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Abstract: SA-PO1066

Measurement Precision Matters: Patient-Reported Outcomes Measurement Information System Preference (PROPr) Score Detects Treatment Effects Missed by EQ-5D-5L in the CONVINCE Randomized Trial

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Klapproth, Christoph Paul, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany
  • Cromm, Krister, Fresenius Medical Care Deutschland GmbH, Bad Homburg, HE, Germany
  • Schappert, Anna, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany
  • Riazy, Leili, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany
  • Fischer, Felix, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany
  • Liegl, Gregor, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany
  • Blankestijn, Peter J., Universiteit Utrecht, Utrecht, UT, Netherlands
  • Bots, Michiel L., Universiteit Utrecht, Utrecht, UT, Netherlands
  • Fischer, Kathrin Irmgard, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany
  • Hegbrant, Jorgen BA, Lunds Universitet, Lund, Skåne County, Sweden
  • Canaud, Bernard J., Universite Paul-Valery Montpellier 3, Montpellier, Occitanie, France
  • Davenport, Andrew, University College London, London, England, United Kingdom
  • Woodward, Mark, The George Institute for Global Health UK, Oxford, England, United Kingdom
  • Barth, Claudia Maria, B Braun Avitum AG, Melsungen, HE, Germany
  • Rose, Matthias, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany
  • Strippoli, Giovanni, Universita degli Studi di Bari Aldo Moro, Bari, Apulia, Italy

Group or Team Name

  • CONVINCE Scientific Committee and CONVINCE investigators
Background

Preference-based measures (PBMs) are central to estimating quality-adjusted life years in cost-effectiveness analyses, yet their responsiveness depends on the performance of their descriptive systems. Compared with EQ-5D-5L, the PROMIS Preference Score (PROPr) incorporates item-response theory-based PROMIS domains and may provide greater sensitivity to modest treatment effects. We compared the responsiveness of PROPr and EQ-5D-5L in the CONVINCE trial of high-dose hemodiafiltration (HDF) versus conventional hemodialysis (HD).

Methods

CONVINCE randomized 1360 patients overall; this secondary analysis included 810 participants with available longitudinal EQ-5D-5L and PROPr data (HDF n=413; HD n=397). PBMs were administered at baseline and every 6 months through 36 months. Longitudinal changes were analyzed using linear mixed-effects models including fixed effects for time, treatment group, and treatment-by-time interaction. Secondary analyses evaluated individual EQ-5D-5L dimensions and PROMIS domains.

Results

Baseline PROPr scores were identical between groups (0.42±0.23), whereas EQ-5D-5L scores were 0.73±0.30 for HD and 0.75±0.28 for HDF. Over follow-up, PROPr detected a significant treatment effect favoring HDF versus HD (interaction β=0.002, 95% CI 0.000 to 0.003; p=0.032), whereas EQ-5D-5L did not (interaction β=0.002, 95% CI -0.000 to 0.003; p=0.079). Domain-level analyses favored HDF for PROMIS Physical Function (p=0.014), PROMIS Social Participation (p=0.026), and EQ-5D-5L Self-Care (p=0.009). Attrition reached 87% by 36 months.

Conclusion

In a large international dialysis RCT with substantial long-term attrition, PROPr identified treatment differences not detected by EQ-5D-5L. Greater domain-level precision may improve sensitivity of PBMs to detect modest treatment effects in nephrology trials and influence downstream cost-effectiveness analyses.

Funding

  • Government Support – Non-U.S.