Michael G. DeGroote Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Struttura Complessa di Medicina Generale II, Ospedale San Paolo, Dipartimento di Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
Am J Hematol. 2024 Jun;99(6):1184-1186. doi: 10.1002/ajh.27298. Epub 2024 Mar 27.
We designed anagreement study to compare the results of bleeding assessments done in tandem by ITP patients and trained research staff. We used a modified version of the ITP Bleeding Scale, which captured the patients' worst bleeding event at any of nine anatomical sites since the time of the last assessment. Interrater agreement was determined using the 2-way kappa for the assessment of severe vs. non-severe bleeds. We analyzed 108 consecutive patients with ITP from the McMaster ITP Registry who had duplicate bleeding assessments. Two-way agreement was excellent for gynecological (k = 0.86, 95% CI 0.71-1.02), gastrointestinal (k = 1), genitourinary (k = 1), pulmonary (k = 1) and intracranial (k = 1) bleeds; good for skin (k = 0.68, 95% CI, 0.54-0.82), oral (k = 0.76, 95% CI, 0.53-0.98) and ocular (k = 0.66, 95% CI, 0.04-1-28) bleeds; and moderate for epistaxis (k = 0.58, 95% CI, 0.21-0.95). Bleeding self-assessments by ITP patients were similar to trained research staff, but disagreements in severity grades were more frequent with skin bleeds, oral bleeds and epistaxis. Bleeding self-assessments could simplify bleeding assessments in clinical trials.
我们设计了一项一致性研究，比较了 ITP 患者和经过培训的研究人员同时进行的出血评估结果。我们使用了改良的 ITP 出血量表，该量表记录了自上次评估以来患者在九个解剖部位中任何一个部位发生的最严重出血事件。使用 2 项 kapp 检验评估严重与非严重出血的评估者间一致性。我们分析了来自麦克马斯特 ITP 登记处的 108 例连续 ITP 患者，他们接受了重复的出血评估。妇科（k=0.86，95%CI 0.71-1.02）、胃肠道（k=1）、泌尿生殖系统（k=1）、肺部（k=1）和颅内（k=1）出血的双向一致性极好；皮肤（k=0.68，95%CI，0.54-0.82）、口腔（k=0.76，95%CI，0.53-0.98）和眼部（k=0.66，95%CI，0.04-1-28）出血的双向一致性良好；鼻出血（k=0.58，95%CI，0.21-0.95）的双向一致性为中度。ITP 患者的出血自我评估与经过培训的研究人员相似，但在皮肤出血、口腔出血和鼻出血的严重程度等级上存在更多分歧。出血自我评估可简化临床试验中的出血评估。
