London School of Hygiene & Tropical...

London School

of Hygiene & Tropical Medicine

MSc. Public Health

A Health Policy Report How could changes of case definitions, ascertainment procedures, and diagnostic and registration conventions have impacted on reductions in the prevalence of leprosy in India, reported over the last decade (taking

the state of Jharkhand as a case study)?

August 2008

LSHTM Candidate Number 470127

Word Count: 9953

LSHTM Candidate Number 470127 2

Acknowledgements

I would like to thank Karen Lock for all her understanding and support,

and express my heartfelt appreciation for all her advice and comments

which were always spot-on, throughout the development and completion

of this project. Also I would like to thank Professors Paul Fine and Diana

Lockwood for their guidance and time.

Lastly, I would also like to thank those who generously gave their time to

be interviewed as well as those who made these interviews possible.


Table of Contents

GLOSSARY & ABBREVIATIONS .....................................................................................................5 EXECUTIVE SUMMARY ....................................................................................................................6 1 INTRODUCTION.........................................................................................................................9

1.1 HISTORY ................................................................................................................................9 1.2 CLASSIFICATION.....................................................................................................................9 1.3 TREATMENT .........................................................................................................................10 1.4 CURRENT SITUATION ...........................................................................................................10 1.5 LEPROSY CONTROL PROGRAMMES IN INDIA ........................................................................13 1.6 LEPROSY PREVALENCE IN INDIA: WHAT IS THE TRUE PICTURE?...........................................14

2 AIMS & OBJECTIVES..............................................................................................................16 2.1 AIM ......................................................................................................................................16 2.2 OBJECTIVES..........................................................................................................................16

3 METHODOLOGY .....................................................................................................................17 3.1 LITERATURE REVIEW ...........................................................................................................17

3.1.1 Selection Criteria............................................................................................................17 3.1.2 Search Strategy for Identification of Studies ..................................................................17 3.1.3 Methods of the Review....................................................................................................18

3.2 SEMI-STRUCTURED INTERVIEWS ..........................................................................................19 3.2.1 Topic Guide ....................................................................................................................20 3.2.2 Selection of interviewees.................................................................................................20 3.2.3 Data Extraction and Thematic Analysis .........................................................................21

4 RESULTS & FINDINGS............................................................................................................22 4.1 LITERATURE REVIEW ...........................................................................................................22

4.1.1 Results of Search Strategy ..............................................................................................22 4.1.2 Findings from the review ................................................................................................22

4.2 SEMI-STRUCTURED INTERVIEWS ..........................................................................................33 4.2.1 Leprosy Elimination Programme....................................................................................33 4.2.2 Case detection.................................................................................................................33 4.2.3 Case diagnosis................................................................................................................35 4.2.4 Case validation ...............................................................................................................36 4.2.5 Case registration ............................................................................................................36 4.2.6 Range/Types of cases......................................................................................................37 4.2.7 Case treatment................................................................................................................38 4.2.8 Case cure ........................................................................................................................38 4.2.9 Prevalence data ..............................................................................................................39 4.2.10 Case reductions and leprosy as a public health problem ..........................................39 4.2.11 Vertical VS Integrated................................................................................................40 4.2.12 Improvements, limitations and shortcomings.............................................................42 4.2.13 Stigma ........................................................................................................................43

5 DISCUSSION ..............................................................................................................................44 6 LIMITATIONS...........................................................................................................................48 7 CONCLUSIONS & RECOMMENDATIONS .........................................................................50

7.1 CONCLUSIONS ......................................................................................................................50 7.2 RECOMMENDATIONS ............................................................................................................51


APPENDIX 1: ANONYMISED COPY OF FINAL REVISED PROTOCOL ................................54 APPENDIX 2: ANONYMISED COPY OF RISK ASSESSMENT FORM.....................................58 APPENDIX 3: ANONYMISED COPY OF LSHTM ETHICS APPROVAL LETTER ................61 APPENDIX 4: LITERATURE REVIEW SEARCH STRATEGY..................................................67 APPENDIX 5: SEMI-STRUCTURED TOPIC GUIDE....................................................................70 APPENDIX 6: CODING SCHEME FOR INTERVIEW ANALYSIS.............................................74 REFERENCES .....................................................................................................................................75


Glossary & Abbreviations

ANCDR- Annual New Case Detection Rates; proxy indicator for leprosy incidence ANM- Auxiliary Nurse Midwife; a type of peripheral health worker at village and

block level in India BI- Bacteriological Index; a logarithmic-scaled measure of density of M. Leprae in

the dermis (skin) CBR- Community Based Rehabilitation; a type of rehabilitation approach GHS- General Healthcare Services IEC- Information, Education & Communication MB- Multibacillary; meaning many bacteria (M. Leprae), a type of leprosy

classification with a BI > 2 MDT- Multi-Drug Therapy MHW- Multi-Purpose Health Worker; another type of peripheral health worker at

village and block level in India MLEC- Modified Leprosy Elimination Campaign NCDR- New Case Detection Rates NGO- Non-Governmental Organisation NLEP- National Leprosy Eradication Programme; the Indian governments’ health

programme for leprosy PB- Paucibacillary; meaning less (paucity) of bacteria (M. Leprae), a type of leprosy

classification with a BI< 2 PHC- Primary Health Centre; the main health service at block level in India PR- Prevalence Rate RFT- Release From Treatment ROM- Rifampicin, Ofloxacin & Minocycline; the regimen for single lesion leprosy SER- Socio-Economic Rehabilitation; another type of rehabilitation approach WHO- World Health Organisation


Executive Summary

Background

In 1991 the World Health Assembly (WHA) passed a resolution to “eliminate leprosy

as a public health problem” by the year 20001. Elimination was defined in this context

as a reduction in prevalence to below 1 per 10,000 population. India achieved

elimination in December 2005 following a dramatic fall in prevalence, particularly

between the years 2000-2005.

Although some states like Jharkhand, as per Government of India figures continue to

have prevalence above 1 per 10,000 the rapid and drastic fall in prevalence seen

nationally in India has been greeted with scepticism by some in scientific and NGO

community- and international queries about what has actually happened2,3. One theory

is that changes to the diagnostic, surveillance and reporting procedures are creating

‘data artefacts’ that are obscuring the true picture of leprosy prevalence and control in

India.

Aims of the project

This paper is a health policy report aimed at gaining insight into the relationship

between the steep fall of leprosy prevalence reported in India and changes to the

diagnostic, surveillance and reporting procedures being followed, looking at the

Indian state of Jharkhand as a case study.


Methods

The research is based on a review of published and unpublished literature and semi-

structured interviews of key staff involved in the delivery of leprosy control services

in the Indian state of Jharkhand, to gain understanding on the issues related to

assessment of prevalence.

Key Findings

While there is no doubt that significant strides have been made towards reducing the

prevalence of leprosy in India, key findings confirm that repeated changes by WHO

and the National Leprosy Eradication Programme (NLEP) to case definitions,

diagnostic conventions (from skin smears to lesion counting), duration & types of

treatment (MB-MDT duration, ROM therapy, accompanied MDT), prevalence

calculations (from period to point prevalence), case detection methods (from active

detection to voluntary reporting), registration conventions, RFT (release from

treatment) protocols, programme structures (from vertical to integrated approaches),

and ineffective coverage and awareness initiatives have had direct and indirect

impacts on the prevalence figures of leprosy in India, obscuring the true extent of the

actual reductions in disease prevalence.

Conclusions

While a more detailed analysis would be required to fully understand the extent of the

impact of these diagnostic, surveillance and treatment changes, this research

underscores the danger of a repeating what happenned with tuberculosis and malaria,

which in the 1960’s were pronounced defeated, only to re-emerge now as global

emergencies4.


The paper suggests policy amendments and new policy initiatives to the National

Leprosy Eradication Programme, and recommends reinstating some past policies and

practices that have gathered a considerable evidence-base of effectiveness, to address

the future challenges of leprosy as a public health problem in India.


1 Introduction

Globally and especially in India, leprosy prevalence has fallen dramatically in the last

decade. That a disease as old as humankind itself has been ‘eliminated’ particularly by

efforts in this millennium, needs to be examined critically before it is accepted as fact.

1.1 History

Leprosy is probably the oldest disease

known to mankind. The word leper

comes from the Greek word ‘lepid’

meaning scaly. In India, leprosy is

known since ancient times as ‘kustha

roga’ and attributed to punishment or

curse from God.

Figure 1: Leprosy, demarcated skin lesions

Modern-day leprosy dates from 1873 when Hansen of Norway discovered

Mycobacterium leprae (M. leprae), the bacterial pathogen that causes leprosy. For

long years, there was no effective remedy for leprosy. The introduction of sulphone

drugs in 1943 marked the beginning of a new era of case-finding and domiciliary

treatment. The decade of 1980s witnessed a change in the strategy of leprosy control

from DDS (Dapsone) monotherapy to multidrug therapy (MDT), due to widespread

emergence of dapsone resistant strains of M. leprae.

1.2 Classification

Several classifications for leprosy exist, i.e. the Madrid5, Ridley-Jopling6 and the

Indian7 classifications; based on clinical, bacteriological, immunological and


histological states of patients. Broadly speaking, the disease manifests in two polar

forms, the lepromatous and tuberculoid forms lying at the two ends of a spectrum that

includes borderline and indeterminate forms. Cases are commonly described as being

either Multibacillary or Paucibacillary. Multibacillary (lepromatous) leprosy is

considered more severe while Paucibacillary (tuberculoid) leprosy is relatively less

severe.

1.3 Treatment

Originally WHO recommended Multibacillary cases to be treated with MDT for 24

months or until the smear became negative (generally 5 years). Subsequently the

acceptable course was reduced by WHO to 12 months, a change that remains

especially controversial in the absence of supporting clinical trials8. Paucibacillary

cases are given MDT for 6 months9 .

1.4 Current Situation

In 1991 the World Health Assembly (WHA) passed a resolution to “eliminate leprosy

as a public health problem” by the year 2000, elimination defined in this context as a

reduction in prevalence to below 1 per 10,000 population. WHO states that this has

now been accomplished10. In December 2005 India announced it had achieved

elimination, according to the National Leprosy Eradication Programme data11.


Figure 2: Trends in Leprosy Prevalence12

In India between 1996 and 2000 leprosy prevalence fell from 5.9 to 5.3 per 10,000

population, a 10% reduction of 0.6 per 10,000 population over 5 years. From 2000 to

2006, the prevalence fell from 5.3 to 0.8 per 10,000 population, a staggering 85%

reduction of 4.5 per 10,000 population over the next five years. WHO explained that

the fall in prevalence was due to improvements in the management of cases, very low

rates of relapse, high cure rates, absence of drug resistance and shorter duration of

treatment with MDT13. As of March 2008, only six States/ Union Territories remain

with prevalence over 1 per 10,000 population; these are D&N Haveli, Chhattisgarh,

Jharkhand, Bihar, Chandigarh & West Bengal11.


Figure 3: Prevalence in Indian states, 31 March 200811

0 0.5 1 1.5 2 2.5

1

Stat

es of I

ndia

Prevalence per 10,000 population

PondicherryLakshadweepDelhiDaman & DiuD & N HaveliChandigarhA & N IslandsWest BengalUttarakhandUttar PradeshTripuraTamil NaduSikkimRajasthanPunjabOrissaNagalandMizoramMeghalayaManipurMaharashtraMadhya PradeshKeralaKarnatakaJammu & KashmirJharkhandHimachal PradeshHaryanaGujaratGoaChhattisgarhBiharAssamArunachal PradeshAndhra Pradesh

The state of Jharkhand historically has

had persistently high leprosy

prevalence and while this continues to

fall in its 24 districts, at 1.11 per

10,000 population this is still above

the national average of 0.7 as of March

200812.


