The SMA Biomarkers Study in the Immediate Postnatal Period of Development Clinical Study (NCT01736553), enrolling through the NINDS NeuroNEXT Clinical Trial Network, seeks to define the natural history of motor function and putative SMA molecular and physiological biomarkers in infants during the first two years of life. This prospective study, which includes healthy infants, is designed to provide reliable, definitive baseline measurements that may be used in the design of future SMA interventional trials. Ensuring the reliability and validity of outcome measures is essential to the success of this study and the integrity of the entire data set in the NeuroNEXT Infant SMA Biomarker Study is dependent upon continued MFT rater reliability training and ongoing testing of the raters. The 15 enrolling study sites are expected to enroll at a low rate and visits are not frequent. Thus, it is important that retraining occur on a regular basis to maintain reliability and maintain technical standardization of motor test administration. Retraining will include education, remediation when needed, monitoring and reliability assessment. In this proposal, we request supplementary funding to allow for training of the motor function test evaluators for the duration of the study. We propose bi-annual retesting of all evaluators using videos produced specifically for this study. We also propose annual in-person meetings for all evaluators for retraining and inter-rater reliability testing of live infants.
|Effective start/end date||6/1/14 → 5/31/17|
- Ohio State University (60041646//MDA287450)
- Muscular Dystrophy Association (60041646//MDA287450)