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Comprehensive Genomic Profiling (CGP) allows for the identification of many targets. Reimbursement decision-making is, however, challenging because besides the health benefits of on-label treatments and costs, other factors related to diagnostic and treatment pathways may also play a role. The aim of this study was to identify which other factors are relevant for the technology assessment of CGP and to summarize the available evidence for these factors. After a scoping search and two expert sessions, five factors were identified: feasibility, test journey, wider implications of diagnostic results, organisation of laboratories, and "scientific spillover". Subsequently, a systematic search identified 83 studies collecting mainly evidence for the factors "test journey" and "wider implications of diagnostic results". Its nature was, however, of limited value for decision-making. We recommend the use of comparative strategies, uniformity in outcome definitions, and the inclusion of a comprehensive set of factors in future evidence generation.
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Background: Soft tissue preservation using a hydroxyapatite-coated abutment in bone conduction hearing implant surgery may lead to improved clinical outcomes over the short (1 year) and long term (3 years). Methods: In this open multi-center, randomized (1:1), controlled clinical trial, subjects with conductive, mixed hearing loss or single-sided sensorineural deafness were randomly assigned to receive the conventional intervention, a titanium abutment with soft tissue reduction surgery (control), or a new intervention, a hydroxyapatite-coated abutment with soft tissue preservation surgery (test). The primary efficacy outcome was the combined endpoint of numbness, pain, peri-abutment dermatitis, and soft tissue thickening/overgrowth after 1 and 3 years. Results: The Intention-to-treat (ITT) population consisted of 52 control subjects and 51 test subjects. The difference between the groups after 1 year of follow-up as measured by the primary efficacy outcome was not statistically significant (p = 0.12) in the ITT population (n = 103), but did reach statistical significance (p = 0.03) in the per-protocol (PP) population (n = 96). It showed an advantage for the test group, with over twice as many subjects (29%) without these medical events during the first year compared to the control group (13%). After 3 years, the difference between the two groups had declined and did not reach statistical significance (24 vs. 10%, ITT p = 0.45). Secondary outcome measures which showed a statistical significant difference during the first year, such as surgical time (15 vs. 25 minutes, p < 0.0001), numbness (90 vs. 69% of subjects experienced no numbness at 1 year, p < 0.01), neuropathic pain at 3 months (p = 0.0087) and the overall opinion of the esthetic outcome (observer POSAS scale at 3 months, p < 0.01) were favorable for the test group. More soft tissue thickening/overgrowth was observed at 3 weeks for the test group (p = 0.016). Similar results were achieved for the long term follow up. Conclusions: Soft tissue preservation with a hydroxyapatite-coated abutment leads to a reduction in the combined occurrence of complications over the first year which is not statistically significant in the ITT population but is in the PP population. This effect decreased for the long-term study follow up of 3 years and did also not reach statistical significance.
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AIMS: To estimate the societal costs and quality of life of people with type 2 diabetes and to compare these results with those of people with normal glucose tolerance or prediabetes. METHODS: Data from 2915 individuals from the population-based Maastricht Study were included. Costs were assessed through a resource-use questionnaire completed by the participants; cost prices were based on Dutch costing guidelines. Quality of life was expressed in utilities using the Dutch EuroQol 5D-3L questionnaire and the SF-36 health survey. Based on normal fasting glucose and 2-h plasma glucose values, participants were classified into three groups: normal glucose tolerance (n = 1701); prediabetes (n = 446); or type 2 diabetes (n = 768). RESULTS: Participants with type 2 diabetes had on average 2.2 times higher societal costs than those with normal glucose tolerance (3,006 and 1,377 per 6 months, respectively) and had lower utilities (0.77 and 0.81, respectively). No significant differences were found between participants with normal glucose tolerance and those with prediabetes. Subgroup analyses showed that higher age, being female and having two or more diabetes-related complications resulted in higher costs (P < 0.05) and lower utilities. CONCLUSIONS: This study showed that people with type 2 diabetes have substantially higher societal costs and lower quality of life than people with normal glucose tolerance. The results provide important input for future model-based economic evaluations and for policy decision-making.
