A framework for the evaluation of new interventional procedures

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• 作者：Tania Lourenco^a ; ^{taniapclourenco@gmail.com} ; ^{tania.lourenco@abdn.ac.uk} ; Adrian M. Grant^b ; Jennifer M. Burr^a ; Luke Vale^c
• 关键词：New interventional procedures ; Medical devices ; Evaluation ; Innovation ; Framework
• 刊名：Health Policy
• 出版年：2012
• 期刊代码：110_01688510
• 类别：med
• 出版时间：March, 2012
• 卷：104
• 期：3
• 页码：234-240
• 文件大小：444 K

摘要

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 鈥榥ew鈥?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.