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首页> 外文期刊>The East African medical journal >Intention-to-treat analysis in the chronic suppurative otitis media trials.
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Intention-to-treat analysis in the chronic suppurative otitis media trials.

机译：慢性化脓性中耳炎试验中的意向治疗分析。

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OBJECTIVE: To determine the extent of application of the intention to treat principle in the chronic suppurative otitis media (CSOM) randomised controlled trials. DESIGN: Data were extracted from 28 CSOM randomised controlled trials. MAIN OUTCOME MEASURES: Conceptual and methodological approaches of dealing with protocol deviations with respect to withdrawal, missing response and non-compliance. RESULTS: Of the 28 CSOM trials included in this study, only one (4%) trial mentioned intention-to-treat (ITT) analysis. However, 10(36%) other trials which did not mention ITT, had no protocol deviations and thus carried out an ITT analysis by default. It is highly likely that a biased treatment effect existed in the trial that mentioned ITT since the authors undertook a complete case analysis disregarding the 22% protocol deviators. There were no attempts in any of the trials to impute for missing responses and carrying out a sensitivity analysis. For trials with a big percentage of protocol deviations, the validity of their results are brought to question. CONCLUSIONS: In practice, not all those entered into a randomised-controlled trial will complete the trial. Thus intention-to-treat analysis is an important aspect of randomised controlled trials of health care interventions which tries to bridge this gap. It is important for authors to explicitly state the protocol deviations, the methods used to handle them and the potential effect with reference to bias and study outcome.
机译：目的：确定意图治疗原则在慢性化脓性中耳炎（CSOM）随机对照试验中的应用范围。设计：数据来自28项CSOM随机对照试验。主要观察指标：处理与退出，遗漏反应和不遵从有关的方案偏差的概念和方法。结果：在这项研究中包括的28项CSOM试验中，只有一项（4％）试验提到了意向性治疗（ITT）分析。但是，其他10个（36％）未提及ITT的试验也没有方案偏差，因此默认情况下进行了ITT分析。由于作者对22％的方案偏离者进行了完整的病例分析，因此很可能在提及ITT的试验中存在偏倚的治疗效果。在任何试验中都没有尝试归因于缺失的应答和进行敏感性分析。对于方案偏差较大的试验，其结果的有效性受到质疑。结论：实际上，并非所有参加随机对照试验的人都将完成试验。因此，意向分析是医疗干预措施随机对照试验的一个重要方面，它试图弥合这一差距。对于作者来说，重要的是要明确说明方案的偏差，处理偏差的方法以及参考偏倚和研究结果的潜在影响。

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