@article{BauernfeindAringerProdingeretal.2009, author = {Bauernfeind, B. and Aringer, M. and Prodinger, Birgit and Kirchberger, I. and Machold, K. and Smolen, J. and Stamm, T.}, title = {Identification of relevant concepts of functioning in daily life in people with systematic Lupus Erythematosus: A patient Delphi exercise}, series = {Arthritis Care \& Research}, volume = {61}, journal = {Arthritis Care \& Research}, number = {1}, pages = {21 -- 28}, year = {2009}, abstract = {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.}, language = {en} } @article{ProdingerNdosiNordenskioeldetal.2015, author = {Prodinger, Birgit and Ndosi, M. and Nordenski{\"o}ld, U. and Stamm, T. and Persson, G. and Andreasson, I. and Lundgren-Nilsson, A.}, title = {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}, series = {Journal of Rehabilitation Medicine}, volume = {47}, journal = {Journal of Rehabilitation Medicine}, number = {2}, pages = {174 -- 182}, year = {2015}, abstract = {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.}, language = {en} } @article{CastrejonCarmonaAgrinieretal.2015, author = {Castrejon, I. and Carmona, L. and Agrinier, N. and Andres, M. and Briot, K. and Caron, M. and Christensen, R. and Consolaro, A. and Curbelo, R. and Ferrer, M. and Foltz, V. and Gonzalez, C. and Guillemin, F. and Machado, P. and Prodinger, Birgit and Ravellil, A. and Scholte-Voshaar, M. and Uhlig, T. and van Tuyl, L. and Zink, A. and Gossec, L.}, title = {The EULAR Outcome Measures Library: development and an example from a systematic review for systemic lupus erythematous instruments}, series = {Clinical and Experimental Rheumatology}, volume = {33}, journal = {Clinical and Experimental Rheumatology}, number = {6}, pages = {910 -- 916}, year = {2015}, abstract = {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.}, language = {en} } @article{MaritzAronskyProdinger2017, author = {Maritz, R. and Aronsky, D. and Prodinger, Birgit}, title = {The Implementation of the International Classification of Functioning, Disability and Health (ICF) in Electronic Health Records - A Systematic Review}, series = {Applied Clinical Informatics}, volume = {8}, journal = {Applied Clinical Informatics}, number = {3}, pages = {964 -- 980}, year = {2017}, abstract = {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.}, language = {en} } @article{GrillFurmanAlghwirietal.2013, author = {Grill, E. and Furman, J.M. and Alghwiri, A.A. and M{\"u}ller, Martin and Whitney, S.L.}, title = {Using core sets of the international classification of functioning, disability and health (ICF) to measure disability in vestibular disorders: study protocol}, series = {Journal of vestibular research}, journal = {Journal of vestibular research}, number = {23(6)}, editor = {B{\´a}r{\´a}ny Society,}, year = {2013}, abstract = {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.}, language = {en} } @article{MuellerWhitneyAlghwirietal.2015, author = {M{\"u}ller, Martin and Whitney, S. L. and Alghwiri, A. and Alshebber, K. and Strobl, R. and Aghadir, A. and Almomani, M. O. and Furman, J. M. and Grill, E.}, title = {Subscales of the vestibular activities and participation questionnaire could be applied across cultures}, series = {European journal of epidemiology}, journal = {European journal of epidemiology}, editor = {PlumX Metrics,}, year = {2015}, abstract = {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.}, language = {en} } @article{MuellerGrillFurmanetal.2012, author = {M{\"u}ller, Martin and Grill, E. and Furman, J.M. and Alghwiri, A.A. and Whitney, S.L.}, title = {Using core sets of the international classification of functioning, disability and health (ICF) to measure disability in vestibular disorders: study protocol}, series = {Barany Society June 10, 2012 Symposium on Measures for Level of Functioning and Quality of Life in People with Vestibular Disorders}, journal = {Barany Society June 10, 2012 Symposium on Measures for Level of Functioning and Quality of Life in People with Vestibular Disorders}, editor = {IOS Press content Library,}, year = {2012}, abstract = {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.}, language = {en} } @article{Hammerschmidt2017, author = {Hammerschmidt, Thomas}, title = {Einflussfaktoren auf die Arzneimittelpreisbildung auf Unternehmensebene}, series = {Recht und Politik im Gesundheitswesen}, volume = {2017}, journal = {Recht und Politik im Gesundheitswesen}, number = {23 / 3}, publisher = {Planimed}, address = {Fahrdorf}, pages = {97-111}, year = {2017}, abstract = {Die Entwicklung der Arzneimittelausgaben in der Gesetzlichen Krankenversicherung (GKV) ist dauerhaft ein gesundheitspolitisches Streitthema. Dabei stehen vor allem die Arzneimittelpreise neuer, patentgesch{\"u}tzter Medikamente im Fokus der gesundheitspolitischen Diskussion. In diesen Diskussionen wird h{\"a}ufig von „Mondpreisen" gesprochen, die in keiner Relation zum Nutzen der neuen Arzneimittel st{\"u}nden. 