Table 2.
Table of SWIFT outcomes
| Outcome | Description and unit of measure | Data collection timepoint or registry source |
|---|---|---|
| Primary outcome | ||
| Health-related quality of life | Mean change in EQ-5D-5L value (utility) from baseline to 12 months (primary outcome) | Baseline, 6 months, 12 months |
| Secondary outcome | ||
| Dialysis withdrawal | Number of participants identified as withdrawal from dialysis | 12 months—collected through ANZDATA |
| Health-related quality of life | Mean change in EQ-5D-5L value (utility) from baseline to 6 months | Baseline, 6 months |
| Health-related quality of life | Mean change in EQ-5D-5L and VAS scores from baseline at 6 months; and from baseline to 12 months | Baseline, 6 months, 12 months |
| Overall survival | All-cause mortality rates at 12 months | 12 months |
| Cause-specific mortality (including deaths due to dialysis withdrawal) | Cause-specific mortality rates at 12 months for dialysis withdrawal, cardiovascular, cancer, infection and other causes | 12 months |
| Fatigue | Mean change in SONG-HD Fatigue score at 12 months | Baseline, 6 months, 12 months |
| Symptom severity | Intervention arm only. Measured by change in IPOS-Renal symptom severity scores | Baseline, 3 months, 6 months, 9 months, 12 months |
| Haemodialysis duration | Average number of hours per treatment | 12 months—collected through ANZDATA |
| Haemodialysis frequency | Number of treatments per week | 12 months—collected through ANZDATA |
| Haemodialysis adequacy | Urea reduction ratio and Kt/V | 12 months—collected through ANZDATA |
| Symptom-related and general healthcare utilisation | Hospitalisations, Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS) items | Assessed through linked administrative records for admitted patient data and Medicare claims |
| Cost-effectiveness | Incremental cost per quality-adjusted life year (QALY) gained reported as an incremental cost effectiveness ratio (ICER) or incremental net benefit (INB) | 12 months; EQ-5D-5L utilities collected as per primary outcome; healthcare use identified from linked administrative records |
Abbreviations: ANZDATA, Australia New Zealand Dialysis and Transplant Registry; EQ-5D-5L, EuroQoL 5-item 5-level preference-based measure of health status; VAS, visual analogue scale; SONG-HD Fatigue, Standardised Outcomes in Nephrology – Haemodialysis, Fatigue; IPOS Renal, Integrated Palliative Outcome Scale – Renal; Kt/V, K=dialyser clearance of urea, t=dialysis time, V=volume of distribution of urea, this is approximately equal to the patient’s total body water