Cautionary Tales in the Interpretation of Clinical Studies Involving Older Persons

Abstract

The care of patients 65 years or older presents a challenge for evidence-based medicine. Such patients are underrepresented in clinical trials, are more vulnerable to treatment-induced harm, and often are unable to fully participate in treatment decisions. We outline several cautionary themes in the interpretation of clinical studies of therapeutic interventions involving older persons as they apply to processes of everyday clinical decision making. In particular, we focus on issues of study design and quality of evidence, choice of outcome measures, missing outcome data, assessment of potential harm, quantifying treatment effects in individual patients (and adjusting these for effect modifiers and reduced life expectancy), eliciting patient values and preferences, prioritizing therapeutic goals and selection of treatments, and assisting patients in adhering to agreed therapeutic regimens.

Examining the Evidence: A Systematic Review of the Inclusion and Analysis of Older Adults in Randomized Controlled Trials

“…The consequence of this, however, is that subjects enrolled in clinical trials, even those in the oldest cohort, often do not represent older patients in the general population. 7 This phenomenon has been demonstrated in a variety of disease states, including cancer, [8][9][10] acute coronary syndrome, 11 chronic kidney disease, 12 cardiovascular disease risk in diabetes, 13 congestive heart failure, 14 and substance abuse.…”

Inclusion and Exclusion in Nutrigenetics Clinical Research: Ethical and Scientific Challenges

“…Evidence of the extent of this phenomenon and its potential impact has been reported and commented on by many authors, in various fields of clinical research [25,29,33,61,85,86,87,88,89,90]. …”

“…Yet, recent studies indicate that such a representation is still limited despite regulations and recommendations [29,33]. Moreover, it has been noted that discussion of diversity, inclusion, and representation in clinical research is often missing from published studies [29,34].…”

Age and Receipt of Guideline-Recommended Medications for Heart Failure: A Nationwide Study of Veterans

“…The SENIORS trial and subgroup analyses of other trials suggest that the benefits and tolerability of angiotensin and beta blockade extend to older adults. [16][17][18][19][20][21] From this perspective, lower rates of guideline-recommended treatment in older adults may represent a missed opportunity. On the other hand, very limited data exist about these treatments in patients of highly advanced age, and several studies suggest that the extent of risk reduction may diminish in the upper reaches of lifespan.…”

“…On the other hand, very limited data exist about these treatments in patients of highly advanced age, and several studies suggest that the extent of risk reduction may diminish in the upper reaches of lifespan. [16][17][18][19][20][21][22][23] Moreover, older patients with heart failure more often have comorbidities that limit life expectancy, add to medication burden, and confer relative or absolute contraindications to guideline-recommended medications. 12,14,24,25 Electronic supplementary material The online version of this article (doi:10.1007/s11606-011-1745-2) contains supplementary material, which is available to authorized users.…”