Evidence map›Paper›PMID 28306144›Full record

ArticleJournal of the American Geriatrics Society2017

Exclusion of Elderly People from Randomized Clinical Trials of Drugs for Ischemic Heart Disease.

Florence T Bourgeois, Liat Orenstein, Sarita Ballakur, Kenneth D Mandl, John P A Ioannidis

Abstract read
In one paragraph

Article in Journal of the American Geriatrics Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 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

42 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Age-based exclusion is common and multifactorial in spinal RCTs: a systematic review and quantitative analysis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Florence T BourgeoisDivision of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts.
Liat OrensteinComputational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts.
Sarita BallakurFaculty of Arts and Sciences, Brown University, Providence, Rhode Island.
Kenneth D MandlDivision of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts.
John P A IoannidisStanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Stanford, California.

Funding

EXCLUSION OF OLDER PATIENTS IN CLINICAL DRUG TRIALSR21AG043715 · NIA · BOSTON CHILDREN'S HOSPITAL · PI BOURGEOIS, FLORENCE, MANDL, KENNETH D. · 2013 to 2014
$494k
NIA NIH HHS R21 AG043715
6 · The paper itself

Abstract

objectivesTo measure exclusion of elderly adults from randomized trials studying drug interventions for ischemic heart disease (IHD) and describe the characteristics of these trials.

designCross-sectional analysis.

settingInterventional clinical trials studying a drug intervention for IHD that started in 2006 and after were identified in ClinicalTrials.gov. Data were extracted on study features, including age-based inclusion criteria. Data on participants and their age distribution were collected from trial publications, investigator inquiry, and result data in ClinicalTrials.gov.

participantsIndividuals aged 65 and older. MEASUREMENTS: Proportion of trials excluding individuals based on age, mean age of trial participants, and proportion of enrolled participants aged 65 and older and 75 and older.

resultsOf 839 identified trials, 446 (53%) explicitly excluded elderly adults. The most-frequent upper age limits were 80 (n = 164) and 75 (n = 114), with a median upper age limit of 80 (interquartile range 75-80). Trials with upper age limit exclusions tended to be smaller (median number of participants 100 vs 201, P < .001) and were more likely to be funded primarily by nonindustry sources (78.3% vs 70.0%, P = .006). The overall mean age of trial participants was 62.7 (mean maximum age 74). The estimated proportion of participants aged 65 and older was 42.5% and the estimated proportion aged 75 and older was 12.3%.

conclusionDespite the high burden of IHD in elderly adults, the majority of drug trials do not enroll participants reflective of age-related prevalence of the disease.

Indexed as

Patient SelectionAgedAged, 80 and overAge FactorsAnti-Arrhythmia AgentsBiomedical ResearchFemaleGuidelines as TopicHumansMaleMyocardial IschemiaRandomized Controlled Trials as TopicResearch SubjectsAnti-Arrhythmia Agentsevidence-based medicineischemic heart diseaseresearch methodology

Identifiers

PMID28306144
PMCPMC5601009

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.