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

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A Correction to this article was published on 16 July 2018

This article has been updated

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.

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Change history

  • 16 July 2018

    In the original publication of the article, the sentence “The ANZCTR is the fifth largest trial registry internationally, with 21,330 registered trials as at January 2018 [5]” in the Introduction section was published incorrectly.

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Acknowledgements

We acknowledge ANZCTR for providing access to the study data and in-kind support, and Thuyen Vu (ANZCTR) for assistance with the search strategy and data retrieval. 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.

Data availability

While we do not have permission to reproduce ANZCTR data used in this analysis, the ANZCTR database is publically and freely available at http://www.anzctr.org.au. Trials registered on the ANZCTR are invited to provide a Universal Trial Number (UTN)—a unique number which aims to facilitate the unambiguous identification of clinical trials registered in Primary Registries in the WHO Registry Network. Obtaining a UTN is not mandatory for registration in the ANZCTR. ANZCTR trials that provide a UTN are displayed on the WHO International Clinical Trials Registry Platform (ICTRP) Search Portal in addition to the ANZCTR website.

Author information

Authors and Affiliations

  1. Faculty of Medicine, Sydney Medical School, Central Clinical School, University of Sydney, Sydney, Australia

    Rebecca Mercieca-Bebber & Madeleine King

  2. Faculty of Science, School of Psychology, University of Sydney, Sydney, Australia

    Rebecca Mercieca-Bebber, Douglas Williams, Margaret-Ann Tait, Chindhu Shunmuga Sundaram, Claudia Rutherford & Madeleine King

  3. NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia

    Rebecca Mercieca-Bebber & Ailsa Langford

  4. Department of Health Services, Policy & Practice, Brown University School of Public Health, Providence, RI, USA

    Jessica Roydhouse

  5. Institute for Health & Ageing, Australian Catholic University, Melbourne, Australia

    Lucy Busija

  6. Auckland City Hospital, Auckland, New Zealand

    Michelle Wilson

  7. University of Auckland, Auckland, New Zealand

    Michelle Wilson

  8. Royal Brisbane and Women’s Hospital (RBWH), Herston, Australia

    Natasha Roberts

  9. Queensland University of Technology (QUT), Brisbane, Australia

    Natasha Roberts

  10. Comparative Health Outcomes, Policy, and Economics (CHOICEc) Institute, University of Washington, Seattle, WA, USA

    Elisabeth Vodicka & Beth Devine

  11. Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA

    Beth Devine

  12. Department of Health Services, University of Washington, Seattle, WA, USA

    Beth Devine

Authors
  1. Rebecca Mercieca-Bebber
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Consortia

the International Society for Quality of Life Research (ISOQOL)

Corresponding author

Correspondence to Rebecca Mercieca-Bebber.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

In accordance with the University of Sydney’s (sponsor) ethical procedures, this research did not include human research participants and therefore human research ethics approval was not required

Informed consent

We obtained permission from the ANZCTR to conduct this research. No human research participants were involved in this study, and therefore informed consent was not required.

Research involving human participants

No human data were included in this analysis.

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Mercieca-Bebber, R., Williams, D., Tait, MA. et al. Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR). Qual Life Res 27, 2581–2591 (2018). https://doi.org/10.1007/s11136-018-1921-5

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