Epilepsy Res., 8 (1991) 252-259
252
Elsevier EPIRES 00400
A comprehensive
community epilepsy programme: the Nakuru project
A.T. Feksi”‘, J. Kaamugishaa*, S. Gatitib*, J.W.A.S. Sander”* and S.D. Shorvond* ‘Provincial General Hospital, Nakuru, Rift Valley Province (Kenya);
‘Regional Medical Centre, Ciba-Geigy, Nairobi (Kenya);
“Institute of Neurology, Queen Square, London, and The National Hospital - Chalfont Centre for Epilepsy, Chalfont St. Peter, Gerrards Cross, Bucks. (V. K.)
(Received 17 October 1990; revision received 3 December 1990; accepted 31 December 1990) Key words: Kenya; Key informant; Primary health care; Untreated epilepsy; Developing countries
The methodology of a programme of investigation of epilepsy carried out at a community health level in Nakuru district, Kenya, East Africa, and the characteristics of patients with tonic-clonic epilepsy in this community, are presented. The study identified a group of 302 patients with untreated generalised tonic-clonic seizures (with or without other seizure types) from the general population. Case finding was carried out using the key informant method over a 1Zmonth period. The clinical characteristics of this cohort of patients, the majority of whom had never had previous contact with a formal medical system, is described. Most were young, living in a rural area, with a mean age of seizure onset of 14 years and a mean duration of seizures of 7 years. Thirty-eight per cent had a clinically evident focal disturbance associated with the tonic-clonic seizures. In 77% of the cases, no aetiology was established. Most cases had had a substantial number of seizures during the course of their condition and only about a third of the patients had less than 1 seizure a month in the previous year. Only 26% had ever had previous anti-epileptic drug treatment. In addition to the medical inquiry, psychological and sociological studies were also conducted and a prospective treatment programme was carried out. Throughout the study, strict definitions and standardised instruments were used, and the study was the result of a collaboration between local investigators, an international neurological team, the Kenyan Government agencies and the pharmaceutical industry. We consider this a model for community-based investigations for the management of epilepsy in developing countries.
INTRODUCTION Epilepsy is a common chronic neurological disorder of considerable public health importance. It carries a social stigma and frequently has severe
* For ICBERG (International Research Group)
Community-based
Epilepsy
Correspondence to: A.T. Feksi, Provincial General Hospital, P.O. Box 71, Nakuru, Rift Valley Province, Kenya.
0920-1211/91/$03.50 @‘J1991 Elsevier Science Publishers B.V.
consequences, both medical and social especially in developing countries’. In Kenya and in Africa in general, hospital and clinical studies have shown that epilepsy is one of the commonest problems seen in out-patient clinics*. Despite this, epilepsy, as with other chronic diseases, generally carries a low priority for health care provision, which tends to be directed to acute, infectious and more lifethreatening conditions. Thus, it is inevitably necessary to show that medical intervention for epilepsy can be succesful and improve quality of life,
253 for scarce resources to be allocated’. There is, however, a dearth of data concerning the management of epilepsy in developing countries, and treatment strategies are commonly based on data from developed countries, usually from hospitals or specialist practices. Extrapolation of such data, however, might not be appropriate’. Little practical work has been carried out in areas without specialist investigatory or treatment facilities in the developing world, and it was to address this need that the current study was devised. A comprehensive epilepsy programme was carried out in Nakuru District, which is situated in the Rift Valley in South West Kenya, East Africa. The programme was carried out at a community level during the periods of October 1986 to September 1988, in which 302 persons with epilepsy presenting with generalised tonic-clonic seizures were identified and entered into the study. We consider this category of patients to be the most important to be targetted for an initial epilepsy control programme in a basic health care setting. The majority of the patients had never received medical treatment, and this gave us the additional opportunity to study epilepsy in its untreated state. The programme was carried out by the collaboration of the local community, the local study team, a neurological team from the Institute of Neurology and the National Society for Epilepsy (U.K.), Kenyan Government Agencies and the pharmaceutical industry (Ciba Geigy). Objectives of theprogramme The overall purpose of this programme of investigation was to test the hypothesis that an epilepsy treatment programme could have a useful effect in a primary health care setting. To this end, the following aims were set: (1) To identify patients with untreated tonic-clonic seizures with non-progressive neurological disease at the community level. These patients were chosen as the most important category of patient with epilepsy to target in a health care programme. (2) To describe the clinical phenomenology, the social and psychological status of these patients, using standardised instruments. (3) To evaluate the effects of a treatment pro-
gramme using carbamazepine or phenobarbitone on the clinical, social and psychological status of these patients, over a prospective 12-month intervention study. (4) To assess the role of trained health visitors in a community management programme of epilepsy. These health visitors, operate at community level, and their functions include the identification of patients with epilepsy, educational counselling of the patients and community figures and ensuring compliance with treatment. (5) To utilise this information for making recommendations for the design of health care programmes for epilepsy in developing countries, without specialised facilities. In this paper, we will outline the overall methodology of the study, the identification of patients and their demographic and clinical features of the patient population. The results of the treatment programme will be described elsewhere. Study area Kenya is located in East Africa and has an area of 402 600 square kilometres with a population of 20 million. The country is geographically divided into a coastal plain, highlands and the Rift Valley. The present programme was carried in the Nakuru district which is located in South West Kenya, within the Great Rift Valley; it covers an area of 5 769 square kilometres. The valley is characterised by a number of extinct and dormant volcanoes and by 3 lakes. Nakuru town lies at the valley floor at an altitude of 1 880 m above sea level. The district population is estimated at 850 000 inhabitants of whom approximately 150 000 live in Nakuru town, and the remaining in rural settings. There is a high proportion of young people, and 63% of the district population is estimated to be below the age of 20 years. The population is largely poor and depends basically upon income from agricultural activities; small-scale farming is common in the district. The population is largely Swahili-speaking, of several tribal backgrounds, of which Kikuyu are the largest group, with significant numbers of Kalenjin, Luo and Luhya4. Health care system The Nakuru district is served by 3 hospitals, one
