Criteria for Early-Stage Parkinson Disease to Be Used in Clinical Trials

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The criteria provides 95.4% specificity and 68.9% sensitivity.
The criteria provides 95.4% specificity and 68.9% sensitivity.

The International Parkinson and Movement Disorder Society created highly specific diagnostic criteria for early-stage Parkinson disease to be used in clinical trials. Information regarding this criteria is published in Movement Disorder.

Researchers adapted the original International Parkinson and Movement Disorder Society clinical diagnostic criteria for Parkinson disease to be used with de novo and early-stage diagnoses (duration <5 years). This was completed by removing duration conditions, long-term disease progressions, and converting "red flags" to absolute exclusion criteria, therefore removing the need for supportive criteria.

Validation was completed by a sensitivity and specificity analysis of 366 patients. An experienced neurologist examined the patients using gold standard clinical tests, followed by another neurologist using only the newly adapted International Parkinson and Movement Disorder Society diagnostic criteria for early-stage Parkinson disease.

According to the clinical tests, 212 patients were diagnosed with Parkinson disease and 152 were diagnosed with non-Parkinson parkinsonism. Using the newly adapted International Parkinson and Movement Disorder Society clinical diagnostic criteria for early-stage Parkinson disease, 68.9% of the Parkinson disease patients met the criteria for Parkinson disease, and 95.4% of the non-Parkinson disease patients did not meet the criteria for Parkinson disease. This indicates a 95.4% specificity and a 4.6% false positive rate. When using the general International Parkinson and Movement Disorder Society clinical diagnostic criteria, 46.7% of the Parkinson disease patients met the criteria for Parkinson disease, indicating a 22.2% increase in sensitivity.

In conclusion, the newly adapted International Parkinson and Movement Disorder Society clinical diagnostic criteria for early-stage Parkinson disease "appears to provide excellent specificity (95.4%) with sufficient sensitivity (68.9%) so as to permit accurate and efficient recruitment for clinical trials."

No financial disclosures reported.

Reference

Berg D, Adler CH, Bloem BR, et al. Movement disorder society criteria for clinically established early Parkinson's disease [published online August 25, 2018]. Mov Disord. doi: 10.1002/mds.27431

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