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1.
  • Nystrand, Camilla, et al. (författare)
  • Indicated Parenting Interventions and Long Term Outcomes : A Health Economic Modeling Study
  • 2018
  • Ingår i: Value in Health. - : Elsevier. - 1098-3015 .- 1524-4733. ; 21, s. S76-S76
  • Konferensbidrag (refereegranskat)abstract
    • Economic evaluations of early interventions for children are augmenting in numbers and a larger focus is put on the longer-term economic returns. However, little is known about the labour market returns from preventive parenting programs. This study estimates the benefits and costs of five parenting interventions: Comet, Connect, the Incredible Years (IY), Cope and bibliotherapy, compared to a waitlist control, for the prevention of persistent externalizing behavior problems in children.
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  • Fränneby, Ulf, et al. (författare)
  • Self-reported adverse events after groin hernia repair, a study based on a national register.
  • 2008
  • Ingår i: Value in Health. - : Wiley. - 1098-3015 .- 1524-4733. ; 11:5, s. 927-932
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVES: In most clinics, follow-up after inguinal hernia surgery is not a routine procedure and complications may pass unnoticed, thus impairing quality assessment. The aim of this study was to investigate the frequency, spectrum, and risk factors of short-term adverse events after groin hernia repair. METHODS: All patients aged 15 years or older with a primary unilateral inguinal or femoral hernia repair recorded in the Swedish Hernia Register (SHR) between November 1 and December 31, 2002 were sent a questionnaire asking about complications within the first 30 postoperative days. RESULTS: Of the 1643 recorded patients, 1448 (88.1%) responded: 1341 (92.6%) were men and 107 (7.4%) women, mean age 59 years. There were 195 (11.9%) nonresponders. Postoperative complications reported in the questionnaire were hematoma in 203 (14.0%) patients, severe pain in 168 (11.6%), testicular pain in 120 (8.3%), and infection in 105 (7.3%). Adverse events were reported in the questionnaire by 391 (23.8%) patients, whereas only 85 (5.2%) were affected according to the SHR. Risk factors for postoperative complications were age below the median (59 years) among the studied hernia patients (OR 1.36; 95% CI 1.06-1.74) and laparoscopic repair (OR 2.66; 95% CI 1.17-6.05). CONCLUSION: Questionnaires provide valuable additional information concerning postoperative complications. We recommend that they become an integrated part of routine postoperative assessment.
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  • Hagell, Peter, et al. (författare)
  • 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
  • Ingår i: Value in Health. - : Wiley-Blackwell. - 1098-3015 .- 1524-4733. ; 13:4, s. 424-430
  • Tidskriftsartikel (refereegranskat)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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  • Kobelt, Gisela, et al. (författare)
  • The burden of ankylosing spondylitis in Spain.
  • 2008
  • Ingår i: Value in Health. - : Elsevier BV. - 1098-3015. ; 11:3, s. 408-415
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: To investigate the burden of ankylosing spondylitis (AS) in Spain, as baseline for economic evaluation of the use of biological agents. METHODS: A cross-sectional retrospective observational study was performed in 601 patients with AS in Spain, using a methodology developed in studies in the United Kingdom and Canada. Patients were mailed a questionnaire asking about their health-care consumption, out-of-pocket expenses, work capacity, need for informal care during the past 3 months, as well as quality of life. Patient's current functional status and disease activity level was assessed using the Bath functional and disease activity indexes (BASFI and BASDAI). RESULTS: The mean age (median) was 47.8 (12.4) years, and the mean disease duration was 18.8 years. Eighty percent of patients were male, and slightly more than half of patients below 65 years of age were working. The mean (median) BASDAI and BASFI scores were 4.3 (2.5) and 3.8 (2.9),respectively, and all levels of disease severity were represented. The mean (median) total annual cost per patient is estimated at euro 20,328 (euro 7920). Direct health care represented 22.8%, investments (adaptations of house and devices) and informal care 43.5%, and productivity losses 33.7%. Costs increased significantly with worsening disease, in particular diminishing physical function, covering a range between euro 5000 and euro 75,000 per patient and year. The mean (median) utility was 0.59 (0.30). Utility showed a significant inverse relation with BASFI and BASDAI, covering a range from 0.80 for patients with BASFI/BASDAI below 3 to 0.25 for patients with BASFI/BASDAI greater than 7. CONCLUSIONS: As in studies in other countries, all types of costs accelerate steeply with worsening disease while utility decreases significantly, indicating the need to prevent disease progression.
