Diversity in pulmonary rehabilitation clinical trials: a systematic review of the literature

ABSTRACT

Background

Underrepresentation of minority groups in clinical trials may hinder the potential benefits of pulmonary rehabilitation (PR) programs for individuals with chronic obstructive pulmonary disease (COPD). The aim of this work was to determine whether participants in PR randomized control trials (RCTs) conducted in the U.S.A., Canada, the UK, and Australia are representative of ethnicity, sex, gender, and sociodemographic characteristics.

Research design

A systematic search was performed for relevant literature from inception to December 2022. Titles and abstracts were screened before undergoing a full article review. Relevant data on reporting of age, sex, gender, ethnicity, and sociodemographic characteristics of participants was extracted.

Results

Thirty-six RCTs met the inclusion criteria. Only 6% of publications reported on ethnicity, with ≥90% of participants reported as ‘White.’ All 36 papers reported on age, with the mean between 60 and 69 years old. Thirty-five studies reported on sex (97%), with the majority (67%) reporting more male than female participants. There was no mention of different genders in any paper. Other sociodemographic factors were reported in 7 (19%) papers.

Conclusions

Inclusivity and representation in clinical trials are essential to ensure that research findings are generalizable. Clinical trialists need to consider the demographics of today’s society during recruitment.

KEYWORDS:

• Clinical trials
• COPD
• ethnicity
• inclusivity
• pulmonary rehabilitation
• race

Author contributions

Sunaina Chopra, Shivani Rana, Reenal Patel, Tessa Hamilton, Alyssa Dalip, Paramvir Malhi, and Pat Camp were involved in the conception, design, analysis, and interpretation of the data. All authors contributed to the drafting of the paper and revising it critically for intellectual content. All authors agreed on the final approval of the version to be published. All authors have agreed to be accountable for all aspects of the work.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have received an honorarium from Expert Review of Respiratory Medicine for their review work. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Supplemental data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/17476348.2024.2324086.

Additional information

Funding

This paper was not funded.