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Abstract: PO0818

Clinical Research Offers Potential Benefit to Patients and No Obvious Harm to Clinical Value

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Rigodon, Vladimir, Frenova Renal Research, Waltham, Massachusetts, United States
  • Jiao, Yue, Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts, United States
  • Larkin, John W., Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts, United States
  • Usvyat, Len A., Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts, United States
  • Guedes, Murilo Henrique, Pontificia Universidade Catolica do Parana, Curitiba, PR, Brazil
  • Moraes, Thyago Proença de, Pontificia Universidade Catolica do Parana, Curitiba, PR, Brazil
  • Pecoits-Filho, Roberto, Pontificia Universidade Catolica do Parana, Curitiba, PR, Brazil
  • Hymes, Jeffrey L., Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts, United States
  • Kossmann, Robert J., Fresenius Medical Care North America, Waltham, Massachusetts, United States
  • Anger, Michael S., Fresenius Medical Care North America, Waltham, Massachusetts, United States
  • Maddux, Franklin W., Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts, United States
  • Mussina, Kurt, Frenova Renal Research, Waltham, Massachusetts, United States
Background

Randomized clinical trials (RCT) are underperformed in nephrology. This may be due to the uncertain impacts on quality measures. We assessed quality outcomes between research-conducting (RF) and research-naïve (NF) dialysis facilities, as well as respective patient outcomes.

Methods

We used data from adult HD patients treated at national provider in the United States from 2017-2018. RF were 1:1 propensity score matched (PSM) to NF on patients/year, patient/facility exposure, % Medicare, % accountable care, region and quality outcomes were compared cross-sectionally. Research participants (RP) from facility analysis were 1:1 PSM to research naïve participants (RNP) at baseline (research participation start or index date) on age, sex, race, Ethnicity, vintage, access, albumin, hemoglobin (hgb), congestive heart failure, ischemic heart disease, diabetes, missed treatments, and hospital day rates. Quality outcomes were compared longitudinally at 6 and 12 months.

Results

We found no differences in quality outcomes between RF and NF facilities. We observed RP had lower hospital day rates at 6 months after research participation start as compared to NRP, as well as higher % with albumin >=4g/dL at 6 and 12 months, higher % with iPTH 150-600 pg/mL within 12 months, and lower anemia target achievement (Figure 1).

Conclusion

We observed no significant differences in quality measures between facilities that conducted clinical trials vs those that did not. Participation in trials was associated with lower hospital day rates and better achievement of nutritional targets, but lower achievement of hemoglobin and transferrin saturation targets. Anemia results might be attributable to conservative hgb repletion in trials of new investigational drugs. Trial conduct appeared to do no harm to quality achievement and provide potential benefits to participants, which may be associated with additional evaluations/monitoring provided.

Funding

  • Commercial Support –