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Costo de Enfermedad , Diabetes Mellitus Tipo 2/economía , Costos de la Atención en Salud , Estado Prediabético/economía , Calidad de Vida , Adulto , Anciano , Estudios de Casos y Controles , Diabetes Mellitus Tipo 2/fisiopatología , Diabetes Mellitus Tipo 2/psicología , Femenino , Humanos , Modelos Lineales , Masculino , Persona de Mediana Edad , Países Bajos , Estado Prediabético/fisiopatología , Estado Prediabético/psicologíaRESUMEN
Background: Eribulin provided significant overall survival (OS) benefit in heavily pretreated advanced breast cancer patients in the EMBRACE trial. We investigated the use of eribulin in daily clinical practice, the relative effectiveness of eribulin versus non-eribulin chemotherapy, and the safety of eribulin in real-world patients included in the SOutheast Netherlands Advanced BREast cancer (SONABRE) registry.Material and methods: Patients treated with eribulin and eligible patients for eribulin who received a different chemotherapy (i.e., non-eribulin group) in ten hospitals in 2013-2017 were included. A multivariate matching algorithm was applied to correct for differences in baseline characteristics between the groups, including the number of previous treatment lines. Progression-free survival (PFS) and OS of eribulin were compared with the matched non-eribulin group through Kaplan-Meier curves and multivariate Cox proportional hazard models. The occurrence of dose delay and reduction was described.Results: Forty-five patients received eribulin according to its registration criteria and 74 patients were eligible for eribulin but received non-eribulin chemotherapy. Matching increased the similarity in baseline characteristics between the eribulin and non-eribulin groups. Median PFS was 3.5 months (95% confidence interval (CI): 2.7-5.5) in the eribulin group and 3.2 months (95% CI: 2.0-4.8) in the matched non-eribulin group (adjusted hazard ratio (HR): 0.83, 95% CI: 0.49-1.38). Median OS was 5.9 months (95% CI: 4.6-11.0) and 5.2 months (95% CI: 4.6-9.5) in the eribulin and non-eribulin groups, respectively (adjusted HR: 0.66, 95% CI: 0.38-1.13). Dose delay or reduction occurred in 14 patients (31%) receiving eribulin.Conclusions: No difference in PFS and OS was observed between eribulin and non-eribulin treated patients. Eribulin had a manageable toxicity profile.
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Neoplasias de la Mama/tratamiento farmacológico , Furanos/uso terapéutico , Cetonas/uso terapéutico , Adulto , Anciano , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/patología , Femenino , Humanos , Persona de Mediana Edad , Análisis Multivariante , Países Bajos/epidemiología , Sistema de Registros , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND AND PURPOSE: The NVALT-11/DLCRG-02 phase III trial (clinicaltrials.gov identifier: NCT01282437) showed that, after standard curative intent treatment, prophylactic cranial irradiation (PCI) decreased the incidence of symptomatic brain metastases (BM) in stage III non-small cell lung cancer (NSCLC) patients compared to observation. In this study we assessed the impact of PCI on health-related quality of life (HRQoL). In addition, an exploratory analysis was performed to assess the impact of neurocognitive symptoms and symptomatic BM on HRQoL. MATERIALS AND METHODS: Stage III NSCLC patients were randomized between PCI and observation. HRQoL was measured using the EuroQol 5D (EQ-5D-3L), EORTC QLQ-C30 and QLQ-BN20 instruments at completion of standard curative intent treatment and 4â¯weeks, 3, 6, 12, 24 and 36â¯months thereafter. Generalized linear mixed effects (GLM) models were used to assess the impact of PCI compared to observation over time on three HRQoL metrics: the EORTC QLQ-C30 global health status and the EQ-5D-3L utility and visual analogue scale (EQ VAS) scores. RESULTS: In total, 86 and 88 patients were included in the PCI and observation arm, with a median follow-up of 48.5â¯months (95% CI 39-54â¯months). Baseline mean HRQoL scores were comparable between the PCI and observation arm for the three HRQoL metrics. In the GLM models, none of the HRQoL metrics were clinically relevant or statistically significantly different between the PCI and the observation arm (p-values ranged between 0.641 and 0.914). CONCLUSION: No statistically significant nor a clinically relevant impact of PCI on HRQoL was observed.
