Vavken P, Culen G, Dorotka R
Universitätsklinik für Orthopädie, Medizinische Universität Wien, Osterreich.
Z Orthop Unfall. 2008 Jan-Feb;146(1):21-5. doi: 10.1055/s-2007-965802.
The demand to routinely apply evidence-based methods in orthopedic surgery increases steadily. In order to do so, however, the validity and reliability of the "evidence" has to be scrutinized.
The object of this study was to assess the quality of the most recent orthopedic evidence and to determine variables that have an influence on quality.
All 2006 controlled trials from orthopedic journals with high impact factors were analysed in a cross-sectional study. A score based on the CONSORT statement was used to assess study quality. Selected variables were tested for their influence on the quality of the study.
Two independent blinded observers reviewed 126 studies. The overall quality was moderate to high. The most neglected parameters were power analysis, intention-to-treat, and concealment. The participation of a methodologically trained investigator increases study quality significantly. There was no difference in study quality irrespective of whether or not there was statistically significant result.
Using our quality score we were able show fairly good results for recent orthopedic studies. The most frequently neglected issues in orthopedic research are blinding, power analysis, and intention-to-treat. This may distort the results of clinical investigations considerably and, especially, lack of concealment causes false-positive findings. Our data show furthermore that participation of a methodologist significantly increases quality of the study and consequently strengthens the reliability of results.
在骨科手术中常规应用循证医学方法的需求稳步增长。然而，要做到这一点，必须仔细审查“证据”的有效性和可靠性。
本研究的目的是评估最新骨科证据的质量，并确定影响质量的变量。
在一项横断面研究中，对骨科高影响因子期刊2006年发表的所有对照试验进行分析。使用基于CONSORT声明的评分来评估研究质量。测试选定变量对研究质量的影响。
两名独立的盲法观察者审查了126项研究。总体质量为中等至高。最常被忽视的参数是功效分析、意向性分析和分配隐藏。接受过方法学培训的研究者参与可显著提高研究质量。无论是否有统计学显著结果，研究质量均无差异。
使用我们的质量评分，我们能够展示近期骨科研究相当不错的结果。骨科研究中最常被忽视的问题是盲法、功效分析和意向性分析。这可能会严重扭曲临床研究结果，尤其是缺乏分配隐藏会导致假阳性结果。我们的数据还表明，方法学家的参与显著提高了研究质量，从而增强了结果的可靠性。
