|
 INTERVENTIONAL
STUDIES
 Comparative
leprosy vaccine trial in South India
Single
dose therapy for single-lesion PB leprosy cases
Controlled
field trial of Efficacy of Vitamin A supplementation in infants
Controlled
field trial of two antenatal care packages
DISEASE
MODELLING
Simulation
model for leprosy transmission and control
HEALTH
SYSTEMS RESEARCH
LQAS
technique for monitoring national programmes
Testing
of WHO design for LEM activities
Evaluation
of National Leprosy Eradication Programme - 2000
Estimation
of immunization coverage
TRADITIONAL
MEDICINE RESEARCH
Kshaarasootra
in the management of fistula-in-ano
Vijayasar
for newly diagnosed NIDDM patients
METHODOLOGICAL
STUDIES
Implications
of misdiagnosis in field trials of vaccines
Impact
of BCG vaccination on the efficacy of antileprosy vaccines
Sample
size estimation for comparing two proportions
Confidence
intervals in medical research
Index
of nutritional status in children aged 5-10 years
MANPOWER
DEVELOPMENT
Field
Epidemiology Training Programme (FETP) - India
Surveillance,
Epidemic Preparedness and Response (SEPR) Workshops
Training
programme on controlled clinical trial
Basic
Course in Statistics for Medical Doctors
| .............................................................................................................................................. |
INTERVENTIONAL
STUDIES
Comparative
leprosy vaccine trial in South India
A controlled, double blind, randomized, prophylactic leprosy vaccine trial was
conducted in South India. Four vaccines, viz., BCG, BCG+ killed M.leprae, M.w.
and ICRC were studied in this trial in comparison with normal saline placebo.
From about 300,000 people, 216,000 were found eligible for vaccination and
among them, 171,400 volunteered to participate in the study. Intake for the
study was completed in two and a half years from January 1991. There was no
instance of serious toxicity or side effects subsequent to vaccination for
which premature decoding was required. All the candidate vaccines were safe for
human use. Decoding was done after the completion of the second resurvey in
December 1998. Results for vaccine efficacy are based on examination of more
than 70% of the original "vaccinated" cohort population, in both the
first and second resurveys. It was possible to assess the overall protective
efficacy of the candidate vaccines against leprosy as such. Observed incidence
rates were not sufficiently high to ascertain the protective efficacy of the
candidate vaccines against progressive and serious forms of leprosy. BCG +
killed M.leprae provided 64% protection (CI: 50.4 - 73.9), ICRC provided 65.5%
protection (CI: 48.0 - 77.0), M.w. gave 25.7% protection (CI: 1.9 - 43.8) and
BCG gave 34.1% protection (CI: 13.5 - 49.8)
(Figure 1). Protection observed with the ICRC vaccine and the
combination vaccine (BCG + killed M.leprae) meets the requirement of public
health utility and these vaccines deserve further consideration for their
ultimate applicability in leprosy prevention.
 |
| .............................................................................................................................................. |
Single
dose therapy for single-lesion PB leprosy cases
Majority of newly detected leprosy cases are being detected at the stage when
the only visible sign of the disease is a single lesion. Possibility of
treating such single-lesion PB cases with three highly bactericidal drugs
administered in a single dose was explored through a clinical trial. A
multicentre double-blind controlled clinical trial was carried out to compare
the efficacy of a combination of Rifampicin 600 mg plus Ofloxacin 400 mg plus
Minocycline 100 mg (ROM) administered as a single dose with that of the
standard six-month WHO / MDT / PB regimen as control. 1483 single lesion cases
who were previously untreated, smear-negative, and no evidence of peripheral
nerve trunk involvement were included in the study. They were randomly
allocated to the study and control groups. Of the 1483 cases admitted, 1381
completed the study. Only 12 patients were categorized as treatment failure and
no difference was observed between the two regimens
(Table 1). Occurrence of side effects and leprosy reactions were
minimal (less than 1%) in both the groups. This study showed that ROM is as
effective as the standard WHO / MDT / PB in the treatment of single lesion PB
leprosy.
