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. 2019 Jan;28(1):253-265.
doi: 10.1007/s11136-018-2000-7. Epub 2018 Sep 18.

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

Jennifer E Flythe  1   2 , Adeline Dorough  3 , Julia H Narendra  3 , Rebecca L Wingard  4 , Lorien S Dalrymple  4 , Darren A DeWalt  5
Affiliations

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

Jennifer E Flythe et al. Qual Life Res. 2019 Jan.

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.

Keywords: Cognitive debriefing interview; Concept elicitation; Content validity; End-stage kidney disease; Hemodialysis; Patient-reported outcome measure; Symptoms.

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Conflict of interest statement

Conflict of Interest: Miss Dorough, Mrs. Narendra and Dr. DeWalt declare that they have no conflicts of interest.

Figures

Figure 1.
Figure 1.
Overall methodology schematic. PROM, patient-reported outcome measure; SMaRRT-HD™, Symptom Monitoring on Renal Replacement Therapy-Hemodialysis.
Figure 2.
Figure 2.
Flow of cognitive debriefing interviews. PROM, patient-reported outcome measure.
See this image and copyright information in PMC

References

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