一项关于家庭送餐治疗有症状腹水的随机对照试验的设计与原理：SALTYFOOD试验
Design and rationale of a randomized-controlled trial of home-delivered meals for the management of symptomatic ascites: the SALTYFOOD trial.
作者信息
Tapper Elliot B, Baki Jad, Hummel Scott, Lok Anna
机构信息
Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.
University of Michigan, Ann Arbor, Michigan, USA.
出版信息
Gastroenterol Rep (Oxf). 2019 Apr;7(2):146-149. doi: 10.1093/gastro/goz005. Epub 2019 Mar 11.
BACKGROUND
When patients with cirrhosis develop ascites, it is associated with sharply increased mortality and healthcare utilization with decreased quality of life. Dietary salt restriction is first-line therapy for ascites but it is limited by poor adherence.
METHODS
We will recruit 40 patients with cirrhosis and ascites who have received a recent paracentesis or hospitalization for a 1:1 randomized trial of standard care (education on salt restriction) versus home-delivered meals. Our primary outcome is the number of paracenteses needed over 12 weeks. Secondary outcomes include hospital-bed days, health-related quality of life (HRQOL, Ascites Symptom Inventory-7 and Visual Analogue Scale) and performance on batteries of physical function including hand grip (kg) and walk speed (m/s). All subjects follow up through a series of calls where any paracenteses, hospital readmissions, weight changes and diuretic dosage changes are recorded. In a final Week 12 visit, knowledge of dietary sodium intake, quality of life and frailty are reassessed, and satisfaction with the meal-delivery program is evaluated. Paired comparison testing will be conducted between the two arms.
DISCUSSION
A nutritionally standardized meal-delivery program for patients with cirrhosis and ascites post discharge has a variety of potential patient-based benefits, including the effective management of ascites, reduction of healthcare utilization and improvement of HRQOL. We have three core hypotheses. First, patients will report interest in and satisfaction with a home-delivered meals program. Second, subjects on a salt-restricted (2 g sodium) meal-delivery program will have fewer therapeutic paracenteses and all-cause readmissions than subjects receiving standard of care. Third, subjects on a salt-restricted (2 g sodium) meal-delivery program will report increased HRQOL compared to subjects receiving standard of care.
背景
肝硬化患者出现腹水时，死亡率会急剧上升，医疗资源利用率增加，生活质量下降。饮食限盐是腹水的一线治疗方法，但因依从性差而受限。
方法
我们将招募40例近期接受过腹腔穿刺或住院治疗的肝硬化腹水患者，进行1:1随机试验，比较标准护理（限盐教育）与上门送餐。我们的主要结局是12周内所需的腹腔穿刺次数。次要结局包括住院天数、健康相关生活质量（HRQOL，腹水症状量表-7和视觉模拟量表）以及包括握力（kg）和步行速度（m/s）在内的一系列身体功能指标。所有受试者通过一系列电话随访，记录任何腹腔穿刺、再次入院、体重变化和利尿剂剂量变化情况。在第12周的最后一次访视中，重新评估饮食钠摄入量知识、生活质量和虚弱状况，并评估对送餐计划的满意度。将在两组之间进行配对比较测试。
讨论
为肝硬化腹水出院患者提供营养标准化的送餐计划对患者有多种潜在益处，包括有效管理腹水、减少医疗资源利用和改善HRQOL。我们有三个核心假设。第一，患者会对上门送餐计划表示感兴趣并满意。第二，接受限盐（2克钠）送餐计划的受试者与接受标准护理的受试者相比，治疗性腹腔穿刺和全因再入院次数会更少。第三，与接受标准护理的受试者相比，接受限盐（2克钠）送餐计划的受试者报告的HRQOL会有所提高。
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