Routine health information system and health facility data for

neglected tropical diseases

Buruli ulcer
Routine health information system and health facility data for
neglected tropical diseases

Buruli ulcer
Routine health information system and health facility data for neglected tropical diseases: Buruli ulcer

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ISBN 978-92-4-010706-9 (print version)

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Contents

Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Approach to development of this guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2 Declarations of interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3 Scope of this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.4 Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.5 Target audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2. About Buruli ulcer data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.1 Key features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2 Data collection and reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.3 WHO-recommended case definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.4 Other WHO-recommended definitions with implications for clinical case management . . . . . . . 4

3. Data quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.1 Timeliness of data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.2 Completeness of data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.3 Internal consistency of reported data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4. Core indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

5. Core analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.1 Epidemiological analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.2 Indicators for reporting clinical examination observations . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.3 Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.4 Treatment data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5.5 Tracking treatment outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

iii
 Acknowledgements

The World Health Organization (WHO) is grateful to the following individuals who contributed to the
development of this guidance. It was prepared in 2024.

Main contributors
The document was drafted by Junerlyn Farah Virrey Agua (WHO Global Neglected Tropical Diseases
Programme [WHO/NTD]), Kingsley Asiedu (WHO/NTD), Yves Barogui (WHO Regional Office for Africa),
Claire Cotton (WHO/NTD), Daniel Argaw Dagne (WHO/NTD), Ibrahima Socé Fall (WHO/NTD), Pamela Sabina
Mbabazi (WHO/NTD) and Alexei Mikhailov (WHO/NTD), Priya Pathak (WHO/NTD).

External reviewers
The following experts (listed alphabetically by country) reviewed the guidance for technical accuracy and
relevance: Earnest Njih Tabah (Cameroon), Aboa Paul Koffi (Côte d’Ivoire), Roch Christian Johnson (France),
Yawovi Agbenyigan Gadah (Togo) and Piham Gnossike (Togo).

Financial support
Funding to support the development of this publication was provided by the Anesvad Foundation, Bilbao,
Spain.

iv
Abbreviations

BU Buruli ulcer
NTD neglected tropical disease
PCR polymerase chain reaction
WHO World Health Organization

v
1. Introduction

Buruli ulcer (BU) is a skin-related neglected tropical disease (skin NTD) caused by infection with
Mycobacterium ulcerans. BU is the third most common mycobacterial disease after tuberculosis and leprosy
in people who are not immunocompromised. The infection manifests in non-ulcerative forms as nodules,
plaques and/or oedemas, which ulcerate within 4–6 weeks and display characteristic undermined edges
and yellowish-white necrotic slough (1). Most lesions occur on the lower limbs.

BU has been reported from 33 countries worldwide. The main foci are in West and Central Africa and in
Australia (Victoria state), where the disease is highly concentrated in small geographical areas. The number
of cases varies seasonally in some countries, whereas in others there is no seasonal trend. The increase
in cases has been associated with heavy periods of rainfall and changes in the environment. In the World
Health Organization (WHO) African Region, fragmentation and destruction of the landscape have been
suggested as risk factors. The niche, ecology and transmission of the environmental human pathogen
M. ulcerans are poorly understood. As a result, active epidemiological surveillance is important to control
the disease, and drivers of its local occurrence should be closely investigated. In areas of Africa endemic
for BU, the prevalence of HIV is high, with rates of 1–5% in adults. However, there is limited information
on the prevalence of BU–HIV coinfection (2).

The mode of transmission of BU is not known. In the absence of a clear understanding of how transmission
occurs and a vaccine against the disease, the main control strategy focuses on early case detection
and comprehensive treatment of individual patients to avoid complications and sequelae. As the exact
transmission route remains unknown, no clear recommendations can be given on prevention, but BCG
vaccine appears to offer some limited protection.

Diagnosis is based on characteristic clinical and epidemiological features, with laboratory-confirmation

using histopathology, culture and polymerase chain reaction (PCR) (3). During the past two decades,
treatment of BU has shifted from mainly surgery to an 8-week course of antibiotics (rifampicin and
clarithromycin) (4).

In 1998, participants at a conference on BU control and research (Yamoussoukro, 6–8 July 1998) expressed
concern about the increasing burden of cases, particularly in West Africa, and recognized the importance
of early case detection and treatment. Signatories to the Yamoussoukro declaration on Buruli ulcer (5) called
upon policy-makers to take action to support control of the disease, pledged to collaborate in research on
its transmission and prevention, and affirmed their determination to intensify action against the disease.

