. 2025 Jun 17;26(1):209.

doi: 10.1186/s13063-025-08852-4.

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^{1

2}, Christopher G Maher^{1

2}, Rowena Ivers³, Andrew J McLachlan⁴, Patrick J Kelly¹, Fiona Blyth¹, Philip James Clare^{1

5

6}, Rachel Thompson⁷, Thomas Lung^{1

8}, Louisa Degenhardt⁶, Sharon Reid⁹, Bradley C Martin¹⁰, Michael Wright¹¹, Rawa Osman¹², Simon D French¹³, Kirsten J McCaffery^{1

14}, Gabrielle Campbell¹⁵, Hazel J Jenkins¹³, Stephanie Mathieson^{1

4}, Monika Boogs¹⁶, Jarrod McMaugh¹⁷, Carol Bennett^{18

19

20}, Fiona Stanaway^#¹, Christina Abdel Shaheed^#^{21

22}

Affiliations

¹ Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
² Institute for Musculoskeletal Health, University of Sydney and Sydney Local Health District, Sydney, NSW, Australia.
³ Graduate School of Medicine, University of Wollongong, Sydney, NSW, Australia.
⁴ Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
⁵ Prevention Research Collaboration, University of Sydney, Sydney, NSW, Australia.
⁶ National Drug and Alcohol Research Centre (NDARC), Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.
⁷ Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
⁸ The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
⁹ Specialty of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
¹⁰ Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences College of Pharmacy, Little Rock, AR, USA.
¹¹ Centre for Health Economics Research Evaluation, University of Technology Sydney, Sydney, NSW, Australia.
¹² Quality Use of Medicines (QUM) Connect, Sydney, NSW, Australia.
¹³ Department of Chiropractic, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, NSW, Australia.
¹⁴ Sydney Health Literacy Lab, School of Public Health, University of Sydney, Sydney, NSW, Australia.
¹⁵ School of Psychology, University of Queensland, Queensland, QLD, Australia.
¹⁶ Painaustralia Consumer Advisory Group, Canberra, ACT, Australia.
¹⁷ Pharmaceutical Society of Australia, Canberra, ACT, Australia.
¹⁸ College of Arts and Social Sciences, The Australian National University, Canberra, ACT, Australia.
¹⁹ Department of Health, Therapeutic Goods Administration National Medicines Scheduling Advisory Committee, Canberra, ACT, Australia.
²⁰ Faculty of Health Science, University of Canberra, Canberra, ACT, Australia.
²¹ Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia. Christina.abdelshaheed@sydney.edu.au.
²² Institute for Musculoskeletal Health, University of Sydney and Sydney Local Health District, Sydney, NSW, Australia. Christina.abdelshaheed@sydney.edu.au.

^# Contributed equally.

PMID: 40528191
PMCID: PMC12175361
DOI: 10.1186/s13063-025-08852-4

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 et al. Trials. 2025.

. 2025 Jun 17;26(1):209.

doi: 10.1186/s13063-025-08852-4.

Authors

Affiliations

¹ Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
² Institute for Musculoskeletal Health, University of Sydney and Sydney Local Health District, Sydney, NSW, Australia.
³ Graduate School of Medicine, University of Wollongong, Sydney, NSW, Australia.
⁴ Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
⁵ Prevention Research Collaboration, University of Sydney, Sydney, NSW, Australia.
⁶ National Drug and Alcohol Research Centre (NDARC), Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.
⁷ Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
⁸ The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
⁹ Specialty of Addiction Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
¹⁰ Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences College of Pharmacy, Little Rock, AR, USA.
¹¹ Centre for Health Economics Research Evaluation, University of Technology Sydney, Sydney, NSW, Australia.
¹² Quality Use of Medicines (QUM) Connect, Sydney, NSW, Australia.
¹³ Department of Chiropractic, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, NSW, Australia.
¹⁴ Sydney Health Literacy Lab, School of Public Health, University of Sydney, Sydney, NSW, Australia.
¹⁵ School of Psychology, University of Queensland, Queensland, QLD, Australia.
¹⁶ Painaustralia Consumer Advisory Group, Canberra, ACT, Australia.
¹⁷ Pharmaceutical Society of Australia, Canberra, ACT, Australia.
¹⁸ College of Arts and Social Sciences, The Australian National University, Canberra, ACT, Australia.
¹⁹ Department of Health, Therapeutic Goods Administration National Medicines Scheduling Advisory Committee, Canberra, ACT, Australia.
²⁰ Faculty of Health Science, University of Canberra, Canberra, ACT, Australia.
²¹ Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia. Christina.abdelshaheed@sydney.edu.au.
²² Institute for Musculoskeletal Health, University of Sydney and Sydney Local Health District, Sydney, NSW, Australia. Christina.abdelshaheed@sydney.edu.au.

