TY - JOUR A1 - Bauernfeind, B. A1 - Aringer, M. A1 - Prodinger, Birgit A1 - Kirchberger, I. A1 - Machold, K. A1 - Smolen, J. A1 - Stamm, T. T1 - Identification of relevant concepts of functioning in daily life in people with systematic Lupus Erythematosus: A patient Delphi exercise JF - Arthritis Care & Research N2 - Objective To identify the most important and relevant concepts of daily functioning from the perspective of patients with systemic lupus erythematosus (SLE). Methods We conducted a consensus‐building, 3‐round, electronic mail survey with SLE patients using the Delphi technique. The Delphi technique is a structured communication process with 4 key characteristics: anonymity, iteration with controlled feedback, statistical group response, and informed input. The concepts contained in the answers of the patients were extracted and linked to the International Classification of Functioning, Disability and Health (ICF). Results Of the total 225 participants, 194 (86.2%) completed the questionnaires from all 3 Delphi rounds. In total, after the third Delphi round, 307 concepts were identified. Ninety concepts (55 in the domain body functions and structures, 16 in activities and participation, and 19 in environmental factors) were considered relevant by at least 50% of the participants in the third round and linked to the ICF. Twelve concepts were considered important by at least 75% of the participants. Conclusion The high number of concepts resulting from this large‐scale patient Delphi approach underlines the great variety of SLE patients' problems in daily functioning. The results of this patient Delphi project supplement the findings of our focus‐group study in establishing a comprehensive overview of the patient perspective in SLE. KW - Systemic lupus erythematosus KW - Patient Delphi exercise KW - Functioning in daily life Y1 - 2009 UR - https://doi.org/10.1002/art.24165 VL - 61 IS - 1 SP - 21 EP - 28 ER - TY - JOUR A1 - Prodinger, Birgit A1 - Ndosi, M. A1 - Nordenskiöld, U. A1 - Stamm, T. A1 - Persson, G. A1 - Andreasson, I. A1 - Lundgren-Nilsson, A. T1 - Rehabilitation provided to patients with rheumatoid arthritis: A comparison of three different Rheumatology clinics in Austria, Sweden and the UK from the perspectives of patients and health professionals JF - Journal of Rehabilitation Medicine N2 - Objective: To explore patients’ and health professionals’ views of outpatient rehabilitation services for patients with rheumatoid arthritis in 3 different rheumatology sites across Europe. Methods: A qualitative multi-method study was conducted with patients and health professionals in Vienna (Austria), Gothenburg (Sweden) and Leeds (UK). Data collection was carried out during focus groups with patients and health professionals. Patients’ hospital records were integrated into the analysis. Data were analysed for site and findings were compared across sites. Results: A total of 20 patients and 20 health professionals participated in 12 focus groups. Although the 3 sites were all publicly funded university clinics, there were differences between sites regarding the structure and content of rehabilitation services. The themes that emerged in the focus groups were: referrals; continuity in rehabilitation; information provided to patients; patients’ organizations; documentation and communication amongst health professionals; interface between primary and specialist care; and prescription practices. Most themes were addressed at all 3 sites, but there were variations in the specifics within themes. Conclusion: Integration of patients’ and health professionals’ views on how rehabilitation services are coordinated and how (parts of) processes are set up elsewhere provide valuable information for the further optimization of rehabilitation services. KW - Delivery of Healthcare KW - Interdisciplinary Communication KW - Multi-centre study KW - Patient perspective KW - Rehabilitation Y1 - 2015 UR - https://doi.org/10.2340/16501977-1914 VL - 47 IS - 2 SP - 174 EP - 182 ER - TY - JOUR A1 - Castrejon, I. A1 - Carmona, L. A1 - Agrinier, N. A1 - Andres, M. A1 - Briot, K. A1 - Caron, M. A1 - Christensen, R. A1 - Consolaro, A. A1 - Curbelo, R. A1 - Ferrer, M. A1 - Foltz, V. A1 - Gonzalez, C. A1 - Guillemin, F. A1 - Machado, P. A1 - Prodinger, Birgit A1 - Ravellil, A. A1 - Scholte-Voshaar, M. A1 - Uhlig, T. A1 - van Tuyl, L. A1 - Zink, A. A1 - Gossec, L. T1 - The EULAR Outcome Measures Library: development and an example from a systematic review for systemic lupus erythematous instruments JF - Clinical and Experimental Rheumatology N2 - Objective: Patient reported outcomes (PROs) are relevant in rheumatology. Variable accessibility and validity of commonly used PROs are obstacles to homogeneity in evidence synthesis. The objective of this project was to provide a comprehensive library of “validated PROs”. Methods: A launch meeting with rheumatologists, PROs methodological experts, and patients, was held to define the library’s aims and scope, and basic requirements. To feed the library we performed systematic reviews on selected diseases and domains. Relevant information on PROs was collected using standardised data collection forms based on the COSMIN checklist. Results: The EULAR Outcomes Measures Library (OML), whose aims are to provide and to advise on PROs on a user-friendly manner albeit based on scientific grounds, has been launched and made accessible to all. PROs currently included cover any domain and, are generic or specifically target to the following diseases: rheumatoid arthritis, osteoarthritis, spondyloarthritis, low back pain, systemic lupus erythematosus, gout, osteoporosis, juvenile idiopathic arthritis, and fibromyalgia. Up to 236 instruments (106 generic and 130 specific) have been identified, evaluated, and included. The systematic review for SLE, which yielded 10 specific instruments, is presented here as an example. The OML website includes, for each PRO, information on the construct being measured and the extent of validation, recommendations for use, and available versions; it also contains a glossary on common validation terms. Conclusion: The OML is an in progress library led by rheumatologists, related professionals and patients, that will help to better understand and apply PROs in rheumatic and musculoskeletal diseases. KW - Rheuma KW - Lupus erythematous KW - Outcome measures KW - Systematic Review Y1 - 2015 VL - 33 IS - 6 SP - 910 EP - 916 ER - TY - JOUR A1 - Maritz, R. A1 - Aronsky, D. A1 - Prodinger, Birgit T1 - The Implementation of the International Classification of Functioning, Disability and Health (ICF) in Electronic Health Records - A Systematic Review JF - Applied Clinical Informatics N2 - Background: The International Classification of Functioning, Disability and Health (ICF) is the World Health Organization’s standard for describing health and health-related states. Examples of how the ICF has been used in Electronic Health Records (EHRs) have not been systematically summarized and described yet. Objectives: To provide a systematic review of peer-reviewed literature about the ICF’s use in EHRs, including related challenges and benefits. Methods: Peer-reviewed literature, published between January 2001 and July 2015 was retrieved from Medline®, CINAHL®, Scopus®, and ProQuest® Social Sciences using search terms related to ICF and EHR concepts. Publications were categorized according to three groups: Requirement specification, development and implementation. Information extraction was conducted according to a qualitative content analysis method, deductively informed by the evaluation framework for Health Information Systems: Human, Organization and Technology-fit (HOT-fit). Results: Of 325 retrieved articles, 17 publications were included; 4 were categorized as requirement specification, 7 as development, and 6 as implementation publications. Information regarding the HOT-fit evaluation framework was summarized. Main benefits of using the ICF in EHRs were its unique comprehensive perspective on health and its interdisciplinary focus. Main challenges included the fact that the ICF is not structured as a formal terminology as well as the need for a reduced number of ICF codes for more feasible and practical use. Conclusion: Different