Figure 4: District-wise Prevalence in Jharkhand in 24 districts, 2007-08 (% districts) 12

42%50%

8%

< 1

1 to 2

>2 to 5

Prevalence Rate

12 districts

10 districts 2 districts

Table 1: A profile of Jharkhand14

Population 21,843,911 ST (Scheduled Tribes) 28% of total. SC (Scheduled Castes) 12% of total Per capita Income Rs. 4161* Density of Population 274 persons / Sq. KM No. of Districts 18 + 4 No. of Sub divisions 33 No. of Blocks 211 No. of Villages 32,620 No. of Villages Electrified 14,667 No. of Villages connected by roads 8484 Health centres 506 Schools 21,386 Universities 5 Total Geographical Area 79.70 Lakh Hect **

*£1= approx 80 Rupees (Rs) ** 1 Lakh = 100,000; 1 Hectare = approx 2.5 Acres

1.5 Leprosy Control Programmes in India

In India, the National Leprosy Control Programme has been operational since 1955,

early case detection and dapsone monotherapy being the main interventions. For

nearly two decades it moved at a slow pace. In 1983 the control programme was

renamed National Leprosy “Eradication” Programme with the goal of eradicating

leprosy by 2000. It was based on early case detection (population and school surveys,


contact examination and voluntary referral), short term multi-drug therapy, health

education, ulcer and deformity care and rehabilitation activities. An appraisal in 1997

indicated that while overall progress was satisfactory, it was uneven in some states.

To address this, the Modified Leprosy Elimination Campaign (MLEC) was launched,

which included short term orientation training in leprosy to health staff, increasing

public awareness and house-to-house case detection for a period of six days. The first

of five such MLEC rounds was conducted in 1997-98 and the fifth in 2003-0415.

Currently the strategy of the National Leprosy Eradication Programme includes11:

• Decentralization of NLEP to States & Districts

• Integration of leprosy services with General Health Care System (GHS)

• Leprosy Training of GHS functionaries

• Early diagnosis & prompt MDT, through routine and special efforts

• Information Education and Communication (IEC) using Local & Mass Media

for reduction of Stigma & Discrimination.

• Prevention of Disability & Medical Rehabilitation.

• Monitoring & Periodic Evaluation

• Inter-sectoral collaboration

• Monitoring & Evaluation

1.6 Leprosy Prevalence in India: What is the true picture?

While the reported reductions worldwide and especially in India are laudable

achievements, such drastic reductions have left many in the scientific and NGO

community sceptical about what has actually happened. One theory is that changes to

the diagnostic, surveillance and reporting procedures are creating ‘data artefacts’ that

are obscuring the true picture of leprosy prevalence and control in India1-3.


The 11th August 2006 WHO Weekly Epidemiological Report (Table 5) indicates that

since 2002, annual case detection in India decreased from 473,658 to 161,457; a 66%

decline of 312,201. Over the same 3 years global figures reduced from 620,638 to

296,499; a 52% decline of 324,139. Thus a staggering 96% of the global decline

(312,201/ 324,139) is accounted for by India. Such figures lend themselves towards

disbelief and scepticism16.

Declaring that leprosy has been eliminated from a country has very serious

implications. A Government making such a declaration may disband its control

programmes and disperse skilled staff. Uncertainties are generated as to who will

provide drug treatment once elimination is achieved, who will train primary health

care workers once vertical programmes become ‘integrated’, what plans will exist for

the long-term care of patients with nerve damage, deformities and disabilities. There

is the danger of a repeat of what happenned with tuberculosis and malaria, which in

the 1960’s were pronounced defeated, only to re-emerge now as global emergencies3.


2 Aims & Objectives

2.1 Aim

To explore the role played by changes to definitions, ascertainment procedures, and

diagnostic and registration conventions in the reported reduction in prevalence of

leprosy in India over the last decade. Recommendations will address issues related to

the assessment of leprosy prevalence.

2.2 Objectives

• To gain understanding about the change in leprosy prevalence in India over the past

decade.

• To explore changes in diagnosis and reporting surveillance systems in India over

the same period.

• To understand how the diagnostic and reporting systems for leprosy are currently

organised in India, using the state of Jharkhand as a case study.

• Draw conclusions about the possible relationship between changes of case

definitions, ascertainment procedures, and diagnostic and registration conventions

(etc) and the dramatic reported reductions in leprosy rates.


3 Methodology

Given the complexity of the research question, a much larger scale research project

would be required to fully explore all relevant issues in depth. This rapid assessment

of the key issues is based on a literature review and semi-structured interviews of key

informants involved in leprosy work on the ground in Jharkhand.

3.1 Literature Review

3.1.1 Selection Criteria The research question called for the exploration of the significance of changes in

diagnosis, reporting and surveillance systems and the prevalence of leprosy in India.

In the time available, a systematic literature review was difficult in the absence of a

single study design that could address all these concepts, with no specific participants,

interventions or outcomes (PICO criteria). Therefore the inclusion criteria for this

review were relevance by title to the concepts of the research question, relevance in

relation to India and/or Jharkhand and relevance by time period (1997-2007).

3.1.2 Search Strategy for Identification of Studies Initially EMBASE & EMBASE Classic were searched. The results were then limited

by the criteria mentioned above, resulting in the initial list of studies. The same search

strategy was used to search MEDLINE, 1950 to July Week 5 2008. The EMBASE

results were matched to MEDLINE’s and new studies were identified. The Web of

Science, CINAHL and TRIP databases were subsequently searched. Internet searches

for non-peer reviewed literature was undertaken of UNAIDS, WHO, World Bank,

National Leprosy Eradication Programme (India), Ministry of Health & Family

Welfare (India), Google scholar, and non-governmental agencies (ILEP, Italian


Association Amici di Raoul Follereau – AIFO, Leprosy Mission, Lepra) websites.

Online archives of the International Journal of Leprosy and Other Mycobacterial

Diseases (till ’05), Leprosy Review & Indian Journal of Dermatology, Venereology &

Leprology were searched (1997-2007). Further manual searching was undertaken

from the Indian Journal of Leprosy 1997-2007. Reference lists in the extracted articles

were also assessed.

Based on the research question, search terms were generated based on the following

major key terms: ‘leprosy’ (keyword, MeSH, other synonyms), ‘Hansen’s disease’

(key word, MeSH), ‘Case defin$’, ‘case finding’, ‘case detection’, ‘case diagnosis’,

‘new case$ or new case$ defin$ or new case$ diagnos$’, ‘registration$ or registration

convention$ or registration protocol$ or registration procedure$’, ‘India/ or Leprosy

Control/ or Leprosy/ or Health Program/ or Prevalence/ or Mycobacterium Leprae/’,

‘India’, ‘Jharkhand’ and so on. The search terms were combined using ‘and’/ ‘or’

where relevant. The search was then limited by year (1997 – 2007), humans and

English language. The actual search strategy is included as appendix 4.

3.1.3 Methods of the Review

Study Identification

The search results were reviewed based on the study titles, for general relevance to

one or more of the terms leprosy, prevalence, elimination, eradication, diagnosis,

registration, case finding/ case detection/ surveillance, India and/or Jharkhand in

various combinations and synonyms. Studies that did not contain any combination of

these or related terms in the title were discarded.


Study Inclusion

Abstracts of the studies identified above were obtained and reviewed for eligibility in

terms of the selection criteria mentioned earlier. Emphasis was on relevance, time

period (’97 to ’07) and Indian context. Articles that did not have abstracts or where

the objectives or relevance were unclear, were withheld till further clarity could be

gained by reading the full text. The full texts of the included studies were obtained.

Studies that had been withheld thus far were excluded based on reviewing the full

text.

Data Extraction & Analysis

The selected studies were reviewed and any data relevant to the concepts of the

research question in any combination were extracted, collated and analysed for

associations between changes of case definitions, ascertainment procedures,

diagnostic and registration conventions (etc) and reductions in leprosy prevalence.

Analysis using validated instruments for assessing quality of studies and data

extraction was not possible, given the nature of the research question.

3.2 Semi-structured Interviews

The literature review was undertaken prior to the semi-structured interviews; so that

its preliminary findings could inform the topic guide for the semi-structured

interviewing. The purpose of the interviews was to understand from individuals

involved in leprosy control programmes in India about how the diagnostic and

reporting systems actually worked in practise and what changes had occurred between

1997 and 2007, specifically in Jharkhand.


3.2.1 Topic Guide

Based on the findings from the literature review, a topic guide was drafted. This was

piloted with a sample of MSc PH students from London School of Hygiene and

Tropical Medicine and further modifications were made. It was then tested for cultural

and contextual appropriateness with colleagues from India and the study version was

finalised. This is included in appendix 5.

3.2.2 Selection of interviewees

The intention was to interview 10 individuals. Interviews were planned for one month

over December 2007. The number of interviews was based on an estimation of what

seemed feasible for the MSc project, and how many interviews would be required to

gain sufficient information on the context of leprosy control in India. Professionals in

the field of leprosy elimination locally in Jharkhand from NGO & Government

settings (General Health Services or specialized leprosy services), directly involved in

diagnosis and case finding were sought for interviews.

Identification and recruitment of interviewees at first instance was done through

contact with a regional level co-ordinator of leprosy elimination activities in a district

of Jharkhand as well as the lead of a key local general health provider in the region.

This enabled the researcher to visit some of the leprosy centres and interview

professionals.

The semi-structured interviews were undertaken following the topic guide (appendix

5) after securing informed and written consent, and recorded either by a digital audio

recorder or by scribing.


3.2.3 Data Extraction and Thematic Analysis

The interviews were transcribed into English. They were then analysed using the

techniques of thematic analysis. Based on the initial interview, a preliminary coding

scheme was generated based on the original key themes from the interview guide.

This was modified in terms of categories and sub-categories as the coding of the

subsequent interviews progressed and new themes emerged, in an iterative process.

The final coding scheme (appendix 6) was generated and the coded extracts of the

various interviews collated under the identified themes. This collated data was then

scrutinized, compared within and across data sets, and analysed, resulting in further

modifications to the coding scheme and the eventual generation of the results.


4 Results & Findings

4.1 Literature Review

4.1.1 Results of Search Strategy

A total of 30 articles were identified that met the inclusion criteria and were reviewed.

These papers were located from the following sources. The EMBASE & EMBASE

Classic search yielded 573 articles. After limiting this result to English language,

humans & 1997-2007, 327 articles resulted. Screening these articles for general

relevance by title and year (1997-2007) narrowed down results to 52 articles. Reading

the abstracts of these articles narrowed down the results to 24 articles of which 11

articles were found relevant to the research question after reading the full text.

MEDLINE search (1980 – 2007 Week 11) using the same search strategy as for

EMBASE yielded the same articles. Searches of Web of Science, CINAHL and TRIP

databases also did not identify any new articles. Further searches of UNAIDS, WHO,

World Bank, National Leprosy Eradication Programme (India), Ministry of Health &

Family Welfare (India), Google scholar and non-governmental agencies (ILEP,

Leprosy Review, Leprosy Mission) websites identified 5 further articles. Manual

searching of the Indian Journal of Leprosy archives (1997-2007) yielded 14 possible

articles of which 7 were included. Searching the references of all included articles

identified 7 further papers.

4.1.2 Findings from the review

A report in the British Journal of Medicine in 200517 stated that doctors in India were

expressing concern about health authorities playing down the number of leprosy


patients in a bid to declare leprosy eliminated from India as a public health problem.

Elimination targets would allegedly be met through “artful manipulation” of the

definition of leprosy and “avoiding active case detection”. The Principal of the

Christian Medical College in Vellore, Tamil Nadu was quoted saying that new cases

were emerging almost unabated and yet they had explicit warnings against being

overenthusiastic in case detection.

