Aim: To determine if the effect of extended hours dialysis onquality of life (QOL) in the ACTIVE Dialysis trial differed according topre‐specified subgroups.
Background: The ACTIVE Dialysis trial of extended hours (≥24 hours perweek) versus standard hours (≤18 hours per week) haemodialysis demonstrated asignificant improvement in QOL as measured by Short Form‐36 (SF‐36) PhysicalComponent Summary (PCS) and Mental Component Summary (MCS).
Methods: The ACTIVE Dialysis trial was an open‐label randomised,blinded endpoint assessment trial. Two hundred participants were enrolled fromfour countries and randomised to 12 months of standard or extended hoursdialysis. The SF‐36 was administered by a blinded interviewer at 3‐monthintervals. Mean difference between extended and standard arms was assessed bymixed linear regression. The overall effect sizes (Cohen’s d: where 0.2‐0.5 isa small effect, 0.5‐0.8 a moderate effect and >0.8 a large effect) werecalculated as the ratio of mean difference to standard deviation. Subgroupvariables were added to the regression model with an interaction with treatmentgroup to test for effect modification.
Results: Extended hours dialysis was associated with significantimprovement in PCS (2.30 [95% CI 0.55‐4.06]; p=0.010) and MCS (2.54 [95% CI0.48‐4.60]; p=0.016). The effect size on both measures was small (PCS 0.24[95%CI 0.06‐0.42; p=0.010], MCS 0.24 [95%CI 0.04‐0.43; p=0.016]). The effect ofextended hours dialysis did not vary significantly by baseline score, region(China vs Australia, Canada, New Zealand), dialysis location (home vsin‐centre/satellite) or dialysis vintage (≤6 months vs >6 months).
Conclusions: Extended hours dialysis leads to a small improvement inphysical and mental QOL. These effects did not differ significantly between keydemographic and clinical subgroups.