Daniela Berg1,2, Charles H Adler3, Bastiaan R Bloem4, Piu Chan5, Thomas Gasser2, Christopher G Goetz6, Glenda Halliday7, Anthony E Lang8, Simon Lewis9, Yuan Li5, Inga Liepelt-Scarfone2,10, Irene Litvan11, Kenneth Marek12, Corina Maetzler1, Taomian Mi5, José Obeso13, Wolfgang Oertel14, C Warren Olanow15, Werner Poewe16, Silvia Rios-Romenets17, Eva Schäffer1, Klaus Seppi16, Beatrice Heim16, Elizabeth Slow8, Matthew Stern18, Ian O Bledsoe19, Günther Deuschl1, Ronald B Postuma17. 1. Department of Neurology, Christian-Albrechts-University of Kiel, Kiel, Germany. 2. Department of Neurodegeneration, Hertie-Institute for Clinical Brain Research, Tübingen, Germany. 3. The Parkinson's Disease and Movement Disorders Center, Department of Neurology, Mayo Clinic, Scottsdale, Arizona, USA. 4. Department of Neurology, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, Netherlands. 5. Xuanwu Hospital of Capitol of Medical University, Beijing, Peoples Republic of China. 6. Rush University Medical Center, Chicago, Illinois, USA. 7. Neuroscience Research Australia & University of New South Wales, Randwick, Australia. 8. Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, Toronto, Ontario, Canada. 9. Brain and Mind Centre University of Sydney, Camperdown, Australia. 10. German Center for Neurodegenerative Diseases, Tübingen, Germany. 11. Department of Neurosciences, University of California San Diego, La Jolla, California, USA. 12. Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA. 13. University of Navarra-Fundación para la Investigación Médica Aplicada (FIMA), Pamplona, Spain. 14. Department of Neurology, Philipps University of Marburg, Marburg, Germany. 15. Department of Neurology, Mount Sinai School of Medicine, New York, New York, USA. 16. Department of Neurology, Innsbruck Medical University, Innsbruck, Austria. 17. Department of Neurology, Montreal General Hospital, Montreal, Quebec, Canada. 18. Penn Neurological Institute, Philadelphia, Pennsylvania, USA. 19. University of California, San Francisco, California, USA.
Abstract
BACKGROUND: In 2015, the International Parkinson and Movement Disorder Society published clinical diagnostic criteria for Parkinson's disease (PD). Although recent validation studies suggest high accuracy, one unmet need is for highly specific criteria for clinical trials in early/de novo PD. OBJECTIVES: The objective of this study was to generate and test a PD diagnostic criteria termed "clinically established early PD." METHODS: We modified the Movement Disorder Society criteria to increase specificity for early PD by removing all disease duration components and changing red flags to absolute exclusions. We then estimated the sensitivity/specificity of clinically established early PD criteria in patients with disease duration <5 years, selected from a 626-patient validation study. RESULTS: After documentation of parkinsonism, 18 individual exclusion criteria are assessed that preclude the diagnosis of "clinically established early PD." Among 212 PD and 152 non-PD patients, the estimated specificity was 95.4%, with 69.8% sensitivity. CONCLUSIONS: We describe high-specificity criteria for de novo PD, which are freely available for use in clinical trials.
BACKGROUND: In 2015, the International Parkinson and Movement Disorder Society published clinical diagnostic criteria for Parkinson's disease (PD). Although recent validation studies suggest high accuracy, one unmet need is for highly specific criteria for clinical trials in early/de novo PD. OBJECTIVES: The objective of this study was to generate and test a PD diagnostic criteria termed "clinically established early PD." METHODS: We modified the Movement Disorder Society criteria to increase specificity for early PD by removing all disease duration components and changing red flags to absolute exclusions. We then estimated the sensitivity/specificity of clinically established early PD criteria in patients with disease duration <5 years, selected from a 626-patient validation study. RESULTS: After documentation of parkinsonism, 18 individual exclusion criteria are assessed that preclude the diagnosis of "clinically established early PD." Among 212 PD and 152 non-PDpatients, the estimated specificity was 95.4%, with 69.8% sensitivity. CONCLUSIONS: We describe high-specificity criteria for de novo PD, which are freely available for use in clinical trials.
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