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18-06-2018 | Uitgave 10/2018

Quality of Life Research 10/2018

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

Tijdschrift:
Quality of Life Research > Uitgave 10/2018
Auteurs:
Rebecca Mercieca-Bebber, 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)
Belangrijke opmerkingen

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s11136-018-1921-5) contains supplementary material, which is available to authorised users.
A correction to this article is available online at https://​doi.​org/​10.​1007/​s11136-018-1934-0.

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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Extra materiaal
Supplementary material 1 (DOCX 41 KB)
11136_2018_1921_MOESM1_ESM.docx
Supplementary material 2 (DOCX 22 KB)
11136_2018_1921_MOESM2_ESM.docx
Literatuur
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