Two Days Versus Five Days of Postoperative Antibiotics for Complex Appendicitis: Cost Analysis of a Randomized, Noninferiority Trial.

OBJECTIVE: To compare costs for 2 days versus 5 days of postoperative antibiotics within the antibiotics after an aPPendectomy In Complex appendicitis trial.Background:Recent studies suggest that restrictive antibiotic use leads to a significant reduction in hospital stays without compromising patient safety. Its potential effect on societal costs remains underexplored. METHODS: This was a pragmatic, open-label, multicenter clinical trial powered for noninferiority. Patients with complex appendicitis (age ≥ 8 years) were randomly allocated to 2 days or 5 days of intravenous antibiotics after appendectomy. Patient inclusion lasted from June 2017 to June 2021 in 15 Dutch hospitals. The final follow-up was on September 1, 2021. The primary trial endpoint was a composite endpoint of infectious complications and mortality within 90 days. In the present study, the main outcome measures were overall societal costs (comprising direct health care costs and costs related to productivity loss) and cost-effectiveness. Direct health care costs were recorded based on data in the electronic patient files, complemented by a telephone follow-up at 90 days. In addition, data on loss of productivity were acquired through the validated Productivity Cost Questionnaire at 4 weeks after surgery. Cost estimates were based on prices for the year 2019. RESULTS: In total, 1005 patients were evaluated in the "intention-to-treat" analysis: 502 patients were allocated to the 2-day group and 503 to the 5-day group. The mean difference in overall societal costs was - €625 (95% CI: -€ 958 to -€ 278) to the advantage of the 2-day group. This difference was largely explained by reduced hospital stay. Productivity losses were similar between the study groups. Restricting postoperative antibiotics to 2 days was cost-effective, with estimated cost savings of €31,117 per additional infectious complication. CONCLUSIONS: Two days of postoperative antibiotics for complex appendicitis results in a statistically significant and relevant cost reduction, as compared with 5 days. Findings apply to laparoscopic appendectomy in a well-resourced health care setting.

ACL reconstruction for all is not cost-effective after acute ACL rupture.

OBJECTIVES: To conduct a cost-utility analysis for two commonly used treatment strategies for patients after ACL rupture; early ACL reconstruction (index) versus rehabilitation plus an optional reconstruction in case of persistent instability (comparator). METHODS: Patients aged between 18 and 65 years of age with a recent ACL rupture (<2 months) were randomised between either an early ACL reconstruction (index) or a rehabilitation plus an optional reconstruction in case of persistent instability (comparator) after 3 months of rehabilitation. A cost-utility analysis was performed to compare both treatments over a 2-year follow-up. Cost-effectiveness was calculated as incremental costs per quality-adjusted life year (QALY) gained, using two perspectives: the healthcare system perspective and societal perspective. The uncertainty for costs and health effects was assessed by means of non-parametric bootstrapping. RESULTS: A total of 167 patients were included in the study, of which 85 were randomised to the early ACL reconstruction (index) group and 82 to the rehabilitation and optional reconstruction group (comparator). From the healthcare perspective it takes 48 460 € and from a societal perspective 78 179 €, to gain a QALY when performing early surgery compared with rehabilitation plus an optional reconstruction. This is unlikely to be cost-effective. CONCLUSION: Routine early ACL reconstruction (index) is not considered cost-effective as compared with rehabilitation plus optional reconstruction for a standard ACL population (comparator) given the maximum willingness to pay of 20 000 €/QALY. Early recognition of the patients that have better outcome of early ACL reconstruction might make rehabilitation and optional reconstruction even more cost-effective.

Socioeconomic differences in healthcare expenditure and utilization in The Netherlands.