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  • Sandblom, Gabriel, et al. (författare)
  • Validation of Gastrointestinal Quality of Life Index in Swedish for assessing the impact of gallstones on health-related quality of life
  • 2009
  • Ingår i: Value in Health. - : Elsevier BV. - 1098-3015 .- 1524-4733. ; 12:1, s. 181-184
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: The aim of the present study was to validate a Swedish translation of the Gastrointestinal Quality of Life Index (GIQLI) questionnaire in patients with gallstone disease. METHODS: Sensitivity to change, internal consistency, and test-retest stability were tested in 187 consecutive patients who underwent planned cholecystectomy. Construct validity was assessed by comparing the GIQLI score with the bodily pain scale of SF-36 and four single-item questions in a separate group of 104 patients. RESULTS: A significant increase in all five domains as well as in the overall GIQLI score 6 months after surgery (all P < 0.05) was seen. All five domains correlated significantly with other measures of gallstone-related symptoms except one single-item question. Intraclass correlations ranged from 0.62 to 0.87. Cronbach's alpha ranged from 0.77 to 0.89. CONCLUSION: The Swedish translation of GIQLI has a high validity and reliability for assessing the impact of gallstones on quality of life.
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  • Ghatnekar, Ola, et al. (författare)
  • The effect of atrial fibrillation on stroke-related inpatient costs in Sweden : a 3-year analysis of registry incidence data from 2001
  • 2008
  • Ingår i: Value in Health. - : Elsevier BV. - 1098-3015 .- 1524-4733. ; 11:5, s. 862-868
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective: Atrial fibrillation (AF) is an important risk factor for stroke. It is prevalent in approximately one-fourth of stroke patients, and predictive of worse outcomes. This study aimed to analyze the effect of AF on stroke-related inpatient costs among first-ever stroke patients in Sweden.Methods: Hospitalizations and death records were monitored for 3 years in 6611 first-ever stroke patients. For stroke as primary diagnosis, inpatient costs were calculated on the basis of length of stay at different wards. For stroke as secondary diagnosis, costs were based on diagnosis-related groups.Results: Patients with AF (24% of all patients) were older (80 years vs. 73 years), had a higher prevalence of hypertension (49% vs. 41%) and/or diabetes (22% vs. 19%), higher risk of experiencing a restroke, and higher case fatality rate (43% vs. 25%) than patients without AF. The average cost per patient over 3 years was euro9004, with no statistically significant difference between AF and non-AF patients. However, a multiple regression analysis showed that the presence of AF resulted in higher costs after considering a number of background factors. Among patients surviving the index event, AF patients had on average euro818 higher inpatient costs over 3 years than non-AF patients (euro10,192 vs. euro9374, P < 0.01). The difference in costs was highest for patients aged <65 years, with a difference of euro4412 (P < 0.01).Conclusion: AF-related strokes are associated with higher 3-year inpatient costs than non-AF strokes when controlling for factors such as case fatality rates, other risk factors for stroke, and age.
