Lucas M.A. Goossens

The cost-utility of rotavirus vaccination with Rotarix™ (RIX4414) in the Netherlands

The objective of this study was to estimate the cost-utility of mass vaccination of 0-4-year-old children with Rotarix in the Netherlands. We used a Markov process with Dutch data on incidence, resource use and costs (GP, hospitalisation, productivity loss and household costs) to compare vaccination to conventional treatment from a societal perspective. Utility loss due to rotavirus-induced diarrhoea was measured using EQ5D, with GPs and paediatricians serving as proxies to fill out the questions. As the costs of a vaccination course ranged from 90 euro to 100 euro per child, the cost-utility ratio varied from 21,900 euro to 35,076 euro per QALY gained. Based on the current study, it is clear that mass vaccination with Rotarix against rotavirus gastroenteritis can be attractive, from an economic and a health care perspective.

Early assisted discharge with generic community nursing for chronic obstructive pulmonary disease exacerbations: results of a randomised controlled trial

Objectives To determine the effectiveness of early assisted discharge for chronic obstructive pulmonary disease (COPD) exacerbations, with home care provided by generic community nurses, compared with usual hospital care. Design Prospective, randomised controlled and multicentre trial with 3-month follow-up. Setting Five hospitals and three home care organisations in the Netherlands. Participants Patients admitted to the hospital with an exacerbation of COPD. Patients with no or limited improvement of respiratory symptoms and patients with severe unstable comorbidities, social problems or those unable to visit the toilet independently were excluded. Intervention Early discharge from hospital after 3 days inpatient treatment. Home visits by generic community nurses. Primary outcome measure was change in health status measured by the Clinical COPD Questionnaire (CCQ). Treatment failures, readmissions, mortality and change in generic health-related quality of life (HRQL) were secondary outcome measures. Results 139 patients were randomised. No difference between groups was found in change in CCQ score at day 7 (difference in mean change 0.29 (95% CI −0.03 to 0.61)) or at 3 months (difference in mean change 0.04 (95% CI –0.40 to 0.49)). No difference was found in secondary outcomes. At day 7 there was a significant difference in change in generic HRQL, favouring usual hospital care. Conclusions While patients’ disease-specific health status after 7-day treatment tended to be somewhat better in the usual hospital care group, the difference was small and not clinically relevant or statistically significant. After 3 months, the difference had disappeared. A significant difference in generic HRQL at the end of the treatment had disappeared after 3 months and there was no difference in treatment failures, readmissions or mortality. Early assisted discharge with community nursing is feasible and an alternative to usual hospital care for selected patients with an acute COPD exacerbation. Trial registration: NetherlandsTrialRegister NTR 1129.

Cost effectiveness of pharmacological maintenance treatment for chronic obstructive pulmonary disease: A review of the evidence and methodological issues

AbstractBackground: Over 200 million people have chronic obstructive pulmonary disease (COPD) worldwide. The number of disease-year equivalents and deaths attributable to COPD are high.Guidelines for the pharmacological treatment of the disease recommend an individualized step-up approach in which treatment is intensified when results are unsatisfactory. Objective: Our objective was to present a systematic review of the cost effectiveness of pharmacological maintenance treatment for COPD and to discuss the methodological strengths and weaknesses of the studies. Methods: A systematic literature search for economic evaluations of drug therapy in COPD was performed inMEDLINE, EMBASE, the Economic Evaluation Database of the UK NHS (NHS-EED) and the European Network of Health Economic Evaluation Databases (EURONHEED). Full economic evaluations presenting both costs and health outcomes were included. Results: A total of 40 studies were included in the review.Of these, 16 were linked to a clinical trial, 14 usedMarkovmodels, eight were based on observational data and two used a different approach. The few studies on combining short-acting bronchodilators were consistent in finding net cost savings compared with monotherapy. Studies comparing inhaled corticosteroids (ICS) with placebo or no maintenance treatment reported inconsistent results. Studies comparing fluticasone with salmeterol consistently found salmeterol to be more cost effective. The cost-effectiveness studies of tiotropium versus placebo, ipratropium or salmeterol pointed towards a reduction in total COPD-related healthcare costs for tiotropium in many but not all studies. All of these studies reported additional health benefits of tiotropium. The cost-effectiveness studies of the combination of inhaled long-acting β2-agonists and ICS all report additional health benefits at an increase in total COPD-related costs in most studies. The cost-per-QALY estimates of this combination treatment vary widely and are very sensitive to the assumptions on mortality benefit and time horizon. Conclusions: The currently available economic evaluations indicate differences in cost effectiveness between COPD maintenance therapies, but for a more meaningful comparison of results it is important to improve the consistency with respect to study methodology and choice of comparator.

