Leprosy is a communicable but curable disease caused by bacteria and it mainly affects the skin and nerves. It progresses slowly with an average incubation period of 3years.Leprosy can affect all ages and both sexes.

The best way to prevent the spread of leprosy is to treat all patients with Multi-drug therapy (MDT). MDT is recognized as a major technological improvement in leprosy control. It’s impact on disease prevalence has lead to the concept at eliminating leprosy as a public health problem with the assumption that below a given level of prevalence, disease transmission will be partially or totally interrupted.

The Government of India launched the leprosy control activities in 1955. In 1983, a new strategy based on MDT was introduced, and the programme was renamed as National Leprosy Eradication Programme (NLEP). The first World Bank supported project was introduced in 1993 with an aim to strengthen infrastructure and facilities for leprosy control. The national prevalence of leprosy declined from 57/10,000 in 1983 to 3.7/10,000 in December 2001.

The 8 endemic states, namely Bihar, Jharkhand, Orissa, Madhya Pradesh, Chattisgarh, Uttar Pradesh, Uttranchal and West Bengal contribute 70% of the total patient load in the country.

The second phase of the World Bank supported project during 2001-2004, is envisaged to consolidate the achievements of leprosy elimination, decentralize the decision making to States/Districts, integrate the programme with general health services and to develop an adequate surveillance system to monitor progress and initiate timely corrective actions.

In order to get a clear picture of the leprosy situation in the country, a Leprosy Elimination Monitoring (LEM) exercise was planned for the second phase of the project, as an additional tool for assessing progress of National Leprosy Eradication programme (NLEP).

Purpose of LEM

The overall aim of the LEM exercise is to assist the decision-makers and programme managers to assess the progress towards leprosy elimination.

Objectives

To assess leprosy activities on specified elimination indicators in various states of the country.

To assess the progress of integration of leprosy control activities with the general health services, on specified key indicators.

To assess the quality of MDT services provided at field level.

To identify potential issues of programme implementation and make practical recommendations for further improvements.

Within the framework of the four-year project, it is planned that a LEM exercise will be undertaken every year in the 12 identified high prevalence states. The LEM will also be carried out in order to monitor more closely the achievements and to take timely corrective measures.

The number of districts per state that will be covered by the LEM exercise will vary according to the leprosy status, total number of districts per state and fund availability. Districts of each state were divided into two categories according to the prevalence rate (less than 5 per 10,000 & more than 5 per 10,000). A sample of 20% of the total districts in each strata per state was considered to be representative of the state. Some final adjustments were made to increase the number of sampled districts with a Prevalence rate (PR) of more than 5.

With these factors in mind, the selection is distributed as follows:

State Selected	Total Districts	Districts with PR>=5	Districts with PR<5	Sample Districts with PR>=5	Sample Districts with PR>=5	Sample Districts Total
Bihar	37	34	3	7	1	8
Madhya Pradesh	45	1	44	1	5	6
Orissa	30	15	15	3	3	6
Uttar Pradesh	70	44	26	9	5	14
West Bengal	18	8	10	2	2	4
Uttaranchal	13	1	12	1	3	4
Jharkhand	18	18	0	6	-	6
Chattisgarh	16	13	3	3	1	4
Tamil Nadu	29	8	21	2	4	6
Andhra Pradesh	23	7	16	1	3	4
Maharashtra	32	8	24	2	4	6
Karnataka	27	4	23	1	5	6
Total	258	161	197	38	34	74

The steps for selection of districts were as follows:

Each state was divided into two areas according to the district prevalence rate (less than or equal to 5 & more than 5);

For each area, a list of districts, including population and number of registered leprosy patients, was prepared;

The appropriate number of districts was randomly selected, according to the state/area category, proportionally to the number of leprosy patients or population;

The final selection of districts is as follows:

State	Selected Districts with PR>=5	Selected Districts with PR<5	Districts Selected
Andhra Pradesh	Guntur	Adilabad, Medak, Rangareddy	4
Bihar	Begusarai, Gaya, Katiyar, Muzzafarpur, Purnea, Saran,W. Champaran	Nawada	8
Chattisgarh	Bisalpur, Korba, Raipur	Sarguja	4
Jharkhand	Bokaro, Garwaha, Gumla, Pakur	-	4
Karnataka	Gulbarga	Belgam, Chamrajanagar, Dharwar, Mandya, Raichur	6
Madhya Pradesh	Khandwa	Bhind, Guna, Khargona, Rewa, Sidhi	6
Maharashtra	Thane, Bhandara	Akola, Ahmednagar, Beed, Nagpur	6
Orissa	Bolangir,Ganjam, Navpada	Cuttack, Koraput, Rayagad	6
Tamil Nadu	Erode, Vilupuram	Dindigul, Rampad, Trinulveli, Salem	6
Uttar Pradesh	Azamgarh, Barbanki, Chandauli, Gorakhpur, Jalaun, Mau, Kaushambhi, Rampur,Unnao	Aligarh, Faizabad, Lalitpur, Muzafarnagar, Sonebadra	14
Uttaranchal	Hardwar	Dehradun, Pauri Garhwal, Udhamsingh Nagar	4
West Bengal	Bankura, Malda	24 Paragana (N), Murshidabad	4

In each district, at least three health facilities in rural areas and one in urban area will be selected.

For LEM purposes, the defination of a health facility is the primary health center (PHC). In high prevalence districts (>5/10,000), it is expected that a sample of 3 PHCs will be visited. However, in low prevalence districts, the number of health facilities to be visited might need to be increased to reach or get close to the required sample size.