BACKGROUND: Worldwide, socioeconomic differences in health and use of healthcare resources have been reported, even in countries providing universal healthcare coverage. However, it is unclear how large these socioeconomic differences are for different types of care and to what extent health status plays a role. Therefore, our aim was to examine to what extent healthcare expenditure and utilization differ according to educational level and income, and whether these differences can be explained by health inequalities. METHODS: Data from 18,936 participants aged 25-79 years of the Dutch Health Interview Survey were linked at the individual level to nationwide claims data that included healthcare expenditure covered in 2017. For healthcare utilization, participants reported use of different types of healthcare in the past 12 months. The association of education/income with healthcare expenditure/utilization was studied separately for different types of healthcare such as GP and hospital care. Subsequently, analyses were adjusted for general health, physical limitations, and mental health. RESULTS: For most types of healthcare, participants with lower educational and income levels had higher healthcare expenditure and used more healthcare compared to participants with the highest educational and income levels. Total healthcare expenditure was approximately between 50 and 150 % higher (depending on age group) among people in the lowest educational and income levels. These differences generally disappeared or decreased after including health covariates in the analyses. After adjustment for health, socioeconomic differences in total healthcare expenditure were reduced by 74-91 %. CONCLUSIONS: In this study among Dutch adults, lower socioeconomic status was associated with increased healthcare expenditure and utilization. These socioeconomic differences largely disappeared after taking into account health status, which implies that, within the universal Dutch healthcare system, resources are being spent where they are most needed. Improving health among lower socioeconomic groups may contribute to decreasing health inequalities and healthcare spending.

Health expenditure of employees versus self-employed individuals; a 5 year study.

It is unclear to what extent self-employed choose to become self-employed. This study aimed to compare the health care expenditures-as a proxy for health-of self-employed individuals in the year before they started their business, to that of employees. Differences by sex, age, and industry were studied. In total, 5,741,457 individuals aged 25-65 years who were listed in the tax data between 2010 and 2015 with data on their health insurance claims were included. Self-employed and employees were stratified according to sex, age, household position, personal income, region, and industry for each of the years covered. Weighted linear regression was used to compare health care expenditures in the preceding (year x-1) between self-employed and employees (in year x). Compared with employees, expenditures for hospital care, pharmaceutical care and mental health care were lower among self-employed in the year before they started their business. Differences were most pronounced for men, individuals ≥40 years and those working in the industry and energy sector, construction, financial institutions, and government and care. We conclude that healthy individuals are overrepresented among the self-employed, which is more pronounced in certain subgroups. Further qualitative research is needed to investigate the reasons why these subgroups are more likely to choose to become self-employed.

Single transitions and persistence of unemployment are associated with poor health outcomes.

BACKGROUND: Although job loss has been associated with decline in health, the effect of long term unemployment is less clear and under-researched. Furthermore, the impact of an economic recession on this relationship is unclear. We investigated the associations of single transitions and persistence of unemployment with health. We subsequently examined whether these associations are affected by the latest recession, which began in 2008. METHODS: In total, 57,911 participants from the Dutch Health Interview Survey who belonged to the labour force between 2004 and 2014 were included. Based on longitudinal tax registration data, single employment transitions between time point 1 (t1) and time point 2 (t2) and persistent unemployment (i.e. number of years individuals were unemployed) between t1 and time point 5 (t5) were defined. General and mental health, smoking and obesity were assessed at respectively time point 3 (t3) and time point 6 (t6). Logistic regression models were performed and interactions with recession indicators (year, annual gross domestic product estimates and regional unemployment rates) were tested. RESULTS: Compared with individuals who stayed employed at t1 and t2, the likelihood of poor mental health at the subsequent year was significantly higher in those who became unemployed at t2. Persistent unemployment was associated with poor mental health, especially for those who were persistently unemployed for 5 years. Similar patterns, although less pronounced for smoking, were found for general health and obesity. Indicators of the economic recession did not modify these associations. CONCLUSIONS: Single transitions into unemployment and persistent unemployment are associated with poor mental and general health, obesity, and to a lesser extend smoking. Our study suggests that re-employment might be an important strategy to improve health of unemployed individuals. The relatively extensive Dutch social security system may explain that the economic recession did not modify these associations.

A cost-effectiveness study of ICT training among the visually impaired in the Netherlands.

