Acta of Shoulder and Elbow Surgery | Volume 1 | Issue 1 | Oct-Dec 2016 | Page 4-6 | Jose Carlos Garcia Jr, Allison Hirst, Joshua Feinberg.
Authors: Jose Carlos Garcia Jr , Allison Hirst , Joshua Feinberg .
 NÆON-Santa Catarina Hospital-São Paulo-Brazil.
 Oxford University-Oxford-UK.
 Maiomenides Medical Center-New York-USA.
Address of Correspondence
Dr. Jose Carlos Garcia Jr., MD, MSc, PhD
NÆON-Hospital Santa Catarina-SP-Brazil
Introduction: Here we introduce the IDEAL Framework and Recommendations for evaluating surgical innovation from an idea of a new technique towards a pivotal trial and beyond. We explain the core concepts here and future editions of this periodical will continue the IDEAL theme. IDEAL offers a rational way to explore the effectiveness and safety of new surgical procedures and medical devices in a more robust, transparent and ethical manner than current practice.
This symposium aims to present to the readers a new rational way to design,conduct and report surgical research based on the principles of the IDEAL-Collaboration and others within shoulder and elbow surgery. We examine how to improve research methods across all stages of evaluating innovation.
Keywords: IDEAL Framework and Recommendations, Research, Surgical Innovations.
The evaluation process for developing new medicines is a well-established and regulated pathway conducted by clinical researchers globally. Several steps are involved to minimize harms whilst rigorously testing efficacy of the drug as below:
1) Pre-Clinical Studies: Here, a new medication is studied outside the laboratory and in vivo using an animal model.
2) Phase 0 Studies: Also known as microdosage studies, these provide data on any potential harms of a new medication when administered in humans as opposed to animals. In addition to ensuring that a drug is safe, these studies help determine its basic pharmacodynamics and pharmacokinetics (6).
3) Phase 1 Studies: These are devoted to analyze efficacy, pharmacodynamics and pharmacokinetics in non-comparative trials.
4) Phase 2 Studies: Small case controlled trials comparing a drug against a placebo or another medicine with known and standardized outcomes.
5) Phase 3 Studies: Large randomized trials, generally multicentre, comparing a new drug against a placebo or another medicine with known and standardized outcomes (16).
6) Phase 4 Studies: Post marketing retrospective trials. More devoted to long term safety and effectiveness (11).
Historically the same rigorous standardized process has not developed in surgical research due to both a lack of regulatory requirements for surgical techniques but also due to several other specific challenges inherent in the nature of surgery as a complex intervention. These challenges include difficulties in defining a standard surgical intervention due to iterative changes being made by surgeons, the involvement of learning curves, attributes of individual surgeons’ effects on outcomes and a lack of agreed standard outcome measures in surgery. In addition there is often a lack of equipoise with both surgeons and patients expressing preferences in treatment. However it is possible to construct high-quality RCTs in surgery to test new techniques. The IDEAL Collaboration (www.ideal-collaboration.net/) (Figure 1), an international group of surgeons and research methodologists have developed a rational way to move towards developing pivotal surgical RCTs via a systematic system using robust study designs. The word IDEAL present the initials of the stages of surgical development as following:
Idea, Development, Exploration, Assessment and Longterm study (7). Stages are broadly similar to those implemented in the pharmaceutical industry. Idea is analogous to phase 0, Development – phase 1, Exploration – phase 2, Assessment – phase 3 and Long-term-study phase 4. The only phase with no parallel in the original IDEAL is the preclinical phase, however it is comparable with surgical cadaveric studies performed to test the surgical idea before the technique reaches the live patients. The IDEAL Collaboration is currently updating the Framework and will provide further guidance on this pre-clinical stage. This has been in response to publications by researchers using IDEAL 0(10) and it being an important stage for developing medical devices – IDEAL has now developed a separate IDEAL-D (14, 16).Indeed creating a pathway for evaluation designed to address the unique characteristics of surgical procedures rather than simply applying drug clinical trials to the surgical field offers many advantages. Further research and development of IDEAL by using the Framework in practice will lead to more robust and comparable data thus providing reliable answers to the central questions within the field of surgery. Therefore the IDEAL-Collaboration developed stages for surgical development in a similar way to phases of clinical trials but respecting the characteristics that surgical trials need.
How to use IDEAL in your research
The IDEAL Collaboration has endorsed a number of suggestions for specific study designs and reporting standards which are recommended at different stages in the Framework. These suggestions are underpinned by a series of general principles for design and reporting, which are based on the different questions to be addressed and the challenges faced at each stage in the process (5).
Study design and reporting ideas for improving evidence on surgical and interventional therapy innovation are as follows:
The IDEAL Framework, Recommendations and Proposals:
Summary of key features
The IDEAL Collaboration grew out of an earlier initiative known as the Balliol Group who held a series of conferences at Balliol College, Oxford in 2007-2009 with a commitment to improve the quality of research in surgery. Their discussions led to the development of the IDEAL framework for describing the stages of development of surgical and interventional innovations, and a series of recommendations about how methodology and reporting of research at each of these stages could be improved. The group also made a series of proposals about how specific groups (publishers, funders, regulators, and professional organizations) can help to change the environment for this kind of research in a positive manner. The three tables below summarise the key issues described in the Lancet publications reporting the IDEAL Framework, Recommendations and Proposals in 2009 (1,4,8) and subsequently further detailed in 3 articles published in the BMJ in 2013 (2,3,9).
