Reporting of health equity considerations in cluster and individually randomized trials

Jennifer Petkovic¹, Janet Jull², Manosila Yoganathan³, Omar Dewidar⁴, Sarah Baird⁵, Jeremy M Grimshaw^{6

7}, Kjell Arne Johansson⁸, Elizabeth Kristjansson⁹, Jessie McGowan¹⁰, David Moher¹¹, Mark Petticrew¹², Bjarne Robberstad¹³, Beverley Shea^{4

6

7}, Peter Tugwell^{6

10

14

15}, Jimmy Volmink¹⁶, George A Wells¹⁷, Margaret Whitehead¹⁸, Luis Gabriel Cuervo¹⁹, Howard White²⁰, Monica Taljaard^{10

21}, Vivian Welch⁴

Affiliations

¹ Bruyere Research Institute, University of Ottawa, Ottawa, ON, Canada. jennifer.petkovic@uottawa.ca.
² School of Rehabilitation Therapy, Queen's University, Kingston, ON, Canada.
³ Infectious Diseases and Prevention Control Branch, Public Health Agency of Canada, Ottawa, ON, Canada.
⁴ Bruyere Research Institute, University of Ottawa, Ottawa, ON, Canada.
⁵ Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.
⁶ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
⁷ Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
⁸ Bergen Centre for Ethics and Priority Setting (BCEPS) Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
⁹ School of Psychology, Faculty of Social Sciences, University of Ottawa, Ottawa, ON, Canada.
¹⁰ School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
¹¹ Ottawa Methods Centre, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
¹² Department of Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, UK.
¹³ Section for Ethics and Health Economics, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
¹⁴ Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
¹⁵ WHO Collaborating Centre for Knowledge Translation and Health Technology Assessment in Health Equity, Bruyère Research Institute, Ottawa, ON, Canada.
¹⁶ Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
¹⁷ Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, ON, Canada.
¹⁸ Public Health, University of Liverpool, Livepool, UK.
¹⁹ Department of Health Systems and Services, Pan American Health Organization, Washington, DC, USA.
²⁰ Campbell Collaboration, Delhi, India.
²¹ Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), The Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada.

PMID: 32245522
PMCID: PMC7118943
DOI: 10.1186/s13063-020-4223-5

Reporting of health equity considerations in cluster and individually randomized trials

Jennifer Petkovic et al. Trials. 2020.

. 2020 Apr 3;21(1):308.

doi: 10.1186/s13063-020-4223-5.

Authors

Affiliations

¹ Bruyere Research Institute, University of Ottawa, Ottawa, ON, Canada. jennifer.petkovic@uottawa.ca.
² School of Rehabilitation Therapy, Queen's University, Kingston, ON, Canada.
³ Infectious Diseases and Prevention Control Branch, Public Health Agency of Canada, Ottawa, ON, Canada.
⁴ Bruyere Research Institute, University of Ottawa, Ottawa, ON, Canada.
⁵ Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.
⁶ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
⁷ Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
⁸ Bergen Centre for Ethics and Priority Setting (BCEPS) Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
⁹ School of Psychology, Faculty of Social Sciences, University of Ottawa, Ottawa, ON, Canada.
¹⁰ School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
¹¹ Ottawa Methods Centre, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
¹² Department of Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, UK.
¹³ Section for Ethics and Health Economics, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
¹⁴ Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
¹⁵ WHO Collaborating Centre for Knowledge Translation and Health Technology Assessment in Health Equity, Bruyère Research Institute, Ottawa, ON, Canada.
¹⁶ Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
¹⁷ Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, ON, Canada.
¹⁸ Public Health, University of Liverpool, Livepool, UK.
¹⁹ Department of Health Systems and Services, Pan American Health Organization, Washington, DC, USA.
²⁰ Campbell Collaboration, Delhi, India.
²¹ Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), The Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada.

PMID: 32245522
PMCID: PMC7118943
DOI: 10.1186/s13063-020-4223-5

Abstract

Background: The randomized controlled trial (RCT) is considered the gold standard study design to inform decisions about the effectiveness of interventions. However, a common limitation is inadequate reporting of the applicability of the intervention and trial results for people who are "socially disadvantaged" and this can affect policy-makers' decisions. We previously developed a framework for identifying health-equity-relevant trials, along with a reporting guideline for transparent reporting. In this study, we provide a descriptive assessment of health-equity considerations in 200 randomly sampled equity-relevant trials.

Methods: We developed a search strategy to identify health-equity-relevant trials published between 2013 and 2015. We randomly sorted the 4316 records identified by the search and screened studies until 100 individually randomized (RCTs) and 100 cluster randomized controlled trials (CRTs) were identified. We developed and pilot-tested a data extraction form based on our initial work, to inform the development of our reporting guideline for equity-relevant randomized trials.

Results: In total, 39 trials (20%) were conducted in a low- and middle-income country and 157 trials (79%) in a high-income country focused on socially disadvantaged populations (78% CRTs, 79% RCTs). Seventy-four trials (37%) reported a subgroup analysis across a population characteristic associated with disadvantage (25% CRT, 49% RCTs), with 19% of included studies reporting subgroup analyses across sex, 9% across race/ethnicity/culture, and 4% across socioeconomic status. No subgroup analyses were reported for place of residence, occupation, religion, education, or social capital. One hundred and forty-one trials (71%) discussed the applicability of their results to one or more socially disadvantaged populations (68% of CRT, 73% of RCT).

Discussion: In this set of trials, selected for their relevance to health equity, data that were disaggregated for socially disadvantaged populations were rarely reported. We found that even when the data are available, opportunities to analyze health-equity considerations are frequently missed. The recently published equity extension of the Consolidated Reporting Standards for Randomized Trials (CONSORT-Equity) may help improve delineation of hypotheses related to socially disadvantaged populations, and transparency and completeness of reporting of health-equity considerations in RCTs. This study can serve as a baseline assessment of the reporting of equity considerations.

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Conflict of interest statement

Dr. Welch reports grants from Canadian Institutes of Health Research and grants from Ontario Early Researcher Award during the conduct of the study. David Moher is supported by a University Research Chair. Jeremy M Grimshaw holds a Canada Research Chair in Health Knowledge Transfer and Uptake. Peter Tugwell holds a Canada Research Chair in Health Equity. All other authors have nothing to disclose.

Figures

**Fig. 1**
Study flow diagram. *RCT* randomized controlled trial, *CRT* cluster randomized trial

**Fig. 2**
Study baseline descriptive characteristics defined by PROGRESS characteristics

See this image and copyright information in PMC

References

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Reporting of health equity considerations in cluster and individually randomized trials

Affiliations

Reporting of health equity considerations in cluster and individually randomized trials

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Research Materials