BACKGROUND: Due to the ageing population, the number of visually impaired people in the Netherlands will increase. To ensure the future availability of services in rehabilitative eye care, we aim to assess the cost-effectiveness of information and communication technology (ICT) training among visually impaired adults from a societal perspective, using primary data from two large rehabilitative eye care providers in the Netherlands. METHODS: Participants were asked to fill in a questionnaire, which used six different instruments at three different time points: pre training, post training and three months post training. We investigated whether the participants' quality of life and well-being improved after the training and whether this improvement persisted three months post training. Economic evaluation was conducted by comparing costs and outcomes before and after training. Quality of life and well-being were derived from the EQ-5D and ICECAP-O, respectively. Costs for productivity losses and medical consumption were obtained from the questionnaires. Information regarding the costs of training sessions was provided by the providers. RESULTS: Thirty-eight participants filled in all three questionnaires. The mean age at baseline was 63 years (SD = 16). The effect of ICT training on ICT skills and participants' well-being was positive and persisted three months after the last training session. Assuming these effects remain constant for 10 years, this would result in an incremental cost-effectiveness ratio (ICER) of € 11,000 per quality-adjusted life-year (QALY) and € 8000 per year of well-being gained, when only the costs of ICT training are considered. When the total costs of medical consumption are included, the ICER increases to € 17,000 per QALY gained and € 12,000 per year of well-being gained. Furthermore, when the willingness-to-pay threshold is € 20,000 per year of well-being, the probability that ICT training will be cost-effective is 75% (91% when including only the costs of ICT training). CONCLUSION: Our study suggests that ICT training among the visually impaired is cost-effective when the effects of ICT training on well-being persist for several years. However, further research involving a larger sample and incorporating long-term effects should be conducted.

The iMTA Productivity Cost Questionnaire: A Standardized Instrument for Measuring and Valuing Health-Related Productivity Losses.

BACKGROUND: Productivity losses often contribute significantly to the total costs in economic evaluations adopting a societal perspective. Currently, no consensus exists on the measurement and valuation of productivity losses. OBJECTIVE: We aimed to develop a standardized instrument for measuring and valuing productivity losses. METHODS: A group of researchers with extensive experience in measuring and valuing productivity losses designed an instrument suitable for self-completion, building on preknowledge and evidence on validity. The instrument was designed to cover all domains of productivity losses, thus allowing quantification and valuation of all productivity losses. A feasibility study was performed to check the questionnaire's consistency and intelligibility. RESULTS: The iMTA Productivity Cost Questionnaire (iPCQ) includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work. Questions for measuring absenteeism and presenteeism were derived from existing validated questionnaires. Because validated measures of losses of unpaid work are scarce, the questions of this module were newly developed. To enhance the instrument's feasibility, simple language was used. The feasibility study included 195 respondents (response rate 80%) older than 18 years. Seven percent (n = 13) identified problems while filling in the iPCQ, including problems with the questionnaire's instructions and routing (n = 6) and wording (n = 2). Five respondents experienced difficulties in estimating the time that would be needed for other people to make up for lost unpaid work. CONCLUSIONS: Most modules of the iPCQ are based on validated questions derived from previously available instruments. The instrument is understandable for most of the general public.

Explaining declining rates of institutional LTC use in the Netherlands: a decomposition approach.

The use of long-term care (LTC) is changing rapidly. In the Netherlands, rates of institutional LTC use are falling, whereas homecare use is growing. Are these changes attributable to declining disability rates, or has LTC use given disability changed? And have institutionalization rates fallen regardless of disability level, or has LTC use become better tailored to needs? We answer these questions by explaining trends in LTC use for the Dutch 65+ population in the period 2000-2008 using a nonlinear variant of the Oaxaca-Blinder decomposition. We find that changes in LTC use are not due to shifts in the disability distribution but can almost entirely be traced back to changes in the way the system treats disability. Elderly with mild disability are more likely to be treated at home than before, whereas severely disabled individuals continue to receive institutional LTC. As a result, LTC use has become better tailored to the needs for such care. This finding suggests that policies that promote LTC in the community rather than in institutions can effectively mitigate the consequences of population aging on LTC spending.

