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Table 1 Types of non-adherence

From: Biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection: statistical analysis plan for the BATCH trial and PRECISE sub-study

Non-adherence step

Reasons or examples

1. PCT results not available

Blood samples not obtained, loss of IV access, blood sample insufficient for laboratory analysis, PCT machine issues, or results not available for ward rounds

2. PCT results not considered

If a PCT result was available, protocol requires that it be considered as part of clinical decision-making

3. PCT algorithm not adhered to

3a. If the PCT result was considered, protocol does not require clinicians to follow the PCT-guided algorithm. Clinical judgement may override the PCT-guided algorithm. Therefore, non-adherence to the PCT-guided algorithm is consistent with adherence to intervention policy

3b. If the PCT result was available but not considered, clinical judgement may or may not agree with the PCT-guided algorithm. Therefore, non-adherence to the PCT-guided algorithm will also be considered independently of adherence to the intervention policy