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Background: The Assessment of Burden of Chronic Conditions (ABCC)-tool was developed to optimise chronic care., Objectives: This study aimed to assess the effectiveness of the ABCC-tool in patients with COPD, asthma, type 2 diabetes, and/or heart failure in primary care in the Netherlands., Methods: The study had a pragmatic, clustered, two-armed, quasi-experimental design. The intervention group (41 general practices; 176 patients) used the ABCC-tool during routine consultations and the control group (14 general practices; 61 patients) received usual care. The primary outcome was a change in perceived quality of care (PACIC; Patient Assessment of Chronic Illness Care) after 18 months. Secondary outcomes included change in the PACIC after 6 and 12 months, and in quality of life (EQ-5D-5L; EuroQol-5D-5L), capability well-being (ICECAP-A; ICEpop CAPability measure for Adults), and patients' activation (PAM; Patient Activation Measure) after 6, 12, and 18 months for the total group and conditions separately., Results: We observed a significant difference in the PACIC after 6, 12, and 18 months (18 months: 0.388 points; 95%CI: 0.089-0.687; p  = 0.011) for the total group and after 6 and 12 months for type 2 diabetes. After 18 months, we observed a significant difference in the PAM for the total group but not at 6 and 12 months, and not for type 2 diabetes. All significant effects were in favour of the intervention group. No significant differences were found for the EQ-5D-5L and the ICECAP-A., Conclusion: Use of the ABCC-tool has a positive effect on perceived quality of care and patients' activation, which makes the tool ready for use in clinical practice. Healthcare providers (e.g. general practitioners and practice nurses) can use the tool to provide person-centred care. Trial registration number: ClinicalTrials.gov Registry (NCT04127383).

Abstract: Neuropathic pain is associated with substantial healthcare costs. However, cost-of-illness studies of small fiber neuropathy (SFN) are scarce. Our aim was to estimate the healthcare, patient and family, and productivity costs of patients with SFN in the Netherlands from a healthcare and societal perspective. In addition, the association of costs with age, pain impact on daily life, anxiety, depression, and quality of life (Qol) were examined. Cost questionnaires were completed by 156 patients with confirmed SFN. The average annual total health care and societal cost (€, 2020) was calculated at patient, SFN adult population, and societal level. The average annual healthcare, patient and family, and productivity costs per patient with a Pain Impact Numerical Rating Scale of 0 to 3 (mild), 4 to 6 (moderate), and 7 to 10 (severe) were calculated by using the cost questionnaire data. Quality of life was determined by the EuroQol 5D utility scores. Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale. Associations of all costs were analyzed using linear regression analyses. At the patient level, the average annual SFN healthcare and societal cost of SFN was €3614 (95% confidence interval [CI] €3171-€4072) and €17,871 (95% CI €14,395-€21,480). At the SFN population level, the average healthcare costs were €29.8 (CI €26.4-€34.2) million, and on a societal level, these were €147.7 (CI 120.5-176.3) million. Severe pain was associated with significant lower Qol and higher depression scores, higher healthcare, patient and family, and productivity costs ( P < 0.001)., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)

Background: Examine whether the use of different ages has an impact on the valuation of EQ-5D-Y health states for a hypothetical child or adolescent., Methods: A survey was administered during regular classes among a convenience sample of university students in the Netherlands. Respondents first valued 6 EQ-5D-Y health states (2 mild, 2 moderate, 2 severe) describing a hypothetical child/adolescent of a certain age on a visual analogue scale (VAS). After 1 h respondents valued the same six health states again but this time the age of the child was different. Age differed between 4, 10 and 16 year old., Results: Number of respondents was 311. No significant differences in valuation of the six health states were found between the age of 10 and 16. One moderate health state was valued significantly better for a 4-year old compared to a 10 and a 16 year old. The same applied for one severe health state that was valued higher for a 4-year old compared to a 16-year old., Conclusion: Our study shows that, except for one moderate and one severe health state, other EQ-5D-Y health states were not valued significantly different when description of age differed. It is possible that problems in specific health domains are considered more severe for older children/adolescents compared to younger children who might still be dependent on their caregivers. Future research should examine whether our findings are also present in a broader set of EQ-5D-Y health states, with a choice-based method like TTO or DCE, and a more heterogeneous sample.

Background: This study estimated the lifetime cost-effectiveness and equity impacts associated with two lifestyle interventions in the Dutch primary school setting (targeting 4-12 year olds)., Methods: The Healthy Primary School of the Future (HPSF; a healthy school lunch and structured physical activity) and the Physical Activity School (PAS; structured physical activity) were compared to the regular Dutch curriculum (N = 1676). An adolescence model, calculating weight development, and the RIVM Chronic Disease Model, calculating overweight-related chronic diseases, were linked to estimate the lifetime impact on chronic diseases, quality adjusted life years (QALYs), healthcare, and productivity costs. Cost-effectiveness was expressed as the additional costs/QALY gained and we used €20,000 as threshold. Scenario analyses accounted for alternative effect maintenance scenarios and equity analyses examined cost-effectiveness in different socioeconomic status (SES) groups., Results: HPSF resulted in a lifetime costs of €773 (societal perspective) and a lifetime QALY gain of 0.039 per child versus control schools. HPSF led to lower costs and more QALYs as compared to PAS. From a societal perspective, HPSF had a cost/QALY gained of €19,734 versus control schools, 50% probability of being cost-effective, and beneficial equity impact (0.02 QALYs gained/child for low versus high SES). The cost-effectiveness threshold was surpassed when intervention effects decayed over time., Conclusions: HPSF may be a cost-effective and equitable strategy for combatting the lifetime burden of unhealthy lifestyles. The win-win situation will, however, only be realised if the intervention effect is sustained into adulthood for all SES groups., Trial Registration: Clinicaltrials.gov ( NCT02800616 ). Registered 15 June 2016 - Retrospectively registered.

