Wu A W, Fink N E, Cagney K A, Bass E B, Rubin H R, Meyer K B, Sadler J H, Powe N R
Departments of Health Policy and Management and Epidemiology, Johns Hopkins University School of Hygiene and Public Health, Baltimore, MD 21205-2223, USA.
Am J Kidney Dis. 2001 Jan;37(1):11-21. doi: 10.1053/ajkd.2001.20631.
The Choices for Healthy Outcomes in Caring for End-Stage Renal Disease ([ESRD] CHOICE) Study was designed to evaluate the effectiveness of alternative dialysis prescriptions. As part of CHOICE, we developed an instrument for measuring health-related quality of life (HRQOL) for patients with ESRD that would complement the Medical Outcomes Study 36-Item Short-Form Survey (SF-36) and be sensitive to differences in dialysis modality (hemodialysis [HD] and peritoneal dialysis [PD]) and dialysis dose. The selection of HRQOL domains to be included was based on: (1) a structured literature review of 47 articles describing 53 different instruments; (2) content analysis of five focus groups with HD and PD patients, nephrologists, and other providers; (3) a survey of 110 dialysis providers about features of different modalities that affect patient HRQOL; and (4) a semistructured survey of 25 patients with ESRD on the effects of dialysis on functioning and HRQOL. To help prioritize domains and items identified by these methods, a representative sample of 136 dialysis patients rated each item for frequency and bother. A panel of nephrologists provided advice about the salience of items to modality or dose. Items and scales were selected with a preference for existing measures tested in patients with ESRD and were tested for reliability and validity. The first four steps yielded 22 HRQOL domains that included 96 items: 8 generic domains in the SF-36 (health perceptions, physical, social, physical and emotional role function, pain, mental health, and energy); 8 additional generic domains (cognitive functioning, sexual functioning, sleep, work, recreation, travel, finances, and general quality of life); and 6 ESRD-specific domains (diet, freedom, time, body image, dialysis access [catheters and/or vascular], and symptoms). New items were developed or adapted to assess ESRD-specific domains. Scales for these items showed adequate internal consistency (Cronbach's alpha > 0.70, except for time [alpha = 0.57] and quality of life [alpha = 0.68]), as well as convergent and discriminant construct validity in a sample of 928 patients. The final questionnaire included 21 domains (time was deleted) and 83 items. We have designed a patient-centered instrument, the CHOICE Health Experience Questionnaire, that addresses domains that may be sensitive to differences in dialysis modality and dose and shows evidence for reliability and validity as a measure of HRQOL in ESRD.
终末期肾病（ESRD）护理健康结局选择（CHOICE）研究旨在评估替代透析方案的有效性。作为CHOICE研究的一部分，我们开发了一种用于测量ESRD患者健康相关生活质量（HRQOL）的工具，该工具将补充医学结局研究36项简短调查问卷（SF - 36），并对透析方式（血液透析[HD]和腹膜透析[PD]）及透析剂量的差异敏感。纳入HRQOL领域的选择基于：（1）对47篇描述53种不同工具的文章进行的结构化文献综述；（2）对5个分别由HD和PD患者、肾病学家及其他医疗服务提供者组成的焦点小组进行的内容分析；（3）对110名透析医疗服务提供者进行的关于不同透析方式影响患者HRQOL特征的调查；以及（4）对25名ESRD患者进行的关于透析对功能和HRQOL影响的半结构化调查。为了帮助确定这些方法所识别领域和项目的优先级，136名透析患者的代表性样本对每个项目的出现频率和困扰程度进行了评分。一组肾病学家就项目对透析方式或剂量的显著性提供了建议。项目和量表的选择优先考虑在ESRD患者中测试过的现有测量方法，并对其可靠性和有效性进行了测试。前四个步骤产生了22个HRQOL领域，包括96个项目：SF - 36中的8个通用领域（健康认知、身体、社会、身体和情感角色功能、疼痛、心理健康和精力）；8个额外的通用领域（认知功能、性功能、睡眠、工作、娱乐、旅行、财务和总体生活质量）；以及6个ESRD特异性领域（饮食、自由、时间、身体形象、透析通路[导管和/或血管]和症状）。开发或改编了新的项目以评估ESRD特异性领域。这些项目的量表显示出足够的内部一致性（克朗巴哈系数> 0.70，时间领域除外[α = 0.57]，生活质量领域除外[α = 0.68]），并且在928名患者的样本中具有收敛效度和区分效度。最终问卷包括21个领域（删除了时间领域）和83个项目。我们设计了一种以患者为中心的工具，即CHOICE健康体验问卷，该问卷涉及可能对透析方式和剂量差异敏感的领域，并显示出作为ESRD患者HRQOL测量工具的可靠性和有效性证据。
