No description available.

The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a leading patient-reported outcome measure of disability. However, patients' perspective of the WHODAS 2.0 self-administered Swedish version have not been sufficiently described. Similarly, knowledge of its construct validity in the general population is missing. This creates a gap because updated norm data to use as reference is also missing. The overall aim of this study was to establish evidence of the measurement properties of the self-administered Swedish version of the WHODAS 2.0. Both qualitative and quantitative methods were adopted. In Study I, interviews with patients (n = 12) with orthopaedic or psychiatric conditions were performed and data were analysed by deductive content analysis. In Study II, a cross-sectional general population survey (n = 3 482) was conducted, and statistical methods based on classical test theory were used in the data analysis. The results show that the items were well understood, acceptable and easy to answer by outpatients, with the exception of six items (Study I).The internal consistency reliability was good or excellent and the construct validity was overall acceptable, with partial support for the factor structure in the general populations (Study II). The self-administered Swedish 36-item version of the WHODAS 2.0 is comparable to other language versions of the instrument. Some of the previous known weaknesses of its construct validity in relation to the item content and insufficient instructions were confirmed. The evidence of overall good content and construct validity together with available norm data supports its use in clinical settings and research.

Background: The prevalence of disability increases with age; therefore with an aging population, interventions to reduce disability are crucial. This thesis adopts a behavioural conceptualisation of disability. The theoretical frameworks of the International Classification of Functioning, Disability and Health (ICF), the Theory of Planned Behaviour (TPB) and the integrated ICF/TPB model are applied to investigate disability and physical activity (PA) behaviours. The thesis aims to: (1) identify the factors involved in the prioritisation of patients for total joint replacement; (2) classify patient pre-operative expectations of total hip replacement (THR) and investigate the relationship between expectations and recovery after surgery, and; (3) test whether the TPB and theory-based interventions can predict and explain PA within individuals. Method: Five studies were conducted. In the first study, health professionals judged whether the items from two prioritisation tools measured each of the ICF constructs. In the second study, surgeons ranked patient vignettes, which differed by constructs from the integrated model, in order of priority for THR. In the third study, a large cohort of THR patients reported expectations of surgery pre-operatively. Health and functioning were also reported pre-operatively and 1-year post-operatively. The fourth and fifth studies were a series of experimental n-of-1 studies using diary methods assessing TPB cognitions and PA behaviours. Results: There is a lack of agreement between judges in relation to the content of many of the items from prioritisation tools. Behavioural and psychological factors can influence prioritisation for THR. The majority of patient expectations of THR addressed activities and social participation; however, the evidence for a relationship between expectations and recovery was limited. The TPB can predict PA within some individuals but the evidence in support of interventions to increase PA was limited. Discussion: The findings provide important clinical and theoretical implications for understanding disability and physical activity behaviours.

Introduction: There has been a continuous development of new technologies in healthcare that are derived from national quality registries. However, this innovation needs to be translated into the workflow of healthcare delivery, to enable children with long-term conditions to get the best support possible to manage their health during everyday life. Since children living with long-term conditions experience different interference levels in their lives, healthcare professionals need to assess the impact of care on children’s day-to-day lives, as a complement to biomedical assessments. Aim: The overall aim of this thesis was to explore and describe the use of instruments about health-related quality of life (HRQOL) in outpatient care for children with long-term conditions on the basis of a national quality registry system. Methods: The research was conducted by using comparative, cross-sectional and explorative designs and data collection was performed by using different methods. The questionnaire DISABKIDS Chronic Generic Measure -37 was used as well as semi-structured interviews and video-recordings from consultations. Altogether, 156 children (8–18 years) and nine healthcare professionals participated in the studies. Children