In 2009, Heads of States of countries affected by BU participated in a second high-level meeting in Benin
(Cotonou, 30 March 2009) and adopted the Cotonou declaration on Buruli ulcer (6), calling for greater political
commitment for BU control through early detection, wider access to antibiotic treatment and support
for research.

In 2013, a WHO meeting on BU control and research (Geneva, 25–27 March 2013) defined four programmatic
targets to be met by endemic countries by the end of 2014 (7). These targets included laboratory (PCR)
confirmation of M. ulcerans infection; lesion category and ulceration at diagnosis as proxies for disease
progression or severity (as a result of late reporting); and functional limitation (reflecting sequelae of
severe and advanced disease and resulting in disability).

1
 In 2022, 11 countries reported 2121 suspected and clinically diagnosed cases to WHO. Of the 982 (46.3%)
laboratory-confirmed cases, 40.7% completed a full course of antibiotic treatment and 25.2% were
classified as category III (late stage) at diagnosis. In 2021, 12 countries reported 1665 cases. Of the
851 (51.1%) laboratory-confirmed cases, 43% completed a full course of antibiotic treatment and 25.5%
were classified as category III at diagnosis.

As of 2023, integrated surveillance, active case-finding and capacity strengthening of health workers has
been increasing in all the countries and territories classified by WHO as endemic. Ending the neglect to attain
the Sustainable Development Goals: a road map for neglected tropical diseases 2021–2030 (“the road map”) (8)
sets disease-specific targets, sub-targets and milestones for BU control. One of the ultimate targets is to
achieve < 10% proportion of cases in category III (late stage) at diagnosis by 2030.

1.1 Approach to development of this guidance

This guidance was developed based on a template provided to health programmes by the WHO Division
of Data, Analytics and Delivery for Impact. WHO regional advisers and disease focal points in the WHO
Global Neglected Tropical Diseases Programme provided technical content in alignment with the road
map. A drafting team comprising WHO technical officers and BU disease experts working on skin NTDs at
global, regional and country levels contributed to the writing and review of initial drafts of the document.
Independent BU experts and selected national programme managers from BU-endemic countries reviewed
the guidance for technical accuracy and relevance.

1.2 Declarations of interest

Contributing disease experts external to WHO submitted signed disclosures of declarations of competing
interests, academic or scientific activities, which were reviewed. No conflicts of interest were identified.

1.3 Scope of this document

This document addresses the collection, aggregation and basic summary analysis of individual data on BU
cases collected at BU treatment centres based on the BU 01 and BU 02 forms. All of the updated forms
are available in Word and PDF formats on the WHO website (9).

Data not specifically addressed in this document are those related to:
community-based active case search activities; and
individual BU patient file number and case management notes.

1.4 Objectives

This document provides guidance on the analysis and use of routine BU data collected at the
health facility level. It presents core facility indicators and analysis, provides suggestions for
questions on review of data quality as well as considerations and limitations for using the data and
analysis. By the end of this document, readers should be able to:
describe core BU indicators and notable trends in incidence, geographical distribution and
progress towards control of the disease;
monitor clinical case management outcomes;
understand how to interpret changes in trends over time, by gender, age group and
location; and
assess data quality and understand its implications when interpreting data.

2 Buruli ulcer
1.5 Target audience
This document is relevant for different members of the health workforce working on BU control, including:
health workers at health facilities diagnosing and treating BU cases;
data clerks at health facilities managing entries into the routine health information system;
data managers and data analysists working with the national routine health information system at
district and higher levels;
ministry of health decision-makers and epidemiologists working in the national BU programmes,
and health information system managers at district and higher levels;
technical staff of partner organizations supporting the strengthening of national BU programmes,
the diagnosis and case management of BU cases in health facilities or health systems; and
consultants and staff working at research institutes involved with the assessment and improvement
of BU control activities and specifically with the analysis of BU data.

1. Introduction 3
 2. About Buruli ulcer data

2.1 Key features

Clinical indicators monitor aggregated data on:
presentation at clinical examination in order to track timing of access to treatment and improve
early detection of cases;
laboratory PCR tests in order to indicate access to diagnosis and capacity to confirm cases;
antibiotics in order to monitor access to treatment and successful completion of treatment regimens;
core morbidity and mortality for all health facilities in endemic countries; and
given the focal nature of the disease, more detailed indicators for BU treatment centres in endemic
areas.

