Abstract
Background
Headache disorders are widespread and disabling. They are common in Georgia, especially headache on ≥15 days/month (HA ≥ 15), but there are no headache services.
Objective
We established headache services meeting local needs, investigating feasibility, consumer uptake and satisfaction, and cost, with an exit strategy bequeathing effective, self-sustaining services that could be rolled out nationwide.
Methods
We created headache centres in Tbilisi and Gori offering free expert care for three visits over three months, and affordable medication thereafter. The primary outcome measure was the percentage of patients using the service beyond the free period – a measure of both satisfaction and sustainability.
Results
Of 1,445 patients (age 43.7 ± 12.4 years; 10.5% male), 49.8% had episodic migraine, 22.5% episodic tension-type headache, 25.7% HA ≥ 15 (24.5% overusing medication) and 2.0% trigeminal autonomic cephalalgias. Only 454 (31.4%) and 51 (3.5%) returned for second and third visits; in these, headache improved and treatment costs decreased. As information about the service spread, five other headache clinics opened in Tbilisi and Kutaisi (western Georgia). Pharmaceutical companies reduced prices (sumatriptan 100 mg from US$7 to US$1).
Conclusion
The study failed to achieve its primary outcome, but sustainable headache services operating to international standards were successfully implemented nonetheless, with demand increasing.
Background
The Global Burden of Disease Survey 2010 (GBD2010) ranked tension-type headache (TTH) and migraine as the second and third most common diseases worldwide (1). More importantly, these primary headache disorders are associated with disability, reduced quality of life (QoL), much public ill health and high economic burdens on both individual and population levels. Migraine is the sixth highest cause of disability worldwide (2) and headache disorders collectively are third (3). The costs of headache disorders in 2012 were well in excess of €100 billion per year in the European Union (4).
In the last 10 years, several studies in countries of the former Soviet Union have estimated the prevalence, headache-attributed burden and socioeconomic impact of migraine, TTH and headache occurring on ≥15 days/month (H ≥ 15)
Lifting The Burden (LTB) is a UK-registered charitable nongovernmental organisation that directs the Global Campaign against Headache in official relationship with the World Health Organization (WHO) (10,11,12). The ultimate objective of the Global Campaign is to support implementation of effective headache services to meet locally-assessed needs, thereby reducing the burden of headache. This is challenging in a resource-limited world. In 2012, LTB, in collaboration with the European Headache Federation (EHF), started a project to implement headache services in Georgia. The hypotheses of the project were that even where no headache services currently existed, either State-supported or in the private sector, they (a) could be developed according to EHF/LTB recommended standards (13,14) with relatively low initial investment, and (b) would be effective and sustainable, reducing headache-related disability and cost. Accordingly, the project objectives were twofold: First, to design and establish adult headache services appropriate to local needs in Georgia while investigating the feasibility of implementation, clinical effectiveness and socioeconomic impact, consumer uptake and satisfaction, and cost; and second, to develop an exit strategy that bequeathed functioning, effective services that were self-sustaining, and also generalizable so that they might be rolled out nationwide.
Methods
Ethics
The project was approved by the Georgian National Council on Bioethics. All participants received written information explaining the research nature of the project, what it would and would not offer, what was expected in return for the service, and the implications of the exit strategy. Written consent was sought for data handling.
Service structure and characteristics
The project ran from 17/01/2012 to 28/12/2012.
We created two interdependent headache clinics, one adopting a supervisory role towards the other, with care provided by four of us (GG, MM, MK and AD) who had trained for several years in the headache clinic of the University of Essen, Germany. They offered outpatient (non-emergency) headache services to people whose main complaint was a primary headache disorder or medication-overuse headache (MOH). The lead clinic in Tbilisi (the capital city, population 2 million) corresponded to levels 2 and 3 according to EHF/LTB service standards (14). The second clinic in Gori, a city in central Georgia (with approximately 100,000 inhabitants), operated at EHF/LTB levels 1–2, referring complicated cases to Tbilisi in line with EHF/LTB standards. The clinics were advertised by leaflets distributed to households and in the media, to local residents who, on entering the project, received free expert care and medications during the first three months, with three visits allowed. After three months, each patient had to pay according to the policy of the clinics for all care received from the project, including medication.
At first visit, patients were assessed, diagnosed, given a treatment plan according to EHF/LTB principles of management (13), educational material (LTB information leaflets appropriate to diagnosis) and kept a headache diary for the next month; they were also prescribed medication if needed. Questionnaires were administered enquiring into the nature and numbers of past investigations for headache, and how much money had been spent because of headache in the previous three months. The second visit was scheduled according to clinical need. During the required third visit (three months after visit 1), medication and other needs were reviewed and information collected about usage of medication, adverse events (AEs), clinical outcome and costs.
