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


	November 2020

4. Setting

List country or continent


	Canada

5. Study Design


	Prospective cohort

6. Crossover Design

Is this a crossover trial?


	Yes No

7. Pain Population


	NPP

8. Pain Condition

Add specific condition here if specified


	Mixed

9. Prior Cannabis Exposure


	NR

10. Age Measure (Mean, Median)


	Mean

11. Age, Years

Input the mean or median age for the entire sample


	61

12. Female %

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


	59

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


	156

23. N Analyzed


	NR (not in the DA)

24. Treatment Duration, weeks

25. Assessment Time Category

26. Funding Source

27. Companion Paper


	None

Arms

Arm Name	Arm Description
Nabilone monotherapy
Gabapentin
Gabapentin + Nabilone

Arm Details

1. Dose Received, mean

Nabilone monotherapy


	1.96 mg/d

Gabapentin


	1,684.6 mg/d

Gabapentin + Nabilone


	NR + 1.75 mg/d

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Continuous	Pain intensity	VAS, 0 to 100 scale	All Participants	3 months
Continuous	Absolute improvement in VAS since initiation	VAS	All Participants	6 months Initiation
Continuous	Brief Pain Index	Pain Interference 0 to 10 scale	All Participants	3 months 6 months
Continuous	Functional Outcomes	SF-36 Physical Functioning,0 to 100 scale at 6 months	All Participants	6 months
Continuous	Quality of Life Outcomes	EQ-5D, VAS 0 to 100 at 6 months	All Participants	6 months
Continuous	Anxiety and Depression Outcomes	Hospital Anxiety and Depression Scale total score, scale unclear	All Participants	6 months
Continuous	Sleep Outcomes	Medical Outcomes Study Sleep Scale, 12 to 71 scale	All Participants	6 months
Categorical	Adverse Events	Any adverse event	All Participants	3 months 6 months
Categorical	Adverse Events	Sedation	All Participants	3 months 6 months
Categorical	Adverse Events	Dizziness	All Participants	3 months 6 months
Categorical	Adverse Events	Withdrawals due to adverse events	All Participants	6 months
Categorical	Adverse event	Serious adverse events	All Participants	6 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)".


	Individual SF-36 domains; Individual depression and anxiety domains for HADS; BPI Pain Severity; EQ-5D index score

2. Other AE Outcomes of Importance reported


	NR

3. Notes

Results

Categorical

Adverse Events (Any adverse event )

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone
3 months
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
					p value
6 months
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
					p value
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone

Adverse Events (Sedation)

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone
3 months
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
					p value
6 months
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
					p value
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone

Adverse Events (Dizziness )

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone
3 months
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
					p value
6 months
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
					p value
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone

Adverse Events (Withdrawals due to adverse events)

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone
6 months
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
					p value
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone

Adverse event (Serious adverse events)

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone
6 months
	Total (N analyzed)				Odds Ratio (OR)
	Events				95% CI low (OR)
	Percentage				95% CI high (OR)
					p value
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone

Continuous

Brief Pain Index (Pain Interference 0 to 10 scale)

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone
3 months
	Mean				Mean Difference (MD)
	SD				95% CI low (MD)
					95% CI high (MD)
6 months
	Mean				Mean Difference (MD)
	SD				95% CI low (MD)
					95% CI high (MD)
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone

Functional Outcomes (SF-36 Physical Functioning,0 to 100 scale at 6 months)

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone
6 months
	Mean				Mean Difference (MD)
	SD				95% CI low (MD)
					95% CI high (MD)
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone

Quality of Life Outcomes (EQ-5D, VAS 0 to 100 at 6 months)

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone
6 months
	Mean				Mean Difference (MD)
	SD				95% CI low (MD)
					95% CI high (MD)
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone

Anxiety and Depression Outcomes (Hospital Anxiety and Depression Scale total score, scale unclear )

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone
6 months
	Mean				Mean Difference (MD)
	SD				95% CI low (MD)
					95% CI high (MD)
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone

Sleep Outcomes (Medical Outcomes Study Sleep Scale, 12 to 71 scale)

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone
6 months
	Mean				Mean Difference (MD)
	SD				95% CI low (MD)
					95% CI high (MD)
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone

Pain intensity ( VAS, 0 to 100 scale)

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone
3 months
	Mean				Mean Difference (MD)
	SD				95% CI low (MD)
					95% CI high (MD)
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone

Absolute improvement in VAS since initiation (VAS)

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone
6 months
	Mean				Mean Difference (MD)
	SD				95% CI low (MD)
					95% CI high (MD)
Initiation
	Mean				Mean Difference (MD)
	SD				95% CI low (MD)
					95% CI high (MD)
		Within Arm Comparisons				Net Comparisons
		Nabilone monotherapy	Gabapentin	Gabapentin + Nabilone		Nabilone monotherapy vs. Gabapentin	Nabilone monotherapy vs. Gabapentin + Nabilone

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?


	No

8. Care provider masked?


	No

9. Outcome assessors masked?


	No

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?


	Unclear

14. Acceptable levels of differential attrition?


	Unclear

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?


	Yes/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

Nabilone monotherapy

Gabapentin

Gabapentin + Nabilone

Outcomes

Outcome Details

1. Other Outcomes Reported (primary)

2. Other AE Outcomes of Importance reported

3. Notes

Results

Categorical

Adverse Events (Any adverse event )

Adverse Events (Sedation)

Adverse Events (Dizziness )

Adverse Events (Withdrawals due to adverse events)

Adverse event (Serious adverse events)

Continuous

Brief Pain Index (Pain Interference 0 to 10 scale)

Functional Outcomes (SF-36 Physical Functioning,0 to 100 scale at 6 months)

Quality of Life Outcomes (EQ-5D, VAS 0 to 100 at 6 months)

Anxiety and Depression Outcomes (Hospital Anxiety and Depression Scale total score, scale unclear )

Sleep Outcomes (Medical Outcomes Study Sleep Scale, 12 to 71 scale)

Pain intensity ( VAS, 0 to 100 scale)

Absolute improvement in VAS since initiation (VAS)

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
Cite
Usage

Contact
About
Contact