Effectiveness of the Coordinated Return to Work model after orthopaedic surgery for lumbar discectomy and hip and knee arthroplasty: a register-based study.

OBJECTIVES: This study examined the effectiveness of an individualised Coordinated Return to Work (CRtW) model on the length of the return to work (RTW) period compared with a standard prescription of 2-3 months RTW during recovery after lumbar discectomy and hip and knee arthroplasty among Finnish working-age population. METHODS: Cohorts on patients aged 18-65 years old with lumbar discectomy or hip or knee arthroplasty were extracted from the electronic health records of eight Finnish hospital districts in 2015-2021 and compiled with retirement and sickness benefits. The overall effect of the CRtW model on the average RTW period was calculated as a weighted average of area-specific mean differences in RTW periods between 1 year before and 1 year after the implementation. Longer-term effects of the model were examined with an interrupted time series design estimated with a segmented regression model. RESULTS: During the first year of the CRtW model, the average RTW period shortened by 9.1 days (95% CI 4.1 to 14.1) for hip arthroplasty and 14.4 days (95% CI 7.5 to 21.3) for knee arthroplasty. The observed differences were sustained over longer follow-up times. For lumbar discectomy, the first-year decrease was not statistically significant, but the average RTW had shortened by 36.2 days (95% CI 33.8 to 38.5) after 4.5 years. CONCLUSIONS: The CRtW model shortened average RTW periods among working-age people during the recovery period. Further research with larger samples and longer follow-up times is needed to ensure the effectiveness of the model as a part of the Finnish healthcare system.

Hospital treatment costs associated with incident complications in patients with type 2 diabetes-real-world study based on electronic patient information systems.

BACKGROUND: Type 2 diabetes (T2D) and its complications cause a significant public health and economic challenge. To enable the optimal resource allocation across different prevention and treatment policies for the management of T2D-related complications, detailed cost estimates related to the complications of T2D are needed. Therefore, the objective of the study was to provide reliable and sufficiently detailed real-world estimates of costs associated with different T2D complications in a Finnish university hospital setting. METHODS: A cohort of T2D patients living in the catchment area of a university hospital during 2012 and 2016 was identified from the comprehensive national FinDM diabetes database for longitudinal assessment of T2D associated complication treatment costs. Data on patient-level events were extracted from the FinDM data and complemented with all accountable services and related detailed costing data gathered from the university hospital's electronic patient information systems by using unique personal identity codes. Patients were screened for their first diagnoses of complications using the same national quality registry definitions as in the FinDM database. Multivariable gamma regression model with a log link function was applied to study the association between baseline factors and complication costs. In addition, an interactive online tool was developed to create predicted costs for complication costs with selected baseline factors. RESULTS: A total of 27 255 prevalent and incident patients with T2D were identified from the national FinDM register. Finally, a total of 16 148 complication episodes for 7 895 patients were included in the cost analyses. The mean estimated one-year hospital treatment costs of T2D-related complication varied from 6 184 to 24 507 euros per complication. Regression analyses showed that coexisting conditions are significantly associated with initial and recurrent complication costs. CONCLUSIONS: The study shows updated Finnish cost estimates and their main cost drivers for T2D-related complications treated in the university hospital setting. The results of our study highlight the significance of guideline implementation, effective preventive treatments for T2D, as well as the importance of treatment adherence to avoid these costly complications.

Digitally Supported Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Secondary Analysis of Long-Term User Engagement Trajectories in a Randomized Controlled Trial.

BACKGROUND: Digital health interventions may offer a scalable way to prevent type 2 diabetes (T2D) with minimal burden on health care systems by providing early support for healthy behaviors among adults at increased risk for T2D. However, ensuring continued engagement with digital solutions is a challenge impacting the expected effectiveness. OBJECTIVE: We aimed to investigate the longitudinal usage patterns of a digital healthy habit formation intervention, BitHabit, and the associations with changes in T2D risk factors. METHODS: This is a secondary analysis of the StopDia (Stop Diabetes) study, an unblinded parallel 1-year randomized controlled trial evaluating the effectiveness of the BitHabit app alone or together with face-to-face group coaching in comparison with routine care in Finland in 2017-2019 among community-dwelling adults (aged 18 to 74 years) at an increased risk of T2D. We used longitudinal data on usage from 1926 participants randomized to the digital intervention arms. Latent class growth models were applied to identify user engagement trajectories with the app during the study. Predictors for trajectory membership were examined with multinomial logistic regression models. Analysis of covariance was used to investigate the association between trajectories and 12-month changes in T2D risk factors. RESULTS: More than half (1022/1926, 53.1%) of the participants continued to use the app throughout the 12-month intervention. The following 4 user engagement trajectories were identified: terminated usage (904/1926, 46.9%), weekly usage (731/1926, 38.0%), twice weekly usage (208/1926, 10.8%), and daily usage (83/1926, 4.3%). Active app use during the first month, higher net promoter score after the first 1 to 2 months of use, older age, and better quality of diet at baseline increased the odds of belonging to the continued usage trajectories. Compared with other trajectories, daily usage was associated with a higher increase in diet quality and a more pronounced decrease in BMI and waist circumference at 12 months. CONCLUSIONS: Distinct long-term usage trajectories of the BitHabit app were identified, and individual predictors for belonging to different trajectory groups were found. These findings highlight the need for being able to identify individuals likely to disengage from interventions early on, and could be used to inform the development of future adaptive interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6574-y.

