Dissertations / Theses: 'Clinical observational study'

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Paulo, António Augusto dos Santos. "Psychosocial and clinical characteristics predicting women’s acceptance of office hysteroscopy: an observational study." Doctoral thesis, Universidade de Aveiro, 2016. http://hdl.handle.net/10773/17072.

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Doutoramento em Ciências e Tecnologias da Saúde - Decisão Clínica
A histeroscopia é hoje uma técnica imprescindível em ginecologia quer no diagnóstico de alterações genitais superiores, quer no tratamento minimamente invasivo, sendo segura, fiável e com poucos efeitos secundários e complicações. A miniaturização dos aparelhos juntamente com aperfeiçoamento técnico (nomeadamente com a abordagem vaginoscópica, sem recurso a espéculo, nem a tração do colo) vieram permitir o seu uso em consultório. Usado sem anestesia reduz os riscos do internamento e tornam o exame acessível; tem contudo a limitação da dor provocada pela instrumentação. Apesar de muitas tentativas analgésicas e anestésicas, o controlo da dor não é satisfatória em algumas doentes nas quais a histeroscopia é difícil de suportar. Este trabalho pretende estabelecer se a dor é menor com os mini histeroscópios do que com os instrumentos convencionais, avaliar quão grave é o problema da dor (quantificando a proporção de mulheres que se queixam) mesmo com este aparelhos mais delgados e tentar saber se existem fatores de risco que favoreçam a dor, ou que pelo contrário protejam a doente. Também se pretende estabelecer se os inquéritos de satisfação às doentes se correlacionam com a pontuação de dor e se a ansiedade interfere com as queixas álgicas. Finalmente também tentámos investigar se uma técnica nova de anestesia local, administrada através do histeroscópio com recurso a uma agulha cistoscópica, reduz a dor e torna o exame mais tolerável. Os resultados mostraram haver redução estatisticamente significativa da perceção da dor com mini histeroscópios em relação a aparelhos convencionais. Mostraram ainda que mesmo com calibres finos há uma proporção de doentes entre 13 e 30% que ainda refere dor moderada a severa e que reduzir o calibre abaixo dos 3,5mm pode não resultar numa redução maior da dor. Quanto a fatores de risco para a dor os nossos resultados não encontraram relação, exceto uma proteção na dor para as doentes obesas, que relacionamos com uma maior impregnação hormonal (androgénica e por via da aromatase, estrogénica). A ansiedade não parece ser importante na dor sentida, ainda que exista uma pouco significativa relação entre traço ansioso e intensidade da dor relatada. No que se refere aos questionários de satisfação, correlacionam-se muito bem com a dor reportada, tendo uma boa sensibilidade e especificidade; sendo simples de administrar e fáceis de interpretar poderiam provavelmente substituir as escalas da dor e ser úteis para eventual seleção das doentes a quem administrar a anestesia local histeroscópica. Finamente a técnica histeroscópica de injeção local de anestésico reduz significativamente a dor e poderá ser uma solução para tornar a intervenção suportável em ambulatório.
Hysteroscopy today is an essential tool in gynaecology both for diagnosis of female upper genital tract abnormalities and for minimally invasive surgery procedures. It is safe, reliable and has few side effects and complications. Diminishment of instrument diameter together with technical improvements (such as the vaginal “no touch” approach without use of speculum or cervical traction) has allowed procedures in office environment. Used without analgesia or aneasthesia it has reduced hospitalization risks and made the examination affordable; it has a drawback which is the level of pain some women refer with instrumentation. Although many attempts with the use of analgesics and anaesthetics have been made, pain control is not satisfactory in some patients for whom hysteroscopy is hard to endure. In this work we aim to establish if pain reporting is lower with mini-hysteroscopes compared to conventional scopes, how big is the problem “pain” (quantifying the proportion of women still complaining) even when using the slender mini-scopes and try to establish if there are risk factors which might influence pain reporting, or on the contrary protect, women from agony. We also explored if satisfaction questionnaires correlate well with pain scores and if patient anxiety interferes with pain. Finally we have investigated if a new local anaesthetic administration technique, with the use of a cystoscopic needle through the hysteroscope, can reduce pain and make the procedure more tolerable. Our results show there is a statistically significant reduction of pain scores when using mini-hysteroscope compared to conventional instruments. They also show that even using smaller caliber scopes there is a proportion of women varying from 13 to 30% who will still complain of moderate to severe pain and that reduction of scopes below 3.5mm diameter may not reduce pain scores any further. As to risk factors for pain, our results have not found relation to pain with risk factors except for some protection for pain in women with high body mass index, and we relate this finding with elevated circulating hormones (androgens which are peripherally converted to estrogens via aromatase in adipose tissue). Anxiety does not seem important in pain reporting, even if a slight statistical significance was found between anxiety trait and pain reporting. As to satisfaction questionnaires, they seem to correlate well with the pain experience and show and excellent sensitivity and specificity: simple to administer and easy to interpret, they could probably replace more complicated pain rating scales and be useful in selecting women who would benefit from local anaesthesia. Finally as to the new technique of applying local anaesthetics “hysteroscopic anaesthesia”, results show a statistical reduction of pain after injection and it could become a practical solution in making hysteroscopy bearable in an office setting.

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Silva, Pedro Miguel Couto Moreira e. "Curricular trainig report as study coordinator in Blueclinical Ltd." Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/15798.

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Mestrado em Biomedicina Farmacêutica
The present report describes in detail the activities and knowledge aquired during my internship as study coordinator in Blueclinical – Investigação e Desenvolvimento em Saúde, Ltd., in order to obtain the master degree in Pharmaceutical Biomedicine. According to the type of services provided, Blueclinical is formed by three business units: Blueclinical Clinical Research Partnership, Blueclinical Phase I and Blueclinical Research and Development. The fact of belonging to such a company gave me the opportunity to be in touch with different areas of pharmaceutical development and to contact with different research teams, which for me was an added advantage to the integration and consolidation of knowledge, as well as in the development and improvement of soft and hard skills. The main activity developed was the coordination of clinical studies, in Unidade Local de Saúde de Matosinhos, E.P.E., which was one of the institutions that established a partnership with Blueclinical, Ltd. During my internship I was able to contact with various stages of development and coordination of clinical trials, which will be reported in this report.
O presente relatório descreve com detalhe as atividades e aprendizagens adquiridas no âmbito do meu estágio curricular como coordenador de estudos na Blueclinical, Lda., para obtenção do grau de mestre de Biomedicina Farmacêutica. De acordo com o tipo de serviços prestados, a Blueclinical pode ser dividida em três unidades de negócio: Blueclinical Clinical Research Partnership, Blueclinical Phase I e Blueclinical Research and Development. O facto de pertencer a esta companhia deu-me a oportunidade de estar em contacto com diferentes áreas do desenvolvimento farmacêutico e de contactar com diferentes equipas de investigação, o que para mim foi uma vantagem para a integração e consolidação de conhecimento, bem como para o desenvolvimento de hard e soft skills. A principal atividade desenvolvida foi a coordenação de estudos clínicos, na Unidade Local de Saúde de Matosinhos, E.P.E., que se insere na rede de hospitais que estabeleceram parceria com a Blueclinical, Lda. Durante o meu estágio pode contactar com diversas fases de coordenação e desenvolvimento de ensaios clínicos, que serão relatadas nesta dissertação.

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McBride, Ali. "Evaluating Fast Track Time Analysis of Clinical Drug Trial Phases Utilizing a Quasi-Experimental Observational Study." The University of Arizona, 2007. http://hdl.handle.net/10150/624440.

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Class of 2007 Abstract
Objectives: In this paper we analyzed the time frame for oncology drugs that were designated as a fast track drug and the time transition from a phase II to phase III clinical trial completion. Methods In our study we utilized oncology drugs that were approved between the years of 2000-2006 (FDA.gov). We then analyzed the CDER data base that provided information to Fast Track drugs that have been approved within the time period as determined by the FDA selection criteria (21 CFR 312.81(a)). Under certain circumstances, the FCA may consider reviewing portions of a marketing application in advance of the complete New Drug Application (NDA) or Biologic License Application (BLA). We will evaluate fast track designated products which may also be eligible to participate in FDA’s Continuous Marketing Applications Pilot 1 or Pilot 2 programs. For our analysis, we specifically selected oncology drugs. In particular, we analyzed 32 drugs from the stated time period. Each fast track drug was then selected and analyzed for its clinical phase development time period based on news announcements during clinical trails. For each announcement we conducted an event study analysis through lexis Nexus with respect to the announcement of a clinical trial enrollment, clinical trials news (Phase I, II, III). Results: The results of our preliminary study show that there was a shorter time to development transition for the fast track oncology drugs. The oncology clinical phase transition from II to three on average lasted 12 months with a range of 2 - 29 months The average length of the phase development had to excludes 4 drugs due to the lack of information provided from the LexisNexis database. The current timeline for fats track drugs has shown a decrease in transition from clinical trials to the market. In the example of Spyrcel, the data from our study had to be excluded, there was a definitive difference in the time to approval process for the drug as compared to other standard review entities. The approvals for dasatinib, or Sprycel, for refractory CML was shown to move through the development to approval in one of the fastest timeframes in modern development. Since its first clinical study on in Gleevec-resistant patients, the medication was decided on entering an accelerated timeline. It took us just 25 months to bring Sprycel from first-in-human dosing to a regulatory submission. In contrast, the industry average for this cycle time is 6.4 years which is three times greater than the cycle time for Sprycel. Conclusions: The new Subpart H regulations state that post-marketing studies to confirm clinical benefit that would consist usually by "studies underway” at the time of accelerated approval, this has not always been the case and is not a requirement (Dagher R, Johnson J, Williams G et al). In conclusion, the accelerated approval program in oncology has been successful in making 18 different products available to patients for 22 different cancer treatment indications since the inception of the fast track program. From the current data and transition information, there is a comparative difference between the clinical phase transitions from phase II to Phase III clinical trials. However, this preliminary data needs to be further evaluated against the standard FDA review process from oncology drugs. Moreover, further studies will be needed to interpret whether the average length of oncology studies biases the value of our study.

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Gilman, Lynn. "Supervisory interventions and treatment adherence an observational study of supervisor interventions and their impact on therapist model adherence /." [Bloomington, Ind.] : Indiana University, 2009. http://gateway.proquest.com/openurl?url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:dissertation&res_dat=xri:pqdiss&rft_dat=xri:pqdiss:3352938.

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Thesis (Ph.D.)--Indiana University, Dept. of Counseling and Educational Instruction, School of Education, 2009.
Title from PDF t.p. (viewed on Feb. 4, 2010). Source: Dissertation Abstracts International, Volume: 70-04, Section: B, page: 2572. Adviser: Thomas L. Sexton.

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Herman, Patricia, Sally Dodds, Melanie Logue, Ivo Abraham, Rick Rehfeld, Amy Grizzle, Terry Urbine, Randy Horwitz, Robert Crocker, and Victoria Maizes. "IMPACT - Integrative Medicine PrimAry Care Trial: protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model." BioMed Central, 2014. http://hdl.handle.net/10150/610366.

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BACKGROUND:Integrative medicine (IM) is a patient-centered, healing-oriented clinical paradigm that explicitly includes all appropriate therapeutic approaches whether they originate in conventional or complementary medicine (CM). While there is some evidence for the clinical and cost-effectiveness of IM practice models, the existing evidence base for IM depends largely on studies of individual CM therapies. This may in part be due to the methodological challenges inherent in evaluating a complex intervention (i.e., many interacting components applied flexibly and with tailoring) such as IM.METHODS/DESIGN:This study will use a combination of observational quantitative and qualitative methods to rigorously measure the health and healthcare utilization outcomes of the University of Arizona Integrative Health Center (UAIHC), an IM adult primary care clinic in Phoenix, Arizona. There are four groups of study participants. The primary group consists of clinic patients for whom clinical and cost outcomes will be tracked indicating the impact of the UAIHC clinic (n=500). In addition to comparing outcomes pre/post clinic enrollment, where possible, these outcomes will be compared to those of two matched control groups, and for some self-report measures, to regional and national data. The second and third study groups consist of clinic patients (n=180) and clinic personnel (n=15-20) from whom fidelity data (i.e., data indicating the extent to which the IM practice model was implemented as planned) will be collected. These data will be analyzed to determine the exact nature of the intervention as implemented and to provide covariates to the outcomes analyses as the clinic evolves. The fourth group is made up of patients (n=8) whose path through the clinic will be studied in detail using qualitative (periodic semi-structured interviews) methods. These data will be used to develop hypotheses regarding how the clinic works.DISCUSSION:The US health care system needs new models of care that are more patient-centered and empower patients to make positive lifestyle changes. These models have the potential to reduce the burden of chronic disease, lower the cost of healthcare, and offer a sustainable financial paradigm for our nation. This protocol has been designed to test whether the UAIHC can achieve this potential.TRIAL REGISTRATION:Clinical Trials.gov NCT01785485.

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Clarson, Lorna Elise. "Risk of incident vascular disease in patients with gout : an observational study in the Clinical Practice Research Datalink." Thesis, Keele University, 2015. http://eprints.keele.ac.uk/2309/.

