Early detection of sensory nerve function impairment in leprosy under field conditions.

AIM: To assess the fine sensation of palms and soles in field conditions, to enable early detection of nerve function impairment before the loss of protective sensation, thus preventing the development of disability. METHODS: A cross-sectional descriptive study was conducted at seven tertiary referral hospitals located in different states in India. This study included all newly diagnosed patients affected by leprosy, who were registered during the period between March 2011 and April 2012. A detailed history was taken along with charting and voluntary muscle testing /sensory testing (VMT/ST) for the diagnosed patients. The sensation was measured using 0.2 gm Semmes-Weinstein filaments for palms and 4 gm for soles first, followed by 2 gm Semmes-Weinstein filaments for palms and 10 gm for soles. RESULTS: Among the 374 patients, 106 were identified with sensory nerve function impairment. Of the 106 patients, 84 were identified with absence of both fine and protective sensation and 22 patients had a loss of fine touch sensation with protective sensation intact. LIMITATION: This study was conducted only among patients who were newly diagnosed with leprosy. Hence, future longitudinal studies in a larger population will add more validity to the study. CONCLUSION: The patients who had loss of fine sensation would have been missed by the normal leprosy programme protocol which uses 2 gm and 10 gm filaments for testing sensory loss before initiating steroid therapy. Further research is needed to determine whether testing for fine sensation with 0.2 gm Semmes-Weinstein filaments for palms and 4 gm for soles can be introduced at all specialized leprosy centres to detect nerve function impairment at an earlier stage followed by steroid therapy.

A comparison of three types of targeted, community-based methods aimed at promoting early detection of new leprosy cases in rural parts of three endemic states in India.

BACKGROUND: India achieved elimination of leprosy nationally in 2005, but since then the number of patients with grade 2 disability at diagnosis increased steadily indicating delay in diagnosis. Therefore, there was a need for public health interventions which can increase case finding in their earlier stage. The objective of this study is to compare the effectiveness of three such community-based interventions; 1) Enhancement of community awareness on leprosy; 2) Education and motivation of "Index" leprosy cases; and 3) Involvement of Non-Formal Health Practitioners (NFHPs) to promote early detection of new cases of leprosy. METHODOLOGY/PRINCIPAL FINDINGS: Three community-based interventions were implemented between April 2016 and March 2018, embedded within the National Leprosy Eradication Program (NLEP) of India. Interventions were 1) increasing awareness through involvement of Gram Panchayat (local government) in the community regarding early signs of leprosy (Awareness), 2) providing health education and motivating newly diagnosed leprosy patients to bring suspects from their contacts (Index) and 3) training local non-formal health practitioners (NFHP). Each intervention was implemented in a group of ten blocks (sub-division of district) with an additional ten blocks as control (with no intervention). The main outcomes were number of new cases detected and number of grade 2 disability among them. They were obtained from the routine NLEP information system and compared between these interventions. On an average, there was an addition of 1.98 new cases in Awareness blocks, 1.13 in NFHP blocks and 1.16 cases in Index intervention blocks per month per block after adjusting for changes in control blocks during the same period. In terms of ratio, there was a 61%, 40% and 41% increase in case notification in awareness, Index and NFHP intervention, respectively. Overall, the percentage of grade 2 disability across intervention blocks declined. CONCLUSION: The Awareness intervention appears to be more effective in detection of new cases, compared to Index case motivation and sensitization of NFHPs. However, it is important to stress that while selecting strategies to increase early diagnosis it is important to determine, which is the most appropriate for each context or area and must be decided depending on the local context.

AZALEP a randomized controlled trial of azathioprine to treat leprosy nerve damage and Type 1 reactions in India: Main findings.