Effectiveness and cost-effectiveness of early assisted discharge for Chronic Obstructive Pulmonary Disease exacerbations: the design of a randomised controlled trial

BackgroundExacerbations of Chronic Obstructive Pulmonary Disease (COPD) are the main cause for hospitalisation. These hospitalisations result in a high pressure on hospital beds and high health care costs. Because of the increasing prevalence of COPD this will only become worse. Hospital at home is one of the alternatives that has been proved to be a safe alternative for hospitalisation in COPD. Most schemes are early assisted discharge schemes with specialised respiratory nurses providing care at home. Whether this type of service is cost-effective depends on the setting in which it is delivered and the way in which it is organised.Methods/DesignGO AHEAD (Assessment Of Going Home under Early Assisted Discharge) is a 3-months, randomised controlled, multi-centre clinical trial. Patients admitted to hospital for a COPD exacerbation are either discharged on the fourth day of admission and further treated at home, or receive usual inpatient hospital care. Home treatment is supervised by general nurses. Primary outcome is the effectiveness and cost effectiveness of an early assisted discharge intervention in comparison with usual inpatient hospital care for patients hospitalised with a COPD exacerbation. Secondary outcomes include effects on quality of life, primary informal caregiver burden and patient and primary caregiver satisfaction. Additionally, a discrete choice experiment is performed to provide insight in patient and informal caregiver preferences for different treatment characteristics. Measurements are performed on the first day of admission and 3 days, 7 days, 1 month and 3 months thereafter. Ethical approval has been obtained and the study has been registered.DiscussionThis article describes the study protocol of the GO AHEAD study. Early assisted discharge could be an effective and cost-effective method to reduce length of hospital stay in the Netherlands which is beneficial for patients and society. If effectiveness and cost-effectiveness can be proven, implementation in the Dutch health care system should be considered.Trial registrationNetherlands Trial Register NTR1129.

Cost-effectiveness of early assisted discharge for COPD exacerbations in The Netherlands.

OBJECTIVES Hospital admissions for exacerbations of chronic obstructive pulmonary disease are the main cost drivers of the disease. An alternative is to treat suitable patients at home instead of in the hospital. This article reports on the cost-effectiveness and cost-utility of early assisted discharge in The Netherlands. METHODS In the multicenter randomized controlled Assessment of GOing Home under Early Assisted Discharge trial (n = 139), one group received 7 days of inpatient hospital treatment (HOSP) and one group was discharged after 3 days and treated at home by community nurses for 4 days. Health care resource use, productivity losses, and informal care were recorded in cost questionnaires. Microcosting was performed for inpatient day costs. RESULTS Seven days after admission, mean change from baseline Clinical Chronic Obstructive Pulmonary Disease Questionnaire score was better for HOSP, but not statistically significantly: 0.29 (95% confidence interval [CI]-0.04 to 0.61). The difference in the probability of having a clinically relevant improvement was significant in favor of HOSP: 19.0%-point (95% CI 0.5%-36.3%). After 3 months of follow-up, differences in effectiveness had almost disappeared. The difference in quality-adjusted life-years was 0.0054 (95% CI-0.021 to 0.0095). From a health care perspective, early assisted discharge was cost saving:-€244 (treatment phase, 95% CI-€315 to-€168) and-€168 (3 months, 95% CI-€1253 to €922). Societal perspective:-€65 (treatment phase, 95% CI-€152 to €25) and €908 (3 months, 95% CI-€553 to €2296). The savings per quality-adjusted life-year lost were €31,111 from a health care perspective. From a societal perspective, HOSP was dominant. CONCLUSIONS No clear evidence was found to conclude that either treatment was more effective or less costly.

