Objective: To examine the experience profile of PD Diary raters in clinical trials

Background: The Parkinson’s Disease (PD) Home Diary (Hauser, 2000)¹ is a widely used subject diary to track motor fluctuations in PD clinical trials. Clinical trials using the diary as an endpoint measure include a training session on proper diary completion and motor state identification, followed by concordance testing. The PD Diary trainer/reviewer role is complex and requires appropriate clinical experience and availability during a trial for the initial subject training and throughout the trial. Because it is a time-demanding task, sites may delegate to staff with more availability than Neurologists, on the basis that it is often considered a PRO and not a clinical scale

Method: 409 raters in 2 global PD clinical trials reported their PD and diary experience, and participated in a diary didactic training. Their role involved conducting subjects training sessions, concordance testing to document subject’s accurate motor state identification, and quality assurance review of in-study diaries. Raters’ PD clinical experience, PD clinical trial experience, PD Diary experience, and number of PD Diary administrations within the last 2 years were examined. The group was divided into Neurologists vs. non-Neurologists

Results: Neurologists reported nearly 3.5 more years of clinical PD experience (M=11.5, SD=9.0) than non-Neurologists (M=8.1, SD=7.4), but nearly the same amount of diary experience (Neurologists: M=5.8, SD=6.2; non-Neurologists: M=5.4, SD=5.8). Neurologists had marginally more PD clinical trial experience as a group (M=7.1, SD=7.7 vs. M=6.1, SD=6.7). Both groups contained approximately 25% of raters who reported no diary administrations in the past 2 years, while 44% of non-Neurologists and 39% of Neurologists had more than 20 administrations in the past 2 years

Conclusion: In these studies, diary raters’ experience profile was shown to be heterogeneous, which is not ideal when the PD Diary is an efficacy measure, as it could introduce more variability in subject training and variability of review of in-study diaries for completion accuracy and unusual patterns of motor state reporting. Clinical trials with the PD Diary as an efficacy measure would benefit from a more homogeneous experience profile of site staff who conduct diary training/review, including more rigorous educational and clinical/research experience requirements

References: 1Hauser RA, Friedlander J, Zesiewicz TA, Adler CH, Seeberger LC, O’Brien CF, et al. A home diary to assess functional status in patients with Parkinson’s disease with motor fluctuations and dyskinesia. Clinical Neuropharmacology. 2000; 23(2):75–81

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MDS Abstracts - https://www.mdsabstracts.org/abstract/the-role-of-the-pd-diary-trainer-reviewer-in-parkinsons-disease-clinical-trials/