Introduction: Standardized measurement of clinical outcomes across sites and over time is critical to clinical trials. Barriers to outcome measure training include availability of standardized materials and time to train, plus wide geographic distribution of trial personnel. To address these, an online training and certification program based on NIHSS testing was developed and implemented for the Fugl Meyer Motor Assessment (FMMA) in support of multisite stroke recovery trials.
Methods: This program includes Fugl Meyer Arm (FMA) and Leg (FML) components, runs on a web host, and is based on a valid, reliable approach to FMMA testing known to decrease variance in scoring (See et al, NNR, 2013;27:732-741). The website hosts training courses, reference manuals, video patient cases for formal certification testing plus 3 rounds of recertification; each round has 2 separate patients. A passing score of 90% is required. After each course, feedback is given.
Results: This program has served as the primary training, certification, and recertification mechanism for 4 multisite recovery trials, including 1 NIH-funded US trial and 3 industry-sponsored international trials. Three trials certify on both FMA and FML, and 1 on FMA only, as primary endpoint. Evaluators are recertified every 4-6 months. The 299 clinicians from 5 countries registered include PT/OT (n=136), MD (n=37), and RN/NP/PA (n=15). For FMA training, 299 persons have registered and 197 completed. For the first round of FMA certification, 267 have registered and 171 passed (mean 1.89 attempts to pass). For the second FMA (first recertification), 78 registered and 65 passed. The passing rate increased with successive rounds of recertification. Similar numbers have been achieved for FML training, certification, and recertification.
Conclusions: The FMMA has established value for capturing treatment-related motor gains in stroke recovery trials. The current online training program is efficient and effective for training, certifying, and recertifying examiners in arm and leg FMMA. Clinical trial assessors training with this program can be expected to provide more accurate and less variable FMMA scores, which increases statistical power, reduces sample sizes, and reduces the cost of clinical trials.