This initial effort of the IDEAL- Collaboration needs to be expanded to many other important points in order to achieve the best surgical designs for surgical trials. It is known that the current status of surgical trials remain something like a babel tower with regard to initiation of a new procedure, performing it in patients and assessing its safety and efficacy. A wide discussion involving the main surgical societies about the organization of these points must be discussed. Within the field of bone and soft tissue lesions for instance, the variability of lesions is an area that requires better standardization of terms. In order to group these conditions accordingly and provide data that can be applied clinically, it may be useful for surgical trials to be designed in such a way that data is collected on those lesions that share the same clinical characteristics.
This would be made possible by studying the most common lesions within one package allowing for variations to be minimized and comparisons to be made more easily. Within shoulder and elbow surgery we can use the example of lesions of the supraspinatus tendon. Lesions of the supraspinatus tendon with retraction Patte(12) type one and two, not compromising the biceps and with 50% or less degeneration (thus three types of degeneration) would most likely result in (2×3=6) the six most common types of lesions. Within the shoulder and elbow surgery community, to agree to group these lesions together, it is necessary to enter into an international agreement to be entitled, for example, the International Standards for Surgical Trials.
Local and international societies of all specialties and subspecialties would need to work together to arrive at this consensus.. While the author’s preferences to certain outcomes and timing to assess must be respected, a minimum of methodological harmonization is a current necessity. To begin this step towards better standardization it is important for this discussion to take place within all the main surgical organizations. Primary trials need to be improved within a rational harmonization and follow the stages that can make surgical trials more reliable and generalizable. Acta for Shoulder and Elbow Surgery is a journal committed to the new patterns from the IDEAL-Collaboration, CONSORT, COMET initiative and others in order to improve the research quality within the orthopedic subspecialty of shoulder and elbow surgery. The practical guides for investigators evaluating new surgical interventions will be better explored in the following volumes of this journal, beginning by the stages 1, 2a and 2b of the IDEAL Framework (13).
Comet-Initiative is Available from: http://www.comet-initiative.org
The CONSORT statement is Available from: http://www.consort-statement.org
Ideal-Collaboration is Available from: http://www.ideal-collaboration.net
1-Barkun JS, Aronson JK, Feldman LS, Maddern GJ, Strasberg SM, for the Balliol Collaboration. Evaluation and stages of surgical innovations. Lancet 2009; 374: 1089–96.
2-Cook JA, McCulloch P, Blazeby JM, Beard DJ, Marinac-Dabic D, Sedrakyan A; IDEAL group. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ. 2013 Jun 18;346:f2820.
3-Ergina PL, Barkun JS, McCulloch P, Cook JA, Altman DG; IDEAL group. IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages. BMJ. 2013 Jun 18;346:f3011.
4-Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien PA, Reeves BC, Seiler CM, for the Balliol Collaboration, Challenges in evaluating surgical innovation. Lancet 2009; 374: 1097-104.
5-Hirst A, Agha RA, Rosin D, McCulloch P. How can we improve surgical research and innovation?: the IDEAL framework for action. Int J Surg. 2013;11(10):1038-42.
6-Kummar S, Rubinstein L, Kinders R, Parchment RE, Gutierrez ME, Murgo AJ et al. Phase 0 clinical trials: conceptions and misconceptions. Cancer Journal 2008, 14(3), May-Jun: 133-137.
7-McCulloch, P., Altman, D.G., Campbel, W.B. et al (2009) ‘No surgical innovation without evaluation: IDEAL recommendations.’ Lancet, 374, pp. 1105-1112.
8-McCulloch P, Altman DG, Campbell WB, et al, for the Balliol Collaboration. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009; 374: 1105–12.
9-McCulloch P, Cook JA, Altman DG, Heneghan C, Diener MK; IDEAL group. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ. 2013 Jun 18;346:f3012.
10-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.
11-National Cancer Institute. Phase IV Trial. Available from: http://www.cancer.gov/dictionary?cdrid=45835 [Accessed 10 August 2016]
12-Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 254:81-86.
13-Pennell CP, Hirst AD, Campbell WB, Sood A, Agha RA, Barkun,JS et al. Practical guide to Idea, Development and Exploration Stages of IDEAL Framework and Recommendations. Br J Surg. 2016 Apr;103(5):607-615.
14-Pennell CP, Hirst A, Sedrakyan A, McCulloch PG. Adapting the IDEAL Framework and Recommendations for medical device evaluation: A modified Delphi survey. Int J Surg. 2016 Apr;28:141-8.
15-Sedrakyan A, Campbell B, Merino JG, Kuntz R, Hirst A, McCulloch P. IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ. 2016 Jun 9;353:i2372.
16-Temple, R. (2000) Current definitions of phases of investigation and the role of the FDA in the conduct of clinical trials. American Heart Journal, 2000 apr;139(4):133-S135.
|How to Cite this article: JC Garcia Jr., Hirst A, Feinberg J. How to improve surgical research: the IDEAL approach. Acta of Shoulder and Elbow Surgery Oct – Dec 2016;1(1):4-7|