Kings Headache Service

1
Dr Andrew Dowson
Assessing the impact of migraine

• Kings Headache Service
• Kings College Hospital
• London, UK

2
Overview

• Definition of impact (disability)
• History of migraine impact
• Recent research into migraine impact
• Assessing migraine impact
• Rationale for using instruments
• Development of new instruments
• Strategies for managing migraine using impact
  measures

3
Definition of impact (disability)

• WHO definition In the context of health
  experience, a disability is any restriction or
  lack (resulting from an impairment) of ability
  to perform an activity in the manner or within
  the range considered normal for a human being'

World Health Organization, 1980.
4
History of migraine impact

• Ancient civilizations
• Classical times
• Medieval
• 18th19th Century
• 19th Century
• 20th21st Century

5
Ancient treatments for migraine
6
Classical times
7
Medieval
8
18th 19th Century
9
19th Century
10
20th Century
11
Recent research into migraine impact

• USA
• Canada
• Japan
• Europe
• Impact in the workplace and in education
• Impact on family and social activities

12
Migraine-related disability in the USA
51
36
Sufferers ()
12
1
None
Mild
Moderate/severe
Dont know
Stewart WF et al. Neurology 199444(suppl
4)2439.
13
Migraine-related disability in Canada
47
Sufferers ()
22
17
14
Edmeads J et al. Can J Neurol Sci 1993201317.
14
Migraine-related disability in Japan
40
34
21
Sufferers ()
5
Sakai F, Igarashi H. Cephalalgia 1997171522.
15
Migraine-related disability in Europe

• 
  
• Always have to lie down
  76
• Postpone household chores 90
• Relations with family and friends
• affected
  54
• Not in control of life
  34
• Disruption of life
  67

Clarke CE et al. Q J Med 1996897784
16
Impact in the workplace USA
Females
100
80
60
Cumulative percent of total lost workday
equivalents
40
20
0
0
20
40
60
80
100
Sufferers ()
Stewart WF et al. Cephalalgia 1996162318
17
Impact in the workplace Europe

• 
  
• Usually miss work
  50
• Difficulty performing work
  72
• Cancel appointments/meetings 67
• Rely on other people
  45
• Perceived effect on promotion 15

Clarke CE et al. Q J Med 1996897784
18
Impact on education

• Total days per year of school missed Children
  with migraine
  7.8 Controls
  3.7
• Days per year lost due to migraine Children
  with migraine
  2.8 Controls
  0

plt0.0001Abu-Arefeh I, Russell G. BMJ
19943097659
19
Impact on family and social activities 1

• Impact on spouse
  Activities cancelled
  76 Tension between spouses
  30 Sexual relations
  impaired 24
• Impact on children Interferes with activities
  
  94 Attention-seeking behaviour
  22 Hostile behaviour
  17

Smith R. Headache 199636278.
20
Impact on family and social activities 2

• 
  
• Affects relations with family
  56
• Affects relations with friends
  35
• Affects relations with other people 33
• Social events cancelled
  54

Kryst S, Scherl ER. Headache Classification and
Epidemiology. (Olesen J, ed) New York, Raven
Press Ltd, 1994 p34550
21
Burden of migraine to society Direct costs

• Total annual costs of medical care (adjusted to
  US)
• USA 1 billion
• Canada 1.9 billion
• Sweden 13 million
• UK 45 million
• Netherlands 300 million
• Australia 31 million

Ferrari MD. Pharmacoeconomics 19981366775
22
Burden of migraine to society Indirect costs

• Total annual indirect costs of migraine due to
  lost productivity (adjusted to US)
• USA 13 billion
• Canada 732 million
• Sweden 1.6 billion
• UK 1.11.3 billion
• Netherlands 1.2 billion
• Spain 1.1 billion
• Australia 568 million

Ferrari MD. Pharmacoeconomics 19981366775
23
Conclusions

• The characteristic features of migraine and its
  accompanying impact have been described
  consistently over the past 2000 years
• Most migraine sufferers report significant impact
  (disability) associated with their attacks
• Disability occurs in paid work, education,
  household tasks and family and leisure activities

24
Assessing migraine impact

• Migraine attacks vary in severity
  from Moderate pain with no activity
  limitations
• to Severe pain and prolonged incapacitation

