Development and structural validation of a shortened version of the Participation Scale.

PURPOSE: To validate a shortened version of the Participation Scale (P-scale) that will be quicker to use and to describe the factor structure found in the P-scale data in various study samples. METHODS: A large multi-country and multi-cultural database was compiled consisting of 5125 respondents. Item analysis, explanatory factor analysis and confirmatory factor analysis were applied to identify items for deletion and investigate the factor structure of the P-scale. RESULTS: The multi-country database included 11 databases from six different countries. Respondents were affected by a range of health conditions, including leprosy, HIV/AIDS, dermatological conditions and various disabilities. Of the respondents included 57% were male. The P-scale Short (PSS) contains 13 items. A two-factor structure, with factors named "work-related participation" (three items) and "general participation" (10 items), showed the best model fit (Comparative Fit Index = 0.983, Tucker Lewis Index = 0.979, Rooted Mean Square Error of Approximation = 0.061). The Cronbach's alphas were very good for both the whole scale and the subscales, 0.91, 0.83 and 0.90, respectively. Correlation between the two factors was high (r = 0.75) indicating that interpreting the P-scale as measuring an overall factor "participation" is still valid. A very high correlation (r = 0.99) was found between the full P-scale and the PSS. CONCLUSIONS: The findings suggest good validity of the P-scale across a range of languages and cultures. However, field testing needs to confirm the validity of the PSS to measure the level of social participation restrictions across cultures and health conditions.

The histological diagnosis of leprosy type 1 reactions: identification of key variables and an analysis of the process of histological diagnosis.

BACKGROUND: Type 1 leprosy reactions (T1R) are a major inflammatory complication of leprosy affecting 30% of patients with borderline leprosy, but there has been no diagnostic evaluation of the histological diagnosis of this entity. METHODS: In a prospective study based in India, skin biopsies were taken from 99 patients with clinically diagnosed T1R and 52 non-reactional controls. These were assessed histologically by four histopathologists whose assessments were then compared. RESULTS: Reactions were under-diagnosed, with 32-62% of clinically diagnosed reactions being given a histological diagnosis. The pathologists showed good specificities (range 72% to 93%) but much poorer sensitivities (range 42% to 78%). The most commonly reported histological features of TIR were cell maturity, oedema and giant cells. Five key variables were identified that the pathologists used in diagnosing a reaction: intra-granuloma oedema, giant cell size, giant cell numbers, dermal oedema and HLA-DR expression. A predictive model for the diagnosis of T1R was developed using stepwise logistic regression analysis, with clinical diagnosis of reaction as an outcome, and then identification of the key variables that each pathologist used in making the diagnosis of T1R. 34-53% of the variation between pathologists could be accounted for. The four pathologists used a similar diagnostic model and for all of them their estimations of epithelioid cell granuloma oedema, dermal oedema, plasma cells and granuloma fraction were significant variables in the diagnosis of T1R. Each pathologist then added in variables that were specific to themselves. CONCLUSIONS: This study has identified T1R as being under-diagnosed in comparison with clinical assessments. Key variables for diagnosing T1R were established. This comparative masked study highlights the need for such studies in other inflammatory conditions.

Response to ciclosporin treatment in Ethiopian and Nepali patients with severe leprosy Type 1 reactions.

Leprosy type 1 reactions (T1R) are immune-mediated events with inflammation of peripheral nerves and skin. We report the clinical outcomes of a closely monitored open prospective trial in which eight Nepali and 33 Ethiopian patients with T1Rs were treated with an Indian generic formulation of ciclosporin (Cn; 5-7.5 mg/kg/day) for 12 weeks and followed up for 24 weeks after starting treatment. Outcomes were measured using a clinical severity score. Among the Nepalis, 75-100% improved in all acute clinical parameters; 67-100% patients maintained improvement, except for those with acute sensory nerve impairment among whom 67% relapsed after stopping treatment. The skin lesions of all Ethiopians on 5 mg/kg/day of Cn improved and 50-60% had peripheral nerve function improvement. Most Ethiopians needed a higher dose of Cn to improve nerve impairment and neuritis, and 50-78% of them developed worse clinical severity scores when Cn was stopped. Four Ethiopians and two Nepalis developed elevated serum creatinine levels on 7.5 mg/kg/day Cn, and three (9%) Ethiopians developed treatable hypertension. This suggests that Cn monotherapy is an effective treatment for severe T1R with few adverse effects. A dose of 5 mg/kg/day seems efficacious in Nepalis, but a higher dose may be required in Ethiopian patients.

