The Swedish pharmaceutical industry is going through structural changes due to the increased cost of drug development. This has led pharmaceutical firms to outsource clinical trials to Clinical Research Organisations (CRO). This thesis explores the inter-firm relationships between pharmaceutical firms and CROs in the Stockholm area, with focus on the development of trust and commitment. The empirical material gathered from nine qualitative interviews with representatives from both parties suggests that trust and commitment are both important factors. Trust is based on competence and reputation whilst commitment is developed through communication. Commitment is highly valued by the companies that wished to develop long-term relationships. The results also point to challenges in the area mainly regarding patient recruitment that due to the high competition amongst the CROs can lead to opportunism when they are overly optimistic of what they can deliver. This is an issue that needs to be addressed as it affects the whole industry.

Under-utilization, premature termination, and lack of between-session engagement have been discussed in the couple therapy literature in terms of how they negatively impact the course and outcome of couple therapy. The goal of the present research was to investigate the discourses that people use when (1) constructing meaning about the act of engaging in couple therapy; (2) constructing what constitutes a positive couple therapy experience; and (3) constructing the influence of couple therapy on daily living. Discourse analysis, with a particular focus on interpretative repertoires (Potter & Wetherell, 1987), was used as the methodology for the three studies reported here. The data included eight semi-structured interviews with individuals who had participated in couple therapy and postings from three different online discussion forums. In study one, two interpretative repertoires -- the “relationship breakdown” repertoire and the “commitment” repertoire -- were constructed from the interview data. The premise of these repertoires is that couples seek couple therapy when they believe their relationship is broken and when they are committed to remaining in the relationship and resolving the problems. I argue that these interpretative repertoires can help us understand the decision or reluctance to enter couple therapy. In study two, one interpretative repertoire -- “the shoe must fit” repertoire -- was constructed from the interview and online data. This repertoire suggests that a particular “fit” between the couple and their therapist needs to be present in order for the couple to have a positive therapy experience. I argue that this interpretative repertoire facilitates understanding the decision to remain in or drop out of couple therapy. In study three, the interpretative repertoire “therapy life is not real life” was constructed from the interview data. According to this repertoire, couple therapy runs alongside daily life, but rarely influences it significantly. In this study, I argue that the “therapy life is not real life” repertoire helps us to better understand between-session engagement in couple therapy. Conclusions and implications for therapists and researchers are discussed.

No description available.

Background: Insufficient physical activity is a public health problem. Nordic healthcare professionals use physical activity on prescription (PaP) to increase physical activity. Purpose: This study aimed to evaluate the effectiveness of PaP that includes organized exercise. Method: Prospective data was obtained from four Swedish counties during fall 2009 and spring 2010. The study population comprised 98 patients whose healthcare professional prescribed PaP to prevent or treat disease. Questionnaires administered at baseline, three and six months after initiating PaP evaluated self-reported physical activity levels, adherence, factors influencing adherence, and experience of PaP. Results: Although the majority of patients receiving PaP including organized exercise are middle-age women, there are a wide distribution regarding e.g., age, socioeconomic status and reason of receiving PaP. Most participants received initial support from healthcare providers and activity organizers, and most were satisfied with the support they got. Approximately 70% participated in several activities at all measuring points. Although PaP including organized exercise increased activity levels only marginally, sedentary behavior decreased significantly. Six months after initiating PaP including organized exercise, 68% adhered to the prescribed physical activity level. Most participants deemed PaP including organized exercise a good method for becoming physically active. However, there is a need for regularly and longer support. Importantly, individualized instruction, adjusted exercise regimens, and support from other participants provide positive reinforcement. On the other hand, PaP with organized exercise imposes additional costs and decreases flexibility including both time commitment and scheduling constraints. Conclusion: Adherence levels to PaP with organized exercise are similar to those achieved by other chronic disease treatments. PaP including organized exercise can decrease sedentary behavior, an important factor in promoting public health in the Nordic countries. / <p>ISBN 978-91-86739-16-4</p>