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Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Carcinoma de Pulmón de Células no Pequeñas/radioterapia , Irradiación Craneana , Estado de Salud , Humanos , Neoplasias Pulmonares/radioterapia , Calidad de Vida , Encuestas y CuestionariosAsunto(s)
Neoplasias Encefálicas/prevención & control , Carcinoma de Pulmón de Células no Pequeñas/prevención & control , Quimioradioterapia/métodos , Irradiación Craneana , Neoplasias Pulmonares/patología , Factores de Edad , Neoplasias Encefálicas/epidemiología , Neoplasias Encefálicas/secundario , Carcinoma de Pulmón de Células no Pequeñas/epidemiología , Carcinoma de Pulmón de Células no Pequeñas/secundario , Ensayos Clínicos Fase III como Asunto , Femenino , Estudios de Seguimiento , Humanos , Neoplasias Pulmonares/terapia , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de Riesgo , Factores de Riesgo , Factores Sexuales , Factores de Tiempo , Resultado del TratamientoRESUMEN
Essentials The value of compression therapy in acute phase of deep vein thrombosis is still unclear. Patients with deep vein thrombosis received acute compression hosiery, bandaging, or none. Acute compression reduces irreversible skin signs related to post thrombotic syndrome. Compression hosiery may be the preferred choice for the acute phase SUMMARY: Background The effectiveness of compression therapy in the acute phase of deep vein thrombosis (DVT) is not yet determined. Objectives To investigate the impact of compression therapy in the acute phase of DVT on determinants of the Villalta score, health-related quality of life (HRQOL), and costs. Patients/Methods Eight hundred and sixty-five patients with proximal DVT (substudy of the IDEAL DVT study) received, immediately after DVT diagnosis, either no compression, multilayer bandaging, or hosiery. In the acute phase and 3 months after diagnosis, HRQOL was determined by use of the EQ-5D, SF6D, and VEINES-QoL intrinsic method (VEINES-QoLint ). At 3 months, signs and symptoms were assessed for the total and separate items of the Villalta score, and healthcare costs were calculated. Results The compression groups had lower overall objective Villalta scores than the no-compression group (1.47 [standard deviation (SD) 1.570] and 1.59 [SD 1.64] versus 2.21 [SD 2.15]). The differences were mainly attributable to irreversible skin signs (induration, hyperpigmentation, and venectasia) and pain on calf compression. Subjective and total Villalta scores were similar across groups. Differences in HRQOL were only observed at 1 month; HRQOL was better for hosiery (EQ-5D 0.86 [SD 0.18]; VEINES-QoLint 0.66 [SD 0.18]) than for multilayer compression bandaging (EQ-5D 0.81 [SD 0.23; VEINES-QoLint 0.62 [SD 0.19]). Mean healthcare costs per patient were 417.08 (354.10 to 489.30) for bandaging, 114.25 (92.50 to 198.43) for hosiery, and 105.86 (34.63 to 199.30) for no compression. Conclusions Initial compression reduces irreversible skin signs, edema, and pain on calf compression. Multilayer bandaging is slightly more effective than hosiery, but has substantially higher costs, without a gain in HRQOL. From a patient and economic perspective, compression hosiery would be preferred when initial compression is applied. TRIAL REGISTRATION: IDEAL DVT study ClinicalTrials.gov number, NCT01429714.