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  • Hagell, Peter, et al. (författare)
  • Whose quality of life? : ethical implications in patient-reported health outcome measurement
  • 2009
  • Ingår i: Value in Health. - 1098-3015 .- 1524-4733. ; 12:4, s. 613-617
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVES: Patient-reported health status questionnaires intend to assess illness and therapy from the patients' perspective. To provide fair and valid assessments, they should be equally relevant to major subsets of respondents. Furthermore, disease-specific measures are assumed to be perceived as more relevant than generic ones. This study assessed these assumptions among people with Parkinson's disease.METHODS: Cross-sectional data from 202 people with Parkinson's disease (54% men; mean age, 70) were analyzed regarding patient-rated relevance and predictors of patient-rated poor relevance of two generic [the 36-item Short Form Health Survey (SF-36) and Nottingham Health Profile (NHP)] and one disease-specific [Parkinson's Disease Questionnaire (PDQ-39)] health status questionnaire.RESULTS: There were no differences in relevance ratings across the questionnaires. Poorer overall quality of life [odds ratio (OR), 2.459] and mental health (OR, 1.023) were associated with poorer patient-rated relevance of the SF-36, and higher age was associated with poorer patient-rated relevance of the PDQ-39 (OR, 1.040). No significant predictors were found for the NHP.CONCLUSIONS: The PDQ-39 failed to meet the assumption that disease-specific scales are more relevant than generic ones. Nevertheless, the most important implication of this study is an ethical one. Because the relevance of the SF-36 and PDQ-39 is perceived as poorer by those who fare least well and by older people, these scales may not reflect the perspectives of these groups. This challenges bioethical principles and threatens scientific validity. Perceived relevance of patient-centered outcomes needs to be considered, or the voice of vulnerable groups may be silenced, fair inferences prohibited, and opportunities for improved care lost.
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  • Koltowska-Häggström, Maria, et al. (författare)
  • Using EQ-5D to derive general population-based utilities for the Quality of Life-Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)
  • 2007
  • Ingår i: Value in Health. - : Elsevier BV. - 1098-3015 .- 1524-4733. ; 10:1, s. 73-81
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective: Disease-oriented quality of life (QoL) measures that are not preference-based lack legitimacy for direct use in cost-utility analyses. This has prompted the search for other methods for deriving utilities. The QoL Assessment of Growth Hormone Deficiency in Adults questionnaire (QoL-AGHDA) is a disease-oriented measure used to assess impairment in QoL in adults with growth hormone deficiency. The present study was designed to generate a model for deriving utilities from the QoL-AGHDA. Methods: The EQ-5D, the QoL-AGHDA, and demographic questions were mailed to a random sample (n = 3005) of the Swedish population (response rate 65%). Multiple regression analysis was used to obtain cross-validated parameters of QoL-AGHDA-based utilities. Two models were developed (simple and full versions). The simple version used the EQ-5Dindex (derived from European values) as the dependent variable, and age, sex, and QoL-AGHDA score as independent variables in a regression analysis. The full model utilized all available demographic information. The QoL-AGHDA scores were thus transformed into a single score (0-1), corresponding to the QoL-AGHDA-based utility. Results: The simple transformation algorithm was U (QoL-AGHDA-based utilities) = 1.05 - 0.0189 x QoL-AGHDA score - 0.00238 x age - 0.0127 x sex (male = 0; female = 1). The mean of the weighted estimate for the population (n =1752) was 0.85 (SD 0.10). The estimate for men (n = 861; mean 0.86; SD 0.10) was higher (P < 0.001) than for women (n = 891; mean 0.84; SD 0.10). Conclusion: For practical reasons, the simple model can be recommended for deriving utilities directly from the QoL-AGHDA for the Swedish population.
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  • Weinstein, M.C., et al. (författare)
  • Principles of Good Practice for Decision Analytic Modeling in Health-Care Evaluation: Report of the ISPOR Task Force on Good Research Practices—Modeling Studies
  • 2003
  • Ingår i: Value in health. - : Elsevier Inc. - 1524-4733 .- 1098-3015. ; 6:1, s. 9-17
  • Tidskriftsartikel (refereegranskat)abstract
    • Mathematical modeling is used widely in economic evaluations of pharmaceuticals and other health-care technologies. Users of models in government and the private sector need to be able to evaluate the quality of models according to scientific criteria of good practice. This report describes the consensus of a task force convened to provide modelers with guidelines for conducting and reporting modeling studies. The task force was appointed with the advice and consent of the Board of Directors of ISPOR. Members were experienced developers or users of models, worked in academia and industry, and came from several countries in North America and Europe. The task force met on three occasions, conducted frequent correspondence and exchanges of drafts by electronic mail, and solicited comments on three drafts from a core group of external reviewers and more broadly from the membership of ISPOR. Criteria for assessing the quality of models fell into three areas: model structure, data used as inputs to models, and model validation. Several major themes cut across these areas. Models and their results should be represented as aids to decision making, not as statements of scientific fact; therefore, it is inappropriate to demand that models be validated prospectively before use. However, model assumptions regarding causal structure and parameter estimates should be continually assessed against data, and models should be revised accordingly. Structural assumptions and parameter estimates should be reported clearly and explicitly, and opportunities for users to appreciate the conditional relationship between inputs and outputs should be provided through sensitivity analyses. Model-based evaluations are a valuable resource for health-care decision makers. It is the responsibility of model developers to conduct modeling studies according to the best practicable standards of quality and to communicate results with adequate disclosure of assumptions and with the caveat that conclusions are conditional upon the assumptions and data on which the model is built.
