To update, clarify, and extend IDEAL concepts and recommendations.
New surgical procedures, devices, and other complex interventions need robust evaluation for safety, efficacy, and effectiveness. Unlike new medicines, there is no internationally agreed evaluation pathway for generating and analyzing data throughout the life cycle of surgical innovations. The IDEAL Framework and Recommendations were designed to provide this pathway and they have been used increasingly since their introduction in 2009. Based on a Delphi survey, expert workshop and major discussions during IDEAL conferences held in Oxford (2016) and New York (2017), this article updates and extends the IDEAL Recommendations, identifies areas for future research, and discusses the ethical problems faced by investigators at each IDEAL stage.
The IDEAL Framework describes 5 stages of evolution for new surgical therapeutic interventions—Idea, Development, Exploration, Assessment, and Long-term Study. This comprehensive update proposes several modifications. First, a “Pre-IDEAL” stage describing preclinical studies has been added. Second we discuss potential adaptations to expand the scope of IDEAL (originally designed for surgical procedures) to accommodate therapeutic devices, through an IDEAL-D variant. Third, we explicitly recognise the value of comprehensive data collection through registries at all stages in the Framework and fourth, we examine the ethical issues that arise at each stage of IDEAL and underpin the recommendations. The Recommendations for each stage are reviewed, clarified and additional detail added.
The intention of this article is to widen the practical use of IDEAL by clarifying the rationale for and practical details of the Recommendations. Additional research based on the experience of implementing these Recommendations is needed to further improve them.
*Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK
†Bristol Centre for Surgical Research, University of Bristol, Bristol, UK
‡University of Exeter Medical School, Exeter, UK
§Health Services Research Unit, University of Aberdeen, Aberdeen, UK
¶Maimonides Medical Center, Brooklyn, NY
||Radboud University Medical Center, Nijmegen, The Netherlands
**Faculty of Health, Social Care and Education, Kingston University and St George's, University of London, London, UK
††Department of Philosophy and Department of Clinical Medicine, Macquarie University, Sydney, Australia
‡‡Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
§§Division of Neurosurgery, Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge, Cambridge, UK
¶¶Surgery Theme, Cambridge Clinical Trials Unit, Cambridge, UK
||||Department of Plastic Surgery, Guy's and St. Thomas’ NHS Foundation Trust, London, UK
***Department of Urology, Minneapolis VAMC and University of Minnesota, Minneapolis MN
†††Weill Cornell Medical College, New York, NY.
Reprints: Peter McCulloch, MD, Professor of Surgical Science and Practice, Nuffield Department of Surgical Sciences (Level 6), John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK. E-mail: firstname.lastname@example.org; Allison Hirst, MSc, IDEAL Collaboration Project Manager/Researcher, Nuffield Department of Surgical Sciences (Level 6), John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK. E-mail: email@example.com.
No specific funding was obtained for this update of IDEAL. The discussion meeting was funded as part of the IDEAL International Conference in Oxford on April 7, 2016 by several sponsors as follows: the Oxford Academic Health Science network (Oxford AHSN), The Health Foundation, Medtronic, and Johnson and Johnson (J&J). It was also supported by BMJ and the Lancet. IDEAL is funded by the Oxford NIHR Biomedical Research Centre, educational grants and meetings income (PMcC and A.H.). J.M.B. is an NIHR Senior Investigator supported in part by the Medical Research Council (MRC) ConDuCT-II (Collaboration and innovation for Difficult and Complex randomized controlled Trials in Invasive procedures) Hub (MR/K025643/1) and the NIHR Bristol Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The views expressed are those of the author and not necessarily those of the UK National Health Service, National Institute for Health Research, or Department of Health.
This paper updates the IDEAL Framework and Recommendations following review at international expert meetings held during IDEAL Conferences in Oxford, UK in 2016 and New York, USA in 2017.
A.D.H. and Y.P. contributed equally as joint first authors.
A.S. and P.Mc.C. contributed equally as joint senior authors on behalf of IDEAL Collaboration (attendees at 2016 Oxford consensus meeting listed in full in Acknowledgements with permission).
The authors report no conflicts of interest.
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.annalsofsurgery.com).