Medical devices are used to diagnose, treat, or prevent a disease or abnormal physical condition without any chemical action in the body. They can also result in unintended incidents and other errors. This thesis was divided into three chapters: i) a systematic review on the recognition, reporting and resolution of incidents related to medical devices and other health technologies; ii) telephone interviews with physicians and registered nurses (RNs) to solicit information on the resolution, reporting and resolution of medical device-related incidents based on their professional experience; and iii) a case study to review the continuous quality improvement (CQI) data retrieved from the wireless smart infusion pump system at The Ottawa Hospital (TOH) and to propose a CQI data analysis process. The systematic review included 30 studies on factors that influence the recognition, reporting and resolution of incidents in hospitals and interventions to improve patient safety. Central themes that emerged for incident reporting were personal attitudes, awareness and perception of incident reporting systems, organizational culture, and feedback to healthcare professionals. In our telephone interviews, physicians and RNs attributed incident recognition to devices not operating based on the manufacturer’s instructions, and to the hospital staff’s knowledge of and professional experience with the use of the medical device, and clinical manifestations of patients. Suggestions to improve medical device safety surveillance centered on education and training to ensure that the staff is able to use the medical device properly and know what would be considered an error, and how to report these errors. The results of the systematic review and interviews helped to inform the design of a medical device surveillance framework in a hospital setting. Our case study assessed the Dose Error Reduction Software compliance and frequency of soft and hard limit alerts with wireless smart infusion pump systems over a one year period. A CQI data analysis process to monitor the performance of wireless smart infusion pumps is proposed. The findings of this doctoral thesis can contribute to the development of a medical device surveillance system that would help to improve health care delivery and patient safety in a health care institution.

Background: Health technology assessment (HTA) is a form of policy analysis to inform recommendations for decision-makers. An equity-focused HTA recommendation consists of one that explicitly addresses the impact of health technologies on individuals disadvantaged in society because of their social conditions. However, there is a need for more evidence on the relationships between patient engagement and the development of equity-focused HTA recommendations. Objectives: The objectives of this dissertation were to examine the association between patient engagement and equity-focused HTA recommendations and identify implementation considerations for patient engagement in HTA. Methods: I used explanatory sequential mixed methods to analyze 60 HTA reports and 11 interviews with patients and analysts from Canadian organizations: the Canadian Agency for Drugs and Technologies in Health (CADTH) and Health Quality Ontario (HQO). Results: Quantitative analysis of the HTA reports showed that patient engagement significantly predicts equity-focused HTA recommendations (OR: 0.26; 95% CI: [0.16 – 0.41]). HTA reviews where HTA analysts directly interviewed patients (OR: 3.85; 95% CI: [2.40 – 6.20]) and where an advisory committee used consensus were more likely to contain equity-focused recommendations (OR: 2.27; 95% CI: [1.35 – 3.84]). Qualitative analysis of the interviews identified strategies for engaging diverse patients in HTA. Conclusion: The findings of this dissertation can inform the designing of patient engagement in HTA.

Mémoire numérisé par la Division de la gestion de documents et des archives de l'Université de Montréal.

Background: Cigarette smoking is a leading preventable factor associated with complications in pregnancy including preterm birth and low birthweight. Past interventions have raised cessation rates by approximately 6% overall (Lumley et al. 2009). Methods: A three-part literature review, two qualitative studies with a total of 36 participants, and the development of an intervention to promote smoking cessation during pregnancy were completed. Central to the design of the research was the creation of the theoretical basis which was developed in line with recommendations from the MRC Framework for Complex Interventions (Craig et al. 2008, Campbell et al. 2000). For part one of the literature review, 24 qualitative and 44 quantitative studies were re-analysed to complete a mixed-methods secondary analysis of the active ingredients in interventions to promote smoking cessation during pregnancy. Part two consisted of an exploration of psychological models and constructs which are likely to predict or influence smoking behaviour during pregnancy. The final part was a discussion regarding the modes of delivery by which an intervention could feasibly be delivered. Qualitative interviews were carried out with participants from stakeholder groups to fill in gaps in literature and determine the acceptability and feasibility of the proposed intervention. The intervention was created using the theoretical basis developed from the findings. Further qualitative interviews, a focus group, and heuristic evaluation were used to determine the acceptability and usability of the intervention for the target group of pregnant smokers. Results and Conclusions: Findings from this work are potentially relevant for a wide range of behaviours and behavioural interventions. An intervention which has a strong grounding in theory and evidence, and is acceptable and feasible for the target group and in clinical practice was developed using evidence gathered in this thesis.

