Guiding Principles for the Conduct of Observational Critical Care Research for Coronavirus Disease 2019 Pandemics and Beyond: The Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study Registry
Open Access
- 15 September 2020
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Critical Care Medicine
- Vol. 48 (11), e1038-e1044
- https://doi.org/10.1097/ccm.0000000000004572
Abstract
Objectives: Use of observational data to inform the response and care of patients during a pandemic faces unique challenges. Design: The Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study COVID 2019 Registry Core data and research methodology team convened over virtual meetings throughout March to June 2020 to determine best practice goals for development of a pandemic disease registry to support rapid data collection and analysis. Setting: International, multi-center registry of hospitalized patients. Patients: None. Interventions: None. Measurements and Main Results: Large-scale observational data collection requires 1) quality assurance and harmonization across many sites; 2) a transparent process for selecting from among many potential research questions; 3) the use of best practices in design of descriptive, predictive, and inferential studies; (4) innovative approaches to characterize random error in the setting of constantly updated data; (5) rapid peer-review and reporting; and (6) transitions from a focus on discovery to implementation. Herein, we describe the guiding principles to best practices and suggestions for innovations to study design and reporting within the coronavirus disease 2019 Viral Infection and Respiratory Illness Universal Study pandemic registry. Conclusions: Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study coronavirus disease 2019 registry sought to develop and implement prespecified best practices combined with grassroots efforts from clinical sites worldwide in order to develop clinically useful knowledge in response to a pandemic.Keywords
This publication has 24 references indexed in Scilit:
- Promoting an open research cultureScience, 2015
- A two-step manuscript submission process can reduce publication biasJournal of Clinical Epidemiology, 2013
- An equity lens can ensure an equity-oriented approach to agenda setting and priority setting of Cochrane ReviewsJournal of Clinical Epidemiology, 2013
- Ensuring relevance for Cochrane reviews: evaluating processes and methods for prioritizing topics for Cochrane reviewsJournal of Clinical Epidemiology, 2013
- A New Taxonomy for Stakeholder Engagement in Patient-Centered Outcomes ResearchJournal of General Internal Medicine, 2012
- The use of complete-case and multiple imputation-based analyses in molecular epidemiology studies that assess interaction effectsEpidemiologic Perspectives & Innovations, 2011
- Priority setting: what constitutes success? A conceptual framework for successful priority settingBMC Health Services Research, 2009
- Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics supportJournal of Biomedical Informatics, 2008
- The Ethics Of Accountability In Managed Care ReformHealth Affairs, 1998