with Type 1 Diabetes (T1D) (n 131) answered the questionnaire DISABKIDS and children with rheumatic diseases, kidney diseases and T1D (n 25) were interviewed after their consultation at the outpatient clinic after the web-DISABKIDS had been used. In total, nine healthcare professionals used the HRQOL instrument as an assessment tool during the encounters which was video-recorded (n 21). Quantitative deductive content analysis was used to describe content in different HRQOL instruments. Statistical inference was used to analyse results from DISABKIDS and qualitative content analysis was used to analyse the interviews and video-recordings. Results: The findings showed that based on a biopsychosocial perspective, both generic and disease-specific instruments should be used to gain a comprehensive evaluation of the child’s HRQOL. The DISABKIDS instrument is applicable when describing different aspects of health concerning children with T1D. When DISABKIDS was used in the encounters, children expressed positive experiences about sharing their results with the healthcare professional. It was discovered that different approaches led to different outcomes for the child when the healthcare professionals were using DISABKIDS during the encounter. When an instructing approach is used, the child’s ability to learn more about their health and how to improve their health is limited. When an inviting or engaging approach is used by the professional, the child may become more involved during the conversations. Conclusions: It could be argued that instruments of HRQOL could be used as a complement to biomedical variables, to promote a biopsychosocial perspective on the child’s health. According to the children in this thesis, feedback on their results after answering to web-DISABKIDS is important, which implies that healthcare professionals need to prioritize time for discussions about results from HRQOL instruments in the encounters. If healthcare professionals involve the child in the discussion of the results of the HRQOL, misinterpreted answers could be corrected during the conversation. Concurrently, this claims that healthcare professionals invite and engage the child.

INTRODUÇÃO: Com o rápido processo de envelhecimento populacional, a incapacidade funcional em idosos tem se tornado um importante problema de saúde pública globalmente. Depressão é uma morbidade bastante prevalente nessa fase da vida e pode estar associada com uma proporção significativa da incapacidade funcional na população de idosos. OBJETIVOS: Avaliar os níveis de incapacidade funcional, os principais fatores associados e o impacto dos transtornos mentais na incapacidade funcional de idosos vivendo na comunidade; examinar os fatores preditores de incapacidade funcional em um período de dois anos. MÉTODO: A presente investigação é parte da coorte prospectiva de base populacional \"São Paulo Ageing & Health Study\" (SPAH), que incluiu idosos com 65 anos ou mais, residentes de uma área economicamente menos favorecida na região Oeste da cidade de São Paulo. Os participantes foram identificados por arrolamento domiciliar e entrevistados em seus domicílios seguindo protocolo padronizado de pesquisa. A avaliação de incapacidade funcional foi realizada com o instrumento \"World Health Organization Disability Assessment Schedule 2.0\", criado para avaliar níveis de incapacidade conforme as definições e critérios da International Classification of Functioning, Disability and Health da Organização Mundial de Saúde, na sua versão com 12 itens. Depressão pelos critérios diagnósticos da CID-10 e sintomas depressivos foram avaliados com o instrumento Geriatric Mental State. Foram examinadas as associações independentes entre os transtornos mentais e incapacidade funcional através de modelos de regressão multivariada e modelos longitudinais multinível. Também foi calculada a Fração Atribuível na População dos transtornos mentais na incapacidade funcional dos idosos. RESULTADOS: Foram incluídos 2.072 idosos no período de 2003 a 2005. Mobilidade, atividades de vida diárias e participação na sociedade foram os domínios de incapacidade funcional mais afetados nessa população. A prevalência de depressão clinicamente significativa foi 26,2% (IC 95% 24,3 - 28,1), sendo 4,8% para depressão CID-10 e 21,4% para sintomas depressivos. Demência, depressão CID-10 e problema em membros apresentaram as associações de maior magnitude com as médias dos escores totais padronizados de incapacidade funcional, seguidos por sintomas depressivos, AVC e DPOC. Sintomas depressivos e depressão CID-10 foram responsáveis por 25,0% do total de incapacidade funcional grave nessa população. Dos idosos incluídos no SPAH, 1.661 foram reavaliados após dois anos. No seguimento, 56,1% dos idosos permaneceram com o mesmo nível de incapacidade funcional, 21,8% melhoraram e 22,1% pioraram. Os idosos que apresentaram sintomas depressivos, depressão CID-10 e demência na inclusão tiveram maior chance de piora da incapacidade funcional após dois anos, independentemente da categoria de