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Aims Patients with suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS) are routinely transferred to the emergency department (ED). A clinical risk score with point-of-care (POC) troponin measurement might enable ambulance paramedics to identify low-risk patients in whom ED evaluation is unnecessary. The aim was to assess safety and healthcare costs of a pre-hospital rule-out strategy using a POC troponin measurement in low-risk suspected NSTE-ACS patients. Methods and results This investigator-initiated, randomized clinical trial was conducted in five ambulance regions in the Netherlands. Suspected NSTE-ACS patients with HEAR (History, ECG, Age, Risk factors) score ≤3 were randomized to pre-hospital rule-out with POC troponin measurement or direct transfer to the ED. The sample size calculation was based on the primary outcome of 30-day healthcare costs. Secondary outcome was safety, defined as 30-day major adverse cardiac events (MACE), consisting of ACS, unplanned revascularization or all-cause death. : A total of 863 participants were randomized. Healthcare costs were significantly lower in the pre-hospital strategy (€1349 ± €2051 vs. €1960 ± €1808) with a mean difference of €611 [95% confidence interval (CI): 353–869; P < 0.001]. In the total population, MACE were comparable between groups [3.9% (17/434) in pre-hospital strategy vs. 3.7% (16/429) in ED strategy; P = 0.89]. In the ruled-out ACS population, MACE were very low [0.5% (2/419) vs. 1.0% (4/417)], with a risk difference of −0.5% (95% CI −1.6%–0.7%; P = 0.41) in favour of the pre-hospital strategy. Conclusion Pre-hospital rule-out of ACS with a POC troponin measurement in low-risk patients significantly reduces healthcare costs while incidence of MACE was low in both strategies. Trial registration Clinicaltrials.gov identifier NCT05466591 and International Clinical Trials Registry Platform id NTR 7346. [ABSTRACT FROM AUTHOR]

Objective The purpose of this study was to assess whether the superior cost-effectiveness of a personalized physical therapy approach (Coach2Move)—which was demonstrated in a previous trial compared with usual care physical therapy (UCP)—can be replicated in daily clinical practice. Methods A multicenter, cluster-randomized, stepped wedge trial with 4 clusters consisting of 4 physical therapist practices in the Netherlands was used to compare a personalized physical therapy approach to elicit physical activity (Coach2Move) versus care as usual. Multilevel analyses for effectiveness were conducted for the amount of physical activity (Longitudinal Aging Study Amsterdam Physical Activity Questionnaire) and functional mobility (Timed "Up & Go" Test) at 3, 6 (primary outcome), and 12 months' follow-up. Secondary outcomes were level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient-Specific Complaints Questionnaires), quality of life (Euro Quality of Life-5 Dimensions-5 Levels [EQ-5D-5L]), and health care expenditures. Results The 292 community-dwelling older adults with mobility problems visiting physical therapists were included in either the Coach2Move (n = 112; mean [SD] age = 82 [5] years; 60% female) or UCP (n = 180; mean [SD] age = 81 (6) years; 62% female) section of the trial. At baseline, Coach2Move participants were less physically active compared with UCP participants (mean difference = −198; 95% CI = −90 to −306 active minutes). At 6 months, between-group mean differences [95% CI] favored Coach2Move participants on physical activity levels (297 [83 to 512] active minutes), functional mobility (−14.2 [−21 to −8]) seconds), and frailty levels (−5 [−8 to −1] points). At 12 months, the physical activity levels of Coach2Move participants further increased, and frailty levels and secondary outcomes remained stable, whereas outcomes of UCP participants decreased. After the Coach2Move implementation strategy, physical therapists utilized significantly fewer treatment sessions compared with before the implementation (15 vs 22). Anticipated cost savings were not observed. Conclusion This study replicated the results of an earlier trial and shows that Coach2Move leads to better mid- and long-term outcomes (physical activity, functional mobility, level of frailty) in fewer therapy sessions compared with UCP. Based on these and earlier findings, the implementation of Coach2Move in physical therapist practice is recommended. Impact This article describes the implementation of the Coach2Move approach, a treatment strategy that has proven to be cost-effective in a previously conducted randomized controlled trial. Implementation of Coach2Move in a real-life setting allowed an evaluation of the effects in a clinically relevant population. Coach2Move has been shown to increase physical activity, improve functional mobility, and reduce frailty more effectively compared with UCP therapy and therefore has application for physical therapists working with older adults in daily clinical practice. Lay summary Coach2Move is a new physical therapy approach for older adults. Implementation of Coach2Move in daily clinical practice can help people better outcomes over a longer period of time against similar costs compared with regular physical therapy. [ABSTRACT FROM AUTHOR]

To evaluate whether the costs of a successful tailored multifaceted strategy to improve hand hygiene compliance outweighed the savings by reducing infection costs in Dutch long-term care facilities (LTCFs). A retrospective cost analysis alongside a stepped-wedge cluster-randomized controlled trial. The study included 14 LTCFs (23 wards) in the Netherlands. The cost analysis was based on the costs of the intervention vs the savings from avoided infections and associated treatment costs. Infection-related costs of the "usual-care" period were compared with the combined infection-related costs and intervention costs from the "intervention" period and the costs in the "post-intervention period." Multilevel analyses, with a linear model with periods as fixed effects, random effects for cluster LTCFs, and fixed effects for each step, were completed. There are no significant differences in total costs considering the 3 periods. When adjusting for time and clustering, the mean infection-related costs per week per LTCF for all the infections combined were highest during "usual-care" before the hand hygiene intervention was performed, namely 680 euros per week. Assuming the effect of the improvement strategy would be present for 12 months, the costs per week in the "intervention" and "post-intervention" periods were 627 euros (95% CI, 383–871) and 731 euros (95% CI, 508–954), respectively. Assuming the effect of the improvement strategy will last longer than 1 year (ie, 18 and 24 months), the average cost for the "intervention period" and the "post-intervention" period decreased to 615 euros and 719 euros during the intervention and 609 euros and 715 euros after the intervention, respectively. Our multifaceted hand hygiene improvement strategy achieves cost savings. The results of our study are the first of an economic analysis of a hand hygiene improvement strategy in LTCFs. The results need to be confirmed by further economic evaluations. [ABSTRACT FROM AUTHOR]

PURPOSE: A large number of targeted treatment options for stage IV nonsquamous non–small-cell lung cancer with specific genetic aberrations in tumor DNA is available. It is therefore important to optimize diagnostic testing strategies, such that patients receive adequate personalized treatment that improves survival and quality of life. The aim of this study is to assess the efficacy (including diagnostic costs, turnaround time (TAT), unsuccessful tests, percentages of correct findings, therapeutic costs, and therapeutic effectiveness) of parallel next generation sequencing (NGS)–based versus sequential single-gene–based testing strategies routinely used in patients with metastasized non–small-cell lung cancer in the Netherlands. METHODS: A diagnostic microsimulation model was developed to simulate 100,000 patients with prevalence of genetic aberrations, extracted from real-world data from the Dutch Pathology Registry. These simulated patients were modeled to undergo different testing strategies composed of multiple tests with different test characteristics including single-gene and panel tests, test accuracy, the probability of an unsuccessful test, and TAT. Diagnostic outcomes were linked to a previously developed treatment model, to predict average long-term survival, quality-adjusted life-years (QALYs), costs, and cost-effectiveness of parallel versus sequential testing. RESULTS: NGS-based parallel testing for all actionable genetic aberrations is on average €266 cheaper than single-gene–based sequential testing, and detects additional relevant targetable genetic aberrations in 20.5% of the cases, given a TAT of maximally 2 weeks. Therapeutic costs increased by €8,358, and 0.12 QALYs were gained, leading to an incremental cost-effectiveness ratio of €69,614/QALY for parallel versus sequential testing. CONCLUSION: NGS-based parallel testing is diagnostically superior over single-gene–based sequential testing, as it is cheaper and more effective than sequential testing. Parallel testing remains cost-effective with an incremental cost-effectiveness ratio of 69,614 €/QALY upon inclusion of therapeutic costs and long-term outcomes. [ABSTRACT FROM AUTHOR]

Background: In case of early pregnancy loss (EPL) women can either choose for expectant, medical or surgical management. One week of expectant management is known to lead to spontaneous abortion in approximately 50% of women. Medical treatment with misoprostol is known to be safe and less costly than surgical management, however less effective in reaching complete evacuation of the uterus. Recently, a number of trials showed that prompt treatment with the sequential combination of mifepristone with misoprostol is superior to misoprostol alone in reaching complete evacuation. In this analysis we evaluate whether the sequential combination of mifepristone with misoprostol is cost-effective compared to misoprostol alone, in the treatment of EPL. Methods and findings: A cost-effectiveness analysis (CEA) from a healthcare perspective was performed alongside a randomised controlled trial (RCT) in which standard treatment with misoprostol only was compared with a combination of mifepristone and misoprostol, in women with EPL after a minimum of one week of unsuccessful management. A limited societal perspective scenario was added. This RCT, the Triple M trial, was a multicentre, randomized, double-blinded, placebo-controlled trial executed at 17 hospitals in the Netherlands. The trial started on June 27th 2018, and ended prematurely in January 2020 due to highly significant outcomes from the predefined interim-analysis. We included 351 women with a diagnosis of EPL between 6 and 14 weeks gestation after at least one week of unsuccessful expectant management. They were randomized between double blinded pre-treatment with oral mifepristone 600mg (N = 175) or placebo (N = 176) taken on day one, both followed by misoprostol orally. In both groups, an intention-to-treat analysis was performed for 172 patients, showing a significant difference in success rates between participants treated with mifepristone and misoprostol versus those treated with misoprostol alone (79.1% vs 58.7% respectively). In this cost-effective analysis we measured the direct, medical costs related to treatment (planned and unplanned hospital visits, medication, additional treatment) and indirect costs based on the IMTA Productivity Cost Questionnaire (iPCQ). Quality Adjusted Life Years (QALY's) were calculated from participants' scores on the SF-36 questionnaires sent digitally at treatment start, and one, two and six weeks later. We found medical treatment with placebo followed by misoprostol to be 26% more expensive compared to mifepristone followed by misoprostol (p = 0.001). Mean average medical costs per patient were significantly lower in the mifepristone group compared to the placebo group (€528.95 ± 328.93 vs €663.77 ± 456.03, respectively; absolute difference €134.82, 95% CI 50,46–219,18, p = 0.002). Both indirect costs and QALY's were similar between both groups. Conclusion: The sequential combination of mifepristone with misoprostol is cost-effective compared with misoprostol alone, for treatment of EPL after a minimum of one week of unsuccessful expectant management. [ABSTRACT FROM AUTHOR]

