A framework for the evaluation of new interventional procedures
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Objectives: 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. Proposed framework: 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.
Lourenco , T , Grant , A M , Burr , J M & Vale , L 2012 , ' A framework for the evaluation of new interventional procedures ' Health Policy , vol 104 , no. 3 , pp. 234-240 . , 10.1016/j.healthpol.2011.11.012
This is an author version of this article. The published version (c) 2011 Elsevier Ireland Ltd. is available at www.sciencedirect.com
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