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Table 2 Revise consent scenarios

From: Protocol implementation during the COVID-19 pandemic: experiences from a randomized trial of stress ulcer prophylaxis

 

Pre-Pandemic

N = 320

Pandemic

N = 3022

Total

N = 3342

Patient consented

45 (14.1)

579 (19.2)

624 (18.7)

Substitute Decision Maker consented

197 (61.6)

1744 (57.7)

1941 (58.1)

Other consented

0 (0.0)

8 (0.3)

8 (0.2)

Opt out Model was used (no Patient or Substitute Decision Maker opted out)

Not applicable

36 (1.2)

36 (1.1)

Patient declined

2 (0.6)

13 (0.4)

15 (0.4)

Substitute Decision Maker declined

56 (17.5)

399 (13.2)

455 (13.6)

No consent encounter – Patient lacked capacity to consent, no Substitute Decision Maker

7 (2.2)

86 (2.8)

93 (2.8)

No consent encounter – Patient died, never had capacity to consent, no Substitute Decision Maker

10 (3.1)

154 (5.1)

164 (4.9)

No consent encounter – Other circumstances

3 (0.9)

3 (0.1)

6 (0.2)

  1. This table shows consent scenarios pre-pandemic and during the pandemic. We defined pre-pandemic as up to and including March 10th, 2020. We defined pandemic as from March 11th up to August 31st, 2022. This analysis includes 2952 patients enrolled, plus 390 patients with a priori consent declined for a total of 3342 patients