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International Journal of Stroke 18(5)
Table 2. Demographics, stroke type, and upper-limb impairment of the accessible population with a confirmed stroke and SAFE
score.
Too severe
Accessible population
Confirmed stroke and reported SAFE score (n = 669)
Age-years, median (IQR)
Sex, n (%)
Male
Female
Baseline measures, median (IQR)
mRS
NIHSS (total)
NIHSS (upper limb sub-score)
Stroke type, n (%)
Ischemic
Haemorrhagic
Both
Lesion side, n (%)
Right
Left
Both
Acute stroke treatment, n (%)
Total SAFE score, n (%)
*Assessed at a median of 1.0 day (1.0, 3.0) post-stroke
(SAFE 0-1)
n = 129
70.0 (55.8, 82.0)
60 (46.9%)
68 (53.1%)
0 (0, 1.0)
17.0 (12.0, 20.0)
4.0 (3.0, 4.0)
100 (77.5%)
25 (19.4%)
4 (3.1%)
57 (44.2%)
66 (51.2%)
6 (4.6%)
74 (57.4%)
0 124 (96.1%)
1 5 (3.2%)
Trial eligible
(SAFE 2-7)
n = 106
76.0 (66.3, 81.8)
57 (53.8%)
49 (46.2%)
0 (0, 1.0)
7.0 (4.0, 14.8)
1.0 (1.0, 3.0)
90 (84.9%)
15 (14.2%)
1 (0.9%)
55 (51.9%)
39 (36.8%)
12 (11.3%)
46 (43.4%)
2 12 (11.3%)
3 8 (7.5%)
4 11 (10.4%)
5 18 (17.0%)
6 36 (34.0%)
7 21 (19.8%)
Length of stay-days, median (IQR)
11.0 (6.0, 22.3)
7.0 (4.0, 11.0)
Too good
(SAFE 8-10)
n = 434
72.0 (61.0, 80.0)
279 (64.2%)
151 (34.8%)
0 (0, 0.3)
5.0 (2.0, 10.0)
0 (0, 1.0)
379 (87.3%)
51 (11.8%)
4 (0.9%)
199 (45.9%)
210 (48.4%)
25 (5.7%)
181 (41.7%)
8 144 (33.2%)
9 35 (8.1%)
10 255 (58.7%)
4.0 (2.0, 7.0)
SAFE: Shoulder abduction and finger extension score; IQR: interquartile range; mRS: modified rankin scale; NIHSS: National Institute of Health
Stroke Scale.
Consent filter
Across the published data set, 440 patients did not consent
to participate despite being eligible. Only one patient in the
prospective data set did not consent.
Study sample
The median sample size of trials in the published literature
was 35.5 participants (24.0, 82.5). There were five participants
recruited to the prospective data set at the time of
analysis (Table 1).
International Journal of Stroke, 18(5)
Discussion
This study systematically investigated the trial sampling
process as a key mechanism to achieve external validity,
which has been acknowledged as an important consideration
during trial development.2,3,17 There are two key findings.
First, our synthesis of published literature suggests
that external validity is not adequately considered in upperlimb
motor recovery trials conducted early post-stroke. Just
over a third of trials did not describe their target population
in the aim and conclusion to a level consistent with
CONSORT recommendations.4 Eighty percent of trials did

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