Background: Long-term community mental health treatment for non-psychotic disorder patients with severe mental illness (SMI) who are perceived as difficult by clinicians, is poorly developed and lacks a structured, goal-centred approach. This study compares (cost-)effectiveness of Interpersonal Community Psychiatric Treatment (ICPT) with Care As Usual (CAU) on quality of life and clinician perceived difficulty in the care for non-psychotic disorder SMI-patients. A multi-centre cluster-randomized clinical tria was conducted in which Community Mental Health Nurses (Clinicians) in three large community mental health services in the Netherlands were randomly allocated to providing either ICPT or CAU to included patients. A total of 56 clinicians were randomized, who treated a total of 93 patients (59 in ICPT-group and 34 in CAU-group). Methods: Primary outcome measure is patient-perceived quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA). Secondary outcome measures include clinician-perceived difficulty, general mental health, treatment outcomes, illness management and recovery, therapeutic relationship, care needs and social network. Patients were assessed at baseline, during treatment (6 months), after treatment (12 months) and at 6 months follow-up (18 months). Linear mixed-effects models for repeated measurements were used to compare mean changes in primary and secondary outcomes between intervention and control group of patients over time on an intention to treat basis. Potential efficiency was investigated from a societal perspective. Economic evaluation was based on general principles of a cost-effectiveness analysis. Outcome measures for health economic evaluation, were costs, and Quality Adjusted Life Years (QALYs). Results: Half of the intended number of patients were recruited. There was no statistically significant treatment effect found in the MANSA (0.17, 95%-CI [− 0.058,0.431], p = 0.191). Treatment effects showed significant improvement in the Different Doctor-Patient Relationship Questionnaire-scores and a significant increase in the Illness Management and Recovery–scale Client-version scores). No effects of ICPT on societal and medical costs nor QALYs were found. Conclusions: This is the first RCT to investigate the (cost)-effectiveness of ICPT. Compared with CAU, ICPT did not improve quality of life, but significantly reduced clinician-perceived difficulty, and increased subjective illness management and recovery. No effects on costs or QALY's were found. Trial registration: NTR 3988, registered 13 May 2013. [ABSTRACT FROM AUTHOR]

Background: Under a constrained health care budget, cost-increasing technologies may displace funds from existing health services. However, it is unknown what services are displaced and how such displacement takes place in practice. The aim of our study was to investigate how the Dutch hospital sector has dealt with the introduction of cost-increasing health technologies, and to present evidence of the relative importance of three main options to deal with cost-increases in health care: increased spending, increased efficiency, or displacement of other services.Methods: We conducted six case-studies and interviewed 84 professionals with various roles and responsibilities (practitioners, heads of clinical department, board of directors, insurers, and others) to investigate how they experienced decision making in response to the cost pressure of cost-increasing health technologies. Transcripts were analyzed thematically in Atlas.ti on the basis of an item list.Results: Direct displacement of high-value care due to the introduction of new technologies was not observed; respondents primarily pointed to increased spending and efficiency measures to accommodate the introduction of the cost-increasing technologies. Respondents found it difficult to identify the opportunity costs; partly due to limited transparency in the internal allocation of funds within a hospital. Furthermore, respondents experienced the entry of new technologies and cost-containment as two parallel processes that are generally not causally linked: cost containment was experienced as a permanent issue to level costs and revenues, independent from entry of new technologies. Furthermore, the way of financing was found important in displacement in the Netherlands, especially as there is a separate budget for expensive drugs. This budget pressure was found to be reallocated horizontally across departments, whereas the budget pressure of other services is primarily reallocated vertically within departments or divisions. Respondents noted that hospitals have reacted to budget pressures primarily through a narrowing in the portfolio of their services, and a range of (other) efficiency measures. The board of directors is central in these processes, insurers are involved only to a limited extent.Conclusions: Our findings indicate that new technologies were generally accommodated by greater efficiency and increased spending, and that hospitals sought savings or efficiency measures in response to cumulative cost pressures rather than in response to single cost-increasing technologies. [ABSTRACT FROM AUTHOR]

Background: Consultation of a nephrologist is important in aligning care for patients with chronic kidney disease (CKD) at the primary-secondary care interface. However, current consultation methods come with practical difficulties that can lead to postponed consultation or patient referral instead.Objective: This study aimed to investigate whether a web-based consultation platform, telenephrology, led to a lower referral rate of indicated patients. Furthermore, we assessed consultation rate, quality of care, costs and general practitioner (GPs') experiences with telenephrology.Methods: Cluster randomized controlled trial with 47 general practices in the Netherlands was randomized to access to telenephrology or to enhanced usual care. A total of 3004 CKD patients aged 18 years or older who were under primary care were included (intervention group n = 1277, control group n = 1727) and 2693 completed the trial. All practices participated in a CKD management course and were given an overview of their CKD patients.Results: The referral rates amounted to 2.3% (n = 29) in the intervention group and 3.0% (n = 52) in the control group, which was a non-significant difference, OR 0.61; 95% CI 0.31 to 1.23. The intervention group's consultation rate was 6.3% (n = 81) against 5.0% (n = 87) (OR 2.00; 95% CI 0.75-5.33). We found no difference in quality of care or costs. The majority of GPs had a positive opinion about telenephrology.Conclusion: The data in our study do not allow for conclusions on the effect of telenephrology on the rate of patient referrals and provider-to-provider consultations, compared to conventional methods. It was positively evaluated by GPs and was non-inferior in terms of quality of care and costs. [ABSTRACT FROM AUTHOR]

Background: The pressure in out-of-hours primary care is high due to an increasing demand for care and rising health-care costs. During the daytime, substituting general practitioners (GPs) with nurse practitioners (NPs) shows positive results to contribute to these challenges. However, there is a lack of knowledge about the impact during out-of-hours. The current study aims to provide an insight into the impact of substitution on resource use, production and direct health-care costs during out-of-hours. Methods: At a general practitioner cooperative (GPC) in the south-east of the Netherlands, experimental teams with four GPs and one NP were compared with control teams with five GPs. In a secondary analysis, GP care versus NP care was also examined. During a 15-month period all patients visiting the GPC on weekend days were included. The primary outcome was resource use including X-rays, drug prescriptions and referrals to the Emergency Department (ED). We used logistic regression to adjust for potential confounders. Secondary outcomes were production per hour and direct health-care costs using a cost-minimization analysis. Results: We analysed 6,040 patients in the experimental team (NPs: 987, GPs: 5,053) and 6,052 patients in the control team. There were no significant differences in outcomes between the teams. In the secondary analysis, in the experimental team NP care was associated with fewer drug prescriptions (NPs 37.1 %, GPs 43 %, p < .001) and fewer referrals to the ED (NPs 5.1 %, GPs 11.3 %, p = .001) than GP care. The mean production per hour was 3.0 consultations for GPs and 2.4 consultations for NPs (p < .001). The cost of a consultation with an NP was €3.34 less than a consultation with a GP (p = .02). Conclusions: These results indicated no overall differences between the teams. Nonetheless, a comparison of type of provider showed that NP care resulted in lower resource use and cost savings than GP care. To find the optimal balance between GPs and NPs in out-of-hours primary care, more research is needed on the impact of increasing the ratio of NPs in a team with GPs on resource use and health-care costs. Trial registration: ClinicalTrials.gov ID NCT01388374. [ABSTRACT FROM AUTHOR]

Background: This study aimed to document the variation in technical efficiency of primary care (PC) practices in delivering evidence-based cardiovascular risk management (CVRM) and to identify associated factors.Methods: This observational study was based on the follow-up measurements in a cluster randomized trial. Patients were recruited from 41 general practices in the Netherlands, involving 106 GPs and 1671 patients. Data on clinical performance were collected from patient records. The analysis focused on PC practices and used a two-stage data envelopment analysis (DEA) approach. Bias-corrected DEA technical efficiency scores for each PC practice were generated, followed by regression analysis with practice efficiency as outcomes and organizational features of general practice as predictors.Results: Not all PC practices delivered recommended CVRM with the same technical efficiency; a significant difference from the efficient frontier was found (p < .000; 95 % CI 1.018-1.041). The variation in technical efficiency between PC practices was associated with training practice status (p = .026). Whether CVRM clinical tasks were performed by a practice nurse or a GP did not influence technical efficiency in a statistical significant way neither did practice size.Conclusions: Technical efficiency in delivering evidence-based CVRM increased with having a training practice status. Nurse involvement and practice size showed no statistical impact. [ABSTRACT FROM AUTHOR]

This paper examines the short run inefficiencies that arise during gradual implementation of a new cost-effective technology in healthcare. These inefficiencies arise when health gains associated with the new technology cannot be obtained immediately because the new technology does not yet supply all patients, and when there is overcapacity for the old technology in the short run because the supply of care is divided among two mutually exclusive technologies. Such efficiency losses are not taken into account in standard textbook cost-effectiveness analysis in which a steady state is presented where costs and effects are assumed to be unchanging over time. A model is constructed to quantify such short run inefficiencies as well as to inform the decision maker about the optimal implementation pattern for the new technology. The model operates by integrating the incremental net benefit equations for both the period of co-existence of mutually exclusive technologies and the period after complete substitution of the old technology. It takes into account the rate of implementation of the new technology, depreciation of capital of the old technology as well as the demand curves for both technologies. The model is applied to the real world case of converting from screen film to digital mammography in the Netherlands. [ABSTRACT FROM AUTHOR]

