Abstract
Methods Stroke, dementia and epilepsy are the greater and most common disabling neurological diseases and were considered in this study. For each mentioned disease we will perform a Systematic reviews of all randomized clinical trials published in any language over the last 5 years with the aim of identifying and analyzing the outcome measures used in the evaluation of any kind of intervention. Fifteen Neurologists are filling out a single computerized form for each single trial assigned. The form has the following information: Characteristics of the trial with relevance on quality, Extent of variability in end points selected and their domains, Scales or techniques used to make the measurement, type of analysis applied and time of measurement, Presence of attrition bias in terms of fraction of patients reported by end points on the number enrolled in the study, Presence of outcome reporting bias in terms of end points declared and non-reported, end points not declared but reported, Source of funding. The valuation of patient and career needs and emotions will be performed with focus group discussions in a parallel section of the study.
Highlights
There is an increasing recognition that Neurological diseases, both chronic and disabling, are effected by multiple domains
Do outcome measures used in neurological clinical research realistically represent the needs and the expectations of patients and their care givers?
It is crucial to select outcome measures and their rating scales to assess the meaningful results of a clinical study
Summary
Do outcome measures used in neurological clinical research realistically represent the needs and the expectations of patients and their care givers?. MG Celani1,2*, MC Bassi, A Bignamini, P Candelaresi, M Carlini, M Cecconi, M Congedo, C Cusi, S Cuzzubbo, D Guerra, S Macone, M Melis, C Motto, K Nardi, V Oppo, R Papetti, C Piersanti, V Piras, A Serafini, AL Sgoifo, E Susani, L Tremolizzo, TA Cantisani. From The 4th Meeting of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative Rome, Italy. From The 4th Meeting of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative Rome, Italy. 19-20 November 2014
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