Em organizações que operam segundo a lógica de serviço há uma mudança estratégica, com o deslocamento da produção de um produto para um valor. Seguindo esta dinâmica, surgiram na Saúde Pública propostas de modelos de atenção alternativos ao hegemônico, centrado em procedimentos e equipamentos. O presente estudo analisou o modelo da Estratégia de Saúde da Família, cuja proposta centra-se nas necessidades do usuário e no vínculo usuário-equipe multiprofissional, tendo como objetivo investigar como a organização e as condições do trabalho influenciam na utilização de recursos imateriais pelas equipes. Consistiu em um estudo de caso realizado junto a oito equipes de saúde da família do município de Caraguatatuba/SP. A metodologia compreendeu observação direta e realização de grupos focais com os profissionais das equipes. A análise abrangeu a categorização dos temas mais relevantes, em especial aqueles que se relacionavam ao uso e desenvolvimento dos recursos imateriais. Os resultados indicaram que, embora os profissionais valorizassem os aspectos relacionais, o processo de trabalho das equipes encontrava-se centrado na produção de procedimentos e informações quantitativos dos atendimentos, não incorporadas às práticas do cuidado. Os recursos imateriais, bem como seus resultados, não encontravam uma forma sistematizada de avaliação. E, dessa forma, enfrentavam desafios para serem apropriados e desenvolvidos como conhecimento pela organização. / Organizations operating according to the service logic imply a strategic change, the shifting of production from that of a product to that of a value. Following such dynamics, new models of attention emerged in the Public Health System, purporting alternatives to the hegemonic model.This study analyzes the model adopted by the Strategy of Family Health, which is focused on the users\' necessities and the bonds between those former and the multi-professional team. Its aim was to investigate how work organization and conditions influence the teams\' utilization of non-material resources. To such purpose a case study was carried out in the city of Caraguatatuba, São Paulo state, Brazil.The methodology comprehended direct observation and focal groups with the teams\' professionals. The analysis covered the categorization of the subjects considered more relevant, especially those concerning the utilization and development of non-material resources. The results pointed out that although relational aspects were valued by the professionals, the teams\' work process was mainly focused on the production of proceedings and information concerning the number of patients assisted, apart from the practices of care.There was no systematic evaluation of the nonmaterial resources and their results, which, therefore, could not be easily appropriated and developed as a knowledge by the organization.

