Efficacy and effectiveness of tumour necrosis factor inhibitors in the treatment of rheumatoid arthritis in randomized controlled trials and routine clinical practice.

Objective: Efficacy of TNF inhibitors in the treatment of RA assessed in randomized controlled trials (RCTs) may not be fully comparable to routine care owing to the stringent inclusion criteria. The objective of this study was to observe the effectiveness of TNF inhibitors in real-world patients and assess the patients' potential eligibility for the RCTs. Methods: RA patients starting a TNF-inhibitor treatment between 2004 and 2014 were identified from the National Register for Biologic Treatment in Finland, which is a longitudinal observational cohort study. Effectiveness was measured using the ACR and EULAR response criteria and by studying the proportion of patients reaching DAS28 remission. The patients' baseline characteristics were compared against the inclusion criteria of 27 RCTs. Results: EULAR moderate and good treatment responses at 6 months were achieved by 69 and 40% of the users of the first TNF inhibitor, respectively. ACR20, ACR50 and ACR70 responses were reached by 48, 27 and 13%, respectively. DAS28 remission was reached by 47%. Only 7.6-44% of the patients would have been potentially eligible for the RCTs. The eligible patients had better treatment responses compared with the non-eligible patients. Different TNF inhibitors were mostly equipotent, but the usage of MTX co-therapy had a major influence on treatment response. Conclusion: Only a small proportion of patients would have been eligible for RCTs, and the efficacy of TNF inhibitors assessed in them cannot be generalized directly into Finnish routine health care.

Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients.

BACKGROUND: Clinical use of biosimilar infliximab (CT-P13) in inflammatory bowel diseases (IBDs) is based on extrapolation of indication from clinical studies performed in rheumatological diseases. Only few data exist of behaviour of infliximab trough levels (TLs) and anti-drug antibodies (ADAs) during switching. AIM: The objective of this study was to evaluate changes in TLs, ADA formation and disease activity after switching from originator infliximab to biosimilar one. METHODS: All our IBD patients receiving maintenance infliximab therapy were switched to biosimilar infliximab. TLs and ADAs were measured before the last originator infusion and before the third biosimilar infusion. Laboratory values, disease activity indices (partial Mayo score and Harvey-Bradshaw index) and demographic data were collected from patient records. RESULTS: A total of 62 patients were included in the final analysis (32 Crohn's disease, 30 ulcerative colitis (UC) or IBD-unclassified). No significant changes in median TLs before (5.5 mg/l) and after switching (5.5 mg/l, p = .05) occurred in the entire study group or in the Crohn's disease (CD) subgroup (5.75 and 6.5 mg/l, p = .68). However, in the subgroup of ulcerative colitis, the change in median TL was significantly different (from 5.2 to 4.25 mg/l, p = .019). Two patients developed ADAs after switching. No changes in disease activity were detected during switching and no safety concerns occurred. CONCLUSIONS: Switching from originator to biosimilar infliximab resulted in statistically significant differences in infliximab TLs in patients with UC but not in patients with Crohn's disease. The clinical significance for this difference is doubtful and in neither group changes in disease activity occurred.

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.

A synthesis of drug reimbursement decision-making processes in organisation for economic co-operation and development countries.

BACKGROUND: The use of a restrictive formulary, with placement determined through a drug-reimbursement decision-making process, is one approach to managing drug expenditures. OBJECTIVE: To describe the processes in drug reimbursement decision-making systems currently used in national publicly funded outpatient prescription drug insurance plans. METHODS: By using the Organisation for Economic Co-operation and Development (OECD) nations as the sampling frame, a search was done in the published literature, followed by the gray literature. Collected data were verified by a system expert within the prescription drug insurance plan in each country to ensure the accuracy of key data elements across countries. RESULTS: All but one country provided at least one publicly funded prescription drug formulary. Many systems have adopted similar processes of drug reimbursement decision making. All but three systems required additional consideration of clinical evidence within the decision-making process. Transparency of recommendations varied between systems, from having no information publicly available (three systems) to all information available and accessible to the public (16 systems). Only four countries did not consider cost within the drug reimbursement decision-making process. CONCLUSIONS: There were similarities in the decision-making process for drug reimbursement across the systems; however, only five countries met the highest standard of transparency, requirement of evidence, and ability to appeal. Future work should focus on examining how these processes may affect formulary listing decisions for drugs between countries.

