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


	August 2021

4. Setting

List country or continent


	U.S.

5. Study Design


	Prospective cohort

6. Crossover Design

Is this a crossover trial?


	Yes No

7. Pain Population


	NR

8. Pain Condition

Add specific condition here if specified


	Chronic non-cancer pain (HIV)

9. Prior Cannabis Exposure


	NR

10. Age Measure (Mean, Median)


	NR

11. Age, Years

Input the mean or median age for the entire sample


	Age ≥ 50: 237 (55%)

12. Female %

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


	28

13. Race, White %

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


	46

14. Race, Black %

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


	45

15. Race, Hispanic/Latino %

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


	7

16. Race, Asian %


	NR

17. Race, Other %

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


	9

18. Pain Duration Measure (Mean, Median)


	At least moderate pain (per the Brief Chronic Pain Questionnaire) for at least 3 months

19. Pain Duration, Months


	At least moderate pain (per the Brief Chronic Pain Questionnaire) for at least 3 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"


	NR

21. Opioid Use at Baseline

Add information for opioid use at baseline.


	NR

22. N Randomized


	433

23. N Analyzed


	NR

24. Treatment Duration, weeks

25. Assessment Time Category

26. Funding Source

27. Companion Paper


	None

Arms

Arm Name	Arm Description
Daily or weekly use of marijuana
Monthly or 1-2 times a month use of marijuana
No use

Arm Details

1. Dose Received, mean

Daily or weekly use of marijuana


	NR

Monthly or 1-2 times a month use of marijuana


	NR

No use


	NA

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Categorical	Opiod use	Opioid initiation A vs. C	Participants A vs. C	Baseline
Categorical	Opiod use	Opiod initiation B vs. C	Participants B vs. C	Baseline
Categorical	Opiod use	Opioid discontinuation A vs. C	Participants A vs. C	Followup
Categorical	Opiod use	Opioid discontinuation B vs. C	Participants B vs. C	Baseline
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

Opiod use (Opioid initiation A vs. C)

Participants A vs. C
		Descriptive Statistics				Between Arm Comparisons
		Daily or weekly use of marijuana	Monthly or 1-2 times a month use of marijuana	No use		All Arms (ANOVA)
Baseline
	Total (N analyzed)				Odds Ratio, Adjusted (adjOR)
					95% CI low (adjOR)
					95% CI high (adjOR)
		Within Arm Comparisons				Net Comparisons
		Daily or weekly use of marijuana	Monthly or 1-2 times a month use of marijuana	No use		All Arms (ANOVA)

Opiod use (Opioid discontinuation A vs. C)

Participants A vs. C
		Descriptive Statistics				Between Arm Comparisons
		Daily or weekly use of marijuana	Monthly or 1-2 times a month use of marijuana	No use		Daily or weekly use of marijuana vs. No use
Followup
	Total (N analyzed)				Odds Ratio, Adjusted (adjOR)
					95% CI low (adjOR)
					95% CI high (adjOR)
		Within Arm Comparisons				Net Comparisons
		Daily or weekly use of marijuana	Monthly or 1-2 times a month use of marijuana	No use		Daily or weekly use of marijuana vs. No use

Adverse Events

All Participants
		Descriptive Statistics				Between Arm Comparisons
		Daily or weekly use of marijuana	Monthly or 1-2 times a month use of marijuana	No use
Followup
	Total (N analyzed)				95% CI low (MD)
	Events				95% CI high (MD)
	Percentage				Odds Ratio (OR)
					95% CI low (OR)
					95% CI high (OR)
					Odds Ratio, Adjusted (adjOR)
					95% CI low (adjOR)
					95% CI high (adjOR)
					p value
		Within Arm Comparisons				Net Comparisons
		Daily or weekly use of marijuana	Monthly or 1-2 times a month use of marijuana	No use

Opiod use (Opiod initiation B vs. C)

Participants B vs. C
		Descriptive Statistics				Between Arm Comparisons
		Daily or weekly use of marijuana	Monthly or 1-2 times a month use of marijuana	No use		All Arms (ANOVA)
Baseline
	Total (N analyzed)				Odds Ratio, Adjusted (adjOR)
					95% CI low (adjOR)
					95% CI high (adjOR)
		Within Arm Comparisons				Net Comparisons
		Daily or weekly use of marijuana	Monthly or 1-2 times a month use of marijuana	No use		All Arms (ANOVA)

Opiod use (Opioid discontinuation B vs. C )

Participants B vs. C
		Descriptive Statistics				Between Arm Comparisons
		Daily or weekly use of marijuana	Monthly or 1-2 times a month use of marijuana	No use		All Arms (ANOVA)
Baseline
	Total (N analyzed)				Odds Ratio, Adjusted (adjOR)
					95% CI low (adjOR)
					95% CI high (adjOR)
		Within Arm Comparisons				Net Comparisons
		Daily or weekly use of marijuana	Monthly or 1-2 times a month use of marijuana	No use		All Arms (ANOVA)

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?


	NA

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 (NR)

14. Acceptable levels of differential attrition?


	Unclear (NR)

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?


	Unclear

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

Daily or weekly use of marijuana

Monthly or 1-2 times a month use of marijuana

No use

Outcomes

Outcome Details

1. Other Outcomes Reported (primary)

2. Other AE Outcomes of Importance reported

3. Notes

Results

Categorical

Opiod use (Opioid initiation A vs. C)

Opiod use (Opioid discontinuation A vs. C)

Adverse Events

Opiod use (Opiod initiation B vs. C)

Opiod use (Opioid discontinuation B vs. C )

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

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