Since
PB leprosy constitutes the major part of the caseload in endemic regions, it
was considered necessary to extend this regimen to cover patients with two to
three skin lesions also. Therefore, a trial was carried out to compare the
efficacy of ROM administered as single dose with that of standard WHO / MDT /
PB six-month regimen. 236 eligible cases were included in the study and were
randomly allocated to the two study groups. Clinical improvement was seen in
most patients in both regimens
(Table2). It was shown that single dose ROM therapy was safe and
acceptable.
|
| .............................................................................................................................................. |
Efficacy
of Vitamin A supplementation in infants
The role of Vitamin A supplementation in reducing morbidity among children has
been the subject of some controversy in recent years. A randomized double blind
placebo controlled field trial was carried out in 51 villages in two contiguous
Primary Health Centres in Villupuram Health Unit District of Tamil Nadu, South
India to assess the impact of Vitamin A supplementation to the mother soon
after delivery and to the infant at six months on morbidity in infancy. 909
newly delivered mothers and their infants formed the pairs for the study. Both
mother and infant received Vitamin A (300,000 IU for mothers and 200,000 IU for
children) in 311 instances (AA); mother received vitamin A but infant received
placebo in 301 instances (AP); and both mother and infant received placebo in
the remaining 297 instances (PP). 233 in the AA group and 228 each in the AP
and PP groups were followed up regularly. The incidence of diarrhoea in these
infants was 97.4%, 96.9% and 94.7% in the three groups, mean number of
diarrhoeal episodes was 4.4, 4.6 and 4.2 and median number of days with
diarrhea was 26, 26 and 22 days, respectively. For ARI, the incidences were
96.6%, 95.6% and 96.1%; mean episodes were 4.8, 5.1 and 4.8, and the median
durations were 32,34 and 34 days, respectively
(Table 3 &
Table 4). Based on these findings it was concluded that prophylactic
administration of mega doses of vitamin A to the mother soon after delivery and
to the infant at six months do not have any beneficial impact on the incidence
of diarrhoea and ARI in infancy.
|
| .............................................................................................................................................. |
Controlled
field trial of two antenatal care packages
Quality antenatal care services have a major contribution to make towards the
reduction of perinatal and neonatal mortality and low birth weight in India. A
randomized community intervention trial was undertaken in 12 subcentres in
Karur Health Unit District, Tamil Nadu, to compare the efficacy of two
antenatal care packages. A newly recommended 'high-risk' strategy package and a
uniform package recommended by the Tamil Nadu Government were each implemented
in 4 randomly selected subcentres by the study team, and the latter was also
delivered by routine health services in the remaining 4 subcentres. Analyses
were based on 294 pregnant women on the high-risk package (HR), 242 on the
Tamil Nadu Government (TNG) package and 335 women in the control series. The HR
package reduced the differences between the high-risk women and the others in
mean hemoglobin and the percentages with preventable neonatal morbidity and low
birth weights and consequently the overall outcome was better in the HR series
than in the TNG Series
(Table5). Finally, the results with the TNG packages were better when
it was implemented by the study team than by the routine health services, in
terms of preventable maternal morbidity and preventable perinatal morbidity,
but there was no impact on birth weight.
|
| .............................................................................................................................................. |
DISEASE
MODELLING
Simulation
model for leprosy transmission and control
Leprosy elimination has been accepted as a time-bound goal. Therefore, as we
approach the time-limit, tools and methods for monitoring trends of the disease
gain importance to assess whether elimination level has been achieved or not.
Developing such a tool for leprosy control is complicated because of the
multiplicity of factors and uncertainties with respect to epidemiology of
leprosy. A simulation model for leprosy transmission and control has been
developed in collaboration with the Erasmus University, Rotterdam. This model
attempts to organize the existing knowledge on leprosy in a coherent framework.
It assesses key indicators like prevalence, incidence and case-detection. Also,
it simulates trends over time under specific user defined assumptions on
leprosy epidemiology and control. The outputs produced by the model can readily
be compared with the observed data. This model describes the process of leprosy
transmission, disease and control in a population, which is followed over time.
