The SANAD (Standard and New Antiepileptic Drugs) study (Marson et al., 2007) is a randomised control trial of standard and new antiepileptic drugs, comparing effects on longer term clinical outcomes. Quality of life (QoL) data were collected by mail at baseline, 3 months, and at 1 and 2 years using validated measures. This data is a subset of the trial for 544 patients randomised to one of 2 drugs: carbamazepine and lamotrigine.
data(epileptic.qol)
A data frame with 1853 observations on the following 9 variables:
id
patients identifier; in total there are 544 patients.
with.time
number of days between registration and the earlier of treatment failure or study analysis time.
trt
a factor with levels CBZ
and LTG
denoting
carbamazepine and lamotrigine, respectively.
with.status
the reason for treatment failure. Coded as
0=
censored; 1=
unacceptable adverse effects;
2=
inadequate seizure control.
time
the time the quality of life measures were recorded (days). The first measurement for each subject is the baseline measurement, however there was variability between the time taken to return the questionnaires; hence the reason this is non-zero. Similarly, the second, third, and fourth follow-up times, which were scheduled for 3-months, 1-year, and 2-years, respectively, also had variability in completion times.
anxiety
a continuous measure of anxiety, as defined according to the NEWQOL (Newly Diagnosed Epilepsy Quality of Life) assessment. Higher scores are indicative of worse QoL.
depress
a continuous measure of depression, as defined according to the NEWQOL (Newly Diagnosed Epilepsy Quality of Life) assessment. Higher scores are indicative of worse QoL.
aep
a continuous measure of the Liverpool Adverse Events Profile (AEP), as defined according to the NEWQOL (Newly Diagnosed Epilepsy Quality of Life) assessment. Higher scores are indicative of worse QoL.
with.status2
a binary indicator of composite treatment
failure (for any reason), coded status2=1
, or right-censoring
status2=0
.
Jacoby A, Sudell M, Tudur Smith C, et al. Quality-of-life outcomes of initiating treatment with standard and newer antiepileptic drugs in adults with new-onset epilepsy: Findings from the SANAD trial. Epilepsia. 2015; 56(3): 460-472.
Marson AG, Appleton R, Baker GA, et al. A randomised controlled trial examining longer-term outcomes of standard versus new antiepileptic drugs. The SANAD Trial. Health Technology Assessment. 2007; 11(37).
Marson AG, Al-Kharusi AM, Alwaidh M, et al. The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial. Lancet. 2007; 365: 2007-2013.
Abetz L, Jacoby A, Baker GA, et al. Patient-based assessments of quality of life in newly diagnosed epilepsy patients: validation of the NEWQOL. Epilepsia. 2000; 41: 1119-1128.
pbc2
, heart.valve
, renal
.