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 Pain Management Program
Behavior-Oriented PhysicalOne of the main components of the Rehabilitation Program, Behavior-oriented PT (+ education)
Cognitive Behavioral TherapyCBT (+ education)
Usual careThis group was not offered any types of interventions included in the research project.

Arm Details

1. Is the program practice-based or system-based?
CPMP
Behavior-Oriented Physical
Cognitive Behavioral Therapy
Usual care
2. How many patients were randomized to this treatment arm?
CPMP
Behavior-Oriented Physical
Cognitive Behavioral Therapy
Usual care
3. Program duration (weeks)
Please report the duration of the program in weeks and include "weeks" in the text box.
CPMP
Behavior-Oriented Physical
Cognitive Behavioral Therapy
Usual care
4. Number of sessions per week
Report as X sessions/week
CPMP
Behavior-Oriented Physical
Cognitive Behavioral Therapy
Usual care
5. Was the program conducted in the inpatient or outpatient setting?
Select one.
CPMP
Behavior-Oriented Physical
Cognitive Behavioral Therapy
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
Behavior-Oriented Physical
Physical Functioning/Reconditioning Components of InterventionPsychological and Mental Health Components of Intervention
Treatment types
Treatment providers
Mode of delivery
Duration of treatment
Tailoring
Adherence
Cognitive Behavioral Therapy
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
Behavior-Oriented Physical
Cognitive Behavioral Therapy
Usual care
8. Additional components of the intervention
CPMP
Behavior-Oriented Physical
Cognitive Behavioral Therapy
Usual care
9. Description of care coordination/collaboration
CPMP
Behavior-Oriented Physical
Cognitive Behavioral Therapy
Usual care

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainSF-36 Bodily pain subscale Females only
  • Females only
  • Baseline
  • Post-treatment
  • 6 months
  • 18 months
ContinuousPainSF-36 Bodily pain subscale Males only
  • Males only
  • Baseline
  • Post-treatment
  • 6 months
  • 18 months
ContinuousQOLSF-36 Physical functioning Females only
  • All Participants
  • Baseline
  • Post-treatment
  • 6 months
  • 18 months
ContinuousQOLSF-36 Physical functioning Males only
  • All Participants
  • Baseline
  • Post-treatment
  • 6 months
  • 18 months
ContinuousPsychological MeasuresSF-36 Mental health subscale Females only
  • All Participants
  • Baseline
  • Post-treatment
  • 6 months
  • 18 months
ContinuousPsychological MeasuresSF-36 Mental health subscale Males only
  • All Participants
  • Baseline
  • Post-treatment
  • 6 months
  • 18 months
CategoricalPatient SatisfactionPerceived appropriateness of the treatment program to treating patient's pain Females only
  • Females only
  • Post-treatment
CategoricalPatient SatisfactionLikelihood of recommending treatment program to a relative with a similar pain condition Females only
  • Females only
  • Post-treatment
CategoricalPatient SatisfactionPerceived appropriateness of the treatment program to treating patient's pain Males only
  • Males only
  • Post-treatment
CategoricalPatient SatisfactionLikelihood of recommending treatment program to a relative with a similar pain condition Males only
  • Males only
  • Post-treatment
CategoricalHarmsAdverse Events
  • All Participants
  • Post-treatment

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


Patient Satisfaction (Perceived appropriateness of the treatment program to treating patient's pain Females only )

Females only
Descriptive StatisticsBetween Arm Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care
Post-treatment
Mean
Odds Ratio (OR)
SD
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care

Patient Satisfaction (Likelihood of recommending treatment program to a relative with a similar pain condition Females only )

Females only
Descriptive StatisticsBetween Arm Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care
Post-treatment
Mean
Odds Ratio (OR)
SD
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care

Patient Satisfaction (Perceived appropriateness of the treatment program to treating patient's pain Males only )

Males only
Descriptive StatisticsBetween Arm Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care
Post-treatment
Mean
Odds Ratio (OR)
SD
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care

Patient Satisfaction (Likelihood of recommending treatment program to a relative with a similar pain condition Males only )

Males only
Descriptive StatisticsBetween Arm Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care
Post-treatment
Mean
Odds Ratio (OR)
SD
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care

Harms (Adverse Events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care
Post-treatment
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Mean
95% CI high (OR)
SD
p value
Within Arm ComparisonsNet Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care

Continuous


Pain (SF-36 Bodily pain subscale Females only)

Females only
Descriptive StatisticsBetween Arm Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Post-treatment
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care

Pain (SF-36 Bodily pain subscale Males only)

Males only
Descriptive StatisticsBetween Arm Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Post-treatment
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care

QOL (SF-36 Physical functioning Females only )

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Post-treatment
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care

QOL (SF-36 Physical functioning Males only )

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Post-treatment
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care

Psychological Measures (SF-36 Mental health subscale Females only )

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Post-treatment
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care

Psychological Measures (SF-36 Mental health subscale Males only )

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Post-treatment
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMP Behavior-Oriented PhysicalCognitive Behavioral TherapyUsual care