Challenges to recruitment of participants with MCI in a multicentric neuropsychological study
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SHORT COMMUNICATION
Challenges to recruitment of participants with MCI in a multicentric neuropsychological study Michela Brambilla1 · Mario A. Parra2 · Sergio Della Sala3 · Federica Alemanno4 · Simone Pomati1 Received: 29 June 2020 / Accepted: 26 September 2020 © Springer Nature Switzerland AG 2020
Abstract 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. Keywords MCI · Recruitment · Eligibility · Clinical research · Neuropsychology
Introduction Difficulty in participant recruitment is a significant barrier to clinical research progress and many trials struggle to complete enrolment in a timely frame despite substantial effort. In Alzheimer’s disease (AD) studies, only a selection of patients are eligible according to recruiting criteria and it was estimated that approximately only 20–25% of people with AD are enrolled in clinical trials [1, 2]. Participants are * Simone Pomati simone.pomati@asst‑fbf‑sacco.it 1
Neurology Unit, Centre for the Treatment and Study of Cognitive Disorders, Luigi Sacco Hospital, Via Giovanni Battista Grassi 74, 20157 Milan, Italy
2
School of Psychological Sciences and Health, University of Strathclyde, Glasgow, UK
3
Human Cognitive Neuroscience, Psychology, University of Edinburgh, Edinburgh, UK
4
Department of Clinical Neuroscience, Specialistic Neurorehabilitation of Neurological, Cognitive and Motor Disorders, San Raffaele Scientific Institute, Milan, Italy
more likely to be eligible and to agree to participate in non‐ pharmacological studies compared with clinical drug trials [1, 3]. One major focus of research on AD is on diagnosis and treatment in prodromal stages, such as Mild Cognitive Impairment (MCI), a condition which, depending on various neurobiological and psychological factors, carries a high risk of developing dementia. Data on recruitment of MCI samples are seldom reported, especially for non-interventional studies. The lack of a consistent and established diagnostic procedures and methods for identifying participants with
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