Objective:

In this analysis, we wanted to explore if PD diary non-compliance is distributed randomly in the dataset or if it has a tendency to accumulate at certain sites.

Background: The Parkinson’s disease (PD) diary is frequently used as an endpoint measure in clinical trials to track efficacy of treatment on motor fluctuations in PD. Study participants are required to document their predominant clinical status in 30-minute intervals during a 24-hour period (48 timeslots). Each study participant is instructed on how to complete the PD diary at the beginning of the study by trained personnel at the trial site. In order to provide meaningful data, the PD diary is expected to have all 48 timeslots filled in each day for which the diary is to be completed. Some percentage of incomplete PD diary entries is expected.

Method: We analyzed data from 96 sites (372 subjects) participating in two clinical trials. Our criterion for PD diary non-compliance was completion of less than 44 timeslots for each 24 hours.

We used Poisson mode analysis to look for potential relationship between a site and PD diary non-compliance. The rate of non-compliance events is modeled using log linear model, and log follow up time is included in the model as an offset. Each site that had more than 1 subject was compared with the remaining sites to determine whether a site had significantly higher non-compliance rate.

Results: The results show that there were 67 sites (119 subjects) with at least one non-compliant event. Most of these sites had only one non-compliant event (related to one subject). However, we were able to identify sites with a significantly higher rate of non-compliant events (related to multiple subjects) compared to the remaining sites.

Conclusion: The results of this analysis suggest that there is a possible trial site factor that impacts PD diary non-compliance. Accumulation of subjects submitting non-compliant PD diaries at certain sites could be related to insufficient initial training or insufficient subject follow-up during the study participation. Fast identification of these sites using data analysis is critical for preservation of the integrity of outcomes.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/trial-site-factor-in-parkinsons-disease-pd-diary-non-compliance/