Abstract: TH-PO801

Impact of Baseline Scores on the Responsiveness of Quality of Life (QOL) Tools to Interventions: An ACTIVE Dialysis Trial Secondary Analysis

Session Information

Category: Dialysis

  • 607 Dialysis: Epidemiology, Outcomes, Clinical Trials - Non-Cardiovascular

Authors

  • Jardine, Meg J., The George Institute for Global Health, UNSW, Sydney, New South Wales, Australia
  • Perkovic, Vlado, The George Institute for Global Health, UNSW, Sydney, New South Wales, Australia
  • Smyth, Brendan, The George Institute for Global Health, UNSW, Sydney, New South Wales, Australia
  • van den Broek-Best, Oliver, The George Institute for Global Health, UNSW, Sydney, New South Wales, Australia
  • Zuo, Li, Peking University People's Hospital , Beijing, China
  • Gray, Nicholas A., Sunshine Coast University Hospital, Birtinya, New South Wales, Australia
  • Chan, Christopher T., Toronto General Hospital, Toronto, Ontario, Canada
  • de Zoysa, Janak Rashme, Waitemata District Health Board, AUCKLAND, New Zealand
  • Howard, Kirsten, University of Sydney, Sydney, New South Wales, Australia
  • Rogers, Kris, The George Institute for Global Health, UNSW, Sydney, New South Wales, Australia

Group or Team Name

  • ACTIVE Dialysis Steering Committee
Background

There is little clarity on the relative validity, reproducibility and generalisability of available tools for measuring the patient experience in the trial context. The ACTIVE Dialysis trial found no benefit from extended hemodialysis (HD) hours for the utility-based QOL measure, EQ-5D, with small but significant benefits for generic health-related SF-36 QOL. Participants in extended hours trials have better average health than patients overall raising the possibility EQ-5D responsiveness may be limited by a ‘ceiling’ effect.
Aim: To explore whether the impact of extended hours HD on QOL scores is dependent on baseline scores.

Methods

The ACTIVE Dialysis trial randomized 200 HD patients to standard (median 12) or extended (median 24) weekly HD hours for 12 months. Dialysis population-validated QOL assessments including the EQ-5D utility instrument and SF-36 Physical (PCS) and Mental (MCS) Composite Scores were administered by blinded interviewers during the trial. After confirming the absence of an interaction of the score with time, the average intervention effect was determined using mixed linear regression and analysed in subgroups defined by tertiles of the relevant baseline score.

Results

Overall extended weekly HD hours had no impact on EQ-5D (mean difference 0.03, CI -0.03, 0.09; p=0.30) with small but significant improvements in PCS and MCS (mean difference PCS 2.30, 95%CI 0.52-4.07; MCS 2.54, 95%CI 0.42-4.65).
The lack of impact on EQ-5D results were consistent across all tertiles (lowest third 0.01 [CI -0.12-0.14, p=0.89], middle third 0.05 [CI -0.03-0.13, p=0.26], highest third 0.02 [CI -0.07-0.12, p=0.60], p-interaction 0.80). The benefits for PCS and MCS were similarly consistent across tertiles (p-interaction: PCS 0.96; MCS 0.34).

Conclusion

The impact of extended dialysis hours on EQ-5D, PCS and MCS QOL was not dependent on baseline scores. The scores appear to be at least internally robust to variation in baseline QOL. NCT00649298

Funding

  • Commercial Support