Although extensive research addresses minorities' low participation in clinical research, most focuses almost exclusively on therapeutic trials. The existing literature might mask important issues concerning minorities' participation in clinical trials, and minorities might actually be overrepresented in phase I safety studies that require the participation of healthy volunteers. It is critical to consider the entire spectrum of clinical research when discussing the participation of disenfranchised groups; the literature on minorities' distrust, poor access, and other barriers to trial participation needs reexamination. Minority participation in clinical trials is an important topic in public health discussions because this representation touches on issues of equality and the elimination of disparities, which are core values of the field.
Patients with limited preoperative ambulatory ability, age > or = 70, dementia, end-stage renal disease, and advanced coronary artery disease perform poorly and should probably be grouped with bedridden patients, who traditionally have been best served with a palliative above knee amputation. Conversely, younger healthy patients with below knee amputations achieved functional outcomes similar to what might be expected after successful lower extremity revascularization. Amputation in these instances should probably not be considered a failure of therapy but another treatment option capable of extending functionality and independent living.
Functional outcome for patients undergoing intervention for critical limb ischemia is not solely determined by the traditional measures of reconstruction patency and limb salvage, but also by certain intrinsic patient comorbidities at the time of presentation. These findings question the benefit of our current approach to critical limb ischemia in functionally impaired, chronically ill patients--patients who undoubtedly will be more prevalent as our population ages.
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