traditional asthma care in primary health care in southern Sweden regarding medical history, lifestyle, self-management, symptoms caused by asthma, effects on sick leave, state of health, quality of life and health care costs. The first part of the investigation comprised a retrospective study of a randomly selected sample of patient records of asthmatics (n=152). The second part, lasting 3 months, was prospective and included consecutive patients visits (n=347).

Results. The ANP approach showed better results in most of the evaluated outcomes such as asthma quality documentation and self-management and the number of asthma symptoms was significantly lower. From a health economic perspective the results were encouraging with respect to ANP.

Conclusion. This alternative asthma strategy, ANP, improved asthma care in primary health care and resulted in economic advantages in the health care sector. However the result may only be generalized to other practices working with asthma nurses in the same way.

Background: Recent trials have shown that treatment with a combination of interferon alfa-2b and ribavirin results in sustained loss of detectable hepatitis C-virus (HCV) RNA in a higher proportion of patients than treatment with interferon alone. Combination therapy, however, is two to three times as expensive as monotherapy. Methods: Based on data from recent randomized clinical trials and a previously published decision model, we developed a Markov model to estimate the cost-effectiveness of initial combination therapy with interferon and ribavirin versus interferon alone for previously untreated patients with chronic HCV infection in Sweden. Clinical praxis and quality adjustments were based on expert estimates and costs were gathered from different health care providers in Sweden. Results: Combination therapy for 24 or 48 weeks, compared to interferon alone, prolonged quality adjusted life expectancy by 0.5 to 1.1 years at marginal cost-effectiveness ratios of US$ 1,400 to US$ 6,000 per DQALY (discounted quality-adjusted life-year) for patients with genotype 1. In genotype 1, 48 weeks compared to 24 weeks of combination therapy prolonged quality adjusted life expectancy by 0.6 years at a marginal cost-effectiveness ratio of $US 9,800 per DQALY. For patients with genotype non-1, combination therapy for 24 or 48 weeks, compared to interferon alone, prolonged quality adjusted life expectancy by 2.3 years, with combination therapy for 24 weeks being money-saving. The results were robust in sensitivity analyses. Conclusion: Combination therapy with interferon and ribavirin increased quality-adjusted life expectancy and was cost-effective for patients with chronic hepatitis C.