^# Contributed equally.

PMID: 40528191
PMCID: PMC12175361
DOI: 10.1186/s13063-025-08852-4

Abstract

Background: Previous 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.

Methods: This 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 registration: The trial has been registered via SWAT222 Christina Abdel Shaheed (2023 NOV 14 1147).pdf.

Keywords: Financial incentive; General practice; Limited English proficiency; Low back pain; Randomised trial; Study within a trial (SWAT).

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Conflict of interest statement

Declarations. Ethics approval and consent to participate {24}: Ethics approval has been received by The University of Sydney (2023/632). Consent for publication {32}: No separate consent for publication is required. The results for the SWAT will be de-identified. Competing interests {28}: The Sydney Pharmacy School receives funding for a postgraduate scholarship from GlaxoSmithKline for a student under the supervision of AM. JM is an employee of the Pharmaceutical Society of Australia. BM receives royalties for the development of an opioid risk prediction tool which is unrelated to the current study protocol. CAS hold grants from Australia’s National Health and Medical Research Council, and Medical Research Future Fund. CM holds several research grants and a research fellowship from the National Health and Medical Research Council (NHMRC); and several grants from the Medical Research Future Fund (MRFF). Both the NHMRC and MRFF are Australian Government medical research funding agencies. He has received research grants from New South Wales Health, Ramsay Hospital Research Foundation, HCF Research Foundation, Arthritis Australia, Australian Rheumatology Association, and Royal Prince Alfred Hospital. His travel expenses have been covered when he has been an invited speaker at a scientific conference.

Figures

**Fig. 1**
SPIRIT figure describing schedule of events. Footnotes: ^* Randomisation allocation takes place at the general practice level. ^& Participant demographics including country of birth, primary language spoken at home, ancestry, English proficiency (rated from very well, well, not well or not well at all). Collected for both patient-participants and study GP participants. ^SWAT outcomes will be collected from baseline through to week 52 and analysed at the end of the study. ^# Includes self-reported serious adverse events and adverse events

**Fig. 2**
Schematic of the study within a trial (SWAT) embedded within the COMFORT trial. *Reimbursement AUD $150: recruitment of CALD patient-participants requiring translation

See this image and copyright information in PMC

References

1. Australian Bureau of Statistics (ABS). Australia's Population by Country of Birth. Canberra: ABS;2021. Available from: https://www.abs.gov.au/statistics/people/population/australias-populatio.... Cited 2024 Apr 9.
1. Australian Bureau of Statistics. Migration, Australia. Canberra: ABS; 2019–20 . Available from: https://www.abs.gov.au/statistics/people/population/migration-australia/.... Cited 2023 Feb 10.
1. Gorman D, Brough M, Ramirez E. How young people from culturally and linguistically diverse backgrounds experience mental health: Some insights for mental health nurses. Int J Ment Health Nurs. 2003;12(3):194–202. 10.1046/j.1440-0979.2003.00289.x. - PubMed
1. Green CR, Anderson KO, Baker TA, et al. The unequal burden of pain: confronting racial and ethnic disparities in pain. Pain Med. 2003;4(3):277–94. 10.1046/j.1526-4637.2003.03034.x. - PubMed
1. Weerasinghe DP, Parr NJ, Yusuf F. Analysis using life tables of the major causes of death and the differences between country of birth groups in New South Wales. Australia Public Health. 2009;123(5):351–7. 10.1016/j.puhe.2009.03.006. - PubMed

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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)

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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)

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