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Large numbers of new medical devices and diagnostics are developed and health services need to identify which ones offer real advantages. The National Institute for Health and Care Excellence (NICE) has introduced a system for assessing technologies that are often notified by companies, based on claims made for their benefits to patients, the National Health Service, and the environment.
Detailed scrutiny of claims made for the benefits of products and the corresponding evidence, seeking associations between these and the selection of products for full evaluation to produce NICE guidance.
Between 2009 and 2015 a NICE committee considered 169 technologies, of which it selected 74 (44 percent) for full evaluation, based on the claims of benefit and the evidence available. An average of 7.5 claims were made per technology; the total number did not influence selection but presence of studies supporting all the claims (p < .001) or any of the claims (p < .05) had a positive influence, as did claims for quicker patient recovery (p < .001). A greater number of studies to support the claims made selection more likely (p < .001), as did cohort studies (p < .05) and surveys (p < .05) but, unexpectedly, not randomized trials. The Medical Device Directive class had no influence.
This study presents categories of claims that may be useful to those developing new products and to others engaged in health technology assessment. It illustrates the importance of relevant evidence and of having a clear vision of the place of new products in care pathways from an early stage.
In 1258, as baronial opposition to Henry III erupted and the government became locked in constitutional conflict, the country found itself in the grip of a serious food crisis. To blame was a run of bad weather and failed harvests. Thousands of famished famine refugees flocked to London in quest of food and charity, where many of them perished and were buried in mass graves. The multiple burials recently discovered and excavated in the cemetery of the hospital of St Mary Spital highlight the plight of the poor at this time of political turmoil. Was their fate part of a global catastrophe precipitated by the VEI7 explosion of Samalas Volcano, Indonesia, the previous year or was powerful solar forcing of global climates responsible for the unusually unstable weather? The answer depends in large measure upon establishing the precise chronology of how the crisis unfolded, drawing upon the surviving documentary record of prices and harvests, the comments of contemporary chroniclers and a range of high-resolution palaeo-climatic proxies. Reexamination of this episode illustrates the potential of environmental history to shed fresh light on familiar historical events and its capacity to place them in a global environmental context.
Objectives: The aim of this study was to review 5 years of activity from a new system devised by the National Institute for Health and Care Excellence (NICE), for assessing medical devices and diagnostics aimed at identifying and speeding adoption of technologies with clinical and cost advantages, compared with current practice in the United Kingdom healthcare system.
Methods: All eligible notified technologies were classified using the Food and Drug Administration and Global Medical Device Nomenclature nomenclatures. Decisions about selecting technologies for full assessment to produce NICE recommendations were reviewed, along with the reasons given to companies for not selecting products.
Results: Between 2009 and 2014, 186 technologies were notified (46 percent therapeutic and 54 percent diagnostic). Thirty-nine were judged ineligible (no regulatory approval), and 147 were considered by an independent committee. Of these, eighty (54 percent) were not selected for full assessment, most commonly because of insufficient evidence (86 percent): there were uncertainties specifically about benefits to the health service (54 percent), to patients (39 percent), and about cost (24 percent). The remaining 67 were selected and assessed for Medical Technology guidance (52 percent) (noninferior and/or lower cost consequences than current practice), for Diagnostics guidance (43 percent) or other NICE recommendations about adoption and use. Classifying technologies by two different systems showed no selection bias for any technology type or disease area.
Conclusions: Identifying new or under-used devices and diagnostics with potential benefits and promoting their adoption is important to health services in the United Kingdom and worldwide. This new system offers a means of fostering both uptake and further research. Lack of research data on new products is a major obstacle to evaluation.
Background: The adoption of new medical devices and diagnostics is often hampered by lack of published evidence which makes conventional health technology assessment (HTA) difficult. We now have 5 years’ experience of the Medical Technologies Advisory Committee of the National Institute for Health and Care Excellence (NICE) in the United Kingdom, addressing this problem. This committee assesses devices and diagnostics against claims of advantage, to produce guidance on adoption for the health service.
Methods: We have reflected on the practical, technical, and intellectual processes we have used in developing guidance for the health service.
Results: When scientific and clinical evidence is sparse, promise and plausibility play an increased part in decision-making. Drivers of promise include a clear design and mechanism of action, the possibility of radical improvement in care and/or resource use, and improving health outcomes for large numbers of patients. Plausibility relates to judgements about the whether the promise is likely to be delivered in a “real world” setting. Promise and plausibility need to be balanced against the amount of evidence available. We examine the influence they may have on decision-making compared with other factors such as risk and cost.
Conclusions: Decisions about adoption of new devices and diagnostics with little evidence are influenced by judgements of their promise and the plausibility of claims that they will provide benefits in a real-world setting. This kind of decision making needs to be transparent and this article explains how these influences can be balanced against the use of more familiar criteria.
We have monitored changes in the radial velocities of 24 bright F, G and K dwarf stars (known spectroscopic binaries excluded) for the past six years at CFHT by imposing the absorption lines of HF gas in the spectra to act as wavelength fiducials. The average external error in the δ(velocities) which are based on some 16 stellar lines is 13 m/s corresponds to 0.6 micron in the spectrum or 0.04 of a diode spacing per line. Reductions are complete for 16 stars. There is no evidence for brown dwarf companions in the sample. Two previously unknown spectroscopic binaries were found, and seven stars show indications of significant, long-term, low-level velocity variations which could be interpreted as purturbations by companions of a few Jupiter masses with periods greater than 12 years except for γ Cep, which may have a period of 2.7 years, and ε Eri. Observing time has been guaranteed for at least two more years at CFHT.