lifting the burden the global campaign to reduce the burden of headache worldwide

Lifting The BurdenThe Global Campaign to

Reduce the Burden of Headache Worldwide

Introduction to the Global CampaignTJ Steiner (UK), for the Global Campaign Committee

The problemHeadache 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 by bringing out all of the available worldwide evidence of the burden attributable to headache and by setting 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


Reduce the Burden of Headache WorldwideA 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 12th in women. Other headache disorders were not included. The present study1 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 International Headache Society criteria for migraine and tension-type headache (TTH), and also studies on headache in general and on “chronic daily headache” (CDH), were included.

Figure 1. Prevalence of adults with an active headache disorder (ie, during last year or less)

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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 5 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.


Reduce the Burden of Headache WorldwideA partnership in action between the World Health Organization,

World Headache Alliance, International Headache Society and European Headache Federation

Prevalence of primary headache disorders 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 estimate the prevalences of migraine, tension-type Headache (TTH) and chronic daily headache (CDH) in the Republic of Georgia.

BACKGROUND: The Republic of Georgia is located in the Caucasus. Its total population in 2000 was 4.4 million, 53% urban and 47% rural, with 1.5 million inhabitants in the Capital city, Tbilisi. No data currently exist on the prevalence and impact of headache disorders in the countries of the former Soviet Union.

A Collaboration between Lifting The Burden and theRussian 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).

http://www.i-h-s.org/




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

A European initiative supported by a grant of the EC Public Health Executive Agencyand promoted by the Centre of Public Research Luxembourg

in partnership with Lifting The Burden

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

EurolightA CONSORTIUM of

24 public bodies, patient organisations, scientific organisations, hospitals and headache experts from 15 different European countries

Colette Andrée (CH/Luxembourg), Guy Dargent (EC/Luxembourg), Marie-Lise Lair (Luxembourg)

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

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Figure 1. Control of migraine in two population samples: data from the Luxembourg pilot

http://www.eurolight-online.org/




Completing the burden mapTJ Steiner (UK) and LJ Stovner (Norway), for the Global Burden Working Group

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

The Republic of Georgia has 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 is under analysis.

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 22 areas of Russia which will be representative of the entire country.




Atlas of headache disordersT Dua (Switzerland), for the Headache Atlas Working Group

IntroductionThere 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.

ObjectiveThe 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 collectionA 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 58, 39 and 39 countries for neurologist, primary-care and patient versions respectively.

Data organization and presentationData 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.

ConclusionIt 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 the Lifting The Burden booth.




Management aids for primary careTJ 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 and 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 or not 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 follows if it is thought that more should be done, may be “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 is often 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 CLASSIFICATIONof

HEADACHE DISORDERS2nd edition

These management aids are published in J Headache Pain 2007; 8 (suppl 1)




Translation protocolsMichele Peters (UK), for the Translations Working Group

Introduction

As Lifting The Burden sets objectives and plans activities worldwide, the documents it develops in English must be made accessible in many languages. Initially 11 other languages are given priority, which collectively are used by half the world (table 1).

The importance of rigorous translation of written materials used in medical management is increasingly recognized and advocated [1,2]. Translation procedures, such as those by Guillemin et al [3], are internationally recognized and underpin recommendations for good translation practices for headache [1]. Quality-controlled translations following standardized protocols increase the likelihood of linguistic and conceptual equivalence between the translated products, and are essential if questionnaires are to be comparable cross-culturally and if lay or professional instruments are to be of equal value in different languages.

Documents for Translation

Lifting the Burden creates three different types of document: •Lay documents (eg, patient

information leaflets)•Technical documents including

information for professionals (eg, management guidelines)

•Hybrid documents aimed at people with headache but to be used either in clinical practice or in research (eg, outcome measures).

Box 1: Translations Working Group•Michele Peters (chairman), University of Oxford, Oxford, UK•José M Bertolote, World Health Organization, Geneva, Switzerland•Caroline Houchin, Oxford Outcomes, Oxford, UK•Taj Kandoura, Oriental Institute, University of Oxford, Oxford, UK•Timothy J Steiner, Imperial College London, London, UK.

References1. Peters M, Passchier J. Translating Instruments for cross-cultural studies in headache research. Headache 2006; 46: 82-91.2. Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: Report of the ISPOR task force for translation and cultural adaptation. Value in Health 2005; 8: 94-1043. Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. Journal of Clinical Epidemiology 1993: 46:1417-1432

The Translation Protocols

Three translation protocols were written, one for each type of document. The procedure for each protocol (figure 1) aims to avoid making translation unnecessarily onerous yet not compromise on rigour.

Similarities between protocols are: •A co-ordinator who is a native speaker of the target language selects the translators, oversees the translations and reports to the Translations Working Group•Translators are native speakers of the target language•At least one forward translator must

be a headache or medical expert•Two forward semantic and conceptual translations •Production from these of a consensus translated version•A quality assessment by members of the respective target audience •Production of a report, including all translated versions and any translation difficulties.

Differences between the three translation protocols include:•The co-ordinator for the hybrid translations must have technical knowledge (ie, able to understand the concepts underlying the instrument to be translated) and the co-ordinator for the technical translations must be a headache expert•Production of one back translation only for hybrid documents•For hybrid and lay documents, the quality assessment also includes a linguistic review.

The Translation Procedure

All translations of Lifting The Burden materials should follow one or other of these protocols as closely as possible.

Table 1: Campaign Languages

•Arabic •Hindi/Urdu•Bengali •Italian•Mandarin •Japanese•English •Portugues

e•French •Russian•German •Spanish

Figure 1: Translation Procedure

The Translations Working Group

A Lifting The Burden working group was formed whose members were either translation specialists or knowledgeable about translation issues and the Global Campaign (Box 1). Their task was to develop protocols that would ensure the rigour and quality of translations whilst being pragmatic and suitable for use in different cultures.

ORIGINAL

FIRST FORWARD TRANSLATION

SECOND FORWARD TRANSLATION

BACK TRANSLATION

RECONCILIATION

REVIEW

FINAL TRANSLATION

TRANSLATION REPORT

HYBRIDLAY AND TECHNICAL

QUALITY ASSESSMENT




A new headache service inthe 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 in 2000 was 4.4 million, 53% urban and 47% rural; 1.5 million inhabitants are in the Capital, Tbilisi.

A Collaboration between Lifting The Burden and theRussian 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 Copenhagen5) social benefit assessed in health economic terms 6) service quality using measures developed by Tanaka Business School, Imperial College London7) 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, 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 physiotherapist2.Batumi, city with 250,000 inhabitants: a level 1-2 clinic with one consultant neurologist supported by one neurologist and one nurse3.Sachkhere, 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.





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