Validation of the Pain Outcomes Profile

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 InterestFinancial 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
• 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 POPPain 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 gt1200 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 POPAAPMs 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 OptionsValidation 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 n50) completed POP at discharge

28
Sample Demographics (n234)

• 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
• gt 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 QuestionnaireAffective 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 patients 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 (Pearsons 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 lt.01, p lt.05

41
Correlations between POP Negative Affect,
Fear and Vitality Scales and other affective
dependent measures (Spearmans 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 lt.01

42
Correlations between POP Scales and MSPQ, MOPDQ
(Spearmans rho, n 234) Discriminant/Concurre
nt Validity

• Curr Avg Mob Adl Vit NA
  Fear
• mspq .11 .26 .30 .29 .21 .49
  .20
• mopdq .40 .30 .53 .50 .33 .37
  .23
• plt.01 plt.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, n50)

• 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
• plt.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
• alex_at_aapainmanage.org, [phone]
• 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 22nd
  Annual Meeting of the American Pain Society,
  Chicago, IL.

49

• 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.