1	Validation of the Pain Outcomes Profile Alexandra Campbell, PhD American Academy of Pain Management Sonora, CA Michael Schatman, PhD Consulting Clinical Psychologist Seattle, 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 Interest Financial Disclosure Michael Schatman, PhD Consulting Clinical Psychologist Seattle, WA Dr. Schatman has no conflict of interest or financial disclosure to make
4	Approaches to Outcomes Measurement in Clinical Settings Administer battery of selected instruments to assess key components of chronic pain experience and functional impairment Administer lengthy multidimensional inventories Rely on chart abstraction of data for Quality Improvement/Outcomes Measurement projects No outcomes measurement strategy
5	Benefits of these Approaches Choice of best instruments available for each important domain of the chronic pain experience Measure most important domains with one comprehensive instrument Data collected accepted and understood by healthcare system Maintain illusion of success until program cancelled by upper management
6	Problems with these Approaches Multiple tests measuring different dimensions (eg., depression, pain, function, etc.): Staff and patient burden re: time to complete, score and interpret; potential for low return on investment Multidimensional inventories: Same as above Chart abstraction: usually retrospective, not useful in patient education, high staff burden No outcomes measurement: may lead to failure of pain program (payors want quality info)
7	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
8	Coping Strategies Questionnaire Strength: Relative brevity (42 items) Limitation: Measures only coping strategies
9	Multidimensional Pain Inventory Strength: Comprehensiveness Limitations: Length (60 items), necessity of computer scoring
10	Behavioral Assessment of Pain Questionnaire Strength: Probably the most comprehensive measure of emotional and behavioral responses to chronic pain Limitation: Length (390 items)
11	Brief Pain Inventory Strength: Brevity (15 items) Limitation: Measures pain intensity and pain interference, but does not address emotional response to pain
12	Chronic Pain Coping Inventory Strength: Well validated, reliable measure of strategies for coping with chronic pain Limitations: Length (64 items), measures only coping strategies
13	Pain Coping Inventory Strength: Measures behavioral, cognitive and psychological dimensions of chronic pain Limitations: Length (92 items), necessity of computer scoring
14	The Origin of the Pain Outcomes Profile (POP) Answers need for brief, clinically useful self-report assessment tool Assesses pain, function and emotional response (multidimensional) Suitable for multiple measurements across treatment Administration time 1-5 minutes Based on National Pain Data Bank Most reliable items from NPDB (Clark et al., 2003) New items created, only 20 items total (see handout) Computer software version in development
15	Domains Assessed by the POP Pain Perception Pain right now Pain on average during the past week Two, 0-10 point Numerical Rating Scales (NRS)
16	Functional Domains Pain interference with Mobility Four, 0-10 point NRS Ability to walk Ability to carry ever day objects Ability to climb stairs Require use of assistive devices (cane, walker, wheelchair)
17	Functional Domains Pain interference with Activities of Daily Living Four, 0-10 point NRS Ability to bathe Ability to dress Ability to use bathroom Ability to manage personal grooming
18	Functional Domains Pain Interference with feelings of Vitality Three, 0-10 point NRS Ability to perform vigorous activities Sense of overall energy Feelings of strength and endurance
19	Emotional Domains Experience of Negative Affect Five, 0-10 point NRS Pain interference with self-esteem, self-worth Feelings of depression today Feelings of anxiety today Difficulty concentrating today Feelings of tension
20	Emotional Domains Fear of increasing activity Two, 0-10 point NRS Amount of worry about re-injury if activity is increased Perception of safety exercising
21	Scoring Instrument Template provided Scale scores calculated: linear aggregation Scoring time minimal For Mobility, Adl, Negative Affect scales: add item scores; divide total by max score possible; multiply by 100 for Percent of Total Score High scores indicate more impairment
22	Scoring Instrument For Vitality scale: add item scores; subtract this total from 30; divide by max score possible; multiply by 100 for Percent of Total Score High scores indicate more impairment
23	Scoring Instrument For Fear scale: Subtract item 23 score from 10 and add to item 14 score; divide by max score possible; multiply by 100 for Percent of Total Score High scores indicate more impairment
24	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
25	Psychometric Properties in 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)
26	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
27	Rehab Options Validation Sample 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