Clinical research is conducted to advance human medicine by developing efficacious treatments and improving patient outcomes when new therapies are developed and implemented. Clinical trials are a subset of the types of clinical research conducted on human volunteers in the development of new drugs, devices and other therapies. Prior to the start of a trial, a country’s regulatory authority must review the trial to ensure it is scientifically and ethically sound. In Canada, the regulatory authority is Health Canada. The International Conference on Harmonization (ICH) of technical requirements for the registration of pharmaceutics for humans aims to provide ethical and scientific quality standards for design, conduct, data collection and reporting in clinical trials. The Good Clinical Practice (GCP) Guidelines were created by the ICH Steering Committee to assure the public that rights, safety and well being of subjects are protected according to the Declaration of Helsinki, and the clinical data obtained in a ICH/GCP compliant clinical trial will meet regulatory requirements. Health Canada has adopted the ICH/GCP Guidelines and therefore, in Canada, all clinical trials involving humans must comply with these Guidelines. The clinical trial coordinator is an important and central position on the research team executing many trial duties and communications. Regulatory authorities, Research Ethics Boards and the sponsor, overlook the role and responsibilities of a highly trained clinical coordinator, despite their vital and central position. The GCP Guidelines also fail to address the role and responsibilities of a clinical coordinator. Disconnect between guidelines, regulatory expectations and actual trial conduct provides an apparent need to formalize and clearly define the role and scope of a clinical coordinator. The Registered Nurse (RN) brings professionalism, knowledge, skill and a holistic perspective to the expanded role of a clinical coordinator and to the clinical trial. Highly trained health professionals are capable of assuming more responsibilities and executing clinical trial design, setup and management as compared to the traditional administrative roles of the clinical coordinator. The expanded role of the clinical coordinator is especially beneficial for Principal Investigator initiated trials due to limited research personnel and resources. Postoperative adhesions are a common complication following pelvic surgery, therefore, this clinical trial is relevant and a response to a healthcare need. My graduate studies focused on the development and set up of the clinical trial Protocol ADE002-2013 Phase I Trial of L-Alanyl-L-Glutamine for the Reduction of Peritoneal Adhesions in Adult Females Undergoing Myomectomy. My thesis is a discussion of general Canadian clinical trial research information followed by an explanation of how we executed the information to design and set up our PI initiated clinical trial. The value of the expanded role of the clinical coordinator as a member of the research team will also be discussed.

A pesquisa clínica patrocinada no Brasil vem crescendo cada vez mais e gerando conhecimento científico em diversas áreas da saúde. O desenvolvimento desses ensaios clínicos envolve aspectos que vão além da geração de fármacos e produtos mais avançados. O grande alicerce da pesquisa clínica está também nos pacientes que aceitam participar de um estudo científico. Estes precisam passar por um processo de consentimento que envolve ter conhecimento sobre todos os aspectos que envolvem a sua participação no ensaio clínico. Dentro desse contexto, surge um grande desafio na área que é como realizar o processo de consentimento de maneira adequada. É preciso levar em consideração aspectos como compreensão, motivações, influências, coerção, benefícios, riscos, entre outros aspectos. O objetivo deste trabalho foi identificar quais os fatores vivenciados pelos participantes de pesquisa clínica durante o processo de consentimento. Foram aplicados questionários a respeito da sua percepção no que envolve a participação na pesquisa clínica. Com os dados gerados foi possível desenvolver um conjunto de recomendações visando o aprimoramento do processo de consentimento em projetos de pesquisa clínica. / Clinical research sponsored in Brazil has been increasing and generating scientific knowledge in several areas of health. The development of these clinical trials involves aspects that go beyond the generation of drugs and more advanced products. The key of clinical research is also in patients who accept to participate in a scientific study. These need to undergo a consent process that involves having knowledge about all aspects that involve their participation in the clinical trial. Within this context, a great challenge arises in the area that is how to carry out the consent process in an appropriate way. It is necessary to take into account aspects such as understanding, motivations, influences, coercion, benefits, risks, among other aspects. The objective of this study was to identify the factors experienced by clinical research participants during the consent process. Questionnaires were applied regarding their perception regarding the participation in clinical research. With the data generated, it was possible to develop a set of recommendations aimed at improving the consent process in clinical research projects.

