Abstract Background Needling is a key step in haemodialysis. Research suggests needling experience is sub-optimal; however, no validated measure exists to inform improvements. We addressed this by developing the Needling Patient Reported Experience Measure (NPREM). Methods We used mixed methods and co-production. All participants were adults with working fistulas/grafts from eight UK kidney centres. Phase 1: Developing concepts and items, In interviews (n=41), we explored patients’ needling experience and identified key aspects of needling using thematic analysis. This informed the 98-item NPREM(v0.1). Phase 2: Piloting the measure Cognitive interviews (n=16) assessed face validity. Items were amended or removed, yielding a 48-item NPREM(v0.2). A pilot survey (n=183) examined initial psychometric properties. NPREM(v0.2) showed good internal consistency (Cronbach's alpha=0.95). Review of analyses resulted in a 35-item NPREM(v0.3). Phase 3: Evaluating the measure's dimensionality, validity, and reliability Patients (n=468) completed the NPREM(v0.3), Vascular Access Quality of Life (VASQoL), EuroQol 5-Dimension-5-Level (EQ5D-5L), Patient Activation Measure (PAM), with a sub-set completing a follow-up NPREM (n=99). Items were evaluated with 28 items retained in the NPREM(v1.0). Confirmatory factor analysis confirmed a unidimensional model fit (CFI=0.899). Validity of the NPREM(v1.0) was good [convergent: VASQoL (r=0.60) and overall experience (r=0.79); divergent: EQ-5D (r=-0.31), EQ-5D VAS (r=0.24) and PAM (r=0.17)]. Test-retest scores were strongly correlated (r=0.88), demonstrating high reliability. Known-groups validity was demonstrated between centre scores (range 5.21 (SD 1.20) to 5.94 (SD 0.75)). Conclusion The NPREM measures patient experience of needling for haemodialysis. It offers kidney services a means of assessing needling experience, informing patient-focused clinical and service improvements.
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