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Table 2 Baseline neurocognitive status and psychoactive medication profiles of study groups

From: Melatonin to prevent delirium in patients with advanced cancer: a double blind, parallel, randomized, controlled, feasibility trial

Characteristic

Study Group

All patients

P value

Placebo

n = 30 (%)

Melatonin

n = 30 (%)

Total

n = 60 (%)

Highest educational level achieved

 Elementary

0 (0.0)

2 (6.7)

2 (3.3)

0.369

 Junior High School

2 (6.7)

1 (3.3)

3 (5.0)

 High School

4 (13.3)

5 (16.7)

9 (15.0)

 University / 3rd level

8 (26.7)

12 (40.0)

20 (33.3)

 Unknown

16 (53.3)

10 (33.3)

26 (43.3)

Consent obtained

 Patient

24 (80.0)

26 (86.7)

50 (83.3)

0.731

 Substitute

6 (20.0)

4 (13.3)

9 (15.0)

Dementia diagnosis documenteda

2 (6.7)

2 (6.7)

4 (6.7)

1.000

Cognitive impairment without dementia

 Documented present

2 (6.7)

2 (6.7)

4 (6.7)

0.748

 Unknown

1 (3.3)

2 (6.7)

3 (5.0)

Short Orientation Memory Concentration Test Score (SOMCT)b

2 (0–5)

3 (0–7)

2 (0–6)

0.307

Previous delirium episode

 Documented record of occurrence

7 (23.3)

6 (20.0)

13 (21.7)

0.521

 Unknown

7 (23.3)

4 (13.3)

11 (18.3)

Mood disorder diagnosis documenteda

2 (6.7)

6 (20.0)

8 (13.3)

0.357

Anxiety disorder documenteda

3 (10.0)

3 (10.0)

6 (10.0)

0.891

Recent neurocognitive symptoms (per history from patient or substitute)c

 Perceptual disturbance

3 (10.0)

3 (10.0)

6 (10.0)

0.665

 Delusional disturbance

0 (0)

0 (0)

0 (0)

0.385

 Attention problemsa

5 (16.7)

7 (23.3)

12 (20.0)

0.658

 Sleep pattern disturbeda

8 (26.7)

2 (6.7)

10 (16.7)

0.080

 Insomnia severity index (ISI) scoreb

11 (4–15)

7.5 (2–13)

9 (3–13)

0.199

Psychoactive medications at admission

 Number prescribedb

3 (1–4)

2 (1–3)

2 (1–4)

0.125

 Morphine equivalent daily dose (MEDD)bd

60 (6–90)

37.5 (4–240)

54 (4.5–132)

0.645

 Diazepam equivalent daily dosebd

0 (0)

0 (0)

0 (0)

0.931

 Prednisone equivalent daily dosebd

11 (0–40)

16.25 (0–45)

12.25 (0–40.0)

0.757

  1. aMissing data in study groups (placebo, melatonin) for categorical variables: dementia diagnosis documented (0, 1); mood disorder diagnosis documented (1, 1); anxiety disorder documented (2, 4); attention problems (4, 2); sleep disturbed (0, 1); missing data were counted as values in statistical analyses
  2. bContinuous variables expressed as median (Q1-Q3); missing data in study groups (placebo, melatonin) for continuous variables: SOMCT score (2, 3); ISI score (1, 0); psychoactive medications (1, 3); diazepam equivalent (4, 6); prednisone equivalent (0, 2)
  3. cSubsyndromal delirium features in the absence of a documented diagnosis of delirium
  4. dOral equivalent in milligrams
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BMC Palliative Care

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