Introdução: O Hospital das Clínicas da Universidade Federal de Pernambuco (HCPE) faz parte da rede de hospitais universitários que são gerenciados pela Empresa Brasileira de Serviços Hospitalares (EBSERH). Em 2014, a EBSERH lançou o Programa de Pesquisas Clínicas Estratégicas para o Sistema Único de Saúde visando a implementação de um modelo de gestão de pesquisas clínicas na rede e, em 2016, o HCUFPE obteve financiamento para implantar um Centro de Pesquisa Clínica na instituição. Objetivo: Desenvolver o planejamento estratégico para a implantação do Centro de Pesquisa Clínica do HCUFPE através do método do Balanced Scorecard. Método: Estudo observacional e descritivo com mapeamento de dados sobre as pesquisas da instituição. Foi desenvolvido o instrumento de coleta de dados no REDCap© com questões fechadas relativas ao perfil do grupo de pesquisa e questões abertas, para composição da matriz SWOT. A aplicação do instrumento foi realizada através de entrevistas com os líderes de grupos de pesquisa. Foi realizada a análise de conteúdo de Bardin através do software Nvivo© e a partir desta, foi elaborado o planejamento estratégico através do método do Balanced Scorecard (BSC). Resultados: Foram identificados90 grupos de pesquisa, a partir da consulta aos registros no setor de pesquisa do hospital. No período de 2015 a 2017, foram registrados 381 projetos de pesquisa, dos quais 91% vinculados às atividades de ensino do hospital e da universidade. Foram entrevistados 29 líderes de pesquisa que pontuaram como pontos fortes para a realização de projetos de pesquisa no hospital o fato de já existirem grupos de pesquisa bem estruturados e a possiblidade de geração de conhecimento e como oportunidades, os avanços na prática clínica. As principais dificuldades citadas foram a inexistência de área física própria e a obtenção e gerenciamento de recursos financeiros para a pesquisa. Conclusão: A partir do mapeamento situacional da pesquisa no HC-UFPE, e da determinação das necessidades dos pesquisadores foi possível traçar iniciativas estratégicas com o objetivo de implementar o Centro de Pesquisa Clínica. O gerenciamento das atividades de pesquisa parece ser essencial para que as metas estabelecidas sejam alcançadas em curto espaço de tempo. / Introduction: The clinical hospital of the federal university of Pernambuco (HC-UFPE) is part of the network of university hospitals that are managed by the brazilian company of hospital services (EBSERH). In 2014, EBSERH launched the strategic clinical research program for the unified health system to implement a clinical research management model in the network and in 2016, the HC-UFPE obtained funding to establish a clinical research center in the institution. Objective: to develop the strategic planning for the implementation of the HCUFPEClinical Research Center through the balanced scorecard method. Method: observational and descriptive study with mapping of data about the institution's research. Conducted interviews with leaders of hospital research groups who were recorded and transcribed to perform SWOT analysis and Bardin content analysis. Results: a total of 90 research groups were identified, from the consultation to the records in the hospital's research sector. Registered 381 research projects in the hospital, from 2015 to 2017, of which, 159 residences, 132 graduate, 40 graduation, 35 clinical trials, 12 pbic, and 3 others. We applied questionnaires to 29 research leaders on the scientific production and infrastructure demand of the research center. the strengths of the institution are: the existence of well-structured research groups, the possibility of generating knowledge, producing improvements in clinical practice and give visibility to the hospital. The main difficulties cited were the acquisition and management of financial and human resources for research, the inexistence of its own physical area and material for research in the institution. Conclusion: Established strategic initiatives: create a course of good clinical practices, offer advice on the Plataforma Brasil to researchers, elaborate internal regulations for the research, reduce time of submission in the CEP and debureaucracy. The use of the BSC method was adequate as a strategy to manage university hospital research.

The intellectual impulsiveness of man to understand the unknown and the continual need of the society to improve healthcare have encouraged extensive investigation on numerous and diverse cause-and-effect relationships. The nature of this endeavor, however, renders the inability of investigator at all levels to escape beyond the narrow conceptual boundary described by an early French philosopher as the vicious cycle. To enjoy the theoretically plausible benefits of refined labor division, data-driven healthcare management, and real-time evidence-based practices, it must first be acknowledged that co-occurrence is better than cause-and-effect in explaining how an observation takes place at a particular time. This paper details a co-occurrence framework, and discusses its implications for the global healthcare system.

A pesquisa clínica patrocinada no Brasil vem crescendo cada vez mais e gerando conhecimento científico em diversas áreas da saúde. O desenvolvimento desses ensaios clínicos envolve aspectos que vão além da geração de fármacos e produtos mais avançados. O grande alicerce da pesquisa clínica está também nos pacientes que aceitam participar de um estudo científico. Estes precisam passar por um processo de consentimento que envolve ter conhecimento sobre todos os aspectos que envolvem a sua participação no ensaio clínico. Dentro desse contexto, surge um grande desafio na área que é como realizar o processo de consentimento de maneira adequada. É preciso levar em consideração aspectos como compreensão, motivações, influências, coerção, benefícios, riscos, entre outros aspectos. O objetivo deste trabalho foi identificar quais os fatores vivenciados pelos participantes de pesquisa clínica durante o processo de consentimento. Foram aplicados questionários a respeito da sua percepção no que envolve a participação na pesquisa clínica. Com os dados gerados foi possível desenvolver um conjunto de recomendações visando o aprimoramento do processo de consentimento em projetos de pesquisa clínica. / Clinical research sponsored in Brazil has been increasing and generating scientific knowledge in several areas of health. The development of these clinical trials involves aspects that go beyond the generation of drugs and more advanced products. The key of clinical research is also in patients who accept to participate in a scientific study. These need to undergo a consent process that involves having knowledge about all aspects that involve their participation in the clinical trial. Within this context, a great challenge arises in the area that is how to carry out the consent process in an appropriate way. It is necessary to take into account aspects such as understanding, motivations, influences, coercion, benefits, risks, among other aspects. The objective of this study was to identify the factors experienced by clinical research participants during the consent process. Questionnaires were applied regarding their perception regarding the participation in clinical research. With the data generated, it was possible to develop a set of recommendations aimed at improving the consent process in clinical research projects.

