Table 1 Outcome measures
Category | Measures | Frequency |
|---|---|---|
Adherence outcomes | Electronic monitoring | Continuously monitored |
● Taking adherence (% prescribed doses taken each day) | ||
● Timing adherence (% doses taken within 2 hours of scheduled time each day) | ||
● Drug holidays (missing ≥2 consecutive doses) | ||
Pharmacy refills | All refills during study interval | |
● Taking adherence (% prescribed doses taken over entire intervention period) | ||
Variability in tacrolimus or sirolimus trough levels | Monthly levels as measured for clinical care | |
● Standard deviation calculated over 6-month intervals | ||
Self-report (Medical Adherence Measure- Medication Module) | 3-month intervals | |
● Taking adherence (% prescribed doses taken, in 3-month intervals) | ||
● Timing adherence (% doses taken within 2 hours of scheduled time, in 3-month intervals) | ||
● Drug holidays (missing ≥2 consecutive doses) | ||
Graft outcomes | Graft failures or deaths (# failures/person-year of follow-up) | All failures during study interval |
● Failure defined as loss of graft function requiring return to dialysis or death from any cause | ||
Acute rejections (# rejections/person-year of follow-up) | All rejections during study interval | |
● Biopsy-proven and presumed rejections, defined as rejections diagnosed by the treating physician based on >20% rise in creatinine | ||
Percent change in estimated glomerular filtration rate (eGFR)* | ||
● Calculated as: | ||
(eGFR at start of intervention – eGFR at study exit) ÷ eGFR at start of intervention | ||
Adverse outcomes | Deaths | All deaths during study interval |
Opportunistic viral infections (CMV, EBV, biopsy-proven polyoma virus nephropathy) | All infections during study interval | |
Hospitalizations (# hospitalizations/ person-year of follow-up) | All hospitalizations during study interval | |
Other medical conditions requiring treatment (# conditions/ person-year of follow-up) | All conditions during study interval |