O objetivo do trabalho é estudar o processo de incorporação de tecnologias médicas no sistema de saúde brasileiro, mediante a realização de um estudo de caso na área de equipamentos de diagnóstico por imagem, com foco nas variáveis que influenciam a tomada de decisão. Considerando que os modernos sistemas de saúde são o resultado da complexa interação de processos econômicos, políticos e sociais, adotou-se a abordagem teórica fornecida pela Economia Política da Saúde, que fornece elementos para discutir a saúde a partir de suas especificidades enquanto mercadoria ou bem econômico, como direito social e como espaço de inovação tecnológica e acumulação de capital. Os métodos utilizados incluíram pesquisa bibliográfica sobre o tema, análise de dados secundários e entrevistas semi-estruturadas com representantes dos principais segmentos que participam do processo de incorporação da tecnologia estudada / This work aims at studying the process of new medical technologies incorporation in the Brazilian healthcare system. For this purpose a case study of a new image diagnostic technology was conducted, focusing the variables that affect decision-making process. Considering that modern healthcare systems are the result of complex interaction of economical, political and social processes, the theoretical approach of Political Economy of Health was adopted, which provides elements to discuss health as a merchandise or an economic good, as a social right, and as a space for technological innovation and capital accumulation. Methods included documental research, data analysis, and semi-structured interviews with main actors and institutions that participate of incorporation process of the studied technology

Este estudo exploratório-descritivo tem como objetivo avaliar o desempenho funcional e a qualidade técnica de um registro eletrônico do processo de enfermagem junto a especialistas em informática, enfermeiros docentes e enfermeiros assistenciais. O Hospital Universitário da Universidade de São Paulo em parceria com a Escola de Enfermagem da Universidade de São Paulo, desenvolveu um registro eletrônico denominado Sistema de Documentação Eletrônica do Processo de Enfermagem da Universidade de São Paulo (PROCEnfUSP), para que pudesse ser utilizado na automação das informações do Processo de Enfermagem, visando à adoção de um Sistema de Apoio à Decisão que pudesse contribuir para a melhoria da gestão, da qualidade da assistência e da satisfação dos pacientes. A garantia da qualidade desse sistema é um importante desafio e meta devido à responsabilidade com os usuários e pacientes. Para assegurar essa qualidade foi realizada uma avaliação do sistema PROCEnf-USP utilizando-se do Modelo de Qualidade proposto pela norma ISO/IEC 25010 e do Processo de Avaliação definido na norma ISO/IEC 25040. Na avaliação dos especialistas em informática, adequação funcional obteve 91% de respostas positivas, confiabilidade 76%, usabilidade 62%, eficiência de desempenho 84%, compatibilidade 86%, segurança 89%, manutenibilidade 93% e portabilidade 92%. Os enfermeiros docentes avaliaram positivamente todas as características, adequação funcional obteve 92%, confiabilidade 89%, usabilidade 84%, eficiência de desempenho 81%, compatibilidade 75% e segurança 100%. Os enfermeiros assistenciais das clínicas médica e cirúrgica do hospital avaliaram adequação funcional com 82% de respostas positivas, confiabilidade 69%, usabilidade 85%, eficiência de desempenho 47% compatibilidade 62% e segurança 98%. Os enfermeiros assistenciais de outras unidades avaliaram adequação funcional com 88%, confiabilidade 61%, usabilidade 80%, eficiência de desempenho 46%, compatibilidade 69% e segurança 100%. Conclui-se que o PROCEnf-USP atingiu mais de 70% de respostas positivas na maioria das características de qualidade avaliadas por todos os especialistas. Entretanto, eficiência de desempenho, confiabilidade e compatibilidade obtiveram índices abaixo do parâmetro estabelecido na avaliação dos enfermeiros assistenciais. Os resultados obtidos neste estudo serão utilizados para a realização de melhorias no sistema. Essa pesquisa propiciará a disseminação do conhecimento de uma área emergente, agregando mais uma iniciativa aos crescentes esforços na área de informática em saúde e em enfermagem / This descriptive exploratory study aims to evaluate functional performance and technical quality of an electronic record for the nursing process with technology experts, teaching staff and nurses. The University Hospital in the University of São Paulo in partnership with the School of Nursing of the University of São Paulo, has developed an electronic record called Electronic Documentation System for the Nursing Process of the University of São Paulo (PROCEnf-USP), to be used for the automation of information of the Nursing Process, aimed at the adoption of a Decision Support System that could contribute to the improvement of management, quality of care and patient satisfaction. The quality guarantee of this system is an important challenge and target, due to responsibility with users and patients. To ensure such quality an assessment of the PROCEnf-USP system was carried out using the Quality Model proposed by ISO/IEC 25010 and the Evaluation Process defined in ISO/IEC 25040. In the evaluation of technology experts the characteristic functional suitability had 91% of positive responses, reliability 76%, usability 62%, performance efficiency 84%, compatibility 86%, security 89%, maintainability 93% and portability 92%.The teaching staff positively evaluated all the characteristics, functional suitability had 92%, reliability 89%, usability 84%, performance efficiency 81%, compatibility 75% and security 100%. The nurses from general medical and surgical hospital evaluated functional suitability with 82% of positive responses, reliability 69%, usability 85%, performance efficiency 47%, compatibility 62% and security 98%. The nurses from other units evaluated functional suitability with 88%, reliability 61%, usability 80%, performance efficiency 46%, compatibility 69% and security 100%. It is concluded that the PROCEnf-USP reached more than 70% of positive responses in the majority of quality characteristics evaluated by specialists. However, performance efficiency, reliability and compatibility found rates below the parameter established in the assessment of nurses. The results of this survey will be used to implement improvements in the system. Such research will allow the spreading of knowledge in an emerging area, thus adding a further initiative to the growth efforts made in the information technology areas of health and nursing.