Marked Improvement in A1C Levels After Initiation of Intermittently Scanned Continuous Glucose Monitoring Is Maintained Over 4 Years in Patients With Type 1 Diabetes.

Objective: This study aimed to demonstrate the effectiveness of long-term use of intermittently scanned continuous glucose monitoring (isCGM) in adult patients with type 1 diabetes. Design and methods: In this retrospective real-world study, 689 patients with type 1 diabetes who were >18 years of age and using isCGM were identified from the electronic patient records in North Karelia, Finland. A1C data were collected before and after the initiation of isCGM. The primary outcome was a change in the mean A1C over time after isCGM started. Results: The greatest reductions in the mean A1C levels were observed 6 months (-0.54% [-5.9 mmol/mol], P <0.001) and 12 months (-0.42% [-4.6 mmol/mol], P <0.001) after the initiation of isCGM. Reduction in A1C remained significant for 4 years, although the mean reduction in A1C was -0.18% (-2.05 mmol/mol) (P = 0.009) at 48 months compared with baseline. In a subgroup analysis, patients with a baseline A1C >9% (75 mmol/mol) benefited the most from initiation of isCGM (reduction -0.97% [-10.6 mmol/mol], P <0.001, at 12 months and -0.92% [-10.1 mmol/mol], P <0.001, at 48 months). Neither sex nor age at the start of isCGM were correlated with A1C reduction. Conclusion: Use of isCGM improves A1C levels significantly in adult patients with type 1 diabetes. Significant reduction in A1C persisted over 4 years of use, although the effect diminished over time.

Cost-effectiveness of physical activity intervention in children - results based on the Physical Activity and Nutrition in Children (PANIC) study.

BACKGROUND: We assessed the cost-effectiveness of a 2-year physical activity (PA) intervention combining family-based PA counselling and after-school exercise clubs in primary-school children compared to no intervention from an extended service payer's perspective. METHODS: The participants included 506 children (245 girls, 261 boys) allocated to an intervention group (306 children, 60 %) and a control group (200 children, 40 %). The children and their parents in the intervention group had six PA counselling visits, and the children also had the opportunity to participate in after-school exercise clubs. The control group received verbal and written advice on health-improving PA at baseline. A change in total PA over two years was used as the outcome measure. Intervention costs included those related to the family-based PA counselling, the after-school exercise clubs, and the parents' taking time off to travel to and participate in the counselling. The cost-effectiveness analyses were performed using the intention-to-treat principle. The costs per increased PA hour (incremental cost-effectiveness ratio, ICER) were based on net monetary benefit (NMB) regression adjusted for baseline PA and background variables. The results are presented with NMB and cost-effectiveness acceptability curves. RESULTS: Over two years, total PA increased on average by 108 h in the intervention group (95 % confidence interval [CI] from 95 to 121, p < 0.001) and decreased by 65.5 h (95 % CI from 81.7 to 48.3, p < 0.001) in the control group, the difference being 173.7 h. the incremental effectiveness was 87 (173/2) hours. For two years, the intervention costs were €619 without parents' time use costs and €860 with these costs. The costs per increased PA hour were €6.21 without and €8.62 with these costs. The willingness to pay required for 95 % probability of cost-effectiveness was €14 and €19 with these costs. The sensitivity analyses revealed that the ICER without assuming this linear change in PA were €3.10 and €4.31. CONCLUSIONS: The PA intervention would be cost-effective compared to no intervention among children if the service payer's willingness-to-pay for a 1-hour increase in PA is €8.62 with parents' time costs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01803776. Registered 4 March 2013 - Retrospectively registered, https://clinicaltrials.gov/ct2/results?cond=&term=01803776&cntry=&state=&city=&dist= .

