Journal
ANNALS OF SURGERY
Volume 273, Issue 1, Pages 82-85Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/SLA.0000000000004180
Keywords
complex interventions; ethics; IDEAL; registries; reporting guidelines; research methodology; surgical innovation; surgical research
Categories
Funding
- Oxford NIHR Biomedical Research Centre
- Medtronic
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This study aimed to define reporting standards for IDEAL format studies, and developed draft checklists for stages 1, 2a, 2b, and 4 through surveys and consensus processes. Participants familiar with IDEAL called for new reporting guidelines for most IDEAL stages except stage 3.
Objective: The aim of this study was to define reporting standards for IDEAL format studies. Background: The IDEAL Framework and Recommendations establish an integrated pathway for evaluation of new surgical techniques and complex therapeutic technologies. However guidance on implementation has been incomplete, and incorrect use is commonly seen. We describe the consensus development of reporting guidelines for the IDEAL stages, and plans for their dissemination and evaluation. Methods: Using the EQUATOR Network recommendations, participants with knowledge of IDEAL were surveyed to determine which IDEAL stages needed reporting guidelines. Draft checklists for stages 1, 2a, 2b, and 4 were subsequently developed by 3 researchers (N.B., A.H., P.M.), and revised through a 2-round Delphi consensus process. A final consensus teleconference resolved outstanding disagreements and clarified wording for checklist items. Results: Sixty-one participants completed the initial survey, a clear majority indicating that new reporting guidelines were needed for IDEAL Stage 1 (69.5%), Stage 2a (78%), Stage 2b (74.6%), and Stage 4 (66%). A proposed set of checklists was modified by survey participants in 2 online Delphi rounds (n = 54 and n = 47, respectively), resulting in a penultimate checklist for each stage. Fourteen expert working group members finalized the checklist items and successfully resolved any outstanding areas without agreement on a consensus call. Conclusions: Participants familiar with IDEAL called for reporting guidelines for studies in all IDEAL stages except stage 3. The checklists developed have the potential to improve standards of reporting and thereby advance the quality of research on surgery and complex interventions and technologies, but require further evaluation in use.
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