辅助护士护理与标准医疗护理对肝硬化患者健康相关生活质量的影响：一项实用、多中心、随机对照研究
Health-related quality of life in patients with liver cirrhosis following adjunctive nurse-based care versus standard medical care: a pragmatic, multicentre, randomised controlled study.
作者信息
Hjorth Maria, Sjöberg Daniel, Svanberg Anncarin, Lo Martire Riccardo, Kaminsky Elenor, Rorsman Fredrik
机构信息
Centre for Clinical Research, Uppsala University, Falun, Sweden
Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
出版信息
BMJ Open Gastroenterol. 2025 Jan 31;12(1):e001694. doi: 10.1136/bmjgast-2024-001694.
OBJECTIVES
Patients have difficulties in understanding how to manage their liver cirrhosis. This highlights a need for support in comprehending health-related information, which remains largely lacking within liver cirrhosis care. Involvement of registered nurses (RNs) in outpatient liver cirrhosis care has potential to improve quality of care and reduce patient mortality. However, the benefits of nursing care on patients' health-related quality of life (HRQoL) are scarcely studied. This study compared HRQoL in patients receiving either standard medical outpatient care or adjunctive, nurse-led care. The risk of malnutrition, decompensation events and mortality were also compared between the two study groups.
METHODS
This was a pragmatic, multicentre, randomised trial, which enrolled 167 patients with liver cirrhosis. The primary outcome measure, HRQoL, was assessed using the RAND-36 questionnaire. The physical component summary (PCS) and the mental component summary (MCS) scores of RAND-36 were compared, using linear mixed-effects models for repeated measures, at 12 and 24 months.
RESULTS
83 patients received standard medical care, and 84 patients received adjunctive, nurse-led care for 24 months. Due to unforeseen circumstances, the final study population of 167 participants was less than the intended 500. Group comparisons were non-significant of the PCS and MCS scores (-1.1, p=0.53 and -0.7, p=0.67, respectively), malnutrition (p=0.62) and decompensation events (p0.46), after 24 months. However, mortality was three times higher in the control group compared with the intervention group (12 vs 4, p=0.04) after 24 months.
CONCLUSIONS
In this study, adjunctive nurse-led care was not superior to standard medical outpatient care regarding HRQoL, risk of developing malnutrition or decompensation. However, RN involvement contributed to early identification of decompensation and reduced mortality.
TRIAL REGISTRATION NUMBER
NCT02957253.
目的
患者在理解如何管理自身肝硬化方面存在困难。这凸显了在理解与健康相关信息方面提供支持的必要性，而在肝硬化护理中这一支持仍普遍缺失。注册护士（RN）参与门诊肝硬化护理有提高护理质量和降低患者死亡率的潜力。然而，护理对患者健康相关生活质量（HRQoL）的益处鲜有研究。本研究比较了接受标准医疗门诊护理或辅助性、护士主导护理的患者的HRQoL。还比较了两个研究组之间营养不良、失代偿事件和死亡率的风险。
方法
这是一项务实的多中心随机试验，纳入了167例肝硬化患者。使用RAND - 36问卷评估主要结局指标HRQoL。在12个月和24个月时，使用重复测量的线性混合效应模型比较RAND - 36的身体成分总结（PCS）和心理成分总结（MCS）得分。
结果
83例患者接受标准医疗护理，84例患者接受辅助性、护士主导护理24个月。由于意外情况，167名参与者的最终研究人群少于预期的500人。两组在24个月后的PCS和MCS得分（分别为 - 1.1，p = 0.53和 - 0.7，p = 0.67）、营养不良（p = 0.62）和失代偿事件（p = 0.46）方面的组间比较无显著差异。然而，24个月后，对照组的死亡率比干预组高3倍（12例 vs 4例，p = 0.04）。
结论
在本研究中，就HRQoL、发生营养不良或失代偿的风险而言，辅助性护士主导护理并不优于标准医疗门诊护理。然而，注册护士的参与有助于早期识别失代偿并降低死亡率。
试验注册号
NCT02957253。
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