Evidence map›Paper›PMID 38350973›Full record

SynthesisInternational journal for equity in health2024

Diversity in randomized clinical trials for peripheral artery disease: a systematic review.

Chandler Long, Abimbola O Williams, Alysha M McGovern, Caroline M Jacobsen, Liesl M Hargens, Sue Duval, Michael R Jaff

Open access · goldAbstract readSystematic Review
In one paragraph

Synthesis in International journal for equity in health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
4.6field-weighted citation impact, top 5% of its field
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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
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 at 3 institutions in 1 country.

Chandler LongDuke Vascular and Endovascular Surgery, Duke University Medical Center, Duke University, Durham, NC, 27707, USA.
Abimbola O WilliamsHealth Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA. bola.williams@bsci.com.
Alysha M McGovernHealth Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA.
Caroline M JacobsenHealth Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA.
Liesl M HargensHealth Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA.
Sue DuvalHealth Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA.
Michael R JaffHealth Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA.
Boston Scientific (United States) · USDuke University Hospital · USUniversity of Minnesota · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSignificant race and sex disparities exist in the prevalence, diagnosis, and outcomes of peripheral artery disease (PAD). However, clinical trials evaluating treatments for PAD often lack representative patient populations. This systematic review aims to summarize the demographic representation and enrollment strategies in clinical trials of lower-extremity endovascular interventions for PAD.

methodsFollowing the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched multiple sources (Medline, EMBASE, Cochrane, Clinicaltrials.gov, WHO clinical trial registry) for randomized controlled trials (RCTs), RCT protocols, and peer-reviewed journal publications of RCTs conducted between January 2012 and December 2022. Descriptive analysis was used to summarize trial characteristics, publication or study protocol characteristics, and the reporting of demographic characteristics. Meta-regression was used to explore associations between demographic characteristics and certain trial characteristics.

resultsA total of 2,374 records were identified. Of these, 59 met the inclusion criteria, consisting of 35 trials, 14 publications, and 10 protocols. Information regarding demographic representation was frequently missing. While all 14 trial publications reported age and sex, only 4 reported race/ethnicity, and none reported socioeconomic or marital status. Additionally, only 4 publications reported clinical outcomes by demographic characteristics. Meta-regression analysis revealed that 6% more women were enrolled in non-European trials (36%) than in European trials (30%).

conclusionsThe findings of this review highlight potential issues that may compromise the reliability and external validity of study findings in lower-extremity PAD RCTs when applied to the real-world population. Addressing these issues is crucial to enhance the generalizability and impact of clinical trial results in the field of PAD, ultimately leading to improved clinical outcomes for patients in underrepresented populations. REGISTRATION: The systematic review methodology was published in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022378304).

Indexed as

Peripheral Arterial DiseaseRandomized Controlled Trials as TopicFemaleHumansMaleClinical trialsDemographic representationEndovascular interventionsEnrollment strategiesHealth disparitiesPeripheral artery diseaseSystematic review

Identifiers

PMID38350973
PMCPMC10865563
OpenAlexW4391776337

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.