Assessing the Carbon Footprint of Telemedicine: A Systematic Review.

Background: Healthcare is responsible for 4% to 10% of carbon emissions worldwide, of which 22% is related to transport. Telemedicine emerged as a potential solution to reduce the footprint, for example, by reducing travel. However, a need to understand which variables to include in carbon footprint estimations in telemedicine limits our understanding of the beneficial impact telemedicine might have on our environment. This paper aims to systematically assess the reported carbon footprint and include variables assessed by the literature, comparing telemedicine with usual care. Methods: The systematic review followed the PRISMA guidelines in PubMed, Medline, Embase and Scopus. A quality assessment was performed using a transparency checklist for carbon footprint calculators. Carbon emissions were evaluated based on four categories, including patient travel, and streamlined life cycle assessment (LCA) for assessing included variables relevant to telemedicine. Results: We included 33 articles from 1117 records for analysis. The average transparency score was 38% (range 18%-68%). The median roundtrip travel distance for each patient was 131 km (interquartile range [IQR]: 60.8-351), or 25.6 kgCO2 (IQR: 10.6-105.6) emissions. There is high variance among included variables. Saved emissions are structurally underestimated by not including external factors such as a streamlined LCA. Conclusions: Telemedicine aids in reducing emissions, with travel distance being the most significant contributor. Additionally, we recommend accounting for the LCA since it highlights important nuances. This review furthers the debate on assessing carbon footprint savings due to telemedicine.

Health economic evaluation of a nurse-assisted online eye screening in home healthcare to reduce avoidable vision impairment (iScreen): study protocol for a cluster randomized controlled trial.

BACKGROUND: Among older people undiagnosed and untreated vision impairment and blindness are common. The leading causes are uncorrected refractive errors and cataracts. Vision problems are associated with a lower quality of life, several health problems, and a higher chance of falling accidents and fractures. To eliminate avoidable vision impairment and blindness, targeted eye screening programs are recommended. Older patients, receiving home healthcare, have not yet been considered as a population at risk who could benefit from eye screening. METHODS: A cluster-randomized controlled trial will be conducted to investigate the cost-effectiveness and cost-utility of online nurse-assisted eye screening in home healthcare, compared to care as usual, in reducing avoidable vision impairment. A healthcare and societal perspective will be used. The study will be performed in collaboration with several home healthcare organizations in the Netherlands. The online eye screening consists of near and distance visual acuity, followed by an Amsler grading test. Measurements in both groups will take place at baseline and after 6 and 12 months of follow-up. A total of 240 participants will be recruited. Older men and women (65 +), who receive home-based nursing and are cognitively able to participate, will be included. The primary outcome will be the change of two lines or more on the Colenbrander-1 M visual acuity chart between baseline and 12-month follow-up. DISCUSSION: An eye screening for populations at risk contributes to the detection of undiagnosed and untreated vision impairment. This may reduce the health-related consequences of vision loss and the high economic burden associated with vision impairment. TRIAL REGISTRATION: ClinicalTrials.gov NCT06058637. Registered on 27 September 2023.

A validation of the ICECAP-O in a population of post-hospitalized older people in the Netherlands.

