Conducting multiple-site clinical trials in medical rehabilitation research.
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.
Fuhrer
Marcus J
MJ
National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 21046, USA.
D019317:Evidence-Based Medicine / Q000592:standards; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards*; D017063:Outcome Assessment, Health Care / Q000592:standards; D026741:Physical Therapy Modalities / Q000592:standards*; D011785:Quality Assurance, Health Care; D012046:Rehabilitation / Q000592:standards*; D012047:Rehabilitation Centers / Q000592:standards*; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards*; D014481:United States