Background: In comparison to other European population-based breast cancer screening programmes, the Dutch programme has a low referral rate, similar breast cancer detection and a high breast cancer mortality reduction. The referral rate in the Netherlands has increased over time and is expected to rise further, mainly following nationwide introduction of digital mammography, completed in 2010. This study explores the consequences of the introduction of digital mammography on the balance between referral rate, detection of breast cancer, diagnostic work-up and associated costs. Methods: Detailed information on diagnostic work-up (chart review) was obtained from referred women (n = 988) in 2000–06 (100% analogue mammography) and 2007 (75% digital mammography) in Nijmegen, the Netherlands. Results: The average referral rate increased from 15 (2000–06) to 34 (2007) per 1000 women screened. The number of breast cancers detected increased from 5.5 to 7.8 per 1000 screens, whereas the positive predictive value fell from 37% to 23%. A sharp rise in diagnostic work-up procedures and total diagnostic costs was seen. On the other hand, costs of a single work-up slightly decreased, as less surgical biopsies were performed. Conclusion: Our study shows that a low referral rate in combination with the introduction of digital mammography affects the balance between referral rate and detection rate and can substantially influence breast cancer care and associated costs. Referral rates in the Netherlands are now more comparable to other countries. This effect is therefore of value in countries where implementation of digital breast cancer screening has just started or is still under discussion. [ABSTRACT FROM PUBLISHER]

Objective. To perform a modelling study on the cost-effectiveness of three outcome-directed strategies in early RA patients: Strategy 1: starting MTX monotherapy, followed by the addition of LEF, followed by MTX with addition of anti-TNF; Strategy 2: start with MTX and LEF combination followed by MTX with anti-TNF; and Strategy 3: immediate start with MTX and anti-TNF.Methods. A validated Markov model was used to evaluate the cost-effectiveness of the three strategies. Effectiveness of the strategies was determined using daily practice data from two cohorts and used as input parameter in the model. Patients treated according to the strategies were matched for baseline 28-joint DAS (DAS-28). Using Monte Carlo simulation, expected costs, quality-adjusted life-years (QALYs) and incremental cost per QALY gained for a 5-year time horizon were calculated following both a health-care and a societal perspective.Results. The percentage of patients in remission and number of QALYs were comparable between the three strategies. Starting with a combination (MTX plus LEF or anti-TNF) was more costly than starting with MTX alone. This resulted in an unfavourable incremental cost–effectiveness ratio for starting on anti-TNF vs initially MTX: health-care perspective of €138 028 and from a societal perspective of €136 150 per QALY gained over 5 years.Conclusion. In this modelling study, starting with MTX or anti-TNF has comparable effectiveness. However, initial anti-TNF was far more expensive than starting with MTX monotherapy. Therefore, based on this study, a treatment strategy starting with MTX monotherapy is favoured over a strategy with MTX and anti-TNF right away in early RA patients. [ABSTRACT FROM PUBLISHER]

The article discusses a randomized trial which compared the cost-effectiveness of colorectal cancer (CRC) screening methods in the Netherlands. CRC screening strategies compared in the trial were immunochemical fecal occult blood testing (I-FOBT), guaiac FOBT, or no screening in patients aged 50-70 years. The trial found that I-FOBT is a cost-effective screening technique for CRC. It also dominated both G-FOBT and no screening.

Objectives. Experience with anti-TNF agents for a decade can be used to research the safety and effectiveness of anti-TNF agents in the long term. The objective of this article is to describe drug survival, disease activity, daily functioning, quality of life and adverse events of TNF-blocking agents in daily clinical practice after 5 years of follow-up.Methods. Data from the Dutch Rheumatoid Arthritis Monitoring (DREAM) register of 1560 RA patients were used for analyses (5-year follow-up, n = 174). Drug survival and time to first serious infection or malignancy were analysed by Kaplan–Meier analysis. Several outcome measures at several follow-up moments were analysed per intention to treat and per protocol.Results. The 5-year drug survival of the first anti-TNF was 45%, and 60% for total use of TNF-blocking agents. Baseline 28-joint DAS (DAS-28) was 5.1 (s.d. 1.3). After 5 years, the mean DAS-28 was 3.2 (s.d. 1.3) in all patients who had started with TNF-blocking agents and 2.9 (s.d. 1.1) in patients who were still on TNF-blocking agents. In the latter group, the HAQ score was 0.88 (s.d. 0.7) and the EuroQol five dimensions (EQ-5D) utility score was 0.7 (s.d. 0.2). Incidence rates of serious infections and malignancies were 2.9 and 0.6 per 100 patient-years, respectively.Conclusion. Five-year follow-up of RA patients treated with TNF-blocking agents showed a 60% drug survival accompanied by sustained low disease activity, normalized function and quality of life similar to that in the general population. The benefit to risk ratio for long-term TNF-blocking therapy remains favourable. [ABSTRACT FROM AUTHOR]

Discusses whether a shift towards integrated health care in the Netherlands represents a Pareto-optimal change. How care demanders, providers and informal caregivers can be expected to benefit from the introduction of integrated health care; Enactment of health care reforms to stimulate policy makers to make economically sound decisions.

Background: Pelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. During a life time, 20% of all women will undergo an operation. In general the guidelines advise a vaginal operation in case of uterine descent: hysterectomy with uterosacral ligament plication (VH), sacrospinous hysteropexy (SSH) or a modified Manchester operation (MM). In the last decade, renewed interest in uterus sparing techniques has been observed. Previous studies have shown non-inferiority between SSH and VH. Whether or not SSH and MM are comparable concerning anatomical and functional outcome is still unknown. The practical application of both operations is at least in The Netherlands a known cause of practice pattern variation (PPV). To reveal any difference between both techniques the SAM-study was designed.Methods: The SAM-study is a randomized controlled multicentre non-inferiority study which compares SSH and MM. Women with symptomatic POP in any stage, uterine descent and POP-Quantification (POP-Q) point D at ≤ minus 1 cm are eligible. The primary outcome is the composite outcome at two years of absence of prolapse beyond the hymen in any compartment, the absence of bulge symptoms and absence of reoperation for pelvic organ prolapse. Secondary outcomes are hospital parameters, surgery related morbidity/complications, pain perception, further treatments for prolapse or urinary incontinence, POP-Q anatomy in all compartments, quality-of-life, sexual function, and cost-effectiveness. Follow-up takes place at 6 weeks, 12 and 24 months. Additionally at 12 weeks, 6 and 9 months cost-effectiveness will be assessed. Validated questionnaires will be used and gynaecological examination will be performed. Analysis will be performed following the intention-to-treat and per protocol principle. With a non-inferiority margin of 9% and an expected loss to follow-up of 10%, 424 women will be needed to prove non-inferiority with a confidence interval of 95%.Discussion: This study will evaluate the effectiveness and costs of SSH versus MM in women with primary POP. The evidence will show whether the existing PPV is detrimental and a de-implementation process regarding one of the operations is needed.Trial Registration: Dutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered. [ABSTRACT FROM AUTHOR]

Background: Occupational therapists may have an added value in the care of patients with Parkinson's disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to evaluate the (cost) effectiveness of occupational therapy in improving daily functioning of patients with Parkinson's disease.Methods/design: A multicenter, assessor-blinded, two-armed randomized controlled clinical trial will be conducted, with evaluations at three and six months. One hundred ninety-two home-dwelling patients with Parkinson's disease and with an occupational therapy indication will be assigned to the experimental group or to the control group (2:1). Patients and their caregivers in the experimental group will receive ten weeks of home-based occupational therapy according to recent Dutch guidelines. The intervention will be delivered by occupational therapists who have been specifically trained to treat patients according to these guidelines. Participants in the control group will not receive occupational therapy during the study period. The primary outcome for the patient is self-perceived daily functioning at three months, assessed with the Canadian Occupational Performance Measure. Secondary patient-related outcomes include: objective performance of daily activities, self-perceived satisfaction with performance in daily activities, participation, impact of fatigue, proactive coping skills, health-related quality of life, overall quality of life, health-related costs, and effectiveness at six months. All outcomes at the caregiver level will be secondary and will include self-perceived burden of care, objective burden of care, proactive coping skills, overall quality of life, and care-related costs. Effectiveness will be evaluated using a covariance analysis of the difference in outcome at three months. An economic evaluation from a societal perspective will be conducted, as well as a process evaluation.Discussion: This is the first large-scale trial specifically evaluating occupational therapy in Parkinson's disease. It is expected to generate important new information about the possible added value of occupational therapy on daily functioning of patients with Parkinson's disease.Trial Registration: Clinicaltrials.gov: NCT01336127. [ABSTRACT FROM AUTHOR]

The article reports a study which examined the effectiveness of post-diagnosis treatment and coordination of care for patients with dementia and their caregivers by memory clinics compared with care provided by general practitioners. The results revealed that there was no difference with regard to post-diagnosis treatment and coordination of care for patients with dementia between memory clinics and general practitioners.