Patient-reported outcomes in coronary artery disease: the relationship between the standard, disease-specific set by the International Consortium for Health Outcomes Measurement (ICHOM) and the generic health-related quality of life instrument 15D.

BACKGROUND: Patient-reported outcome (PRO) instruments measure health gains, including changes in health-related quality of life (HRQoL). Previous studies have assessed the reliability and relationship of multiple HRQoL instruments in search of the optimal instrument for feasible measurement of PROs. Although the 15D instrument was shown to have the best sensitivity and construct validity among cardiac patients, it is unknown how well it captures relevant disease-specific information scores compared to instruments included in the International Consortium for Health Outcomes Measurement (ICHOM) standard set. The aim of this study was to investigate whether the disease-specific PRO instruments and a generic HRQoL instrument capture disease related symptoms in coronary artery disease (CAD) patients. METHODS: Health status and HRQoL were assessed with the instruments included in the ICHOM standard set: Seattle Angina Questionnaire short-form (SAQ-7), Rose Dyspnea Scale (RDS), two-item Patient Health Questionnaire (PHQ-2), and with the 15D HRQoL instrument at baseline and 1 year from the treatment in a university hospital setting. Spearman correlation and explanatory factor analysis were used to assess the relationship of baseline scores and 1-year change in scores of 297 patients. RESULTS: At baseline, the overall 15D score and SAQ-physical limitation (SAQ-PL), 15D "breathing" and SAQ-PL, as well as "breathing" and RDS showed moderately strong correlations. The factor interpreted to reflect "Breathing-related physical activity", based on high loadings of "breathing", RDS, SAQ-PL, "mobility", "vitality", and "usual activities", explained 19.2% of the total variance. Correlations between 1-year changes in scores were fair. The factor of "Breathing-related physical activity", with significant loading of RDS, SAQ-PL, "breathing, "usual activities", "vitality", "sexual activity", "mobility", and disease-specific quality of life explained 20.5% of the total variance in 1-year change in scores. The correlation of angina frequency measured by SAQ-7 and the 15D instrument was poor. CONCLUSIONS: The 15D detects dyspnea and depression similarly to RDS and PHQ-2 but not angina similarly to the SAQ-7. This may call for supplementing the 15D instrument with a disease-specific instrument when studying CAD patients.

Total cost of care increases significantly from early to mild Alzheimer's disease: 5-year ALSOVA follow-up.

INTRODUCTION: We studied the costs of formal and informal care in relation to Alzheimer's disease (AD) progression. METHODS: 231 persons with AD with a family caregiver were followed up for 5 years. The Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) was used to measure AD progression. Health and social care unit costs were used for formal care costs. An opportunity cost method for lost leisure time was applied to analyse the cost of informal care. RESULTS: Total cost of care in early stage AD (CDR-SB ≤ 4) was 16,448€ (95% CI 13,722-19,716) annually. In mild (CDR-SB 4.5-9), moderate (CDR-SB 9.5-15.5) and severe (CDR-SB ≥ 16) AD, the total costs were 2.3, 3.4 and 4.4 times higher, respectively. A one-unit increase in CDR-SB increased the total, formal and informal costs by 15, 11 and 18%, respectively. CONCLUSIONS: Compared to early AD, the costs of total, formal and informal care are remarkably higher already in mild AD. This finding emphasises early diagnosis, interventions and family support for persons with AD and their caregivers.

Pharmacy-based screening to detect persons at elevated risk of type 2 diabetes: a cost-utility analysis.

BACKGROUND: Early identification of people at elevated risk of type 2 diabetes (T2D) is an important step in preventing or delaying its onset. Pharmacies can serve as a significant channel to reach these people. This study aimed to assess the potential health economic impact of screening and recruitment services in pharmacies in referring people to preventive interventions. METHODS: A decision analytic model was constructed to perform a cost-utility analysis of the expected national health economic consequences (in terms of costs and quality-adjusted life years, QALYs) of a hypothetical pharmacy-based service where people screened and recruited through pharmacies would participate in a digital lifestyle program. Cost-effectiveness was considered in terms of net monetary benefit (NMB). In addition, social return on investment (SROI) was calculated as the ratio of the intervention and recruitment costs and the net present value of expected savings. Payback time was the time taken to reach the break-even point in savings. In the base scenario, a 20-year time horizon was applied. Probabilistic and deterministic sensitivity analyses were applied to study robustness of the results. RESULTS: In the base scenario, the expected savings from the pharmacy-based screening and recruitment among the reached target cohort were 255.3 m€ (95% CI - 185.2 m€ to 717.2 m€) in pharmacy visiting population meaning 1412€ (95% CI - 1024€ to 3967€) expected savings per person. Additionally, 7032 QALYs (95% CI - 1344 to 16,143) were gained on the population level. The intervention had an NMB of 3358€ (95% CI - 1397€ to 8431€) using a cost-effectiveness threshold of 50,000 €/QALY. The initial costs were 122.2 m€ with an SROI of 2.09€ (95% CI - 1.52€ to 5.88€). The expected payback time was 10 and 8 years for women and men, respectively. Results were most sensitive for changes in effectiveness of the intervention and selected discount rate. CONCLUSIONS: T2D screening and recruitment to prevention programs conducted via pharmacies was a dominant option providing both cost savings and QALY gains. The highest savings can be potentially reached by targeting recruitment at men at elevated risk of T2D.

