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Table 5 Specific reasons for protocol deviation (n = 179)

From: Characterising deviation from treat-to-target strategies for early rheumatoid arthritis: the first three years

Reasons

Patients experiencing deviation, n (%)

Number of deviations

Total frequency (%)

Median (IQR) deviation/patient

Toxicity

   

  Gastrointestinal

46 (23.2)

80

1 (1 to 2)

  Haematological

25 (12.6)

61

2 (1 to 3)

  Central nervous system

26 (13.1)

35

1 (1 to 2)

  Abnormal liver function

18 (9.1)

28

1 (1 to 2)

  Skin and hair

13 (6.6)

16

1 (1 to 1)

  Fatigue

12 (6.1)

14

1 (1 to 1)

  Muco-cutaneous

9 (4.5)

13

1 (1 to 2)

  Other 1

8 (4.0)

9

1 (1 to 1)

Comorbidities

   

  Infection

28 (14.1)

45

1 (1 to 2)

  Other co-morbidities 2

51 (25.8)

134

2 (1 to 4)

Patient-related

   

  Poor concordance

71 (35.9)

106

1 (1 to 2)

  Reluctance to modify therapy

48 (24.2)

94

1 (1 to 3)

  Other 3

20 (10.1)

21

1 (1 to 1)

Physician-related

   

  Wait and see

50 (25.3)

95

1 (1 to 3)

  Limited option

11 (5.6)

27

1 (1 to 5)

  Persistent disease 4

14 (7.1)

15

2 (1 to 2)

  Other 5

65 (32.8)

84

1 (1 to 2)

Other 6

35 (17.7)

66 (7.3)

1 (1 to 2)

  1. 1Respiratory, cardiovascular disease, weight loss et cetera; 2other muscle-skeletal conditions such as osteoarthritis and fibromyalgia, respiratory disease, cancer and pregnancy; 3social issues such as relocation or other problems; 4deviation related to persistent disease activity was intensification when dose modification criteria were not fulfilled; 5patient in remission, risk of toxicity, risk of flare et cetera; 6awaiting laboratory results, awaiting approval of biological disease modifiying anti-rheumatic drugs (DMARDs), logistic reasons, prophylaxis for tuberculosis before initiating biological DMARDs.