Leprosy Mailing List – September 18, 2019
Ref.: (LML) 8 pillars of a highly effective programme
From: Joel Almeida, London and Mumbai
Dear Pieter and colleagues,
Great colleagues keep providing steadily more pieces of the jigsaw. We need to put these together and boost the effectiveness of our field programmes. What does a highly effective programme look like? The scheme below is based on current HD knowledge as well as highly effective programmes in HD and other diseases. LML's many experts can improve the scheme.
Current situation
The recurrence rate of disease is high after even 24 months of MDT, especially among patients with a high initial BI. This allows continuing transmission in even the best-run programmes that use all our promising innovations.
Figure 1. Recurrence rate (endogenous relapse + exogenous reinfection) after release from 24 months of MDT in Cebu, Philippines, based on Balagon et al, 2009 (1). Patients with an initial BI greater than 4+ showed even higher recurrence rates.
Once we protect LL patients after MDT, concentrated bacilli will be unavailable (except from armadillos). That is necessary for zero transmission. Shandong demonstrated this by achieving near-zero transmission.
Figure 2. New case detection rate contrasting 24 months of MDT in Wenshan/Yunnan (upper line) with prolonged MDT in Weifang/Shandong (lower line). The decline of HD levelled off in Wenshan/Yunnan (upper line) once LL patients were left unprotected after 24 months of MDT. (2)
Shandong achieved a 20%/year decline in incidence rate leading to near-zero transmission. This was by using
a) periodic skin camps for case finding with
b) prolonged anti-microbial protection for LL patients.
We can match or exceed that achievement. We need to ensure active case finding focused on diagnosing LL patients, and post-MDT chemoprophylaxis for LL patients. Currently only well-informed private practitioners in endemic countries give anti-microbial protection to LL patients after the usual duration of MDT. This same level of protection needs to be available to all LL patients. It is critical to interrupting transmission.
Figure 3. Trend in MB cases worldwide 1985 to 2017 (source: WHO Weekly Epidemiological Record). The true rate of decline is likely to fall well short of the 20%/year decline demonstrated in Weifang/Shandong (Fig. 2), even allowing for the changing criteria for MB classification.
The 8 pillars of a highly effective programme
The 8 pillars below are likely to make for a highly effective programme. Some of these are already in use in well-run programmes. These 8 pillars can be tailored to each locality. Some tasks require skilled specialist workers, the rest can be allocated to multi-purpose workers or even volunteers.
1. Political commitment
Generate political commitment, educate political leaders (local, provincial, national) about the disease and our plans to end it. Obtain sufficient investment (from government, NGOs, foundations, philanthropists, other sponsors). Government can appoint a lead agency (government or NGO) to devise, guide & monitor implementation in a given geographical area. Involve cured persons, local politicians, professional associations, NGOs, private practitioners and civil society organisations in local planning and implementation.
Our bid for increased investment rests on 2 main grounds:
a) The great and increasing burden of disability caused by HD. The WHO & IHME (Institute for Health Metrics and Evaluation) measure this in DALYs (prevalence of disability x weight of disability). A total-population survey in rural Maharashtra state, India, showed that over 2300 persons per million population had visible deformity attributable to HD.(3) A pilot survey in 2 rural areas of India discovered visible deformity among 15% to 33% of previously treated patients.(4) The frequency of neuropathic pain, psychological symptoms and ostracism compound the weight of disability attributable to HD. HD is more important than sometimes recognised.
b) Near-zero transmission in Shandong, using prolonged anti-microbial protection for LL patients. (2) We know how to match that: include monthly post-MDT chemoprophylaxis for LL patients. Shandong's demonstration of near-zero transmission argues strongly for boosted investment to spread the success.
2. Training
Develop locally appropriate training manuals based on the implementation plan. Recruit and train staff, NGOs and volunteers. Follow up with periodic supervision visits, and on-the-job training.
3. Supplies
Set up reliable supply systems (prevent stock-outs of supplies including MDT, prednisolone, graded monofilaments and lab supplies).
4. Skin smear services
Skin smears are necessary to help recognise & classify LL patients, especially those with only subtle or equivocal signs. Otherwise some of the most highly bacillated patients can be missed altogether in even door-to-door surveys. Smears can be collected by mobile paramedical workers. Supervisory visits can help maintain the quality of skin smear techniques.
5.Case finding
Active case finding (especially for LL patients) in high-incidence areas & also in the most densely populated neighbourhoods of towns & cities.
