Mapping outcomes in randomised radiology trials: Protocol for a scoping review

Area of Science:

• Radiology
• Clinical Trials
• Health Outcomes Research

Background:

• Standardized outcome measurement is crucial for comparable radiological clinical trials.
• Contemporary radiological randomized clinical trials (RCTs) lack a consistent approach to defining and operationalizing outcomes.

Purpose of the Study:

• To systematically map outcome definitions and operationalization in current radiological RCTs.
• To inform the development of a core outcome set for radiology studies, including adaptive platform trials (APTs) and observational studies.
• To support the advancement of value-based radiology.

Main Methods:

• A scoping review following PRISMA-P and PRISMA-ScR guidelines.
• Searched high-impact medical and radiological journals for articles published from January 1, 2023.
• Duplicate screening and data extraction of trial characteristics and outcome details, including operationalization and statistical analysis.

Main Results:

• The review will provide a comprehensive overview of how outcomes are currently handled in radiological RCTs.
• Data extraction will detail outcome types, definitions, measurement tools, and statistical approaches used.
• Descriptive synthesis will summarize current practices without bias evaluation.

Conclusions:

• This scoping review will establish a foundation for a Delphi process to define core outcomes in radiology.
• The identified core outcomes will enhance consistency and comparability across radiological APTs and RCTs.
• This work aims to promote value-based radiology through standardized outcome measurement.