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.

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<p><strong>Introduction:</strong> In Ontario alone, an estimated 6,700 people (3,000 women; 3,700 men) will die of lung cancer in 2011 (Canadian Cancer Society, 2011). A diagnosis of cancer is associated with complex decisions; the array of choices of cancer treatments brings about hope, but also anxiety over which treatment is best suited for the individual patient (Blank, Graves, Sepucha et al., 2006). The overall cancer experience depends on the quality of this decision (Blank et al., 2006). Clinical practice guidelines are knowledge translation tools to facilitate treatment decision-making. In Ontario, guidelines have been developed and disseminated with the purpose to inform clinical decisions, improve evidence based practice, and to reduce unwanted practice variation in the province. But has this been achieved? To study this issue, the purpose of the current study was to gain an in-depth understanding and develop a theoretical framework of how Ontario physicians are making treatment decisions with their non-small cell lung cancer patients. The following research questions guided the study: (a) How do physicians make treatment decisions with their stage II, stage IIIA and stage IIIB non-small cell lung cancer patients in Ontario? (b) How do knowledge translation tools, such as Cancer Care Ontario guidelines, influence the decision-making process?</p> <p><strong>Methods:</strong> A qualitative approach of grounded theory, following a social constructivist paradigm outlined by Kathy Charmaz (2006), was used in this study. 21 semi-structured interviews were conducted; 16 interviews with physicians and 5 with health care administrators. The method of analysis integrated grounded theory philosophy to identify the treatment decision-making process in non-small cell lung cancer, from the physician perspective.</p> <p><strong>Findings:</strong> The theory depicts the treatment decision-making process to involve five key “guides” (or factors) to inform the treatment-decision making process: the unique patient, the unique physician, the family, the clinical team, and the clinical evidence.</p> <p><strong>Conclusion:</strong> Decision-making roles in lung cancer are complex and nuanced. The use of evidence, such as, clinical practice guidelines, is one of many considerations. Information from a large number of sources and a wide array of factors, people, emotions, preferences, clinical expertise, experiences, and clinical evidence informs the dynamic process of treatment decision-making. This theory of the treatment decision-making process (from the physician perspective) has implications relevant to treatment decision-making research, theory development, and guideline development for non-small cell lung cancer.</p> / Master of Science (MSc)