1. DOCUMENTING MEDICAL NECESSITY THRU OUTCOMES ASSESSMENT

2. OUTCOMES Outcomes Assessment Collection and recording of information relative to health processes Outcomes Management Using information in a way that enhances patient care (Hansen DT, Mior S, Mootz RD in Yeomans SG: The Clinical Application of Outcomes Assessment, Stamford Connecticut, Appleton & Lange, 2000)

3. The Era of Outcomes Assessment Outcomes in clinical practice provide the mechanism by which the health care provider, the patient, the public, and the payer are able to assess the end results of care and its effect upon the health of the patient and society. (Anderson & Weinstein, 1994).

4. Survival To survive, in fact to flourish, in this era of accountability health care providers must be prepared to maintain and be able to provide appropriate documentation and patient records in a clinically efficient and economical manner. (Hansen, 1994).

5. Health Policy With the dawning, of the “era of accountability,” there are new social mandates directed toward health care providers and health-related facilities. Measurements of quality, satisfaction, efficacy, and effectiveness now serve as essential elements for health care decisions and matters of health policy. (Hansen DT, Mior S, Mootz RD in Yeomans SG: The Clinical Application of Outcomes Assessment, Stamford Connecticut, Appleton & Lange, 2000)

6. Outcome Meanings Health Care Customer - Meaning of Outcomes Payers-purchasers Cost containment Regulators HCP compliance Administrators Efficiency-low utilization Clinical Researchers Proof of a premise Outcomes Experts Patient’s benefit Health Care Providers Clinical-Health Status (Hansen DT, Mior S, Mootz RD in Yeomans SG: The Clinical Application of Outcomes Assessment, Stamford Connecticut, Appleton & Lange, 2000)

7. Outcomes Criteria Utility Is it useful? Reliability Is it dependable? Validity Does it do what it is supposed to? Sensitivity Can it identify patients with a condition? Specificity Can it identify those that do not have the condition? Responsiveness Can it measure differences over time?

8. Outcome Measures Appropriate for Clinical Use Questionnaires General health status Pain Functional status Patient satisfaction Physiological outcomes Utilization measures Cost measures

9. Outcomes Measures Appropriately Used When outcome measures are appropriately used and integrated into an evidence-based, patient- centered model of practice, there is accountability and quality assurance. (Hansen DT, Mior S, Mootz RD in Yeomans SG: The Clinical Application of Outcomes Assessment, Stamford Connecticut, Appleton & Lange, 2000)

10. Subjective Questionnaires Subjective outcomes assessment information is gathered by the patient in self-administered questionnaires and scored by either the: health care provider staff members or by a computer.

11. Subjective Questionnaires In spite of the definition associated with the term “subjective,” these “pen-and- paper tools” have been described as very valid and reliable – in many cases more so than many of the “objective’ tests that health care providers have relied upon for years. (Chapman-Smith, 1992; Hansen, 1994; Mootz, 1994).

12. Subjective vs Objective It must be emphasized that although the term “subjective” carries negative connotations, the reliability/validity data published regarding these methods of collecting outcomes is exceptional, typically out-performing the test-retest reliability and validity of most “objective” physical performance tests. (Chapman-Smith, 1992).

13. Classification of Outcome Assessment Tools Subjective (Patient Driven) General Health Pain Perception Condition or Disease Specific Psychometric Disability Prediction Patient Satisfaction Objective (HCP Driven) Range of Motion Strength - Endurance Nonorganic Proprioception Cardiopulmonary Developmental

14. Outcomes Assessment Tools It is important to remember to utilize the same outcome assessment tool through the course of case management with each patient.

15. General Health Questionnaires (GHQ) One can benefit from the use of a GHQ because it is not condition-specific and, therefore, can be applied to virtually any complaint. Yeomans SG: The Clinical Application of Outcomes Assessment, Stamford Connecticut, Appleton & Lange, 2000

16. Application of General Health Questionnaires (GHQ) The application of a GHQ should, at minimum, be used at the following intervals: At the time of the initial presentation for baseline establishment of outcomes assessment. To identify problems for prompt management. At a plateau in care or discharge for outcomes assessment of the treatment benefits or lack thereof. Six months after discharge in order to evaluate the long-term benefits of treatment.

