Oklahoma State University, 1111 W. 17th St., Tulsa, OK 74107, United States.
Diabetes Res Clin Pract. 2017 Dec;134:91-105. doi: 10.1016/j.diabres.2017.10.007. Epub 2017 Oct 14.
To analyze the robustness of randomized controlled trials (RCTs) referenced in the American Diabetes Association's Standards of Medical Care in Diabetes-2017 using the Fragility Index (FI) and Fragility Quotient (FQ).
We performed a systematic survey of all RCTs referenced in the Standards of Medical Care in Diabetes-2017. One investigator screened for trials and then recorded data from them, including sample size per group, event rate per group, and the dichotomous outcome analyzed by trialists. The FI and FQ for each outcome were calculated. Outcomes were then surveyed to determine whether the outcome used for analysis aligned with the guideline recommendation.
Thirty-five RCTs were included in this study. Thirty-three of 35 (94%) FIs were based on the trial outcomes referenced in the clinical practice guideline. The median sample size was 2548 participants ([IQR], 522-6946). The median total number of events for each outcome was 403 (IQR, 86-969). Nineteen (54%) P Values were below 0.05, 8 (22.4%) were below 0.01. The median FI for all trials was 16 (IQR, 4-29). The median FQ was 0.007 (IQR, 0.003-0.014). FI was not related to risk of bias or Science Citation Index but was significantly correlated with sample size (for significant trials; r=0.77, P < .001, for neutral trials; r=0.76, P < .001).
We found that the robustness of RCTs varied, but on the whole were not robust in nature. Most trials demonstrated a modest FI and FQ. As a result, conclusions drawn from these trials should take this information into account.
使用脆弱指数（FI）和脆弱性分数（FQ）分析 2017 年美国糖尿病协会《糖尿病医疗护理标准》中引用的随机对照试验（RCT）的稳健性。
我们对《糖尿病医疗护理标准》中引用的所有 RCT 进行了系统调查。一名调查员筛选试验，然后记录从试验中获得的数据，包括每组的样本量、每组的事件发生率以及试验人员分析的二分结果。计算了每个结果的 FI 和 FQ。然后调查结果，以确定用于分析的结果是否与指南建议一致。
本研究共纳入 35 项 RCT。35 项 RCT 中有 33 项（94%）的 FI 基于临床实践指南中引用的试验结果。中位数样本量为 2548 名参与者（[IQR]，522-6946）。每个结果的中位数总事件数为 403（IQR，86-969）。19 项（54%）P 值<0.05，8 项（22.4%）P 值<0.01。所有试验的中位数 FI 为 16（IQR，4-29）。中位数 FQ 为 0.007（IQR，0.003-0.014）。FI 与偏倚风险或科学引文索引无关，但与样本量显著相关（对于显著试验；r=0.77，P<0.001，对于中性试验；r=0.76，P<0.001）。
我们发现 RCT 的稳健性存在差异，但总体上并不稳健。大多数试验显示出适度的 FI 和 FQ。因此，应考虑从这些试验中得出的结论。