BACKGROUND: Leprosy Type 1 reactions are difficult to treat and only 70% of patients respond to steroid treatment. Azathioprine has been used as an immune-suppressant and we tested its efficacy in treating leprosy T1R. METHODOLOGY: Randomised controlled trial adding azathioprine to steroid treatment for leprosy reactions. This trial was conducted in four leprosy hospitals in India. Patients with a new leprosy Type 1 reaction affecting either skin or nerve were recruited. They were given a 20 week course of oral prednisolone either with placebo or azathioprine 50mg for 24, 36 or 48 weeks. Outcomes were measured using a verified combined clinical reaction severity score (CCS) and the score difference between baseline and end of study calculated. An intention to treat analysis was done on the 279 patients who had an outcome. PRINCIPAL FINDINGS: 345 patients were recruited, 145 were lost due to adverse events, loss to follow up or death. 36% needed extra steroids due to a recurrence of their skin and/or nerve reaction. 76% of patients had improvements in their CCS the end of the study, 22% had no change and 1.1% deteriorated. Adding azathioprine to steroid treatment did not improve CCS. So the improvements were attributable to treatment with steroids. We analysed the skin, sensory and motor scores separately and found that skin improvement contributed most with 78.9% of patients having skin improvement, azathioprine treatment for 48 weeks improved sensory scores it also improved motor scores but so did treatment with prednisolone alone. We identified significant adverse effects attributable to steroid treatment. When azathioprine and Dapsone were given together significant numbers of patients developed significant anaemia. CONCLUSIONS: Azathioprine is not recommended for the treatment of leprosy reactions and does not improve steroid treatment. Recurrent reactions are a major challenge. We have also identified that 65% of patients with sensory and 50% with motor nerve damage do not improve. Future studies should test giving azathioprine in the treatment of nerve damage and giving a higher dose for 48 weeks to patients. These findings highlight the difficulty in switching off leprosy inflammation and the need for better treatments for reactions and nerve damage. There is also a research need to identify patients who have recurrences and optimize treatments for them. Patients with recurrences may benefit from combined treatment with steroids and azathioprine. We have also shown that significant numbers of patients treated with steroids develop adverse effects and this needs to be highlighted in leprosy programmes. Research is needed to identify patients who do not respond to steroid treatment and develop alternative treatments for them. TRIAL REGISTRATION: ClinicalTrials.gov This trial was registered with the Indian Council of Medical research clinical Trial register as a clinical trial Number-REFCTRI/2016/12/007558.

ENLIST 1: An International Multi-centre Cross-sectional Study of the Clinical Features of Erythema Nodosum Leprosum.

Erythema nodosum leprosum (ENL) is a severe multisystem immune mediated complication of borderline lepromatous leprosy and lepromatous leprosy. ENL is associated with skin lesions, neuritis, arthritis, dactylitis, eye inflammation, osteitis, orchitis, lymphadenitis and nephritis. The treatment of ENL requires immunosuppression, which is often required for prolonged periods of time and may lead to serious adverse effects. ENL and its treatment is associated with increased mortality and economic hardship. Improved, evidence-based treatments for ENL are needed; however, defining the severity of ENL and outcome measures for treatment studies is difficult because of the multiple organ systems involved. A cross-sectional study was performed, by the members of the Erythema Nodosum Leprosum International STudy (ENLIST) Group, of patients with ENL attending seven leprosy referral centres in Brazil, Ethiopia, India, Nepal, the Philippines and the United Kingdom. We systematically documented the clinical features and type of ENL, its severity and the drugs used to treat it. Patients with chronic ENL were more likely to be assessed as having severe ENL. Pain, the most frequent symptom, assessed using a semi-quantitative scale was significantly worse in individuals with "severe" ENL. Our findings will determine the items to be included in a severity scale of ENL which we are developing and validating. The study also provides data on the clinical features of ENL, which can be incorporated into a definition of ENL and used for outcome measures in treatment studies.

