Polit Denise F, Gillespie Brigid M
Humanalysis, Inc., Saratoga Springs, New York 12866, USA.
Nurs Res. 2009 Nov-Dec;58(6):391-9. doi: 10.1097/NNR.0b013e3181bf1505.
In randomized controlled trials (RCTs), the intention-to-treat (ITT) principle, which involves maintaining study participants in the treatment groups to which they were randomized regardless of postrandomization withdrawal, is the recommended analytic approach for preserving the integrity of randomization, yet little is known about the use of ITT in nursing RCTs.
The purpose of this study was to describe the extent to which nurse researchers who conduct RCTs state that they have used ITT, the extent to which they adhere to ITT principles, and the methods they use to handle missing data.
Data regarding ITT analysis, participant flow, rates of attrition, and methods of handling missing data were extracted and coded from a consecutive sample of 124 RCTs published in 16 nursing journals in 2007 and 2008.
ITT was declared in only 15.3% of the nursing RCTs, and a definition of ITT was offered in fewer than half of these studies. On the basis of the authors' descriptions of analytic procedures, it was concluded that 10.5% of those claiming ITT use had used a per-protocol analysis rather than an ITT analysis. Overall, 46.8% of the RCTs were classified as having either a classic or a modified ITT analysis, indicating that many nurse researchers are not stating their actual adherence to ITT, despite advice to do so in the Consolidated Standards of Reporting Trials guidelines.
Nurse researchers conducting RCTs should be more diligent in following the Consolidated Standards of Reporting Trials guidelines about ITT, documenting ITT use in their reports, clarifying their definition of ITT, and presenting flowcharts that describe subject flow. Readers of nursing reports, in evaluating evidence from RCTs, should not rely on stated use of ITT but should examine how analyses were conducted.
在随机对照试验（RCT）中，意向性分析（ITT）原则建议，无论随机分组后是否退出，都应将研究参与者保留在其随机分配的治疗组中，这是保持随机化完整性的推荐分析方法，但对于ITT原则在护理RCT中的应用知之甚少。
本研究旨在描述开展RCT的护士研究人员声明使用ITT的程度、他们遵循ITT原则的程度以及处理缺失数据的方法。
从2007年和2008年发表在16种护理期刊上的124项RCT连续样本中提取并编码有关ITT分析、参与者流程、损耗率和处理缺失数据方法的数据。
仅15.3%的护理RCT声明使用了ITT，且不到一半的研究给出了ITT的定义。根据作者对分析程序的描述，得出结论：在声称使用ITT的研究中，10.5%采用的是符合方案分析而非ITT分析。总体而言，46.8%的RCT被归类为进行了经典或改良的ITT分析，这表明尽管《报告试验的统一标准》指南建议护士研究人员声明其对ITT原则的实际遵循情况，但许多人并未这样做。
开展RCT的护士研究人员应更加严格地遵循《报告试验的统一标准》指南中关于ITT的规定，在报告中记录ITT的使用情况，阐明其对ITT的定义，并提供描述研究对象流程的流程图。护理报告的读者在评估RCT证据时，不应仅依赖声明的ITT使用情况，而应检查分析是如何进行的。
