Excess mortality among people with podoconiosis: secondary analysis of two Ethiopian cohorts.

BACKGROUND: While morbidity attributable to podoconiosis is relatively well studied, its pattern of mortality has not been established. METHODS: We compared the age-standardised mortality ratios (SMRs) of two datasets from northern Ethiopia: podoconiosis patients enrolled in a 1-y trial and a Health and Demographic Surveillance System cohort. RESULTS: The annual crude mortality rate per 1000 population for podoconiosis patients was 28.7 (95% confidence interval [CI] 17.3 to 44.8; n=663) while that of the general population was 2.8 (95% CI 2.3 to 3.4; n=44 095). The overall SMR for the study period was 6.0 (95% CI 3.6 to 9.4). CONCLUSIONS: Podoconiosis patients experience elevated mortality compared with the general population and further research is required to understand the reasons.

Cost-effectiveness and social outcomes of a community-based treatment for podoconiosis lymphoedema in the East Gojjam zone, Ethiopia.

BACKGROUND: Podoconiosis is a disease of the lymphatic vessels of the lower extremities that is caused by chronic exposure to irritant soils. It results in leg swelling, commonly complicated by acute dermatolymphangioadenitis (ADLA), characterised by severe pain, fever and disability. METHODS: We conducted cost-effectiveness and social outcome analyses of a pragmatic, randomised controlled trial of a hygiene and foot-care intervention for people with podoconiosis in the East Gojjam zone of northern Ethiopia. Participants were allocated to the immediate intervention group or the delayed intervention group (control). The 12-month intervention included training in foot hygiene, skin care, bandaging, exercises, and use of socks and shoes, and was supported by lay community assistants. The cost-effectiveness analysis was conducted using the cost of productivity loss due to acute dermatolymphangioadenitis. Household costs were not included. Health outcomes in the cost-effectiveness analysis were: the incidence of ADLA episodes, health-related quality of life captured using the Dermatology Life Quality Index (DLQI), and disability scores measured using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0). RESULTS: The cost of the foot hygiene and lymphoedema management supplies was 529 ETB (69 I$, international dollars) per person per year. The cost of delivery of the intervention as part of the trial, including transportation, storage, training of lay community assistants and administering the intervention was 1,890 ETB (246 I$) per person. The intervention was effective in reducing the incidence of acute dermatolymphangioadenitis episodes and improving DLQI scores, while there were no significant improvements in the disability scores measured using WHODAS 2.0. In 75% of estimations, the intervention was less costly than the control. This was due to improved work productivity. Subgroup analyses based on income group showed that the intervention was cost-effective (both less costly and more effective) in reducing the number of acute dermatolymphangioadenitis episodes and improving health-related quality of life in families with monthly income <1,000 ETB (130 I$). For the subgroup with family income ≥1,000 ETB, the intervention was more effective but more costly than the control. CONCLUSIONS: Whilst there is evident benefit of the intervention for all, the economic impact would be greatest for the poorest.

Lymphoedema management to prevent acute dermatolymphangioadenitis in podoconiosis in northern Ethiopia (GoLBeT): a pragmatic randomised controlled trial.

