Dataset Information

Estimation of the effect of dalfampridine-ER on health utility by mapping the MSWS-12 to the EQ-5D in multiple sclerosis patients.

ABSTRACT: Trials have not assessed the effect of dalfampridine-extended release (dalfampridine-ER) on health utility. We sought to evaluate the effect of dalfampridine-ER tablets (prolonged-release fampridine in Europe) on health utility in patients with multiple sclerosis (MS) by mapping subjects' individual item scores from the 12-Item Multiple Sclerosis Walking Scale (MSWS-12) onto the Euroqol 5-Dimension (EQ-5D) health utility index.Data from study MS-F203, a randomized trial of dalfampridine-ER tablets, 10 mg twice daily, in patients with MS, were used to calculate the health utility scores with two MSWS-12 to EQ-5D mapping equations (one derived in a North American [NA] registry, the other a United Kingdom [UK] registry). MS-F203 participants were categorized as dalfampridine-ER 20%-responders (achieving ?20% improvement on the Timed 25-Foot Walk), dalfampridine-ER 20%-nonresponders (<20% improvement), or placebo patients. Mean change in health utility scores from baseline to each double-blind treatment evaluation (visits 3-6 occurring at post-randomization weeks 2, 6, 10, and 14) and each off-drug follow-up evaluation (visits 7-8 occurring at weeks 16 and 18) were calculated and reported as effect sizes (ESs).Using the NA-derived equation, dalfampridine-ER 20%-responders demonstrated improvement in health utility vs. placebo; starting at week 6 (mean difference in ES?=?0.44, p?=?0.002) and maintained at weeks 10 (ES?=?0.41, p?=?0.01) and 14 (ES?=?0.71, p??0.05 at weeks 16 and 18). Dalfampridine-ER 20%-nonresponders did not show improvement vs. placebo at any visit (p?>?0.05 for all). When using the UK-derived equation, improvement was seen in dalfampridine-ER 20%-responders vs. placebo at weeks 2, 6, 10, and 14 (ESs?=?0.49, 0.55, 0.59, and 0.99; p??0.05 for both). Dalfampridine-ER 20%-nonresponders showed no improvement at any visit (p?>?0.05 for all).Regardless of the equation used, dalfampridine-ER response was associated with an improvement in health utility.

SUBMITTER: Limone BL

PROVIDER: S-EPMC3699372 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature

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Estimation of the effect of dalfampridine-ER on health utility by mapping the MSWS-12 to the EQ-5D in multiple sclerosis patients.

Limone Brendan L BL Sidovar Matthew F MF Coleman Craig I CI

Health and quality of life outcomes 20130626

<h4>Background</h4>Trials have not assessed the effect of dalfampridine-extended release (dalfampridine-ER) on health utility. We sought to evaluate the effect of dalfampridine-ER tablets (prolonged-release fampridine in Europe) on health utility in patients with multiple sclerosis (MS) by mapping subjects' individual item scores from the 12-Item Multiple Sclerosis Walking Scale (MSWS-12) onto the Euroqol 5-Dimension (EQ-5D) health utility index.<h4>Methods</h4>Data from study MS-F203, a randomi ...[more]

PMID: 23799913

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Project description:BackgroundEQ5D is a generic measure of health. It provides a single index value for health status that can be used in the clinical and economic evaluation of healthcare. Oxford Knee Score (OKS) is a joint-specific outcome measure tool designed to assess symptoms and function in osteoarthritis patients after joint replacement surgery. Though widely used, it has the disadvantage of lacking health index value. To fill the gap between functional and generic questionnaires with economic value, we linked generic EQ-5D-5L to the specific OKS to give a single index value for health status in KOA patients.Questions/purposesDeveloping and evaluating an algorithm to estimate EuroQoL generic health utility scores (EQ-5D-5L) from the disease-specific OKS using data from patients with knee osteoarthritis (KO).Patients and methodsThis is a cross-sectional study of 571 patients with KO. We used four distinct mapping algorithms: Cumulative Probability for Ordinal Data, Penalized Ordinal Regression, CART (Classification and Regression Trees), and Ordinal random forest. We compared the resultant models' degrees of accuracy.ResultsMobility was best predicted by penalized regression with pre-processed predictors, usual activities by random forest, pain/discomfort by cumulative probability with pre-processed predictors, self-care by random forest with RFE (recursive feature elimination) predictors, and anxiety/depression by CART with RFE predictors. Model accuracy was lowest with anxiety/depression and highest with mobility and usual activities. Using available country value sets, the average MAE was 0.098 ± 0.022, ranging from 0.063 to 0.142; and the average MSE was 0.020 ± 0.008 ranging from 0.008 to 0.042.ConclusionsThe current study derived accurate mapping techniques from OKS to the domains of EQ-5D-5L, allowing for the computation of QALYs in economic evaluations. A machine learning-based strategy offers a viable mapping alternative that merits further exploration.

Project description:In oncology, health-related quality of life (HRQoL) data are often collected using disease-specific patient questionnaires while generic, patient-level utility data required for health economic modeling are often not collected.We developed a mapping algorithm for multiple myeloma that relates HRQoL scores from the European Organization for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-MY20 to a utility value from the European QoL-5 Dimensions (EQ-5D) questionnaire. Data were obtained from 154 multiple myeloma patients who had participated in a multicenter cohort study in the UK or Germany. All three questionnaires were administered at a single time point. Scores from all 19 domains of the QLQ-C30 and QLQ-MY20 instruments were univariately tested against EQ-5D values and retained in a multivariate regression model if statistically significant. A 10-fold cross-validation model selection method was also used as an alternative testing means. Two models were developed: one based on QLQ-C30 plus QLQ-MY20 scores and one based on QLQ-C30 scores alone. Adjusted R-squared, correlation coefficients, and plots of observed versus predicted EQ-5D values were presented for both models.Mapping revealed that Global Health Status/QoL, Physical Functioning, Pain, and Insomnia were significant predictors of EQ-5D utility values. Similar results were observed when QLQ-MY20 scores were excluded from the model, except that Emotional Functioning and became a significant predictor and Insomnia was no longer a significant predictor. Adjusted R-squared values were of similar magnitude with or without inclusion of QLQ-MY20 scores (0.70 and 0.69, respectively), suggesting that the EORTC QLQ-MY20 adds little in terms of predicting utility values in multiple myeloma.This algorithm successfully mapped EORTC HRQoL data onto EQ-5D utility in patients with multiple myeloma. Current mapping will aid in the analysis of cost-effectiveness of novel therapies for this indication.

Dataset Information

Estimation of the effect of dalfampridine-ER on health utility by mapping the MSWS-12 to the EQ-5D in multiple sclerosis patients.

Publications

Estimation of the effect of dalfampridine-ER on health utility by mapping the MSWS-12 to the EQ-5D in multiple sclerosis patients.

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