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  • Berg, Jenny, et al. (författare)
  • Determinants of Utility Based on the EuroQol Five-Dimensional Questionnaire in Patients with Chronic Heart Failure and Their Change Over Time: Results from the Swedish Heart Failure Registry
  • 2015
  • Ingår i: Value in Health. - : Wiley: No OnlineOpen / Elsevier. - 1098-3015 .- 1524-4733. ; 18:4, s. 439-448
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: There is limited information on drivers of utilities in patients with chronic heart failure (CHF). Objectives: To analyze determinants of utility in CHF and drivers of change over 1 year in a large sample from clinical practice. Methods: We included 5334 patients from the Swedish Heart Failure Registry with EuroQol five-dimensional questionnaire information available following inpatient or outpatient care during 2008 to 2010; 3495 had 1-year follow-up data Utilities based on Swedish and UK value sets were derived. We applied ordinary least squares (OLS) and two-part models for utility at inclusion and OLS regression for change over 1 year, all with robust standard errors. We assessed the predictive accuracy of both models using cross-validation. Results: Patients mean age was 73 years, 65% were men, 19% had a left ventricular ejection fraction of 50% or more, 23% had 40% to 49%, 27% had 30% to 39%, and 31% had less than 30%. For both models and value sets, utility at inclusion was affected by sex, age, New York Heart Association class, ejection fraction, hemoglobin, blood pressure, lung disease, diabetes, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, nitrates, antiplatelets, and diuretics. The OLS model performed slightly better than did the two-part model on a population level and for capturing utility ranges. Change in utility over 1 year was influenced by age, sex, and (measured at inclusion) disease duration, New York Heart Association class, blood pressure, ischemic heart disease, lung disease, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and antiplatelets. Conclusions: Utilities in CHF and their change over time are influenced by diverse demographic and clinical factors. Our findings can be used to target clinical interventions and for economic evaluations of new therapies.
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  • Berg, Jenny, et al. (författare)
  • Economic Evaluation of Elective Cesarean Section on Maternal Request Compared With Planned Vaginal Birth-Application to Swedish Setting Using National Registry Data
  • 2023
  • Ingår i: Value in Health. - : Elsevier BV. - 1098-3015 .- 1524-4733. ; 26:5, s. 639-648
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: There is a lack of consensus around the definition of delivery by cesarean section (CS) on maternal request, and clinical practice varies across and within countries. Previous economic evaluations have focused on specific populations and selected complications. Our aim was to evaluate the cost-effectiveness of CS on maternal request compared with planned vaginal birth in a Swedish context, based on a systematic review of benefits and drawbacks and national registry data on costs.Methods: We used the results from a systematic literature review of somatic risks for long-and short-term complications for mother and child, in which certainty was rated low, moderate, or high using the Grading of Recommendations Assessment, Development and Evaluation. Swedish national registry data were used for healthcare costs of delivery and complications. Utilities for long-term complications were based on a focused literature review. We constructed a decision tree and conducted separate analyses for primi-and multiparous women. Costs and effects were discounted by 3% and the time horizon was varied between 1 and 20 years.Results: Planned vaginal birth leads to lower healthcare costs and somatic health gains compared with elective CS without medical indication over up to 20 years. Although there is uncertainty around, for example, quality-of-life effects, results remain stable across sensitivity analyses.Conclusions: CS on maternal request leads to increased hospitalization costs in a Swedish setting, taking into account short -and long-term consequences for both mother and child. Future research needs to study the psychological consequences related to different delivery methods, costs in outpatient care, and productivity losses.