Purpose: We aimed to evaluate quality of life (QoL) using the European Quality of Life Five-Dimensions questionnaire (EQ-5D-3L) in a real-world cohort of Dutch advanced breast cancer (ABC) patients. Secondary, we reported differences in QoL between subgroups of patients based on age, comorbidity, tumor-, and treatment characteristics, and assessed the association of duration of metastatic disease and time to death with QoL., Methods: ABC patients who attended the outpatient clinic between October 2010 and May 2011 were asked to fill out the EQ-5D-3L questionnaire. Patient-, disease-, and treatment characteristics were obtained from the medical files. Health-utility scores were calculated. Subgroups were described and compared for utility scores by parametric and non-parametric methods., Results: A total of 92 patients were included with a median utility score of 0.691 (Interquartile range [IQR] 0.244). Patients ≥ 65 years had significantly worse median utility scores than younger patients; 0.638 versus 0.743, respectively (p = 0.017). Moreover, scores were significantly worse for patients with versus those without comorbidity (medians 0.620 versus 0.725, p = 0.005). Utility scores did not significantly differ between subgroups of tumor type, type of systemic treatment, number of previous palliative treatment(s), or number or location of metastatic site(s). The remaining survival was correlated with utility scores (correlation coefficient (r) = 0.260, p = 0.0252), especially in the subgroup < 65 years (r = 0.340, p = 0.0169), whereas there was no significant correlation with time since metastatic diagnosis (r = - 0.106, p = 0.3136)., Conclusion: Within this real-world cross-sectional study, QoL was significantly associated with age, comorbidity, and remaining survival duration. The observation of a lower QoL in ABC patients, possibly indicating the last period of life, may assist clinical decision-making on timing of cessation of systemic antitumor therapy.

Purpose: To determine the effect of revascularisation for peripheral arterial disease (PAD) on QoL in the first and second year following diagnosis, to compare the effect depicted by Short Form Six Dimensions (SF-6D) and EuroQoL five Dimensions (EQ-5D) utilities, and Visual Analogue Scale (VAS) scores and to analyse heterogeneity in treatment response., Methods: Longitudinal data from 229 PAD patients were obtained in an observational study in southern Netherlands. Utility scores were calculated with the international (SF-6D) and Dutch (EQ-5D) tariffs. We analysed treatment effect at years 1 and 2 through propensity score-matched ANCOVAs. Thereby, we estimated the marginal means (EMMs) of revascularisation and conservative treatment, and identified covariates of revascularisation effect., Results: A year after diagnosis, 70 patients had been revascularised; the EMMs of revascularisation were 0.038, 0.077 and 0.019 for SF-6D, EQ-5D and VAS, respectively (always in this order). For conservative treatment these were - 0.017, 0.038 and 0.021. At 2-year follow-up, the EMMs of revascularisation were 0.015, 0.077 and 0.027, for conservative treatment these were - 0.020, 0.013 and - 0.004. Baseline QoL (and rest pain in year 2) were covariates of treatment effect., Conclusions: We measured positive effects of revascularisation and conservative treatment on QoL a year after diagnosis, the effect of revascularisation was sustained over 2 years. The magnitude of effect varied between the metrics and was largest for the EQ-5D, which may be most suitable for QoL measurement in PAD patients. Baseline QoL influenced revascularisation effect, in clinical practice this may inform expected QoL gain in individual patients.

Aim: To compare health-related quality of life (HRQoL) descriptions and utility scores in newly diagnosed peripheral arterial disease (PAD) patients, using two most widely used instruments, EuroQol 5D (EQ-5D) and Medical Outcome Study 36-item Short-Form Health Status Survey (SF-36)., Methods: Patients' self-assessment of HRQoL was measured by the Dutch versions of the EQ-5D and SF-36 in the 204 patients., Results: Mean utility scores ranged from 0.675 for Short-Form Six-Dimension, 0.648 for the EQ-5D UK tariff and 0.715 for the Dutch EQ-5D tariff. A moderate correlation between the utility scores was found due to different valuation techniques of these instruments., Conclusion: Both instruments have clinical validity for use in the PAD and can be used alongside each other to provide a holistic assessment of the HRQoL. Before using these two instruments interchangeably for utility score calculations and healthcare resource allocation, a thorough sensitivity analysis is necessary to explore the robustness of the value argument based on these utility scores.

Healthcare evaluations are used for optimal allocation of healthcare budgets. Most studies assess the effects of care in terms of Quality-Adjusted Life Years (QALY): the product of survival and quality of life per life year. Currently, quality of life is determined by questionnaires that measure mostly in terms of what a person actually 'does' or 'is' (functioning). This approach has some practical and ethical limitations which affect how we value our healthcare system. In the past decades, an alternative movement called the capability approach has attracted considerable interest. This philosophy advocates enabling people in terms of capabilities: that is, the extent to which a person is able or willing to function. This ensures that people have the freedom to achieve without a particular belief as to what constitutes a good life being imposed upon them. The ICEpop CAPability measure for Adults (ICECAP) questionnaire was developed in the United Kingdom by Coast et al. to evaluate quality of life based on this approach. Dutch translations of ICECAP-A (for adults) and ICECAP-O (for the elderly) are available and may prove to be especially beneficial in fields where treatment effects are not confined to health gains.