Medication use among inflammatory bowel disease patients: excessive consumption of antidepressants and analgesics.

OBJECTIVE: Little is known about differences in the use of medications between inflammatory bowel disease (IBD) patients and the general population. The aims of this study were to observe those differences and to discuss reasons for them. The relation between medication use and HRQoL of IBD patients was examined. MATERIAL AND METHODS: The use of prescribed medication of 2831 IBD patients and 5662 control subjects were scrutinized and compared by utilizing a national reimbursement register. Annual costs and number of defined daily doses (DDD) of medications were calculated. The relationship between medications and health-related quality of life (HRQoL) of IBD patients was examined by using a postal questionnaire including a generic (15D) and a disease-specific (IBDQ) HRQoL tool. The questionnaire also included demographic questions and questions about IBD patients' use of biological medications. RESULTS: Use of antidepressants (OR: 1.44, 95% CI: 1.28-1.61), anxiolytics (OR: 1.52, 95% CI: 1.31-1.78), oral bisphosphonates (OR: 6.08, 95% CI: 4.56-8.11), cardiovascular medications (OR: 1.38, 95% CI: 1.24-1.54), antibiotics (OR: 4.01, 95% CI: 3.57-4.51), proton pump inhibitors (OR: 3.90, 95% CI: 3.48-4.36), and nonsteroidal anti-inflammatory analgesics (OR: 1.17, 95% CI: 1.07-1.28) was significantly more common in IBD than among the controls. Those who used antidepressants, anxiolytics, or analgesics had significantly impaired HRQoL (p < 0.001). CONCLUSIONS: IBD patients and general population differ in terms of their medicine use in many respects, and especially use of analgesics and antidepressants is more common among IBD patients. Use of antidepressants, anxiolytics, and analgesics was related to impaired HRQoL.

Healthcare costs and mortality associated with serious fluoroquinolone-related adverse reactions.

The aim of this study was to estimate healthcare costs and mortality associated with serious fluoroquinolone-related adverse reactions in Finland from 2008 to 2019. Serious adverse reaction types were identified from the Finnish Pharmaceutical Insurance Pool's pharmaceutical injury claims and the Finnish Medicines Agency's Adverse Reaction Register. A decision tree model was built to predict costs and mortality associated with serious adverse drug reactions (ADR). Severe clostridioides difficile infections, severe cutaneous adverse reactions, tendon ruptures, aortic ruptures, and liver injuries were included as serious adverse drug reactions in the model. Direct healthcare costs of a serious ADR were based on the number of reimbursed fluoroquinolone prescriptions from the Social Insurance Institution of Finland's database. Sensitivity analyses were conducted to address parameter uncertainty. A total of 1 831 537 fluoroquinolone prescriptions were filled between 2008 and 2019 in Finland, with prescription numbers declining 40% in recent years. Serious ADRs associated with fluoroquinolones lead to estimated direct healthcare costs of 501 938 402 €, including 11 405 ADRs and 3,884 deaths between 2008 and 2019. The average mortality risk associated with the use of fluoroquinolones was 0.21%. Severe clostridioides difficile infections were the most frequent, fatal, and costly serious ADRs associated with the use of fluoroquinolones. Although fluoroquinolones continue to be generally well-tolerated antimicrobials, serious adverse reactions cause long-term impairment to patients and high healthcare costs. Therefore, the risks and benefits should be weighed carefully in antibiotic prescription policies, as well as with individual patients.

Effectiveness and cost-effectiveness of a people-centred care model for community-living older people versus usual care ─ A randomised controlled trial.

