Evidence map›Paper›PMID 28346503›Full record

SynthesisPloS one2017

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

Floor J van Deudekom, Iris Postmus, Danielle J van der Ham, Alexander B Pothof, Karen Broekhuizen, Gerard J Blauw, Simon P Mooijaart

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  11. Neoadjuvant chemotherapy in older patients with gastric cancer undergoing surgery: a population-based cohort study.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Floor J van DeudekomDepartment of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.
Iris PostmusDepartment of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.
Danielle J van der HamDepartment of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.
Alexander B PothofInstitute for Evidence-Based Medicine in Old Age (IEMO), Leiden, The Netherlands.
Karen BroekhuizenDepartment of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.
Gerard J BlauwDepartment of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.
Simon P MooijaartDepartment of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo 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.

methodsPubMed 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.

resultsIn 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.

conclusionSomatic 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.

Indexed as

AgedAged, 80 and overAgingFemaleFrail ElderlyGeriatric AssessmentHumansMaleMental CompetencyMiddle AgedPhysical FitnessRandomized Controlled Trials as TopicSocial Environment

Identifiers

PMID28346503
PMCPMC5367677

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.