Objective: To determine the validity of the Parkinson’s disease (PD) home diary for quantification of motor states in patients with advanced PD and motor fluctuations.

Background: The PD home diary has been frequently used in clinical studies to assess effects of novel treatments on motor fluctuations in advanced PD. However, the diary has not been extensively validated against direct clinical observation, which ultimately remains the gold standard for objectifying motor fluctuations.

Method: We performed a prospective, observational cohort study (VALIDATE-PD) in 51 PD patients with motor fluctuations, who screened negative for dementia on the Montreal Cognitive Assessment. Patients were instructed to complete the PD home diary half-hourly for three consecutive days. After one day of diary training, participants were observed by a trained physiotherapist, who independently evaluated motor states half-hourly throughout daytime supported by a 7-meter Timed Up and Go Test. Simultaneously, disease severity was judged by patients and observer using the Patient Global Impression Scale (PGI) and Clinical Global Impression Scale (CGI), respectively.

Results: We included 51 patients (26 males, 25 females) with a median age of 65 years and disease duration of 10 years, who had been suffering from motor fluctuations since 61 months. Overall agreement (Cohen’s kappa) between patient and observer diary entries was 59.8% (0.387). Patients documented more On without dyskinesia (52.3% vs. 38.9%, P<0.001) and less On with dyskinesia (21.5% vs. 34.2%, P<0.001), whereas proportions for Off intervals were not different between patient and observer diaries (26.2% vs. 27.0%, P=0.97). Temporal agreement between diary ratings was unsatisfactory, particularly for On with dyskinesia. The analyses of PGI and CGI moreover revealed profound discrepancies in the judgement of disease severity between patients and the observer across individual motor states and indicated an altered perception of normality in PD patients, who regarded themselves to be normal during 10.1% of Off intervals and 27.5% of On periods with dyskinesia.

Conclusion: Our study suggests that the PD home diary insufficiently reflects actual motor states compared to direct clinical observation. Future studies should investigate whether wearable sensor technology can substitute patient diaries to assess motor states more objectively.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/validation-of-the-pd-home-diary-for-assessment-of-motor-fluctuations-in-advanced-parkinsons-disease/