incapacidade na inclusão do estudo e das morbidades físicas presentes. CONCLUSÃO: Os transtornos mentais em idosos, principalmente os sintomas depressivos e a depressão CID-10, apresentam associações e impacto importantes na incapacidade funcional. Além disso, são fatores preditores de piora na incapacidade funcional em idosos. Sabe-se que depressão e sintomas depressivos são doenças potencialmente preveníveis e tratáveis, e que sua adequada abordagem em idosos pode culminar com a diminuição da incapacidade funcional, melhora da qualidade de vida e diminuição dos custos em saúde / BACKGROUND: With the fast population aging, functional disability in the elderly has become a major public health issue globally. Depression is a very prevalent morbidity in this life period and may be associated with a significant proportion of functional disability in the elderly population. AIMS: To assess the level of functional disability, the main comorbidities associated and the impact of mental disorders on functional disability in the elderly living in the community; to investigate the predictors of functional disability in a period of two years. METHOD: The present investigation is part of a population-based prospective cohort study \"São Paulo Ageing & Health Study\" (SPAH), which included participants aged 65 or older living in an economically underprivileged area in the western region of São Paulo city. Participants were identified by household enrollment and interviewed in their homes using a standardized research protocol. The assessment of disability was performed with the 12-item version of the \"World Health Organization Disability Assessment Schedule 2.0,\" created to assess levels of disability according to the definitions and criteria of the International Classification of Functioning, Disability and Health of the World Health Organization. ICD-10 depression and depressive symptoms were assessed with the Geriatric Mental State instrument. We examined the independent associations between mental disorders and functional disability through multivariate regression models and longitudinal multilevel models. We also calculated the Population Attributable Fraction of mental disorders on functional disability in elderly. RESULTS: We included 2072 elderly from 2003 to 2005. Mobility, activities of daily living and participation in society were the most affected domains of functional disability in this population. The prevalence of clinically significant depression was 26,2% (CI 95% 24,3 to 28,1), 4,8% for ICD-10 depression and 21,4% for depressive symptoms. Dementia, ICD-10 depression and limb problems were highly associated with the mean of functional disability overall standardized scores, followed by depressive symptoms, stroke and COPD. Depressive symptoms and ICD-10 depression accounted for 25,0% of severe functional disability in this population. Among the elderly included in SPAH, 1661 were reassessed after two years. In this follow-up, 56,1% of the elderly remained with the same level of functional disability, 21,8% improved and 22,1% worsened. The elderly who presented depressive symptoms, ICD-10 depression and dementia at baseline had a higher risk of worsening disability after two years, independently of the category of disability and physical morbidities at baseline. CONCLUSION: Mental disorders in older adults, particularly depressive symptoms and ICD-10 depression, have significant associations and impact on functional disability. Also, they are predictive factors of worsening disability. It is known that depression and depressive symptoms are potentially preventable and treatable diseases and a proper approach may lead to a decreased functional disability, improved quality of life and decreased healthcare costs

O envelhecimento da população mundial é um fenômeno novo, ao qual, mesmo os países desenvolvidos, ainda estão tentando adaptar-se como envelhecer de forma saudável, priorizando esforços na manutenção da independência e autonomia do indivíduo. Os princípios deste envelhecimento com qualidade de vida descrevem o idoso como pró-ativo, definindo seus objetivos e lutando para alcançá-los, reunindo recursos que são úteis na adaptação à mudança e ativamente envolvidos na manutenção do bem-estar. Este modelo compreende desde a satisfação com a vida a modelos baseados em conceitos de independência, controle, competências sociais e cognitivas. O objetivo desta pesquisa é a caracterização do perfil dos idosos que participam do Centro de Convivência do Idoso (CCI) quanto ao sexo, idade, estado civil, etnia autodeclarada, escolaridade, ocupação, renda individual, número de filhos, naturalidade, condições de moradia, meio de locomoção que utiliza para ir ao CCI e atividade física preferida e descrever as condições de saúde e desempenho nas atividades de vida diária dos idosos participantes de CCI, segundo a Classificação Internacional de Funcionalidade, Incapacidade e Saúde(CIF). Pesquisa do tipo exploratória, descritiva, transversal, com abordagem quantitativa, realizado em CCIs do Vale Paraíba, São