New Information on the Use of the Pain Outcomes Profile

1. New Information on the Use of the Pain Outcomes Profile Alexandra Campbell, PhD American Academy of Pain Management Sonora, CA Michael Schatman, PhD Consulting Clinical Psychologist Redmond, WA

2. Conflict of Interest/Financial Disclosure Alexandra Campbell, PhD Director, Pain Program Accreditation Outcomes Measurement American Academy of Pain Management Sonora, CA Dr. Campbell is employed by the American Academy of Pain Management, the publisher of the Pain Outcomes Profile

3. Conflict of InterestFinancial Disclosure Michael Schatman, PhD Consulting Clinical Psychologist Redmond, Washington Dr. Schatman was the developer of the Accredited Pain Program at PinnacleHealth Rehab Options and is a Pain Program Accreditation Surveyor (Independent Contractor)

4. Comprehensive Measures of Emotional and Behavioral Sequelae of Chronic Pain Coping Strategies Questionnaire Rosentiel & Keefe, 1983 Multidimensional Pain Inventory Kerns, Turk & Rudy, 1985 Behavioral Assessment of Pain Questionnaire Tearnan & Lewandowski, 1992 Brief Pain Inventory Cleeland & Ryan, 1994 Chronic Pain Coping Inventory Jensen et al., 1995 Pain Coping Inventory Eimer & Allen, 1998 Profile of Chronic Pain: Screen Ruehlman et al, 2005 Intro re: multi vs uni dimensional pain assessment- Michael CSQ Strength: Relative brevity (42 items) Limitation: Measures only coping strategies, does not assess emotional or behavioral responses to pain MPI Strength: Comprehensiveness, relative brevity Limitations: Necessity of computer scoring, lack of sensitivity to treatment-related changes, methodolgically questionable development (e.g., inadequate sample size for the analyses conducted), substantial redundancy between some of the scales BAP Strength: Probably the most comprehensive measure of emotional and behavioral responses to chronic pain Limitation: Length (390 items) BPI Strength: Brevity (15 items) Limitation: Measures pain intensity and pain interference, but does not address emotional response to pain CPCI Strength: Well validated, reliable measure of strategies for coping with chronic pain Limitations: Length (64 items), measures only coping strategies � does not address emotional or behavioral responses to chronic pain PCI Strength: Measures behavioral, cognitive and psychological dimensions of chronic pain Limitations: Length (92 items), necessity of computer scoring Intro re: multi vs uni dimensional pain assessment- Michael CSQ Strength: Relative brevity (42 items) Limitation: Measures only coping strategies, does not assess emotional or behavioral responses to pain MPI Strength: Comprehensiveness, relative brevity Limitations: Necessity of computer scoring, lack of sensitivity to treatment-related changes, methodolgically questionable development (e.g., inadequate sample size for the analyses conducted), substantial redundancy between some of the scales BAP Strength: Probably the most comprehensive measure of emotional and behavioral responses to chronic pain Limitation: Length (390 items) BPI Strength: Brevity (15 items) Limitation: Measures pain intensity and pain interference, but does not address emotional response to pain CPCI Strength: Well validated, reliable measure of strategies for coping with chronic pain Limitations: Length (64 items), measures only coping strategies � does not address emotional or behavioral responses to chronic pain PCI Strength: Measures behavioral, cognitive and psychological dimensions of chronic pain Limitations: Length (92 items), necessity of computer scoring

5. Profile of Chronic Pain: Screen Strength: Brevity (15-item screening tool) Limitations: Designed as a screening tool for the general population, not normed on clinical populations This is a newer tool��cite studies they emailed to meThis is a newer tool��cite studies they emailed to me

6. The Origin of the Pain Outcomes Profile (POP) Brief, clinically useful self-report assessment tool Assesses pain, function and emotional response Suitable for multiple measurements across treatment Administration time 1-5 minutes 20 items total (see handout) Based on National Pain Data Bank Most reliable items from NPDB (Clark et al., 2003)Based on National Pain Data Bank Most reliable items from NPDB (Clark et al., 2003)

