A Systematic Review Assessing the Under-Representation of Elderly Adults in COVID-19 Trials

Abstract

<jats:title>Abstract</jats:title> <jats:p><jats:bold>Background</jats:bold>Coronavirus disease (COVID-19) has caused a pandemic threatening millions of people worldwide. Yet studies specifically assessing the geriatric population are scarce. We aimed to examine the participation of elderly patients in therapeutic or prophylactic trials on COVID-19.<jats:bold>Methods</jats:bold>In this review, randomized controlled trials (RCTs; n=12) comparing<jats:bold> </jats:bold>therapeutic or prophylactic interventions registered on preprint repositories and/or published since December 2019 were analyzed. We aimed to describe the age of included patients, the presence of an upper age limit and of adjusted analyses on age, any exclusion criteria that could limit participation of elderly adults such as comorbidities, cognitive impairment, limitation of life expectancy; and the assessment of long-term outcomes such as the need of rehabilitation of institutionalization. Mean participant ages were reported and compared with observational studies.<jats:bold>Results</jats:bold>Twelve RCTs assessing drug therapy for COVID-19 were included. Mean age of patients included in RCTs was 56.3 years. An upper age limit was applied in three published trials (25%) and in 200/650 (31%) trials registered at clinicaltrials.gov. One trial reported a subgroup analysis in patients ≥65. Patients were excluded for liver-function abnormalities in eight trials, renal disease in six, cardiac disease or risk of <jats:italic>torsade de pointes</jats:italic> in five, and four for cognitive or mental criteria, which are frequent comorbidities in the oldest patients. Only three trials allowed a family member to provide consent. Patients enrolled in RCTs were on average 20 years younger than those included in large (n≥1000) observational studies. Seven studies had as their primary outcome a clinical endpoint, but none reported cognitive, functional or quality of life outcomes or need for rehabilitation or long-term care facility placement.<jats:bold>Conclusions</jats:bold>Elderly patients are clearly underrepresented in RCTs, although they comprise the population hardest hit by the COVID-19 pandemic. Long-term outcomes such as the need of rehabilitation or institutionalization were not reported. Future investigations should target specifically this vulnerable population.</jats:p>

Real-world effectiveness of COVID-19 vaccines: a literature review and meta-analysis

“…(Jones et al, 2021, Rudolph et al, 2021, Zaqout et al, 2021 Given the highest mortality observed in the elderly of long-term care facilities and higher exposure risk for health care workers (Team, 2020, Wu and McGoogan, 2020, Zhou et al, 2020, many countries have prioritized both high-risk groups for vaccinations (Britton et al, 2021, Lopez Bernal et al, 2021. However, elderly patients are less represented in clinical trials which mainly enrolled young population (Prendki et al, 2020). We synthesized evidence in real-world by vaccinated population.…”

Sleep monitoring challenges in patients with neurocognitive disorders: A cross‐sectional analysis of missing data from activity trackers

“…Fitbit activity monitors have been compared to PSG in outpatient settings with healthy individuals and demonstrate acceptable agreement in terms of total sleep time, sleep efficiency, 14 sensitivity (ability to detect true sleep) and accuracy (ability to detect both true sleep and true wakefulness) 15 . Although wrist activity monitors provide an alternate method to measure sleep for clinical and research and there is fair agreement in healthy populations, their ability to measure sleep in hospitalized patients with neurocognitive disorders remains untested 16 …”

“…15 Although wrist activity monitors provide an alternate method to measure sleep for clinical and research and there is fair agreement in healthy populations, their ability to measure sleep in hospitalized patients with neurocognitive disorders remains untested. 16 Our objective was to compare the consistency of activity monitors to record and measure sleep between study participants with and without neurocognitive diagnoses.…”

Profile of humoral and cellular immune responses to single doses of BNT162b2 or ChAdOx1 nCoV-19 vaccines in residents and staff within residential care homes (VIVALDI): an observational study

“…Given the clinical vulnerability of LTCF residents to COVID-19, there is considerable interest in understanding the immune correlates of vaccine protection within this group. However, older and more frail populations are often under-represented in vaccine trials, [3][4][5][6] making the extrapolation of data from registration studies directly to resident populations in LTCFs difficult. [7][8][9] Although most COVID-19 vaccine schedules comprise the administration of two doses, several countries such as the UK have adopted a policy of delaying the second dose to increase the proportion of the population vaccinated with at least one dose.…”