Comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals: Statistical analysis plan for a cluster-randomised controlled trial

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-03-13 DOI:10.1016/j.cct.2025.107881

Gabor Mihala , Ruth Eleanor Hubbard , Benignus Logan , David Wayne Johnson , Andrea Katharina Viecelli , Andrew Benjamin Forbes

{"title":"Comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals: Statistical analysis plan for a cluster-randomised controlled trial","authors":"Gabor Mihala , Ruth Eleanor Hubbard , Benignus Logan , David Wayne Johnson , Andrea Katharina Viecelli , Andrew Benjamin Forbes","doi":"10.1016/j.cct.2025.107881","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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<sup>2</sup>) 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.</div></div><div><h3>Conclusions</h3><div>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.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT04538157</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107881"},"PeriodicalIF":2.0000,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425000758","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background

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.

Methods

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/1.73m²) 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.

Conclusions

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.

Trial registration

ClinicalTrials.gov NCT04538157

查看原文本刊更多论文

对患有慢性肾脏疾病的虚弱老年人进行综合老年病学评估，以提高患者确定目标的实现：一项聚类随机对照试验的统计分析计划。

背景：虚弱在老年慢性肾脏疾病（CKD）患者中非常普遍，并且与更复杂的医疗保健需求相关。作为以人为本的护理的一部分，医疗保健规划应根据个人的需要和期望的结果进行调整。综合老年病评估（CGA）是一种干预措施，通过确定一个人的医疗、功能和社会心理问题，然后制定协调的、有针对性的管理计划，有助于促进这一目标的实现。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自己设定的目标，如目标实现量表（GAS）所衡量的那样。本文介绍了GOAL试验的统计分析计划（SAP）。GOAL试验是一项实用、多中心、优势、开放标签、分组随机对照试验，旨在招募500名体弱的老年人（虚弱指数>0.25，年龄≥65岁或 ≥ 55 岁，如果是原住民），患有中度至重度CKD（估计肾小球滤过率 2），在澳大利亚16家医院进行12个 个月的随访。主要问题（3 个月时CGA对GAS的影响）将使用混合效应线性回归建模。SAP详细说明了分析和报告方法。结论：本文描述的SAP是GOAL试验的统计学家和临床医生领导反复合作的结果。试验完成前统计方法的说明将有助于对收集到的数据进行公正的分析。试验注册：ClinicalTrials.govNCT04538157。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.