title: PROMISE AND PLAUSIBILITY: HEALTH TECHNOLOGY ADOPTION DECISIONS WITH LIMITED EVIDENCE.
abstract: 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.
authors.affiliation: Medical Technologies Advisory Committee,National Institute for Health and Care Excellence.
authors.forename: Bruce
authors.initials: B
authors.lastname: Campbell
authors.affiliation: Medical Technologies Advisory Committee,National Institute for Health and Care Excellence Department of Eye & Vision Science,Institute of Ageing & Chronic Disease,University of Liverpoolpcknox@liv.ac.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: Knox
mesh_terms: D020811:Biomedical Technology / Q000191:economics; D003362:Cost-Benefit Analysis / Q000379:methods; D003659:Decision Making, Organizational; D004059:Diffusion of Innovation; D004864:Equipment and Supplies; D012308:Risk Management; D006113:United Kingdom
keywords: Evidence; Innovation; Medical technology; Promise; Technology assessment