2.2 Data collection and reporting

Data from BU programmes are collected using basic data collection forms: BU 01 and BU 02 (9). Data from
health facilities are aggregated on a health facility reporting form for onward reporting to the national level.

2.3 WHO-recommended case definitions

2.3.1 Suspected case
Any person with painless nodule, papule, plaque or oedema evolving into a painless ulcer with undermined
edges, often leading to invalidating sequelae in an endemic area.

2.3.2 Confirmed case

A suspected BU case confirmed by direct microscopy, histopathology, culture, mycolactone test or PCR.
Currently, PCR is the main test used (the other tests can be used but have lower sensitivity).

2.4 Other WHO-recommended definitions with implications for clinical

case management
2.4.1 Type of case
New BU case: a person presenting with a BU ulcer lesion who has not previously received a complete
course of antibiotic treatment for the disease.
Recurrent BU case: a patient who has previously received a complete course of antibiotic treatment
for BU and who presents with a lesion at another site or lesions at the same site within 1 year of
the end of the last antibiotic treatment.

4
2.4.2 Joint limitation at initial clinical examination
A patient who is unable to move an affected joint over the normal range of movement at the time of
clinical diagnosis.

2.4.3 Category of case at initial clinical examination

Category I: a BU case who presents with a single lesion ≤ 5 cm in diameter
Category II: a BU case who presents with a single lesion 5–15 cm in diameter
Category III: a BU case who presents with a single lesion > 15 cm in diameter, with multiple lesions,
lesions at critical sites or osteomyelitis.

2. About Buruli ulcer data 5

 3. Data quality

One of the challenges of interpreting health facility data is that responsibility for data recording, entry,
cleaning and management is distributed across many individuals and programme entities. Unlike special
studies or surveys, resources for entering and cleaning data are often limited in health facilities, impacting
the quality and usability of routine monitoring data. Systems and protocols must therefore be established
to enhance good data collection and reporting to facilitate data analysis and use. However, as for all data
sources, any analysis must consider whether the results are affected by data quality issues.

The WHO data quality review (DQR) toolkit provides guidance for defining measures of data quality,
conducting a desk review to assess data quality, and conducting data verification of routine facility
data systems (10, 11). The domains used most frequently for periodic assessments of BU ulcer data are
summarized below.

3.1 Timeliness of data

Data timeliness refers to whether reporting units submit their data according to the timeline set by national
health information management system guidelines.

3.2 Completeness of data

Data completeness measures the extent to which priority data elements are included in each report.
Both timeliness and completeness of reporting can be assessed at national level and at any subnational
level (e.g. facility, district, regional). Both timeliness and completeness can also be assessed separately
for specific data forms used in reporting. For example, the collection of BU samples and completion of
the laboratory request form, the time between collection and transfer to the reference laboratory for PCR
and vice-versa, the time it takes for the health facility to receive the results can assessed both in timeliness
and completeness. Delays on either side can lead to postponement of antibiotic treatment.

3.3 Internal consistency of reported data

The internal consistency of reported data takes multiple forms: from identifying outliers (i.e. reported
values which are unusually high or low compared with those of other reporting units or compared with
historical performance). Indicators which are related to each other can also be used to develop internal
consistency checks (e.g. if a country is reporting a high number of BU cases in adults in Africa, such as
80% compared with the normal figure of about 50%), automatically, something is wrong with the clinical
diagnosis. In the same way, if more than 80% of cases lesions are on the lower limb instead of 60%, then
there is a problem with the clinical diagnosis. This is the reason why it is important that health workers
diagnosing and treating BU cases should carefully consider the history, clinical and epidemiological factors
in making the diagnosis.

6
4. Core indicators

The recommended minimum core indicators, definitions, disaggregation and data sources for BU
monitoring and surveillance are provided in Table 1. Obtaining data from individual BU case registers as
the first primary data collection point is the method preferred over aggregate forms to ensure high data
quality.