4.1.2.1 How has prevalence been distorted?

What appears to emerge from the literature is that repeated changes of definitions,

ascertainment procedures, and diagnostic and registration conventions, by both WHO

and the National Leprosy Eradication Programme significantly distorted the true

reductions to leprosy prevalence in India, adversely affecting the ability of the

scientific community to monitor what actually happened2.

Particularly over the last decade, WHO has made several changes to leprosy policies

and guidelines that were adopted by the NLEP and have had major impacts on

prevalence data of India. Additionally, NLEP itself implemented operational practises

and policies that further compounded these inaccuracies and distortions.

4.1.2.2 How did WHO guidelines and policies affect prevalence in India?

a. By changing the way prevalence is calculated

Changing period prevalence to point prevalence: At the start of the elimination

programme, year prevalence was used to report the number of registered patients.

Later WHO advised that this should be changed to point prevalence to include only

those patients on the registers as of 31st December of the year, resulting in a marked

decline in the numbers registered and an automatic decrease in prevalence18. This


especially affected PB cases which form 90% of cases in India, since these are treated

either by ROM or 6 month MDT and are presumably no longer on the registers by the

end of the year.

b. By changing the definition of a case

WHO defined a “case” of leprosy as a person showing clinical signs of leprosy, with

or without bacteriological confirmation of the diagnosis, and who has not yet

completed a full course of treatment with MDT19. This definition was adopted by

NLEP in India and resulted in only patients currently on MDT being included in the

prevalence count, effectively excluding patients with ongoing complications or

disabilities4,20.

c. By changing diagnostic classifications

Generally an accepted criterion for the diagnosis of leprosy was positive findings for

any two of the following three criteria 8,21:

I. Loss of sensation in a skin lesion to light touch

II. Enlarged nerve among all palpable peripheral nerves

III. Positive skin smear

The slit-skin smear was key to estimating bacterial load and classifying patients, for

treatment purposes, as multibacillary or paucibacillary. According to some experts

this was the weakest link in implementation of the MDT programme22,23. The advent

of HIV/AIDS and poor quality control on slit-skin smears shifted the focus to clinical

classification of PB & MB cases24,25,26.

WHO (WHO expert committee, 7th report, 1998)27 decided that counting skin lesions

would be no less sensitive than counting bacilli in a skin smear:

I. Paucibacillary single lesion case defined as a patient with one skin lesion


II. Paucibacillary, 2 – 5 lesions

III. Multibacillary, more than 5 lesions

Neurological assessments and slit skin smears do not contribute to this

classification18. Neuritic leprosy, which accounts for a significant proportion of

leprosy in the Indian subcontinent28,29,30 manifests with neural signs and/or symptoms,

without any clinically evident skin involvement31. Such cases are very likely to be

missed using the above classification32,33,34,35.

The WHO document states that in 70% of patients, diagnosis can be made by a single

sign: an anaesthetic skin patch. In 2002 an evidence based group convened by the

International Leprosy Association, found that the other 30% are multibacillary

patients, who are more likely to be infectious and to develop nerve damage4,36.

d. By changing treatment durations and regimens

In 1998, the WHO expert committee on Leprosy concluded that the duration of the

MDT regimen for MB leprosy could be shortened to 12 months (from 24 months). It

was even suggested that all leprosy patients should be treated for only 6 months

despite the lack of scientific evidence to support this18,37. By shortening the treatment

duration for MB-MDT from 24 to 12 months, the number of MB registrations halved,

thus improving statistics and excluding large numbers of MB cases from point

prevalence data18,38.

Further, on the basis of field trials and clinical studies WHO decided that a single

dose combination of rifampicin- ofloxacin- minocycline (ROM) was an acceptable

and cost-effective alternative regimen for the treatment of single lesion PB

leprosy18,27. ROM therapy improved statistics in India, a country with a relatively high


proportion of single lesion cases and 90% PB cases. This effectively wiped out the

group from the prevalence data18.

A case is considered cured once the therapy is completed regardless of the

bacteriological load. There were no definite data establishing that 1 year MB-MDT

treatment would be sufficient to prevent relapses; in fact, there were some indications

that patients with high number of bacilli (a BI of 4-6) might relapse39. Moreover, it

could be expected that the number of leprosy reactions in the year after RFT would

increase, leading to more disability in the so-called ‘cured’ patients8,40,41.

In 2002, WHO proposed a new treatment called ‘accompanied MDT’42, whereby

patients are given all the medicines for the full 6 or 12 month course of treatment at

their first visit, with the proviso that someone close to the patient will take

responsibility for helping the patient complete the course of treatment. This is a

curious reversal of policy, where for the ten years prior to this the strength of the

leprosy programme lay in the monthly supervision of medication, which also meant

that nerve damage was picked up early and health education could be ongoing4.

4.1.2.3 How did operational practises and policies of NLEP affect prevalence?

a. ROM Therapy from 1998 – 2002

Single dose treatment for single lesion paucibacillary patients; through ROM therapy

was introduced in January 199843 and was in vogue for about five years till 2002.

These cases never came into prevalence data since they received only a single dose

treatment. They should have been counted as new cases44.


b. Changing from active case detection to voluntary reporting

Official guidelines launched in March 2005 recommended that the state should stop

actively searching for cases and register only those with confirmed diagnosis45.

Earlier in January 2005, in the South East Regional meeting of National leprosy

programme managers46 it was decided that every leprosy case detected by primary

health care workers was to be confirmed as leprosy by a special team at the district

level. This approach of 100% validation was adopted from 2005. Various methods of

active case detection were to be discontinued and case detection was to be taken up by

voluntary reporting. These decisions affected case detection enormously with 100%

validation rarely feasible and a significant proportion of cases never getting examined

for confirmation44.

c. Underdetection & Underdiagnosis

While increasing attention was being given to ‘overdetection’, ‘underdetection’ was

being ignored, perhaps because it was difficult to estimate and less appealing to

programme managers and therefore had no apparent mandate47. The few sample

surveys conducted using traditional methods48 or Lot Quality Assurance Sampling

(LQAS)49 have revealed sample prevalence 4-5 times higher than recorded

prevalence. Even after five LECs and with reasonably effective MDT service, the

extent of underdetection is very high50. Underdiagnosis is more likely in borderline

lepromatous and lepromatous leprosy because of low degree of suspicion. These are

the cases that are likely to transmit infection in the community47.

In several high endemic states such as Bihar, the decline in prevalence is dramatic.

Deliberate under-detection of cases during the year 2003-04 by the over-zealous staff

due to pressure at all levels to achieve elimination by 2005 could have contributed to


the steep decline in the PR51. In fact, there was a report from a reputed NGO with

credible leadership that several new cases in an endemic district under its support

were not reported during the first quarter of 200551,52.

Cases are missed on account of non-coverage of certain areas or population groups

(working men, difficult to reach areas, tribal populations, people below poverty line

etc.)53. Marginalisation on account of gender and poverty, inaccessibility to health

services, opportunity costs, disabilities and stigma were some known factors that

influence case detection activities54.

d. Changing from vertical to integrated programmes

The integration of leprosy programmes into the general health services, moving away

from the erstwhile vertical programmes, has resulted in widening health care

networks, bringing diagnosis and treatment services closer to the patient38 and more

workers involved in the diagnosis and treatment of leprosy18. But these advantages

have been nullified by lack of staff at PHC’s and not enough health centres. E.g. in

Bihar there is 1 health centre for every 200,000 population, in contrast with South

India, where there is 1 for every 30,000 population38,55. Lack of proper trained and

specialised staff, compounded with lack of consensus over case definitions, absence

of common standards for instrumentation and procedures related to sensory testing of

anaesthetic patches has resulted in over and under diagnosis of cases56. In 2004, inter-

observer variation for diagnosis was estimated at 50% and validation of diagnosis

conducted in various places revealed wrong diagnosis ranging between 10 & 30 %56. )


e. Target setting

Targets provide an inescapable sense of urgency among health workers44. In the

NLEP the targets were of two kinds; the first target was to detect at least a minimum

specified number of cases and the other was in respect to marching towards

elimination by year 2000, pre-fixing prevalence figures for the year44. To achieve the

goal of elimination by the year 2000, targets were prepared after committing to the

goal of elimination57 and projections were made on such targets. Setting targets was

eventually considered counterproductive to the assessment of surveillance data and

was discontinued by the Government of India58.

f. Excluding data

Data from private health practitioners and dermatologists that serve large segments of

the population are not included in official prevalence data. NGO’s and private

practitioners that are not part of the governments elimination programme may serve a

significant segment of society and their patients are not included in official

figures38,59.

g. Masking sub-national high prevalences

In large countries such as India, national averages do not mean anything. Severe

problems in some high prevalence states can easily be masked and averaged out by

well-performing low prevalence states60. Prevalence at sub-national levels, provided

sub-national populations are sufficiently large, is of greater relevance60.


4.1.2.4 What other effects did all these changes have in India?

a. Epidemiological Paradox Comparing the data for prevalence and new case detection rates over the same time

periods (1984-2002) shows that while prevalence dropped dramatically, the incidence

figures have remained almost constant38. New case detection rates taken together with

the proportion of cases treated with MB-MDT and the high rates among children

(~17%) indicate that leprosy continues to be transmitted in the community38,61.

Leprosy is a chronic disease with relatively low mortality and potentially high

morbidity. Prevalence in such diseases is a function of incidence and duration, given

by the equation: P = I x D (P- prevalence, I- incidence & D- duration)2,52

The situation in India has become paradoxical, because the original meanings of P, D

and I have been changed to:52

P = Cases of leprosy needing MDT for the first time per 10,000 population

I = New Case Detection rate and

D = Duration of MDT

The current situation has thus created an “epidemiological paradox” where prevalence

has become less than incidence for a chronic disease52, as can be seen in Fig. 5! As

Figure 5: Prevalence and new case detection rate for leprosy in India. '84-'02 38


durations of MDT got reduced from life-long treatment, to 10 years to 2 years to 1

year, and now for only 6 months, the prevalence rate reflects largely this diminishing

factor52,20.

b. Social Stigma and case detection

Due to prevailing negative perceptions of leprosy and social stigma, persons

suspecting leprosy delay seeking effective treatment till irreversible symptoms

develop. By then, the disease would have spread within the body and would also have

been transmitted to contacts. It is obvious that drugs alone can never solve a public

health problem, such as leprosy, due to public attitudes and health behavior

conditioned by massive prejudices, inadequate knowledge & several socioeconomic

factors in accessing MDT or anti-reactional drugs, etc62,63. This has been further

exacerbated by the implementation of voluntary reporting as a method for case

detection and dismantling specialist leprosy infrastructure through integration.

c. Reduced government spending on an ‘eliminated’ disease

With elimination declared, resources are becoming limited in relation to leprosy work

in India. Field workers say new cases are emerging continuously but there are not

enough resources to help them. A leprosy expert in Osmania Medical College,

Hyderabad said that trained leprosy workers are being diverted for HIV work or as

multi-purpose health workers. He claimed that India would soon lose trained leprosy

personnel and track of the disease and it would become a simmering problem like

malaria59.


4.1.2.5 Alternative explanation for reductions in prevalence

Some WHO experts are saying that the dramatic reductions in India were mainly due

to the minimization of operational factors, such as wrong diagnosis, re-registration of

cases, delayed treatment completion, overtreatment etc. Better treatment compliance

rates and regular updating of registers were also identified as important contributory

factors64. Re-registration of old or cured cases as new patients, ranging between 33-

82%53 has been observed.

Some researchers say that because leprosy eradication was administered as a vertical

programme and was poorly integrated into general heath services, this hindered case

detection and treatment. The social stigma associated with being seen, and easily

identified and labelled by the community, while taking treatment from special leprosy

centres acted as a deterrent to voluntary reporting31.

