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- Delgado-Ortega, L., et al.
(author)
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PCV45 Health Economic Evaluation of Ticagrelor in Patients with Acute Coronary Patients (ACS) Based on the Plato Study from A Spanish Health Care Perspective
- 2011
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In: Value in Health. - : Elsevier. - 1098-3015 .- 1524-4733. ; 14:7, s. A372-A372
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Journal article (other academic/artistic)abstract
- ObjectivesPLATO was a multi centered, double blind, randomized study that included 18,624 ACS patients from 43 countries, comparing ticagrelor + aspirin versus clopidogrel + aspirin. The PLATO demonstrated that ticagrelor was superior on the primary composite endpoint: myocardial infarction, stroke, cardiovascular death (HR 0.84, 95% CI: 0.77 to 0.92) without an increase in major bleedings compared to clopidogrel, and whether the strategy of choice was invasive or conservative. The aim of this analysis is to estimate direct health care costs from a Spanish health care perspective (excluding drug costs because ticagrelor price has not yet been established).MethodsResource utilization was pre specified in the PLATO trial and included hospitalization bed days, investigations, interventions and blood products. Direct health care costs per patient at 12 months were estimated by multiplying the resource use with Spanish unit costs derived from the Spanish database e-salud, the GRDs of the Ministry of Health, published literature, and the CMBD 2008.ResultsTicagrelor resulted in numerically fewer bed days (mean difference per patient 0.21, 95% CI -0.16 to 0.59), PCIs (mean difference per patient 0.01, 95% CI -0.01 to 0.03) and CABGs (mean difference per patient 0.01, 95% CI: 0.00 to 0.01). Ticagrelor is associated with €341 reduction per patient (95% CI: 31 to 652) in healthcare costs at 12 months compared to clopidogrel. The reduction in healthcare costs was mainly due to fewer hospital days and cardiovascular interventions in the ticagrelor group. The reduction in cost increased over the 12-month treatment period consistent with the rate of clinical events over time in the PLATO study.ConclusionsTreatment with ticagrelor is associated with cost savings in patients with ACS at 12 months compared with clopidogrel (excluding drug costs) from a Spanish health care perspective. However, the total cost savings will depend on drug price, data not available yet.
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- Doward, Lynda C., et al.
(author)
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International Development of the Unidimensional Fatigue Impact Scale (U-FIS)
- 2010
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In: Value in Health. - : Elsevier BV. - 1098-3015. ; 13:4, s. 463-468
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Journal article (peer-reviewed)abstract
- Objective: The 22-item Unidimensional Fatigue Impact Scale (U-FIS) provides an index of the impact of fatigue on patients with multiple sclerosis (MS). The objective is to produce eight new language versions of the U-FIS: Canadian-English, Canadian-French, French, German, Italian, Spanish, Swedish, and US-English. Methods: The U-FIS was translated via two translation panels. Cognitive debriefing interviews conducted with patients in each country assessed face and content validity. Scaling and psychometric properties were assessed via survey data with patients in each country completing the U-FIS, Nottingham Health Profile (NHP), and demographic questions. Results: Cognitive debriefing interviews demonstrated U-FIS acceptability. Analysis of postal survey data showed all new language versions to be unidimensional. Reliability was high, with test-retest correlations and internal-consistency coefficients exceeding 0.85. Initial evidence of validity was provided by moderate to high correlations with NHP scales. The U-FIS was able to discriminate between groups based on employment status, perceived MS severity, and general health. Conclusion: The U-FIS is a practical new measure of the impact of fatigue. It was successfully adapted into eight new languages to broaden availability for researchers. Psychometric analyses indicated that the new language versions were unidimensional and reproducible with promising construct validity.
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| 24. |
- Ekman, M., et al.
