Estimation of health-related utility (EQ-5D index) in subjects with seasonal allergic rhinoconjunctivitis to evaluate health gain associated with sublingual grass allergen immunotherapy

Abstract Background: Grass allergen immunotherapy (AIT) reduces symptom severity in seasonal allergic rhinoconjunctivitis (ARC) but its impact on general health-related utility has not been characterised for the purposes of economic evaluation. The aim of this study was to model the preferred measure of utility, EQ-5D index, from symptom severity and estimate incremental quality adjusted life years (QALYs) associated with SQ-standardised grass immunotherapy tablet (GRAZAX®, 75,000 SQ-T/2,800 BAU, ALK, Denmark). Methods: Data were analysed from five consecutive pollen seasons in a randomised placebo controlled trial of GRAZAX®. Binomial and Gaussian mixed effects modelling related weekly EQ-5D index score to daily symptom and medication scores (DSS & DMS respectively). In turn, daily EQ-5D index was estimated from ARC symptoms and medication use

Evidence-Based Research Series-Paper 2 : Using an Evidence-Based Research approach before a new study is conducted to ensure value

Background and Objectives There is considerable actual and potential waste in research. The aim of this article is to describe how using an evidence-based research approach before conducting a study helps to ensure that the new study truly adds value. Study Design and Setting Evidence-based research is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this second article of the evidence-based research series, we describe how to apply an evidence-based research approach before starting a new study. Results Before a new study is performed, researchers need to provide a solid justification for it using the available scientific knowledge as well as the perspectives of end users. The key method for both is to conduct a systematic review of earlier relevant studies. Conclusion Describing the ideal process illuminates the challenges and opportunities offered through the suggested evidence-based research approach. A systematic and transparent approach is needed to provide justification for and to optimally design a relevant and necessary new study

Evidence-Based Research Series-Paper 3: Using an Evidence-Based Research approach to place your results into context after the study is performed to ensure usefulness of the conclusion

Background and Objective There is considerable actual and potential waste in research. Using evidence-based research (EBR) can ensure the value of a new study. The aim of this article, the third in a series, is to describe an EBR approach to putting research results into context. Study Design and Setting EBR is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this third and final article of a series, we describe how to use the context of existing evidence to reach and present a trustworthy and useful conclusion when reporting results from a new clinical study. Results We describe a method, the EBR approach, that by using a systematic and transparent consideration of earlier similar studies when interpreting and presenting results from a new original study will ensure usefulness of the conclusion. Conclusion Using an EBR approach will improve the usefulness of a clinical study by providing the context to draw more valid conclusions and explicit information about new research needs

Cost-effectiveness of SQ® HDM SLIT-tablet in addition to pharmacotherapy for the treatment of house dust mite allergic rhinitis in Germany

William Green,1 Jörg Kleine-Tebbe,2 Ludger Klimek,3 Julie Hahn-Pedersen,4 Jakob Nørgaard Andreasen,4 Matthew Taylor1 1York Health Economics Consortium, University of York, York, UK; 2Allergy and Asthma Center, Westend, Berlin, 3Center for Rhinology and Allergology, Wiesbaden, Germany; 4ALK-Abelló, Hørsholm, Denmark Background: Allergic rhinitis is a global health problem that burdens society due to associated health care costs and its impact on health. Standardized quality (SQ®) house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet is a sublingually administered allergy immunotherapy tablet for patients with persistent moderate to severe HDM allergic rhinitis despite use of allergy pharmacotherapy.Objective: To assess the cost-effectiveness of SQ HDM SLIT-tablet in Germany for patients suffering from HDM allergic rhinitis.Methods: A pharmacoeconomic analysis, based on data collected in a double-blinded, phase III randomized placebo-controlled trial (n=992), was undertaken to compare SQ HDM SLIT-tablet in addition to allergy pharmacotherapy to placebo plus allergy pharmacotherapy. Quality-adjusted life year (QALY) scores and health care resource use data recorded in the trial were applied to each treatment group and extrapolated over a nine-year time horizon. A series of scenarios were used to investigate the impact of changes on long-term patient health for both treatment groups, which was measured by annual changes in QALY scores. Deterministic and probabilistic sensitivity analyses were also performed. Results: In the base case analysis, compared with allergy pharmacotherapy, SQ HDM SLIT-tablet led to a QALY gain of 0.31 at an incremental cost of €2,276 over the nine-year time horizon, equating to an incremental cost-effectiveness ratio of €7,519. The treatment was cost-effective for all scenarios analyzed; however, results were sensitive to changes in individual parameter values during the deterministic sensitivity analysis.Conclusion: SQ HDM SLIT-tablet in addition to pharmacotherapy is cost-effective compared with allergy pharmacotherapy plus placebo for the treatment of persistent moderate to severe HDM allergic rhinitis that is not well controlled by allergy pharmacotherapy. Keywords: SQ HDM SLIT-tablet, allergic rhinitis, house dust mite, cost-utility analysi

Estimation of measurement uncertainties in X-ray computed tomography metrology using the substitution method

This paper presents the application of the substitution method for the estimation of measurement uncertainties using calibrated workpieces in X-ray computed tomography (CT) metrology. We have shown that this, well accepted method for uncertainty estimation using tactile coordinate measuring machines, can be applied to dimensional CT measurements. The method is based on repeated measurements carried out on a calibrated master piece. The master piece is a component of a dose engine from an insulin pen. Measurement uncertainties estimated from the repeated measurements of the master piece were transferred on to additionally scanned uncalibrated workpieces which provided the necessary link for achieving traceable measurements

Quantitative analysis of scaling error compensation methods in dimensional X-ray computed tomography

X-ray Computed Tomography (CT) has become an important technology for quality control of industrial components. As with other technologies, e.g., tactile coordinate measurements or optical measurements, CT is influenced by numerous quantities which may have negative impact on the accuracy and repeatability of dimensional and geometrical measurements. The aim of this paper is to discuss different methods for the correction of scaling errors and to quantify their influence on dimensional measurements. Scaling errors occur first and foremost in CT systems with no built-in compensation of positioning errors of the manipulator system (magnification axis). This article also introduces a new compensation method for scaling errors using a database of reference scaling factors and discusses its advantages and disadvantages. In total, three methods for the correction of scaling errors - using the CT ball plate, using calibrated features measured by CMM and using a database of reference values - are presented and applied within a case study. The investigation was performed on a dose engine component of an insulin pen, for which several dimensional measurands were defined. The component has a complex geometry and is made of brass, which makes its measurements with CT challenging. It is shown that each scaling error correction method results in different deviations between CT measurements and reference measurements from a CMM. Measurement uncertainties were estimated for each method, taking into consideration the contributions related to the applied correction method. The newly suggested approach using the database appeared to work well, indicating, that if the properties of a CT system under investigation are monitored using a reference object (ball bar in our case), a correction factor based on individual selected magnification factors can be applied for scaling error correction of any object, and thus no additional scanning of a reference object is needed