Corticosteroids for treating nerve damage in leprosy.

BACKGROUND: Leprosy causes nerve damage which can result in nerve function impairment and disability. Corticosteroids are commonly used for treating nerve damage, although the long-term effect is uncertain. OBJECTIVES: To assess the effects of corticosteroids on nerve damage in leprosy. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Group Register, the Cochrane Central Register of Controlled Trials (Issue 4), MEDLINE (from 1966), EMBASE (from 1980), CINAHL (from 1980), LILACS (from 1982) in January 2006. We checked reference lists of the studies identified, the Current Controlled Trials Register (www.controlled-trials.com), conference proceedings and contacted trial authors. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of corticosteroids for nerve damage in leprosy. DATA COLLECTION AND ANALYSIS: The primary outcome was improvement in sensory and motor nerve function after one year. Secondary outcomes were improvement in nerve function after two years, change in nerve pain and tenderness, and adverse events. Two authors independently extracted data and assessed trial quality. We contacted trial authors for additional information. We collected adverse effects and cost effectiveness information from the trials and non-randomised studies. MAIN RESULTS: We included three randomised controlled trials involving 513 people. Two trials compared prednisolone with placebo. One trial treated mild sensory impairment of less than six months duration and the other trial treated nerve function impairment of 6 to 24 months duration. Both trials examined an effect twelve months from the start of treatment. There was no significant difference in nerve function improvement between people treated with prednisolone or with placebo. The third trial compared three corticosteroid regimens for severe type 1 reactions. This trial did not report the prespecified outcomes. However, after 12 months, a significantly higher proportion of individuals on a 3-month course of prednisolone required extra corticosteroids compared to the groups with a high-dose and low-dose regimen of five months duration. Diabetes and peptic or infected ulcer were sometimes reported as serious adverse events in the placebo-controlled trials, but not significantly more often in the corticosteroid than placebo groups. AUTHORS' CONCLUSIONS: Corticosteroids are used for treating acute nerve damage in leprosy, but evidence from randomised controlled trials does not show a significant long-term effect. Randomised controlled trials are needed to establish their effectiveness, the optimal regimens and to examine new therapies.

Promoting early detection in leprosy--a literature review to identify proven and potential interventions addressing patient-related delay.

OBJECTIVES: The objective of the literature review was to identify proven and potential interventions to promote early diagnosis and start of treatment in leprosy, specifically, forms of intervention addressing needs at the local or primary level. DESIGN: Using a structured search procedure, we identified recent leprosy-related publications describing proven interventions. To identify potential interventions the search was extended to publications assessing knowledge and attitudes towards leprosy and extended again to identify publications relating to patient-related delay in the context of other infectious diseases. RESULTS: The review identified just 19 publications reporting leprosy-related interventions that included a form of evaluation of which only 10 directly addressed patient-related delay. These included health education interventions focussed on people directly affected by leprosy, their family members and other key individuals or groups within the local community. We identified no reports of interventions focussed specifically on the needs of women. CONCLUSIONS: Our conclusion is that the evidence base available to inform the choice of small-scale interventions to promote early detection at the primary level is extremely limited. There is an urgent need to develop and extend the range of proven interventions, specifically those that address the needs of women, those that explore and develop the health promotion potential of people previously affected by,leprosy and those that exploit the potential of individuals with leadership roles within the community. This will require careful attention to planning, implementation, evaluation and reporting of interventions.

Factors contributing to delay in diagnosis and start of treatment of leprosy: analysis of help-seeking narratives in northern Bangladesh and in West Bengal, India.

The objective of our research was to identify factors contributing to delay in diagnosis and start of treatment in leprosy, focussing on patients' narratives of help-seeking behaviour. Our research took place in Purulia, West Bengal, India and in Nilphamari, northern Bangladesh. Between January and August 2000, we conducted semi-structured interviews with 104 patients that explored each individual's narrative of help-seeking behaviour and the context of beliefs and attitudes towards leprosy. Subsequently we surveyed 356 patients currently receiving treatment for leprosy and recorded specific aspects of each help-seeking action and their reports of local beliefs and attitudes towards leprosy. Delay was estimated from time of first symptoms through to start of effective treatment (mean 18 months, median 9 months in Purulia and mean 20 months, median 12 months in Nilphamari). The number of help-seeking actions ranged from 1 to 7. Time committed to first actions contributed 86% (Nilphamari) and 79% (Purulia) to total delay. The most important contributor to delay in the first action occurred when people simply monitored or ignored first symptoms, 80% in Nilphamari and 67% in Purulia. With delay longer than 12 months as outcome, logistic regression analyses identified age over 35 years, multiple visits to practitioners in traditional medicine and multiple visits to health service practitioners as predictive of delay. Attending a nearby clinic and exposure to health education materials were predictive of early presentation reduced delay.