The model is age-specific. It has pre-defined structure of compartments
representing various health conditions with respect to leprosy and flow,
between the compartments
(Figure 2).
One
of the experiments carried out to examine the immediate application of the
model for programme monitoring was with respect to immunoprophylaxis where we
had imagined a reduction of about 65% leprosy incidence, irrespective of
infection status of given individuals. The model predicts a sharper decline in
incidence of leprosy and strong possibility for achieving elimination of
leprosy and even its eradication over two decades
(Figure 3).
Through
a series of experiments, sensitive input parameters for the model were
identified and realistic values were fixed for them. Through a series of
experiments and field activities specifically taken up for validation purposes,
we presently have a fairly satisfactory epidemiological model for leprosy.
Further research and improvements on the model are continuing as an incremental
exercise so that the model can be used for immediate programme purposes and
predictions.
|
| .............................................................................................................................................. |
HEALTH
SYSTEMS RESEARCH
LQAS
technique for monitoring national programmes
There is a need for a systematic and standardized approach for monitoring and
evaluating leprosy elimination programs. Prevalence of leprosy in different
geographical areas can be called very low or rare in statistical sense.
Conventional survey methods to monitor leprosy control programs, therefore,
need very large samples, which are expensive and time-consuming. Further, with
the lowering of prevalence to the near-desired target level, 1 case per 10,000
population at national or subnational levels, the programme administrators'
concern will be shifted to smaller areas, e.g. districts, for assessment and,
if needed, for necessary interventions. Lot Quality Assurance Sampling (LQAS),
quality control tool in industry, was considered to identify districts /
regions having a prevalence of leprosy at or above a certain target level,
e.g., 1 in 10,000. This technique was also considered for identifying districts
/ regions at or below the target level of 1 per 10,000 i.e., areas where the
elimination level is attained.
Various
situations and strategies were simulated using a hypothetical computerized
population of 10 million persons. This population mimics the actual population
in terms of the empirical information on rural / urban distributions and the
distribution of households by size for the State of Tamil Nadu. The results in
four different prevalence situations met the required limits. The usefulness of
this technique was examined in an endemic district in Tamil Nadu and found to
yield satisfactory results. It was concluded that LQAS method could be
considered for rapid assessment of the leprosy situation.
|
| .............................................................................................................................................. |
Testing
of WHO design for LEM activities
Introduction of multi drug therapy (MDT) by WHO has brought many changes in the
leprosy control programme. Our country started implementing MDT in 1983 and
through a phased expansion, the entire country was brought under the cover of
MDT by 1997. To monitor the progress towards elimination, WHO has identified a
set of indicators to be used under the leprosy elimination monitoring (LEM).
These indicators will assess specific issues of the programme, namely, the
status of MDT service, quality of patient-care and progress towards
elimination. In Tamil Nadu, MDT programme was in operation through leprosy
control units as a vertical programme since 1990. A cross-sectional survey was
conducted in 10 randomly selected PHCs in one endemic district in Tamil Nadu to
assess the extent and quality of MDT services at district level and to field
test WHO recommended schedules. LEM is a useful exercise to improve quality of
routine reporting system. If it is conducted in the same period every year in
all the districts, the progress of work can be compared. The survey methodology
was rapid and cost-effective requiring minimum skills for analysis. LEM
exercise can be incorporated in the ongoing leprosy elimination programme as an
in-built monitoring system.
|
| .............................................................................................................................................. |
Evaluation
of National Leprosy Eradication Programme - 2000
Government of India with the assistance of World Bank and World Health
Organization under took 7th evaluation of NLEP. Govt. of India and World Bank
appointed NIE and its Director as consultant for this activity. There were two
distinct components in this exercise:
1. Validation study in 5 endemic States with a component of evaluation for
World Bank Project Implementation Plan (PIP).
2. Validation / evaluation study in the remaining States and Union Territories
with a component of evaluation for PIP.
