Objective: To identify the areas with specific training needs for Rater Training Programs (RTP) on the Hauser Diary in Parkinson’s disease (PD) clinical trials

Background: In PD clinical trials where the Hauser Diary is an efficacy measure, RTP frequently include a knowledge test to quiz raters’ performance and assimilation of the guidelines provided during the scale training. The number and type of items failed or answered incorrectly by the raters serves to identify potential areas for re-training for the entire group or for discussion with particular raters, when they fail more items than expected or their responses are different from the rest of the raters

Method: 373 raters accepted as diary trainers/reviewers in two global PD clinical trials, completed a knowledge test after attending a didactic presentation on the Hauser Diary. The knowledge tests included 20 items each, covering six topic categories: 1. Inclusion/Exclusion criteria related to the diary. 2. Basic concepts related to the diary. 3. Diary study conventions and schedule of administration. 4. Diary invalid entries and diary validity criteria. 5. Components of the diary training at the Screening visit. 6. Study procedures and criteria for successful concordance test

Results: Topics 1 and 2 were the areas where raters showed a better performance and less errors, while topics 3, 4 and 6, were identified as the areas with more errors or with more variability in the rater’s performance, indicating these were the most difficult to assimilate for raters after the didactic presentation. Topic 5 showed moderate percent of errors

Conclusion: RTP for clinical trials where the Hauser Diary is one of the efficacy measures could improve efficiency by including some hand-on activities, in addition to the didactic presentation, particularly for those areas identified as the most complex and difficult for raters. This would help raters to integrate and consolidate the information that otherwise might not be properly assimilated only after a didactic presentation, particularly when raters have no or limited previous research experience. For topics showing a moderate yet variable percent of fails, RTP could develop complementary training materials (i.e. a visual guide or infographic) for use as refresher during the study

« Back to MDS Virtual Congress 2021

MDS Abstracts - https://www.mdsabstracts.org/abstract/the-hauser-diary-knowledge-test-as-a-tool-to-improve-rater-training-programs-in-parkinsons-disease-clinical-trials/