4.1.2.6 WHO Elimination Hypothesis: Eradication or Elimination?

The idea of elimination was based on the hypothesis that at a prevalence of less than 1

per 10,000 population, transmission of leprosy in the community would be

interrupted. The International Leprosy Association’s Technical Forum noted that there

was little evidence to support this hypothesis65. Leprosy has a long incubation period

from 2 – 20 years66; newly diagnosed patients may have transmitted the disease to

others in their family or community long before their disease is detected38. Eradication

would imply that a disease reaches zero prevalence and zero transmission, which is

improbable with the disease characteristics of leprosy52.


4.2 Semi-structured interviews

4.2.1 Leprosy Elimination Programme

Guidelines, policies and targets

All the informants said that guidelines and policies were disseminated from national

level down through states to districts, blocks and villages. One informant said that

about ten years ago skin smears were done to confirm cure before patients were

released from treatment (RFT) and this changed to RFT once the MDT course was

completed adding “it was the government policy… it keeps changing any time…”

This concurs with the literature review findings, the implication being that at the most

a case would remain registered for 12 months, after which it would no longer be

included in prevalence data, regardless of the actual cure status.

All informants maintained that the government did not set any targets. NGOs set their

own targets in relation to rehabilitation work according to the mandates of their

funding agencies.

Campaigns

One informant said that the government had conducted an awareness campaign

(BLAC- block level awareness campaign) recently, prior to which one had been done

four years ago, which coincides with the last (fifth) MLEC (Modified Leprosy

Elimination Campaign) in 2003-04. Another said that NGO’s have been involved in

IEC activities for many years, using individual, group and mass level approaches.

4.2.2 Case detection “…though the survey is over now but still we are doing the survey because we believe

that there is a lot of hidden cases…”


“…though they (government) are asking help from us, they are involving us also but

our party is… umm… totally off doing survey… because nowadays whatever case we

are finding by any means, it will be treated as voluntary reporting…”

“…the reason was government accepted that… umm… it is a leprosy free area so no

further detection is necessary. But there are two things, number one… umm… I think

that this is arbitrarily deterred… and number two who can say that within this ten

years further cases won’t come up?...”

“INT: I see…. so, you do not do case detection officially….

ANS: No…”

Four out of five informants said that NGO’s no longer undertook active case detection,

at least in official capacity. One reason offered was that any cases they detected were

treated by the government as voluntary reporting, so there was no recognition for this

work. While one informant maintained that the peripheral health workers still did door-

to-door surveys and also said there had been no changes over the years to the way case

detection was done, the rest said that in general active case detection had been stopped;

three of them stating that NGO’s had stopped since 2001. This is interesting because

the literature review findings revealed that active case detection had officially stopped

as per NLEP guidelines since March 2005. If NGO’s had ceased active detection since

2001, this would have had a significant impact on case finding and subsequent

prevalence data between 2001 and 2005, particularly since Jharkhand is highly

endemic for leprosy. However unofficially they still did this through school surveys

and village meetings as they believed there were a lot of hidden cases in the

community, even though their efforts were not subsequently acknowledged.


4.2.3 Case diagnosis “ANS: But now there is no such thing as a relapsed case… they are calling them old

cases and treating them…

INT: That means these cases are not appearing on the register…

ANS: No… they are not appearing on the register…”

“Around 1982 when MDT was introduced, MB and PB was used. In those days smears

were done and doctors who were scientifically inclined did biopsies. This stopped

afterwards.”

All informants maintained that provisional diagnosis through the detection of cardinal

signs of leprosy was routinely done by peripheral health workers (Anganwadi

workers, ANM’s & MHW’s) as well as by NGO’s during school and village

meetings. The suspected cases were referred to the PHC for confirmation. This is in

line with findings from the literature review.

All informants said that cases were diagnosed by the medical officer at the PHC

through clinical examination for patches and nerve enlargement and no skin smears

were taken to confirm the diagnosis.

Two informants said that smears to confirm diagnosis had been done till 2000, being

stopped at the time the programme was integrated into general health services after

which diagnosis was done by clinical examination alone. This is in agreement with the

findings from the literature review. One informant appeared to not know if smears had

been used in the past to diagnose cases, even though this informant had been working

in the leprosy field for a considerable time at a senior level. Three informants said that

till as recently as 2006-07, NGOs had been involved in case detection, diagnosis,

registration and treatment of leprosy cases in their designated districts/ blocks.


While relapsed cases, like new cases needed to be registered, one informant said that

the approach taken by PHC’s was to consider them as old cases and therefore not

register them. This would impact on prevalence data quite significantly, as in endemic

states such as Jharkhand there would be a significant number of relapsed cases.

While one informant said that overdiagnosis happened in the past but was now very

rare after validation started, others were unable to comment on this.

4.2.4 Case validation Three informants said that case validation and quality assurance was undertaken by

the DLO. This was started in 2003-04 and was done by a multi-disciplinary validation

team, comprising the DLO and representatives from WHO and NGO’s, that visits

block PHC’s fairly frequently at pre-arranged times. The literature review showed

that a 100% validation approach was adopted since March 200544. If case validation

was indeed carried out since 2003-04, then the high prevalences in Jharkhand since

then cannot be put down to overdiagnosis or re-registration as alternative views of

prevalence decreases suggest64. If one added to the equation the fact that active case

detection by NGO’s ceased in 2001 and officially by NLEP in 2005, then there is a

much higher likelihood of under rather than over detection and diagnosis.

4.2.5 Case registration

Informants said that cases were registered at PHC level if the medical officer was

satisfied that the case was new. Relapsed cases were regarded as old cases and

although they were provided treatment, they were not registered. NGO’s no longer

registered cases. Further they said that registered cases were taken off the prevalence

register once they were released from treatment (RFT) - six months for PB cases and

12 months for MB cases, regardless of bacterial load. Re-registration was not


common and occurred when a case already registered in one district, migrated to

another and claims to be a new case.

This corroborates findings from the literature review that changes to the RFT (release

from treatment) protocols artificially reduced prevalence.

4.2.6 Range/Types of cases “INT: ….and have you seen children…with leprosy…?

ANS: Yes absolutely, it happens a lot…”

Most informants said that majority of cases of leprosy were PB (Paucibacillary), with

one informant making the observation that in places where literacy, education and

awareness were greater more PB cases were observed, while areas with less

education, awareness and hygiene had more MB cases. One informant said that MB

cases were more common.

While all informants agreed that in general all types of cases had reduced, they said

that in children leprosy continued unabated with relatively little change to the

numbers seen, making up around 10-15% of the cases according to one informant.

Most children with leprosy had a positive family history for leprosy although one

informant was quick to point out that this need not be the case. In the pre-MDT era

deformities were very common but now the deformity rate had come down.

Deformities were mostly of grade 2 (visible deformity/ damage present in hands and

feet and severe visual impairment).

The fact that leprosy continues unabated in children, with a positive family history of

leprosy in most cases, is evidence of continued active transmission of leprosy in the

region and underscores that there are major shortcomings in early case detection.


4.2.7 Case treatment

All informants maintained that there was no longer any single lesion ROM therapy.

The duration of treatment for PB cases was 6 months to be completed in 9 months, for

MB cases 12 months to be completed in 18 months. An informant said that from 1986

till 1996 MB cases were treated with 24 months of MDT. In the past NGO’s were

closely involved in detection, diagnosis, treatment and registration of cases but now

only the government health services did this. This corroborates literature review

findings.

Informants said that once cases were diagnosed and registered at the PHC, it provided

the first months MDT. Subsequent months of MDT are provided by peripheral health

workers, who monitored the cases for improvements and signs of reactions or

complications, which if present resulted in the case being referred back to the PHC for

further management. This appears to be a variant form of ‘accompanied MDT’

advocated by WHO in 20024 and contrasts with ‘supervised MDT’ that was

recommended earlier. This arrangement has a high possibility of delayed treatment

completion, overtreatment, poor treatment compliance rates, failure to detect

complications or reactions, relapses and less opportunity for health education.

4.2.8 Case cure

Informants were of the view that with completion of the full prescribed course of

MDT the assumption was that the patient is cured. One informant said this is

considered ‘100% cured’. Treatment completion results in patient being ‘released

from treatment’ or ‘RFT’, which is done at the PHC once the medical officer is

satisfied that no complications or reactions are in evidence. The case is removed from

the prevalence register. Till 1996 smears were done to determine if cases were cured.


The literature review revealed that there was no definite data establishing that 1 year

MB-MDT treatment would be sufficient to prevent relapses; in fact, there were some

indications that the patients with high number of bacilli (a BI of 4-6) might relapse39.

Moreover, it could be expected that the number of leprosy reactions in the year after

RFT would increase, leading to more disability in the so-called ‘cured’ patients8,40,41.

To regard completion of MDT course as evidence of 100% cure is inaccurate and this

definition of a cured case exacerbates the endemicity of leprosy in India.

4.2.9 Prevalence data

Informants said that prevalence was calculated as the total balance of cases under

treatment in an area divided by the total population of that area, multiplied by 10,000

to give the prevalence per 10,000 population. It was calculated monthly at every block

PHC. Each block reported to the district (DLO) and from all the districts, the data went

to the state (SLO). One informant said that prevalence was calculated by randomly

surveying a thousand people in an area to find how many of them had leprosy, giving

the prevalence per thousand population. Earlier the denominator was per 1000

population, but this was changed to per 10,000. Only one informant seemed certain

about the way prevalence was calculated.

4.2.10 Case reductions and leprosy as a public health problem

“I would say that leprosy is still a public health problem. Particularly awareness issues.

In middle class families there is a lot of stigma associated with leprosy, even though it

is much less than before. General health workers do not have much training in relation

to leprosy particularly on the course duration. Training on leprosy needs to be more

detailed to multi-purpose health worker level.”


All respondents said that the prevalence of leprosy had been greatly reduced. NGOs

had a key role to play in this. However respondents felt that there were a lot of hidden

cases and also that unless the social stigma of the disease was removed one could not

say leprosy was eliminated. One respondent felt that there had not been significant

reductions in prevalence locally. Most respondents maintained that it was still a public

health issue, due to the presence of hidden cases, the challenges of SER/CBR and

social stigma.

4.2.11 Vertical VS Integrated

While one respondent felt that the integrated system worked better, another felt it

could have been introduced later because unless social stigma was tackled and the

barriers created by the absence of social acceptance of the disease removed,

integration was counter-productive. In the erstwhile vertical model there were

specialised leprosy centres to which patients came for dressings, physiotherapy and

treatment. Many of these were shut down as recently as two-three months ago and

subsequently the patients were reluctant to visit the general health services due to the

fear of social ostracism.

“First you remove the social stigma. Socially acceptance must be beyond on

government level or do some machinery… put some machinery then only you can

realise. Generalism is what…when there is a social acceptance is there. As long as

you don’t have acceptance of leprosy patient in the society, so how can you generalise

this?”

“…social acceptance must be there for leprosy is integrated. If you declare

integrated… government generalised the cases, it doesn’t have meaning. Because


when leprosy is a stigma, unless and until you remove the social obstacles, no

integration is there. Integration start from the social obstacles first… then to your

medicine part and hospital part… many thing can be done, many thing has to be done,

specially for the deformity cases.”

“… If you have seen Calcutta based newspapers… I have read two-three months

earlier, so many leprosy hospitals… those who are set out for leprosy only… either

they have stopped because all the doctors, staffs… those who are deputed for the

leprosy patients, they have withdrawn… they have deputed some other hospitals…

that hospital has been closed or building is this there because integration is there. So

leprosy patient having ulcer or deformity, those…those who are used to come that

hospital…they are feeling little hesitant…they are not attending to general hospital…

not attending general hospital. So this is practical… practically we have seen.” …

One informant said that in the vertical programme there was improved networking

between NGO’s and the government, with better trained, knowledgeable and

experienced staff and consequently better care. But the social stigma extended to

those workers involved in leprosy work themselves, compounded by the existence of

separate leprosy wards in general hospitals.