(author)
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PMH30 The Societal Cost of Depression: Evidence from 10,000 Swedish Patients in Psychiatric Care
- 2012
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In: Value in Health. - 1098-3015. ; 15:4
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Conference paper (peer-reviewed)abstract
- Objectives Depression is a major health problem. Previous studies on the cost of depression have mainly taken a primary care perspective. Such studies do not include all patients with depression, and should be completed by cost estimates from psychiatric care. The objectives of this study were to estimate the annual societal cost of depression per patient in psychiatric care in Sweden, and to relate costs to disease severity, depressive episodes, hospitalization, and patient functioning. Methods Retrospective resource use data in inpatient and outpatient care for 2006-2008, as well as ICD-10 diagnoses and Global Assessment of Functioning (GAF), were obtained from Northern Stockholm psychiatric clinic with a catchment area including 47% of the adult inhabitants in Stockholm city. This data set was combined with national register data on prescription pharmaceuticals and sick leave to estimate the societal cost of depression. Results The study included 10,593 patients (63% women). The average annual societal cost per patient was around USD 21,000 in 2006-2008. The largest cost item was indirect costs due to productivity losses (89%), and the second largest was outpatient care (6%). Patients with mild, moderate or severe depression had an average cost of approximately USD 18,000, USD 21,000, and USD 29,000, respectively. Total costs were significantly higher during depressive episodes, for patients with co-morbid psychosis or anxiety, for hospitalized patients, and for patients with low GAF scores. Conclusions The largest share of societal costs for patients with depression in psychiatric care is indirect. The total costs were higher than previously reported from a primary care setting, and strongly related to hospitalization, episodes of active depression, and global functioning. This suggests that effective treatment and rehabilitation that avoid depressive episodes and hospitalization may not only improve patient health, but also reduce the societal cost of depression.
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- Hagell, Peter, et al.
(author)
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Effects of method of translation of patient-reported health outcome questionnaires : a randomized study of the translation of the Rheumatoid Arthritis Quality of Life (RAQoL) Instrument for Sweden
- 2010
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In: Value in Health. - : Wiley-Blackwell. - 1098-3015 .- 1524-4733. ; 13:4, s. 424-430
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Journal article (peer-reviewed)abstract
- AIMS: To compare two versions of a questionnaire translated using forward-backward (FB) translation and dual-panel (DP) methodologies regarding preference of wording and psychometric properties.METHODS: The Rheumatoid Arthritis Quality of Life instrument was adapted into Swedish by two independent groups using FB and DP methodologies, respectively. Seven out of thirty resulting items were identical. Nonidentical items were evaluated regarding preference of wording by 23 bilingual Swedes, 50 people with rheumatoid arthritis (RA), and 2 lay panels (n = 11). Psychometric performance was assessed from a postal survey of 200 people with RA randomly assigned to complete one version first and the other 2 weeks later.RESULTS: Preference did not differ among the 23 bilinguals (P = 0.196), whereas patients and lay people preferred DP over FB item versions (P < 0.0001). Postal survey response rates were 74% (FB) and 75% (DP). There were more missing item responses in the FB than the DP version (6.9% vs. 5.6%; P < 0.0001). Floor/ceiling effects were small (FB, 6.1/0%; DP, 4.4/0.7%) and reliability was 0.92 for both versions. Construct validity was similar for both versions. Differential item functioning by version was detected for five items but cancelled out and did not affect estimated person measures.CONCLUSIONS: The DP approach showed advantages over FB translation in terms of preference by the target population and by lay people, whereas there were no obvious psychometric differences. This suggests advantages of DP over FB translation from the patients' perspective, and does not support the commonly held view that FB translation is the "gold standard."
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| 31. |
- Hagell, Peter, et al.
(author)
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Effects of Method of Translation of Patient-Reported Health Outcome Questionnaires: A Randomized Study of the Translation of the Rheumatoid Arthritis Quality of Life (RAQoL) Instrument for Sweden.
- 2010
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In: Value in Health. - : Elsevier BV. - 1098-3015. ; 13, s. 424-430
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Journal article (peer-reviewed)abstract
- ABSTRACT Aims: To compare two versions of a questionnaire translated using forward-backward (FB) translation and dual-panel (DP) methodologies regarding preference of wording and psychometric properties. Methods: The Rheumatoid Arthritis Quality of Life instrument was adapted into Swedish by two independent groups using FB and DP methodologies, respectively. Seven out of thirty resulting items were identical. Nonidentical items were evaluated regarding preference of wording by 23 bilingual Swedes, 50 people with rheumatoid arthritis (RA), and 2 lay panels (n = 11). Psychometric performance was assessed from a postal survey of 200 people with RA randomly assigned to complete one version first and the other 2 weeks later. Results: Preference did not differ among the 23 bilinguals (P = 0.196), whereas patients and lay people preferred DP over FB item versions (P < 0.0001). Postal survey response rates were 74% (FB) and 75% (DP). There were more missing item responses in the FB than the DP version (6.9% vs. 5.6%; P < 0.0001). Floor/ceiling effects were small (FB, 6.1/0%; DP, 4.4/0.7%) and reliability was 0.92 for both versions. Construct validity was similar for both versions. Differential item functioning by version was detected for five items but cancelled out and did not affect estimated person measures. Conclusions: The DP approach showed advantages over FB translation in terms of preference by the target population and by lay people, whereas there were no obvious psychometric differences. This suggests advantages of DP over FB translation from the patients' perspective, and does not support the commonly held view that FB translation is the "gold standard."