Assessment instruments
We recorded demographical variables (age and gender; socioeconomic status [SES] was assessed by doctors’ overall impression during the study visits). We collected information on the temporal profile of the headache, its clinical characteristics, use of acute and preventative medications, and utilisation of health care. Management was guided by applying the Headache Under-Response to Treatment (HURT) questionnaire (15). Headache days/month over the prior months were assessed from the headache diaries, lost productive time by the Headache-Attributed Lost Time (HALT) index (16) and QoL by WHOQoL-8 (17). Psychiatric comorbidities (anxiety and depression) were assessed using the Hospital Anxiety and Depression Scale (HADS) (18,19).
Treatments
Medications were prescribed in accordance with European standard principles (14) using, as far as possible since resources were limited, medications that pharmaceutical companies donated and imported for the purpose. For medications that we had to purchase, we negotiated reduced prices. Available for acute migraine were aspirin + C tablets (effervescent aspirin 400 mg in combination with ascorbic acid 240 mg), paracetamol tablets 500 mg, domperidone tablets 10 mg and sumatriptan tablets 100 mg. Available for migraine prophylaxis were bisoprolol tablets 5 mg and amitriptyline tablets 25 mg.
For TTH acute treatment we used aspirin + C and/or paracetamol tablets. For TTH prophylaxis we used amitriptyline.
Outcome assessment
The primary measure of outcome was defined as the percentage of patients who continued to use the headache service beyond the free treatment period, which we deemed to be a measure of satisfaction and indicator of sustainability. Secondary measures included assessments of clinical effectiveness (headache frequency, HALT index and expenditure on treatments), patients’ satisfaction and improvement in QoL.
Survey of defaulters
We randomly selected 100 patients from those who did not return for scheduled follow-up visits. We contacted these in a post-study survey asking their reason(s) for non-adherence via phone interview.
Drug price negotiation
In parallel with the direct provision of care, we negotiated with pharmaceutical companies to bring down medication prices. We argued that, in the next several years, substantial numbers of patients with headache would be seen in the headache clinics; therefore, medications should be affordable and, if so, demand would rise.
Analysis and statistics
Demographic, clinical and economic variables were compared between patients with episodic migraine, episodic TTH and H ≥ 15. We did not compare baseline and follow-up data because of the low number of patients who finished the study.
We analysed HALT data by grading according to total days lost in the preceding 3 months: grade I (0–5 days) was regarded as minimal impact, grade II (6–10 days) as mild or infrequent impact, grade III (11–19 days) as moderate impact and grade IV (≥20 days) as severe impact. We analysed WHOQoL-8 by total scores (range 8–40). In applying HADS, we took ≥11 as the threshold score for anxiety or depression caseness (19).
We summarised continuous variables as means with standard deviations (SDs) and medians, and reported categorical variables as proportions (%). We made statistical comparisons using Pearson’s chi-squared, Fisher’s exact 2-tailed and Student’s t-tests. Statistical analyses were performed using SPSS 17.0. We regarded p < 0.05 as significant.
Results
Initially, and unexpectedly, we encountered almost universal mistrust among the population. The flyers delivered to neighbourhood households were ignored: After 1,000 were distributed during the first three months, only seven patients visited the clinics. Most people considered headache as a usual part of their life and did not believe it was a medical problem that could be treated successfully. Many were frankly suspicious of free medical care and treatment. We therefore involved the Ministry of Health and several TV channels and newspapers to explain the project aims to the population. These measures were quickly successful, and a waiting list developed.
The two centres registered 1,445 outpatients (mean age 43.7 ± 12.4 years), 152 (10.5%) male and 1,293 (89.5%) female. About three quarters (74.9%) were married or in partnerships; only 5.3% lived alone. Most (85.2%) were assessed as having low SES.
Patients came generally from the severe end of the headache spectrum. Many had been misdiagnosed (“intracranial hypertension” and “chronic cerebral ischaemia” were common labels) and very few had adequate treatment. Almost none received triptans. Many expressed their expectations of investigations including brain scans.
