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Challenges to recruitment of participants with MCI in a multicentric neuropsychological study
Michela Brambilla1, Mario A Parra2, Sergio Della Sala3
1Neurology Unit, Centre for the Treatment and Study of Cognitive Disorders, Luigi Sacco Hospital, Via Giovanni Battista Grassi 74, 20157, Milan, Italy.
Background:
Data on recruitment of Mild Cognitive Impairment (MCI) samples are seldom reported and this issue can be an important source of research waste.
Aim:
To describe the recruitment challenges and reasons for non-eligibility faced during a bi-centre clinical study assessing the predictive value of a neuropsychological battery of the progression to dementia.
Methods:
Potential MCI participants were identified from databases of the two memory clinics based in Milan (Italy) and invited to the screening assessment.
Results:
About 50% of the cases initially identified were ineligible according to inclusion/exclusion criteria and the two sites took 22 months to recruit the planned 150 people. The main reasons for non-eligibility were the MMSE score (41%), age (14%), presence of cerebrovascular disorders (9%), perceptual deficits (6%), neurological (6%) or psychiatric (4%) comorbidities and low education (5%).
Conclusion:
Awareness of the reasons for exclusion and of the time needed to recruit the planned sample would provide hints for the planning of future studies on MCI.
Insights
Recruiting Mild Cognitive Impairment (MCI) participants for dementia studies is challenging, with nearly 50% ineligible. Understanding these recruitment barriers, like low MMSE scores, is crucial for future research efficiency.
Area of Science:
- Neurology
- Gerontology
- Clinical Psychology
Background:
- Recruitment data for Mild Cognitive Impairment (MCI) cohorts are rarely published, contributing to significant research waste.
- Effective participant recruitment is vital for the success of clinical studies investigating cognitive decline.
Purpose of the Study:
- To identify and analyze recruitment challenges and reasons for participant ineligibility.
- To assess the predictive value of a neuropsychological battery for dementia progression in a bi-center study.
Main Methods:
- Potential MCI participants were identified from memory clinic databases in Milan.
- Participants underwent screening assessments to determine eligibility based on predefined inclusion/exclusion criteria.
Main Results:
- Approximately 50% of initially identified potential participants were ineligible.
- Recruitment of 150 individuals took 22 months, with key exclusion reasons including low Mini-Mental State Examination (MMSE) scores (41%), advanced age (14%), and comorbidities.
- Other exclusion factors comprised cerebrovascular disorders (9%), perceptual deficits (6%), neurological (6%) or psychiatric (4%) conditions, and low education (5%).
Conclusions:
- Awareness of common reasons for exclusion is essential for optimizing future MCI study recruitment.
- Understanding recruitment timelines and barriers aids in better-informed study design and resource allocation for dementia research.
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