Kidney Week

Abstract: PO0818

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

Session Information

• Dialysis Care: Epidemiology and the Patient Experience
  November 04, 2021 | Location: On-Demand, Virtual Only
  Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

• 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Rigodon, Vladimir, Frenova Renal Research, Waltham, Massachusetts, United States

Vladimir Rigodon

• Jiao, Yue, Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts, United States

Yue Jiao,

• Larkin, John W., Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts, United States

John W. Larkin,

• Usvyat, Len A., Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts, United States

Len A. Usvyat,

• Guedes, Murilo Henrique, Pontificia Universidade Catolica do Parana, Curitiba, PR, Brazil

Murilo Henrique Guedes,

• Moraes, Thyago Proença de, Pontificia Universidade Catolica do Parana, Curitiba, PR, Brazil

Thyago Proença de Moraes,

• Pecoits-Filho, Roberto, Pontificia Universidade Catolica do Parana, Curitiba, PR, Brazil

Roberto Pecoits-Filho,

• Hymes, Jeffrey L., Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts, United States

Jeffrey L. Hymes,

• Kossmann, Robert J., Fresenius Medical Care North America, Waltham, Massachusetts, United States

Robert J. Kossmann,

• Anger, Michael S., Fresenius Medical Care North America, Waltham, Massachusetts, United States

Michael S. Anger,

• Maddux, Franklin W., Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts, United States

Franklin W. Maddux,

• Mussina, Kurt, Frenova Renal Research, Waltham, Massachusetts, United States

Kurt Mussina,

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 – Fresenius Medical Care North America