25
The need for tools to assess migraine impact

• No objective method to assess medical need
• Poor communication between patients and
  physicians
• Inefficient treatment strategies
• Trial and error
• Stepped care

26
Barriers to migraine care
Yes
Yes
Yes
Yes
Migrainepatients inneed of care
Ongoingassessmentof control
Goodoutcome
Appropriatelytreated
Diagnosed
Consulting
No
No
No
No
Motivate patient to seek care
Improve diagnosis
Improve treatment
Encourage follow-up
27
Measuring the impact of migraine

• Define parameters for assessing impact of
  migraine to the sufferer and to society
• Develop a simple to use tool which captures this
  information in a reliable and valid manner

28
Migraine impact to the sufferer

• Pain intensity is the most important
  aspect Reported more frequently than other
  symptoms Usually severe
• Sufferers consulting a physician do so mostly for
  pain relief

Edmeads J et al. Can J Neurol Sci 1993201317
29
Migraine impact on society

• Headache-related disability is the most important
  determinant of migraines societal impact
  measured in economic terms

de Lissovoy G, Lazarus SS. Neurology
199444(suppl 4)5662
30
Grading migraine severity

• Two studies Von Korff et al Washington County
  Study

31
Von Korff study

• Graded severity of primary care patients with
  back pain, headache and jaw pain Pain
  intensity Disability Persistence Recency of
  onset

Von Korff M et al. Pain 19925013349
32
Paindisability link

• Pain intensity and disability measures formed a
  reliable hierarchical scale Pain intensity
  scaled lower range of severity Disability
  scaled upper range of severity
• Persistence and recency of onset did not scale
  with pain intensity or disability

Von Korff M et al. Pain 19925013349
33
Pain impact grades

• Four severity grades identifiedGrade I low pain
  intensity and low disabilityGrade II high pain
  intensity and low disabilityGrade III high
  disability which was moderately limitingGrade
  IV high disability which was severely limiting

Von Korff M et al. Pain 19925013349
34
Primary care headache patients

• Grading system tested on 740 headache patients
  over 2-year period
• Individual sufferer Pain impact increased as
  severity grade increased
• Society Direct and indirect costs increased as
  severity grade increased

Von Korff MR, Stang PE. Headache Classification
and Epidemiology (J Olesen ed). New York Raven
Press, 1994pp36771
35
Impact on the individual

• Pain Impact (activity limitations, depression and
  poor-to-fair self-rated QoL)

60
40
Extent of disability
20
Grade II Grade I
Grade IV Grade III
0
1 month
1 year
2 years
Von Korff MR, Stang PE. Headache Classification
and Epidemiology (J Olesen ed). New York Raven
Press, 1994p36771
36
Impact on society Direct costs

• Total cost of headache care per year per patient

1000
800
600
Mean cost of headache care (US)
400
200
0
I
II
III
IV
Migraine severity grade at baseline
Von Korff MR, Stang PE. Headache Classification
and Epidemiology (J Olesen ed). New York Raven
Press, 1994p36771
37
Impact on society Indirect costs

• Unemployment rate

30
Severity grade at baseline
Grade II Grade I
Grade IV Grade III
20
Unemployed ()
10
0
Baseline
Year 1
Year 2
Von Korff MR, Stang PE. Headache Classification
and Epidemiology (J Olesen ed). New York Raven
Press, 1994p36771
38
Washington County Study

• Telephone interview identified migraine sufferers
  in the general population
• Sufferers rated most recent headache in previous
  5 days
• Pain intensity rated from 010
• Disability rated as none, partial or all day

Stewart WF et al. Neurology 199444(suppl
4)2439.
39
Paindisability link
10
9
8
7
6
Pain rating
5
4
3
2
1
0
None
Partial
All day
Disability
Stewart WF et al. Neurology 199444(suppl 4)2439
40
Conclusions

• An impact (disability) grading system has the
  potential to describe the burden of migraine both
  to the individual sufferer and to society
• This provides a foundation for grading migraine
  severity

41
New instruments for assessing migraine impact

• Migraine Disability Assessment Questionnaire
  (MIDAS)
• Headache Impact Test (HIT)

42
Rationale for MIDAS

• The MIDAS Questionnaire was developed as a tool
  to
• Improve physicianpatient communication
• Motivate disabled migraine sufferers to seek care
• Identify patients with high treatment needs
• Provide a rational basis for treatment decisions
  and follow-up

