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license.txt: 581 bytes, checksum: 44ea52f0b7567232681c6e3d72285adc (MD5) / This paper discusses topics related to the planning and implementation of nonrandomised clinical studies in oral and maxillofacial surgery. A well-conducted case-series is appropriate to demonstrate the safety of a surgical intervention. The case-series design involves the provision of a defined intervention to a group of patients with the ultimate objective of describing the final outcome, including such occurrences as complications. There is no alternative procedure serving as a control. The key aspects are to ensure enrolment of all eligible patients and to obtain a sufficiently large sample size to allow precise and valid estimation of complication risks. Targeted complications should be clearly defined and fully documented during a pre-defined follow-up period. Loss to follow-up should be minimised.Comparative studies are required to demonstrate treatment effectiveness. If a randomised controlled trial (RCT) is not feasible, an observational design such as a cohort or a case-control study should be considered. In observational designs, the treatment decision is made by the surgeons. In a case-control study, patients are selected based on their outcomes and their treatment or exposure status is recorded retrospectively. In a cohort study, groups of patients are selected based on their treatment and are followed for outcomes. There are numerous variations. Data can be collected prospectively or retrospectively; comparison groups may be concurrent or non-concurrent, or studied at different locations. The optimal design is tailored to clinical questions and research settings, while keeping in mind the respective methodological strengths and weaknesses of available options. The strength of the observational study is its proximity to daily clinical practice. The limitations are the possibility of numerous biases and confounding factors. Despite many challenges to the internal validity of non-randomised studies in orthopaedics surgery, it is possible to use such designs in order to provide reasonably valid answers to clinically important questions. / [. . . ] Essa tese apresenta três artigos: o primeiro relacionado a estratégias no planejamento e na condução de estudos não aleatórios na Cirurgia e Traumatologia Bucomaxilofacial (CTBMF), esse artigo faz considerações sobre o tipo de pesquisa clínica adotada peculiarmente na área de CTBMF, considerando as dificuldades e limitações de se realizar estudos clínicos baseados em fortes evidências científicas nessa área; o segundo; uma revisão de literatura sobre o ameloblastoma enfocando os aspectos histopatológicos e as implicações clínicas na indicação dos tratamentos; e o terceiro é um estudo experimental em tíbias de ratos que avalia o reparo ósseo em cavidades submetidas ao contato com solução de Carnoy. O primeiro estudo avalia os possíveis desenhos e estratégias para se conduzir um estudo clínico. No caso de tratamento de ameloblastomas o melhor desenho que 10 proporcionará uma evidencia científica válida são séries-de-casos prospectivos e ou estudos coorte. O segundo artigo faz uma revisão da literatura sobre os tipos anatomopatológicos de ameloblastomas com o objetivo de determinar uma relação entre as características histológicas e o comportamento biológico do tumor. E finalmente, no terceiro artigo, a solução de Carnoy é testada experimentalmente em cavidades ósseas e as alterações no reparo ósseo são avaliadas, essa solução tem sido utilizada para diminuir a taxa de recidiva do ameloblastoma unicístico, após a enucleação do tumor [. . . ]
| Identifer | oai:union.ndltd.org:IBICT/urn:repox.ist.utl.pt:RI_PUC_RS:oai:meriva.pucrs.br:10923/477 |
| Date | January 2008 |
| Creators | Takahashi, André |
| Contributors | Pagnoncelli, Rogério Miranda |
| Publisher | Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre |
| Source Sets | IBICT Brazilian ETDs |
| Language | Portuguese |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, info:eu-repo/semantics/doctoralThesis |
| Source | reponame:Repositório Institucional da PUC_RS, instname:Pontifícia Universidade Católica do Rio Grande do Sul, instacron:PUC_RS |
| Rights | info:eu-repo/semantics/openAccess |
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