Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Changes in Opioid Use |
Changes in opioid use will be measured using milligram morphine equivalents per day. This will be collected every two weeks throughout the 36-week study period. |
Every 2 weeks for 36 weeks |
|
| Primary |
Changes in Pain Severity: Pain Severity Scale of the Brief Pain Inventory (BPI) |
Changes in pain severity will be measured using the Pain Severity Scale of the Brief Pain Inventory (BPI), which asks about the participant's pain at its worst, at its best, on overage and right now. It uses an 11-point scale ranging from 0 to 10, where 0 indicates no pain at all and 10 indicates the worst pain imaginable. The mean severity of all four individual scores will be used for the main analysis (total of all four scores divided by four). Pain severity will be assessed every two weeks, measuring the change across the course of the study. |
Every 2 weeks for 36 weeks |
|
| Primary |
Changes in Pain Interference: Pain Interference Scale of the Brief Pain Inventory (BPI) |
Changes in pain interference will be measured with the Pain Interference Scale of the Brief Pain Inventory (BPI), which uses an 11-point scale to measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. On the scale, 0 indicates that pain has not interfered with the activity at all and 10 indicates that pain has completely interfered with the activity. BPI Pain Interference will scored as the mean of the scores on seven interference items (total of all seven scores divided by seven). Pain interference will be assessed every two weeks, measuring the change across the course of the study. |
Every 2 weeks for 36 weeks |
|
| Primary |
Occurrence of Adverse Events |
Occurrence adverse events over a 36 week period will be recorded using an adverse events questionnaire that is consistent with reporting guidelines and asks: 1) if the patient has experienced any events as a result of any of the treatments received (yes/no); 2) what adverse events were experienced (choose from a drop-down list or 'other'); 3) how long the event lasted (hours or days); 4) How severe the adverse event was (0-10 scale, where 0 indicates not severe at all and 10 indicates very severe). Each occurrence (the type of adverse event and duration and severity) will be recorded individually for reporting purposes as well as descriptive purposes. |
Every 2 weeks for 36 weeks |
|
| Secondary |
Adverse Childhood Experiences (ACE) Questionnaire |
The Adverse Childhood Experiences (ACE) Questionnaire will be used to identify adverse childhood experiences. It has shown good reliability and predictive validity. Several studies have demonstrated its ability to predict the onset of chronic pain in adults and it has been shown to be associated with initiation of opioid use, opioid dependence, opioid misuse, and likelihood of experiencing an opioid overdose. The questionnaire has 10 questions about various stressful childhood experiences. For each question an answer of No = 0 and and answer of Yes = 1. The total score out of 10 possible points will be used. This questionnaire will be administered only once at baseline. |
Baseline |
|
| Secondary |
9-item Patient Health Questionnaire (PHQ-9) |
The PHQ-9 demonstrates good reliability and validity and will be used to screen for depression using a cut-score of 10 points as has been suggested in the literature. The PHQ-9 has 9 questions, which all start with, "Over the past two weeks, how often have you been bothered by the following problem...:" The participant answers each one on a four-point Likert Scale, where 0 indicates not bothered at all and 3 indicates bothered nearly every day. The total score out of a possible 27 points will be used. This questionnaire will be administered only once at baseline to describe the population. |
Baseline |
|
| Secondary |
Post-traumatic Stress Disorder (PTSD) Checklist - Civilian Version |
The PTSD Checklist - Civilian Version will be used to identify the presence and severity of post-traumatic stress symptoms. The checklist has 17 questions. The instructions begin with: "Below is a list of problems and complaints that people sometimes have in response to stressful life experiences. Please read each one carefully, then pick the answer that indicates how much you have been bothered by that problem in the last month." The answers are on a five-point scale, where 1 indicates not bothered at all and 5 indicates extremely bothered. The total severity score out of a possible 85 points will be used. A score range of 17-29 shows little to no severity; a score range of 28-29 shows some PTSD symptoms; a score range of 30-44 shows moderate to moderately high severity of PTSD symptoms; and a score range of 45-85 shows high severity of PTSD symptoms. This questionnaire will be administered only once at baseline to describe the population |
Baseline |
|
| Secondary |
Health-related Quality of Life: EuroQOL-5D (EQ-5D-5L) |
Health-related quality of life will be measured with the EuroQOL-5D (EQ-5D-5L). This questionnaire has two parts: the first is the 5-question 'descriptive system', which asks respondents to 'select the ONE statement that BEST describes your health TODAY' for 5 health dimensions: mobility, self care, usual activities, pain/discomfort, anxiety/depression. The 5 statements for each dimension are "no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5)". The 5 answers form a 5-digit code describing the respondent's 'health state'. Eg. the health state '12345' indicates no problems with mobility, slight problems with washing/dressing, moderate problems with usual activities, severe pain or discomfort and extreme anxiety or depression.