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Gout is the most prevalent inflammatory arthritis, predominantly managed in primary care. Both hyperuricaemia (the biochemical precursor to gout) and other inflammatory arthritides, e.g. rheumatoid arthritis, have been shown to increase risk of vascular disease. This thesis aims to investigate the risk of incident cardiovascular, cerebrovascular and peripheral vascular disease in primary care gout patients. A systematic review identified 17 studies investigating gout and vascular diseases. Meta-analysis showed increased mortality from all cardiovascular and coronary heart disease. Increased incidence of, but not mortality from myocardial infarction was found. Few studies investigated the association between gout and cerebrovascular or peripheral vascular disease. A retrospective cohort study used data from the Clinical Practice Research Datalink to examine the risk of incident cardiovascular, cerebrovascular and peripheral vascular disease in 8386 gout patients and 39766 age-, gender- and practice-matched controls, in the ten years following diagnosis of gout (or matched date) using Cox proportional hazards and multilevel discrete-time event history analysis. Risk was also investigated by gender and with follow-up limited to one, two and five years. The effect of exposure to drugs used to treat both gout and vascular risk factors on the magnitude of risk was examined using a cohort and nested case-control study design. The strongest association identified was between gout and peripheral vascular disease. Women with gout had the greatest excess vascular risk and experienced a wider range of vascular events. Exposure to drugs used to manage vascular risk factors was associated with increased likelihood of a vascular event, but use of gout treatments such as allopurinol did not influence incident vascular risk. This suggests that gout patients, particularly women, should have screening for and aggressive management of vascular risk factors, although as conventional approaches may be insufficient, further research is required to establish the optimum risk reduction strategy.

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Brink, Filip. "Safe handling of antineoplastic drugs at a public hospital in Guangzhou, China : an observational study in clinical practice." Thesis, Sophiahemmet Högskola, 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:shh:diva-2471.

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Background Antineoplastic drugs constitute an important cornerstone in treating malignant cancer diseases. The nurses administering these drugs risk developing short- and long-term side effects from exposure if not properly protected by personal protective equipment. The National Institute for Occupational Safety & Health produces guidelines and recommendations for healthcare personnel handling antineoplastic drugs in order to minimise exposure. Aim The aim of this study was to observe and describe registered nurses’ compliance to National Institute for Occupational Safety & Health guidelines and recommendations concerning the use of personal protective equipment during drug administration at a public hospital in Guangzhou, China. Method Data was collected at three different departments using structured direct observations, totalling 211 administrations encompassing day and evening shifts. Results Total compliance to National Institute for Occupational Safety & Health guidelines and recommendations was 0 percent as a result of non-existent gown use. The overall compliance for the use of double gloves was 76,3 percent. The Department of Medical Oncology had the highest department-specific compliance rate for double gloves at 80,7 percent, whereas the evening shift at Chemotherapy Outpatient Department boasted the highest shift-specific compliance rate for the same item at 83,3 percent. Conclusion Interventions are needed concerning the use of personal protective equipment, in particular the use of gowns. Obtained hospital-specific guidelines did not include the procedure of drug administration, warranting the implementation of hospital-specific standard operating procedure guidelines encompassing this aspect.

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Sham, Mohamed Ehtaih. "Shape modified radial artery adipo-facio cutaneous perforator flap- An observational anatomical vascular analysis & prospective randomized control clinical study." Doctoral thesis, Universitat Autònoma de Barcelona, 2019. http://hdl.handle.net/10803/667764.

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Resumen y antecedentes del estudio: Se describen varias modificaciones en la recolección de un colgajo radial del antebrazo. Para lograr una cosecha y un diseño de aletas fiables y seguros, se debe tener una comprensión muy clara de los perforadores de la arteria radial, en relación con su distribución, territorio y flujo. El propósito de este estudio es determinar la ubicación, el tamaño y el territorio vascular de los perforadores cutáneos de la arteria radial y demostrar la aplicación de la modificación de la forma del colgajo libre de antebrazo radial basado en sus perforadores distales y proximales en varios defectos de cabeza y cuello. Materiales y Métodos: Estudio anatómico: Se disecaron 12 cadáveres humanos frescos y 24 antebrazos de cadáver para determinar el número, ubicación, tamaño y territorio vascular del perforador de la arteria radial. El territorio cutáneo de los perforadores distalmente dominantes se analizó mediante inyecciones de azul de metileno y un angiograma tomográfico computarizado tridimensional para determinar la red vascular. Estudio clínico: 15 pacientes con diversos defectos del cuello de la cabeza después de las resecciones oncológicas se reconstruyeron con un colgajo de antebrazo libre adipo-fascio cutáneo de forma modificada. A todos estos pacientes se les realizó un seguimiento prospectivo de la curación del sitio del donante, el déficit del nervio sensorial y motor, la función y la calidad de vida para la evaluación del sitio del donante. Resultados: Se disecaron 24 antebrazos de cadáver, se diseccionaron un total de 222 perforadores para un promedio de 18,5 perforadores por antebrazo.127 perforadores (57.20%) se distribuyeron radialmente y 95 perforadores (42.79%) tuvieron una distribución cubital. Se identificaron 90 perforadores (40,54%) en el lado distal (estilo radial) y 132 perforadores (59,45%) se identificaron en el lado proximal (epicóndilo lateral). El número medio de perforadores, en el lado radial fue 10.6 y 7.9 en el lado cubital, la comparación de ambos usando la prueba de t de Student da un valor de P de 0.006, que es significativo. La comparación del número medio de perforadores en el lado distal fue de 7.5 y el lado proximal fue de 11.0; la prueba t de Student Paired da un valor de P de 0.003, que fue estadísticamente significativo. Comparando el diámetro medio de los perforadores en el lado distal (1.11) y el lado proximal (0.86), el lado que usa la prueba t de Student Paired da un valor de P de 0.01 que fue estadísticamente significativo. Se realizó una prueba de ji cuadrado para comparar el diámetro medio de los perforadores en el lado distal, que eran más de 1 mm (80%) y menos de 1 mm (20%) y en el lado proximal más de 1 mm (35,6%) y menos de 1 mm (64,4). %). Se obtuvo un valor de Chi cuadrado de 42.406, el valor del grado de libertad fue 1 y se alcanzó un valor de P de <0.001 que se encontró que era altamente significativo. Las inyecciones de azul de metileno demostraron grupos tanto en el antebrazo proximal como en el distal y también marcaron el territorio cutáneo del colgajo. La angiografía tomográfica computarizada tridimensional revela una red de vasos enlazantes que se comunican entre los perforadores adyacentes y que corren paralelos a la arteria radial. Un total de 15 pacientes fueron reconstruidos con un colgajo de antebrazo radial con forma modificada después de resecciones oncológicas. La curación de heridas en los 15 pacientes fue buena, y la evaluación de la cicatriz fue mejor que el colgajo radial tradicional del antebrazo. No hubo déficit sensorial o nervioso. Aunque la longitud del pedículo fue comparativamente más corta en el colgajo modificado en forma, sin embargo, no hubo ningún problema en la anastomosis a los vasos del cuello. Conclusión: El aumento en el conocimiento del territorio vascular de los perforadores de la arteria radial con respecto a los números, el tamaño, la ubicación y el territorio cutáneo puede llevar al uso expandido del colgajo del antebrazo radial basado solo en el perforador distal o proximal. La técnica de forma modificada para la recolección del colgajo del antebrazo radial permite el cierre primario del sitio donante. El sitio donante está mejor curado y muestra un patrón predicho, que es funcional y estéticamente bueno.
Resume and background of the study: Several modifications are described in harvesting a radial forearm flap. In order to achieve a reliable, safe flap harvest & design one must have a very clear understanding of radial artery perforators, relative to its distribution, territory & flow. The purpose of this study is to determine the location, size & vascular territory of the radial artery cutaneous perforators & to demonstrate application of shape modification of radial forearm free flap based on its distal & proximal perforators in various in head & neck defects. Materials & Methods: Anatomical Study: 12 fresh human cadavers & 24 cadaveric forearms were dissected to determine the number, location, size & vascular territory of radial artery perforator. The cutaneous territory of distally dominant perforators was analyzed using methylene blue injections & three-dimensional computed tomographic angiogram to determine the vascular network. Clinical Study: 15 patients with various head neck defects following oncological resections were reconstructed with shape modified adipo-fascio cutaneous free forearm flap. All these patients were prospectively followed for donor site healing, motor & sensory nerve deficit, function & quality of life questioner for donor site assessment. Results: 24 cadaveric forearms were dissected, a total of 222 perforators were dissected for an average of 18.5 perforators per forearm.127 perforators (57.20%) were radially distributed and 95 perforators (42.79%) had ulnar distribution. 90 perforators (40.54%) were identified on distal side (Radial styloid) and 132 perforators (59.45%) were identified on proximal side (Lateral epicondyle). Mean number of perforators, on radial side was 10.6 and 7.9 on ulnar side, comparison of both using student t paired test gives a P value of 0.006, which is significant. Comparison of mean number of perforators on the distal side was 7.5 and proximal side was 11.0, Student Paired t test gives a P value of 0.003, which was statistically significant. Comparison of mean Diameter of perforators on Distal side (1.11) and Proximal side (0.86), side using Student Paired t test gives a P value of 0.01 which was statistically significant. A chi square test was done to compare mean diameter of perforators on distal side, which were more than 1mm (80%) and less than 1mm (20%) and on proximal side more than 1mm (35.6%) and less than 1mm (64.4%). Chi square value of 42.406 was obtained, degree of freedom value was 1 and P value of <0.001 was achieved which was found to be highly significant. Methylene blue injections demonstrated clusters both in proximal and distal forearm and also marked the cutaneous territory of flap. Three- dimensional computed tomographic angiography reveals a network of linking vessels found to communicate between adjacent perforators and running parallel to radial artery. A total of 15 patients were reconstructed with shape modified radial forearm flap following oncologic resections. Wound healing in all 15 patients was good, with scar assessment faring better than traditional radial forearm flap. There was no sensory or motor nerve deficit. Although pedicle length was comparatively shorter in shape- modified flap, nevertheless there was no problem in anastomosing to neck vessels. Conclusion: Increase in knowledge of vascular territory of radial artery perforators with regards to numbers, size, location, and cutaneous territory can lead to expanded use of radial forearm flap based on either distal or proximal perforator alone. Shape modified technique for harvesting radial forearm flap allows primary closure of donor site. Donor site is better healed and shows a predicted pattern, which is functionally and aesthetically good.

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In-Uba, Mariana José Manuel. "Curricular training report: 7 months as a study coordinator at Blueclinical LTD." Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/15773.

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Mestrado em Biomedicina Farmacêutica
The present report describes in detail the activities undertaken under the coordination of clinical and observational studies during the curricular internship at Blueclinical Ltd., inserted in the Master of Pharmaceutical Biomedicine. Blueclinical Ltd.company operates in three different areas: R&D consultancy, management and coordination of trial centers, and a phase I unit. The curricular internship had the duration of seven months during which I was able to perform different tasks relating to coordination of clinical trials in Centro Hospitalar do Baixo Vouga, E.P.E., (CHBV) in Aveiro, Portugal. This academic internship allowed me to develop theoretical and practical skills in the field of clinical trials and observational studies. I also had the opportunity to further the knowledge I gained throughout my academic journey. During this internship, I had the opportunity to interact with different health professionals and develop my knowledge in the field of several therapeutic indications. I also could interact with distinct monitors and sponsors. This experience allowed me to improve time management, communication and problems resolution skills.
O presente relatório descreve de forma detalhada as atividades realizadas no âmbito da coordenação de estudos clínicos e observacionais durante o estágio curricular na empresa Blueclinical Lda., inserido no Mestrado de Biomedicina Farmacêutica. A empresa Blueclinical Lda. opera em três áreas distintas: consultadoria em investigação e desenvolvimento, gestão e coordenação dos centros de ensaio, e unidade de Fase I. O estágio curricular teve a duração de sete meses ao longo dos quais tive a possibilidade de executar diferentes tarefas relacionadas com a coordenação de ensaios clínicos no Centro Hospitalar do Baixo Vouga, E.P.E., em Aveiro (CHBV). Este estágio curricular permitiu-me desenvolver competências teóricas e práticas em matéria de coordenação de ensaios clínicos e estudos observacionais. Também tive a oportunidade de aprofundar o conhecimento que adquiri ao longo do meu percurso académico. Durante esta experiência, eu tive ainda oportunidade de interagir com diversos profissionais de saúde e desenvolver o meu conhecimento no campo de diferentes indicações terapêuticas. Também pude interagir com vários monitores e promotores. Esta experiência permitiu-me desenvolver as minhas competências relativas à gestão de tempo, comunicação e resolução de problemas.

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Hearnshaw, Sarah. "A Prospective, Observational Study Describing Patients Characteristic, Endoscopic Diagnoses and Therapies, and the use and effetcs on Clinical Outcomes of Red Blood Cell Transfusion." Thesis, University of Newcastle Upon Tyne, 2008. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.499334.

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Rancitelli, D. "HEALING AND REMODELING OF CONNECTIVE TISSUE GRAFT AROUND IMPLANTS WITH POOR KERATINIZED MUCOSA.INFLUENCE OF PROVISIONALIZATION TIMING (DELAYED VS IMMEDIATE) USING BOPT ABUTMENTS.A CLINICAL OBSERVATIONAL CONTROLLED PILOT STUDY." Doctoral thesis, Università degli Studi di Milano, 2017. http://hdl.handle.net/2434/473014.

