A method for standardizing procedures in rehabilitation: use in the extremity constraint induced therapy evaluation multisite randomized controlled trial.

Abstract Morris DM, Taub E, Macrina DM, Cook EW, Geiger BF. A method for standardizing procedures in rehabilitation: use in the Extremity Constraint Induced Therapy Evaluation multisite randomized controlled trial. Objective An enduring problem in the field of rehabilitation has been the lack of standardization in the protocols of treatments and tests. To develop a process evaluation method to standardize the administration of rehabilitation procedures used in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial, a randomized controlled trial of upper-extremity constraint-induced therapy implemented across 7 sites. Design Process evaluation. Setting Research laboratory. Participants Convenience sample or research personnel. Interventions Not applicable. Main Outcome Measures Checklist scoring sheets were developed to rate videotapes using systematic application of prescribed steps for each of 5 procedures across 3 time periods. Time periods were immediately after training, and 1 and 2 years later. A performance score of at least 90% was required before individual research personnel were allowed to participate in the trial. Results Overall performance scores ranged from 85.8% to 95% of performance items correctly executed. There was a significant improvement in standard performance of procedures between the first time period (immediately after training) and each of the subsequent time periods for all but 1 procedure. The scoring of standardized performance when carried out with routine participant testing and training did not differ significantly from scoring from videotaped sessions submitted for standardization rating for 2 of the procedures, suggesting adequate validity of scoring from videotape. Conclusions The present method was successful in assessing protocol fidelity for the EXCITE research personnel and represents 1 means of addressing the longstanding problem in rehabilitation of the lack of standardization in administering different treatments and tests.