Hahn Marianne, Gröschel Sonja, Othman Ahmed, Brockstedt Lavinia, Civelek Arda, Brockmann Marc A, Gröschel Klaus, Uphaus Timo
Department of Neurology and Focus Program Translational Neuroscience (FTN), Rhine main Neuroscience Network (rmn2), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
Department of Neuroradiology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
J Neurointerv Surg. 2024 Apr 23;16(5):471-477. doi: 10.1136/jnis-2023-020435.
Missing outcome data (MOD) is a common problem in clinical trials and registries, and a potential bias when drawing conclusions from these data. Identifying factors associated with MOD may help to increase follow-up rates and assess the need for imputation strategies. We investigated MOD in a multicenter, prospective registry study of mechanical thrombectomy (MT) in large vessel occlusion ischemic stroke.
13 082 patients enrolled in the German Stroke Registry-Endovascular Treatment from May 2015 to December 2021 were analyzed with regard to MOD (90 day modified Rankin Scale, mRS). Univariate logistic regression analyses identified factors unbalanced between patients with and without MOD. Subgroup analyses were performed to identify patients for whom increased efforts to perform clinical follow-up after hospital discharge are needed.
We identified 19.7% (2580/13 082) of patients with MOD at the 90 day follow-up. MOD was more common with higher pre-stroke disability (mRS 3-5, 32.2% vs mRS 0-2, 13.7%; P<0.001), absence of bridging intravenous thrombolysis, longer time to treatment, and in patients with high post-stroke disability at discharge (mRS 3-5 vs 0-2: OR 1.234 (95% CI 1.107 to 1.375); P<0.001). In contrast, MOD was less common with futile recanalization (thrombolysis in cerebral infarction (TICI) score of 0-2a, 12.4% vs TICI 2b-3, 15.0%; P=0.001). In patients discharged alive with well documented baseline characteristics, shorter hospital stay (OR 0.992 (95% CI 0.985 to 0.998); P=0.010) and discharge to institutional care or hospital (OR 1.754 (95% CI 1.558 to 1.976); P<0.001) were associated with MOD.
MOD in routine care MT registry data was not random. Increased efforts to perform clinical follow-up are needed, especially in the case of higher pre-stroke and post-stroke disability and discharge to hospital or institutional care.
NCT03356392.
缺失结局数据(MOD)是临床试验和登记研究中的常见问题,也是从这些数据得出结论时的潜在偏倚。识别与MOD相关的因素可能有助于提高随访率,并评估采用插补策略的必要性。我们在一项关于大血管闭塞性缺血性卒中机械取栓术(MT)的多中心前瞻性登记研究中调查了MOD情况。
分析了2015年5月至2021年12月纳入德国卒中登记-血管内治疗的13082例患者的MOD情况(90天改良Rankin量表,mRS)。单因素逻辑回归分析确定了有MOD和无MOD患者之间不平衡的因素。进行亚组分析以确定出院后需要加强临床随访的患者。
我们在90天随访时发现19.7%(2580/13082)的患者存在MOD。MOD在卒中前残疾程度较高(mRS 3 - 5,32.2%对比mRS 0 - 2,13.7%;P<0.001)、未进行桥接静脉溶栓、治疗时间较长以及出院时卒中后残疾程度较高的患者中更为常见(mRS 3 - 5对比0 - 2:比值比1.234(95%置信区间1.107至1.375);P<0.001)。相比之下,再通无效(脑梗死溶栓(TICI)评分0 - 2a,12.4%对比TICI 2b - 3,15.0%;P = 0.001)时MOD较少见。在基线特征记录良好且存活出院的患者中,住院时间较短(比值比0.992(95%置信区间0.985至0.998);P = 0.010)以及出院后入住机构护理或医院(比值比1.754(95%置信区间1.558至1.976);P<0.001)与MOD相关。
常规护理MT登记数据中的MOD并非随机出现。需要加强临床随访工作,尤其是对于卒中前和卒中后残疾程度较高以及出院后入住医院或机构护理的患者。
NCT03356392