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Meaningful Quality Measures for MS:

A Case-Based Interactive Workshop

Agenda

Introduction and Polling Questions Edward Fox, MD, PhD

Case #1 and Discussion of Quality Measuresin Patient Care Colleen Harris, MN, NP, MSCN

Case #2 and Discussion of Quality Measures in Disease Assessment Corey Ford, MD, PhD

Panel Discussion and Q & A

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Dampened Expectations

An expert is somebody who is more than 50 miles from home, has no responsibility for implementing the advice he gives, and shows slides.

-- Edwin Meese

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Definitions

“Meaningful” – having a serious important, or useful quality or purpose*– To Whom?

– Involving quality or quantity of life?

– In a cost-effective manner?

* Merriam-Webster Dictionary

Definitions

“Quality” – a high level of of value or excellence*– Reproducible?

– Global?

– Useful in a typical setting?

* Merriam-Webster Dictionary

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Definitions

“Measure” – amount or degree of something*– Based on the objective or subjective?

– Quantifiable?

– Easily understood by patients and HCP alike?

* Merriam-Webster Dictionary

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Polling Question #1

Can quality measures be applied to the subjective symptoms of MS?– 1. If given enough time, yes– 2. Only for some symptoms, others are

incapable of being quantified or studied– 3. No, subjective is inherently unmeasurable

Polling Question #2

Which of the following symptoms of MS has the best quality measures?– 1. Depression– 2. Spasticity– 3. Pain– 4. Urinary Urgency– 5. Fatigue

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Polling Question #3

What is the biggest detrimental factor to our use of Meaningful Quality Measues in daily patient care?– 1. Poor access to tools such as questionnaires– 2. Unwillingness of patients to participate– 3. Limited value of the findings– 4. Not enough time to review results

Case 1

45 year old male with RRMSOn three different medications for

over the past 8 years, fair adherence and tolerance

Multiple current issues with depression, bladder, and pain

MRI-brain shows chronic changes without acute new lesions over 3 years

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Evaluating the Quality of  our Management Strategies

Colleen Harris MN NP MSCNNurse Practitioner/ManagerUniversity of Calgary MS Clinic

Quality Indicators in MS Determining whether persons with MS receive appropriate, comprehensive  health care requires tools for measuring quality.

Quality indicators can refer to the quality of structural aspects of care, processes of care, and outcomes of care.

Experts have identified symptoms such as bladder dysfunction, spasticity, pain, and depression as care domains that require indicators to evaluate effectiveness of treatment and management. Cheng et al (2010) Multiple Sclerosis,  16(8) 970 – 980

Evaluation strategies becoming more important with surfacing issues around quality assurance and reimbursement. 

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Quality Indicators for Complex Symptoms

1. Depression

2. Bladder dysfunction

3. Spasticity

4. Pain

Crayton H, et al. Neurology. 2004;63(11Suppl5):S12-S18.

Depression in MS

The most common mood disorder in patients with MS: lifetime occurrence approx 50% of patients

Etiology is unknown (related to MS pathophysiology, meds used to treat MS, or the challenges of living with MS)

Weak association may exist between depression and disease‐modifying therapies

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Bashir K, et al. Handbook of Multiple Sclerosis. 2002.

Comprehensive Management

Provide a supportive, therapeutic environment

Identify risk factors (screening, self‐report, environmental factors, family history)

Combination psychotherapy and antidepressants

Wellness focus (exercise)

Be alert for suicidal ideation/plan

Assess and reassess continually

Adjust medications appropriately

Indicators Assessment process or tool – interview with health practitioner, tools such as Beck Depression, CES‐D

Provide Treatment for depression –

Medication  

Counselling

Follow up to determine effectiveness

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Assessment Questions Do you feel hopeful about the future?

Do you have thoughts of suicide and have you considered a plan?

Do you look forward to, and plan future activities in your life?

If you are being treated, is your treatment effective?

When to Refer

Suicidal ideation

Lack of efficacy or intolerance of anti depressants

Persistent anxiety

Bipolar symptoms

Pseudobulbar affect

Psychosis

Personality and behaviour changes

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Bladder Dysfunction

Data from Crayton H, et al. Neurology. 2004;63(11 Suppl 5):S12-S18.

