Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas
Autor(a) principal: | |
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Data de Publicação: | 2003 |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10451/32911 |
Resumo: | Randomized controlled trials (RCTs) constitute the methodological gold standard to generate therapeutic or preventive evidence. Diagnostic or prognostic evidence is given by studies with different designs, rather than RCTs. Given the structural design that a RCT must present to be valid--discussed in previous issues of the Journal--one major question is the applicability of trial results to populations or individual patients that are different from those analyzed in that trial. In other words, how does the cardiologist know whether to apply a specific treatment--whose efficacy and risk profile have been defined in a good quality RCT, i.e. one with valid and important results--to his/her individual patient? The simplest solution would be found in the answer to the question: "Could my patient have been enrolled in the study by satisfying its inclusion and exclusion criteria?" If the answer is "yes", then it would be sound to apply the study results to the patient, so long as it is done carefully. If the answer is "no" (because the patient presents different demographic features or serious comorbidities not found in the trial subjects, for example), then transfer of the therapeutic results from the trial would be seriously compromised. The evaluation of these questions is complex and, due to its importance, deserves a systematic approach. In this article we will present some practical guidelines on whether to reject the applicability of RCT results to patients who are different from those included in the trial. |
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Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticasApplicability of clinical trial results to the individual patient : practice guidelinesRandomized controlled trialsExternal validityApplicability of trial resultsEvidence-based cardiologyRandomized controlled trials (RCTs) constitute the methodological gold standard to generate therapeutic or preventive evidence. Diagnostic or prognostic evidence is given by studies with different designs, rather than RCTs. Given the structural design that a RCT must present to be valid--discussed in previous issues of the Journal--one major question is the applicability of trial results to populations or individual patients that are different from those analyzed in that trial. In other words, how does the cardiologist know whether to apply a specific treatment--whose efficacy and risk profile have been defined in a good quality RCT, i.e. one with valid and important results--to his/her individual patient? The simplest solution would be found in the answer to the question: "Could my patient have been enrolled in the study by satisfying its inclusion and exclusion criteria?" If the answer is "yes", then it would be sound to apply the study results to the patient, so long as it is done carefully. If the answer is "no" (because the patient presents different demographic features or serious comorbidities not found in the trial subjects, for example), then transfer of the therapeutic results from the trial would be seriously compromised. The evaluation of these questions is complex and, due to its importance, deserves a systematic approach. In this article we will present some practical guidelines on whether to reject the applicability of RCT results to patients who are different from those included in the trial.Os ensaios clínicos aleatorizados, prospectivos e controlados (randomized controlled trials – RCTs) constituem o gold-standard da metodologia para gerar evidência científica, mas predominantemente no caso de intervenções terapêuticas e/ou preventivas: no caso de estudos diagnósticos ou prognósticos, o desenho é completamente diverso. Dado o esquema estrutural a que um ensaio clínico deve obedecer para ser válido – matéria já discutida na Revista – uma questão primordial terá necessariamente que ver com a aplicabilidade dos resultados encontrados num RCT a populações e/ou doentes individuais, diferentes dos analisados nesse ensaio específico. Por outras palavras, como é que o cardiologista prático sabe quando deve utilizar num seu doente individual um determinado tratamento, cuja eficácia e risco foram definidos num RCT de boa qualidade, isto é, com resultados válidos e importantes? A solução mais simples seria encontrada na resposta à questão: «Será que o meu doente poderia ter participado – satisfazendo os critérios de inclusão e exclusão - no referido estudo?» Se a resposta fosse «sim», então a aplicabilidade dos achados do estudo ao doente assenta em terreno sólido, ainda que devesse ser feita com prudência. Se, pelo contrário, a resposta fosse «não» – porque o doente apresenta características demográficas muito diversas ou patologias concomitantes graves não presentes nos sujeitos do estudo, por exemplo – então a transferência dos dados terapêuticos fica muito comprometida. A análise destas questões não é fácil e merece, pela sua importância, uma abordagem sistematizada. Neste artigo iremos resumir algumas regras práticas no sentido de rejeição (ou não) da aplicabilidade dos resultados de um ensaio clínico a outros doentes, diferentes dos incluídos no estudo.Sociedade Portuguesa de CardiologiaRepositório da Universidade de LisboaCarneiro, António Vaz2018-04-19T15:56:31Z2003-022003-02-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/32911porRev Port Cardiol 2003;22 (2):259-2680870-2551info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-07-14T15:22:23ZPortal AgregadorONG |
dc.title.none.fl_str_mv |
Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas Applicability of clinical trial results to the individual patient : practice guidelines |
title |
Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas |
spellingShingle |
Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas Carneiro, António Vaz Randomized controlled trials External validity Applicability of trial results Evidence-based cardiology |
title_short |
Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas |
title_full |
Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas |
title_fullStr |
Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas |
title_full_unstemmed |
Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas |
title_sort |
Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas |
author |
Carneiro, António Vaz |
author_facet |
Carneiro, António Vaz |
author_role |
author |
dc.contributor.none.fl_str_mv |
Repositório da Universidade de Lisboa |
dc.contributor.author.fl_str_mv |
Carneiro, António Vaz |
dc.subject.por.fl_str_mv |
Randomized controlled trials External validity Applicability of trial results Evidence-based cardiology |
topic |
Randomized controlled trials External validity Applicability of trial results Evidence-based cardiology |
description |
Randomized controlled trials (RCTs) constitute the methodological gold standard to generate therapeutic or preventive evidence. Diagnostic or prognostic evidence is given by studies with different designs, rather than RCTs. Given the structural design that a RCT must present to be valid--discussed in previous issues of the Journal--one major question is the applicability of trial results to populations or individual patients that are different from those analyzed in that trial. In other words, how does the cardiologist know whether to apply a specific treatment--whose efficacy and risk profile have been defined in a good quality RCT, i.e. one with valid and important results--to his/her individual patient? The simplest solution would be found in the answer to the question: "Could my patient have been enrolled in the study by satisfying its inclusion and exclusion criteria?" If the answer is "yes", then it would be sound to apply the study results to the patient, so long as it is done carefully. If the answer is "no" (because the patient presents different demographic features or serious comorbidities not found in the trial subjects, for example), then transfer of the therapeutic results from the trial would be seriously compromised. The evaluation of these questions is complex and, due to its importance, deserves a systematic approach. In this article we will present some practical guidelines on whether to reject the applicability of RCT results to patients who are different from those included in the trial. |
publishDate |
2003 |
dc.date.none.fl_str_mv |
2003-02 2003-02-01T00:00:00Z 2018-04-19T15:56:31Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10451/32911 |
url |
http://hdl.handle.net/10451/32911 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
Rev Port Cardiol 2003;22 (2):259-268 0870-2551 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Sociedade Portuguesa de Cardiologia |
publisher.none.fl_str_mv |
Sociedade Portuguesa de Cardiologia |
dc.source.none.fl_str_mv |
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
instname_str |
Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
instacron_str |
RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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1777303345258561536 |