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Table 2 Table of SWIFT outcomes

From: The Symptom Monitoring with Feedback Trial (SWIFT): protocol for a registry-based cluster randomised controlled trial in haemodialysis

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

  1. 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