BACKGROUND: There is a need for effective and cost-effective interprofessional care models that support older people to maintain their quality of life (QoL) and physical performance to live longer independently in their own homes. OBJECTIVES: The objectives were to evaluate effectiveness, QoL and physical performance, and cost-utility of a people-centred care model (PCCM), including the contribution of clinically trained pharmacists, compared with that of usual care in primary care. METHODS: A randomised controlled trial (RCT) with a two-year follow-up was conducted. The participants were multimorbid community-living older people, aged ≥75 years. The intervention comprised an at-home patient interview, health review, pharmacist-led clinical medication review, an interprofessional team meeting, and nurse-led care coordination and health support. At the baseline and at the 1-year and 2-year follow-ups, QoL (SF-36, 36-Item Short-Form Health Survey) and physical performance (SPPB, Short Performance Physical Battery) were measured. Additionally, a physical dimension component summary in the SF-36 was calculated. The SF-36 data were transformed into SF-6D scores to calculate quality-adjusted life-years (QALYs). Healthcare resource use were collected and transformed into costs. A healthcare payer perspective was adopted. Incremental cost-effectiveness ratio (ICER) was calculated, and one-way sensitivity analysis was performed. RESULTS: No statistically or clinically significant differences were observed between the usual care (n = 126) and intervention group (n = 151) patients in their QoL; at the 2-year follow-up the mean difference was -0.02, (95 % CI -0.07; 0.04,p = 0.56). While the mean difference between the groups in physical performance at the 2-year follow-up was -1.02, (-1.94;-0.10,p = 0.03), between the physical component summary scores it was -7.3, (-15.2; 0.6,p = 0.07). The ICER was -73 638€/QALY, hence, the developed PCCM dominated usual care, since it was more effective and less costly. CONCLUSIONS: The cost-utility analysis showed that the PCCM including pharmacist-led medication review dominated usual care. However, it had no effect on QoL and the effect towards physical performance remained unclear.

Health service use and costs associated with fluoroquinolone-related tendon injuries.

The aim of this study was to assess costs and health service use associated with tendon injuries after the use of fluoroquinolone antimicrobials in Finland during 2002-2012. This retrospective observational study included data from the Finnish Pharmaceutical Insurance Pool's pharmaceutical injury claims. In total, 145 compensated claimants aged ≥18 years presenting tendon injuries after the use of fluoroquinolones (FQs) were included in the study. Outcomes of interest were the number of outpatient visits to primary, secondary, tertiary, and private healthcare services, hospital days, rehabilitation and their costs. Regression models were used to analyze the impact of patient characteristics on hospital days, as well as the relationship between patient characteristics and tendon ruptures. Direct costs of a tendon injury averaged 14,800€ and indirect costs were estimated to be 9,077€ for employed claimants. Fifty-one percent of the claimants were hospitalized, with an average duration of 21 days. Hospitalization was the costliest form of health service use with an average of 9,915€ per hospital episode. Hospital days and direct costs increased with the severity of the injury. Tendon ruptures, in particular bilateral ruptures, required substantially more hospital days and their direct costs were significantly higher than those of uncomplicated tendinitis. Concurrent use of oral corticosteroids and increasing age were associated with a higher likelihood of tendon ruptures. Although rare, FQ-related tendon injuries can result in considerable costs and health service use. Medical staff should remain vigilant when prescribing FQs, especially in groups at increased risk for tendon injuries.

Is longer waiting time for total knee replacement associated with health outcomes and medication costs? Randomized clinical trial.

BACKGROUND: The aim of this prospective randomized study was to evaluate the effect of waiting time (WT) on health-related quality of life (HRQoL), knee pain and physical function, and the use and costs of medication of patients awaiting total knee replacement. METHODS: When placed on the waiting list, 438 patients were randomized into a short waiting time (SWT ≤ 3 months) or a nonfixed waiting time (NFWT > 3 months) group. HRQoL was measured by the 15D, and pain and physical function by modified Knee Society Clinical Rating System at baseline, admission, and 3 and 12 months postoperatively. The costs of medication due to osteoarthritis were calculated at the same measurement points. All analyses were performed using the intention-to-treat principle. RESULTS: The mean WT was 94 and 239 days in the SWT and NFWT groups, respectively. Apart from higher weekly cost of medication in the SWT group at admission and better HRQoL in the NFWT group 1 year postoperatively, there were no statistically significant differences between the groups in other outcomes during the follow-up. CONCLUSION: Those in the SWT group had higher weekly costs of medication at admission, and reached better HRQoL 3 months earlier than those in the NFWT group, but the latter had better HRQoL after operation. Otherwise, the length of WT was not associated with different health and HRQoL outcomes in the groups.