The second part asks respondents to rate their global health today on a visual analogue scale from 0-100, where 100 means the best health imaginable and 0 means the worst health imaginable. |
Baseline |
|
| Secondary |
Change in patient specific functional scale (PSFS) |
Changes in function will be measured with the Patient-Specific Functional Scale. Participants are asked to identify three important activities that they are having difficulty doing or are unable to do as a result of their primary condition. For each activity, they are asked to use an 11-point scale to rate their difficulty, where 0 indicates they are able to perform activity at the same level as before the injury or problem (No issues) and 10 indicates they are unable to perform activity (Cannot perform). The mean score will be used (sum of the activity scores divided by the number of activities). Minimum detectable change (90%CI) for average score = 2 points. The same activities will be rated at baseline, 12 weeks and 36 weeks, and the changes in mean scores between time points will be recorded. |
Baseline, 12 weeks, 36 weeks |
|
| Secondary |
Global Rating of Change in function (12-weeks) |
Changes in Global Rating of Change in Functional Abilities will be measured using an 11-point scale ranging from -5 (much worse) to +5 (completely recovered) as has been recommended in the literature for self-reported rating of change. This will be measured at 12 weeks and 36 weeks, recording the change across time points. |
12-weeks |
|
| Secondary |
Global Rating of Change in function (36-weeks) |
Changes in Global Rating of Change in Functional Abilities will be measured using an 11-point scale ranging from -5 (much worse) to +5 (completely recovered) as has been recommended in the literature for self-reported rating of change. This will be measured at 12 weeks and 36 weeks, recording the change across time points. |
36 weeks |
|
| Secondary |
Goal Attainment Scale (12-weeks) |
Changes in the attainment of three stated functional goals will be measured using the Goal Attainment Scale. This is a 5-point scale, used to assess attainment of individual goals, ranging from -2 to +2, where -2 indicates a level of attainment much less than expected, 0 indicates the expected level of attainment, and +2 indicates a level of attainment much more than expected. The mean score will be used (sum of the attainment scores divided by the number of attainment scores). The goals will be identified at baseline and goal attainment will be measured at 12 weeks and 36 weeks. |
12-weeks |
|
| Secondary |
Goal Attainment Scale (36-weeks) |
Changes in the attainment of three stated functional goals will be measured using the Goal Attainment Scale. This is a 5-point scale, used to assess attainment of individual goals, ranging from -2 to +2, where -2 indicates a level of attainment much less than expected, 0 indicates the expected level of attainment, and +2 indicates a level of attainment much more than expected. The mean score will be used (sum of the attainment scores divided by the number of attainment scores). The goals will be identified at baseline and goal attainment will be measured at 12 weeks and 36 weeks. |
12-weeks and 36 weeks |
|
| Secondary |
Satisfaction with care (12-weeks): 11-point scale |
Satisfaction with Care will be measured using an 11-point scale ranging from -5 (very dissatisfied) to +5 (very satisfied) as has been recommended in the literature for self-reported rating of change. This will be measured this at 12 weeks and 36 weeks. |
12-weeks |
|
| Secondary |
Satisfaction with care (36-weeks): 11-point scale |
Satisfaction with Care will be measured using an 11-point scale ranging from -5 (very dissatisfied) to +5 (very satisfied) as has been recommended in the literature for self-reported rating of change. We will measure this at 12 weeks and 36 weeks. |
36-weeks |
|