3. Registered
prevalence trends and case detection trends for the years 1993-1999 are given
in
Figure 4 &
Figure 5. Nation wide application of MDT over the last few years has
not resulted in change or decline with respect to occurrence of new cases. The
presently identified 5 endemic States (Bihar, Uttar Pradesh, Madhya Pradesh,
Orissa and West Bengal) and Tamil Nadu, Andhra Pradesh and Maharashtra call for
some special attention, in-depth studies, effective and efficient
implementation of NLEP activities through the inevitable horizontal health
system approach. In any case, vertical systems become redundant, less
productive and very expensive, once the case load reaches very low levels. Good
quality MDT drugs were available in sufficient quantity in all parts of the
country. In the coming year, IEC programmes focused on marginalized population
and children will have to be developed and their effectiveness ensured.
|
| .............................................................................................................................................. |
Estimation
of immunization coverage
A WHO 30-cluster survey for estimating immunization coverages in infants was
undertaken in each of the five districts in Tamil Nadu, strictly according to
the specifications laid out in the WHO manual. The main aim was to examine
whether the technique would provide estimates with the required degree of
precision under Indian conditions. Of 60 sample survey estimates, 57 had the
targeted degree of precision (i.e., 95% confidence limits of ± 10
percentage points), which is in excellent agreement with expectation. The
proportions of infants on whom immunization was initiated were very high for
DPT vaccine (88-99%) and Polio vaccine (85-99%); however, of those who had
received the first dose, 23-39% did not complete the 3-dose schedule. Estimated
coverage with measles vaccine ranged from 53 to 97%. Better health education
regarding the need for immunization and correct spacing between doses, and more
effective motivation at the time of administration of the first dose of DPT /
Polio vaccine, were identified as important areas for corrective action.
A
randomized field study was undertaken in five districts of Tamil Nadu to
compare two rapid methods for determining immunization coverages in infants.
One was a standard method recommended by the WHO and the other was a variant of
it that is employed by the Government of India (GOI). In both the methods, 30
areas are selected at the first stage by probability proportional to population
size linear systematic sampling. In each of the chosen clusters, a household is
selected at random in the case of the WHO method, and with this starting point
a cluster of households is visited in a prespecified manner until seven
children aged 12-23 months are identified and their immunization status
assessed. With the Indian variant, the only difference is in the choice of the
first household, the recommended procedure invariably resulting in it being
close to the village centre. Consequently, persons residing in the periphery,
usually belonging to the weaker sections (SC / ST, Backward Classes) and
probably having lower coverages, may go under-represented in the GOI method,
and this could lead to over-estimation of coverages. The study showed that
there was some evidence that this was so, although almost all the differences
in coverages for DPT, Oral Polio, BCG and Measles vaccines were less than 5%. A
subsidiary study in three of the five districts compared the GOI method with a
Purposive method to determine the maximal extent of the potential bias. In the
latter method, the first household was deliberately selected in a pocket
comprising of weaker sections. This comparison showed that there was
substantial bias in the case of Measles coverage, the GOI method yielding 4% to
13% higher coverages and a suggestion of bias (2% to 5%) in the case of Oral
Polio Vaccine coverage. These findings indicate that it would be best to select
the first household at random in the chosen areas for study, if necessary by
preparing sampling frames of the households in the selected areas.
|
| .............................................................................................................................................. |
TRADITIONAL
MEDICINE RESEARCH
Kshaarasootra
in the management of fistula-in-ano
Fistula-in-ano is an age old, common condition prevalent all over the world. A
multicentric, randomized controlled trial was carried out at Bombay,
Chandigarh, New Delhi and Wardha to evaluate the efficacy of Kshaarasootra
(Ayurvedic medicated thread) in the management of fistula-in-ano, in comparison
with conventional surgery. Complete healing was noted in all 265 patients in
the Kshaarasootra series and in all 237 patients in the surgery series (Table
6). The median healing time was, however, significantly longer in the
kshaarasootra series (8 weeks) than in surgery series (4 weeks). Patients in
both the series were followed up for one year after the completion of
treatment, and the recurrence rates (Table
7), based on 150 patients in each series are 4% in the Kshaarasootra
series and 11% in the surgery series, a significant difference (P = 0.03).
