Extraction form for project: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain

Design Details

1. Trial Name
2. What kind of study is this?
3. Month/Year Study Included
Add the month and year the study was included in the review
4. Setting
List country or continent
5. Study Design
6. Crossover Design
Is this a crossover trial?
7. Pain Population
8. Pain Condition
Add specific condition here if specified
9. Prior Cannabis Exposure
10. Age Measure (Mean, Median)
11. Age, Years
Input the mean or median age for the entire sample
12. Female %
Input the whole number here for the entire study sample - no need to add %
13. Race, White %
Add % White for entire sample and round to nearest whole number - no need to add %
14. Race, Black %
Add % Black for entire sample and round to nearest whole number - no need to add %
15. Race, Hispanic/Latino %
Add % Hispanic/Latino for entire sample and round to nearest whole number - no need to add %
16. Race, Asian %
17. Race, Other %
Add % Other Race for entire sample and round to nearest whole number - no need to add %
18. Pain Duration Measure (Mean, Median)
19. Pain Duration, Months
20. Psychiatric Comorbidity %
Add % psychiatric comorbidity for entire sample and round to nearest whole number - no need to add %. If excluded from inclusion criteria, say "Excluded"
21. Opioid Use at Baseline
Add information for opioid use at baseline.
22. N Randomized
23. N Analyzed
24. Treatment Duration, weeks
25. Assessment Time Category
26. Funding Source
27. Companion Paper

Arms

Arm NameArm Description
Medical cannabis program - patient driven choices
Treatment as usual

Arm Details

1. Dose Received, mean
Medical cannabis program - patient driven choices
Treatment as usual

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPain intensityVAS
  • All Participants
  • 3 months
ContinuousPain Distress ScaleDistress Scale
  • All Participants
  • 3 months
ContinuousFunction Pain Disability Index
  • All Participants
  • 3 months
ContinuousFunction SF-36 Functioning
  • All Participants
  • 3 months
ContinuousQuality of lifeSF-36 General Health
  • All Participants
  • 3 months
ContinuousDepression Beck Depression Inventory
  • All Participants
  • 3 months
ContinuousAnxiety Beck Anxiety Inventory
  • All Participants
  • 3 months
ContinuousSleep Quality/InterferencePittsburgh Sleep Quality Index
  • All Participants
  • 3 months
CategoricalAny Adverse Events
  • All Participants
  • 3 months

Outcome Details

1. Other Outcomes Reported (primary)
What other primary outcomes, besides: "Pain Response >= 30%", "Pain Severity (Change)", "Pain Interference (Change)", "Function/Disability (Change)".
2. Other AE Outcomes of Importance reported
3. Notes

Results

Categorical


Any Adverse Events

All Participants
Descriptive StatisticsBetween Arm Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
3 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Medical cannabis program - patient driven choicesTreatment as usual

Continuous


Pain intensity (VAS)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual
3 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual

Pain Distress Scale (Distress Scale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual
3 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual

Function (Pain Disability Index )

All Participants
Descriptive StatisticsBetween Arm Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual
3 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual

Function (SF-36 Functioning)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual
3 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual

Quality of life (SF-36 General Health)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual
3 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual

Depression (Beck Depression Inventory)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual
3 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual

Anxiety (Beck Anxiety Inventory )

All Participants
Descriptive StatisticsBetween Arm Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual
3 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual

Sleep Quality/Interference (Pittsburgh Sleep Quality Index)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual
3 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
Within Arm ComparisonsNet Comparisons
Medical cannabis program - patient driven choicesTreatment as usual
Medical cannabis program - patient driven choices
vs.
Treatment as usual

Risk of Bias Assessment

1. What kind of study is this?
Choose whether this is an RCT or an Observational Study
2. Randomization Adequate?
ROB2.0
3. Did the study attempt to enroll all (or a random sample of) patients meeting inclusion criteria (inception cohort)?
4. Allocation Concealment Adequate?
Ottawa
5. Groups similar at baseline?
6. Did the study use accurate methods for ascertaining exposures and potential confounders (i.e., age, sex, other medications)?
7. Patients masked?
8. Care provider masked?
9. Outcome assessors masked?
10. Were outcome assessors and/or data analysts blinded to the exposure being studied?
11. Intention-to-treat (ITT) analysis?
12. Did the study perform appropriate statistical analyses on potential confounders (i.e. age, sex, other medications)?
13. Acceptable levels of overall attrition?
14. Acceptable levels of differential attrition?
15. Did the article report attrition or missing data?
16. Is there important differential loss to followup or overall high loss to followup or missing data?
17. Were outcomes prespecified and defined, and ascertained using accurate methods?
18. Assessment of Bias