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Aim of the study : the aim of the present study was to investigate the most effective timing of the surgical-prosthetic procedure in order to obtain a stable soft tissue augmentation around dental implants using BOPT abutments. Materials and Methods : Overall, 13 patients have been enrolled. A total amount of 21 implants have been placed and they have been alternatively assigned to the case (immediate provisionalization) or control group (delayed provisionalization) on the basis of the waiting list. The clinical criteria adopted for the enrollment in the study were the partial edentulism in which the teeth were lost at least 2 months before the date of implant placement with KM lower than 2 mm or inadequate soft tissues volume for a proper ridge contour. The two parameters evaluated for test and control groups were the apico-coronal migration and the soft tissue gain after grafting procedure. Results : gingival recession: for the control group 10 implants were analyzed between first and second evaluation. The mean difference was - 0.011 ± 0.8 mm (95% CI: - 0.3 to 0.27mm). For the test group 9 implants were analyzed between first and second evaluation. The mean difference was 0.0 ± 0.8mm (95% CI: - 0.35 to 0.37mm). Soft tissue gain: for the control group 8 implants were analyzed at the first evaluation. The mean augmentation was 1.17± 0.55 mm (95% CI: 1.12 to 1.45 mm). For the test group 4 implants were analyzed at the first evaluation. The mean augmentation was 0.82 ± 0.52 mm (95% CI: 0.85 to 0.65 mm). Conclusions : Both the prosthetic-surgical approaches are valid in order to treat limited horizontal defects with the application of connective tissue graft without recurring to costly, invasive and long lasting guided bone regeneration procedures. Considering the lack of available information from the preliminary results it is impossible to assess which is the best therapeutic option. A total amount of 34 implants will be necessary to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8.

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Tenkorang, Joanna N. "Rapid Access Cardiology : A prospective observational study to determine its effectiveness at identifying patients with coronary disease, significant arrhythmias and heart failure, and the clinical implications of such a service." Thesis, Imperial College London, 2009. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.508591.

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Shiomi, Hiroki. "Association of onset to balloon and door to balloon time with long term clinical outcome in patients with ST elevation acute myocardial infarction having primary percutaneous coronary intervention: observational study." Kyoto University, 2013. http://hdl.handle.net/2433/174776.

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Lord, Tanya. "Early Detection and Treatment of Acute Clinical Decline in Hospitalized Patients: An Observational Study of ICU Transfers and an Assessment of the Effectiveness of a Rapid Response Program: A Dissertation." eScholarship@UMMS, 2011. https://escholarship.umassmed.edu/gsbs_diss/561.

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The Institute for Healthcare Improvement (IHI) has promoted implementing a RRS to provide safer care for hospitalized patients. Additionally, the Joint Commission made implementing a RRS a 2008 National Patient Safety Goal. Although mandated, the evidence to support the effectiveness of a RRS to reduce cardiac arrests on hospital medical or surgical floors and un-anticipated ICU transfers remains inconclusive, partly because of weak study designs and partly due to a failure of published studies to report all critical aspects of their intervention. This study attempted to evaluate the effectiveness and the implementation of a RRS on the two campuses of the UMass Memorial Medical Center (UMMMC). The first study presented was an attempt to identify the preventability and timeliness of floor to ICU transfers. This was done using 3 chief residents who reviewed 100 randomly selected medical records. Using Cohen’s kappa to assess the inter-rater reliability it was determined that 13% of the cases could have possibly been preventable with earlier intervention. The second study was an evaluation of the effectiveness of the Rapid Response System. Outcomes were cardiac arrests, code calls and floor to ICU admissions. There were two study periods 24 months before the intervention and 24 months after. A Spline regression model was used to compare the two time periods. Though there was a consistent downward trend over all 4 years there were no statistically significant changes in the cardiac arrests and ICU transfers when comparing the before and after periods. There was a significant reduction in code calls to the floors on the University campus. The third study was a modified process evaluation of the Rapid Response intervention that will assess fidelity of RRS implementation, the proportion of the intended patient population that is reached by the RRS, the overall number of RRS calls implemented (dose delivered) and the perceptions of the hospital staff affected by the RRS with respect to acceptability and satisfaction with the RRS and barriers to utilization. The process evaluation showed that that the Rapid Response System was for the most part being used as it was designed, though the nurses were not using the specific triggers as a deciding factor in making the call. Staff satisfaction with the intervention was very high. Overall these studies demonstrated the difficulty in clearly defining outcomes and data collection in a large hospital system. Additionally the importance of different study designs and analysis methods are discussed.

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Marques, Tiago Emanuel Domingues Costa. "Curricular training report at W4Research: contract research organization." Master's thesis, Universidade de Aveiro, 2016. http://hdl.handle.net/10773/17082.

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Mestrado em Biomedicina Farmacêutica
O presente relatório destina-se a descrever as atividades desenvolvidas no âmbito do estágio curricular que teve lugar na W4Research, uma Contract Research Organization (CRO). O estágio teve a duração de 8 meses durante os quais o estagiário desempenhou funções de CRA sendo o principal foco a monitorização de estudos observacionais. Para além da principal atividade, foram ainda desenvolvidas funções em áreas adjacentes à investigação clínica, tais como, o Medical Writing e a gestão da qualidade. Este trabalho pretende mostrar a visão obtida e os pontos de vista do estagiário enquanto monitor de estudos observacionais.
This report intends to describe the activities carried out under the traineeship which took place in W4Research, a Contract Research Organization (CRO). The internship had the duration of 8 months during which the trainee worked as a CRA, being the main focus the monitoring of observational studies. Besides the main activity, the trainee also had the opportunity to perform adjacent functions to the clinical research, such as Medical Writing and quality management areas. This document intends to show the obtained vision and the points of view of the trainee while monitoring observational studies.

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Manuel, Manuarii. "Étude des distorsions du répertoire immunitaire en tant que facteur pronostique de risque chez les patientes souffrant d’un cancer du sein métastatique en 1ère rechute : étude de la valeur pronostique de la lymphopénie et de la divpénie." Thesis, Lyon 1, 2012. http://www.theses.fr/2012LYO10029.

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Des travaux antérieurs de l’équipe ont démontré l’impact majeur de la lymphopénie (<1Giga/L), détectée avant tout traitement, sur la survie globale des patients atteints d’un cancer solide en phase métastatique, soulignant ainsi l’importance du système immunitaire dans le contrôle de la progression tumorale. Au cours de mon projet de thèse, j’ai analysé l’apport de la diversité combinatoire de la chaine β du TCR, autre indicateur de la qualité du système immunitaire, en tant que marqueur pronostique chez des patientes atteintes de cancer du sein en phase métastatique. J’ai pu montrer qu’un score combinant la diversité des TCR et le nombre de lymphocytes (score NDL) est un facteur indépendant de mauvais pronostic en analyse multivariée. Ce score permet l’identification d’une sous population de patientes à risque qui présente à la fois une lymphopénie et une faible diversité (< 33%) combinatoire du TCR et pour laquelle une très forte réduction de la médiane de survie est observée. Nous avons également réalisé une étude plus approfondie de l’impact des sous-populations de lymphocytes et des cytokines plasmatiques produites. En parallèle, j’ai été amené à développer des tests de biologie moléculaire pour améliorer l’étude de la diversité du répertoire des TCR au niveau génomique. Ces travaux nous ouvrent la voie vers de nouvelles stratégies thérapeutiques qui intégreraient les perturbations du système immunitaire. En effet, suite à ces résultats, un essai clinique basé sur l’administration d’IL-7, cytokine permettant l’expansion des cellules T avant ou pendant la chimiothérapie vient d’être activé au Centre Léon Bérard
Previous work of the team demonstrated the major impact of lymphopenia (<1Giga/L), detected before treatment, on overall survival of patients with solid metastatic cancer, highlighting the importance of immune system in controlling tumor progression. During my thesis project, I analyzed the contribution of the combinatorial diversity of the TCR β chain, another indicator of the quality of the immune system, as a prognostic marker in patients with metastatic breast cancer. I was able to show that a score combining the diversity of TCR and the number of lymphocytes (score NDL) is an independent factor of poor prognostic in multivariate analysis. This score allows identification of a subpopulation of patients at risk who has both a lymphopenia and a low combinatorial diversity (<33%) of TCR and for which a reduction in the median survival was observed. We also made further study of the impact of subpopulations of lymphocytes and plasma cytokines. In parallel, I developed molecular tests to improve the study of TCR repertoire diversity at the genomic level. This work opens the door to new therapeutic strategies that would consider immune system dysfunctions. Indeed, following these results, a clinical trial based on the administration of IL-7 cytokine for the expansion of T cells before or during chemotherapy has been activated at the Centre Léon Bérard

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Langmuir, David Allan. "Making sense of teacher collaboration : a case study of two teachers’ engagement in clinical supervision." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1998. http://www.collectionscanada.ca/obj/s4/f2/dsk2/ftp02/NQ34574.pdf.

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BACIGALUPPI, SUSANNA. "Ruolo e potenziale delle cellule progenitrici endoteliali nel vasospamo cerebrale." Doctoral thesis, Università degli Studi di Milano-Bicocca, 2011. http://hdl.handle.net/10281/27113.

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Title: Role and potential of endothelial progenitor cells in cerebral vasospasm Abstract: Background and aim: Despite many treatment approaches, cerebral vasospasm and delayed ischemic neuronal damage (DIND) still represent a serious threat to patients with subarachnoid haemorrhage (SAH). Endothelial progenitor cells (EPC) have been involved as prognostic indicators in several vascular diseases and mesenchymal stem cells already have shown some benefits in ischemic injury. Aim of this study was to investigate the therapeutic potential of endothelial progenitor cells (EPC) and mesenchymal stem cells (MSC) in attenuating or preventing vasospasm and DIND in patients with SAH. Methods: Given the emergent role of DIND as a result of multifactorial hypoperfusion stress in the outcome of SAH patients, the efficacy of EPC and MSC in reducing neuronal damage has been evaluated in an in vitro model of ischemia, namely the oxygen glucose deprivation (OGD), on primary rat cortical neuronal cultures. Further, we tested in a clinical observational study SAH patients with and without vasospasm for different recruitment patterns of circulating EPC. To this purpose arterial blood samples were collected at various timepoints from admission to discharge of the patients. On these samples real-time quantitative PCR (RT-qPCR) was performed to detect gene expression relative to EPCs, since cytofluorimetric analysis appeared not sensitive enough to detect this rare cell population. Results: Though present results need further confirmation, in vitro it was observed that both MSC and EPC treatment through conditioned medium or co-culture in transwell- although with some differences - mediate a survival advantage for OGD stressed neurons. Furthermore stem cell mediated treatment showed efficacy even when applied 24 hours after OGD stress induction. RT-qPCR results from a small sample of SAH patients might indicate an early mobilization of EPC related gene expression in subjects that do not develop vasospasm with a peak around day 4, whereas the expression of these genes remain invariably low in patients that develop vasospasm as in controls not affected by SAH. Conclusions: MSCs and EPCs seem to have an important potential role in preventing DIND in vitro as well as EPC recruitment might associate with lack of vasospasm in SAH patients. Further studies are needed to confirm these results and to prove a causal relationship between EPCs and vasospasm protection.

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Luk, Siu-luen, and 陸兆鑾. "A study on childhood hyperactivity: clinical observation and a local survey." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 1989. http://hub.hku.hk/bib/B31981409.

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Luk, Siu-luen. "A study on childhood hyperactivity : clinical observation and a local survey /." [Hong Kong : University of Hong Kong], 1989. http://sunzi.lib.hku.hk/hkuto/record.jsp?B12827198.

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Poupart, Alison. "The development and field test of a Mealtime Interaction Clinical Observation Tool : a pilot study and clinical research portfolio." Thesis, University of Glasgow, 2016. http://theses.gla.ac.uk/7593/.

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Objective: The purpose of this study was to develop and test psychometric properties of a Mealtime Interaction Clinical Observation Tool (MICOT) that could be used to facilitate assessment and behavioural intervention in childhood feeding difficulties. Methods: Thematic analysis of four focus groups with feeding and behaviour experts identified the content and structure of the MICOT. Following refinement, inter-rater reliability was tested between three healthcare professionals. Results: Six themes were identified for the MICOT, which utilises a traffic-light system to identify areas of strength and areas for intervention. Despite poor inter-rater reliability, for which a number of reasons are postulated, some correlation between psychologists’ ratings was evident. Healthcare professionals liked the tool and reported that it could have good clinical utility. Conclusion: The study provides a promising first version of a clinical observation tool that facilitates assessment and behavioural intervention in childhood feeding difficulties.

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Reinoso, Gustavo Alejandro. "Correlational study between structured clinical observations and the Sensory Integration and Praxis Test." Diss., NSUWorks, 2005. https://nsuworks.nova.edu/hpd_ot_student_dissertations/39.

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"December 2005" A dissertation submitted in partial fulfillment of the requirements for the degree of Doctor of Occupational Therapy. Typescript (.pdf) Project Advisor : Ferol Menks Ludwig The purpose of this study was to determine if structured observations were associated with the Sensory Integration and Praxis Tests (SIPT). Structured observations have been utilized in sensory integration for many years to assist therapists in assessing children with sensory integration dysfunction. The sample for this study consisted of 21 children ages 5-8 treated with a sensory integration frame of reference in a treatment and training center in west Los Angeles. Sensory integration dysfunction was tested using the SIPT and a set of 10 different structured observations including the supine flexion postural test, prone extension, slow motions, postrotary nystagmus, diadochokinesis, finger-to-thumb opposition, finger-to-nose, the modified Schilder's arm extension test, and the heel-to-toe measure of balance. Results show a small degree of association and highlight the complementary role of both measures. Data reduction indicated that a few structured observations better described two profiles of the SIPT; the low average bilateral integration and sequencing and visuo-somatodyspraxia. Three factors best described the most common structured observations in the group of children with low average bilateral integration and sequencing disorder and included aspects of motor planning and bilateral sequencing; vestibulo-proprioceptive and cerebellar aspects of speed, acceleration, and trajectory. The forward linear regression analysis indicated that structured observations could only predict a small portion of the variability of the different measures of the SIPT.

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Stanton, Andrew E. "Problem asthma clinic : cohort observational study of the upper airway and breathing pattern." Thesis, University of Glasgow, 2006. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.437960.

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Mohamed, Safia. "A comparative clinical case study of a traditional and positive psychological psychometric feedback." Diss., University of Pretoria, 2010. http://hdl.handle.net/2263/25537.

