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
ExerciseAerobics (primarily) and resistance training
Usual CareEducation and lifestyle advise; could include various other treatments

Arm Details

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

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousFunctionFibromyalgia Impact Questionnaire - Total score
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 18 months
ContinuousPainFibromyalgia Impact Questionnaire - Pain subscale
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 18 months
ContinuousDepressionFibromyalgia Impact Questionnaire - Depression subscale
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 18 months
ContinuousAnxietyFibromyalgia Impact Questionnaire - Anxiety subscale
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 18 months
ContinuousHealthcare utilizationNumber of contacts with General Practitioner
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 18 months
ContinuousHealthcare utilizationNumber of contacts with Medical Specialist
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 18 months
ContinuousHealthcare utilizationNumber of contacts with Physiotherapist
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 18 months
ContinuousHealthcare utilizationNumber of contacts with Paramedical Professionals
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 18 months
ContinuousHealth-related Quality of LifeEQ5D
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 18 months
ContinuousGlobal Impression of HealthEQ5D - overall impression of health
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 18 months
ContinuousSick LeaveHours of Sick Leave Per Week
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 18 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

Continuous


Function (Fibromyalgia Impact Questionnaire - Total score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPExerciseUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Immediately Post-intervention
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPExerciseUsual Care

Pain (Fibromyalgia Impact Questionnaire - Pain subscale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPExerciseUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Immediately Post-intervention
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPExerciseUsual Care

Depression (Fibromyalgia Impact Questionnaire - Depression subscale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPExerciseUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Immediately Post-intervention
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPExerciseUsual Care

Anxiety (Fibromyalgia Impact Questionnaire - Anxiety subscale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPExerciseUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Immediately Post-intervention
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPExerciseUsual Care

Healthcare utilization (Number of contacts with General Practitioner )

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPExerciseUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Immediately Post-intervention
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPExerciseUsual Care

Healthcare utilization (Number of contacts with Medical Specialist)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPExerciseUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Immediately Post-intervention
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPExerciseUsual Care

Healthcare utilization (Number of contacts with Physiotherapist)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPExerciseUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Immediately Post-intervention
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPExerciseUsual Care

Healthcare utilization (Number of contacts with Paramedical Professionals)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPExerciseUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Immediately Post-intervention
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPExerciseUsual Care

Health-related Quality of Life (EQ5D)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPExerciseUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Immediately Post-intervention
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPExerciseUsual Care

Global Impression of Health (EQ5D - overall impression of health)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPExerciseUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Immediately Post-intervention
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPExerciseUsual Care

Sick Leave (Hours of Sick Leave Per Week)

All Participants
Descriptive StatisticsBetween Arm Comparisons
CPMPExerciseUsual Care
Baseline
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Immediately Post-intervention
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
18 months
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SE
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
CPMPExerciseUsual Care