Inability to Store Inability to Empty Combination

Symptoms• Urgency/frequency• Incontinence• Nocturia• PVR <100 mL

Symptoms• Urgency, hesitancy• Double voiding• Frequency• Incomplete emptying• PVR >100 mL

Symptoms• Urgency, hesitancy• Double voiding• Incomplete emptying• Dribbling incontinence

PVR = post-voiding residual

Treatment Goals

• Maintain renal function

• Establish normal voiding patterns

• Reduce symptoms and improve QOL

Non-pharmacologic Approaches• Bladder training and behavior modification

• Intermittent or continuous catheterization

• Dietary modification

Prevention of Secondary Symptoms • Avoid urinary tract infection and reflux

by effective bladder emptying

Pharmacologic Treatment• Antimuscarinics/anticholinergics

• Alpha blockers

• Anti-spasticity agents/nerve blocks

Management of Bladder Dysfunction

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Cheng E M et al (2010) Quality indicators in multiple sclerosis. Mutiple Sclerosis 16(8) 970-980

Indicators

Assess urinary symptoms

Assess for UTI

Management based on post void residual urine

Avoid treatment of asymptomatic bacteriuria

Test for antibiotic susceptibility with recurrent UTI

Assessment Questions Do you feel you empty your bladder completely?

Do you have dribbling or incontinence?

How often do you get up at night to empty your bladder?

Have you had a recent UTI?

Are you a prisoner of your bath room?

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Facilitating Quality: Developing UTI Guidelines, an Alberta Experience Multiple Sclerosis and  Management of  Urinary Tract Infection Clinical Practice Guideline | November 2013. For the complete guideline refer to the TOP website: www.topalbertadoctors.org

Guideline Includes: Patient assessment tool to help identify symptomatic bladder symptoms

Guided procedure for physicians to assess for and treat UTI

Antibiotic schedule

Developed by a group of physician and nurse specialists: MS neurologist/nurses, internal medicine ‐infectious disease , urologist, and primary care physician

What we Learned from Experts Dip stick totally unreliable for assessing UTI ‐ go right to culture

Getting patients to drink jugs of water not going to prevent UTI’s – no evidence, and makes bladder symptoms worse

Don’t wait to start antibiotics once urine culture collected

Make sure to follow up with culture results and stop or switch antibiotics when necessary

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When to Refer Persistent UTI’s

Co‐existing bladder problems – obstetrical issues, prostrate issues

Kidney involvement – stones, renal failure

Ongoing incontinence not managed by  ISC

Botox injections

Crayton H, et al. Neurology. 2004; 63(11 Suppl 5):S12-S18. Johnson J, Porter B. In: Advanced Concepts in Multiple Sclerosis Nursing Care. 2001:117-136.

Spasticity in MS

Hypertonicity of muscles “tightness, pulling, tugging, aching”

Results from demyelination in descending CNS pathways

Different muscle groups involved depending on lesion location

Spasticity may increase over time without new CNS lesions

Results in:

Increased resistance to stretch

Accentuation of deep tendon reflexes and clonus

Uncontrolled flexor responses and extensor spasms

Limited mobility 

Excessive energy expenditure

Pain and discomfort

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Non-pharmacologic interventions

Surgicalinterventions

Technologicalinterventions

Pharmacologic interventions

Regional and local agents

Schapiro RT. Neurorehabil Neural Repair. 2002;16(3):223-231.Schapiro RT, Schneider DM. In: Comprehensive Nursing Care in Multiple Sclerosis. 2002:31-52.

Spasticity Management

• Stretching• Positioning• Seating• Range of motion• Orthotics• Physical therapy

Non-pharmacologic Pharmacologic

• Baclofen • Tizanidine• Gabapentin • Levetiracetam • Diazepam • Onabotulinum toxin A

Surgical

• Baclofen pump

Data from Crayton H, et al. Neurology. 2004;63(11 Suppl 5):S12-S18.