Thorough clinical examination in good light
+ skin smears
+ examine contacts for signs of disease
+ counselling by peers and NGO staff for newly diagnosed patients
+ record disability status (visible deformity, eye hand foot score)
+ record GIS location for every newly diagnosed patient, eg., using smartphones with a GIS app and an online recording/reporting system
In the remaining areas, all house-to-house surveys for any purpose can be requested to include a search for signs of HD. Smartphones, with access to a downloadable image library, can help diagnosis by inexperienced persons. A printed atlas of clinical signs can also be very useful. However, inexperienced persons still easily can miss those LL patients who show only subtle signs.
Shandong used periodic skin camps for case finding. These can be quite effective because expert clinicians can confirm diagnosis without delay. Skin smears can be collected. Peer counsellors and NGO staff can be present to assist newly diagnosed patients. Also, BCG can be made available at each skin camp for contacts of newly diagnosed patients. Skin camps are a useful option for case finding.
6. Case management:
A) MB-MDT for MB patients, PB-MDT for PB patients (check for regular ingestion of drugs during quarterly home visits to MB patients).
B) Quarterly nerve function assessment (MB patients) using graded monofilaments + prompt prednisolone treatment if needed. Equip paramedical workers with transport so that each worker can make quarterly visits to all the MB patients in their allocated area.
C) At collection of each patient's last MDT blister pack, examine the patient and record their disability status (eye hand foot score).
D) Treatment for complications (type 1 reaction, ENL, pain, psychological symptoms, other complaints) as required
E) Post-MDT chemoprophylaxis for all LL patients (using 3 bactericidal drugs monthly eg., rifampicin, moxifloxacin, minocycline)
F) Rehabilitation + inclusion services (surgery, physiotherapy, orthotics, prosthetics, psychological support services, vocational training, access to disability pension and other entitlements, income generation training, liaison with relevant organisations including human rights NGOs, legal aid, advocacy training etc.)
7. Recording and reporting system
Analyse successive cohorts for treatment completion, age, sex, HD classification, & disability status before/after MDT. Use a GIS to identify epidemiological hot spots. Intensify supervisory visits to under-performing health centres. Establish symbolic awards for high-performing health centres. Ensure continuous improvement of implementation, with periodic supervisory visits.
8. Public education
Can include messages such as the following -
Most new patients found by door-to-door surveys are non-infectious even before treatment. All treated patients soon become non-infectious.
Effective treatment is available free of charge at government health centres.
Hansen's Disease is caused by a germ that can be killed by effective treatment. It is not a sign of shame nor a punishment for past behaviour.
Nearly everyone is naturally immune to HD. Those who lack natural immunity can catch the germ if sufficiently exposed, regardless of how wealthy they are.
HD can be harmless if properly treated, but can lead to serious damage to limbs, nerves, eyes and minds if left untreated.
Examine yourself and your children for signs that might suggest HD: thickened skin especially on ears, skin nodules, persistent stuffy nose with hard crusts, skin patches with loss of sensation, weakness in hands, difficulty in holding a pen or pencil, dropping things frequently, difficulty in raising toes off the ground, loss of eyebrow hair. If in doubt, visit your nearest government health centre and ask to be examined.
If no experienced government health staff are available, look for an NGO dealing with HD, or a specialist dermatologist. Members of professional associations (Indian Association of Leprologists, Sociedade Brasileira de Hansenologia etc.) are mostly well trained and experienced.
Here is a list of the 8 pillars, which work together to ensure the detection and sufficient protection of LL patients, enabling near-zero transmission as in Shandong.
1. Generate political commitment & obtain finance
2. Recruit and train personnel, ensure supervision visits and follow-up training
3. Ensure a reliable uninterrupted supply system
4. Provide skin smear services
5. Do active case finding, especially for LL patients
6. Ensure comprehensive case management, including post-MDT chemoprophylaxis for LL patients and quarterly assessment of nerve function for MB patients, using prednisolone when needed
7. Establish and use a recording and reporting system, monitor outcomes & continuously improve implementation
8. Educate the public
Sample surveys
In addition to the 8 implementation pillars above, we need periodic door-to-door sample surveys by teams including expert clinicians, to monitor the true epidemiological situation and trends. Periodic sample surveys have been ordered by India's Supreme Court. The National Sample Survey of HD in India, using expert clinicians and door-to-door visits, showed that 6 out of every 10 HD patients in India remained undiagnosed by the routine programme.(5) Active case finding with door-to-door campaigns now forms part of the Indian programme. In Brazil, one town was believed to have a low incidence rate of HD. However, expert clinicians then found many highly bacillated MB patients who had remained undiagnosed despite prominent signs of HD. (6) Sample surveys by teams including expert clinicians are necessary to reveal the true situation.
