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

BACKGROUND: New surgical procedures, devices and other complex interventions need robust evaluation for safety, efficacy and effectiveness. The IDEAL Framework and Recommendations lay out a pathway to achieve this and offer general guidance on how studies at each stage should be reported. However, researchers require some assistance in translating theory into practice. We will develop a set of reporting guidelines for each IDEAL stage where deemed necessary through Delphi consensus methodology. METHODS: For each IDEAL stage requiring a new set of reporting guidelines, we will use the following process. We will search for the relevant reporting guidelines already in existence and use principles developed by the IDEAL Collaboration to compile the initial long list of potential checklist items. In each round, the participants will rate the importance of reporting each element on a nine-point Likert scale as proposed by the GRADE group. Sequential rounds and questionnaire administration and completion will take place until a final set of items is produced. There will then be a final consensus meeting of a working group to condense and refine the final recommendations for the reporting guidelines.