7. The POP Questionnaire Pain Outcomes Profile (POP) Scales: Pain Intensity Right Now (0-10) Pain on Average Past Week (0-10) Mobility (5 items, 0-10 items) Adls (4 items, 0-10) Negative Affect (5 items, 0-10) Vitality (3 items, 0-10) Measures pain I;nterference with�.mob & adl Directly asseses amount of neg affect and limitations in vitalityMeasures pain I;nterference with�.mob & adl Directly asseses amount of neg affect and limitations in vitality

10. Scoring Instrument Template provided Scale scores calculated: linear aggregation Scoring time minimal High scores indicate more impairment (see handout) Demonstrate scoring Go over scoring with attendees live Reverse scoring for a few items in Vitality and Fear scalesDemonstrate scoring Go over scoring with attendees live Reverse scoring for a few items in Vitality and Fear scales

12. Cumulative Patient Scoring Record Easily track POP scores across consecutive administrations for individual patients More objective estimate of self-reported pain and functional impairment Can be placed in chart for convenient tracking of progress across treatment Can be used in patient education to demonstrate functional improvement when pain relief may be less prominent Give examples of how scores can show different outcomes�.Give examples of how scores can show different outcomes�.

14. Use of the POP in Clinical Practice Why use multiple measures (e.g. Visual Analogue or Numerical Pain Rating Scale, Oswestry, Beck Depression Inventory, Tampa Scale of Kinesophobia) when the POP will give you all of this information? MichaelMichael

15. Use of the POP in Clinical Practice Time is money Patients may become discouraged or frustrated by having to take multiple measures at initial assessment as well as at the completion of treatment Clinical experience suggests that patients are less defensive when taking the POP, although this needs to be empirically substantiated MichaelMichael

16. Use of the POP in Clinical Practice Increasing demand for outcomes measurement in order to receive third-party reimbursement

17. Psychometric Properties:VA Samples Equivalent core scales (mob, adl, vit, NA, fear) administered to >1200 veterans with chronic pain (instrument named Pain Outcomes Questionnaire in VA system) Scales demonstrated reliability, stability, generalizability, convergent validity, discriminant and predictive validity, and sensitivity to change (Clark et al., 2003) To quickly review�.To quickly review�.

18. Validation of the POP:AAPM�s Action Plan Administer POP to large sample(s) of non-VA chronic pain patients in different settings Assess reliability and validity by comparing POP scales with �gold standard� measures of pain and functional impairment Assess sensitivity of POP to treatment related change Collect normative data for publication Validate Spanish language version of POP This is the Academy�s ongoing plan for validating the psychometrics of the POP��we are still in this processThis is the Academy�s ongoing plan for validating the psychometrics of the POP��we are still in this process

19. PinnacleHealth Rehab OptionsValidation Sample #1 Over 234 patients completed the POP as part of evaluation for participation in a comprehensive pain management program Patients who successfully finished program (currently n=50) completed POP at discharge How many of you heard last year�s POP presentation? If none go over data in detail, if a lot go over quickly. Subjects were 162 consecutive patients (83 male, 79 female; mean age = 43 years; mean educ. = 12 years; married = 52.5%) with chronic pain (mean = 69 months; median = 39 months) in the cervical (23.5%) or lumber/sacral (76.5%) spine. Most (80%) were not working at the time of evaluation and 46% had open worker's compensation or litigation claims. Fifty-four percent had had one or more surgical procedures for pain and 64% were taking opioids as prescribed. Nineteen percent were not taking opioids and 17% were described as overutilizing opioids. Mean narcotic daily consumption (mg morhpine eqivalent) was 154 mg (median = 32.5 mg.) How many of you heard last year�s POP presentation? If none go over data in detail, if a lot go over quickly. Subjects were 162 consecutive patients (83 male, 79 female; mean age = 43 years; mean educ. = 12 years; married = 52.5%) with chronic pain (mean = 69 months; median = 39 months) in the cervical (23.5%) or lumber/sacral (76.5%) spine. Most (80%) were not working at the time of evaluation and 46% had open worker's compensation or litigation claims. Fifty-four percent had had one or more surgical procedures for pain and 64% were taking opioids as prescribed. Nineteen percent were not taking opioids and 17% were described as overutilizing opioids. Mean narcotic daily consumption (mg morhpine eqivalent) was 154 mg (median = 32.5 mg.)