Health-related quality of life and costs of switching originator infliximab to biosimilar one in treatment of inflammatory bowel disease.

Effectiveness, efficacy and safety of biosimilar infliximab (CT-P13) in inflammatory bowel disease (IBD) patients has been shown in previous studies. Limited data exist on health-related quality of life (HRQoL) of switching originator to biosimilar infliximab (IFX) in IBD patients. The objective of this study was to evaluate impact of switching originator to biosimilar IFX on HRQoL, disease activity, and health care costs in IBD maintenance treatment.In this single-center prospective observational study, all IBD patients receiving maintenance IFX therapy were switched to biosimilar IFX. HRQoL was measured using the generic 15D health-related quality of life instrument (15D) utility measurement and the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ). Crohn Disease Activity Index (CDAI) or Partial Mayo Score (pMayo), and fecal calprotectin (FC) served for evaluation of disease activity. Data were collected at time of switching and 3 and 12 months after switching. Patients' characteristics, clinical background information and costs were collected from patient records and the hospital's electronic database.Fifty-four patients were included in the analysis. No statistically significant changes were observed in 15D, CDAI, pMayo, and FC during 1-year follow-up. IBDQ scores were higher (P = .018) in Crohn disease 3 months after switching than at time of switching. Costs of biosimilar IFX were one-third of costs of originator one. Total costs related to secondary health care (excluding costs of IFX), were similar before and after the onset of biosimilar IFX.HRQoL and disease activity were after switching from originator to biosimilar IFX comparable, but the costs of biosimilar IFX were only one-third of those of the originator one.

The effect of waiting time on health-related quality of life, pain, and physical function in patients awaiting primary total hip replacement: a randomized controlled trial.

OBJECTIVE: This prospective randomized study assessed the effect of waiting time (WT) on health outcomes in Finnish patients admitted to hospital for primary total hip replacement (THR). METHODS: A total of 395 consecutive patients with a need for a primary THR because of osteoarthritis and who were placed on the waiting list between August 2002 and November 2003. After placement on the waiting list, the patients were randomly assigned to a short WT (

Fluoroquinolone-related adverse events resulting in health service use and costs: A systematic review.

BACKGROUND AND OBJECTIVES: Adverse events (AEs) associated with the use of fluoroquinolone antimicrobials include Clostridium difficile associated diarrhea (CDAD), liver injury and seizures. Yet, the economic impact of these AEs is seldom acknowledged. The aim of this review was to identify health service use and subsequent costs associated with ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin -related AEs. METHODS: A literature search covering Medline, SCOPUS, Cinahl, Web of Science and Cochrane Library was performed in April 2017. Two independent reviewers systematically extracted the data and assessed the quality of the included studies. All costs were converted to 2016 euro in order to improve comparability. RESULTS: Of the 5,687 references found in the literature search, 19 observational studies, of which five were case-controlled, fulfilled the inclusion criteria. Hospitalization was an AE-related health service use outcome in 17 studies. Length of hospital stay associated with AEs varied between <5 and 45 days. The estimated cost of an AE episode ranged between 140 and 18,252 €. CDAD was associated with the longest stays in hospital. Ten studies reported AE-related length of stays and five evaluated costs associated with AEs. Due to the lack of published literature, health service use and costs associated with many high-risk FQ-related AEs could not be evaluated. CONCLUSIONS: Because of the wide clinical use of fluoroquinolones, in particular serious fluoroquinolone-related AEs can have substantial economic implications, in addition to imposing potentially devastating health complications for patients. Further measures are required to prevent and reduce health service use and costs associated with fluoroquinolone-related AEs. Equally, better-quality reporting and additional published data on health service use and costs associated with AEs are needed.

