Develop initial InsPECT reporting items and generate evidence underpinning comprehensiveness and relevance of potential outcome reporting items.
The development of InsPECT will follow recommended methodology for developing and disseminating reporting guidelines and involves a) setting up a content and methods expert steering committee, methodological, and knowledge user groups and b) a literature review to synthesize evidence on the reporting of outcomes in clinical trials.
Validation of InsPECT will involve a Delphi consensus process to ensure InsPECT reporting items are meaningful to knowledge users, such as patients, clinicians, funders, and journal editors. The content of the statement will be reviewed by clinical trialists with expertise in validation, feasibility, and reliability testing, and in various disease areas.
Evaluate the validity, reliability, and usability of the InsPECT checklist and obtain global consensus.
Produce and disseminate the final checklist and a comprehensive document that is acceptable, feasible, and demonstrates the fidelity and sustainability of the InsPECT reporting guideline.
Our knowledge translation plan includes publication of the InsPECT checklist with an explanation and elaboration guide containing examples of good reporting for each item; webinars; partners’ social media (Twitter, LinkedIn); Café Scientifique; and conference presentations. The InsPECT guideline will also be featured on the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) website.