Design issues in a non-regulatory trial.
J Long Term Eff Med Implants
; 19(3): 223-33, 2009.
Article
em En
| MEDLINE
| ID: mdl-20939783
ABSTRACT
Randomized, controlled trials (RCTs) represent the highest level of evidence attainable. Although up to 60% of clinical questions cannot be answered by an RCT, it is still the ideal method of comparing orthopedic implants. The strength of the findings of RCTs is a result of the investigators ability to limit bias through careful attention to study design. Bias may be limited through randomization, allocation concealment, and blinding. Unfortunately, RCTs involving different surgical techniques or implants present many challenges that may introduce bias and threaten the validity of study results. The purpose of this review is to outline these issues and present possible solutions to these challenges, with the ultimate goal of improving surgeons understanding of how to design and critically appraise RCTs involving orthopedic implants.
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Base de dados:
MEDLINE
Assunto principal:
Ortopedia
/
Próteses e Implantes
/
Ensaios Clínicos Controlados Aleatórios como Assunto
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Ano de publicação:
2009
Tipo de documento:
Article