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
IPMP
Usual Care Usual care often included use of prescription and non-prescription pain medications, infrequent primary care visits for back pain, and use of ancillary services such as physical therapy by a minority of patients.

Arm Details

1. Is the program practice-based or system-based?
IPMP
Usual Care
2. How many patients were randomized to this treatment arm?
IPMP
Usual Care
3. Program duration (weeks)
Please report the duration of the program in weeks and include "weeks" in the text box.
IPMP
Usual Care
4. Number of sessions per week
Report as X sessions/week
IPMP
Usual Care
5. Was the program conducted in the inpatient or outpatient setting?
Select one.
IPMP
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.
IPMP
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
IPMP
Usual Care
8. Additional components of the intervention
IPMP
Usual Care
9. Description of care coordination/collaboration
IPMP
Usual Care

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalFunctionProportion of patients with greater than a one-third reduction in Roland Disability Questionnaire score
  • All Participants
  • 2 months
  • 6 months
  • 12 months
  • 24 months
ContinuousFunctionRoland Disability Questionnaire
  • All Participants
  • Baseline
  • 2 months
  • 6 months
  • 12 months
  • 24 months
ContinuousPainPain intensity numeric rating scale
  • All Participants
  • Baseline
  • 2 months
  • 6 months
  • 12 months
  • 24 months
CategoricalFunctionProportion of patients who missed ≥30 days from usual activities (work, school housework) in past 3 months
  • All Participants
  • Baseline
  • 2 months
  • 6 months
  • 12 months
  • 24 months
ContinuousOtherBack pain worry
  • All Participants
  • Baseline
  • 2 months
  • 6 months
  • 12 months
  • 24 months
ContinuousOtherFear-avoidance beliefs
  • All Participants
  • Baseline
  • 2 months
  • 6 months
  • 12 months
  • 24 months
ContinuousQOLSF-36 Social functioning subscale
  • All Participants
  • Baseline
  • 6 months
  • 12 months
  • 24 months
ContinuousQOLSF-36 Mental Component Summary Score
  • All Participants
  • Baseline
  • 6 months
  • 12 months
  • 24 months
CategoricalProgram-related outcomesProportion receiving workers compensation or disability payments for back pain
  • All Participants
  • Baseline
  • 2 months
  • 6 months
  • 12 months
  • 24 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


Function (Proportion of patients with greater than a one-third reduction in Roland Disability Questionnaire score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care ( Usual care...)
2 months
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
p value
Percentage
6 months
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
p value
Percentage
12 months
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
p value
Percentage
24 months
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care ( Usual care...)

Function (Proportion of patients who missed ≥30 days from usual activities (work, school housework) in past 3 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care ( Usual care...)
Baseline
Percentage
p value
2 months
Percentage
p value
6 months
Percentage
p value
12 months
Percentage
p value
24 months
Percentage
p value
Within Arm ComparisonsNet Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care ( Usual care...)

Program-related outcomes (Proportion receiving workers compensation or disability payments for back pain)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care ( Usual care...)
Baseline
Percentage
p value
2 months
Percentage
p value
6 months
Percentage
p value
12 months
Percentage
p value
24 months
Percentage
p value
Within Arm ComparisonsNet Comparisons
IPMPUsual Care
IPMP
vs.
Usual Care ( Usual care...)

Continuous


Function (Roland Disability Questionnaire)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
2 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
6 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
12 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
24 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
Within Arm ComparisonsNet Comparisons
IPMPUsual Care

Pain (Pain intensity numeric rating scale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
2 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
6 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
12 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
24 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
Within Arm ComparisonsNet Comparisons
IPMPUsual Care

Other (Back pain worry)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
2 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
6 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
12 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
24 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
Within Arm ComparisonsNet Comparisons
IPMPUsual Care

Other (Fear-avoidance beliefs)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
2 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
6 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
12 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
24 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
p value (MD)
Mean Difference, Adjusted (adjMD)
95% CI low (adjMD)
95% CI high (adjMD)
Within Arm ComparisonsNet Comparisons
IPMPUsual Care

QOL (SF-36 Social functioning subscale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
Baseline
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI high (adjMD)
6 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI high (adjMD)
12 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI high (adjMD)
24 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI high (adjMD)
Within Arm ComparisonsNet Comparisons
IPMPUsual Care

QOL (SF-36 Mental Component Summary Score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual Care
Baseline
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI high (adjMD)
6 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI high (adjMD)
12 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI high (adjMD)
24 months
Mean
Mean Difference, Adjusted (adjMD)
SD
95% CI low (adjMD)
95% CI high (adjMD)
Within Arm ComparisonsNet Comparisons
IPMPUsual Care