1. Kings Headache Service Kings College Hospital London, UK Dr Andrew Dowson Assessing the impact of migraine

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 18th–19th Century 19th Century 20th–21st 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 Stewart WF et al. Neurology 1994;44(suppl 4):24–39. NoneMildModerate/ severe Don’t know Sufferers (%) 12 51 36 1

13. Migraine-related disability in Canada Edmeads J et al. Can J Neurol Sci 1993;20:131–7. Sufferers (%) 22 47 17 14

14. Migraine-related disability in Japan Sakai F, Igarashi H. Cephalalgia 1997;17:15–22. Sufferers (%) 5 21 40 34

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 1996;89:77–84

16. Impact in the workplace – USA Stewart WF et al. Cephalalgia 1996;16:231–8 100 80 60 40 20 0 0 406080100 Cumulative percent of total lost workday equivalents Sufferers (%) Females

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 1996;89:77–84

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 *** p<0.0001 Abu-Arefeh I, Russell G. BMJ 1994;309:765–9

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 1996;36:278.

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; p345–50

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 1998;13:667–75

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 = $1.1–1.3 billion –Netherlands = $1.2 billion –Spain = $1.1 billion –Australia = $568 million Ferrari MD. Pharmacoeconomics 1998;13:667–75

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 Migraine patients in need of care Diagnosed Appropriately treated Ongoing assessment of control Good outcome Improve diagnosis Improve treatment Encourage follow-up Consulting Motivate patient to seek care No Yes

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 1993;20:131–7

29. Migraine impact on society Headache-related disability is the most important determinant of migraine’s societal impact measured in economic terms de Lissovoy G, Lazarus SS. Neurology 1994;44(suppl 4):56–62

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 1992;50:133–49

32. Pain–disability 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 1992;50:133–49

33. Pain impact grades Four severity grades identified Grade I:low pain intensity and low disability Grade II:high pain intensity and low disability Grade III:high disability which was moderately limiting Grade IV:high disability which was severely limiting Von Korff M et al. Pain 1992;50:133–49

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, 1994;pp367–71

35. Impact on the individual Von Korff MR, Stang PE. Headache Classification and Epidemiology (J Olesen ed). New York: Raven Press, 1994;p367–71 0 20 40 60 1 month 1 year 2 years Grade IV Grade III Grade II Grade I Extent of disability Pain Impact (activity limitations, depression and poor-to-fair self-rated QoL)

36. Impact on society – Direct costs Von Korff MR, Stang PE. Headache Classification and Epidemiology (J Olesen ed). New York: Raven Press, 1994;p367–71 Mean cost of headache care ($US) Migraine severity grade at baseline 1000 800 600 400 200 0 IIIIIIIV Total cost of headache care per year per patient

37. Impact on society – Indirect costs Von Korff MR, Stang PE. Headache Classification and Epidemiology (J Olesen ed). New York: Raven Press, 1994;p367–71 Unemployed (%) 0 10 20 30 Baseline Year 1 Year 2 Severity grade at baseline Grade IV Grade III Grade II Grade I Unemployment rate

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 0–10 Disability rated as none, partial or all day Stewart WF et al. Neurology 1994;44(suppl 4):24–39.

39. Pain–disability link Stewart WF et al. Neurology 1994;44(suppl 4):24–39 1 0 2 3 4 5 6 7 8 9 10 None Partial All day Pain rating Disability

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 physician–patient 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. 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 1999;19:107–14

45. Scoring the MIDAS Questionnaire Stewart WF et al. Cephalalgia 1999;19:107–14 Add up total scores from Questions 1–5 GradeDefinitionMIDAS score Medical need IMinimal or infrequent disability0–5Low IIMild or infrequent disability6–10Moderate IIIModerate disability11–20High IVSevere disability21+High

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 2000;11:63–73

47. ASA, NSAIDs (Triptans) ASA, NSAIDs (Triptans) NSAIDs, DHE (Triptans) NSAIDs, DHE (Triptans) Triptans, DHE, butorphanol MIDAS Grade I MIDAS Grade II MIDAS Grade III/IV Disability assessment Use of MIDAS to specify treatment

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

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 HDI 10 20 MSQ 40 30 HImQ 10 20 MIDAS 80 30 50 20 40 10 20 40 30 70 60 80 50 10 20 40 30 70 60 80 50 60 70 60 70 80 50 Most Severe Least Severe Range (%) 49 96 35 46

54. Moderate ‘HIT’ matches questions to each patient’s severity level ‘HIT’ matches questions to each patient’s severity level 10 30 40 70 80 Severe Mild 50 60 40 20

55. Distribution of DynHA headache severity scores: Headache sufferers, US population (n=1016) Distribution of DynHA headache severity scores: Headache sufferers, US population (n=1016) 20 40 50 30 60 70 80 10 Moderate Headache Moderate Headache Migraine Population Averages Most Severe Least Severe

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 2000;54:www.aan.com/public/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 2000;54:www.aan.com/public/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 2000;54:www.aan.com/public/practiceguidelines/03.pdf

64. US Headache Consortium Guidelines: Schematic Attack frequency Attack severity Degree of disability Non-headache symptoms Patient participation – preference – prior response – co-existent conditions IHS criteria Migraine diagnosis Disability assessment Patient communication and education Individualised management Stratified care Matchar DB et al. Neurology 2000;54:www.aan.com/public/practiceguidelines/03.pdf IMPACT

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 2000;54:www.aan.com/public/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 individual’s 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 patient’s needs Patient’s needs assessed according to: –Nature of attacks –Impact of migraine on individual’s life –Demands of the patient’s 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?