Introdução: Os estudos clínicos promovem inovação no âmbito da saúde e podem proporcionar novos tratamentos e benefícios à população. Os estudos de intervenção com medicamentos são fundamentais para demonstrar a eficácia, a toxicidade e a segurança de novas terapias. O uso de medicamentos experimentais na assistência médica é uma realidade observada tanto na continuidade do tratamento pelos participantes após o término da pesquisa, como na possibilidade do uso assistencial destes medicamentos. A Agência Nacional de Vigilância Sanitária (Anvisa) regulamenta, com base na RDC n. 38/2013, três Programas assistenciais com medicamentos experimentais: Acesso Expandido, Uso Compassivo e Fornecimento de Medicamento Pós-Estudo. Mais recentemente, uma nova alternativa está em desenvolvimento no Hospital de Clínicas de Porto Alegre, definida como Uso Assistencial Extraordinário. Objetivos: Propor fluxos e materiais informativos para orientar a prática e a condução de Programas de Acesso Expandido, Uso Compassivo, Fornecimento de Medicamento Pós-Estudo e Uso Assistencial Extraordinário no Hospital de Clínicas de Porto Alegre, assim como em outras instituições de saúde. Métodos: Foram revisadas as publicações acerca do assunto, analisados alguns fluxogramas existentes na condução dos Programas acima citados, bem como realizado questionário aos profissionais que atuam nesta área no CPC-HCPA. Resultados: Foram elaborados fluxos e materiais informativos para a condução destes distintos Programas, considerando as diretrizes éticas, regulatórias e de boas práticas, que visam auxiliar a prática e a educação dos profissionais envolvidos. / Introduction: Clinical research can provide valuable evidence to support to health care system in informed decision making. At the same time, from the patient perspective, trials can the way to gain access to more appropriate treatments. The main goal of intervention studies is to determine safety and efficacy of new therapies. The Agência Nacional de Vigilância Sanitária (Anvisa) regulates, based on RDC n° 38/2013, three care programs with experimental drugs: Expanded Access, Compassionate Use and Post-trial Access. Also, in the Hospital de Clínicas de Porto Alegre, a new alternative program is being explored - defined as Extraordinary Care Use. Objectives: Propose guidelines to Expanded Access, Compassionate Use, Post-trial Access programs and Extraordinary Care Use in the format of flow sheets and informative leaflets at Hospital de Clínicas de Porto Alegre, and perhaps become a benchmarking project to other institutions. Methods: After review of literature and analysis of existing flow sheets on how to conduct the above mentioned programs, we administered a survey questionnaire on challenges encountered by investigators from clinical research center at our institution. Results: Flow sheets and informative materials were developed to support professionals their research groups in conducting clinical interventional initiatives, considering the ethical, regulatory and good practices guidelines.