The integrated approach resulted in increased capacity for leprosy work and many

patients felt less stigmatised going to a general health service for leprosy. Staff

attitudes towards leprosy patients also improved with greater understanding,

sympathy and openness. Because peripheral health workers could do home visits for

any number of reasons, many families felt less stigmatised. Lack of specialised,

experienced staff and the lack of training used to be a problem but this is apparently

no longer the case.


Some informants said that the programme was still vertical in many places, with little

real integration. Earlier, when there was a vertical set-up, more patients were

registered as the case detection and diagnosis was better. Now due to the distances a

patient had to travel to get the closest PHC, many cases remained unregistered and

untreated for a long time, resulting in greater severity and complications while

transmitting the infection to the community. Despite the increased numbers of staff

involved in leprosy work at the periphery through integration, the patient had to still

visit the PHC at first instance for confirmation, registration and treatment before the

peripheral workers could extend support locally.

4.2.12 Improvements, limitations and shortcomings

One respondent felt that it was necessary to incentivise case detection at the

periphery, in order to find hidden cases. In pulse polio drives apparently peripheral

workers are told that if they brought in a certain number of cases they would get a

cash bonus. Others said there was a lot of room for improvement in IEC, campaigning

and public awareness initiatives. This could be tied in with the ongoing government

campaign, the total literacy mission. A lot more work was needed in the rehabilitation

of leprosy patients with disabilities and deformities both medically and socially.

Survey and active case detection were still very important, as many cases of leprosy

were not coming forward voluntarily due to stigma and also lack of awareness about

leprosy.

“So...that survey or say your reaching to this people is very essential. It won’t be

proper to expect particularly in this area where their literacy rate is very poor that they

will just come forward and disclose that they are having this sort of things. Neither


they can detect…uhh…the disease…if at all they can detect…out of that stigma or the

fear or the some sort of shame they can’t disclose.”

“Voluntarily they cannot come forward….so we have to reach out to them.”

“And if we take it granted that who will have the disease and they will come forward

in this Indian context, or in the context of this region… umm… it is too much to

expect.”

4.2.13 Stigma

All respondents said that social stigma prevented patients from going to general health

services. Stigma hampered with rehabilitation work and placed severe limitations on

the occupational opportunities of leprosy patients in addition to those already

experienced by them on account of deformities and disabilities. They said that one

could not say a patient of leprosy was cured or that leprosy was eliminated unless

stigma was removed. Integration too would always remain incomplete unless stigma

and other barriers to access were addressed.

“So ultimately they have taken medicine but while their social status… you cannot

say we are cured… ultimately stigmatized is there… social acceptance is not there…

so until and unless you put a patient in that level where he can move here and there,

he or she can earn his butter and… bread and butter… then treatment is not cured, so

far NGO sense of concern is there. So far medical is concerned you have taken…

given medicine, it’s cured. But we feel until and unless you develop that person in his

previous life it’s not completed.”


5 Discussion It is evident from the literature review that numerous changes to case definitions,

ascertainment procedures, and diagnostic and registration conventions over the last

two decades have directly or indirectly impacted on leprosy prevalence. Findings

from the semi-structured interviews corroborate these findings locally in Jharkhand.

The prevalence of leprosy in India has most definitely declined, but the true extent

remains unclear. The fact that in 2003 the Indian Council for Medical Research found

leprosy prevalence in Agra 40 times higher than official figures67 and the few sample

surveys that have been conducted through traditional methods48 and Lot Quality

Assurance Sampling (LQAS)49 revealed sample prevalence 4-5 times higher than

recorded prevalence, underscores this ambiguity.

Apart from the issue of whether or not prevalence has reached “elimination” levels in

a country that has almost 80% of the global burden of leprosy38,68, the whole

elimination hypothesis itself, that prevalence under 1 per 10,000 population interrupts

the transmission of leprosy in a population, is highly contested65. Perhaps the

elimination concept has now served its purpose and might even become detrimental to

public health2. The elimination rhetoric has come close to eliminating leprosy

research2,69. Funders and young researchers are not attracted to an officially

“eliminated” disease and there is little active research on the subject despite our

continued ignorance about its natural history2.


While prevalence dropped dramatically, the incidence figures have remained almost

constant38. New case detection rates taken together with the proportion of cases

treated with MB-MDT and the high rates among children (~17%) indicate that leprosy

continues to be transmitted in the community38,61. The impact of MDT on prevalence

and case detection trends across India was earlier examined in a workshop conducted

by the Indian Association of Leprologists in Chennai, in 199370. It observed that in the

face of rapid decline in prevalence following MDT, NCDR remained quite steady.

NCDRs for several countries clearly demonstrated that MDT did not result in a

precipitous decline in NCDR71. Thus prevalence reductions could not be attributed

directly to MDT per se. Unchanged levels of new case detection could be explained

by intensive case finding in some states, but examination of state-level data did not

support such a hypothesis53. Hence even in the absence of active case finding

strategies such a level of decline is not convincing.

Prevalence figures have been influenced by changes to case definitions whereby a

case is only a case so long as it is being treated with MDT. Once the treatment is

completed, the case is considered cured which when married to the WHO

recommended convention of MDT lasting 12 months only (in MB cases and 6 months

for PB cases) and changing from period to point prevalence18, results in many cases

being excluded from prevalence data regardless of their true status4,20. From 1998 to

2002 a substantial proportion of cases never made it into prevalence or incidence data

on account of single dose ROM therapy for single lesion paucibacillary cases, which

is particularly common in India43,44.


Findings from the literature review and the interviews underline the role of social

stigma in the reluctance of leprosy patients to seek treatment and care. Two changes

in the leprosy programme, switching from a vertical to an integrated leprosy

programme and the cessation of active case detection in preference for voluntary

reporting, have further compounded this situation as individuals fearing social

ostracism and marginalisation are hardly likely to come forward voluntarily, that too

to a general health care system. Marginalisation on account of gender and poverty,

inaccessibility to health services, opportunity costs, disabilities and stigma are some

known factors that influence case detection activities54.

In 2003 WHO opined that the ‘case detection trends in India are not showing any

appreciable decline and there is no clear explanation for the persistence of this

situation in spite of the highly specialised and expensive vertical programme in

operation for close to 50 years’72. For political leaders achievement of leprosy

elimination has been and is a highly attractive objective, besides having one problem

less in their portfolio60. Perhaps this explains, to some extent the complex political

and economic realities in which the leprosy eradication programme sits and the

urgency to reach so-called ‘elimination’?

An alternative explanation for the reductions is that they were mainly due to the

minimization of operational factors, such as wrong diagnosis, re-registration of cases,

delayed treatment completion, overtreatment etc.; and better treatment compliance

rates and regular updating of registers were also important contributory factors64.

Others say that leprosy has a strongly committed constituency, which is not easy to

dismantle irrespective of the size of the problem, with this constituency lobbying and


working towards sustaining the remaining anti-leprosy activities60. The subtext is that

such a constituency would want to demonstrate that leprosy is still not eliminated, in

order to remain viable as many vested interests, livelihoods and jobs were at stake.


6 Limitations

As mentioned earlier, the aim was to obtain 10 interviews but ultimately 5 were

possible. It took considerable time to find informants prepared to be speak on record

(a lot was said off the record but this cannot be included in the research). Predictably

the initial informants were from non-governmental settings. Representatives from the

government involved directly in the local leprosy eradication programme (District

Civil Surgeon, District Leprosy Officer and others) were identified, contacted and

they even discussed issues off the record. Eventually they agreed to be interviewed for

the project, but during fieldwork they were all transferred en-mass to another district

with other officials replacing them. Apparently it is the policy of the government to

transfer district leprosy teams within a year with practically no notice, to other

districts to curb corruption. This left insufficient time during the fieldwork in India to

contact new government interviewees. Ideally 10 interviews or more would have

greater validity and representativeness, although it should be noted that there was a

considerable degree of coherence of responses, suggesting it was unlikely that

additional interviews would have identified significantly different themes. .

The nature of the research question meant that a systematic literature review was not

possible in this instance. With greater time and resources, more grey literature could

have been obtained and more articles that provided possible alternative explanations

to the hypothesis unearthed.

This research merely scratches the surface of what is a complex and difficult question.

More detailed and extensive research is required to fully answer it. One possible line


of analysis is co-relating the volume of the chemotherapy drugs (supplied for free

through WHO by the Nippon Foundation) consumed over a period of time to

prevalence within a particular region or country, to possibly give a better idea of

prevalence than official prevalence data itself.


7 Conclusions & Recommendations

7.1 Conclusions

Declaring a disease eliminated from a country has very serious implications. Despite

more than 20 years of MDT, leprosy has not been eradicated. Leprosy patients are

highly infectious and M.Leprae can remain viable outside the human host for many

months. The mean incubation period of lepromatous disease is 10 years. These factors

make it difficult to completely eradicate the disease21 and there is no evidence that the

global initiative has lead to the disappearance of infection or disease from any

population2. Perhaps we are failing to understand some important aspect of the

disease’s natural history2.

With elimination declared, resources are becoming scarce for the continued efforts

necessary to keep this enigmatic disease at bay. Integration has resulted in the loss of

skilled and experienced leprosy workers and the lack of training to general health staff

has further compounded the situation. Cessation of active case detection will continue

to contribute to a rise in hidden cases. In the absence of effective IEC, campaigning

and public awareness initiatives, voluntary reporting will not be effective in new case

detection.

Social stigma in relation to leprosy is ingrained in society. Fear of social ostracism

and discrimination discourage patients from accessing services or even being

diagnosed. Socio-economic rehabilitation of leprosy cases is greatly hampered by this.


Ignoring the reality of the problem will not make it go away. Declarations of

elimination on paper do not magically rid a country of a disease. Much to the

contrary, it is possible the leprosy will re-emerge as a major health issue unless it is

addressed according to the ground realities.

7.2 Recommendations

Reinstating active case detection

While it is an expensive proposition to re-implement active detection all over India,

this should be done in regions that continue to demonstrate high prevalence of

leprosy. Jharkhand is a case in point where the prevalence is above the national

average with 12 districts having prevalences between 1 & 2 and 2 districts having

prevalences between 2 and 5, yet there is no active case detection. Hidden cases that

are missed because of voluntary reporting will eventually resurface at later more

complicated stages, having transmitted the infection to many others by then. A cost-

effectiveness analysis of re-implementing active case detection would undoubtedly

reveal that the costs of managing such cases later far exceed any cost considerations

of re-implementing active case detection now.

Surveillance

Surveillance must be undertaken in an integrated setting using clinically relevant

indicators. The number of new cases will drop as a result of integration and it is

critical to establish whether patients with leprosy are being missed by the surveillance

system47. These areas should use active case finding.


Effective IEC, campaigning and public awareness initiatives

Effective awareness campaigns will uncover more hidden cases, dispel many myths

and misconceptions and also help to counter the stigma attached with leprosy. It will

help SER programmes and sign-post local services to leprosy patients. The frequency,

duration and coverage of campaigns need to be improved. Tying in leprosy awareness

campaigns with the total literacy mission is an effective way forward.

Training general health staff

Since the programme is integrated into general health services, continued training and

refresher training need to be made mandatory for all medical staff. Such workshops

must include modules on attitudes and values and challenging stigma.

Parallel vertical programmes

It is clear from the evidence of this report, that the leprosy programme is not fully

integrated into general health services in many areas. The advantages of integrated

services have been nullified by lack of staff at PHC’s and not enough health centres.

