Evidence map›Paper›PMID 37918873›Full record

ArticleBMJ global health2023

'Being disabled' as an exclusion criterion for clinical trials: a scoping review.

Guido Camanni, Ornella Ciccone, Alessandro Lepri, Chiara Tinarelli, Chiara Bedetti, Sandra Cicuttin, Nicola Murgia, Sandro Elisei

Abstract readScoping Review
In one paragraph

Article in BMJ global health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing 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

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

  1. Pooled it
  2. Review
  3. Review
  4. Article
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  8. Article
  9. Article
  10. Diversity, Equity, and Inclusion in Biomedical Research and Publishing.Indian journal of psychological medicine · 2026
    Article
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  12. Article
  13. Article
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  15. Article
  16. Reducing translational science roadblocks to disability research.Journal of clinical and translational science · 2025
    Article
  17. Disability inclusion in national surveys.Health affairs scholar · 2024
    Article
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

8 authors.

Guido CamanniRehabilitation Unit, Istituto Serafico, Assisi; Perugia, Italy guidocamanni@serafico.it.ORCID 0000-0003-0881-5426
Ornella CicconeRehabilitation Unit, Istituto Serafico, Assisi; Perugia, Italy.
Alessandro LepriRehabilitation Unit, Istituto Serafico, Assisi; Perugia, Italy.
Chiara TinarelliRehabilitation Unit, Istituto Serafico, Assisi; Perugia, Italy.
Chiara BedettiDepartment of Neurology, Città di Castello Hospital, Citta di Castello, Italy.
Sandra CicuttinRehabilitation Unit, Istituto Serafico, Assisi; Perugia, Italy.
Nicola MurgiaDepartment of Environmental Science and Prevention, University of Ferrara, Ferrara, Italy.
Sandro EliseiRehabilitation Unit, Istituto Serafico, Assisi; Perugia, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeople with disabilities (PWDs) are often excluded from biomedical research, but comprehensive data regarding their participation in clinical trials are not available. The objective of this study was to assess the rates of exclusion of PWDs from recent medical scientific research.

methodsThe protocol of the study was designed according to PRISMA-ScR (PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) extension for Scoping Reviews) guidelines. All completed interventional clinical trials registered on ClinicalTrials.gov between 2010 and 2020 regarding the 10 leading causes of global disability-adjusted life-years according to the Global Burden of Disease Study were analysed. An exclusion criterion from the study was considered explicit if it could be associated with one of the following seven categories: disability, physical impairment, cognitive impairment, behavioural or psychiatric disorders, language and communication impairment, sensory impairment. Comorbidities not more clearly defined and researcher discretion regarding exclusion of study participants were considered to be 'implicit exclusion criteria'. We assessed the appropriateness of explicit exclusion criteria in relation to the primary objectives of the trials and labelled them as 'absolute', 'relative' or 'questionable'.

resultsThe total number of trials analysed was 2710; 170 were paediatric trials (6.3%), 2374 were adult trials (87.6%) and 166 were trials including subjects of all ages (6.1%). Explicit exclusion criteria were found in 958 trials (35.3%). The disability category most frequently excluded was behavioural or psychiatric disorders, present in 588 trials (61.4%). In only 3% and 1% of the trials, the exclusion criteria were considered either 'absolute' or 'questionable', while in 96% the exclusion criteria were judged as 'relative'. Implicit exclusion criteria were present in 1205 trials (44.5%).

conclusionsThis study highlights the high rate of exclusion of PWDs from biomedical research and the widespread use of ill-defined exclusion criteria in clinical trials. It underscores the importance of more inclusive study designs so that PWDs can become active participants in research.

Indexed as

Clinical Trials as TopicPatient SelectionPersons with DisabilitiesHumansBiomedical ResearchDisability-Adjusted Life YearsDisabled PersonsGlobal Burden of DiseaseMinority GroupsReview Literature as TopicSystematic Reviews as Topic

Identifiers

PMID37918873
PMCPMC10626873

What OpenQuestion holds

Textmetadata
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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.