Silvia M. A. A. Evers

Criteria list for assessment of methodological quality of economic evaluations : Consensus on Health Economic Criteria

OBJECTIVES The aim of the Consensus on Health Economic Criteria (CHEC) project is to develop a criteria list for assessment of the methodological quality of economic evaluations in systematic reviews. The criteria list resulting from this CHEC project should be regarded as a minimum standard. METHODS The criteria list has been developed using a Delphi method. Three Delphi rounds were needed to reach consensus. Twenty-three international experts participated in the Delphi panel. RESULTS The Delphi panel achieved consensus over a generic core set of items for the quality assessment of economic evaluations. Each item of the CHEC-list was formulated as a question that can be answered by yes or no. To standardize the interpretation of the list and facilitate its use, the project team also provided an operationalization of the criteria list items. CONCLUSIONS There was consensus among a group of international experts regarding a core set of items that can be used to assess the quality of economic evaluations in systematic reviews. Using this checklist will make future systematic reviews of economic evaluations more transparent, informative, and comparable. Consequently, researchers and policy-makers might use these systematic reviews more easily. The CHEC-list can be downloaded freely from http://www.beoz.unimaas.nl/chec/.

Stereotactic Treatment of Intracerebral Hematoma by Means of a Plasminogen Activator. A Multicenter Randomized Controlled Trial (SICHPA)

Background and Purpose— Treatment of intracerebral hematoma (ICH) is controversial. An advantage of neurosurgical intervention over conservative treatment of ICH has not been established. Recent reports suggest a favorable effect of stereotactic blood clot removal after liquefaction by means of a plasminogen activator. The SICHPA trial was aimed at investigating the efficacy of this treatment. Methods— A stereotactically placed catheter was used to instill urokinase to liquefy and drain the ICH in 6-hour intervals over 48 hours. From 1996 to 1999, 13 centers entered 71 patients into the study. Patients were randomized into a surgical group (n=36) and a nonsurgical group (n=35). Admission criteria were the following: age >45 years, spontaneous supratentorial ICH, Glasgow Eye Motor score ranging from 2 to 10, ICH volume >10 cm3, and treatment within 72 hours. The primary end point was death at 6 months. As secondary end points, ICH volume reduction and overall outcome measured by the modified Rankin scale were chosen. The trial was prematurely stopped as a result of slow patient accrual. Results— Seventy patients were analyzed. Overall mortality at day 180 after stroke was 57%; this included 20 of 36 patients (56%) in the surgical group and 20 of 34 patients (59%) in the nonsurgical group. A significant ICH volume reduction was achieved by the intervention (10% to 20%, P <0.05). Logistic regression analysis indicated the possibility of efficacy for surgical treatment (odds ratio, 0.23; 95% confidence interval, 0.05 to 1.20;P =0.08). The odds ratio of mortality combined with modified Rankin scale score 5 at 180 days was also not statistically significant (odds ratio, 0.52; 95% confidence interval, 1.2 to 2.3;P =0.38). Conclusions— Stereotactic aspiration can be performed safely and in a relatively uniform manner; it leads to a modest reduction of 18 mL of hematoma reduction over 7 days when compared with control, which has a 7-mL reduction, and therefore may improve prognosis.

Results of a Multicenter Randomized Controlled Trial of the Clinical Effectiveness of Schema Therapy for Personality Disorders

OBJECTIVE The authors compared the effectiveness of 50 sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C, paranoid, histrionic, or narcissistic personality disorder. METHOD A multicenter randomized controlled trial, with a single-blind parallel design, was conducted between 2006 and 2011 in 12 Dutch mental health institutes. A total of 323 patients with personality disorders were randomly assigned (schema therapy, N=147; treatment as usual, N=135; clarification-oriented psychotherapy, N=41). There were two cohorts of schema therapy therapists, with the first trained primarily with lectures and the second primarily with exercises. The primary outcome was recovery from personality disorder 3 years after treatment started (assessed by blinded interviewers). Secondary outcomes were dropout rates and measures of personality disorder traits, depressive and anxiety disorders, general psychological complaints, general and social functioning, self-ideal discrepancy, and quality of life. RESULTS A significantly greater proportion of patients recovered in schema therapy compared with treatment as usual and clarification-oriented psychotherapy. Second-cohort schema therapists had better results than first-cohort therapists. Clarification-oriented psychotherapy and treatment as usual did not differ. Findings did not vary with specific personality disorder diagnosis. Dropout was lower in the schema therapy and clarification-oriented psychotherapy conditions. All treatments showed improvements on secondary outcomes. Schema therapy patients had less depressive disorder and higher general and social functioning at follow-up. While interview-based measures demonstrated significant differences between treatments, differences were not found with self-report measures. CONCLUSIONS Schema therapy was superior to treatment as usual on recovery, other interview-based outcomes, and dropout. Exercise-based schema therapy training was superior to lecture-based training.