254 of which, in Nakuru town, serves as a district hospital, and by 7 health centres and 37 dispensaries. The district hospital (Provincial General Hospital) is the most important provider of health care and contains basic facilities for x-ray, biochemistry and chemical pathology and surgery, and is staffed by general and specialist doctors. There are no EEG or CT scanning facilities, and if more sophisticated health attention is required, the patient may be referred to Nairobi. The district hospital is also the base for the Provincial Psychiatrist (A.T.F.), who acted as the principal investigator in the study and who has a long-standing specialist interest, training and practice in epilepsy. Health centres are permanently staffed with paramedical staff and community nurses whilst the dispensaries are run mainly by community nurses4. METHODS Pre-study activities
A weekly epilepsy clinic was set up at the Nakuru Provincial Hospital, run by the Provincial Psychiatrist (A.T.F.). Additional staff included a community health physician, a clinical psychologist, a visiting sociologist and several administrative officers. The epilepsy programme was based in this clinic. The overall programme design was formulated by this local team, teams from London and from the Kenyan Government, with the collaboration of a pharmaceutical company (Ciba Geigy). The initial aim of the study was to pilot a series of instruments designed to describe the clinical phenomenology and to assess social, psychological, and medical aspects. All these instruments were standardised and piloted in a small pilot population. A feature of their usage was that all terms were strictly defined, and careful definitions strictly adhered to in the analysis. The definitions, for instance, used to designate a generalised tonicclonic seizure, are shown in Table I. These medical instruments were based on previous experience from a community survey in the United Kingdom’. The next stage was to recruit 16 health workers and 1 social worker. The health workers were chosen from an initial list of 26 potential candidates from the locality. These health workers re-
ceived 1 month of basic training in epilepsy and in the study methodology, given by the study team. Their function was to identify patients using the key informant method3 and to act in the role of health visitors in the community management epilepsy programme. The training programme comprised community health issues, counselling of patients in various aspects of epilepsy, the diagnosis of generalised tonic-clonic seizures and other epilepsy-related topics. They were instructed on how to interview persons with epilepsy and their relatives and on the importance of bringing about changes in attitude towards epilepsy amongst the patients’ relatives and the community itself. The study programme was sanctioned by the Kenyatta National Hospital Ethical Committee in Nairobi and approved by the Kenyan Ministry of Health. In parallel to these pre-study activities, a public information campaign was launched, with publicity by leaflets, posters, and public meetings convened by chiefs and other community leaders. A logistic system for case referral and follow-up was put in place, and a comprehensive method of patient flow established. Once the clinic was initiated, it was extensively advertised. This included information at 3 local hospitals, visits by the study team to all health centres and dispensaries in the region, to schools, administrative officers and key community figures. These pre-study activities were considered very important for the successful outcome of the study itself. Case identification
Case finding was carried out over a 12-month period. Patients were identified at a local level using the key informant method, described in detail elsewhere3. Key informants were chosen from responsible members of his/her society, clinical officers, nursing officers, birth attendants, traditional healers, school teachers, heads of social, government or other official facilities and organisations. Another group of key informants was selected with the help of chiefs, elders of the community, youth leaders, landlords, businessmen and by other community figures. Designated key informants were then given a short instruction in epilepsy and asked to identify cases known to them through their social network. Those referred by
255 the key informant were then seen by a health worker and all cases in whom the health worker suspected active epilepsy were invited to attend the epilepsy clinic in Nakuru district hospital. The patients were accompanied by a close friend or relative, who had personally observed the seizures. Inclusion criteria
The epilepsy clinic was held every Friday, and patients and their relatives were seen by the principal investigator (A.T.F.) for diagnostic confirmation. The diagnosis was established on clinical grounds using a strict diagnostic protocol and algorithm. Suitable patients who fulfilled the following criteria were admitted to the study: (A) Aged between 6 and 65 years. (B) History of generalised tonic-clonic seizures, with or without other seizure types, and who had had 2 or more tonic-clonic seizures in the previous 12 months. (C) Were not on active antiepileptic drug treatment (defined as the administration of an antiepileptic drug in the previous 3 months). Written and informed consent was obtained from all patients who agreed (parents in the case of children) to take part in the study after careful explanation. All patients and their informants were then interviewed, and the patient examined using a standard protocol and the findings recorded. In the medical arm of the study special stress was placed on the collection of data regarding previous medical treatment of the epilepsy, the duration of
the epilepsy and seizure frequency. A putative aetiology was attributed to each patient on historical grounds only, as no special investigations were routinely carried out unless a potential treatable cause for the epilepsy or a progressive neurological condition was suspected. The patients were then entered into a treatment study. This was a randomised prospective trial carried out over 12 months using 2 well-established anti-epileptic drugs: carbamazepine and phenobarbitone. The study will be reported in detail elsewhere. Psychological and socio-anthropological data were also collected and the methodology and results of these arms of the programme will also be reported elsewhere. RESULTS Clinical and demographic findings in the initial cohort
Over the 1Zmonth period in which recruitment took place, over 650 persons were referred to the clinic, and 529 patients with active seizures were identified. Of these, 302 met the study criteria and agreed to take part in the prospective treatment programme. Reasons for the non-inclusion of the remaining 227 patients included lack of consent, non-residence in Nakuru district, pregnancy, alcohol or drug abuse, or failure to meet study inclusion criteria. Patients who were not included in the study were, however, offered treatment, follow-
TABLE I Definitions of a generalised tonic-clonic seizure
If criteria i-iii are positive, and any two of iv-x are positive, the diagnosis of a generalised tonic-clonic seizure is considered. If x is positive, diagnosis of secondary generalised seizure is considered.
