Wong Maylene, Staszewsky Lidia, Volpi Alberto, Latini Roberto, Barlera Simona, Höglund Christer
VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd. 500/6641, Los Angeles, CA 90073, USA.
J Am Soc Echocardiogr. 2002 Apr;15(4):293-301. doi: 10.1067/mje.2001.115103.
To qualify 302 multinational echocardiography sites to record and read serial studies and to monitor quality in 5010 patients randomized into Valsartan in Heart Failure Trial (Val-HeFT).
Decentralized echocardiography reading is unprecedented in large clinical trials.
Single and duplicate recordings, and triplicate readings of echocardiographic variables were submitted to 3 core laboratories. Quality of recording was defined with a 16-point scoring system; accuracy of reading by agreement with core readings; reproducibility by agreement between the duplicate studies.
Seventy-five percent of initial submissions were approved for recording, and 50% for reading. Resubmissions were evaluated until approval. Initial scores of sites approved with 1 versus 2 submissions differed, 13.8 +/- 1.4 versus 10.6 +/- 2.0, P <.001; final score was similar, 13.4 +/- 1.6, P = ns. Initial score of sites approved after 3 or more submissions differed, 9.5 +/- 1.9, P <.001; final score improved to 12.7 +/- 1.9, but remained lower, P <.001. Expressed as 95% limits of agreement (mean difference +/- 1.96 x SD), accuracy = -0.04 +/- 0.74 cm for left ventricular internal end-diastolic diameter (LVIDd); -0.29 +/- 14.3% for ejection fraction (EF); reproducibility = 0.00 +/- 0.53 cm for LVIDd; -0.25 +/- 8.3% for EF. Quality of random sampling at baseline, 4, 12, and 18 months showed recording scores of 11.7 +/- 2.7, 12.3 +/- 2.4, 12.1 +/- 2.2, and 11.4 +/- 2.0, P =.24. Power analysis revealed differences of 0.09 cm for LVIDd, and 0.86% for EF detectable with a power of 90% and alpha of 5%.
The qualifying process improved echocardiography recording and reading to bring 95% of the sites to an equivalent level of quality. Monitoring quality found that recording quality and reading accuracy were maintained 18 months into the trial. Reproducibility, given the large sample size, will be able to detect small changes in LVIDd and EF.
使302个跨国超声心动图检查点具备记录和解读系列研究的能力，并对5010例随机纳入心力衰竭缬沙坦试验（Val-HeFT）的患者进行质量监测。
在大型临床试验中，分散式超声心动图解读尚无先例。
超声心动图变量的单次和重复记录以及三次解读结果被提交至3个核心实验室。记录质量采用16分评分系统定义；解读准确性通过与核心解读结果的一致性来确定；重复性通过重复研究之间的一致性来评估。
75%的初始提交记录被批准用于记录，50%被批准用于解读。重新提交的材料会一直评估到获得批准为止。一次提交即获批准的检查点的初始分数与两次提交才获批准的检查点不同，分别为13.8±1.4和10.6±2.0，P<.001；最终分数相似，为13.4±1.6，P=无显著差异。三次或更多次提交后获批准的检查点的初始分数不同，为9.5±1.9，P<.001；最终分数提高到12.7±1.9，但仍较低，P<.001。以95%一致性界限（平均差异±1.96×标准差）表示，左心室内径舒张末期（LVIDd）的准确性=-0.04±0.74cm；射血分数（EF）的准确性=-0.29±14.3%；LVIDd的重复性=0.00±0.53cm；EF的重复性=-0.25±8.3%。基线、4个月、12个月和18个月时随机抽样的质量显示记录分数分别为11.7±2.7、12.3±2.4、12.1±2.2和11.4±2.0，P=.24。功效分析显示，当功效为90%、α为5%时，LVIDd可检测到的差异为0.09cm，EF可检测到的差异为0.86%。
资格认定过程提高了超声心动图记录和解读水平，使95%的检查点达到了同等质量水平。质量监测发现，试验进行18个月时记录质量和解读准确性得以维持。鉴于样本量较大，重复性将能够检测到LVIDd和EF的微小变化。
