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
IPMPMultidisciplinary intervention consisting of telephone-delivered CBT plus functioning/reconditioning.
Usual careThis group received the usual care from their family physician, although the precise care delivered, if any, was not recorded.
Telephone-delivered CBT alone7 weekly sessions (30-45 minutes each), plus 1 session 3 months, and 1 session 6 months after randomization Patients had a choice of the type of CBT they preferred: behavioral activation (increasing, decreasing, pacing activities), cognitive restructuring (identifying and evaluating unhelpful thinking styles), or lifestyle changes (managing sleep, fatigue, irritability)
Exercise alone6 monthly appointments (20 to 60 minutes each) with further instruction to exercise at least 2 days per week and on non-gym days to engage in everyday actives (e.g. walking) Specific exercises were negotiated between fitness instructor and patient. The protocol allowed exercises to be changed but maintained the goal of improving cardiorespiratory fitness.

Arm Details

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

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalPainChronic Pain Grade questionnaire Grade IV
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 3 months
  • 24 months
ContinuousQOLSF-36 Physical Component Summary Score
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 3 months
ContinuousQOLSF-36 Mental Component Summary Score
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 3 months
CategoricalPatient satisfactionClinical global impression change score of 6 or 7 (indicating much better or very much better)
  • All Participants
  • Immediately Post-intervention
  • 3 months
  • 24 months
ContinuousQOLGeneral Health Questionnaire
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 3 months
  • 24 months
ContinuousPain copingVanderbilt Pain Management Inventory Passive Coping Score
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 3 months
  • 24 months
ContinuousPain copingVanderbilt Pain Management Inventory Active Coping Score
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 3 months
  • 24 months
ContinuousKinesiophobia Tampa Scale for Kinesiophobia
  • All Participants
  • Baseline
  • Immediately Post-intervention
  • 3 months
  • 24 months
Adverse EventAdverse eventDeath due to cancer
  • All Participants
  • 24 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

Adverse Event


Adverse event (Death due to cancer)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone
24 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone

Categorical


Pain (Chronic Pain Grade questionnaire Grade IV)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone
Baseline
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Immediately Post-intervention
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
3 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
24 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone

Patient satisfaction (Clinical global impression change score of 6 or 7 (indicating much better or very much better))

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone
Immediately Post-intervention
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
3 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
24 months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone

Continuous


QOL (SF-36 Physical Component Summary Score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Immediately Post-intervention
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone

QOL (SF-36 Mental Component Summary Score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Immediately Post-intervention
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone

QOL (General Health Questionnaire)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Immediately Post-intervention
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
24 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone

Pain coping (Vanderbilt Pain Management Inventory Passive Coping Score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Immediately Post-intervention
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
24 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone

Pain coping (Vanderbilt Pain Management Inventory Active Coping Score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Immediately Post-intervention
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
24 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone

Kinesiophobia ( Tampa Scale for Kinesiophobia)

All Participants
Descriptive StatisticsBetween Arm Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone
Baseline
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Immediately Post-intervention
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
3 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
24 months
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
IPMPUsual careTelephone-delivered CBT aloneExercise alone