Skip to main content
SpringerLink
Log in

Demographic Disparities in Recruitment for Clinical Trials Focused on Endoscopic Bariatric Therapies

  • Brief Communication
  • Published:
Obesity Surgery Aims and scope Submit manuscript

Abstract

Background and Aims

Studies have shown that there are multiple disparities in the recruitment for clinical trials across medical specialties, which makes it challenging to translate research findings to the real world. We performed a systematic review of RCTs focused on EBTs and examined the sex, racial, and ethnic background and age of participants.

Methods

A systematic search of trials pertaining to EBTs was performed. Demographic details from all trials were abstracted and recorded and compared to real-world demographics of obesity in the United States, as reported in the NHANES 2017–March 2020.

Results

A total of 11 trials were included. Mean age of all patients was 43.50 ± 9.25, which differs from the age distribution of obesity in the population (35% between 40 and 59 years). Mean female representation was 89%, which is higher than real-world estimates (50%). A mean of 74% of participants were white, with underrepresentation of African American (21%) and Hispanic (10%) participants as compared to real-world estimates.

Conclusion

Populations affected by obesity are not equitably reflected in clinical trials focused on endoscopic bariatric therapies.

Graphical Abstract

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

References

  1. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291:2720–6.

    Article  CAS  PubMed  Google Scholar 

  2. Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of obesity and severe obesity among adults: United States, 2017-2018 NCHS Data Brief. 2020;(360):1–8.

  3. Johnson-Mann CN, Cupka JS, Ro A, et al. A systematic review on participant diversity in clinical trials-have we made progress for the management of obesity and its metabolic sequelae in diet, drug, and surgical trials. J Racial Ethn Health Disparities. 2022. https://doi.org/10.1007/s40615-022-01487-0.

  4. Powell-Wiley TM, Osei Baah F, Thompson K. Bariatric surgery and cardiovascular outcomes: what can we learn from more representative cohorts? J Am Coll Cardiol. 2022;79:1438–40.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Nafiu OO, Mpody C, Michalsky MP, et al. Unequal rates of postoperative complications in relatively healthy bariatric surgical patients of white and black race Surg Obes Relat Dis. 2021;17:1249–55.

  6. Ouni A, Spaulding A, Khosla AA, et al. Outcomes and trends of endoscopic bariatric therapies (EBT) Among Minority Populations. Obes Surg. 2023;33:513–22.

    Article  PubMed  Google Scholar 

  7. Douglas A, Bhopal RS, Bhopal R, et al. Recruiting South Asians to a lifestyle intervention trial: experiences and lessons from PODOSA (Prevention of Diabetes & Obesity in South Asians). Trials. 2011;12:220.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Gastroenterology and Hepatology, Mayo Clinic, 200 First St SW, Rochester, MN, 55905, USA

    Khushboo Gala, Wissam Ghusn, Raseen Tariq, Barham K. Abu Dayyeh & Victor Chedid

Authors
  1. Khushboo Gala
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Wissam Ghusn
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Raseen Tariq
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Barham K. Abu Dayyeh
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Victor Chedid
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Victor Chedid.

Ethics declarations

Ethical Approval

This article does not contain any studies with human participants or animals performed by any of the authors.

Informed Consent

Informed consent does not apply.

Conflict of Interest

Barham K. Abu Dayyeh is a consultant for DyaMx, Boston Scientific, USGI Medical, and Endo-TAGSS; gets research support from Boston Scientific, USGI Medical, Apollo Endosurgery, Spatz Medical, GI Dynamics, Cairn Diagnostics, Aspire Bariatrics, and Medtronic; and is speaker for Johnson and Johnson, Endogastric Solutions, and Olympus. Other authors do not have a conflict of interest or disclosures.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Key points

1. Trials for EBT designed without oversight of diversity in recruitment.

2. Systematic review of EBT RCTs with data compared to real-world data.

3. Decreased representation: young adult, elder, male, AA, and Hispanic participants.

Supplementary Information

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Gala, K., Ghusn, W., Tariq, R. et al. Demographic Disparities in Recruitment for Clinical Trials Focused on Endoscopic Bariatric Therapies. OBES SURG 33, 3699–3702 (2023). https://doi.org/10.1007/s11695-023-06854-2

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11695-023-06854-2

Keywords

Search

Navigation