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Table 6 Baseline characteristics of participants subsequently with and without at least 1 Medical adverse event (AE) or serious adverse event (SAE)

From: Monitoring adverse social and medical events in public health trials: assessing predictors and interpretation against a proposed model of adverse event reporting

 

At least 1 Medical SAE/AE

N = 532

Participants without a Medical SAE/AE

N = 1086

Unadjusted ORa (95% CI), p value

Adjusted ORb (95% CI), p value

Baseline characteristic

n

Median (25th to 75th centile) or %

n

Median (25th to 75th centile) or %

  

Maternal age (years)

532

17.9 (16.9 to 18.9)

1086

17.8 (16.9 to 18.8)

1.05 (0.97 to 1.15), 0.226

 

Ethnicity

    

Overall p value = 0.240

 

 White background

473

88.9

952

87.7

Ref

 

 Mixed background

34

6.4

55

5.1

1.45 (0.90 to 2.36), 0.130

 

 Asian background

12

2.3

15

1.4

1.69 (0.68 to 4.22), 0.259

 

 Black background

11

2.1

60

5.5

0.65 (0.30 to 1.39), 0.265

 

 Other background

2

0.4

4

0.4

1.59 (0.27 to 9.45), 0.609

 

Relationship status

    

Overall p value = 0.847

 

 Married

8

1.5

12

1.1

Ref

 

 Separated

51

9.6

114

10.5

0.73 (0.26 to 2.06), 0.557

 

 Closely involved/boyfriend

407

76.5

815

75.0

0.67 (0.32 to 1.80), 0.426

 

 Just friends

66

12.4

145

13.4

0.67 (0.24 to 1.88), 0.448

 

Live with father of baby

 No

349

71.8

763

76.8

Ref

 

 Yes

137

28.2

231

23.2

1.16 (0.88 to 1.52), 0.285

 

 Missing

46

 

92

   

Family subjective social status

527

5.7 (5.0 to 7.0)

1080

5.7 (5.0 to 7.0)

1.00 (0.93 to 1.07), 0.916

 

Personal subjective social status

529

6.8 (6.0 to 8.0)

1082

6.9 (6.0 to 8.0)

0.98 (0.92 to 1.04), 0.439

 

NEETc

 No

279

61.0

530

57.4

ref

 

 Yes

178

39.0

393

42.6

0.98 (0.76 to 1.26), 0.869

 

 Not applicable

75

 

163

   

Receive any welfare benefits

 No

346

65.0

686

63.3

Ref

 

 Yes

186

35.0

398

36.7

1.02 (0.81 to 1.30), 0.848

 

 Missing

0

 

2

   

Ever been homeless

 No

419

78.8

885

81.5

Ref

 

 Yes

113

21.2

201

18.5

1.24 (0.93 to 1.64), 0.146

 

Socio-economic status: Index of Multiple Deprivation Scored

528

39.1 (25.9 to 51.3)

1078

39.2 (24.8 to 52.6)

1.01 (0.99 to 1.01), 0.078

1.01 (0.998 to 1.01), 0.106

EQ5D-Binary

 Less than perfect health

220

41.4

365

33.7

Ref

Ref

 Perfect health

312

58.6

718

66.3

0.73 (0.58 to 0.93), 0.012

0.98 (0.74 to 1.29), 0.881

 Not answered

0

 

3

   

Self-rated health

    

Overall p-value = 0.141

 

 Excellent

86

6.2

177

16.3

Ref

 

 Good

345

64.8

740

68.1

1.00 (0.73 to 1.36), 0.985

 

 Fair

92

17.3

160

14.7

1.20 (0.81 to 1.79), 0.359

 

 Poor

9

1.7

9

0.8

2.84 (1.02 to 7.95), 0.046

 

Limiting long-term illness:

 No

416

78.2

923

85.0

Ref

ref

 Yes

116

21.8

163

15.0

1.53 (1.14 to 2.06), 0.005

1.37 (1.01 to 1.88), 0.046

Generalized Self-efficacy Scalee

526

30.0 (27.0 to 33.0)

1066

30.0 (28.0 to 33.0)

1.00 (0.97 to 1.02), 0.869

 

Adaptive functioningf

Difficulty in at least 1 basic skill

 No

372

70.3

813

74.9

ref

Ref

 Yes

157

29.7

273

25.1

1.38 (1.07 to 1.78), 0.013

1.18 (0.91 to 1.54), 0.219

 Missing

3

 

0

   

Adaptive functioningf

Had 3 or less life skills (out of 5)

 No

387

72.9

791

73.2

ref

 

 Yes

144

27.1

290

26.8

1.11 (0.87 to 1.43), 0.404

 

 Missing

1

 

5

   

Adaptive functioningf

At least 1 burden

 No

354

67.0

777

72.0

Ref

Ref

 Yes

174

33.0

302

28.0

1.26 (0.98 to 1.61), 0.069

1.09 (0.84 to 1.41), 0.543

 Missing

3

 

7

   

Substance abuseg

513

1.3 (0.0 to 2.0)

1025

1.4 (0.0 to 2.0)

0.98 (0.91 to 1.06), 0.612

 

Antisocial behaviour Score

528

2.4 (1.0 to 4.0)

1081

2.4 (1.0 to 4.0)

1.06 (0.99 to 1.13), 0.089

1.01 (0.95 to1.09), 0.689

Social support

526

85.1 (77.6 to 98.7)

1077

84.8 (77.6 to 98.7)

1.00 (0.99 to 1.01), 0.784

 

Relationship quality

428

28.4 (26.0 to 32.0)

849

28.8 (25.0 to 31.0)

1.00 (0.98 to 1.03), 0.825

 

Family resources

510

13.3 (11.0 to 16.0)

1041

13.4 (11.0 to 17.0)

0.98 (0.95 to 1.01), 0.145

 

Psychological distress/mental health

529

22.4 (17.0 to 27.0)

1080

21.1 (16.0 to 25.0)

1.04 (1.02 to 1.06), < 0.001

1.03 (1.01 to 1.05), 0.004

Arm

 Control

243

45.7

567

52.2

Ref

Ref

 Intervention

289

54.3

519

47.8

1.32 (1.05 to 1.65), 0.016

1.34 (1.07 to 1.70), 0.012

  1. aOR predicts a Social AE and adjusted for site; bAdjusted for site and all other candidate predictors in model; cDefinition of NEET: Not in Education Employment or Training Status (applicable only to those whose academic age is > 16 years at baseline interview); dHigher IMD: Index of Multiple Deprivation score indicated more deprivation; eHigher score indicates higher level of self-efficacy; fHigher score indicates better management of day-to-day lives and routines (for each of the three sub-scales); gCRAFFT screening test for substance-related risks and problems in adolescents;
  2. Odds ratios (ORs) bolded and in italics indicate variable significant at 10% at univariable level and remained so at multivariable level
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