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INTRODUCTION: The aim of our analysis was to assess the real-world cost-effectiveness of bevacizumab in addition to taxane treatment versus taxane monotherapy for HER2-negative metastatic breast cancer compared with the cost-effectiveness based on the efficacy results from a trial. METHODS: A state transition model was built to estimate costs, life years (LYs) and quality-adjusted life years (QALYs) for both treatments. Two scenarios were examined: a real-world scenario and a trial-based scenario in which transition probabilities were primarily based on a real-world cohort study and the E2100 trial, respectively. In both scenarios, costs and utility parameter estimates were extracted from the real-world cohort study. Moreover, the Dutch health care perspective was adopted. RESULTS: In both the real-world and trial scenarios, bevacizumab-taxane is more expensive (incremental costs of 56,213 and 52,750, respectively) and more effective (incremental QALYs of 0.362 and 0.189, respectively) than taxane monotherapy. In the real-world scenario, bevacizumab-taxane compared to taxane monotherapy led to an incremental cost-effectiveness ratio (ICER) of 155,261 per QALY gained. In the trial scenario, the ICER amounted to 278,711 per QALY gained. CONCLUSION: According to the Dutch informal threshold, bevacizumab in addition to taxane treatment was not considered cost-effective for HER2-negative metastatic breast cancer both in a real-world and in a trial scenario.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Bevacizumab/administración & dosificación , Bevacizumab/economía , Neoplasias de la Mama/economía , Hidrocarburos Aromáticos con Puentes/economía , Análisis Costo-Beneficio , Progresión de la Enfermedad , Docetaxel , Femenino , Recursos en Salud/economía , Recursos en Salud/estadística & datos numéricos , Humanos , Estimación de Kaplan-Meier , Países Bajos , Paclitaxel/administración & dosificación , Paclitaxel/economía , Años de Vida Ajustados por Calidad de Vida , Receptor ErbB-2/metabolismo , Taxoides/administración & dosificación , Taxoides/economíaRESUMEN
BACKGROUND: Unhealthy lifestyles in early childhood are a major global health challenge. These lifestyles often persist from generation to generation and contribute to a vicious cycle of health-related and social problems. This design article presents a study evaluating the effects of two novel healthy school interventions. The main outcome measure will be changes in children's body mass index (BMI). In addition, lifestyle behaviours, academic achievement, child well-being, socio-economic differences, and societal costs will be examined. METHODS: In close collaboration with various stakeholders, a quasi-experimental study was developed, for which children of four intervention schools (n = 1200) in the southern part of the Netherlands are compared with children of four control schools (n = 1200) in the same region. The interventions started in November 2015. In two of the four intervention schools, a whole-school approach named 'The Healthy Primary School of the Future', is implemented with the aim of improving physical activity and dietary behaviour. For this intervention, pupils are offered an extended curriculum, including a healthy lunch, more physical exercises, and social and educational activities, next to the regular school curriculum. In the two other intervention schools, a physical-activity school approach called 'The Physical Activity School', is implemented, which is essentially similar to the other intervention, except that no lunch is provided. The interventions proceed during a period of 4 years. Apart from the effectiveness of both interventions, the process, the cost-effectiveness, and the expected legal implications are studied. Data collection is conducted within the school system. The baseline measurements started in September 2015 and yearly follow-up measurements are taking place until 2019. DISCUSSION: A whole-school approach is a new concept in the Netherlands. Due to its innovative, multifaceted nature and sound scientific foundation, these integrated programmes have the potential to form a template for primary schools worldwide. The effects of this approach may extend further than the outcomes associated with well-being and academic achievement, potentially impacting legal and cultural aspects in our society. TRIAL REGISTRATION: The study protocol was registered in the database ClinicalTrials.gov on 14-06-2016 with the reference number NCT02800616 .
