MSc, 420 Delaware St SE MMC 295, Minneapolis, MN 55455, USA.
Stroke. 2013 Jan;44(1):237-9. doi: 10.1161/STROKEAHA.112.667220. Epub 2012 Dec 11.
The reliability of hematoma volume (HV) measurement using the ABC/2 method in multicenter clinical trials is unknown. We determined the accuracy of ABC/2 method as an on-site test in comparison with the gold standard central HV-assessment and semiautomatic HV-assessment. Method- We analyzed data from an acute intracerebral hemorrhage multicenter clinical trial. HV was measured by site investigators to determine enrollment eligibility (<60 cm(3)) using the ABC/2 method (on-site HV), and independently by the core-imaging laboratory using computer-based analysis (Medical Image Processing, Analysis, and Visualization [MIPAV] HV). HV was also measured by ABC/2 method (central HV) at the core-imaging laboratory to assess the difference in measurements between on-site (multiple raters with variable experiences) and central (single experienced rater) HVs.
Fifty-six subjects were analyzed (mean age 62±15 years; 45% women). On-site HV values showed a significantly lower correlation with the MIPAV HV (r=0.63) than central HV and MIPAV HV (r=0.93) values. The correlation between on-site HV and central HV values was modest (r=0.51). A total of 73% of the central HVs were within 25% of the corresponding MIPAV HVs, whereas only 46% of the on-site HVs were within 25% of the corresponding MIPAV HVs (P<0.001). One protocol violation occurred as a result of inaccuracy of on-site HV measurement.
On-site HV measurements showed high variability, but the impact on the eligibility determination was small. Centralized remeasurements of HVs with feedback to the sites may increase the reliability of the on-site HV measurements.
ABC/2 法测量血肿体积（HV）在多中心临床试验中的可靠性尚不清楚。我们通过与金标准中心 HV 评估和半自动 HV 评估比较，确定了 ABC/2 法作为现场测试的准确性。方法：我们分析了一项急性脑出血多中心临床试验的数据。通过现场调查员使用 ABC/2 法（现场 HV）测量 HV，以确定入选资格（<60cm³），并由核心成像实验室使用基于计算机的分析（医学图像处理、分析和可视化[MIPAV]HV）独立测量 HV。在核心成像实验室也使用 ABC/2 法（中心 HV）测量 HV，以评估现场（多位经验不等的测量者）和中心（经验丰富的单一测量者）HV 测量之间的差异。
56 例患者被分析（平均年龄 62±15 岁；45%为女性）。现场 HV 值与 MIPAV HV 的相关性明显较低（r=0.63），而与中心 HV 和 MIPAV HV 的相关性较高（r=0.93）。现场 HV 值与中心 HV 值的相关性适中（r=0.51）。73%的中心 HV 与相应的 MIPAV HV 相差 25%以内，而只有 46%的现场 HV 与相应的 MIPAV HV 相差 25%以内（P<0.001）。由于现场 HV 测量不准确，发生了 1 例方案违反。
现场 HV 测量值具有高度变异性，但对入选资格的确定影响较小。对 HV 进行集中复测并将结果反馈给各现场可能会提高现场 HV 测量的可靠性。
