Evidence map›Paper›PMID 36110923›Full record

ArticleBMJ neurology open2022

Dementia clinical trials over the past decade: are women fairly represented?

Ana-Catarina Pinho-Gomes, Jessica Gong, Katie Harris, Mark Woodward, Cheryl Carcel

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ neurology open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

5 authors.

Ana-Catarina Pinho-GomesThe George Institute for Global Health, Imperial College London, London, UK.ORCID 0000-0001-9895-1493
Jessica GongThe George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.ORCID 0000-0001-6027-7640
Katie HarrisThe George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.
Mark WoodwardThe George Institute for Global Health, Imperial College London, London, UK.
Cheryl CarcelThe George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.ORCID 0000-0001-8942-953X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Lack of progress in finding disease-modifying treatments for dementia may be due to heterogeneity in treatment effects among subgroups, such as by sex. Therefore, we investigated the characteristics of dementia trials completed in the last decade, with a focus on women's representation and sex-disaggregated outcomes. Methods: Clinical trials on dementia completed since 2010 were identified from ClinicalTrials.gov. Randomised, phase III/IV trials with ≥100 participants were selected to quantify women's representation among participants, by computing the participation to prevalence ratio (PPR) and investigate whether sex-disaggregated analyses had been performed. Results: A total of 1351 trials were identified between January 2010 and August 2021 (429 520 participants), of which 118 were eligible for analysis of women's representation and sex-stratified analysis. Only 113 reported the sex of participants and were included in the analysis of women's representation. Of the 110 469 participants in these 113 trials, 58% were women, lower than their estimated representation in the global dementia population of 64%. The mean PPR was 0.90 (95% CI 0.86 to 0.94). Women's participation tended to be higher when the first or last authors of the trial report were women. Eight out of the 118 trials reported sex-disaggregated outcomes, and three of those found significant sex differences in efficacy outcomes. None of the trials reported screening failures or adverse events stratified by sex. Conclusions: Overall, women and men were equally represented in dementia trials carried out over the past decade, but women's representation was lower than in the underlying dementia population. Sex-disaggregated efficacy and safety outcomes were rarely reported.

Indexed as

alzheimer's diseasedementiarandomised trialsvascular dementia

Identifiers

PMID36110923
PMCPMC9445798

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.