T-11: Subject Training is Needed For Key Terminology in Gastrointestinal Clinical Trials

Poster Presenter

Elisa S. Conrad

Clinical Science Advisor
ERT
United States

Objectives

To examine the accuracy of subject’s knowledge of the term “constipation” to determine the need for subject training in gastrointestinal clinical trials.

Method

1003 participants responded to questions on an online survey in which they were asked about their knowledge of the term “constipation.” Demographic data were also collected.

Results

Participants were asked “Imagine you are participating in a clinical trial and asked to report on your constipation in a diary. Do you understand the meaning of constipation, Yes/No.” Participants were then asked “Which of the following describes constipation? Select all that apply” A. Loose, watery bowel movements, B. Lumpy or hard bowel movements, C. Straining, D. Fewer than 3 bowel movements in a week, E. Diarrhea, F. Fewer than 8 bowel movements in a week, G. Incontinence Although 99% of participants answered “yes” to question 1 (that they understand the meaning of “constipation,”) only 34% chose the correct response options (B. Lumpy or hard bowel movements, C. Straining, & D. Fewer than 3 bowel movements in a week.) The remaining 66% selected either only partially or fully incorrect responses.

Conclusion

Patient-reported outcomes (PROs) data rely on the subjects understanding and interpretation of the questions being asked. Assessments often require patients to report symptom severity, frequency, or intensity, or the impact of symptoms on quality of life. Subjects understanding of the questions and response options is paramount to the integrity of the data. Many PROs contribute to primary or key secondary endpoints in pivotal clinical trials. Additionally, FDA Guidance on Ulcerative Colitis specially recommends that “patients should be trained on the completion of the event log or diary,” given that diaries in this indication and general therapeutic area are often complex and use unfamiliar terminology. As the results of this study demonstrate, the majority of subjects do not understand the intended meaning of “constipation,” a term often used in gastrointestinal studies, which can be detrimental to primary endpoint data. This problem can be remedied in the form of interactive training videos on the trial device, where such definitions and key concepts can be explained and reviewed offline at any time.