Reliability and Completeness of Medical Charts as to Events or Adverse Reactions in Clinical Research

Detalhes bibliográficos
Autor(a) principal: Sarmento, Roberta Monteiro Batista
Data de Publicação: 2011
Outros Autores: Obadia, Renata de Castro Moura, Camacho, Patrícia Gonçalves, Rocha, Manuela Rios de Lima, Thuler, Luiz Claudio Santos
Tipo de documento: Artigo
Idioma: por
Título da fonte: Revista Brasileira de Cancerologia (Online)
Texto Completo: https://rbc.inca.gov.br/index.php/revista/article/view/654
Resumo: Introdution: For a clinical trial to be properly, safely and efficiently conducted, it is necessary that research integrity be preserved. Therefore, some specific information is essential, including events or adverse reactions. Objectives: To analyze the degree of reliability and completeness of medical records in relation to medical and nursing records according to selected aspects of the events or adverse events experienced by the research subjects; to verify the existence of start and end dates of events or adverse reactions reported by doctors; to observe the presence of graduation of events or adverse reactions in medical reports; to notice if there is data in medical records that relate the events or adverse reactions to the investigational drug; to identify the degree/rate of agreement between the physician and nurses reporting in the records of events or adverse reactions. Method: Documental, exploratory and descriptive study. The sample consisted of 40 charts of patients enrolled in the Brazilian National Cancer Institute who participated in clinical research protocols between 2005 and 2006. Results: 828 events were identified and only 1.5% of those which were recorded by research professionals had start and end dates, graduation, and relationship/causality; 30.3% of events were recorded in conformity by nurses and doctors. Conclusion: There are many reasons why adverse events are not efficiently captured, but efforts are needed to improve quality of clinical trial data and compliance with regulatory requirements aiming to protect research subjects.  
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spelling Reliability and Completeness of Medical Charts as to Events or Adverse Reactions in Clinical ResearchFidedignidad y Completud de los Prontuarios Médicos con respecto a los Eventos o Reacciones Adversas en Investigación ClínicaFidedignidade e Completude dos Prontuários Médicos em Relação aos Eventos ou Reações Adversas em Pesquisa ClínicaEnsaio ClínicoToxicidade de DrogasNeoplasiasRegistros MédicosRegistros de EnfermagemClinical TrialDrug ToxicityNeoplasmsMedical RecordsNursing RecordsEnsayo ClínicoToxicidad de MedicamentosNeoplasiasRegistros MédicosRegistros de EnfermeríaIntrodution: For a clinical trial to be properly, safely and efficiently conducted, it is necessary that research integrity be preserved. Therefore, some specific information is essential, including events or adverse reactions. Objectives: To analyze the degree of reliability and completeness of medical records in relation to medical and nursing records according to selected aspects of the events or adverse events experienced by the research subjects; to verify the existence of start and end dates of events or adverse reactions reported by doctors; to observe the presence of graduation of events or adverse reactions in medical reports; to notice if there is data in medical records that relate the events or adverse reactions to the investigational drug; to identify the degree/rate of agreement between the physician and nurses reporting in the records of events or adverse reactions. Method: Documental, exploratory and descriptive study. The sample consisted of 40 charts of patients enrolled in the Brazilian National Cancer Institute who participated in clinical research protocols between 2005 and 2006. Results: 828 events were identified and only 1.5% of those which were recorded by research professionals had start and end dates, graduation, and relationship/causality; 30.3% of events were recorded in conformity by nurses and doctors. Conclusion: There are many reasons why adverse events are not efficiently captured, but efforts are needed to improve quality of clinical trial data and compliance with regulatory requirements aiming to protect research subjects.  