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- Heintz, Emelie, et al.
(author)
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QALY weights for diabetic retinopathy : a comparison of health state valuations with HUI-3, EQ-5D, EQ-VAS, and TTO.
- 2012
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In: Value in Health. - : Elsevier. - 1098-3015 .- 1524-4733. ; 15:3, s. 475-484
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Journal article (peer-reviewed)abstract
- Objective: To estimate quality-adjusted life-year weights for patients with diabetic retinopathy by using various methods and to investigate the empirical validity of the different measures.Methods: The study population comprised 152 patients with diabetes in Östergötland County, Sweden. Participants were interviewed by telephone by using the time trade-off (TTO) method and a visual analogue scale (EQ-VAS) (direct valuations) as well as the EuroQol five-dimensional questionnaire (EQ-5D) and the health utilities index mark 3 (HUI-3) (indirect valuations). The quality-adjusted life-year weights were adjusted for potential confounders by using analysis of covariance. The empirical validity of the measures was examined by testing their ability to detect hypothetical differences between severity levels of diabetic retinopathy and by investigating the correlation between the measures and the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25).Results: All measures detected significant differences in scores between patient groups classified according to visual impairment in the better eye (analysis of covariance, P < 0.05), but only HUI-3 and EQ-VAS detected significant differences between patient groups classified according to visual impairment or pathological progression in the worse eye. HUI-3 recorded a difference of 0.43 in values between normal vision and blindness in the better eye, which was more than twice the differences captured by the other measures (0.15–0.20). In addition, HUI-3 showed the highest correlation with NEI VFQ-25 (r = 0.54; P < 0.001).Conclusions: In cost-utility analyses, the choice of quality-adjusted life-year measure may affect whether an intervention is considered cost-effective. Furthermore, if decisions are to be based on values from the general public, HUI-3 can be recommended for cost-utility analyses of interventions directed at diabetic retinopathy.
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- Holm-Larsen, Tove, et al.
(author)
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The Nocturia Impact Diary: A Self-Reported Impact Measure to Complement the Voiding Diary
- 2014
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In: Value in Health. - : Wiley/ Elsevier. - 1098-3015 .- 1524-4733. ; 17:6, s. 696-706
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Journal article (peer-reviewed)abstract
- Background: Nocturia is a chronic, fluctuating disease that disrupts sleep and has a wide-ranging impact on quality of life. Valid tools to measure the patient-reported impact of nocturia are essential for evaluating the value of treatment, but the available tools are suboptimal. Objectives: This study reports the development and validation of the Nocturia Impact Diary an augmented form of the Nocturia Quality of Life questionnaire designed to be completed in conjunction with the widely used 3-day voiding diary. Methods: The process comprised three steps: Step 1: Development of a concept pool using the Nocturia Quality of Life questionnaire and data from relevant studies; Step 2: Content validity study; Step 3: Psychometric testing of construct validity, reliability, and sensitivity of the diary in a randomized, placebo controlled study in patients with nocturia. Results: Step 1: Fourteen items and 4 domains were included in the first draft of the diary. Step 2: Twenty-three patients with nocturia participated in the cognitive debriefing study. Items were adjusted accordingly, and the content validity was high. Step 3: Fifty-six patients were randomized to desmopressin orally disintegrating tablet or placebo. The diary demonstrated high construct validity, with good sensitivity and a good fit to Rasch model, as well as high internal consistency, discriminatory ability, and acceptable sensitivity to change. Results indicated that the diary was unidimensional. Conclusions: The Nocturia Impact Diary is a convenient, validated patient-reported outcome measure it should be used in conjunction with a voiding diary to capture the real-life consequences of nocturia and its treatment.
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| 43. |
- Hoogendoorn, Martine, et al.