Purchases of medical therapy recommended for coronary artery disease before and after elective revascularisation.

AIMS: We studied the purchases of medical therapy recommended for coronary artery disease patients before and after elective revascularisation (percutaneous coronary intervention (PCI) or coronary bypass grafting (CABG)). METHODS: All patients who underwent an elective PCI (N = 1557) or CABG (N = 1768) at the Heart Center, Kuopio University hospital between 2007 and 2014 were included. Data were collected from the hospital's coronary register and national registers, and obtained for 3 years before and 1 year after the revascularisation. RESULTS: Altogether 85.2% of PCI patients and 88.1% of CABG patients had purchased lipid-modifying agents before the procedure, and 94.9% and 96.8% during the post-procedure follow-up year, respectively. Beta-blocking agents were purchased by 84.9% of PCI patients before and by 87.9% after the procedure and by 86.3% of CABG patients before and 97.1% after the operation. Of PCI patients, 64.3% had purchased organic long-acting nitrates before the procedure and 54.4% also after the procedure. Among CABG patients, the purchase of organic long-acting nitrates fell from 59.7% before to 10.1% after the operation. The use of ADP receptor blocking agents increased in PCI patients (26.3 to 83.9%) and the use of warfarin in CABG patients (9.4 to 21.3%). Medication purchases were more common among those who had greater use of hospital services before and after the procedures. CONCLUSIONS: In both PCI and CABG patients, the use of medical therapy before and after revascularisation procedure complied with current guidelines. Purchases of long-acting nitrates were common in the PCI group even after the procedure.

Impact of co-payment level increase of antidiabetic medications on glycaemic control: an interrupted time-series study among Finnish patients with type 2 diabetes.

BACKGROUND: A new special reimbursement scheme (SRS) for non-insulin medications used for treatment of hyperglycaemia in type 2 diabetes (T2D) was implemented in Finland on January 1, 2017. The new SRS affected all community-dwelling Finnish T2D patients as all community-dwelling residents are eligible for reimbursement for prescription medications. The aim of the study was to evaluate the impact of this co-payment increase on glycaemic control among Finnish T2D patients. METHODS: Data on glycaemic control were collected with HbA1c measures from electronic health records from primary health care and specialized care in the North Karelia region, Finland, from patients with a confirmed T2D diagnosis in 2012 who were alive on January 1, 2017 (n = 8436). Average HbA1c levels were measured monthly 36 months before and 33 months after the policy change. Consumption of diabetes medications was measured with defined daily doses (DDDs) based on reimbursed medication purchases. Interrupted time series design analysed with segmented regression model was applied to examine the effect of the policy change on average HbA1c levels. RESULTS: Eight thousand one hundred forty-three T2D patients had at least one HbA1c measurement within 01/2014-9/2019. Mean age of the patients was 68.1 (SD 11.3) years and 53.0% were women. Average time since T2D diagnosis was 11.5 (SD 6.1) years. An estimated increase of 0.81 (95% confidence interval, CI, 0.04-1.58) mmol/mol in average HbA1c levels was detected at the time of the policy change. In subgroup analyses, strongest effects were detected among patients who used only other diabetes medications than insulin or metformin in 2016 (3.56 mmol/mol, 95% CI 2.50-4.62). Meanwhile, yearly consumption of diabetes medications decreased slightly from 618.9 (SD 487.8) DDDs/patient in 2016 to 602.9 (SD 475.6) DDDs/patient in 2017 (p = 0.048). CONCLUSIONS: Simultaneously with the increase of the co-payment level, the average HbA1c level increased among T2D patients from the North Karelia region, Finland. This may be explained by the decreased consumption of diabetes medications between 2016 and 2017. Special attention should be allocated to glycaemic control of patients utilizing only other antidiabetic medications than metformin or insulin.

