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1. Visions and reality: the idea of competence-oriented assessment for German medical students is not yet realised in licensing examinations

Author

Huber-Lang, Markus, Palmer, Annette, Grab, Claudia, Boeckers, Anja, Boeckers, Tobias Maria, and Oechsner, Wolfgang

Subjects
medical competence, high-stakes exam, alignment, roles, NKLM, Special aspects of education, LC8-6691, Medicine
Abstract

Objective: Competence orientation, often based on the CanMEDS model, has become an important goal for modern curricula in medical education. The National Competence Based Catalogue of Learning Objectives for Undergraduate Medical Education (NKLM) has been adopted in Germany. However, it is currently unknown whether the vision of competence orientation has also reached the licensing examination procedures.Methods: Therefore, a prospective, descriptive, single-centre, exemplary study design was applied to evaluate 4051 questions/tasks (from 28 examiners at 7 two-day licensing oral-practical exams) for undergraduate medical students at the University of Ulm. The oral and practical questions/tasks as well as the real bedside assessment were assigned to specific competence roles (NKLM section I), categories (NKLM section II) and taxonomy levels of learning domains.Results: Numerous questions/tasks were set per candidate (day 1/2: 70±24/86±19 questions) in the licensing oral-practical exam. Competence roles beyond the “medical expert” were scarcely considered. Furthermore, practical and communication skills at the bedside were hardly addressed (less than 3/15 min). Strikingly, there was a significant predominance of questions with a low-level taxonomy. Conclusions: The data indicate a misalignment of competence-oriented frameworks and the “real world” licensing practical-oral medical exam, which needs improvement in both evaluation and education processes.

Published
2017
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2. Effekte und Nachhaltigkeit von Trainingsworkshops für den mündlich-praktischen Teil des M2-Examens [Effects and Sustainability of Trainings for the Oral and Practical Part of the German Final Exam in Medicine]

Author

Öchsner, Wolfgang, Huber-Lang, Markus, and Geiler, Sandra

Subjects
Medical Education, Final Exam, Oral Examinations, Examiner Training, Lehrforschung, Staatsexamen Medizin, mündlich-praktische Prüfungen, Prüfertrainings, Special aspects of education, LC8-6691, Medicine (General), R5-920
Abstract

[english] Study Goals: It is known that the manifold limitations of oral and practical examinations can be improved by specific training. With the help of an online survey, our present study analyzes the effects that can be achieved by the training conducted at the University of Ulm for examiners in the final medical examination, the long-lasting impact of the training, and differences among participant subgroups.Method: All 367 participants in the training at Ulm (2007- 2012) were contacted via email. Sixty-three persons responded to the survey that included 28 items concerning demographic data, effectiveness, and sustainability.Results: Six main effects of the training were identified (meaning effects rated with a grade of 1 or 2 on a 6-point scale by two thirds of the participants, with 1=“applicable” and 6=“not applicable”; cumulated percentage of answers of 1 or 2 in parentheses):The responses of participants trained more than two years ago were not significantly different from the answers given by recently trained persons. This is an argument for the sustainability of the training effects.Furthermore, participants without relevant prior experience in oral/practical examinations profited significantly more from the trainings, especially in the areas of stress reduction, confidence in grading, and competence in critical discrimination of grading.Conclusion: The positive and sustained effects of the examiner training argue for continuing the training program, especially for inexperienced examiners. Expansion of the successful training program to include the first medical exam should be considered.[german] Zielsetzung: Die vielfältigen Limitationen mündlich-praktischer Prüfungen können bekanntermaßen durch spezifische Trainings günstig beeinflusst werden. Die vorliegende Studie analysiert daher anhand eines Fragebogens die in Ulm durchgeführten Trainings für Staatsexamensprüfer, deren Nachhaltigkeit und mögliche Unterschiede zwischen den Teilnehmer-Subgruppen.Methode: Alle 367 Teilnehmer der bisherigen Ulmer Prüfertrainings (2007 – 20012) wurden per e-Mail angeschrieben. 63 Personen beantworteten die Umfrage, die insgesamt 28 Items zu demografischen Daten und zu Effektivität und Nachhaltigkeit der Trainings enthielt. Ergebnisse: Es ließen sich 6 wesentliche Trainingseffekte nachweisen (Trainingseffekte, die von mindestens zwei Dritteln der Befragungsteilnehmer auf einer Skala von 1 = „trifft zu“ bis 6 = „trifft nicht zu“ mit den Skalenstufen 1 oder 2 beantwortet wurden; kumulierte Prozentzahl in Klammern): Die Antworten der Teilnehmer, deren Training länger als 2 Jahre zurücklag, unterschieden sich nicht signifikant von den Antwortmittelwerten der übrigen Teilnehmer, was für die Nachhaltigkeit der Trainingseffekte spricht.Teilnehmer ohne relevante Vorerfahrung als Prüfer profitierten signifikant stärker von den Trainings, insbesondere in den Bereichen Stressreduktion, Sicherheit in der Notenfindung und kritischere Notengebung.Schlussfolgerung: Die Studie liefert Hinweise für nachhaltig positive Effekte der M2-Prüfertrainings, die für die weitere Durchführung der Trainings sprechen, insbesondere als Trainingsangebot für unerfahrene Prüfer. Die Ausweitung der Trainings erscheint daher auch für Prüfer in den M1-Prüfungen sinnvoll.