(author)
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Cost-Effectiveness Models for Chronic Obstructive Pulmonary Disease: Cross-Model Comparison of Hypothetical Treatment Scenarios
- 2014
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In: Value in Health. - : Elsevier BV. - 1098-3015. ; 17:5, s. 525-536
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Journal article (peer-reviewed)abstract
- Objectives To compare different chronic obstructive pulmonary disease (COPD) cost-effectiveness models with respect to structure and input parameters and to cross-validate the models by running the same hypothetical treatment scenarios. Methods COPD modeling groups simulated four hypothetical interventions with their model and compared the results with a reference scenario of no intervention. The four interventions modeled assumed 1) 20% reduction in decline in lung function, 2) 25% reduction in exacerbation frequency, 3) 10% reduction in all-cause mortality, and 4) all these effects combined. The interventions were simulated for a 5-year and lifetime horizon with standardization, if possible, for sex, age, COPD severity, smoking status, exacerbation frequencies, mortality due to other causes, utilities, costs, and discount rates. Furthermore, uncertainty around the outcomes of intervention four was compared. Results Seven out of nine contacted COPD modeling groups agreed to participate. The 5-year incremental cost-effectiveness ratios (ICERs) for the most comprehensive intervention, intervention four, was €17,000/quality-adjusted life-year (QALY) for two models, €25,000 to €28,000/QALY for three models, and €47,000/QALY for the remaining two models. Differences in the ICERs could mainly be explained by differences in input values for disease progression, exacerbation-related mortality, and all-cause mortality, with high input values resulting in low ICERs and vice versa. Lifetime results were mainly affected by the input values for mortality. The probability of intervention four to be cost-effective at a willingness-to-pay value of €50,000/QALY was 90% to 100% for five models and about 70% and 50% for the other two models, respectively. Conclusions Mortality was the most important factor determining the differences in cost-effectiveness outcomes between models.
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| 45. |
- Jaldell, Henrik, 1968-, et al.
(author)
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Time Is Money, But How Much? The Monetary Value of Response Time for Thai Ambulance Emergency Services
- 2014
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In: Value in Health. - : Elsevier. - 1098-3015 .- 1524-4733. ; 17:5, s. 555-560
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Journal article (peer-reviewed)abstract
- ObjectiveTo calculate the monetary value of the time factor per minute and per year for emergency services.MethodsThe monetary values for ambulance emergency services were calculated for two different time factors, response time, which is the time from when a call is received by the emergency medical service call-taking center until the response team arrives at the emergency scene, and operational time, which includes the time to the hospital. The study was performed in two steps. First, marginal effects of reduced fatalities and injuries for a 1-minute change in the time factors were calculated. Second, the marginal effects and the monetary values were put together to find a value per minute.ResultsThe values were found to be 5.5 million Thai bath/min for fatality and 326,000 baht/min for severe injury. The total monetary value for a 1-minute improvement for each dispatch, summarized over 1 year, was 1.6 billion Thai baht using response time.ConclusionsThe calculated values could be used in a cost-benefit analysis of an investment reducing the response time. The results from similar studies could for example be compared to the cost of moving an ambulance station or investing in a new alarm system.
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- Jönsson, L, et al.
(author)
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Analyzing overall survival in randomized controlled trials with crossover and implications for economic evaluation
- 2014
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In: Value in Health. - : Wiley: No OnlineOpen / Elsevier. - 1098-3015. ; 17:6, s. 707-713
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Journal article (peer-reviewed)abstract
- Background: Offering patients in oncology trials the opportunity to cross over to active treatment at disease progression is a common strategy to address ethical issues associated with placebo controls but may lead to statistical challenges in the analysis of overall survival and cost-effectiveness because crossover leads to information loss and dilution of comparative clinical efficacy. Objectives: We provide an overview of how to address crossover, implications for risk-effect estimates of survival (hazard ratios) and cost-effectiveness, and how this influences decisions of reimbursement agencies. Two case studies using data from two phase III sunitinib oncology trials are used as illustration. Methods: We reviewed the literature on statistical methods for adjusting for crossover and recent health technology assessment decisions in oncology. Results: We show that for a trial with a high proportion of crossover from the control arm to the investigational arm, the choice of the statistical method greatly affects treatment-effect estimates and cost-effectiveness because the range of relative mortality risk for active treatment versus control is broad. With relatively frequent crossover, one should consider either the inverse probability of censoring weighting or the rank-preserving structural failure time model to minimize potential bias, with choice dependent on crossover characteristics, trial size, and available data. A large proportion of crossover favors the rank-preserving structural failure time model, while large sample size and abundant information about confounding factors favors the inverse probability of censoring weighting model. When crossover is very infrequent, methods yield similar results. Conclusions: Failure to correct for crossover may lead to suboptimal decisions by pricing and reimbursement authorities, thereby limiting an effective drug's potential.
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