Objective: To evaluate the cost-effectiveness of specialized multidisciplinary tinnitus treatment based on cognitive behavioral therapy, compared with care as usual., Design: Randomized controlled trial including an economic evaluation from a health-care and societal perspective, using a one-year time horizon., Setting: Audiologic center., Patients: A referred sample of 626 patients with tinnitus were eligible for participation. Approximately 492 patients were included in the study. Eighty-six (35%) of 247 patients in the usual care group, and 74 (30%) of 245 patients in the specialized care group were lost to follow-up by month 12., Main Outcome Measures: Quality adjusted life years (QALYs) as measured with the Health Utilities Index Mark III and cost in US dollars., Results: Compared with patients receiving usual care, patients who received specialized care gained on average 0.015 QALYs (95% bootstrapped confidence interval [BCI], -0.03 to 0.06). The incremental costs from a societal perspective are $357 (95% BCI,-$1,034 to $1,785). The incremental cost per QALY from a societal perspective amounted to $24,580. The probability that SC is cost-effective from a societal perspective is 58% for a willingness to pay for a QALY of $45,000., Conclusion: Specialized multidisciplinary tinnitus treatment based on cognitive behavioral therapy is cost-effective as compared with usual care. Although uncertainty surrounding the incremental costs and effects is considerable, sensitivity analysis indicated that cost-effectiveness results were robust.

To examine the impact of late treatment-related xerostomia and dysphagia on health-related quality of life (HRQOL) in head and neck cancer (HNC) patients after radiotherapy. A multi-center cross-sectional survey was performed. Patients with a follow-up of at least 6months after curative radiotherapy, without evidence of recurrent disease were eligible for inclusion. The Euroqol-5D questionnaire (EQ-5D) was filled out and toxicity was scored and converted to the RTOG scale. The EQ-5D measures generic HRQOL in terms of utility and visual analogue scale (VAS) scores. Missing data on the EQ-5D were imputed using multiple imputation. HRQOL was compared between subgroups of patients with and without toxicity. Subsequently, the impact of xerostomia and dysphagia on HRQOL was analyzed using multivariate regression analyses. Both analyses were performed separately for utility scores and VAS scores. The study population was composed of 396 HNC patients. The average utility and VAS scores were 0.85 (scale 0-1) and 75 (scale 0-100). Subgroups of patients with xerostomia and/or dysphagia showed statistically significantly lower utility and VAS scores (P=0.000-0.022). The multivariate regression model showed that xerostomia and dysphagia were negative predictors of both utility and VAS scores. Other factors which influenced HRQOL in at least one of the two regression models were: sex, tumor location and the addition of surgery to radiotherapy. Xerostomia and dysphagia diminish generic HRQOL. Moreover dysphagia affects patients' HRQOL stronger than xerostomia., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Objectives: Expressing the outcomes of treatment in quality-adjusted life years is increasingly important as a tool to aid decision makers concerning the allocation of scarce resources within the health care sector. A quality-adjusted life year is a measure of life expectancy that is weighted by health-related quality of life. These weights are referred to as utility scores and are usually measured by multiattribute utility measures. Several studies found that different utility measures provide different estimates of the same person's level of utility. The aim of this study was to investigate which of two widely used utility measures, the EQ-5D and the HUI mark III, is preferred in a tinnitus population., Methods: Baseline and follow-up data on EQ-5D and HUI mark III of 429 patients of a randomized controlled clinical trial, investigating cost-effectiveness of usual care versus specialized care of tinnitus, were included. Agreement, discriminative power, and responsiveness of the health state description and the utility scores were examined., Results: Corresponding dimensions of the EQ-5D and HUI mark III showed large correlations; although ceiling effects were more frequently observed in the EQ-5D. Mean utility scores for EQ-5D (0.77; SD 0.22) and HUI mark III (0.64; SD 0.28) were significantly different (Wilcoxon signed ranks test, p < 0.001), and agreement was low to moderate (intraclass correlation coefficient = 0.53). Both health state description and utility scores of both measures discriminated between different severity groups. These groups were based on baseline scores of the Tinnitus Questionnaire. The HUI mark III had a higher ability than the EQ-5D to detect improved patients from randomly selected pairs of improved and unimproved patients., Conclusion: This study shows that different utility measures lead to different health state descriptions and utility scores among tinnitus patients. However, both measures are capable of discriminating between clinically different groups. The HUI mark III is more responsive than the EQ-5D, and therefore preferred in a tinnitus population.

