Vasic Jelena, Petranova Tzvetanka, Povoroznyuk Vladyslav, Barbu Carmen Gabriela, Karadzic Mirjana, Gojkovic Filip, Elez Jelena, Winzenrieth Renaud, Hans Didier, CulaficVojinovic Violeta, Poiana Catalina, Dzerovych Nataliia, Rashkov Rasho, Dimic Aleksandar
Department of Physical Medicine and Rehabilitation, Railway Healthcare Center, Belgrade, Serbia.
J Bone Miner Metab. 2014 Sep;32(5):556-62. doi: 10.1007/s00774-013-0529-7. Epub 2013 Nov 7.
The aim of the study was to assess the clinical performance of the model combining areal bone mineral density (aBMD) at spine and microarchitecural texture (TBS) for the detection of the osteoporotic fracture. The Eastern European Study is a multicenter study (Serbia, Bulgaria, Romania and Ukraine) evaluating the role of TBS in routine clinical practice as a complement to aBMD. All scans were acquired on Hologic Discovery and GE Prodigy densitometers in a routine clinical manner. The additional clinical values of aBMD and TBS were analyzed using a two steps classification tree approach (aBMD followed by TBS tertiles) for all type of osteoporotic fracture (All-OP Fx). Sensitivity, specificity and accuracy of fracture detection as well as the Net Reclassification Index (NRI) were calculated. This study involves 1031 women subjects aged 45 and older recruited in east European countries. Clinical centers were cross-calibrated in terms of BMD and TBS. As expected, areal BMD (aBMD) at spine and TBS were only moderately correlated (r (2) = 0.19). Prevalence rate for All-OP Fx was 26 %. Subjects with fracture have significant lower TBS and aBMD than subjects without fracture (p < 0.01). TBS remains associated with the fracture even after adjustment for age and aBMD with an OR of 1.27 [1.07-1.51]. When using aBMD T-score of -2.5 and the lowest TBS tertile thresholds, both BMD and TBS were similar in terms of sensitivity (35 vs. 39 %), specificity (78 vs. 80 %) and accuracy (64 vs. 66 %). aBMD and TBS combination, induced a significant improvement in sensitivity (+28 %) and accuracy (+17 %) compared to aBMD alone whereas a moderate improvement was observed in terms of specificity (+9 %). The overall combination gain was 36 % as expressed using the NRI. aBMD and TBS combination decrease significantly the number of subjects needed to diagnose from 7 for aBMD alone to 2. In a multi-centre Eastern European cohort, we have shown that the use of TBS in addition to the aBMD permit to reclassified correctly more than one-third of the overall subjects. Furthermore, the number of subjects needed to diagnose fell to 2 subjects. Economical studies have to be performed to evaluate the gain induced by the use of TBS for the healthcare system.
本研究的目的是评估结合脊柱面积骨密度(aBMD)和微结构纹理(TBS)的模型在检测骨质疏松性骨折方面的临床性能。东欧研究是一项多中心研究(塞尔维亚、保加利亚、罗马尼亚和乌克兰),评估TBS在常规临床实践中作为aBMD补充的作用。所有扫描均以常规临床方式在Hologic Discovery和GE Prodigy骨密度仪上进行。对于所有类型的骨质疏松性骨折(All-OP Fx),使用两步分类树方法(先aBMD,后TBS三分位数)分析aBMD和TBS的附加临床价值。计算骨折检测的敏感性、特异性和准确性以及净重新分类指数(NRI)。本研究纳入了1031名年龄在45岁及以上的东欧国家女性受试者。临床中心在骨密度和TBS方面进行了交叉校准。正如预期的那样,脊柱面积骨密度(aBMD)和TBS仅呈中度相关(r(2)=0.19)。All-OP Fx的患病率为26%。骨折患者的TBS和aBMD显著低于无骨折患者(p<0.01)。即使在调整年龄和aBMD后,TBS仍与骨折相关,OR为1.27[1.07-1.51]。当使用aBMD T评分-2.5和最低TBS三分位数阈值时,BMD和TBS在敏感性(35%对39%)、特异性(78%对80%)和准确性(64%对66%)方面相似。与单独使用aBMD相比,aBMD和TBS联合使用可显著提高敏感性(提高28%)和准确性(提高17%),而在特异性方面有适度提高(提高9%)。使用NRI表示,总体联合增益为36%。aBMD和TBS联合使用显著减少了诊断所需的受试者数量,从单独使用aBMD时的7人降至2人。在一个多中心东欧队列中,我们已经表明,除aBMD外使用TBS可使超过三分之一的总体受试者得到正确重新分类。此外,诊断所需的受试者数量降至2人。必须进行经济学研究以评估使用TBS给医疗系统带来的收益。