approaches and technical solutions exist for integrating the ICF in EHRs, such as combining the ICF with other existing standards for EHR or selecting ICF codes with natural language processing. Though the use of the ICF in EHRs is beneficial as this review revealed, the ICF could profit from further improvements such as formalizing the knowledge representation in the ICF to support and enhance interoperability. KW - International Classification of Functioning KW - Disability and health KW - Electronic health records KW - Reference standards KW - Medical Informatics Y1 - 2017 UR - https://doi.org/10.4338/ACI2017050078 VL - 8 IS - 3 SP - 964 EP - 980 ER - TY - JOUR A1 - Grill, E. A1 - Furman, J.M. A1 - Alghwiri, A.A. A1 - Müller, Martin A1 - Whitney, S.L. ED - Bárány Society, T1 - Using core sets of the international classification of functioning, disability and health (ICF) to measure disability in vestibular disorders: study protocol JF - Journal of vestibular research N2 - 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. KW - Vertigo KW - Dizziness KW - Quality of life KW - Activities of daily living Y1 - 2013 IS - 23(6) ER - TY - JOUR A1 - Müller, Martin A1 - Whitney, S. L. A1 - Alghwiri, A. A1 - Alshebber, K. A1 - Strobl, R. A1 - Aghadir, A. A1 - Almomani, M. O. A1 - Furman, J. M. A1 - Grill, E. ED - PlumX Metrics, T1 - Subscales of the vestibular activities and participation questionnaire could be applied across cultures JF - European journal of epidemiology N2 - 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. KW - Dizziness KW - Vertigo KW - Quality of life KW - Activities of daily living KW - social participation Y1 - 2018 ER - TY - JOUR A1 - Müller, Martin A1 - Grill, E. A1 - Furman, J.M. A1 - Alghwiri, A.A. A1 - Whitney, S.L. ED - IOS Press content Library, T1 - Using core sets of the international classification of functioning, disability and health (ICF) to measure disability in vestibular disorders: study protocol JF - Barany Society June 10, 2012 Symposium on Measures for Level of Functioning and Quality of Life in People with Vestibular Disorders N2 - 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. KW - Dizziness KW - Vertigo KW - Quality of life Y1 - 2012 ER - TY - JOUR A1 - Hammerschmidt, Thomas T1 - Einflussfaktoren auf die Arzneimittelpreisbildung auf Unternehmensebene JF - Recht und Politik im Gesundheitswesen N2 - Die Entwicklung der Arzneimittelausgaben in der Gesetzlichen Krankenversicherung (GKV) ist dauerhaft ein gesundheitspolitisches Streitthema. Dabei stehen vor allem die Arzneimittelpreise neuer, patentgeschützter Medikamente im Fokus der gesundheitspolitischen Diskussion. In diesen Diskussionen wird häufig von „Mondpreisen“ gesprochen, die in keiner Relation zum Nutzen der neuen Arzneimittel stünden. Die Diskussion zwischen „Mondpreisen“ und der seitens der Arzneimittelhersteller notwendigen Preisen zur Amortisierung von Forschungs- und Entwicklungskosten greift zu kurz. Die vorliegende Analyse leistet einen Beitrag dazu, die Faktoren detaillierter zu beleuchten, die bei der Preisfindung forschender pharmazeutischer Unternehmen für neue Arzneimittel eine Rolle spielen. Die Analyse folgt dabei der Perspektive des Arzneimittelherstellers. Zum einen muss das Unternehmen die betriebswirtschaftlichen Rahmenbedingungen berücksichtigen, die eine Untergrenze für den erforderlichen Preis determinieren. Zum anderen bestimmt der Wert des Medikamentes in seinem Wettbewerbsumfeld eine Obergrenze für den Preis. Aus betriebswirtschaftlicher Perspektive lässt sich festhalten, dass die umsatzstärksten Pharmaunternehmen einen hohen Reingewinn erzielen, die Dividendenrendite von 3% eine im Gesundheitssektor hohe Profitabilität aus Sicht der Kapitalgeber ausweist. Die Pharmabranche erzielt im Vergleich zu anderen Sektoren wie der Technologiebranche oder dem Rohstoffsektor jedoch keine Überrenditen. Unternehmensseitig stellen die Marketing-, Vertriebs- und Verwaltungs- (29%), die Herstellungs- (29%) und Forschungs- und Entwicklungs- (F&E) (17%) sowie die Kapitalkosten (14%) die wesentlichen Kostenblöcke dar. Die Produktionskosten spielen in der Diskussion um