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 (combined patient and provider) + usual careProvider randomized to intervention then patients within those clinics randomized to intervention.
IPMP (provider only) + usual careProvider randomized to intervention then patients within those clinics randomized to usual care.
IPMP (patient only) + usual careProvider randomized to usual care then patients within those clinics randomized to intervention.
Usual careProvider randomized to usual care then patients within those clinics randomized to usual care. Usual care includes any of standard treatments for OA given by a PCP and referral to other providers or specialists. Provider and patient participants in this group received no additional intervention during the study period.

Arm Details

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

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousFunctionEstimated percentage improving ≥12% on WOMAC score from baseline (5.8 point reduction)
  • All Participants
  • 12 months
ContinuousFunctionEstimated percentage improving ≥18% on WOMAC score from baseline (8.7 point reduction)
  • All Participants
  • 12 months
ContinuousFunctionWOMAC total
  • All Participants
  • Baseline
  • 6 month ∆ from baseline
  • 12 month ∆ from baseline
ContinuousQOLPHQ-8
  • All Participants
  • Baseline
  • 12 month ∆ from baseline
ContinuousPainWOMAC Pain subscale
  • All Participants
  • Baseline
  • 6 month ∆ from baseline
  • 12 month ∆ from baseline
ContinuousFunctionWOMAC Function subscale
  • All Participants
  • Baseline
  • 6 month ∆ from baseline
  • 12 month ∆ from baseline
ContinuousFunctionSPPB (Physical Function)
  • All Participants
  • Baseline
  • 12 month ∆ from baseline

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 (Estimated percentage improving ≥12% on WOMAC score from baseline (5.8 point reduction))

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)
12 months
Percentage
Odds Ratio (OR)
Mean
95% CI low (OR)
SD
95% CI high (OR)
95% CI low
p value
95% CI high
Within Arm ComparisonsNet Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)

Function (Estimated percentage improving ≥18% on WOMAC score from baseline (8.7 point reduction))

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)
12 months
Percentage
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
95% CI low
p value (MD)
95% CI high
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)

Function (WOMAC total)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (combined patient and provider) + usual care (Provider...)
vs.
Usual care (Provider...)

IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)

IPMP (patient only) + usual care (Provider...)
vs.
Usual care (Provider...)
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
6 month ∆ from baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
12 month ∆ from baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI low
95% CI high (MD)
95% CI high
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (combined patient and provider) + usual care (Provider...)
vs.
Usual care (Provider...)
IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)
IPMP (patient only) + usual care (Provider...)
vs.
Usual care (Provider...)

QOL (PHQ-8)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
Baseline
Mean
Mean Difference (MD)
95% CI low
95% CI low (MD)
95% CI high
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
12 month ∆ from baseline
Mean
Mean Difference (MD)
95% CI low
95% CI low (MD)
95% CI high
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care

Pain (WOMAC Pain subscale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)

IPMP (patient only) + usual care (Provider...)
vs.
Usual care (Provider...)

IPMP (combined patient and provider) + usual care (Provider...)
vs.
Usual care (Provider...)
Baseline
Mean
Mean Difference (MD)
95% CI low
95% CI low (MD)
95% CI high
95% CI high (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
6 month ∆ from baseline
Mean
Mean Difference (MD)
95% CI low
95% CI low (MD)
95% CI high
95% CI high (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
12 month ∆ from baseline
Mean
Mean Difference (MD)
95% CI low
95% CI low (MD)
95% CI high
95% CI high (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)
IPMP (patient only) + usual care (Provider...)
vs.
Usual care (Provider...)
IPMP (combined patient and provider) + usual care (Provider...)
vs.
Usual care (Provider...)

Function (WOMAC Function subscale)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (combined patient and provider) + usual care (Provider...)
vs.
Usual care (Provider...)

IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)

IPMP (patient only) + usual care (Provider...)
vs.
Usual care (Provider...)
Baseline
Mean
Mean Difference (MD)
95% CI low
95% CI low (MD)
95% CI high
95% CI high (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
6 month ∆ from baseline
Mean
Mean Difference (MD)
95% CI low
95% CI low (MD)
95% CI high
95% CI high (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
12 month ∆ from baseline
Mean
Mean Difference (MD)
95% CI low
95% CI low (MD)
95% CI high
95% CI high (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (combined patient and provider) + usual care (Provider...)
vs.
Usual care (Provider...)
IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)
IPMP (patient only) + usual care (Provider...)
vs.
Usual care (Provider...)

Function (SPPB (Physical Function))

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (combined patient and provider) + usual care (Provider...)
vs.
Usual care (Provider...)

IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)

IPMP (patient only) + usual care (Provider...)
vs.
Usual care (Provider...)
Baseline
Mean
Mean Difference (MD)
95% CI low
95% CI low (MD)
95% CI high
95% CI high (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
12 month ∆ from baseline
Mean
Mean Difference (MD)
95% CI low
95% CI low (MD)
95% CI high
95% CI high (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
IPMP (combined patient and provider) + usual careIPMP (provider only) + usual careIPMP (patient only) + usual careUsual care
IPMP (combined patient and provider) + usual care (Provider...)
vs.
Usual care (Provider...)
IPMP (provider only) + usual care (Provider...)
vs.
Usual care (Provider...)
IPMP (patient only) + usual care (Provider...)
vs.
Usual care (Provider...)