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首页> 外文期刊>The Journal of Bone and Joint Surgery. American Volume >How many patients? How many limbs? Analysis of patients or limbs in the orthopaedic literature: a systematic review.
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How many patients? How many limbs? Analysis of patients or limbs in the orthopaedic literature: a systematic review.

机译：有多少病人？几肢？骨科文献中患者或四肢的分析：系统综述。

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BACKGROUND: Clinical studies assessing orthopaedic interventions often include data from two limbs or multiple joints within single individuals. Without appropriate design or statistical approaches to address within-individual correlations, this practice may contribute to false precision and possible bias in estimates of treatment effect. We conducted a systematic review of the orthopaedic literature to determine the frequency of inappropriate inclusion of nonindependent limb or joint observations in clinical studies. METHODS: We identified seven orthopaedic journals with high Science Citation Index impact factors and retrieved all clinical studies for 2003 for any intervention on any limb or joint. RESULTS: We identified 288 clinical studies, 143 of which involved two limbs or multiple joint observations from single individuals. These studies included nineteen randomized clinical trials (13%) fifty-eight two-group cohort studies (41%), and sixty-six one-group cohort studies (46%). Seventy-six (53%) ofthe 143 studies involved statistical comparisons between patient groups with use of tests of association, and an additional sixty studies (42%) presented estimates of proportions without statistical comparisons. Only sixteen of the seventy-six studies involving statistical comparisons involved the use of any technique or methodological approach to account for multiple, nonindependent observations. A median of approximately 13% of the patients in these studies contributed more than one observation. The median proportion of nonindependent observations to total observations (the unit of analysis) was approximately 23%. CONCLUSIONS: Our findings suggest that a high proportion (42%) of clinical studies in high-impact-factor orthopaedic journals involve the inappropriate use of multiple observations from single individuals, potentially biasing results. Orthopaedic researchers should attend to this issue when reporting results.
机译：背景：评估骨科干预措施的临床研究通常包括来自单个个体中两个肢体或多个关节的数据。如果没有适当的设计或统计方法来解决个体内部的相关性，这种做法可能会导致错误的准确性，并可能导致治疗效果的估计偏倚。我们对整形外科文献进行了系统的回顾，以确定在临床研究中不恰当地纳入非独立肢体或关节观察的频率。方法：我们确定了七种具有高科学引文索引影响因子的骨科杂志，并检索了2003年所有对任何肢体或关节进行干预的临床研究。结果：我们鉴定了288项临床研究，其中143项涉及两个肢体或来自单个个体的多个关节观察结果。这些研究包括十九项随机临床试验（13％），五十八项两组研究（41％）和六十六项一组研究（46％）。 143项研究中的76项（53％）涉及使用关联测试进行的患者组之间的统计比较，另有60项研究（42％）提出了没有统计比较的比例估计。在涉及统计比较的76项研究中，只有16项涉及使用任何技术或方法来解释多个非独立观察结果。在这些研究中，约有13％的患者中位数贡献了一项以上的观察结果。非独立观测值占总观测值（分析单位）的中位数比例约为23％。结论：我们的发现表明，高影响因子整形外科杂志中的临床研究中有很大一部分（42％）涉及对单个个体的多个观察结果的不当使用，可能会导致结果产生偏差。骨科研究人员在报告结果时应注意这一问题。

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