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1.
Lancet ; 374(9695): 1089-96, 2009 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-19782874

RESUMO

Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.


Assuntos
Difusão de Inovações , Procedimentos Cirúrgicos Operatórios , Avaliação da Tecnologia Biomédica , Pesquisa Biomédica , Estudos de Avaliação como Assunto , Medicina Baseada em Evidências , Humanos , Procedimentos Cirúrgicos Operatórios/métodos , Procedimentos Cirúrgicos Operatórios/estatística & dados numéricos
2.
Lancet ; 374(9695): 1105-12, 2009 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-19782876

RESUMO

Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.


Assuntos
Estudos de Avaliação como Assunto , Procedimentos Cirúrgicos Operatórios , Resultado do Tratamento , Pesquisa Biomédica , Ensaios Clínicos como Assunto , Políticas Editoriais , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Apoio à Pesquisa como Assunto , Procedimentos Cirúrgicos Operatórios/normas
3.
Lancet ; 374(9695): 1097-104, 2009 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-19782875

RESUMO

Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.


Assuntos
Pesquisa Biomédica , Procedimentos Cirúrgicos Operatórios , Atitude do Pessoal de Saúde , Viés , Competência Clínica , Ensaios Clínicos como Assunto , Estudos de Avaliação como Assunto , Cirurgia Geral , Humanos , Observação , Complicações Pós-Operatórias , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Operatórios/classificação , Procedimentos Cirúrgicos Operatórios/educação , Avaliação da Tecnologia Biomédica
4.
Am J Surg ; 183(4): 399-405, 2002 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-11975927

RESUMO

The intellectual infrastructures of evidence-based medicine (EBM) are the levels of evidence and the grades of recommendation for the following types of research articles: therapy/prevention, etiology/harm, prognosis, diagnosis, differential diagnosis/symptom prevalence study, economic analysis/decision analysis. The levels of evidence for therapy (1 to 5) progress from systematic reviews (with homogeneity) of randomized control trials (RCT) of high quality, level 1, to level 5-expert opinion without explicit critical appraisal, or based on physiology, bench research, or "first principles." The grades of recommendation (A, B, C, D) are founded on the quality of the evidence defined by its level. These grades are aimed at helping clinicians understand the source from whence came statements in, for example, guidelines. The development of surgical procedures and their introduction into practice has not depended upon the RCT but rather upon an enthusiast performing a case series, sometimes with clearly defined results. Should all operations and procedures be evaluated by an RCT? Clearly not, and the levels of evidence support this quite clearly with the "all or none" research category as level 1c. This relates to frequent clinical situations requiring a solution often immediate, eg, pus, a ruptured aneurysm, a sucking chest wound, that do not lend themselves to a trial, as the control regimen (doing nothing) would lead to death. Techniques evolve with experience usually based on an understanding of pathophysiology. At what point should an RCT enter into the resolution of surgical therapies? Can observational studies correctly designed and carried out do the job? Two new study classifications have been introduced: in level 1, category c "all or none" studies; and in level 2, category c "outcomes" research. In neither is there much definition. Are these the areas into which the evaluation of new surgical procedures and technology should be placed? The surgical community is faced with dramatic changes in technology and evolving techniques, and needs to define the rules of evidence applicable to their discipline with the same rigor that the EBM gurus have used, in order for surgeons to define evidence-based surgical practice.


Assuntos
Medicina Baseada em Evidências/classificação , Procedimentos Cirúrgicos Operatórios , Humanos , Guias de Prática Clínica como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Procedimentos Cirúrgicos Operatórios/métodos , Procedimentos Cirúrgicos Operatórios/normas , Avaliação da Tecnologia Biomédica
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