Article 6 (see Poster 177): Multisite Randomized Controlled Trials for Neurorehabilitation: Lessons Learned from the International SIRROWS Trial

Objectives: To determine the feasibility of creating a clinical trial structure uniting clinicians in an international network to conduct studies of neurorehabilitation interventions within the context of usual inpatient care, without any external funding. Design: Multisite single-blind randomized controlled trial. Setting: Inpatient rehabilitation facilities. Participants: Site principal investigators, intervention therapists, blinded evaluators, and site coordinators. Interventions: Each principal investigator and blinded evaluator received a manual of operations for the online database and a unique user identification and password. The blinded assessors also received protocols and data forms for all outcome measures. The intervention therapists received protocols concerning the study interventions. A quarterly newsletter from the coordinating center engaged participants, updated recruitment across sites, and answered questions via a question-and-answer column. Main Outcome Measures: Recruitment rate, number of sites who participated. Results: 18 sites in 8 countries enrolled 179 eligible participants in less than 2 years. Recruitment rate averaged 9–10 patients per month. Strategies facilitating study success were: use of simple and reliable outcome measures that could be easily implemented in clinical practice without need for training or funding, an uncomplicated intervention that was not difficult to standardize, use of electronic newsletters to motivate and communicate with sites, and an online data entry system. Obstacles included acquiring follow up data beyond discharge and tracking reasons for exclusion. Conclusions: There is widespread international interest by clinicians to participate in neurorehabilitation clinical trials. A clinical trials network may provide opportunity for clinicians to engage in clinical research as well as improve subject recruitment rates. Furthermore, we learned about each site's population and limitations to aid preparation and design for the next trial with the group.