E.g. in Bihar there is 1 health centre for every 200,000 population, in contrast with

South India, where there is 1 for every 30,000 population38,55. In such regions,

maintaining specialist leprosy initiatives in partnership with local NGO’s till such a

time that capacity issues of general health services are resolved would best serve the

interests of those afflicted with this disease.


Incentivising case detection at peripheral health worker level

Innovative schemes to motivate peripheral health workers to find leprosy cases should

be piloted in high prevalence districts/ blocks. If this is found effective then it should

be extended to other high prevalence districts/ blocks.

Confirming cure by skin smears

HIV/AIDS and poor quality control on slit-skin smears not withstanding, it is

essential particularly in multibacillary cases to confirm cure by bacteriological load as

opposed to RFT after MDT course completion. Ideally this should apply to diagnosis

as well, but it is better to overdiagnose leprosy than to release from treatment leprosy

patients that are still infectious and liable to relapse. Poor quality control of smears is

addressed through better training, providing standardised equipment and standardised

procedure protocols.

Moving away from elimination rhetoric

The national leprosy eradication programme must recognise the limitations of an

elimination (& prevalence)-centric focus, particularly since there is no evidence to

support the WHO elimination hypothesis65. The elimination concept has run its course

and served its purpose. The programme must focus on new case detection rates,

disability rates, proportion of new cases that are children and proportion of MB cases

instead, as these provide are more accurate assessment of active disease transmission.

More emphasis should be placed on the socio-economic rehabilitation of leprosy

cases.


Appendix 1: Anonymised copy of final revised protocol

LONDON SCHOOL OF HYGIENE & TROPICAL MEDICINE MSc Public Health Project Protocol 2006-2007 CANDIDATE NAME: XXXXXXX MSc Public Health Stream name………MSc. Public Health General If you are a Half-time student please indicate whether this is your 1st or 2nd year of study

PROJECT TYPE: (please indicate which type of project you intend to undertake, i.e. Health Policy Report or Literature Review or Research Project)

Health Policy Report TITLE OF PROJECT: How could changes of case definitions, ascertainment procedures, and diagnostic and registration conventions have impacted on reductions in the prevalence of leprosy in India, reported over the last decade (taking the state of Jharkhand as a case study)? BACKGROUND: (i.e. why this topic is of interest/relevance. If your project involves work with a specific organisation, please give details) In 1991 the World Health Assembly (WHA) passed a resolution to “eliminate leprosy as a public health problem” by the year 2000, elimination defined in this context as a reduction in prevalence to below 1 per 10,000 population. India achieved elimination in December 2005; according to the National Leprosy Eradication Programme data (‘Current Leprosy Situation in India as on March 2006’, National Leprosy Eradication Programme). This was achieved following a dramatic fall in prevalence, particularly between the years 2000-2005. Although some states like Jharkhand, as per Government of India figures continue to have prevalence above 1 per 10,000 such drastic reductions have left many in the scientific and NGO community sceptical about what has actually happened (‘Leprosy: what is being “eliminated”?’ Professor Paul Fine; WHO International Bulletin, Volume 85/1/06-039206; Professor Paul Fine & Dr. Diana Lockwood, personal communication). One theory is that changes to the diagnostic, surveillance and reporting procedures are creating ‘data artefacts’ that are obscuring the true picture of leprosy prevalence and control in India. This research is aimed at gaining insight into the co-relationship between this steep


fall in prevalence and changes to the diagnostic, surveillance and reporting procedures being followed, looking at the Indian state of Jharkhand as a case study. AIMS: Make recommendations to the Government of India, based on the findings about the role played by changes to definitions, ascertainment procedures, and diagnostic and registration conventions in the reported reduction in prevalence of leprosy in India over the last decade. Recommendations will address issues related to the assessment of leprosy prevalence. OBJECTIVES: • To gain understanding about the change in leprosy prevalence in India over the

past decade. • To understand how the diagnostic and reporting system actually works in practise,

in India, informed by the interviews to be conducted in India. • To explore changes in diagnosis, reporting and surveillance systems in India over

the same period. • Draw conclusions about the possible relationship between changes of case

definitions, ascertainment procedures, and diagnostic and registration conventions (etc) and the dramatic reported reductions in leprosy rates.

METHODOLOGY: (please note that methods of literature review should be detailed and specific)

Phase 1: Reviewing the literature Initially the research will take the form of reviewing the literature available to shed light on the reasons for the drastic changes in prevalence rates reported in India over the past decade. The review will seek to inform the research about the various factors purported to contribute to the elimination of leprosy in India, and whether similar trends and factors have contributed to reductions in other countries. Further, the review will provide insight into role played by changes to definitions, ascertainment procedures, and diagnostic and registration conventions in the reported reduction in prevalence of leprosy in India over the last decade The search strategy for this review will be to break down the research question into concepts and frame search items. This will be followed by bibliographical database searches for each of the search items and subsequent combined searches. The search items for this review could be: ‘case definitions’, ‘surveillance OR case finding’, ‘diagnosis OR case confirmation’, ‘case registration OR reporting’, ‘prevalence’, ‘leprosy OR Hansen’s Disease’, ‘India OR Jharkhand’, ‘reduction OR elimination OR control’, ‘reasons’, ‘policy changes’ etc, and search combinations thereof. Grey literature searches will involve free text terms and concepts. The databases that will be searched include Cochrane Library, WHO weekly Epidemiological Record, Pub Med, Medline, EMBASE, CAB Direct, IBSS, SIGLE, TRIP database, Development databases etc. Grey literature from the Government of India as well as NGO’s working in India will be included in the review. Grey literature will be sought through internet search engines as well as specific NGO websites (Leprosy Mission, Lepra, Damien Foundation, Nippon Foundation, ILEP etc.), Government of India NLEP website, CAB Direct, IBSS, SIGLE, Google search engine etc. Data will also be directly sought from agencies working in India.


Literature will also be searched directly from the LSHTM library and other medical libraries. Articles will be selected from the search results and other sources, based on the formulated eligibility criteria, such as year of publication, geographical location, language(s) and specific subject material. After quality assessment, data extraction and synthesis will be undertaken followed by report writing and recommendations. The objectives of the study may not be answerable through a single line of questioning. It may well be necessary to pursue multiple lines of enquiry, each tailored to meet the specific requirements of the objective they are linked to (i.e. case definitions & diagnostic conventions, registration and reporting procedures, ascertainment procedures, leprosy prevalence etc.), as any single search may not provide a clear picture or adequate data. The data thus gathered will be collated to provide an overall view of what is actually going on. Phase 2: Qualitative Research Through semi-structured interviews of key people in the field of leprosy internationally as well as locally on the ground in Jharkhand, further clarity will be sought as to the real picture of what is happening in India. Eminent public health professionals who are observing and commenting on the changing face of leprosy in India will be interviewed. Workers in local NGO’s in Jharkhand will also be interviewed to find out what the local procedures are in terms of diagnosis, surveillance and reporting of cases and whether, if at all, such procedures have changed in the past decade and how. All semi-structured interviews will be preceded by securing informed written consent. The qualitative data thus obtained will be transcribed, coded, analysed and correlated to the findings from the reviewing of literature and some understanding will be gained to answer the research question. ETHICAL CONSIDERATIONS: (Will you need ethical approval and research governance approval. If so, what have you done about this? Who will you approach, and when? By when do you expect approval and what are your alternatives if approval is not obtained in time?) Written, informed consent is to be obtained from all persons being interviewed. Local ethics approval is not required and informed consent should suffice. The literature review itself does not require ethical approval. FEASIBILITY ISSUES: (What could cause this project to fail? What plans do you have in case it fails? If you are to use existing data how will you obtain this data?) Access to people for interviewing, particularly in Jharkhand may become an issue, particularly considering the nature of the research question which can appear to be critical of the Government Leprosy Programme. However some amount of interviewing will be feasible particularly in relation to the key public health specialists as well as some key workers in Jharkhand. Contact has already been established with two local NGO’s running leprosy programmes in Jharkhand, to potentially conduct semi-structured interviews, observe & document first-hand how the grass-roots activities are being conducted. In the unlikely worst-case scenario of not being able to secure any relevant interviews, the literature review component itself should provide useful and sufficient


insights to answer the research question. The literature review itself is likely to require considerable grey literature for greater depth of understanding and insight into the research question. REFERENCES: ‘Leprosy: what is being “eliminated”?’ Professor Paul Fine; WHO International Bulletin, Volume 85/1/06-039206 ‘Leprosy Elimination- A virtual phenomenon or a reality?’ Diana N J Lockwood; BMJ, 2002 June 22; 324(7352): 1516-1518. Professor Paul Fine & Dr. Diana Lockwood (personal communication). ‘Current Leprosy Situation in India as on March 2006’, NLEP current statistics report online. NLEP (National Leprosy Eradication Programme) Government of India website. WHO international and SEARO (South East Asian Regional Office) websites.


Appendix 2: Anonymised copy of risk assessment form

TAUGHT COURSE STUDENT PROJECT RISK ASSESSMENT FORM 1. This summary and assessment must address all planned aspects of the student project. 2. The student, in conjunction with the project supervisor, must complete both pages of the assessment. 3. Sufficient detail should be provided so that the location of the project is clear. i.e. Give more detail than just

“London” in answer as to where the project is to be carried out. 4. Projects involving biological, chemical and radiological hazards must be referred to the Departmental Safety

Supervisor. 5. Itineraries and contact details for projects involving work overseas must be lodged with the Teaching Office before

the work starts. 6. This summary must be completed and all signatures obtained before work is started. 7. A copy of the completed form must be held by the Course Organiser, and retained for two years.

Full Name of Student XXXXXXXX

Course MSc. Public Health

Project Supervisor xxxxxx

Project Title

How could changes of case definitions, ascertainment procedures, and diagnostic and registration conventions have impacted on reductions in the prevalence of leprosy in India, reported over the last decade (taking the state of Jharkhand as a case study)?

Summary of project aims

Make recommendations to the Government of India addressing issues related to the assessment of leprosy prevalence in that country.

Where will the project be carried out?

London UK & the Indian state of Jharkhand

Will the project involve work overseas? If yes, where?

India, Jharkhand State

Will the project involve significant work away from LSHTM sites? If yes, where?

Yes, interviews with key informants in India and London, at the offices of NGO’s, Universities and Government Departments.

Does the project involve work with pathogenic organisms / human blood / radiochemicals?

No

If the Project involves work overseas:

Will the project be based in an established field station / research institute? If yes, where?

No. The overseas work will be based from Jharkhand and will involve interviewing key workers engaged in leprosy control work locally, at the offices of the NGO’s as well as on field trips in and around Jharkhand.

Is ethical approval required for the project? If yes, has it been granted?

Ethics approval sought from LSHTM. Locally, written informed consent of the persons interviewed.

What supervision arrangements are proposed while away from LSHTM?

Contact will be maintained by e-mail and when possible telephonically, with LSHTM project supervisor xxxx.

Give the contact details for the off-site supervisor where applicable

Not applicable.

Will the project involve lone / isolated work? If yes, state how you can contacted while working.

Project will involve accompanying workers on their field visits and one to one interviews either in those settings or at the project office. Contact will be maintained through mobile phone (local number will be intimated to LSHTM supervisor), telephone and email.

Has appropriate travel insurance been arranged?

I have ongoing travel insurance whenever I travel abroad.

If the Project involves significant work within the U.K., away from the LSHTM sites in London:

Will the project be based in an established college / hospital etc? If yes, where?


Is ethical approval required for the project? If yes, has it been granted?

Will the project involve home / personal visits?

Will the project involve lone / isolated work?