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  • Bergthorsdottir, R, et al. (författare)
  • Health-Related Quality of Life In Patients With Adrenal Insufficiency Receiving Plenadren Compared With Immediate-Release Hydrocortisone
  • 2015
  • Ingår i: Value in Health. - : Elsevier. - 1098-3015 .- 1524-4733. ; 18:7
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundPrevious studies in patients with primary adrenal insufficiency (PAI) on conventional replacement therapy suggest decreased health-related quality of life (HRQoL), and that patients report more frequently fatigue, increased anxiety and inability to work compared to background population.ObjectivesTo study self-reported health status with EQ-5D in patients with PAI. Patients treated with Plenadren (modified-release hydrocortisone) were compared with patients treated with immediate release hydrocortisone (IRHC) replacement therapy.MethodsThis was a cross-sectional, multi-centre, non-interventional survey of patients with PAI receiving Plenadren or immediate release hydrocortisone (IRHC) replacement.SubjectsOne hundred thirty-four adult patients with PAI of whom 36 (19 females [53%]) were treated with Plenadren and 98 (77 females [79%]) were treated with IRHC, were included.MAIN OUTCOME MEASUREHRQoL described by the EQ-5D, a generic preference-based measure of health.RESULTSPatients on Plenadren and on IRHC had a mean ± SD age of 53.1 ± 12.7 years and 48.0 ± 13.1 years, respectively (P=0.043). The majority of the patients were diagnosed more than 5 years ago (69%). The mean ± SD daily Plenadren and IRHC doses were 27.0 ± 6.8 mg and 26.6 ± 10.9 mg, respectively (P=0.807). 47% of the Plenadren patients had been receiving Plenadren and 82% of the IRHC patients had been receiving IRHC for more than 3 years. Patients receiving Plenadren had better HRQoL measured by the EQ-5D questionnaire compared to patients replaced with IRHC (0.76 ± 0.18 vs 0.68 ± 0.18, respectively [P=0.040]).CONCLUSIONSReplacement therapy with Plenadren in patients with PAI confers measurable benefit on HRQoL relative to IRHC as estimated by the EQ-5D questionnaire, and may therefore be advantageous when compared to IRHC substitution.
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  • Caccamisi, Andrea, et al. (författare)
  • PRM92 - Automatic Extraction and Classification of Patients’ Smoking Status from Free Text Using Natural Language Processing
  • 2016
  • Ingår i: Value in Health. - : Elsevier BV. - 1098-3015 .- 1524-4733. ; 19:7
  • Tidskriftsartikel (refereegranskat)abstract
    • ObjectivesTo develop a machine learning algorithm for automatic classification of smoking status (smoker, ex-smoker, non-smoker and unknown status) in EMRs, and validate the predictive accuracy compared to a rule-based method. Smoking is a leading cause of death worldwide and may introduce confounding in research based on real world data (RWD). Information on smoking is often documented in free text fields in Electronic Medical Records (EMRs), but structured RWD on smoking is sparse.Methods32 predictive models were trained with the Weka machine learning suite, tweaking sentence frequency, classifier type, tokenization and attribute selection using a database of 85,000 classified sentences. The models were evaluated using F-Score and Accuracy based on out-of-sample test data including 8,500 sentences. The error weight matrix was used to select the best model, assigning a weight to each type of misclassification and applying it to the models confusion matrices.ResultsThe best performing model was based on the Support Vector Machine (SVM) Sequential Minimal Optimization (SMO) classifier using a polynomial kernel with parameter C equal to 6 and a combination of unigrams and bigrams as tokens. Sentence frequency and attributes selection did not improve model performance. SMO achieved 98.25% accuracy and 0.982 F-Score versus 79.32% and 0.756, respectively, for the rule-based model.ConclusionsA model using machine learning algorithms to automatically classify patients smoking status was successfully developed. This algorithm would enable automatic assessment of smoking status directly from EMRs, obviating the need to extract complete case notes and manual classification.