Background: Many strategies have been designed and evaluated to address poor hand hygiene compliance. Unfortunately, well-designed economic evaluations of hand hygiene improvement strategies are lacking. Objective: To compare the cost-effectiveness of two successful implementation strategies for improving nurses' hand hygiene compliance and reducing hospital acquired infections (HAI's). Design and setting: A cost-effectiveness analysis alongside a cluster randomised controlled trial was conducted in 67 nursing wards of three hospitals in the Netherlands. The evaluation used a hospital perspective. Participants: All affiliated nurses of the nursing wards. Wards were randomly assigned to either the control group (n = 30) or the experimental group (n = 37). Methods: The control group received a state-of-the-art strategy including education, reminders feedback and optimising materials and facilities. The experimental group received a team and leaders-directed strategy which included all elements of the state-ofthe- art strategy supplemented with interventions aimed at the social context of teams and enhancing leadership. The most efficient implementation strategy was determined by the incremental costeffectiveness ratio per extra percentage of hand hygiene compliance gained and the incremental cost-effectiveness ratio per additional percentage reduction in the HAI rate. Bootstrap methods were used to determine confidence intervals for these incremental cost-effectiveness ratio's. Two scenarios of 15 and 30% were used to express the association between increased hand hygiene compliance and the reduction in HAIs. Results: The team and leaders-directed strategy was significantly more effective in improving hand hygiene compliance. The mean difference effect was 8.91% (95% CI, 0.75-17.06). This extra increase was achieved at an average cost of €5497 per ward. The incremental cost per extra percentage of hand hygiene gained on ward level was €622. The incremental cost per additional percentage reduction in the HAI rate on ward level was €2074 (30% scenario) and €4125 (15% scenario). Within the 30% scenario, there is a probability of 90% that the team and leaders-directed strategy is cost-effective and within the 15% scenario, there is a probability of 70% that the team and leaders-directed strategy is cost-effective. Conclusions: Optimising hand hygiene compliance through a team and leaders-directed strategy is cost-effective as compared to a state-of-the-art strategy. [ABSTRACT FROM AUTHOR]

Background: No-rinse disposable wash gloves are increasingly implemented in health care to replace traditional soap and water bed baths without proper evaluation of (cost) effectiveness. Objectives: To compare bed baths for effects on skin integrity and resistance against bathing and costs. Design: Cluster randomized trial. Setting: Fifty six nursing home wards in the Netherlands. Participants: Five hundred adult care-dependent residents and 275 nurses from nursing home wards. Methods: The experimental condition 'washing without water' consists of a bed bath with disposable wash gloves made of non-woven waffled fibers, saturated with a no-rinse, quickly vaporizing skin cleaning and caring lotion. The control condition is a traditional bed bath using soap, water, washcloths and towels. Both conditions were continued for 6 weeks. Outcome measures were prevalence of skin damage distinguished in two levels of severity: any skin abnormality/lesion and significant skin lesions. Additional outcomes: resistance during bed baths, costs. Results: Any skin abnormalities/lesions over time decreased slightly in the experimental group, and increased slightly in the control group, resulting in 72.7% vs 77.6% of residents having any skin abnormalities/lesions after 6 weeks, respectively (p = 0.04). There were no differences in significant skin lesions or resistance after 6 weeks. Mean costs for bed baths during 6 weeks per resident were estimated at €218.30 (95%CI 150.52-286.08) in the experimental group and €232.20 (95% CI: 203.80-260.60) in the control group (difference €13.90 (95%CI: 25.61-53.42). Conclusion: Washing without water mildly protects from skin abnormalities/lesions, costs for preparing and performing bed baths do not differ from costs for traditional bed bathing. Thus, washing without water can be considered the more efficient alternative. [ABSTRACT FROM AUTHOR]

Background: The association of isolated tumor cells and micrometastases in regional lymph nodes with the clinical outcome of breast cancer is unclear. Methods: We identified all patients in the Netherlands who underwent a sentinel-node biopsy for breast cancer before 2006 and had breast cancer with favorable primary-tumor characteristics and isolated tumor cells or micrometastases in the regional lymph nodes. Patients with node-negative disease were randomly selected from the years 2000 and 2001. The primary end point was disease-free survival. Results: We identified 856 patients with node-negative disease who had not received systemic adjuvant therapy (the node-negative, no-adjuvant-therapy cohort), 856 patients with isolated tumor cells or micrometastases who had not received systemic adjuvant therapy (the node-positive, no-adjuvant-therapy cohort), and 995 patients with isolated tumor cells or micrometastases who had received such treatment (the node-positive, adjuvant-therapy cohort). The median follow-up was 5.1 years. The adjusted hazard ratio for disease events among patients with isolated tumor cells who did not receive systemic therapy, as compared with women with node-negative disease, was 1.50 (95% confidence interval [CI], 1.15 to 1.94); among patients with micrometastases, the adjusted hazard ratio was 1.56 (95% CI, 1.15 to 2.13). Among patients with isolated tumor cells or micrometastases, the adjusted hazard ratio was 0.57 (95% CI, 0.45 to 0.73) in the node-positive, adjuvant-therapy cohort, as compared with the node-positive, no-adjuvant-therapy cohort. Conclusions: Isolated tumor cells or micrometastases in regional lymph nodes were associated with a reduced 5-year rate of disease-free survival among women with favorable early-stage breast cancer who did not receive adjuvant therapy. In patients with isolated tumor cells or micrometastases who received adjuvant therapy, disease-free survival was improved. N Engl J Med 2009;361:653-63. [ABSTRACT FROM AUTHOR]

Advance care planning (ACP) is seldom initiated with people with dementia (PWD) and mainly focuses on medical end-of-life decisions. We studied the effects of an educational intervention for general practitioners (GPs) aimed at initiating and optimizing ACP, with a focus on discussing medical and nonmedical preferences of future care. A single-blinded cluster randomized controlled trial. In 2016, 38 Dutch GPs (all from different practices) completed the study. They recruited 140 PWD, aged ≥65 years at any stage and with any type of dementia, from their practice. Intervention group GPs were trained in ACP, including shared decision-making and role-playing exercises. Control group GPs provided usual care. The primary outcome was ACP initiation: the proportion of PWD that had at least 1 ACP conversation documented in their medical file. Key secondary outcomes were the number of medical (ie, resuscitation, hospital admission) and nonmedical (ie, activities, social contacts) preferences discussed. At the 6-month follow-up, subjects' medical records were analyzed using random effect logistics and linear models with correction for GP clustering. 38 GP clusters (19 intervention; 19 control) included 140 PWD (intervention 73; control 67). Four PWD (2.9%) dropped out on the primary and key secondary outcomes. After 6 months, intervention group GPs initiated ACP with 35 PWD (49.3%), and control group GPs initiated ACP with 9 PWD (13.9%) [odds ratio (OR) 1.99; P =.002]. Intervention group GPs discussed 0.8 more medical [95% confidence interval (CI) 0.3, 1.3; P =.003] and 1.5 more nonmedical (95% CI 0.8, 2.3; P <.001) preferences per person with dementia than control group GPs. Our educational intervention increased ACP initiation, and the number of nonmedical and medical preferences discussed. This intervention has the potential to better align future care of PWD with their preferences but because of the short follow-up, the GPs' long-term adoption remains unknown. [ABSTRACT FROM AUTHOR]

Objectives Although a growing number of older people are dying in care homes, palliative care has developed in these settings only recently. Cross-country representative comparative research hardly exists in this area. As part of a large EU-funded project, we aim to undertake representative comparative research in care homes in Europe, to describe and compare 6 countries in terms of (1) resident outcomes, quality and costs of palliative and end-of-life care; and (2) palliative care structures and staff knowledge and attitudes toward palliative care. We also aim to explore country, facility, staff, patient, and care characteristics related to better outcomes at resident level. Design and Methods To obtain a representative nationwide sample, we will conduct a large-scale cross-sectional study of deceased residents in care homes in Belgium, Finland, Italy, the Netherlands, Poland, and the United Kingdom, using proportional stratified random sampling (taking into account region, facility type and bed capacity). In each country, all participating care homes retrospectively report all deaths of residents in and outside the facilities over the previous 3-month period. For each case, structured questionnaires, including validated instruments, are sent to (1) the administrator/manager, (2) staff member most involved in care, (3) treating physician (general practitioner or elderly care physician), and (4) a closely involved relative. It is estimated that, per country, 50 care homes are needed on average to obtain a minimum of 200 deceased residents. Collected data include clinical and sociodemographic characteristics, quality of dying, quality and costs of palliative care and end-of-life care, and palliative care structures at the facility level and country level. To obtain a representative view of staff knowledge and attitudes regarding palliative care, PACE will conduct a cross-sectional study of staff working in the participating care homes. Conclusion Considering the growing challenges associated with aging in all European countries, there is an urgent need to build a robust international comparative evidence base that can inform the development of policies to target improved palliative care in care homes. By describing this research protocol, we hope to inform international research in care homes on how to perform representative end-of-life care research in these settings and better understand which systems are associated with better outcomes. [ABSTRACT FROM AUTHOR]

Background: Preoperative colorectal cancer care pathways for older patients show considerable practice variation between Dutch hospitals due to differences in interpretation and implementation of guideline-based recommendations. This study aims to report this practice variation in preoperative care between Dutch hospitals in terms of technical efficiency and identifying associated factors., Methods: Data on preoperative involvement of geriatricians, physical therapists and dieticians and the clinicians' judgement on prehabilitation implementation were collected using quality indicators and questionnaires among colorectal cancer surgeons and specialized nurses. These data were combined with registry-based data on postoperative outcomes obtained from the Dutch Surgical Colorectal Audit for patients aged ≥75 years. A two-stage data envelopment analysis (DEA) approach was used to calculate bias-corrected DEA technical efficiency scores, reflecting the extent to which a hospital invests in multidisciplinary preoperative care (input) in relation to postoperative outcomes (output). In the second stage, hospital care characteristics were used in a bootstrap truncated regression to explain variations in measured efficiency scores., Results: Data of 25 Dutch hospitals were analyzed. There was relevant practice variation in bias-corrected technical efficiency scores (ranging from 0.416 to 0.968) regarding preoperative colorectal cancer surgery. The average efficiency score of hospitals was significantly different from the efficient frontier (p = <0.001). After case-mix correction, higher technical efficiency was associated with larger practice size (p = <0.001), surgery performed in a general hospital versus a university hospital (p = <0.001) and implementation of prehabilitation (p = <0.001)., Conclusion: This study showed considerable variation in technical efficiency of preoperative colorectal cancer care for older patients as provided by Dutch hospitals. In addition to higher technical efficiency in high-volume hospitals and general hospitals, offering a care pathway that includes prehabilitation was positively related to technical efficiency of hospitals offering colorectal cancer care., Competing Interests: The authors have declared that no competing interests exist.

