doi: 10.53962/kyep-h9
Created on 2022-12-08.
Last updated on 2022-12-14.
This is a collection of supplementary material describing the project ALL-IN-META-BCG-CORONA, designed as a replication package for anyone that wants to reproduce our work or start a similar project. It accompanies the following paper:
Bacillus Calmette-Guérin vaccine to reduce COVID-19 infections and hospitalisations in healthcare workers – a living systematic review and prospective ALL-IN meta-analysis of individual participant data from randomised controlled trials
Risk-of-bias assessment protocol BR trial
BR trial risk-of-bias assessment
Bacillus Calmette-Guérin vaccine to reduce COVID-19 infections and hospitalisations in healthcare workers – a living systematic review and prospective ALL-IN meta-analysis of individual participant data from randomised controlled trials
doi: 10.1101/2022.12.15.22283474
ALL-IN-META-BCG-CORONA MedRxiv preprint posted December 19, 2022, including seven trials: NL, SA, US, DK, HU, BR and AF.
ALL-IN-META-BCG-CORONA R code to reproduce analysis and figures
R code to reproduce the ALL-IN-META-BCG-CORONA two-stage statistical analyses.
ALL-IN-META-BCG-CORONA Summary data
Summary statistics to reproduce the ALL-IN-META-BCG-CORONA two-stage statistical analyses.
ALL-IN-META-BCG-CORONA Statistical Analysis Plan V1
First version of the Statistical Analysis Plan (SAP) shared with the participating trials in June, 2020.
ALL-IN-META-BCG-CORONA Working instructions for data-uploaders V1
First version of the Working Instructions for data-uploaders shared with the participating trials in June, 2020.
ALL-IN-META-BCG-CORONA Tutorial on processing e-value sequence by calendar date
Tutorial referred to in the Working instructions for data-uploaders to check their processed data in the dashboard, and later in the paper. This tutorial refers to a tutorial on Left-truncation that is added as a supporting material to this module.
ALL-IN-META-BCG-CORONA Statistical Analysis Plan V2
SAP updated with new study definitions, specifically: updated definition of COVID-19 events including those detected by antigen test and lung CT and time-to-event definitions with censoring at date of COVID-19 specific vaccination (Pfizer-BioNtech/Moderna/Janssen etc)
ALL-IN-META-BCG-CORONA Working instructions for data-uploaders V2
Working instructions updated for uploading data for completed trials, specifically: updated time-to-event definitions with censoring at date of COVID-19 specific vaccination (Pfizer-BioNtech/Moderna/Janssen etc)
BCG revaccination of health workers in Brazil to improve innate immune responses against COVID-19: A structured summary of a study protocol for a randomised controlled trial
doi: 10.1186/s13063-020-04822-0
BR trial protocol journal publication
Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark
doi: 10.1186/s13063-020-04714-3
DK trial protocol journal publication
Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials
doi: 10.1186/s13063-020-04389-w
NL trial protocol journal publication
ALL-IN-META-BCG-CORONA Newsletter 4
Fourth newsletter approaching the conclusion of the collaboration, with a call for data checking for COVID-19 event definitions and censoring at first COVID-19 specific vaccination, and a statement from July 2021 on excluding one trial.
ALL-IN-META-BCG-CORONA Newsletter 3
Third newsletter following the publication of meta-analysis results in the dashboard (behind login), with a description of the criteria for trial inclusion, and the data-analysis decision to censor participants at the date of first COVID-19 specific vaccination.
ALL-IN-META-BCG-CORONA Newsletter 2
Second newsletter following the launch of the Webinar, with a summary of the Q&A sessions in five categories: (1) blinding, (2) practical constraints of continuous monitoring, (3) security and archiving of the data, (4) heterogeneity/trial inclusion and (5) subgroups
ALL-IN-META-BCG-CORONA Newsletter 1
First newsletter explaining the collaboration and statistical approach (scheduling a Webinar) of the meta-analysis as a 'Leading' source of information, and proposing the Governance Structure.