Pasi Aronen

Does arthroscopic acromioplasty provide any additional value in the treatment of shoulder impingement syndrome?: A TWO-YEAR RANDOMISED CONTROLLED TRIAL

We report a randomised controlled trial to examine the effectiveness and cost-effectiveness of arthroscopic acromioplasty in the treatment of stage II shoulder impingement syndrome. A total of 140 patients were randomly divided into two treatment groups: supervised exercise programme (n = 70, exercise group) and arthroscopic acromioplasty followed by a similar exercise programme (n = 70, combined treatment group). The main outcome measure was self-reported pain on a visual analogue scale of 0 to 10 at 24 months, measured on the 134 patients (66 in the exercise group and 68 in the combined treatment group) for whom endpoint data were available. An intention-to-treat analysis disclosed an improvement in both groups but without statistically significant difference in outcome between the groups (p = 0.65). The combined treatment was considerably more costly. Arthroscopic acromioplasty provides no clinically important effects over a structured and supervised exercise programme alone in terms of subjective outcome or cost-effectiveness when measured at 24 months. Structured exercise treatment should be the basis for treatment of shoulder impingement syndrome, with operative treatment offered judiciously until its true merit is proven.

An occupational health intervention programme for workers at high risk for sickness absence. Cost effectiveness analysis based on a randomised controlled trial.

Objectives: To determine whether, from a healthcare perspective, a specific occupational health intervention is cost effective in reducing sickness absence when compared with usual care in occupational health in workers with high risk of sickness absence. Methods: Economic evaluation alongside a randomised controlled trial. 418 workers with high risk of sickness absence from one corporation were randomised to intervention (n = 209) or to usual care (n = 209). The subjects in the intervention group were invited to occupational health service for a consultation. The intervention included, if appropriate, a referral to specialist treatment. Register data of sickness absence were available for 384 subjects and questionnaire data on healthcare costs from 272 subjects. Missing direct total cost data were imputed using a two-part regression model. Primary outcome measures were sickness absence days and direct healthcare costs up to 12 months after randomisation. Cost effectiveness (CE) was expressed as an incremental CE ratio, CE plane and CE acceptability curve with both available direct total cost data and missing total cost data imputed. Results: After one year, the mean of sickness absence was 30 days in the usual care group (n = 192) and 11 days less (95% CI 1 to 20 days) in the intervention group (n = 192). Among the employees with available cost data, the mean days of sickness absence were 22 and 24, and the mean total cost €974 and €1049 in the intervention group (n = 134) and in the usual care group (n = 138), respectively. The intervention turned out to be dominant—both cost saving and more effective than usual occupational health care. The saving was €43 per sickness absence day avoided with available direct total cost data, and €17 with missing total cost data imputed. Conclusions: One year follow-up data show that occupational health intervention for workers with high risk of sickness absence is a cost effective use of healthcare resources.

Rates of Serious Infections and Malignancies Among Patients with Rheumatoid Arthritis Receiving Either Tumor Necrosis Factor Inhibitor or Rituximab Therapy

Objective. Because of the role of tumor necrosis factor (TNF) in host defense, it was hypothesized that its inhibition might lead to an increased risk of malignancies and infections. The objective of our study was to assess the incidence of serious infections leading to hospitalization and malignancies among patients with rheumatoid arthritis (RA) receiving either TNF inhibitor or rituximab (RTX) therapy. Methods. The study population was identified from the National Register for Biologic Treatment in Finland and the hospital records of Central Finland Central Hospital for conventional disease-modifying antirheumatic drug (cDMARD) users. Data on infections and malignancies were acquired from national healthcare registers. A Poisson model was used to calculate the adjusted incidence rate ratios (aIRR) and was composed of age, sex, time from diagnosis, year of the beginning of the followup, rheumatoid factor status, Disease Activity Score at 28 joints, Health Assessment Questionnaire, prior malignancy, prior serious infection, prior biologic use, and time-updated use of methotrexate, sulfasalazine, hydroxychloroquine, and oral corticosteroids as confounders. Results. In total, during the followup of 10,994 patient-years, 92 malignancies and 341 serious infections were included in the analyses. The aIRR of infections compared to cDMARD users were 1.2 (95% CI 0.63–2.3), 0.84 (95% CI 0.53–1.3), 0.98 (95% CI 0.60–1.6), and 1.1 (95% CI 0.59–1.9) for the patients treated with infliximab (IFX), etanercept, adalimumab, and RTX, respectively. The crude rates of malignancies were highest among the users of cDMARD and RTX, and lowest among patients treated with IFX with no differences in aIRR. Conclusion. Our results provide some reassurance of the safety of biologic treatments in the treatment of RA.