Background: Inguinal hernia repair, gallbladder removal, and knee- and hip replacements are the most commonly performed surgical procedures, but all are subject to practice variation and variable patient-reported outcomes. Shared decision-making (SDM) has the potential to reduce surgery rates and increase patient satisfaction. This study aims to evaluate the effectiveness of an SDM strategy with online decision aids for surgical and orthopaedic practice in terms of impact on surgery rates, patient-reported outcomes, and cost-effectiveness., Methods: The E-valuAID-study is designed as a multicentre, non-randomized stepped-wedge study in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis in six surgical and six orthopaedic departments. The primary outcome is the surgery rate before and after implementation of the SDM strategy. Secondary outcomes are patient-reported outcomes and cost-effectiveness. Patients in the usual care cluster prior to implementation of the SDM strategy will be treated in accordance with the best available clinical evidence, physician's knowledge and preference and the patient's preference. The intervention consists of the implementation of the SDM strategy and provision of disease-specific online decision aids. Decision aids will be provided to the patients before the consultation in which treatment decision is made. During this consultation, treatment preferences are discussed, and the final treatment decision is confirmed. Surgery rates will be extracted from hospital files. Secondary outcomes will be evaluated using questionnaires, at baseline, 3 and 6 months., Discussion: The E-valuAID-study will examine the cost-effectiveness of an SDM strategy with online decision aids in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis. This study will show whether decision aids reduce operation rates while improving patient-reported outcomes. We hypothesize that the SDM strategy will lead to lower surgery rates, better patient-reported outcomes, and be cost-effective., Trial Registration: The Netherlands Trial Register, Trial NL8318, registered 22 January 2020. URL: https://www.trialregister.nl/trial/8318 .

Introduction: Because of the lack of prehospital protocols to rule out a non-ST-segment elevation acute coronary syndrome (NSTE-ACS), patients with chest pain are often transferred to the emergency department (ED) for thorough evaluation. However, in low-risk patients, an ACS is rarely found, resulting in unnecessary healthcare consumption. Using the HEART (History, ECG, Age, Risk factors and Troponin) score, low-risk patients are easily identified. When a point-of-care (POC) troponin measurement is included in the HEART score, an ACS can adequately be ruled out in low-risk patients in the prehospital setting. However, it remains unclear whether a prehospital rule-out strategy using the HEART score and a POC troponin measurement in patients with suspected NSTE-ACS is cost-effective., Methods and Analysis: The ARTICA trial is a randomised trial in which the primary objective is to investigate the cost-effectiveness after 30 days of an early rule-out strategy for low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) presentation at the ED (control group) or (2) POC troponin T measurement (intervention group) and transfer of the care to the general practitioner in case of a low troponin T value. In total, 866 patients will be included. Follow-up will be performed after 30 days, 6 months and 12 months., Ethics and Dissemination: This trial has been accepted by the Medical Research Ethics Committee region Arnhem-Nijmegen. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses., Trial Registration Number: Netherlands Trial Register (NL7148)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

New technologies may displace existing, higher-value care under a fixed budget. Countries aim to curtail adoption of low-value technologies, for example, by installing cost-effectiveness thresholds. Our objective is to estimate the opportunity cost of hospital care to identify a threshold value for the Netherlands. To this aim, we combine claims data, mortality data and quality of life questionnaires from 2012 to 2014 for 11,000 patient groups to obtain quality-adjusted life-year (QALY) outcomes and spending. Using a fixed effects translog model, we estimate that a 1% increase in hospital spending on average increases QALY outcomes by 0.2%. This implies a threshold of €73,600 per QALY, with 95% confidence intervals ranging from €53,000 to €94,000 per QALY. The results stipulate that new technologies with incremental cost effectiveness ratios exceeding the Dutch upper reference value of €80,000 may indeed displace more valuable care., (© 2019 The Authors. Health Economics published by John Wiley & Sons, Ltd.)

Objective: To evaluate age-dependent productivity loss caused by menstruation-related symptoms, measured in absenteeism (time away from work or school) and presenteeism (productivity loss while present at work or school)., Methods: Design/setting: internet-based, cross-sectional survey conducted in the Netherlands from July to October 2017., Participants: 32 748 women aged 15-45 years, recruited through social media., Outcome Measures: self-reported lost productivity in days, divided into absenteeism and presenteeism; impact of menstrual symptoms; reasons women give when calling in sick; and women's preferences regarding the implications of menstruation-related symptoms for schools and workplaces., Results: A total of 13.8% (n=4514) of all women reported absenteeism during their menstrual periods with 3.4% (n=1108) reporting absenteeism every or almost every menstrual cycle. The mean absenteeism related to a woman's period was 1.3 days per year. A total of 80.7% (n=26 438) of the respondents reported presenteeism and decreased productivity a mean of 23.2 days per year. An average productivity loss of 33% resulted in a mean of 8.9 days of total lost productivity per year due to presenteeism. Women under 21 years were more likely to report absenteeism due to menstruation-related symptoms (OR 3.3, 95% CI 3.1 to 3.6). When women called in sick due to their periods, only 20.1% (n=908) told their employer or school that their absence was due to menstrual complaints. Notably, 67.7% (n=22 154) of the participants wished they had greater flexibility in their tasks and working hours at work or school during their periods., Conclusions: Menstruation-related symptoms cause a great deal of lost productivity, and presenteeism is a bigger contributor to this than absenteeism. There is an urgent need for more focus on the impact of these symptoms, especially in women aged under 21 years, for discussions of treatment options with women of all ages and, ideally, more flexibility for women who work or go to school., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To investigate the morbidity that is associated with the learning curve of minimally invasive esophagectomy., Background: Although learning curves have been described, it is currently unknown how much extra morbidity is associated with the learning curve of technically challenging surgical procedures., Methods: Prospectively collected data were retrospectively analyzed of all consecutive patients undergoing minimally invasive Ivor Lewis esophagectomy in 4 European expert centers. The primary outcome parameter was anastomotic leakage. Secondary outcome parameters were operative time and textbook outcome ("optimal outcome"). Learning curves were plotted using weighted moving average and CUSUM analysis was used to determine after how many cases the plateau was reached. Learning associated morbidity was calculated with area under the curve analysis., Results: This study included 646 patients. Three of the 4 hospitals reached the plateau of 8% anastomotic leakage. The length of the learning curve was 119 cases. The mean incidence of anastomotic leakage decreased from 18.8% during the learning phase to 4.5% after the plateau had been reached (P < 0.001). Thirty-six extra patients (10.1% of all patients operated on during the learning curve) experienced learning associated anastomotic leakage, that could have been avoided if patients were operated by surgeons who had completed the learning curve. The incidence of textbook outcome increased from 28% to 53% and the mean operative time decreased from 344 minutes to 270 minutes., Conclusions: A considerable number of 36 extra patients (10.1%) experienced learning associated anastomotic leakage. More research is urgently needed to investigate how learning associated morbidity can be reduced to increase patient safety during learning curves.

Objective: To analyze cost-effectiveness of Pain Exposure Physical Therapy compared to conventional treatment alongside a randomized controlled trial (NCT00817128) in patients with complex regional pain syndrome type 1, where no clinical difference was shown between the two groups in an intention-to-treat analysis., Design: Randomized controlled trial with 9 months follow-up., Setting: Patients were recruited from hospitals and general practitioners in the region around a university hospital., Subjects: A total of 56 patients, 45 (80.4%) female, were randomized. About 4 patients in the intervention and 11 patients in the conventional group switched groups. The mean (SD) age was 44.3 (16.6) years, and in 37 (66.1%) patients, the upper extremity was affected., Interventions: Patients received either Pain Exposure Physical Therapy (maximum of five sessions), or conventional treatment conforming with the Dutch multidisciplinary guideline., Main Measures: For the economic evaluation difference between the groups in health-related quality of life (quality-adjusted life years (QALYs)), and the clinical outcomes Impairment level Sum Score-Restricted Version and Pain Disability was determined based on the intention-to-treat analysis as well as differences in both healthcare-related costs and travel expenses. Cost-effectiveness planes were constructed using bootstrapping to compare effects and costs., Results: No significant effects were found for QALYs (mean difference = -0.02; 95% confidence interval (CI) -0.10 to 0.04) and clinical outcomes. A cost minimization analysis showed a significant difference in costs between groups. The conventional treatment was 64% more expensive than the Pain Exposure Physical Therapy., Conclusion: This economic analysis shows that Pain Exposure Physical Therapy compared to conventional treatment is cost-effective.

Background: Over the last 20 years, integrated care programs for frail elderly people aimed to prevent functional dependence and reduce hospitalization and institutionalization. However, results have been inconsistent and merely modest. To date, evidence on the cost-effectiveness of these programs is scarce. We evaluated the cost-effectiveness of the CareWell program, a multicomponent integrated care program for frail elderly people., Methods: Economic evaluation from a healthcare perspective embedded in a cluster controlled trial of 12 months in 12 general practices in (the region of) Nijmegen. Two hundred and four frail elderly from 6 general practices in the intervention group received care according to the CareWell program, consisting of multidisciplinary team meetings, proactive care planning, case management, and medication reviews; 165 frail elderly from 6 general practices in the control group received usual care. In cost-effectiveness analyses, we related costs to daily functioning (Katz-15 change score i.e. follow up score minus baseline score) and quality adjusted life years (EQ-5D-3 L)., Results: Adjusted mean costs directly related to the intervention were €456 per person. Adjusted mean total costs, i.e. intervention costs plus healthcare utilization costs, were €1583 (95% CI -4647 to 1481) higher in the intervention group than in the control group. Incremental Net Monetary Benefits did not show significant differences between groups, but on average tended to favour usual care., Conclusions: The CareWell primary program was not cost-effective after 12 months. From a cost-effectiveness perspective, widespread implementation of the program in its current form cannot be recommended., Trial Registration: The study was registered in the ClinicalTrials.govProtocol Registration System: ( NCT01499797 ; December 26, 2011). Retrospectively registered.

