Brown Stephanie A, Tyrer Freya, Clarke Amy L, Lloyd-Davies Laetitia H, Niyi-Odumosu Faatihah A, Nah Ryan Guo Quan, Stein Andrew G, Tarrant Carolyn, Smith Alice C
University Hospitals of Leicester NHS Trust Leicester, Leicester, UK.
Department of Health Sciences, University of Leicester, Leicester, UK.
J Ren Care. 2018 May 24. doi: 10.1111/jorc.12247.
Chronic kidney disease (CKD) is associated with a range of symptoms, even at early stages. The importance of patient symptom experience is increasingly recognised, but validated symptom scores are lacking.
This study aimed to refine an existing symptom questionnaire for use with patients not requiring renal replacement therapy (RRT), carry out content validity testing and explore convergent validity by comparing symptom scores with quality of life (QoL).
A mixed-methods approach involving questionnaires, semi-structured interviews and a focus group.
Patients with CKD not undergoing RRT and expert health professionals.
Two hundred and nineteen patients completed an existing symptom questionnaire. The most commonly reported symptoms were identified, and descriptions refined in 11 semi-structured interviews. The questionnaire design was reviewed by a focus group. Content validity was established by a panel of expert health professionals. Seventy patients completed both the symptom questionnaire and a health-related QoL questionnaire (EQ-5D-5L).
Thirteen common symptoms were identified. During the content validity phase, 13/16 experts responded (81%); 10/13 symptoms had 'excellent' or 'good' evaluation scores, and the content validity index of the whole questionnaire was 0.81, falling within the recommended threshold. Total symptom frequency scores, number of symptoms and the frequencies of 10/13 individual symptoms were all strongly associated with health-related QoL (EQ-5D-5L index score; p < 0.002 for all).
This work has provided a new, validated symptom score for patients with CKD not requiring RRT for clinical management and research purposes.
慢性肾脏病（CKD）即便在早期阶段也与一系列症状相关。患者症状体验的重要性日益得到认可，但缺乏经过验证的症状评分。
本研究旨在完善现有的症状问卷，以供不需要肾脏替代治疗（RRT）的患者使用，进行内容效度测试，并通过将症状评分与生活质量（QoL）进行比较来探索收敛效度。
采用包括问卷、半结构化访谈和焦点小组的混合方法。
未接受RRT的CKD患者和专业健康专家。
219名患者完成了现有的症状问卷。确定了最常报告的症状，并在11次半结构化访谈中对描述进行了完善。焦点小组对问卷设计进行了审查。由专业健康专家小组确定内容效度。70名患者同时完成了症状问卷和与健康相关的生活质量问卷（EQ-5D-5L）。
确定了13种常见症状。在内容效度阶段，16名专家中有13名做出回应（81%）；13种症状中有10种的评估得分是“优秀”或“良好”，整个问卷的内容效度指数为0.81，落在推荐阈值范围内。总症状频率得分、症状数量以及13种个体症状中的10种症状的频率均与健康相关生活质量（EQ-5D-5L指数得分）密切相关（所有p值均<0.002）。
这项工作为不需要RRT的CKD患者提供了一种新的、经过验证的症状评分，用于临床管理和研究目的。