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Promoción de la Salud/métodos , Evaluación de Programas y Proyectos de Salud/métodos , Servicios de Salud Escolar , Instituciones Académicas , Niño , Protección a la Infancia , Preescolar , Protocolos Clínicos , Análisis Costo-Beneficio , Curriculum , Ejercicio Físico , Femenino , Promoción de la Salud/economía , Humanos , Estilo de Vida , Masculino , Países Bajos , Ensayos Clínicos Controlados no Aleatorios como Asunto , Evaluación de Programas y Proyectos de Salud/economíaRESUMEN
UNLABELLED: ESSENTIALS: Elastic compression stocking (ECS) therapy is used to prevent post-thrombotic syndrome (PTS). We aimed to elicit patient preferences regarding ECS therapy after deep vein thrombosis. The most valued attributes were PTS risk reduction and the ability to put on the ECS independently. Heterogeneous results with respect to education level stress the importance of proper counselling. BACKGROUND: Elastic compression stocking (ECS) therapy is used for prevention of post-thrombotic syndrome (PTS) after deep vein thrombosis (DVT). Current evidence on its effectiveness is conflicting. Compliance, a major determinant of the effectiveness of ECS therapy, remained largely ignored in former studies. OBJECTIVES: To gain insight into preferences regarding ECS therapy in patients after DVT. PATIENTS/METHODS: A discrete choice experiment was conducted 3 months after DVT in patients enrolled in the IDEAL DVT study, a randomized controlled trial comparing 2 years of ECS therapy with individually tailored duration of ECS therapy for the prevention of PTS. Nine unlabeled, forced-choice sets of two hypothetical types of ECS were presented to each patient. Data were analyzed with multinomial logit models. RESULTS: The respondent sample consisted of 81% (300/369) of invited patients. The most important determinants of preference were PTS risk reduction and putting on the ECS. Patients were willing to increase the duration of therapy by 1 year if this increases the PTS risk reduction with 10%. Patients accepted an increase in the risk of PTS of 29% if they were able to put on the ECS themselves. Preferences were heterogeneous with respect to education level. CONCLUSIONS: Reduction of the risk of PTS and the ability to put on the ECS without help are the most important characteristics of ECS therapy. Physicians should pay considerable attention to patient education regarding PTS. In addition, patients should be supported in their ability to put on and take off the ECS independently. These rather simple interventions could improve compliance.
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Conocimientos, Actitudes y Práctica en Salud , Cooperación del Paciente , Prioridad del Paciente , Síndrome Postrombótico/prevención & control , Medias de Compresión , Trombosis de la Vena/terapia , Adulto , Anciano , Conducta de Elección , Consejo , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Países Bajos , Educación del Paciente como Asunto , Síndrome Postrombótico/diagnóstico , Síndrome Postrombótico/etiología , Medición de Riesgo , Factores de Riesgo , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Trombosis de la Vena/complicaciones , Trombosis de la Vena/diagnóstico , Trombosis de la Vena/psicologíaRESUMEN
BACKGROUND: Non-inferiority trials are performed when the main therapeutic effect of the new therapy is expected to be not unacceptably worse than that of the standard therapy, and the new therapy is expected to have advantages over the standard therapy in costs or other (health) consequences. These advantages however are not included in the classic frequentist approach of sample size calculation for non-inferiority trials. In contrast, the decision theory approach of sample size calculation does include these factors. The objective of this study is to compare the conceptual and practical aspects of the frequentist approach and decision theory approach of sample size calculation for non-inferiority trials, thereby demonstrating that the decision theory approach is more appropriate for sample size calculation of non-inferiority trials. METHODS: The frequentist approach and decision theory approach of sample size calculation for non-inferiority trials are compared and applied to a case of a non-inferiority trial on individually tailored duration of elastic compression stocking therapy compared to two years elastic compression stocking therapy for the prevention of post thrombotic syndrome after deep vein thrombosis. RESULTS: The two approaches differ substantially in conceptual background, analytical approach, and input requirements. The sample size calculated according to the frequentist approach yielded 788 patients, using a power of 80% and a one-sided significance level of 5%. The decision theory approach indicated that the optimal sample size was 500 patients, with a net value of 92 million. CONCLUSIONS: This study demonstrates and explains the differences between the classic frequentist approach and the decision theory approach of sample size calculation for non-inferiority trials. We argue that the decision theory approach of sample size estimation is most suitable for sample size calculation of non-inferiority trials.