What supervision / contact arrangements are proposed while away from LSHTM?

If Project Involves work with Pathogenic Organisms, Human Blood or Radiochemicals: (form to be signed by Departmental Safety Supervisor *)

Organism/s to be used

Potential Routes of Infection

Radiochemical/s to be used

Laboratories where work with pathogens / radioisotopes will be carried out

Disinfectants/Disposal

Health Surveillance required

Additional Information:

Are there any special needs, disability-related issues or other concerns that may need to be taken into account?

Do these need to be considered in planning arrangements?

Do these need to considered in relation to the location of the project?

Do they impact on supervision arrangements?

Do arrangements for access to specialist medical treatment need to be considered?

Student Signature

………………………………………………….. I agree to comply with the relevant safety requirements

Date

Supervisor Signature

………………………………………………….. I agree that is a reasonable summary of the project

Date

M.Sc. Course Organiser Signature ………………………………………………….. I agree that this project may proceed

Date

Departmental Safety Supervisor (only required if project involves work with pathogens or radiochemicals)

………………………………………………….. I agree that this project may proceed

Date

The table below must be completed for all potentially hazardous activities likely to be carried out during the

project, especially those identified above. Please refer to the Guidance Notes and School safety documentation for further information.

Project Title

Procedure Precautions


(continue on additional sheets if required)


Appendix 3: Anonymised copy of LSHTM ethics approval letter

London School of Hygiene & Tropical Medicine

Ethics application form : MSc research project (MSC1)

Section 2 : If your project is completely new or is collecting any new data from a previous study:

For use of Research Ethics Committee No ……………………………………… Date Rec’d ………………………………. Approved by …………………………. Date ……………………………………….

Overall assessment of quality of ethical application Excellent Good Satisfactory

(Approved without (Approved with (Approved after discussions) amendments) minor amendments)

Comment by Ethics Committee ………………………………………………………………..

1. Project Title

How could changes of case definitions, ascertainment procedures, and diagnostic

and registration conventions have impacted on reductions in the prevalence of leprosy in India, reported over the last decade (taking the state of Jharkhand as a case study)?

2. Give an outline of the proposed project. Sufficient detail must be given to allow the Committee to make an informed decision without reference to other documents.

(Expand box to answer)

(max 300 words) In 1991 the World Health Assembly (WHA) passed a resolution to “eliminate leprosy as a public health problem” by the year 2000, elimination defined in this context as a reduction in prevalence to below 1 per 10,000 population. India achieved elimination in December 2005 following a dramatic fall in prevalence, particularly between the years 2000-2005. Although some states like Jharkhand, as per Government of India figures continue to have prevalence above 1 per 10,000 such drastic reductions have left many in the scientific and NGO community sceptical about what has actually happened (‘Leprosy: what is being “eliminated”?’ Professor Paul Fine; WHO International Bulletin, Volume 85/1/06-039206; Professor Paul Fine & Dr. Diana Lockwood, personal communication). One theory is that changes to the diagnostic, surveillance and reporting procedures are creating ‘data artefacts’ that are obscuring the true picture of leprosy prevalence and control in India. This project is a health policy report aimed at gaining insight into the co-relationship between the steep fall of leprosy prevalence reported in India and changes to the


diagnostic, surveillance and reporting procedures being followed, looking at the Indian state of Jharkhand as a case study. It will be in two phases, the first a review of published and unpublished literature to gain understanding on the issues related to assessment of prevalence. The findings of this review will inform the second phase of the project which is semi-structured oral interviews of key elimination programme functionaries involved in the delivery of leprosy control services in the Indian state of Jharkhand. This phase is aimed at understanding how the diagnostic and reporting system actually works in practise, in India. The findings from both the phases will be collated into the final report for the project.

3. Is project a randomised trial?

NO

4. Will any biological samples be collected and if so specify which

NO 5. Specify the number (with scientific justification for sample size), age, gender, source and

method of recruiting subjects for the study.

The researcher will endeavour to interview at least 10 individuals, through semi-structured interviews after securing informed and written consent. The number is based on an estimation of what is realistically possible, the nature of the interviews being qualitative. The intention is to interview: 1. A minimum of 6 professionals in the field of leprosy elimination locally in Jharkhand

from NGO & Government settings (General Health Services or specialized leprosy services), directly involved in diagnosis and case finding. They may be doctors, trained leprosy workers or programme managers

2. A minimum of 2 district level co-ordinators in Jharkhand from either or both NGO and governmental settings

3. 1 national level key informant 4. 1 international level key informant Informants in (1) will provide information related to actual activities in the field in relation to leprosy programmes. Interviewing functionaries in the NGO and Government sectors will provide a balanced perspective and may even provide some contrasting views and feedback. In (2) the district level co-ordinators will provide information from a more distal and overall perspective and about state level interventions. The international and national informants will be able to comment on a national and global strategic level as well as broader scientific, epidemiological and political perspectives. Recruitment: The researcher has established contact and co-operation from a regional level co-ordinator of leprosy elimination activities in Jharkhand as well as the lead of a key local general health provider in the region. This will enable the researcher to visit some of the leprosy centres or services and interview professionals in categories (1) & (2). The international level key informant has already been contacted and will be interviewed locally in London after categories (1), (2) & (3) informants have been interviewed. The feedback from these completed interviews will inform that interview. The national level informant is likely to be from WHO in Delhi, but will be interviewed telephonically.


6. State the likely duration of the project, and where it will be undertaken.

The researcher is a half-time student, willing to commit time to the research which will be conducted over the span of the master’s course at LSHTM. Phase one research (Literature review) will be done in London, phase two in the Indian state of Jharkhand, through semi-structured interviews to be conducted in December ’07- January ‘08.

7. State the potential distress, discomfort or hazards, and their likelihood, that research subjects may be exposed to (these may include physical, biological and/or psychological hazards). What precautions are being taken to control and modify these hazards?

Not applicable

8. Specify how confidentiality will be maintained. When small numbers are involved, indicate how possible identification of individuals will be avoided. See Guidance notes at http://intra.lshtm.ac.uk/reference/ethicsstuds.html

The confidentiality of those interviewed will be safeguarded in the following ways: • aiming to interview ten key informants with similar job roles, so that there are enough

interviews to prevent the singling out of individuals • describing the findings without using any specific names or references in any part of the

report, that can help identify the key informant in the report • giving each participant the option in the consent form of not being quoted at all,

anonymously or otherwise, or included in any of the analyses • Use of written consent forms • Semi-structured interviews will be digitally recorded but no names will recorded,

anonymity will be preserved by assigning codes to each interview instead

9. State the manner in which consent will be obtained and supply copies of the information sheet and consent form. ◊ Written consent is normally required. Where not possible, explain why and confirm

that a record of those giving verbal consent will be kept. ◊ Where appropriate, please state if and how the information and consent form will be

translated into local language(s). See Guidance notes at http://intra.lshtm.ac.uk/reference/ethicsstuds.html

The participants will be verbally explained the nature of the research. The information sheet will be read out in English/ Hindi/ Bengali (depending on the preference of the interviewee) and informed written consent will obtained. The sample information sheets and consent form follow this form. NB. All languages are spoken fluently by the interviewer.

10. Local Ethical Approval. Give details of local approval to be obtained prior to the commencement of fieldwork. (If you cannot identify an Ethical Committee or if the study has been approved by several different organisations, eg. NGOs give this information and show that as much as possible has been done to obtain approval.)

Local ethical approval not required as interviewing staff about health care systems.


Participant Information Sheet _____________________________________________________________________________________________

Study Title: How could changes of case definitions, ascertainment procedures, and diagnostic and registration conventions have impacted on reductions in the prevalence of leprosy in India, reported over the last decade (taking the state of Jharkhand as a case study)? Principle investigator XXXX _____________________________________________________________________________________________ Dear Participant You are being invited to take part in a research study. Before you decide to participate, it is important that you understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. If there is anything that is not clear or you would like to know more about, please ask the researcher [XXXX] in person. It is important that you think about whether you wish to take part so please take time to decide. Thank you for reading this. What is the purpose of the study? This research project is being carried out at the London School of Hygiene and Tropical Medicine as part fulfilment of a Masters degree in Public Health by XXXX. In 1991 the World Health Assembly (WHA) passed a resolution to “eliminate leprosy as a public health problem” by the year 2000, elimination defined in this context as reduction in prevalence to below 1 per 10,000 population. India achieved elimination in December 2005 following a dramatic fall in prevalence, particularly between the years 2000-2005, although some states like Jharkhand, as per Government of India figures continue to have prevalence above 1 per 10,000. This research is aimed at gaining insight into the co-relationship between the fall in prevalence and changes to the diagnostic, surveillance and reporting procedures being followed, looking at the Indian state of Jharkhand as a case study. What is the overall objective of the study, its importance and the reason why the subject’s cooperation is requested? The main objectives of this research project are: • To gain understanding about the change in leprosy prevalence in India over the

past decade. • To understand how the diagnostic and reporting system actually works in practise,

in India, informed by the interviews to be conducted in India. • To explore changes in diagnosis, reporting and surveillance systems in India over

the same period. In order to understand the current diagnostic, reporting and surveillance systems for leprosy in India, it is necessary to interview health providers engaged in leprosy control fieldwork. The reason your cooperation is requested is because you are involved in such delivery and can provide important information that will help this researcher to understand such systems better. Do I have to take part? It is up to you whether or not to take part in this research. If you decide to take part you will be given this information sheet to keep and be asked to sign a consent form.


Even when you decide to take part, you are still free to withdraw at any time and without giving any reasons. What will happen to me if I take part? If you agree to take part, you will be asked questions related to the topics mentioned above. Questions will be asked in a private area, possibly your office. The interview will be recorded digitally, and notes of the discussion will be taken. If you do not feel comfortable to be recorded, the recorder will not be used. No names will be recorded and all files will be kept anonymously to ensure confidentiality. The interview will take about 30 to 45 minutes, depending on the amount of information you wish to share and the time you have at your disposal. Only this researcher will look at your answers given during the interview. You will NOT be asked to include your name; instead an identification code will be assigned to each interview ensuring that you remain ANONYMOUS. This means that no-one will know that you as an individual have participated in the research and given information. Because your name will not be written with your answers, no one will know what you said. No quotes or other results arising from your participation in this study will be included in any reports, even anonymously, without your agreement. Are there any reasons you should not participate? You should not participate if you do not want your views to be part of the analysis in the research study. What are the possible risks or discomforts? This researcher does not foresee the likelihood of any possible risks or discomforts as the questions are related to procedures and systems used in the field for leprosy cases. Will my taking part in this study be kept confidential? All information collected during the course of the research will be kept strictly CONFIDENTIAL and secured against unauthorised access. What will happen to the results of the research study? At the end of the study the findings will be written up into a policy report which will be submitted to the London School of Hygiene and Tropical Medicine. The report will be available in their library for 5 years. NO identifying information about you will be included in the report or any papers emanating from the research. Will you be paid for participating? You will not receive payment for participating in this research study. Contact for further information If you have any questions regarding this study please speak directly to XXXX. If you have questions after the interview is over, please contact him by phone or via email. Ethical Committees which have approved the study London School of Hygiene and Tropical Medicine Ethical Committee. _____________________________________________________________________________________________ Thank you for taking the time to read this information!


Participant Consent Form _____________________________________________________________________________________________ Date: / /2007/08 Interview Identification Number: Study Title: How could changes of case definitions, ascertainment procedures, and diagnostic and registration conventions have impacted on reductions in the prevalence of leprosy in India, reported over the last decade (taking the state of Jharkhand as a case study)? Principle investigator XXXXX

Declaration (Please Tick appropriate boxes)

I confirm that I have read and understood the information sheet for the above study and have had the opportunity to ask questions.

