Evidence map›Paper›PMID 40528191›Full record

ArticleTrials2025

Evaluating the effect of incentives on recruiting people with low back pain with limited English proficiency as part of the COMFORT cluster randomised controlled trial: a study protocol for a study within a trial (SWAT).

Lisa Vizza, Christopher G Maher, Rowena Ivers, Andrew J McLachlan, Patrick J Kelly, Fiona Blyth, Philip James Clare, Rachel Thompson, Thomas Lung, Louisa Degenhardt and 14 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

24 authors.

Lisa VizzaSydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Christopher G MaherSydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Rowena IversGraduate School of Medicine, University of Wollongong, Sydney, NSW, Australia.
Andrew J McLachlanSydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Patrick J KellySydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Fiona BlythSydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Philip James ClareSydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Rachel ThompsonSydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Thomas LungSydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Louisa DegenhardtNational Drug and Alcohol Research Centre (NDARC), Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.
Sharon ReidSpecialty of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Bradley C MartinDivision of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences College of Pharmacy, Little Rock, AR, USA.
Michael WrightCentre for Health Economics Research Evaluation, University of Technology Sydney, Sydney, NSW, Australia.
Rawa OsmanQuality Use of Medicines (QUM) Connect, Sydney, NSW, Australia.
Simon D FrenchDepartment of Chiropractic, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, NSW, Australia.
Kirsten J McCafferySydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Gabrielle CampbellSchool of Psychology, University of Queensland, Queensland, QLD, Australia.
Hazel J JenkinsDepartment of Chiropractic, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, NSW, Australia.
Stephanie MathiesonSydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Monika BoogsPainaustralia Consumer Advisory Group, Canberra, ACT, Australia.
Jarrod McMaughPharmaceutical Society of Australia, Canberra, ACT, Australia.
Carol BennettCollege of Arts and Social Sciences, The Australian National University, Canberra, ACT, Australia.
Fiona Stanaway *Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Christina Abdel Shaheed *Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia. Christina.abdelshaheed@sydney.edu.au.ORCID http://orcid.org/0000-0003-1258-5125

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious research has reported that Australians with limited English proficiency are less likely to be included in clinical trials due to language, literacy, and cultural factors. In the pain field, participants with limited English proficiency are three times more likely to be excluded from research, whereas in low back pain trials, 1 in 5 participants are excluded. This low representation can limit the generalisability of research findings to Australia's diverse population, and strategies are required to facilitate the inclusion of participants with limited English proficiency in clinical trials. This study within a trial (SWAT) embedded within a registered cluster randomised trial (ACTRN12622001505796) will evaluate a strategy to improve recruitment of participants with limited English proficiency who speak Arabic, Cantonese, Mandarin or Italian. These were chosen as they are the top non-English languages spoken at home in Australia.

methodsThis SWAT will evaluate the effect of per-participant monetary incentive to facilitate the recruitment of participants with limited English proficiency (in Arabic, Chinese and Italian communities) from participating general practices enrolled in the COMFORT trial. In brief, the COMFORT trial will randomise general practices in a 1:1 ratio to either (i) intervention (educational outreach visits to support GPs to provide opioid stewardship for their patients with low back pain with non-drug strategies including heat wraps and patient education about judicious opioid use) or (ii) control (usual care). In this embedded SWAT, the randomisation schedule will also randomly allocate general practices 1:1 to either (a) SWAT intervention (monetary incentive aimed at enhancing recruitment of individuals with limited English proficiency) or (b) SWAT control (no additional incentive). The SWAT primary outcome will be the proportion of participants with limited English proficiency enrolled into the COMFORT trial in the SWAT intervention versus SWAT control. Data collection, analyses and general study procedures will follow the COMFORT protocol. DISCUSSION: This SWAT will determine whether a per-participant monetary incentive facilitates greater recruitment of people with limited English proficiency who speak Arabic, Cantonese, Mandarin or Italian by participating GPs.

trial registrationThe trial has been registered via SWAT222 Christina Abdel Shaheed (2023 NOV 14 1147).pdf.

Indexed as

Limited English ProficiencyLow Back PainMotivationPatient SelectionAustraliaHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicFinancial incentiveGeneral practiceLimited English proficiencyLow back painRandomised trialStudy within a trial (SWAT)

Identifiers

PMID40528191
PMCPMC12175361

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.