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Ensayos Clínicos como Asunto/métodos , Teoría de las Decisiones , Trombosis de la Vena/epidemiología , Humanos , Países Bajos/epidemiología , Tamaño de la Muestra , Medias de Compresión , Trombosis de la Vena/economía , Trombosis de la Vena/terapiaRESUMEN
BACKGROUND: Several clinical guidelines recommend the use of proton pump inhibitors (PPIs) in patients taking low-dose aspirin but report no or limited supporting data. We conducted a systematic review and meta-analysis to examine the effects of co-administration of PPIs in patients taking low-dose aspirin on the risks of adverse gastrointestinal (GI) and cardiovascular (CV) events, and on patient adherence to aspirin. METHODS: We searched PUBMED, EMBASE and Cochrane Central Register of Controlled Trials databases for relevant articles published through November 2013. We included randomised controlled trials (RCTs) and observational studies in patients taking low-dose aspirin with and without PPIs. Risk of bias was assessed using the Cochrane Collaboration's tool (for RCTs) and the Newcastle-Ottawa Scale (for observational studies). Pooled risk ratios (RRs) were computed using a random-effects model. RESULTS: We included 13 studies, of which 12 (2 RCTs and 10 observational studies) reported on GI events, and one (cohort study) on both GI bleeding and CV events. No study reported on adherence to aspirin. Co-administration of PPIs in patients receiving low-dose aspirin was associated with risk reductions of 73% (RR 0.27, 95% CI 0.17-0.42) and 50% (RR 0.50, 95% CI 0.32-0.80) in the occurrence of peptic ulcer and GI bleeding respectively. There was evidence of bias in publications reporting on the GI events. CONCLUSIONS: The practice of co-prescribing PPIs in patients taking low-dose aspirin is supported by some data, but the evidence is rather weak. It currently remains unclear whether the benefits of co-administration of PPIs in users of low-dose aspirin outweigh their potential harms.
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Aspirina/administración & dosificación , Enfermedades Cardiovasculares/prevención & control , Hemorragia Gastrointestinal , Salud Global , Inhibidores de la Bomba de Protones/uso terapéutico , Antiinflamatorios no Esteroideos/administración & dosificación , Relación Dosis-Respuesta a Droga , Quimioterapia Combinada , Estudios de Seguimiento , Hemorragia Gastrointestinal/inducido químicamente , Hemorragia Gastrointestinal/epidemiología , Hemorragia Gastrointestinal/prevención & control , Humanos , Incidencia , Pronóstico , Factores de Riesgo , Factores de TiempoRESUMEN
BACKGROUND: The cost-effectiveness of the 70-gene signature (70-GS) (MammaPrint®) has earlier been estimated using retrospective validation data. Based on the prospective 5-year survival data of the microarRAy-prognoSTics-in-breast-cancER (RASTER) study, the aim here was to evaluate the cost-effectiveness reflecting the actual use in clinical practice, including reality-based compliance rates. METHODS: Costs and outcomes (quality-adjusted-life-years (QALYs)) were calculated in node-negative (N-) patients included in the RASTER study (n=427). Sensitivity and specificity of the 70-gene and Adjuvant! Online (AO) were based on 5-year distant-disease-free survival (DDFS). Subgroup analyses were performed for two groups for whom benefit of the 70-gene had earlier been reported: (1) ductal, oestrogen receptor-positive (ER+), tumour diameter 10-30 mm, grade II, age 40-70; (2) ductal, oestrogen receptor-positive, tumour diameter 5-30 mm, grade II/III and age 40-70. RESULTS: Based on 5-year survival data, the cost-effectiveness of the 70-gene signature versus AO was prospectively confirmed. The total health care costs per patient were 26,786 for the 70-gene and 29,187 for AO. The quality adjusted life years yielded 12.49 and 11.88, respectively. The subgroups retrieved slightly higher life gains and higher costs, but all resulted finally in a favourable position for the 70-gene signature. CONCLUSIONS: The use of the 70-gene signature, as judged appropriate by doctors and patients and supported by a low risk 70-gene signature as an oncological safe choice, was also found to be cost-effective.