We diagnosed episodic migraine in 720 patients (49.8%) and episodic TTH in 325 (22.5%), including 233 patients (22.3%) who had both disorders. We diagnosed H ≥ 15 in 371 (25.6%), of whom almost all (354 [24.5% of all patients]) had MOH. The most overused medications were the NSAID/caffeine combination, used by 26.2% of MOH patients, and NSAIDs alone, used by 18.3%; triptans were overused by only 2.3%.
We diagnosed trigeminal autonomic cephalalgias in 29, cluster headache in 24 (1.7%), and episodic paroxysmal hemicrania in 5 (0.3%). These patients were treated, but their data have not been analysed.
Episodic migraine patients reported headache for a mean of 18.4 ± 11.9 years. Headache frequency was ≤2 days/month in 164 (22.7%), 3–5 days/month in 259 (35.9%) and 6–15 days/month in 297 (41.2%). Episodic TTH patients reported headache for a mean of 11.7 ± 9.3 years. Headache frequency was ≤2 days/month in 71 (21.8%), 3–5 days/month in 106 (32.6%) and 6–15 days/month in 148 (45.5%). Patients with H ≥ 15 (including those with MOH) reported a mean duration of 6.8 ± 6.7 years.
We compared proportions with comorbidities in those with episodic headache (migraine and/or TTH) and those with H ≥ 15. HADS caseness for depression was more common with H ≥ 15 (35.4%) than with episodic headache (20.6%; Pearson chi-squared = 32.371, p < 0.0001). We found similarly for HADS caseness for anxiety (43.5% vs. 25.9%; Pearson chi-squared = 39.791, p < 0.0001).
The average WHOQoL-8 score for episodic migraine was 25.0, for episodic TTH 24.8 and for H ≥ 15 23.5 (a higher score indicating better QoL). The differences were not significant (Student’s t-test).
Headache-attributed lost time (HALT index grade) in patients at entry.
Equating to HALT grades I-IV numerically to 1–4; data were missing for 43 patients with episodic headache and 42 with headache on ≥15 days/month.
Investigations in patients prior to entry.
Fisher’s exact 2-tailed test.
Expenditure on headache by patients before and after entry.
US$1.00 ≈ GEL1.8. *Student’s t-test.
Clinical outcomes
Of the 1,455 patients attending for the first visit, only 454 (31.4%) returned for the second visit and 51 (3.5%) for the third. Headache frequency decreased among episodic headache patients: In those with migraine, the proportion with infrequent headache (≤2 days/month) increased from 22.7% to 53.3%, while the proportion with headache on 6–15 days/month decreased from 41.2% to 8.9%. In patients with TTH, the proportion with headache on ≤2 days/month increased from 21.8% to 50.0%, while the proportion with headache on 6–15 days/month decreased from 45.5% to 0%. However, because most patients failed to return even once, clinical outcomes could be assessed in only small numbers. Furthermore, with outcomes unknown in the majority of cases, these data could not be regarded as representative. However, the vast majority of those returning (85.2%) were judged adherent to the recommended treatment(s).
The proportion with HALT grade IV decreased in those with episodic headache from 55.0% to 24.0% (Pearson chi-squared = 2.000; p = 0.096) and in those with H ≥ 15 from 78.1% to 46.0% (Pearson chi-squared = 2.000; p = 0.096). Average monthly expenditure on headache fell significantly, both in the episodic headache group (from GEL19.40 to GEL8.40 [p = 0.016; Student’s t-test]) and among those with H ≥ 15 (from GEL19.10 to GEL13.00 [p = 0.042]) (Table 3).
In view of the low numbers and likely biases, we did not analyse patients’ satisfaction or QoL.
In the survey of 100 non-returning patients, unforeseen circumstances were most commonly cited (by 36) as the cause. However, 25 reported that the medical care had been successful, or had taught them how to manage their headache. Negative reasons were cited by 12 who “did not believe in free medical services”, 12 who were disappointed because they had not received CT or MRI examinations and three who said their headaches had become worse or were no better.
Other outcomes
We convinced pharmaceutical companies that medications should be affordable: One company, and then many others, brought prices down. The price for sumatriptan 100 mg fell from US$7 to US$1 per tablet.
An unforeseen and very important result came about as news of the headache service spread to the populations of Tbilisi and Gori, and many more patients sought care from the clinics (currently about 400/year in Tbilisi and 150/year in Gori). Four additional headache clinics opened in Tbilisi to meet demand: There are now five in Tbilisi and one in Gori, and another in Kutaisi (a city of 200,000 inhabitants in western Georgia), each seeing 100–400 patients per year. Although the clinics charge (as for most medical care in Georgia), demand is increasing.