A Estratégia de Saúde da Família foi implantada pelo Ministério da Saúde, em 1994, para orientar o sistema de saúde brasileiro em direção a Atenção Primária à Saúde. A partir de então, a ampliação da cobertura de equipes de ESF tem estado entre as metas de governo. Para consecução deste propósito, o perfil dos profissionais e a formação se caracterizam como um grande diferencial, com papel determinante em uma reorientação desta magnitude e abrangência. A Residência Multiprofissional em Saúde foi uma das políticas criadas neste sentido. O Grupo Hospitalar Conceição oferece esta modalidade de formação desde 2004. Objetivo: Avaliar a adequação do Programa da Residência Integrada em Saúde, na ênfase Saúde da Família e Comunidade, do GHC, como uma tecnologia de formação de profissionais em APS para o SUS, através de dados coletados junto aos seus egressos. Métodos: O delineamento é um estudo de caso descritivo com associação da metodologia quantitativa e qualitativa, orientado pela avaliação de inferência causal proposta por Habicht et al. A coleta das informações se deu de maneira virtual através de um questionário semiestruturado em formato autoaplicável. A população pesquisada foram 74 profissionais egressos do Programa formados entre os anos de 2005 e de 2008. Resultados: O estudo contou com a participação de 77% dos egressos do Programa. Os dados encontrados revelam uma população de profissionais jovens, predominantemente, do sexo feminino. Estes profissionais exercem suas atividades em 19 cidades, sendo que, na cidade de Porto Alegre se concentram mais de metade deles. 76% dos egressos estão vinculados ao setor público e 49% atuam diretamente na APS. A maioria dos participantes afirma que a formação alterou a forma de perceber a realidade em APS, melhorou suas habilidades e aumentou os conhecimentos. Conclusões: As evidências produzidas no estudo fornecem subsídios para considerar o Programa como uma tecnologia adequada à formação de profissionais de saúde em APS para o SUS. / The Family Health Strategy, an initiative from the Ministry of Health, started in 1994, providing guidelines to the Brazilian Health System towards Primary Health Care. Since then, there was a remarkable increase in the strategy coverage. To pursue this objective, the professional profiles and their formation are characterized as great differentials, with a pivotal role in a reorientation of such magnitude. The Health Interprofessional Residency was one of these government policies created with this scope, and the Grupo Hospitalar Conceição has been offering this continuum education course since 2004. Objective: To evaluate the fitting adequation of The Health Interprofessional Residency, emphasis in Family and Community Health, as a good technology to train health professionals in Primary Health Care in the context of Brazilian Health System, using data collected from professionals graduated in the Residency program. Methods: The design is based on a descriptive study case, associating quantitative and qualitative methodologies, relying on the evaluation of causal inference proposed by Habicht et al. The information was collected by a virtual mode with a semi structured and self-administered questionnaire. Professionals (74) that concluded the program between 2005 and 2008 were selected to be included in the sample. Results: The response rate was 77%. The population was mainly composed by young individuals, predominantly females. These individuals perform their professional activities in 19 different cities; more than 50% were working in the State capital city (Porto Alegre). From the individuals interviewed, 76% of them were public servants and 49% were working directly in Primary Health Care. Most of the participants stated that the training during Residency had significantly changed their view in relation to the reality in Primary Health Care, improving their skills and increasing their knowledge. Conclusion: The findings from this study show that the Residency Program could be considered a good technology for training Primary Health Care professionals for the Brazilian Health System.