Paulo. Foram incluídos no estudo aqueles que atendiam aos critérios de inclusão com idade igual ou superior a 60 anos, participantes, há pelo menos três meses completos e no máximo um ano dos CCIs, que constituíram o campo de pesquisa. O estudo caracterizou-se pelo predomínio de mulheres, idade média de 72 anos, casadas, etnia autodeclarada branca, com 5-10 anos de educação escolar, aposentadas, com média de renda mensal de um salário mínimo, por meio do instrumento de coleta foi possível observar que a maior parte das categorias da CIF selecionadas era pouco comprometida com dificuldade leve ou sem dificuldade. / The aging world population is a new phenomenon, which even developed countries are still trying to adapt to aging in a healthy way, prioritizing efforts to maintain the independence and autonomy of the individual. The principles of this aging quality of life describe the elderly as proactive, setting goals and striving to achieve them, gathering resources that are useful in adapting to change and actively involved in maintaining wellness. This model comprises from life satisfaction to models based on concepts of independence, control, social and cognitive skills. The goal of this research is to characterize the profile of the elderly participating in the Elderly Community Centre (CCI) regarding gender, age, marital status, self-reported ethnicity, education, occupation, individual income, number of children, nationality, living conditions , means of transportation you use to go to the CCI and preferred physical activity and describe the health and performance in activities of daily living of the elderly participants from CCI, according to the International Classification of Functioning, Disability and Health(ICF). Research An exploratory, descriptive , Cross-sectional quantitative approach carried out in CCIs Paraíba Valley, São Paulo. The study included those who met the inclusion criteria of age or over 60 years, participating for at least three months and complete within one year of the CCIs, which were the search field. The study was characterized by the predominance of women, mean age 72 years, married, self-reported ethnicity white, with 5-10 years of education, retired, with an average monthly income of a minimum wage, through the data collection instrument was observed that most of ICF categories selected was somewhat compromised with slight difficulty or no difficulty.

A Classificação Internacional de Funcionalidade, Incapacidade e Saúde (CIF) contextualiza a saúde do individuo sob uma perspectiva integrativa, considerando os aspectos relativos ao meio em que vivem. Seu modelo biopsicossocial se aproxima do modelo de abordagem do Conceito Bobath (CB). Este conceito é conhecido por apresentar bons resultados na clínica mas limitações no registro da evolução dos pacientes. Com a divulgação da CIF, vislumbrou-se a possibilidade de registrar os ganhos funcionais obtidos com a terapêutica Bobath. O objetivo deste estudo foi apresentado em dois artigos. O primeiro artigo se refere ao relato de experiências de uso da CIF como forma de estimular sua aplicabilidade. O segundo tem como objetivo refletir sobre a congruência entre a CIF e o CB e discutir a aplicação de ambos na reabilitação neurológica. O resultado apresenta diferentes estratégias de uso da Classificação e sugere sua aplicação em conjunto com o CB, exemplificando uma forma de uso em um centro de reabilitação. A divulgação da classificação em conjunto com uma abordagem já utilizada, seja sob um formato total ou parcial, ou sob uma estrutura nova ou préestabelecida, pode trazer benefícios para a sua disseminação, facilitando o treinamento de profissionais e permitindo registro dos ganhos funcionais obtidos em terapia. / The International Classification of Functioning, Disability and Health (ICF) contextualizes the individual\'s health in an integrative perspective, considering the aspects of the environment in which they live. Its biopsychosocial model approaches the treatment model used in the Bobath Concept (BC). This concept is known to have good clinical results but limitations in recording the outcome. With the release of ICF, the possibility of registering the functional gains obtained with Bobath therapy have been envisioned. The objective of this study was presented in two articles. The first article refers to the reporting experiences of using the ICF as a way of stimulating their applicability. The second one aims to reflect on the congruence between the ICF and the BC and discuss the application of both in neurological rehabilitation. The result shows different strategies for use of the Classification and suggests its use together with the BC, one way to use in a rehabilitation center has been exemplified. The widespread use of the classification associated with an approach already used, either in full or partial format, or under a new structure or pre-established one, can bring benefits for its dissemination, facilitate the training of professionals and allowing the record of gains obtained from functional therapy.

