Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mHealth Screening to Prevent Strokes (mSToPS).

<h4>Background</h4>Atrial fibrillation (AF) is common, often without symptoms, and is an independent risk factor for mortality, stroke and heart failure. It is unknown if screening asymptomatic individuals for AF can improve clinical outcomes.<h4>Methods</h4>mSToPS was a prag...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Steven R Steinhubl, Jill Waalen, Anirudh Sanyal, Alison M Edwards, Lauren M Ariniello, Gail S Ebner, Katie Baca-Motes, Robert A Zambon, Troy Sarich, Eric J Topol
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/49d3aab9559a4e43859d99b34bc79b36
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:49d3aab9559a4e43859d99b34bc79b36
record_format	dspace
spelling	oai:doaj.org-article:49d3aab9559a4e43859d99b34bc79b362021-12-02T20:13:49ZThree year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mHealth Screening to Prevent Strokes (mSToPS).1932-620310.1371/journal.pone.0258276https://doaj.org/article/49d3aab9559a4e43859d99b34bc79b362021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0258276https://doaj.org/toc/1932-6203<h4>Background</h4>Atrial fibrillation (AF) is common, often without symptoms, and is an independent risk factor for mortality, stroke and heart failure. It is unknown if screening asymptomatic individuals for AF can improve clinical outcomes.<h4>Methods</h4>mSToPS was a pragmatic, direct-to-participant trial that randomized individuals from a single US-wide health plan to either immediate or delayed screening using a continuous-recording ECG patch to be worn for two weeks and 2 occasions, ~3 months apart, to potentially detect undiagnosed AF. The 3-year outcomes component of the trial was designed to compare clinical outcomes in the combined cohort of 1718 individuals who underwent monitoring and 3371 matched observational controls. The prespecified primary outcome was the time to first event of the combined endpoint of death, stroke, systemic embolism, or myocardial infarction among individuals with a new AF diagnosis, which was hypothesized to be the same in the two cohorts but was not realized.<h4>Results</h4>Over the 3 years following the initiation of screening (mean follow-up 29 months), AF was newly diagnosed in 11.4% (n = 196) of screened participants versus 7.7% (n = 261) of observational controls (p<0.01). Among the screened cohort with incident AF, one-third were diagnosed through screening. For all individuals whose AF was first diagnosed clinically, a clinical event was common in the 4 weeks surrounding that diagnosis: 6.6% experienced a stroke,10.2% were newly diagnosed with heart failure, 9.2% had a myocardial infarction, and 1.5% systemic emboli. Cumulatively, 42.9% were hospitalized. For those diagnosed via screening, none experienced a stroke, myocardial infarction or systemic emboli in the period surrounding their AF diagnosis, and only 1 person (2.3%) had a new diagnosis of heart failure. Incidence rate of the prespecified combined primary endpoint was 3.6 per 100 person-years among the actively monitored cohort and 4.5 per 100 person-years in the observational controls.<h4>Conclusions</h4>At 3 years, screening for AF was associated with a lower rate of clinical events and improved outcomes relative to a matched cohort, although the influence of earlier diagnosis of AF via screening on this finding is unclear. These observational data, including the high event rate surrounding a new clinical diagnosis of AF, support the need for randomized trials to determine whether screening for AF will yield a meaningful protection from strokes and other clinical events.<h4>Trail registration</h4>The mHealth Screening To Prevent Strokes (mSToPS) Trial is registered on ClinicalTrials.gov with the identifier NCT02506244.Steven R SteinhublJill WaalenAnirudh SanyalAlison M EdwardsLauren M ArinielloGail S EbnerKatie Baca-MotesRobert A ZambonTroy SarichEric J TopolPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 10, p e0258276 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Steven R Steinhubl Jill Waalen Anirudh Sanyal Alison M Edwards Lauren M Ariniello Gail S Ebner Katie Baca-Motes Robert A Zambon Troy Sarich Eric J Topol Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mHealth Screening to Prevent Strokes (mSToPS).
