From the Parkinson's Disease and Movement Disorders Center, Department of Neurology (C.H.A., J.N.C., E.D.-D.), and Department of Biostatistics (J.G.H.), Mayo Clinic, Scottsdale; Civin Laboratory for Neuropathology (T.G.B., L.I.S., B.N.D.) and Cleo Roberts Center (H.A.S., M.N.S., S.A.J., C.M.B.), Banner Sun Health Research Institute, Sun City, AZ; and University of Arizona College of Medicine (H.A.S., M.N.S., S.A.J.), Phoenix.
Neurology. 2014 Jul 29;83(5):406-12. doi: 10.1212/WNL.0000000000000641. Epub 2014 Jun 27.
Determine diagnostic accuracy of a clinical diagnosis of Parkinson disease (PD) using neuropathologic diagnosis as the gold standard.
Data from the Arizona Study of Aging and Neurodegenerative Disorders were used to determine the predictive value of a clinical PD diagnosis, using 2 clinical diagnostic confidence levels, PossPD (never treated or not clearly responsive) and ProbPD (responsive to medications). Neuropathologic diagnosis was the gold standard.
Based on first visit, 9 of 34 (26%) PossPD cases had neuropathologically confirmed PD while 80 of 97 (82%) ProbPD cases had confirmed PD. PD was confirmed in 8 of 15 (53%) ProbPD cases with <5 years of disease duration and 72 of 82 (88%) with ≥5 years of disease duration. Using final diagnosis at time of death, 91 of 107 (85%) ProbPD cases had confirmed PD. Clinical variables that improved diagnostic accuracy were medication response, motor fluctuations, dyskinesias, and hyposmia.
Using neuropathologic findings of PD as the gold standard, this study establishes the novel findings of only 26% accuracy for a clinical diagnosis of PD in untreated or not clearly responsive subjects, 53% accuracy in early PD responsive to medication (<5 years' duration), and >85% diagnostic accuracy of longer duration, medication-responsive PD. Caution is needed when interpreting clinical studies of PD, especially studies of early disease that do not have autopsy confirmation. The need for a tissue or other diagnostic biomarker is reinforced.
This study provides Class II evidence that a clinical diagnosis of PD identifies patients who will have pathologically confirmed PD with a sensitivity of 88% and specificity of 68%.
以神经病理学诊断为金标准，确定临床帕金森病（PD）诊断的诊断准确性。
使用亚利桑那州衰老和神经退行性疾病研究的数据，使用 2 种临床诊断置信水平（PossPD（从未治疗或反应不明确）和 ProbPD（对药物有反应））来确定临床 PD 诊断的预测值。神经病理学诊断为金标准。
根据首次就诊，34 例 PossPD 病例中有 9 例（26%）经神经病理学证实患有 PD，而 97 例 ProbPD 病例中有 80 例（82%）经证实患有 PD。在病程<5 年的 15 例 ProbPD 病例中有 8 例（53%）和病程≥5 年的 82 例病例中有 72 例（88%）证实患有 PD。在死亡时的最终诊断中，107 例 ProbPD 病例中有 91 例（85%）证实患有 PD。提高诊断准确性的临床变量包括药物反应、运动波动、运动障碍和嗅觉减退。
使用 PD 的神经病理学发现作为金标准，本研究确立了一个新的发现，即在未经治疗或反应不明确的患者中，临床诊断 PD 的准确性仅为 26%，在对药物有反应的早期 PD（<5 年病程）中准确性为 53%，而在病程较长、药物反应良好的 PD 中诊断准确性>85%。在解释 PD 的临床研究时需要谨慎，尤其是那些没有尸检证实的早期疾病研究。需要进一步研究组织或其他诊断生物标志物。
本研究提供了 II 级证据，表明临床 PD 诊断可以识别出患有经病理证实的 PD 的患者，其敏感性为 88%，特异性为 68%。
