A protocol for the development of reporting guidelines for IDEAL stage studies

Area of Science:

• Medical Innovation Evaluation
• Surgical Procedure Reporting

Background:

• Robust evaluation of new surgical procedures, devices, and complex interventions is crucial for safety, efficacy, and effectiveness.
• The IDEAL Framework provides a pathway for this evaluation and guidance on study reporting.
• Researchers need practical assistance to implement the IDEAL Framework's theoretical recommendations.

Purpose of the Study:

• To develop a set of practical reporting guidelines for each stage of the IDEAL Framework.
• To address the need for assistance in translating IDEAL theory into practice.
• To ensure comprehensive and standardized reporting of studies on medical interventions.

Main Methods:

• Utilize Delphi consensus methodology to develop reporting guidelines.
• Search for existing reporting guidelines and adapt them using IDEAL Collaboration principles.
• Employ a nine-point Likert scale for rating checklist item importance, similar to the GRADE group's approach.
• Conduct sequential rounds of questionnaires and a final consensus meeting for refinement.

Main Results:

• A consensus-driven set of reporting guidelines for IDEAL stages will be produced.
• The guidelines will facilitate standardized reporting of studies on medical interventions.
• The process will refine and condense recommendations for practical application.

Conclusions:

• The developed reporting guidelines will enhance the practical application of the IDEAL Framework.
• Standardized reporting will improve the evaluation of new surgical procedures and complex interventions.
• This initiative supports robust evidence generation for medical innovations.