BACKGROUND: Various healthcare and social services may impact not only health, but wellbeing as well. Such effects may be more fully captured by capability-wellbeing instruments than with Health-related Quality of Life (HrQol) instruments. The aim of this study is to validate the ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) capability wellbeing instrument in a population of post-hospitalized older people admitted to a hospital 3 months earlier. METHODS: 296 post-hospitalized older people in the Netherlands were interviewed 3 months after admission between September 2010 and January 2011. We investigated the convergent validity of the ICECAP-O and overall wellbeing measures (Cantril's ladder and Social Production Function: Instrument for Level of Well-being (SPF-IL)), as well as with various health measures (EQ5D, Katz-15 Instrumental Activities of Daily Living (IADL) scale, Geriatric Depression Scale (GDS) and the Medical Outcomes Study Short form (SF-20) social functioning dimension). Additionally, we assessed discriminant validity by comparing several relevant subgroups in our sample (based on age, depression, IADL dependency, living situation, etc.). We also investigated the relationship between overall wellbeing and the ICECAP-O, controlling for HrQol and background characteristics. RESULTS: This study suggests that the ICECAP-O has good convergent validity with wellbeing measures as well as health measures and discriminates between various groups of post-hospitalized older people. Wellbeing measured by both Cantril's ladder and SPF-IL is associated with the ICECAP-O in a multivariate analysis controlling for HRQoL as well. CONCLUSION: The ICECAP-O seems to be a valid instrument of capability-wellbeing in older, post-hospitalized people, showing good convergent validity with health and wellbeing instruments, and is able to discriminate between elderly with various health profiles. The ICECAP-O measure seems to capture both health and wellbeing. Therefore it is a promising instrument for assessing the outcomes of health and social services aimed at older people.

Cost-effectiveness of arthroscopic partial meniscectomy versus physical therapy for traumatic meniscal tears in patients aged under 45 years.

Aims: The aim of this study was to evaluate the cost-effectiveness of arthroscopic partial meniscectomy versus physical therapy plus optional delayed arthroscopic partial meniscectomy in young patients aged under 45 years with traumatic meniscal tears. Methods: We conducted a multicentre, open-labelled, randomized controlled trial in patients aged 18 to 45 years, with a recent onset, traumatic, MRI-verified, isolated meniscal tear without knee osteoarthritis. Patients were randomized to arthroscopic partial meniscectomy or standardized physical therapy with an optional delayed arthroscopic partial meniscectomy after three months of follow-up. We performed a cost-utility analysis on the randomization groups to compare both treatments over a 24-month follow-up period. Cost utility was calculated as incremental costs per quality-adjusted life year (QALY) gained of arthroscopic partial meniscectomy compared to physical therapy. Calculations were performed from a healthcare system perspective and a societal perspective. Results: A total of 100 patients were included: 49 were randomized to arthroscopic partial meniscectomy and 51 to physical therapy. In the physical therapy group, 21 patients (41%) received delayed arthroscopic partial meniscectomy during follow-up. Over 24 months, patients in the arthroscopic partial meniscectomy group had a mean 0.005 QALYs lower quality of life (95% confidence interval -0.13 to 0.14). The cost-utility ratio was €-160,000/QALY from the healthcare perspective and €-223,372/QALY from the societal perspective, indicating that arthroscopic partial meniscectomy incurs additional costs without any added health benefit. Conclusion: Arthroscopic partial meniscectomy is arthroscopic partial meniscectomy is unlikely to be cost-effective in treating young patients with isolated traumatic meniscal tears compared to physical therapy as a primary health intervention. Arthroscopic partial meniscectomy leads to a similar quality of life, but higher costs, compared to physical therapy plus optional delayed arthroscopic partial meniscectomy.

Effects of the DICE Method to Improve Timely Recognition and Treatment of Neuropsychiatric Symptoms in Early Alzheimer's Disease at the Memory Clinic: The BEAT-IT Study.