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Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/genética , Perfilación de la Expresión Génica , Regulación Neoplásica de la Expresión Génica , Adulto , Anciano , Neoplasias de la Mama/diagnóstico , Quimioterapia Adyuvante/economía , Análisis Costo-Beneficio , Femenino , Humanos , Cadenas de Markov , Persona de Mediana Edad , Análisis de Secuencia por Matrices de Oligonucleótidos/economía , Evaluación de Resultado en la Atención de Salud/economía , Pronóstico , Estudios Prospectivos , Años de Vida Ajustados por Calidad de Vida , Receptores de Estrógenos/metabolismo , Medición de Riesgo/economía , Análisis de Supervivencia , Factores de Tiempo , Carga Tumoral/efectos de los fármacosRESUMEN
PURPOSE: This study describes the effects and costs of hearing screening and rehabilitation in residential care homes for the elderly. It was hypothesized that offering an in-house hearing screening and rehabilitation program would be an effective strategy to increase hearing aid ownership among the residents. METHOD: All 705 residents of 8 residential care homes in the Netherlands were invited to participate in a hearing screening (pure-tone audiometry) and rehabilitation (hearing aids) program. Resident participation was analyzed, and the costs were calculated. RESULTS: A total of 243 residents (34%) participated in the screening, 222 (91%) of whom had hearing loss. Ninety-one (41%) of the screening participants with hearing loss started rehabilitation, which was successful for 50 (55%) of them. Hearing aid ownership among the residents with hearing loss increased from 28% at the start of the program to 33% at the end. The costs were 1,896 (US $2,480) per successfully rehabilitated resident. Hearing aid trials and hearing aids together accounted for 83% of the total costs. CONCLUSION: The effectiveness of the program was limited, as hearing aid ownership increased only slightly. Cost reduction measures should focus on decreasing the number of unsuccessful hearing aid trials.
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Audífonos/estadística & datos numéricos , Pérdida Auditiva/diagnóstico , Hogares para Ancianos/economía , Anciano , Anciano de 80 o más Años , Audiometría de Tonos Puros , Femenino , Audífonos/economía , Pérdida Auditiva/economía , Pérdida Auditiva/rehabilitación , Humanos , Masculino , Tamizaje Masivo/economía , Tamizaje Masivo/métodos , Países BajosRESUMEN
BACKGROUND: In patients initially suspected of deep venous thrombosis (DVT) the diagnosis can be confirmed in approximately 10 to 30% of cases. For the majority of patients this means that eventually an alternative diagnosis is assigned. OBJECTIVE: To assess the frequency distribution of alternative diagnoses and subsequent management of patients in primary care after initial exclusion of DVT. In addition, assess the value of ultrasound examination for the allocation of alternative diagnoses. METHODS: Data were recorded by general practitioners alongside a diagnostic study in primary care in the Netherlands (AMUSE). Additional data were retrieved from a three-month follow-up questionnaire. A descriptive analysis was performed using these combined data. RESULTS: The most prevalent diagnoses were muscle rupture (18.5%), chronic venous insufficiency (CVI) (14.6%), erysipelas/cellulitis (12.6%) and superficial venous thrombosis (SVT) (10.9%). Alternative diagnoses were based mainly on physical examination; ultrasound examination (US) did not improve the diagnostic yield for the allocation of alternative diagnoses. In about 30% of all cases, a wait and see approach was used (27 to 41%). During the three-month follow-up nine patients were diagnosed with venous thromboembolic disease, three of which occurred in patients with the working diagnosis of SVT (p=0.026). CONCLUSIONS: We found that after exclusion of DVT in general practice a wait and see policy in the primary care setting is uneventful for almost one third of patients, but with the alternative diagnosis of SVT, patients may require closer surveillance since we found a significant association with thrombosis in these patients.