Question: What is the effect of a multifaceted intervention with participation of patients on improvement of patient-centredness in fertility care?, Summary Answer: A multifaceted intervention with participation of patients did not improve total patient-centredness scores provided by women in fertility care., What Is Known Already: We should provide care that takes into account the preferences and needs of patients, i.e. patient-centred care. Especially infertile patients who suffer from a high emotional burden of treatment could benefit from a more patient-centred approach in healthcare. However, the improvement of patient-centred care is still needed, because effective strategies to come to improvement are lacking., Study Design, Size and Duration: A cluster RCT was performed within 32 Dutch fertility clinics, covering about one-third of all Dutch hospitals. After randomization, 16 clinics in the intervention group were exposed to a multifaceted improvement strategy for patient-centred fertility care for 1 year. This strategy comprised audit and feedback, educational outreach visits and patient-mediated interventions. The remaining 16 clinics in the control group performed care as usual., Participants/materials, Setting and Methods: The clinics' levels of patient-centredness were measured, using the validated Patient-centredness Questionnaire-Infertility (PCQ-Infertility). At baseline measurement, a total of 1620 women in couples undergoing fertility care (this included both male, female, mixed infertility and infertility of unknown cause) in one of the participating clinics were randomly selected to participate in the study and complete the questionnaire. For the after measurement, we randomly selected a comparable sample of 1565 women in infertile couples. Both women who had already started their treatment before the start of the study (67%) and women who started their treatment after the start of this study (33%) were included. To avoid bias, we only included the responses of non-pregnant respondents., Main Results and Role of Chance: The final analysis involved 30 clinics. A total of 946 women (response 58.4%) completed their questionnaire at baseline measurement and also a total of 946 women (response 60.4%) at after measurement. After excluding the pregnant patients, respectively 696 and 730 questionnaires were eligible for analysis at baseline and after measurement. The total score of case-mix adjusted PCQ-Infertility at after measurement did not differ significantly between the intervention and control group (B = 0.06; 95% confidence interval (CI) = -0.04-0.15; P = 0.25). However, scores on the continuity of care subscale were significantly higher in the intervention group compared with the control group (B = 0.20; 95% CI = 0.00-0.40; P < 0.05). The addition of three interaction terms to the model had a significant impact: (i) being younger than 36 years, (ii) beginning treatment after the study had started and (iii) using complementary and alternative medicine. If women met all three conditions, the scores in the intervention group were on average 0.31 points higher compared with the control group (95% CI = 0.14-0.48; P = <0.001)., Limitations, Reasons for Caution: Our response rates are sufficient, but the responses of many women are still lacking which might have biased our results. Furthermore, the PCQ-Infertility scores at baseline measurement were already reasonably high, which could have limited the effect of the multifaceted improvement strategy. Because we only included women in infertile couples in our study, we cannot draw conclusions on the effect of an improvement strategy for patient-centred fertility care for partners., Wider Implication of the Findings: A multifaceted intervention with participation of patients did not improve total patient-centredness scores, although some effect could be observed in specific groups of women and in specific dimensions of patient-centredness. These results can guide future research, in which we should focus more on personalized strategies and outcome measures., Study Funding/competing Interests: This work was supported by Merck Sharp & Dohme (MSD), The Netherlands. There are no competing interests., Trial Registration: Clinical Trials NCT01481064., (© The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Study Question: What are patients and insurers willing to pay for different aspects of fertility care, with a particular focus on patient-centredness?, Summary Answer: In fertility care, both patients and health insurers place a high value on patient-centred factors, also when taking into account the effectiveness of fertility care. WHAT IS KNOWN ALREADY?: The benefit patients derive from fertility treatment may arise from several aspects of their care, such as the effectiveness, safety or patient-centred factors. Patient-centredness is recognized as an important, multi-dimensional concept, including domains on the organizational level (e.g. information provision) and on the human level (e.g. patient involvement)., Study Design, Size, and Duration: We performed a discrete choice experiment (DCE) within 32 Dutch fertility clinics and five large health insurance companies in the Netherlands. A total of 996 infertile patients who underwent at least one treatment cycle for their fertility problem and 84 healthcare insurers participated in the study which was executed in the summer of 2012., Participants/materials, Setting, Methods: All participating patients and health insurers completed a DCE about their preferences in fertility care regarding the effectiveness, patient-centredness of care and additional costs. Logistic regression analysis was subsequently used to determine what both patients and health insurers were willing to pay for a one-step increase in patient-centred care and 1% higher pregnancy rates., Main Results and the Role of Chance: Five hundred and fifty patients (55.2%) and 45 healthcare insurers (53.6%) completed the DCE questionnaire. Patients were willing to pay a median amount of €463 for a relevant one-step increase in patient-centred care and €107 for 1% increase in pregnancy rates. Healthcare insurers' valuations were lower: €191 for more patient-centred care and €60 for 1% increase in pregnancy rates. The willingness-to-pay values depended on patients' age, patients' ethnicity, income, and treatment type and on health insurers' age., Limitations, Reasons for Caution: An important limitation of a DCE study is that other attributes, that were not included in our study, are relevant as well. Therefore, our study participants might make other choices in real life compared with our hypothetical DCE scenarios. We tried to prevent this potential bias by selecting the most important attributes from the literature, using the input of an expert panel and performing a pilot study to test the validity of our questionnaire., Wider Implications of the Findings: This study emphasizes the importance of patient-centredness aspects of care for both infertile patients and their insurers. Therefore, efforts by policymakers and clinicians to improve these aspects of care would increase the overall value patients derive from their fertility treatment. Moreover, although insurers placed a lower monetary value on patient-centredness aspects than patients, it is arguable that insurers' purchasing decisions should be guided by patient rather than insurer preferences. Finally, given the relatively high monetary value patients place on patient-centred aspects of their fertility care, there may be a willingness to allow for some optional co-payments for this quality of care dimension., Study Funding/competing Interests: This work was supported by Merck Sharp and Dohme, the Netherlands. No competing interests declared., Trial Registration Number: Clinical Trials NCT01834313., (© The Author 2014. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objective: Increased recall rates in the Dutch breast cancer screening program call for a new assessment strategy aiming to reduce unnecessary costs and anxiety. Diagnostic work-up (usual care) includes multidisciplinary hospital assessment and is similar for all recalled women, regardless of the radiologist's suspicion of breast cancer. This is similar in many Canadian settings. We developed a novel assessment strategy that offers women with a low suspicion of breast cancer a quick and non-invasive assessment by a screening radiologist (intervention). We compared these two strategies in a cost-effectiveness analysis based on a randomized controlled trial: multicentre randomized controlled trial (MASS trial, Netherlands National Trial Register: NTR1480)., Methods: Participants were enrolled between August 2010 and December 2012 and were randomly assigned to either the intervention or control group (allocation ratio 2:1). Fourteen assessment centres participated in the study. Questionnaires were used to record quality of life (EuroQol-5D), health care use and costs after recall., Results: Our study comprised 366 women, of whom 288 were randomly assigned to the intervention group and 88 to the control group. The mean difference in cost was €153/CAD $226 (95% confidence interval €107-199/CAD $158-294, p&lt;0.001). We found no significant differences in quality of life. The bootstrapped incremental cost-effectiveness ratios in the cost-effectiveness plane showed that the intervention was the efficient, cost-saving modality., Conclusion: Our data show the benefits of tailoring diagnostic assessment to the screening radiologist's suspicion of breast cancer. Scenarios of implementing such a strategy in the Dutch screening or health care system are currently being discussed with various stakeholders.

Background: Dementia-care mapping (DCM) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes., Methods: Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training, a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study. A single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. We measured costs related to health care consumption, falls and psychotropic drug use at the resident level and absenteeism at the staff level. Data were extracted from resident files and the nursing home records. Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home. Total costs were evaluated by means of linear mixed-effect models for longitudinal data, with the unit as a random effect to correct for dependencies within units., Results: 34 units from 11 nursing homes, including 318 residents and 376 nursing staff members participated in the cost analyses. Analyses showed no difference in total costs. However certain changes within costs could be noticed. The intervention group showed lower costs associated with outpatient hospital appointments over time (p = 0.05) than the control group. In both groups, the number of falls, costs associated with the elderly-care physician and nurse practitioner increased equally during the study (p<0.02)., Conclusions: DCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes' preferences, may determine whether they adopt the DCM method., Trial Registration: Dutch Trials Registry NTR2314.

Background: Older adults can benefit from physical activity in numerous ways. Physical activity is considered to be one of the few ways to influence the level of frailty. Standardized exercise programs do not necessarily lead to more physical activity in daily life, however, and a more personalized approach seems appropriate. The main objective of this study is to investigate whether a focused, problem-oriented coaching intervention ('Coach2Move') delivered by a physiotherapist specializing in geriatrics is more effective for improving physical activity, mobility and health status in community-dwelling older adults than usual physiotherapy care. In addition, cost-effectiveness will be determined., Methods/design: The design of this study is a single-blind randomized controlled trial in thirteen physiotherapy practices. Randomization will take place at the individual patient level. The study population consists of older adults, ≥70 years of age, with decreased physical functioning and mobility and/or a physically inactive lifestyle. The intervention group will receive geriatric physiotherapy according to the Coach2Move strategy. The control group will receive the usual physiotherapy care. Measurements will be performed by research assistants not aware of group assignment. The results will be evaluated on the amount of physical activity (LASA Physical Activity Questionnaire), mobility (modified 'get up and go' test, walking speed and six-minute walking test), quality of life (SF-36), degree of frailty (Evaluative Frailty Index for Physical Activity), fatigue (NRS-fatigue), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire) and health care costs., Discussion: Most studies on the effect of exercise or physical activity consist of standardized programs. In this study, a personalized approach is evaluated within a group of frail older adults, many of whom suffer from multiple and complex diseases and problems. A complicating factor in evaluating a new approach is that it may not be automatically adopted by clinicians. Specific actions are undertaken to optimize implementation of the Coach2Move strategy during the trial. Whether or not these will be sufficient is a matter we will consider subsequently, using quality indicators and process analysis., Trial Registration: The Netherlands National Trial Register: NTR3527.