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The purpose of this clinical case study was to compare clients’ and an Educational Psychologist’s experiences of a psychometric feedback from a traditional perspective with feedback from the perspective of positive psychology. The study consulted relevant literature and integrated readings to design frameworks to guide the two modes of feedback. A mixed-method research approach was applied, with a dominant focus on the qualitative aspects of this study (Qualquan), guided by an interpretivist epistemology. Four adolescent girls and an Educational Psychologist were conveniently selected to participate, with two girls participating in the pilot phase and two in the data collection phase. After the pilot the interview frameworks were adapted. Psychometric profiles were used to generate quantitative data, while audio-visual recordings of the feedback interviews, interview transcripts, field notes , the researcher’s and Educational Psychologist’s reflections, and participants’ pre- and post-feedback narratives contributed to the qualitative data for the study. Following thematic analysis it emerged that the clients’ experienced four similarities between the two modes of feedback interviews. Both feedback interviews were experienced as satisfactory and positive experiences; both modes provided self- and career knowledge to the participants; both were experienced as comprehensive feedbacks and the Educational Psychologist highlighted both strengths and weaknesses of the client in each mode. However, the participant who experienced the positive psychological feedback interview received an additional strength-building opportunity. The lack of significant differentiation between the two modes of feedback interviews may be indicative of the value of the therapeutic alliance between therapists and client. This study’s main contribution to Educational Psychology theory and practice is a framework for a positive psychological feedback interview, which may create opportunities for strength-building discussions.
Dissertation (MEd)--University of Pretoria, 2011.
Educational Psychology
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Thurin, Jean-Michel. "Caractériser et comprendre le processus de changement des psychothérapies complexes : modélisation des processus, mécanismes et conditions des changements associés à la psychothérapie de 66 enfants et adolescents présentant des troubles du spectre autistique." Thesis, Sorbonne Paris Cité, 2017. http://www.theses.fr/2017USPCB104/document.

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La méthodologie de l’évaluation en psychothérapie s’est longtemps limitée aux résultats issus d’essais cliniques comparatifs de groupes. L’objectif, engagé dans les années 2000, de comprendre ce qui cause son efficacité a engagé un renouvellement méthodologique. Son application concrète est peu documentée. La première partie présente, à partir d’une revue de la littérature centrée sur l’introduction de la recherche sur le processus associée aux résultats, comment le paradigme interactionnel multifactoriel de la psychothérapie a stimulé le développement de méthodes adaptées à la complexité et à l’observation en conditions naturelles. La seconde partie introduit autour de cinq axes principaux les questions méthodologiques générales et spécifiques de cette nouvelle orientation : 1. une épistémologie interactionnelle et transactionnelle ; 2. Un recentrage sur les études mixtes intensives de cas ; 3. Une investigation clinique et théorique multifocale des processus et mécanismes de changement ; 4. une forte relation clinicien-chercheur ; 5. une approche statistique innovante. La troisième partie expose l’expérience et les questions soulevées par la mise en œuvre de ce programme dans le cadre d’un réseau de recherche clinique centré sur les pratiques, du recueil des données jusqu’à l’analyse des processus et mécanismes de changement, et les résultats qui en sont issus. La quatrième partie présente une revue détaillée de la littérature. Ce travail devrait favoriser les collaborations avec les disciplines connexes et l’efficience des traitements par une meilleure connaissance des conditions et des mécanismes de changement associée au développement d’une base de données issue d’études de cas
The methodology of assessment in psychotherapy has long been limited to results from comparative group clinical trials. The objective, expressed in the 2000s, to understand what is causing its effectiveness has involved a methodological renewal. Its concrete application is poorly documented. The first part presents, from a review of the literature focusing on the introduction of research on the process associated with outcomes, how the multifactorial interactional paradigm of psychotherapy has stimulated the development of methods adapted to the complexity and observation in natural conditions. The second part introduces the general and specific methodological questions of this new orientation around five main axes: 1. an interactional and transactional epistemology; 2. A refocusing on intensive mixed case studies; 3. A multifocal clinical and theoretical investigation of the processes and mechanisms of change; 4. a strong clinical-researcher relationship; 5. an innovative statistical approach. The third part presents the experience and issues raised by the implementation of this program as part of a practice-oriented clinical research network, from data collection to analysis of processes and mechanisms of change, and results. The fourth part presents a detailed review of the literature. This work should foster collaborations with related disciplines and treatment efficiency through a better understanding of the conditions and mechanisms of change associated with the development of a case study database

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PEROTTI, MARIO. "EFFICACIA DEL PASSAGGIO A DEGLUDEC DA UN’ALTRA INSULINA BASALE (GLARGINE/ DETEMIR) IN UNA COORTE DI PAZIENTI CON DIABETE MELLITO TIPO 1 ( DMT1) IN CONDIZIONI DI REALE PRATICA CLINICA." Doctoral thesis, Università degli Studi di Milano-Bicocca, 2019. http://hdl.handle.net/10281/241121.

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La terapia del diabete tipo 1 può oggi essere più flessibile e personalizzata grazie alla disponibilità di numerosi tipi di insulina che differiscono tra loro per la farmacocinetica (inizio, picco e durata di azione). Il miglior controllo glicometabolico può essere ottenuto attraverso una terapia multiniettiva secondo uno schema basal-bolus, il quale prevede 3 somministrazioni preprandiali di un analogo rapido, che esprime meglio la fisiologica secrezione insulinica determinata dai pasti e da 1 iniezione di insulina ad azione lenta, necessaria per rispondere al fabbisogno insulinico nei periodi di digiuno (interprandiale e notturno). Il raggiungimento di un controllo glicemico ottimale mediante trattamento insulinico intensivo determina un riduzione del rischio di complicanze micro e macrovascolari, ma conduce inevitabilmente a un incremento dell’incidenza di ipoglicemie, con conseguenze potenzialmente negative per il sistema cardiovascolare e neurologico. Ottimizzare la terapia farmacologica mediante l’utilizzo di nuovi analoghi dell’insulina ad azione lenta in grado di offrire un minore rischio di ipoglicemia rappresenta un punto di fondamentale importanza. Insulina degludec presenta molte delle caratteristiche che definiscono il profilo ideale di un’insulina basale. Dopo la somministrazione nel sottocute, grazie alla particolare ingegneria chimica, degludec viene assorbita in modo continuo e uniforme con un effetto ipoglicemizzante stabile e una durata di azione che supera le 42 ore. Dopo circa tre giorni di terapia è possibile raggiungere lo steady state condizione farmacocinetica in cui i livelli circolanti di insulina si mantengano stabili riducendo così la variabilità day-to day L'utilizzo di degludec è stato ampiamente analizzato nel corso di studi clinici randomizzati ( RCT) sia in pazienti con diabete mellito tipo I sia in pazienti con diabete mellito tipo II. I risultati mostrano una non inferiorità di degludec rispetto a glargine in termine di target glicemici, ma una superiorità di degludec rispetto a glargine in termini di riduzione degli episodi di ipoglicemia soprattutto notturni. Tuttavia il contesto clinico di uno studio randomizzato può non essere completamente riproducibile nella pratica clinica quotidiana. Obiettivo di questo studio retrospettivo è la valutazione dell’efficacia clinica di degludec in una coorte di pazienti affetti da diabete mellito tipo 1 precedentemente trattati con diverso analogo lento ( glargine o detemir) nella pratica clinica quotidiana di real-life. I risultati di questo studio mostrano un impatto positivo di degludec nella gestione terapeutica di pazienti con diabete mellito tipo 1 in linea con precedenti studi clinici randomizzati . Il passaggio a degludec da un altro analogo basale ( glargine o detemir) è in grado di migliorare il controllo glicemico, con una riduzione media dei valori di HbA1c di 0,20 % [-0,24;-0.17] a 6 mesi rispetto al basale (p <0.001). Inoltre i dati descritti in questo lavoro hanno evidenziato una riduzione del rischio di ipoglicemia sia totale ( rate ratio 0,79 [0,69: 0,89]), sia notturna (rate ratio 0,54 [0,42; 0,69]) sia grave (rate ratio 0,15 [0,09; 0,24]) a 6 mesi dalla modifica di terapia (p <0.001). Tale significatività rimane per tutto il periodo di follow-up di 12 mesi. Infine dopo 6 mesi di terapia con degludec, la dose totale di insulina giornaliera è diminuita del 11% rispetto al basale (p <0,001). Sulla base di questi dati, possiamo affermare che la terapia insulinica con degludec rappresenta un valido strumento terapeutico nella pratica clinica quotidiana, in grado di migliorare il compenso glicemico e la qualità di vita dei pazienti, favorendo così il raggiungimento di obiettivi glicemici più ambiziosi.
Type 1 diabetes (DMT1) leads to absolute insulin deficiency due to immunologic destruction of the islet cells. Therefore affected patients need lifelong insulin treatment. Newer therapies for type 1 diabetes are aimed at developing insulin delivery systems that mimick normal physiology, identifying newer insulins that mimick endogenous insulin. To reproduce physiologic insulin secretion, both long- and short-acting insulins are used. Long-acting insulin, given at bedtime, suppresses glucose output from the liver overnight and provides basal insulin between meals; bolus doses of short-acting insulin modulate glucose excursions associated with carbohydrate consumption. Optimal glycemic control is necessary to reduce the risk for diabetes complications. However, tight glucose control carries a risk for hypoglycemia. Hypoglycemia may accelerate the vascular complications of diabetes by increasing platelet aggregation, leading to higher cardiovascular risk and all-cause mortality. Even brief hypoglycemia can cause profound dysfunction of the brain. Insulin administration by subcutaneous route has intrinsic limitations that, together with the pharmacokinetic (PK) profile of insulin formulations, do not reproduce the physiological patterns of insulin secretion. Insulin degludec (IDeg) is an ultra-long insulin analog that has unique pharmacokinetic and pharmacodynamic properties with a half-life of more than 24 h and a duration of action of more than 42 h. Compared to insulin glargine , the insulin degludec glucose-lowering action at steady state shows four time lower day-to day variability. Randomized clinical studies of degludec have shown a reduction in nocturnal hypoglycemia compared to insulin glargine. Given this background, IDeg is an ultra-long insulin analog that exhibits low intra-individual variability and whose efficacy is comparable to IGlar, but which presents as advantages flexibility in dose timing and lower risk of hypoglycemia, benefits that may impact quality of life and adherence to therapy. In Europe data on the use or effect of degludec in the general diabetes population not exist yet. Thus collection of data under routine clinical practice is highly warranted in order to access the effectiveness of degludec in real-life clinical setting. Aim of this retrospective non interventional study is to evaluate the clinical effectiveness of switching to IDeg in insulin treated patients with DMT1 under condition of routine clinical care. In all patients (n: 900), basal insulin was switched to IDeg at least 6 months before the start of data collection. Baseline was defined as the most recent recording during the 3-month period before first prescription of IDeg. Values are presented as mean [95%CI]. HbA1c decreased by -0.20 % [-0.24; -0.17%] at 6 months vs baseline (P < .001). Rate ratio of overall (0.79 [0.69; 0.89]), non-severe nocturnal (0.54 [0.42; 0.69]) and severe (0.15 [0.09; 0.24]) hypoglycaemia was significantly lower in the 6-month post-switch period vs the pre-switch period (P < .001 for all). Total daily insulin dose decreased by -4.88 [-5.52; -4.24] U (-11%) at 6 months vs baseline (P < .001). This study demonstrates that switching patients to IDeg from other basal insulins improves glycaemic control and significantly reduces the risk of hypoglycaemia in routine clinical practice.

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Beament, Tania L. "A mixed-method study to evaluate the effectiveness of a policy-driven tool to improve the recognition of and response to clinical deterioration in acute care." Thesis, Edith Cowan University, Research Online, Perth, Western Australia, 2022. https://ro.ecu.edu.au/theses/2518.

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Background: Contemporary literature identifies that clinical deterioration in the acute care setting requires an optimum level of management and that the failure to recognise this deterioration and respond effectively results in increased mortality rates. The early detection of clinical deterioration and the successful rescue of a patient relies heavily on the effectiveness of hospital systems, communication systems and multidisciplinary collaboration. Objectives: To evaluate the effectiveness of the strategies implemented to improve the escalation of care for patients who deteriorate in hospital. Specifically, the study examined the introduction of a revised observation chart, the experiences of nurses in using the chart, and whether its use resulted in the appropriate escalation of care. Method: A mixed-methodology approach combining a longitudinal study design with cross-sectional data collection. A quantitative research method was adopted to extract the results from the medical records of patients who had experienced a Medical Emergency Team (MET) call and establish the rate of compliance with the new policy. Patient information sourced from administrative datasets, including discharge abstracts extracted from the hospital's morbidity system and MET call database, were used to determine changes in the rates of MET calls and mortality pre- and post- policy implementation. Qualitative data collection involved focus group discussions on nurses’ experiences of implementing the policy and use of the Adult Observation Response Chart tool. The study was undertaken in the multi-day wards at one of Western Australia’s tertiary hospitals, where a new escalation policy was implemented as part of the State healthcare policy for the recognition of, and response to, the deteriorating patient. Results: A statistically significant increase in the rate of MET calls in the post-policy intervention period compared to the pre-policy intervention phase was observed, the odds increasing by 12% post-policy intervention. Additionally, the study found a strong correlation between the number of MET calls and the Charlson Index Score (the higher the Charlson Index Score, the more likely a MET call was made). Mortality rate was not significantly different between the two periods after adjustment for other relevant factors. Three major themes were identified: chart design, communication, and the impact of the policy implementation on nurses and patients. Conclusion: Recognising, responding to, and managing the deteriorating patient is complex, challenging, and multifaceted. The study highlighted the need for effective strategies to support the recognition of clinical deterioration and response in critical situations to enhance patient safety, optimise resources and positively change practice. Findings from the study emphasised the challenges faced when implementing a new policy leading to a change in practice. Recommendations include the refinement of policy and removal of barriers that can impact the implementation of evidence-based practice and the opportunity to improve patient outcomes.