Introducción: Para que un ensayo clínico sea conducido de forma adecuada, segura y eficiente, es necesaria que la integridad de la investigación sea preservada. Por lo tanto, algunas informaciones específicas son imprescindibles, entre ellas los eventos o reacciones adversas. Objetivos: Analizar el grado de confiabilidad y de completitud de los prontuarios médicos en relación con los registros médicos y de los enfermeros de acuerdo con los aspectos seleccionados de los eventos o reacciones adversas experimentadas por los sujetos de la investigación; averiguar la existencia de fechas de inicio y término de los eventos o reacciones adversas relatadas por los médicos; observar la presencia de la graduación de los eventos o reacciones adversas en las fichas médicas; constatar si existen datos en las fichas médicas que relacionen los eventos o reacciones adversas a la droga en investigación; identificar el grado/porcentual de concordancia entre el relato del médico y del enfermero. Identificar el grado/porcentual de concordancia entre el relato médico y del enfermero en los registros de eventos o reacciones adversas. Método: Estudio documental, exploratorio, descriptivo. La casuística consistió en 40 prontuarios de pacientes apuntados en el Instituto Nacional de Cáncer que participaron en los protocolos de Investigación Clínica entre 2005 y 2006. Resultados: Fueron identificados 828 eventos y sólo el 1,5% de los registrados por los profesionales de investigación presentaban fecha de inicio y fin, graduación y relación/ causalidad; 30,3% de los eventos fueron registrados en conformidad por los enfermeros y por los médicos. Conclusión: Son muchos los motivos por los cuales los eventos adversos no son capturados de forma eficiente, sin embargo son necesarios esfuerzos para que la calidad de los datos de estudios clínicos y para que el cumplimiento de las exigencias regulatorias sean garantizadas y la protección a los sujetos de la investigación lograda.  Introdução: Para que um ensaio clínico seja conduzido de forma adequada, segura e eficiente, é necessário que a integridade da pesquisa seja preservada. Portanto, algumas informações específicas são imprescindíveis, entre elas, os eventos ou reações adversas. Objetivos: Analisar o grau de fidedignidade e de completude dos prontuários médicos em relação aos registros médicos e dos enfermeiros de acordo com os aspectos selecionados dos eventos ou reações adversas experimentados pelos sujeitos de pesquisa; verificar a existência das datas de início e término dos ventos ou reações adversas relatados pelos médicos; observar a presença da graduação dos eventos ou reações adversas nos relatórios médicos; constatar se existem dados nos relatórios médicos que relacionem os eventos ou reações adversas com a droga investigacional; identificar o grau/percentual de concordância entre o relato médico e do enfermeiro nos registros de eventos ou reações adversas. Método: Estudo documental, exploratório, descritivo. A casuística constituiu-se de 40 prontuários de pacientes matriculados no Instituto Nacional de Câncer José Alencar Gomes da Silva que participaram de protocolos de Pesquisa Clínica entre 2005 e 2006. Resultados: Foram identificados 828 eventos e apenas 1,5% dos que foram registrados pelos profissionais de pesquisa apresentava data de início e fim, graduação e relação/causalidade; 30,3% dos eventos foram registrados em conformidade pelos enfermeiros e pelos médicos. Conclusão: Muitos são os motivos pelos quais os eventos adversos não são capturados de forma eficiente, porém esforços são necessários para que a qualidade dos dados de estudos clínicos e o cumprimento das exigências regulatórias sejam garantidos visando a proteger os sujeitos de pesquisa.  INCA2011-12-30info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionArtigos, Avaliado pelos paresapplication/pdfhttps://rbc.inca.gov.br/index.php/revista/article/view/65410.32635/2176-9745.RBC.2011v57n4.654Revista Brasileira de Cancerologia; Vol. 57 No. 4 (2011): Oct./Nov./Dec.; 535-540Revista Brasileira de Cancerologia; Vol. 57 Núm. 4 (2011): oct./nov./dic.; 535-540Revista Brasileira de Cancerologia; v. 57 n. 4 (2011): out./nov./dez. ; 535-5402176-9745reponame:Revista Brasileira de Cancerologia (Online)instname:Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA)instacron:INCAporhttps://rbc.inca.gov.br/index.php/revista/article/view/654/434Sarmento, Roberta Monteiro Batista Obadia, Renata de Castro MouraCamacho, Patrícia Gonçalves Rocha, Manuela Rios de Lima Thuler, Luiz Claudio Santos info:eu-repo/semantics/openAccess2021-11-29T20:15:36Zoai:rbc.inca.gov.br:article/654Revistahttps://rbc.inca.gov.br/index.php/revistaPUBhttps://rbc.inca.gov.br/index.php/revista/oairbc@inca.gov.br0034-71162176-9745opendoar:2021-11-29T20:15:36Revista Brasileira de Cancerologia (Online) - Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA)false
dc.title.none.fl_str_mv Reliability and Completeness of Medical Charts as to Events or Adverse Reactions in Clinical Research
Fidedignidad y Completud de los Prontuarios Médicos con respecto a los Eventos o Reacciones Adversas en Investigación Clínica
Fidedignidade e Completude dos Prontuários Médicos em Relação aos Eventos ou Reações Adversas em Pesquisa Clínica
title Reliability and Completeness of Medical Charts as to Events or Adverse Reactions in Clinical Research
spellingShingle Reliability and Completeness of Medical Charts as to Events or Adverse Reactions in Clinical Research
Sarmento, Roberta Monteiro Batista
Ensaio Clínico
