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Table 6 Type of protocol deviation

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

Type Number of deviations Total P -value #
Criteria-based DAS28-based
Continued rather than escalating     
Toxicity 33 26 59
Patient-related 92 63 155
Physician-related 83 60 143
Comorbidity 79 42 121
Other* 42 17 59
Total, n (%) 329 (58.1) 208 (63.0) 537 (59.9) 0.005
Tapered rather than continuing/escalating     
Toxicity 31 22 53
Patient-related 25 13 38
Physician-related 11 12 23
Comorbidity 4 3 7
Other* 1 0 2
Total, n (%) 72 (12.7) 50(15.2) 122 (13.6) 0.077
Discontinued rather than continuing/escalating     
Toxicity 68 28 96
Patient-related 20 5 25
Physician-related 0 0 0
Comorbidity 37 14 51
Other 0 0 0 0.076
Total, n (%) 125 (22.1) 47 (14.2) 172 (19.2)  
Dose escalated rather than continuing     
Toxicity 0 0 0
Patient-related 2 0 2
Physician-related 29 20 49
Comorbidity 0 0 0
Other* 2 1 3
Total, n (%) 33 (5.8) 21 (6.4) 54 (6.1) 0.402
Other**     
Toxicity 1 0 1
Patient-related 0 1 1
Physician-related 3 3 6
Comorbidity 0 0 0
Other* 3 0 3
Total, n (%) 7 (1.3) 4 (1.2) 11 (1.2) 0.843
Total deviation 566 330 896 0.016
  1. *Examples of other type of protocol violation include awaiting laboratory results, awaiting approval of biological disease modifying anti-rheumatic drugs, prophylaxis for latent tuberculosis before initiating biologics, and other logistic reasons or unknown reason. #Statistical tests based on the chi-square test compared the frequency of responses (clinic visits with deviation versus no deviation) between patient groups due to specific types of deviation. **Unknown, addition of very high unusual dose or intensification of two or more drugs at a time, intensifying instead of tapering/discontinuing.