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  • Chen, Gang, et al. (författare)
  • Assessing the Health-Related Quality of Life of Australian Adolescents : An Empirical Comparison of the Child Health Utility 9D and EQ-5D-Y Instruments
  • 2015
  • Ingår i: Value in Health. - : Elsevier BV. - 1098-3015 .- 1524-4733. ; 18:4, s. 432-438
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: To examine the performance of two recently developed preference-based instruments-the Child Health Utility 9D (CHU9D) and the EuroQol five-dimensional questionnaire Youth version (EQ-5D-Y)-in assessing the health related quality of life (HRQOL) of Australian adolescents. Methods: An online survey including the CHU9D and the EQ-5D-Y, self-reported health status, and a series of sociodemographic questions was developed for administration to a community-based sample of adolescents (aged 11-17 years). Individual responses to both instruments were translated into utilities using scoring algorithms derived from the Australian adult general population. Results: A total of 2020 adolescents completed the online survey. The mean +/- SD utilities of the CHU9D and the EQ-5D-Y were very similar (0.82 +/- 0.13 and 0.83 +/- 0.19, respectively), and the intraclass correlation coefficient (0.80) suggested good levels of agreement. Both instruments were able to discriminate according to varying levels of self-reported health status (P < 0.001). Although exhibiting good levels of agreement overall, some wide divergences were apparent at an individual level. Conclusions: The study results are encouraging and illustrate the potential for both the CHU9D and the EQ-5D-Y to be more widely used for measuring and valuing the HRQOL of adolescent populations in Australia and internationally. Generating adolescent-specific scoring algorithms pertaining to each instrument and an empirical comparison of the resulting utilities is a natural next step. More evidence is required from the application of the CHU9D and the EQ-5D-Y in specific patient groups in adolescent health settings to inform the choice of instrument for measuring and valuing the HRQOL for the economic evaluation of adolescent health care treatments and services.
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  • Coaquira, Castro J., et al. (författare)
  • INTERNAL, EXTERNAL, AND CROSS-VALIDATION OF THE DEDUCE MODEL, A COST-UTILITY TOOL USING PATIENT-LEVEL MICROSIMULATION TO EVALUATE SENSOR-BASED GLUCOSE MONITORING SYSTEMS IN TYPE 1 AND TYPE 2 DIABETES
  • 2022
  • Ingår i: Value in Health. - : ELSEVIER SCIENCE INC. - 1098-3015 .- 1524-4733. ; 25:12 Suppl., s. S11-S11
  • Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
    • Objectives: For health care decision-makers, the use of computer simulation modelsr equires transparency, precision and accuracy. Systematic comparisons of diabetes models, per Mount Hood Challenges, have shown significant variability in results between models. We developed and validated a new cost-effectiveness model (the DEtermination of Diabetes Utilities, Costs, and Effects [DEDUCE] model) in both type 1 and 2 diabetes mellitus (T1DM, T2DM) to evaluate sensor-based glucose monitoring.Methods: This Excel-based patient-level microsimulation model used a cost-utility approach to compare sensor-based glucose monitoring systems to self-monitoring of blood glucose (SMBG) testing over a specified time horizon (1 to 100 years) with yearly cycles. The model used the Sheffield risk engine for T1DM and the Risk Equations for Complications Of type 2 Diabetes (RECODe) risk engine for T2DM to predict macro- and microvascular events. Inputs, model architecture, and subse-quent validation analyses were reviewed and informed by an advisory board of health economists, endocrinologists and diabetologists.Results: Internal validation (comparing model predictions to observed outcomes from studies from which the risk equations were derived) and external validation (predictions compared to external datasets) demonstrated high precision (R2 $ 0.98) and reasonable accuracy (mean absolute percentage error [MAPE] ranging from 7.64-68%) with regards to macrovascular outcomes for T1DM, and high precision (R2 = 0.94) and high accuracy (MAPE = 19.8%) with regards to all-cause mortality in T2DM. Cross validation (comparing model outcomes between DEDUCE and published results from models participating in previous Mount Hood Challenges) indicated that DEDUCE had the best accuracy (MAPE = 36%) and non-inferior precision (R2 = 0.16) relative to other T1DM models, and second-to-best accuracy (MAPE = 25.03%) and high precision (R2 = 0.95) relative to other T2DM models.Conclusions: In both T1DM & T2DM, DEDUCE suitably predicted key outcomes and performed favorably compared with existing models that participated in the Mount Hood Challenges, including the Core Diabetes Model.
