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

Jennifer E. Flythe, Adeline Dorough, Julia H. Narendra, Rebecca L. Wingard, Lorien Dalrymple, Darren A. DeWalt

Research output: Contribution to journalArticlepeer-review

4 Scopus citations


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.

Original languageEnglish (US)
JournalQuality of Life Research
StateAccepted/In press - Jan 1 2018
Externally publishedYes


  • Cognitive debriefing interview
  • Concept elicitation
  • Content validity
  • End-stage kidney disease
  • Hemodialysis
  • Patient-reported outcome measure
  • Symptoms

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health


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