Cost‐effectiveness of an experimental caries‐control regimen in a 3.4‐yr randomized clinical trial among 11–12‐yr‐old Finnish schoolchildren

The aim of this study was to assess the cost-effectiveness of an experimental caries-control regimen in a randomized clinical trial (RCT) conducted in Pori, Finland, in 2001-2005. Children (n = 497) who were 11-12 yr of age and had at least one active initial caries lesion at baseline were studied. The children in the experimental group (n = 250) were offered an individually designed patient-centered regimen for caries control. The children in the control group (n = 247) received standard dental care. Furthermore, the whole population was exposed to continuous community-level oral health promotion. Individual costs of treatment procedures and outcomes (DMFS increment score) for the follow-up period of 3.4 yr were calculated for each child in both groups. The incremental cost-effectiveness ratio was euro 34.07 per averted DMF surface. The experimental regimen was more effective, and also more costly. However, the total costs decreased year after year, and for the last 2 yr the experimental regimen was less expensive than the standard dental care. The experimental regimen would probably have been more cost-effective than standard dental care if the follow-up period had been longer, the regimen less comprehensive, and/or if dental nurses had conducted the preventive procedures.

Health-related quality of life after kidney transplantation: who benefits the most?

The influence of dialysis modalities on HRQoL before and after kidney transplantation (KT) and the role of adherence to medication on HRQoL have not been fully studied. Sixty four dialysis patients who answered the 15D HRQoL survey during dialysis were surveyed again after KT. Adherence and employment were also investigated. The mean 15D score was highest among home hemodialysis patients (HHD) and lowest among in‐center hemodialysis patients (icHD). After KT, the mean 15D score improved significantly in 78.6% of peritoneal dialysis patients (PD), 47.6% of HHD, and 53.8% of icHD. Then, mean 15D score remained unchanged in 28.6% of HHD and in 23.1% of icHD patients. A deterioration in the 15D score occurred in 14.3% of PD, 23.1% of icHD, and 23.8% of HHD patients, and this was influenced by the number of pills (P = 0.04). Adherence to medication was the lowest in PD, timing being the most challenging task showing a connection to higher creatinine concentration (never forgot 1.41 mg/dl vs. forgot 2.08 mg/dl P = 0.05). Employed patients had a higher mean 15D score. The icHD and PD patients benefited the most from KT and HHD the least. Low pill burden and employment were linked to a better HRQoL.

Economic evaluation of drug-eluting stents: a systematic literature review and model-based cost-utility analysis.

OBJECTIVES The aim of this study was to systematically review economic analyses comparing drug-eluting stents (DES) to bare metal stents (BMS) in patients who undergo percutaneous coronary intervention to form an overall view about cost-effectiveness of DES and to construct a simple decision analysis model to evaluate the cost-utility of DES. METHODS Electronic databases searched from January 2004 to January 2006 were Cochrane Database of Systematic Reviews; DARE, HTA, EED (NHS CRD); MEDLINE(R) In-Process, Other Non-Indexed Citations, MEDLINE(R). References of the papers identified were checked. We included randomized controlled trials (RCT) or model-based cost-effectiveness analyses comparing DES to BMS in patients with coronary artery disease. The methodological quality of the papers was assessed by Drummonds criteria. Baseline characteristics and results of the studies were extracted and data synthesized descriptively. A decision tree model was constructed to evaluate the cost-utility of DES in comparison to BMS, where health-related quality of life was measured by the 15D. RESULTS We identified thirteen good-quality economic evaluations. In two of these based on RCTs, DES was found cost-effective. In six studies, it was concluded that DES might probably be a cost-effective strategy in some circumstances, but not as a single strategy, and four studies concluded that DES is not cost-effective. One study did not draw a clear conclusion. In our analysis, the overall incremental cost-effectiveness ratio was Euros 98,827 per quality-adjusted life-years gained. Avoiding one revascularization with DES would cost Euros 4,794, when revascularization with BMS costs Euros 3,260. CONCLUSIONS The evidence is inconsistent of whether DES would be a cost-effective treatment compared with BMS in any healthcare system where evaluated. A marked restenosis risk reduction should be achieved before use of DES is justifiable at present prices. When considering adoption of a new health technology with a high incremental cost within a fixed budget, opportunity cost in terms of untreated patients should be seriously considered as a question of collective ethics.

Economic evaluation of multidisciplinary rehabilitation after primary total knee arthroplasty based on a randomized controlled trial

To conduct an economic evaluation of a multidisciplinary, biopsychosocial outpatient rehabilitation program implemented 2–4 months after total knee arthroplasty (TKA), compared with conventional orthopedic care.