¿Por qué algunos pacientes no completan la multiterapia? perspectavimas clasificadas de personas con lepra, sus cabeza de familia y vecinos en cuatro estados de la India / No disponible

Resulta fundamental revisar y comprender la importancia relativa de los factores percibidos por los afectados de lepra como obstáculos que les impiden completar el número de dosis requeridas en el tiempo necesario para optimizar la adherencia a la multiterapia (MDT). Objetivo: Para explorar los factores personales, familiares, sociales, comunitarios, de actitud, prácticos, geográficos, culturales y tradicionales que pueden influenciar la adherencia al tratamiento, se llevó a cabo un estudio en dos fases identificando los temas mediante grupos focales y la correspondiente clasificación de los mismos. Métodos: Mediante una entrevista con lista de comprobación se recopilaron las perspectivas de 895 encuestados (320 afectados por lepra que no pudieron completar el tratamiento, 302 de sus “cabezas de familia” y 273 de sus miembros comunitarios) en cuatro estados de la India, p. ej. Andhra Pradesh (Salur), Chhattisgarh (Chandkhuri), Maharashtra (Kothara) y Uttar Pradesh (Barabanki). Resultados: Los hallazgos sugieren que percibir cambios positivos en sus síntomas, así como no percibir mejoría puede conllevar a no completar la MDT. Los problemas con la planificación y el gasto del transporte también son temas clave. Un mejor control de las expectativas de las personas afectadas por lepra y la reducción de la carga del tratamiento también pueden ser estrategias importantes. La importancia del estigma y la pobreza se percibieron a través de varios temas, ninguno de los cuales fue particularmente clasificado como muy prioritario. Conclusiones: La naturaleza y diversidad de los temas percibidos por los encuestados en cada una de las regiones, sugiere que los determinantes de adherencia son complejos y multifactoriales. Se recomiendan más planteamientos comunitarios con una mejor coordinación

To maximise successful completion of multi-drug therapy (MDT) and optimise treatment outcomes for people with leprosy, it is vital to understand the relative importance of perceived factors which prevent them from completing the required number of doses in time. Objective: To explore personal, family, social, community, attitudinal, practical, geographical, cultural and traditional factors which may influence adherence to treatment, a two-phase study was undertaken comprising issue identification via focus groups, and a ranking exercise via individual interview. Study Design: The perspectives of 895 respondents (320 people affected by leprosy who were not able to complete treatment, 302 of their ‘operational heads of family’, and 273 of their nearby community members) across four states of India namely i.e. Andhra Pradesh (Salur), Chhattisgarh (Chandkhuri), Maharashtra (Kothara) and Uttar Pradesh (Barabanki) were collected, using a checklist interview method. Results: Findings suggest that seeing positive changes in their symptoms as well as not seeing improvement can lead to non-completion of MDT. Problems with scheduling and travel expenses were also key issues. Better management of the expectations of people affected by leprosy and reducing the burden of treatment may be important strategies. The importance of stigma and poverty were noted through a number of issues, none of which were particularly highly ranked. Conclusions: The nature and diversity of perceived issues identified across respondent type and particularly region, suggest that the determinants of adherence are complex and multi-factorial. More community based approaches with greater coordination at the community level are recommended

What stops people completing multi-drug therapy? Ranked perspectives of people with leprosy, their head of family and neighbours--across four Indian states.

UNLABELLED: Summary To maximise successful completion of multi-drug therapy (MDT) and optimise treatment outcomes for people with leprosy, it is vital to understand the relative importance of perceived factors which prevent them from completing the required number of doses in time. OBJECTIVE: To explore personal, family, social, community, attitudinal, practical, geographical, cultural and traditional factors which may influence adherence to treatment, a two-phase study was undertaken comprising issue identification via focus groups, and a ranking exercise via individual interview. STUDY DESIGN: The perspectives of 895 respondents (320 people affected by leprosy who were not able to complete treatment, 302 of their 'operational heads of family', and 273 of their nearby community members) across four states of India namely i.e. Andhra Pradesh (Salur), Chhattisgarh (Chandkhuri), Maharashtra (Kothara) and Uttar Pradesh (Barabanki) were collected, using a checklist interview method. RESULTS: Findings suggest that seeing positive changes in their symptoms as well as not seeing improvement can lead to non-completion of MDT. Problems with scheduling and travel expenses were also key issues. Better management of the expectations of people affected by leprosy and reducing the burden of treatment may be important strategies. The importance of stigma and poverty were noted through a number of issues, none of which were particularly highly ranked. CONCLUSIONS: The nature and diversity of perceived issues identified across respondent type and particularly region, suggest that the determinants of adherence are complex and multi-factorial. More community based approaches with greater coordination at the community level are recommended.

