873 1030
Table 1 – Baseline characteristics of RCTs
Study ID (year), country,
design, recruitment period
PROM tool used
Interventions
N
Age: mean (SD),
median [range]
FU (mo):
mean (SD),
median [range]
T stage
Gleason score:
n
or mean (SD)
PSA:
mean (SD),
median [range]
Comorbidity
Crook
(2011)
[11]
, North America,
RCT–prospective, 2002–2004
Radical
prostatectomy
66
61.4 (6.2)
62.4 [38.4–78]
NR but inclusion
criteria: either
T1c or T2a
NR but inclusion
criteria: 6
5.5 (2.1)
50%
aEPIC
Brachytherapy
102
59.4 (5.9)
5.3 (2.8)
40.9%
aDonovan
(2016)
[12]
, UK, RCT,
1999–2009
Active monitoring
545
62 (5)
T1c: 410 (75%)
T2: 135 (25%)
6: 421 (77%)
7: 111 (20%)
8–10: 13 (2%)
Missing: 0
4.7 [3.7–6.7]
EPIC
EORTC QLQ-C30
Radical
prostatectomy
553
62 (5)
EORTC QLQ-C30 was
assessed at 60 mo
EPIC was assessed
at 72 mo
T1c: 410 (74%)
T2: 143 (26%)
6: 422 (76%)
7: 120 (22%)
8–10: 10 (2%)
Missing: 1
4.9 [3.7–6.7]
NR
EBRT
545
62 (5)
T1c: 429 (79%)
T2: 116 (21%)
6: 423 (78%)
7: 108 (20%)
8–10: 14 (3%)
Missing: 0
4.8 [3.7–6.7]
Giberti
(2009)
[13]
, Italy, RCT,
1999–2002
Radical
prostatectomy
100
65.2 [57–74]
68.2 [60–102]
T1c: 64 (64%)
T2a: 36 (36%)
5.9
7.8 [3.5–10]
NR
EORTC QLQ-C30
EORTC QLQ-PR25
Brachytherapy
100
65.6 [56–74]
T1c: 59 (59%)
T2a: 41 (41%)
5.7
7.5 [2.9–9.3]
EBRT = external beam radiotherapy; EPIC = Expanded Prostate Cancer Index Composite; FU = follow-up; N = number of patients; NR = not reported; PROM = patient-reported outcome measure; PSA = prostate-specific
antigen; RCT = randomised controlled trial; SD = standard deviation.
a
Percentage of patients taking medications for diabetes mellitus, hypertension, or cardiovascular disease.
E U R O P E A N U R O L O G Y 7 2 ( 2 0 1 7 ) 8 6 9 – 8 8 5
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