W-17: Subject Training Substantially Improves Understanding of Key Terminology in Gastrointestinal Clinical Trials

Poster Presenter

Michael Sadler

Clinical Science Advisor
ERT
United States

Objectives

To examine the effect of training on patient/observer comprehension of terminology commonly seen in patient-reported assessments in gastrointestinal clinical trials.

Method

1099 participants completed an online survey that included a question about rectal bleeding (pre-training) followed by brief instruction, followed by the identical question repeated (post-training) Demographic data was also collected.

Results

Participants were asked “Imagine you are participating in a clinical trial and asked to report on your rectal bleeding daily in a diary. On one particular day, you did not have a stool. What response should you select in the diary that day from the options below?” • Do not complete a diary that day. • Select No blood seen • Select Streaks of blood with stool less than half the time • Select Obvious blood (more than just streaks) or streaks of blood with stool most of the time Of the 884 who responded to both pre-and post-training questions, only 48% answered the pre-training question correctly, “No blood seen.” Brief “guidance for reporting rectal bleeding” was then presented: If you do not have a stool during a given day select ‘No blood seen.” It is important to complete a diary every day, even if you do not have a stool that day. Following this brief instruction, 85% of those respondents who initially selected an incorrect response selected the correct response. The pre/post-instruction difference was statistically significant by two-tailed McNemar’s test: X2 = 202.126, P <0.001.

Conclusion

Subjects or observers in clinical trials may not understand the meaning of “rectal bleeding,” a key patient- or observer-reported sign, causing inaccuracy in primary endpoint data. This problem can be remedied in the form of training, ideally interactive training via electronic data collection methods, e.g. diaries implemented on handheld device where such definitions and key concepts can be reviewed offline at any time. Such training for patient-reported and observer-reported outcome instruments, including definitions, is consistent with 2016 FDA draft guidance on ulcerative colitis: clinical trial endpoints.