Background: Malignant lymphomas constitute a diverse group of cancers of lymphocytes. One well-known disease is Hodgkin's lymphoma; the others are classified as non-Hodgkin's lymphoma (NHL). NHLs are the most common hematologic neoplasms in adults worldwide, and in 2012 over 170,000 new cases were estimated in the United States and Europe.In previous studies, several practice gaps in hospital care for patients with NHL have been identified. To decrease this variation in care, the present study aims to perform a problem analysis in which barriers to and facilitators for optimal NHL care will be identified and, based on these findings, to develop (tailored) improvement strategies. Subsequently, we will assess the effectiveness, feasibility and costs of the improvement strategies., Methods/design: Barriers and facilitators will be explored using the literature, using interviews and questionnaires among physicians involved in NHL care, and patients diagnosed with NHL. The results will be used to develop a tailored improvement strategy. A cluster randomized controlled trial involving 19 Dutch hospitals will be conducted. Hospitals will be randomized to receive either an improvement strategy tailored to the barriers and facilitators found or, a standard strategy of audit and feedback.The effects of both strategies will be evaluated using previously developed quality indicators. Adherence to the indicators will be measured before and after the intervention period based on medical records from newly diagnosed NHL patients. To study the feasibility of both strategies, a process evaluation will be additionally performed. Data about exposure to the different elements of the strategies will be collected using questionnaires. Economic evaluation from a healthcare perspective will compare the two implementation strategies, where the costs of the implementation strategy and changes in healthcare consumption will be assessed., Discussion: The presence of variation in the use of diagnostic tests, treatment, and follow-up between different physicians in different hospitals in the Netherlands is important for patients. To reduce the existing variation in care, implementation of tailored interventions to improve NHL care is necessary., Trial Registration: This trial is registered at ClinicalTrial.gov as the PEARL study, registration number NCT01562509.

Objective: To evaluate the influence of adherence to the Systematic Care Program for Dementia (SCPD) intervention protocol on patient and caregiver outcomes., Design: Data were drawn from the SCPD study-a single-blind, multicenter, cluster-randomized, controlled trial. Multivariate regression analyses were used to assess the influence of adherence on patient and caregiver outcomes., Setting: Six community mental health services (CMHSs) across the Netherlands., Participants: Forty-eight mental health professionals treating 125 patient-caregiver dyads who were referred to the CMHS because of suspected patient dementia., Intervention: Training of professionals in the SCPD and its subsequent use. The SCPD consists of a systematic assessment of caregiver problems and consequent interventions., Measurements: The dependent variables were caregiver's sense of competence, caregiver's depressive symptoms, caregiver's distress due to the patient's behavioral problems, and the severity of patient's behavioral problems. The main independent variables were adherence to the SCPD intervention protocol and the intensity of the SCPD interventions. The follow-up lasted 12 months., Results: Caregivers treated by adhering professionals had a better sense of competence than caregivers treated by nonadhering professionals at follow-up. No differences between intervention groups and controls were found for the other outcomes., Conclusion: Nonadherence to the intervention protocol might be a reason for the difference found in the sense of competence between the intervention groups. Furthermore, the intensity of the SCPD might have been too low. Moreover, it might be that overburdened caregivers found it difficult to make effective use of the help offered to them. A qualitative process analysis should be executed to explore more in-depth clarifications., (Copyright © 2013 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.)

Background: Cardiovascular risk management is largely provided in primary healthcare, but not all patients with established cardiovascular diseases receive preventive treatment as recommended. Accreditation of healthcare organizations has been introduced across the world with a range of aims, including the improvement of clinical processes and outcomes. The Dutch College of General Practitioners has launched a program for accreditation of primary care practices, which focuses on chronic illness care. This study aims to determine the effectiveness and efficiency of a practice accreditation program, focusing on patients with established cardiovascular diseases., Methods/design: We have planned a two-arm cluster randomized trial with a block design. Seventy primary care practices will be recruited from those who volunteer to participate in the practice accreditation program. Primary care practices will be the unit of randomization. A computer list of random numbers will be generated by an independent statistician. The intervention group (n = 35 practices) will be instructed to focus improvement on cardiovascular risk management. The control group will be instructed to focus improvement on other domains in the first year of the program. Baseline and follow-up measurements at 12 months after receiving the accreditation certificate are based on a standardized version of the audit in the practice accreditation program. Primary outcomes include controlled blood pressure, serum cholesterol, and prescription of recommended preventive medication. Secondary outcomes are 15 process indicators and two outcome indicators of cardiovascular risk management, self-reported achievement of improvement goals and perceived unintended consequences. The intention to treat analysis is statistically powered to detect a difference of 10% on primary outcomes. The economic evaluation aims to determine the efficiency of the program and investigates the relationship between costs, performance indicators, and accreditation., Discussion: It is important to gain more information about the effectiveness and efficiency of the practice accreditation program to assess if participation is worthwhile regarding the quality of cardiovascular risk management. The results of this study will help to develop the practice accreditation program for primary care practices.

Background: Pain Exposure Physical Therapy is a new treatment option for patients with Complex Regional Pain Syndrome type 1. It has been evaluated in retrospective as well as in prospective studies and proven to be safe and possibly effective. This indicates that Pain Exposure Physical Therapy is now ready for clinical evaluation. The results of an earlier performed pilot study with an n = 1 design, in which 20 patients with Complex Regional Pain Syndrome type 1 were treated with Pain Exposure Physical Therapy, were used for the design and power calculation of the present study.After completion and evaluation of this phase III study, a multi-centre implementation study will be conducted.The aim of this study is to determine whether Pain Exposure Physical Therapy can improve functional outcomes in patients with Complex Regional Pain Syndrome type 1., Methods/design: This study is designed as a single-blinded, randomized clinical trial. 62 patients will be randomized with a follow-up of 9 months to demonstrate the expected treatment effect. Complex Regional Pain Syndrome type 1 is diagnosed in accordance with the Bruehl/International Association for the Study of Pain criteria. Conventional therapy in accordance with the Dutch guideline will be compared with Pain Exposure Physical Therapy. Primary outcome measure is the Impairment level SumScore, restricted version., Discussion: This is the first randomized controlled study with single blinding that has ever been planned in patients with Complex Regional Pain Syndrome type 1 and does not focus on a single aspect of the pain syndrome but compares treatment strategies based on completely different pathophysiological and cognitive theories.

Background: Hand hygiene prescriptions are the most important measure in the prevention of hospital-acquired infections. Yet, compliance rates are generally below 50% of all opportunities for hand hygiene. This study aims at evaluating the short- and long-term effects of two different strategies for promoting hand hygiene in hospital nurses., Methods/design: This study is a cluster randomised controlled trial with inpatient wards as the unit of randomisation. Guidelines for hand hygiene will be implemented in this study. Two strategies will be used to improve the adherence to guidelines for hand hygiene. The state-of-the-art strategy is derived from the literature and includes education, reminders, feedback, and targeting adequate products and facilities. The extended strategy also contains activities aimed at influencing social influence in groups and enhancing leadership. The unique contribution of the extended strategy is built upon relevant behavioural science theories. The extended strategy includes all elements of the state-of-the-art strategy supplemented with gaining active commitment and initiative of ward management, modelling by informal leaders at the ward, and setting norms and targets within the team. Data will be collected at four points in time, with six-month intervals. An average of 3,000 opportunities for hand hygiene in approximately 900 nurses will be observed at each time point., Discussion: Performing and evaluating an implementation strategy that also targets the social context of teams may considerably add to the general body of knowledge in this field. Results from our study will allow us to draw conclusions on the effects of different strategies for the implementation of hand hygiene guidelines, and based on these results we will be able to define a preferred implementation strategy for hospital based nursing., Trial Registration: The study is registered as a Clinical Trial in ClinicalTrials.gov, dossier number: NCT00548015.

Objective: To evaluate the effects of a multifaceted empowerment strategy on the actual use of single embryo transfer after in vitro fertilisation., Design: Randomised controlled trial., Setting: Five in vitro fertilisation clinics in the Netherlands., Participants: 308 couples (women aged <40) on the waiting list for a first in vitro fertilisation cycle., Interventions: The multifaceted strategy aimed to empower couples in deciding how many embryos should be transferred. The strategy consisted of a decision aid, support of a nurse specialising in in vitro fertilisation, and the offer of reimbursement by way of an extra treatment cycle. The control group received standard care for in vitro fertilisation., Main Outcome Measures: Use of single embryo transfer in the first and second treatment cycles as well as decision making variables and costs of the empowerment strategy., Results: After the first treatment cycle, single embryo transfer was used by 43% (65/152) of couples in the intervention group and 32% (50/156) in the control group (difference 11%, 95% confidence interval 0% to 22%; P=0.05). After the second treatment cycle, single embryo transfer was used by 26% (14/154) of couples in the intervention group compared with 16% (8/51) in the control group (difference 10%, -6% to 26%; P=0.20). Compared with couples receiving standard care, those receiving the empowerment strategy had significantly higher empowerment and knowledge levels but no differences in anxiety levels. Mean total savings per couple in the intervention group were calculated to be €169.75 (£146.77; $219.12)., Conclusions: A multifaceted empowerment strategy encouraged use of single embryo transfer, increased patients' knowledge, reduced costs, and had no effect on levels of anxiety or depression. This strategy could therefore be an important tool to reduce the twin pregnancy rate after in vitro fertilisation. This trial did not, however, demonstrate the anticipated 25% difference in use of single embryo transfer of the power calculation., Trial Registration: ClinicalTrials.gov NCT00315029.