Household costs of leprosy reactions (ENL) in rural India.

BACKGROUND: Erythema nodosum leprosum (ENL) is a common immune-mediated complication of lepromatous (LL) and borderline lepromatous (BL) leprosy. Most patients experience chronic or multiple acute ENL over many years during an economically active period of their lives. Understanding the economic burden of ENL is essential to provide effective patient support, yet this area has not been investigated. METHODS: Ninety-one patients with LL or BL leprosy attending a leprosy hospital in Purulia district of West Bengal, India, were interviewed using a structured questionnaire. Cases (n = 53) were identified as those who had one or more episodes of ENL within the last 3 years. Controls (n = 38) had LL or BL leprosy but no history of ENL. Data were collected on household income, direct and indirect costs, and coping strategies. FINDINGS: The total household cost was Rs 1543 per month or 27.9% (IQR 13.2-52.6) of monthly household income for cases, and Rs 237 per month or 4.9% (IQR 1.7-13.4) of monthly household income for controls. Indirect costs accounted for 65% of total household costs for cases. Direct costs accounted for the remaining 35% of household costs, and resulted almost entirely from treatment-seeking in the private sector. Total household costs exceeded 40% of household income for 37.7% of cases (n = 20) and 2.6% of controls (n = 1) [1 USD = 59 INR]. INTERPRETATION: Households affected by ENL face significant economic burden and are at risk of being pushed further into poverty. Health policy should acknowledge the importance of private sector provision and the significant contribution to total household costs of lost productivity (indirect cost). Further work is needed to explore this area and identify solutions.

Reconstructive surgery in children to correct ulnar claw hand deformity due to leprosy.

OBJECTIVES: To study the impact of tendon transfer surgery for ulnar claw hand correction in children with leprosy. SUBJECTS AND METHODS: All the children who underwent reconstructive surgery for ulnar nerve paralysis during the period 2007 to 2012 were included in the study. Unassisted angle, grasp contact, pinch contact and functional assessment were the main outcome measures. All the surgical procedures were performed by the same surgeon and pre- and post-operative therapy protocol was same for all the patients. A common surgical audit form was used to record assessments for all the patients. RESULTS: In this case series, 82 hands of 79 patients with ulnar paralysis were included. All the children had lasso surgery. In 83% of hands, flexor digitorum superficialis of middle or ringer finger was used, while in the remaining patients palmaris longus or extensor carpi radialis longus with fascia lata graft was used as the motor tendon. The unassisted angle decreased in all the patients, indicating correction of claw fingers. Hand function improved after surgery and it showed steady progress during follow-up. CONCLUSION: The deformity due to leprosy in the hands of children is a tragedy as it hampers the use of hands in daily routine activities, school work and other social interactions. Tendon transfer surgery should be done on children to correct established clawed fingers as it yields good results and helps in facilitating hand function to complete daily activities and lead a normal life.

A conceptual protocol for translational research in the complex reality of leprosy.

In response to an international strategy to prioritise and focus research efforts in leprosy, this conceptual protocol outlines a research plan to address key translational research priorities. The protocol describes in broad terms a five-phase psychosocial and service-related research programme to facilitate: prevention of delay in diagnosis, improvement of adherence with multi-drug therapy, the roll out of chemoprophylaxis and increased participation in community based rehabilitation. The protocol proposes a model of research utilisation and the notion of complexity to form an integrating theoretical framework for exploring and enhancing research translation. The proposed sequential research programme is characterised by traditional and participatory strategies, culminating in participatory implementation of findings. Publication of the conceptual protocol prior to operationalisation and commencement of the research aims to encourage debate, refinement of strategies, collaboration and the optimisation of resources.

Enhancing counselling strategies for leprosy patients through the participation scale.

