Evidence map›Paper›PMID 41535873›Full record

ArticleTrials2026

Making trials more inclusive of people experiencing socioeconomic disadvantage: developing the INCLUDE socioeconomic disadvantage framework.

Frances C Sherratt, Katie Biggs, Heidi R Green, Liam Bishop, Clara Martins de Barros, Shaun Treweek

Abstract read
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

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

2 citing papers in PubMed.

  1. Adapting an Osteoarthritis Peer Mentorship Intervention for Remote Delivery to People Experiencing Socioeconomic Disadvantage: A Multi-Method Approach.Health expectations : an international journal of public participation in health care and health policy · 2025
    Article
  2. 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

6 authors.

Frances C SherrattDepartment of Public Health, Policy & Systems, University of Liverpool, Liverpool, UK. sherratt@liverpool.ac.uk.ORCID http://orcid.org/0000-0003-4147-9305
Katie BiggsSheffield Clinical Trials Research Unit (CTRU), University of Sheffield, Sheffield, UK.
Heidi R GreenFreelance Health Equity and Patient Involvement Specialist, Aberdeenshire, UK.
Liam BishopLeeds Institute for Clinical Trials Research (LICTR), School of Medicine, University of Leeds, Leeds, UK.
Clara Martins de BarrosIndependent Scholar, Epsom, UK.
Shaun TreweekAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeople experiencing socioeconomic disadvantage are persistently underrepresented in clinical trials, yet they experience a significantly greater burden of disease than those not experiencing socioeconomic disadvantage. Trials need to be inclusive to ensure that treatments are safe and effective for those who need them most. Resources are needed to support researchers in designing and implementing trials that are inclusive of people experiencing socioeconomic disadvantage. Building on the National Institute for Health and Care Research (NIHR) INCLUDE initiative, we developed the INCLUDE Socioeconomic Disadvantage Framework to support researchers in making trials more inclusive.

methodsThe Framework was developed over five phases: (1) outlining an initial draft of the Framework, (2) refining the initial draft Framework with public contributors, (3) refining the draft Framework with wider contributors, (4) finalising the Framework with all contributors, and (5) launch and application of the Framework.

resultsThe Framework entails four key questions: (1) Who should my trial results apply to? (2) Are people from different socioeconomic backgrounds likely to respond to the intervention in different ways? (3) Will my trial intervention and/or comparator make it harder for people from different socioeconomic backgrounds to take part in the trial? (4) Will the way I have planned and designed my trial make it harder for people from different socioeconomic backgrounds to take part? The Framework includes worksheets to support trial teams in considering strategies to address barriers to inclusion. In 2023, the Framework was launched at a webinar with ~300 registrants and is currently available to download from the Trial Forge website: https://www.trialforge.org/trial-diversity/socioeconomic-disadvantage-framework/ . Public contributor considerations, collated through project meetings, to make trials more inclusive for people experiencing socioeconomic disadvantage are also appendaged to this article to support trial teams further.

conclusionThe Framework and public contributor considerations can be used to support researchers to design and conduct more inclusive trials. Future work should include evaluation of such Frameworks, further engagement with funders to increase uptake, and development and evaluation of strategies to improve inclusion.

Indexed as

Clinical Trials as TopicPatient SelectionResearch DesignVulnerable PopulationsDiversity, Equity, InclusionHumansLow Socioeconomic StatusSocioeconomic Disparities in HealthSocioeconomic FactorsConductDesignInclusivitySocioeconomic disadvantageTrialsTrials methodologyUnderrepresented groupsUnderserved groups

Identifiers

PMID41535873
PMCPMC12888448

What Socratic 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 Socratic graph.