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
CPMPCoordinated Psychological, Medical, Educational, and Physiotherapeutic interventions (PSYMEPHY)
Standard pharmacologic therapyPatients received: - Tricyclic antidepressant (amitriptyline, maximum dose of 75 mg/day) - Analgesic (paracetamol, maximum dose of 4 g/day) - Opioid central analgesic (tramadol, maximum dose of 400 mg/day)

Arm Details

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

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainVisual Analogue Scale - Current pain
  • All Participants
  • Baseline
  • 6 months
ContinuousPainFibromyalgia Impact Questionnaire - Pain sub scale
  • All Participants
  • Baseline
  • 6 months
  • 6 months change
ContinuousPainFibromyalgia Impact Questionnaire - Total
  • All Participants
  • Baseline
  • 6 months
  • 6 months change
ContinuousPainFibromyalgia Impact Questionnaire - Physical impairment sub scale
  • All Participants
  • Baseline
  • 6 months
  • 6 months change
ContinuousQOLLikelihood of using active coping strategies
  • All Participants
  • Baseline
  • 6 months
  • 6 months change
ContinuousQOLLikelihood of using passive coping strategies
  • All Participants
  • Baseline
  • 6 months
  • 6 months change
ContinuousQOLFibromyalgia Impact Questionnaire - anxiety sub scale
  • All Participants
  • Baseline
  • 6 months
  • 6 months change
ContinuousQOLHospital Anxiety and Depression scale - anxiety sub scale
  • All Participants
  • Baseline
  • 6 months
  • 6 months change
ContinuousQOLFibromyalgia Impact Questionnaire - depression sub scale
  • All Participants
  • Baseline
  • 6 months
  • 6 months change
ContinuousQOLHospital Anxiety and Depression scale - depression sub scale
  • All Participants
  • Baseline
  • 6 months
  • 6 months change

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

Continuous


Pain (Visual Analogue Scale - Current pain)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPStandard pharmacologic therapy
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPStandard pharmacologic therapy

Pain (Fibromyalgia Impact Questionnaire - Pain sub scale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPStandard pharmacologic therapy
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months change
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPStandard pharmacologic therapy

Pain (Fibromyalgia Impact Questionnaire - Total)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPStandard pharmacologic therapy
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months change
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPStandard pharmacologic therapy

Pain (Fibromyalgia Impact Questionnaire - Physical impairment sub scale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPStandard pharmacologic therapy
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months change
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPStandard pharmacologic therapy

QOL (Likelihood of using active coping strategies)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPStandard pharmacologic therapy
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months change
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPStandard pharmacologic therapy

QOL (Likelihood of using passive coping strategies)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPStandard pharmacologic therapy
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months change
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPStandard pharmacologic therapy

QOL (Fibromyalgia Impact Questionnaire - anxiety sub scale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPStandard pharmacologic therapy
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months change
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPStandard pharmacologic therapy

QOL (Hospital Anxiety and Depression scale - anxiety sub scale )

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPStandard pharmacologic therapy
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months change
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPStandard pharmacologic therapy

QOL (Fibromyalgia Impact Questionnaire - depression sub scale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPStandard pharmacologic therapy
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months change
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPStandard pharmacologic therapy

QOL (Hospital Anxiety and Depression scale - depression sub scale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPStandard pharmacologic therapy
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
6 months change
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPStandard pharmacologic therapy