Department of Advanced Nursing Science / MCur

Ständige Weiterentwicklungen von Behandlungsmöglichkeiten, die Technisierung der Medizin und die Liberalisierung des Gesundheitssystems führen auf Seiten der Versorger zu vermehrten Anstrengungen, die eigenen Geschäftsprozesse in Klinischen Pfaden zu dokumentieren, um auf dieser Basis eine medizinische und betriebswirtschaftliche Optimierung durchzuführen. Für die Entwicklung Klinischer Pfade ist die Einbeziehung Medizinischer Leitlinien unablässig, da sie für definierte Symptomkomplexe den aktuellen Stand der Forschung aggregieren. Gleichwohl sind sie Schulungsunterlagen, direkte Entscheidungshilfen oder Aufklärungsdokumente für Patienten und damit keinesfalls ausschließlich auf die Entwicklung Klinischer Pfade ausgerichtet. Dadurch geht die Leitlinien-getriebene Entwicklung Klinischer Pfade mit einem hohen interpretativen Aufwand auf Seiten der Anwender einher. Aus der Motivation diesen Prozess methodisch zu unterstützen, leitet sich die zentrale Forschungsfrage der Arbeit ab: Wie kann eine Methode gestaltet sein, die eine zielgerichtete Ableitung von Klinischen Pfaden aus Medizinischen Leitlinien zulässt? Dieser Frage nimmt sich die vorliegende Arbeit an und präsentiert einen referenzmodellbasierten Ansatz, diese bestehende methodische Lücke zu schließen. Das Lösungsartefakt setzt dabei direkt auf Seiten der Medizinischen Leitlinie an. Die Methode, kurz MAC, besteht aus drei Methodenfragmenten: dem Rollenmodell, in welchem die Aufgabenträgertypen und ihre Verantwortlichkeiten beschrieben werden, dem Produktfragment, welches den Entwurf einer Modellierungssprache zur Kodierung von Medizinischen Leitlinien und deren Wiederverwendung in Klinischen Pfaden auf Basis einer Referenzmodelladaption vorsieht, und dem Vorgehensmodell, in dem Handlungsanweisungen für die zuvor beschriebenen Aufgabenträgertypen spezifiziert sind. Die Arbeit leistet damit einen Beitrag zum Methodenspektrum der Wirtschaftsinformatik. Forschungsmethodisch ordnet sich die Arbeit in die gestaltungsorientierte Artefaktforschung (Design Science) ein.:Teil A - Zusammenfassung Abbildungsverzeichnis Tabellenverzeichnis Abkürzungsverzeichnis 0 Einleitung 0.1 Hintergrund 0.2 Gegenstand und Motivation 0.3 Forschungsdesign 0.3.1 Wissenschaftstheoretische Positionierung 0.3.2 Forschungsziel 0.3.3 Forschungsmethode 1 Aufbau der Arbeit 1.1 Publikation P1: Konzeptuelle Modellierung im klinischen Umfeld 1.2 Publikation P2: Reference Modeling in Health Care – State-of-the-art and Proposal for the Construction and Application of a Reference Model 1.3 Publikation P3: From Clinical Practice Guideline to Clinical Pathway – Issues of Reference Model-Based Approach 1.4 Publikation P4: Anforderungen an eine Methode zur Ableitung Klinischer Pfade aus Medizinischen Leitlinien 1.5 Publikation P5: Methode zur Ableitung Klinischer Pfade aus Medizinischen Leitlinien 2 Fazit 2.1 Beitrag der Arbeit 2.2 Kritische Würdigung und weiterer Forschungsbedarf Literaturverzeichnis Anhang A Teil B - Einzelpublikationen

The subject of my dissertation is fraud in clinical trials in terms of ethics and law. The aim of my research was to analyze the frequency of fraud in clinical trials of a given sample of data collected, identify the main fraudsters and to analyze the causes that led participants in clinical trials to commit fraud. In the theoretical part of my dissertation I defined the concepts of clinical trials, deception, ethical issues and the relevant legal framework. The practical part contains the results of the data analysis of the incidence and causes of fraud, the main actors of fraud and conception of recommendations, which appears to be essential for the prevention of fraud in clinical trials. The data analysis and participant observation show that during 107 GCP (Good Glinical Practice) audits conducted during the period of 2008-2013 in 22 countries, 14 revelations of fraud in clinical trials were identified, which represents 13.1 %. Most often fraud was committed by investigators, a total of 47.6 % of all observed groups of cheating clinical trial participants. The main causes that led investigators to commit fraud represent a lack of eligible patients, financial gain and personality traits. Based on the results obtained during my research I highlighted in the practical part of my dissertation the ethical...