BACKGROUND: Neuropsychiatric symptoms (NPS) are highly prevalent in Alzheimer's disease (AD) and are associated with negative outcomes. However, NPS are currently underrecognized at the memory clinic and non-pharmacological interventions are scarcely implemented. OBJECTIVE: To evaluate the effectiveness of the Describe, Investigate, Create, Evaluate (DICE) method™ to improve the care for NPS in AD at the memory clinic. METHODS: We enrolled sixty community-dwelling people with mild cognitive impairment or AD dementia and NPS across six Dutch memory clinics with their caregivers. The first wave underwent care as usual (n = 36) and the second wave underwent the DICE method (n = 24). Outcomes were quality of life (QoL), caregiver burden, NPS severity, NPS-related distress, competence managing NPS, and psychotropic drug use. Reliable change index was calculated to identify responders to the intervention. A cost-effectiveness analysis was performed and semi-structured interviews with a subsample of the intervention group (n = 12). RESULTS: The DICE method did not improve any outcomes over time compared to care as usual. Half of the participants of the intervention group (52%) were identified as responders and showed more NPS and NPS-related distress at baseline compared to non-responders. Interviews revealed substantial heterogeneity among participants regarding NPS-related distress, caregiver burden, and availability of social support. The intervention did not lead to significant gains in quality-adjusted life years and well-being years nor clear savings in health care and societal costs. CONCLUSION: The DICE method showed no benefits at group-level, but individuals with high levels of NPS and NPS-related distress may benefit from this intervention.

Forecasting lifetime and aggregate long-term care spending: accounting for changing disability patterns.

OBJECTIVE: The impact population aging exerts on future levels of long-term care (LTC) spending is an urgent topic in which few studies have accounted for disability trends. We forecast individual lifetime and population aggregate annual LTC spending for the Dutch 55+ population to 2030 accounting for changing disability patterns. METHODS: Three levels of (dis)ability were distinguished: none, mild, and severe. Two-part models were used to estimate LTC spending as a function of age, sex, and disability status. A multistate life table model was used to forecast age-specific prevalence of disability and life expectancy (LE) in each disability state. Finally, 2-part model estimates and multistate projections were combined to obtain forecasts of LTC expenditures. RESULTS: LE is expected to increase, whereas life years in severe disability remain constant, resulting in a relative compression of severe disability. Mild disability life years increase, especially for women. Lifetime homecare spending--mainly determined by mild disability--increases, whereas institutional spending remains fairly constant due to stable LE with severe disability. Lifetime LTC expenditures, largely determined by institutional spending, are thus hardly influenced by increasing LE. Aggregate spending for the 55+ population is expected to rise by 56.0% in the period of 2007-2030. CONCLUSIONS: Longevity gains accompanied by a compression of severe disability will not seriously increase lifetime spending. The growth of the elderly cohort, however, will considerably increase aggregate spending. Stimulating a compression of disability is among the main solutions to alleviate the consequences of longevity gains and population aging to growth of LTC spending.

Capabilities and quality of life in Dutch psycho-geriatric nursing homes: an exploratory study using a proxy version of the ICECAP-O.

PURPOSE: To validate the ICECAP-O capability measure in psycho-geriatric elderly in nursing homes, we compared the capability scores of restrained and unrestrained clients. Both nursing staff and family were used as proxies for assessing clients' capabilities. METHOD: For 122 psycho-geriatric elderly, a total of 96 nursing professionals and 68 family members completed a proxy questionnaire. We investigated the convergent and discriminant validity of the ICECAP-O and measures of care dependency, health-related quality of life, and overall quality of life. We also directly compared ICECAP-O scores of the 56 clients for whom both nursing staff and family members had completed the questionnaire. RESULTS: Convergent validity between ICECAP-O and care dependency, health-related, and overall quality of life measures could be established, as well as discriminant validity for the restrained and unrestrained groups. Nursing and family proxy ICECAP-O tariffs were not significantly correlated. DISCUSSION: ICECAP-O measures a more general concept than health-related quality of life and can differentiate between restrained and non-restrained psycho-geriatric clients. Since nurses seem to be able to assess the current quality of life of clients using the ICECAP-O more precisely than the family proxies, for now the use of nursing proxies is recommended in a nursing home setting.

Similarities and differences between five European drug reimbursement systems.

