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. 2024 Jun 28;25:424. doi: 10.1186/s13063-024-08281-9

Table 4.

Primary and secondary outcomes and measures

Outcome	Measures	Level of analysis	Data sources	Timepoints
Primary Outcome
Safety	All-cause ED visits, hospitalizations or death	Patient	Patient’s EMR (dialysis and hospital EMR)	Enrollment to end-of-study event
Main Secondary Outcomes
Health-related quality of life	^aIllness Intrusiveness Rating Scale	Patient	Patient	Baseline^b and monthly
	EuroQOL-5D-5L score	Patient	Patient	Baseline^b and semi-annually^c
	Employment status	Patient & Care partner	Patient & Care partner	Baseline^b and semi-annually^c
	Hospital-free days per 100 patient-days	Patient	Patient’s EMR (dialysis and hospital EMR)	Enrollment to end-of-study event
Residual kidney function	^aChange in urine output (mL/24 h)	Patient	Patient	Baseline^b and every 3 months or more often when needed
	Change in kidney urea clearance (mL/min/1.73 m²)	Patient	Patient
	Change in kidney creatinine clearance (mL/min/1.73 m²)	Patient	Patient
Other Secondary Outcomes
Care partner burden	Zarit Caregivers Burden Scale	Caregiver	Caregiver	Baseline and semi-annually
Functional status and fatigue	Time to recover from HD	Patient	Patient	Baseline^b and monthly
Functional status and fatigue	SONG-HD Fatigue score	Patient	Patient	Baseline^b and semi-annually^c
Cognitive function	Trail Making Test Part B score	Patient	Patient	Baseline^b and semi-annually^c
Volume management	Interdialytic weight gain; Residual weight; Ultrafiltration rate (mL/kg/hour)	Patient	Patient’s EMR (dialysis and hospital EMR)	Baseline^b and monthly
Blood pressure control	Average pre- and post- dialysis blood pressure; Number of prescribed antihypertensive agents	Patient	Patient’s EMR (dialysis and hospital EMR)	Baseline^b and monthly
Solute clearance, electrolyte and acid-base homeostasis	Total stdKt/V; Pre-HD serum sodium, potassium, and bicarbonate	Patient	Patient’s EMR (dialysis and hospital EMR)	Baseline^b and monthly
Nutrition	Serum albumin concentration; Normalized protein catabolic rate	Patient	Patient’s EMR (dialysis and hospital EMR)	Baseline^b and monthly

^aMain secondary outcomes

^bPre-randomization

^cSemi-annually: months 6, 12, 18, and 24 of study participation. EMR, electronic medical record