Guidance for reporting outcomes in clinical trials: scoping review protocol

Area of Science:

• Clinical research methodology
• Evidence-based medicine
• Biostatistics

Background:

• Incomplete reporting of clinical trial outcomes limits evidence-based decision-making for patients, families, and clinicians.
• Harmonized reporting is crucial for research synthesis, replication, and advancement.
• The Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is being developed to address this gap.

Purpose of the Study:

• To conduct a scoping review to identify and synthesize existing guidance on reporting outcomes in clinical trials.
• To inform the development of the InsPECT tool by evaluating current reporting guidelines.

Main Methods:

• A comprehensive scoping review following the Joanna Briggs Institute methodology.
• Searches will include electronic databases, grey literature, and snowballing techniques.
• Two independent reviewers will screen, extract data, and analyze guidance for common features and comparison with InsPECT items.

Main Results:

• The review will characterize existing trial outcome reporting guidance and its sources.
• Findings will be used to refine candidate InsPECT items and identify areas for new guidance.
• Quantitative measures will assess the frequency and nature of reporting recommendations.

Conclusions:

• The scoping review will provide an evidence base for the InsPECT tool.
• Standardized outcome reporting through InsPECT will enhance the reliability and utility of clinical trial evidence.
• Dissemination via peer-reviewed publication will support the adoption of harmonized reporting standards.