(9 (ii) (iii) (iv) & (vii) (viii) (ix) (x)
Loss of consciousness l-30 min Bilateral tonic contracture Bilateral clonic movements Sphincteric incontinence Fall Injury with fall, including bums Tongue-biting Post-ictal muscular aching Post-ictal drowsiness, sleep, confusion or headache Post-ictal unilateral limb weakness
TABLE II Demographic features of the cohort ofpatients with epilepsy n = 302: males, 173 (57%); females, 129 (43%). Mean age, 21 years (range: 6 to 65 years); location: living in rural areas, 234 (77%); urban area, 68 (23%). Age (years)
n
70
5- 9 10-14 15-19 20-29 30-39 40-49 50-59 XX
37 60 59 76 42 16 8 4
12 20 20 25 14 5 3 1
256 up and referral to the regular hospital clinics where relevant. Demographic features of the 302 patients studied is given in Table II. There was a preponderance of males, the majority being young and living in rural areas. Age of onset of the seizure disorder is shown in Table III. In the great majority the onset was in the first 2 decades. The majority had long histories of seizures, the mean duration of epilepsy was 7 years. Seizure classification is given in Table III. There was clinical evidence in 115 patients of a focal onset for the seizures, and it is likely that this would have been much higher if EEG had been used before seizure classification. Aetiology was attributed on clinical grounds alone, and this is also shown in Table III. In the majority of TABLE III Clinical details of
thepatients n
%
179 61 54
59 20 18
8
3
24 18 13 9 5 233
8 6 4 3 2 77
Age of onset of epilepsy < 2years 2-4 years 5-9 years lo-14 years 15-19 years 20-39 years >40 years (Mean age of onset 14 years; range O-63 years)
16 40 58 65 46 66 11
5 13 19 22 15 22 4
Duration of epilepsy < 2years 2-4 years 5-9 years >lO years (Mean duration 7 years; range l-40 years)
64 82 68 88
21 27 23 29
seizare classitlcation Generalised Secondarily Partial with Generalised seizures
tonic-clonic seizures generahsed seizures secondarily generalisation tonic-clonic + other generalised
Likely aetiologies Infection Birth trauma Head trauma Hereditary/familial Other Unknown
TABLE IV
Seizurefrequency Mean number of seizures 25 (range 2-360 seizures). n
%
Since onset (estimated) 10 or less seizures More than 10 seizures Not known
27 256 19
15 78 6
Previous year 10 or less seizures More than 10 seizures
98 204
32 68
cases no cause was identified. The seizures were severe in most cases, the mean number of seizures in a 1Zmonth period previous to the study was 25 seizures. Seizure frequency in the year before the study and the estimated number of seizures since the onset of epilepsy is shown in Table IV. Treatment status is shown in Table V. The majority of cases had never been treated, and of the 26% of patients who had had previous treatment, this was often only on an irregular basis. The commonest drugs previously used were phenobarbitone and phenytoin. The full results of the prospective clinical trial will be published elsewhere. It is sufficient to say here that the effectiveness of anti-epileptic drug
TABLE V Treatment status
Never on treatment Past treatment
n
%
223 79
74% 26%
No. of drugs used in past treatment 1 drug 2 drugs More than 2 drugs
47 28 4
Drugs used in the past Phenobarbitone Phenytoin Carbamazepine Diazepam Other
59 37 13 5 3
257 treatment in this largely untreated group was uniformly good, and comparable to that seen in new cases in developed countries. DISCUSSION There are a number of practical problems in delivering health care in developing countries, one of the commonest of which is the lack of wellequipped medical facilities and manpower. A recurring recommendation from governments and health care agencies has been to emphasise the role of health workers in all areas of primary health care. The WHO expert panel has recommended that health workers could be used for the diagnosis and treatment of tonic-clonic seizures’, and this was also one of the consensus recommendations of the ICBERG workshop held in Delhi, India in October 1989*. In most developing countries, public health policies are usually primarily aimed at acute or infectious diseases, or other conditions which carry a high mortality. Epilepsy, like other chronic conditions, carries a high socio-economic and personal morbidity, but a low mortality, and such conditions are given low priority in national health policies, both in developing and developed countries: this in spite of the high prevalence of epilepsy and the availability of treatment. To date there have been only a few community programmes concerned with the management of epileps$*‘, either from the developed or developing world. In 1986, a community-based project was initiated in Nakuru. This was a comprehensive programme which involved the partnership of several government agencies, community agencies, academia and industry, and it was overseen by the principal investigator, who was the psychiatrist to the region. The study was carried out in several stages. First, a pilot study was carried to design and standardise the instruments and test the methodology. Second, a campaign was launched to identify patients in the population with untreated tonic-clonic seizures. Demographic and clinical features of these patients were then investigated. Finally, a treatment programme was carried out prospectively over 12 months by a communitybased team of health workers overseen by the psy-
chiatrist and the community health physician. During this phase, clinical, psychological and socio-anthropological data were collected and the effect of treatment on these aspects measured. In this paper, the methodology of the study has been outlined, and the baseline demographic and clinical features of the cohort described. We do not purport to have carried out a prevalence study of epilepsy, nor to have identified every case of active epilepsy in the community, as we did not include patients on treatment or those without tonicclonic seizures. Nevertheless, we consider our cohort otherwise largely unselected and representative of a significant proportion of patients with severe untreated epilepsy in developing countries, and, more importantly, the group of patients towards whom primary health care in epilepsy should be aimed. The group has a number of important characteristics: the patients were young, usually living in rural areas, with an age of onset of epilepsy under 14 years in over half the sample. The tonic-clonic seizures frequently had a focal onset, but the aetiology of the epilepsy was established in less than onethird of cases. Many patients had moderate or severe epilepsy, and only a third had had less than 10 seizures in the previous year. This is the first description of a group of this size of patients with epilepsy in a developing country. The group is younger than a similar population in a developed country, probably reflecting different demographic structures, but the range of causes and type of seizures seem similar. The frequency of seizures is probably greater than that in an equivalent population in a developed country, and this may be due to the deficiency in the provision of antiepileptic drug treatment. Herein lies the major difference between the epileptic population in the developed and developing world. In Nakuru, only 26% of these identified patients had ever had any sort of antiepileptic drug treatment, and in many, treatment had been limited both in time and extent. A similar treatment gap has been found in other developing countries, by ICBERG members, thus, in countries as diverse as the Philippines, Ecuador and Pakistan, the proportion of untreated patients at any one time having been found to be between 80-94%. This failure to pro-
