Two recent papers published in European Urology provide an excellent example of a surgical research team utilizing the IDEAL Framework Recommendations for a new surgical procedure:
Menon M, Abaza R, Sood A, Ahlawat R, Ghani KR, Jeong W, Kher V, Kumar RK,
Bhandari M. Robotic Kidney Transplantation with Regional Hypothermia: Evolution of a Novel Procedure Utilizing the IDEAL Guidelines (IDEAL Phase 0 and 1). Eur Urol. 2013 Nov 20. pii: S0302-2838(13)01208-6. doi:10.1016/j.eururo.2013.11.011. [Epub ahead of print] PubMed PMID: 24287316.
Menon M, Sood A, Bhandari M, Kher V, Ghosh P, Abaza R, Jeong W, Ghani KR,
Kumar RK, Modi P, Ahlawat R. Robotic Kidney Transplantation with Regional
Hypothermia: A Step-by-step Description of the Vattikuti Urology
Institute-Medanta Technique (IDEAL Phase 2a). Eur Urol. 2013 Dec 19. pii:
S0302-2838(13)01327-4. doi: 10.1016/j.eururo.2013.12.006. [Epub ahead of print]
PubMed PMID: 24388099.
One of the authors, Dr Akshay Sood, shares a workshop presentation on the studies available here as a pdf: Sood_Akshay_IDEAL presentation
Dr Sood explains the rational behind these studies: ” Primum non nocere: the IDEAL guidelines address the critical issue of patient safety during innovation in surgery (or in any procedure). They recognize the differences in medical versus surgical innovation, and propose a non-stifling, stepped framework which would allow innovators to introduce and disseminate new techniques in an evidence based manner while minimizing the risk to the patients.
We, utilizing the IDEAL guidelines*, developed our novel technique of Robotic Kidney Transplantation with Regional Hypothermia. Our team consisted of surgeons experienced in both robotics and kidney transplantation and dedicated research fellows for patient follow-up and data collection. The technique was envisioned by Dr. Mani Menon, the Chair of the Vattikuti Urology Institute at the Henry Ford Hospital. Phase 0-2a studies were performed in collaboration with Dr. Rajesh Ahlawat (Chair of Urology at the Medanta Hospital) and Dr. Ronney Abaza (Director of Robotic Surgery at the Ohio State University) with support from Dr. Wooju Jeong, Dr. Khurshid Ghani, Dr. Akshay Sood (all from the Vattikuti Urology Institute) and Dr. Vijay Kher (Chief of Nephrology at the Medanta Hospital), Dr. Prasun Ghosh and Dr. Sangeeta Khanna (both from Medanta Hospital). The workshop was led by Dr. Mahendra Bhandari (Vattikuti Urology Institute).
Our study is currently in IDEAL phase 2b-3 (in collaboration with Dr. Pranjal Modi, the Chair of Urology at the Institute of Kidney Disease and Research Center, having adopted the technique and performed more than 60 cases). We describe the key developments during each phase as the technique progressed through different phases in the accompanying presentation (more details can be found in the papers published on the subject). We believe, to the best of our knowledge, that this is the first study to utilize the IDEAL model systematicallyfrom phase-0 onwards in development of a new technique.
We found the IDEAL framework to be extremely conscientious to both the needs of the patients and the innovators, and hope that our workshop would encourage more innovators to adopt this model and the methods described therein, for evidence based development of new surgical techniques.”
*Idea/Innovation [phase-1], Development [phase-2a], Exploration [phase-2b], Assessment [phase-3] and Long-term study [phase-4]
Mr Peter McCulloch, IDEAL Collaboration Chair, comments: ” This is exciting news. We agree with Dr Sood that his team are, as far as we are aware, the first to take a surgical innovation through consecutive stages of the IDEAL Framework using the guidance provided in the Recommendations. The information supplied in their published articles demonstrates the benefits of this approach and we congratulate them on their pioneering work. It was particularly pleasing to see the clear demonstration (see presentation) of how safety concerns were integral to the development of their plans at every step, but did not prevent them from producing a methodologically defensible and extremely transparent report of their studies.
Their description of the Stage 0 work, alluded to only in passing in the original IDEAL publications, shows how important this stage is in setting out the pre-human background work which is needed before the first-in-man experience. The Collaboration have taken note and will be adding more material on this to the website in the coming months.
The detailed and clear description of the Stage 1/2a studies, including the use of SPC techniques such as CUSUM demonstrates the added value of the IDEAL prospective development study (PDS) format. The core of this is slide 13, which shows, just as recommended by IDEAL, the sequence of cases performed and the changes in technique and indication which occurred during the Development stage. IDEAL would like to see additional information on this graph to match up these changes with outcome measures, and we hope Dr Sood and his group will take this additional step in future publications, but the value of the reporting format is, we think self-evident.
We look forward to hearing more, as the group are actively pursuing the next stage in the IDEAL Framework, a Prospective Exploration Study to develop consensus amongst surgeons in different centres, establish that learning curves and quality standards have been dealt with, and develop power calculations for a definitive RCT. We are very pleased that Dr Sood and his colleagues have agreed to work with us in qualitative studies, so that we can learn from their experiences and improve the Recommendations. We hope that the Urological and wider surgical community will follow this lead!”