17. Normative Data - Rand 36 General Health Questionnaire ScaleNormative - Exam 1 - Exam 2 Health perception72 4666 Physical functioning 84 4278 Role – Physical81 059 Role – Emotional81 2227 Social functioning83 5570 Bodily Pain75 068 Mental health75 4272 Energy/fatigue61 2248 Ware et al, 1993

18. Rand 36 – General Health Questionnaire This can serve as a very practical reference tool to use for patient report of findings, to insurers to justify “medical necessity” for additional care, and to the health care provider to facilitate the decision making process of case management (referral, discharge).

19. Rand 36 Scales Some of the scales – such as physical function, pain, and role (physical) of the RAND-36 are sensitive to change over time and parallel the patient’s symptomatology quite well.

20. Outcome-Based Practice Correlating this information to the patient’s specific clinical data and then making a clinical decision based on the results represents a difficult but important step in making the “paradigm shift” into becoming an “outcome-based” practice. Yeomans SG: The Clinical Application of Outcomes Assessment, Stamford Connecticut, Appleton & Lange, 2000

21. Pain Perception Visual Analogue Scales Reliable and valid (Jensen and Karoly, 1993). Advantages over other measurement methods (Scott and Huskisson 1976, Price et al 1994).

22. Quadruple Visual Analogue Scale (QVAS) Four specific factors - Von Korff et al, 1992 CURRENT Pain Level AVERAGE or TYPICAL Pain Level Pain level at its BEST Pain level at its WORST Final Score Ratings are averaged x 10 = TOTAL SCORE (Range 0 – 100)

23. QVAS – Guidelines Chronic Patient Average Pain = Last 6 months Frequency Every 2 weeks since a patient’s failure to progress over a 2-week period may indicate a need for a change in management approaches (Haldeman et al, 1993).

24. Condition-specific Over 40 low back functional questionnaires exist with five identified by researchers as “gold standards” (Kopec and Esdaile, 1995). Sickness Impact Profile (Bergner et al, 1981) Roland-Morris Disability Questionnaire (Roland and Morris, 1983) Oswestry Low Back Pain Disability Questionnaire (Fairbank et al, 1980). Million Visual Analogue Scale (Million et al, 1982). Waddell Disability Index (Waddell, 1984).

25. Oswestry Questionnaire (Discharge Score) A score of 11% may be used as an appropriate cut-off score for health care providers to consider for discharge and/or return to work in an uncomplicated Low Back Pain case. (Erhard et al 1994)

26. Revised Oswestry Retitled section 8, now identified as “Social Life,” This section was originally entitled “sex life” and was left blank quite often by respondents. In the revised version, all ten sections are completed more often than in the original version. Hudson-Cook N, Tomes-Nicholson K, Breen AC. A Revised Oswestry Back Disability Questionnaire. Manchester Univ Press, 1989.

27. Oswestry - Score Interpretation 0-20% Minimal Disability 20-40% Moderate Disability 40-60% Severe Disability 60-80% Crippled 80-100%Bed Bound or Exaggerating

28. Oswestry Score – Statistically Significant Change (Minimal-Moderate Disability) Initial Score -Change Necessary 0-82 5-124 9-16 5 13-20 8 17-24 8 Stratford et al, 1988

29. Roland-Morris Disability Questionnaire (RMQ) Total Possible Score = 24. “The best single study of assessing short- term outcomes of primary care patients with low back pain “(Von Korff and Saunders, 1996) Scores greater than 13 = Significant disability associated with an unfavorable outcome (Von Korff and Saunders, 1996) Any change of less than 4 points is both too small to matter and too small to be reliable (Stratford et al, 1996)

30. Neck Disability Inventory (NDI) “was designed by modifying the Oswestry Low Back Pain Disability Questionnaire” “The instrument was utilized on an initial sample of 17 consecutive patients with whiplash injuries with good statistical significance reported”.

31. Copenhagen Neck Functional Disability Scale (CNFDS) “CNFDS demonstrates short-term and day-to-day reliability internal consistency practicality accurate patient perceptions regarding functional status and pain doctor’s global assessment responsiveness to change over long periods of time

32. CNFDS Score Range Maximum point score is 30 and “indicates that the individual is extremely disabled because of neck trouble, whereas a score of 0 indicates that there is no neck trouble present.”

