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Type II error in the spine surgical literature.

机译：脊柱外科文献中的II型错误。

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STUDY DESIGN: A literature review. OBJECTIVES: To determine the frequency of potential type II errors published in the spine surgical literature. SUMMARY OF BACKGROUND DATA: The randomized controlled trial is the strongest clinical evidence available in investigational medicine. Unfortunately, it is common for randomized controlled trials published in peer-reviewed journals not to report a primary question or a sample size calculation. When the null hypothesis is accepted and the power of a study is unreported, the validity of a study's findings may be significantly limited. To our knowledge, the spine literature has not been appraised to determine the frequency of type II errors. METHODS.: A literature search was conducted of MED-LINE, PubMed, and Cochrane databases, using the key words of "spine" and "surgery" between 1967 and 2002. Trials were included if they were of a 2-group randomized controlled trial design, which reported a nonsignificant difference in the primary outcome. The frequency of reporting the primary outcome and sample size calculation was determined. The sample size was assessed to determine whether the trial had sufficient patients to detect a 10%, 25%, and 35% relative difference in the primary outcome for a power of 80%. RESULTS: A total of 37 studies satisfied the inclusion criteria. Six studies reported a sample size calculation (17%). Of the remaining 31 studies, 5 explicitly stated a primary outcome (14%). The mean type II error (beta error) was 82%. CONCLUSION: The spine surgical literature is plagued with a high potential for type II error. A trial's methodology should be scrutinized to prevent misinterpretation of the results.
机译：研究设计：文献综述。目的：确定脊柱外科文献中潜在的II型错误发生率。背景数据摘要：随机对照试验是研究医学中最有力的临床证据。不幸的是，在同行评议的期刊上发表的随机对照试验通常没有报告主要问题或样本量计算，这很常见。当原假设被接受且研究的功效未得到报告时，研究结果的有效性可能会受到很大的限制。据我们所知，尚未评估脊柱文献以确定II型错误发生的频率。方法：对1967年至2002年之间MED-LINE，PubMed和Cochrane数据库进行了文献检索，关键词为“脊柱”和“手术”。如果这些试验属于2组随机对照试验，则包括在内。设计，报告的主要结果无显着差异。确定了报告主要结果和样本量计算的频率。评估样本量以确定该试验是否有足够的患者以80％的功效检测出主要结局的10％，25％和35％相对差异。结果：共有37项研究符合纳入标准。六项研究报告了样本量计算（17％）。在其余31项研究中，有5项明确表明了主要结果（14％）。 II型平均错误（β错误）为82％。结论：脊柱外科文献困扰着II型错误的高可能性。应该仔细研究试验的方法，以防止对结果的误解。

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