As lesões medulares traumáticas (LMT) são comumente geradoras de deficiências e levam a limitações na execução de atividades, como também à restrição de participação em situações concretas de vida. Conhecer os indivíduos com LMT em termos de independência funcional permite aos serviços de reabilitação estruturarem-se para atenderem às demandas dessa população de forma mais eficiente. Estudo de delineamento metodológico objetivou construir e validar instrumento baseado no Core Set resumido da CIF para indivíduos com lesão medular aguda traumática. A pesquisa, aprovada pelo Comitê de Ética, foi realizada em três etapas: etapa 1:Elaboração do instrumento a partir do Core set resumido da CIF para lesão medular aguda: \"Instrumento baseado no Core set resumido da CIF para indivíduos com Lesão Medular Aguda Traumática\"; etapa 2: Validação do instrumento e coleta de dados; etapa 3: Aplicação do pré-teste.O instrumento para validação de face e conteúdo continha13 categorias que integraram os componentes da CIF: funções do corpo (3), estrutura do copo (1), atividades e participação (9), perfazendo um total de 109 itens. Em cada seção do instrumento tinha um campo para sugestões. A validade de conteúdo do instrumento foi realizada por um comitê de dezesseis juízes.Os resultados demonstraram que a maioria dos juízes de conteúdo eram do sexo feminino, jovens, com idade entre 30 e 39 anos. Quanto à titulação acadêmica e área de atuação, a maioria tinha doutorado e eram docentes, assim como, realizavam estudos sobre a CIF e à utilizavam na sua prática clinica.Cada item do instrumento foi avaliado em mais de 70% pelos avaliadores, sendo considerado aceitável para a validação de conteúdo. Na maioria dos itens, os juízes fizeram sugestões que visavam à modificação de termos, para serem substituídos ou reformulados, a partir do conceito apreendido, para que a estrutura e a propriedade do instrumento não fossem alteradas de modo significativo. Foram sugestões pertinentes que favoreceram a adequação do instrumento, a fim de facilitar a compreensão dos itens propostos pelo publico alvo. O pré-teste foi realizado no Centro de Reabilitação do HCFMRP-USP, participaram da pesquisa 10 indivíduos com diagnóstico de LTME, com até 6 meses lesão.A maioria eram do sexo masculino, com média de idade de 43 anos, sendo a principal etiologia do trauma os acidentes automobilísticos. Quanto à escolaridade verificou-se que a maioria dos participantes tinha ensino fundamental completo ou incompleto. Nesta etapa, houve substituição de alguns termos técnicos para melhor compreensão pelo público alvo. Mediante a análise entre os pesquisadores e após consenso das modificações sugeridas pelos especialistas e público alvo, foi elaborada a versão final do instrumento. Ressalta-se que o instrumento contribuíra na prática clinica como uma ferramenta inovadora a ser utilizado pela equipe multidisciplinar, na avaliação da funcionalidade para o planejamento da assistência, com foco nas necessidades individuais e nos resultados mais efetivos das intervenções no processo de reabilitação / Traumatic spinal cord injuries (TSCI) are usually the cause of disabilities and limited performance of some activities as well as limited participation in some life moments. Knowing if TSCI patients are functional dependent helps the rehabilitation services to be organized to effectively meet the demand of that population. The goal of the methodological design study was to create and validate an instrument based on summed up ICF Core Set for patients with acute traumatic spinal cord injury. The survey was approved by the Ethics Committee and it was divided in three phases: Phase 1 - Elaboration of the instrument based on summed up ICF Core Set for acute spinal cord injury: \"Instrument based on summed up ICF Core Set for patients with Acute Traumatic Spinal Cord Injury\"; Phase 2 - Validation of the instrument and data collect; Phase 3 - Implementation of the pre-test. Face and content validation tool had 13 categories which were part of ICF components: body functions (3), body structure (1), activities and participation (9); in total 109 items. Every section of the tool had a specific place for suggestions. A sixteen-judge committee validated the content. The results showed that most of the judges were 30 to 39-year-old women, with