e-Monitoring of Asthma Therapy to Improve Compliance in children (e-MATIC): a randomised controlled trial

Real-time medication monitoring (RTMM) is a promising tool for improving adherence to inhaled corticosteroids (ICS), but has not been sufficiently tested in children with asthma. We aimed to study the effects of RTMM with short message service (SMS) reminders on adherence to ICS, asthma control, asthma-specific quality of life and asthma exacerbation rate; and to study the associated cost-effectiveness. In a multicentre, randomised controlled trial, children (aged 4–11 years) using ICS were recruited from five outpatient clinics and were given an RTMM device for 12 months. The intervention group also received tailored SMS reminders, sent only when a dose was at risk of omission. Outcome measures were adherence to ICS (RTMM data), asthma control (childhood asthma control test questionnaire), quality of life (paediatric asthma quality of life questionnaire) and asthma exacerbations. Costs were calculated from a healthcare and societal perspective. We included 209 children. Mean adherence was higher in the intervention group: 69.3% versus 57.3% (difference 12.0%, 95% CI 6.7%–17.7%). No differences were found for asthma control, quality of life or asthma exacerbations. Costs were higher in the intervention group, but this difference was not statistically significant. RTMM with tailored SMS reminders improved adherence to ICS, but not asthma control, quality of life or exacerbations in children using ICS for asthma. e-Monitoring with tailored SMS reminders improves adherence to ICS, but not clinical outcomes in children with asthma http://ow.ly/4mWMgx

Should I Stay or Should I Go Home? A Latent Class Analysis of a Discrete Choice Experiment on Hospital-At-Home

OBJECTIVES This study aimed 1) to quantify the strength of patient preferences for different aspects of early assisted discharge in The Netherlands for patients who were admitted with a chronic obstructive pulmonary disease exacerbation and 2) to illustrate the benefits of latent class modeling of discrete choice data. This technique is rarely used in health economics. METHODS Respondents made multiple choices between hospital treatment as usual (7 days) and two combinations of hospital admission (3 days) followed by treatment at home. The latter was described by a set of attributes. Hospital treatment was constant across choice sets. Respondents were patients with chronic obstructive pulmonary disease in a randomized controlled trial investigating the cost-effectiveness of early assisted discharge and their informal caregivers. The data were analyzed using mixed logit, generalized multinomial logit, and latent-class conditional logit regression. These methods allow for heterogeneous preferences across groups, but in different ways. RESULTS Twenty-five percent of the respondents opted for hospital treatment regardless of the description of the early assisted discharge program, and 46% never opted for the hospital. The best model contained four latent classes of respondents, defined by different preferences for the hospital and caregiver burden. Preferences for other attributes were constant across classes. Attributes with the strongest effect on choices were the burden on informal caregivers and co-payments. Except for the number of visits, all attributes had a significant effect on choices in the expected direction. CONCLUSIONS Considerable segments of respondents had fixed preferences for either treatment option. Applying latent class analysis was essential in quantifying preferences for attributes of early assisted discharge.

Effectiveness of the Assessment of Burden of COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled trial in primary and hospital care