258 vide adequate treatment in developing countries is one major reason for evaluating treatment programmes, as we have done here. The results of the community management programme will be described elsewhere, but it is noticeable how successful this was, and how enthusiastic the individuals with epilepsy and their families were in coming forward for treatment. Initial case-finding was carried out largely by the key informant method, but as time elapsed more and more patients with epilepsy from the district presented to the clinic, and within a year of initiation of the campaign more patients appeared spontaneously, than were identified using the key informant method. Several points should be emphasised which were crucial to the success of this study, and which are important issues for the health care management of epilepsy in developing countries in general. (A) The importance of health workers operating from a community base cannot be overemphasised. These workers could carry out tasks for which more trained personnel would have little time. Furthermore, they have an understanding of the local region and the local population and the empathy engendered is an important aspect of any treatment programme. It is vital, however, that the activities of these health workers are monitored and controlled by a professional team; this monitoring was highly and successfully performed by the Provincial Psychiatrist. Indeed, the psychiatric services of an extensive region (it is over 5 000 square kilometres) and a large population (850 000 people) were covered by the single psychiatrist, and to be effective, in a condition like epilepsy, health workers and assistants were necessary to carry out day-to-day activities. We would further recommend that epilepsy education be on the curriculum of all health care workers as it is one of the most prevalent chronic diseases encountered in such communities. (B) The study concentrated on identifying untreated patients with tonic-clonic seizures. This group of patients comprise the largest population of patients with epilepsy, and can be usefully targeted for primary health care programmes. Identification of patients with other types of seizures, particularly complex partial seizures or absence seizures, would add considerably to the difficulties of
training health care workers and require more complex education. Furthermore, most patients with long-standing complex partial seizures in the developing world have coexisting tonic-clonic seizures. (C) The key informant method provides a highly economic and time-effective method of identifying patients at a community level. This is discussed elsewhere3, but we would recommend it for any community-based management programme for epilepsy. This method is perhaps equalled only by a house-to-house screening of the whole population, which would require a much more intensive effort. (D) The study concentrated on psychological and socio-anthropological aspects, as well as the medical considerations. This is of great importance in determining the effectiveness of treatment not only on seizure frequency, but also on quality of life. Furthermore, such information is essential in designing an appropriate programme for any individual community. These aspects will be discussed elsewhere. (E) Finally, we would like to suggest the importance of institutional collaboration, which we feel was largely responsible for the success of this study. The principal investigator (A.T.F.) co-ordinated a local team, an international academic input, governmental input and the logistic and financial support from the pharmaceutical industry (Ciba Geigy). Each of these players contributed specific expertise, and allowed the study to be larger and more complex than any individual unit would have been able to design or to prosecute. Again, we would strongly urge that such a collaborative effort is the only way in which large-scale studies such as this can be carried out in medical or community settings in rural areas of developing countries. The results of the treatment programme on seizure control, psychological and socio-anthropological aspects and on quality of life will be described elsewhere. We feel, however, that we have proven that it is feasible to deliver appropriate care to people with epilepsy in the context of primary health care in a developing country, with resources similar to Nakuru. This is possible by a medically led, community-based programme with
259 a team of health workers. A further aspect of the study, which is of great importance, has been the opportunity to look at the effect of treatment in a population of largely previously untreated patients, many of whom had a long history of untreated epilepsy. It has been suggested that early treatment of epilepsy will alter the prognosis of the condition, and the longer the time that elapses before treatment is started, the more likely is epilepsy to become intractable6. Over half of this cohort had had epilepsy for more than 5 years, and almost a third for more than 10 years; the majority of people had a high seizure frequency and the great majority had never received antiepileptic drug treatment. Thus, we have had the opportunity to study the effect of a prospective trial of treatment in this largely untreated group with chronic epilepsy, and to compare this with the effects of treatment amongst newly diagnosed, previously untreated cases.
ACKNOWLEDGEMENTS ICBERG (International Community-Based Epilepsy Research Group) is an informal and academic research group. Members are affiliated to the International League against Epilepsy and are professionals with an interest in epidemiological studies and in the management of epilepsy in the community. ICBERG would like to thank Ciba Geigy for financial and logistic support, the National Society for Epilepsy (U.K.) for logistic support and the Ministry of Health of Kenya for making it possible for the study to be conducted. We would also particularly like to thank Dr. Russell Ellisson and Dr. F. van Andel, who were a major force in this study, and whose tireless enthusiasm and support ensured its success.
REFERENCES 1 Hart, Y.M., Sander, J.W.A.S. and Shorvon, SD., The National General Practice Study of epilepsy: objectives and study methodology, Neuroepidemiology, 8 (1989) 221-227. 2 Shorvon, SD., Hart, Y.M., Sander, J.W.A.S. and Van Andel, F.G., The Management of Epilepsy in Developing Countries: an ‘ICBERG’ Symposium
Series,
Manual. No.
International
Congress
and
175, Royal Society of Medicine,
London, 1991. 3 Kaamugisha, J. and Feksi, A.T., Determining the prevalence of epilepsy in the semi-urban population of Nakuru, Kenya, comparing two independent methods not apparently used before in epilepsy studies, Neuroepidemiology, 7 (1988) 115-121.