description	<h4>Background</h4>Atrial fibrillation (AF) is common, often without symptoms, and is an independent risk factor for mortality, stroke and heart failure. It is unknown if screening asymptomatic individuals for AF can improve clinical outcomes.<h4>Methods</h4>mSToPS was a pragmatic, direct-to-participant trial that randomized individuals from a single US-wide health plan to either immediate or delayed screening using a continuous-recording ECG patch to be worn for two weeks and 2 occasions, ~3 months apart, to potentially detect undiagnosed AF. The 3-year outcomes component of the trial was designed to compare clinical outcomes in the combined cohort of 1718 individuals who underwent monitoring and 3371 matched observational controls. The prespecified primary outcome was the time to first event of the combined endpoint of death, stroke, systemic embolism, or myocardial infarction among individuals with a new AF diagnosis, which was hypothesized to be the same in the two cohorts but was not realized.<h4>Results</h4>Over the 3 years following the initiation of screening (mean follow-up 29 months), AF was newly diagnosed in 11.4% (n = 196) of screened participants versus 7.7% (n = 261) of observational controls (p<0.01). Among the screened cohort with incident AF, one-third were diagnosed through screening. For all individuals whose AF was first diagnosed clinically, a clinical event was common in the 4 weeks surrounding that diagnosis: 6.6% experienced a stroke,10.2% were newly diagnosed with heart failure, 9.2% had a myocardial infarction, and 1.5% systemic emboli. Cumulatively, 42.9% were hospitalized. For those diagnosed via screening, none experienced a stroke, myocardial infarction or systemic emboli in the period surrounding their AF diagnosis, and only 1 person (2.3%) had a new diagnosis of heart failure. Incidence rate of the prespecified combined primary endpoint was 3.6 per 100 person-years among the actively monitored cohort and 4.5 per 100 person-years in the observational controls.<h4>Conclusions</h4>At 3 years, screening for AF was associated with a lower rate of clinical events and improved outcomes relative to a matched cohort, although the influence of earlier diagnosis of AF via screening on this finding is unclear. These observational data, including the high event rate surrounding a new clinical diagnosis of AF, support the need for randomized trials to determine whether screening for AF will yield a meaningful protection from strokes and other clinical events.<h4>Trail registration</h4>The mHealth Screening To Prevent Strokes (mSToPS) Trial is registered on ClinicalTrials.gov with the identifier NCT02506244.
format	article
author	Steven R Steinhubl Jill Waalen Anirudh Sanyal Alison M Edwards Lauren M Ariniello Gail S Ebner Katie Baca-Motes Robert A Zambon Troy Sarich Eric J Topol
author_facet	Steven R Steinhubl Jill Waalen Anirudh Sanyal Alison M Edwards Lauren M Ariniello Gail S Ebner Katie Baca-Motes Robert A Zambon Troy Sarich Eric J Topol
author_sort	Steven R Steinhubl
title	Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mHealth Screening to Prevent Strokes (mSToPS).
title_short	Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mHealth Screening to Prevent Strokes (mSToPS).
title_full	Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mHealth Screening to Prevent Strokes (mSToPS).
title_fullStr	Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mHealth Screening to Prevent Strokes (mSToPS).
title_full_unstemmed	Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mHealth Screening to Prevent Strokes (mSToPS).
title_sort	three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mhealth screening to prevent strokes (mstops).
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/49d3aab9559a4e43859d99b34bc79b36
work_keys_str_mv	AT stevenrsteinhubl threeyearclinicaloutcomesinanationwideobservationalsitelessclinicaltrialofatrialfibrillationscreeningmhealthscreeningtopreventstrokesmstops AT jillwaalen threeyearclinicaloutcomesinanationwideobservationalsitelessclinicaltrialofatrialfibrillationscreeningmhealthscreeningtopreventstrokesmstops AT anirudhsanyal threeyearclinicaloutcomesinanationwideobservationalsitelessclinicaltrialofatrialfibrillationscreeningmhealthscreeningtopreventstrokesmstops AT alisonmedwards threeyearclinicaloutcomesinanationwideobservationalsitelessclinicaltrialofatrialfibrillationscreeningmhealthscreeningtopreventstrokesmstops AT laurenmariniello threeyearclinicaloutcomesinanationwideobservationalsitelessclinicaltrialofatrialfibrillationscreeningmhealthscreeningtopreventstrokesmstops AT gailsebner threeyearclinicaloutcomesinanationwideobservationalsitelessclinicaltrialofatrialfibrillationscreeningmhealthscreeningtopreventstrokesmstops AT katiebacamotes threeyearclinicaloutcomesinanationwideobservationalsitelessclinicaltrialofatrialfibrillationscreeningmhealthscreeningtopreventstrokesmstops AT robertazambon threeyearclinicaloutcomesinanationwideobservationalsitelessclinicaltrialofatrialfibrillationscreeningmhealthscreeningtopreventstrokesmstops AT troysarich threeyearclinicaloutcomesinanationwideobservationalsitelessclinicaltrialofatrialfibrillationscreeningmhealthscreeningtopreventstrokesmstops AT ericjtopol threeyearclinicaloutcomesinanationwideobservationalsitelessclinicaltrialofatrialfibrillationscreeningmhealthscreeningtopreventstrokesmstops
_version_	1718374700769345536

Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mHealth Screening to Prevent Strokes (mSToPS).

Ejemplares similares