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Table 5 Baseline characteristics of participants with and without at least 1 Social adverse event (AE)

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 Social AE

N = 208

Participants without a Social AE

N = 1410

Unadjusted ORa (95% CI), p value

Adjusted ORb (95% CI), p value

n

Median (25th to 75th centile) or %

n

Median (25th to 75th centile) or %

  

Baseline characteristic

 Maternal age (years)

208

17.6 (16.7 to 18.6)

1410

17.9 (17.0 to 18.8)

0.84 (0.74 to 0.94), 0.004

0.78 (0.67 to 0.90), 0.001

 Ethnicity

    

Overall p value = 0.189

 

  White background

190

91.3

1235

87.6

Ref

 

  Mixed background

13

6.2

76

5.4

1.07 (0.57 to 2.02), 0.834

 

  Asian background

3

1.4

24

1.7

0.59 (0.15 to 2.26), 0.439

 

  Black background

2

1.0

69

4.9

0.22 (0.05 to 0.95), 0.042

 

  Other background

0

0.0

6

0.4

–

 

 Relationship status

    

Overall p value = 0.275

 

  Married

2

1.0

18

1.3

Ref

 

  Separated

27

13.0

138

9.8

2.13 (0.44 to 10.30), 0.346

 

  Closely involved/boyfriend

156

75.0

1066

75.6

1.46 (0.32 to 6.78), 0.627

 

  Just friends

23

11.0

188

13.3

1.20 (0.24 to 5.87), 0.823

 

 Live with father of baby

  No

127

68.3

985

76.1

Ref

 

  Yes

59

31.7

309

23.8

1.32 (0.94 to 1.88), 0.113

 

  Missing

22

 

116

   

 Family subjective social status

207

5.4 (5.0 to 7.0)

1400

5.6 (5.0 to 7.0)

0.90 (0.83 to 0.99), 0.022

1.01 (0.91 to 1.12), 0.879

 Personal subjective social status

208

6.7 (5.0 to 8.0)

1403

6.9 (6.0 to 8.0)

0.92 (0.85 to 1.00), 0.041

0.96 (0.88 to 1.05), 0.386

 NEETc:

  No

89

53.9

720

59.3

Ref

 

  Yes

76

46.1

495

40.7

1.41 (1.00 to 1.98), 0.050

 

  Not applicable

43

 

195

   

 Receive any benefits

  No

112

53.8

920

65.3

Ref

Ref

  Yes

96

46.2

488

34.7

1.61 (1.19 to 2.18), 0.002

1.60 (1.09 to 2.35), 0.016

  Missing

0

 

2

   

 Ever been homeless

  No

141

67.8

1163

82.5

Ref

Ref

  Yes

67

32.2

247

17.5

2.08 (1.49 to 2.91), < 0.001

1.50 (0.99 to 2.28), 0.059

 Socio-economic status: Index of Multiple Deprivation Scored

207

39.1 (24.5 to 51.6)

1399

39.2 (25.2 to 52.1)

1.01 (1.00 to 1.02), 0.188

 

 EQ5D-Binary

  Less than perfect health

97

46.6

488

34.7

Ref

Ref

  Perfect health

111

53.4

919

65.3

0.70 (0.51 to 0.95), 0.023

0.94 (0.63 to 1.38), 0.739

  Not answered

0

 

3

   

 Self-rated health

    

Overall p value = 0.414

 

  Excellent

28

13.5

235

16.7

Ref

 

  Good

143

68.8

942

66.8

1.23 (0.79 to 1.91), 0.355

 

  Fair

32

15.4

220

15.6

1.17 (0.67 to 2.04), 0.573

 

  Poor

5

2.4

13

0.9

2.61 (0.82 to 8.27), 0.103

 

 Limiting long-term illness:

  No

160

76.9

1179

83.6

Ref

Ref

  Yes

48

23.1

231

16.4

1.38 (0.96 to 2.00), 0.086

1.17 (0.77 to 1.77), 0.460

 Generalized Self-efficacy Scalee

204

29.2 (27.0 to 32.0)

1388

30.1 (28.0 to 33.0)

0.95 (0.92 to 0.98), 0.002

 

 Adaptive functioningf

 Difficulty in at least 1 basic skill

  No

137

65.9

1048

74.5

ref

Ref

  Yes

71

34.1

359

25.5

1.70 (1.23 to 2.35), 0.001

1.36 (0.94 to 1.96), 0.103

  Missing

0

 

3

   

 Adaptive functioningf

 Had 3 or less life skills (out of 5)

  No

157

75.8

1021

72.7

Ref

 

  Yes

50

24.2

384

27.3

0.92 (0.65 to 1.31), 0.648

 

  Missing

1

 

5

   

 Adaptive functioningf

 At least 1 burden

  No

134

65.0

997

71.2

Ref

 

  Yes

72

35.0

404

28.8

1.25 (0.91 to 1.72), 0.172

 

  Missing

1

 

9

   

 Substance abuseg

199

1.6 (0.0 to 3.0)

1399

1.3 (0.0 to 2.0)

1.23 (1.02 to 1.24), 0.014

0.93 (0.83 to 1.05), 0.233

 Antisocial behaviour Score

205

3.1 (2.0 to 4.0)

1404

2.3 (1.0 to 4.0)

1.30 (1.19 to 1.42), < 0.001

1.22 (1.09 to 1.36), < 0.001

 Social support

205

81.5 (73.7 to 96.1)

1398

85.4 (77.6 to 98.7)

0.99 (0.98 to 0.996), 0.003

1.00 (0.99 to 1.01), 0.969

 Relationship quality

171

26.9 (24.0 to 31.0)

1106

28.2 (26.0 to 32.0)

0.94 (0.91 to 0.97), < 0.001

Not includedh

 Family resources

203

12.4 (9.5 to 15.0)

1348

13.5 (11.0 to 17.0)

0.93 (0.90 to 0.97), < 0.001

0.96 (0.92 to 1.00), 0.063

 Psychological distress/mental health

207

23.0 (18.0 to 27.0)

1402

21.3 (16.0 to 26.0)

1.03 (1.01 to 1.06), 0.003

1.01 (0.98 to 1.04), 0.585

 Arm

  Control

100

48.1

710

50.4

Ref

 

  Intervention

108

51.9

700

49.6

1.10 (0.81 to 1.48), 0.545

 
  1. aOR predicts a Social AE and adjusted for site; bAdjusted for site and all other candidate predictors in model; cDefinition of Not in Education, Employment, or Training (NEET): not in education employment or training status (applicable only to those whose academic age is > 16 years at baseline interview); dHigher IMD 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; h due to question only applicable to those in a relationship
  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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