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Table 3 Outcomes of interest in the e-nephro study

From: Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design

Populations

Outcomes of interest

Primary outcome of interest

 Population 1

Cost-result ratio, where result is achievement of blood pressure (systolic ≤ 130 and diastolic ≤ 80 mmHg) and proteinuria (≤0.5 g/24 h or proteinuria/creatininuria ≤ 50 mg/mmol) recommended targets at V3 [33].

 Populations 2 and 3

Cost-result ratio, where result is the cumulative number of days of acute-care hospitalisation over the 1-year study period (from V1 to V3).

Secondary outcomes of interest

 Populations 1, 2, and 3

Medication compliance measured by the French questionnaire by Girerd [34]

Anxiety/depression level, measured with the Hospitalization Anxiety Depression Scale (HADS) [35, 36]

Quality-of-life, measured with the KDQoL V36 questionnaire [37] for populations 1, 2 and the ReTransQoL questionnaire [38] for population 3

 Intervention group of populations 1, 2, and 3 + healthcare practio-ners

Acceptability of the telemedicine system, measured with the French version of the Service User Technology Acceptability Questionnaire (WSD SUTAQ) for telemonitoring projects [39, 40].

The patient dropout rate from the telemedicine system will also be considered an indicator of the patient acceptability.

 Populations 1 and 3

1-year change in glomerular filtration rate measured with the MDRD formula [41]

 Population 3

Number of planned nephrology outpatient visits actually performed, and the number of unplanned visits and hospitalisations over the 1-year study period

 Population 2

Event-free survival at 1 year, an event being defined here as return to in-centre dialysis or hospitalisation

 

Anaemia control, defined as achievement of haemoglobin, ferritin and coefficient of transferrin saturation recommended targets