Introdução: O Hospital das Clínicas da Universidade Federal de Pernambuco (HCPE) faz parte da rede de hospitais universitários que são gerenciados pela Empresa Brasileira de Serviços Hospitalares (EBSERH). Em 2014, a EBSERH lançou o Programa de Pesquisas Clínicas Estratégicas para o Sistema Único de Saúde visando a implementação de um modelo de gestão de pesquisas clínicas na rede e, em 2016, o HCUFPE obteve financiamento para implantar um Centro de Pesquisa Clínica na instituição. Objetivo: Desenvolver o planejamento estratégico para a implantação do Centro de Pesquisa Clínica do HCUFPE através do método do Balanced Scorecard. Método: Estudo observacional e descritivo com mapeamento de dados sobre as pesquisas da instituição. Foi desenvolvido o instrumento de coleta de dados no REDCap© com questões fechadas relativas ao perfil do grupo de pesquisa e questões abertas, para composição da matriz SWOT. A aplicação do instrumento foi realizada através de entrevistas com os líderes de grupos de pesquisa. Foi realizada a análise de conteúdo de Bardin através do software Nvivo© e a partir desta, foi elaborado o planejamento estratégico através do método do Balanced Scorecard (BSC). Resultados: Foram identificados90 grupos de pesquisa, a partir da consulta aos registros no setor de pesquisa do hospital. No período de 2015 a 2017, foram registrados 381 projetos de pesquisa, dos quais 91% vinculados às atividades de ensino do hospital e da universidade. Foram entrevistados 29 líderes de pesquisa que pontuaram como pontos fortes para a realização de projetos de pesquisa no hospital o fato de já existirem grupos de pesquisa bem estruturados e a possiblidade de geração de conhecimento e como oportunidades, os avanços na prática clínica. As principais dificuldades citadas foram a inexistência de área física própria e a obtenção e gerenciamento de recursos financeiros para a pesquisa. Conclusão: A partir do mapeamento situacional da pesquisa no HC-UFPE, e da determinação das necessidades dos pesquisadores foi possível traçar iniciativas estratégicas com o objetivo de implementar o Centro de Pesquisa Clínica. O gerenciamento das atividades de pesquisa parece ser essencial para que as metas estabelecidas sejam alcançadas em curto espaço de tempo. / Introduction: The clinical hospital of the federal university of Pernambuco (HC-UFPE) is part of the network of university hospitals that are managed by the brazilian company of hospital services (EBSERH). In 2014, EBSERH launched the strategic clinical research program for the unified health system to implement a clinical research management model in the network and in 2016, the HC-UFPE obtained funding to establish a clinical research center in the institution. Objective: to develop the strategic planning for the implementation of the HCUFPEClinical Research Center through the balanced scorecard method. Method: observational and descriptive study with mapping of data about the institution's research. Conducted interviews with leaders of hospital research groups who were recorded and transcribed to perform SWOT analysis and Bardin content analysis. Results: a total of 90 research groups were identified, from the consultation to the records in the hospital's research sector. Registered 381 research projects in the hospital, from 2015 to 2017, of which, 159 residences, 132 graduate, 40 graduation, 35 clinical trials, 12 pbic, and 3 others. We applied questionnaires to 29 research leaders on the scientific production and infrastructure demand of the research center. the strengths of the institution are: the existence of well-structured research groups, the possibility of generating knowledge, producing improvements in clinical practice and give visibility to the hospital. The main difficulties cited were the acquisition and management of financial and human resources for research, the inexistence of its own physical area and material for research in the institution. Conclusion: Established strategic initiatives: create a course of good clinical practices, offer advice on the Plataforma Brasil to researchers, elaborate internal regulations for the research, reduce time of submission in the CEP and debureaucracy. The use of the BSC method was adequate as a strategy to manage university hospital research.