doctorate degree and they were professors who also studied ICF and applied it in their clinics. The evaluators checked more than 70% of each item of the tool and it was considered enough for the validation of the content. The judges made some suggestions for most of the items in order to replace or redesign the terms so that the structure and the effect of the tool would not be significantly changed. Those suggestions were relevant and they helped adjusting the tool to make easier for the community to understand the items. The pre-test was performed at Rehabilitation Center of HCFMRP-USP; ten patients who have had TSCI for up to 6 months participated on the survey. Most of them were 43 -year- old men, who studied up to elementary school, with a trauma caused by a car crash. At this stage some technical terms were replaced in order to help the community understanding. After the analysis of the researchers and the modifications suggested by the experts and the community, a final version of the tool was elaborated. In clinical practice this instrument was a new tool used by the multidisciplinary team when evaluating the functioning of helping individual necessities and more effective results of the interventions on the rehabilitation process

Made available in DSpace on 2016-04-29T14:16:45Z (GMT). No. of bitstreams: 1 Viviane Duarte Correia.pdf: 2938227 bytes, checksum: 2783ac28709cfca4fd350f5a7e994220 (MD5) Previous issue date: 2015-10-05 / The Cerebral Palsy (CP) is the most common cause of severe disability in childhood. Understand the circumstances in with the children with CP live is one of the premises treated in the World Report s recommendations on Disability (2012). Therefore, this study presents an analysis of the social contribution of the International Classification of Functioning, Disability and Health (ICF) in children with Cerebral Plasy. General Purpose: Know the socioeconomic and demographic universes of the children with CP based on the ICF. Specific: Detect environmental and family factors that may affect the rehabilitation process, according to the health domain of ICF; contribute to the theoretical and methodological structure of the practice of social work in rehabilitation teams of people with disabilities. Methodology: This is quantitative, qualitative and descriptive study. The subjects are 25 children and youngs, between 0 and 18 years diagnosed with CP followed by the Physical Medicine and Reabilitation Institute, Lucy Montoro Network, in the units of the southern region of São Paulo city. A family caregiver of each child with CP, was interviewed by two instruments, prepared by the researcher: Socioeconomic and demographic profile of patients with cerebral palsy; and Social Assessment based on the International Classification of Functioning, Disability and Health. Results: The survey revealed that family arrangements could interfere with treatment in children with CP. Families of children with CP, subjects of this study, have lower incomes. The support received is given by the patient s nuclear family. Most of the patients had trouble in social interactions. The housing policy showed the worst indexes, followed by education policy. For transport and health policies, there was intensity variation, however, they were assessed as facilitating the context of life of the patient. Negative attitudes of society had the lowest scores evaluation. Conclusions: The CIF represents an appropriate assessment model to obtains subsidies, that are necessary and sensitive for the analysis of human -social reality, lived by a child with CP. Furthermore, it assists in identifying disabling barriers and allows an analysis on the provision of public services / A Paralisia Cerebral (PC) é causa mais comum de deficiência física grave na infância. Compreender as circunstâncias em que vivem as crianças com PC é umas das premissas tratadas nas recomendações do Relatório Mundial sobre a Deficiência (2012). Para tanto, este estudo apresenta uma análise social sobre a contribuição da Classificação Internacional de Funcionalidade, Incapacidade e Saúde (CIF) em crianças com PC. Objetivos Geral: Conhecer os universos sócio econômico e demográfico de crianças com PC, com base na CIF. Específicos: Detectar fatores socioambientais e familiares que possam interferir no processo de