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Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension

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Abstract

Purpose

This study assessed the uptake of the CONsolidated Standards of Reporting Trials (CONSORT)—Patient-Reported Outcomes (PRO) statement; determined if use of CONSORT-PRO was associated with more complete reporting of PRO endpoints in randomised controlled trials (RCTs) and identified the extent to which high-impact journals publishing RCTs with PRO endpoints endorse CONSORT-PRO.

Methods

CONSORT-PRO citations were identified by systematically searching Medline, EMBASE and Google from 2013 (year CONSORT-PRO released) to 17 December 2015. RCTs that cited CONSORT-PRO (cases) were compared to a comparable control sample of RCTs in terms of adherence to CONSORT-PRO using t tests. General linear models assessed the relationship between CONSORT-PRO score and key, pre-specified variables. The 100 highest-impact journals that published RCTs with PRO endpoints (2014–2015) were identified via a systematic Medline search. Instructions for authors were reviewed to determine whether journals endorsed CONSORT-PRO.

Results

Total CONSORT-PRO scores ranged from 47 to 100% for cases and 25–96% for controls. Cases had significantly higher total CONSORT-PRO scores compared to controls: t = 2.64, p = 0.01. ‘Citing CONSORT-PRO’, ‘journal endorsing CONSORT-PRO’ and ‘dedicated PRO paper’ were significant predictors of higher CONSORT-PRO adherence score: R 2 = 0.48, p < 0.001. 11/100 top-ranked journals endorsed CONSORT-PRO in their instructions to authors, seven of these journals published RCTs included as cases in this study.

Conclusion

This study demonstrated improved PRO reporting associated with journal endorsement and author use of the CONSORT-PRO extension. Despite growing awareness, more work is needed to promote appropriate use of CONSORT-PRO to improve completeness of reporting; in particular, stronger journal endorsement of CONSORT-PRO.

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Acknowledgements

This paper was reviewed and endorsed by the International Society for Quality of Life Research (ISOQOL) Board of Directors as an ISOQOL publication and does not reflect an endorsement of the ISOQOL membership.

We would like to acknowledge members of the ISOQOL Best Practices for PROs—Reporting Taskforce who were not directly involved in this study: Dagmar Amtmann, Claire Burbridge, Sandra Nolte, Claire Snyder, Galina Velikova, Tracey Young and Carole White. RMB is supported by Sydney Catalyst, courtesy of the Cancer Institute New South Wales. MK is supported by the Australian Government, courtesy of Cancer Australia.

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Authors and Affiliations

  1. Central Clinical School, Sydney Medical School, University of Sydney, Quality of Life Office, Level 6 North, Chris O’Brien Lifehouse C39Z, Sydney, NSW, 2006, Australia

    Rebecca Mercieca-Bebber & Madeleine T. King

  2. Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Sydney, NSW, 2006, Australia

    Rebecca Mercieca-Bebber & Madeleine T. King

  3. Cancer Care and Epidemiology, Cancer Research Institute, Queen’s University, Kingston, ON, K7L 3N6, Canada

    Julie Rouette, Michael J. Palmer & Michael Brundage

  4. Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK

    Melanie Calvert

  5. RTI Health Solutions, Research Triangle Park, NC, University of North Carolina, Chapel Hill, NC, 27709, USA

    Lori McLeod

  6. Psychology, School of Social Sciences, Faculty of Health and Social Sciences, Leeds Beckett University, City Campus, Leeds, LS1 3HE, UK

    Patricia Holch

  7. Patient Reported Outcomes Research Group, Leeds Institute of Cancer Studies and Pathology, Bexley Wing, St James’s Hospital, University of Leeds, Beckett Street, Leeds, LS9 7TF, UK

    Patricia Holch

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  1. Rebecca Mercieca-Bebber
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on behalf of the International Society for Quality of Life Research (ISOQOL) Best Practice for PROs—Reporting Taskforce

Corresponding author

Correspondence to Rebecca Mercieca-Bebber.

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Conflict of interest

Co-authors Calvert, Brundage and King were involved in the original development of CONSORT-PRO, however received no direct benefit from the findings reported here. Prof. Calvert has received grant funding from Macmillan, NIHR, Health Foundation and consultancy payments from Astellas Pharma, and Ferring Pharma, all of which are outside the submitted work. The potential conflicts have not had an impact on the design, conduct, or reporting of the submitted work. This project did not receive any funding.

Ethics statement

This article is an analysis of PRO reporting of RCTs and of journals’ instructions to authors. It did not involve direct study of human participants, and therefore, human research ethics approval was not required.

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Mercieca-Bebber, R., Rouette, J., Calvert, M. et al. Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension. Qual Life Res 26, 1427–1437 (2017). https://doi.org/10.1007/s11136-017-1508-6

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