Background and Aims: The EuroQol 5D (EQ-5D) is a standardised instrument for measuring health-related quality of life (HRQoL). It provides a utility score for health, and a self-rating of HRQoL (EQ-VAS). In this study, the EQ-5D was used to assess HRQoL in survivors of non-small cell lung cancer (NSCLC). The influence of tumour stage, adverse events, initial treatment and presence of recurrence was examined., Methods: Patients treated for NSCLC were sent a questionnaire, consisting of the EQ-5D, EQ-VAS and questions regarding adverse events. Tumour stage, date and type of initial treatment, and presence of recurrence were derived from patient files once patients had completed the questionnaire and informed consent form. Influencing factors were examined by exploring subgroups and using multiple regression analysis., Results: Of the 374 patients contacted, 260 (70%) returned a completed questionnaire. The EQ-VAS generated an average self-rated health of 69 (SD 18). The mean utility score was 0.74 (SD 0.27). Respondents with severe adverse events (dyspnoea grade ≥ 3) had statistically significantly lower utility scores than respondents without severe adverse events (median 0.52 vs 0.81; p <0.001). Subgroups based on a patient's initial treatment modality revealed statistically significantly different utility scores (p=0.010)., Conclusion: The results of the present study provide original data on HRQoL during survival of NSCLC. Adverse events were found to have a considerable impact on HRQoL. This stresses the need to search for treatment modalities that not only improve survival, but also reduce adverse events.

Purpose: This randomized clinical equivalence trial was designed to evaluate health-related quality of life (HRQoL) after fast-track treatment for low-risk coronary artery bypass (CABG) patients., Methods: Four hundred and ten CABG patients were randomly assigned to undergo either short-stay intensive care treatment (SSIC, 8 h of intensive care stay) or control treatment (care as usual, overnight intensive care stay). HRQoL was measured at baseline and 1 month, and one year after surgery using the multidimensional index of life quality (MILQ), the EQ-5D, the Beck Depression Inventory and the State-Trait Anxiety Inventory., Results: At one month after surgery, no statistically significant difference in overall HRQoL was found (MILQ-score P-value=.508, overall MILQ-index P-value=.543, EQ-5D VAS P-value=.593). The scores on the MILQ-domains, physical, and social functioning were significantly higher at one month postoperatively in the SSIC group compared to the control group (P-value=.049; 95%CI: 0.01-2.50 and P-value=.014, 95% CI: 0.24-2.06, respectively). However, these differences were no longer observed at long-term follow-up., Conclusions: According to our definition of clinical equivalence, the HRQoL of SSIC patients is similar to patients receiving care as usual. Since safety and the financial benefits of this intervention were demonstrated in a previously reported analysis, SSIC can be considered as an adequate fast-track intensive care treatment option for low-risk CABG patients.

Objectives: This study explores several variables of the EQ-5D child version, a multi-attribute utility instrument, in children with chronic conditions., Methods: A convenience sample was selected from hospital outpatient records and school records. The sample included children aged 7-18 years with the following chronic conditions: asthma, rheumatic disorders, diabetes, and speech/language and/or hearing disorders. The practicality, convergent validity, and discriminant power were compared with a generic quality of life questionnaire for children (TACQOL) and the 2-week test-retest reliability was assessed., Results: A total of 182 children or their parents completed the first questionnaire and 161 children/parents completed both questionnaires. The practicality of the EQ-5D was good. Low to moderate correlations were found between the utilities and VAS scores and the TACQOL scales. The discriminant power of the EQ-5D items was low overall and was greater for children with a rheumatic disorder than for children with the other conditions. In the subset of children who experienced no health change between the test and the retest, the reliability of the EQ-5D was moderate to high., Conclusions: The EQ-5D seems suitable for children, although the use of an additional disease-specific questionnaire is still recommended. The EQ-5D seems the most suitable for children with a chronic physical condition and appears to be reliable for children with a stable health status.

Rationale, Aims and Objectives: The aim of the study was to evaluate the effects on, and the relationship between, asthma symptoms, asthma-specific quality of life and medical consumption of a nurse-led telemonitoring intervention compared with regular care in asthma in the Netherlands., Methods: One hundred and nine asthmatic outpatients (56 children; 53 adults) were randomly assigned to the treatment arms (12-month follow-up). The control group received regular outpatient care, while the intervention group used an asthma monitor with modem at home with an asthma nurse as the main caregiver. Clinical asthma symptoms and medical consumption were measured by using diaries. Asthma-specific quality of life was measured by the (Paediatric) Asthma Quality of Life Questionnaire., Results: The study population generally represented mild to moderate asthmatics. The results show improvement in follow-up, but no statistically significant difference between the groups was observed. Moderate to high correlations were found within the outcome parameters, but the most remarkable was the low and statistically significant correlation between asthma-specific quality of life (daily functioning) and the self-reported beta-2 agonists., Conclusion: Overall, the telemonitoring programme evaluated in this study did not significantly decrease asthma symptoms or medical consumption, or improve asthma-specific quality of life. The results showed that a telemonitoring programme on its own is not a guarantee of success. The patients' perception of asthma-specific quality of life (daily functioning) should be a key element in asthma telemonitoring programmes.

Objectives: To generate insight into the differences between utility measures EuroQol 5D (EQ-5D), Health Utilities Index Mark II (HUI2) and Mark III (HUI3) and their impact on the incremental cost-effectiveness ratio (ICER) for hearing aid fitting, Methods: Persons with hearing complaints completed EQ-5D, HUI2 and HUI3 at baseline and, when applicable, after hearing aid fitting. Practicality, construct validity, agreement, responsiveness and impact on the ICER were examined., Results: All measures had high completion rates. HUI3 was capable of discriminating between clinically distinctive groups. Utility scores (n = 315) for EQ-5D UK and Dutch tariff (0.83; 0.86), HUI2 (0.77) and HUI3 (0.61) were significantly different, agreement was low to moderate. Change after hearing aid fitting (n = 70) for HUI2 (0.07) and HUI3 (0.12) was statistically significant, unlike the EQ-5D UK (0.01) and Dutch (0.00) tariff. ICERs varied from 647,209 euros/QALY for the EQ-5D Dutch tariff to 15,811 euros/QALY for HUI3., Conclusion: Utility scores, utility gain and ICERs heavily depend on the measure that is used to elicit them. This study indicates HUI3 as the instrument of first choice when measuring utility in a population with hearing complaints, but emphasizes the importance of a clear notion of what constitutes utility with regard to economic analyses.

