Horse-Racing Effect and Clinical Trials in Older Persons
نویسندگان
چکیده
INTRODUCTION The standard methodologies for the design and conduction of randomized controlled trials (RCTs) are often difficult to be directly applied when older persons compose the target population (Pahor and Cesari, 2012). In fact, specific methodological adaptations are often required to guarantee the feasibility of the trial, ensure the participants’ adherence/compliance to the protocol, and allow the unbiased/proper interpretation of the findings. In this paper, we present the case of a frequently ignored issue potentially affecting the interpretation of results generated by RCTs. In particular, we describe how the health status fluctuations of older persons (especially in the presence of frailty) may bias the randomization procedures. Possible solutions to such phenomenon are also offered.
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