Explore thyself: is it time for metacognition screening in clinical trials?

Area of Science:

• Neuroscience
• Clinical Research Methodology

Background:

• Participant self-report is crucial for evaluating Parkinson's Disease (PD) therapeutics.
• Current clinical trial designs often overlook participants' ability to accurately self-report due to potential cognitive or behavioral disturbances.
• Metacognition, essential for self-reflection, is not typically assessed in PD trial screening.

Purpose of the Study:

• To highlight the importance of metacognition in the self-reported outcomes of Parkinson's Disease clinical trials.
• To propose the assessment of metacognitive ability as a critical component in screening and conducting PD trials.

Main Methods:

• Review of existing literature on self-report in clinical trials and metacognition.
• Discussion of the potential impact of metacognitive deficits on self-reported data in Parkinson's Disease.

Main Results:

• Metacognitive impairment is a potential concern in individuals eligible for Parkinson's Disease studies.
• The lack of metacognitive assessment may compromise the validity of self-reported outcomes in PD trials.

Conclusions:

• Assessing metacognition during screening or study conduct could enhance the reliability of self-reported data in Parkinson's Disease research.
• Future research should model the impact of varying metacognitive capabilities on trial outcomes and develop assessment tools.