Cuerda Maria Cristina, Apezetxea Antonio, Carrillo Lourdes, Casanueva Felipe, Cuesta Federico, Irles Jose Antonio, Virgili Maria Nuria, Layola Miquel, Lizán Luis
Hospital General Universitario Gregorio Marañon, Madrid, Spain.
Organización Sanitaria Integrada Bilbao Basurto, Bilbai, Spain.
Adv Ther. 2016 Oct;33(10):1728-1739. doi: 10.1007/s12325-016-0384-8. Epub 2016 Jul 28.
NutriQoL (Nestlé Health Science, Vevay, Switzerland) is a questionnaire developed to assess the health-related quality-of-life (HRQoL) of patients with home enteral nutrition (HEN) irrespective of their underlying condition and route of administration. The aim of this work is assessing the questionnaire's reliability and responsiveness to change.
Two cohorts of patients with HEN and their primary caregivers were enrolled to assess reliability and responsiveness, respectively. All participants had to be 18 years of age or older, without mental deterioration (≤3 or 4 errors in the Pfeiffer's test) and with sufficient functional status (>40 points on Karnovsky's performance status scale). When the patients' ability to respond to the questionnaire was impaired due to underlying disease, their caregivers answered on their behalf. NutriQoL was administered in two and three visits to reliability and responsiveness cohorts, respectively. Test-retest reliability and internal consistency were assessed by the intra-class correlation coefficient (ICC) and the Cronbach's α, respectively. Responsiveness was evaluated by standardized effect size and standardized response mean between basal visit and third visit. Finally, the minimal clinically important difference (MCID) was estimated.
A total of 54 and 86 participants were recruited to the reliability and responsiveness cohort, respectively. Thirty-five caregivers were selected to assess the inter-observer reliability. ICC values confirmed the good reproducibility level (ICC >0.75) of the questionnaire in both "physical functioning and activities of daily living" and "social life" domains and total score. The assessment of internal consistency in both domains of the questionnaire showed good internal consistency in visit 2. ICC showed the excellent agreement level between caregiver and patient in the global NutriQoL score. Finally, patients classified as having a minimal change in their health reported a mean (standard deviation) MCID in NutriQoL score of 0.63 (11.51).
NutriQoL is a reliable and unique instrument to measure the HRQoL in HEN patients. NutriQoL detects changes in the health status of the patient. Nevertheless, further research is needed to determine the full extent of the questionnaire responsiveness.
NutriQoL（雀巢健康科学公司，瑞士韦韦）是一份用于评估家庭肠内营养（HEN）患者健康相关生活质量（HRQoL）的问卷，无论其潜在病情和给药途径如何。本研究的目的是评估该问卷的可靠性和对变化的反应性。
分别招募了两组HEN患者及其主要照护者来评估可靠性和反应性。所有参与者年龄须在18岁及以上，无精神衰退（在 Pfeiffer 测试中错误≤3或4个）且功能状态良好（卡诺夫斯基表现状态量表得分>40分）。当患者因基础疾病而无法回答问卷时，由其照护者代为回答。NutriQoL分别在可靠性队列和反应性队列中进行了两次和三次访视。重测信度和内部一致性分别通过组内相关系数（ICC）和克朗巴哈α系数进行评估。通过标准化效应量和基础访视与第三次访视之间的标准化反应均值来评估反应性。最后，估计最小临床重要差异（MCID）。
分别有54名和86名参与者被纳入可靠性队列和反应性队列。选择了35名照护者来评估观察者间信度。ICC值证实了该问卷在“身体功能和日常生活活动”以及“社会生活”领域和总分方面具有良好的再现性水平（ICC>0.75）。问卷两个领域的内部一致性评估显示在第二次访视时具有良好的内部一致性。ICC显示在NutriQoL全球得分方面，照护者与患者之间具有极好的一致性水平。最后，被归类为健康有最小变化的患者报告NutriQoL得分的平均（标准差）MCID为0.63（11.51）。
NutriQoL是一种可靠且独特的工具，用于测量HEN患者的HRQoL。NutriQoL能检测出患者健康状况的变化。然而，需要进一步研究以确定该问卷反应性的完整程度。