Transient local burning and increased discharge from the fistulous opening were
observed in most patients treated with Kshaarasootra. Mild and incontinence was
observed in 8 patients treated with Kshaarasootra and 13 patients treated with
surgery. Kshaarasootra offers an effective, ambulatory and safe alternative
treatment for patients with fistula-in-ano. It also constitutes a new drug
delivery technique for conditions like anal fistula.
|
| .............................................................................................................................................. |
Vijayasar
for newly-diagnosed NIDDM patients
The therapeutic options in the treatment of non-insulin-dependent diabetes
mellitus (NIDDM) include dietary modification, oral hypoglycemics and insulin.
Vijayasar (Pterocarpus marsupium) which is used by Ayurvedic physicians to
treat diabetes mellitus is expected to have a role specifically in the
treatment of NIDDM. A flexible dose open trial was undertaken in four centres
in India to evaluate the efficacy of Vijaysar in the treatment of
newly-diagnosed or untreated mild NIDDM patients. Of 97 patients studied,
control of blood glucose (both fasting and postprandial levels) had been
attained in 67 (69%) patients by 12 weeks of treatment. The dose on which
control was attained was 2g of the extract in about 73% of the patients, 3g in
about 16% and 4g in 10%. Among 93 patients who completed 12 weeks of treatment,
both the fasting and postprandial blood glucose levels fell significantly
(Table 8). No significant change was observed in the mean levels of
lipids. Other laboratory parameters remained stable during the treatment period
of 12 weeks. Also, no side-effects were reported. Hence, it is concluded that
Vijayasar is useful in the treatment of newly-diagnosed or untreated mild NIDDM
patients.
To
extend the above conclusion to all NIDDM cases, and to assess the relative
efficacy of Vijayasar vis-à-vis an allopathic drug (Rastinon),
controlled, comparative, randomized multicentric flexible dose double-blind
trial was conducted at four centres admitting 371 eligible patients. The
findings of this study have demonstrated that Vijayasar is as good as Rastinon
in terms of reduction in blood glucose levels
(Figure 6).
A
3-volume dossier covering all studies done on Vijayasar has been compiled and
the process of transfer of technology is on.
|
| .............................................................................................................................................. |
METHODOLOGICAL
STUDIES
Implications
of misdiagnosis in field trials of vaccines
Vaccine trials are usually based on large numbers of subjects distributed over
a relatively wide area, and there may be many physicians involved in diagnosis
of the new cases in the study population. Under these conditions, an accurate
and clear-cut definition of disease and standardized test procedures are very
essential, and this need is widely appreciated. Obviously, it is also important
to employ the most efficient diagnostic test i.e., the test capable of
detecting the maximum number of cases (i.e., possessing maximum sensitivity)
and having the least risk of classifying a non-case as a case (i.e., possessing
maximum specificity). However, this cannot always be ensured under field
conditions, on account of considerations such as simplicity, cost and
work-load. In consequence, less efficient diagnostic tests are sometimes
deployed, and a certain amount of misdiagnosis (classifying cases as noncases
and vice-versa) is accepted as inevitable. It is demonstrated that even a
slight lowering of the specificity, from 100 to 98 per cent, leads to
substantial underestimation of vaccine efficacy, and sometimes even to a
failure to statistically demonstrate protection. Lowered sensitivity also has
the same type of impact, but on a much smaller scale. Failure to detect
protection can be avoided by substantial increases in the sample size, but
these have no remedial effect on the underestimation of the vaccine efficacy.
