Bruce Campbell, MS, FRCP, FRCS. Chairman, Interventional Procedures and Medical Technologies Advisory Committees, UK National Institute for Health and Care Excellence, London explains how the IDEAL framework can help the work of NICE:
The development of the IDEAL framework and the promise that it offers are important to NICE. The National Institute for Health and Care Excellence publishes guidance for the UK National Health Service that depends crucially on evaluation of good evidence. Its guidance extends across pharmaceuticals (for which good research evidence is routine, as a result of regulatory demand); pathways of care for different conditions (published evidence is variable and expert opinion is very important); and procedures and devices, for which the published evidence base is typically poor.
NICE Interventional Procedures guidance focusses on the safety and efficacy of procedures 1. The procedures can be notified by anyone (mostly by clinicians, but also by hospitals, patients, insurers, horizon scanners and manufacturers). Often procedures are at a very early stage of use in the UK: it is the intention of NICE to evaluate them and publish guidance before they start to disseminate. NICE needs evidence about each procedure and that is often hard to find. The perceived difficulties in setting up trials, lack of clinical equipoise and absence of commercial sponsorship are some of the reasons. Where new procedures depend on a device, the paltry requirements for evidence to obtain a CE mark (to allow marketing in Europe), frequent design modifications, and short market life, are disincentives to spending money on well-designed research studies.
The widespread adoption of the IDEAL principles would be a very significant step in creating a more substantial evidence base for evaluations by NICE, to produce useful guidance. It would also be of great value to other organisations which need to assess interventions at an early stage of their use – notably the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK and the FDA (Food and Drugs Administration) in the USA, when procedures involve new devices. The recording of adverse events from the very start of use of a new procedure (Idea and Development) would greatly increase confidence in judging safety. At present many published reports do not even include a description of adverse outcomes. Readily available documentation about the early use and development of a procedure would give insight into any changes that had been made to increase its safety, based on the experience of the innovators and others using it.
The Exploration and Assessment stages are those at which procedures (and devices) commonly come to the attention of NICE for Interventional Procedures guidance and also for Medical Technologies evaluation, which addresses the advantages to patients and the health service of specific commercial products (devices) 2. Comprehensive information about safety and efficacy outcomes would greatly facilitate Interventional Procedures guidance; and good comparative evidence would be a boon for assessing value propositions for adoption of devices.
With regard to Long-term study, collection of data through registers and databases has long been an aspiration of the NICE Interventional Procedures programme, especially for procedures which seem promising but which are relatively new. NICE would like to be able to recommend submission of data to some kind of “register” for all procedures with an evidence base which leaves uncertainties about the longer term 3. Routine achievement of that goal through adoption of the IDEAL principles would greatly facilitate review and updating of NICE guidance.
- Campbell B. Regulation and safe adoption of new medical devices and
procedures. Br Med Bull. 2013;107:5-18. doi: 10.1093/bmb/ldt022. Epub 2013 Jul
29. PubMed PMID: 23896485
- Campbell B, Stainthorpe AC, Longson CM. How can we get high quality routine
data to monitor the safety of devices and procedures? BMJ. 2013 May 7;346:f2782. doi: 10.1136/bmj.f2782. PubMed PMID: 23653341