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  • Colson, Abigail R., et al. (författare)
  • Antimicrobial Resistance : Is Health Technology Assessment Part of the Solution or Part of the Problem?
  • 2021
  • Ingår i: Value in Health. - : Elsevier. - 1098-3015 .- 1524-4733. ; 24:12, s. 1828-1834
  • Tidskriftsartikel (refereegranskat)abstract
    • Antimicrobial resistance is a serious challenge to the success and sustainability of our healthcare systems. There has been increasing policy attention given to antimicrobial resistance in the last few years, and increased amounts of funding have been channeled into funding for research and development of antimicrobial agents. Nevertheless, manufacturers doubt whether there will be a market for new antimicrobial technologies sufficient to enable them to recoup their investment. Health technology assessment (HTA) has a critical role in creating confidence that if valuable technologies can be developed they will be reimbursed at a level that captures their true value. We identify 3 deficiencies of current HTA processes for appraising antimicrobial agents: a methods-centric approach rather than problem-centric approach for dealing with new challenges, a lack of tools for thinking about changing patterns of infection, and the absence of an approach to epidemiological risks. We argue that, to play their role more effectively, HTA agencies need to broaden their methodological tool kit, design and communicate their analysis to a wider set of users, and incorporate long-term policy goals, such as containing resistance, as part of their evaluation criteria alongside immediate health gains.
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  • Coyne, Karin S, et al. (författare)
  • Development and Validation of the AFImpact: An Atrial Fibrillation-Specific Measure of Patient-Reported Health-Related Quality of Life.
  • 2017
  • Ingår i: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. - : Elsevier BV. - 1524-4733. ; 20:10, s. 1355-1361
  • Tidskriftsartikel (refereegranskat)abstract
    • Improvement in health-related quality of life is a key therapeutic goal of disease management in atrial fibrillation (AF).To describe the development of the AFImpact, an AF-specific health-related quality-of-life patient-reported outcome measure.Development and validation of the AFImpact comprised a qualitative stage, consisting of a literature review and concept elicitation interviews (91 patients with AF), item generation, and cognitive debriefing (30 patients with AF), and a quantitative stage, consisting of evaluation of the instrument's psychometric properties (313 patients with AF). Preliminary responsiveness to change was assessed in 118 patients undergoing cardioversion.On the basis of the literature review and concept elicitation interviews, 75 items were generated. Factor analyses guided a reduction to 18 items. Three domains were confirmed: vitality (7 items), emotional distress (8 items), and sleep (3 items). The 18-item AFImpact demonstrated high item convergent and discriminant validity. Cronbach α coefficients showed high internal consistency reliability. Test-retest reliability of individual items in stable patients (n = 33) was satisfactory, with intraclass correlation coefficients ranging from 0.61 to 0.86. All three AFImpact domain scores differentiated patients who reported different levels of overall health, thereby supporting known-groups validity. Scores for each item improved after cardioversion, with effect sizes ranging from -0.19 to -0.65.Psychometric evaluations support the reliability and validity of the AFImpact as a patient-reported outcome instrument to measure the impact of AF, with preliminary results in patients undergoing cardioversion supporting responsiveness to change.
