1. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide Introduction to the Global Campaign TJ Steiner (UK), for the Global Campaign Committee The problem Headache disorders are real and often lifelong illnesses. They are highly prevalent, affecting men, women and children everywhere, and they are disabling. In the World Health Report 2001, the World Health Organization ranked migraine among the top 20 causes in the world of years of healthy life lost to disability. Migraine alone is the cause of an estimated 400,000 lost days from work or school every year per million of the population in developed countries. Migraine harms family and social relationships and damages quality of life. Migraine, however, is only one of the headache disorders with public-health importance: others, including tension-type headache and the various chronic daily headaches, together are believed to be responsible for at least as much disability as migraine. If this is correct, headache disorders collectively are in the top ten – and possibly the top five – causes of disability worldwide. Appropriate health care alleviates this burden, but still it persists everywhere. This is principally because health systems that should provide this care do not reach many who need it. A new solution Lifting The Burden is a response to this health-care failure, which has its roots in education failure. Launched in 2004, Lifting The Burden is a formal collaboration between the World Headache Alliance, the International Headache Society, the European Headache Federation and the World Health Organization. The first objective of Lifting The Burden is to know the size of the headache problem in all regions of the world. This can be achieved partly by bringing out all of the available worldwide evidence of the burden attributable to headache, but it is necessary also to set up new studies where the evidence is lacking or of poor quality. The second objective is to exploit this evidence, as a means of persuading governments and other health- service policy-makers, health-care providers, people directly affected by headache and the general population that headache manifestly should have higher priority for treatment. Lifting The Burden is founded on the belief that the basis of the health-care solution for headache in most parts of the world is education. Hence, the third objective is to work with local policy-makers and other key stakeholders to plan and implement health-care services for headache that are appropriate to local systems, resources and locally-assessed needs. Within these services, better diagnosis and better care, and better understanding amongst patients and the public, will all be fostered through education. Lifting The Burden believes that most headache management belongs in primary care, where education must be supplemented by clinical management supports if diagnosis and management are to be optimized. These include diagnostic aids and algorithms; region- based management guidelines developed by harmonizing existing guidelines; information sheets for patients, to aid understanding and promote compliance with treatment; and universally acceptable indices of treatment outcome. Lifting The Burden envisions a future world in which headache disorders are recognized everywhere as real, disabling and deserving of medical care. In this world, all who need headache care have access to it, without artificial barriers. Lifting The Burden gratefully acknowledges unrestricted financial and/or logistic support from the following (in alphabetical order): Allergan; Almirall; Astra Zeneca; Bayer Healthcare; Glaxo SmithKline; Janssen-Cilag; Merck, Sharp and Dohme; Pfizer

2. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide A partnership in action between the World Health Organization, World Headache Alliance, International Headache Society and European Headache Federation BACKGROUND In WHO’s World Health Report 2001, migraine was ranked 19th among causes of years of life lost to disability overall, and 12 th in women. Other headache disorders were not included. The present study 1 collates and presents all existing evidence of the world prevalence and burden of headache disorders. The global burden of headache LJ Stovner (Norway), K Hagen (Norway), R Jensen (Denmark), Z Katsarava (Germany), R Lipton (USA), AI Scher (USA), TJ Steiner (UK), J-A Zwart (Norway) METHODS A comprehensive Medline search for population-based studies of headache and migraine used the search terms headache epidemiology or migraine epidemiology or headache prevalence or migraine prevalence. References listed in relevant publications were also examined. All identified articles were screened for various aspects of methodology and design, and type of content, in order to select methodologically adequate studies of interest for our purpose. Population-based studies applying 1988 or 2004 IHS criteria for migraine or tension-type headache (TTH), and also studies on headache in general or chronic daily headache (CDH), were included. Figure 1. Prevalence of adults with a headache disorder within the last year Globally, 46% of adults had an active headache disorder, with 1- year prevalences of 42% for TTH, 11% for migraine and 3% for CDH (figure 1). There were marked differences between continents, and all headache types seemed least prevalent in Africa. Applying various formulae to calculate the burden of illness from prevalence, headache frequency (mean headache days per person in the population), intensity and/or duration (where such data existed), we found that the worldwide disability attributable to TTH was larger than that due to migraine (figure 2). CONCLUSIONS 1. Although studies are lacking for important regions of the world, it is clearly documented that headache is a major health problem on all continents. 2. There are differences in headache prevalence between the continents, but at present it is impossible to know if these are real or due to methodological differences between studies. 3. TTH appears to impose greater burden on the population than migraine, and the disability due to all headache is therefore almost certainly at least twice that of migraine. 4. If correct, these calculations bring headache disorders collectively into the 10 most disabling conditions worldwide, and into the five most disabling for women. Figure 2. Headache burden 1 Stovner LJ et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia 2007; 27: 193-210. RESULTS Of 107 studies deemed methodologically adequate and relevant, most were from Western Europe and North America and most concerned migraine (see map). Relatively few studies concerned TTH (figure 1) and no studies, or studies of only limited value for the present purpose, existed for large and populous areas such as mainland China, India, countries of the former USSR and large parts of Africa.

3. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide A partnership in action between the World Health Organization, World Headache Alliance, International Headache Society and European Headache Federation Prevalence of idiopathic headache in the Republic of Georgia Z Katsarava (Germany/Georgia), M Kukava (Georgia), E Mirvelashvili (Georgia), A Tavadze (Georgia), A Dzagnidze (Georgia), M Djibuti (Georgia) and TJ Steiner (UK) BACKGROUND and AIM The Republic of Georgia is located in the Caucasus. Its total population is about 4.4 million, 53% urban and 47% rural, with 1.5 million inhabitants in the Capital city, Tbilisi. No previous epidemiological study of headache disorders has been carried out in countries of the former Soviet Union. The aim of this study was to estimate the prevalences of migraine, tension-type headache (TTH) and chronic daily headache (CDH) in Georgia. A Collaboration between Lifting The Burden and the Russian Linguistic Subcommittee of the International Headache Society PRINCIPAL FINDINGS To the screening question “Have you had headache in the last year not related to a cold, flu, hangover or head injury?” 616 (48%) subjects replied “yes”. The estimated 1-year prevalence of migraine was 13% (n=169; 95% CI 12–14%), of TTH 33% (n=422; 95% CI 31–34%) and of CDH 8% (n=105; 95% CI 7-9%). 583 subjects used acute medication for their headaches. The vast majority took combination analgesics and none used triptans. 39 subjects (3% of the total sample) overused acute headache medication. None of the respondents had seen a neurologist for headache, and none was receiving preventative drugs. CONCLUSIONS This is the first population-based estimate of the prevalence of primary headache disorders in a country of the former Soviet Union. Migraine and tension-type headache have prevalences similar to those found elsewhere. Chronic daily headache is somewhat more prevalent. The study reveals that no headache service exists in the Republic of Georgia, which may explain the high prevalence of chronic daily headache, including probable medication-overuse headache. Population based validation of the questionnaire: In second step we validated a Georgian language self- administered questionnaire in a population-derived sample of 186 subjects with headache, recruited randomly during the first stage of the pilot. All subjects completed the questionnaire and then were examined by one of two headache-experienced neurologists who were blind to the questionnaires. Sensitivities and specificities were, respectively, 0.75 and 0.96 for migraine, 0.79 and 0.86 for TTH, and 0.61 and 0.84 for migraine+TTH (kappa = 0.68). Main study Using similar door-to-door methodology, we surveyed two populations: one urban, in Tbilisi (n=1,136), and one rural, in the eastern region of Kakheti (n=565). These yielded 1,298 biologically unrelated adults (>16 years) of whom 722 (56%) were women. Mean age was 45±13 years. Tbilisi Kakheti PROJECT DESIGN Pilot Phase: During a small pilot we established and tested the methodology. Medical residents with a structured questionnaire visited adjacent households in Tbilisi to interview a pre-defined target of 100 biologically unrelated subjects. All respondents reporting headache in the previous year, as well as random 20 non- headache controls, were examined by a neurologist. The response rate was 70%. The questionnaire had sensitivities of 89% for migraine and 67% for TTH (overall kappa = 0.74).

4. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide A partnership in action between the World Health Organization, World Headache Alliance, International Headache Society and European Headache Federation Prevalence of headache disorders in the Republic of Moldova G Pavlic (Moldova), S Odobescu (Moldova), L Rotaru (Moldova), C Craciun (Moldova), L Ciobanu (Moldova), G Corcea (Moldova), TJ Steiner (UK), Z Katsarava (Germany) and I Moldovanu (Moldova) BACKGROUND and AIM The Republic of Moldova is a former-USSR country of 4.3 million people. No population-based epidemiological study of headache disorders has been conducted there. The aim of this study was to estimate the one-year prevalences of migraine, tension-type headache (TTH) and chronic daily headache (CDH) in Moldova. A Collaboration between Lifting The Burden and the Russian Linguistic Subcommittee of the International Headache Society PRINCIPAL FINDINGS Of 3,165 subjects contacted, 2,511 (79%) responded. Of these, 1,341 (53.4%) reported headache in the last year. Migraine was diagnosed in 440 respondents (17.5%; 95% CI:16.1-19.1%), 382 (15.2%) having migraine without aura and 58 (2.3%) migraine with aura (figure 1). TTH was diagnosed in 450 respondents (17.9%; 95% CI: 16.5-19.5%), only 26 (1.0%) having infrequent episodic TTH, 346 (13.8%) having frequent episodic TTH and 78 (3.1%) having chronic TTH. CDH of all types was diagnosed in 119 subjects (4.7%; 95% CI: 4.0-5.6%). CONCLUSIONS The estimated prevalences of migraine and CDH were comparable with findings from other countries in Europe. The prevalence of episodic TTH, however, was lower. A possible explanation for this is that headache is not considered as a medical problem by the general population in Moldova, and many individuals, most likely those with infrequent episodic TTH, may not have reported occasional headache. PROJECT DESIGN The methods were based on those previously tested in Georgia. In a validation study in Tbilisi, Georgia, the response rate to the survey questionnaire was 70%. As a diagnostic instrument, the questionnaire had sensitivities of 89% for migraine and 67% for TTH (overall kappa = 0.74). Eight neurology residents trained by the principal investigator (IM) contacted adjacent households in the Capital of Moldova, Chisinau, and in a rural area of Hancesti. They sought data from approximately 3,000 subjects using the questionnaire. As a check, 10% of all subjects who reported headache were later interviewed and examined by IM personally. % of respondents Hancesti Chisinau Figure 1. Prevalences of headache disorders in Moldova n=2,511

5. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide A partnership in action between the World Health Organization, World Headache Alliance, International Headache Society and European Headache Federation Completing the burden map Z Katsarava (Germany), LJ Stovner (Norway), T Dua (Switzerland) and TJ Steiner (UK) INTRODUCTION To build knowledge of the world burden of headache, the first objective of Lifting The Burden, the Global Burden Working Group has collated all existing prevalence data for headache disorders, adding to those on migraine already assimilated into the World Health Report 2001. The result is headache maps of the world, which highlight areas of very deficient knowledge in large and populous areas. These gaps in our knowledge should be filled, requiring new epidemiological studies in priority areas. GEORGIA AND MOLDOVA These countries of the former USSR have been the testing ground to develop a door-to-door methodology for population surveys in countries whose infra-structure does not support other methods of contact. A burden-of-headache study in each is under analysis. SOUTH AFRICA The continent of Africa is a huge area where knowledge of the burden of headache is almost totally lacking. A local group in South Africa has commenced plans for a population- based study there, again sampling urban and rural populations, and acknowledging ethnic diversity which may be relevant. If successful, these plans will be extended to selected countries in both East Africa and West Africa. CHINA China is a high priority because of its size and because the prevalence of headache there is almost certainly underestimated (adversely affecting the estimate of global burden). A local Working Group has been formed and a protocol is under development for a population-based survey in six regions of China, including Tibet, each to include urban and rural areas. Once these epidemiological studies and estimates of burden attributable to headache are complete, Lifting The Burden expects to have demonstrated unequivocally that headache disorders collectively are in the top 10 causes of disability in the world. INDIA In India, the prevalence of headache disorders may be high but good epidemiological data do not exist. This country is also a high priority because of its size. A local Working Group has set out detailed proposals for a population-based study of urban and rural populations in and around Jaipur, Mumbai, Kolkata and Bangalore. RUSSIA This country is a large area of Europe and Asia with little knowledge of headache burden. A local Working Group has come together with the support also of the IHS Russian Linguistic Subcommittee. Plans are being laid for a population-based survey sampling urban and rural populations in 21 of the 22 areas of Russia which will be representative of the entire country.

6. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide A partnership in action between the World Health Organization, World Headache Alliance, International Headache Society and European Headache Federation PRIMARY HEADACHES IN EUROPE It is estimated that more than 50 million Europeans suffered from migraine during the last year, and lost 180 million days from work or school. The estimated cost was in excess of € 20 billion. Data on other headache disorders are few but the most common, tension-type headache, probably accounts for even greater losses. Health sector policy makers are constrained in their ability to take decisions on effective measures to reduce the impact of headache disorders – on those affected directly, on their families and colleagues, on their carers in the case of children, and on society – because knowledge of this impact on each of these is very incomplete. Knowledge is needed for action in Europe Eurolight is a partnership activity within Lifting The Burden: the Global Campaign to reduce the burden of headache worldwide supported by a grant of the EC Public Health Executive Agency and promoted by the Centre of Public Health Research, Luxembourg EUROLIGHT Launched in May 2007, Eurolight is a response to this need. Its methods were developed and tested in a pilot study in Luxembourg (figure 1). Eurolight is the first consortium of stakeholders to collect data on headache at EU level, bringing together relevant medical, scientific and lay organizations will study the general population prevalence of headache disorders in Lithuania, a country in a part of eastern Europe where epidemiological data are lacking will survey mostly patient populations in 10 representative European countries, using similar methods in each to produce comparable findings throughout will gather qualitative as well as quantitative data that describe impact, in a broad sense, of each headache disorder of public-health importance: migraine, tension-type headache and chronic daily headache will assess personal suffering, consequences for work, education and family life, and the needs for better disease management will produce systematic data to complement epidemiological evidence of the burden of headache in Europe is holistic, patient-driven and respectful of scientifically validated methods Eurolight A CONSORTIUM of 24 public bodies, patient and scientific organizations, hospitals and headache experts from 15 different European countries C Andrée (Luxembourg/Switzerland) and TJ Steiner (UK) for the Eurolight Project Steering Committee Eurolight’s over-arching objective: to provide a justification that headache should be high amongst health-care priorities in Europe For more information: Tel: +41 61 423 1080 Fax: +41 61 423 1082 www.eurolight-online.org Figure 1. Control of migraine in two population samples: data from the Luxembourg pilot

7. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide A partnership in action between the World Health Organization, World Headache Alliance, International Headache Society and European Headache Federation Atlas of headache disorders Tarun Dua (Switzerland), Lars Jacob Stovner (Norway), Gøril Bruvik Gravdahl (Norway), Ulla Schultz (UK), Timothy J Steiner (UK) and Shekhar Saxena (Switzerland) INTRODUCTION There is considerable evidence that the global burden of headache disorders is high. However, little is known about the resources available to meet this burden. In order to fill this knowledge gap, an international survey is being carried out within the framework of World Health Organization (WHO) Project Atlas and as part of Lifting The Burden. The two documents previously published within this framework for neurological disorders are Atlas: country resources for neurological disorders and Atlas: epilepsy care in the world. OBJECTIVE The aim of this survey is to collect information on the epidemiology of headache disorders, their impact on society, the availability of resources to provide treatment, and the current management practices worldwide. It is envisaged that the Atlas of headache disorders will be a key tool to inform policy development and to support national and regional advocacy initiatives. DATA COLLECTION A group of international experts identified areas where there was a need to collect information and put together a draft questionnaire with accompanying glossary. This questionnaire was validated and feedback from this exercise was used to derive the final version of the questionnaire to be sent to all the countries. The questionnaire is divided into three sections: neurologist version, primary-care version and patient version, to be filled by a neurologist or other secondary-care headache specialist, a primary-care physician and a patient (or representative of a patient advocacy group) respectively. Multiple sources have been drawn upon to identify respondents from the countries: members of the World Headache Alliance, the International Headache Society and the European Headache Federation; key members of national neurological societies identified through the World Federation of Neurology; contacts developed during the production of the Neurology Atlas and Epilepsy Atlas; contacts in other countries known to respondents; and literature search. Data collection began in November 2006 and a total of 474 focal points have been contacted in 169 countries. Currently we have received data from 68, 47 and 43 countries for neurologist, primary-care and patient versions respectively. DATA ORGANIZATION AND PRESENTATION Data are organized into eight major themes (table 1). They will be presented at global and WHO region levels in the form of maps or graphics or as written text. For each of the themes, specific limitations will be highlighted. These must be kept in mind when interpreting the data. The Atlas of headache disorders will also include brief reviews of selected topics, which summarize medical, lifestyle, social and economic issues affecting people with headache disorders. CONCLUSION It is hoped that the Atlas of headache disorders will stimulate global and national programmes in the headache field. It will be a reference for health professionals, planners and policy makers at national and international levels, helping them plan, develop and provide better care and services for people with headache disorders throughout the world. Table 1: Data to be included in the Atlas of Headache Disorders National Professional/Patient Associations Epidemiology Diagnosis and assessment Treatment Human resources Impact on society Information/data collection system Issues of care of people with headache disorders Are you from a country with an absence of data (shown in grey) and able to assist in data collection? If so, please contact Lifting The Burden.

8. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide A partnership in action between the World Health Organization, World Headache Alliance, International Headache Society and European Headache Federation Research by low and middle income countries in the primary headache disorders Farrah J Mateen (USA), Tarun Dua (Switzerland), Timothy J Steiner (UK) and Shekhar Saxena (Switzerland) INTRODUCTION Headache is ubiquitous, and a significant and largely unaddressed burden of ill health and disability in all countries. Yet, most research on headache disorders comes from high income countries. The contribution of low and middle income (LAMI) countries to research in this field has not been characterized. A first step in Lifting The Burden is to identify and fill knowledge gaps. Therefore our aim was to determine the type and amount of research on primary headache disorders in LAMI countries over the past decade. METHODS We searched 68 internationally-accessible databases using the keywords headache, headache disorders, primary and migraine for the 10 years 1997 to 2006. All clinical research, case series, clinical trials and retrospective studies in any language were included, provided that at least an abstract was available in English. Basic science articles, animal studies, single case reports and publications which did not present new clinical research data (commentaries, historical articles, reviews, conference summaries, editorials, reviews and guidelines) were excluded. Country classification into four groups according to gross national income per capita was based on World Bank categorization (July 2006): low (US$ 875 or less), lower middle (US$ 876-3,465), upper middle (US$ 3,466-10,725) or high (US$ 10,726 or more). Each LAMI country name was used as a search term. We also checked the institutional affiliations of corresponding authors and geographic regions where work was conducted. We ascertained that each abstract (a) derived from that particular country (and was not about relocated migrants from that country) and (b) pertained to primary headache as defined by ICD-10 (not headache as a symptom). Multi-centre studies with data contributions from different countries were counted multiple times, once for each country that participated. RESULTS A total of 227 publications were found, mostly from three countries: Brazil (57), Turkey (31) and Iran (26). Of a possible 151 LAMI countries, 32 were represented (see table). Of the 54 low income countries, only 8 had produced research in primary headache disorders and, of the 24 publications, primary authors of two were from institutions in high income countries. Most articles were found via PubMed (62.5%), but many were indexed only in Embase (15%) or other databases (22.5%). Clinical studies of drug treatment accounted for 14.5% of all LAMI research, whereas clinical studies not involving drugs made up the largest proportion: 40.5% (Figure 1). Of all LAMI publications, migraine was the focus of 49%, paediatric populations were exclusively studied in 15%; epidemiological studies accounted for 37%; economic or health services capacity research made up only 7.9%. Figure 1. Theme of publications on primary headache disorders from low- and middle-income countries, 1997-2006 Countries in the income group (n) Countries contributing to headache research (n [%] ) Articles (n) Low income 548 [14.8]24 Lower middle income 5813 [22.4]127 Upper middle income 3911 [28.2]76 CONCLUSIONS The contribution of LAMI countries to headache research is small and derived from few countries. Therapy of headache disorders accounts for approximately a third of the published work. This survey was limited to studies with at least abstracts in English. Other LAMI country work may exist in non-English databases or non- indexed journals.

9. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide A partnership in action between the World Health Organization, World Headache Alliance, International Headache Society and European Headache Federation Management aids for primary care TJ Steiner (UK), for the Diagnostic Aids Working Group, Patient Information Writing Committee and Outcome Measures Working Group INTRODUCTION Medical management of headache disorders, for the vast majority of people affected by them, can and should be carried out in primary care. It does not require specialist skills. Nonetheless, non-specialists throughout the world may have received limited training in the diagnosis and treatment of headache. As Lifting The Burden moves towards interventional projects, planning and implementing health-care solutions for headache in various world regions, primary-care physicians will need support to provide best care based on timely and correct diagnosis. Through several working groups, Lifting The Burden is developing a range of management aids expressly to assist primary-care physicians faced with these very common disorders. The aim is to benefit both physicians and patients. Whilst physicians are helped to deliver care more efficiently and more cost-effectively, there should be better outcomes for the many people with headache who need medical treatment. OUTCOME MEASURES Assessment of a headache disorder as a prelude to planning best management requires more than diagnosis: there should be some measure of its impact on the patient’s life and lifestyle. There are many ways in which recurrent or persistent headache can damage life. Finding a simple measure to summarize these, whilst being equally applicable to all of the common headache disorders, is a challenge. The MIDAS instrument developed by Stewart and Lipton has proved extremely useful with a simple concept: it estimates active time lost through the disabling effect of headache, and expresses the result in a number with intuitively meaningful units (hours). The Headache-Attributed Lost Time (HALT) index is a direct and close derivative of MIDAS developed by Lifting The Burden to use wording that is more easily translated. Whenever treatment is started, or changed, follow- up ensures that optimum treatment has been established; or it recognizes that it has not and identifies further changes that may be needed. It is not always easy to know whether the outcome achieved by an individual patient is the best that he or she can reasonably expect. For the non- specialist, one question that sometimes arises is: “What further effort, in hope of a better outcome, is justified?” A second question, which may follow when it is thought that more should be done, is “What is it that needs changing?” A working group is developing the Headache Under-Response to Treatment (HURT) index, an outcome measure designed to aid management by suggesting answers to these two questions. This index is currently undergoing validation. DIAGNOSTIC AIDS The Diagnostic Aids Working Group, in collaboration with the Chairman of the IHS Classification Sub-committee, has produced a core cut-down version of International Classification of Headache Disorders, 2nd edition (ICHD-II). In time, region-specific variations will be developed for use around the world. Later, this Group will formulate diagnostic algorithms. PATIENT INFORMATION LEAFLETS Headache management is facilitated if the patient understands his or her headache disorder and the treatment being proposed for it. Compliance is improved and a better outcome is likely. Explanation takes time, which often is not available. A writing group is developing a series of Patient Information Leaflets to be handed to patients at the time of diagnosis. The group includes an international review panel of headache specialists, primary-care physicians and patient representatives whose task is to ensure cross-cultural relevance in these leaflets. Those already produced include leaflets on each of the four important headache disorders in primary care (migraine, tension-type headache, cluster headache and medication-overuse headache). A fifth explains some of the relationships between female hormones and headache, which commonly raise questions from patients. INTERNATIONAL CLASSIFICATION of HEADACHE DISORDERS 2nd edition These management aids are published in J Headache Pain 2007; 8 (suppl 1)

10. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide A partnership in action between the World Health Organization, World Headache Alliance, International Headache Society and European Headache Federation European principles of management of common headache disorders in primary care TJ Steiner (UK), K Paemeleire (Belgium), R Jensen (Denmark), D Valade (France), L Savi (Italy), MJA Lainez (Spain), H-C Diener (Germany), P Martelletti (Italy) and EGM Couturier (The Netherlands) INTRODUCTION Headache disorders are amongst the top 10 causes of disability in Europe. Four of these are important in primary care because they are common and responsible for almost all headache-related burden. Management of these, for the vast majority of people affected by them, can and should be carried out in primary care. It does not require specialist skills. Nonetheless, it is recognized that non-specialists