Introdução: Os primeiros 1000 dias de vida representam uma janela de oportunidade para que a criança possa atingir o seu potencial máximo de crescimento e desenvolvimento na vida adulta. Diversas iniciativas no mundo reúnem estratégias para proteger a primeira infância. Às experiências acumuladas em países como os Estados Unidos e Inglaterra mobilizaram um grupo de pesquisadores da Universidade de São Paulo a construir o Programa Jovens Mães Cuidadoras. Este programa foi adaptado e validado para a realidade brasileira e vem sendo aprimorado em fase piloto. Um dos desafios do Programa Jovens Mães Cuidadoras relaciona-se à complexidade das visitas domiciliares realizadas e o instrumento de trabalho das enfermeiras visitadoras. Desafios que se não forem superados comprometem a escalabilidade e a gestão de resultados do programa. Objetivo: Reestruturar a forma do principal instrumento de trabalho das enfermeiras visitadoras para a fase de gestação. Método: Este é um estudo exploratório de desenvolvimento tecnológico por prototipação através da abordagem Design Thinking (DT). Resultado e Discussão: A partir de uma mentalidade digital foi prototipado um novo protocolo de visitas que recebeu recursos de atratividade, ganhou uma identidade visual, adotou um padrão de organização e de quantificação dos resultados. Isso tudo para contribuir com a gestão, a comunicação e a escalabilidade do Programa Jovens Mães Cuidadoras. Considerações finais: O desafio da enfermagem na era digital consiste na inovação da maneira de pensar e planejar os processos de cuidado. Empregar uma lógica digital ao principal instrumento de trabalho das enfermeiras visitadoras se configurou num ato de cuidar da comunicação e investir na gestão do cuidado destinado as gestantes e à primeira infância. Espera-se que as contribuições deste estudo reflitam na qualidade da atenção à primeira infância através da possibilidade de escalabilidade do mesmo para o Brasil. Produto final: Protocolo Renovado de Intervenção da Fase Gestação / Introduction: The first 1000 days of life represent a window of opportunity for the child to reach his full potential for growth and development in adult life. Several initiatives around the world bring together strategies to protect early childhood. The experiences accumulated in countries such as the United States and England mobilized a group of researchers from the University of São Paulo to build the \"Young Mothers Caregivers Program\". This program has been adapted and validated for the Brazilian reality and has been improved in the pilot phase. One of the challenges of the \"Young Mothers Caregivers Program\" relates to the complexity of home visits and the working instrument of visiting nurses. Challenges that are not overcome compromise the scalability and results management of the program. Objective: To restructure the form of the main working instrument of the visiting nurses to the gestational phase. Method: This is an exploratory study of technological development by prototyping through the Design Thinking (DT) approach. Outcome and Discussion: From a digital frame, a new protocol of visits was introduced that received resources of attractiveness, gained a visual identity, adopted a pattern of organization and quantification of the results. All this to contribute to the management, communication and scalability of the \"Young Mothers Caregivers Program. Conclusions: The challenge of nursing in the digital age is to innovate the way of thinking and to plan care processes. Employing a digital logic to the main instrument of work of visiting nurses was configured in an act of taking care of communication and investing in the management of care for pregnant and early childhood. The contributions of this study are expected to reflect on the quality of early childhood care through the possibility of scaling the same to Brazil. Final product: Prototype version of the Intervention Protocol for the Gestational Phase

In the early 1990s claims were made that in all areas of health care, “30-40% of patients do not receive treatments of proven effectiveness”, and, “20-25% of patients have treatments that are unnecessary or potentially harmful”. Many such practices were diffused prior to the acceptance of modern evidence-based standards of clinical- and cost-effectiveness. I define disinvestment in the context of health care as the processes of withdrawing (partially or completely) resources from any existing health care practices, procedures, technologies or pharmaceuticals that are deemed to deliver little or no health gain relative to their cost, and thus are not efficient health resource allocations. Arguably disinvestment has been central to Evidence-Based Medicine(EBM) for well over a decade