Jennifer E Flythe1,2, Adeline Dorough3, Julia H Narendra3, Rebecca L Wingard4, Lorien S Dalrymple4, Darren A DeWalt5. 1. Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina (UNC) Kidney Center, UNC School of Medicine, 7024 Burnett-Womack CB #7155, Chapel Hill, NC, 27599-7155, USA. jflythe@med.unc.edu. 2. Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC, USA. jflythe@med.unc.edu. 3. Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina (UNC) Kidney Center, UNC School of Medicine, 7024 Burnett-Womack CB #7155, Chapel Hill, NC, 27599-7155, USA. 4. Medical Office, Fresenius Medical Care North America, Waltham, MA, USA. 5. Division of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina, UNC School of Medicine, Chapel Hill, NC, USA.
Abstract
PURPOSE: To describe the process and preliminary qualitative development of a new symptom-based patient-reported outcome measure (PROM) intended to assess hemodialysis treatment-related physical symptoms. METHODS: Experienced interviewers conducted concept elicitation and cognitive debriefing interviews with individuals receiving in-center hemodialysis in the United States. Concept elicitation interviews involved eliciting spontaneous reports of symptom experiences and probing to further explore and confirm concepts. We used patient-reported concepts to generate a preliminary symptom PROM. We conducted 3 rounds of cognitive debriefing interviews to evaluate symptom relevance, item interpretability, and draft item structure. We iteratively refined the measure based on cognitive interview findings. RESULTS: Forty-two adults receiving in-center hemodialysis participated in the concept elicitation interviews. A total of 12 symptoms were reported by > 10% of interviewees. We developed a 13-item initial draft instrument for testing in 3 rounds of cognitive interviews with an additional 52 hemodialysis patients. Participant responses and feedback during cognitive interviews led to changes in symptom descriptions, division of the single item "nausea/vomiting" into 2 distinct items, removal of daily activity interference items, addition of instructions, and clarification about the recall period, among other changes. CONCLUSIONS: Symptom Monitoring on Renal Replacement Therapy-Hemodialysis (SMaRRT-HD™) is a 14-item PROM intended for use in hemodialysis patents. SMaRRT-HD™ uses a single treatment recall period and a 5-point Likert scale to assess symptom severity. Qualitative interview data provide evidence of its content validity. SMaRRT-HD™ is undergoing additional testing to assess measurement properties and inform measure scoring.
PURPOSE: To describe the process and preliminary qualitative development of a new symptom-based patient-reported outcome measure (PROM) intended to assess hemodialysis treatment-related physical symptoms. METHODS: Experienced interviewers conducted concept elicitation and cognitive debriefing interviews with individuals receiving in-center hemodialysis in the United States. Concept elicitation interviews involved eliciting spontaneous reports of symptom experiences and probing to further explore and confirm concepts. We used patient-reported concepts to generate a preliminary symptom PROM. We conducted 3 rounds of cognitive debriefing interviews to evaluate symptom relevance, item interpretability, and draft item structure. We iteratively refined the measure based on cognitive interview findings. RESULTS: Forty-two adults receiving in-center hemodialysis participated in the concept elicitation interviews. A total of 12 symptoms were reported by > 10% of interviewees. We developed a 13-item initial draft instrument for testing in 3 rounds of cognitive interviews with an additional 52 hemodialysis patients. Participant responses and feedback during cognitive interviews led to changes in symptom descriptions, division of the single item "nausea/vomiting" into 2 distinct items, removal of daily activity interference items, addition of instructions, and clarification about the recall period, among other changes. CONCLUSIONS: Symptom Monitoring on Renal Replacement Therapy-Hemodialysis (SMaRRT-HD™) is a 14-item PROM intended for use in hemodialysis patents. SMaRRT-HD™ uses a single treatment recall period and a 5-point Likert scale to assess symptom severity. Qualitative interview data provide evidence of its content validity. SMaRRT-HD™ is undergoing additional testing to assess measurement properties and inform measure scoring.
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