Table 1. Buruli ulcer core indicators for monitoring and surveillance

Core indicators Definition Disaggregation Comments

Epidemiology
Number of Number of suspected BU cases • By type of patient (new/ • Number of BU cases is part of
suspected BU cases recurrent) the core morbidity data.
• By age group (years) • This indicator is part of the SDG
(< 5, 5–14, ≥ 15) indicators for NTDs.
• By sex
• By administrative unit(s)
Number of Number of laboratory PCR confirmed BU • By type of patient (new/ • Number of BU cases is part of
confirmed BU cases cases recurrent) the core morbidity data.
• By age group (years)
(< 5, 5–14, ≥ 15)
• By sex
• By administrative unit(s)
Confirmed BU Number of new PCR confirmed BU cases • At lowest administrative • Based on the number of new BU
incidence per 10 000 population level available cases reported.
= Number of new BU cases / population of • Population data at finest
administrative area × 10 000 administrative level are
required.
Number of endemic Number of endemic villages, where at • At finest administrative • Based on the number of new BU
villages least 1 new confirmed BU case has been level available cases reported.
reported within the past 3 years
Population at Population at risk at district level where at • At district level • Based on the number of new
district level at risk least 1 new confirmed BU case has been autochthonous BU cases
of BU reported during the past 3 years reported.
• Population data at finest
administrative level are
required.
Proportion of cases % of PCR confirmed BU cases by each • By type of referral (self-
detected by type of referral type = Number of cases detected referral, third party, other)
referral by referral type / Total number of PCR • At finest administrative
confirmed BU cases × 100 level available

7
 Core indicators Definition Disaggregation Comments
Clinical examination
Proportion of PCR % of joint limitation among PCR BU • From lowest administrative • Data from BU register (BU 02)
confirmed cases confirmed cases = number of PCR level to district level • Indicative of late detection
with joint limitation confirmed BU cases presenting joint
• WHO recommends that less
limitation / total number of PCR confirmed
than 15% of the BU cases
BU cases × 100
should present with joint
limitation
Proportion of % of PCR confirmed BU category III cases • From lowest administrative • Data from BU register (BU 02)
PCR confirmed = number of PCR confirmed BU category to district level • Indicative of late detection
Category III BU III cases / total number of PCR confirmed
• WHO recommends that less
cases BU cases × 100
than 25% of the BU cases
should present in category III.
Proportion of HIV+ ‘% of HIV+ among PCR confirmed BU • From lowest administrative
PCR confirmed BU cases = number of HIV+ cases among PCR level to district level
cases confirmed BU cases / total number of PCR
confirmed BU cases × 100
Individual treatment outcomes
Proportion of % of antibiotic treatment completed* = • From lowest administrative • Data from BU register (BU 01)
antibiotic treatment Number of new PCR confirmed BU cases level to district level
completed of PCR that have completed their antibiotic
confirmed BU cases treatment / Total number of new PCR
confirmed BU cases treated x 100
* Antibiotic treatment completed: 56 doses
completed within a period of 70 days
(flexible approach). If a patient misses
7 days/doses or less (continuously or
intermittently), this is considered antibiotic
treatment completed. But all patients
should be encouraged to complete the
56 days of treatment continuously.
Proportion of PCR % of PCR confirmed BU cases treated by • From lowest administrative
confirmed BU cases surgery = Number of PCR confirmed BU level to district level
receiving surgery cases treated by surgery / Total number of
PCR confirmed cases × 100
Proportion of % of healed PCR confirmed BU cases = • From lowest administrative
healed PCR Number of healed PCR confirmed BU level to district level
confirmed BU cases cases / Total number of PCR confirmed BU
cases × 100
Proportion of PCR % of PCR confirmed BU cases lost to follow • From lowest administrative
confirmed BU cases up = Number of PCR confirmed BU cases level to district level
lost to follow up lost to follow up* / Total number of PCR
confirmed BU cases × 100
* Lost to follow up = patient disappears
after starting treatment and is not
recovered.
BU: Buruli ulcer; NTD: neglected tropical disease; PCR: polymerase chain reaction; SDG: Sustainable Development Goal.

8 Buruli ulcer
5. Core analyses

This section summarizes each of the recommended core data quality analyses and the factors to consider
in their interpretation.

The purposes of the core analyses are:

to assess the suitability of the data in guiding analysis of BU programme indicators;
to identify the weaknesses in data quality, including accuracy, completeness, timeliness and
consistency; and
to identify health facilities with data quality issues and challenges in implementing BU programme
interventions.

The four types of analysis are:

geographical location of cases (Fig. 1);
time series trends, by month, by year (Fig. 2);
data disaggregation by gender, age-group, geographical location and BU wound category; and
clinical treatment outcomes.