20. Correlations Between POP Scales (Pearson�s r, n = 234) Discriminant Validity Avg MOB ADL VIT NA Fear Curr .68** .39** .36** .11 .30** .20** Avg .32** .43** .09 .34** .14* MOB .53** .28** .42** .33** ADL .18** .52** .33** VIT .31** .20** NA .38** **p <.01, * p <.05 The important thing to note here is that most of the POP scales are not highly correlated with each other, except for current pain and average pain which are fairly strongly correlated as expected, and mobility and adls which are moderately correlated. This is not unexpected as the items assessing both adls and mobility involve the interference by pain with various bodily movements. The moderate correlation between adls and negative affect is interesting and may relect the fact that higher levels of negative affect, such as seen in clinical depression, are associated with impairment in a person�s ability to engage in self-care.The important thing to note here is that most of the POP scales are not highly correlated with each other, except for current pain and average pain which are fairly strongly correlated as expected, and mobility and adls which are moderately correlated. This is not unexpected as the items assessing both adls and mobility involve the interference by pain with various bodily movements. The moderate correlation between adls and negative affect is interesting and may relect the fact that higher levels of negative affect, such as seen in clinical depression, are associated with impairment in a person�s ability to engage in self-care.

21. Correlations Between POP Negative Affect, Fear and Vitality Scales and Other Affective Measures (Spearman�s rho, n = 234) Concurrent Validity BDI-II BAI MPQ-a TSK-13 NA .78 .69 .53 .38 Fear .39 .33 .20 .59 Vit .40 .25 .20 .08 ns All rs p <.01 The negative affect scale of the POP correlates quite strongly with the Beck Depression Inventory II and fairly strongly with the Beck Anxiety Inventory. It also correlates well with the affective words of the McGill Pain Questionnaire. Note also that the Fear scale correlated fairly highly with the Tampa kinesiophobia scale, another independently validated fear of movement scale. If we can reliably assess domains of affect and pain related-fear with as few as 5 and 2 items, the patient and the busy clinician will be a lot happier! The negative affect scale of the POP correlates quite strongly with the Beck Depression Inventory II and fairly strongly with the Beck Anxiety Inventory. It also correlates well with the affective words of the McGill Pain Questionnaire. Note also that the Fear scale correlated fairly highly with the Tampa kinesiophobia scale, another independently validated fear of movement scale. If we can reliably assess domains of affect and pain related-fear with as few as 5 and 2 items, the patient and the busy clinician will be a lot happier!

22. Correlations Between POP Scales and MSPQ, MOPDQ (Spearman�s rho, n = 234) Discriminant/Concurrent Validity Curr Avg Mob Adl Vit NA Fear mspq .11 .26** .30** .29** .21** .49** .20** mopdq .40** .30** .53** .50** .33** .37** .23** **p<.01 *p<.05

23. Rehab Options Treatment Components Physiatric Medical Management Individual Psychological Counseling (2-3X qw) Psycho Educational Groups (2X qw) Nursing Educational Groups Biofeedback/Relaxation Training Physical Therapy Occupational Therapy Aquatics Vocational Counseling Dietary Counseling Mike describe the treatment program briefly�.Mike describe the treatment program briefly�.

24. POP Sensitivity to Change (MANOVA, n=50) Intake � Discharge F(1,49) Curr (1-10) 1.94 36.17* Avg (1-10) 1.94 61.96* Mob (1-100 15.82 37.30* Adl (1-100) 7.09 8.81* Vit (1-100) 17.85 56.26* NA (1-100) 14.51 26.28* Fear (1-100) 18.90 36.29* *p<.05 50 Patients who successfully finished the program completed the POP at discharge These results have been reported back to the Accredited facility, Pinnacle Health Rehab Options for reporting to program administrators��program refinements could be made based on results, but this program seems to be doing very well as evidenced by the data! It seems that this program is especially good, at least immediately following treatment, at alleviating patient�s fear of increasing activity50 Patients who successfully finished the program completed the POP at discharge These results have been reported back to the Accredited facility, Pinnacle Health Rehab Options for reporting to program administrators��program refinements could be made based on results, but this program seems to be doing very well as evidenced by the data! It seems that this program is especially good, at least immediately following treatment, at alleviating patient�s fear of increasing activity

25. Previously Presented POP Validity Data Campbell & Schatman. Concurrent validity of the negative affect and fear scales of the Pain Outcomes Profile, Poster presented, American Pain Society Meeting, Boston, MA, March 30 � April 2, 2005. Schatman & Campbell. Concurrent validity of the pain and physical interference scales of the Pain Outcomes Profile in chronic spinal pain patients, Paper presented, North American Spine Society, Philadelphia, PA, September 27 � October 1, 2005.

