Abstract
BackgroundAnemia is a frequent complication of chronic kidney disease (CKD) that negatively affects patients’ health-related quality of life.MethodsWe 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.ResultsMost 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.ConclusionThe 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.
Highlights
Anemia is a frequent complication of chronic kidney disease (CKD) that negatively affects patients’ health-related quality of life
Anemia is a frequent complication of chronic kidney disease (CKD) that increases in prevalence and severity as kidney function declines [1, 2]
The various steps in the development process are as follows: Step 1 We conducted a targeted review of literature articles published between January 2006 and March 2016 using the following search string: (CKD OR “Chronic Kidney Disease”) AND AND questionnaire, to identify concepts to explore during subsequent qualitative patient interviews, and to identify existing CKD and anemiaspecific patient-reported outcome (PRO) measures
Summary
Anemia is a frequent complication of chronic kidney disease (CKD) that negatively affects patients’ health-related quality of life. Common symptoms of anemia of CKD include low energy, fatigue, and decreased physical function, which can negatively affect patients’ health-related quality of life (HRQoL) [2]. For. Patient-reported outcome (PRO) measures capture concepts such as the symptoms and/or impacts of a disease from the patient’s perspective [3,4,5]. Patient-reported outcome (PRO) measures capture concepts such as the symptoms and/or impacts of a disease from the patient’s perspective [3,4,5] They are increasingly being used as part of the evaluation of new treatment options or when comparing the efficacy of different treatments [3, 6]. Over the past several years, various agencies and organizations, including the US Food and Drug Administration (FDA), International Society of Pharmacoeconomic and Outcomes Research (ISPOR), and European
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