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Celulitis (Flemón)/diagnóstico , Atención Primaria de Salud/normas , Insuficiencia Venosa/diagnóstico , Trombosis de la Vena/diagnóstico , Diagnóstico Diferencial , Humanos , Examen Físico , Factores de Riesgo , Ultrasonografía/estadística & datos numéricos , Espera VigilanteRESUMEN
AIMS: To determine the 12-month, societal cost-effectiveness of involving urinary incontinence (UI) nurse specialists in primary care compared to care-as-usual by general practitioners (GPs). METHODS: From 2005 until 2008 an economic evaluation was performed alongside a pragmatic multicenter randomized controlled trial comparing UI patients receiving care by nurse specialists with patients receiving care-as-usual by GPs in the Netherlands. One hundred eighty-six adult patients with stress, urgency, or mixed UI were randomly allocated to the intervention and 198 to care-as-usual; they were followed for 1 year. Main outcome measures were Quality Adjusted Life Year (QALY(societal) ) based on societal preferences for health outcomes (EuroQol-5D), QALY(patient) based on patient preferences for health outcomes (EuroQol VAS), and Incontinence Severity weighted Life Year (ISLY) based on patient-reported severity and impact of UI (ICIQ-UI SF). Health care resource use, patient and family costs, and productivity costs were assessed. Data were collected by three monthly questionnaires. Incremental cost-effectiveness ratios were calculated. Uncertainty was assessed using bootstrap simulation, and the expected value of perfect information was calculated (EVPI). RESULTS: Compared to care-as-usual, nurse specialist involvement costs 16,742/QALY(societal) gained. Both QALY(patient) and ISLY yield slightly more favorable cost-effectiveness results. At a threshold of 40,000/QALY(societal,) the probability that the intervention is cost-effective is 58%. The EVPI amounts to 78 million. CONCLUSIONS: Based on these results, we recommend adopting the nurse specialist intervention in primary care, while conducting more research through careful monitoring of the effectiveness and costs of the intervention in routine practice.
Asunto(s)
Costos de la Atención en Salud , Enfermeras Clínicas/economía , Atención Primaria de Salud/economía , Incontinencia Urinaria/enfermería , Anciano , Anciano de 80 o más Años , Análisis Costo-Beneficio , Femenino , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Encuestas y Cuestionarios , Resultado del Tratamiento , Incontinencia Urinaria/economíaRESUMEN
OBJECTIVES: The Exercise Therapy in Peripheral Arterial Disease (EXITPAD) study has shown supervised exercise therapy (SET) to be more effective regarding walking distance and quality of life than a 'go home and walk' advice (WA) for patients with intermittent claudication. The present study aims to assess the cost-effectiveness of SET versus WA. PATIENTS AND METHODS: Data from the EXITPAD study, a 12-month randomised controlled trial in 304 patients with claudication, was used to study the proportion of costs to walking distance and quality of life. Two different incremental cost-effectiveness ratios (ICERs) were calculated for SET versus WA: costs per extra metre on the treadmill test, and costs per quality-adjusted life year (QALY). QALYs were based on utilities derived from the EuroQoL-5 dimensions (EQ-5D). RESULTS: Mean total costs were higher for SET than for WA (3407 versus 2304 Euros), mainly caused by the costs of exercise therapy. The median walking distance was 620 m for SET and 400 m for WA. QALYs were 0.71 for SET and 0.67 for WA. All differences were statistically significant. The ICER for cost per extra metre on the 12-month treadmill test was 4.08. For cost per QALY, the ICER was 28,693. CONCLUSION: At a willingness-to-pay threshold of 40,000 per QALY, SET likely is a cost-effective therapeutic option for patients with claudication.