Very highly specific diagnostic tests are therefore recommended for use in
vaccine trials. In situations where such tests do not exist or are
impracticable in the field, procedures are suggested for minimizing the dangers
from lowered specificity and lowered sensitivity.
|
| .............................................................................................................................................. |
Impact
of BCG vaccination on the efficacy of antileprosy vaccines
Treatment of active cases of leprosy continues to be the main thrust of leprosy
control programmes in most countries. In the last 5 years, there have been some
major advances in vaccine development. This mathematical study demonstrates
that the interpretation of the findings of field trials of new antileprosy
vaccines could be compensated by partial protection against leprosy conferred
by BCG vaccination programme for tuberculosis. First, the trial's ability to
detect protective effect ('Power') is reduced; this can be compensated by
scaling up the trial size, but the increase often tends to become large.
Secondly, if the new vaccine has a lower protective effect in those who had
prior BCG vaccination, than in those had not, the trial will underestimate
vaccine efficacy, the extent of underestimation being substantial when BCG
coverage is high or the relative efficacy of the vaccine in the BCG vaccinated
is low. Despite these problems, it s argued that it would be more realistic to
undertake the vaccine trial in the total population, irrespective of prior BCG
status, especially in countries with moderate BCG coverages.
|
| .............................................................................................................................................. |
Sample
size estimation for comparing two proportions
In medical research, situations are frequently encountered where the comparison
between two treatments is to be made on the basis of the proportion of patients
showing a particular response. The statistical determination of the sample size
in these situations is based on (i) the likely values of the two proportions ;
(ii) the acceptable level of Type I error, namely, the error of rejecting the
null hypothesis of equality of the two proportions when it is true; and (iii)
the acceptable level of Type II error (its complement is called 'Power'),
namely, the error of accepting the null hypothesis when it is untrue, and an
alternate hypothesis of a pre-specified difference between the two proportions
is true. Determination of the exact sample size is cumbersome and
time-consuming, and a wide array of approximations are therefore available.
The
approximate sample size methods are the Normal deviate methods (with or without
a continuity correction), the Arc sine methods (with or without a continuity
correction), and methods of Fleiss, Kramer-Greenhouse, Casagranda-Pike-Smith,
Fleiss-Tytun-Ury, and Ury-Fleiss. An arithmetical study of these methods, in
comparison with an Exact method, indicates that for the equal sample size in
the two groups situation, the Arc sine method with a continuity correction
offers the closest approximation.
Various
approximate methods available for computing the sample size to compare two
proportions are quite adequate in most instances. These are mechanically
employed for sample size determination in vaccine trials of diseases with low
incidence (less than 5 per thousand) such as typhoid, tuberculosis and leprosy.
There is a method, based on a 2-sample Poisson test that would be more
appropriate for use in such situations. Use of the specific Poisson-based
method leads to appreciable savings in sample size when the disease incidence
is low, and is recommended.
|
| .............................................................................................................................................. |
Confidence
intervals in medical research
The last four decades have seen increasing use of statistical methods in the
fields of medicine and public health. Significance tests and P values have
become commonplace in all leading medical journals. By and large, this has been
a good development, and investigators have learnt to avoid building up
hypotheses to explain differences or associations that could easily be due to
chance fluctuations. However, in recent years and coinciding with the
increasing availability of computers, statistical software packages and
programmable pocket calculators, there has been an upsurge of
significance-testing, sometimes bordering on the indiscriminate.
Confidence
interval approach is more informative than a mere test of statistical
significance, and should therefore be employed as an useful adjuvant. Since
proportions are widely quoted in medical literature and as the determination of
the exact confidence limits for a binomial proportion is iterative and
time-consuming, an assessment is made of 15 published methods which provide
approximate confidence limits; the 'Square root transformation' method is
recommended since it is accurate and the computation of limits is relatively
easy. In the case of a difference between two proportions, the usual method may
be employed if sample sizes exceed 75; for smaller sample sizes (even for sizes
of 5), the Jeffreys-Perks method is very satisfactory and is recommended.
|
| .............................................................................................................................................. |
Index
of nutritional status in children aged 5-10 years
Anthropometric measurements are usually employed to assess the nutritional
status of individuals. Earlier studies in India have shown that weight for
height (%) and weight /(height)2 are indices that are well correlated with the
current nutritional status of infants and pre-school children. Attempts have
been made in adults aged over 18 years also to identify anthropometric indices
closely associated with body build. However, similar reports in children aged
5-15 years are rare.