33. Headache Disability Inventory (HDI) 25 question – condition specific often used in conjunction with the NDI for patients suffering from cervicogenic headaches (Jacobson et al, 1994) 12 emotional questions 13 functional questions

34. HDI Interpretation 100 Points = Maximum possible Score Headache Severity (Jacobson et al, 1994) 2-32 = Mild 33-59 = Moderate 60 + = Severe Positive Treatment Results 29 point total score change (Jacobson et al, 1994)

35. Dizziness Handicap Inventory (DHI) 25 questions evaluate the impact of vestibular system disease or dizziness on everyday life Functional: 9 items Emotional: 9 items Physical: 7 items

36. DHI Studies “good internal consistency, reliability, & validity demonstrated (Jacobson & Newman 1990). “found to correlate with balance function tests that included electronystagmography, rotation testing, and platform posturography (Jacobson et al, 1991)

37. Tinnitus Handicap Inventory (THI) 25 questions “developed to track patients who suffer from tinnitus pre- and post- treatment” (Newman 1996) Functional: 12 items Emotional: 8 items Catastrophic: 5 items (identifies patients with psychosocial concerns) “found to be valid, responsive, and easy to score and interpret.”

38. Temporomandibular Disorder Disability Index (TMD) 10 questions and scored similar to Oswestry “the tool has face-validity”

39. Spinal Stenosis Questionnaire 18 items Symptom Severity : 7 Items Physical Function: 5 Items Satisfaction: 6 Items

40. Spinal Stenosis Studies “was found to be reproducible, valid, internally consistent, and responsive to clinical change in a geriatric spinal stenosis population pre and post- surgery” (Stucki et al, 1996). This measure is meant to be used in conjunction with other existing spine and health status instruments.

41. Shoulder Injury Self- Assessment of Function 15 item ADL tool included in the American Shoulder and Elbow Surgeons SEF (Barrett, 1987; Rowe, 1987) 0 = Normal 60 = Self-assessed Disabiltiy

42. Shoulder Pain and Disability Index (SPADI) 13 point questionnaire measuring Pain Disability Scale has been shown responsive to Improved Change Worsened Change

43. Elbow Performance Index 100 point index (Morrey, 1993) Pain - 45 points Motion - 20 points Stability - 10 points Function - 25 points

44. Carpal Tunnel Syndrome Questionnaire (CTSQ) “strength lies in its ability to track outcomes based on SYMPTOM SEVERITY and FUNCTION, which are two of the primary reasons presented to health care providers.” 19 questions demonstrating “reproducibility, internal consistency, validity and responsiveness” Symptom Severity: 11 items Functional Status: 8 items

45. CTSQ Reproducibility and Consistency “In comparing inter-rater agreement to objective measures, Levine et al point out the superior scores gathered by the CTSQ compared to the inter-rater agreement in ECG interpretation or between radiologists regarding the presence of osteoarthritis…” (Levine 1993)

46. CTSQ Measures “this dispels the myth that so-called soft (subjective) outcomes such as the CTSQ are less valuable when compared to objective measures when, in fact, the subjective measures are often more sensitive, specific, and responsive than many objective measures.” (Koran, 1975)

47. CTSQ Validity “CTSQ and traditional physical examination measures of median nerve function capture different but complementary outcome information. Therefore, symptom severity and functional status cannot be reliably compared to sensibility or nerve conduction testing.” (Levine et al, 1993)

48. Patient-Rated Wrist Evaluation 150 point index Pain - 50 points Function Specific Activities - 60 points Usual Activities - 40 points

49. Hip Rating Questionnaire 100 point index (Johanson et al, 1992) Pain Walking Function Arthritis

50. Patellofemoral Function Scale (PFS) 8 item ADL tool “demonstrating potential to detect clinical change” (Reid, 1992) 16 = Normal 0 = Functional Disability

51. Subjective Knee Score Questionnaire (SKSQ) 8 questions rating symptoms and specific sport functions Symptoms = Pain - Swelling - Stability Sport Function = Activity Level–Walking- Stairs-Running-Jumping/Twisting 100 = Normal 6 = Functional Disability