4 Nakuru District Development Plan, Ministry of Finance and Planning, Nairobi, 1988. 5 Watts, A.E., A model for managing epilepsy in a rural community in Africa, Br. Med. J., 298 (1989) 805-807. 6 Shorvon, SD., The temporal aspects of prognosis in epilepsy, J. Neurol. Neurosurg. Psychiatry, 47 (1984) 1157-1165. 7 Shorvon, S.D. and Farmer, P., Epilepsy in developing countries, Epilepsia, 29 (1988) S36-S54. 8 World Health Organization, Mental Health and Psychosocial Development. Tech. Rep. Ser., WHO, Geneva, 1977. 9 World Health Organization, Community control of epilepsy: report on an informal consultation for the development of a strategy and protocol, WHO Publications, Geneva, 1985.
252
Elsevier EPIRES 00400
A comprehensive
community epilepsy programme: the Nakuru project
A.T. Feksi”‘, J. Kaamugishaa*, S. Gatitib*, J.W.A.S. Sander”* and S.D. Shorvond* ‘Provincial General Hospital, Nakuru, Rift Valley Province (Kenya);
‘Regional Medical Centre, Ciba-Geigy, Nairobi (Kenya);
“Institute of Neurology, Queen Square, London, and The National Hospital - Chalfont Centre for Epilepsy, Chalfont St. Peter, Gerrards Cross, Bucks. (V. K.)
(Received 17 October 1990; revision received 3 December 1990; accepted 31 December 1990) Key words: Kenya; Key informant; Primary health care; Untreated epilepsy; Developing countries
The methodology of a programme of investigation of epilepsy carried out at a community health level in Nakuru district, Kenya, East Africa, and the characteristics of patients with tonic-clonic epilepsy in this community, are presented. The study identified a group of 302 patients with untreated generalised tonic-clonic seizures (with or without other seizure types) from the general population. Case finding was carried out using the key informant method over a 1Zmonth period. The clinical characteristics of this cohort of patients, the majority of whom had never had previous contact with a formal medical system, is described. Most were young, living in a rural area, with a mean age of seizure onset of 14 years and a mean duration of seizures of 7 years. Thirty-eight per cent had a clinically evident focal disturbance associated with the tonic-clonic seizures. In 77% of the cases, no aetiology was established. Most cases had had a substantial number of seizures during the course of their condition and only about a third of the patients had less than 1 seizure a month in the previous year. Only 26% had ever had previous anti-epileptic drug treatment. In addition to the medical inquiry, psychological and sociological studies were also conducted and a prospective treatment programme was carried out. Throughout the study, strict definitions and standardised instruments were used, and the study was the result of a collaboration between local investigators, an international neurological team, the Kenyan Government agencies and the pharmaceutical industry. We consider this a model for community-based investigations for the management of epilepsy in developing countries.
INTRODUCTION Epilepsy is a common chronic neurological disorder of considerable public health importance. It carries a social stigma and frequently has severe
* For ICBERG (International Research Group)
Community-based
Epilepsy
Correspondence to: A.T. Feksi, Provincial General Hospital, P.O. Box 71, Nakuru, Rift Valley Province, Kenya.
0920-1211/91/$03.50 @‘J1991 Elsevier Science Publishers B.V.
consequences, both medical and social especially in developing countries’. In Kenya and in Africa in general, hospital and clinical studies have shown that epilepsy is one of the commonest problems seen in out-patient clinics*. Despite this, epilepsy, as with other chronic diseases, generally carries a low priority for health care provision, which tends to be directed to acute, infectious and more lifethreatening conditions. Thus, it is inevitably necessary to show that medical intervention for epilepsy can be succesful and improve quality of life,
253 for scarce resources to be allocated’. There is, however, a dearth of data concerning the management of epilepsy in developing countries, and treatment strategies are commonly based on data from developed countries, usually from hospitals or specialist practices. Extrapolation of such data, however, might not be appropriate’. Little practical work has been carried out in areas without specialist investigatory or treatment facilities in the developing world, and it was to address this need that the current study was devised. A comprehensive epilepsy programme was carried out in Nakuru District, which is situated in the Rift Valley in South West Kenya, East Africa. The programme was carried out at a community level during the periods of October 1986 to September 1988, in which 302 persons with epilepsy presenting with generalised tonic-clonic seizures were identified and entered into the study. We consider this category of patients to be the most important to be targetted for an initial epilepsy control programme in a basic health care setting. The majority of the patients had never received medical treatment, and this gave us the additional opportunity to study epilepsy in its untreated state. The programme was carried out by the collaboration of the local community, the local study team, a neurological team from the Institute of Neurology and the National Society for Epilepsy (U.K.), Kenyan Government Agencies and the pharmaceutical industry (Ciba Geigy). Objectives of theprogramme The overall purpose of this programme of investigation was to test the hypothesis that an epilepsy treatment programme could have a useful effect in a primary health care setting. To this end, the following aims were set: (1) To identify patients with untreated tonic-clonic seizures with non-progressive neurological disease at the community level. These patients were chosen as the most important category of patient with epilepsy to target in a health care programme. (2) To describe the clinical phenomenology, the social and psychological status of these patients, using standardised instruments. (3) To evaluate the effects of a treatment pro-
gramme using carbamazepine or phenobarbitone on the clinical, social and psychological status of these patients, over a prospective 12-month intervention study. (4) To assess the role of trained health visitors in a community management programme of epilepsy. These health visitors, operate at community level, and their functions include the identification of patients with epilepsy, educational counselling of the patients and community figures and ensuring compliance with treatment. (5) To utilise this information for making recommendations for the design of health care programmes for epilepsy in developing countries, without specialised facilities. In this paper, we will outline the overall methodology of the study, the identification of patients and their demographic and clinical features of the patient population. The results of the treatment programme will be described elsewhere. Study area Kenya is located in East Africa and has an area of 402 600 square kilometres with a population of 20 million. The country is geographically divided into a coastal plain, highlands and the Rift Valley. The present programme was carried in the Nakuru district which is located in South West Kenya, within the Great Rift Valley; it covers an area of 5 769 square kilometres. The valley is characterised by a number of extinct and dormant volcanoes and by 3 lakes. Nakuru town lies at the valley floor at an altitude of 1 880 m above sea level. The district population is estimated at 850 000 inhabitants of whom approximately 150 000 live in Nakuru town, and the remaining in rural settings. There is a high proportion of young people, and 63% of the district population is estimated to be below the age of 20 years. The population is largely poor and depends basically upon income from agricultural activities; small-scale farming is common in the district. The population is largely Swahili-speaking, of several tribal backgrounds, of which Kikuyu are the largest group, with significant numbers of Kalenjin, Luo and Luhya4. Health care system The Nakuru district is served by 3 hospitals, one