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Ayre, Colin A. "Delay to diagnosis and specialist consultation following anterior cruciate ligament injury : a study investigating the nature of, and factors associated with, pathway delay." Thesis, University of Bradford, 2016. http://hdl.handle.net/10454/14627.

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Background: Historically the identification of ACL injuries upon initial presentation is low and considerable diagnostic delays have been reported. However, specific evidence on the individual elements of, and factors which influence delay, is lacking. Aims: The overarching aim was to provide a comprehensive picture of delay to diagnosis and specialist consultation, including factors which influence delay. An additional aim was to determine whether the approach to examining acute knee injuries varied as a consequence of varying patient presentation or experience of the assessing clinician. Methods: Study 1: Cross -sectional survey. Study 2: Non-participant direct observation methodology. Results: Data from 194 patients were analysed in the survey. Only 15.5% of patients were given a correct diagnosis of ACL rupture at the initial consultation. Median delay to diagnosis was 67.5 days (IQR= 15 to 178 days) and specialist consultation 108 days (IQR= 38 to 292 days). The factors most influential on delay were whether a follow-up appointment was arranged after attending A&E, whether the site of attendance operated an acute knee clinic and whether MRI was performed. The direct observation study showed wide variation in approach to injury assessment. Specialist clinicians performed the most comprehensive examination. A&E clinicians were more likely to assess for bony, neurovascular and gross tendon injuries as opposed to ligamentous or meniscal injury. Conclusions: The diagnostic rate of ACL injury at initial presentation remains low. Considerable delays to diagnosis and specialist consultation are apparent following ACL injury, the majority of which is attributable to health system delay.

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Suassuna, Natália Maria da Silva Fernandes. "Diálise peritoneal no Brasil: descrição de uma coorte e fatores de risco para sobrevivência da técnica e do paciente." Universidade Federal de Juiz de Fora (UFJF), 2009. https://repositorio.ufjf.br/jspui/handle/ufjf/5472.

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O presente estudo utilizou registros sistematizados de dados nacionais e locais sobre pacientes em terapia renal substitutiva (TRS) fundamentais para o conhecimento epidemiológico da realidade do tratamento dialítico. Estes dados podem permitir uso mais racional dos recursos econômicos, identificação das intervenções, visando à melhoria da terapêutica, diminuição da morbimortalidade desses pacientes. No Brasil, a Sociedade Brasileira de Nefrologia, mantém, desde 1999, registros parciais sobre pacientes em TRS. Os objetivos do estudo foram coletar dados demográficos, clínicos, laboratoriais e desfechos (óbito, recuperação da função renal, transferência para hemodiálise, falência da técnica, transplante renal, tranferência para outro centro ou perda de seguimento) de pacientes em diálise peritoneal (DP) tratados em centros de todas as regiões do Brasil para descrição das características epidemiológicas desta população e avaliação dos fatores relacionados à falência da técnica e mortalidade. Para tal foi desenhado um estudo multicêntrico, envolvendo centros de todas as regiões do país, iniciado em dezembro de 2004 e com seguimento até outubro de 2007. Foi desenhado um software com os dados preenchidos off fine e enviados on fine a um servidor. Neste ponto, os dados foram extrídos em MySQL, sendo montada uma base de dados, posteriormente, transportada para o software estatístico SPSS 13.0 e SAS. Ao final, foram analisados 6.198 pacientes de 102 centros. Os resultados mostram que o Brasil apresenta um baixo número de pacientes em diálise peritoneal, com um viés de seleção para esta modalidade, onde a maioria dos pacientes apresenta inúmeras comorbidades tendo como indicação clínica "única possibilidade terapêutica ou indicação médica". Apesar disto, há um baixo índice de complicações infecciosas (1 episódio de peritonite/30 meses) e a taxa de saída no período inicial de 34 meses foi de 37,7%, com um média anual de 13,3%. A meta mais difícil de ser alcançada é a hemoglobina, notadamente em diabéticos e pacientes egressos de outras TRSs. A principal causa de saída foi óbito (21%), sendo as causas cardiovasculares as mais prevalentes (40%). Entre os principais fatores relacionados à mortalidade e falência da técnica foram encontrados a idade, diabetes mellitus, doença cardiovascular. Houve relação direta da mortalidade da população geral com a mortalidade da população em diálise peritoneal. Foram observadas diferenças regionais importantes quanto às taxas e motivos de saídas nas diversas regiões do país, bem como, a ocorrência da "epidemiologia reversa" da obesidade nesses pacientes. O estudo permitiu traçar o perfil epidemiológico dos pacientes em diálise peritoneal no Brasil e concluir que, a despeito do importante viés de seleção, nosso país apresenta uma diálise peritoneal adequada, comparada a países desenvolvidos europeus.
Systematic registers of local and national data on patients in renal replacement therapy (TRS) are critical to the epidemiological knowledge of the reality of the dialysis treatment. These data may allow more rational use of economic resources, identify interventions to improve the treatment, and to decrease morbidity and mortality of these patients. In Brazil, the most recent dialysis register made available by the Brazilian Society of Nephrology is based on data obtained from 1999 patients on renal replacement therapy. This study aimed to collect demographic, clinical, laboratory and outcomes (death, recovery of renal function, transfer to hemodialysis, the technical failure, kidney transplantation, transfer to another center or loss of follow-up) of patients on peritoneal dialysis (PD) treated in dialysis clinics located in all regions of Brazil to describe the epidemiological characteristics of this population and assess the factors related to the risk of the technique failure and mortality of patients. A multicenter study was designed involving patients of 102 centers in all the regions of the Brazil, initiated in December of 2004, with the last set of date obtained in October 2007. A software was designed with the data registered offline and sent online to a central server. The data were extracted in MySQL and originating a database that was initially validated and then transfered to the statistical software SPSS 13.0 and SAS. This extraction was performed in two stages. At the end of the study, 6198 patients were analyzed. Brazil has a low number of patients on peritoneal dialysis, with a selection bias for this treatment modality, where the majority of patients presents numerous co-morbidities and and has peritoneal dialysis as the only therapeutic option. There is a low rate of infectious complications (1 episode of peritonite/30 months) and the rate of drop-out during the study was 37.7%, with an annual average of 13.3%. The more difficult goal to be achieved is the hemoglobin, especially in diabetic patients and arising from hemodialysis. The main cause of drop-out was death (21%), being the cardiovascular diseases the most prevalent (40%). Age, diabetes mellitus, cardiovascular disease were among the main factors related to mortality and failure of the technique. It was seen a positive direct relationship of mortality when the general population was compared with patients on peritoneal dialysis. Furthermore, we observed marked regional differences in the rates and reasons for dropouts of patients in the different regions of the country. It was also seen the existence of the "reverse epidemiology" of obesity in these patients. In conclusion, our study allowed us to outline an epidemiological profile of peritoneal dialysis in Brazil and confirm the good quality of PD that is offered to our patients when compared to developed European countries, despite of the selection bias at the choice of TRS.

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Chien, Hui-Wen. "Understanding the Nursing Home Care Processor: An Ethnographic Study." Thesis, The University of Sydney, 2009. http://hdl.handle.net/2123/6389.

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Aim and significance: The aim of this research was to explore the phenomenon of Australian nursing home care from the perspective of those who provide and receive it. Its focus is on the processes of ‘quality care’ provision and the meanings and evaluations that care providers attach to their work. In other words, its purpose was to shed light on the practices based on a conceptualisation of care that is entwined with the mechanisms of ‘care’ production and identity creation, or what actually happens in the daily life of the complex social phenomenon that is a nursing home. A related aim was to add to understandings of clinical nursing competence and develop tools that will assist nurses to conceptualise and implement positive change in this setting. Background: The provision of care to our elderly has become a major concern with the ageing of the world population. This is occurring in the context of decline in the capacity of families to take on the responsibility of elder care, and of increasing commercialisation of medical care. Governments have responded by shifting their responsibilities from direct care provision to become auditors of the business of care provision that is supported by public funding. However poor care delivery has largely been hidden from the public gaze. Governments present themselves as having systems in place, creating the illusion of rational control; in reality, like the market economy, there is a ‘black box’ of unknown factors driven by human impulse. The aim of this study was to open up the black box of ‘quality care’ to direct observation, drawing insights from the literature on organisational culture and with a focus on the frontline worker and the construct of quality assurance. Specific research objectives were to: • Document the beliefs and attitudes of care providers towards elderly people in general and the needs of nursing home residents in particular • Elicit the range of meanings and evaluations that care providers attach to their work • Describe their constructions of ‘care’ and ‘quality of care’ and the organisational factors they believe to impact (positively and negatively) on their ability to provide it. • Through in-depth understanding of a particular setting, generate grounded theoretical insights into the phenomenon of quality of residential care that are more widely applicable Method: The study adopted a paradigmatic bricoleur approach, seeking to develop connections between a diverse range of methodologies. These included combinative ethnography, phenomenology, hermeneutics and traditional grounded theory. Conceptual insights were drawn from organisational studies, psychosocial nursing and coping theory. The research site was an Australian for-profit suburban nursing home. The student investigator conducted more than 500 hours of participant observation, recording extensive field notes which were analysed through the perspective of a hermeneutic middle way horizon that directed an augmented constant comparison traditional grounded theory approach. Additional data were collected through formal indepth interviews with six key stakeholders. Interviews were tape recorded, transcribed in full and analysed to reveal themes that were brought within a hermeneutic circle that spiralled recursively from the whole to the part and back to the whole. Findings: Eight key interrelated factors in the production of care within the nursing home were identified: internal and external accountability (the accreditation system); economic considerations; management and training; advocacy; characteristic of residents; care providers’ working conditions and environmental stressors; organisational culture; and the work/care styles of individual care providers. I have categorised the latter into two main types: ‘tortoises’ and ‘hares’. This typology is then used to generate a process-driven schematic diagram that tracks a hypothetical novice care provider through the process of learning how to produce ‘care’. Specifically, I found that nursing home ‘care’ is the outcome of a complex social process involving the interplay between resident, relative, care provider, proprietor, quality assessors and government within the phenomenon of the nursing home. Such care, indeed the phenomenon of the nursing home itself, is not a stable, controllable entity but is in a constant state of flux – what I refer to as a moral ecology. In their everyday practice, care providers devise a construction of ‘quality care’ that is more clearly grounded in their own worldviews and the development of the own identity than in the formal quality assurance system of standards, guidelines and evaluations. Conclusion: Understanding the ‘black box’ of processes that produce care is the key to identifying courses of action that will improve care outcomes. The study findings also question the validity, assumptions and significance of the accreditation system, which only identifies some of the component variables, disregarding both the complexity within the ‘black box’ and failing to acknowledge that the quality of care outcomes is overwhelmingly dependent on individual care providers.

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Chien, Hui-Wen. "Understanding the Nursing Home Care Processor: An Ethnographic Study." University of Sydney, 2009. http://hdl.handle.net/2123/6389.

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Abstract:

Doctor of Philosophy
Aim and significance: The aim of this research was to explore the phenomenon of Australian nursing home care from the perspective of those who provide and receive it. Its focus is on the processes of ‘quality care’ provision and the meanings and evaluations that care providers attach to their work. In other words, its purpose was to shed light on the practices based on a conceptualisation of care that is entwined with the mechanisms of ‘care’ production and identity creation, or what actually happens in the daily life of the complex social phenomenon that is a nursing home. A related aim was to add to understandings of clinical nursing competence and develop tools that will assist nurses to conceptualise and implement positive change in this setting. Background: The provision of care to our elderly has become a major concern with the ageing of the world population. This is occurring in the context of decline in the capacity of families to take on the responsibility of elder care, and of increasing commercialisation of medical care. Governments have responded by shifting their responsibilities from direct care provision to become auditors of the business of care provision that is supported by public funding. However poor care delivery has largely been hidden from the public gaze. Governments present themselves as having systems in place, creating the illusion of rational control; in reality, like the market economy, there is a ‘black box’ of unknown factors driven by human impulse. The aim of this study was to open up the black box of ‘quality care’ to direct observation, drawing insights from the literature on organisational culture and with a focus on the frontline worker and the construct of quality assurance. Specific research objectives were to: • Document the beliefs and attitudes of care providers towards elderly people in general and the needs of nursing home residents in particular • Elicit the range of meanings and evaluations that care providers attach to their work • Describe their constructions of ‘care’ and ‘quality of care’ and the organisational factors they believe to impact (positively and negatively) on their ability to provide it. • Through in-depth understanding of a particular setting, generate grounded theoretical insights into the phenomenon of quality of residential care that are more widely applicable Method: The study adopted a paradigmatic bricoleur approach, seeking to develop connections between a diverse range of methodologies. These included combinative ethnography, phenomenology, hermeneutics and traditional grounded theory. Conceptual insights were drawn from organisational studies, psychosocial nursing and coping theory. The research site was an Australian for-profit suburban nursing home. The student investigator conducted more than 500 hours of participant observation, recording extensive field notes which were analysed through the perspective of a hermeneutic middle way horizon that directed an augmented constant comparison traditional grounded theory approach. Additional data were collected through formal indepth interviews with six key stakeholders. Interviews were tape recorded, transcribed in full and analysed to reveal themes that were brought within a hermeneutic circle that spiralled recursively from the whole to the part and back to the whole. Findings: Eight key interrelated factors in the production of care within the nursing home were identified: internal and external accountability (the accreditation system); economic considerations; management and training; advocacy; characteristic of residents; care providers’ working conditions and environmental stressors; organisational culture; and the work/care styles of individual care providers. I have categorised the latter into two main types: ‘tortoises’ and ‘hares’. This typology is then used to generate a process-driven schematic diagram that tracks a hypothetical novice care provider through the process of learning how to produce ‘care’. Specifically, I found that nursing home ‘care’ is the outcome of a complex social process involving the interplay between resident, relative, care provider, proprietor, quality assessors and government within the phenomenon of the nursing home. Such care, indeed the phenomenon of the nursing home itself, is not a stable, controllable entity but is in a constant state of flux – what I refer to as a moral ecology. In their everyday practice, care providers devise a construction of ‘quality care’ that is more clearly grounded in their own worldviews and the development of the own identity than in the formal quality assurance system of standards, guidelines and evaluations. Conclusion: Understanding the ‘black box’ of processes that produce care is the key to identifying courses of action that will improve care outcomes. The study findings also question the validity, assumptions and significance of the accreditation system, which only identifies some of the component variables, disregarding both the complexity within the ‘black box’ and failing to acknowledge that the quality of care outcomes is overwhelmingly dependent on individual care providers.