Impact of type 2 diabetes treated with non-insulin medication and number of diabetes-coexisting diseases on EQ-5D-5 L index scores in the Finnish population.

BACKGROUND: Type 2 diabetes (T2D) causes significant health and economic burden. In addition to comorbidities there are also coexisting diseases linked to obesity, lifestyle and T2D. The aim of this study was to examine the effect of T2D and T2D-coexisting diseases on health-related quality of life (HRQoL) in the Finnish population and whether it is T2D or the coexisting diseases that have the largest impact on HRQoL. METHODS: The study was based on a national cross-sectional population survey (n = 5305). Respondents' HRQoL was measured using the EQ-5D-5 L instrument. Our study included diabetic respondents treated with non-insulin medications (NI-T2D) with or without insulin and non-diabetic respondents, whereas diabetic respondents not taking any anti-diabetic medications or treated with insulin alone were excluded. A crosswalk algorithm was used to convert EQ-5D-5 L index scores into EQ-5D-3 L index scores as a sensitivity analysis. A two-part model was used to examine the association between T2D and coexisting diseases and HRQoL. RESULTS: The unadjusted mean (SD) EQ-5D-5 L index scores for non-diabetics (n = 4856) was 0.90 (0.13) and 0.85 (0.16) for respondents with NI-T2D (n = 449). With adjustment for demographic factors, the difference in EQ-5D-5 L index scores was 0.036 (95% CI 0.023-0.050). After adjusting for the number of coexisting diseases, the EQ-5D-5 L index scores among respondents with NI-T2D and three or more coexisting diseases were lower when compared to all non-diabetics but not when compared to non-diabetics with similar number of coexisting diseases. The number of T2D-coexisting diseases had a larger effect on EQ-5D-5 L index scores in younger age groups (20 and 40 years old). CONCLUSIONS: Lower EQ-5D-5 L index score is associated with NI-T2D when compared to non-diabetic respondents. When compared to non-diabetics, the disutility associated with NI-T2D increases as more coexisting diseases appear. The disutility effect of coexisting diseases was equally large in non-diabetics and respondents with NI-T2D. Thus, public health interventions targeting the prevention of both T2D and its coexisting diseases have potential to have significant benefits also in terms of HRQoL.

Digitally supported program for type 2 diabetes risk identification and risk reduction in real-world setting: protocol for the StopDia model and randomized controlled trial.

BACKGROUND: The StopDia study is based on the convincing scientific evidence that type 2 diabetes (T2D) and its comorbidities can be prevented by a healthy lifestyle. The need for additional research is based on the fact that the attempts to translate scientific evidence into actions in the real-world health care have not led to permanent and cost-effective models to prevent T2D. The specific aims of the StopDia study following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework are to 1) improve the Reach of individuals at increased risk, 2) evaluate the Effectiveness and cost-effectiveness of the digital lifestyle intervention and the digital and face-to-face group lifestyle intervention in comparison to routine care in a randomized controlled trial (RCT), and 3) evaluate the Adoption and Implementation of the StopDia model by the participants and the health care organizations at society level. Finally, we will address the Maintenance of the lifestyle changes at participant level and that of the program at organisatory level after the RCT. METHODS: The StopDia study is carried out in the primary health care system as part of the routine actions of three provinces in Finland, including Northern Savo, Southern Carelia, and Päijät-Häme. We estimate that one fifth of adults aged 18-70 years living in these areas are at increased risk of T2D. We recruit the participants using the StopDia Digital Screening Tool, including questions from the Finnish Diabetes Risk Score (FINDRISC). About 3000 individuals at increased risk of T2D (FINDRISC ≥12 or a history of gestational diabetes, impaired fasting glucose, or impaired glucose tolerance) participate in the one-year randomized controlled trial. We monitor lifestyle factors using the StopDia Digital Questionnaire and metabolism using laboratory tests performed as part of routine actions in the health care system. DISCUSSION: Sustainable and scalable models are needed to reach and identify individuals at increased risk of T2D and to deliver personalized and effective lifestyle interventions. With the StopDia study we aim to answer these challenges in a scientific project that is fully digitally integrated into the routine health care. TRIAL REGISTRATION: ClinicalTials.gov . Identifier: NCT03156478 . Date of registration 17.5.2017.

The effects of reimbursement reform of antidiabetic medicines from the patients' perspective - a survey among patients with type 2 diabetes in Finland.