The health care field has become increasingly more complex, requiring new nurses to be prepared upon graduation to respond to a variety of complex situations. Unfortunately, many graduates from associate degree nursing (ADN) programs are not able to think critically upon entering the work force. This presents a major problem for the nurse and for the employer. The purpose of the study, therefore, was to gain a deeper understanding of the graduates' perceptions of their ability to critically think during their first year of clinical practice, and if they believed their program prepared them to be critical thinkers. The key research questions focused on how the novice nurses reconciled their performance on a critical thinking, online assessment, the Health Sciences Reasoning Test (HSRT), with their perception of their critical thinking skills, and if they felt prepared, during their first year of clinical practice, to critically think. The conceptual framework applied was Bloom's Taxonomy and Tanner's clinical judgment model. A purposeful sampling of 7 novice nurses from 3 ADN programs was chosen. After completing the HSRT, audio-taped phone interviews were conducted. The data indicated that the participants felt unprepared to respond to emergent patient situations, thus undermining their self-worth and clinical competency. The participants agreed there was a need for a critical thinking course in ADN curriculum. A project was created for a 9-week critical thinking course, incorporating theory, clinical practice, and simulation exercises. Social change is expected to occur when student nurses are able to critically think upon graduation, resulting in positive patient outcomes, both of which will benefit patients, their families, and their communities.

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The subject of my dissertation is fraud in clinical trials in terms of ethics and law. The aim of my research was to analyze the frequency of fraud in clinical trials of a given sample of data collected, identify the main fraudsters and to analyze the causes that led participants in clinical trials to commit fraud. In the theoretical part of my dissertation I defined the concepts of clinical trials, deception, ethical issues and the relevant legal framework. The practical part contains the results of the data analysis of the incidence and causes of fraud, the main actors of fraud and conception of recommendations, which appears to be essential for the prevention of fraud in clinical trials. The data analysis and participant observation show that during 107 GCP (Good Glinical Practice) audits conducted during the period of 2008-2013 in 22 countries, 14 revelations of fraud in clinical trials were identified, which represents 13.1 %. Most often fraud was committed by investigators, a total of 47.6 % of all observed groups of cheating clinical trial participants. The main causes that led investigators to commit fraud represent a lack of eligible patients, financial gain and personality traits. Based on the results obtained during my research I highlighted in the practical part of my dissertation the ethical...

Les troubles douloureux de l’épaule (TDE) affectent jusqu’à 55% de la population générale et sont souvent difficiles à traiter. L’objectif de cette thèse était de développer une intervention de mobilisation des connaissances permettant d’implanter les recommandations de guides de pratique clinique (GPC) couvrant la prise en charge des TDE. Pour ce faire, un processus basé sur le cadre conceptuel Knowledge-to-Action a été utilisé. D’abord, une revue systématique des recommandations des GPC à implanter pour améliorer la prise en charge des TDE a été effectuée. Puis, les écarts dans la pratique des cliniciens ont été identifiés à l’aide d’un sondage documentant la prise en charge des TDE ainsi qu’une étude évaluant la concordance entre les physiothérapeutes et les orthopédistes au niveau du diagnostic et de la prise en charge des TDE. Ensuite, les déterminants à l’implantation des recommandations des GPC ont été identifiés en procédant à deux études qualitatives ciblant les expériences et les attentes des patients vivant avec un TDE, puis les barrières et facilitateurs à l’implantation des recommandations des GPC identifiés par les cliniciens. Enfin, l’utilisation du Behaviour Change Wheel et des déterminants ont permis d’identifier des stratégies visant à implanter les recommandations de GPC sur la prise en charge des TDE en première ligne de soins. La revue systématique des GPC a permis de déterminer qu’initialement, les TDE ne requièrent généralement pas d’imagerie médicale et de référence à un médecin spécialiste, mais qu’un programme de réadaptation actif est requis. Selon les résultats du sondage, les médecins de famille (n=76) ont recommandé plus d’imagerie que les physiothérapeutes (n=175). Jusqu’à deux physiothérapeutes sur trois ont sélectionné des traitements non recommandés par les GPC. Les résultats de l’étude de concordance démontrent