254 of which, in Nakuru town, serves as a district hospital, and by 7 health centres and 37 dispensaries. The district hospital (Provincial General Hospital) is the most important provider of health care and contains basic facilities for x-ray, biochemistry and chemical pathology and surgery, and is staffed by general and specialist doctors. There are no EEG or CT scanning facilities, and if more sophisticated health attention is required, the patient may be referred to Nairobi. The district hospital is also the base for the Provincial Psychiatrist (A.T.F.), who acted as the principal investigator in the study and who has a long-standing specialist interest, training and practice in epilepsy. Health centres are permanently staffed with paramedical staff and community nurses whilst the dispensaries are run mainly by community nurses4. METHODS Pre-study activities
A weekly epilepsy clinic was set up at the Nakuru Provincial Hospital, run by the Provincial Psychiatrist (A.T.F.). Additional staff included a community health physician, a clinical psychologist, a visiting sociologist and several administrative officers. The epilepsy programme was based in this clinic. The overall programme design was formulated by this local team, teams from London and from the Kenyan Government, with the collaboration of a pharmaceutical company (Ciba Geigy). The initial aim of the study was to pilot a series of instruments designed to describe the clinical phenomenology and to assess social, psychological, and medical aspects. All these instruments were standardised and piloted in a small pilot population. A feature of their usage was that all terms were strictly defined, and careful definitions strictly adhered to in the analysis. The definitions, for instance, used to designate a generalised tonicclonic seizure, are shown in Table I. These medical instruments were based on previous experience from a community survey in the United Kingdom’. The next stage was to recruit 16 health workers and 1 social worker. The health workers were chosen from an initial list of 26 potential candidates from the locality. These health workers re-
ceived 1 month of basic training in epilepsy and in the study methodology, given by the study team. Their function was to identify patients using the key informant method3 and to act in the role of health visitors in the community management epilepsy programme. The training programme comprised community health issues, counselling of patients in various aspects of epilepsy, the diagnosis of generalised tonic-clonic seizures and other epilepsy-related topics. They were instructed on how to interview persons with epilepsy and their relatives and on the importance of bringing about changes in attitude towards epilepsy amongst the patients’ relatives and the community itself. The study programme was sanctioned by the Kenyatta National Hospital Ethical Committee in Nairobi and approved by the Kenyan Ministry of Health. In parallel to these pre-study activities, a public information campaign was launched, with publicity by leaflets, posters, and public meetings convened by chiefs and other community leaders. A logistic system for case referral and follow-up was put in place, and a comprehensive method of patient flow established. Once the clinic was initiated, it was extensively advertised. This included information at 3 local hospitals, visits by the study team to all health centres and dispensaries in the region, to schools, administrative officers and key community figures. These pre-study activities were considered very important for the successful outcome of the study itself. Case identification
Case finding was carried out over a 12-month period. Patients were identified at a local level using the key informant method, described in detail elsewhere3. Key informants were chosen from responsible members of his/her society, clinical officers, nursing officers, birth attendants, traditional healers, school teachers, heads of social, government or other official facilities and organisations. Another group of key informants was selected with the help of chiefs, elders of the community, youth leaders, landlords, businessmen and by other community figures. Designated key informants were then given a short instruction in epilepsy and asked to identify cases known to them through their social network. Those referred by
255 the key informant were then seen by a health worker and all cases in whom the health worker suspected active epilepsy were invited to attend the epilepsy clinic in Nakuru district hospital. The patients were accompanied by a close friend or relative, who had personally observed the seizures. Inclusion criteria
The epilepsy clinic was held every Friday, and patients and their relatives were seen by the principal investigator (A.T.F.) for diagnostic confirmation. The diagnosis was established on clinical grounds using a strict diagnostic protocol and algorithm. Suitable patients who fulfilled the following criteria were admitted to the study: (A) Aged between 6 and 65 years. (B) History of generalised tonic-clonic seizures, with or without other seizure types, and who had had 2 or more tonic-clonic seizures in the previous 12 months. (C) Were not on active antiepileptic drug treatment (defined as the administration of an antiepileptic drug in the previous 3 months). Written and informed consent was obtained from all patients who agreed (parents in the case of children) to take part in the study after careful explanation. All patients and their informants were then interviewed, and the patient examined using a standard protocol and the findings recorded. In the medical arm of the study special stress was placed on the collection of data regarding previous medical treatment of the epilepsy, the duration of
the epilepsy and seizure frequency. A putative aetiology was attributed to each patient on historical grounds only, as no special investigations were routinely carried out unless a potential treatable cause for the epilepsy or a progressive neurological condition was suspected. The patients were then entered into a treatment study. This was a randomised prospective trial carried out over 12 months using 2 well-established anti-epileptic drugs: carbamazepine and phenobarbitone. The study will be reported in detail elsewhere. Psychological and socio-anthropological data were also collected and the methodology and results of these arms of the programme will also be reported elsewhere. RESULTS Clinical and demographic findings in the initial cohort
Over the 1Zmonth period in which recruitment took place, over 650 persons were referred to the clinic, and 529 patients with active seizures were identified. Of these, 302 met the study criteria and agreed to take part in the prospective treatment programme. Reasons for the non-inclusion of the remaining 227 patients included lack of consent, non-residence in Nakuru district, pregnancy, alcohol or drug abuse, or failure to meet study inclusion criteria. Patients who were not included in the study were, however, offered treatment, follow-
TABLE I Definitions of a generalised tonic-clonic seizure
If criteria i-iii are positive, and any two of iv-x are positive, the diagnosis of a generalised tonic-clonic seizure is considered. If x is positive, diagnosis of secondary generalised seizure is considered.
