Mathias Susan D, Blum Steven I, Sikirica Vanja, Johansen Kirsten L, Colwell Hilary H, Okoro Tony
Health Outcomes Solutions, PO Box 2343, Winter Park, FL, 32790, USA.
GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA, 19426, USA.
J Patient Rep Outcomes. 2020 Jul 29;4(1):64. doi: 10.1186/s41687-020-00215-8.
Anemia is a frequent complication of chronic kidney disease (CKD) that negatively affects patients' health-related quality of life.
We conducted qualitative concept elicitation (CE) and cognitive debriefing (CD) interviews to assess the frequency, duration, and severity of symptoms and impacts associated with anemia of CKD and to facilitate the development of a new patient-reported outcome (PRO) measure. We interviewed 36 patients with CKD and hemoglobin levels ≥8.0 to <12.0 g/dL using a semi-structured interview guide developed specifically for this study until saturation was reached. We used MAXQDA to perform qualitative analysis of interview transcripts to determine the most relevant symptoms and impacts (based on the frequency of concept mentions) experienced by participants.
Most participants had stage 4/5 CKD (81%) and were being treated with an erythropoietin stimulating agent (69%). Spontaneously reported symptoms included feeling tired (79%), shortness of breath (39%), and weak/lacking strength (36%). We developed the Chronic Kidney Disease and Anemia Questionnaire (CKD-AQ), which includes 23 items assessing frequency and severity of the most relevant symptoms and impacts identified by patients with anemia of CKD. The CD interviews confirmed the clarity and relevance of the concepts identified in the CE phase.
The CKD-AQ is a novel PRO measure that captures the frequency and severity of the most relevant symptoms and impacts associated with anemia of CKD. Future studies will evaluate its psychometric properties and its potential utility in anemia management.
贫血是慢性肾脏病(CKD)常见的并发症,对患者与健康相关的生活质量产生负面影响。
我们进行了定性概念引出(CE)和认知反馈(CD)访谈,以评估与CKD贫血相关症状的发生频率、持续时间和严重程度及其影响,并促进一种新的患者报告结局(PRO)指标的开发。我们使用专门为本研究制定的半结构化访谈指南,对36例血红蛋白水平≥8.0至<12.0 g/dL的CKD患者进行访谈,直至达到饱和。我们使用MAXQDA对访谈记录进行定性分析,以确定参与者经历的最相关症状和影响(基于概念提及的频率)。
大多数参与者患有4/5期CKD(81%),并正在接受促红细胞生成素刺激剂治疗(69%)。自发报告的症状包括感到疲倦(79%)、呼吸急促(39%)和虚弱/乏力(36%)。我们开发了慢性肾脏病与贫血问卷(CKD-AQ),其中包括23个项目,用于评估CKD贫血患者确定的最相关症状和影响的发生频率和严重程度。CD访谈证实了CE阶段确定的概念的清晰度和相关性。
CKD-AQ是一种新型的PRO指标,可反映与CKD贫血相关的最相关症状和影响的发生频率和严重程度。未来的研究将评估其心理测量特性及其在贫血管理中的潜在效用。