que l’accord entre physiothérapeutes et orthopédistes était bon au niveau du diagnostic et modéré au niveau du triage des candidats chirurgicaux. Les patients souffrant de TDE interrogés (n=13) ont mentionné, dans la première étude qualitative, avoir attendu que leur douleur soit incapacitante avant de consulter un professionnel. Ces participants s’attendaient alors à recevoir un diagnostic clair et à être référés pour des tests d’imagerie. Finalement, ils espéraient recevoir des explications complètes et se voir proposer des options pertinentes de traitements. Les 19 physiothérapeutes et 16 médecins de famille interrogés dans la deuxième étude qualitative ont indiqué comme barrières à l’utilisation des recommandations des GPC : le manque de connaissances, le manque d’habileté à réaliser une évaluation clinique de l’épaule et la crainte de ne pas détecter une pathologie grave, si présente, sans un test d’imagerie. Le temps insuffisant de consultation avec les patients, leurs attentes et le manque d’accès à certains soins ont aussi été indiqués comme des barrières. Les principales stratégies identifiées suivant ces études incluent donc des interventions éducatives, la préparation de champions cliniques et la création d’équipes cliniques interdisciplinaires. À l’aide de ces stratégies, l’implantation pilote de l’intervention sera réalisée dans des groupes de médecine familiale. L’impact potentiellement bénéfique de cette implantation pourrait, à terme, améliorer la prise en charge des patients atteints de TDE. / Shoulder pain is a common and difficult to manage condition that can affect up to 55% of the general population. To optimize shoulder pain management in primary care, the main objective of this thesis was to develop a knowledge mobilization intervention to implement the recommendations from clinical practice guidelines (CPGs) covering the management of different shoulder disorders. A knowledge mobilization process based on four steps of the Knowledge-to-Action framework was used in this thesis. First, a systematic review of CPGs was performed to identify recommendations to be implemented for improving shoulder pain management in primary care. Then, the evidence-practice gaps were assessed using a survey documenting family physicians and physiotherapists shoulder pain management as well as in a study evaluating the concordance between physiotherapists and orthopedists for shoulder pain diagnosis and management. The determinants influencing CPGs recommendations’ implementation were identified by conducting two qualitative studies. The first study explored the experiences and expectations of patients living with shoulder pain and the second aimed to interview clinicians for identifying barriers and facilitators to the implementation of CPGs recommendations. Finally, based on the identified determinants and using the Behaviour Change Wheel method, we identified strategies for implementing CPGs recommendations covering the management of shoulder pain in primary care. Based on the systematic review of shoulder CPGs, we identified that shoulder pain generally does not initially require diagnostic imaging and referral to a medical musculoskeletal specialist, but that an active rehabilitation program is required. According to the survey results, family physicians (n=76) recommended more imaging than physiotherapists (n=175) for rotator cuff tendinopathy and adhesive capsulitis, although this is not indicated. Up to two out of three physiotherapists selected treatments not recommended by CPGs in the management of shoulder pain. The results of the concordance study showed that the agreement between physiotherapists and orthopedists was good in terms of diagnosis and moderate in terms of triage of surgical candidates. Patients (n=13) interviewed in the first qualitative study reported waiting until their shoulder pain was disabling before seeing a family physician or a physiotherapist. Participants expected a clear diagnosis and imaging tests to explain their shoulder pain. They also wished to receive clear and thorough explanations and relevant treatment options. The 19 physiotherapists and 16 family physicians that participated in focus groups indicated as barriers to the use of CPGs recommendations: lack of knowledge, poor skills in performing a clinical evaluation and fear of not identifying a serious pathology without medical imaging. Patients’ expectations, insufficient consultation time with patients and lack of patients’ access to certain care, such as rehabilitation treatments were also identified as barriers. The main strategies identified following these studies therefore include educational interventions, the preparation of clinical champions and the creation of interdisciplinary clinical teams. Using these strategies, pilot implementation of the intervention will be carried out in family medicine groups. The potentially beneficial impact of this implantation could ultimately improve the management of patients with shoulder pain in primary care.