26. Previously Presented POP Validity Data Campbell, A. & Schatman, M. (2005) Validation of the Pain Outcomes Profile, Lecture, 16th Annual Clinical Meeting, American Academy of Pain Management, San Diego, CA, September 23, 2005. Campbell, A. Linking Pain Practice Standards with Outcomes Measurement: Improving Treatment Quality through Clinical Pain Research, Paper presented, Agency for Healthcare Research and Quality Conference: Translating Research in Policy and Practice, Washington, DC, July 11, 2006.

27. PinnacleHealth Rehab OptionsValidation Sample #2Test-Retest Reliability 36 patients completed the POP as part of evaluation for participation in a comprehensive pain management program; 27 cases selected for test-retest reliability analysis (outliers excluded) Patients completed the POP at initial evaluation and at admission to the program (mean time between POP admins = 25.48 days; SD = 13.50) One of the hardest studies to do in the clinical �real world� is one examining the test-tetest reliability of an instrument. Ideally, subjects complete an instrument about two weeks apart, with no intervening treatment between administrations. In clinical settings where patients may have been waiting a long time in pain, the treating clinician may begin treatment, for example a medication trial, during the first visit even if the patient has not completed evaluations by other providers in the program. In talking with Paula Spoonhour, the program manager at Rehab Options, it became clear that patients completed the POP at their initial evaluation appointment, but that their formal admission into the program and the initiation of any new treatment did not begin until sometime later�..So we decided to administer the POP at ADMISSION to the program in addition to evaluation. The collection of these data is ongoing and I can only report on a small sample right now. One of the hardest studies to do in the clinical �real world� is one examining the test-tetest reliability of an instrument. Ideally, subjects complete an instrument about two weeks apart, with no intervening treatment between administrations. In clinical settings where patients may have been waiting a long time in pain, the treating clinician may begin treatment, for example a medication trial, during the first visit even if the patient has not completed evaluations by other providers in the program. In talking with Paula Spoonhour, the program manager at Rehab Options, it became clear that patients completed the POP at their initial evaluation appointment, but that their formal admission into the program and the initiation of any new treatment did not begin until sometime later�..So we decided to administer the POP at ADMISSION to the program in addition to evaluation. The collection of these data is ongoing and I can only report on a small sample right now.

28. Sample Demographics (n=27) Female = 13; male = 14 Mean age = 38 (range = 18-58 years) Married = 67% Mean educ. = 12 years Mean pain duration = 50 months (4yrs) Mean avg. narc daily consum = 93 mg morphine equivalent (range = 0 � 683 mg, SD= 164) The sample was about evenly split, male and female, about 38 years old, mostly married and high school educated. The mean time subjects had been experiencing chronic pain was 4 years and many were already on pain medications at the time of evaluation.The sample was about evenly split, male and female, about 38 years old, mostly married and high school educated. The mean time subjects had been experiencing chronic pain was 4 years and many were already on pain medications at the time of evaluation.

29. Demographics, cont. Circumstances of Onset of Pain Work-related accident = 37% MVA = 7% Arthritis = 4% Other = 52% A large proportion of the cause of patients� pain was work related,A large proportion of the cause of patients� pain was work related,

30. Demographics, cont. Anatomical Location of Pain Cervical = 15% Lumbar/Sacral = 33% Headache = 4% Lumbar/Sacral + Lower Extremity = 26% Other = 22% The site of pain was distributed mostly over lumbar/sacral, lumbar/sacral and leg, and cervical areas�..The site of pain was distributed mostly over lumbar/sacral, lumbar/sacral and leg, and cervical areas�..

31. Demographics, cont. Number of Surgical Procedures for Pain None = 59% One = 11% Two = 11% > Two = 19% Most patients had not had any surgical procedures for their pain problem but about one-fifth had had more than one surgery�Most patients had not had any surgical procedures for their pain problem but about one-fifth had had more than one surgery�

32. Demographics, cont. Litigation Status Ongoing = 26% N/A = 74% Work Status Not working = 74% Working = 26% About a quarter had ongoing litigation and about three quarters were unable to work due to pain.About a quarter had ongoing litigation and about three quarters were unable to work due to pain.

