Skip to main content

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