Fig. 1. Geolocation of cases

Distribution of Buruli ucler in endemic communities, 2012

Atlantic ocean
Number of cases
0–5 cases Decentralised centres
6–18 cases Rivers
19+ cases Lakes

Data source: National Leprosy and Buruli Ulcer Control Programme, Benin.

9
 Fig. 1. continued

Distribution of Buruli ucler in endemic communities, 2016

Atlantic ocean
Number of cases
0–5 cases Decentralised centres
6–18 cases Rivers
19+ cases Lakes

Data source: National Leprosy and Buruli Ulcer Control Programme, Benin.

Fig. 2. Time series trends, by month and by year

Last 3 months
HMIS Reporting rate ANC Reporting rate NTD Reporting rate NTD_1 Reporting rate Core reporting rates trend monthly
National / Region A / District A-1 30 33.3 30 30
National / Region A / District A-2 28 0 28 29 Last 12 months
National / Region A / District A-3 33.3 0 33.3 31.5
100 97
National / Region A / District A-4 33.3 0 33.3 33.3 95
96 96
95
94 94 94 94
National / Region A / District A-5 23.8 3 23.8 30 92
93
92 92
93
92
93
92
91 91 91 91
National / Region A / District A-6 33.3 31.4 33.3 31.5 90
89
90
89
90 90
90 88 87 88 87 87
National / Region A / District A-7 31.9 1.5 31.9 31.9 86 86
85 84 84 85
National / Region B / District B-1 23 17.9 23 28.7 82 83 82
81
National / Region B / District B-2 33.3 1.7 33.3 33.3 80 79 80
80 78
National / Region B / District B-3 27.3 0 27.3 33.3
National / Region B / District B-4 33.3 30.2 33.3 33.3

70
%

Last 12 months HIV Case surveillance

Immunization
- Reporting- rate
Reporting
Malariarate
burden reduction
NTD - Reporting
- Reporting
rate
rate
July 2024 88 92 85 78
August 2024 89 90 84 80 60
September 2024 87 91 86 79
October 2024 90 93 88 81
November 2024 91 94 87 80 50
December 2024 89 92 89 82
January 2025 92 95 90 83
February 2025 90 93 91 82 40
March 2025 91 94 92 84 July 2024 August 2024 September October Novem ber December January 2025 February March 2025 April 2025 May 2025 June 2025
April 2025 93 96 93 85 2024 2024 2024 2024 2025
May 2025 92 97 94 86 HIV Case surveillance - Reporting rate Immunization - Reporting rate Malaria burden reduction - Reporting rate NTD - Reporting rate
June 2025 94 96 95 87

Data source: Ministry of Health data. In: WHO Integrated Data Platform (12).

10 Buruli ulcer
 5.1 Epidemiological analysis
Before interpreting trends in the epidemiological data, any data quality issues should be investigated
(10, 11). If you see any sudden changes in trends, first check the data to make sure there has not been any
error in data entry.

5.1.1 Purpose
The purpose of the epidemiological analysis is:
to monitor trends in disease incidence;
to monitor geographical location of cases;
to assess progress towards control of the disease;
to track the geographical distribution of cases in relation to the location of BU treatment centres;
and
to monitor case-load at each major treatment facility.

5.1.2 Type
The type of analysis is time series by: (a) Number of cases by year (b) Number of cases globally and by
WHO region and country (see examples in Fig. 3 and Fig. 4).

Fig. 3. Number of BU cases reported globally, 2002–2020

7000

6000 5954

5378
5035 5156 5084
5000 4913
4748
Number of cases reported

4009
4000
3269 3353
3215
3000 2703
2630
2243 2353 2271
2043 2119
1973 1952
2000 1861
1665
1459

1000

0
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2025 2024
Year
Data source: Ministry of Health data. In: WHO Global Health Observatory (13).

5. Core analyses 11
 Fig. 4. Number of BU cases reported by country (Australia), 1991–2021

400
376
364
348
350 341

308
300 297 291
Number of cases reported

250
221
198
200

150 143

105 111
100 89
72 74
61
50 47 40 42
32 34 35
14
0
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2025 2024
Year
Data source: WHO Global Health Observatory (13).

5.1.3 Interpretation
Charts and maps depict the pattern of prevalence in several districts. It is important to consider the
efficiency of the existing surveillance system, especially community activities such as outreach and active
case-finding, and the capacity of the health system to confirm and report cases.

