ASSESSING THE VALUE OF INNOVATIVE MEDICAL DEVICES AND DIAGNOSTICS: THE IMPORTANCE OF CLEAR AND RELEVANT CLAIMS OF BENEFIT
| Autor: | Chris Pomfrett, Lee Dobson, Mirella Marlow, Bernice Dillon, Joanne Higgins, Mark Campbell, Bruce H. Campbell |
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| Rok vydání: | 2018 |
| Předmět: |
Technology Assessment
Biomedical Scrutiny Biomedical Cost-Benefit Analysis media_common.quotation_subject Nice Assessment Evaluation studies State Medicine law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Cost Savings Excellence law Humans 030212 general & internal medicine Biomedical technology health care economics and organizations Diagnostic Techniques and Procedures computer.programming_language media_common Actuarial science 030503 health policy & services Health Policy Reproducibility of Results Health technology Technology assessment Directive United Kingdom Equipment and Supplies Patient Safety 0305 other medical science Psychology computer Cohort study |
| Zdroj: | International Journal of Technology Assessment in Health Care |
| ISSN: | 1471-6348 0266-4623 |
| Popis: | Objectives:Large numbers of new medical devices and diagnostics are developed and health services need to identify which ones offer real advantages. The National Institute for Health and Care Excellence (NICE) has introduced a system for assessing technologies that are often notified by companies, based on claims made for their benefits to patients, the National Health Service, and the environment.Methods:Detailed scrutiny of claims made for the benefits of products and the corresponding evidence, seeking associations between these and the selection of products for full evaluation to produce NICE guidance.Results:Between 2009 and 2015 a NICE committee considered 169 technologies, of which it selected 74 (44 percent) for full evaluation, based on the claims of benefit and the evidence available. An average of 7.5 claims were made per technology; the total number did not influence selection but presence of studies supporting all the claims (p < .001) or any of the claims (p < .05) had a positive influence, as did claims for quicker patient recovery (p < .001). A greater number of studies to support the claims made selection more likely (p < .001), as did cohort studies (p < .05) and surveys (p < .05) but, unexpectedly, not randomized trials. The Medical Device Directive class had no influence.Conclusions:This study presents categories of claims that may be useful to those developing new products and to others engaged in health technology assessment. It illustrates the importance of relevant evidence and of having a clear vision of the place of new products in care pathways from an early stage. |
| Databáze: | OpenAIRE |
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