Spasticity Management

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Indicators Assessment – neuro exam, Modified Ashworth Work –up of spasticity

Rule out Infection New disease activity Unmanaged pain

Manage persistent spasticity

Cheng E M et al (2010) Quality indicators in multiple sclerosis. Multiple Sclerosis  16(8) 970‐980

ROM = range of motion

Modified Ashworth Scale

Score Criteria

0 No increased tone

1 Slight increased tone (catch and release at end of ROM)

1+ Slight increase in tone manifested by a catch followed by min. resistance throughout the remainder of the ROM (less than half the ROM)

2 Marked increase in tone through most of ROM but affected part(s) move easily

3 Considerable increased tone, passive movement difficult

4 Affected part(s) rigid in flexion or extension

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Assessment Questions Do you wake up at night with jumpy or stiff legs?

Do you experience stiffness when you get up in the morning?

Do you experience painful cramping?

When your driving do your legs or feet cramp or become stiff?

When to Refer To physio 

for stretching, 

mobility issues

seating

To rehab specialist physician 

when Botox required

To  surgeon

intrathecal baclofen pump

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1. Benrud-Larson LM, Wegener ST. NeuroRehabilitation. 2000;14(3):127-137. 2. Solaro C, et al. Neurology. 2004;63(5):919-921. 3. Svendsen KB, et al. Arch Neurol. 2003;60(8):1089-1094. 4. Archibald CJ, et al. Pain. 1994;58(1):89-93. 5. Thompson AJ. Curr Opin Neurol. 1998;11(4):305-309. 6. Stenager E, et al. Acta Neurol Scand. 1991;84(3):197-200.

Pain in Multiple Sclerosis

A complex sensory phenomenon, multifactorial

Reported in up to 80% of MS patients1‐3

Common cause of disability in MS4

Under‐recognized and inadequately managed5, 6

Most MS‐related pain is manageable

Indaco A, et al. Acta Neurol (Napoli). 1994;16(3):97-102.Kerns RD, et al. J Rehab Res Dev. 2002;39(2):225-232.Stenager E, et al. Acta Neurol Scand. 1991;84(3):197-200.

Acute vs Chronic Pain

Acute syndromes

Neuralgic pain (eg, trigeminal neuralgia)

Painful optic neuritis

Lhermitte’s syndrome

Chronic syndromes

Neurogenic pain (eg, dysesthesia)

Musculoskeletal pain (eg, low back pain)

Spasticity/spasms

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0 10 20 30 40 50 60

Svendsen KB, et al. Arch Neurol. 2003;60(8):1089-1094. Copyright © 2003 American Medical Association.

Patients with MSReference subjects

Extremities(not muscles

or joints)

JointsBackHead

Muscles

NeckEyes

Abdomen

Chest

Face

% of Patients

*

*

*

**

Anatomic Distribution

N = 1540

*P<0.001

Measuring Pain

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Terms Used to Describe Quality of Pain(From McGill Pain Questionnaire) Flickering, quivering, pulsing, throbbing. Beating

Pinching, pressing, gnawing, cramping

Dull, sore, hurting, aching, heavy

Spreading, radiating, penetrating, piercing

Hot, burning, scalding, searing

Tingling, itchy, smarting, stingingMelzack  & Torgerson (1971) McGill University ‐Montreal, Canada

Proposed Indicators Assessment and identification of type of pain

Education/goal setting about pain managment

Address factors that might exacerbate pain (while also treating the pain):  anxiety, depression, sleeplessness, psychosocial stressors

Utilize non‐pharmacologic strategies

Medications tailored to the nature and severity of the pain 

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Assessment Questions When did your pain first occur?

Where is the location of your pain? – (can use diagrams)

Can you describe your pain? (use descriptors from the  McGill Inventory ie. aching, prickly, burning) 

How severe is your pain? – simple visual analog scale

What strategies have you used to manage your pain both over the counter,CAMS, and prescription? –Ensure accurate account.