reabilitação, de acordo com os domínios de saúde da CIF; contribuir para a estruturação teórico-metodológica da prática do Serviço Social nas equipes de reabilitação da pessoa com deficiência. Metodologia: Trata-se de estudo quantitativo, qualitativo e descritivo. Tem como sujeitos 25 crianças e jovens, de 0 a 18 anos, diagnosticados com Paralisia Cerebral (PC), em acompanhamento no Instituto de Medicina Física e Reabilitação do HCFMUSP, Rede Lucy Montoro, nas unidades da região sul, do município de São Paulo. Foram entrevistados um familiar cuidador de cada criança, utilizando-se dois instrumentos, elaborados pela própria pesquisadora: Perfil socioeconômico e demográfico dos pacientes com Paralisia Cerebral e Avaliação Social com base na Classificação Internacional de Funcionalidade, Incapacidade e Saúde. Resultados: A pesquisa revelou que os arranjos familiares podem interferir no tratamento em reabilitação física da criança com PC. As famílias de crianças com PC, objetos deste estudo, têm menores rendas. O apoio recebido é dado, basicamente, pelo núcleo familiar do paciente. A maioria dos pacientes apresentou dificuldades de interações sociais. A política de habitação apresentou os piores índices, seguida da política de educação. Para as políticas de transporte e saúde, houve variação de intensidade, no entanto, foram avaliadas como facilitadores ao contexto de vida do paciente. Atitudes negativas da sociedade obtiveram os piores scores de avaliação. Conclusões: A CIF apresenta um modelo de avaliação apropriado à obtenção de subsídios, necessários e sensíveis à análise da realidade humano-social, vivida pela criança com PC. Outrossim, auxilia na identificação das barreiras incapacitantes e permite uma análise sobre a oferta de serviços públicos na região Sul do município de São Paulo

Os sistemas de farmacovigilância fundamentam as decisões sobre segurança no uso de medicamentos regulamentados por autoridades de saúde. Estudá-los e propor estratégias de melhorias contribuem para fortalecer os sistemas de saúde, aperfeiçoando a qualidade da assistência à saúde e assegurando a segurança do paciente e coletividade. A Tese objetivou analisar a evolução e desempenho do sistema brasileiro de farmacovigilância, denominado de SINAF, e as notificações dos pacientes com suspeitas de reações adversas a medicamentos (RAMs) registradas no Notivisa-medicamento no período de 2008 a 2013 e propor uma lista-referência de códigos da CID-10 para vigilância de RAMs e intoxicações medicamentosas (IMs). A Tese compreende seis artigos científicos organizados para publicação. No primeiro, uma revisão de escopo apresentou uma perspectiva histórica para caracterizar a evolução do SINAF e lacunas identificadas no processo, como a ausência de comissão de farmacovigilância que atenda aos requisitos mínimos de um sistema de farmacovigilância propostos pela Organização Mundial da Saúde. Os artigos 2, 3 e 4 analisaram características relacionadas com o desempenho do SINAF. O artigo 2 revelou que não há preferência digital da idade na base de dados das notificações de eventos adversos a medicamentos (EAMs) do Notivisa-medicamento. Mediante uma análise comparativa, o artigo 3 mostrou diferenças entre o formulário para notificação de EAMs utilizado no SINAF e de outros doze países latinoamericanos (Argentina, Bolívia, Chile, Colômbia, Costa Rica, Cuba, Guatemala, México, Panamá, Peru, Uruguai e Venezuela), sobretudo na quantidade de variáveis para preenchimento, podendo contribuir com a subnotificação de casos. No artigo 4 – um estudo de avaliação de sistemas de vigilância de saúde pública –, revelou que o desempenho do Notivisa-medicamento foi considerado satisfatório para três atributos (flexibilidade, validade e erro preditivo positivo) e deficitário para a maioria deles (simplicidade, aceitabilidade, representatividade, completude, consistência, oportunidade e clareza metodológica). O artigo 5, mediante estudo descritivo e retrospectivo, encontrou uma taxa de notificação de RAMs de 22,8/ 1 milhão de habitantes/ano. Trata-se de taxa bastante inferior a países de alta renda como Nova Zelândia, Suécia, Austrália e Suíça que possuem mais de 300 notificações por milhão, como em relação a países de média renda, como a África do Sul, com taxa de 77 por milhão de habitantes. A população feminina (60,5%) prevaleceu