Objective Assessing the effectiveness of the Assessment of Burden of COPD (ABC) tool on disease-specific quality of life in patients with chronic obstructive pulmonary disease (COPD) measured with the St. Georges Respiratory Questionnaire (SGRQ), compared with usual care. Methods A pragmatic cluster randomised controlled trial, in 39 Dutch primary care practices and 17 hospitals, with 357 patients with COPD (postbronchodilator FEV1/FVC ratio <0.7) aged ≥40 years, who could understand and read the Dutch language. Healthcare providers were randomly assigned to the intervention or control group. The intervention group applied the ABC tool, which consists of a short validated questionnaire assessing the experienced burden of COPD, objective COPD parameter (eg, lung function) and a treatment algorithm including a visual display and treatment advice. The control group provided usual care. Researchers were blinded to group allocation during analyses. Primary outcome was the number of patients with a clinically relevant improvement in SGRQ score between baseline and 18-month follow-up. Secondary outcomes were the COPD Assessment Test (CAT) and the Patient Assessment of Chronic Illness Care (PACIC; a measurement of perceived quality of care). Results At 18-month follow-up, 34% of the 146 patients from 27 healthcare providers in the intervention group showed a clinically relevant improvement in the SGRQ, compared with 22% of the 148 patients from 29 healthcare providers in the control group (OR 1.85, 95% CI 1.08 to 3.16). No difference was found on the CAT (−0.26 points (scores ranging from 0 to 40); 95% CI −1.52 to 0.99). The PACIC showed a higher improvement in the intervention group (0.32 points (scores ranging from 1 to 5); 95% CI 0.14 to 0.50). Conclusions This study showed that use of the ABC tool may increase quality of life and perceived quality of care. Trial registration number NTR3788; Results.

Mapping the clinical chronic obstructive pulmonary disease questionnaire onto generic preference-based EQ-5D values

OBJECTIVES To develop a model to predict EuroQol five-dimensional questionnaire (EQ-5D) values from clinical chronic obstructive pulmonary disease (COPD) questionnaire (CCQ) scores. METHODS We used data from three clinical trials (the Randomized Clinical Trial on Effectiveness of Integrated COPD Management in Primary Care [RECODE], the Assessment Of Going Home Under Early Assisted Discharge [GO-AHEAD], and the Health Status Guided COPD Care [MARCH]). Data were randomly split into an estimation sample and a validation sample. The conceptual similarity between patient-reported CCQ and preference-based EQ-5D scores was assessed using correlation and principal-component analysis. Different types of models were estimated with increasing complexity. We selected the final models on the basis of mean absolute error and root mean square error when comparing predicted and observed values from the same population (internal validity) and from different trial populations (external validity). We also developed models for different country-specific EQ-5D value sets. RESULTS The principal-component analysis showed that the CCQ domains functional state and mental state are associated with four dimensions of the EQ-5D. The EQ-5D dimension pain/discomfort formed a separate construct on which no CCQ item loaded. The mean observed EQ-5D values were not significantly different from the mean predicted EQ-5D values in internal validation samples but did significantly differ in external validation samples. The models underestimated EQ-5D values in milder health states and overestimated them in more severe health states. The predictive ability of the models was similar across different EQ-5D value sets. CONCLUSIONS The models can predict mean EQ-5D values that are similar to observed mean values in a similar population. The overestimating/underestimating of the low/high EQ-5D values, however, limits its use in Markov models. Therefore, mapping should be used cautiously.

Adjusting for COPD severity in database research: developing and validating an algorithm

Purpose When comparing chronic obstructive lung disease (COPD) interventions in database research, it is important to adjust for severity. Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines grade severity according to lung function. Most databases lack data on lung function. Previous database research has approximated COPD severity using demographics and healthcare utilization. This study aims to derive an algorithm for COPD severity using baseline data from a large respiratory trial (UPLIFT). Methods Partial proportional odds logit models were developed for probabilities of being in GOLD stages II, III and IV. Concordance between predicted and observed stage was assessed using kappa-statistics. Models were estimated in a random selection of 2/3 of patients and validated in the remainder. The analysis was repeated in a subsample with a balanced distribution across severity stages. Univariate associations of COPD severity with the covariates were tested as well. Results More severe COPD was associated with being male and younger, having quit smoking, lower BMI, osteoporosis, hospitalizations, using certain medications, and oxygen. After adjusting for these variables, co-morbidities, previous healthcare resource use (eg, emergency room, hospitalizations) and inhaled corticosteroids, xanthines, or mucolytics were no longer independently associated with COPD severity, although they were in univariate tests. The concordance was poor (kappa = 0.151) and only slightly better in the balanced sample (kappa = 0.215). Conclusion COPD severity cannot be reliably predicted from demographics and healthcare use. This limitation should be considered when interpreting findings from database studies, and additional research should explore other methods to account for COPD severity.