Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)

Abstract Background It is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes. The objective of the Stepped-wedge Cluster Randomized Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) trial is to evaluate...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Yaseen M. Arabi, Ramesh Kumar Vishwakarma, Hasan M. Al-Dorzi, Eman Al Qasim, Sheryl Ann Abdukahil, Fawaz K. Al-Rabeah, Huda Al Ghamdi, Ebtisam Al Ghamdi, the SCREEN Trial Group
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Sepsis Alert Screening qSOFA Mortality Electronic medical records Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/5faa6159cec648a59dd9aea11bd8fafb
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:5faa6159cec648a59dd9aea11bd8fafb
record_format	dspace
spelling	oai:doaj.org-article:5faa6159cec648a59dd9aea11bd8fafb2021-11-28T12:28:31ZStatistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)10.1186/s13063-021-05788-31745-6215https://doaj.org/article/5faa6159cec648a59dd9aea11bd8fafb2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05788-3https://doaj.org/toc/1745-6215Abstract Background It is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes. The objective of the Stepped-wedge Cluster Randomized Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) trial is to evaluate whether an electronic screening for sepsis compared to no screening among hospitalized ward patients reduces all-cause 90-day in-hospital mortality. Methods and design This study is designed as a stepped-wedge cluster randomized trial in which the unit of randomization or cluster is the hospital ward. An electronic alert for sepsis was developed in the electronic medical record (EMR), with the feature of being active (visible to treating team) or masked (inactive in EMR frontend for the treating team but active in the backend of the EMR). Forty-five clusters in 5 hospitals are randomized into 9 sequences of 5 clusters each to receive the intervention (active alert) over 10 periods, 2 months each, the first being the baseline period. Data are extracted from EMR and are compared between the intervention (active alert) and control group (masked alert). During the study period, some of the hospital wards were allocated to manage patients with COVID-19. The primary outcome of all-cause hospital mortality by day 90 will be compared using a generalized linear mixed model with a binary distribution and a log-link function to estimate the relative risk as a measure of effect. We will include two levels of random effects to account for nested clustering within wards and periods and two levels of fixed effects: hospitals and COVID-19 ward status in addition to the intervention. Results will be expressed as relative risk with a 95% confidence interval. Conclusion The SCREEN trial provides an opportunity for a novel trial design and analysis of routinely collected and entered data to evaluate the effectiveness of an intervention (alert) for a common medical problem (sepsis in ward patients). In this statistical analysis plan, we outline details of the planned analyses in advance of trial completion. Prior specification of the statistical methods and outcome analysis will facilitate unbiased analyses of these important clinical data. Trial registration ClinicalTrials.gov NCT04078594 . Registered on September 6, 2019Yaseen M. ArabiRamesh Kumar VishwakarmaHasan M. Al-DorziEman Al QasimSheryl Ann AbdukahilFawaz K. Al-RabeahHuda Al GhamdiEbtisam Al Ghamdithe SCREEN Trial GroupBMCarticleSepsisAlertScreeningqSOFAMortalityElectronic medical recordsMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Sepsis Alert Screening qSOFA Mortality Electronic medical records Medicine (General) R5-920
spellingShingle	Sepsis Alert Screening qSOFA Mortality Electronic medical records Medicine (General) R5-920 Yaseen M. Arabi Ramesh Kumar Vishwakarma Hasan M. Al-Dorzi Eman Al Qasim Sheryl Ann Abdukahil Fawaz K. Al-Rabeah Huda Al Ghamdi Ebtisam Al Ghamdi the SCREEN Trial Group Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)
