Michela Brambilla1, Mario A Parra2, Sergio Della Sala3, Federica Alemanno4, Simone Pomati5. 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. 5. Neurology Unit, Centre for the Treatment and Study of Cognitive Disorders, Luigi Sacco Hospital, Via Giovanni Battista Grassi 74, 20157, Milan, Italy. simone.pomati@asst-fbf-sacco.it.
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.
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.
Authors: Mark W Bondi; Emily C Edmonds; Amy J Jak; Lindsay R Clark; Lisa Delano-Wood; Carrie R McDonald; Daniel A Nation; David J Libon; Rhoda Au; Douglas Galasko; David P Salmon Journal: J Alzheimers Dis Date: 2014 Impact factor: 4.472
Authors: Orestes V Forlenza; Breno S Diniz; Márcia Radanovic; Franklin S Santos; Leda L Talib; Wagner F Gattaz Journal: Br J Psychiatry Date: 2011-05 Impact factor: 9.319
Authors: B Winblad; K Palmer; M Kivipelto; V Jelic; L Fratiglioni; L-O Wahlund; A Nordberg; L Bäckman; M Albert; O Almkvist; H Arai; H Basun; K Blennow; M de Leon; C DeCarli; T Erkinjuntti; E Giacobini; C Graff; J Hardy; C Jack; A Jorm; K Ritchie; C van Duijn; P Visser; R C Petersen Journal: J Intern Med Date: 2004-09 Impact factor: 8.989