throughout Europe may have received limited training in the diagnosis and treatment of headache. A Collaboration between Lifting The Burden and the European Headache Federation We hope for benefits for both patients and physicians. In the first case, there should be better outcomes for the many people with headache who need medical treatment. In the second, physicians are helped to deliver appropriate care more efficiently and more cost-effectively. PURPOSE These management principles 1 are the output of a collaboration between the European Headache Federation (EHF) and Lifting The Burden. Their purpose is to help primary-care physicians correctly diagnose these few disorders, manage them well, recognize warnings of serious headache disorders and refer for specialist care when appropriate. They aim to give straightforward, easily- followed guidance to physicians who are assumed to be non-expert. They acknowledge that availability and regulatory approval of drugs, and reimbursement policies, vary from country to country. For that reason, different possible options are set out wherever appropriate. Otherwise, the emphasis is on unambiguous advice. DEVELOPMENT The process was review of all treatment guidelines in use in Europe, published or otherwise available in English, and harmonization by selection of whatever recommendations within them carried most weight. Evidence-based recommendations were preferred to those without explicit supporting evidence, whilst discordance between recommendations was resolved through reference to original evidence or, where this was lacking, through consensus of expert opinion. DESIGN and USAGE The principles are likely to be most useful if they are read through at least once in their entirety, but are set out in 12 stand-alone management aids in three sections: Guides to diagnosis (some parts of these will need to be assimilated into routine practice, whereas other parts can serve as check lists and aide-mémoires) 1. Headache as a presenting complaint 2. Diagnosis of headache 3. Typical features of the common headache disorders 4. Differential diagnosis of the common headache disorders Guides to management (these are information sources to be referred to once the diagnosis has been made; management aid #6 includes guidance on information to patients) 5. General aspects of headache management 6. Advice to patients 7. Medical management of acute migraine 8. Prophylactic management of migraine 9. Medical management of tension-type headache 10. Medical management of cluster headache 11. Management of medication-overuse headache Guide to referral (a reference and reminder) 12. Headache management in primary care: when to refer 1. TJ Steiner, K Paemeleire, R Jensen, D Valade, L Savi, MJA Lainez, H-C Diener, P Martelletti, EGM Couturier. European principles of management of common headache disorders in primary care. J Headache Pain 2007; 8 suppl 1: S3-S21.

11. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide A partnership in action between the World Health Organization, World Headache Alliance, International Headache Society and European Headache Federation The organisation of headache services TJ Steiner (UK) and R Jensen (Denmark) on behalf of European Headache Federation and Lifting The Burden INTRODUCTION Prevalence statistics reveal that, for every 1,000,000 people in Europe, 110,000 adults have migraine (90,000 with significantly disability), 600,000 have occasional other headaches (mostly episodic tension-type headache and less disabled), and 30,000 have headache every day (most of whom are significantly disabled) 1-3. In other words, for every 1,000,000 of the population of a country, 120,000 adults have disabling headache and are likely to benefit from good headache care. The child population (for whom fewer data exist) have needs also. These numbers are a huge challenge to adequate health-care provision. It is a clear and inescapable conclusion that most headache management belongs in primary care. There is no clinical reason to counter this. A Collaboration between Lifting The Burden and the European Headache Federation NEEDS ASSESSMENT Assumptions needs arise in the child population at half the rate per head of adults “demand” is expressed by only 50% of those in need (ie, 50% who might benefit from medical care do not seek it) minimum consultation need is 1 hr in every 2 yr (30 min for first visit and 30 min total for 1-3 follow-up appointments) per adult patient and double this per child patient (ie, 1 hour/year) no wastage occurs through failures by patients to attend appointments 1 day is 7 hours and 1 week is 4 days of patient- contact time (1 day per week is required for administration, audit and continuing professional development) and 48 weeks are worked per year Further assumptions for specialist care 10% of presenting patients may benefit from specialist referral 4 minimum consultation need is 1 hr/yr per adult (45 min for first visit and 15 min for follow-up) and 1.25 hr/yr per child patient need for inpatient management is very low (<1% of presenting patients) and can be ignored Estimated number of adults/children with headache-care needs Expected demand (hr/wk of medical consultation) 120,000/15,000 780 hours (28 full-time equivalents [FTEs]) Figure 1. Headache care needs assessment overall for every 1,000,000 people Estimated number of adults/children with headache-care needs Expected demand (hr/wk of medical consultation) 12,000/1,500 140 hours (5 FTEs) 1. Steiner TJ, Scher AI, Stewart WF, Kolodner K, Liberman J, Lipton RB. Cephalalgia 2003; 23: 519-527. 