External validity of randomized controlled trials in older adults, a systematic review

<div><p>Background</p><p>To critically assess the external validity of randomized controlled trials (RCTs) it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics.</p><p>Methods</p><p>PubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ≥ 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria.</p><p>Results</p><p>In total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63–70) and the median percentage of men in the trials was 60 (IQR 45–72). In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%). When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials.</p><p>Conclusion</p><p>Somatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs.</p></div

Proportion of RCT’s in older patients that report on geriatric assessments in the patient characteristics.

<p>Showing the proportion of trials reporting geriatric assessments in the population descriptives or in- and exclusion criteria.</p

Main trial characteristics of the 300 included RCTs.

<p>Main trial characteristics of the 300 included RCTs.</p

Proportion of RCT’s in older patients that report on different geriatric assessments*.

<p>Showing the distribution of different geriatric measurements and expressed as percentage of the total trials (n = 300). *Some articles reporting more than one domain: 14 articles reporting two geriatric domains, eight articles reporting three geriatric domains and only one article reports four geriatric domains.</p

Flow chart for inclusion of studies.

<p>PRISMA flow chart of the result from the performed search strategy and selection process.</p