Cost-effectiveness of abatacept, tocilizumab and TNF-inhibitors compared with rituximab as second-line biologic drug in rheumatoid arthritis.

OBJECTIVES: The objective of this study was to evaluate the cost-effectiveness of abatacept, tocilizumab, and tumor necrosis factor (TNF) inhibitors as compared with rituximab in Finnish rheumatoid arthritis patients, who have previously been treated with TNF inhibitors. METHODS: A patient-level simulation model was developed to predict costs and outcomes associated with four biological drugs (abatacept, tocilizumab, rituximab and TNF inhibitors) in the treatment of rheumatoid arthritis. Following lack of efficacy or adverse events, the patients were switched to another biological drug until all four options were exhausted. After that, the patients were assumed to receive a 6th line treatment until death. The patients' baseline characteristics and regression models used in the simulation were based on observational data from the National Register for Biological Treatments in Finland. Direct costs comprised drug costs, administration costs, costs of switching, and outpatient and inpatient care, while indirect costs included disability pension and sick leaves due to rheumatoid arthritis. Several subgroup and deterministic sensitivity analyses were conducted. RESULTS: Drug costs were the lowest for rituximab, but when administration costs and costs of switching were included, drug costs were the lowest for TNF inhibitors. Abatacept was associated with the highest drug costs, whereas rituximab was associated with the highest healthcare costs. In total, TNF inhibitors had the lowest direct costs, while rituximab had the highest direct costs. The amount of quality-adjusted life years (QALY) gained ranged from 9.405 for rituximab to 9.661 for TNF inhibitors. TNF inhibitors, abatacept, and tocilizumab were dominant in comparison to RTX. CONCLUSIONS: TNF inhibitors, abatacept, and tocilizumab had lower costs and higher QALYs than rituximab, and therefore, they were dominant in comparison to rituximab. As TNF inhibitors had the lowest costs and highest QALYs, they were the most cost-effective treatment option.

The effect of co-morbidities on health-related quality of life in patients placed on the waiting list for total joint replacement.

BACKGROUND: Co-morbidity is a powerful predictor of health care outcomes and costs, as well as an important cofounder in epidemiologic studies. The effect of co-morbidities is generally related to mortality or complications. This study evaluated the association between co-morbidity and health-related quality of life (HRQoL) in patients awaiting total joint replacement. METHODS: A total of 893 patients were recruited to the study between August 2002 and November 2003 in four Finnish hospitals. The effect of co-morbidity on HRQoL was measured by the generic 15D instrument and by a Visual Analog Scale (VAS). Comparative variance analysis of socio-demographic and clinical characteristics was described by using either an independent samples t-test or the Chi-square test. The differences in each of the 15D dimensions and the overall 15D single index score for patients were calculated. Two-sided p-values were calculated with the Levene Test for Equality of Variances. RESULTS: Patients with co-morbidity totaled 649; the incidence of co-morbidity was 73%. The mean number of co-morbidities among the patients was two. At baseline the 15D score in patients with and without co-morbidity was 0.778 vs 0.816, respectively. The difference of the score (0.038) was clinically and statistically significant (P < 0.001). The patients' scores with and without co-morbidity on the different 15D dimensions related to osteoarthritis-moving, sleeping, usual activities, discomfort and symptoms, vitality and sexual activity-were low in both groups. Patients with co-morbidity scored lower on the dimensions of moving, vitality and sexual activity compared to the patients without co-morbidity. Co-morbidity was significantly associated with a reduced HRQoL. Patients without co-morbidity had poorer VAS, arthritis had strong effect to their quality of life compared to the patients with co-morbidity. CONCLUSION: Assessing co-morbidity in patients placed on the waiting list for joint replacement may be useful method to prioritization in medical decision-making for healthcare delivery. The assessment of co-morbidities during waiting time is important as well as evaluating how the co-morbidity may affect the final outcomes of the total joint replacement.

Is longer waiting time associated with health and social services utilization before treatment? A randomized study.