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Mario, Romain. "Conversion et influence des assujettissements au milieu scolaire dans l'étude autonome des mathématiques : comment les très bons élèves de lycée étudient les mathématiques après la classe : observation anthropologique et suivi biographique de quelques cas exemplaires." Thesis, Aix-Marseille, 2012. http://www.theses.fr/2012AIXM3001/document.

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Dans cette thèse, nous nous sommes intéressé aux très bons élèves et à leur façon d'étudier les mathématiques, en tenant compte du fait que tout ce qu'il y a à étudier mathématiquement n'est pas désigné par les professeurs. Partant de l'hypothèse que leur façon d'étudier leur permet de mieux réussir, nous avons suivi pendant deux années scolaires de très bons élèves de cinq établissements différents. Par une enquête anthropologique et ethnologique de terrain, nous les avons observés après les séances de cours en classe, sur leur lieu de travail (le bureau, la chambre ou un coin spécialement aménagé); en train de faire des exercices, des enquêtes, des recherches mathématiques sur les objets d'études des grands chapitres de la classe terminale scientifique (l'analyse, lois de probabilités continues, la géométrie, les similitudes...) ; chacun à sa manière, avec des supports didactiques de son choix. Cette forme d'observation particulière que nous appelons avec Mercier la méthode des épisodes biographiques, nous a permis de constituer des épisodes de leur biographie en mathématique, c'est-à-dire des moments où l'on peut attester qu'une question nouvelle se pose à eux, qu'ils apprennent quelque chose de nouveau en cherchant la réponse à la question donnée, et qu'ils identifient ce qu'ils ont appris en l'interrogeant depuis ce qu'ils savaient déjà. Nous montrons ainsi, comment les très bons élèves de terminales scientifiques fabriquent un répertoire de savoirs efficaces: leur répertoire épistémologique et heuristique. Pour construire ce répertoire, ils ont besoin d'aller enquêter loin de la classe, dans l'espace ou dans le temps (dans de nombreux manuels, scolaires ou non, dans des anciens livres, sur internet, quelques fois avec l'aide d'un membre de la famille ou d'un copain). C'est cette manière d'enquêter que nous appelons la transhumance didactique
In this thesis, we were interested in the very good students and their way studying mathematics taking account of the fact that what there is to study mathematically is not always indicated by the professor in the courses of the various school grades. Based on the hypothesis that their way of studying enables them to succeed better in mathematics, we followed very good students from five different schools for two school years. Thus, using anthropological and ethnological field study methods, we observed the students after classroom hour, in their individual workplace settings (office, room or an especially arranged corner) doing exercises, investigations, mathematical research studies, each one in different way, with different didactic supports. This particular kind of observation, that we are calling the biographic episode method, enabled us to constitute episodes of their cognitive biography in mathematics, in other words moments of independent study where one can observe that they are faced with a news question, they learn something new by seeking the answer to a given problem, and they identify what they learned by questioning it in what they knew already. Thus we show how last year secondary school science students manufacture or build a directory of effective knowledge: the epistemological and heuristic directory. To build this directory, they need to seek learning away from the classroom, physically or temporally (using many textbooks or not, old textbooks, the Internet, or with the help of a family member or friend). It is this need for investigation which we call didactic transhumance

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Gouveia, Lourdes de Fátima Lima Lourenço Bacelar. "Há paixão em ser bebé: Reflexões teórico-clínicas - amar e pensar o bebé." Master's thesis, Instituto Superior de Psicologia Aplicada, 2003. http://hdl.handle.net/10400.12/538.

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Charles, Kathryn L. "Towards the specification of a computer system to facilitate the learning of the partitive quotient fraction construct." Thesis, Queensland University of Technology, 1998. https://eprints.qut.edu.au/36571/1/36571_Digitised%20Thesis.pdf.

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A "Specification Document" was developed for the design of a constructivist, hypermedia learning environment (CHLE) to facilitate the knowledge construction of fractions. Specifications for the design of the CHLE were created from an investigation into children's knowledge construction of fractions. This entailed a review of the mathematical structure of fractions to build fraction tasks which were then used to investigate children's understandings of fractions. The investigation was couched in the constructivist paradigm. Guba and Lincoln's (1989) methodology of constructivist inquiry incorporating the Hermeneutic Dialectic Circle was adopted. Clinical interviews, talk-aloud protocols and non-participant observations operated within the Hermeneutic Dialectic Circle. Findings from the investigation addressed: (i) teaching interventions, (ii) children's strategies for solving the fraction tasks, and (iii) the goodness of the analog objects used in the tasks. Teaching interventions involved task sequencing and teaching episodes to assist children over impasses or gaps in their knowledge. Task sequencing moved from circular region models to rectangular region models and length models. One to six analog objects (representative of these three models) were shared between two, three, four, five and six people. Task sequencing was unique for each child and contingent upon each child's knowledge constructions of fractions. Findings indicated that children who did not possess sound knowledge of the partitive quotient fraction construct relied heavily upon their knowledge of the part-whole fraction construct to quantify each person's share. In most cases, this knowledge was fractured and incomplete, therefore most teaching episodes focused on partwhole notions. Children employed four categories of strategies to solve the tasks. These strategies were categorised according to their ability to: (i) generate fair shares, (ii) facilitate the accurate quantification of each of the shares, and (iii) facilitate a conceptual mapping between the concrete activity and the partitive quotient fraction construct. Category 1 strategies met all three criteria. Category 2 strategies met only the first two criteria. Category 3 strategies met only the first criteria and Category 4 strategies met none of the criteria. The goodness of the analog objects was judged according to three criteria: (i) ecological validity, (ii) abstract ability, and (iii) ease of partitioning. Findings revealed that the icecream bar (rectangular region model) and the licorice strap (length model) were easier to partition than the pizza and apple pie (circular region models) but lacked ecological validity. The pizza and apple pie had ecological validity but were difficult to partition. The cake ("wide" rectangular region model) did not have ease of partitioning because it supported both vertical and horizontal partitioning. The circular region models of the pikelet and the pancake did not satisfy any of the criteria and were not considered suitable analogs for inclusion in the design of the CHLE. The findings from the teaching interventions and strategies were translated into "Content" specifications, and the findings from the goodness of the analog objects were translated into "Context" specifications. These two sets of specifications informed the Specification Document for the design of the CHLE. Specifications were presented as: (i) scenarios which correlated instructional objectives of the CHLE with "WHAT" the children should do to meet these instructional objectives and "HOW" the system should address the "WHAT", (ii) interface design as it applies to Object Orientated User Interfaces (OOUI's), and (iii) vignettes which are supported with accompanying screens to indicate screen layout, typography, language, graphics, illustrations, and the look, feel and operation of the system. The CHLE was designed to embody realistic contexts in which children construct their own knowledge as a consequence of their experiences with the fraction tasks.

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Alves, José Miguel da Silva. "Optic Neuropathy: a 15-year retrospective observational study." Master's thesis, 2020. https://hdl.handle.net/10216/128909.

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Introdução: As neuropatias ópticas têm várias etiologias possíveis e, por vezes, o diagnóstico estabelecido ab initio é redefinido após novas investigações e/ou novos eventos neurológicos. Neste estudo, pretendemos identificar possíveis factores preditivos que possam ditar essa mudança de diagnóstico durante o seguimento. Métodos: Analisámos retrospectivamente os registos médicos de 156 doentes internados com neuropatias ópticas no Departamento de Neurologia do Centro Hospitalar Universitário de São João, entre Janeiro de 2004 e Agosto de 2019. Foram analisados dados clínicos, laboratoriais e imagiológicos, protocolos de tratamento e dados relativos à evolução clínica dos doentes durante o tempo de seguimento do estudo. Resultados: No momento da alta do internamento, a nossa coorte era composta por 83 doentes com neuropatias ópticas idiopáticas (53,2%), 38 com nevrites ópticas relacionadas com esclerose múltipla (24,4%), 23 com neuropatias ópticas isquémicas (14,7%), 5 com nevrites ópticas relacionadas com doença do espectro da neuromielite óptica (3,2%) e 7 com outros diagnósticos (4,5%). Durante o seguimento, 129 doentes mantiveram o diagnóstico de alta do internamento (82,7%) enquanto que em 27 o diagnóstico foi redefinido durante o tempo de seguimento (17,3%). Nestes últimos, o tempo médio entre a admissão e a mudança no diagnóstico foi de 12,3 (5,4 - 42,9) meses. A análise multivariada (Regressão de Cox) demonstrou que os pacientes com neuropatia óptica atípica (presença de um dos seguintes achados clínicos: envolvimento ocular bilateral, acuidade visual ≤ 0,1 na admissão, agravamento ou recuperação não-substancial da acuidade visual durante o internamento) tinham menor risco de ter o seu diagnóstico inicial alterado durante o seguimento (HR = 0,320, 95% CI = 0,138-0,743, p = 0,008). Conclusão: O nosso estudo demonstra que alguns doentes admitidos com neuropatias óticas podem ter o seu diagnóstico redefinido durante o seguimento. Além disso, verifica que os doentes com neuropatias ópticas atípicas têm menor propensão a alterar de diagnóstico durante o seguimento.
Purpose: Optic neuropathies (ON) have several aetiologies and sometimes the diagnosis established ab initio is redefined after further investigations and/or new neurological events. We aim to identify possible predictive factors that may dictate that diagnostic change during follow-up. Methods: We retrospectively reviewed the medical records of 156 patients with ON admitted to the ward of our Neurology Department, between January 2004 and August 2019. Clinical, laboratory and imaging data, as well as treatment protocols and follow-up were analysed. Results: At the time of discharge from the ward, our cohort comprised 83 idiopathic ON (53.2%), 38 multiple sclerosis-related ON (24.4%), 23 ischemic ON (14.7%), 5 neuromyelitis optica spectrum disorder-related ON (3.2%), and 7 with other diagnoses (4.5%). During follow-up, 129 patients retained the ward's discharge diagnosis (82.7%) while in 27 it was redefined (17.3%). The median time between admission and change in diagnosis was 12.3 (5.4 - 42.9) months. Multivariate Cox regression analysis demonstrated that the patients with atypical optic neuropathy (presence of one of these clinical findings: bilateral eye involvement, visual acuity ≤ 0.1 at admission, worsening or non-substantial recovery of visual acuity during hospitalization) had lower risk of having the initial diagnosis changed (HR = 0.320, 95% CI = 0.138-0.743, p = 0.008). Conclusion: Our study illustrates that some patients admitted with optic neuropathy may have their diagnosis redefined during follow-up. Furthermore, it demonstrates that patients with atypical ON are those in which the diagnosis is more likely to remain during follow-up.

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Alves, José Miguel da Silva. "Optic Neuropathy: a 15-year retrospective observational study." Dissertação, 2020. https://hdl.handle.net/10216/128909.

