Document Detail

A framework for the evaluation of new interventional procedures.
MedLine Citation:
PMID:  22192887     Owner:  NLM     Status:  MEDLINE    
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.
Tania Lourenco; Adrian M Grant; Jennifer M Burr; Luke Vale
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2011-12-21
Journal Detail:
Title:  Health policy (Amsterdam, Netherlands)     Volume:  104     ISSN:  1872-6054     ISO Abbreviation:  Health Policy     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-02-27     Completed Date:  2012-07-02     Revised Date:  2013-07-15    
Medline Journal Info:
Nlm Unique ID:  8409431     Medline TA:  Health Policy     Country:  Ireland    
Other Details:
Languages:  eng     Pagination:  234-40     Citation Subset:  H    
Copyright Information:
Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.
Health Services Research Unit, Institute of Applied Health Sciences, University of Aberdeen, UK.
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MeSH Terms
Equipment and Supplies*
Evaluation Studies as Topic*
Great Britain
Grant Support
//Chief Scientist Office

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