Risk factors for participation restriction in leprosy and development of a screening tool to identify individuals at risk.

The World Health Organisation International Classification of Functioning, Disability and Health defines participation as involvement in a life situation. Participation restrictions are problems experienced in any life situation, for example, in relationships or in employment. Our research explored risk factors for participation restrictions experienced by people affected by leprosy. Our objective was to develop a screening tool to identify individuals at risk. An initial round of qualitative fieldwork in eight centres in Nepal, India and Brazil identified 35 potential risk factors for participation restriction. These were then further assessed through quantitative fieldwork in six centres in India and Brazil. In all, 264 individuals receiving leprosy treatment or rehabilitation services made a retrospective assessment of their status at time of diagnosis. Their level of participation restriction was assessed using the Participation Scale. Regression analysis identified risk factors for participation restriction including fear of abandonment by family members (odds ratio 2.63, 95% CI 1.35-5.13) and hospitalization at diagnosis (3.98, 1.0-7.32). We recommend four consolidated items as the basis for a simple screening tool to identify individuals at risk. These are the physical impact of leprosy, an emotional response to the diagnosis, female gender and having little or no education. Such a tool may form the basis for a screening and referral procedure to identify newly diagnosed individuals at risk of participation restrictions and in need of actions that may prevent such restrictions.

Delay in presentation in the context of local knowledge and attitude towards leprosy--the results of qualitative fieldwork in Paraguay.

OBJECTIVE: The primary objective of our research was to explore help-seeking behavior in the context of knowledge, attitude, and practice as factors contributing to delay in presentation in leprosy. The secondary objective was to demonstrate the value of basic qualitative research methods in this context. METHODOLOGY: Fieldwork was based at the Hospital Mennonita Km 81, the referral center for leprosy services in Paraguay. We adopted exclusively qualitative methods for fieldwork, effectively carrying out a rapid assessment of factors contributing to delay. We relied on multiple sources of information and the use of multiple methods to ensure the validity of our findings. RESULTS: Our findings linked delay in presentation to traditional beliefs, lack of awareness of the early symptoms of leprosy, stigma, seeking help from natural healers, and to interactions with the health services. Traditional beliefs diminish the importance of the early symptoms of leprosy. Stigma has an impact on decisions to seek help. Natural healers have maintained their traditional status in society; their preferred treatments for leprosy are ineffective. Only rarely do natural healers refer to the health services. Once presented to the health services, some individuals affected by leprosy experienced lengthy delays in diagnosis and start of treatment. DISCUSSION: To address the traditional values of a society and provide effective public health initiatives is a clearly a major challenge for program organizers and for health education. Increased awareness of leprosy and sensitivity to its social consequences among health service practitioners is a further priority.

Delay in presentation, an indicator for nerve function status at registration and for treatment outcome--the experience of the Bangladesh Acute Nerve Damage Study cohort.

The objective of our research was to relate delay in presentation in the Bangladesh Acute Nerve Damage Study cohort to intake status and to treatment outcome. The Bangladesh Acute Nerve Damage Study (BANDS) is a prospective cohort study of 2664 consecutive newly registered patients at clinics run by the Danish-Bangladesh Mission Leprosy (DBLM) project in Nilphamari, northern Bangladesh. The 1-year intake began in April 1995. Three-year follow-up for PB cases and 5 years for MB cases was completed in 2001. Delay in presentation in the BANDS cohort is associated with increased signs of nerve function impairment at registration. Individuals presenting with no nerve impairment and maintaining nerve function to the end of follow-up had the shortest mean delays. Individuals presenting with impairment that did not improve during follow-up had the longest mean delays. Discussion focuses on the value of setting a threshold value defining early presentation. Since the WHO Grade 2 disability rate effectively sanctions lengthy delays where there is no impairment, an indicator relating directly to delay is preferred as an indicator for good practice in leprosy control.

The treatment of acute nerve function impairment in leprosy: results from a prospective cohort study in Bangladesh.