In addition to the 3 PHCs, one urban health facility will be selected per district. For operational purposes and logistical reasons, it is planned that the urban health facility at district headquarters will be selected.

In case the information about leprosy cases is not available Health facility wise, then the list of Leprosy Control Units (LCUs) in the districts will be prepared considering the population and number of leprosy cases for collection of information about the case finding, prevalence and detection trends. From each of the selected LCUs one PHC/CHC will be selected at simple random sample for integration indicators.

Sampling methodology in rural areas

For each district selected, use the already prepared list of health facilities, including the block population and the number of registered leprosy patients;

Randomly select 3 or more health facilities (5 for low prevalence districts) proportionally to the number of patients.

From the list of Government health facilities (hospitals, dispensaries etc.) and Leprosy NGOs providing leprosy services at district headquarter, select one facility by simple random sampling.

It is assumed that the sample units are the leprosy patients. In order to give an estimate of the required information needed per district, data collection should include at least:

Reviewing 200 patient records for indicators on prevalence and case finding activities (If number is less then review all the available for the year)

Reviewing 200 patients records taken out of treatment registers and/or individual records for accessibility of MDT and case holding,

Interviewing 50 patients for delay in diagnosis and accessibility to MDT (for under treatment cases only),

Reviewing all state and district reports of the 5 previous year-trends.

All the required information has to be collected from existing patient records, leprosy registers, reporting forms and stock bin cards in selected health facilities, as well as annual data as reported by the selected districts and states. In addition, interviews of a sample of patients have to be conducted for the computation of several indicators.

Data from leprosy registers and individual records should be collected as follows:

For case finding activities indicators: all new patients diagnosed as leprosy during the past 12 months from the time of the monitor’s visit;

For prevalence indicators: all patients diagnosed as leprosy as on 31 March.

For case holding indicators: data from a cohort of registered patients: cohort of MB patients defined as patients having started MB MDT during the period July1997 to May; and cohort of PB patients having started PB MDT June2000 to May 2001.

Appropriate tools have been developed and used at the health facility level to ease data collection from patient registers, records interview of leprosy cases and medical officials of health Facilities.

Each monitor team will compile district data from the selected facilities on summary sheets. After completion, NIHFW will be responsible for collecting all forms, consolidating the district data and entering it into a data entry and analysis programme that has been developed by WHO/HQ. Some adaptations of the software will be needed and done by NIHFW.

NIHFW will present the data in tables, according to the list of indicators and submit the preliminary results to the LEM Core group for its analysis and interpretation. NIHFW will prepare the preliminary report.

Data will be presented state wise. The study report, including summary tables, graphics and recommendations for actions, will be discussed and finalised with the LEM core group, before the final printing.

The results will be shared with the local, district, state and central authorities in order to take corrective actions. WHO will provide a report framework to NIHFW.

The present LEM survey was carried out in a standardized way across the country from 19th May to 13th June 2003 and the validation of Leprosy diagnosis study from 12th to 31st July 2003 with the aim to assist the decision makers and programme managers to assess the progress towards leprosy elimination.

The LEM survey was undertaken in the 13 high endemic states, namely UP, Uttaranchal, MP, Chattisgarh, Bihar, Jharkhand, Orissa, West Bengal, Tamil Nadu, Andhra Pradesh, Maharashtra and Delhi. The districts in each state were divided into 2 strata according to the prevalence rate of leprosy (>= & <5/10,000). A sample of 20% of the total districts in each stratum per state was considered to be representative of the state. A total of 77 districts were covered.

In 2003, the LEM monitors covered nearly 500 health facilities, of which 81% were in rural areas. They interviewed 4634 patients and 10324 community members. The monitors reviewed 36616 patient’s records and examined 367174 MDT blister packs. Finally, the validation teams have seen 1737 newly detected leprosy cases, out of the 2541 listed by the NLEP.

The major recommendations of the LEM 2003 were as follows:

1) Improve the quality of the leprosy diagnosis and grouping at health facility level, by strictly applying standard procedures for testing the skin sensory deficit and nerve thickening.

2) Every newly detected case would be asked questions about potential MDT treatment in the past, to avoid re-registration of cases.

3) The leprosy register should be updated monthly, at the time of reporting, thus deleting patients according to the standard definitions.

4) Enhance the MDT coverage in rural and urban areas (including slums) by making MDT services available through all functioning health facilities and on all working days.

5) Enhance the case detection among female, especially in the states where the female detection ratio is low.

6) Improve the MDT stock management at health facilities by regular indent based on the case load for all categories of blister packs to prevent drug excess, shortage, damaged and expired MDT blister packs. Use the new government of India guidelines on MDT stock management.

7) Re-deploy excess of MDT to other blocks/districts, based on the patient-months indicator and destroy expired MDT drugs.

8) All the personnel involved in leprosy control activities should follow the government of India guidelines on fixed duration MDT treatment (12 doses for MB and 6 doses for PB cases)

9) Ensure the completion of treatment for all patients under MDT, especially in Delhi and large urban areas. Patients likely to be irregular should be provided with the option of Accompanied MDT.

10) Adequate counseling of patients, especially at the time of diagnosis and initiation of treatment, should be promoted.

11) Ensure that all the SIS document and formats are available and used at health facility and district levels.

12) Improve the completeness, timeliness and accuracy of reporting.