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, Interdisciplinary rehabilitation
Waitlist controlNo treatment during first phase of study (6 months), then offered A at the end of the waiting list plus an additional 16-week course of either individualized physiotherapy or occupational therapy in the second study phase

Arm Details

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

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainFIQ Pain VAS
  • All Participants
  • Baseline
  • 6 month ∆ change from baseline
ContinuousPainFIQ Total
  • All Participants
  • Baseline
  • 6 month ∆ change from baseline
ContinuousQOLSF-36 Physical Composite Score
  • All Participants
  • Baseline
  • 6 month ∆ change from baseline
ContinuousQOLSF-36 - Mental Composite Score
  • All Participants
  • Baseline
  • 6 month ∆ change from baseline
ContinuousQOLSF-36 Physical Functioning Subscale
  • All Participants
  • Baseline
  • 6 month ∆ change from baseline
CategoricalQOLProportion of patients considered to be responders on the SF-36 MCS
  • All Participants
  • 6 months
CategoricalQOLProportion of patients considered to be responders on the SF-36 PCS
  • All Participants
  • 6 months
ContinuousPsychological measuresGAD-10
  • All Participants
  • Baseline
  • 6 month ∆ change from baseline
ContinuousPsychological measuresMDI
  • All Participants
  • Baseline
  • 6 month ∆ change from baseline
ContinuousPsychological measuresCSQ pain catastrophizing score
  • All Participants
  • Baseline
  • 6 month ∆ change from baseline
ContinuousPsychological measuresPSEQ
  • All Participants
  • Baseline
  • 6 month ∆ change from baseline
CategoricalHarmsAdverse Events
  • All Participants
  • 6 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


QOL (Proportion of patients considered to be responders on the SF-36 MCS)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)
6 months
Total (N analyzed)
Risk Ratio (RR)
Events
95% CI low (RR)
Percentage
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)

QOL (Proportion of patients considered to be responders on the SF-36 PCS)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
All Arms (ANOVA)
6 months
Total (N analyzed)
95% CI low (MD)
Events
95% CI high (MD)
Percentage
SD (adjMD)
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control
All Arms (ANOVA)

Harms (Adverse Events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
6 months
Total (N analyzed)
6 month ∆
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD (adjMD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
Risk Ratio (RR)
95% CI low (RR)
95% CI high (RR)
p value
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control

Continuous


Pain (FIQ Pain VAS)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Minimum
Maximum
6 month ∆ change from baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Minimum
Maximum
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)

Pain (FIQ Total)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
6 month ∆ change from baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)

QOL (SF-36 Physical Composite Score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
Waitlist control (No treatment...)
vs.
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Minimum
Maximum
6 month ∆ change from baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Minimum
Maximum
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
Waitlist control (No treatment...)
vs.

QOL (SF-36 - Mental Composite Score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
p value (MD)
Median
25th percentile
75th percentile
Maximum
6 month ∆ change from baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
p value (MD)
Median
25th percentile
75th percentile
Maximum
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)

QOL (SF-36 Physical Functioning Subscale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Maximum
6 month ∆ change from baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Maximum
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)

Psychological measures (GAD-10)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Maximum
6 month ∆ change from baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Maximum
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)

Psychological measures (MDI)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Maximum
6 month ∆ change from baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Maximum
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)

Psychological measures (CSQ pain catastrophizing score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
Median
25th percentile
75th percentile
Maximum
6 month ∆ change from baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
Median
25th percentile
75th percentile
Maximum
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control
CPMP (Comprehensive...)
vs.
Waitlist control (No treatment...)

Psychological measures (PSEQ)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPWaitlist control
vs.
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
p value (MD)
Median
25th percentile
75th percentile
Maximum
6 month ∆ change from baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
p value (MD)
Median
25th percentile
75th percentile
Maximum
Within Arm ComparisonsNet Comparisons
CPMPWaitlist control
vs.