OBJECTIVES

: Patients’ beliefs about the consequences of reporting depressive symptoms affects their willingness to report such symptoms. We assessed the beliefs of patients with depression or bipolar disorder diagnoses, concerning the consequences of reporting that their depressive symptoms were not improving.

METHODS

: General population volunteers who reported a diagnosis of either depression or bipolar disorder completed an anonymized online survey. Respondents were asked, “You are participating in a clinical trial for depression. You are asked to report changes in your symptoms. If you report that your depressive symptoms are not improving, which of the following might occur?” Response options included: I might be discontinued from the trial; I may not get fully compensated for my participation in the trial; It may affect my course of treatment in the trial; All of the above; None of the above.

RESULTS

: The study included 293 respondents, age 18 – 85 (average age 46), 79% female, 66% with at least some college. Only 45% (n=133) answered correctly “None of the above.” 28% (n=81) answered “All of the above.” 26% (n=75) responded “It may affect my course of treatment in the trial.” 4 respondents selected “I might be discontinued from the trial” or “I may not get fully compensated for my participation in the trial.” More than half (55%, n=161) had concerns that could bias the accuracy of their responses.

CONCLUSIONS

: Individuals with depression or bipolar disorder diagnoses, in the absence of education, may be reluctant to report lack of improvement in depression for reasons unrelated to their actual subjective experience of symptoms. Training on the purpose of PROs, the importance of accurate and unbiased reporting is recommended, consistent with 2018 EMA guidance which advises “education and training of patients before completion of the questionnaire, including that there is no incorrect answer and explaining the purpose of the assessment.”