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Abstract:

Introdução: As neuropatias ópticas têm várias etiologias possíveis e, por vezes, o diagnóstico estabelecido ab initio é redefinido após novas investigações e/ou novos eventos neurológicos. Neste estudo, pretendemos identificar possíveis factores preditivos que possam ditar essa mudança de diagnóstico durante o seguimento. Métodos: Analisámos retrospectivamente os registos médicos de 156 doentes internados com neuropatias ópticas no Departamento de Neurologia do Centro Hospitalar Universitário de São João, entre Janeiro de 2004 e Agosto de 2019. Foram analisados dados clínicos, laboratoriais e imagiológicos, protocolos de tratamento e dados relativos à evolução clínica dos doentes durante o tempo de seguimento do estudo. Resultados: No momento da alta do internamento, a nossa coorte era composta por 83 doentes com neuropatias ópticas idiopáticas (53,2%), 38 com nevrites ópticas relacionadas com esclerose múltipla (24,4%), 23 com neuropatias ópticas isquémicas (14,7%), 5 com nevrites ópticas relacionadas com doença do espectro da neuromielite óptica (3,2%) e 7 com outros diagnósticos (4,5%). Durante o seguimento, 129 doentes mantiveram o diagnóstico de alta do internamento (82,7%) enquanto que em 27 o diagnóstico foi redefinido durante o tempo de seguimento (17,3%). Nestes últimos, o tempo médio entre a admissão e a mudança no diagnóstico foi de 12,3 (5,4 - 42,9) meses. A análise multivariada (Regressão de Cox) demonstrou que os pacientes com neuropatia óptica atípica (presença de um dos seguintes achados clínicos: envolvimento ocular bilateral, acuidade visual ≤ 0,1 na admissão, agravamento ou recuperação não-substancial da acuidade visual durante o internamento) tinham menor risco de ter o seu diagnóstico inicial alterado durante o seguimento (HR = 0,320, 95% CI = 0,138-0,743, p = 0,008). Conclusão: O nosso estudo demonstra que alguns doentes admitidos com neuropatias óticas podem ter o seu diagnóstico redefinido durante o seguimento. Além disso, verifica que os doentes com neuropatias ópticas atípicas têm menor propensão a alterar de diagnóstico durante o seguimento.
Purpose: Optic neuropathies (ON) have several aetiologies and sometimes the diagnosis established ab initio is redefined after further investigations and/or new neurological events. We aim to identify possible predictive factors that may dictate that diagnostic change during follow-up. Methods: We retrospectively reviewed the medical records of 156 patients with ON admitted to the ward of our Neurology Department, between January 2004 and August 2019. Clinical, laboratory and imaging data, as well as treatment protocols and follow-up were analysed. Results: At the time of discharge from the ward, our cohort comprised 83 idiopathic ON (53.2%), 38 multiple sclerosis-related ON (24.4%), 23 ischemic ON (14.7%), 5 neuromyelitis optica spectrum disorder-related ON (3.2%), and 7 with other diagnoses (4.5%). During follow-up, 129 patients retained the ward's discharge diagnosis (82.7%) while in 27 it was redefined (17.3%). The median time between admission and change in diagnosis was 12.3 (5.4 - 42.9) months. Multivariate Cox regression analysis demonstrated that the patients with atypical optic neuropathy (presence of one of these clinical findings: bilateral eye involvement, visual acuity ≤ 0.1 at admission, worsening or non-substantial recovery of visual acuity during hospitalization) had lower risk of having the initial diagnosis changed (HR = 0.320, 95% CI = 0.138-0.743, p = 0.008). Conclusion: Our study illustrates that some patients admitted with optic neuropathy may have their diagnosis redefined during follow-up. Furthermore, it demonstrates that patients with atypical ON are those in which the diagnosis is more likely to remain during follow-up.

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Totosy, de Zepetnek Julia O. "Clinical assessment of body composition after spinal cord injury. An observational study." Thesis, 2009. http://hdl.handle.net/10012/4851.

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Background: Persons who sustain a spinal cord injury (SCI) experience a dramatic loss of muscle and bone, and a dramatic increase in adipose tissue. It has been suggested that the muscle atrophy, obesity, and sublesional osteoporosis (SLOP) that occurs after SCI is due in part to the loss of voluntary control of the skeletal muscles in the lower extremities, impaired energy metabolism below the level of the lesion, and cessation of sufficient mechanical strain on bone. The prevalence of obesity and SLOP after SCI leads to increased cardiovascular disease and fracture risk, respectively. Current body composition screening procedures for the general population fail to identify individuals with SCI who are obese or have SLOP. Muscle contractions provide physiological loads on bone; thereby a muscle-bone relationship is proposed with proportional declines in muscle and bone after SCI. In addition, both positive and negative relationships have been proposed between adipose tissue and bone; increased skeletal load bearing from excess adipose tissue mass may account for the positive associations reported to date. Due to a lack of load bearing activity after SCI, there should be a negative association between adipose tissue and bone. Objectives: The primary objective is to characterize body composition among adults with chronic SCI using valid, reliable, and interpretable measures, and to suggest screening procedures for the detection of obesity and SLOP in this population. The secondary objectives are to explore the associations between: 1) muscle and bone, and 2) adipose tissue and bone. Design and Setting: Cross sectional observational. Population: A sample of 16 individuals (13 men, 3 women) with chronic SCI participated in this study. The neurological level of lesion ranged from C3-T12, with 9 motor complete and 7 incomplete SCI. Average±standard deviation for age was 51.12±12.37 years, and duration of injury 16.5±7.87 years. An additional 29 individuals with chronic SCI were included when exploring the relationship between muscle and bone. Forty-one individuals (31 men, 9 women) were included in this analysis; the neurological level of lesion ranged from C2-T12, with 13 motor complete and 28 incomplete SCI. Average±standard deviation for age was 48.7±13.36 years, and duration of injury 114.22±10.4 years. Methods: Lean tissue, adipose tissue, and bone tissue were measured via surrogates of body adiposity, as well as two different scanning technologies. Lean tissue was assessed via muscle cross sectional area (CSA) (mm2) and muscle density (mg/cm3), and measured using peripheral quantitative computed tomography (pQCT). Adipose tissue was assessed via body mass index (BMI) (kg/m2), waist circumference (WC) (cm), and % body fat, and measured using a floor scale, tape measure, and dual energy x-ray absorptiometry (DXA), respectively. Bone tissue was assessed via hip, distal femur, and proximal tibia areal bone mineral density (aBMD) (g/cm2) using DXA, as well as cortical thickness (mm) and total volumetric bone mineral density (vBMD) (mg/cm3) at the 1/3 proximal tibia, and trabecular vBMD (mg/cm3) and total vBMD (mg/cm3) at the distal tibia using pQCT. The relationships between muscle and bone, and adipose tissue and bone, were determined by correlating muscle CSA with indices of bone strength, and indices of obesity with indices of SLOP, respectively. Results: The majority of participants had lean tissue values below able-bodied norms (67-100%). When using the able-bodied definition of BMI >30 kg/m2, 19% of individuals were obese, whereas 63% and 81% were obese when using SCI-specific definitions of BMI >25 kg/m2 or >22 kg/m2, respectively. One hundred percent of individuals had SLOP using distal femur Z-score, and over 50% were at risk of fracture using distal femur fracture threshold of <0.78 g/cm2. Weak (r=0.42) to moderate (r=0.57) correlations were found between muscle CSA and indices of bone strength, supporting the theory of a muscle-bone unit. No correlations were found between adipose tissue and bone. Conclusions: Based on the cohort data, we propose that individuals with ≥2 risk factors (female, ≥60 years of age, duration of injury (DOI) ≥10, tetraplegia, motor complete) should be screened for obesity using % body fat from DXA as well as a combination of carefully interpreted SCI-specific BMI and WC. In addition, these same individuals should be screened for SLOP using a distal femur Z-score and fracture threshold from DXA. It is clear that due to the prevalence of obesity and SLOP in this population, intervention for prevention or treatment is essential. The presence of a muscle-bone unit indicates that muscle atrophy contributes to a reduction in bone strength; this is clinically important, as muscle strength is potentially amenable to rehabilitation intervention. No correlation was found between adipose tissue and bone. Future work should continue to explore these relationships using appropriate technology.

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Ehlers, Natalia Lydia Maria. "A prospective, observational study of cryptococcal infection and clinical and ophthalmologic outcomes." Thesis, 2006. https://hdl.handle.net/10539/26644.

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A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfilment of the requirements for the degree of Master of Medicine in Ophthalmology. Johannesburg,2006.
Cryptococcosis is a serious fungal infection. Neurological, pulmonary and cutaneous complications are more commonly found in the immunocompetent host. Long-term ocular sequelae have not been well investigated.
IT2019

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Carvalho, Inês Almeida Andrade Medeiros de. "Epidemiology of Central Nervous System Infections in Newborn: an Observational Study." Master's thesis, 2019. https://hdl.handle.net/10216/119820.

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Carvalho, Inês Almeida Andrade Medeiros de. "Epidemiology of Central Nervous System Infections in Newborn: an Observational Study." Dissertação, 2019. https://hdl.handle.net/10216/119820.

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Rocha, Leonor Figo Araújo Coelho da. "Quality of Life in Adolescent Idiopathic Scoliosis after Surgery: an Observational Study." Master's thesis, 2022. https://hdl.handle.net/10216/140411.

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Objetivo: Este estudo tem como objetivo avaliar a qualidade de vida após a cirurgia de doentes com Escoliose Idiopática do Adolescente (EIA), quando comparados com indivíduos saudáveis, e determinar a relação entre os resultados radiológicos e de qualidade de vida. Métodos: Neste estudo transversal, foram incluídos doentes EIA tratados cirurgicamente entre 2014 e 2019, bem como controlos de idades correspondentes. A qualidade de vida foi avaliada usando os questionários SF36 e SRS24 em ambos os grupos. A evolução radiológica do grupo de EIA foi avaliada através da medição dos ângulos de Cobb pré e pós-operatórios. Resultados: Foram recrutados 43 doentes com EIA e 50 controlos correspondentes. Com exceção dos critérios de saúde geral e alteração da saúde no SF36 e a auto-imagem geral e função por condição das costas no SRS24, todos os outros parâmetros de qualidade de vida foram significativamente mais altos no grupo controlo. Apenas a auto-imagem pós-cirúrgica no SRS24 teve uma correlação significativa com a redução do ângulo de Cobb. Conclusão: Os doentes com EIA, mesmo 5 anos após a cirurgia, apresentam uma qualidade de vida globalmente inferior, quando comparados com indivíduos saudáveis. Adicionalmente, os parâmetros de qualidade de vida correlacionam-se de forma limitada com a correção do ângulo de Cobb. Isto enfatiza a necessidade de ferramentas apropriadas para avaliar o sucesso do procedimento, ao invés de depender apenas dos resultados radiológicos.
Purpose: This study aims to evaluate the post-surgery quality of life of patients with Adolescent Idiopathic Scoliosis (AIS), when compared to healthy control individuals, and to assess the relationship between their radiological outcomes and self-reported quality of life. Methods: In this cross-sectional study, surgically-treated AIS patients between 2014 and 2019 were enrolled, along with age matching controls. Quality of life (QoL) data was gathered using SF36 and SRS24 questionnaires in both groups. Pre and postoperative Cobb angles were measured to assess AIS patients' radiological evolution. Results: Forty-three AIS patients and fifty age-matched controls were enrolled. Except for SF36 general health and health change and SRS24 general self-image and functioning from back condition, all other QoL parameters were significantly higher in the control group. Apart from SRS24 postoperative self-image, no other parameter had a significant correlation with Cobb angle reduction. Conclusion: AIS patients, even about 5 years after surgery, reported an overall worst QoL, when compared to matched healthy individuals, but this reported QoL correlated poorly with correction of Cobb angle. This highlights the need for appropriate tools to assess the success of this procedure, rather than to rely solely on the radiological outcomes.

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Picelli, Alessandro. "Relationship between ultrasonographic, electromyographic and clinical parameters in adult stroke patients with spatic equinus: an observational study." Doctoral thesis, 2014. http://hdl.handle.net/11573/918204.

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CONTI, NIBALI ROBERTO. "Relevance and costs of constipation as the only cause of functional gastrointestinal disorders in childhood: prospective observational study in clinical practice." Doctoral thesis, 2018. http://hdl.handle.net/11570/3146705.

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BACKGROUND: Functional gastrointestinal disorders (FGIDs) are common in children of all ages and have a considerable impact on the patient’s quality of life, on the families and on the health care system costs. Recent data indicate that both overt and occult constipation may have a causative role in most cases. OBJECTIVE: The main objective is to establish the prevalence of both overt and occult constipation as the only cause of most FGIDs. DESIGN: Observational prospective study. All patients with overt or occult constipation were treated with polyethylene glycol (PEG ) at disimpaction dose followed by maintenance dose and then reassessed at two months follow-up. SETTING: Tertiary pediatric gastroenterology outpatient clinic. PARTICIPANTS: All consecutive patients referred to the outpatient clinic between January and July 2018, aged 4-18 years, with FGIDs according to Rome IV criteria. Patients with gastrointestinal alarm features were excluded. Of 272 patients accessing the clinic, 209 were excluded because of not fulfilling the eligibility criteria, 63 consecutive patients were enrolled in the study, none refused to participate, 45 completed the follow-up up to now. EXPOSURE: Patients were treated with PEG 1.5 gr/Kg/day for 3 days, then with half dose for 2 months. MAIN OUTCOMES AND MEASURES: The hypothesis being tested was formulated before the data collection. The main endpoint was defined as a decrease of more than an half in frequency and severity of FGIDs, by using pain severity and pain frequency scores. RESULTS: Prevalence of functional constipation (FC) according to Rome IV was 63.5%, PEG treatment prescribed to all patients suffering for at least one FGID was successful in 42 patients (93%). The difference between the prevalence of FC according to Rome IV criteria and the prevalence of constipation as the only cause of FGIDs was highly significant (p<0.001). CONCLUSION AND RELEVANCE: Results support the hypothesis that overt or occult constipation is the main significant cause of most FGIDs. For the first time, results highlight the relationship between constipation and irritable bowel syndrome (IBS) with diarrhea and IBS mixed type. These findings may result in an improved management of children with FGIDs and in a substantial decrease of health care costs.

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Fox, Rebecca. "An observational study of demographic, clinical and angiographic characteristics of patients post myocardial infarction at Vancouver Hospital and at Seattle area hospitals." Thesis, 1997. http://hdl.handle.net/2429/7606.