An
age-independent anthropometric index to identify undernourished children in the
age group of 5-10 years was evolved. Employing a mathematical approach (linear
regression analysis) on data from 238 children, the index was derived tobe
wt/(ht)2. Employing this index, a classification rule for identifying the
undernourished was evolved, using as the 'Gold standard' a WHO classification
based on NCHS standards. The sensitivity of the classification rule was 95%,
the specificity was 92% and the overall efficiency was 92%.
|
| .............................................................................................................................................. |
MANPOWER
DEVELOPMENT
Field
Epidemiology Training Programme (FETP) - India
Epidemiology is recognized as the basic diagnostic discipline of public health.
Internationally, Field Epidemiology Training Programmes have helped in
developing a country's public health capability. FETP focuses on developing
competencies that are consistent with national needs and priorities. The model
for the training is learning by doing. In India, there is a gross inadequacy of
public health expertise. To remedy this situation NIE has started in the year
2001, a two-year FETP leading to the award of Master of Applied Epidemiology
(MAE) degree. The course is being run by NIE as an off-campus course of the
Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST),
Thiruvananthapuram. The primary goal of the programme is to foster professional
development of field trained epidemiologists who are competent in the practical
application of epidemiologic methods to a wide range of contemporary public
health problems. Scholars from different parts of the country are undergoing
the programme.
|
| .............................................................................................................................................. |
Surveillance,
Epidemic Preparedness and Response Workshops
Significant progress has been achieved
in the fields of medical sciences, technology
and Public Health. In spite of this, frequent
outbreaks of several Communicable Diseases
are observed in various parts of the country.
Owing to lack of trained manpower, appreciation
of an epidemic as a Public Health Emergency
and prompt action has been lacking. To
help bridge the existing gaps in knowledge
and expertise and as a step towards fulfilling
its mandate of strengthening the human
resource base in this discipline, NIE
conducts WHO - sponsored workshop-cum-training
programmes on "Surveillance, Epidemic
Preparedness and Response". So far,
a total of 80 Public Health professionals
involved in or responsible for epidemic
investigation and management at district
or state levels have been trained.
|
| .............................................................................................................................................. |
Training
programme on controlled clinical trial
The Institute has a long tradition of association with various clinical trials
including the classical study on home / sanatorium treatment for tuberculosis,
multicentric trial of single dose therapy for PB leprosy cases, field trial of
four candidate vaccines for leprosy etc. Clinical trials with Traditional
Remedies sponsored by the ICMR are being monitored by the Institute. Also, the
Institute has been providing advice to various agencies for developing clinical
trial protocols. The Institute has been organizing 2-week training programme on
"Controlled Clinical Trials" with special reference to Good Clinical
Practice (GCP) guidelines annually. The course is designed for research workers
engaged in clinical trials or desirous of conducting clinical trials in future.
The main objective of this programme is to impart information on various
aspects of controlled clinical trial methodology so that, on completion of the
course, the participants would be able to develop good protocol for their
clinical trials and also conduct them efficiently. The methodology being
adopted is class room lectures, practicals, group participative activities,
guest lectures by experts and site-visit to a clinical trial centre. So far,
five such programmes have been conducted, in which about 80 clinical trialists
from all over the country participated.
|
| .............................................................................................................................................. |
Basic
Course in Statistics for Medical Doctors
There is a need to train medical doctors in proper appreciation of statistical
methods to improve the quality of medical research and to have meaningful
collaboration between medical doctors and statisticians. In this context, the
Basic Course in Statistics is being conducted annually. The main objective of
the course is to demystify statistics and to promote better understanding of
the logic of various statistical methods and their underlying concepts. The
programme consists of lectures, practicals and group activities. So far, 12
such programmes have been conducted and about 250 doctors were trained.
|
| .............................................................................................................................................. |
|