Oesophageal Doppler monitoring: the role of NICE

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In their editorial, Ghosh et al. are critical of National Institute for Health and Clinical Excellence (NICE) Medical Technology Guidance 3 on CardioQ™ Oesophageal Doppler monitoring, but their description of the facts and their analysis are inaccurate [1]. Medical technologies guidance is different in its context and intent from other NICE publications and it is important that these differences are clearly understood. The NICE medical technologies programme aims to identify technologies that offer advantages to patients and to the service over ‘current management’. Its focus on the claims of specific commercial products (which may have a short market life) is fundamental to developing guidance quickly for the NHS. Moreover, consideration of the issues and uncertainties in the case for adoption of a specific product can help to guide practice in general and the use of other technologies that are claimed to offer similar benefits. Manufacturers notify potential topics; they are not identified by members of the Medical Technologies Advisory Committee (MTAC), which is an advisory body, independent of NICE. The Medical Technologies Advisory Committee is responsible for selecting notified products for which NICE guidance is likely to be of value to the NHS. Submissions are not prepared by NICE’s contracted external assessment centres; these academic centres provide independent critiques of submissions prepared by manufacturers. There is no requirement for hospital trusts to ‘report back to NICE’; medical technology guidance recommends whether trusts should consider adopting technologies, based on clear statements about their likely clinical and cost advantages. Ghosh et al. question the robustness of the evidence base on which the recommendations were made. Evidence for medical devices and diagnostic tests is typically sparse (specifically compared with pharmaceuticals and especially if a technology is relatively new). The NICE medical technologies programme aims to stimulate the development of more and better quality evidence by working with manufacturers and by fostering research. Ghosh et al. criticise manufacturer funding for many of the trials and researchers. It is to the credit of manufacturers when they do fund trials. The Medical Technologies Advisory Committee considers all the features of trial evidence, irrespective of funding source, on the basis of quality, robustness, quantity and potential sources of bias. Ghosh et al. also point out that outcome measures and patient groups were heterogeneous among the available studies; in our experience, this is a common characteristic of clinical evidence, which is why we have developed a deliberative, structured and balanced approach to decision-making. The wide range of clinicians, scientists, lay people and other disciplines on MTAC aims to provide the necessary skills and expertise to weigh evidence and other factors, and to make difficult judgements. The advice of clinical experts is a very important part of the information available to the Committee in making its recommendations. Experts are nominated by stakeholders, including professional societies and manufacturers, and there are robust processes for managing conflicts of interest. We encourage specialist clinicians, including Ghosh and colleagues, to become involved in future medical technology evaluations by seeking to be nominated as experts in their specialty. We would also encourage clinical experts to respond to public consultation, which is a very influential step in the production of NICE guidance.