43
The MIDAS Questionnaire
44
The MIDAS Questionnaire

• Paper-based questionnaire, accessible at
  surgeries and pharmacists
• 5 questions assessing the days lost due to
  migraine over a 3-month period
• Paid work
• Household work
• Family and social activities
• Total lost days are summed and categorised into 4
  severity grades
• Two unscored questions assess headache frequency
  and pain intensity

Stewart WF et al. Cephalalgia 19991910714
45
Scoring the MIDAS Questionnaire
Grade Definition MIDAS score Medical
need I Minimal or infrequent
disability 05 Low II Mild or
infrequent disability 610 Moderate III Moderate
disability 1120 High IV Severe
disability 21 High

• Add up total scores from Questions 15

Stewart WF et al. Cephalalgia 19991910714
46
The MIDAS Questionnaire summary of research and
clinical testing

• Research criteria
• Reliability
• Content validity (accuracy)
• Construct validity
• External validity
• Clinical practice criteria
• Face validity
• Easy to use
• Easy to score
• Intuitively meaningful

Lipton RB et al. Rev Contemp Pharmacother
2000116373
47
Use of MIDAS to specify treatment

• ASA, NSAIDs
• (Triptans)

MIDAS Grade I

• NSAIDs, DHE
• (Triptans)

MIDAS Grade II
Disability assessment

• Triptans, DHE, butorphanol

MIDAS Grade III/IV
48
MIDAS strengths and weaknesses

• Strengths
• Aid to communication between physicians and
  patients
• Widely used by headache specialists and
  neurologists
• Aid to referral for primary care physicians
• Sensitive to change can be used as an outcome
  measure following treatment

49
MIDAS strengths and weaknesses

• Weaknesses
• May not cover the full spectrum of headache due
  to its brevity
• Grade scores may not indicate medical need
• Many disabled patients score as Grade I
• Weighting of questionnaire towards headache
  frequency
• Patients with frequent headaches (e.g. CDH) tend
  to score as Grade IV
• Not accepted as a stratification tool to aid
  choice of treatment

50
Headache Impact Test (HIT)

• Web-based test, accessible to all headache
  sufferers
• Dynamic questionnaire covering the full headache
  range
• In practice, 5 questions sufficient to grade the
  majority of headache sufferers

51
(No Transcript)
52
Features of dynamic assessments

• Questions are not printed on forms in advance
• Items are sampled dynamically from all areas of
  headache impact
• All levels of disability and impact are measured
• Patients are questioned until clinical standards
  of score precision are met
• Scores and interpretation guidelines are based on
  modern psychometric methods
• Clinicians choose the amount of precision they
  need for their purpose

53
Ranges covered by four questionnaires
Most Severe
80
80
80
80
70
70
70
70
60
60
60
60
50
50
50
50
40
40
40
40
30
30
30
30
20
20
20
20
20
20
Least Severe
10
10
10
10
HDI
MSQ
HImQ
MIDAS
Range () 49 96
35 46
54
HIT matches questions to each patients
severity level
80
Severe
70
Moderate
60
50
Mild
40
40
30
20
10
55
Distribution of DynHA headache severity scores
Headache sufferers, US population (n1016)
Most Severe
80
70
Migraine
Moderate Headache
60
Averages
50
Population
40
30
20
Least Severe
10
56
Dynamic HIT is brief and accurate

• Clinical standard of accuracy was achieved in 5
  or fewer questions by
• 98 of those with migraine
• 97 with severe headache
• 87 with moderate headache
• 61 with mild headache

57
Advantages of Dynamic HIT

• Brevity of a short form
• Accuracy required for measuring individual
  patients at all levels (mild to severe impact)
• Comparability with widely-used questionnaires
• Basis for an improved HIT static short form
• Availability to all on the Internet

58
Sample Patient Report Headache Impact Test
(HIT)

• Your score
• Your progress
• What your score means
• What you should do

59
Sample Clinician Report Headache Impact Test
(HIT)

• Patient score
• Patient progress
• Interpretation
• About the test

60
Strategies for managing migraine using impact
measures

• US Headache Consortium Guidelines
• US Primary Care Network Guidelines
• UK MICPA Guidelines

