Objective: Evaluate the psychometric properties of (i) the “5-2-1” criteria and (ii) consensus-driven clinical indicators of suspected advanced Parkinson’s disease (APD).

Background: Recent consensus panel has identified 15 clinical indicators of suspected APD based on motor, non-motor and functional symptoms [1]. Of these indicators, “5-2-1” represents a combination of objective motor measures which anchor on 3 key aspects of PD.

Method: A retrospective analysis of a multi-country dataset (Adelphi Parkinson’s Disease Specific Programme 2017-2020) was conducted. Device-aided therapy-naïve patients from G7 countries (US, UK, Germany, France, Italy, Spain, Japan) who were on oral PD therapy were included. The “5-2-1” criteria were defined as taking ≥5 doses of oral levodopa per day, having off symptoms for ≥2 hrs of waking day, or having ≥1 hr of troublesome dyskinesia. The psychometric properties of consensus-clinical indicators were evaluated based on: (i) relative accuracy and (ii) construct validity. Accuracy was measured based on a balance of sensitivity and specificity (area under the curve – AUC). Multivariable logistic regression models were run for all indicators predicting clinician assessment of APD. Construct validity was examined via known-group comparisons of UPDRS-score, cognitive function, quality of life, and caregiver burden between patients with and without the clinical indicators.

Results: The analytic sample (n=4853) included 41% intermediate and 15% APD patients as ascertained by neurologists. All clinical indicators demonstrated high accuracy and construct validity on all outcomes of interest [Table 1]. Patients having “5-2-1” were 7x more likely to be deemed APD by neurologists (OR 6.84; 95% CI: 5.50, 8.51). The “5-2-1” criteria and individual clinical indicators demonstrated high diagnostic performance in identifying APD patients (AUC≥ 0.80) [Table 1]. The “5-2-1” criteria and individual indicators demonstrated convergent and divergent validity in identifying patients with high disease burden based on UPDRS-score, cognitive function, quality of life, and caregiver burden [Table 1].

Conclusion: Validated clinical indicators of APD such as the “5-2-1” criteria may provide a simple and objective approach for timely identification and treatment optimization of patients inadequately controlled on oral medications.

References: 1. Antonini A, Stoessl AJ, Kleinman LS, et al. Developing consensus among movement disorder specialists on clinical indicators for identification and management of advanced Parkinson’s disease: a multi-country Delphi-panel approach. Current Medical Research and Opinion. 2018;34(12):2063-2073.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/does-5-2-1-identify-patients-with-suspected-advanced-parkinsons-disease-evidence-of-clinical-accuracy-from-g7-countries/