When to Refer When you have somewhere to refer to – pain programs not readily available and wait lists are long

Complex  medication schedules

When it is hard to distinguish pain from complicated psycho‐social issues

When you need to enlists multi‐disciplinary specialists

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Summary Improving “Comprehensive MS Care Quality” is our responsibility

Symptom management is complex and we need to provide standard practice to all care providers involved in MS care delivery

Incorporating established quality indicators not as difficult as it seems

Measurement and improvement are possible

Polling Question #1

Can quality measures be applied to the determination of disease activity?– 1. Yes, we have the tools present currently– 2. Only in limited cases can we accurately

predict the course of MS– 3. No, MS is not standardized enough to

apply measurements of disease activity

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Polling Question #2

Which of the following disease measures is the most dependable in following a patient’s condition?– 1. Relapse rate– 2. Disability progression– 3. MRI findings

Polling Question #3

What is the biggest detrimental factor to our use of Meaningful Quality Measues to determine the clinical status of a patient?– 1. Neurologic exam is too variable from HCP

to HCP– 2. Neurologic exam is too variable within a

given patient’s day– 3. Poor visualization of the pathology– 4. Not enough correlation between measures

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Case 2

27 year old female with RRMSOn an injectable medication for 1

year, fully adherent to medicationSingle relapse, mild ON, full

recoveryMRI-brain shows 2 small new

subcortical lesions

Evaluating the Effectiveness of  Treatment Plans in the Office Setting

Corey C. Ford, MD, PhD

MS Specialty Clinic

University of NM HSC

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AHRQ Definitions of Quality or Clinical performance Quality measures: enable the user to quantify the quality of a selected aspect of care by comparing it to an evidence‐based criterion that specifies what is better quality.

Clinical measures*:  assess the degree to which a provider competently and safely delivers the appropriate clinical services to the patient within the optimal time period.

AHRQ website:  http://www.qualitymeasures.ahrq.gov/tutorial/varieties.aspx

AHRQ Clinical Performance Measures Process: A health care‐related activity performed for, on behalf of, or by a patient.

Example: The percentage of patients who receive a follow up MRI scan 6 months after starting a new drug.

Access: Access to care is the attainment of timely and appropriate health care by patients

Outcome: An outcome of care is a health state of a patient resulting from health care.

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AHRQ Clinical Performance Measures Structure: Structure of care is a feature of a health care organization or clinician related to the capacity to provide high quality health care.

Example: Use of electronic health care record

Patient Experience: A patient's observations of and participation in health care.

Example: Provider communication

Meaningful performance measures Importance of measure

Validity of measure, is it evidence based?

Is it predictive and actionable?

Is it attainable or realistic?

Is it incentive based? P4P, eg. E‐prescribing

Biggest metric insurance companies use is cost per patient per year

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Possible MS measures‐general Clinical outcomes

Patient safety

Processes and test ordering, eg. MRI, U/A

Access to care

Patient satisfaction

Cost of care

Cost effectiveness

Possible MS measures‐specific Annualized relapse rate Timed 25’ walk EDSS

Formal exam Patient reported

MRI measures Burden of disease: lesion number and/or volume Contrast enhancing lesions Brain atrophy Non conventional imaging?

Cognitive testing (in office or formal) Low contrast visual acuity

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Problems with MS outcomes What if the provider doesn’t have control over an outcome or intervention? Ideally metrics should be clinical outcomes, eg. less disability, longer productive work cycle, less need for long term care or disability payments, better QOL, etc.

But…....individual patients have diverse outcomes

Newer treatments may be more effective than older agents, so logically they should be used.

If payers limit or deny access to potentially more effective agents based on cost issues, then certain clinical outcome metrics by which providers are measured are handicapped.

Goals of DMT in RRMS Typical treatment outcomes in MS 

Reduce relapses; extend time between relapses 

Reduce severity of relapses 

Prevent or extend time to disability milestones as measured by the Expanded Disability Status Scale (EDSS) and other disability measures (e.g., Multiple Sclerosis Functional Composite)

Prevent or extend time to onset of secondary progressive MS

Prevent or reduce the number and size of new and enhancing lesions on MRI

Limit overall MRI lesion burden in the central nervous system (CNS)

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Goals of MS Therapy and Indicators of Suboptimal Response

Emerging treatment goals in MS Reduce measures of axonal damage, CNS atrophy, and evidence of microscopic disease via conventional MRI and advanced imaging modalities

Modify biomarkers associated with inflammatory disease activity and neurodegeneration in MS

Extend time during which there is no evidence of disease activity (NEDA)

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NEDA: No Evidence of Disease Activity In MS “full responders” to DMT might be defined as: 

No relapses 

No sustained disability worsening on examination (as measured by EDSS) 