61
US Headache Consortium Guidelines - Goals

• Reduce attack frequency, severity, and disability
• Reduce reliance on poorly tolerated and
  ineffective medication
• Improve quality of life
• Avoid acute headache medication escalation
• Educate patients to manage their disease
• Decrease headache related distress and
  psychological symptoms

Matchar DB et al. Neurology 200054www.aan.com/pu
blic/practiceguidelines/03.pdf
62
US Headache Consortium Guidelines Management
principles

• Establish a diagnosis
• Educate patients about their condition and its
  treatment
• Establish realistic expectations
• Encourage patients to participate in their own
  management
• Discuss treatment / medication preferences

Matchar DB et al. Neurology 200054www.aan.com/pu
blic/practiceguidelines/03.pdf
63
US Headache Consortium Guidelines Management
principles

• Individualise management
• Treatment choice depends on
• Attack frequency and severity
• Presence and degree of disability
• Associated symptoms
• Prior response to medications
• Co-morbid and co-existent conditions

Matchar DB et al. Neurology 200054www.aan.com/pu
blic/practiceguidelines/03.pdf
64

US Headache Consortium Guidelines Schematic
Migraine diagnosis
Disability assessment
Patient communication and education
Individualised management
Stratified care
IHS criteria

• Attack frequency
• Attack severity
• Degree of disability
• Non-headache symptoms
• Patient participation
• preference
• prior response
• co-existent conditions

IMPACT
Matchar DB et al. Neurology 200054www.aan.com/pu
blic/practiceguidelines/03.pdf
65
US Headache Consortium Guidelines
Recommendations for treatment

• Use migraine-specific agents (e.g. triptans,
  ergots, DHE)
• as first-line treatment in patients with moderate
  or severe headache
• in those who respond poorly to NSAIDs and
  combination medications
• Non-oral route of administration if severe nausea
  or vomiting
• Rescue medication for non-responsive migraine
• Guard against medication-overuse headache

Matchar DB et al. Neurology 200054www.aan.com/pu
blic/practiceguidelines/03.pdf
66
US Primary Care Network Guidelines

• Impact-based recognition of migraine
• Acute treatment strategy
• Preventive treatment strategy
• Special considerations
• Behavioural and physical treatments
• Chronic headache disorders
• Specific patient groups
• System management

67
Impact-based recognition of migraine

• How do headaches interfere with your life?
• How frequently do you experience headaches of any
  type?
• Has there been any change in your headache
  pattern over the last 6 months?
• How often and how effectively do you use
  medication to treat headaches?

68
Acute treatment strategy

• Identify components of migraine symptomatology
  that allow for early intervention
• Select best treatment for each patient
• Instruct patients on proper use of medications
• Encourage use of a headache diary
• Provide patient education
• Tailor intervention to the individuals needs to
  maintain or return the patient to full function

69
Preventive treatment strategy

• Reduce attack frequency, severity or duration
• Improve responsiveness to treatment of acute
  attacks
• Improve function and reduce disability
• Prevent the evolution of episodic headaches to
  CDH
• Treat co-morbid disorders

70
UK MIPCA Guidelines

• Individualised approach
• Treatment is prescribed according to each
  patients needs
• Patients needs assessed according to
• Nature of attacks
• Impact of migraine on individuals life
• Demands of the patients lifestyle

71
Initial management strategy

• Initial consultation
• Diagnosis
• Review previous treatments
• Discuss pattern/frequency of attacks
• Initiate acute treatments for sufferers
  experiencing ?4 attacks per month
• Simple analgesic ? anti-emetic
• Oral triptan if analgesic previously unsuccessful

72
Follow-up management strategy

• Oral triptan (nasal or sc if required)
• Alternative triptan
• Migraine prophylaxis plus acute treatments
• Frequent headaches diagnosis of CDH
• Consider referral

73
Overall conclusions

• Migraine is a remarkably disabling condition
• Measuring the impact (disability) of migraine
  aids the assessment of migraine severity
• Tools that assess the impact of migraine are now
  available
• US and UK management guidelines advocate the
  assessment of migraine impact

74
Topics for discussion

• Does MIPCA endorse impact testing for migraine in
  primary care?
• If so, which test should be used?
• How should impact testing be used in primary
  care?
• Should the change in impact measure be used as an
  outcome measure?