OBJECTIVES: The aim of our study is to compare five European drug reimbursement systems, describe similarities and differences, and obtain insight into their strengths and weaknesses and formulate policy recommendations. METHODS: We used the analytical Hutton Framework to assess in detail drug reimbursement systems in Austria, Belgium, France, the Netherlands, and Sweden. We investigated policy documents, explored literature, and conducted fifty-seven interviews with relevant stakeholders. RESULTS: All systems aim to balance three main objectives: system sustainability, equity and quality of care. System impact, however, is mainly assessed by drug expenditure. A national reimbursement agency evaluates reimbursement requests on a case-by-case basis. The minister has discretionary power to alter the reimbursement advice in Belgium, France, and the Netherlands. All systems make efforts to increase transparency in the decision-making process but none uses formal hierarchical reimbursement criteria nor applies a cost-effectiveness threshold value. Policies to deal with uncertainty vary: financial risk-sharing by price/volume contracts (France, Belgium) versus coverage with evidence development (Sweden, the Netherlands). Although case-by-case revisions are embedded in some systems for specific groups of drugs, systematic (group) revisions are limited. CONCLUSIONS: As shared strengths, all systems have clear objectives reflected in reimbursement criteria and all are prepared to pay for drugs with sufficient added value. However, all systems could improve the transparency of the decision-making process; especially appraisal lacks transparency. Systems could increase the use of (systematic) revisions and could make better use of HTA (among others cost-effectiveness) to obtain value for money and ensure system sustainability.

European drug reimbursement systems' legitimacy: five-country comparison and policy tool.

OBJECTIVES. In a democratic system, decision makers are accountable for the reasonableness of their decisions. This presumes (i) transparency, (ii) relevance of the decision criteria, (iii) revisability of decisions, and (iv) enforcement/regulation. We aim to (i) evaluate the extent to which drug reimbursement decision-making processes in different contexts meet these conditions and (ii) develop, starting from these findings, a framework for improving the transparency and the relevance of used decision criteria. METHODS. We evaluated the Austrian, Belgian, French, Dutch, and Swedish drug reimbursement systems. Based on this evaluation, we developed a framework for improving the transparency of drug reimbursement decision-making processes. It makes explicit the questions often addressed implicitly during decision-making processes as well as criteria for answering each question. RESULTS. Transparency of appraisal processes varies across systems. Justification with explicit criteria is generally limited. Although relevant criteria are similar across systems, their operationalization varies and their role in the appraisal process is not always clear. All systems seem to implicitly address five key questions, relating to (i) the medical, therapeutic, and societal need for treatment; (ii) preparedness to pay for treating the condition as a principle and (iii) for using the treatment under consideration; (iv) preparedness to pay more compared with alternatives; and (v) actual willingness to pay from public resources. CONCLUSIONS. Transparency of the appraisal process can be improved by using an explicit decision framework. Systematic use of such a framework enhances consistency across decisions, allows justification of value judgments, and thus enhances legitimacy of societal decision making.

No Added Value of Duloxetine in Patients With Chronic Pain due to Hip or Knee Osteoarthritis: A Cluster-Randomized Trial.

OBJECTIVE: To assess the effectiveness of duloxetine in addition to usual care in patients with chronic osteoarthritis (OA) pain. The cost-effectiveness and whether the presence of symptoms of centralized pain alters the response to duloxetine were secondary objectives. METHODS: We conducted an open-label, cluster-randomized trial. Patients with chronic hip or knee OA pain who had an insufficient response to acetaminophen and nonsteroidal antiinflammatory drugs were included. Randomization took place at the general practice level, and patients received duloxetine (60 mg/day) in addition to usual care or usual care alone. The presence of centralized pain was defined as a modified PainDETECT Questionnaire score >12. The primary outcome measure was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores (scale 0-20) at 3 months after the initiation of treatment. Our aim was to detect a difference between the groups of a clinically relevant effect of 1.9 points (effect size 0.4). We used a linear mixed model with repeated measurements to analyze the data. RESULTS: In total, 133 patients were included, and 132 patients were randomized into treatment groups. A total of 66 patients (at 31 practices) were randomized to receive duloxetine in addition to usual care, and 66 patients (at 35 practices) were randomized to receive usual care alone. We found no differences in WOMAC pain scores between the groups at 3 months (adjusted difference -0.58 [95% confidence interval (95% CI) -1.80, 0.63]) or at 12 months (adjusted difference -0.26 [95% CI -1.86, 1.34]). In the subgroup of patients with centralized pain symptoms, we also found no effect of duloxetine compared to usual care alone (adjusted difference -0.32 [95% CI -2.32, 1.67]). CONCLUSION: We found no effect of duloxetine added to usual care compared to usual care alone in patients with chronic knee or hip OA pain. Another trial including patients with centralized pain symptoms should be conducted to validate our results.