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  • Delgado-Ortega, L., et al. (författare)
  • 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
  • Ingår i: Value in Health. - : Elsevier. - 1098-3015 .- 1524-4733. ; 14:7, s. A372-A372
  • Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)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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  • Denoncourt, R. N., et al. (författare)
  • Burden of Illness for Patients with Hereditary Attr Amyloidosis with Polyneuropathy Begins with Symptom Onset and Increases with Disease Progression
  • 2016
  • Ingår i: Value in Health. - : Elsevier. - 1098-3015 .- 1524-4733. ; 19:7, s. A436-A436
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: Hereditary ATTR amyloidosis with polyneuropathy (hATTR-PN), also known as familial amyloidotic polyneuropathy (FAP), is an inherited, progressive disease leading to death within 5-15 years. hATTR-PN is due to a mutation in the transthyretin (TTR) gene. Patisiran is an investigational, RNA interference (RNAi) therapeutic targeting TTR. This abstract aims to further characterize hATTR-PN burden of illness.Methods: The ongoing, patisiran Phase 3 APOLLO trial was utilized to collect patient-reported EQ-5D, Norfolk-DN, Rasch-built Overall Disability Scale (R-ODS), and healthcare resource utilization from hATTR-PN patients with symptomatic disease.Results: APOLLO included 225 patients; median age of 62 years (range: 24-82), median neurological impairment score (NIS) of 6-141.6 and representative of the global patient population (19 countries) with a broad range of mutations and disease severities. At baseline, 57 patients had a Polyneuropathy Disability (PND) Score I and 168 patients had a PND Score ≥ II. By FAP Stage, 104 were FAP Stage 1 and 121 were FAP Stage 2. 41 patients (PND Score ≥ II) reported ≥1 hospitalization of ≥3 nights in duration due to hATTR-PN in the 12 months prior to enrollment. Mean EQ-5D scores were 0.76 (PND Score I) and 0.59 (PND Score ≥ II). Patients reported perceived health status on the EQ-VAS with mean scores of 66.9 (PND Score I) and 51.3 (PND Score ≥ II). Mean Norfolk-QoL-DN scores were 35.5 (PND Score I) and 66.0 (PND Score ≥ II). 145 patients (131 PND Score ≥ II) reported they cannot work because of hATTR-PN. Mean R-ODS scores were 40.9 and 25.9 for PND Score I and PND Score ≥ II, respectively.Conclusions: These data, from the largest controlled study of patients with hATTR-PN to date, further demonstrate that patients experience considerable burden of illness early in the course of disease and this burden increases with disease progression.
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  • Geale, Kirk, et al. (författare)
  • Estimating the Value of A New Antibiotic : A Novel Approach Using Esbl As A Case Study
  • 2016
  • Ingår i: Value in Health. - : Elsevier. - 1098-3015 .- 1524-4733. ; 19:7, s. A422-A423
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: Develop a model capable of estimating the value of a new antibiotic for use in treating last-line patients not eligible for, or having failed on, all currently available antibiotic treatments.Methods: Ten annual cohorts of incident last-line patients (total of 314) infected with extended spectrum beta-lactamase (ESBL) -producing bacteria were modelled from the onset of the last-line infection over the course of their remaining life, in a scenario where a new antibiotic was available and one where it was not. Efficacy was measured by mortality, where 5% (95%) of patients died due to the infection in the scenario with(out) a new antibiotic. In the scenario with a new antibiotic, the mortality rate increased by 0.5% annually. Costs including lab tests, hospital stays, and productivity loss were calculated in both scenarios. Quality-adjusted life-years gained (QALYs) were estimated using weights for patients with an infection (0.61) and after recovery (0.84), in addition to disutility incurred by one caregiver per patient (-0.14). Differences in costs, QALYs, deaths, and days off work were calculated between the two arms; costs and QALYs were discounted to the present year. The value of a new antibiotic is reflected in the incremental results.Results: In the last-line ESBL population of 314 patients over 10 years, the availability of a new antibiotic resulted in SEK 20.4 million in cost saving, 2795 QALYs gained, 273 fewer infection-caused deaths, and 2198 fewer days off work.Conclusions: Valuation of a new antibiotic is a high public health priority due to increasing antibiotic resistance and decreasing rates of development of new antibiotics. Access to a new antibiotic for last-line patients provides a large benefit to society, using ESBL as case-study. The results are conservative as they exclude factors that are relatively difficult to estimate such as the risk of an outbreak.
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