Introduction and situation analysis
The Peoples Republic of China is situated to the east of the Asian continent. It covers 9,600,000 km2 and is divided into 23 provinces, 5 autonomous regions and 4 municipalities. These divisions contain 335 districts, 2858 counties, 48,000 towns and 822,000 villages.
According to the national records, in 1998 China had a population of 1.25 billion people of 56 different ethnic groups. The urban population was 379 million (30.4%) and the rural population was 869 million (69.6%). The Chinese gross national product (GNP) was ¥7955 billion (US$980.2 billion with GNP/capita being US$780) in 1999; urban resident income was ¥5425 whilst rural resident net income was ¥2160 in 1998.
Since the adoption of policies leading to economic reform and opening to the outside world, the Chinese primary health-care system (the three-tier rural medical care system: county town village) has further developed its disease control activities and health campaigns. The system now provides comprehensive and sustainable health care to rural and semi-rural populations and covers the great majority of the population. There are two million professional health workers (including western and Chinese physicians), averaging 1.6 per 1000 population. The medical care system is currently undergoing reforms with the result that health service coverage is expanding. This is part of the Chinese governments efforts to attain the strategic goal of health for all.
One of the greatest problems facing people with epilepsy is the stigma placed upon them by the community. Studies in China suggest that people with epilepsy are generally withdrawn from society; they feel isolated and are either overprotected or neglected.
- To generate procedures that would improve the identification and management of people with convulsive forms of epilepsy, in rural and semi-rural areas of the country, within the existing primary health care system and with community participation.
- To develop a model of epilepsy treatment at primary health level that could be applied nation-wide.
- To assess current management practices (identification, treatment and follow-up) of patients with convulsive forms of epilepsy in rural and semi-rural areas of the country.
- To estimate: a) the prevalence of active forms of convulsive epilepsy, b) the scale of the treatment gap via an active case finding methodology, and c) changes the project may bring to these figures in the study area.
- To ascertain the knowledge, attitudes and practice of epilepsy amongst health practitioners at primary health level prior to the study and after they have undergone training for epilepsy.
- To develop technical norms for the identification, education, treatment and follow-up of patients with epilepsy at primary health care level.
- To carry out a feasibility study, by primary health care doctors, of the treatment of convulsive forms of epilepsy using phenobarbital.
- To develop a programme for continuous professional education on epilepsy for primary health.
- To promote public awareness about epilepsy via an educational programme aimed at the community.
- To develop local advocacy and support groups for people with epilepsy.
- To reduce the economic and social burden of epilepsy in the study areas.
This demonstration project was composed of three parts:
- Epidemiological estimation: to provide a realistic estimation of the prevalence of untreated active epilepsy in the study areas.
- Service Delivery (intervention study): to cover the issues of diagnosis, phenobarbital treatment, follow up referral networks.
- Educational, social and community intervention: to cover the educational and social aspects of the project.
- Epidemiological Estimation
A door-to-door survey was carried out in 5 representative counties each with a population of about 10,000 people (total population: 50,000). A screening questionnaire was designed to identify patients with convulsive seizures. The questionnaire was validated at the Beijing Neurological Institute for specificity and sensitivity. The questionnaire was based on the WHO screening questionnaire previously used in China and on the ICBERG screening instrument. Adjustments to the questionnaire were made accordingly.
All participants were trained to use the validated screening questionnaire and mastered the standard before survey. The survey was repeated using a similar methodology and instruments at the end of a four-year period to ascertain whether there had been a measurable change in the treatment gap in the areas surveyed.
- Service Delivery (Intervention Study)
Patients who qualified for entry into the study received treatment with phenobarbital according to the technical norms set out. The town hospital physicians completed a study entry form at this point. Demographic details and a pragmatic retrospective estimation of the numbers of seizures, particularly convulsions, which the patient had experienced in the previous, week, month and year, were recorded. A record of the current occupation status of the patient (work and school) was made. If the patient was employed, or attended school, an estimation of absence from work or school due to epilepsy was made and recorded.
The senior primary health care physicians and village doctor explained to the patient the importance of regular compliance with medication and how it should be used. The patient was informed about common side-effects of the medication and advised to report to the doctor any untoward effect that they might experience once treatment had started. The patient was provided with contact information for the primary health care team and also instructed on the importance of follow up visits.
Patients included in the study were invited to attend the town hospital or village clinic every two weeks for the first two months, and monthly thereafter, for dose adjustments, side-effects assessment, compliance checking and to receive further supply of the medication. The doctor filled out a follow-up form for each visit. Number of seizure, side effects and effects of treatment were recorded. If the patient reported the presence of side effects, the senior primary health care physicians dealt with these according to instructions in the technical norms. In case of doubts, or if the side-effects were severe or persistent, the patient was referred to the local neurologist.
Compliance was assessed at every follow-up appointment according to given instructions. The patient or his/her parents recorded the seizures, the medication taken, any effects of the treatment and other issues. Those patients working or at school were questioned about their attendance record from the previous visit and any changes of occupational status were recorded. The village doctor could at any time request a review by the senior physician if severe side-effects developed, or in the case of clinical uncertainty, or if the patients seizure control proved to be difficult. The patient was reviewed at least once every three months by the local neurologist in charge of the case.