The objective of this study was to evaluate hearing aid fitting from a societal viewpoint, rather than the more traditional patient perspective. The effects of hearing aid fitting on generic quality of life (EuroQol), social functioning (SF36), auditory disability, productivity at paid and unpaid labour, and medical consumption, were assessed in a prospective study among 80 moderately hearing-impaired first-time hearing aid applicants. The study showed that hearing aid fitting solved problems with paid employment, but did not seem to affect unpaid work. Use of medical services remained relatively stable after first-time hearing aid fitting. The Amsterdam Inventory proved to be a useful questionnaire to assess the effects on hearing disability. No effects of hearing aid fitting on generic quality of life could be determined with the EuroQol, while hearing aid fitting did lead to an improvement in one aspect of generic quality of life; namely social functioning.

Aims: The primary aim was to explore the age dependency of health state values derived via trade-offs between health-related quality of life (HRQoL) and life years in a discrete choice experiment (DCE). The secondary aim was to explore if people weigh life years and HRQoL differently for children, adolescents, adults, and older adults. Methods: Participants from the general population of the Netherlands and China first completed a series of choice tasks offering choices between two EQ-5D-Y states with a given lifespan. The choice model captured the value of a year in full health, disutility determined by EQ-5D-Y, and a discount rate. Next, they received a slightly different choice task, offering choices between two lives that differed in HRQoL and life expectancy but produced the same number of quality-adjusted life years (QALYs). Participants were randomly assigned to fill out the survey for three or four age frames: a hypothetical person of 10, 15, 40, and 70 years (the last one only applicable to China) to allow the age dependency of the responses to be explored. Results: A total of 1,234 Dutch and 1,818 Chinese people administered the survey. Controlling for time preferences, we found that the agreement of health state values for different age frames was generally stronger in the Netherlands than in China. We found no clear pattern of differences in the QALY composition in both samples. The probability distribution over response options variedmost when levels for lifespan or severity were at the extremes of the spectrum. Conclusion/discussion: The magnitude and direction of age effects on values seemed dimension- and country specific. In the Netherlands, we found a few differences in dimension-specific weights elicited for 10- and 15-year-olds compared to 40-year-olds, but the overall age dependency of values was limited. A stronger age dependency of values was observed in China, where values for 70-year-olds differed strongly fromthe values for other ages. The appropriateness of using existing values beyond the age range for which they weremeasured needs to be evaluated in the local context. [ABSTRACT FROM AUTHOR]

As part of its Single Technology Appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (GlaxoSmithKline [GSK]) of Benlysta (belimumab) to submit evidence regarding its clinical and cost effectiveness, for the review and possible extension of a previously conditionally approved intravenous formulation of belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus (SLE). Kleijnen Systematic Reviews Ltd, in collaboration with Maastricht University Medical Centre+, was commissioned to act as the independent Evidence Review Group (ERG). This paper summarises the company submission (CS), presents the ERG's critical review of the clinical and cost-effectiveness evidence in the CS, highlights the key methodological considerations, and describes the development of the NICE guidance by the NICE Appraisal Committee.This appraisal is different to the previous appraisal in three ways: (1). This appraisal expands its definition of 'high disease activity'. (2). In TA397, belimumab was approved, with a managed access arrangement (MAA), for adults only. This appraisal includes subjects aged 5 years or older. (3). The original appraisal included an intravenous formulation only, but the current appraisal also includes a new subcutaneous formulation in the form of a prefilled pen.The company was required to collect real-world data from the British Isles Lupus Assessment Group Biologics Register (BILAG-BR), including data on the efficacy, safety, and effect on health-related quality of life of belimumab versus rituximab. This appraisal considers these data as well as additional clinical trial evidence presented in the company's updated submission to address uncertainties identified during the original appraisal. The ERG identified three major concerns with the evidence presented on the clinical effectiveness in the current submission; namely, short follow-up in the main comparative trials (BLISS-SC, BLISS-52 and BLISS-76); using the propensity score-matching (PSM) analysis in calibrating the cost-effectiveness model can severely bias the results in favour of belimumab; and BILAG-BR data are not suitable for a comparison of belimumab with rituximab.The main issue in the economic analysis was the uncertainty about long-term disease activity progression and resulting organ damage. The company's approach of calibrating modelled organ damage to longer-term data analysed using the PSM analysis was methodologically inappropriate. The final analysis comparing belimumab with standard treatment for the intravenous formulation resulted in an incremental cost-effectiveness ratio of £12,335 per quality-adjusted life-year (QALY) gained and £30,278 per QALY gained in the company's and ERG's base-case analyses, respectively. For the subcutaneous formulation, the final analysis resulted in £8480 per QALY gained and £29,313 per QALY gained in the company's and ERG's base-case analyses, respectively. NICE recommended belimumab in both intravenous and subcutaneous formulations as an add-on treatment option for active autoantibody-positive SLE in the HDA-2 subgroup. [ABSTRACT FROM AUTHOR]

