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Assessing the impact of migraine Dr Andrew Dowson Kings Headache Service Kings College Hospital London, UK 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 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. History of migraine impact • • • • • • Ancient civilizations Classical times Medieval 18th–19th Century 19th Century 20th–21st Century Ancient treatments for migraine Classical times Medieval 18th – 19th Century 19th Century 20th Century Recent research into migraine impact • • • • • • USA Canada Japan Europe Impact in the workplace and in education Impact on family and social activities Migraine-related disability in the USA 60 51 Sufferers (%) 50 40 36 30 20 12 10 1 0 None Mild Stewart WF et al. Neurology 1994;44(suppl 4):24–39. Moderate/ severe Don’t know Sufferers (%) Migraine-related disability in Canada 50 45 40 35 30 25 20 15 10 5 0 47 22 17 14 None Mild Edmeads J et al. Can J Neurol Sci 1993;20:131–7. Moderate Severe Sufferers (%) Migraine-related disability in Japan 45 40 35 30 25 20 15 10 5 0 40 34 21 5 None Mild Sakai F, Igarashi H. Cephalalgia 1997;17:15–22. Moderate Severe Migraine-related disability in Europe % Always have to lie down Postpone household chores Relations with family and friends affected Not in control of life Disruption of life Clarke CE et al. Q J Med 1996;89:77–84 76 90 54 34 67 Impact in the workplace – USA Cumulative percent of total lost workday equivalents Females 100 80 60 40 20 0 0 20 40 60 Sufferers (%) Stewart WF et al. Cephalalgia 1996;16:231–8 80 100 Impact in the workplace – Europe % Usually miss work Difficulty performing work Cancel appointments/meetings Rely on other people Perceived effect on promotion Clarke CE et al. Q J Med 1996;89:77–84 50 72 67 45 15 Impact on education • Total days per year of school missed – – • Children with migraine Controls 7.8*** 3.7 Days per year lost due to migraine – – Children with migraine Controls *** p<0.0001 Abu-Arefeh I, Russell G. BMJ 1994;309:765–9 2.8 0 Impact on family and social activities –1 • Impact on spouse – – – • Activities cancelled Tension between spouses Sexual relations impaired % 76 30 24 Impact on children – – – Interferes with activities Attention-seeking behaviour Hostile behaviour Smith R. Headache 1996;36:278. 94 22 17 Impact on family and social activities – 2 • • • • Affects relations with family Affects relations with friends Affects relations with other people Social events cancelled Kryst S, Scherl ER. Headache Classification and Epidemiology. (Olesen J, ed) New York, Raven Press Ltd, 1994; p345–50 % 56 35 33 54 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 = $31 million Ferrari MD. Pharmacoeconomics 1998;13:667–75 Burden of migraine to society: Indirect costs • Total annual indirect costs of migraine due to lost productivity (adjusted to US$) – – – – – – – 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 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 Assessing migraine impact • Migraine attacks vary in severity from: – – Moderate pain with no activity limitations to Severe pain and prolonged incapacitation 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 Barriers to migraine care Yes Migraine patients in need of care Consulting No Motivate patient to seek care Yes Diagnosed No Improve diagnosis Yes Appropriately treated No Improve treatment Yes Ongoing assessment of control No Encourage follow-up Good outcome 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 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 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 Grading migraine severity • Two studies – – Von Korff et al Washington County Study 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 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 Pain impact grades • Four severity grades identified Grade I: Grade II: Grade III: Grade IV: low pain intensity and low disability high pain intensity and low disability high disability which was moderately limiting high disability which was severely limiting Von Korff M et al. Pain 1992;50:133–49 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 Impact on the individual Pain Impact (activity limitations, depression and poor-to-fair self-rated QoL) Extent of disability 60 40 20 Grade IV Grade III 0 1 month Grade II Grade I 1 year Von Korff MR, Stang PE. Headache Classification and Epidemiology (J Olesen ed). New York: Raven Press, 1994;p367–71 2 years Impact on society – Direct costs Total cost of headache care per year per patient Mean cost of headache care ($US) 1000 800 600 400 200 0 I II III Migraine severity grade at baseline Von Korff MR, Stang PE. Headache Classification and Epidemiology (J Olesen ed). New York: Raven Press, 1994;p367–71 IV Impact on society – Indirect costs Unemployment rate 30 Severity grade at baseline Unemployed (%) Grade IV Grade III Grade II Grade I 20 10 0 Baseline Year 1 Von Korff MR, Stang PE. Headache Classification and Epidemiology (J Olesen ed). New York: Raven Press, 1994;p367–71 Year 2 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. Pain–disability link 10 9 8 Pain rating 7 6 5 4 3 2 1 0 None Partial Disability Stewart WF et al. Neurology 1994;44(suppl 4):24–39 All day 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 New instruments for assessing migraine impact • Migraine Disability Assessment Questionnaire (MIDAS) • Headache Impact Test (HIT) 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 The MIDAS Questionnaire 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 1999;19:107–14 Scoring the MIDAS Questionnaire Grade Definition MIDAS score Medical need 0–5 Low 6–10 11–20 21+ Moderate High High Add up total scores from Questions 1–5 I II III IV Minimal or infrequent disability Mild or infrequent disability Moderate disability Severe disability Stewart WF et al. Cephalalgia 1999;19:107–14 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 Use of MIDAS to specify treatment Disability assessment MIDAS Grade I ASA, NSAIDs (Triptans) MIDAS Grade II NSAIDs, DHE (Triptans) MIDAS Grade III/IV Triptans, DHE, butorphanol 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 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 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 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 Ranges covered by four questionnaires Most Severe Least Severe Range (%) 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 10 10 10 10 HDI HImQ MIDAS MSQ 49 96 35 46 ‘HIT’ matches questions to each patient’s severity level 80 Severe 70 60 50 Mild 40 30 20 10 Moderate Distribution of DynHA headache severity scores: Headache sufferers, US population (n=1016) Most Severe 70 Migraine Averages 80 Moderate Headache Population 60 50 40 30 20 Least Severe 10 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 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 Sample Patient Report: Headache Impact Test (HIT) • Your score • Your progress • What your score means • What you should do Sample Clinician Report: Headache Impact Test (HIT) • Patient score • Patient progress • Interpretation • About the test Strategies for managing migraine using impact measures • US Headache Consortium Guidelines • US Primary Care Network Guidelines • UK MICPA Guidelines 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 2000;54:www.aan.com/public/practiceguidelines/03.pdf 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 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 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? 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 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 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 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 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 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 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?