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Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5133 (Published 09 September 2014) Cite this as: BMJ 2014;349:g5133

Re: Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies

We congratulate the authors on a rigorously conducted piece of work appraising the evidence base for these orthopaedic implants utilising both published reports and registry data. The study confirms that the ‘status quo’ regarding the introduction of new device technologies is no longer acceptable.

The IDEAL Collaboration (http://www.ideal-collaboration.net/) is a leading international group aiming to improve how surgery and devices are evaluated to ensure safety for patients. The IDEAL has put forward proposals for all stakeholders to invest in research methods and systems of careful evaluation to promote a controlled and evidence based introduction of both surgical and device innovations. IDEAL has worked with regulators on harmonizing the approaches in the past 3 years. (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm278...)

We would encourage all stakeholders in this process in particular regulators to review and act upon our proposals detailed in the Lancet in 2009 (McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12) outlined below:

Editors
• Promotion of IDEAL reporting and design standards
• Assistance by editors with the development of registries of surgical protocols and reports
• Calls for specific prospective study designs

Funders (both service and research)
• Provide specific funding for well-designed early-stage surgical innovation
• Demand evidence of benefit for new techniques
• Link funding to adequate scientific evaluation
• Support well-designed surgical databases, registries, and reporting systems

Regulators
• Provide rapid, flexible, and expert ethical oversight for early-stage innovation
• Link provisional approval to evaluation or registration of all cases
• Accept IDEAL approved study designs as evidence of appropriate evaluation
• Raise the burden of proof for full licensing of new devices to demonstration of efficacy

Professional societies
• Ensure guidelines explicitly support IDEAL model of technical development and evaluation
• Require members to use appropriate registers for the various stages of innovation as a condition of specialist recognition

Competing interests: No competing interests

24 September 2014
Peter McCulloch
Professor of Surgery and Chair of IDEAL Collaboration
Allison Hirst, IDEAL Collaboration Project Manager
Nuffield Dept of Surgical Sciences, University of Oxford
Level 6, John Radcliffe Hospital, Oxford, UK