(9 (ii) (iii) (iv) & (vii) (viii) (ix) (x)
Loss of consciousness l-30 min Bilateral tonic contracture Bilateral clonic movements Sphincteric incontinence Fall Injury with fall, including bums Tongue-biting Post-ictal muscular aching Post-ictal drowsiness, sleep, confusion or headache Post-ictal unilateral limb weakness
TABLE II Demographic features of the cohort ofpatients with epilepsy n = 302: males, 173 (57%); females, 129 (43%). Mean age, 21 years (range: 6 to 65 years); location: living in rural areas, 234 (77%); urban area, 68 (23%). Age (years)
n
70
5- 9 10-14 15-19 20-29 30-39 40-49 50-59 XX
37 60 59 76 42 16 8 4
12 20 20 25 14 5 3 1
256 up and referral to the regular hospital clinics where relevant. Demographic features of the 302 patients studied is given in Table II. There was a preponderance of males, the majority being young and living in rural areas. Age of onset of the seizure disorder is shown in Table III. In the great majority the onset was in the first 2 decades. The majority had long histories of seizures, the mean duration of epilepsy was 7 years. Seizure classification is given in Table III. There was clinical evidence in 115 patients of a focal onset for the seizures, and it is likely that this would have been much higher if EEG had been used before seizure classification. Aetiology was attributed on clinical grounds alone, and this is also shown in Table III. In the majority of TABLE III Clinical details of
thepatients n
%
179 61 54
59 20 18
8
3
24 18 13 9 5 233
8 6 4 3 2 77
Age of onset of epilepsy < 2years 2-4 years 5-9 years lo-14 years 15-19 years 20-39 years >40 years (Mean age of onset 14 years; range O-63 years)
16 40 58 65 46 66 11
5 13 19 22 15 22 4
Duration of epilepsy < 2years 2-4 years 5-9 years >lO years (Mean duration 7 years; range l-40 years)
64 82 68 88
21 27 23 29
seizare classitlcation Generalised Secondarily Partial with Generalised seizures
tonic-clonic seizures generahsed seizures secondarily generalisation tonic-clonic + other generalised
Likely aetiologies Infection Birth trauma Head trauma Hereditary/familial Other Unknown
TABLE IV
Seizurefrequency Mean number of seizures 25 (range 2-360 seizures). n
%
Since onset (estimated) 10 or less seizures More than 10 seizures Not known
27 256 19
15 78 6
Previous year 10 or less seizures More than 10 seizures
98 204
32 68
cases no cause was identified. The seizures were severe in most cases, the mean number of seizures in a 1Zmonth period previous to the study was 25 seizures. Seizure frequency in the year before the study and the estimated number of seizures since the onset of epilepsy is shown in Table IV. Treatment status is shown in Table V. The majority of cases had never been treated, and of the 26% of patients who had had previous treatment, this was often only on an irregular basis. The commonest drugs previously used were phenobarbitone and phenytoin. The full results of the prospective clinical trial will be published elsewhere. It is sufficient to say here that the effectiveness of anti-epileptic drug
TABLE V Treatment status
Never on treatment Past treatment
n
%
223 79
74% 26%
No. of drugs used in past treatment 1 drug 2 drugs More than 2 drugs
47 28 4
Drugs used in the past Phenobarbitone Phenytoin Carbamazepine Diazepam Other
59 37 13 5 3
257 treatment in this largely untreated group was uniformly good, and comparable to that seen in new cases in developed countries. DISCUSSION There are a number of practical problems in delivering health care in developing countries, one of the commonest of which is the lack of wellequipped medical facilities and manpower. A recurring recommendation from governments and health care agencies has been to emphasise the role of health workers in all areas of primary health care. The WHO expert panel has recommended that health workers could be used for the diagnosis and treatment of tonic-clonic seizures’, and this was also one of the consensus recommendations of the ICBERG workshop held in Delhi, India in October 1989*. In most developing countries, public health policies are usually primarily aimed at acute or infectious diseases, or other conditions which carry a high mortality. Epilepsy, like other chronic conditions, carries a high socio-economic and personal morbidity, but a low mortality, and such conditions are given low priority in national health policies, both in developing and developed countries: this in spite of the high prevalence of epilepsy and the availability of treatment. To date there have been only a few community programmes concerned with the management of epileps$*‘, either from the developed or developing world. In 1986, a community-based project was initiated in Nakuru. This was a comprehensive programme which involved the partnership of several government agencies, community agencies, academia and industry, and it was overseen by the principal investigator, who was the psychiatrist to the region. The study was carried out in several stages. First, a pilot study was carried to design and standardise the instruments and test the methodology. Second, a campaign was launched to identify patients in the population with untreated tonic-clonic seizures. Demographic and clinical features of these patients were then investigated. Finally, a treatment programme was carried out prospectively over 12 months by a communitybased team of health workers overseen by the psy-
chiatrist and the community health physician. During this phase, clinical, psychological and socio-anthropological data were collected and the effect of treatment on these aspects measured. In this paper, the methodology of the study has been outlined, and the baseline demographic and clinical features of the cohort described. We do not purport to have carried out a prevalence study of epilepsy, nor to have identified every case of active epilepsy in the community, as we did not include patients on treatment or those without tonicclonic seizures. Nevertheless, we consider our cohort otherwise largely unselected and representative of a significant proportion of patients with severe untreated epilepsy in developing countries, and, more importantly, the group of patients towards whom primary health care in epilepsy should be aimed. The group has a number of important characteristics: the patients were young, usually living in rural areas, with an age of onset of epilepsy under 14 years in over half the sample. The tonic-clonic seizures frequently had a focal onset, but the aetiology of the epilepsy was established in less than onethird of cases. Many patients had moderate or severe epilepsy, and only a third had had less than 10 seizures in the previous year. This is the first description of a group of this size of patients with epilepsy in a developing country. The group is younger than a similar population in a developed country, probably reflecting different demographic structures, but the range of causes and type of seizures seem similar. The frequency of seizures is probably greater than that in an equivalent population in a developed country, and this may be due to the deficiency in the provision of antiepileptic drug treatment. Herein lies the major difference between the epileptic population in the developed and developing world. In Nakuru, only 26% of these identified patients had ever had any sort of antiepileptic drug treatment, and in many, treatment had been limited both in time and extent. A similar treatment gap has been found in other developing countries, by ICBERG members, thus, in countries as diverse as the Philippines, Ecuador and Pakistan, the proportion of untreated patients at any one time having been found to be between 80-94%. This failure to pro-