I understand what is required of me and what will happen if I take part in the

study.

My questions concerning this study have been answered by the researcher.

I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason.

I do / do not agree to quotes or other results arising from my participation in the

study being included, even anonymously in any reports about the study.

I agree for comments I give to be used in the written report of the above study.

I agree to take part in the above study. Subject's Agreement By signing your name on this sheet of paper, it means that you agree to voluntarily take part in this study. _______________________________________________________ ______________________________ Signature of Research Subject Date _______________________________________________________ Printed Name of Research Subject _______________________________________________________ _______________________________ Signature of Person Obtaining Consent Date _______________________________________________________ Printed Name of Person Obtaining Consent


Appendix 4: Literature Review Search Strategy

Literature Review Search Strategy

# 1. TUBERCULOID LEPROSY/ or LEPROSY CONTROL/ or LEPROSY EPIDEMIOLOGY/ or

LEPROSY/ or LEPROSY VACCINE/ or LEPROMATOUS LEPROSY/ or

MULTIBACILLARY LEPROSY/ or BORDERLINE LEPROSY/ or PAUCIBACILLARY

LEPROSY/

# 2. leprosy.mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title,

device manufacturer, drug manufacturer name]

# 3. Hansen's disease.mp. [mp=title, abstract, subject headings, heading word, drug trade name,

original title, device manufacturer, drug manufacturer name]

# 4. 1 or 2 or 3

# 5. case defin$.mp. [mp=title, abstract, subject headings, heading word, drug trade name, original

title, device manufacturer, drug manufacturer name]

# 6. exp Disease Classification/

# 7. Infection/ or Diagnostic Accuracy/ or Nerve Injury/ or Skin Disease/ or Leprosy/ or

Multibacillary Leprosy/ or Leprosy Control/

# 8. (case$ or case finding or case finding polic$).mp. [mp=title, abstract, subject headings, heading

word, drug trade name, original title, device manufacturer, drug manufacturer name]

# 9. (case diagnosis or diagnosis).mp. [mp=title, abstract, subject headings, heading word, drug

trade name, original title, device manufacturer, drug manufacturer name]

# 10. (leprosy case diagnosis or leprosy diagnosis).mp. [mp=title, abstract, subject headings, heading

word, drug trade name, original title, device manufacturer, drug manufacturer name]

# 11. (leprosy case$ or leprosy case finding or leprosy case finding polic$).mp. [mp=title, abstract,

subject headings, heading word, drug trade name, original title, device manufacturer, drug

manufacturer name]

# 12. (new case$ or new case$ defin$ or new case$ diagnos$).mp. [mp=title, abstract, subject

headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer

name]


# 13. (leprosy new case$ or leprosy new case$ defin$ or leprosy new case$ diagnos$).mp. [mp=title,

abstract, subject headings, heading word, drug trade name, original title, device manufacturer,

drug manufacturer name]

# 14. 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13

# 15. (registration$ or registration convention$ or registration protocol$ or registration

procedure$).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original


# 16. India/ or Leprosy Control/ or Leprosy/ or Health Program/ or Prevalence/ or Mycobacterium

Leprae/

# 17. leprosy prevalence.mp. [mp=title, abstract, subject headings, heading word, drug trade name,


# 18. exp PREVALENCE/

# 19. prevalenc$.mp. [mp=title, abstract, subject headings, heading word, drug trade name, original


# 20. 16 or 17 or 18 or 19

# 21. 16 and 17 and 18 and 19

# 22. leprosy incidence$.mp. [mp=title, abstract, subject headings, heading word, drug trade name,


# 23. Mycobacterium Leprae/ or Leprosy/ or Incidence/

# 24. incidence$.mp. [mp=title, abstract, subject headings, heading word, drug trade name, original


# 25. exp INCIDENCE/

# 26. 22 or 23 or 24 or 25

# 27. 22 and 23 and 24 and 25

# 28. India.mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title,

device manufacturer, drug manufacturer name]

# 29. Jharkhand.mp. [mp=title, abstract, subject headings, heading word, drug trade name, original


# 30. 4 and 14 and 28

# 31. 4 and 15 and 28


# 32. 30 and 31

# 33. 4 and 20 and 28

# 34. 4 and 26 and 28

# 35. 33 and 34

# 36. limit 30 to (human and english language and yr="1997 - 2007")






# 42. 7 or 10 or 11 or 13

# 43. 5 or 6 or 8 or 9 or 12

# 44. 4 and 28 and 42



# 47. 4 and 21 and 28

# 48. 4 and 27 and 28

# 49. from 45 keep 1,8,11-12,18,21,30-31,36-45,53,58-59,62,68,71,75,80,87,89,95,99-100,106-

107,109,112,120,132-133,142,148,152,165,168-169,172-173,180,188,198-199,225-

226,275,278,281,289,316-317,320,323,326

# 50. from 45 keep 323,326

# 51. from 45 keep 323,326

# 52. from 45 keep 9-10


Appendix 5: Semi-structured Topic Guide

Interview topic guide for leprosy services in Jharkhand, India ______________________________________________________________ Semi-structured interview schedule for those involved in the delivery &/or management of regional leprosy elimination programmes and services. Aims of interviews: • To understand how the diagnostic and reporting system actually works in practice in India • To explore changes in diagnosis, reporting and surveillance systems in India All interviews are confidential, anonymous & will be recorded digitally unless the interviewee requests otherwise. Bulleted points following some questions are the prompts. ______________________________________________________________ 1. Introduction by interviewer and assigning anonymous identifier for

the interview 2. Introductory background questions

2.1. Could you tell me a little about yourself and your role in the service? • What is your title and your role here? • Could you describe your background (doctor &/or project manager/ other)? • Who do you work with? 2.2. How long have you been working in this setting and in the field of leprosy in general?

3. Leprosy case detection

3.1. Can you describe to me how cases are detected here? • Through active/ passive/ voluntary detection?

3.2. Can you tell me the way cases were detected in the past? For example before 2004?

Before 2000?

4. Leprosy case diagnosis

4.1. Can you tell me how new cases are diagnosed? • Is it by lesion count/ slit skin smear? • Definition of a new case? • Who does the diagnosis? 4.2. Can you describe how case diagnosis was done in the past? • For example before 2004? Before 2000? • In some countries, skin smear was used including India in the past. 4.3. What do you do to confirm the diagnosis?


• If diagnosis is through skin lesion count alone, then are any smears done for doubtful cases of cases of indeterminate leprosy?

5. Case registration

5.1. Which cases are registered on records? • Do single lesion cases get registered? • What types of cases are included: new case/relapsed cases/ deformities/ reactions? • What is the actual process? 5.2. How long do they remain on the register? • Is a case that has received the full course of MDT considered cured and taken off the

register? 5.3. Can you tell me how case registration was done in the past? • How long were cases kept on the register in the past? • Were single lesion cases registered in the past? If so how long ago? 5.4. Can cases be re-registered? 5.5. Can you describe how this may happen?

6. Types of leprosy cases

6.1. Can you describe the range of types of leprosy cases you get here? • Are there more PB or MB cases seen at your centre? 6.2. What types of deformities do you see in patients? How common is it to see patients

with deformities/ disabilities? 6.3. Do you see children with leprosy? • Generally what type of leprosy? • Is there a family history of leprosy?

7. Treatment

7.1. Can you tell me how many months therapy you give to Paucibacillary and Multibacillary cases?

• Are single lesion PB cases given single dose ROM therapy? • Duration of treatment of PB cases? • Duration for MB cases 12 months or 24 months? 7.2. How long was the treatment duration in the past? • For example before 2004 &/or 2000? 7.3. For a diagnosed case of leprosy, is the treatment supervised MDT or accompanied? • Clarify what is meant by accompanied MDT. 7.4. When is a case no longer a case (cured)? 7.5. In the past, when was a case no longer a case?

8. Data recording & reporting

8.1. Can you tell me how you estimate and report prevalence data? Which cases are included in the prevalence?


• What happens to cases treated in the early part of the year, are they included in the prevalence data for the year?

8.2. What sort of targets does the Government set locally? • Does the Government give you targets annually/ half-yearly/ quarterly or none at all? 8.3. What happens if you exceed the target or do not reach it? • If you find more cases than your target numbers, are these excess cases registered? • Is diagnostic accuracy considered in cases of under/ over achieving targets? 8.4. How do you feel about the targets? Do you feel they are usually realistic or do you

feel pressured to achieve them? • Pressure from whom?

8.5. Can you tell me who sets you the guidelines for the different aspects of the leprosy

programme? (Central/ State/ District/ Local) 8.6. How is the data from your centre collected and reported to the Government? Who do

you report to? • Is it sent out annually/ 6 monthly/ quarterly? • Actual process?

9. Quality of services (Diagnostic accuracy, validation, training, referrals)

9.1. What are the IEC activities conducted from your centre? • Frequency? • How is it done and who does it? 9.2. What is the next point of referral for your centre? 9.3. How is the referral done? 9.4. What happens to patients when they are referred? • What sort of health service is the next referral point? • What are the facilities and common reasons for referrals? • Actual processes? 9.5. What training/ refresher courses are offered to you/ your staff? • Who comes to do it? • What is the training for? • Duration and frequency? • Who receives the training? • Is it sufficient? 9.6. Have any validation tests been carried out at your centre? • To check whether the diagnosis is correct or not? 9.7. What measures are in place to ensure the quality of diagnosis? 9.8. Can you tell me of any past/present instances of over-diagnosis?

10. Opinions and views

10.1. Do you feel there is a real decrease in the number of leprosy cases in your area? 10.2. Do you feel that leprosy is no longer a public health issue in India?


10.3. The leprosy control/elimination programme in India was a so-called ‘vertical’ programme in the past. Over the last five years or so, this approach has been replaced by a more integrated approach into general health services. Could you comment on what you feel the benefits and the drawbacks of either approach have been?

10.4. In your opinion have the current guidelines and practices for leprosy elimination

resulted in better case detection, diagnosis and treatment of leprosy? Is there anything more that could be done locally &/or at state level &/or nationally

11. Is there anything else you would like to add or comment upon?


Appendix 6: Coding Scheme for interview analysis

Categories

1. Leprosy Elimination Programme 1.1. Village level 1.2. Block Level 1.3. District level 1.4. State level 1.5. National level 1.6. Roles & responsibilities

(Workers/NGO's/Govt.) 1.7. Referrals 1.8. Guidelines & policies 1.9. Targets 1.10. Funding 1.11. Campaigns 2. Leprosy case detection 2.1. Current 2.2. Past 2.3. Changes 3. Leprosy case diagnosis 3.1. Provisional 3.2. Clinical 3.3 Past 3.4. Changes in diagnostic conventions 3.5. Over-diagnosis 4. Case verification 4.1. Case confirmation/ validation 4.2. Quality assurance 5. Case registration 5.1. Registration procedure 5.2. Removal from the register 5.3. Re-registration

6. Range/ types of leprosy cases 6.1. PB/ MB/ single lesion 6.2. Children 6.3. Deformities and complications 7. Case treatment 7.1. Single lesion 7.2. Duration 7.3. Current 7.4. Past 7.5. Changes 7.6. Administration 7.7. Cured cases/ treatment completion 8. Prevalence data 8.1. Calculation 8.2. Reporting 8.3. Changes 8.4. Figures 9. Opinions 9.1. On case reductions 9.2. Leprosy as a public health issue 9.3. Vertical VS. Integrated 9.4. Improvements 9.5. Limitations/ shortcomings 9.6. Challenges 10. Values and attitudes 10.1. Stigma 10.2. Discrimination 10.3. Judgemental 10.4. Status & power (increased/

decreased/ changes) 10.5. Defensiveness 10.6. Resentment 10.7. Hostility 10.8. Guardedness


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