In this paper, the outcome of 132 patients having acute nerve function impairment (NFI) is reported at 4 and 12 months after the start of prednisolone treatment. In all, 68% of sensory nerves and 67% of motor nerves showed improvement at 12 months, with no statistical difference in responsiveness of various nerves to prednisolone. Duration and severity of impairment were not found significant predictors of treatment outcome. A core of 32% of impaired nerves did not respond to prednisolone, and 12% of impaired nerves had functional deterioration despite treatment. The mean eye-hand-foot (EHF) score improved from 2.02 to 1.33 in the treatment group (median score improved from 2 to 1). Approximately one-third of all patients requiring prednisolone treatment did not receive it, an important reason being that some patients developed new NFI against a background of chronic impairment, and were thus overlooked. The 'unjustly untreated' group of patients had a spontaneous sensory nerve function improvement rate of 62% and a motor nerve function improvement rate of 33% at 12 months from onset of NFI. The EHF score showed no statistically significant improvement.

Incidence rates of acute nerve function impairment in leprosy: a prospective cohort analysis after 24 months (The Bangladesh Acute Nerve Damage Study).

In this paper, the incidence rates and cumulative incidence of nerve function impairment (NFI) and leprosy reactions over 24 months follow-up of the prospective cohort of 2664 new leprosy cases are presented. Graphs showing the cumulative incidence of NFI relative to time since registration are presented. Hazard ratios (HRs) for the development of NFI for four variables are given. The majority of patients who developed NFI after registration did so in the first year (67% of multibacillary (MB) patients, and 91% of paucibacillary (PB) patients who developed NFI). Thirty-three percent of all MB patients who developed NFI after registration did so in the second year of follow-up. No PB patients developed NFI for the first time in the last 6 months of follow-up. However, seven NFI events occurred amongst PB patients in that period, amongst those who had already had one NFI event. The incidence rate (IR) of NFI amongst MB patients was 24/100 person-years at risk (PYAR), and amongst PB patients was 1.3/100 PYAR. The HR for the development of NFI amongst MB patients compared with PB patients was 16 using univariate analysis. Amongst patients who had long-standing NFI present at registration, the IR was 27/100 PYAR compared with 1.7/100 PYAR amongst those who did not have long-standing NFI. The HR for developing acute NFI amongst those with long-standing NFI present at registration compared with those without was 14 using univariate analysis. When multivariate regression analysis is applied, the apparently significant univariate HRs for sex and age disappeared. The resultant multivariate HR for leprosy group is 8.8, and 6.1 for the presence/absence of long-standing NFI at registration. In all, 142/166 (86%) of all new NFI events were silent, underlining the need for regular nerve function testing. IRs are presented for the four 6-month periods of the 24-month follow-up. They show a clear stepwise reduction over the total period. The IRs amongst MB patients and those with long-standing NFI present at registration are very high at 34 and 41/100 PYAR, respectively, for the first 6 months of follow-up. Even during the final 6-month period, the IR is maintained at a moderately high level (18 and 15/100 PYAR, respectively).

A clinical prediction rule for nerve-function impairment in leprosy patients.

BACKGROUND: Nerve-function impairment (NFI) commonly occurs during or after chemotherapy in leprosy and is the key pathological process leading to disability and handicap. We describe the development of a simple clinical prediction rule for estimating the risk of NFI occurrence. METHODS: New leprosy cases who presented to a centre in Bangladesh were recruited and followed up for 2 years in a field setting. We used multivariable regression analysis by Cox's proportional hazards model to identify predictive variables for NFI. Discriminative ability was measured by a concordance statistic. Internal validity was assessed with bootstrap resampling techniques. FINDINGS: 2510 patients were followed up for 2 years, 166 developed NFI. A simple model was developed with leprosy group (either paucibacillary leprosy [PB] or multibacillary leprosy [MB]) and the presence of any nerve-function loss at registration as predictive variables. Patients with PB leprosy and no nerve-function loss had a 1.3% (95% CI 0.8-1.8%) risk of developing NFI within 2 years of registration; patients with PB leprosy and nerve-function loss, or patients with MB leprosy and no nerve-function loss had a 16.0% (12-20%) risk; and patients with MB leprosy with nerve-function loss had a 65% (56-73%) risk. INTERPRETATION: Our prediction rule can be used to plan surveillance of new leprosy patients. Patients at low risk of NFI may need no follow-up beyond their course of chemotherapy (6 months); patients with intermediate risk need a minimum of 1 year of surveillance; and patients with high risk should have at least 2 years of surveillance for new NFI. Current recommendations for surveillance of patients with leprosy (for the duration of chemotherapy only) exclude an important group of patients who are at risk of developing NFI after completion of treatment.