2. Stovner L, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA: Cephalalgia 2007; 27: 193-210. 3. Lipton RB, Scher AI, Steiner TJ, Kolodner K, Liberman J, Stewart WF. Neurology 2003; 60: 441-448. 4. Laughey WF, Holmes WF, MacGregor AE, Sawyer JPC. Cephalalgia 1999; 19: 328-329. MEETING NEEDS: proposals for consultation Headache services should be organized on three levels: Level 1. Headache primary care: meeting the needs of 90% of people consulting for headache. One FTE physician can provide level 1 care for a population of 35,000, and act as gatekeeper to: Level 2. Headache clinics: trained physicians in primary or secondary care providing more advanced care to 10% of patients seen at level 1. One FTE physician can provide level 2 care for a population of 200,000, referring as necessary to: Level 3. Specialist headache centres: hospital- based with full time inpatient facilities and access to equipment and specialists in other disciplines for diagnosis and management of the underlying causes of all secondary headache disorders. Level 3 provides advanced care to 10% of patients seen at level 2 and supports acute services for patients presenting with headache. One FTE physician can provide level 3 care for a population of 2,000,000. Figure 2. Headache care needs assessment in specialist care for every 1,000,000 people

12. Lifting The Burden The Global Campaign to Reduce the Burden of Headache Worldwide A partnership in action between the World Health Organization, World Headache Alliance, International Headache Society and European Headache Federation A new headache service in the Republic of Georgia Z Katsarava (Germany/Georgia), M Kukava (Georgia), A Dzagnidze (Georgia), E Mirvelashvili (Georgia), M Djibuti (Georgia), R Jensen (Denmark), LJ Stovner (Norway) and TJ Steiner (UK) AIM: To establish a new headache service in the Republic of Georgia and investigate its impact on headache- related disability, overall health and quality of life of people with headache. BACKGROUND: The Republic of Georgia is selected for the first interventional project of Lifting The Burden. Its population is about 4.4 million, 53% urban and 47% rural; 1.5 million inhabitants are in the Capital city, Tbilisi. A Collaboration between Lifting The Burden and the Russian Linguistic Subcommittee of the International Headache Society Evaluation will be after 6 months and 1 year in all compliant patients and in 10% of non-compliant patients. Outcome variables: 1)headache days per month, recorded in headache diaries 2)headache-related disability (lost active time) and outcome assessed by Lifting The Burden’s HALT and HURT indices 3)overall wellbeing assessed by SF 12 4)patient satisfaction assessed by questionnaire developed in Glostrup Headache Centre, University of Copenhagen 5)social benefit assessed in health economic terms 6)service quality using measures developed within Lifting The Burden by Department of Public Health, University of Oxford 7)willingness to pay. Clinic 1 Clinic 3 Clinic 2 PRINCIPAL HYPOTHESIS: that development of a headache service according to EHF recommendations and standards requires a relatively low initial investment and results in an effective and sustainable service which reduces headache-related disability and improves overall health of people with headache. No headache service currently exists in the country. A recent epidemiological survey showed that the prevalences of primary headache disorders were similar to those in Europe and USA. It furthermore revealed that people with headache neglect their illness, not considering headache as a medical problem. PROJECT DESIGN Three headache clinics will be established: 1.Tbilisi, the Capital city with 1.5 million inhabitants: an EHF level 2-3 clinic, with one consultant neurologist supported by two neurologists, one nurse and one physiotherapist 2.Batumi, a city with 250,000 inhabitants: a level 1-2 clinic with one consultant neurologist supported by one neurologist and one nurse 3.Sachkhere, a town with 20,000 inhabitants: a level 1 clinic with one neurologist and one nurse. Headache services will be offered primarily to the inhabitants of the catchments areas (4,000 households, or 10,000 people) of each clinic. All patients will receive cost-free headache services for 3 months, and must then make payment for their further care and medications. This is the exit strategy, designed to assess sustainability. Month 1: First contact with doctor: history and examination, diagnosis, treatment plan, headache diary, educational materials, drugs if needed (domperidone and aspirin or ibuprofen). Month 2: Follow-up contact with doctor: review of headache diary, review of treatment, further drugs as required (domperidone, aspirin or ibuprofen, triptan tablets [up to 2 doses free, but additional doses at 2 Lari per tablet], atenolol or propranolol or amitriptyline). Month 3: Follow-up contact with nurse (or doctor if necessary): review of headache diary, drugs as for month 2.