Toxicidade de Drogas
Neoplasias
Registros Médicos
Registros de Enfermagem
Clinical Trial
Drug Toxicity
Neoplasms
Medical Records
Nursing Records
Ensayo Clínico
Toxicidad de Medicamentos
Neoplasias
Registros Médicos
Registros de Enfermería
title_short Reliability and Completeness of Medical Charts as to Events or Adverse Reactions in Clinical Research
title_full Reliability and Completeness of Medical Charts as to Events or Adverse Reactions in Clinical Research
title_fullStr Reliability and Completeness of Medical Charts as to Events or Adverse Reactions in Clinical Research
title_full_unstemmed Reliability and Completeness of Medical Charts as to Events or Adverse Reactions in Clinical Research
title_sort Reliability and Completeness of Medical Charts as to Events or Adverse Reactions in Clinical Research
author Sarmento, Roberta Monteiro Batista
author_facet Sarmento, Roberta Monteiro Batista
Obadia, Renata de Castro Moura
Camacho, Patrícia Gonçalves
Rocha, Manuela Rios de Lima
Thuler, Luiz Claudio Santos
author_role author
author2 Obadia, Renata de Castro Moura
Camacho, Patrícia Gonçalves
Rocha, Manuela Rios de Lima
Thuler, Luiz Claudio Santos
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Sarmento, Roberta Monteiro Batista
Obadia, Renata de Castro Moura
Camacho, Patrícia Gonçalves
Rocha, Manuela Rios de Lima
Thuler, Luiz Claudio Santos
dc.subject.por.fl_str_mv Ensaio Clínico
Toxicidade de Drogas
Neoplasias
Registros Médicos
Registros de Enfermagem
Clinical Trial
Drug Toxicity
Neoplasms
Medical Records
Nursing Records
Ensayo Clínico
Toxicidad de Medicamentos
Neoplasias
Registros Médicos
Registros de Enfermería
topic Ensaio Clínico
Toxicidade de Drogas
Neoplasias
Registros Médicos
Registros de Enfermagem
Clinical Trial
Drug Toxicity
Neoplasms
Medical Records
Nursing Records
Ensayo Clínico
Toxicidad de Medicamentos
Neoplasias
Registros Médicos
Registros de Enfermería
description Introdution: For a clinical trial to be properly, safely and efficiently conducted, it is necessary that research integrity be preserved. Therefore, some specific information is essential, including events or adverse reactions. Objectives: To analyze the degree of reliability and completeness of medical records in relation to medical and nursing records according to selected aspects of the events or adverse events experienced by the research subjects; to verify the existence of start and end dates of events or adverse reactions reported by doctors; to observe the presence of graduation of events or adverse reactions in medical reports; to notice if there is data in medical records that relate the events or adverse reactions to the investigational drug; to identify the degree/rate of agreement between the physician and nurses reporting in the records of events or adverse reactions. Method: Documental, exploratory and descriptive study. The sample consisted of 40 charts of patients enrolled in the Brazilian National Cancer Institute who participated in clinical research protocols between 2005 and 2006. Results: 828 events were identified and only 1.5% of those which were recorded by research professionals had start and end dates, graduation, and relationship/causality; 30.3% of events were recorded in conformity by nurses and doctors. Conclusion: There are many reasons why adverse events are not efficiently captured, but efforts are needed to improve quality of clinical trial data and compliance with regulatory requirements aiming to protect research subjects.  
publishDate 2011
dc.date.none.fl_str_mv 2011-12-30
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
Artigos, Avaliado pelos pares
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://rbc.inca.gov.br/index.php/revista/article/view/654
10.32635/2176-9745.RBC.2011v57n4.654
url https://rbc.inca.gov.br/index.php/revista/article/view/654
identifier_str_mv 10.32635/2176-9745.RBC.2011v57n4.654
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://rbc.inca.gov.br/index.php/revista/article/view/654/434
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 INCA
publisher.none.fl_str_mv INCA
dc.source.none.fl_str_mv Revista Brasileira de Cancerologia; Vol. 57 No. 4 (2011): Oct./Nov./Dec.; 535-540
Revista Brasileira de Cancerologia; Vol. 57 Núm. 4 (2011): oct./nov./dic.; 535-540
Revista Brasileira de Cancerologia; v. 57 n. 4 (2011): out./nov./dez. ; 535-540
2176-9745
reponame:Revista Brasileira de Cancerologia (Online)
instname:Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA)
instacron:INCA
instname_str Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA)
instacron_str INCA
institution INCA
reponame_str Revista Brasileira de Cancerologia (Online)
collection Revista Brasileira de Cancerologia (Online)
repository.name.fl_str_mv Revista Brasileira de Cancerologia (Online) - Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA)
repository.mail.fl_str_mv rbc@inca.gov.br
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