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Table 2 The traffic light system for progression criteria of this feasibility study to randomised controlled trial

From: A mixed-methods feasibility study of a comorbidity-adapted exercise program for low back pain in older adults (COMEBACK): a protocol

  Green Amber Red
Trial recruitment Recruitment of 24 participants with low back pain and comorbidity within 3 months Recruitment of 24 participants with low back pain and comorbidity within 3–6 months Twelve participants with low back pain and comorbidity are not recruited within 6 months
At least 75% retention of participants through follow-up At least 50% retention of participants through follow-up Less than 45% retention of participants through follow-up
Protocol adherence At least 75% of participants complete more than half of the exercise program sessions At least 50% complete more than half of the exercise program sessions Less than 45% complete more than half of the exercise program sessions
Outcome data At least 80% of participants do not find the outcomes so burdensome that they would not participate in the study again At least 70% of participants do not find the outcomes so burdensome that they would not participate in the study again Less than 70% of participants do not find the outcomes so burdensome that they would not participate in the study again
At least 80% of data is not missing due to attrition or lost to follow-up At least 50% of data is not missing due to attrition or lost to follow-up A total of 25% of data is missing due to attrition or lost to follow-up
Improvements in low back pain and function found clinically relevant by at least 50% of the participants Improvements in low back pain and function found clinically relevant by at least 25% of the participants Improvements in low back pain and function found clinically relevant by less than 25% of the participants
Improvements in quality of life and illness burden by at least 50% of the participants Improvements in quality of life and illness burden by at least 25% of the participants Improvements in quality of life and illness burden by less than 25% of the participants
No serious study-related adverse events during the study period Less than five serious study-related adverse events during the study period Five or more serious study-related adverse events during the study period
  1. Green (go), where there are no concerning issues that threaten the success of the trial; amber (amend), where there are remediable issues, thereafter proceeding with caution; red (stop), when there are intractable issues that cannot be remedied