no total de pacientes (26.554), assim como, a raça/cor branca (58,1%). A idade variou de 0 a 112 anos (mediana = 46 anos). Quase 1/3 (32,5%) das suspeitas de RAMs ocorreram em populações vulneráveis (idosos e crianças). Foram avaliados 54.288 pares de medicamento-reação adversa, onde prevaleceram as reações adversas graves (59,2%), com destaque para as que resultaram em efeito clinicamente importante (83,1%). O estudo 6 propôs uma lista-referência com 691 códigos da CID-10, sendo 360 (52,1%) relacionados com RAMs e 331 (47,9%) com IMs. Um total de 511 (73,9%) códigos estão relacionados com casos de admissão hospitalar e/ou óbito. Os achados da Tese evidenciam a necessidade de mudanças em diferentes aspectos estudados do SINAF, como forma de contribuir na produção de informações completas, fidedignas e mais representativas sobre danos ocasionados por medicamentos comercializados no país. / The pharmacovigilance systems support the decisions on safety when using medications regulated by health authorities. Analyzing them and proposing improvement strategies are ways to make healthcare systems stronger, improving the quality of healthcare assistance, making sure the patient is safe and that the population is ensured. The dissertation was aimed at analyzing the evolution and performance of the Brazilian pharmacovigilance system, SINAF, and the notification of patients with suspected adverse drug reactions (ADRs) registered with the notification system NOTIVISA/medication from 2008 through 2013, as well as proposing a reference list of ICD-10 codes for surveillance of ADRs and intoxication due to medication (IDM). The dissertation is comprised of six scientific articles ready to be published. The first one, a scoping review, presents a historical perspective to demonstrate the development process of SINAF and the gaps identified during the process, such as the absence of a pharmacovigilance commission that complies with the minimum requirements of a pharmacovigilance system as proposed by World Health Organization. Articles 2, 3 and 4 presents an analysis of the performance-related characteristics of SINAF. Article 2 reveals that there is no digital age preference in the adverse drug events (ADEs) database belonging to NOTIVISA/medication. Using a comparative analysis, article 3 shows differences between the form for ADEs notification using SINAF and in other twelve Latin-American countries (Bolivia, Chile, Colombia, Costa Rica, Cuba, Guatemala, Mexico, Panama, Peru, Uruguay and Venezuela), highlighting the number of variables to complete, and it may collaborate with the sub-notification of cases. Article 4 – a study on the evaluation of public health surveillance systems over time – reveal that the performance of NOTIVISA/medication was considered satisfactory regarding three attributes (flexibility, validity and positive predictive error) and deficient regarding most of the others (simplicity, acceptability, representability, integrality, consistency, opportunity and methodological clarity). Article 5, by means of a descriptive and retrospective study, found an ADR notification rate of 22.8/million inhabitants/year. This is a much lower rate than in high income countries, such as New Zealand, Sweden, Australia and Switzerland, which have over 300 notifications per million, when compared against average income, such as South Africa, with a rate of 77/million inhabitants. Female population (60.5%) prevailed in the total number of patients (26,554), as well as white race/color (58.1%). Age was between 0 - 112 years old (median = 46 years). Almost 1/3 (32.5%) of the suspected ADRs occurred in vulnerable populations (elderly and children). 54,288 pairs of medication/adverse reactions were assessed. Severe adverse reactions prevailed (59.2%), and attention is drawn to those resulting in clinically important effect (83.1%). Study 6 proposes a reference list with 691 ICD-10 codes; 360 (52.1%) out of them are ADRs-related and 331 (47.9%) out of them are IDM. A total of 511 (73.9%) codes are related to cases of hospital admission and/or death. The dissertation findings prove the need of changes across different aspects in SINAF as a way to contribute to production of complete, reliable and representative information on damages caused by commercially available drugs in Brazil.