Background: It is hypothesized that, for patients with hearing loss, surgically placing an implant/abutment combination whilst leaving the subcutaneous tissues intact will improve cosmetic and clinical results, increase quality of life (QoL) for the patient, and reduce medical costs. Here, incremental costs and consequences associated with soft tissue preservation surgery with a hydroxyapatite (HA)-coated abutment (test) were compared with the conventional approach, soft tissue reduction surgery with an all-titanium abutment (control). Methods: A cost-consequence analysis was performed based on data gathered over a period of 3 years in an open randomized (1:1) controlled trial (RCT) running in four European countries (The Netherlands, Spain, France, and Sweden). Subjects with conductive or mixed hearing loss or single-sided sensorineural deafness were included. Results: During the first year, in the Netherlands (NL), France (FR), and Spain (ES) a net cost saving was achieved in favor of the test intervention because of a lower cost associated with surgery time and adverse event treatments [NL €86 (CI −50.33; 219.20), FR €134 (CI −3.63; 261.30), ES €178 (CI 34.12; 97.48)]. In Sweden (SE), the HA-coated abutment was more expensive than the conventional abutment, which neutralized the cost savings and led to a negative cost (SE €-29 CI −160.27; 97.48) of the new treatment modality. After 3 years, the mean cost saving reduced to €17 (CI −191.80; 213.30) in the Netherlands, in Spain to €84.50 (CI −117.90; 289.50), and in France to €80 (CI −99.40; 248.50). The mean additional cost in Sweden increased to €-116 (CI −326.90; 68.10). The consequences in terms of the subjective audiological benefit and Health-related quality of life (HRQoL) were comparable between treatments. A trend was identified for favorable results in the test group for some consequences and statistical significance is achieved for the cosmetic outcome as assessed by the clinician. Conclusions: From this multinational cost-consequence analysis it can be discerned that health care systems can achieve a cost saving during the first year that regresses after 3 years, by implementing soft tissue preservation surgery with a HA-coated abutment in comparison to the conventional treatment. The cosmetic results are better. (sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236). [ABSTRACT FROM AUTHOR]

Objective: Combatting disparities in health outcomes among children is a major public health concern. This study focuses on two questions: (1) To what extent does socioeconomic status (SES) contribute to disparities in health outcomes? and (2) To what extent can social inequalities in health outcomes be explained by differences in children's health behaviours?Design: This study included 2-year follow-up data of 1259 children (4-12 years of age) who participated in the 'Healthy Primary School of the Future' project (ClinicalTrials.gov NCT02800616). SES was measured by maternal and paternal education and household income (adjusted for family size). Health outcomes were body mass index (BMI) z-score, health resource use, school absenteeism, health-related quality of life and psychosocial health, measured over 2 years of follow-up (2015-2017). Health behaviours included physical activity, and consumption of fruits, vegetables and sweetened beverages. Associations between SES and baseline health behaviours were examined, and mixed models for repeated measures were used to assess associations between SES and health outcomes over 2 years of follow-up.Results: A high socioeconomic background was significantly associated with better health outcomes (all outcomes). For example, children with a low SES had higher BMI z-scores (beta coefficient: 0.42, 95% CI 0.22 to 0.62) and higher consumption healthcare costs (ratio of mean costs: 2.21, 95% CI 1.57 to 3.10). Effects of SES changed very little after controlling for health behaviours.Discussion: Our findings strongly suggest that socioeconomic background has a pervasive impact on disparities in child health, but gives little support to the idea that social inequalities in child health can be tackled by means of lifestyle interventions. [ABSTRACT FROM AUTHOR]

• This study is the first to demonstrate the value of diagnosing axSpA for patients and society. • Of available diagnostic algorithms for axSpA, modification 2 of the Berlin algorithm (inflammatory back pain not mandatory for axSpA diagnosis) has optimal health-economic performance. • A perfect diagnostic test for axSpA could cost up to €7500 per referred patient. • It is worthwhile to invest in more accurate diagnosis of axSpA; both sensitivity and specificity can be targeted for this. To demonstrate the value of diagnosing axSpA, by comparing health and costs associated with available diagnostic algorithms and perfect diagnosis. Using data from SPACE and other cohorts, a model was developed to estimate health (quality-adjusted life-years, QALYs) and costs (healthcare consumption and work productivity losses) of different diagnostic algorithms for axSpA amongst patients with low back pain referred to a rheumatologist, over a 60-year horizon. The model combined a decision-tree (diagnosis) with a state-transition model (treatment). The three algorithms (Berlin [BER, highest specificity], Modification 1 [M1; less strict inflammatory back pain (IBP) criterion] and Modification 2 [M2; IBP not mandatory as entry criterion, highest sensitivity]) were compared. Changes in sensitivity/specificity were explored and the value of perfect diagnosis was investigated. For each correctly diagnosed axSpA patient, up to 4.7 QALYs and €60,000 could be gained/saved, considering a societal perspective. Algorithm M2 resulted in more health and lower costs per patient (24.23 QALYs; €157,469), compared to BER (23.96 QALYs; €159,423) and M1 (24.15 QALYs; €158,417). Hypothetical improvements in M2 sensitivity resulted in slightly more value compared to improvements in specificity. Perfect diagnosis can cost €7,500 per patient and still provide enough value. Correct diagnosis of axSpA results in substantial health and cost benefits for patients and society. Not requiring IBP as mandatory for diagnosis of axSpA (algorithm M2) provides more value and would be preferable. A considerably more expensive diagnostic algorithm with better accuracy than M2 would still be considered good value for money. [ABSTRACT FROM AUTHOR]

