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?
Single Choice
RCT
Observational
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?
Single Choice
Yes
No
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
Single Choice
Short term (1 to <6 months)
Intermediate term (6 to <12 months)
Long term (≥1 year)
26. Funding Source
Single Choice
Industry
Government
Nonprofit
Mixed
Other
None
27. Companion Paper

Arm Details

1. Dose Received, mean
Interventions and Comparisons:

Outcome Details

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

Risk of Bias Assessment

1. What kind of study is this?
Choose whether this is an RCT or an Observational Study
Pain Response >= 30%:
Single Choice
RCT
Observational
2. Randomization Adequate?
ROB2.0
Dependency
  • Question Position: 1
    • - Option: RCT
    Pain Response >= 30%:
    3. Did the study attempt to enroll all (or a random sample of) patients meeting inclusion criteria (inception cohort)?
    Dependency
  • Question Position: 1
    • - Option: Observational
    Pain Response >= 30%:
    Single Choice
    Yes
    No
    Unclear
    4. Allocation Concealment Adequate?
    Ottawa
    Dependency
  • Question Position: 1
    • - Option: RCT
    Pain Response >= 30%:
    5. Groups similar at baseline?
    Pain Response >= 30%:
    6. Did the study use accurate methods for ascertaining exposures and potential confounders (i.e., age, sex, other medications)?
    Dependency
  • Question Position: 1
    • - Option: Observational
    Pain Response >= 30%:
    Single Choice
    Yes
    No
    Unclear
    7. Patients masked?
    Dependency
  • Question Position: 1
    • - Option: RCT
    Pain Response >= 30%:
    8. Care provider masked?
    Dependency
  • Question Position: 1
    • - Option: RCT
    Pain Response >= 30%:
    9. Outcome assessors masked?
    Dependency
  • Question Position: 1
    • - Option: RCT
    Pain Response >= 30%:
    10. Were outcome assessors and/or data analysts blinded to the exposure being studied?
    Dependency
  • Question Position: 1
    • - Option: Observational
    Pain Response >= 30%:
    Single Choice
    Yes
    No
    Unclear
    11. Intention-to-treat (ITT) analysis?
    Dependency
  • Question Position: 1
    • - Option: RCT
    Pain Response >= 30%:
    12. Did the study perform appropriate statistical analyses on potential confounders (i.e. age, sex, other medications)?
    Dependency
  • Question Position: 1
    • - Option: Observational
    Pain Response >= 30%:
    Single Choice
    Yes
    No
    Unclear
    13. Acceptable levels of overall attrition?
    Dependency
  • Question Position: 1
    • - Option: RCT
    Pain Response >= 30%:
    14. Acceptable levels of differential attrition?
    Dependency
  • Question Position: 1
    • - Option: RCT
    Pain Response >= 30%:
    15. Did the article report attrition or missing data?
    Dependency
  • Question Position: 1
    • - Option: Observational
    Pain Response >= 30%:
    Single Choice
    Yes
    No
    Unclear
    16. Is there important differential loss to followup or overall high loss to followup or missing data?
    Dependency
  • Question Position: 1
    • - Option: Observational
    Pain Response >= 30%:
    17. Were outcomes prespecified and defined, and ascertained using accurate methods?
    Dependency
  • Question Position: 1
    • - Option: Observational
    Pain Response >= 30%:
    Single Choice
    Yes
    No
    Unclear
    18. Assessment of Bias
    Pain Response >= 30%:
    Single Choice
    Low
    Moderate
    High

    Suggested Arms

    NameDescription
    Interventions and ComparisonsAdd labels for the interventions and comparisons (currently found in columns for Intervention A, Intervention B, Intervention C, Intervention D). For THC or CBD studies, list the ratio category in the Name field for the intervention (i.e., High-THC, Comparable THC, Low-THC). For other interventions list the specific cannabinoid (e.g., CBDV) or plant-based substance. Add other details (titration, etc.) into the Description field. Most studies in this review only have two interventions (A & B) - not necessary to add additional arms if not part of the study.
    Total All Arms combined

    Please see downloadable data for more

    Suggested Outcomes

    TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)
    CategoricalAny Adverse Events
    CategoricalCognitive deficits
    CategoricalCUD
    CategoricalDizziness
    CategoricalNausea
    CategoricalPain Response >= 30%
    CategoricalPsychosis
    CategoricalSedation
    CategoricalSerious Adverse Events
    CategoricalWithdrawal Due to Adverse Events
    ContinuousAnxiety (Change)
    ContinuousDepression (Change)
    ContinuousFunction / Disability (Change)
    ContinuousOpioid Use
    ContinuousPain Interference (Change)
    ContinuousPain Severity (Change)
    ContinuousQuality of Life
    ContinuousSleep Quality/Interference

    Please see downloadable data for more