258 vide adequate treatment in developing countries is one major reason for evaluating treatment programmes, as we have done here. The results of the community management programme will be described elsewhere, but it is noticeable how successful this was, and how enthusiastic the individuals with epilepsy and their families were in coming forward for treatment. Initial case-finding was carried out largely by the key informant method, but as time elapsed more and more patients with epilepsy from the district presented to the clinic, and within a year of initiation of the campaign more patients appeared spontaneously, than were identified using the key informant method. Several points should be emphasised which were crucial to the success of this study, and which are important issues for the health care management of epilepsy in developing countries in general. (A) The importance of health workers operating from a community base cannot be overemphasised. These workers could carry out tasks for which more trained personnel would have little time. Furthermore, they have an understanding of the local region and the local population and the empathy engendered is an important aspect of any treatment programme. It is vital, however, that the activities of these health workers are monitored and controlled by a professional team; this monitoring was highly and successfully performed by the Provincial Psychiatrist. Indeed, the psychiatric services of an extensive region (it is over 5 000 square kilometres) and a large population (850 000 people) were covered by the single psychiatrist, and to be effective, in a condition like epilepsy, health workers and assistants were necessary to carry out day-to-day activities. We would further recommend that epilepsy education be on the curriculum of all health care workers as it is one of the most prevalent chronic diseases encountered in such communities. (B) The study concentrated on identifying untreated patients with tonic-clonic seizures. This group of patients comprise the largest population of patients with epilepsy, and can be usefully targeted for primary health care programmes. Identification of patients with other types of seizures, particularly complex partial seizures or absence seizures, would add considerably to the difficulties of
training health care workers and require more complex education. Furthermore, most patients with long-standing complex partial seizures in the developing world have coexisting tonic-clonic seizures. (C) The key informant method provides a highly economic and time-effective method of identifying patients at a community level. This is discussed elsewhere3, but we would recommend it for any community-based management programme for epilepsy. This method is perhaps equalled only by a house-to-house screening of the whole population, which would require a much more intensive effort. (D) The study concentrated on psychological and socio-anthropological aspects, as well as the medical considerations. This is of great importance in determining the effectiveness of treatment not only on seizure frequency, but also on quality of life. Furthermore, such information is essential in designing an appropriate programme for any individual community. These aspects will be discussed elsewhere. (E) Finally, we would like to suggest the importance of institutional collaboration, which we feel was largely responsible for the success of this study. The principal investigator (A.T.F.) co-ordinated a local team, an international academic input, governmental input and the logistic and financial support from the pharmaceutical industry (Ciba Geigy). Each of these players contributed specific expertise, and allowed the study to be larger and more complex than any individual unit would have been able to design or to prosecute. Again, we would strongly urge that such a collaborative effort is the only way in which large-scale studies such as this can be carried out in medical or community settings in rural areas of developing countries. The results of the treatment programme on seizure control, psychological and socio-anthropological aspects and on quality of life will be described elsewhere. We feel, however, that we have proven that it is feasible to deliver appropriate care to people with epilepsy in the context of primary health care in a developing country, with resources similar to Nakuru. This is possible by a medically led, community-based programme with
259 a team of health workers. A further aspect of the study, which is of great importance, has been the opportunity to look at the effect of treatment in a population of largely previously untreated patients, many of whom had a long history of untreated epilepsy. It has been suggested that early treatment of epilepsy will alter the prognosis of the condition, and the longer the time that elapses before treatment is started, the more likely is epilepsy to become intractable6. Over half of this cohort had had epilepsy for more than 5 years, and almost a third for more than 10 years; the majority of people had a high seizure frequency and the great majority had never received antiepileptic drug treatment. Thus, we have had the opportunity to study the effect of a prospective trial of treatment in this largely untreated group with chronic epilepsy, and to compare this with the effects of treatment amongst newly diagnosed, previously untreated cases.
ACKNOWLEDGEMENTS ICBERG (International Community-Based Epilepsy Research Group) is an informal and academic research group. Members are affiliated to the International League against Epilepsy and are professionals with an interest in epidemiological studies and in the management of epilepsy in the community. ICBERG would like to thank Ciba Geigy for financial and logistic support, the National Society for Epilepsy (U.K.) for logistic support and the Ministry of Health of Kenya for making it possible for the study to be conducted. We would also particularly like to thank Dr. Russell Ellisson and Dr. F. van Andel, who were a major force in this study, and whose tireless enthusiasm and support ensured its success.
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4 Nakuru District Development Plan, Ministry of Finance and Planning, Nairobi, 1988. 5 Watts, A.E., A model for managing epilepsy in a rural community in Africa, Br. Med. J., 298 (1989) 805-807. 6 Shorvon, SD., The temporal aspects of prognosis in epilepsy, J. Neurol. Neurosurg. Psychiatry, 47 (1984) 1157-1165. 7 Shorvon, S.D. and Farmer, P., Epilepsy in developing countries, Epilepsia, 29 (1988) S36-S54. 8 World Health Organization, Mental Health and Psychosocial Development. Tech. Rep. Ser., WHO, Geneva, 1977. 9 World Health Organization, Community control of epilepsy: report on an informal consultation for the development of a strategy and protocol, WHO Publications, Geneva, 1985.