Discussion
This was a path-finding interventional project to establish headache care where none existed in a lower-middle-income country. The ground was carefully prepared, firstly by conducting a large population-based survey of headache prevalence and burden (demonstrating need) (5) and of willingness to pay for effective care (9), and secondly by ensuring that health-care providers were well trained.
We failed on the primary outcome measure (percentage of patients continuing with care after the three months of free care). We considered this measure would indicate both patients’ satisfaction and service sustainability, but perhaps it was not well chosen. Nonetheless, we succeeded in our ultimate aim of bequeathing effective and self-sustaining services, which are expanding rapidly to meet increasing demand: There are seven headache clinics in a country where there were none, and no recognition of the need for any. We secured substantial reductions in drug prices, so that medication became generally affordable. In these ways, over 10 years of sustained effort, we transformed the medical landscape of the country.
It is worth noting that the vast majority of patients discontinued the project during its free phase rather than after. While a third (36%) of those surveyed cited unspecified “unforeseen circumstances”, a quarter (25%) had learned to manage their headache and felt no need to come back – clearly project successes. Another quarter (27%) had negative reasons for not returning (unfulfilled expectation of cerebral imaging, or suspicion of free care), but only 3% reported treatment failures. Those who continued with care were generally adherent, and experienced substantial improvements in headache and reduced costs.
As a group, the patients were typical demographically and clinically of those seen in many headache clinics in Europe. While most suffered from migraine or TTH, a sizeable number (22.3%) had both and a quarter (25.7%) had H ≥ 15, almost all overusing medication. Many had been misdiagnosed after unnecessary expensive investigations, but very few patients had adequate treatment. Triptans were rarely used, being neither easily available nor affordable.
It was an incidental discovery that the vast majority of patients with H ≥ 15 (354/371; 95.4%) were over-using medication. This is at odds with the finding in our earlier epidemiological survey that, of participants reporting H ≥ 15, only 10 out of 87 (11.5%) also admitted to medication overuse (5). It is generally unwise to make comparisons between patient and population samples, but nonetheless it is highly improbable that consulting bias can explain such a large discrepancy. All people with H ≥ 15 are greatly in need of medical care, and can be expected to seek it. It is much more likely that the population survey, with interviews conducted by unannounced visits to households, failed to capture medication overuse. If so, we substantially underestimated the prevalence of (probable) MOH in Georgia, which may after all be very similar to the 7.1% in Russia (6).
We anticipated some mistrust. We foresaw the rather widespread belief that headache was a usual part of life, not a medical problem that could be treated successfully. This was why we built in free care – in order to persuade people that this belief was misplaced by demonstrating the effectiveness of good care. We also anticipated some suspicion of free care as inherent in Georgian nature, but not to the extent encountered. These factors defeated us in our primary outcome measure but, after appearances on several TV channels and in local newspapers, not in our ultimate aim. There are further lessons here.
This was the first successful interventional project of the Global Campaign against Headache, enacting its ultimate purpose of working with local stakeholders to plan and implement effective headache services designed to meet locally-assessed needs (11,12). In order to fulfil that purpose and create an ideal, several major limitations were imposed by the nature and structure of health care in Georgia. First, we could not call upon the State for medications, but had to cover the costs of these ourselves, with limited finances, or rely on donations from pharmaceutical companies. This restricted the number and variety of medications (aspirin, paracetamol, domperidone and sumatriptan tablets for acute treatment, and bisoprolol and amytriptyline for preventative treatment). However, all of these are recognised (if not first-line) treatments, with established clinical efficacy. Second, we would not have chosen to establish the headache centres in the private sector if there had been a State-supported alternative, but there was not. This is why our prior surveys were important. Third, primary care is not strong in Georgia. Headache services are ideally established on three levels, with their basis in primary care (14). Most people needing health care for headache could and should be treated in primary care: Only a small proportion can be met by specialist centres alone. But we had to start somewhere.
The next steps of this project are twofold. The first step is to spread the service countrywide, establishing more headache centres. Although this has already started under the momentum of this project, it will take time because of the need for training health-care providers in specialist care. The second step is to introduce headache services into primary care, with full support from specialist care as recommended in the European service model (14). This will require the education of primary care doctors across the country, but it is the only means by which headache care can meet the requirement.
Conclusion
Although this study failed to achieve its primary outcome, sustainable headache services operating to international standards were successfully implemented nonetheless. Demand is increasing. As a path-finding interventional project, this study provided useful lessons for others that follow.
Footnotes
Public health relevance
Headache services Global burden of headache
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.