By Todd Feaster, PsyD, Clinical Program Scientist for Alzheimer’s Disease at Bracket
Rater Training is a well-accepted best practice for most Alzheimer’s disease trials; but ongoing ratings scale and clinical outcomes Quality Assurance is still only implemented intermittently, and there is an ongoing discussion about the best ways to conduct this QA.
Worksheet and ratings reviews are the most common methods; paper documentation QA, confirmation of score totals based on worksheets, and in many cases review of supporting materials, such as drawings and other performance based tasks. There are several good reasons to expand these reviews to more rigorous audio and video reviews of patient interviews, informant interviews, and cognitive testing. However, it can be expensive and cumbersome.
Next week at the Alzheimer’s Association International Conference in Toronto, Bracket will be presenting new data on how these audio reviews can supplement other, more passive quality assurance measures. Outcomes that rely on subjective patient interviews are still at risk for noise or incorrect data being entered into an EDC. Adding audio reviews of scale administrations enables detection of additional errors that are not apparent on worksheet review alone, thereby further improving data quality over the course of a trial.
A few examples of errors that may only be identified through an audio or video review of a clinical interview or cognitive test include;
- Incorrect prompts or help offered by a rater to a patient having difficulty answering a question.
- Incorrect tabulation of the number of words remembered during a word recall test.
- Incorrect time allotted for time-based performance tasks.
Past research has demonstrated the clear improvement that eCOA can have on data quality. Nevertheless, the use of eCOA for difficult, subjective rating scales like the ADAS-Cog and CDR-SB should still be combined with a comprehensive training program and ongoing quality assurance.
To learn more about how Bracket can combine Rater Training, eCOA, and Quality Assurance for your AD program, stop by booth 524 at AAIC in Toronto, or Contact Us to schedule a demo.