Nicole A Bilbro1,2, Allison Hirst1, Arsenio Paez3,4, Baptiste Vasey1, Maria Pufulete5, Art Sedrakyan6, Peter McCulloch1. 1. University of Oxford, Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford, UK. 2. Maimonides Medical Center, Department of Surgery, Brooklyn, NY. 3. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. 4. Northeastern University, Department of Physical Therapy, Movement, and Rehabilitation Sciences, Boston, MA. 5. Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol Royal Infirmary, Bristol, UK. 6. Weill Cornell Medical College, New York, NY.
Abstract
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.
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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Authors: Kaiping Zhang; Yanfang Ma; Qianling Shi; Jianfei Shen; Jinlin Wu; Xianzhuo Zhang; Panpan Jiao; Grace S Li; Xueqin Tang; René Horsleben Petersen; Calvin S H Ng; Alfonso Fiorelli; Nuria M Novoa; Benedetta Bedetti; Giovanni Battista Levi Sandri; Steven Hochwald; Toni Lerut; Alan D L Sihoe; Leandro Cardoso Barchi; Sebastien Gilbert; Ryuichi Waseda; Alper Toker; Diego Gonzalez-Rivas; Robert Fruscio; Marco Scarci; Fabio Davoli; Guillaume Piessen; Bin Qiu; Stephen D Wang; Yaolong Chen; Shugeng Gao Journal: Gland Surg Date: 2021-07
Authors: Kaiping Zhang; Yanfang Ma; Qianling Shi; Jinlin Wu; Jianfei Shen; Yulong He; Xianzhuo Zhang; Panpan Jiao; Grace S Li; Xueqin Tang; Rene Horsleben Petersen; Calvin S H Ng; Alfonso Fiorelli; Nuria M Novoa; Benedetta Bedetti; Giovanni Battista Levi Sandri; Steven Hochwald; Toni Lerut; Alan D L Sihoe; Leandro Cardoso Barchi; Sebastien Gilbert; Ryuichi Waseda; Alper Toker; Diego Gonzalez-Rivas; Robert Fruscio; Marco Scarci; Fabio Davoli; Guillaume Piessen; Bin Qiu; Stephen D Wang; Yaolong Chen; Shugeng Gao Journal: Gland Surg Date: 2021-08
Authors: Marc M Huttman; Harry F Robertson; Alexander N Smith; Sarah E Biggs; Ffion Dewi; Lauren K Dixon; Emily N Kirkham; Conor S Jones; Jozel Ramirez; Darren L Scroggie; Benjamin E Zucker; Samir Pathak; Natalie S Blencowe Journal: J Robot Surg Date: 2022-09-08
Authors: Baptiste Vasey; Myura Nagendran; Bruce Campbell; David A Clifton; Gary S Collins; Spiros Denaxas; Alastair K Denniston; Livia Faes; Bart Geerts; Mudathir Ibrahim; Xiaoxuan Liu; Bilal A Mateen; Piyush Mathur; Melissa D McCradden; Lauren Morgan; Johan Ordish; Campbell Rogers; Suchi Saria; Daniel S W Ting; Peter Watkinson; Wim Weber; Peter Wheatstone; Peter McCulloch Journal: Nat Med Date: 2022-05-18 Impact factor: 87.241
Authors: Baptiste Vasey; Myura Nagendran; Bruce Campbell; David A Clifton; Gary S Collins; Spiros Denaxas; Alastair K Denniston; Livia Faes; Bart Geerts; Mudathir Ibrahim; Xiaoxuan Liu; Bilal A Mateen; Piyush Mathur; Melissa D McCradden; Lauren Morgan; Johan Ordish; Campbell Rogers; Suchi Saria; Daniel S W Ting; Peter Watkinson; Wim Weber; Peter Wheatstone; Peter McCulloch Journal: BMJ Date: 2022-05-18
Authors: Isabel M A Brüggenwirth; Veerle A Lantinga; Michel Rayar; Aad P van den Berg; Hans Blokzijl; Koen M E M Reyntjens; Robert J Porte; Vincent E de Meijer Journal: BMJ Open Gastroenterol Date: 2022-01