Patients were withdrawn from the study if one or more of the following situation arose:
- The treatment was found not to be effective by the supervising doctor.
- The patient experiences an important deterioration in seizure control (i.e. an increase of 50% or more of seizures or status epilepticus).
- Patient or guardian decided against continuing treatment.
- The patient was found to be non-complaint with the treatment in 3 consecutive opportunities.
- The patient failed to attend 3 follow-up appointments.
- The patient was found to have a progressive neurological disorder.
- The patient developed a heart, liver or kidney condition.
- The patient developed severe side-effects to phenobarbital, confirmed by the supervising doctor.
If a patient withdrew from the study, a termination form was filled out recording the reasons for the drop out. The patient received alternative or further treatment or was referred to another level of care, according to clinical needs.
All physicians and a number of village doctors in each of the study areas received basic epilepsy training. This was provided by the team of the Beijing Neurosurgical Institute and by the local neurologists who collaborated in the study. The training module covered the following aspects:
- Epidemiology of epilepsy
- Public health aspects of epilepsy
- Causes of epilepsy
- Differential diagnosis of epilepsy
- Diagnosis of epilepsy and particularly of generalised tonic clonic convulsions
- Drug treatment of epilepsy
- Management of epilepsy
- Nature of the study and how to fill in the study forms
Each of the doctors attending this project in training received a work plan.
Prior to the start of training all doctors completed a questionnaire to ascertain their knowledge, attitudes and practice (KAP) in relation to epilepsy. To assess the effectiveness of the training module, all participants were asked to complete the same questionnaire between 3 and 6 months later. A Chinese version of the KAP questionnaire, developed by the Pan American Health Organisation (PAHO), was used.
An educational programme about epilepsy was introduced throughout the study areas via a number of media channels and aimed to show the general community that epilepsy is a treatable disorder. The programme provided information about:
- The nature of epilepsy: it characteristics, cause and prognosis.
- The nature of treatment, its objectives, the use of medication, the importance of compliance, the potential side effects of medication and the duration of treatment.
- General health measures and emergency treatment of seizures.
The content of the programme was prepared by the team at the Beijing Neurological Institute and by the Beijing Epilepsy Association. Information sheets were handed to the patients and their families. A number of local physicians and neurologists lectured the patients and their families on a regular basis.
Lectures and group discussions for patients and their families were also arranged during this time, and community leaders and local teachers were presented with information about epilepsy, its causes and its treatment. Patients were encouraged by the media and by community leaders to come for free diagnostic assessment and for management when appropriate.
In addition, an educational programme, aimed at decreasing social stigma in areas of social relations, employment, leisure activities, schooling, etc., was developed. This was aimed at local primary and secondary school teachers because they exercise an important role in their communities. The aim of this programme was to address attitudes regarding aetiology, shame and to explain that epilepsy is not infectious. A revised version of the instrument used in a survey of public awareness, understanding and attitudes toward epilepsy in Henan province was completed by the teachers before and after the educational programme to assess changes.
Other activities carried out in the communities included:
- Informing people about epilepsy through public-address systems
- Disseminating materials on epilepsy
- Putting up posters
- Developing local Advocacy/Support Groups.
A second epidemiological survey was carried out between September and December 2004 after the above interventional and educational studies had been completed. This showed a minimum lifetime prevalence rate of 6.2/1,000 which is slightly lower than that of the previous survey. The prevalence of active epilepsy was 4.5/1000, similar to that found previously. In this survey half of the patients with active epilepsy had received anti-epileptic treatment in the previous week.
Organizational Context and Management Structure
Dr L Prilipko and Hanneke M de Boer were the Facilitators of this project on behalf of the Global Campaign Secretariat and also acted as supervisors/monitors of the project. Prof JW Sander was the Scientific Project Leader. The Department of Disease Control and the Department of International Co-operation of the Ministry of Health, Peoples Republic of China were responsible for the Demonstration Project and delegated the tasks of ensuring concerted action to the Beijing Neurosurgical Institute.
An Executive Committee was established at the Beijing Neurosurgical Institute. The members included each local co-ordinator and leader of the Public Health Bureaus.
An advisory panel was also constituted and consisted of a representative of WHO, a representative of the Global Campaign Against Epilepsy, a representative of the local WHO office, members of the Executive Committee, the local co-ordinators, a member appointed by the local Public Health Bureau from each of the counties involved, a representative of the Neurological Society of China, a representative of the Beijing Epilepsy Association and representatives from the Ministry of Health.
This Demonstration Project was successful in implementing treatment and management of convulsive forms of epilepsy in rural areas of China. Physicians with basic training have been shown to be able to treat people with epilepsy using Phenobarbital as the first option. This cost effective approach can make a difference to the treatment gap in epilepsy; which was reduced by about 13% between 2001 and 2004.
Phenobarbital treatment as a first option for epilepsy has now been extended to 80 counties in 15 provinces in China. By the end of August 2008, over 35,000 people with epilepsy had been treated according to this protocol. It is scheduled to become part of a national epilepsy programme in the next few years.
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