








key: cord-348306-e8hdx4u2
authors: Li, Jie; Pavlov, Ivan; Laffey, John G.; Roca, Oriol; Mirza, Sara; Perez, Yonatan; McNicholas, Bairbre; Cosgrave, David; Vines, David; Tavernier, Elsa; Ehrmann, Stephan
title: Meta-trial of awake prone positioning with nasal high flow therapy: Invitation to join a pandemic collaborative research effort
date: 2020-07-24
journal: J Crit Care
DOI: 10.1016/j.jcrc.2020.07.020
sha: 
doc_id: 348306
cord_uid: e8hdx4u2

• Awake prone positioning is a promising intervention to improve patient's oxygenation and likely to reduce the need for intubation. Despite reports of its use during the COVID-19 pandemic, controlled evidence is lacking. • A meta-trial, with harmonized inclusion and outcome criteria and a global interim analysis plan, may enable to get a high level of evidence within the short period of time required by the pandemic, through performing a prospective meta-analysis of the generated data across countries. • Clinicians and researchers around the world are invited to join the “Meta-trial of awake prone positioning with nasal high flow therapy” project by contacting the core investigator group: Awake.Prone.Meta.Trial@gmail.com.

The ongoing coronavirus disease pandemic (COVID-19) poses a great challenge to healthcare systems worldwide. Beyond challenges for direct patient care, optimal conduct of research under the specific conditions of the pandemic is a matter of concern and discussion. We present the meta-trial concept as a scientifically, clinically, ethically and socially sound method to carry out optimal clinical research in the setting of a pandemic. We take the example of such a meta-trial, set up to investigate prone positioning among awake patients undergoing nasal high flow therapy and invite journal readers to join this collaborative research effort. The meta-trial concept enables researchers to combine the agility of smaller national trials into a much larger international project in a short period of time (Table 1) .

Meta-trial interim analysis enables to detect a positive or negative response to the scientific question as soon as an adequate sample size is reached across several J o u r n a l P r e -p r o o f countries, thus potentially speeding up the research process dramatically (9, 10).

Adherence to methodological standards of individual trials represents a guarantee of a high level of overall final quality. Furthermore, by estimating the treatment effect across the various trials upfront, the meta-trial may provide stronger evidence in favor of external validity and replicability of the individual trials.

To the best of our knowledge, the meta-trial concept has never been experienced in real life across several countries, and feasibility uncertainties do exist. The present project may serve as a guidance for future research projects set up in a pandemic context. J o u r n a l P r e -p r o o f  Awake prone positioning is a promising intervention to improve patient's oxygenation and likely to reduce the need for intubation. Despite reports of its use during the COVID-19 pandemic, controlled evidence is lacking.

 A meta-trial, with harmonized inclusion and outcome criteria and a global interim analysis plan, may enable to get a high level of evidence within the short period of time required by the pandemic, through performing a prospective meta-analysis of the generated data across countries.

 Clinicians and researchers around the world are invited to join the "Meta-trial of awake prone positioning with nasal high flow therapy" project by contacting the core investigator group: Awake.Prone.Meta.Trial@gmail.com J o u r n a l P r e -p r o o f

Intensive care management of coronarvirus disease 2019 (COVID-19): Challenges and Recommendations

Patient eligibility for randomized controlled trials in critical care medicine: an international two-center observational study

Prone position for acute respiratory distress syndrome. A systematic review and meta-analysis

Finding alternatives to the dogma of power based sample size calculation: is a fixed sample size prospective metaexperiment a potential alternative

Clinical research networks are key to accurate and timely assessment of pandemic clinical severity