No or minimal MRI activity (i.e. 1 small new T2 lesions in the first 2 years in someone who is otherwise stable) 

Changing DMT: Efficacy reasons

No response or suboptimal therapeutic response

Initial response followed by breakthrough disease

Neutralizing antibodies leading to suboptimal response

Introduction of new therapy that may offer better management of disease

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Changing DMT: Safety reasons

Significant  adverse events such as liver toxicity or decreased blood counts

Comorbid condition or new safety consideration (e.g., pregnancy, development of renal disease)

Change in patient’s risk profile for adverse events  (e.g.,  JC virus  antibody conversion)

Development of tolerability problems over time (e.g., skin damage)

Introduction of new therapy that may offer better safety

Changing DMT: Patient‐related Reasons Difficulties with adherence to therapy

Desire to try different administration method

Perceived lack of efficacy of current therapy

Introduction of new therapy that may offer better tolerability

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MRI as a surrogate marker of MS outcomes Sormani et al. 2009 showed a strong correlation between treatment effects on MRI outcomes (new T2 or CEL lesions) and clinical relapses in a large meta‐analysis of over 6500 RRMS patients in 23 randomized double‐blind placebo‐controlled trials.

In 2010 they further demonstrated a significant correlation between MRI outcomes and disability worsening by EDSS.

These studies apply to group data and may not be predict outcome for individual patients.

MRI measures of outcome T2 lesion burden, number or volume of lesions

T1 black holes reflecting tissue damage

Contrast enhancing lesions indicating active inflammation with BBB breakdown and axonal loss

Brain atrophy.  Whole brain atrophy correlates with disability and axonal loss and could be obtained routinely.  More gray matter atrophy in SPMS (Fisniku, et al. 2008).

Gray matter atrophy better predicts disability and cognitive impairment (Roosendaal, et al. 2011)

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MRI Guidelines (CMSC) Previously issued guidelines from the CMSC recommend monitoring using brain MRI:  As a baseline prior to starting a new DMT 

To evaluate an unexpected clinical worsening. (This includes a breakthrough relapse on therapy or unexpected increase in clinical symptoms while on therapy); 

For re‐assessment before starting or modifying therapy; 

To assess subclinical disease activity every 1 to 2 years, particularly in the first several years of disease; the exact frequency may vary depending on the patient’s clinical course and other clinical features.

Significance of MS lesions at CIS

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Role of MRI in initiating DMT following a CIS Several studies support institution of early DMT in patients with 

a CIS to slow or prevent early axonal damage

O’Riordan, Brex and Fisniku studies. Upwards of 90% of patients with 2 or more baseline MRI lesions progressed to RRMS in about 15 years. More also reached EDSS > 5.5.

But, 80% of those with no MRI lesions at baseline did not progress to RRMS at 20 years.

Any (even 1) lesion on baseline MRI predicts subsequent development of further MS activity

Placebo groups in CIS trials are more disabled over time with just 

a 2 year delay "Time is brain“

Guidelines for early MS treatment

The presence of 2‐3 lesions typical of MS on baseline MRI at CIS should prompt consideration of early treatment once other diseases are excluded. 

Patients with CIS and other enhancing MRI lesions not related to the CIS meet McDonald criteria for CDMS

Spinal cord T2 lesions on early MRI predict both conversion to MS and subsequent disability

Patient concerns and preferences should always be considered in the treatment decision making process whenever possible. 

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MRI Recommendations after an Acute MS Relapse Important to obtain baseline scan at time first or new DMT is started to serve as comparison for subsequent follow up scans 

Suboptimal response or failure may be indicated by:

Enhancing activity (≥ 1 enhancing lesions) or ≥2 T2 lesions in Year 1 of therapy suggest DMT failure

Unacceptable increase in T2 or T1 lesion load 

Significant development of atrophy 

Other outcome measures Optical coherence tomography

OCT measures retinal nerve fiber layer thickness and macular volumes and correlates with clinical measures such as low‐contrast letter acuity and visual field testing

The unaffected eyes of patients with MS are often abnormal, even without a history of optic neuritis.

Cognitive testing

Limited modalities practical in clinic

Referral for a more detailed cognitive battery may be indicated

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Panel DiscussionQ&A

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Mixed Signals