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

Design Details

1. Trial Name


	NA

2. What kind of study is this?

3. Month/Year Study Included

Add the month and year the study was included in the review


	May 2021

4. Setting

List country or continent


	Canada

5. Study Design


	Matched cohort

6. Crossover Design

Is this a crossover trial?


	Yes No

7. Pain Population


	NR

8. Pain Condition

Add specific condition here if specified


	NR

9. Prior Cannabis Exposure


	NR

10. Age Measure (Mean, Median)


	Mean

11. Age, Years

Input the mean or median age for the entire sample


	52

12. Female %

Input the whole number here for the entire study sample - no need to add %


	55

13. Race, White %

Add % White for entire sample and round to nearest whole number - no need to add %


	NR

14. Race, Black %

Add % Black for entire sample and round to nearest whole number - no need to add %


	NR

15. Race, Hispanic/Latino %

Add % Hispanic/Latino for entire sample and round to nearest whole number - no need to add %


	NR

16. Race, Asian %


	NR

17. Race, Other %

Add % Other Race for entire sample and round to nearest whole number - no need to add %


	NR

18. Pain Duration Measure (Mean, Median)


	NR

19. Pain Duration, Months


	NR

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"


	NR

21. Opioid Use at Baseline

Add information for opioid use at baseline.


	NR

22. N Randomized


	10,746

23. N Analyzed


	NR

24. Treatment Duration, weeks

25. Assessment Time Category

26. Funding Source

27. Companion Paper


	None

Arms

Arm Name	Arm Description
Chronic opioid users authorized to use medical cannabis
Controls who did not receive authorization for medical cannabis

Arm Details

1. Dose Received, mean

Chronic opioid users authorized to use medical cannabis


	NR

Controls who did not receive authorization for medical cannabis


	NA

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Continuous	Opiod use	Level change after medical cannabis authorization	All Participants	Followup
Continuous	Opiod Use	Trend change after medical cannabis authorization	All Participants	Followup
Continuous	Opiod Use	Overall absolute effect after medical cannabis authorization	All Participants	Followup
Categorical	Opioid Use	Prescription opioid discontinuation	All Participants	Followup
Categorical	Adverse Events		All Participants	Followup

Outcome Details

1. Other Outcomes Reported (primary)

What other primary outcomes, besides: "Pain Response >= 30%", "Pain Severity (Change)", "Pain Interference (Change)", "Function/Disability (Change)".


	NR

2. Other AE Outcomes of Importance reported


	NR

3. Notes

Results

Categorical

Opioid Use (Prescription opioid discontinuation)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Chronic opioid users authorized to use medical cannabis	Controls who did not receive authorization for medical cannabis		All Arms (ANOVA)
Followup
	Total (N analyzed)			Odds Ratio, Adjusted (adjOR)
	Events			95% CI low (adjOR)
	Percentage			95% CI high (adjOR)
		Within Arm Comparisons			Net Comparisons
		Chronic opioid users authorized to use medical cannabis	Controls who did not receive authorization for medical cannabis		All Arms (ANOVA)

Adverse Events

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Chronic opioid users authorized to use medical cannabis	Controls who did not receive authorization for medical cannabis
Followup
	Total (N analyzed)			Mean Difference (MD)
	Events			Odds Ratio (OR)
	Percentage			95% CI low (OR)
	Note			95% CI high (OR)
				Odds Ratio, Adjusted (adjOR)
				95% CI low (adjOR)
				95% CI high (adjOR)
				p value
		Within Arm Comparisons			Net Comparisons
		Chronic opioid users authorized to use medical cannabis	Controls who did not receive authorization for medical cannabis

Continuous

Opiod use (Level change after medical cannabis authorization)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Chronic opioid users authorized to use medical cannabis	Controls who did not receive authorization for medical cannabis		Chronic opioid users authorized to use medical cannabis vs. Controls who did not receive authorization for medical cannabis
Followup
	Total (N analyzed)			Weekly OME difference
				95% CI low (MD)
				95% CI high (MD)
				p value
		Within Arm Comparisons			Net Comparisons
		Chronic opioid users authorized to use medical cannabis	Controls who did not receive authorization for medical cannabis		Chronic opioid users authorized to use medical cannabis vs. Controls who did not receive authorization for medical cannabis

Opiod Use (Trend change after medical cannabis authorization)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Chronic opioid users authorized to use medical cannabis	Controls who did not receive authorization for medical cannabis		Chronic opioid users authorized to use medical cannabis vs. Controls who did not receive authorization for medical cannabis
Followup
	Total (N analyzed)			Weekly OME difference
				95% CI low (MD)
				95% CI high (MD)
				p value
		Within Arm Comparisons			Net Comparisons
		Chronic opioid users authorized to use medical cannabis	Controls who did not receive authorization for medical cannabis		Chronic opioid users authorized to use medical cannabis vs. Controls who did not receive authorization for medical cannabis

Opiod Use (Overall absolute effect after medical cannabis authorization)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Chronic opioid users authorized to use medical cannabis	Controls who did not receive authorization for medical cannabis		Chronic opioid users authorized to use medical cannabis vs. Controls who did not receive authorization for medical cannabis
Followup
	Total (N analyzed)			Weekly OME difference
				95% CI low (MD)
				95% CI high (MD)
				p value
		Within Arm Comparisons			Net Comparisons
		Chronic opioid users authorized to use medical cannabis	Controls who did not receive authorization for medical cannabis		Chronic opioid users authorized to use medical cannabis vs. Controls who did not receive authorization for medical cannabis

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?


	Yes

6. Did the study use accurate methods for ascertaining exposures and potential confounders (i.e., age, sex, other medications)?

7. Patients masked?


	Unclear

8. Care provider masked?


	Unclear

9. Outcome assessors masked?


	Unclear

10. Were outcome assessors and/or data analysts blinded to the exposure being studied?

11. Intention-to-treat (ITT) analysis?


	Unclear

12. Did the study perform appropriate statistical analyses on potential confounders (i.e. age, sex, other medications)?

13. Acceptable levels of overall attrition?


	Not reported

14. Acceptable levels of differential attrition?


	Not reported

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?


	No

17. Were outcomes prespecified and defined, and ascertained using accurate methods?

18. Assessment of Bias

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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

4. Setting

5. Study Design

6. Crossover Design

7. Pain Population

8. Pain Condition

9. Prior Cannabis Exposure

10. Age Measure (Mean, Median)

11. Age, Years

12. Female %

13. Race, White %

14. Race, Black %

15. Race, Hispanic/Latino %

16. Race, Asian %

17. Race, Other %

18. Pain Duration Measure (Mean, Median)

19. Pain Duration, Months

20. Psychiatric Comorbidity %

21. 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 Details

1. Dose Received, mean

Chronic opioid users authorized to use medical cannabis

Controls who did not receive authorization for medical cannabis

Outcomes

Outcome Details

1. Other Outcomes Reported (primary)

2. Other AE Outcomes of Importance reported

3. Notes

Results

Categorical

Opioid Use (Prescription opioid discontinuation)

Adverse Events

Continuous

Opiod use (Level change after medical cannabis authorization)

Opiod Use (Trend change after medical cannabis authorization)

Opiod Use (Overall absolute effect after medical cannabis authorization)

Risk of Bias Assessment

1. What kind of study is this?

2. Randomization Adequate?

3. Did the study attempt to enroll all (or a random sample of) patients meeting inclusion criteria (inception cohort)?

4. Allocation Concealment Adequate?

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

Resources
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Usage

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