Professional education & talent acquisition
Professional societies such as the Indian Association of Leprologists, the Brazilian Hansenology Society and others are educating the next generation of experts. We could also keep inviting the brightest young people in endemic areas to participate in efforts against HD. They can contribute high-quality clues and analysis from the front-lines. Endemic countries such as India and Brazil export brilliant talent across the world. The CEOs of Microsoft, Google, Adobe, Mastercard, Diageo, and many other large enterprises are exports from endemic countries. It would be good to share our enthusiasm and passion for this great work with gifted young people in endemic countries, and ask them at every opportunity: "Would you like to help end Hansen's Disease?" We can create openings for exceptionally gifted young people to participate in ending HD. Salaries remain lower in most endemic countries than in affluent countries, making this approach reasonably affordable. High-calibre talent at the front-lines, existing and new, can help improve the quality and relevance of our technical advice.
Research
MDR (multiple-drug resistant) bacilli provide a persuasive argument for boosted investment in research of all types.
Other measures
Evidence of epidemiological impact, or lack of it, might strengthen or weaken the case for other measures.
A) MIP vaccine for newly diagnosed MB patients and their contacts (7). This is demonstrably effective among persons without genetically determined anergy. That still leaves some others, who have genetically determined anergy.
B) Chemoprophylaxis among contacts. It seems wise to avoid single-drug usage so that the selection of drug-resistant bacilli is discouraged. If attempting treatment of contacts, we could ensure that only combinations of bactericidal drugs are used, and for a sufficient duration to cure sub-clinical MB disease.
A systematic protocol can help to identify LL patients, who sometimes show no clear signs of disease. For example,
Serological testing among contacts (8) ->
if serology is positive, require expert clinical examination and take skin smears to rule out MB disease ->
if MB disease found by clinical exam or positive skin smear, give full MB-MDT ->
in other serologically positive contacts, give a combination of drugs to reduce the risk of selecting drug-resistant bacilli.
MDR (multiple-drug resistant) bacilli could be disastrous and set us back by decades, leading eventually to increased transmission. That is why it is so important to avoid the use of single drugs (monotherapy) among contacts.
These 8 pillars above can be tailored for local use. Shandong achieved a 20%/year decline in incidence rate leading to near-zero transmission. We can match or exceed that success in our own areas by including active case-finding for LL patients and post-MDT chemoprophylaxis for LL patients, within these 8 pillars. Wouldn't it be good to succeed? Let's do it.
Joel Almeida
References
1. Balagon MF, Cellona RV, dela Cruz E et al. Long-Term Relapse Risk of Multibacillary Leprosy after Completion of 2 Years of Multiple Drug Therapy (WHO-MDT) in Cebu, Philippines. American Journal of Tropical Medicine and Hygiene, 2009; 81, 5: 895-9.
2. Li HY, Weng XM, Li T et al. Long-Term Effect of Leprosy Control in Two Prefectures of China, 1955-1993. Int J Lepr Other Mycobact Dis. 1995 Jun;63(2):213-221.
3. Ganapati R, Pai VV, Tripathi A. Can primary health centres offer care to the leprosy disabled after integration with general health services? - a study in rural India. Lepr Rev 2008, 79:340–341
4. Aggarwal A, Pandey A. Inverse sampling to study disease burden of leprosy. Indian J Med Res 132, October 2010, 438-441.
5. Katoch K, Aggarwal A, Yadav VS, Pandey. A National sample survey to assess the new case disease burden of leprosy in India. Indian Journal of Medical Research, 2017; 146(5): 585-605.
6. Bernardes Filho F, Aparecida de Paula N, Leite MN et al. Evidence of hidden leprosy in a supposedly low endemic area of Brazil. Mem Inst Oswaldo Cruz. 2017 Dec; 112(12): 822–828.
7. Sharma P, Mukherjee R, Talwar GP et al. Immunoprophylactic effects of the anti-leprosy Mw vaccine in household contacts of leprosy patients: clinical field trials with a follow up of 8-10 years. Lepr Rev. 2005 Jun;76(2):127-43.
8. Leturiondo AL, Noronha AB, Oliveira do Nascimento MO et al. Performance of serological tests PGL1 and NDO-LID in the diagnosis of leprosy in a reference Center in Brazil. BMC Infectious Diseases volume 19, Article number: 22 (2019)
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LML - S Deepak, B Naafs, S Noto and P Schreuder
LML blog link: http://leprosymailinglist.blogspot.it/
Contact: Dr Pieter Schreuder << editorlml@gmail.com
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