Higher vs Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia (COVID STEROID 2) trial: Protocol for a secondary Bayesian analysis.
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Granholm Anders, Munch Marie Warrer, Myatra Sheila Nainan, Vijayaraghavan Bharath Kumar Tirupakuzhi, Cronhjort Maria, Wahlin Rebecka Rubenson, Jakob Stephan M, Cioccari Luca, Kjaer Maj-Brit Nørregaard, Vesterlund Gitte Kingo, Meyhoff Tine Sylvest, Helleberg Marie, Møller Morten Hylander, Benfield Thomas, Venkatesh Balasubramanian, Hammond Naomi, Micallef Sharon, Bassi Abhinav, John Oommen, Jha Vivekanand, Kristiansen Klaus Tjelle, Ulrik Charlotte Suppli, Jørgensen Vibeke Lind, Smitt Margit, Bestle Morten H, Andreasen Anne Sofie, Poulsen Lone Musaeus, Rasmussen Bodil Steen, Brøchner Anne Craveiro, Strøm Thomas, Møller Anders, Khan Mohd Saif, Padmanaban Ajay, Divatia Jigeeshu Vasishtha, Saseedharan Sanjith, Borawake Kapil, Kapadia Farhad, Dixit Subhal, Chawla Rajesh, Shukla Urvi, Amin Pravin, Chew Michelle S, Gluud Christian, Lange Theis, Perner Anders
Аннотация
METHODS: This protocol outlines the rationale and statistical methods for a secondary, pre-planned Bayesian analysis of the primary outcome (days alive without life support at day 28) and all secondary outcomes registered up to day 90. We will use hurdle-negative binomial models to estimate the mean number of days alive without life support in each group and present results as mean differences and incidence rate ratios with 95% credibility intervals (CrIs). Additional count outcomes will be analysed similarly and binary outcomes will be analysed using logistic regression models with results presented as probabilities, relative risks and risk differences with 95% CrIs. We will present probabilities of any benefit/harm, clinically important benefit/harm and probabilities of effects smaller than pre-defined clinically minimally important differences for all outcomes analysed. Analyses will be adjusted for stratification variables and conducted using weakly informative priors supplemented by sensitivity analyses using sceptic priors.
DISCUSSION: This secondary, pre-planned Bayesian analysis will supplement the primary, conventional analysis and may help clinicians, researchers and policymakers interpret the results of the COVID STEROID 2 trial while avoiding arbitrarily dichotomised interpretations of the results.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT04509973; EudraCT: 2020-003363-25.