5.2 Indicators for reporting clinical examination observations

Buruli ulcer often starts as a painless swelling (nodule), a large painless area of induration (plaque) or a
diffuse painless swelling of the legs, arms or face (oedema). The disease may progress with no pain and
fever. Without treatment, or sometimes during antibiotic treatment, the nodule, plaque or oedema will
ulcerate within 4 weeks. Bone is occasionally affected, causing deformities. Lesions are frequent in the
limbs: 35% on the upper limbs, 55% on the lower limbs and 10% on other parts of the body. Health workers
should be careful when diagnosing the disease in patients with lower leg lesions to avoid confusion with
other causes of ulceration such as diabetes, arterial and venous insufficiency lesions.

The disease is classified into three categories of severity:

category I single small lesion (32%);
category II non-ulcerative and ulcerative plaque forms (35%); and
category III disseminated and mixed forms such as osteitis, osteomyelitis and joint involvement
(33%).

The objective of BU control is to minimize suffering, disabilities and socioeconomic burden. Early detection
and antibiotic treatment are the cornerstones of the control strategy. The core clinical indicators used to
measure progress in BU control are:
the proportion of cases in category III (late stage) at diagnosis;
the proportion of laboratory-confirmed cases; and
the proportion of confirmed cases who have completed a full course of antibiotic treatment.

12 Buruli ulcer
 Additional indicators may be used to track criteria for referral to level 2 and 3 health care facilities. These
include:
all ulcers > 2 cm;
all oedematous and plaque forms;
lesions involving deeper structures including bone;
lesions on the head and neck, genitalia, breast and fingers;
difficult diagnoses (clinically and by laboratory methods); and
systemically unwell patients.

5.2.1 Rationale for clinical indicators

Category III lesions are indicators of late detection. WHO recommends that the proportion of category III
lesions should be less than 10% at diagnosis time by 2030.

The indicator for ulcerative lesions should be interpreted with caution as it is strongly influenced by patient
immunity. Indeed, patients with high immunity may not present big lesions several weeks or months
after infection. Conversely, patients with low immunity may develop extensive lesions within a few days.

5.2.2 Analysis
The types of analysis are:
category of lesions by gender and by age-group; and
category of lesions, over time.

Fig. 5 provides an example of the proportion of category III lesions over time, depicting a decrease from
49.1% in 2010 to 34.9% in 2018 and showing progress over the years in early diagnosis.

Fig. 5. Category III lesions, 2010–2018

Category I Category II Category III Linear (Category III)

60%

50% 49% 49%

48%
43% 42% 43%
40% 39% 38%
Proportion (in %)

35%

30%

20%

10%

0%
2010 2011 2012 2013 2014 2015 2016 2017 2018
Year
Data source: National Leprosy and Buruli Ulcer Control Programme, Benin.

5. Core analyses 13
 Fig. 6 shows an example of category II lesions over time, depicting a linear increase.

Fig. 6. Category II lesions, 2010–2018

Lesions Ulcerated lesions Linear (ulcerated)

100%

80%
Proportion (in %)

60%

40%

20%

0%
2010 2011 2012 2013 2014 2015 2016 2017 2018
Year
Data source: National Leprosy and Buruli Ulcer Control Programme, Benin.

5.2.3 Interpretation
Ulcerated lesions are indicators of late detection. WHO recommends that the proportion of ulcerated
lesions at diagnosis should be less than 60%. The proportion of ulcerated lesions varied between 60%
and 78% from 2010 to 2018 (see also Fig. 6).

5.3 Diagnosis
This section summarizes each of the core analyses that are recommended for the diagnosis of BU and
the factors to be taken into consideration in their interpretation.

5.3.1 Purpose
The purpose of the core analysis is to monitor access to, type and performance of BU diagnosis.

Four standard laboratory methods can be used to confirm BU: IS2404 PCR, direct microscopy, histopathology
and culture. The turnaround time of a PCR test is 3–7 days. Better and simpler diagnostics are desirable
to enable early confirmation of diagnosis and facilitate timely management of the disease.

5.3.2 Analysis
The analysis is of laboratory PCR-confirmed cases, over time by gender and by age-group.

5.3.3 Interpretation
PCR for IS2404 is the reference standard for confirmation of BU. WHO recommends that at least 95% of
suspected cases should be confirmed by PCR by 2030. The proportion of PCR-confirmed cases presented
in Fig. 7 varies between 76% and 97%; this is a good performance.

