Extraction form for project: IPMP (Integrated Pain Management Programs)

Design Details

1. What type of program does the study assess (IPMP or CPMP)?
Integrated Pain Management Program (IPMP): Based in, integrated with, coordinated by primary care. Comprehensive Pain Management Program (CPMP): Referral based and separate from primary care.
2. In what country was the study conducted?
List all applicable countries.
3. What study design was used?
Please select the appropriate study design for the study. If the study design is not listed, you may add the appropriate study design.
4. Mean age
Report across all patients included in relevant study arms. Round to whole number. Include the word "years" after reporting the mean age.
5. % male
Report across all patients included in relevant study arms. Round to whole number. Include "%" symbol.
6. % Non-white
Report across all patients included in relevant study arms. Round to whole number. Include "%" symbol. If not reported, put NR.
7. Mean duration of pain or symptoms
Report across all patients included in relevant study arms. Round to whole number. Report duration in terms of months. If not reported, put NR.
8. Pain etiology/type
9. Disability
Disability can be measured in several ways. For example, authors may report the percent of patients receiving disability payments or they may report the mean score of a continuous disability scale such as the Pain Disability Index. Either are appropriate here, just be explicit about what is being reported.
10. Comorbidities
Extract the percent of patients with relevant comorbidities. Round percentages to whole numbers. If not reported, put NR.
% Depression diagnosis
% Anxiety diagnosis
% PTSD disagnosis
% Overweight or obese
% w/ Substance Use Disorder
% Smokers
% Suicidal
11. Randomized, Analyzed, and Attrition (at longest followup point)
For attrition report as: % (n/N)
Randomized
Analyzed
Attrition
12. How was the study funded?
13. Notes and comments

Arms

Arm NameArm Description
CPMPComprehensive
Usual CareNot otherwise specified

Arm Details

1. Is the program practice-based or system-based?
CPMP
Usual Care
2. How many patients were randomized to this treatment arm?
CPMP
Usual Care
3. Program duration (weeks)
Please report the duration of the program in weeks and include "weeks" in the text box.
CPMP
Usual Care
4. Number of sessions per week
Report as X sessions/week
CPMP
Usual Care
5. Was the program conducted in the inpatient or outpatient setting?
Select one.
CPMP
Usual Care
6. Physical Functioning/Reconditioning & Psychological and Mental Health Components of Intervention
For treatment providers, you may write-in any options that are needed that are not already presented. For duration of treatment report as "X sessions per week over X weeks", when possible. For anything not reported, put NR.
CPMP
Physical Functioning/Reconditioning Components of InterventionPsychological and Mental Health Components of Intervention
Treatment types
Treatment providers
Mode of delivery
Duration of treatment
Tailoring
Adherence
Usual Care
Physical Functioning/Reconditioning Components of InterventionPsychological and Mental Health Components of Intervention
Treatment types
Treatment providers
Mode of delivery
Duration of treatment
Tailoring
Adherence
7. Medication Review and/or Management Components of Intervention
CPMP
Usual Care
8. Additional components of the intervention
CPMP
Usual Care
9. Description of care coordination/collaboration
CPMP
Usual Care

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainBack Pain VAS
  • All Participants
  • Baseline
  • 4 months
  • 24 months
  • 60 months
ContinuousPainLeg Pain VAS
  • All Participants
  • Baseline
  • 4 months
  • 24 months
  • 60 months
ContinuousPatient subjective disability due to back pain VAS (scale 0 to 30, higher=decreased function)
  • All Participants
  • Baseline
  • 4 months
  • 24 months
  • 60 months
ContinuousUtilizationNumber of contacts made to family doctors, specialists, physical therapists, chiropractors, hospital staff, or other health-care professionals
  • All Participants
  • Baseline
  • 4 months
  • 24 months
  • 60 months
CategoricalHarmsAdverse Events
  • All Participants
  • 60 months
CategoricalUtilizationProportion of patients who underwent back surgery during the study period
  • All Participants
  • Baseline
  • 4 months
  • 24 months
  • 60 months
CategoricalUtilizationProportion of patients taking prescription pain medications
  • All Participants
  • Baseline
  • 4 months
  • 24 months
  • 60 months
CategoricalUtilizationProportion of patients hospitalized due to low back pain
  • All Participants
  • Baseline
  • short term
  • Long term (60 months)

Outcome Details

N/A

Risk of Bias Assessment

1. Randomization adequate?
Rating
2. Allocation concealment adequate?
Rating
3. Groups similar at baseline?
Rating
4. Outcome assessors masked?
Rating
5. Care providers masked?
Rating
6. Patient masked?
Rating
7. Reporting of attrition, crossovers, adherence, and contamination?
Rating
8. Loss to followup acceptable?
Overall ≤20%?
Difference between groups <10%?
9. Intention-to-treat (ITT) analysis?
Overall ≤20%?
10. Outcomes prespecified?
Overall ≤20%?
11. Quality determination
Overall ≤20%?

Results

Categorical


Harms (Adverse Events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPUsual Care
60 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
CPMPUsual Care

Utilization (Proportion of patients who underwent back surgery during the study period)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPUsual Care
Baseline
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
4 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
24 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
60 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
CPMPUsual Care

Utilization (Proportion of patients taking prescription pain medications)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPUsual Care
Baseline
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
4 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
24 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
60 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
CPMPUsual Care

Utilization (Proportion of patients hospitalized due to low back pain)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPUsual Care
Baseline
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
short term
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Long term (60 months)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
CPMPUsual Care

Continuous


Pain (Back Pain VAS )

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
4 months
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
24 months
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
60 months
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPUsual Care

Pain (Leg Pain VAS)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
4 months
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
24 months
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
60 months
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPUsual Care

Patient subjective disability due to back pain (VAS (scale 0 to 30, higher=decreased function))

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
4 months
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
24 months
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
60 months
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPUsual Care

Utilization (Number of contacts made to family doctors, specialists, physical therapists, chiropractors, hospital staff, or other health-care professionals)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPUsual Care
Baseline
Total (N analyzed)
Odds Ratio (OR)
Median
95% CI low (OR)
25th percentile
95% CI high (OR)
75th percentile
p value
4 months
Total (N analyzed)
Odds Ratio (OR)
Median
95% CI low (OR)
25th percentile
95% CI high (OR)
75th percentile
p value
24 months
Total (N analyzed)
Odds Ratio (OR)
Median
95% CI low (OR)
25th percentile
95% CI high (OR)
75th percentile
p value
60 months
Total (N analyzed)
Odds Ratio (OR)
Median
95% CI low (OR)
25th percentile
95% CI high (OR)
75th percentile
p value
Within Arm ComparisonsNet Comparisons
CPMPUsual Care