Development and content validity of a hemodialysis symptom patient-reported outcome measure.

Autor: Flythe JE; 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.; Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC, USA. jflythe@med.unc.edu., Dorough A; 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., Narendra JH; 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., Wingard RL; Medical Office, Fresenius Medical Care North America, Waltham, MA, USA., Dalrymple LS; Medical Office, Fresenius Medical Care North America, Waltham, MA, USA., DeWalt DA; Division of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina, UNC School of Medicine, Chapel Hill, NC, USA.
Jazyk: angličtina
Zdroj: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation [Qual Life Res] 2019 Jan; Vol. 28 (1), pp. 253-265. Date of Electronic Publication: 2018 Sep 18.
DOI: 10.1007/s11136-018-2000-7
Abstrakt: 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.
Databáze: MEDLINE
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