Publicação
Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas
| 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. |
|---|---|
| Autores principais: | Carneiro, António Vaz |
| Assunto: | Randomized controlled trials External validity Applicability of trial results Evidence-based cardiology |
| Ano: | 2003 |
| País: | Portugal |
| Tipo de documento: | artigo |
| Tipo de acesso: | acesso aberto |
| Instituição associada: | Universidade de Lisboa |
| Idioma: | português |
| Origem: | Repositório da Universidade de Lisboa |
| _version_ | 1866810328994545664 |
|---|---|
| author | Carneiro, António Vaz |
| author_facet | Carneiro, António Vaz |
| author_role | author |
| contributor_name_str_mv | Repositório Científico de Acesso Aberto da ULisboa |
| country_str | PT |
| creators_json_txt | [{\"Person.name\":\"Carneiro, António Vaz\",\"Person.identifier.orcid\":\"0000-0002-2783-0544\"}] |
| datacite.contributors.contributor.contributorName.fl_str_mv | Repositório Científico de Acesso Aberto da ULisboa |
| datacite.creators.creator.creatorName.fl_str_mv | Carneiro, António Vaz |
| datacite.date.Accepted.fl_str_mv | 2003-02-01T00:00:00Z |
| datacite.date.available.fl_str_mv | 2018-04-19T15:56:31Z |
| datacite.date.embargoed.fl_str_mv | 2018-04-19T15:56:31Z |
| datacite.rights.fl_str_mv | http://purl.org/coar/access_right/c_abf2 |
| datacite.subjects.subject.fl_str_mv | Randomized controlled trials External validity Applicability of trial results Evidence-based cardiology |
| datacite.titles.title.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 |
| dc.contributor.none.fl_str_mv | Repositório Científico de Acesso Aberto da ULisboa |
| dc.creator.none.fl_str_mv | Carneiro, António Vaz |
| dc.date.Accepted.fl_str_mv | 2003-02-01T00:00:00Z |
| dc.date.available.fl_str_mv | 2018-04-19T15:56:31Z |
| dc.date.embargoed.fl_str_mv | 2018-04-19T15:56:31Z |
| dc.format.none.fl_str_mv | application/pdf |
| dc.identifier.none.fl_str_mv | http://hdl.handle.net/10451/32911 |
| dc.language.none.fl_str_mv | por |
| dc.publisher.none.fl_str_mv | Sociedade Portuguesa de Cardiologia |
| dc.rights.none.fl_str_mv | http://purl.org/coar/access_right/c_abf2 |
| dc.subject.none.fl_str_mv | Randomized controlled trials External validity Applicability of trial results Evidence-based cardiology |
| dc.title.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 |
| dc.type.none.fl_str_mv | http://purl.org/coar/resource_type/c_6501 |
| 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. |
| dirty | 0 |
| eu_rights_str_mv | openAccess |
| format | article |
| fulltext.url.fl_str_mv | https://repositorio.ulisboa.pt/bitstreams/df7a4340-4aea-402b-ac3f-431c9c2b47c6/download |
| id | ul_72f77e41a229119ca014ba2f2fcd472a |
| identifier.url.fl_str_mv | http://hdl.handle.net/10451/32911 |
| instacron_str | ul |
| institution | Universidade de Lisboa |
| instname_str | Universidade de Lisboa |
| language | por |
| network_acronym_str | ul |
| network_name_str | Repositório da Universidade de Lisboa |
| oai_identifier_str | oai:repositorio.ulisboa.pt:10451/32911 |
| organization_str_mv | urn:organizationAcronym:ul |
| person_str_mv | Carneiro, António Vaz Carneiro, António Vaz http://orcid.org/0000-0002-2783-0544 0000-0002-2783-0544 |
| publishDate | 2003 |
| publisher.none.fl_str_mv | Sociedade Portuguesa de Cardiologia |
| reponame_str | Repositório da Universidade de Lisboa |
| repository_id_str | urn:repositoryAcronym:ul |
| service_str_mv | urn:repositoryAcronym:ul |
| spelling | porSociedade Portuguesa de Cardiologiapt_PTRandomized 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.application/pdfpt_PTAplicação ao doente individual dos resultados dos ensaios clínicos : regras práticasAlternativeTitlept_PTApplicability of clinical trial results to the individual patient : practice guidelinesPersonalCarneiro, António VazDSpacehttp://dspace.org/items/376d157f-1127-4663-9d99-038dac28f37dDSpacehttp://dspace.org/items/376d157f-1127-4663-9d99-038dac28f37dVaz CarneiroAntónioORCIDhttp://orcid.org0000-0002-2783-0544Researcher IDhttps://www.researcherid.comL-8026-2013Scopus Author IDhttps://www.scopus.com7006837792HostingInstitutionOrganizationalRepositório Científico de Acesso Aberto da ULisboae-mailmailto:repositorio@reitoria.ulisboa.ptrepositorio@reitoria.ulisboa.ptISSNIsPartOf0870-25512018-04-19T15:56:31Z2003-022003-02-01T00:00:00ZHandlehttp://hdl.handle.net/10451/32911http://purl.org/coar/access_right/c_abf2open accessRandomized controlled trialsExternal validityApplicability of trial resultsEvidence-based cardiology52924 bytesliteraturehttp://purl.org/coar/resource_type/c_6501journal articlehttp://purl.org/coar/access_right/c_abf2application/pdffulltexthttps://repositorio.ulisboa.pt/bitstreams/df7a4340-4aea-402b-ac3f-431c9c2b47c6/downloadRevista Portuguesa de Cardiología222259268 |
| 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 |
| status | SINGLETON |
| subject.fl_str_mv | Randomized controlled trials External validity Applicability of trial results Evidence-based cardiology |
| title | 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_short | Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas |
| title_sort | Aplicação ao doente individual dos resultados dos ensaios clínicos : regras práticas |
| topic | Randomized controlled trials External validity Applicability of trial results Evidence-based cardiology |
| topic_facet | Randomized controlled trials External validity Applicability of trial results Evidence-based cardiology |
| url | http://hdl.handle.net/10451/32911 |
| visible | 1 |