Assessing the Quality of Evidence From Randomized, Controlled Drug and Nutritional Supplement Trials Conducted Among Nursing Home Residents Between 1968 and 2004: What Can We Learn?

Background: An estimated 1.5 million residents of nursing homes (NH) in the United States were prescribed an average of 7 to 8 medications each month. However, it is unknown which of these prescribed drugs and nutritional supplements have been tested for use among NH residents who often have distinct and complex needs compared with other geriatric patients. This pilot study addresses the quantity and quality of randomized, controlled drug and nutritional supplement trials that have been conducted among NH residents. Method: Using multiple search strategies and review protocol, I assessed the quality of evidence from randomized, controlled drug and nutritional supplement trials that had a parallel-group design, were conducted among NH residents, and were published in English between 1968 and October 2004. Internal validity of the trials was examined by assessing adequately reporting power calculation, drop-outs (completion fraction), randomization and allocation concealment, blind status, and intention-to-treat analysis. External validity of the trials was examined by assessing adequately reporting the sample description, the inclusion and exclusion criteria, the recruitment process, and comorbidities and harm. Result. Relatively few drug and nutritional supplements have been tested among NH residents by well-designed and executed randomized controlled trials (N = 42). The total number of participants (N = 7941) is small. The quality of many trials is poor. Conclusions: Given the limited number and poor quality of existing trials conducted among NH residents in this pilot study, I conclude that there is a limited body of evidence that could be used to establish quality of care standards or pay for performance criteria for drug therapy and nutritional supplements in NH. Long-term care providers face a great challenge in practicing evidence-based medicine in prescribing drugs and nutritional supplements. (J Am Med Dir Assoc 2009; 10: 28-35)