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					   DOCUMENTING
 MEDICAL NECESSITY
       THRU
OUTCOMES ASSESSMENT
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)
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).
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).
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)
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)
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?
Outcome Measures
Appropriate for Clinical Use
   Questionnaires
       General health status
       Pain
       Functional status
       Patient satisfaction
   Physiological outcomes
   Utilization measures
   Cost measures
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)
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.
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).
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).
Classification of Outcome
Assessment Tools
   Subjective                     Objective
         (Patient Driven)                   (HCP Driven)
       General Health                 Range of Motion
        Pain Perception                 Strength - Endurance
    
                                    
       Condition or Disease
        Specific                       Nonorganic
       Psychometric                   Proprioception
       Disability Prediction          Cardiopulmonary
       Patient Satisfaction           Developmental
Outcomes Assessment Tools
   It is important to remember
    to utilize the same outcome
    assessment tool through the
    course of case management
    with each patient.
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
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.
    Normative Data - Rand 36
    General Health Questionnaire
    Scale                 Normative - Exam 1 - Exam 2
        Health perception       72    46       66
        Physical functioning    84    42       78
        Role – Physical         81     0       59
        Role – Emotional        81    22       27
        Social functioning      83    55       70
        Bodily Pain             75     0       68
        Mental health           75    42       72
        Energy/fatigue          61    22       48
             Ware et al, 1993
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).
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.
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
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).
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)
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).
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).
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)
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.
Oswestry - Score
Interpretation
   0-20%     Minimal Disability
   20-40%    Moderate Disability
   40-60%    Severe Disability
   60-80%    Crippled
   80-100%   Bed Bound or
              Exaggerating
Oswestry Score –
Statistically Significant Change
(Minimal-Moderate Disability)
   Initial Score -            Change Necessary
       0-8                    2
       5-12                   4
       9-16                   5
       13-20                  8
       17-24                  8
           Stratford et al, 1988
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)
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”.
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
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.”
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
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)
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
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)
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.”
Temporomandibular Disorder
Disability Index (TMD)
   10 questions and scored similar to
    Oswestry
   “the tool has face-validity”
Spinal Stenosis Questionnaire
   18 items
       Symptom Severity : 7 Items
       Physical Function: 5 Items
       Satisfaction: 6 Items
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.
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
Shoulder Pain and Disability
Index (SPADI)
   13 point questionnaire measuring
       Pain
       Disability
   Scale has been shown responsive to
       Improved Change
       Worsened Change
Elbow Performance Index
   100 point index (Morrey, 1993)
       Pain         -    45 points
       Motion      -     20 points
       Stability   -    10 points
       Function    -    25 points
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
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)
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)
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)
Patient-Rated Wrist Evaluation
   150 point index
       Pain                    -    50 points
       Function
            Specific Activities -   60 points
            Usual Activities    -   40 points
Hip Rating Questionnaire
   100 point index (Johanson et al, 1992)
       Pain
       Walking
       Function
       Arthritis
Patellofemoral Function Scale
(PFS)
   8 item ADL tool “demonstrating
    potential to detect clinical change”
    (Reid, 1992)
   16 = Normal
   0 = Functional Disability
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
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
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
Tests Comprising Waddell’s
Signs
   Tenderness
       Superficial
       Nonanatomic
   Simulation
       Axial loading
       Trunk rotation
   Distraction
       Straight Leg Raising
   Regional
       Nonanatomic weakness
       Nonanatomic sensation
   Over-reaction
Psychometric Assessment
Tools - DRAM
   Distress and Risk Assessment Method
    DRAM (Feuerstein 1987)
       Modifed Somatic Perception Questionnaire
        (MSPQ)
       Modified Zung Depression Index
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
Red Flags of Low Back Pain
   Cancer
   Infection
   Spinal Fracture
   Cauda Equina
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.
Risk Factor Assessment
(Standard Questionnaire)
   Risk of a Prolonged Recovery – Score
       Mild       -    82 - 114
       Moderate -     115 – 143
       Severe   -      > 143
Risk Factor Assessment
(Re-Exam Questionnaire)
   Risk of a Prolonged Recovery – Score
       Mild     -     51 - 71
       Moderate -     72 - 89
       Severe   -      > 89
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
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
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.”
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.
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
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
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
“Medical Necessity”
   The fully developed clinical record
    defines the “medical necessity” of the
    case in the eyes of the insurer.
“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)

				
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