33. Number of Days Between Evaluation POP and Admission POP Administrations (n=27) Mean No. of Days Between POP administrations: 25 Range: 3 � 49 days Standard Deviation: 13.49 days Again, since this was a convenience sample of pain patients in a clinical setting, there was quite a large range in the duration of time between Evaluation and Admission POP administrations, as well as a good deal of variability in these data. In the more controlled academic psychometric literature, the usual time period for looking at test-retest reliability is from one to two weeks. I was not sure if this would affect the analysis but I predicted, that with such a small n, if anything, correlations between pre and post test might not be significant or very large�.Again, since this was a convenience sample of pain patients in a clinical setting, there was quite a large range in the duration of time between Evaluation and Admission POP administrations, as well as a good deal of variability in these data. In the more controlled academic psychometric literature, the usual time period for looking at test-retest reliability is from one to two weeks. I was not sure if this would affect the analysis but I predicted, that with such a small n, if anything, correlations between pre and post test might not be significant or very large�.

34. Partial Correlations: POP Scores at Evaluation and Admission(Controlling for Days Between POPs, n=27) Current Pain: .76 (p=.00) Average Pain: .64 (p=.00) Mobility: .86 (p=.00) Adls: .81 (p=.00) Vitality: .45 (p=.01) Negative Affect: .61 (p=.00) Fear: .76 (p=.00) In spite of these limitations, controlling for the number of days between POP administrations, correlations are above .70 for current pain, mobility, adls and fear scale scores at Evaluation and Admission�..indicating good test retest reliability for those scales of the POP. The correlations for Avg pain and Negative affect are approaching an acceptable level. The small sample size makes absolute conclusions for these two scales difficult at this point. The Vitality scale correlation was not very large, possibly due to the small sample size and greater variability in the data.In spite of these limitations, controlling for the number of days between POP administrations, correlations are above .70 for current pain, mobility, adls and fear scale scores at Evaluation and Admission�..indicating good test retest reliability for those scales of the POP. The correlations for Avg pain and Negative affect are approaching an acceptable level. The small sample size makes absolute conclusions for these two scales difficult at this point. The Vitality scale correlation was not very large, possibly due to the small sample size and greater variability in the data.

35. Interpretation of Sample #2 ResultsTest-Retest Reliability Caveat: The sample size is small; these results are preliminary The mean length of time between test and retest is long, compared with the most commonly used periods in the literature (about 1-2 weeks) As more data is gathered this analysis will be redone with a shorter test-retest gap and a larger �n� The Vitality Scale of the POP seems to be the least reliable Again, the sample size is small and the test-retest gap is large. After more data comes in, I will repeat this analysis.Again, the sample size is small and the test-retest gap is large. After more data comes in, I will repeat this analysis.

36. Number of Days Between Admission POP and Discharge POP Administrations (n=21) Mean No. of Days Between POP administrations: 56 Range: 35 - 80 days Standard Deviation: 13.08 days Next, we looked at correlations between POP scores at admission to the Rehab Options program and POP scores at Discharge from the program, again controlling for the number of days between POP administrations.Next, we looked at correlations between POP scores at admission to the Rehab Options program and POP scores at Discharge from the program, again controlling for the number of days between POP administrations.

37. Partial Correlations: POP Scores at Admission and Discharge(Controlling for Days Between POPs, n=21) Current Pain: .35 (p=.07) Average Pain: .11 (p=.32) Mobility: *.50 (p=.01) Adls: *.61 (p=.002) Vitality: .11 (p=.31) Negative Affect: .24 (p=.16) Fear: *.61 (p.002) Although the correlations between Mobility, Adls and Fear scale scores obtained at admission and discharge are still significant, they are much lower than those between Evaluation and Admission, when no (new) treatment was being carried out�.. We might expect the rank order of scores in the sample distribution to be similar, since the comparison is within subjects, but they are much less similar after treatment. This is one indication that the POP is sensitive to change. A MANOVA will be done on this sample after a sufficient number of patients have made it through the program to see if there are statistically significant differences between POP scores after treatment.Although the correlations between Mobility, Adls and Fear scale scores obtained at admission and discharge are still significant, they are much lower than those between Evaluation and Admission, when no (new) treatment was being carried out�.. We might expect the rank order of scores in the sample distribution to be similar, since the comparison is within subjects, but they are much less similar after treatment. This is one indication that the POP is sensitive to change. A MANOVA will be done on this sample after a sufficient number of patients have made it through the program to see if there are statistically significant differences between POP scores after treatment.

