Charles H Adler1, Thomas G Beach2, Joseph G Hentz2, Holly A Shill2, John N Caviness2, Erika Driver-Dunckley2, Marwan N Sabbagh2, Lucia I Sue2, Sandra A Jacobson2, Christine M Belden2, Brittany N Dugger2. 1. 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. cadler@mayo.edu. 2. 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.
Abstract
OBJECTIVES: Determine diagnostic accuracy of a clinical diagnosis of Parkinson disease (PD) using neuropathologic diagnosis as the gold standard. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. CLASSIFICATION OF EVIDENCE: 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%.
OBJECTIVES: Determine diagnostic accuracy of a clinical diagnosis of Parkinson disease (PD) using neuropathologic diagnosis as the gold standard. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. CLASSIFICATION OF EVIDENCE: 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%.
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