Published
2013
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3. ‘Stealth’ corporate innovation: an emerging threat for therapeutic drug development

Author

John P. A. Ioannidis, Antonio M. Risitano, Brian V. Geisbrecht, Bo Nilsson, Daniel Ricklin, Alberto Mantovani, B. Paul Morgan, Tom Eirik Mollnes, Ronald P. Taylor, John D. Lambris, Mohamed R. Daha, Taroh Kinoshita, E. Sander Connolly, Dimitrios C. Mastellos, Robert A. Montgomery, Ruben Pio, V. Michael Holers, Piet Gros, Berhane Ghebrehiwet, George Hajishengallis, Anna M. Blom, Markus Huber-Lang, Mastellos, Dimitrios C, Blom, Anna M, Connolly, E Sander, Daha, Mohamed R, Geisbrecht, Brian V, Ghebrehiwet, Berhane, Gros, Piet, Hajishengallis, George, Holers, V Michael, Huber-Lang, Marku, Kinoshita, Taroh, Mollnes, Tom E, Montgomery, Robert A, Morgan, B Paul, Nilsson, Bo, Pio, Ruben, Ricklin, Daniel, Risitano, Antonio M, Taylor, Ronald P, Mantovani, Alberto, Ioannidis, John P A, and Lambris, John D

Subjects
0301 basic medicine, Immunology, Corporate innovation, Article, ComputingMilieux_GENERAL, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Drug development, Data transparency, Accountability, Immunology and Allergy, Engineering ethics, Business, 030215 immunology
Abstract

Therapeutic innovations of potentially great clinical impact should embrace the overarching values of research accountability, data transparency and validation through the scientific peer-review process.

Published
2019

4. Feasibility and safety of treating non-unions in tibia, femur and humerus with autologous, expanded, bone marrow-derived mesenchymal stromal cells associated with biphasic calcium phosphate biomaterials in a multicentric, non-comparative trial

