Participation of Elderly Adults in Randomized Controlled Trials Addressing Antibiotic Treatment of Pneumonia

Avni, Tomer; Shiver-Ofer, Shahaf; Leibovici, Leonard; Tacconelli, Evelina; DeAngelis, Giulia; Cookson, Barry; Pagani, Léonardo

doi:10.1111/jgs.13250

Cited by 23 publications

(25 citation statements)

References 60 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Avni et al have demonstrated that patients included in randomized controlled trials (RCTs) on the treatment of community-acquired pneumonia (CAP) are significantly younger than patients included in observational studies. 80 We have recently compared (unpublished data) the characteristics of included versus excluded patients from a randomized controlled trial evaluating treatment of MRSA invasive infections. 81 Excluded patients were significantly more likely to be bedridden, dementic and had a higher Charlson comorbidity score.…”

Section: Representation Of the Elderly In Clinical Trialsmentioning

confidence: 99%

Bloodstream infections in older patients

et al. 2016

Self Cite

View full text Add to dashboard Cite

Section: Representation Of the Elderly In Clinical Trialsmentioning

confidence: 99%

Bloodstream infections in older patients

et al. 2016

Self Cite

View full text Add to dashboard Cite

“…Elderly adults are often excluded from randomised controlled trials, e.g. in bacterial pneumonia . However, the eTG are evidence‐based and formally embraced by our institution, so adherence to these guidelines should therefore be promoted.…”

Section: Discussionmentioning

confidence: 99%

Antibiotic antics – audit of compliance with Antibiotic Therapeutic Guidelines in older patients

Xiao

McMullen

Ingham

et al. 2016

Pharmacy Practice and Res

View full text Add to dashboard Cite

Background Appropriate antibiotic stewardship is of great importance given increasingly high rates of microbial antibiotic resistance and the vulnerability of older persons to adverse drug effects. Aim To assess prescriber compliance with Antibiotic Therapeutic Guidelines when prescribing for older patients admitted to our geriatric service, and if deficits were identified in the initial audit, to conduct an educational intervention, with re‐audit planned thereafter. Method Patients admitted to our geriatric Medical Admissions Unit (MAU) and treated with antibiotics for infection (confirmed or presumed) were prospectively audited (August–October 2013). Demographic details, antibiotics treatment, microbiology culture and sensitivities, and prescribing teams were recorded. Following educational intervention, MAU admissions were re‐audit (January 2014). Results Initial (electronic) Therapeutic Guidelines (eTG) compliance for both audits was similar with no statistical significance (15%). Compliance rates ‘at any stage of admission’ was also not statistically significantly different 43% in 2013, 54% in 2014 (p = 0.81). There was no association between the team initiating therapy (emergency vs medical team) and compliance. Conclusion Rates of compliance with eTG are suboptimal in our institution. Furthermore, the brief, targeted educational intervention was not effective and further exploration of means to improve antibiotic compliance is needed.

show abstract

“…33 In a similar fashion, Avni et al showed that elderly patients were often excluded from RCTs assessing bacterial pneumonia and reported that the participants were signi cantly younger than in observational studies. 11 This serves to remind us the underrepresentation of elderly in RCTs in general. 34 The obvious under-representation of the elderly in COVID-19 trials is an acute manifestation of a larger problem: the elderly tend to be disproportionately excluded from RCTs in all domains.…”

Section: Observational Studiesmentioning

confidence: 99%

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

Prendki¹,

Tau

Avni

et al. 2020

Preprint

Self Cite

View full text Add to dashboard Cite

Abstract BackgroundCoronavirus 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.MethodsIn this review, randomized controlled trials (RCTs; n=12) comparing 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.ResultsTwelve 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 torsade de pointes 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.ConclusionsElderly 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.

show abstract

Participation of Elderly Adults in Randomized Controlled Trials Addressing Antibiotic Treatment of Pneumonia

Abstract: Elderly adults are often excluded from RCTs of bacterial pneumonia. No data were found on the comparative efficacy of antibiotic treatment in elderly adults and the general population.

Cited by 23 publications

References 60 publications

Bloodstream infections in older patients

Bloodstream infections in older patients

Antibiotic antics – audit of compliance with Antibiotic Therapeutic Guidelines in older patients

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

Contact Info

Product

Resources

About