Arzneimittelpreise eine untergeordnete Rolle, was bei der Größe dieses Kostenblocks erstaunt. Die vorliegende Studie ergänzt die bisherigen, häufig kritisierten Schätzungen von F&E-Kosten um einen neuen Ansatz auf Basis der in Geschäftsberichten ausgewiesenen F&E-Kosten. F&E ist geprägt durch steigende Ausgaben, lange Kapitalbindung und eine Vielzahl nicht erfolgreicher Entwicklungsprogramme – nur eines von acht klinischen Entwicklungsprogrammen führt zu einer erfolgreichen Zulassung. Die F&E-Kosten eines Arzneimittels inklusive der Weiterentwicklungen in andere Indikationsgebiete oder anderer Darreichungsformen liegen zwischen 2,2 und 3,1 Mrd. $ mit einem Mittelwert von 2,6 Mrd. $. Nur ca. 60% der Arzneimittel erwirtschaften die F&E-Kosten im Verlaufe des Produktlebenszyklus. Berücksichtigt man alle Kosten, so müsste ein Arzneimittel durchschnittlich ca. 15 Mrd. $ Umsatz über den gesamten Produktlebenszyklus erreichen, was nur von jedem vierten bis siebten Medikament erreicht wird. Die Preissetzung für neue Arzneimittel erfolgt derart, dass eine notwendige Querfinanzierung von nicht erfolgreichen Arzneimittelentwicklungen und Medikamenten mit zu niedrigem Umsatz ermöglicht wird. Neben den betriebswirtschaftlichen Rahmenbedingungen spielt letztlich für die Preisfindung der Wert des Arzneimittels im Vergleich zu relevanten Wettbewerbsprodukten die entscheidende Rolle. In der Regel ist das Wettbewerbsumfeld durch einen monopolistischen Wettbewerb geprägt. Arzneimittelhersteller berücksichtigen in rationaler Weise Produkteigenschaften, die über den patientenrelevanten Nutzen im AMNOG hinausgehen zur Preisdifferenzierung im wettbewerblichen Umfeld. Zu derartigen Produkteigenschaften zählen Verbesserung von sogenannten Surrogatendpunkten, aber auch kürzere Behandlungsdauern, weniger invasive Darreichungsformen und länger getaktete, weniger häufige Arzneimitteleinnahme, welche einen Wert des Arzneimittels aus Sicht des Patienten widerspiegeln. KW - Arzneimittelpreise KW - Pharmazeutische Industrie KW - Forschungs- und Entwicklungskosten KW - Wert von Arzneimitteln Y1 - 2017 VL - 2017 IS - 23 / 3 PB - Planimed CY - Fahrdorf ER - TY - RPRT A1 - Hammerschmidt, Thomas T1 - Factors influencing the outcomes of the AMNOG benefit assessment N2 - 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. T3 - Rosenheimer Beiträge - 1 KW - AMNOG, HTA, benefit assessment, pharmaceuticals, Germany KW - AMNOG KW - health technology assessment KW - pharmaceutical KW - benefit assessment KW - Germany Y1 - 2017 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:861-opus4-2291 ER - TY - JOUR A1 - Hammerschmidt, Thomas T1 - Benachteiligt das AMNOG systematisch Medikamente in der Indikation "Diabetes mellitus"? Häufigere Marktrücknahmen als in anderen Indikationen JF - Diabetes aktuell N2 - Seit 2011 müssen Hersteller neuer Medikamente infolge des AMNOG deren Zusatznutzen gegenüber einer sogenannten "zweckmäßigen Vergleichstherapie" nachweisen. Mit derzeit 17 Nutzenbewertungen ist der Diabetes mellitus die Indikation, in der bislang die meisten Medikamente beurteilt wurden. Allerdings fallen die Nutzenbewertungen für Antidiabetika wesentlich schlechter aus als in anderen Indikationen. Meist erhalten sie entweder keinen Zusatznutzen oder nur einen geringen Zusatznutzen in einer Teilpopulation. Wegen dieser schlechten Bewertungen und der geringpreisigen generischen zweckmäßigen Vergleichstherapie nehmen Hersteller seit der Einführung des AMNOG Antidiabetika häufiger vom Markt als Medikamente in anderen Indikationen. Die Auswahl an Antidiabetika ist demzufolge in Deutschland deutlich eingeschränkt, und pharmazeutische Unternehmen erwarten in Zukunft eine verspätete Markteinführung in Deutschland. Um dieser Entwicklung entgegenzuwirken, müssen Hersteller mehr Daten zu langfristigen Outcomes der Arzneimitteltherapie generieren und diese in den Prozess einbringen. Dies ist jedoch nur möglich, wenn der AMNOG-Prozess entsprechend angepasst wird. KW - AMNOG KW - Nutzenbewertung KW - Arzneimittelpreise KW - Opt-out KW - Diabetes mellitus Y1 - 2016 VL - 2016 IS - 13 (8) PB - Georg Thieme Verlag Stuttgart - New York ER -