Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche, Unité de Recherche Clinique, Lyon, 69003, France.
BMC Public Health. 2012 Aug 1;12:585. doi: 10.1186/1471-2458-12-585.
Scientific evidence supports decision-making on the use of implantable medical devices (IMDs) in clinical practice, but IMDs are thought to be far less investigated than drugs. In the USA, studies have shown that approval process of high-risk medical devices was often based on insufficiently robust studies, suggesting that evidence prior to marketing may not be adequate. This study aimed to ascertain level of evidence available for IMDs access to reimbursement in France.
The objective was to examine the scientific evidence used for IMDs assessment by the French National Authority for Health. We collected all public documents summarising supportive clinical data and opinions concerning IMDs issued in 2008. An opinion qualifies the expected benefit (EB) of the IMD assessed as sufficient or insufficient, and if sufficient, the level of improvement of the expected benefit (IEB) on a scale from major (level I) to no improvement (level V). For each opinion, the study with the highest level of evidence of efficacy data, and its design were collected, or, where no studies were available, any other data sources used to establish the opinion.
One hundred and two opinions were analysed, with 72 reporting at least one study used for assessment (70.6%). When considering the study with the highest level of evidence: 34 were clinical non-comparative studies (47.2%); 29 were clinical comparative studies of which 25 randomised controlled trials (40.3%); 5 were meta-analyses of randomised controlled trials (6.9%); and 4 were systematic literature reviews (5.6%). The opinions were significantly different according to the study design (p < 0.001). The most frequent design for insufficient EB, IEB level V and IEB level IV was a non-comparative study (10/19, 52.6%; 15/24, 62.5%; and 8/15, 53.3%; respectively). For the 30 opinions with no supporting clinical study, 16 (53.3%) were based on an expert-based process, 9 (30.0%) were based on the conclusions of a previous opinion (all concluding IEB level V), and 5 (16.7%) reported no data (concluding insufficient EB for 4 and IEB level V for 1).
This study confirmed that level of evidence of clinical evaluation of IMDs is low and needs to be improved.
科学证据支持在临床实践中对植入式医疗器械（IMD）的使用做出决策，但人们认为 IMD 的研究远不及药物广泛。在美国，研究表明，高风险医疗器械的审批过程通常基于不够稳健的研究，这表明上市前的证据可能并不充分。本研究旨在确定法国 IMD 获得报销的准入可获得的证据水平。
本研究旨在检查法国国家卫生局（ HAS ）用于评估 IMD 的科学证据。我们收集了 2008 年发布的所有总结 IMD 评估支持性临床数据和意见的公开文件。一项意见对评估 IMD 的预期获益（ EB ）是否充足进行定性，若充足，则根据获益改善程度（ IEB ）从重大（一级）到无改善（五级）进行分级。对于每项意见，我们收集了其证据效力最高的研究，以及研究设计，或在无研究可用的情况下，收集了用于建立意见的任何其他数据来源。
分析了 102 项意见，其中 72 项（ 70.6% ）报告至少有一项用于评估的研究。当考虑证据效力最高的研究时： 34 项为非对照临床研究（ 47.2% ）； 29 项为对照临床研究，其中 25 项为随机对照试验（ 40.3% ）； 5 项为随机对照试验的荟萃分析（ 6.9% ）； 4 项为系统文献综述（ 5.6% ）。意见的差异与研究设计显著相关（ p <0.001 ）。对于 EB 不足、IEB 等级 V 和 IEB 等级 IV 的意见，最常见的设计是非对照研究（ 10/19 ， 52.6% ； 15/24 ， 62.5% ； 8/15 ， 53.3% ）。对于 30 项无支持临床研究的意见， 16 项（ 53.3% ）基于专家意见， 9 项（ 30.0% ）基于之前意见的结论（均为 IEB 等级 V ）， 5 项（ 16.7% ）报告无数据（ 4 项为 EB 不足， 1 项为 IEB 等级 V ）。
本研究证实， IMD 临床评估的证据水平较低，需要提高。