OBJECTIVE: To determine whether longer waiting time for major joint replacement is associated with health and social services utilization before treatment. METHODS: When placed on the waiting list, patients were randomized to short (

Evaluating waiting time effect on health outcomes at admission: a prospective randomized study on patients with osteoarthritis of the knee joint.

AIMS: To evaluate the effect of waiting on health-related quality of life (HRQoL), pain and physical function in patients awaiting primary total knee replacement (TKR) due to osteoarthritis. METHODS: Some 438 patients awaiting TKR were randomized to a short waiting time (WT) group (< or =3 months) or a non-fixed WT group. In the final assessment, 310 patients (213 women) with a mean age of 68 years were included. HRQoL was measured on being placed on the waiting list and again at hospital admission using the generic 15D. Patients' self-report pain and physical function were evaluated using a scale modified from the Knee Society Clinical Rating System. RESULTS: The median WTs for patients with short and non-fixed WT were 73 days (range 8-600 days) and 266 days (range 28-818 days), respectively. At admission, as assessed by the intention-to-treat analysis, there were no statistically significant differences between the groups in the 15D total score and disease-specific pain and function. CONCLUSIONS: Our study showed that longer WT did not result in worse pre-operative HRQoL.

Effectiveness and drug survival of TNF-inhibitors in the treatment of psoriatic arthritis: A prospective cohort study.

BACKGROUND AND OBJECTIVES: Tumor necrosis factor (TNF)-inhibitors are used to treat psoriatic arthritis (PsA), but only a limited number of observational studies on this subject have been published thus far. The aim of this research was to analyze the effectiveness and drug survival of TNF-inhibitors in the treatment of PsA. METHODS: PsA patients identified from the National Register for Biologic Treatment in Finland (ROB-FIN) starting their first, second, or third TNF-inhibitor treatment between 2004 and 2014 were included. Effectiveness was measured using ACR and EULAR response criteria and modeled using ordinal logistic regression. Treatment persistence was analyzed using Kaplan-Meier survival analysis and Cox proportional hazards model. RESULTS: The study comprised 765 patients and 990 TNF-inhibitor treatment courses. EULAR moderate treatment responses at 6 months were achieved by 68% and 37% of the users of the first and the second or the third biologic, respectively. The probabilities of discontinuing the treatment within 12 and 24 months were 20% and 28%, respectively. Adjusted treatment responses to all TNF-inhibitors were similar; however, co-therapy with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) was not associated with better effectiveness. Adalimumab [hazard ratio (HR) = 0.62; 95% confidence interval (CI): 0.44-0.88] was superior to infliximab in drug survival while etanercept (HR = 0.77, 95% CI: 0.55-1.1) and golimumab (HR = 0.75, 95% CI: 0.46-1.2) did not differ from it. Co-medication with csDMARDs did not statistically improve drug survival. CONCLUSION: All available TNF-inhibitors showed similar treatment responses with or without csDMARDs. Adalimumab was associated with better drug survival when compared to infliximab.

Health-related quality of life in patients waiting for major joint replacement. A comparison between patients and population controls.

BACKGROUND: Several quality-of-life studies in patients awaiting major joint replacement have focused on the outcomes of surgery. Interest in examining patients on the elective waiting list has increased since the beginning of 2000. We assessed health-related quality of life (HRQoL) in patients waiting for total hip (THR) or knee (TKR) replacement in three Finnish hospitals, and compared patients' HRQoL with that of population controls. METHODS: A total of 133 patients awaiting major joint replacement due to osteoarthritis (OA) of the hip or knee joint were prospectively followed from the time the patient was placed on the waiting list to hospital admission. A sample of controls matched by age, gender, housing and home municipality was drawn from the computerised population register. HRQoL was measured by the generic 15D instrument. Differences between patients and the population controls were tested by the independent samples t-test and between the measurement points by the paired samples t-test. A linear regression model was used to explain the variance in the 15D score at admission. RESULTS: At baseline, 15D scores were significantly different between patients and the population controls. Compared with the population controls, patients were worse off on the dimensions of moving (P < 0.001), sleeping (P < 0.001), sexual activity (P < 0.001), vitality (P < 0.001), usual activities (P < 0.001) and discomfort and symptoms (P < 0.001). Further, psychological factors--depression (P < 0.001) and distress (P = 0.004)--were worse among patients than population controls. The patients showed statistically significantly improved average scores at admission on the dimensions of moving (P = 0.026), sleeping (P = 0.004) and discomfort and symptoms (P = 0.041), but not in the overall 15D score compared with the baseline. In patients, 15D score at baseline (P < 0.001) and body mass index (BMI) (P = 0.020) had an independent effect on patients' 15D score at hospital admission. CONCLUSION: Although patients' HRQoL did not deteriorate while waiting, a consistently worse HRQoL was observed in patients waiting for major joint replacement compared with population controls.