Background: Many patients with Parkinson's disease are treated with physiotherapy. We have developed a community-based professional network (ParkinsonNet) that involves training of a selected number of expert physiotherapists to work according to evidence-based recommendations, and structured referrals to these trained physiotherapists to increase the numbers of patients they treat. We aimed to assess the efficacy of this approach for improving health-care outcomes., Methods: Between February, 2005, and August, 2007, we did a cluster-randomised trial with 16 clusters (defined as community hospitals and their catchment area). Clusters were randomly allocated by use of a variance minimisation algorithm to ParkinsonNet care (n=8) or usual care (n=8). Patients were assessed at baseline and at 8, 16, and 24 weeks of follow-up. The primary outcome was a patient preference disability score, the patient-specific index score, at 16 weeks. Health secondary outcomes were functional mobility, mobility-related quality of life, and total societal costs over 24 weeks. Analysis was by intention to treat. This trial is registered, number NCT00330694., Findings: We included 699 patients. Baseline characteristics of the patients were comparable between the ParkinsonNet clusters (n=358) and usual-care clusters (n=341). The primary endpoint was similar for patients within the ParkinsonNet clusters (mean 47.7, SD 21.9) and control clusters (48.3, 22.4). Health secondary endpoints were also similar for patients in both study groups. Total costs over 24 weeks were lower in ParkinsonNet clusters compared with usual-care clusters (difference euro727; 95% CI 56-1399)., Interpretation: Implementation of ParkinsonNet networks did not change health outcomes for patients living in ParkinsonNet clusters. However, health-care costs were reduced in ParkinsonNet clusters compared with usual-care clusters., Funding: ZonMw; Netherlands Organisation for Scientific Research; Dutch Parkinson's Disease Society; National Parkinson Foundation; Stichting Robuust., (Copyright 2010 Elsevier Ltd. All rights reserved.)

Unlabelled: Childhood urinary tract infections (UTIs) can lead to renal scarring and ultimately to terminal renal failure, which has a high impact on quality of life, survival, and health-care costs. Variation in the treatment of UTIs between practices is high., Objective: To assess the cost-effectiveness of a maximum care model for UTIs in children, implying more testing and antibiotic treatment, compared with current practice in primary care in The Netherlands., Methods: We performed a probabilistic modeling study using Markov models. Figures used in the model were derived from a systematic review of the research literature. Multidimensional Monte Carlo simulation was used for the probabilistic analyses., Results: Maximum care gained 0.00102 (males) and 0.00219 (girls) QALYs (quality-adjusted life-years) and saved 42.70 euro (boys) and 77.81 euro (girls) in 30 years compared with current care, and was thus dominant. Net monetary benefit of maximum care ranged from 20 euro to 200 euro for a willingness to pay for a QALY ranging from 0 euro to 80,000 euro, respectively. Maximum care was also dominant over improved current care, although less dominant than to current care., Conclusions: This study suggested that maximum care for childhood UTI was dominant in the long run to current care, meaning that it delivered more quality of life at lower costs. Nevertheless, making firm conclusions is not possible, given the limitations of the input data.

Favourable cost-effectiveness of innovative technologies is more and more a necessary condition for implementation in clinical practice. But proven cost-effectiveness itself does not guarantee successful implementation. The reason for this is a potential discrepancy between long run efficiency, on which cost-effectiveness is based, and short run efficiency. Long run and short run efficiency is dependent upon economies of scale. This paper addresses the potential discrepancy between long run and short run efficiency of innovative technologies in healthcare, explores diseconomies of scale in Dutch hospitals and suggests what strategies might help to overcome hurdles to implement innovations due to that discrepancy.

Background: There is growing interest in geriatric care for community-dwelling older people. There are, however, relatively few reports on the economics of this type of care. This article reports about the cost-effectiveness of the Dutch Geriatric Intervention Program (DGIP) compared to usual care in frail older people at 6-month follow-up from a health care system's point of view., Methods: We conducted this economic evaluation in an observer-blind randomized controlled trial (Dutch EASYcare Study: ClinicalTrials.gov Identifier NCT00105378). Difference in treatment effect was calculated as the difference in proportions of successfully treated patients (prevented functional decline accompanied by improved well-being). Incremental treatment costs were calculated as the difference in mean total care costs. The incremental cost-effectiveness ratio (ICER) was expressed as total cost per successful treatment. Bootstrap methods were used to determine confidence intervals (CI) for these measures., Results: The average cost of the intervention under study (DGIP) was 998 euros (95% CI, 888-1108). The increment in total cost resulting from DGIP was a little over 761 euros (-3336 to 4687). Hospitalization and institutionalization costs were less; home care, adult day care, and meals-on-wheels costs were higher. There was a significant difference in proportions of successful treatments of 22.3% (4.3-41.4). The number needed to treat was approximately 4.7 (2.3-18.0). The ICER is 3418 euros per successful treatment (-21,458 to 45,362). The new treatment is cost-effective at a willingness-to-pay of 34,000 euros., Conclusion: The results of this economic evaluation suggest that DGIP is an effective addition to primary care for frail older people at a reasonable cost.

Objective: To assess the cost effectiveness of community based occupational therapy compared with usual care in older patients with dementia and their care givers from a societal viewpoint., Design: Cost effectiveness study alongside a single blind randomised controlled trial., Setting: Memory clinic, day clinic of a geriatrics department, and participants' homes. Patients 135 patients aged > or =65 with mild to moderate dementia living in the community and their primary care givers., Intervention: 10 sessions of occupational therapy over five weeks, including cognitive and behavioural interventions, to train patients in the use of aids to compensate for cognitive decline and care givers in coping behaviours and supervision., Main Outcome Measures: Incremental cost effectiveness ratio expressed as the difference in mean total care costs per successful treatment (that is, a combined patient and care giver outcome measure of clinically relevant improvement on process, performance, and competence scales) at three months after randomisation. Bootstrap methods used to determine confidence intervals for these measures., Results: The intervention cost 1183 euros (848 pounds sterling, $1738) (95% confidence interval 1128 euros (808 pounds sterling, $1657) to 1239 euros (888 pounds sterling, $1820)) per patient and primary care giver unit at three months. Visits to general practitioners and hospital doctors cost the same in both groups but total mean costs were 1748 euros (1279 pounds sterling, $2621) lower in the intervention group, with the main cost savings in informal care. There was a significant difference in proportions of successful treatments of 36% at three months. The number needed to treat for successful treatment at three months was 2.8 (2.7 to 2.9)., Conclusions: Community occupational therapy intervention for patients with dementia and their care givers is successful and cost effective, especially in terms of informal care giving.

Purpose: Current guidelines (ie, by the American Society of Clinical Oncology and the European Organisation for Research and Treatment of Cancer) do not recommend secondary infection prophylaxis, whereas, in contrast, caregivers prefer secondary prophylaxis to chemotherapy dose reduction after an episode of febrile neutropenia (FN). Because granulocyte colony-stimulating factor (G-CSF) is expensive, this study investigates the economic consequences of secondary prophylactic use of different prophylactic strategies (antibiotics, antibiotics plus G-CSF, and a combined sequential approach) in a population at risk of FN, using a Markov model., Methods: The input for the model is mainly based on the clinical outcome and patient-based cost data set (adopting the health care payer's perspective for the Netherlands) derived from a randomized study on primary prophylaxis in small-cell lung cancer (SCLC) patients; establishing mean cost of an episode FN of euro3,290 and prophylaxis of euro79 (antibiotics) +/- euro1,616 (G-CSF) per cycle. The economic analysis was analyzed probabilistically using first- and second-order Monte Carlo simulation. The incremental cost-effectiveness ratio (ICER) was defined as cost per FN-free cycle., Results: Secondary prophylaxis with antibiotics was the least expensive strategy (mean, euro4,496/patient). The strategy antibiotics plus G-CSF was most expensive (mean, euro 8,998/patient). Comparison of these two strategies resulted in an unacceptably high ICER (euro343,110 per FN-free cycle) in the Dutch context. In scenarios using higher FN-related costs (as found in the United States), the strategies are less distinct in their monetary effects, but still favor antibiotics., Conclusion: This model-based economic analysis demonstrates that in the Netherlands and most likely also in the United States, if secondary prophylaxis is preferred, the strategy with antibiotics is recommended.

Background: Cost-effectiveness remains an issue surrounding the introduction of laparoscopic donor nephrectomy (LDN)., Methods: In a randomized controlled trial the cost-effectiveness of LDN versus mini-incision open donor nephrectomy (ODN) was determined. Fifty donors were included in each group. All in-hospital costs were documented. Postoperatively, case record forms were sent to the donors during 1-year follow-up to record return-to-work and societal costs. To offset costs against quality of life, the Euroqol-5D questionnaire was administered preoperatively and 3, 7, 14, 28, 90, 180, and 365 days postoperatively., Results: Mean total costs were euro6,090 (US$7,308) after LDN and euro4,818 ($5,782) after ODN (P<0.001). Disposables influenced the cost difference most. Mean productivity loss was 68 and 75 days after LDN and ODN respectively, corresponding to euro783 ($940) gained per donor after LDN. The main gain in quality of life in the LDN group was realized within 4 weeks postoperatively. LDN resulted in a mean gain of 0.03 quality-adjusted life years at mean costs of euro1,271 ($1,525) and euro488 ($586) from a healthcare perspective and a societal perspective, respectively. This implies that one additional Quality-Adjusted Life Year after LDN costs about euro16,000 ($19,200) from a societal point of view and about euro41,000 ($49,200) from a health-care perspective. Activities other than work were resumed significantly earlier after LDN (66 vs. 91 days, P=0.01)., Conclusion: In addition to a clinically relevant donor-experienced benefit from LDN, this technique appeared, given a societal perspective, a cost-efficient procedure mainly due to less productivity losses.