Conducting multiple-site clinical trials in medical rehabilitation research

• Published in: American journal of physical medicine & rehabilitation Vol. 84; no. 11; p. 823
• Main Author: Fuhrer, Marcus J
• Format: Journal Article
• Language: English
• Published: United States 01.11.2005
• Subjects: Evidence-Based Medicine - standards; Humans; Multicenter Studies as Topic - standards; Outcome Assessment (Health Care) - standards; Physical Therapy Modalities - standards; Quality Assurance, Health Care; Rehabilitation - standards; Rehabilitation Centers - standards; Reproducibility of Results; Research Design - standards; United States; United States
• ISSN: 0894-9115
• DOI: 10.1097/01.phm.0000184103.57599.01

This article examines the distinctive opportunities and challenges of multiple-site clinical trials, as distinguished from trials conducted by a single program. Among the topics discussed are: the role of clinical trials generally in medical rehabilitation research; definitions of "clinical trials" and "multiple site"; the distinction between exploratory and capstone trials; the potential advantages and disadvantages of multiple-site trials; planning issues in terms of sampling designs, the choice of outcome measures, approaches to dealing with intervention fidelity, organizational structures, authorship, and the conduct of collateral studies; and implementation issues in terms of pilot-testing procedures, handling emerging issues, and optimizing communication.