The importance of job control for workers with decreased work ability to remain productive at work.

PURPOSE: Workers with decreased work ability are at greater risk of reduced productivity at work. We hypothesized that work-related characteristics play an important role in supporting workers to remain productive despite decreased work ability. METHODS: The study population consisted of 10,542 workers in 49 different companies in the Netherlands in 2005-2009. Productivity loss at work was defined on a 10-point scale by asking how much work was actually performed during regular hours on the last regular workday when compared with normal. Independent variables in the logistic regression analysis were individual characteristics, work-related factors, and the work ability index. Additive interactions between work-related factors and decreased work ability were evaluated by the relative excess risk due to interaction (RERI). RESULTS: The odds ratios and 95% confidence intervals (CI) for the likelihood of productivity loss at work were 2.03 (1.85-2.22), 3.50 (3.10-3.95), and 5.54 (4.37-7.03) for a good, moderate, and poor work ability, compared with an excellent work ability (reference group). Productivity loss at work was associated with lack of job control, poor skill discretion, and high work demands. There was a significant interaction between decreased work ability and lack of job control (RERI = 0.63 95% CI 0.11-1.16) with productivity loss at work. CONCLUSION: The negative effects on work performance of decreased work ability may be partly counterbalanced by increased job control. This suggests that interventions among workers with (chronic) disease that cause a decreased work ability should include enlargement of possibilities to plan and pace their own activities at work.

Cost-effectiveness of exercise therapy versus general practitioner care for osteoarthritis of the hip: design of a randomised clinical trial.

BACKGROUND: Osteoarthritis (OA) is the most common joint disease, causing pain and functional impairments. According to international guidelines, exercise therapy has a short-term effect in reducing pain/functional impairments in knee OA and is therefore also generally recommended for hip OA. Because of its high prevalence and clinical implications, OA is associated with considerable (healthcare) costs. However, studies evaluating cost-effectiveness of common exercise therapy in hip OA are lacking. Therefore, this randomised controlled trial is designed to investigate the cost-effectiveness of exercise therapy in conjunction with the general practitioner's (GP) care, compared to GP care alone, for patients with hip OA. METHODS/DESIGN: Patients aged ≥ 45 years with OA of the hip, who consulted the GP during the past year for hip complaints and who comply with the American College of Rheumatology criteria, are included. Patients are randomly assigned to either exercise therapy in addition to GP care, or to GP care alone. Exercise therapy consists of (maximally) 12 treatment sessions with a physiotherapist, and home exercises. These are followed by three additional treatment sessions in the 5th, 7th and 9th month after the first treatment session. GP care consists of usual care for hip OA, such as general advice or prescribing pain medication. Primary outcomes are hip pain and hip-related activity limitations (measured with the Hip disability Osteoarthritis Outcome Score [HOOS]), direct costs, and productivity costs (measured with the PROductivity and DISease Questionnaire). These parameters are measured at baseline, at 6 weeks, and at 3, 6, 9 and 12 months follow-up. To detect a 25% clinical difference in the HOOS pain score, with a power of 80% and an alpha 5%, 210 patients are required. Data are analysed according to the intention-to-treat principle. Effectiveness is evaluated using linear regression models with repeated measurements. An incremental cost-effectiveness analysis and an incremental cost-utility analysis will also be performed. DISCUSSION: The results of this trial will provide insight into the cost-effectiveness of adding exercise therapy to GPs' care in the treatment of OA of the hip. This trial is registered in the Dutch trial registry http://www.trialregister.nl: trial number NTR1462.