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Symptom frequency and severity in vestibular disorders often do not correlate well with patients' restrictions of activities of daily living and limitations of participation.
Due to the lack of appropriate patient reported outcome measures (PRO), the extent of limitations and restrictions is mostly unknown. The International Classification of Functioning, Disability and Health (ICF) is a conceptual framework and classification to evaluate all aspects of health and disability. An ICF-based measure, the Vestibular and Participation Measure (VAP), was recently proposed.
Also, an ICF Core Set for vertigo, dizziness and balance disorders was developed to describe what aspects of functioning should be measured. This study protocol describes the development and cross-cultural validation of a new measure, the VAP-extended (VAP-e), based on VAP and ICF Core Set on three continents.
To determine objectivity and cross-cultural validity of the VAP and to find potentially redundant items, Rasch models will be used. The VAP-e will be created by modifying or adding items from the Activities and Participation and Environmental Factors component of the ICF Core Set. Reliability, objectivity and responsiveness of the VAP-e will be tested.
Objectives
The objective of this study was to assess the objectivity, cross-cultural validity, and convergent validity of the Vestibular Activities and Participation (VAP) questionnaire among four countries, Germany, United States, Jordan, and Saudi Arabia.
Study Design and Setting
This was a cross-sectional study conducted in four specialized outpatient dizziness clinics in Germany, United States, Jordan, and Saudi Arabia.
Results
A total of 453 participants were included in the study. The Rasch analysis revealed two separate subscales. Subscale 1 items included focusing attention, lying down, standing, bending, lifting and carrying objects, and sports. Subscale 2 items included walking long distances, climbing, running, moving around within buildings other than home, using transportation, and driving. The Pearson product–moment correlation between the Dizziness Handicap Inventory and the summary score of the VAP subscale 1 was 0.66 and was 0.64 for subscale 2.
Conclusion
Owing to its shortness and intercultural adaptability, the new two-scale version of the VAP questionnaire lends itself to clinical practice and research across countries to estimate the effect of vertigo and dizziness on activity limitation and participation restrictions. Psychometrically sound summary scores can be calculated. More extended versions of the VAP can be used for comprehensive clinical assessment where summary scores are not needed or a more detailed documentation is warranted.
Symptom frequency and severity in vestibular disorders often do not correlate well with patients' restrictions of activities of daily living and limitations of participation. Due to the lack of appropriate patient reported outcome measures (PRO), the extent of limitations and restrictions is mostly unknown.
The International Classification of Functioning, Disability and Health (ICF) is a conceptual framework and classification to evaluate all aspects of health and disability. An ICF-based measure, the Vestibular and Participation Measure (VAP), was recently proposed. Also, an ICF Core Set for vertigo, dizziness and balance disorders was developed to describe what aspects of functioning should be measured.
This study protocol describes the development and cross-cultural validation of a new measure, the VAP-extended (VAP-e), based on VAP and ICF Core Set on three continents. To determine objectivity and cross-cultural validity of the VAP and to find potentially redundant items, Rasch models will be used. The VAP-e will be created by modifying or adding items from the Activities and Participation and Environmental Factors component of the ICF Core Set.
Reliability, objectivity and responsiveness of the VAP-e will be tested.
In countries with large import dependencies, several studies on strategically important metals have classified raw materials as being critical by combining supply and vulnerability risks. In case of availability, the most critical raw materials are metallic ores and industrial minerals. Within the scope of developing resource efficient buildings, innovative building technologies, such as renewable energy systems, are becoming increasingly integral parts of buildings. Since critical raw materials are essential components in building technologies, they will also play an important role in the housing sector.
In this context, it is crucial to consider how sustainability goals in the housing sector are affected by raw material criticality. This paper addresses supply and vulnerability risks of indium, which is contained in thin-film photovoltaics, in order to identify their impacts on future developments in the housing sector. Raw material availability is significantly influenced by the demand and supply of raw materials. To implement risk factors for a criticality assessment in sector-specific material flows, their impacts are analysed and modelled using a dynamic, macro-economic approach. Assuming different energy scenarios in the German housing sector up to 2050, the model reveals the raw material criticality by pointing out supply risks in order to derive recommendations.
The automotive value chain is experiencing significant transformation. Due to changed mobility use patterns and external conditions such as climate change, scarcity of resources and local air pollution, car manufacturers offer connectivity services and are forced to launch electric mobility. Most of the electric vehicles have additional, complementary products and services. As other market participants also engage in this field car manufacturers must decide whether they transform their business model. Therefore, the questions arise which are the determining key criteria for the business models, what are the business segments car manufacturers are engaged and how car manufacturers are preparing for the transformation. By using qualitative content analysis, key criteria for business model analysis are derived. The portfolio analysis of six car manufacturers in the German market unveils that a few car manufacturers are in an advanced state while others follow with a considerable lag, or even, are behind.
Background: Since 2011, pharmaceutical companies have to proof the added benefit of new drugs in Germany. The benefit assessment is in relation to an “appropriate comparator therapy” (ACT) defined by the Federal Joint Committee (FJC). Based on the benefit assessment, a reimbursement price is negotiated. In order to proof added benefit, it is essential to provide evidence on patient-relevant outcomes from direct head-to-head comparisons with the ACT. Indirect treatment comparisons and evidence based on surrogate parameters are usually not sufficient. FJC often splits the indication into different subpopulations.
Objective: The objective was to analyse whether factors beyond the clinical evidence have influence on the benefit assessment of the FJC.
Methods: All benefit assessments between 2011 and 2015 were included in the analysis. The benefit for each drug was calculated by weighting the evidence grade, strength of evidence and size of subpopulations. Drugs were then clustered in high, low or no benefit. Univariate logistic regression was used to identify variables with potential influence (p<0.25). Those variables were included in a multivariate logistic regression model and variables with p>0.1 were excluded in a stepwise approach.
Results: The final multivariate logistic regression identified that following variables increase the chance of getting a higher benefit: pharmacologically innovative drug, drugs in disease areas with high unmet medical need, drugs in oncology or infectious diseases, and drugs for which the FJC can split the assessment into subpopulations.
Conclusions: The analysis identified variables beyond clinical evidence that influence the benefit assessment by the FJC and provided a better understanding of decision making by the FJC.