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.

¿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.

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.

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.