Lack of Effectiveness of a Multidisciplinary Fall-Prevention Program in Elderly People at Risk: A Randomized, Controlled Trial

OBJECTIVES: To assess whether a pragmatic multidisciplinary fall‐prevention program was more effective than usual care in preventing new falls and functional decline in elderly people.

Medication-overuse headache in patients with cluster headache

Objective: Medication-overuse headache (MOH) in cluster headache (CH) patients is incompletely described, perhaps because of the relatively low prevalence of CH. Methods: The authors describe a retrospective series of 17 patients (13 men, 4 women) with CH who developed MOH in association with overuse of a wide range of monotherapies or varying combinations of simple analgesics (n = 9), caffeine (n = 1), opioids (n = 10), ergotamine (n = 3), and triptans (n = 14). The series includes both episodic (n = 7) and chronic (n = 10) CH patients. Results: A specific triptan-overuse headache diagnosis was made in 3 patients, an opioid-overuse headache diagnosis was made in 1 patient, and an ergotamine-overuse headache diagnosis was made in 1 patient. In approximately half of the patients (n = 8), the MOH phenotype was a bilateral, dull, and featureless daily headache. In the other 9 patients, the MOH was characterized by at least one associated feature, most commonly nausea (n = 6), exacerbation with head movement (n = 5), or throbbing character of the pain (n = 5). The common denominator in 15 patients was a personal or family history, or both, of migraine. The 2 other patients gave a family history of unspecified headaches. Medication withdrawal was attempted and successful in 13 patients. Conclusions: Medication-overuse headache is a previously underrecognized and treatable problem associated with cluster headache (CH). CH patients should be carefully monitored, especially those with a personal or family history of migraine.

Dutch Tariff for the Five-Level Version of EQ-5D

BACKGROUND In 2009, a new version of the EuroQol five-dimensional questionnaire (EQ-5D) was introduced with five rather than three answer levels per dimension. This instrument is known as the EQ-5D-5L. To make the EQ-5D-5L suitable for use in economic evaluations, societal values need to be attached to all 3125 health states. OBJECTIVES To derive a Dutch tariff for the EQ-5D-5L. METHODS Health state values were elicited during face-to-face interviews in a general population sample stratified for age, sex, and education, using composite time trade-off (cTTO) and a discrete choice experiment (DCE). Data were modeled using ordinary least squares and tobit regression (for cTTO) and a multinomial conditional logit model (for DCE). Model performance was evaluated on the basis of internal consistency, parsimony, goodness of fit, handling of left-censored values, and theoretical considerations. RESULTS A representative sample (N = 1003) of the Dutch population participated in the valuation study. Data of 979 and 992 respondents were included in the analysis of the cTTO and the DCE, respectively. The cTTO data were left-censored at -1. The tobit model was considered the preferred model for the tariff on the basis of its handling of the censored nature of the data, which was confirmed through comparison with the DCE data. The predicted values for the EQ-5D-5L ranged from -0.446 to 1. CONCLUSIONS This study established a Dutch tariff for the EQ-5D-5L on the basis of cTTO. The values represent the preferences of the Dutch population. The tariff can be used to estimate the impact of health care interventions on quality of life, for example, in context of economic evaluations.

Modeling the Future Burden of Stroke in the Netherlands Impact of Aging, Smoking, and Hypertension

Background and Purpose— In the near future, the number of stroke patients and their related healthcare costs are expected to rise. The purpose of this study was to estimate this expected increase in stroke patients in the Netherlands. We sought to determine what the future developments in the number of stroke patients due to demographic changes and trends in the prevalence of smoking and hypertension in terms of the prevalence, incidence, and potential years of life lost might be. Methods— A dynamic, multistate life table was used, which combined demographic projections and existing stroke morbidity and mortality data. It projected future changes in the number of stroke patients in several scenarios for the Dutch population for the period 2000 to 2020. The model calculated the annual number of new patients by age and sex by using incidence rates, defined by age, sex, and major risk factors. The change in the annual number of stroke patients is the result of incident cases minus mortality numbers. Results— Demographic changes in the population suggest an increase of 27% in number of stroke patients per 1000 in 2020 compared with 2000. Extrapolating past trends in the prevalence of smoking behavior, hypertension, and stroke incidence resulted in an increase of 4%. Conclusions— The number of stroke patients in the Netherlands will rise continuously until the year 2020. Our study demonstrates that a large part of this increase in the number of patients is an inevitable consequence of the aging of the population.