Making sense of rehabilitation projects: classification by objectives.

Rehabilitation of disabled persons can take many different forms according to the socio-cultural and political context in which it is undertaken. Some approaches have emphasized the restoration of the physical function of the client, while others have looked beyond to psychological and social well-being. Some have built on the expertise of professionals while others have emphasized the caring capacity available in the family and the community and sought to reinforce it. Besides providing a wide range of possible services to disabled persons, rehabilitation seeks to change the attitudes that prevail in society as a whole and promote the integration of disabled people into society with equal rights and opportunities. This paper reviews a range of models and approaches which have been put forward in the international debate on rehabilitation. Furthermore, four dimensions are described which can be used to characterize and define classes of rehabilitation projects based on the objectives that are defined for them. Thus types of rehabilitation projects can be distinguished. Management, evaluation and technical support for rehabilitation projects need to take these essential characteristics into account.

Delay in presentation and start of treatment in leprosy: experience in an out-patient clinic in Nepal.

Delayed presentation is a recognized risk factor for disability in leprosy but is the result of complex interactions between physical, social, economic and psychological factors. The present study is a response to the situation in an outpatient clinic in Nepal where the wide variation in delay in presentation was a cause for concern. A purpose-written questionnaire was used to collect information on 166 consecutive outpatient admissions. The data included demographics, the first symptom of leprosy, first actions, initial help-seeking behaviour, the reasons for finally seeking treatment and experience with professional health services. Initial analysis found a relationship between delay in presentation and age, rural environment, leprosy classification, walking time, housing not shared with another person affected by leprosy, and an inappropriate first action. The relationship with lack of education and total travel time just failed to reach significance. Further analysis identified that for the study population initial lack of awareness of leprosy and an inappropriate first action were the primary contributors to delay. Extensive and effective health education is needed to address this situation.

Nerve function impairment in leprosy: design, methodology, and intake status of a prospective cohort study of 2664 new leprosy cases in Bangladesh (The Bangladesh Acute Nerve Damage Study).

The Bangladesh Acute Nerve Damage Study (BANDS) is a prospective cohort study designed to investigate epidemiological, diagnostic, therapeutic and operational aspects of acute nerve function impairment in leprosy. The study is based at a single centre in Bangladesh, in an area with a high prevalence of leprosy. The centre, Danish Bangladesh Leprosy Mission, has a well-established vertical leprosy control programme. In this paper, the study design and methodology are described, together with definitions of nerve function impairment (NFI) used in this and subsequent papers. The study recruited 2664 new leprosy cases in a 12-month period. The male:female ratio is 1.25:1, and 17.61% of the cohort are under 15 years of age. In all, 83.33% of the cohort are paucibacillary (PB), and 16.67% multibacillary (MB). However, the MB rate amongst males is 19.72%, and amongst females is 12.85%, despite an equal period of delay to diagnosis. 55% of patients presented for treatment within 12 months of developing symptoms 6.12% of the total number of cases were smear positive, and 36.71% of the MB cases were smear positive. 9.61% of the total number of cases were graded as having World Health Organisation (WHO) disability grade 1, and 5.97% had grade 2. Amongst MB cases, 27.48% had WHO grade 1 disability present, and 18.24% had grade 2 present, compared with 6.04% and 3.51%, respectively, amongst PB cases. A total of 11.90% of the cohort had sensory NFI of any kind, and 7.39% had motor NFI. Ninety patients presented with NFI needing treatment (3.38%), and of these, 61 (67.78%) had silent NFI. MB patients had a prevalence of reaction/NFI needing treatment nearly 7 times higher than PB cases (15.32% amongst MB; 2.30% amongst PB), and males nearly double that of females (5.67% amongst males, 2.96% amongst females). The most commonly affected nerve by function impairment was the posterior tibial (sensory) with 6.46% of nerves affected (9.38% of patients), followed by the ulnar nerve with 3.23% of nerves impaired (5.56% of patients). Future research and publications, building on this foundation, will focus on the following areas: the incidence of NFI and reactive events, the risk factors for developing NFI, and the response to treatment of patients developing acute NFI.