14 Buruli ulcer
Fig. 7. PCR-confirmed cases, 2010–2018

Negative Positive Linear (positive)

100% 97% 97%

91% 93%
90%
85% 85% 87%
80% 76%
Proportion (in %)

60%

40%

20%

0%
2010 2011 2012 2013 2014 2015 2016 2017 2018
Year
Data source: National Leprosy and Buruli Ulcer Control Programme, Benin.

Laboratory PCR confirmation is influenced by the ability of health workers to identify suspected cases, collect
appropriate samples and transport them to the laboratory. It is important that health workers are properly
trained in sample collection and that laboratories organize periodic internal and external quality controls.

5.4 Treatment data

5.4.1 Purpose
The purpose of the analysis is to monitor:
access to treatment, by sex, by age group; and
completion of treatment, by sex and by ag group.

5.4.2 Analysis
The completion rate is highly influenced by the accessibility to treatment and the availability of antibiotics
at health facilities. It is important to monitor completion of treatment to reduce antibiotic resistance. WHO
recommends that, by 2030, at least 98% of confirmed cases should complete a full course of antibiotic
treatment. Further analysis of the data by gender and age-group can identify the characteristics of
individuals not completing treatment, so that appropriate remedial approaches can be implemented to
increase treatment completion rates in the context of the affected population (Fig. 8).

Fig. 8. Completion of treatment

Antibiotic treatment not completed (1%)

Antibiotic treatment completed (99%)

Data source: Buruli ulcer detection and treatment centre, Lalo, Benin, 2019.

5. Core analyses 15
 5.5 Tracking treatment outcomes
5.5.1 Purpose
The purpose of tracking treatment outcomes is to monitor:
the initial and longer-term effectiveness of treatment (recurrence);
the presence of disability at the time of the healing; and
patients who are cured without surgery.

The example in Fig. 9 shows that one in three patients received surgery and 40% healed with antibiotic
treatment alone.

Fig. 9. Monitoring of patients who are cured without surgery

Treatment in progress Antibiotic only

(32%) (40%)

Antibiotic and surgery

(28%)

Data source: Buruli ulcer detection and treatment centre, Lalo, Benin, 2019.

These indicators are strongly influenced by the precocity of the diagnosis, the availability of surgical services
and the attitude of health workers towards surgery decision-making. Indeed, small lesions (category I
and II) generally heal without surgery. Health workers are therefore encouraged to delay the decision to
operate, especially for patients with lesions in critical areas such as the face and genital areas.

A functional limitation score should be applied to describe the scope of joint movement, such as:
1 Moves easily normally: the patient can perform the limb movement without difficulty and at a level
comparable with that of other community members of the same sex and age.
2 Moves with difficulty: the patient can perform the limb movement but the level of performance is
not the same as before BU, the level is not comparable with that of other community members of
the same sex and age, or the activity could be performed at the same level but only with difficulty.
3 Unable to move at all: the patient cannot perform the limb movement without help from others
because of BU, both if physically impossible and if not possible because the patient for example
is avoiding the activity since he or she is afraid to damage the scar tissue.

16 Buruli ulcer
5.5.2 Analysis
It is important to show the outcome of the intervention at the end of the patient’s care. The presence of
disability at the time of healing is indicative of gaps in early diagnosis and in quality of patient care including
wound care, pain management and prevention of disabilities (Fig. 10).

Fig. 10. Monitoring disability at the time of healing

Healed with limitation of

movement at any joint (2%)

Healed without limitation of

movement at any joint (98%)

Data source: Buruli ulcer detection and treatment centre, Lalo, Benin, 2019.

5.5.3 Interpretation
It is important to show the outcome of clinical treatment at the end of the patient’s care. Interventions such
as wound and lymphoedema management and surgery (mainly debridement and skin grafting) should be
used as needed to speed up healing, thereby shortening the duration of hospitalization. Physiotherapy is
required in severe cases to prevent disability. Patients left with disability require long-term rehabilitation.
These same interventions are applicable to other NTDs such as leprosy and lymphatic filariasis, and should
be made accessible to patients through implementation of WHO’s integrated skin NTD approach (13) and
the WHO morbidity management and disability prevention aide-mémoire (14).

5. Core analyses 17
 References

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18 Buruli ulcer
Global Neglected Tropical Diseases Programme
World Health Organization
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1211 Geneva 27
Switzerland
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