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 f{\"u}r neue Arzneimittel eine Rolle spielen. Die Analyse folgt dabei der Perspektive des Arzneimittelherstellers. Zum einen muss das Unternehmen die betriebswirtschaftlichen Rahmenbedingungen ber{\"u}cksichtigen, die eine Untergrenze f{\"u}r den erforderlichen Preis determinieren. Zum anderen bestimmt der Wert des Medikamentes in seinem Wettbewerbsumfeld eine Obergrenze f{\"u}r den Preis. Aus betriebswirtschaftlicher Perspektive l{\"a}sst sich festhalten, dass die umsatzst{\"a}rksten Pharmaunternehmen einen hohen Reingewinn erzielen, die Dividendenrendite von 3\% eine im Gesundheitssektor hohe Profitabilit{\"a}t aus Sicht der Kapitalgeber ausweist. Die Pharmabranche erzielt im Vergleich zu anderen Sektoren wie der Technologiebranche oder dem Rohstoffsektor jedoch keine {\"U}berrenditen. Unternehmensseitig stellen die Marketing-, Vertriebs- und Verwaltungs- (29\%), die Herstellungs- (29\%) und Forschungs- und Entwicklungs- (F\&E) (17\%) sowie die Kapitalkosten (14\%) die wesentlichen Kostenbl{\"o}cke dar. Die Produktionskosten spielen in der Diskussion um Arzneimittelpreise eine untergeordnete Rolle, was bei der Gr{\"o}ße dieses Kostenblocks erstaunt. Die vorliegende Studie erg{\"a}nzt die bisherigen, h{\"a}ufig kritisierten Sch{\"a}tzungen von F\&E-Kosten um einen neuen Ansatz auf Basis der in Gesch{\"a}ftsberichten ausgewiesenen F\&E-Kosten. F\&E ist gepr{\"a}gt durch steigende Ausgaben, lange Kapitalbindung und eine Vielzahl nicht erfolgreicher Entwicklungsprogramme - nur eines von acht klinischen Entwicklungsprogrammen f{\"u}hrt 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. Ber{\"u}cksichtigt man alle Kosten, so m{\"u}sste ein Arzneimittel durchschnittlich ca. 15 Mrd. \$ Umsatz {\"u}ber den gesamten Produktlebenszyklus erreichen, was nur von jedem vierten bis siebten Medikament erreicht wird. Die Preissetzung f{\"u}r neue Arzneimittel erfolgt derart, dass eine notwendige Querfinanzierung von nicht erfolgreichen Arzneimittelentwicklungen und Medikamenten mit zu niedrigem Umsatz erm{\"o}glicht wird. Neben den betriebswirtschaftlichen Rahmenbedingungen spielt letztlich f{\"u}r die Preisfindung der Wert des Arzneimittels im Vergleich zu relevanten Wettbewerbsprodukten die entscheidende Rolle. In der Regel ist das Wettbewerbsumfeld durch einen monopolistischen Wettbewerb gepr{\"a}gt. Arzneimittelhersteller ber{\"u}cksichtigen in rationaler Weise Produkteigenschaften, die {\"u}ber den patientenrelevanten Nutzen im AMNOG hinausgehen zur Preisdifferenzierung im wettbewerblichen Umfeld. Zu derartigen Produkteigenschaften z{\"a}hlen Verbesserung von sogenannten Surrogatendpunkten, aber auch k{\"u}rzere Behandlungsdauern, weniger invasive Darreichungsformen und l{\"a}nger getaktete, weniger h{\"a}ufige Arzneimitteleinnahme, welche einen Wert des Arzneimittels aus Sicht des Patienten widerspiegeln.}, language = {de} } @techreport{Hammerschmidt2017, type = {Working Paper}, author = {Hammerschmidt, Thomas}, title = {Factors influencing the outcomes of the AMNOG benefit assessment}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:861-opus4-2291}, pages = {16}, year = {2017}, abstract = {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.}, subject = {AMNOG}, language = {en} } @article{Hammerschmidt2016, author = {Hammerschmidt, Thomas}, title = {Benachteiligt das AMNOG systematisch Medikamente in der Indikation "Diabetes mellitus"? H{\"a}ufigere Marktr{\"u}cknahmen als in anderen Indikationen}, series = {Diabetes aktuell}, volume = {2016}, journal = {Diabetes aktuell}, number = {13 (8)}, publisher = {Georg Thieme Verlag Stuttgart - New York}, pages = {385-394}, year = {2016}, abstract = {Seit 2011 m{\"u}ssen Hersteller neuer Medikamente infolge des AMNOG deren Zusatznutzen gegen{\"u}ber einer sogenannten "zweckm{\"a}ßigen Vergleichstherapie" nachweisen. Mit derzeit 17 Nutzenbewertungen ist der Diabetes mellitus die Indikation, in der bislang die meisten Medikamente beurteilt wurden. Allerdings fallen die Nutzenbewertungen f{\"u}r 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 zweckm{\"a}ßigen Vergleichstherapie nehmen Hersteller seit der Einf{\"u}hrung des AMNOG Antidiabetika h{\"a}ufiger vom Markt als Medikamente in anderen Indikationen. Die Auswahl an Antidiabetika ist demzufolge in Deutschland deutlich eingeschr{\"a}nkt, und pharmazeutische Unternehmen erwarten in Zukunft eine versp{\"a}tete Markteinf{\"u}hrung in Deutschland. Um dieser Entwicklung entgegenzuwirken, m{\"u}ssen Hersteller mehr Daten zu langfristigen Outcomes der Arzneimitteltherapie generieren und diese in den Prozess einbringen. Dies ist jedoch nur m{\"o}glich, wenn der AMNOG-Prozess entsprechend angepasst wird.}, language = {de} }