52. Ankle Grading System 100 point index ( Mazur et al, 1979) Pain - 50 points Function - 6 points Walking - 6 points Support - 6 points Hills (up) - 3 points Hills (down)- 3 points Stairs (up) - 3 points Stairs (down) 3 points Toe Rising - 5 points Running - 5 points ROM - 10 points

53. Waddell Nonorganic Low Back Signs Objective measures for evaluating abnormal psychosocial issues (Waddell et al, 1980) 8 tests that make up the 5 Waddell Signs 3 or more positives, nonorganic LBP is considered

54. Tests Comprising Waddell’s Signs Tenderness Superficial Nonanatomic Simulation Axial loading Trunk rotation Distraction Straight Leg Raising Regional Nonanatomic weakness Nonanatomic sensation Over-reaction

55. Psychometric Assessment Tools - DRAM Distress and Risk Assessment Method DRAM (Feuerstein 1987) Modifed Somatic Perception Questionnaire (MSPQ) Modified Zung Depression Index

56. DRAM – Distress and Risk Assessment Method Type Modified Zung MSPQ Normal <17 NA At Risk 17-33 <12 Distressed/Depressive >33 NA Distressed/Somatic 17-33 >12

57. Red Flags of Low Back Pain Cancer Infection Spinal Fracture Cauda Equina

58. Red Flag Questionnaire “Red Flags” of serious disease should be sought from the earliest possible time. Patient management can then focus on de-medicalizing the problem by: Reassuring the patient that there is nothing seriously wrong, That “hurt” does not necessarily equal “harm”, Increasing activities as soon as possible.

59. Risk Factor Assessment (Standard Questionnaire) Risk of a Prolonged Recovery – Score Mild - 82 - 114 Moderate - 115 – 143 Severe - > 143

60. Risk Factor Assessment (Re-Exam Questionnaire) Risk of a Prolonged Recovery – Score Mild - 51 - 71 Moderate - 72 - 89 Severe - > 89

61. Range of Motion Discriminates between various assessment and treatment outcomes Provides important clinical information inspite of controversies associated Has proven to be an objective outcome assessment tool

62. Strength and Endurance Testing – Alaranta “valid, reliable, safe, practical, and responsive measures of trunk strength and endurance.” 4 Tests (Alaranta et al, 1994) Repetitive sit-up Repetitive arch-up Repetitive squatting Static back endurance Normative values 508 male/female employees white-collar and blue-collar age: 35-54

63. Alaranta Test Procedures Repetitive sit-ups - arch-ups - squatting 50 reps maximum 2-3 seconds per repetition “If the motion becomes clearly jerky or asymmetrical, the test should be stopped” Static Back Endurance 240 seconds maximum “test discontinued if aggravated by pain or muscle spasm.”

64. Alaranta Test Guidelines Patient warmup for 5 minutes prior to beginning testing (ei. bicycle ergometer, etc) Tests are retested in the same order 1-minute interval between each test Tester may count repetitions aloud but should remain as neutral as possible Test terminated if patient told more than one time to correct trunk motion Patient informed about mild painful feelings in tested muscle groups during the couple of days following the maximal test.

65. Alaranta Normative Values Age 35-54 Males Females Repetitive sit-up 27 +/- 14 19 +/- 14 Repetitive arch-up 28 +/- 14 24 +/- 14 Repetitive squatting 37 +/- 13 21 +/- 12 Static endurance 97 +/- 53 87 +/- 59

66. Satisfaction Questionnaire (SQ) 14 item measure of satisfaction modified from The Chiropractic Satisfaction Questionnaire Includes items on interpersonal quality technical quality time spent cost of care satisfaction with care Median Score = 90 / 100

67. 4 Steps to Become Outcomes Based Utilize subjective/objective tools Score the tools at the initial visit to establish baseline measures Repeat the instrument after 2-4 week intervals to track the effects of treatment changes Base clinical decisions on the outcome results

68. “Medical Necessity” The fully developed clinical record defines the “medical necessity” of the case in the eyes of the insurer.

69. “Medical Necessity” Documentation Provider must document Etiology of complaint (onset, severity, frequency, duration Patient’s health history Current subjective complaints Current objective clinical findings Diagnosis Treatment plan Measurements of patient improvement (outcome assessment)