BACKGROUND: In Finland, the reimbursement rate for antidiabetic medicines other than insulins was lowered from 100 to 65% at the beginning of 2017. The objective of this study was to examine the effects of this reform experienced by patients with type 2 diabetes. The objective was also to explore if socio-economic status affects this experience. METHODS: The data were collected by conducting a survey among Finnish adults with type 2 diabetes (n = 603). The baseline survey was conducted in November-December 2016. A second follow-up survey was conducted at the end of 2017 where the participants' experience of the reimbursement reform was surveyed with an open-ended question. Free-form inductive content analysis was used to categorize the answers. The association between the participants' characteristics and reporting an effect caused by the reimbursement reform was studied with binomial logistic regression. RESULTS: 285 (47.3%) participants reported an effect of some kind caused by the reimbursement reform. The most common reported effects were economic effects (32.7%) and annoyance (12.4%). Having financial difficulties in purchasing antidiabetic medicines (odds ratio (OR) 5.20, 95% confidence interval (Cl) 2.99-9.06) or not having annual deductible exceeded (OR 2.17, 95% CI 1.19-3.95), and use of certain antidiabetic medication groups at baseline were associated with reporting an effect. Socio-economic status was not associated with the likelihood of reporting an effect. CONCLUSIONS: Almost half of the participants with type 2 diabetes reported an effect, most commonly economic effects, such as increased expenditure or difficulty in purchasing medicines, after the reimbursement reform. It is important to study the effects of reimbursement reforms also from the patients' perspective.

Cost-effectiveness analysis of secukinumab versus other biologics and apremilast in the treatment of active Psoriatic arthritis: a Finnish perspective.

OBJECTIVE: To study cost-effectiveness of an interleukin (IL)-17A inhibitor secukinumab, with other biologics and apremilast in patients with Psoriatic arthritis (PsA) from payer perspective in Finland. METHODS: In this semi-Markov model, subcutaneous (SC) secukinumab was compared with SC treatments etanercept and its biosimilar, certolizumab pegol, adalimumab and its biosimilar, golimumab, ustekinumab, intravenous (IV) treatment infliximab, as well as oral non-biologic apremilast. Patients without prior exposure (naïve) to biologics and without moderate to severe psoriasis were considered for secukinumab 150 mg group. Secukinumab 300 mg group included naïve patients with moderate to severe psoriasis and all patients with prior biologic exposure. The PsA Response Criteria (PsARC) at 12-week was primary criteria for treatment response. Other clinical as well as cost related model inputs were derived from relevant clinical trials as well as Finnish publications. The key model outcomes were quality-adjusted life years and incremental cost-effectiveness ratio. An annual 3% discount rate was applied to all future costs and benefits. Model input variations were assessed through sensitivity analyses and alternative scenario analyses. RESULTS: For a lifetime horizon (60 years), secukinumab 150 mg dominated all branded SC biologics and apremilast with highest QALY of 8.01 and lowest lifetime cost of €187,776, while it was cost-effective against IV infliximab among biologic-naïve patients without moderate to severe psoriasis. Secukinumab 300 mg was cost-effective against all branded SC biologics and apremilast and dominated IV infliximab among biologic-naïve patients with moderate to severe psoriasis, while it was cost-effective in biologic experienced patients. With the one-way sensitivity analysis, PsARC response, drug acquisition cost, and health assessment questionnaire score were the most important parameters affecting the outcomes. Across all treatment groups, patients on secukinumab were most likely to achieve highest net monetary benefit than other competitors in probabilistic sensitivity analysis. With alternative scenario analysis, results largely remained unchanged. CONCLUSIONS: Secukinumab is a cost-effective treatment for PsA patients from a Finnish payer's perspective.

Health-related quality of life in relation to symptomatic and radiographic definitions of knee osteoarthritis: data from Osteoarthritis Initiative (OAI) 4-year follow-up study.

