Labek G, Todorov S, Lübbeke-Wolff A, Haderer B, Krivanek S
Klinik für Orthopädie, Medizinische Universität Innsbruck, Anichstr. 35, A-6020, Innsbruck, Österreich.
Orthopade. 2012 Oct;41(10):853-9. doi: 10.1007/s00132-012-1945-4.
The value of outcome quality data from clinical studies is an issue of controversial debate particularly in the context of adverse events. The aim of this study is to present and evaluate the data available from clinical studies for products that show inferior outcome in registers and to assess the possibility to draw valid conclusions from these data. STUDY DESIGN AND ANALYTICAL METHODS: Based on a structured literature research, a comparative analysis was made of the revision rates of 12 products showing significantly inferior average results in registers. The primary outcome parameter was the revision rate for any reason calculated using a standardized methodology and the parameter of revisions per 100 observed component years.
For 5 out of 12 products not a single comparable study was available and relatively few data were available for the remaining products. A conventional meta-analysis revealed that only three products showed results that were comparable with those from registers. For 75% of products good results were published. There was not a single case where it would have been possible to identify or isolate the problems that had led to the underperformance observed on the basis of clinical studies alone.
Clinical sample-based studies are not a suitable and reliable means to recognize potential product or handling problems and avoid risks for patients and physicians. In this respect registers can provide an essential contribution.
临床研究结果质量数据的价值是一个存在争议的话题，尤其是在不良事件方面。本研究的目的是展示和评估临床研究中有关在登记册中显示疗效较差的产品的数据，并评估从这些数据中得出有效结论的可能性。
基于结构化文献研究，对登记册中平均结果显著较差的12种产品的翻修率进行了比较分析。主要结局参数是使用标准化方法计算的任何原因导致的翻修率以及每100个观察到的组件年的翻修参数。
12种产品中有5种没有可比较的研究，其余产品的数据相对较少。传统的荟萃分析显示，只有3种产品的结果与登记册中的结果具有可比性。75%的产品发表了良好的结果。没有一个案例能够仅根据临床研究确定或分离出导致观察到的表现不佳的问题。
基于临床样本的研究不是识别潜在产品或操作问题以及避免患者和医生风险的合适且可靠的方法。在这方面，登记册可以做出重要贡献。
