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Systematic Review in Drug's Safety and Clinical

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Systematic Review in Drug's Safety and Clinical Ana Sofia Martins Penedones SYSTEMATIC REVIEW: METHODOLOGICAL ASPECTS OF ITS ROLE IN DRUG SAFETY ASSESSMENT Tese no âmbito do Doutoramento em Ciências Farmacêuticas, ramo de Farmácia Clínica orientada pelo Professor Doutor Francisco Jorge Batel Marques e apresentada à Faculdade de Farmácia da Universidade de Coimbra. Março de 2020 Faculdade de Farmácia da Universidade de Coimbra Systematic review: methodological aspects of its role in drug safety assessment Ana Sofia Martins Penedones Tese no âmbito do Doutoramento em Ciências Farmacêuticas, ramo de Farmácia Clínica orientada pelo Professor Doutor Francisco Jorge Batel Marques e apresentada à Faculdade de Farmácia da Universidade de Coimbra. Março de 2020 2 All the research work presented in this thesis was performed in strict collaboration of the Laboratory of Social Pharmacy and Public Health, Faculty of Pharmacy, University of Coimbra and the Centre for Health Technology Assessment and Drug Research, Association for Innovation and Biomedical Research on Light and Image, under the supervision of Professor Francisco Jorge Batel Marques. Todos os trabalhos apresentados nesta tese foram realizados em estreita colaboração entre o Laboratório de Sociofarmácia e Saúde Pública da Faculdade de Farmácia da Universidade de Coimbra e o Centro de Avaliação de Tecnologias em Saúde e Investigação do Medicamento da Associação para Investigação Biomédica e Inovação em Luz e Imagem, sob a supervisão do Professor Doutor Francisco Jorge Batel Marques. 3 4 Agradecimentos Ao meu orientador, Professor Doutor Francisco Batel Marques, pela oportunidade em integrar o seu grupo de trabalho no CHAD – Centre for Health Technology Assessment and Drug Research na AIBILI – Innovation and Biomedical Research on Light and Image. Pelo seu voto de confiança ao longo destes anos, que me permitiram um crescimento profissional e pessoal. Obrigada pelo desafio proposto, por todos os momentos de aprendizagem, pelos bons ensinamentos e orientação científica. Por todos os conselhos, motivação e paciência demonstrados. Ao Professor Doutor Carlos Alves pelo seu valioso contributo na realização deste projeto, pela sua disponibilidade e paciência no esclarecimento de qualquer dúvida. Ao Doutor Diogo Mendes pela interajuda nas tarefas do CHAD e pela sua boa disposição. A todos os elementos da equipa do CHAD agradeço a amizade, companheirismo, troca de ideias, momentos de discussão e desabafos. À AIBILI, instituição que me acolheu, pela forma como fui recebida, pela oportunidade em integrar a sua equipa, pela sua preciosa contribuição neste projeto e a todos os seus colaboradores pela simpatia e disponibilidade demonstradas. À Faculdade de Farmácia da Universidade de Coimbra pela oportunidade e pelos recursos disponibilizados para realizar este projeto. A todos os meus amigos que me acompanham desde o início desta fase académica. Por todas os conselhos e palavras de alento. Pela sua amizade e cumplicidade vividas. À minha família, em especial aos meus avós, pais e irmã, pelo seu apoio, pela motivação e paciência e por nunca terem deixado de acreditar em mim. Ao meu avô que em pequenina me falava do prestígio da Universidade de Coimbra e dos seus doutores. Obrigada a todos! 5 6 Table of Contents Agradecimentos................................................................................................................................... 5 Table of Contents ............................................................................................................................... 7 List of Figures ..................................................................................................................................... 11 List of Tables ...................................................................................................................................... 13 List of Abbreviations ........................................................................................................................ 15 Publications ......................................................................................................................................... 17 Abstract ............................................................................................................................................... 19 Resumo ............................................................................................................................................... 21 Chapter I - Systematic Review ....................................................................................................... 23 1.1. Definition............................................................................................................................... 23 1.2. Historical framework ......................................................................................................... 23 1.3. The need to perform a systematic review .................................................................... 24 1.4. Characteristics of systematic review .............................................................................. 26 1.4.1. Meta-analysis ..................................................................................................................... 26 1.5. How to perform a systematic review ............................................................................. 27 1.5.1. Recommendations to perform and/ or to report a systematic review ............... 27 1.5.2. Steps to perform a systematic review ......................................................................... 