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Quality of Life Research

, Volume 27, Issue 10, pp 2581–2591 | Cite as

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

  • Rebecca Mercieca-BebberEmail author
  • Douglas Williams
  • Margaret-Ann Tait
  • Jessica Roydhouse
  • Lucy Busija
  • Chindhu Shunmuga Sundaram
  • Michelle Wilson
  • Ailsa Langford
  • Claudia Rutherford
  • Natasha Roberts
  • Madeleine King
  • Elisabeth Vodicka
  • Beth Devine
  • the International Society for Quality of Life Research (ISOQOL)
Article

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

Patient-reported outcomes Quality of life Clinical trial registration Clinical trial endpoint Patient-reported outcome measures 

Notes

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.

Compliance with ethical standards

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.

Supplementary material

11136_2018_1921_MOESM1_ESM.docx (41 kb)
Supplementary material 1 (DOCX 41 KB)
11136_2018_1921_MOESM2_ESM.docx (22 kb)
Supplementary material 2 (DOCX 22 KB)

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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Rebecca Mercieca-Bebber
    • 1
    • 2
    • 3
    Email author
  • Douglas Williams
    • 2
  • Margaret-Ann Tait
    • 2
  • Jessica Roydhouse
    • 4
  • Lucy Busija
    • 5
  • Chindhu Shunmuga Sundaram
    • 2
  • Michelle Wilson
    • 6
    • 7
  • Ailsa Langford
    • 3
  • Claudia Rutherford
    • 2
  • Natasha Roberts
    • 8
    • 9
  • Madeleine King
    • 1
    • 2
  • Elisabeth Vodicka
    • 10
  • Beth Devine
    • 10
    • 11
    • 12
  • the International Society for Quality of Life Research (ISOQOL)
  1. 1.Faculty of Medicine, Sydney Medical School, Central Clinical SchoolUniversity of SydneySydneyAustralia
  2. 2.Faculty of Science, School of PsychologyUniversity of SydneySydneyAustralia
  3. 3.NHMRC Clinical Trials CentreUniversity of SydneySydneyAustralia
  4. 4.Department of Health Services, Policy & PracticeBrown University School of Public HealthProvidenceUSA
  5. 5.Institute for Health & AgeingAustralian Catholic UniversityMelbourneAustralia
  6. 6.Auckland City HospitalAucklandNew Zealand
  7. 7.University of AucklandAucklandNew Zealand
  8. 8.Royal Brisbane and Women’s Hospital (RBWH)HerstonAustralia
  9. 9.Queensland University of Technology (QUT)BrisbaneAustralia
  10. 10.Comparative Health Outcomes, Policy, and Economics (CHOICEc) InstituteUniversity of WashingtonSeattleUSA
  11. 11.Department of Biomedical Informatics and Medical EducationUniversity of WashingtonSeattleUSA
  12. 12.Department of Health ServicesUniversity of WashingtonSeattleUSA

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