Rebecca Mercieca-Bebber1,2,3, Douglas Williams4, Margaret-Ann Tait4, Jessica Roydhouse5, Lucy Busija6, Chindhu Shunmuga Sundaram4, Michelle Wilson7,8, Ailsa Langford9, Claudia Rutherford4, Natasha Roberts10,11, Madeleine King12,4, Elisabeth Vodicka13, Beth Devine13,14,15. 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.
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.
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.
Entities:
Keywords:
Clinical trial endpoint; Clinical trial registration; Patient-reported outcome measures; Patient-reported outcomes; Quality of life
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