Skip to main content

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.