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

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, SCREEN Trial Group, Yaseen M Arabi, Abdulmohsen Alsaawi, Ali M Al Khathaami, Raed H AlHazme, Abdullah Al Mutrafy, Eman Al Qasim, Sheryl Ann Abdukahil, Fawaz K Al-Rabeah, Huda Al Ghamdi, Ebtisam Al Ghamdi, Khadega A Abuelgasim, Abdulaleem Alatassi, Georges Nammour, Angela Caswell, John Alchin, Hasan M Al-Dorzi, Mufareh Edah AlKatheri, Ahmad Alharbi, Raed Al Almoodi, Joan Jones, Saad Al-Qahtani, Salih Bin Salih, Nahar Alselaim, Nabiha Tashkandi, Ramesh Kumar Vishwakarma, Zeyad Alyousef, Mohamed S Al Moammary, Soud Rasheed, Amal Matroud, Rasha Ebeid Al Anazi, Haifa Al Shammari, Majid M Alshamrani, Saleh Qasim, Saeed Obbed, Mohammed Al Qarni, Abdul Rahman Jazieh, Mohammed Al Zahrani, Fahad Al-Hameed, Adnan A Munshi, Wasil Jastaniah, Hassan AlMarhabi, Emad AlWafi, Ali H Alyami, Arwa O Yamani, Hadia Al Tabsh, Basem R Banat, Omar Abuskout, Anna Liza Marcelo, Mayadah M Alhabshi, Abdullah Al Hamdan, Ali Al Qarni, Ahmed Al Arfaj, Hani T Mustafa, Mohammad Shahin, Abdulaziz A Ghamdi, Jamielah Yaakob, Jamal Chalabi, Johanna E Greyvenstein, Abdulaziz Al Qasem, Hattan Esilan, Sami Musalam Aliyyen, Christa Myumi Sian, Turki Alwasaidi, Amar M Alhasani, Ibrahim J Jaber, Noha Omaish, Mohammad Abdrabo, Ahmad S Qureshi, Azura Abdrahim, Naif Almughamisi, Azurahazri Abd Rahim, Ahmed Al Shouabi, Shaher Qahtani, Mariam Alansari, Hanan Al Somali, Clara Masala, Gaber Madram, Wafa Nasser, Fatimah Talaqof, Maryam Almulhim, 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, SCREEN Trial Group, Yaseen M Arabi, Abdulmohsen Alsaawi, Ali M Al Khathaami, Raed H AlHazme, Abdullah Al Mutrafy, Eman Al Qasim, Sheryl Ann Abdukahil, Fawaz K Al-Rabeah, Huda Al Ghamdi, Ebtisam Al Ghamdi, Khadega A Abuelgasim, Abdulaleem Alatassi, Georges Nammour, Angela Caswell, John Alchin, Hasan M Al-Dorzi, Mufareh Edah AlKatheri, Ahmad Alharbi, Raed Al Almoodi, Joan Jones, Saad Al-Qahtani, Salih Bin Salih, Nahar Alselaim, Nabiha Tashkandi, Ramesh Kumar Vishwakarma, Zeyad Alyousef, Mohamed S Al Moammary, Soud Rasheed, Amal Matroud, Rasha Ebeid Al Anazi, Haifa Al Shammari, Majid M Alshamrani, Saleh Qasim, Saeed Obbed, Mohammed Al Qarni, Abdul Rahman Jazieh, Mohammed Al Zahrani, Fahad Al-Hameed, Adnan A Munshi, Wasil Jastaniah, Hassan AlMarhabi, Emad AlWafi, Ali H Alyami, Arwa O Yamani, Hadia Al Tabsh, Basem R Banat, Omar Abuskout, Anna Liza Marcelo, Mayadah M Alhabshi, Abdullah Al Hamdan, Ali Al Qarni, Ahmed Al Arfaj, Hani T Mustafa, Mohammad Shahin, Abdulaziz A Ghamdi, Jamielah Yaakob, Jamal Chalabi, Johanna E Greyvenstein, Abdulaziz Al Qasem, Hattan Esilan, Sami Musalam Aliyyen, Christa Myumi Sian, Turki Alwasaidi, Amar M Alhasani, Ibrahim J Jaber, Noha Omaish, Mohammad Abdrabo, Ahmad S Qureshi, Azura Abdrahim, Naif Almughamisi, Azurahazri Abd Rahim, Ahmed Al Shouabi, Shaher Qahtani, Mariam Alansari, Hanan Al Somali, Clara Masala, Gaber Madram, Wafa Nasser, Fatimah Talaqof, Maryam Almulhim

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.

Keywords: Alert; Electronic medical records; Mortality; Screening; Sepsis; qSOFA.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Patient flow according to the CONSORT flowchart

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Source: PubMed

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