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Protocol for a CONSORT extension for reporting pragmatic and explanatory trials designed using the PRECIS tool
Jeremy Y Ng1, Merrick Zwarenstein2, Azadeh Barzideh3
1Institute of General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany; Robert Bosch Center for Integrative Medicine and Health, Bosch Health Campus, Stuttgart, Germany; Centre for Journalology, Methodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Faculty of Health Sciences, Department of Health Research, Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada; Faculty of Health, School of Public Health, University of Technology Sydney, Sydney, Australia.
This research updates reporting guidelines for pragmatic trials to improve real-world evidence. The revised CONSORT-PRECIS will enhance clarity on trial design, settings, and outcomes for better healthcare decisions.
Area of Science:
- Clinical Trials Methodology
- Health Services Research
- Evidence-Based Practice
Background:
- The Consolidated Standards of Reporting Trials (CONSORT) extension for pragmatic trials, first published in 2008, requires updating to reflect current understanding and challenges in trial design.
- Pragmatic trials aim to inform real-world decision-making by comparing interventions under usual care conditions, distinct from explanatory trials that test mechanistic hypotheses under controlled settings.
Purpose of the Study:
- To systematically update the CONSORT extension for pragmatic trials, ensuring reporting guidelines align with contemporary best practices.
- To enhance the clarity and applicability of findings from both pragmatic and explanatory randomized trials (RCTs).
Main Methods:
- A five-step protocol including a scoping review, an international Delphi process with diverse stakeholders, guideline finalization, and pilot testing.
- Engaging trialists, methodologists, clinicians, policymakers, biostatisticians, regulators, funders, editors, and patient partners to achieve consensus on necessary revisions.
Main Results:
- The updated CONSORT extension (CONSORT-PRECIS) will emphasize transparent reporting of trial intention, design, settings, delivery, outcomes, and analysis.
- Improved reporting aims to enhance the understanding and applicability of trial findings for clinical practice and healthcare decision-making.
Conclusions:
- The revised CONSORT extension will promote greater transparency and completeness in reporting pragmatic and explanatory trials.
- This update seeks to support informed healthcare decisions, foster trust in research findings, and advance scientific knowledge.
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