Future of Data Analytics in the Era of the General Data Protection Regulation in Europe

The development of evidence to demonstrate ‘value for money’ is regarded as an important step in facilitating the search for the optimal allocation of limited resources and has become an essential component in healthcare decision making. Real-world evidence collected from de-identified individuals throughout the continuum of healthcare represents the most valuable source in technology evaluation. However, in the European Union, the value assessment based on real-world data has become challenging as individuals have recently been given the right to have their personal data erased in the case of consent withdrawal or when the data are regarded as being no longer necessary. This act may limit the usefulness of data in the future as it may introduce information bias. Among healthcare stakeholders, this has become an important topic of discussion because it relates to the importance of data on one side and to the need for personal data protection on the ot

A Systematic Review of Cost-Effectiveness Studies of Interventions with a Personalized Nutrition Component in Adults

Objectives: Important links between dietary patterns and diseases have been widely applied to establish nutrition interventions. However, knowledge about between-person heterogeneity regarding the benefits of nutrition intervention can be used to personalize the intervention and thereby

A new test of the construct validity of the CarerQol instrument: measuring the impact of informal care giving

Purpose: Most economic evaluations of health care programmes do not consider the effects of informal care, while this could lead to suboptimal policy decisions. This study investigates the construct validity of the CarerQol instrument, which measures and values carer effects, in a new population of informal caregivers. Methods: A questionnaire was distributed by mail (n = 1,100, net response rate = 21%) to regional informal care support centers throughout the Netherlands. Two types of construct validity, i.e., convergent and clinical validity, have been analyzed. Convergent validity was assessed with Spearman's correlation coefficients and multivariate correlation between the burden dimensions (CarerQol-7D) and the valuation component (CarerQol-VAS) of the CarerQol. Additionally, convergent validity was analyzed with Spearman's correlation coefficients between the CarerQol and other measures of subjective caregiver burden (SRB, PU). Clinical validity was evaluated with multivariate correlation between CarerQol-VAS and CarerQol-7D, characteristics of caregivers, care recipients and care situation among the whole sample of caregivers and subgroups. Results: The positive (negative) dimensions of CarerQol-7D were positively (negatively) related to CarerQol-VAS, and almost all had moderate strength of convergent validity. CarerQol-VAS was positively associated with PU and negatively with SRB. The CarerQol-VAS reflects differences in important background characteristics of informal care: type of relationship, age of the care recipient and duration of care giving were associated with higher CarerQol-VAS scores. These results confirmed earlier tests of the construct validity of the CarerQol. Furthermore, the dimensions of CarerQol-7D significantly explained differences in CarerQol-VAS scores among subgroups of carers. Conclusion: Notwithstanding the limitations of our study, such as the low response rate, this study shows that the CarerQol provides a valid means to measure carer effects for use in economic evaluations. Future research should derive a valuation set for the CarerQol and further address the instrument's content validity, sensitivity and reliability

Cost Effectiveness of Continuous Terbinafine Compared with Intermittent Itraconazole in the Treatment of Dermatophyte Toenail Onychomycosis: An Analysis Based on Results from the L.I.ON. Study

Objective: To compare the costs and effectiveness of 2 oral antifungal treatment regimens in patients with dermatophyte toenail onychomycosis. Design and methods: A cost-effectiveness analysis using a model based on data from the Lamisil versus Itraconazole in Onychomycosis (L.I.ON.) study, a randomised controlled trial comparing continuous terbinafine with intermittent itraconazole. The trial included 4 treatment arms: terbinafine 250 mg/day for 12 or 16 weeks (T12, T16) and itraconazole 400 mg/day for 1 week in every 4 weeks for 12 or 16 weeks (I3, I4). Cost calculations for 6 countries (Finland, Germany, Iceland, Italy, The Netherlands, UK) included costs for medication, physician visits, laboratory tests, management of adverse events and management of relapse. Effectiveness was based on complete cure rates (mycological cure plus 100% toenail clearing). Costs per complete cure were determined and both average and incremental cost-effectiveness ratios were calculated. Perspective: Healthcare system. Main outcome measures and results: In the L.I.ON. study, terbinafine was seen to be more effective than itraconazole (cure rates, 45.8 vs 23.4%). In most comparisons (5 of the 6 countries), the costs of T12 were statistically significantly lower than those of I3 [range: -37 to -173 euros (EUR); 1998 values; 1.172 US dollars = EUR1], indicating that T12 was the dominant strategy (i.e. less expensive and more effective). One exception (Finland) showed an incremental cost-effectiveness ratio of EUR524 per additional cure. In the other 5 countries, T16 and I4 were essentially equal in cost, but the greater effectiveness of T16 (cure rates, 55.1 vs 25.9%) resulted in a situation of extended dominance. Conclusion: From a healthcare system perspective, continuous terbinafine is less costly and more effective than intermittent itraconazole in the treatment of dermatophyte toenail onychomycosis.Antifungals, Cost effectiveness, Itraconazole, Onychomycosis, Pharmacoeconomics, Terbinafine

Modeling the economic impact of medication adherence in type 2 diabetes: a theoretical approach

David S Cobden1, Louis W Niessen2, Frans FH Rutten1, W Ken Redekop11Department of Health Policy and Management, Section of Health Economics – Medical Technology Assessment (HE-MTA), Erasmus MC, Erasmus University Rotterdam, The Netherlands; 2Department of International Health, Johns Hopkins University School of Public Health, Johns Hopkins Medical Institutions, Baltimore, MD, USAAims: While strong correlations exist between medication adherence and health economic outcomes in type 2 diabetes, current economic analyses do not adequately consider them. We propose a new approach to incorporate adherence in cost-effectiveness analysis.Methods: We describe a theoretical approach to incorporating the effect of adherence when estimating the long-term costs and effectiveness of an antidiabetic medication. This approach was applied in a Markov model which includes common diabetic health states. We compared two treatments using hypothetical patient cohorts: injectable insulin (IDM) and oral (OAD) medications. Two analyses were performed, one which ignored adherence (analysis 1) and one which incorporated it (analysis 2). Results from the two analyses were then compared to explore the extent to which adherence may impact incremental cost-effectiveness ratios.Results: In both analyses, IDM was more costly and more effective than OAD. When adherence was ignored, IDM generated an incremental cost-effectiveness of $12,097 per quality-adjusted life-year (QALY) gained versus OAD. Incorporation of adherence resulted in a slightly higher ratio ($16,241/QALY). This increase was primarily due to better adherence with OAD than with IDM, and the higher direct medical costs for IDM.Conclusions: Incorporating medication adherence into economic analyses can meaningfully influence the estimated cost-effectiveness of type 2 diabetes treatments, and should therefore be ­considered in health care decision-making. Future work on the impact of adherence on health ­economic outcomes, and validation of different approaches to modeling adherence, is warranted.Keywords: economics, modeling, adherence, diabetes, cost-effectivenes