A framework for the evaluation of new interventional procedures

Tania Lourenco, Adrian M. Grant, Jennifer M. Burr, Luke Vale

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)234-240
Number of pages7
JournalHealth Policy
Volume104
Issue number3
Early online date21 Nov 2011
DOIs
Publication statusPublished - Mar 2012

Keywords

  • New interventional procedures
  • Medical devices
  • Evaluation
  • Innovation
  • Framework

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