{'fraction_non_alphanumeric': 0.016055045871559634, 'fraction_numerical': 0.0014595496246872393, 'mean_word_length': 5.336856010568032, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
The governance of innovation

The public assumes that all medical innovation is fully evaluated and tested by good research. If patients are the subjects of research then they have the protection of research ethics committees and clinical governance arrangements. Drugs must show evidence of efficacy and safety to the regulatory authorities such as the Food and Drugs Administration in the USA and the Medicines and Healthcare products Regulatory Agency in the UK. Only after licensing, including clear stipulations about the indications for use, can these products be used in routine clinical practice. With this background it seems surprising that there are no equivalent processes for the ‘approval’ of new procedures1,2. Many operations have never been the subject of properly controlled research, and their introduction into clinical practice is not formally monitored. The transition of a new procedure into everyday clinical practice depends on a number of factors, including clinicians’ aspirations to improve the quality of the care they provide and, for some, the intrinsic appeal a novel procedure holds. Commercial issues may be important: there are financial motives on the part of industry to encourage the use of new devices, and new procedures are frequently established in private practice before the nationally funded healthcare services. In this setting media claims (often promoted by clinical enthusiasts) may stimulate public demand for a procedure even in the face of inadequate scientific evidence. There are also disincentives to using a new procedure. These include fear of litigation if things go wrong, reluctance of both private and public healthcare organizations to fund novel techniques, and variable acceptance of the evidence on the results. Systems for central reporting of adverse outcomes of procedures are less well developed than those for drugs (except, perhaps when a device is involved); this leads both to clinical uncertainty and a lower margin of patient safety1,2. Introducing clinical governance to cover new operations has several problems. It is necessary to define what constitutes a ‘procedure’, and also the difference between a ‘new’ and an ‘old’ technique. Few procedures are totally novel and many are modifications of existing practice, perhaps involving a new approach (for example laparoscopic rather than open) or applying established technology to a new indication (for example laser or radiofrequency ablation used for different diseases in different parts of the body). In addition, the results of an operation may vary depending on the choice of device used and may change significantly as device technology advances. Any system of governance for new procedures must be able cope with the regulations covering the devices required to perform them. Procedures are also operator dependent; successful outcomes and avoidance of complications are influenced by training and experience. This is further complicated by the fact that different operators may undertake the same task in slightly different ways and techniques may vary even within a single unit. Finally, the support facilities and the team available within a unit may significantly affect outcomes. The UK is the first country in the world to have developed a system for monitoring the introduction of new procedures into its National Health Service (NHS). This requires clinicians to notify the National Institute of Clinical Excellence (NICE) of any technique being used for the first time3,4. Once notified, NICE prepares an overview of reported research on the procedure and seeks advice from specialists. Its Interventional Procedures Advisory Committee then considers the safety and efficacy of the procedure, and drafts guidance about its use within the NHS, including any special restrictions3. If there are doubts about the quality and/or quantity of supporting evidence it is recommended that patients are provided with clear information to allow them make as informed a choice as possible on whether or not to accept the new method. Particularly thorough audit is advised, with local review of outcomes, and NICE may recommend collection of data on all patients undergoing the procedure in the form of registries established by national specialist societies that are themselves asked to formulate training standards for selected operations. Recommendations often stipulate that local clinical governance leads should be informed before a procedure is adopted, so that hospitals are aware when novel techniques are being employed. This guidance aims to help clinicians to innovate in a responsible way, and to offer patients the opportunity of well informed choice. When assessment of comparative clinical effectiveness and cost effectiveness is an important issue