Faculty of Medicine, Sydney Medical School, Central Clinical School, University of Sydney, Sydney, Australia.
Faculty of Science, School of Psychology, University of Sydney, Sydney, Australia.
Qual Life Res. 2018 Oct;27(10):2581-2591. doi: 10.1007/s11136-018-1921-5. Epub 2018 Jun 18.
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.
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.
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%).
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.
了解包含患者报告结局（PROs）的试验数量、类型和地区，有助于了解患者体验在健康和干预措施研究中是如何被考虑的。ClinicalTrials.gov（2007-2013 年）注册的 27%的试验包含 PROs；然而，没有提供地区细分，也没有对澳大利亚新西兰临床试验注册中心（ANZCTR）进行审查。我们旨在确定在 ANZCTR 注册的具有 PRO 终点的试验，并描述其特征。
从 2005 年开始，系统地对 ANZCTR 进行了检索，以查找具有 PRO 终点的试验。检索词包括患者报告结局质量生活仪器数据库和网格启用措施中列出的 PRO 措施，以及通用 PRO 术语（如“生活质量”（QOL））。使用既定框架对试验终点进行单独编码，以确定用于分析的具有 PRO 的试验。
在注册的 13666 项试验中，有 6168 项（45.1%）包含 PRO。2006 年至 2016 年，包含 PRO 的研究比例有所增加（r=0.74，p=0.009）。在这 6168 项试验中，有 17961 个单独的 PRO 终点，包括症状/功能结局/特定于疾病的 QOL（65.6%）、通用 QOL（13.2%）、患者报告的体验（9.9%）、患者报告的行为（7.9%）。心理健康是最常见的类别（99.8%包含 PRO），其次是物理医学/康复（65.6%）、肌肉骨骼（63.5%）、公共卫生（63.1%）和癌症（54.2%）。
我们的发现表明，在 ANZ，PRO 越来越多地用于评估健康和干预措施。我们的综述确定了具有有限患者报告信息的试验类别，并为未来关于 PRO 发现对临床护理影响的工作提供了基础。
