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dc.contributor.authorLourenco, Tania
dc.contributor.authorGrant, Adrian M.
dc.contributor.authorBurr, Jennifer M.
dc.contributor.authorVale, Luke
dc.identifier.citationLourenco , 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 .
dc.identifier.otherPURE: 22155483
dc.identifier.otherPURE UUID: 9e526383-e059-48d6-a6e3-c040108f19e0
dc.identifier.otherWOS: 000301808900005
dc.identifier.otherScopus: 84857440121
dc.identifier.otherORCID: /0000-0002-9478-738X/work/60196209
dc.description.abstractObjectives: 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.
dc.relation.ispartofHealth Policyen
dc.rightsThis is an author version of this article. The published version (c) 2011 Elsevier Ireland Ltd. is available at www.sciencedirect.comen
dc.subjectNew interventional proceduresen
dc.subjectMedical devicesen
dc.subjectRA Public aspects of medicineen
dc.titleA framework for the evaluation of new interventional proceduresen
dc.typeJournal articleen
dc.contributor.institutionUniversity of St Andrews.School of Medicineen
dc.description.statusPeer revieweden

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