38. Conclusions and Next Steps The Pain Outcomes Profile shows promise as a brief, clinically useful, reliable and valid multidimensional pain outcomes measurement tool Psychometric analysis of the POP at the level of individual items will be performed and the tool will be revised as necessary Future studies will continue to examine test-retest reliability, validity and sensitivity to change in different pain populations So,So,

39. The Future of Outcomes Measurement Use of similar scales across pain programs will allow for program comparability by clients and payors Use of online data collection will allow for instant benchmarking Clinical Quality Improvement methodology can be used to answer specific treatment questions at multiple sites Looking at the bigger picture, use of similar� Eventually, we hope to create an online data collection portal that will allow the promise of the National Pain Data Bank, which was really ahead of its time, to be realized in a more user-friendly way��then pain programs may be able to obtain reports in real-time�. I would like to be able next to come up with annual quality improvement or clinical research questions that our accredited programs could participate in answering with the Academy� To encourage participation in these projects I will offer an annual �best quality improvement/research project� award..Looking at the bigger picture, use of similar� Eventually, we hope to create an online data collection portal that will allow the promise of the National Pain Data Bank, which was really ahead of its time, to be realized in a more user-friendly way��then pain programs may be able to obtain reports in real-time�. I would like to be able next to come up with annual quality improvement or clinical research questions that our accredited programs could participate in answering with the Academy� To encourage participation in these projects I will offer an annual �best quality improvement/research project� award..

40. Current Research Partnerships The Puerto Rico VA is currently in the process of proposing a project to validate the Spanish POP The US Naval Hospital in Bremerton, WA is using the POP in a residency training program for family practice physicians A researcher at Harvard Medical School has included the Spanish POP in a grant proposal The National Pain Institute will be examining the Spanish POP in a Cuban immigrant population With the amount of attention being paid to pain treatment disparities among different ethnic groups currently, the validation of the Spanish version of the POP is an extremely timely and important project. The most recent proposal is from the NPI which consists of seven different pain programs across Florida and evaluates close to 300 patients per month, many of them only Spanish-speaking. It is vital to With the amount of attention being paid to pain treatment disparities among different ethnic groups currently, the validation of the Spanish version of the POP is an extremely timely and important project. The most recent proposal is from the NPI which consists of seven different pain programs across Florida and evaluates close to 300 patients per month, many of them only Spanish-speaking. It is vital to

41. Ongoing Research To participate in clinical research using the POP: Contact Dr. Campbell at the Academy. Email your CV, a description of the clinical program, typical patients, program process, outcomes measures currently used, ideas for study design Depending on current needs a collaborative relationship may be established for data collection and analysis meme

42. Selected References Campbell, A. & Cole, B.E. (2006) Interdisciplinary Pain Management Programs: The AAPM Model. In Weiner�s Pain Management: A practical guide for clinicians, 7th Ed., Eds: Mark Boswell and B. Eliot Cole. Taylor & Francis, NY. Clark, M.E., Gironda, R.J., & Young, R.W. Jr. (2003). Development and validation of the Pain Outcomes Questionnaire-VA [Electronic version]. Journal of Rehabilitation Research and Development, 40(5), 381.

43. Selected References (cont.) Cohen, B., Clark, M.E. & Gironda, R.W. (2003). Assessing fear of (re)injury among chronic pain patients: Revision of the Tampa Scale of Kinesiophobia. Poster presented at the 22nd Annual Meeting of the American Pain Society, Chicago, IL. Kerns, R.D., Turk, D.C., & Rudy, T.E. (1985). The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain, 23, 345-356. Melzack, R. (1975) The McGill Pain Questionnaire: Major properties and scoring methods. Pain, 1, 277-299. Ruehlman, L.S., Karoly, P., Newton, C., & Aiken, L.S. (2005). The development and preliminary validation of a brief measure of chronic pain impact for use in the general population. Pain, 113, 82-90.