BACKGROUND: The purpose was to quantify the decrement in health utility (referred as disutility) associated with knee osteoarthritis (OA) and different symptomatic and radiographic uni- and bilateral definitions of knee OA in a repeated measures design of persons with knee OA or at increased risk of developing knee OA. METHODS: Data were obtained from the Osteoarthritis Initiative database. SF-12 health-related quality of life was converted into SF-6D utilities, and were then handled as the health utility loss by subtracting 1.000 from the utility score, yielding a negative value (disutility). Symptomatic OA was defined by radiographic findings (Kellgren-Lawrence, K-L, grade ≥ 2) and frequent knee pain in the same knee. Radiographic OA was defined by five different definitions (K-L ≥ 2 unilaterally / bilaterally, or the highest / mean / combination of K-L grades of both knees). Repeated measures generalized estimating equation (GEE) models were used to investigate disutility in relation to these different definitions. RESULTS: Utility decreased with worsening of symptomatic or radiographic status of knee OA. The participants with bilateral and unilateral symptomatic knee OA had 0.03 (p < 0.001) and 0.02 (p < 0.001) points lower utility scores, respectively, compared with the reference group. The radiographic K-L grade 4 defined as the mean or the highest grade of both knees was related to a decrease of 0.04 (p < 0.001) and 0.03 (p < 0.001) points in utility scores, respectively, compared to the reference group. CONCLUSIONS: Knee OA is associated with diminished health-related quality of life. Health utility can be quantified in relation to both symptomatic and radiographic uni- and bilateral definitions of knee OA, and these definitions are associated with differing disutilities. The performance of symptomatic definition was better, indicating that pain experience is an important factor in knee OA related quality of life.

Quality of Life in relation to neuropsychiatric symptoms in Alzheimer's disease: 5-year prospective ALSOVA cohort study.

OBJECTIVE: To examine the association between neuropsychiatric symptoms (NPS) with self- and caregiver-rated Quality of Life (QoL) for patients with Alzheimer's disease (AD) during a 5-year follow-up. METHODS: The ALSOVA 5-year follow-up study included, at baseline, 236 patients with either very mild (Clinical Dementia Rating Scale (CDR) 0.5), or mild (CDR 1) AD, together with their caregivers from three Finnish hospital districts. QoL was evaluated using patient self-reported, and caregiver-rated, QoL in AD (QoL-AD) scores. NPS were assessed using the Neuropsychiatric Inventory (NPI), and AD severity was evaluated using the CDR, with cognition tested by the mini-mental state examination. The performance of daily activities was assessed using the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory. RESULTS: Over the 5-year follow-up period, patient self-reported QoL-AD scores did not change significantly (p = 0.245), despite increases in their NPS. However, caregiver-rated patient QoL-AD scores declined significantly (p ≤ 0.001), as total NPI scores increased during follow-up. No NPS at baseline, and only apathy at follow-up, correlated significantly (p = 0.007) with patient self-rated QoL-AD scores. Caregiver-rated patient QoL-AD scores correlated significantly with most NPS, especially (p ≤ 0.001) apathy, agitation, anxiety, irritability, depression, and delusions at baseline, and delusions, hallucinations, apathy, appetite disturbances, and anxiety during follow-up. CONCLUSIONS: Patient rated QoL-AD scores are an unreliable tool with which to evaluate the success of therapy for NPS. Instead, caregiver-rated scores for patients correlated well with NPI scores, and health care professionals in the clinic should preferentially use these. Copyright © 2017 John Wiley & Sons, Ltd.

Use of psychotropic medications in relation to neuropsychiatric symptoms, cognition and functional performance in Alzheimer's disease over a three-year period: Kuopio ALSOVA study.

BACKGROUND: Psychotropic medications are widely prescribed to manage neuropsychiatric symptoms (NPS) of Alzheimer's disease (AD). Our objective was to investigate the longitudinal associations between psychotropic medication use and NPS, cognition, and functional performance in persons with very mild or mild AD at baseline. METHODS: Data were collected as part of the prospective three-year study of home-dwelling persons with AD and their caregivers (n = 236 dyads). The associations between psychotropic medication use and clinical measures were analyzed using repeated measures Generalized Estimating Equation (GEE) models. NPS, cognition, daily functioning, and disease severity were assessed with NPI, CERAD-NB, or MMSE, ADCS-ADL, and CDR-SOB, respectively. All analyses were adjusted for age, gender, education, and co-morbidities. RESULTS: The prevalence of benzodiazepines and related medications increased from 16% to 24% (p = 0.031), antidepressants from 11% to 18% (p = 0.057), and antipsychotics from 4% to 16% (p = 0.011) in the three years following AD diagnosis. In adjusted multivariable analyses, a one-point increase in NPI increased the odds of using any psychotropic medication class by 4% (odds ratio (OR) 1.04, 95% confidence interval (CI) 1.01-1.07). ADCS-ADL (1/OR 1.04, 95% CI 1.02-1.06) and CDR-SOB (OR 1.27, 95% CI 1.13-1.42) were associated with use of antipsychotics. CERAD-NB and MMSE were not associated with any psychotropic medication class use in the models. CONCLUSIONS: Psychotropic medication use increased significantly in relation to increasing dependency in AD, especially with NPS. Furthermore, the use of antipsychotics increased with disease severity, and with decline in daily functioning. Cognitive performance was not associated with psychotropic medication use.