Cost-utility of routine cataract surgery.

BACKGROUND: If decisions on health care spending are to be as rational and objective as possible, knowledge on cost-effectiveness of routine care is essential. Our aim, therefore, was to evaluate the cost-utility of routine cataract surgery in a real-world setting. METHODS: Prospective assessment of health-related quality of life (HRQoL) of patients undergoing cataract surgery. 219 patients (mean (SD) age 71 (11) years) entering cataract surgery (in 87 only first eye operated, in 73 both eyes operated, in 59 first eye had been operated earlier) filled in the 15D HRQoL questionnaire before and six months after operation. Direct hospital costs were obtained from a clinical patient administration database and cost-utility analysis performed from the perspective of the secondary care provider extrapolating benefits of surgery to the remaining statistical life-expectancy of the patients. RESULTS: Mean (SD) utility score (on a 0-1 scale) increased statistically insignificantly from 0.82 (0.13) to 0.83 (0.14). Of the 15 dimensions of the HRQoL instrument, only seeing improved significantly after operation. Mean utility score improved statistically significantly only in patients reporting significant or major preoperative seeing problems. Of the subgroups, only those whose both eyes were operated during follow-up showed a statistically significant (p < 0.001) improvement. Cost per quality-adjusted life year (QALY) gained was euro5128 for patients whose both eyes were operated and euro8212 for patients with only one eye operated during the 6-month follow-up. In patients whose first eye had been operated earlier mean HRQoL deteriorated after surgery precluding the establishment of the cost per QALY. CONCLUSION: Mean utility gain after routine cataract surgery in a real-world setting was relatively small and confined mostly to patients whose both eyes were operated. The cost of cataract surgery per quality-adjusted life year gained was much higher than previously reported and associated with considerable uncertainty.

Cost-utility analysis of routine neurosurgical spinal surgery.

OBJECT: Cost-utility analysis is currently the preferred method with which to compare the cost-effectiveness of various interventions. The authors conducted a study to establish the cost-utility results of routine neurosurgery-based spinal interventions by examining patient-derived values. METHODS: Two hundred seventy patients undergoing surgery for cervical or lumbar radicular pain filled in the 15-dimensional health-related quality of life (HRQOL) questionnaire before and 3 months after surgery. Quality-adjusted life years (QALYs) were calculated using the utility data and the expected remaining life years of the patients. The mean HRQOL score (scale, 0-1) increased after cervical surgery (169 patients, mean age 52 years, 40% women) from 0.81 +/- 0.11 preoperatively, to 0.85 +/- 0.11 at 3 months, and after lumbar surgery (101 patients, mean age 54 years, 59% women) from 0.79 +/- 0.10 preoperatively, to 0.85 +/- 0.12 at 3 months (p < 0.001). Of the 15 dimensions of health, improvement in the following was documented in both groups: sleeping, usual activities, discomfort and symptoms, depression, distress, vitality, and sexual activity (p < 0.05). The cost per QALY gained was Euro 2774 and 1738 for cervical and lumbar operations, respectively. In cases in which surgery was delayed the cost per QALY was doubled. CONCLUSIONS: Spinal surgery led to a statistically significant and clinically important improvement in HRQOL. The cost per QALY gained was reasonable, less than half of that observed, for example, for hip replacement surgery or angioplasty treatment of coronary artery disease; however, a prolonged delay in surgical intervention led to an approximate doubling of the cost per QALY gained by the treatment.