Mihala Gabor, Hubbard Ruth Eleanor, Logan Benignus, Johnson David Wayne, Viecelli Andrea Katharina, Forbes Andrew Benjamin
Centre for Health Services Research, The University of Queensland, 34 Cornwall Street, Woollongabba, Queensland, Australia; Australasian Kidney Trials Network, The University of Queensland, 37 Kent Street, Woolloongabba, Queensland, Australia,.
Centre for Health Services Research, The University of Queensland, 34 Cornwall Street, Woollongabba, Queensland, Australia; Department of Geriatric Medicine, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, Queensland, Australia,; Australian Frailty Network, The University of Queensland, 199 Ipswich Road, Woolloongabba, Queensland, Australia,.
Contemp Clin Trials. 2025 May;152:107881. doi: 10.1016/j.cct.2025.107881. Epub 2025 Mar 13.
Frailty is highly prevalent in older people with chronic kidney disease (CKD) and associated with more complex healthcare needs. As part of person-centred care, healthcare planning should be tailored to the individual's needs and their desired outcomes. Comprehensive Geriatric Assessment (CGA) is an intervention which can help facilitate this by identifying a person's medical, functional, and psychosocial problems, and then tailoring a coordinated, targeted management plan. The GOAL trial was designed to establish whether, compared to usual care, a CGA would better enable a person to achieve their own set goals, as measured by Goal Attainment Scaling (GAS). This paper presents the statistical analysis plan (SAP) for the GOAL trial.
The GOAL trial is a pragmatic, multi-centre, superiority, open-label, cluster-randomised controlled trial designed to enrol 500 frail, older people (Frailty Index >0.25, aged ≥65 or ≥ 55 years if First Nations people) with moderate to severe CKD (estimated glomerular filtration rate < 59 mL/min/1.73m) across 16 hospital sites in Australia, and 12 months of follow-up. The primary question (effect of CGA on GAS at 3 months) will be modelled using mixed-effects linear regression. The SAP details the analysis and reporting methods.
The SAP described here resulted from an iterative, collaborative effort among statisticians and clinician leads of the GOAL trial. Specification of statistical methods prior to trial completion will contribute to unbiased analyses of the collected data.
ClinicalTrials.govNCT04538157.
衰弱在患有慢性肾脏病（CKD）的老年人中极为普遍，且与更复杂的医疗保健需求相关。作为以患者为中心的护理的一部分，医疗保健规划应根据个人需求及其期望的结果进行定制。综合老年医学评估（CGA）是一种干预措施，它可以通过识别个人的医疗、功能和心理社会问题，然后制定一个协调的、有针对性的管理计划来帮助实现这一点。GOAL试验旨在确定与常规护理相比，CGA是否能更好地使患者实现其自身设定的目标，这通过目标达成量表（GAS）来衡量。本文介绍了GOAL试验的统计分析计划（SAP）。
GOAL试验是一项务实的、多中心的、优效性的、开放标签的整群随机对照试验，旨在招募500名衰弱的老年人（衰弱指数>0.25，年龄≥65岁；如果是原住民，则年龄≥55岁），这些老年人患有中度至重度CKD（估计肾小球滤过率<59 mL/min/1.73m²），分布在澳大利亚的16个医院站点，并进行12个月的随访。主要问题（CGA对3个月时GAS的影响）将使用混合效应线性回归进行建模。SAP详细说明了分析和报告方法。
此处描述的SAP是由GOAL试验的统计学家和临床负责人通过反复协作努力得出的。在试验完成前确定统计方法将有助于对收集到的数据进行无偏分析。
ClinicalTrials.govNCT04538157。