yet despite general advances in EBM, this topic remains relatively unexplored. This thesis examines the ongoing challenges that exist within the Australian context relating to effective disinvestment. Upper airway surgical procedures for the treatment of adult Obstructive Sleep Apnoea Syndrome (OSA) are used as a case study to contextualise these challenges. This thesis has six sections: 1. A review of the literature outlines developments in EBM broadly and provides a detailed background to OSA, including the numerous treatment options for the condition. This review examines evidence that highlights the importance of ‘highly effective treatment’ over ‘subtherapeutic treatment’ as a necessity to confer improved health outcomes in OSA. It is argued that claims of surgical success inherent in most published results of surgery effectiveness fail to assimilate contemporary evidence for clinically significant indicators of success. 2. Section two comprises the first reported meta-analysis in this area. It presents the pooled success rates of surgery according to various definitions. Specifically, when the traditional ‘surgical’ definition of success is applied the pooled success rate for Phase I (i.e. soft palate) surgical procedures is 55% (that is 45% fail). However, using a more stringent definition (endorsed by the peak international sleep medicine body), success is reduced to 13% (that is 87% fail). Similarly for Phase II (i.e. hard palate) procedures success rates decrease from 86% to 43% respectively when moving from a surgical to a medical definition of success. That various medical specialties differentially define treatment success, I argue, creates uncertainty for observers and non-clinical participants in this debate (eg policy stakeholders and patients). This represents a barrier to disinvestment decisions. 3. Results are presented from a clinical audit of surgical cases conducted as a component of this thesis. Both clinical effectiveness and procedural variability of surgery are reported. A unique methodology was utilised to capture data from multiple centres. It is the first time such a methodology has been reported to measure procedural variability alongside clinical effectiveness (inclusive of a comparative treatment arm). The observed cohort (n=94) received 41 varying combinations of surgery in an attempt to treat OSA. Results on effectiveness demonstrate an overall physiological success rate of 13% (according to the most stringent definition; phases I and II combined). This demonstration of procedural variability combined with limited effectiveness highlights clinical uncertainty in the application of surgical procedures. 4. Section four outlines how a qualitative phase of enquiry, directed at exploring the perspectives and experiences of surgery recipients, was approved by three independent research ethics review boards but was not supported by a small group of surgeons, resulting in the project being canceled. Potential consequences of this for impeding health services research (HSR) are discussed. 5. Two sets of results are reported from a qualitative phase of enquiry (semi-structured interviews) involving senior Australian health policy stakeholders. The first results are of policy stakeholders’ perspectives on the surgical meta-analysis and clinical audit studies in 2 and 3 above. The second results are from an extended series of questions relating to challenges and direction for effecting disinvestment mechanisms in Australia. Stakeholder responses highlight that Australia currently has limited formal systems in place to support disinvestment. Themes include how defining and proving inferiority of health care practices is not only conceptually difficult but also is limited by data availability and interpretation. Also, as with any policy endeavour there is the ever-present need to balance multiple interests. Stakeholders pointed to a need, and a role, for health services and policy research to build methodological capacity and decision support tools to underpin disinvestment. 6. A final discussion piece is presented that builds on all previous sections and summarises the specific challenges that exist for disinvestment, including those methodological in nature. The thesis concludes with potential solutions to address these challenges within the Australian and international context. Systematic policy approaches to disinvestment represent one measure to further improve equity, efficiency, quality of care, as well as sustainability of resource allocation. / http://proxy.library.adelaide.edu.au/login?url= http://library.adelaide.edu.au/cgi-bin/Pwebrecon.cgi?BBID=1297655 / Thesis (Ph.D.) -- University of Adelaide, School of Population Health and Clinical Practice, 2007