Table 1.
Traffic light criteria
| Criteria | Traffic light criteria | ||
|---|---|---|---|
| Green light | Yellow light | Red light | |
| 1. Participant enrollment | |||
| a. Proportion of eligible patients who were missed or unable to be contacted between 2 and 12 weeks (remote enrollment/COVID) | Less than 10% were missed or unable to be contacted | 10 to 30% were missed or unable to be contacted | Greater than 30% were missed or unable to be contacted |
| b. Proportion of eligible patients who provided informed consent | Greater than 50% provided informed consent | 25 to 50% provided informed consent | Less than 25% provided informed consent |
| c. Number of participants enrolled per month | Greater than 10 participants enrolled per month | 5–10 participants enrolled per month | Less than 5 participants enrolled per month |
| 2. Acceptability of online, self-led CBT intervention to patients | |||
| a. Proportion of participants who were randomized to CBT and completed the program | Greater than 75% completed the program | 50 to 75% completed the program | Less than 50% completed the program |
| b. Proportion of CBT-arm participants who withdrew from CBT | Less than 15% withdrew from the program | 15 to 35% withdrew from the program | Greater than 35% withdrew from the program |
| 3. Compliance with the protocol | |||
| a. Proportion of randomization errors | Fewer than 5% errors | 5 to 10% errors | Greater than 10% errors |
| b. Proportion of participants who completed all required baseline activities (initial surveys, CBT registration, and assessment) | Greater than 90% completed the baseline activities | 80 to 90% completed the baseline activities | Less than 80% completed the baseline activities |
| 4. Complete follow-up | |||
| a. Proportion of participants who completed each follow-up visit with study staff | Greater than 90% complete each visit | 80 to 90% complete each visit | Less than 80% complete each visit |
| b. Proportion of participants who completed the primary outcome measure (chronic post surgical pain [CPSP]) at each follow-up visit | Greater than 90% completed the CPSP | 80 to 90% completed the CPSP | Less than 80% completed the CPSP |
| c. Overall proportion of participants who withdrew from the study | Less than 10% withdrew from the study | 10 to 30% withdrew from the study | Greater than 30% withdrew from the study |