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Compression therapy, prescribed as elastic compression stockings, is the cornerstone in the management of post-thrombotic syndrome. The effectiveness of elastic compression stockings has recently been called into question in a large randomized placebo-controlled trial. The findings however may be less contradictory than assumed and presented. The mechanistic substrate for the effectiveness of compression therapy is based on its ability to counteract venous hypertension, which is a central aspect in the pathophysiology of post-thrombotic syndrome. Nevertheless, despite elastic compression stockings a significant percentage (20–50%) of patients develops post-thrombotic syndrome, suggesting that there are other factors to be considered next to compression. Every patient has an individual baseline risk value, constituted of non-modifiable and modifiable risk factors (i.e. age, sex, bodyweight etcetera). Straining patients at risk is therefore crucial. Exploring additional or alternative forms of therapy is desirable as well since these are in addition to the risk factors, costs aspects and quality of life, puzzle pieces in the management of post-thrombotic syndrome, which once pieced together enables multifactorial yet individualized therapy. [ABSTRACT FROM AUTHOR]

The article analyzes the perceived burden of informal caregivers and how they currently cope with caregiver burden. It explores the ideas of caregivers about potential solutions to diminish their burden. The main sources of burden are cited, including time-consuming and exhaustive nature of caring, becoming totally absorbed by the caregiving situation, and a perceived lack of support.

Background Asymptomatic Peripheral Arterial Disease (PAD) is associated with greater risk of acute cardiovascular events. This study aims to determine the cost-effectiveness of one time only PAD screening using Ankle Brachial Index (ABI) test and subsequent anti platelet preventive treatment (low dose aspirin or clopidogrel) in individuals at high risk for acute cardiovascular events compared to no screening and no treatment using decision analytic modelling. Methods A probabilistic Markov model was developed to evaluate the life time cost-effectiveness of the strategy of selective PAD screening and consequent preventive treatment compared to no screening and no preventive treatment. The analysis was conducted from the Dutch societal perspective and to address decision uncertainty, probabilistic sensitivity analysis was performed. Results were based on average values of 1000 Monte Carlo simulations and using discount rates of 1.5 % and 4 % for effects and costs respectively. One way sensitivity analyses were performed to identify the two most influential model parameters affecting model outputs. Then, a two way sensitivity analysis was conducted for combinations of values tested for these two most influential parameters. Results For the PAD screening strategy, life years and quality adjusted life years gained were 21.79 and 15.66 respectively at a lifetime cost of 26,548 Euros. Compared to no screening and treatment (20.69 life years, 15.58 Quality Adjusted Life Years, 28,052 Euros), these results indicate that PAD screening and treatment is a dominant strategy. The cost effectiveness acceptability curves show 88 % probability of PAD screening being cost effective at the Willingness To Pay (WTP) threshold of 40000 Euros. In a scenario analysis using clopidogrel as an alternative anti-platelet drug, PAD screening strategy remained dominant. Conclusion This decision analysis suggests that targeted ABI screening and consequent secondary prevention of cardiovascular events using low dose aspirin or clopidogrel in the identified patients is a cost-effective strategy. Implementation of targeted PAD screening and subsequent treatment in primary care practices and in public health programs is likely to improve the societal health and to save health care costs by reducing catastrophic cardiovascular events. [ABSTRACT FROM AUTHOR]

Background: New research criteria for the diagnosis of Alzheimer's disease (AD) have recently been developed to enable an early diagnosis of AD pathophysiology by relying on emerging biomarkers. To enable efficient allocation of health care resources, evidence is needed to support decision makers on the adoption of emerging biomarkers in clinical practice. The research goals are to 1) assess the diagnostic test accuracy of current clinical diagnostic work-up and emerging biomarkers in MRI, PET and CSF, 2) perform a cost-consequence analysis and 3) assess long-term cost-effectiveness by an economic model. Methods/design: In a cohort design 241 consecutive patients suspected of having a primary neurodegenerative disease are approached in four academic memory clinics and followed for two years. Clinical data and data on quality of life, costs and emerging biomarkers are gathered. Diagnostic test accuracy is determined by relating the clinical practice and new research criteria diagnoses to a reference diagnosis. The clinical practice diagnosis at baseline is reflected by a consensus procedure among experts using clinical information only (no biomarkers). The diagnosis based on the new research criteria is reflected by decision rules that combine clinical and biomarker information. The reference diagnosis is determined by a consensus procedure among experts based on clinical information on the course of symptoms over a two-year time period. A decision analytic model is built combining available evidence from different resources among which (accuracy) results from the study, literature and expert opinion to assess long-term cost-effectiveness of the emerging biomarkers. Discussion: Several other multi-centre trials study the relative value of new biomarkers for early evaluation of AD and related disorders. The uniqueness of this study is the assessment of resource utilization and quality of life to enable an economic evaluation. The study results are generalizable to a population of patients who are referred to a memory clinic due to their memory problems. Trial registration: NCT01450891 [ABSTRACT FROM AUTHOR]

