Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)

Rebecca Mercieca-Bebber^{1

2

3}, Douglas Williams⁴, Margaret-Ann Tait⁴, Jessica Roydhouse⁵, Lucy Busija⁶, Chindhu Shunmuga Sundaram⁴, Michelle Wilson^{7

8}, Ailsa Langford⁹, Claudia Rutherford⁴, Natasha Roberts^{10

11}, Madeleine King^{12

4}, Elisabeth Vodicka¹³, Beth Devine^{13

14

15}; International Society for Quality of Life Research (ISOQOL)

Affiliations

¹ Faculty of Medicine, Sydney Medical School, Central Clinical School, University of Sydney, Sydney, Australia. Rebecca.Mercieca@sydney.edu.au.
² Faculty of Science, School of Psychology, University of Sydney, Sydney, Australia. Rebecca.Mercieca@sydney.edu.au.
³ NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia. Rebecca.Mercieca@sydney.edu.au.
⁴ Faculty of Science, School of Psychology, University of Sydney, Sydney, Australia.
⁵ Department of Health Services, Policy & Practice, Brown University School of Public Health, Providence, RI, USA.
⁶ Institute for Health & Ageing, Australian Catholic University, Melbourne, Australia.
⁷ Auckland City Hospital, Auckland, New Zealand.
⁸ University of Auckland, Auckland, New Zealand.
⁹ NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia.
¹⁰ Royal Brisbane and Women's Hospital (RBWH), Herston, Australia.
¹¹ Queensland University of Technology (QUT), Brisbane, Australia.
¹² Faculty of Medicine, Sydney Medical School, Central Clinical School, University of Sydney, Sydney, Australia.
¹³ Comparative Health Outcomes, Policy, and Economics (CHOICEc) Institute, University of Washington, Seattle, WA, USA.
¹⁴ Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA.
¹⁵ Department of Health Services, University of Washington, Seattle, WA, USA.

PMID: 29915979
DOI: 10.1007/s11136-018-1921-5

Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)

Rebecca Mercieca-Bebber et al. Qual Life Res. 2018 Oct.

. 2018 Oct;27(10):2581-2591.

doi: 10.1007/s11136-018-1921-5. Epub 2018 Jun 18.

Authors

Affiliations

¹ Faculty of Medicine, Sydney Medical School, Central Clinical School, University of Sydney, Sydney, Australia. Rebecca.Mercieca@sydney.edu.au.
² Faculty of Science, School of Psychology, University of Sydney, Sydney, Australia. Rebecca.Mercieca@sydney.edu.au.
³ NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia. Rebecca.Mercieca@sydney.edu.au.
⁴ Faculty of Science, School of Psychology, University of Sydney, Sydney, Australia.
⁵ Department of Health Services, Policy & Practice, Brown University School of Public Health, Providence, RI, USA.
⁶ Institute for Health & Ageing, Australian Catholic University, Melbourne, Australia.
⁷ Auckland City Hospital, Auckland, New Zealand.
⁸ University of Auckland, Auckland, New Zealand.
⁹ NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia.
¹⁰ Royal Brisbane and Women's Hospital (RBWH), Herston, Australia.
¹¹ Queensland University of Technology (QUT), Brisbane, Australia.
¹² Faculty of Medicine, Sydney Medical School, Central Clinical School, University of Sydney, Sydney, Australia.
¹³ Comparative Health Outcomes, Policy, and Economics (CHOICEc) Institute, University of Washington, Seattle, WA, USA.
¹⁴ Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA.
¹⁵ Department of Health Services, University of Washington, Seattle, WA, USA.

PMID: 29915979
DOI: 10.1007/s11136-018-1921-5

Erratum in

Correction to: Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR).
Mercieca-Bebber R, Williams D, Tait MA, Roydhouse J, Busija L, Sundaram CS, Wilson M, Langford A, Rutherford C, Roberts N, King M, Vodicka E, Devine B; International Society for Quality of Life Research (ISOQOL). Mercieca-Bebber R, et al. Qual Life Res. 2018 Oct;27(10):2593. doi: 10.1007/s11136-018-1934-0. Qual Life Res. 2018. PMID: 30014457

Abstract

Aims: It is important to understand the number, types and regions of trials that include patient-reported outcomes (PROs) to appreciate how patient experiences have been considered in studies of health and interventions. Twenty-seven percent of trials registered with ClinicalTrials.gov (2007-2013) included PROs; however, a regional breakdown was not provided and no reviews have been conducted of the Australia New Zealand Clinical Trials Registry (ANZCTR). We aimed to identify trials registered with ANZCTR with PRO endpoints and describe their characteristics.

Methods: ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with PRO endpoints. Search terms included PRO measures listed in Patient-Reported Outcomes Quality of Life Instrument Database and Grid-Enabled Measures, as well as generic PRO terms (e.g. "quality of life" (QOL)). Trial endpoints were individually coded using an established framework to identify trials with PROs for the analysis.

Results: Of 13,666 registered trials, 6168 (45.1%) included a PRO. The proportion of studies including PROs increased between 2006 and 2016 (r = 0.74, p = 0.009). Among the 6168 trials, there were 17,961 individual PRO endpoints, including symptoms/functional outcomes/condition-specific QOL (65.6%), generic QOL (13.2%), patient-reported experiences (9.9%), patient-reported behaviours (7.9%). Mental health was the most common category (99.8% included PROs), followed by physical medicine/rehabilitation (65.6%), musculoskeletal (63.5%), public health (63.1%), and cancer (54.2%).

Discussion: Our findings suggest growing use of PROs in the assessment of health and interventions in ANZ. Our review identifies trial categories with limited patient-reported information and provides a basis for future work on the impact of PRO findings in clinical care.

Keywords: Clinical trial endpoint; Clinical trial registration; Patient-reported outcome measures; Patient-reported outcomes; Quality of life.

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References

1. Lancet. 2014 Jan 18;383(9913):267-76 - PubMed
1. Qual Life Res. 2013 Aug;22(6):1161-75 - PubMed
1. JAMA. 2018 Feb 6;319(5):483-494 - PubMed
1. J Am Acad Orthop Surg. 2016 Nov;24(11):744-749 - PubMed
1. J Clin Oncol. 2016 Aug 20;34(24):2925-34 - PubMed

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Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)

Affiliations

Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)

Authors

Affiliations

Erratum in

Abstract

References

MeSH terms

LinkOut - more resources

Full Text Sources

Other Literature Sources

Miscellaneous