Development and content validity of a hemodialysis symptom patient-reported outcome measure
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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.
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.
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.
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.
KeywordsSymptoms Hemodialysis Content validity Concept elicitation Cognitive debriefing interview End-stage kidney disease Patient-reported outcome measure
The authors would like to thank all study participants for sharing their experiences and perspectives on hemodialysis-related symptoms and the symptom measure. The authors also thank Dr. Emaad Abdel-Rahman and research liaisons, Lisa Johnson and Nino McHedlishvili, for their help in facilitating concept elicitation interviews at the University of Virginia. Finally, the authors thank the advisors who contributed to measure development: Derek Forfang, Lori Hartwell, Robert Kossmann, Mahesh Krishnan, Francesca Tentori, and David Thissen.
This work was supported by an unrestricted, investigator-initiated research Grant (A17-1082) from Renal Research Institute (RRI), a subsidiary of Fresenius Medical Care (FMC), North America. RRI played no role in study design; collection, analysis, and interpretation of data; writing the report; or the decision to submit the report for publication. Dr. Flythe is supported by National Institute of Diabetes and Digestive and Kidney Diseases of the National Institute of Health Grant K23 DK109401.
Compliance with ethical standards
Conflict of interest
Dr. Flythe has received investigator-initiated research funding from the Renal Research Institute, a subsidiary of Fresenius Medical Care, North America. In the past 2 years, Dr. Flythe has received consulting fees from Fresenius Medical Care, North America and speaking honoraria from American Renal Associates, American Society of Nephrology, Baxter, National Kidney Foundation, and multiple universities. Dr. Dalrymple and Ms Wingard are employees of Fresenius Medical Care, North America and have performance share-options/stock-options. Miss Dorough, Mrs. Narendra, and Dr. DeWalt declare that they have no conflicts of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study was approved by the Institutional Review Boards of the University of North Carolina at Chapel Hill (17-0038 and 17-1252) and the University of Virginia (19928).
Informed consent was obtained from all individual participants included in the study.
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