27 1.6. Limitations of systematic reviews .................................................................................... 35 1.7. References ............................................................................................................................ 36 Chapter 2 - Systematic Review in drug’s safety and clinical assessment .............................. 41 2.1. Pharmacovigilance ............................................................................................................... 41 2.2. Methods in Pharmacovigilance ......................................................................................... 44 2.3. Role of systematic review in pharmacovigilance .......................................................... 46 2.5. Objectives of this thesis ..................................................................................................... 48 2.7. References ............................................................................................................................ 49 Chapter 3 - Recommendations to conduct and report systematic reviews in medical literature: a scoping review ............................................................................................................ 53 7 Table of Contents 3.1. Abstract ................................................................................................................................ 53 3.2. Introduction ......................................................................................................................... 53 3.3. Methods ................................................................................................................................ 55 3.3.1. Literature search and data selection ........................................................................... 55 3.3.2. Data extraction ................................................................................................................ 56 3.3.3. Data analysis...................................................................................................................... 56 3.4. Results ................................................................................................................................... 57 3.5. Discussion ............................................................................................................................. 61 3.6. Conclusion ........................................................................................................................... 65 3.7. References ............................................................................................................................ 66 3.8. Appendix ............................................................................................................................... 69 Chapter 4 - Methodologic Assessment of the Systematic Reviews of Ophthalmic Adverse Drug Reactions Published in Ophthalmology Journals: A Systematic Review .................... 93 4.1. Abstract ................................................................................................................................ 93 4.2. Introduction ......................................................................................................................... 93 4.3. Methods ................................................................................................................................ 95 4.3.1. Literature Search and Data Selection ......................................................................... 95 4.3.2. Data Extraction and Quality Assessment ................................................................... 96 4.3.3. Data Analysis .................................................................................................................... 96 4.4. Results ................................................................................................................................... 96 4.5. Discussion
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    chromosome be active in a sufficient proportion of cells 9. Schwartz M, Yang HM, Niebuhr E, Rosenberg T, Page DC. in a tissue in which the gene is expressed then a female Regional localisation of polymorphic DNA loci on the proximal long arm of the X chromosome using deletions may manifest the disease in that tissue. If cells of only associated with choroideremia. Hum Genet 1988;78:156-60. parts of that tissue are affected then a mosaic pattern may 10. Van Bokhoven H, Van den Hurk JA, Bogerd L, Philippe C. be demonstrated. The X-inactivation ratio determines the Gilgenkrantz S, DeJong P, et al. Cloning and characterisation degree to which the tissue is affected and in our patient of the human choroideremia gene. Hum Mol Genet 1994;3:1041-6. could explain the laterality of involvement. 11. Lyon MF. Gene action in the X-chromosome of the mouse It might be argued that these changes are due to other (Mus musculus). Nature 1961;190:372. causes. Age-related macular degeneration is a possibility; 12. Jay B. X-linked retinal disorders and the Lyon hypothesis. however, the relatively early age of onset, paucity of Trans Ophthalmol Soc UK 1985;104:836-44. drusen and marked asymmetry of the macular findings 13. Flannery JG, Bird AC, Farber DB, Weleber RG, Bok D. A histopathologic study of a choroideremia carrier. Invest are somewhat atypical. Serpiginous choroiditis Ophthalmol Vis Sci 1990;31:229-36. commencing at and involving solely the macular region 14. Mansour AM, Jampol LM, Packo KH, Hrisomalos NF. has been described.l4,ls Involvement is bilateral, Macular serpiginous choroiditis.
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