Author

Nicola Baldini, Elena Veronesi, Nathalie Chevallier, Enrique Gómez-Barrena, Philippe Rosset, Pierre Layrolle, Philippe Hernigou, Cristina Avendaño-Solá, Gabriela Ciapetti, Sandrine Fleury, Massimo Dominici, Tiziana Montemurro, Rosaria Giordano, José Cordero-Ampuero, Jose Rafael Cabrera, M.N. Fernández, Hélène Rouard, Juan Carlos Rubio-Suárez, Ramin Lotfi, Markus Rojewski, Christian Ehrnthaller, Luc Sensebé, Hubert Schrezenmeier, Markus Huber-Lang, Florian Gebhard, Charles Henri Flouzat-Lachaniette, Norma G. Padilla-Eguiluz, Julien Stanovici, Davide Maria Donati, Carmen Panaitescu, Rosa Gonzalo-Daganzo, Eduardo García-Rey, Servicio de Cirugía Ortopédica y Traumatología [Madrid, Spain], Universidad Autonoma de Madrid (UAM)-Hospital Universitario La Paz-IdiPAZ and Facultad de Medicina [Madrid, Spain], Service de Chirurgie Orthopédique et Traumatologique 2 [CHU Tours], Hôpital Trousseau (Tours)-Université Francois Rabelais [Tours]-Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Department of Traumatology, Hand-, Plastic-, and Reconstructive Surgery [Ulm, Germany], Universität Ulm - Ulm University [Ulm, Allemagne]-Center of Surgery [Ulm, Germany], Biomécanique cellulaire et respiratoire (BCR), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Centre National de la Recherche Scientifique (CNRS), Laboratory for Orthopaedic Pathophysiology and Regenerative Medicine [Bologna, Italy], University of Bologna-Department of Biomedical and Neuromotor Sciences [Bologna, Italy], Istituto Ortopedico Rizzoli [Bologna, Italy]-Istituto Ortopedico Rizzoli [Bologna, Italy], Etablissement Français du Sang Ile de France (EFS), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Necker - Enfants Malades [AP-HP], STROMALab, Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement Français du Sang-Centre National de la Recherche Scientifique (CNRS), Servicio de Hematología [Madrid, Spain], Universidad Autonoma de Madrid (UAM)-Hospital Universitario Puerta de Hierro-Majadahonda [Madrid, Spain], Cell Factory, Center for Cellular Therapy and Cryobiology [Milano, Italy], Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Victor Babes University of Medicine and Pharmacy [Timisoara, Romania], Laboratory of Cellular Therapies [Modena, Italy], University - Hospital of Modena and Reggio Emilia [Modena, Italy]- Department of Medical and Surgical Sciences for Children & Adults [Modena, Italy], Institute for Clinical Transfusion Medicine and Immunogenetic Ulm [Ulm, Germany], Institut für Klinische Transfusionsmedizin und Immungenetik Ulm -IKT [Ulm, Germany], Physiopathologie de la Résorption Osseuse et Thérapie des Tumeurs Osseuses Primitives, Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM), EU-FP7-HEALTH-2009, REBORNE Project (GA: 241876)., Hospital Universitario La Paz-IdiPAZ and Facultad de Medicina [Madrid, Spain]-Universidad Autonoma de Madrid (UAM), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)-Université Francois Rabelais [Tours]-Hôpital Trousseau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre National de la Recherche Scientifique (CNRS)-Ecole Nationale Vétérinaire de Toulouse (ENVT), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Etablissement Français du Sang-Institut National de la Santé et de la Recherche Médicale (INSERM), Victor Babeş University of Medicine and Pharmacy (UMFT), Physiopathologie des Adaptations Nutritionnelles (PhAN), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), UAM. Departamento de Cirugía, UAM. Departamento de Farmacología, UAM. Departamento de Medicina, Instituto de Investigación Sanitaria Hospital Universitario de La Paz (IdiPAZ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Université Francois Rabelais [Tours]-Hôpital Trousseau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Gómez-Barrena, Enrique, Rosset, Philippe, Gebhard, Florian, Hernigou, Philippe, Baldini, Nicola, Rouard, Helène, Sensebé, Luc, Gonzalo-Daganzo, Rosa M., Giordano, Rosaria, Padilla-Eguiluz, Norma, García-Rey, Eduardo, Cordero-Ampuero, José, Rubio-Suárez, Juan Carlo, Stanovici, Julien, Ehrnthaller, Christian, Huber-Lang, Marku, Flouzat-Lachaniette, Charles Henri, Chevallier, Nathalie, Donati, Davide Maria, Ciapetti, Gabriela, Fleury, Sandrine, Fernandez, Manuel-Nicolá, Cabrera, José-Rafael, Avendaño-Solá, Cristina, Montemurro, Tiziana, Panaitescu, Carmen, Veronesi, Elena, Rojewski, Markus Thoma, Lotfi, Ramin, Dominici, Massimo, Schrezenmeier, Hubert, Layrolle, Pierre, Universidad Autónoma de Madrid (UAM)-Hospital Universitario La Paz-IdiPAZ and Facultad de Medicina [Madrid, Spain], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Trousseau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Université Francois Rabelais [Tours], University of Bologna/Università di Bologna-Department of Biomedical and Neuromotor Sciences [Bologna, Italy], Universidad Autónoma de Madrid (UAM)-Hospital Universitario Puerta de Hierro-Majadahonda [Madrid, Spain], Institut National de la Recherche Agronomique (INRA)-Université de Nantes (UN), and maurice, sandrine

Subjects
Calcium Phosphates, Biocompatible Materials, 02 engineering and technology, Bone tissue engineering, Fractures, Bone, Femur, media_common, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, 0303 health sciences, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, 021001 nanoscience & nanotechnology, 3. Good health, Clinical trial, medicine.anatomical_structure, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Mechanics of Materials, [SDV.IB]Life Sciences [q-bio]/Bioengineering, 0210 nano-technology, medicine.medical_specialty, Bioceramic, Medicina, Biophysics, Ceramics and Composite, Bioengineering, Mesenchymal Stem Cell Transplantation, Non-union, Transplantation, Autologous, Non union, Expanded autologous BM-hMSC, Biomaterials, 03 medical and health sciences, medicine, media_common.cataloged_instance, Humans, Humerus, Tibia, European union, [SDV.IB.BIO]Life Sciences [q-bio]/Bioengineering/Biomaterials, 030304 developmental biology, Cell Proliferation, [SDV.IB] Life Sciences [q-bio]/Bioengineering, business.industry, Mesenchymal stem cell, Mesenchymal Stem Cells, ATMP, Biomaterial, Surgery, [SDV.IB.BIO] Life Sciences [q-bio]/Bioengineering/Biomaterials, Biophysic, Fractures, Ununited, Ceramics and Composites, Feasibility Studies, Bone marrow, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

