Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health Cohort study protocol

Introduction: Prostate-specific antigen (PSA) is the main tool for early detection, risk stratification and monitoring of prostate cancer (PCa). However, there are controversies about the use ofPSAas a population screening test because of the high potential for overdiagnosis and overtreatment associ...

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Autores: Bernal-Soriano, MC, Parker, LA, Lopez-Garrigos, M, Hernandez-Aguado, I, Caballero-Romeu, JP, Gomez-Perez, L, Alfayate-Guerra, R, Pastor-Valero, M, Garcia, N, Lumbreras, B
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2019
País:España
Institución:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p13180
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/13180
Access Level:acceso abierto
Palabra clave:false negative reactions
false positive reactions
prostate disease
prostate-specific antigen
quality in health care
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spelling Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health Cohort study protocolBernal-Soriano, MCParker, LALopez-Garrigos, MHernandez-Aguado, ICaballero-Romeu, JPGomez-Perez, LAlfayate-Guerra, RPastor-Valero, MGarcia, NLumbreras, Bfalse negative reactionsfalse positive reactionsprostate diseaseprostate-specific antigenquality in health careIntroduction: Prostate-specific antigen (PSA) is the main tool for early detection, risk stratification and monitoring of prostate cancer (PCa). However, there are controversies about the use ofPSAas a population screening test because of the high potential for overdiagnosis and overtreatment associated. The net benefit of screening is unclear and according to the available recommendations, it should be offered to well-informedmen with an adequate health status and a life-expectancy of at least 10 years or tomen at elevated risk of having PCa. In addition, the factors that influence test results are unclear, as is impact of false positive or negative results on patient health. Our objective is to assess the clinical and analytical factors associated with the presence of false positive and false negative results and the diagnostic/therapeutic process followed by these patients. Methods and analysis: A prospective observational cohort study will be carried out. We will include a cohort of patients with a positive PSA result (1.081 patients) and a sample of patients with negative results (572 patients); both will be followed for 2 years by reviewingmedical records to assess the variables associated with these results, as well as characteristics of patient management after a positive PSA value. We will include those patients with a PSA determination from2 hospitals in the Valencian Community. Patients who have been previously diagnosed with prostate cancer or who are being followed for previous high PSA values will be excluded. Discussion: The study will estimate the frequency of false positive and false negative PSA results in routine clinical practice, and allow us to quantify the potential harm caused. Study registration: Clinicaltrials.gov (https://clinicaltrials.gov/): NCT03978299, June 7, 2019.LIPPINCOTT WILLIAMS & WILKINS2019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/13180MEDICINEISSN: 00257974ISSNe: 15365964reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p131802026-06-11T12:45:17Z
dc.title.none.fl_str_mv Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health Cohort study protocol
title Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health Cohort study protocol
spellingShingle Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health Cohort study protocol
Bernal-Soriano, MC
false negative reactions
false positive reactions
prostate disease
prostate-specific antigen
quality in health care
title_short Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health Cohort study protocol
title_full Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health Cohort study protocol
title_fullStr Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health Cohort study protocol
title_full_unstemmed Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health Cohort study protocol
title_sort Factors associated with false negative and false positive results of prostate-specific antigen (PSA) and the impact on patient health Cohort study protocol
dc.creator.none.fl_str_mv Bernal-Soriano, MC
Parker, LA
Lopez-Garrigos, M
Hernandez-Aguado, I
Caballero-Romeu, JP
Gomez-Perez, L
Alfayate-Guerra, R
Pastor-Valero, M
Garcia, N
Lumbreras, B
author Bernal-Soriano, MC
author_facet Bernal-Soriano, MC
Parker, LA
Lopez-Garrigos, M
Hernandez-Aguado, I
Caballero-Romeu, JP
Gomez-Perez, L
Alfayate-Guerra, R
Pastor-Valero, M
Garcia, N
Lumbreras, B
author_role author
author2 Parker, LA
Lopez-Garrigos, M
Hernandez-Aguado, I
Caballero-Romeu, JP
Gomez-Perez, L
Alfayate-Guerra, R
Pastor-Valero, M
Garcia, N
Lumbreras, B
author2_role author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv false negative reactions
false positive reactions
prostate disease
prostate-specific antigen
quality in health care
topic false negative reactions
false positive reactions
prostate disease
prostate-specific antigen
quality in health care
description Introduction: Prostate-specific antigen (PSA) is the main tool for early detection, risk stratification and monitoring of prostate cancer (PCa). However, there are controversies about the use ofPSAas a population screening test because of the high potential for overdiagnosis and overtreatment associated. The net benefit of screening is unclear and according to the available recommendations, it should be offered to well-informedmen with an adequate health status and a life-expectancy of at least 10 years or tomen at elevated risk of having PCa. In addition, the factors that influence test results are unclear, as is impact of false positive or negative results on patient health. Our objective is to assess the clinical and analytical factors associated with the presence of false positive and false negative results and the diagnostic/therapeutic process followed by these patients. Methods and analysis: A prospective observational cohort study will be carried out. We will include a cohort of patients with a positive PSA result (1.081 patients) and a sample of patients with negative results (572 patients); both will be followed for 2 years by reviewingmedical records to assess the variables associated with these results, as well as characteristics of patient management after a positive PSA value. We will include those patients with a PSA determination from2 hospitals in the Valencian Community. Patients who have been previously diagnosed with prostate cancer or who are being followed for previous high PSA values will be excluded. Discussion: The study will estimate the frequency of false positive and false negative PSA results in routine clinical practice, and allow us to quantify the potential harm caused. Study registration: Clinicaltrials.gov (https://clinicaltrials.gov/): NCT03978299, June 7, 2019.
publishDate 2019
dc.date.none.fl_str_mv 2019
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fisabio.portalinvestigacion.com/publicaciones/13180
url https://fisabio.portalinvestigacion.com/publicaciones/13180
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv LIPPINCOTT WILLIAMS & WILKINS
publisher.none.fl_str_mv LIPPINCOTT WILLIAMS & WILKINS
dc.source.none.fl_str_mv MEDICINE
ISSN: 00257974
ISSNe: 15365964
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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