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

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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

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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.