Background: ORTHO-1 is a European, multicentric, first in human clinical trial to prove safety and feasibility after surgical implantation of commercially available biphasic calcium phosphate bioceramic granules associated during surgery with autologous mesenchymal stromal cells expanded from bone marrow (BM-hMSC) under good manufacturing practices, in patients with long bone pseudarthrosis. Methods: Twenty-eight patients with femur, tibia or humerus diaphyseal or metaphyso-diaphyseal non-unions were recruited and surgically treated in France, Germany, Italy and Spain with 100 or 200 million BM-hMSC/mL associated with 5–10 cc of bioceramic granules. Patients were followed up during one year. The investigational advanced therapy medicinal product (ATMP) was expanded under the same protocol in all four countries, and approved by each National Competent Authority. Findings: With safety as primary end-point, no severe adverse event was reported as related to the BM-hMSC. With feasibility as secondary end-point, the participating production centres manufactured the BM-hMSC as planned. The ATMP combined to the bioceramic was surgically delivered to the non-unions, and 26/28 treated patients were found radiologically healed at one year (3 out of 4 cortices with bone bridging). Interpretation: Safety and feasibility were clinically proven for surgical implantation of expanded autologous BM-hMSC with bioceramic. Funding: EU-FP7-HEALTH-2009, REBORNE Project (GA: 241876)., The research leading to these results has received funding from the European Research Council under the European Union's Seventh Framework Programme (FP7/FP7-HEALTH-2009); REBORNE Project (GA: 241876)

Published
2017

5. Compstatin: a C3-targeted complement inhibitor reaching its prime for bedside intervention

Author

Petros Kokkinos, George Hajishengallis, Florea Lupu, Markus Huber-Lang, Dimitrios C. Mastellos, Bo Nilsson, Antonio M. Risitano, Daniel Ricklin, John D. Lambris, Despina Yancopoulou, Ali Reza Biglarnia, Mastellos, Dimitrios C, Yancopoulou, Despina, Kokkinos, Petro, Huber Lang, Marku, Hajishengallis, George, Biglarnia, Ali R., Lupu, Florea, Nilsson, Bo, Risitano, ANTONIO MARIA, Ricklin, Daniel, and Lambris, John D.

Subjects
Drug, In silico, media_common.quotation_subject, Clinical Biochemistry, Computational biology, Bioinformatics, Biochemistry, Peptides, Cyclic, Article, Complement inhibitor, Drug Discovery, Medicine, Animals, Humans, Opsonin, media_common, Cp40, Innate immune system, Drug discovery, business.industry, Animal, Clinical translation, Medicine (all), Complement-based drug design, General Medicine, Complement C3, Complement system, Cell killing, Complement Inactivating Agent, Complement Inactivating Agents, Nonhuman primate model, Peptidic C3 inhibitor, Drug Design, Peptide, Compstatin, business, Peptides, Human
Abstract

There is a growing awareness that complement plays an integral role in human physiology and disease, transcending its traditional perception as an accessory system for pathogen clearance and opsonic cell killing. As the list of pathologies linked to dysregulated complement activation grows longer, it has become clear that targeted modulation of this innate immune system opens new windows of therapeutic opportunity for anti-inflammatory drug design. Indeed, the introduction of the first complement-targeting drugs has reignited a vibrant interest in the clinical translation of complement-based inhibitors. Compstatin was discovered as a cyclic peptide that inhibits complement activation by binding C3 and interfering with convertase formation and C3 cleavage. As the convergence point of all activation pathways and a molecular hub for crosstalk with multiple pathogenic pathways, C3 represents an attractive target for therapeutic modulation of the complement cascade. A multidisciplinary drug optimization effort encompassing rational 'wet' and in silico synthetic approaches and an array of biophysical, structural and analytical tools has culminated in an impressive structure-function refinement of compstatin, yielding a series of analogues that show promise for a wide spectrum of clinical applications. These new derivatives have improved inhibitory potency and pharmacokinetic profiles and show efficacy in clinically relevant primate models of disease. This review provides an up-to-date survey of the drug design effort placed on the compstatin family of C3 inhibitors, highlighting the most promising drug candidates. It also discusses translational challenges in complement drug discovery and peptide drug development and reviews concerns related to systemic C3 interception.

Published
2014

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