Department of Orthopaedics, Innsbruck Medical University, Innsbruck, Austria.
Acta Orthop. 2011 Apr;82(2):131-5. doi: 10.3109/17453674.2011.566134. Epub 2011 Mar 24.
The reproducibility of results and potential confounders in sample-based studies is important to consider in the assessment of studies. Comprehensive arthroplasty registers could serve as a reference dataset for comparative analyses. We analyzed an implant that is frequently used worldwide, the Oxford unicompartmental knee replacement, in order to identify potential confounders inherent in the datasets and to evaluate the outcome achieved with this implant.
We performed a structured literature review of the data published on the revision rate of the Oxford medial unicompartmental arthroplasty. Both clinical follow-up studies and worldwide registry data were included. Confidence intervals were calculated to determine the statistical significance of differences.
A substantial proportion of the published data (52-68% depending on the method of calculation) is derived from studies involving participation of the institution that developed the implant. The results published by this group show a statistically significant deviation from the reference datasets from registers or independent studies. Data from the developing hospital show mean revision rates that are 4 times lower than those based on worldwide register data, and 3 times lower than the ones quoted in independent studies. On average, the data published in independent studies are reproducible in registry data.
A conventional meta-analysis of clinical studies is substantially affected by the influence of the developing hospital, and is therefore subject to bias. For assessment of the outcome of implants, registry data are superior and, in terms of reference data for the detection of potential bias factors in the literature, could make an essential contribution to meta-analyses.
在评估研究时,基于样本的研究结果的可重复性和潜在混杂因素非常重要。全面的关节置换登记处可以作为比较分析的参考数据集。我们分析了一种在全球范围内广泛使用的植入物,即牛津单髁膝关节置换,以确定数据集固有的潜在混杂因素,并评估该植入物的治疗效果。
我们对牛津内侧单髁关节置换翻修率的已发表数据进行了系统的文献回顾。纳入了临床随访研究和全球登记数据。置信区间用于确定差异的统计学意义。
大量已发表的数据(根据计算方法的不同,为 52%-68%)来自于参与植入物开发机构的研究。该组发表的结果与来自登记处或独立研究的参考数据集存在统计学显著偏差。来自开发医院的数据显示,平均翻修率比全球登记处数据低 4 倍,比独立研究中的数据低 3 倍。平均而言,独立研究中发表的数据在登记处数据中具有可重复性。
临床研究的常规荟萃分析受到开发医院的影响较大,因此存在偏倚。对于植入物治疗效果的评估,登记处数据更优,并且在检测文献中潜在混杂因素的参考数据方面,可以对荟萃分析做出重要贡献。