Table 3.
Primary and secondary analysis overview
| Objective | Outcome | Hypothesis | Method of Analysis | |
|---|---|---|---|---|
| Name | Type | |||
| To determine if CBT reduces the prevalence of moderate to severe persistent post-surgical pain over 12 months post-fracture | Persistent post-surgical pain as defined by the WHO, and of ≥ 4/10 severity | Binary | The prevalence of persistent post-surgical pain over 12 months post-fracture will be lower in the CBT treatment group compared to the usual care group | Logistic regression |
| Secondary Objective 1 | ||||
| To determine if CBT improves physical and mental functioning over 12 months post-fracture | SF-36 PCS | Continuous | Participants receiving CBT will have higher SF-36 PCS scores over 12 months compared to participants who do not receive CBT | GEE |
| SF-36 MCS | Continuous | Participants receiving CBT will have higher SF-36 MCS scores over 12 months compared to participants who do not receive CBT | GEE | |
| Secondary Objective 2 | ||||
| To determine if CBT improves return to function over 12 months post-fracture | Return to ≥ 80% of pre-injury functioning | Binary | The proportion of participants who report ≥ 80% of pre-injury functioning will be greater in the CBT group than the usual care group over 12 months post-fracture | Logistic regression |
| Return to full function with respect to work, leisure activities, and responsibilities around the home | Binary | The proportion of participants who have returned, without limitations, to: (1) work, (2) leisure activities, and (3) responsibilities around the home will be higher among participants in the CBT group than participants in the usual care group | Logistic regression | |
| Secondary Objective 3 | ||||
| To determine if CBT reduces pain over 12 months post-fracture | BPI-SF Average Pain Severity Score | Continuous | Participants receiving CBT will have lower pain severity scores over 12 months compared to participants who do not receive CBT | GEE |
| BPI-SF Pain Interference Score | Continuous | Participants receiving CBT will have lower pain interference scores over 12 months compared to participants who do not receive CBT | GEE | |
| Secondary Objective 4 | ||||
| To determine if CBT reduces the proportion of participants prescribed opioid class medications at 6 and 12 months | Taking an opioid class medication | Binary | The proportion of participants prescribed opioids at 6 and 12 months will be lower in participants receiving the CBT compared to participants who do not receive CBT | Logistic regression |
| Amount of opioid class medication consumed | Continuous | Participants receiving CBT will be prescribed less opioids (morphine equivalent dose per day) compared to participants who do not receive CBT | GEE | |