Cost of Stroke in the Netherlands From a Societal Perspective

BACKGROUND AND PURPOSE Cerebrovascular disorders are associated with a high level of morbidity and mortality and call for considerable resources. The objective of this study was to determine from a societal perspective the medical consumption (direct costs) and productivity losses (indirect costs) caused by cerebrovascular disorders in the Netherlands. METHODS This study can be characterized as a cost-of-illness study based on prevalence data. All data gathered refer to 1993. Cerebrovascular disorders are defined according to the International Classification of Diseases, 9th Revision (ICD-9) classification. Data from medical registrations and national statistics have been analyzed. For both direct and indirect costs, volume and cost components are presented. To test the likelihood of the assumptions, a sensitivity analysis was performed. RESULTS The cost of cerebrovascular disorders in the Netherlands in 1993 amounted to 2.5 billion Dutch guilders, of which 1.9 billion were spent on medical consumption. It was found that direct costs are generated mainly by the long-term care of inpatients (nursing homes and hospitals). The productivity losses were relatively low in comparison with other diseases, probably due to the fact that most patients with cerebrovascular disorders are elderly. CONCLUSIONS More than 3% of the Dutch annual healthcare budget is spent on patients suffering from cerebrovascular disorders. Costs in the future may be influenced by, among other things, demographic changes, new therapies, and cost-reduction programs introduced by the government.

Utilities of the EQ-5D: transferable or not?

BackgroundWithin the framework of economic evaluations, the transferability of utility scores between jurisdictions remains unclear. The EQ-5D is a generic instrument for measuring health-related quality of life in economic evaluations, which can be used for comparing utility scores across countries. At present, the EQ-5D has several national value sets or tariffs. Nevertheless, utility estimates from foreign studies are often used directly for cost-effectiveness estimates, without adapting by applying the appropriate national value set. It is unclear if this practice is advisable, due to dissimilarities between the national value sets.ObjectiveTo examine the effects of differences in national EQ-5D value sets on absolute and marginal utilities of health states, and determine to what degree these differences can be explained by methodological factors.MethodsFirst, the relative importance of the EQ-5D domains for the utility estimates was compared across the 15 value sets. Second, two hypothetical health states for a depressed patient and a pain patient (21232 and 33321) were selected for additional analysis, by comparing the utilities as scored by the value sets. The marginal influence of a one-level deterioration in a domain of these health states on the utility estimate was then determined. Third, the differences between the value sets were examined in more detail by using multilevel analysis to examine the role of methodological differences in the valuation studies.ResultsDifferences can be perceived between the national value sets of the EQ-5D in the preferences for the domains. The utilities of the two hypothetical health states show that the value sets differ substantially. Furthermore, the differences between the marginal values of the deteriorations are large, which can be explained partly by the type of valuation method. Other methodological differences also influence the value sets.ConclusionAll results indicate that the differences between the EQ-5D value sets are considerable and should not be ignored. The differences can largely be explained by methodological differences in the valuation studies. The remaining differences may reflect cultural dissimilarities between countries. Therefore, further research should focus on investigating the transferability of utilities across countries or agreeing on a standard to perform valuation studies. For the time being, transferring utilities from one country to another without any adjustment is not advisable.

Economic Evaluation in Stroke Research A Systematic Review

BACKGROUND AND PURPOSE The purpose of this review is to provide insight into the quality of economic evaluation in the field of cerebrovascular diseases (CVD) on the basis of a systematic analysis. METHODS A literature search was performed using several sources. Trial-based full economic evaluation studies, were included in this review. The quality of the studies was independently assessed by 2 reviewers using a checklist. RESULTS Twenty-three articles were found to comply with our inclusion and exclusion criteria. Only a few studies mentioned the perspective of the study, and in these cases it was always the societal perspective. The majority of the studies were cost-minimization and cost-effectiveness analyses based on cohort studies. All studies included healthcare costs, and in some instances patient and family costs were considered. Costs were usually measured by tariffs. Clinical end points and mortality were used to measure effects. Cost and effect measurements were based on hospital records. CONCLUSIONS Only a few full economic evaluations have been undertaken in the domain of CVD. In most of the studies, the technical execution and methodology were limited.