Early psychosocial intervention does not delay institutionalization in persons with mild Alzheimer disease and has impact on neither disease progression nor caregivers' well-being: ALSOVA 3-year follow-up.

OBJECTIVES: Early diagnosis, initiation of Alzheimer's disease (AD) therapy and programs that support care of persons with AD at home are recommended. The objective of this study was to assess the effect of early psychosocial intervention on delaying the institutionalization of persons with AD. We also assessed the influence of intervention on AD progression, behavioral symptoms, and health-related quality of life (HRQoL) in persons with AD and caregivers. METHODS: Kuopio ALSOVA study, a prospective, randomized intervention study with a 3-year follow-up, was carried out at memory clinics. Home-dwelling persons with very mild or mild AD (n = 236) and AD-targeted therapy and their family caregivers (n = 236) were randomized to the intervention or control group (1:2). Psychosocial intervention including education, counseling, and social support was given during the first 2 years (16 days). The primary outcome was the cumulative risk (controlled for death) of institutionalization over 36 months. Secondary outcomes were adjusted mean changes from baseline in disease severity, cognition, daily activities, behavior, and HRQoL for persons with AD; and change in psychological distress, depression, and HRQoL for caregivers. RESULTS: No differences were found in nursing home placement after the 36-month follow-up between intervention and control groups. No beneficial effects of the intervention were found on the secondary outcomes. CONCLUSIONS: The psychosocial intervention did not delay nursing home placement in persons with AD and had no effect on patient well-being, disease progression, or AD-related symptoms or caregiver well-being. Instead of automatically providing psychosocial intervention courses, individualized support programs may be more effective.

Impact of Alzheimer's disease on the family caregiver's long-term quality of life: results from an ALSOVA follow-up study.

PURPOSE: To examine caregivers' health-related quality of life (HRQoL) and well-being during the first 3 years after their family member's Alzheimer's disease (AD) diagnosis and assessed the relationship between caregivers' HRQoL, well-being, and the severity of AD. Further, to compare of caregivers' HRQoL to general population. METHODS: Longitudinal design (36 months) after AD diagnosis of 236 caregiver-patient dyads. Linear regression was used to assess age- and gender-adjusted association between repeated measurements of caregivers' HRQoL and the severity of AD. For comparison with general population, the National Health 2011 Health Examination Survey data was utilized. RESULTS: Caregivers had significantly lower HRQoL than age- and gender-standardized counterparts. Severity of AD was significantly (p < 0.05) associated with the mobility and depression dimensions of caregiver's HRQoL but not with the total HRQoL index score. CONCLUSIONS: Caregivers' HRQoL seems to deteriorate earlier than previously noted. The severity of AD has not that great impact on caregiver's HRQoL as assumed.

Paid expenditures and productivity costs associated with permanent disability pensions in patients with spinal disorders: Nationwide Finnish Register-based Study, 1990-2010.

PURPOSE: The objective of this study is to present the paid expenditures and productivity costs of disability pensions (DP) due to spinal disorders (SD) in Finland during 1990-2010. METHODS: This study is a register-based national study. All new cases aged 20-64 that were granted a DP due to SD were identified from the nationwide register maintained by the Finnish Centre of Pensions. The data included sex, age group, year of the DP decision, main cause of incapacity (diagnosis) leading to permanent DP and yearly paid expenditures for DPs. Annual productivity costs were estimated based on labour force participation rate and the employment rate adjusted gross domestic product. RESULTS: A total of 39,107 individuals (18,072 females, 21,035 males) received DPs during the study period. SDs generated 9,372 million euros extra cost during this period due to DP (females 3.5 billion, males 5.9 billion). The total DP expenditures paid increased during the first half of 1990s but decreased during the second half of 1990s (-44.8 %). For degenerative SD cases, the DP expenditure was 5.1 billion €, disc disease 3.5 billion € and for other SDs 0.7 billion €. Males, compared to females, were expected to have a rate 1.22 times greater costs due to DPs. The estimated total annual productivity costs due to SDs have been over six times higher than expenditures paid for DPs per year. The costs of DPs are different compared to occurrence rates due to salary and early retirement age differences between genders. CONCLUSION: Despite a significant decrease in DP-associated expenditures due to SDs after 1993, the annual expenditures have stayed on a high level in Finland.