28	Sample Demographics (n=234) Female = 124; male = 110 Mean Age = 43 (range = 18-82) Married = 53% Mean Educ. = 12.5 years Mean Pain Duration = 75.5 months (6yrs) Mean Avg. Narc Daily Consumption = 140 mg morphine equivalent
29	Demographics, cont. Circumstances of Onset of Pain Work-related accident = 45% MVA = 15% Insidious = 20% Other = 20%
30	Demographics, cont. Anatomical Location of Pain Cervical = 16% Lumbar/Sacral = 53% Headache = 7% Diffuse = 7% Other = 17%
31	Demographics, cont. Number of Surgical Procedures for Pain None = 50% One = 23% > One = 27%
32	Demographics, cont. Litigation Status Ongoing = 45% Settled = 10% N/A = 45% Work Status Not working = 77% Working = 23%
33	Other Measures Administered Affective Dimension Beck Depression Inventory-II Beck Anxiety Inventory McGill Pain Questionnaire-Affective Words Functional Domains Modified Oswestry Pain Disability Questionnaire Modified Somatic Perception Questionnaire Pain-related Fear Tampa Kinesiophobia Scale-Revised
34	Beck Depression Inventory-II (BDI-II) 1996 revision of the original Beck Depression Inventory (Beck et al., 1961) Less reliant upon items pertaining to physical symptoms Validity and reliability among pain patients supported through numerous studies
35	Beck Anxiety Inventory (BAI) Beck, 1990 Designed to discriminate anxiety from depression while displaying convergent validity Reliability and validity among pain patients well-supported empirically
36	McGill Pain Questionnaire Affective Clusters 5 clusters of words taken from the MPQ (Melzack, 1975) Measures the affective component of pain (items measuring the sensory and evaluative components are omitted) Validated for a wide variety of pain conditions (Wilkie et al., 1990)
37	Modified Oswestry (Baker et al., 1989) Based upon original Oswestry Low Back Pain Questionnaire (Fairbanks et al., 1980) Designed for LBP patients, but used for other conditions as well (Blunt et al., 1998) Measures patient’s perceptions of their levels of disability Scoring system allows for determination of percentage of perceived disability Several versions have been constructed over the past 25 years and found to be reliable and valid
38	Modified Somatic Perception Questionnaire (MSPQ) Main, 1983 Measures heightened body awareness and somatization Originally designed for use specifically with chronic back pain patients Found to be useful in assessing patients with a wide variety of physical problems Reliability and validity well-supported (e.g., Deyo et al., 1989, Greenough & Fraser, 1991, Sikorski et al., 1995)
39	Tampa Scale of Kinesiophobia – Revised (TSK-13) Based upon lengthier original TSK (Kori, Miller & Todd, 1990) Revised in 2003 (Carter-Sand, Clark & Gironda) Better internal consistency and sensitivity than original Measures fear of movement/(re)injury Reliability and validity supported in numerous studies Factor structure recently criticized by Burwinkle, Robinson & Turk (2005), although their study used the original form of the TSK
40	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
41	Correlations between POP Negative Affect, Fear and Vitality Scales and other affective dependent 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
42	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
43	Rehab Options Treatment Components Physiatric Medical Management Individual Psychological Counseling (2-3X qw) Psychoeducational Groups (2X qw) Nursing Educational Group Biofeedback/Relaxation Training Physical Therapy Occupational Therapy Aquatics Vocational Counseling Dietary Counseling
44	POP Sensitivity to Change (MANOVA, n=50) Intake Discharge M SD M SD F(1,49) Curr 6.36 1.71 4.42 2.02 36.17* Avg 6.68 1.22 4.74 1.65 61.96* Mob 43.12 20.57 27.30 15.76 37.30* Adl 21.21 18.70 14.12 14.36 8.81* Vit 64.85 15.91 47.00 13.88 56.26* NA 49.07 23.21 34.56 19.04 26.28* Fear 52.10 25.74 33.20 19.84 36.29* *p<.05
45	Summary & Conclusions The Pain Outcomes Profile shows promise as a brief, clinically useful, reliable and valid multidimensional outcomes measurement tool that can detect treatment related change in pain and function Future studies will examine test-retest reliability, validity and sensitivity in different pain populations The Spanish version of the POP is available for field-testing and study (see handout)
46	Ongoing Research To participate in clinical research using the POP: Contact Dr. Campbell at the Academy membership@aapainmanage.org, (209) 533-9744 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
47	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
48	Selected References 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. 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 22^nd Annual Meeting of the American Pain Society, Chicago, IL.
49	"Main," Main, C.J. (1983). The Modified Somatic Perception Questionnaire (mspq). Journal of Psychosomatic Research, 27, 503-514. Melzack, R. (1975) The McGill Pain Questionnaire: Major properties and scoring methods. Pain, 1, 277-299.