title: A framework for the evaluation of new interventional procedures.
abstract: OBJECTIVE
  The introduction of new interventional procedures is less regulated than for other health technologies such as pharmaceuticals. Decisions are often taken on evidence of efficacy and short-term safety from small-scale usually observational studies. This reflects the particular challenges of evaluating interventional procedures - the extra facets of skill and training and the difficulty defining a 'new' technology. Currently, there is no framework to evaluate new interventional procedures before they become available in clinical practice as opposed to new pharmaceuticals. This paper proposes a framework to guide the evaluation of a new interventional procedure.
  A framework was developed consisting of a four-stage progressive evaluation for a new interventional procedure: Stage 1: Development; Stage 2: Efficacy and short-term safety; Stage 3: Effectiveness and cost-effectiveness; and Stage 4: Implementation. The framework also suggests the types of studies or data collection methods that can be used to satisfy each stage.
  
  
  CONCLUSIONS
  This paper makes a first step on a framework for generating evidence on new interventional procedures. The difficulties and limitations of applying such a framework are discussed.
authors.affiliation: Health Services Research Unit, Institute of Applied Health Sciences, University of Aberdeen, UK. taniapclourenco@gmail.com
authors.forename: Tania
authors.initials: T
authors.lastname: Lourenco
authors.forename: Adrian M
authors.initials: AM
authors.lastname: Grant
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Burr
authors.forename: Luke
authors.initials: L
authors.lastname: Vale
mesh_terms: D004864:Equipment and Supplies; D005069:Evaluation Studies as Topic; D006801:Humans; D006113:United Kingdom