Cost-effectiveness of biologic compared with conventional synthetic disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis: a Register study

OBJECTIVE The aim of this study was to explore the cost-effectiveness of biological DMARDs (bDMARDs) compared with conventional synthetic DMARDs (csDMARDs) for RA using real-world data from Finnish registers. METHODS RA patients starting their first bDMARD and comparator patients using csDMARDs during 2007-11 were obtained from the National register of biologic treatments in Finland and the Jyväskylä Central Hospital patient records. Propensity score matching was applied to adjust for differences between bDMARD and csDMARD users. Effectiveness was measured in quality-adjusted life years (QALY) and based on the register of biologic treatments in Finland and Jyväskylä Central Hospital patient records, whereas the direct costs were obtained from relevant Finnish national registers. Patients were followed up for 2 years, and both costs and effectiveness for the second year were discounted at 3%. The incremental cost-effectiveness ratio (ICER) with 95% CI was calculated based on bootstrapped mean costs and effectiveness. RESULTS Of 1581 RA patients meeting study inclusion criteria, 552 bDMARD and 220 csDMARD users were included in analyses after matching. Mean costs for bDMARDs and csDMARDs were €55 371 and €24 879, while mean effectiveness was 1.23 and 1.20 QALYs, respectively. Consequent ICER was €902 210/QALY. Results were confirmed in sensitivity analyses. CONCLUSION The high incremental cost and the small, non-significant difference in effectiveness resulted in high ICER, suggesting that bDMARDs are not cost-effective. Regardless of matching, latent confounders may introduce bias to the results.

Cost-effectiveness of intensive adjuvant chemotherapy for high-risk breast cancer: Is tailored and dose-escalated chemotherapy with growth factor support (GFS) more costly and less effective than marrow-supported high-dose chemotherapy – results from a randomized study

Based on randomized studies bone-marrow supported (BMS) high-dose chemotherapy (HDCT) is not superior to conventional CT as adjuvant treatment for high-risk breast cancer. To compare the cost-effectiveness of these treatments we examined the data of Finnish patients in the SBG9401 trial 1. Patients were randomized to receive either dose-escalated (de FEC) (group A, n =59) or FEC and HDCT+BMS (group B, n =70). They received adjuvant radiotherapy (RT) + tamoxifen. All direct health care costs of first line treatment at the oncology units were considered as well as productivity costs within the first 3 years of follow-up. Effectiveness was measured by the number of survival days during 5 years of follow-up. The mean direct health care costs were significantly higher in group B (25 829 € in group A vs. 36 605 € in group B, p <0.001), mainly due to a higher number of hospital days. Half of the costs in group A was due to the use of filgrastim (15 335 € in A and 2969 € in B, p <0.001). The costs of RT were only 5% of total costs. There was no statistically significant difference between the groups in the number of survival days, but sensitivity analysis based on bootstrapping suggested that treatment A would be a less costly and more effective alternative in a great majority of cases.

Cost-utility of waiting time in total joint replacements: a randomized clinical trial.

In many Western countries, long waiting times for elective surgery are a concern. Major joint replacement is an example of a type of surgery with a high volume of demand and relatively long waiting periods for patients. As populations get older, the prevalence of slowly progressive diseases, such as osteoarthritis (OA) in hip and knee joints, is increasing. Over three-quarters of a million total hip and knee replacement surgeries are done in the United States annually (1). Furthermore, according to March et al. (1997), the costs of OA have been estimated to account for up to 1–2.5 percent of the Gross National Product (GNP) in several developed countries (2). In Finland, a total of 11,104 total joint replacements (TJRs) were performed in 2004 (hip 6,600 and knee 5,905), with the median waiting time of 181 days for the surgery (hip 153 and knee 209 days). Until 2007, the number of TJRs was 17,334 (hip 7,698 and knee 9,636), with a median waiting time of 120 and 142 days, respectively (3;4). The mean waiting time for elective surgical procedures is approximately 3 months in several countries and the maximum waiting times can stretch into years. An important question is what effect do longer waiting times, brought about by lower rates of surgery, have on patient welfare. Health status is likely to deteriorate (on average) with waiting and welfare will be lower if there is postponement of the benefit from surgery (time preference). However, the OECD Waiting Times study found surprisingly little evidence, from a review of the medical literature, of significant deterioration of health or worsening of surgical outcomes as a result of waiting for elective surgery in those countries where waiting times are up to 3 or 6 months, depending on the condition (5). Surgeons seem to be good at triage, that is, at re-prioritizing patients whose con-