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Both the American and the Canadian health care systems are faced with the challenge of determining the most cost-effective care. As such, research results which demonstrate evidence of long term outcomes will effect health policy especially related to widespread and/or costly events and procedures such as myocardial infarction (MI) and revascularization. In addition, patients with chronic disease pose very difficult economic and ethical decisions within global budgets over choices of treatments for the sickest patients as opposed to those who might derive greater long term benefit. Previous comparisons between the U.S. and Canada have shown that demographic and clinical characteristics of MI patients are similar. Although rates of catheterization and revascularization are reported, the characteristics of those selected for these procedures have not been widely examined. Conclusions have been drawn on the relationship between the level of care and resulting poorer functional outcomes of Canadians versus Americans based on these rates of procedures. A comparison between Vancouver and Seattle MI database patients who undergo cardiac catheterization provided an opportunity to determine whether regionalization of technology and capping of expenditures has prompted Canadian clinicians to select a different group of patients for these procedures as compared to those selected in Seattle. Method Demographic, clinical and hospital stay data was extracted from the Seattle and Vancouver databases and merged with procedural data for all patients who had angiography within 90 days of MI at University of Washington (including those from Group Health Central and Northwest Hospitals) and Vancouver Hospital during the period 1988-1994. A total of 545 Seattle and 293 Vancouver patients comprised the sample. Descriptive statistics, 95% confidence intervals and p values were obtained to detect differences in patient charactersitics, complications, treatment and angiographic variables. A comparison of prognostic factors for severity of coronary artery disease between the University of Washington and Vancouver Hospital patients was done using a logistic regression model. Results Seattle and Vancouver post-MI patients who had angiography were demonstrated to have important similar characteristics (such as age, sex, severity of MI, bypass procedures and total MI treatment). Seattle patients were more commonly treated with direct and rescue angioplasty procedures as compared to thrombolytic therapy at Vancouver Hospital. The mean length of hospital stay and days to procedures were significantly shorter for Seattle patients as compared to those in Vancouver. In addition, V H patients had procedures more commonly on readmission as compared to Seattle patients whose procedures were performed during initial hospitalization. The primary comparison between University of Washington and Vancouver Hospitals demonstrated that clinicians selected similar patients for procedures. Furthermore, following angiography, Vancouver patients had more angioplasty and equivalent bypass surgery performed as compared to Seattle. Both groups of patients demonstrated indications for angiography and significant coronary artery disease. Regionalization of catheterization facilities and funding from global budgets have contributed to a longer waiting time for procedures in Canada and, in some cases, a restricted number of procedures performed.

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Goode, Susan May. "The effects of a primary care clinic closure on patients: a prospective observational study." Thesis, 2015. http://hdl.handle.net/1959.13/1305747.

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Masters Research - Masters of Philosophy (MPhil)
Objective: To examine the effect of a primary care clinic closure on patients’ access to health care and on patient physical and mental health. Methods: A prospective cohort study. Within one month of the closure of a primary care clinic in the Central Coast region, NSW, Australia, all clinic patients aged 16 years or older were invited to participate in the study via completion of baseline and 6-month follow-up surveys which included items on demographics, medical history, access to health services, physical and mental health and perceived effects of the clinic closure. Univariate analyses were conducted via paired t-tests for continuous variables and chi squared tests for categorical variables. Multivariate analysis was conducted using multiple logistic and linear regression models. Results: The baseline survey was completed by 214 participants, with 150 participants completing the follow-up survey. The majority of participants (79%) had found a new regular GP within 6 months of the clinic closure. On multivariate analysis, having not found a new regular GP was associated with reporting reduced use of primary care services and problems with access to primary care services in the six months following the closure. Participants without a regular GP reported the clinic closure having greater negative impact on their access to health services and their physical and emotional health. Discussion: Patients without a usual source of care have reduced access to health services with associated delays in seeking health care, which could potentially have serious consequences. Patients who remain unattached to a PCP have lower self-rated general health and perceive that the clinic closure had a greater impact on their physical and emotional health. Conclusion: The clinic closure had significant impacts on a sub-set of patients who were not able to locate a new regular GP in the following six months. Implications: There is scope for a systems approach to facilitate patient transition between primary care practices.

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"Clinical observation and experimental study of the efficacy of a Chinese medicine formula on maligant tumour bone metastasis diseases." Thesis, 2006. http://library.cuhk.edu.hk/record=b6074268.

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At present, there is no cure for bone metastasis. The current goals in patient care are to palliate pain, prevent pathological bone fracture and increase the strength and function of bone, so as to extend the life expectancy and maintain a good quality of life. Bisphosphonate treatment is the currently standard therapy of bone metastasis and is commonly used by physicians; it alleviates the tumour-induced hypercalcemia in 90% of patients and reduces the metastatic bone pain in 50% of patients. Moreover, it also prevents the pathological fracture of the affected bones. However, while effective, bisphosphonate injections are very costly, though its oral formulation is less expensive it is also less efficacious, and causes gastrointestinal discomfort. Furthermore, prolonged use of bisphosphonate treatment may lead to certain adverse effects, including hypocalcemia. These factors will prohibit the longterm use of such medication as it can negatively affect the treatment outcome.
Based on enormous medical potentials illustrated by the aforementioned findings, BBYNG deserves wider clinical application, large-scale clinical study on its preventive effect against bone metastasis and detailed investigation of its mode(s) of action in the body.
Based on the above-described understanding of Chinese medicine and bone metastasis, supplementing the kidney and strengthening bone could be the basic principle for the treatment of bone metastasis using Chinese medicine. In view of this theory, and in addition to the clinical observation and a thorough search of the available literature, we selected relevant kidney-tonifying Chinese herbs, namely (Fructus Ligustri Lucidi), (Rhizoma Drynariae), (Herba Epimedii), (Psoralea Corylifolia) and wide-spectrum anticancer herbs (Herba Hedyotidis Diffusae) for the preparation of a combined formula--BBYNG.
Chinese medicine has long been used to treat cancers. Its advantages reside in its holistic properties, which bring palliative, corrective and convalescing functions against damage caused by radiotherapy, chemotherapy and surgery. These features position Chinese medicines as the adjuvant to orthodox cancer treatment. During the late stage of tumour development, when standard therapy is no longer effective, Chinese medicine plays a critical role as an integrated therapy. Searching for a safe, inexpensive and effective Chinese medicine preparation suitable for prolonged use as adjunct therapy in late cancer cases is of paramount importance.
Clinical results. Both Chinese medicine and Western medicine treated patients showed no significant change in their blood parameters or liver and kidney examinations before and after drug administration; Male subjects on BBYNG, their bone mass density remained stable after 6 months treatment and the subjects on OSTAC showed slightly decreased In females, subjects on BBYNG remained stable, but subjects on OSTAC slightly increased.
Clinical study. The study was designed as a randomized, parallel-group comparison between BBYNG formula and Bisphosphonate. The patients who meet the inclusion/exclusion criteria were randomly assigned to receive either BBYNG granules, which was prepared by a GMP manufacturer, or Clodronic acid. The treatment period was 6 months (24 weeks). For both groups, various clinical parameters such as body functions, blood examinations, bone density (BMD) assessment, X-ray examinations, pain intensity and quality of life were evaluated and compared.
Conclusions. (1) As an adjuvant to patients with bone metastases, BBYNG is effective in relieving the metastatic bone pain, improving the quality of life. (2) In the animal model, BBYNG reduced the metastatic bone damage, prolonged the survival and enhanced the T lymphocyte immunity in the tumour-bearing mice. (3) In vitro study on the breast and lung cancer cell lines showed that BYYNG could induce apoptosis and prevent tumour cell invasion. It suggests that BYYNG may restrict tumour growth and development, thus reducing the occurrence of bone metastasis.
In accordance with Chinese medicine, bone metastasis can be categorized into "bone tumour" "bone erosion" "bone wilting" "bone necrosis" and "bone impediment". The main cause of bone metastasis is twofold: cancer toxicity, and in Chinese medicine theory, the kidney governs the bone marrow, if the kidney is not functioning in balance, then the bone will become weak. Cancer toxicity is the "pathogenic cause" to skeletal metastases, while kidney weakness decreases the body defence against the cancer. A vicious cycle ensues when cancer and kidney deficiency and bone weakness occurs simultaneously coincidently and worsens the conditions.
In vitro study on tumour cell lines. The anticancer effects of different concentrations of BBYNG formula and various single components against human breast cancer and lung cancer cell lines were evaluated by cell viability test (MTT assay), cell apoptosis test and invasion suppression test.
In vitro study results. BBYNG and the aqueous extracts of its component herbs at very low drug concentrations stimulated the growth of three tumour cell lines tested. When the concentrations were slightly increased, they showed an inhibitory effect on cancer cell proliferation. As the drug concentrations further increased, the extracts showed cytotoxic effects on these tumor cells. At the noncytotoxic dose, the extracts could trigger apoptosis and enhance the caspase-3 activity in all three tumour cell lines. In addition, at this "non toxic" concentration, the extracts markedly inhibited the in vitro invasive property of the 4T1 breast cancer cell lines in our Matrigel invasion model. Thus these in vitro results suggested that BBYNG possess anticancer, invasion-inhibitory and anti-metastatic activities.
In vivo animal study results. (Tumour growth was slower in the BBYNG treatment group when compared to the OSTAC and control groups, but this was not significantly difference) BBYNG significantly delayed tumour growth in tumour bearing mice, but it did not minimize the tumour size markedly. Moreover, BBNYG did minimize the mobility restriction caused by tumours, reduce the damage to bones, prolong the survival time and enhanced the T lymphocyte immunity.
In vivo animal study. A well-established animal model for breast cancer was used to evaluate and compare the pharmacological effects of BBYNG formula and Clodronic acid, as shown by different indicators such as tumour progression, animal's mobility, survival time, bone metastasis-induced fracture intensity and the immunological status of the tumour-bearing mice.
Malignant tumour is characterized by early metastasis. Among them 37 to 80 (depending on which type of cancer) patients show tendency of bone metastasis. Bone metastasis is usually accompanied by various complications, such as severe pain, pathological bone fracture, hypercalcemia, and bone marrow suppression, which can substantially affect the quality of life of the patients. Thus, the prevention and treatment of bone metastasis in cancer is an issue worth pursuing.
Malignant tumours leading to high mortality and morbidity are a serious threat to human health. It is the leading cause of death in China. In Hong Kong, there are over 20 thousand new cancer cases and more than 1100 people die due to cancers every year.
Study objectives. To elucidate the efficacy and some pharmacological aspects of BBYNG in regard to the treatment of bone metastasis through clinical observation and different laboratory experiments. This study would be of significant reference value to the disease-oriented drug formulation and application, mechanistic study and research methodology of the treatment of bone metastasis using Chinese medicines.
The clinical and laboratory experimental results are summarized as below:
The research study is composed of three parts, the clinical study, in vivo animal study and in vitro study on tumour cell lines. The research methods used are as follows:
Those on BBYNG treatment showed more a stable and satisfactory quality of life than those in the Western medicine-treated group. For the Clodronic acid treatment group, patients generally showed worsened symptoms and quality of life deteriorated. The ECOG index of the BBYNG group was statistically better than that of the Clodronic acid group. Within the 72-week clinical observational period, the mortality of Clodronic acid group is significantly higher that of the BBYNG group. The effects of BBYNG group as presented in relieving the pain-induced influence on patients' emotion, interpersonal relationship and entertainment was more pronounced than that in the Clodronic acid group.
Wu Ka.
論文(哲學博士)--香港中文大學, 2006.
參考文獻(p. 299-324).
Adviser: Leung Ping Chung.
Source: Dissertation Abstracts International, Volume: 68-03, Section: B, page: 1570.
Electronic reproduction. Hong Kong : Chinese University of Hong Kong, [2012] System requirements: Adobe Acrobat Reader. Available via World Wide Web.
Electronic reproduction. [Ann Arbor, MI] : ProQuest Information and Learning, [200-] System requirements: Adobe Acrobat Reader. Available via World Wide Web.
Abstracts in Chinese and English.
School code: 1307.
Lun wen (zhe xue bo shi)--Xianggang Zhong wen da xue, 2006.
Can kao wen xian (p. 299-324).
Wu Ka.

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47

Mabaso, Suzan Saleleni. "Evaluation of a decentralised primary health care training programme." Diss., 2006. http://hdl.handle.net/10500/2435.

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A quantitative, descriptive, explorative design was used to evaluate a decentralised primary health care training programme at a training unit in the Limpopo Province. The study sought to determine to what extent the newly qualified diplomates were able to manage patients appropriately when faced with the realities, such as the shortage of personnel, large numbers of patients, shortage of resources and time constraints in the real situation without the support and guidance from medical practitioners and senior nursing personnel. Data were collected by observing the diplomates as they managed patients with hypertension by making use of checklists. The diplomates were also interviewed by making use of an in interview schedule. The major inferences drawn from this study was that these diplomates were competent in the management of these patients and were satisfied with their abilities and training.
Health Studies
M. A. (Health Studies)

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48

Mulaudzi, Mulatedzi Precious. "Experiences of professional nurses working in the Maximum Security Ward - A Case study of Hayani Hospital, Vhembe District." Diss., 2019. http://hdl.handle.net/11602/1308.

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MCur
Departrment of Advanced Nursing Science
In mental health, a Maximum-Security Ward is a special setting for care of patients who are unique and exceptional. People who have committed crimes due to their mental conditions are admitted for care, treatment and rehabilitation. Patients admitted in this ward are verbally and physically aggressive, violent, unpredictable, unmanageable and at times manipulative. Professional nurses working in the Maximum-Security Ward are at risk of suffering from occupational stress, burnout, lack motivation and are anxious. The aim of this study is to investigate the experiences of professional nurses working in the Maximum-Security Ward at Hayani hospital. A qualitative approach using a descriptive, exploratory and contextual design was used. A purposive, convenient sampling was used to sample professional nurses working in the Maximum-Security Ward of Hayani hospital. In-depth interviews were used to collect data. A voice recorder was utilised to record all data and the researcher being the main instrument for data collection. Dependability, confirmability and transferability were upheld to ensure trustworthiness of the findings. Data was analysed using Tech’s eight steps approach. Three themes with their categories and subcategories emerged after data analysis. The themes were as follows: the participants’ views on type of patients admitted in the ward, participants’ views on safety in the ward and participants’ views on staff interaction. The study recommended the following: Emotional counselling and debriefing sessions to be conducted at regular intervals or after a traumatic incident. Motivational and team building activities to be organised for professional nurses. Safety of professional nurses must be of significant value. More support is needed in times of emotional difficulties. Development of a model to support professional nurses.
NRF

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