Concepts to be considered when appraising applicability of evidence to older people - adverse event reporting

Overview

Adverse event reporting in clinical trials is often less rigorous and less complete than efficacy outcome reporting - a critical appraisal concept particularly relevant to geriatric practice, where treatment burden and harm are often as important as benefit
Trials are typically designed (powered) to detect the primary efficacy outcome, not adverse events - meaning trials frequently lack the statistical power to reliably detect true differences in less common harms, especially in the population subgroups most likely to experience them

Adverse events are often reported using inconsistent definitions and thresholds for severity across trials, and may be under-ascertained if follow-up methods are not specifically designed to capture them (e.g. passive spontaneous reporting versus active systematic screening for a specific harm)
Trials frequently exclude patients most susceptible to harm (multimorbid, frail, older patients, polypharmacy) - meaning trial-reported adverse event rates likely underestimate real-world harm in exactly the population geriatric clinicians are treating

Ask specifically how adverse events were ascertained (active surveillance vs passive reporting) when appraising a trial's reported safety profile, not just how many were reported

Post-marketing surveillance (Phase IV) and real-world observational data are often more informative than the original trial data for characterising true adverse event rates and rare/long-term harms in the actual population being treated
Post-marketing surveillance, pharmacovigilance, trial design and statistical power for safety outcomes

A trial's clean adverse event profile does not guarantee real-world safety in older, multimorbid, polypharmacy patients who were largely excluded from that trial - post-marketing safety signals can take years to accumulate and be formally recognised, and real-world data often reveal a different, less favourable safety picture in the population actually being treated in practice

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