Background: Tinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus, quality of life is often impaired. At present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests that a comprehensive multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of a comprehensive treatment provided by a specialized tinnitus center versus usual care. This paper describes the study protocol. Methods/Design: In a randomized controlled clinical trial 198 tinnitus patients will be randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus sufferers referred to the audiological centre are eligible. Included patients will be followed for 12 months. Primary outcome measure is generic quality of life (measured with the Health Utilities Index Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the number of patients to include is 198. Economic evaluation will be performed from a societal perspective. Discussion: This is, to our knowledge, the first randomized controlled trial that evaluates a comprehensive treatment of tinnitus and includes a full economic evaluation from a societal perspective. If this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated. Trial Registration: The trial has been registered at ClinicalTrial.gov. The trial registration number is NCT00733044 [ABSTRACT FROM AUTHOR]

Objective: To determine the cost-effectiveness of hearing-aid fitting. Design: Cost-effectiveness analysis using a Markov model based on aggregate data and results from a prospective intervention study. Setting: The cost-effectiveness study was based in the general community. The prospective study was hospital based, as 85% of the first-time hearing-aid users attend a hospital in the process of hearing-aid fitting. Patients: The prospective intervention study included adult first-time hearing-aid users with no contraindications for hearing-aid use. Intervention: The usual process of hearing-aid fitting in the Netherlands. Main Outcome Measure: Costs per quality-adjusted life-year (QALY). The QALYs were based on EuroQol scores. We included direct and indirect costs in the analysis. Results: The mean improvement on the EuroQol measure was 0.03 (95% confidence interval [CI], -0.03 to 0.08), and on the hearing-specific visual analog scale, 0.27 (95% CI, 0.22-0.31). The base-case outcome based on the EuroQol was €15 807/QALY (US $17 072/QALY) (CI, -€24 239/QALY to €3718/QALY). Conclusions: On the basis of this base-case estimate, fitting of hearing aids is considered a cost-effective health care intervention. The CI indicates that the result is not unambiguously positive, probably because the EuroQol lacked sensitivity for the evaluation of hearing-aid fitting. Until now, no study has found an effect of hearing-aid fitting on generic quality of life. Therefore, measures are needed that are suitable for the evaluation of the effects of interventions for sensory disabilities, such as the fitting of hearing aids, on generic quality of life. [ABSTRACT FROM AUTHOR]

The article presents a study that investigates the effectiveness of a stepped-care approach in patients with varying tinnitus severity. It indicates that the primary outcome measures were health-related quality of life, tinnitus severity, and tinnitus impairment. It suggests that stepped-care tinnitus management is more effective than is usual care for improvement of health-related quality of life.

Background This study investigated the cost effectiveness of guideline-recommended (American Society of Clinical Oncology, European Society of Medical Oncology) urokinase plasminogen activator (uPA)/plasminogen activator inhibitor-1 (PAI-1) biomarkers to guide adjuvant chemotherapy decisions for hormone receptor-positive, node-negative early breast cancer patients at intermediate risk of relapse, in France, Germany, and The Netherlands. Methods uPA/PAI-1 testing was compared to chemotherapy for all patients and to no chemotherapy in two age-related subgroups (35–49 and 50–75 years). A partitioned survival analysis was performed using patient-level data for survival outcomes and secondary sources. Mean quality-adjusted life years (QALYs) and costs were estimated over a lifetime horizon to calculate the incremental net monetary benefit (INMB) at a willingness-to-pay of €50,000/QALY. Uncertainty was explored through bootstrap and probabilistic sensitivity analysis using 5000 replicates. Results In the 35–49 year age group, INMBs were negative when uPA/PAI-1 testing was compared to chemotherapy for all patients but positive when it was compared to no chemotherapy for the three countries. In the 50–75 year age group, INMBs of uPA/PAI-1 testing compared to both reference strategies were positive in the three countries, with cost-effectiveness probabilities for the uPA/PAI-1 strategy of 65%, 70%, and 59% for France, Germany, and the Netherlands, respectively, compared with chemotherapy for all patients, and 64%, 58%, and 65%, respectively, compared with no chemotherapy. Conclusions uPA/PAI-1 testing could allow the selection of patients older than 50 years requiring chemotherapy in this population, but the cost effectiveness of this strategy is uncertain. Chemotherapy for all patients is the most cost-effective strategy for patients younger than 50 years. [ABSTRACT FROM AUTHOR]

Objective To explore the potential value of obtaining momentary, instead of retrospective, accounts of the description and valuation of a person’s own health-related quality of life (HRQOL). Methods Momentary HRQOL was examined with the experience sampling method (ESM) in 139 participants from four different samples. The ESM consists of a so-called beep questionnaire that was administered 10 times a day by an electronic device. Feasibility was determined by assessing willingness to participate in the study and by analyzing the percentage of dropouts and the number of completed beep questionnaires. Multilevel analysis was used to investigate the relation between momentary HRQOL and momentary feelings and symptoms. The relation between momentary outcomes and the EuroQol visual analogue scale was investigated with a multiple regression model. Results The overall participation rate was low, but there were no dropouts and the number of completed beeps was comparable to that in other studies. Multilevel analysis showed that feelings and symptoms were significant predictors of momentary HRQOL. The strength of these relations differed among three patient groups and a population-based sample. The EuroQol visual analogue scale was not predicted by momentary feelings and symptoms. Conclusions We can conclude that the use of the ESM to measure accounts of the momentary experience of health in different populations is feasible. Retrospective measures may provide a biased account of the impact of health problems in the daily lives of people who are affected. Moreover, the bias may be different in different conditions. [ABSTRACT FROM AUTHOR]