description	Abstract Background It is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes. The objective of the Stepped-wedge Cluster Randomized Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) trial is to evaluate whether an electronic screening for sepsis compared to no screening among hospitalized ward patients reduces all-cause 90-day in-hospital mortality. Methods and design This study is designed as a stepped-wedge cluster randomized trial in which the unit of randomization or cluster is the hospital ward. An electronic alert for sepsis was developed in the electronic medical record (EMR), with the feature of being active (visible to treating team) or masked (inactive in EMR frontend for the treating team but active in the backend of the EMR). Forty-five clusters in 5 hospitals are randomized into 9 sequences of 5 clusters each to receive the intervention (active alert) over 10 periods, 2 months each, the first being the baseline period. Data are extracted from EMR and are compared between the intervention (active alert) and control group (masked alert). During the study period, some of the hospital wards were allocated to manage patients with COVID-19. The primary outcome of all-cause hospital mortality by day 90 will be compared using a generalized linear mixed model with a binary distribution and a log-link function to estimate the relative risk as a measure of effect. We will include two levels of random effects to account for nested clustering within wards and periods and two levels of fixed effects: hospitals and COVID-19 ward status in addition to the intervention. Results will be expressed as relative risk with a 95% confidence interval. Conclusion The SCREEN trial provides an opportunity for a novel trial design and analysis of routinely collected and entered data to evaluate the effectiveness of an intervention (alert) for a common medical problem (sepsis in ward patients). In this statistical analysis plan, we outline details of the planned analyses in advance of trial completion. Prior specification of the statistical methods and outcome analysis will facilitate unbiased analyses of these important clinical data. Trial registration ClinicalTrials.gov NCT04078594 . Registered on September 6, 2019
format	article
author	Yaseen M. Arabi Ramesh Kumar Vishwakarma Hasan M. Al-Dorzi Eman Al Qasim Sheryl Ann Abdukahil Fawaz K. Al-Rabeah Huda Al Ghamdi Ebtisam Al Ghamdi the SCREEN Trial Group
author_facet	Yaseen M. Arabi Ramesh Kumar Vishwakarma Hasan M. Al-Dorzi Eman Al Qasim Sheryl Ann Abdukahil Fawaz K. Al-Rabeah Huda Al Ghamdi Ebtisam Al Ghamdi the SCREEN Trial Group
author_sort	Yaseen M. Arabi
title	Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)
title_short	Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)
title_full	Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)
title_fullStr	Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)
title_full_unstemmed	Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)
title_sort	statistical analysis plan for the steppedwedge cluster randomized trial of electronic early notification of sepsis in hospitalized ward patients (screen)
publisher	BMC
publishDate	2021
url	https://doaj.org/article/5faa6159cec648a59dd9aea11bd8fafb
work_keys_str_mv	AT yaseenmarabi statisticalanalysisplanforthesteppedwedgeclusterrandomizedtrialofelectronicearlynotificationofsepsisinhospitalizedwardpatientsscreen AT rameshkumarvishwakarma statisticalanalysisplanforthesteppedwedgeclusterrandomizedtrialofelectronicearlynotificationofsepsisinhospitalizedwardpatientsscreen AT hasanmaldorzi statisticalanalysisplanforthesteppedwedgeclusterrandomizedtrialofelectronicearlynotificationofsepsisinhospitalizedwardpatientsscreen AT emanalqasim statisticalanalysisplanforthesteppedwedgeclusterrandomizedtrialofelectronicearlynotificationofsepsisinhospitalizedwardpatientsscreen AT sherylannabdukahil statisticalanalysisplanforthesteppedwedgeclusterrandomizedtrialofelectronicearlynotificationofsepsisinhospitalizedwardpatientsscreen AT fawazkalrabeah statisticalanalysisplanforthesteppedwedgeclusterrandomizedtrialofelectronicearlynotificationofsepsisinhospitalizedwardpatientsscreen AT hudaalghamdi statisticalanalysisplanforthesteppedwedgeclusterrandomizedtrialofelectronicearlynotificationofsepsisinhospitalizedwardpatientsscreen AT ebtisamalghamdi statisticalanalysisplanforthesteppedwedgeclusterrandomizedtrialofelectronicearlynotificationofsepsisinhospitalizedwardpatientsscreen AT thescreentrialgroup statisticalanalysisplanforthesteppedwedgeclusterrandomizedtrialofelectronicearlynotificationofsepsisinhospitalizedwardpatientsscreen
_version_	1718407955828703232

Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)

Ejemplares similares