BACKGROUND & OBJECTIVES: Counsellors provide psychological support, appropriate education and coping skills to persons affected by adverse events. Counselling of leprosy patients is essential to enable them to cope with perceived stigma as well as managing severe enacted stigma at home, place of work or elsewhere. Professional counselling was instituted at the Leprosy Mission Community Hospital in Naini, Allahabad District, India, in 2004. In this paper we describe how the use of the Participation Scale helped in developing Counselling strategies for a variety of leprosy patients. MATERIAL & METHODS: A random sample of 250 leprosy patients visiting the hospital for the first time during 2011-2012 were chosen, 50 each from those with only hidden patches (Grade 0a), patients with visible patches (Grade 0b), those with only anaesthesia or weakness (Grade I), patients with paralytic deformities (Grade 2a), and patients with visible disabilities and ulcers Grade 2b). The P-scale consisting of 18 items was administered in the local language (Hindi) and used by the Counsellor along with relevant clinical and socioeconomic details. RESULTS: There were 84 women and 166 men, distributed in all the five categories. Overall, 142 patients out of 250 (56.8%) had no participation restrictions; 39 (15.6%) had mild social restrictions; 20 (8.0%) had moderate, 28 (11.2%) had severe and 21 (84%) had extreme participation restrictions. Paradoxically, there were some cases without severe deformity who are also subjected to restrictions. Patients in Grades 0a and 0b, had practically no severe or even moderate restrictions in their social participation, but their perceived stigma was high, requiring suitable leprosy education, family counselling and coping skills to feel confident that they were capable of normal work like any of their peers. Counselling became more intensive in Grade 1 and for almost all in Grade 2, who experienced moderate to severe restrictions in meeting new people, participating in social activities and indulging in socioeconomic activities. Counselling for such groups of patients required multiple approaches, including in-depth leprosy education for regular treatment, self-care measures, mobilisation of coping skills, self-confidence and acceptance counselling, and follow-up counselling for thos released from treatment after multidrug therapy. CONCLUSIONS & RECOMMENDATIONS: The P-scale provides essential information to enable a Counsellor to offer more meaningful and balanced counselling to leprosy-affected people, especially in coping with enacted stigma. Education oriented counselling and psychological supportive counselling are necessary adjuncts for clinical care and treatment. Client-oriented counselling allows clients to freely express their fears and anxieties, and promotes coping skills and confidence.

Assessment of needs and quality care issues of women with leprosy.

OBJECTIVES: Leprosy causes not just physical but psychosocial and economic problems which are further magnified in women due to gender disadvantages especially in developing countries. In order to determine the needs and quality care issues of women leprosy patients attending a hospital/health care facility, a research project was done. DESIGN: All women leprosy patients attending a Leprosy Referral Hospital in Kolkata, India during 2006 were interviewed in depth and clinically assessed, using a standardised proforma. FINDINGS: Of 104 women studied, half below 40 years of age and 70% above 40 years, had visible disability, and some had diabetes, low back pain etc. Nearly 60% preferred to hide their disease but even so, some had social problems. Most women delayed going to hospital, until their husband/guardian felt it was necessary. They had to complete their household chores before setting out for the hospital, and after their return. A considerable amount of time was spent waiting at various service points which conflicted with their domestic work, and lowered their social worth if they were away too long. This de-motivated them from visiting hospitals, even for follow up visits. Medical advice given--such as avoiding prolonged walking and standing, working with hot utensils etc., was not practical. CONCLUSION: Hospitals can do much to address the needs of women leprosy patients and. provide quality services. National programmes should give a higher priority to offering culturally acceptable health education to promote early reporting.

Patients' perceptions of reconstructive surgery in leprosy.

Reconstructive surgery has made significant advances in correcting deformities in leprosy. However, several patients seem hesitant and unenthusiastic to take advantage of this facility. A study was therefore carried out at the Leprosy Mission Hospital in Kolkata during 1999, to assess patients' perceptions to reconstructive surgery. Of about 300 patients operated during 1991-1997, 117 were interviewed using a Visual Analogue Scale on their pre-operative expectations and satisfaction after surgery. Nearly 40% had their expectations fully met, another 40% partially, and about 10% perceived benefits more than expected. Less than 5% were not satisfied. Results are presented for surgery on hand, foot and eye among males and females, and the implications for future discussed.