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Table 3 Outcome measures for the total cohort as well as patients able (strictly personal) and unable to consent (legal representative)

From: Selection bias in clinical stroke trials depending on ability to consent

 

Total cohort

Strictly personal

Legal representative

P-value

OR (95% CI)

Discharge mRS, median (IQR)

5 (4–5)

4 (4–5)

5 (4–5)

< 0.001

MWU

Discharge BI, median (IQR)

10 (0–35)

25 (10–40)

5 (0–20)

< 0.001

MWU

Discharge location, n (%)

   

Somers‘Δ

0.094

 Home

16 (7.8)

8 (7.3)

8 (8.5)

  

 Rehabilitation hospital

164 (80.4)

92 (84.4)

71 (75.5)

  

 Other acute care hospital

17 (8.3)

8 (7.3)

9 (9.6)

  

 Nursing home

7 (3.4)

1 (0.9)

6 (6.4)

  

Death in hospital, n (%)

11 (4.8)

1 (0.8)

10 (9.3)

0.004

12.1 (1.5–96.5)

mRS at 3 months, median (IQR)

4 (3–6)

4 (3–5)

5 (4–6)

< 0.001

MWU

Any SAE, n (%)

68 (29.7)

33 (27.5)

35 (32.4)

0.469

1.3 (0.7–2.2)

During hospitalisation, n (%)

     

 Fever

152 (67.3)

69 (59.0)

83 (76.9)

0.005

2.3 (1.3–4.1)

 Delirium

19 (8.5)

8 (6.8)

11 (10.4)

0.472

1.6 (0.6–4.1)

 Leukocytosis

71 (33.6)

36 (32.1)

34 (34.7)

0.770

1.1 (0.6–2.0)

 Mechanical ventilation

24 (10.8)

11 (9.4)

13 (12.4)

0.521

1.4 (0.6–3.2)

Infection, n (%)

99 (43.6)

44 (37.3)

54 (50.0)

0.061

1.7 (1.0–2.9)

 Pneumonia

65 (28.5)

32 (26.9)

33 (30.6)

0.560

1.2 (0.7–2.1)

 Sepsis

3 (1.3)

2 (1.7)

1 (0.9)

1.0

0.5 (0.1–6.1)

 Urinary tract infection

25 (11.0)

12 (10.1)

13 (12.0)

0.676

1.2 (0.5–2.8)

 Other infection

55 (24.1)

26 (21.8)

28 (25.9)

0.533

1.3 (0.7–2.3)

  1. All p-values given are calculated using Fisher’s exact test except where explicitly stated a Mann-Whitney-U-test (MWU) or Somers’ Δ correlation; Abbreviations: mRS modified Rankin Scale, BI Barthel Index, SAE serious adverse event, PCT procalcitonin