BACKGROUND: Podoconiosis (also known as endemic, non-filarial elephantiasis) affects about 4 million subsistence farmers in tropical Africa. Poor awareness of the condition and inadequate evidence for the efficacy of treatment mean that no government in an endemic country yet offers lymphoedema management for patients with podoconiosis. Among patients with filarial lymphoedema, trials suggest that limb care is effective in reducing the most disabling sequelae: episodes of acute dermatolymphangioadenitis. We aimed to test the hypothesis that a simple, inexpensive lymphoedema management package would reduce the incidence of acute dermatolymphangioadenitis in adult patients with podoconiosis in northern Ethiopia. METHODS: We did a pragmatic randomised controlled trial at health posts and health centres in 18 sub-districts of Aneded woreda (district) in Amhara, northern Ethiopia. Participants were adults aged 18 years and older, had a diagnosis of at least stage 2 podoconiosis (persistent lymphoedema) and a negative antigen test for filariasis, and intended to remain within Aneded woreda for the duration of the trial. Patients were randomly assigned (1:1) to either receive a package containing instructions for foot hygiene, skin care, bandaging, exercises, and use of socks and shoes, with support by lay Community Podoconiosis Agents at monthly meetings (intervention group) or to receive no intervention (control group). Participants were aware of their group assignment, but researchers doing all analyses were masked to treatment group. The primary outcome was incidence of acute dermatolymphangioadenitis episodes in the total period of observation of each participant, measured by use of validated patient self-reported pictorial diaries. This trial was registered with the International Standard Randomised Controlled Trials Number Register, number ISRCTN67805210. FINDINGS: Between Dec 1, 2014, and June 30, 2015, 1339 patients were screened, and 696 patients were enrolled and randomly allocated to treatment groups. We allocated 350 patients to the intervention group and 346 patients to the control group. 321 (92%) patients from the intervention group and 329 (95%) patients from the control group provided follow-up results at 12 months. During the 12 months of follow-up, 16 550 new episodes of acute dermatolymphangioadenitis occurred during 765·2 person-years. The incidence of acute dermatolymphangioadenitis was 19·4 episodes per person-year (95% CI 18·9-19·9) in the intervention group and 23·9 episodes per person-year (23·4-24·4) in the control group. The ratio of incidence rate in the intervention group to that of the control group was 0·81 (0·74 to 0·89; p<0·0001), with a rate difference of -4·5 (-5·1 to -3·8) episodes per person-year. No serious adverse events related to the intervention were reported. INTERPRETATION: A simple, inexpensive package of lymphoedema self-care is effective in reducing the frequency and duration of acute dermatolymphangioadenitis. We recommend its implementation by the governments of endemic countries. FUNDING: Joint Global Health Trials scheme (from the Wellcome Trust, the UK Medical Research Council, and UK Aid).

Willingness to pay for footwear, and associated factors related to podoconiosis in northern Ethiopia.

BACKGROUND: In Northern Ethiopia, use of footwear by the rural community is limited, and non-governmental organizations provide footwear for school children as a means of preventing podoconiosis. However, this is not a sustainable strategy. This study assessed willingness to pay for footwear among people with and without podoconiosis. METHODS: A comparative cross-sectional community-based study was conducted in Mecha and Gozamen woredas among randomly selected people with and without podoconiosis. Trained health extension workers collected data using an interviewer-administered structured questionnaire. The data were entered into EPI-Data and exported to SPSS version 16.0 statistical software package for analysis. RESULTS: The willingness to pay for footwear among people with and without podoconiosis was 72.3% and 76.7% respectively (p=0.30). People with podoconiosis in the lower quintiles of economic status were less likely to be willing to pay for footwear than those in the higher quintiles. CONCLUSIONS: There is substantial willingness to pay for footwear. The expressed willingness to pay indicates demand for footwear in the community, suggesting an opportunity for shoe companies. There are still a substantial proportion of individuals not willing to pay for footwear. This requires intensified public education and social transformation to bring about change in behavior towards footwear use if elimination of podoconiosis within our generation is to be achieved.

Using Qualitative Methods to Explore Lay Explanatory Models, Health-Seeking Behaviours and Self-Care Practices of Podoconiosis Patients in North-West Ethiopia.

BACKGROUND: Podoconiosis (endemic non-filarial elephantiasis) is a chronic, non-infectious disease resulting from exposure of bare feet to red-clay soil in tropical highlands. This study examined lay beliefs about three under-researched aspects of podoconiosis patients' care: explanatory models, health-seeking behaviours and self-care. METHODS: In-depth interviews and focus group discussions were undertaken with 34 participants (19 male, 15 female) between April-May 2015 at podoconiosis treatment centres across East and West Gojjam regions in north-west Ethiopia. RESULTS: Explanatory models for podoconiosis included contamination from blood, magic, soil or affected individuals. Belief in heredity or divine punishment often delayed clinic attendance. All participants had tried holy water treatment and some, holy soil. Herbal treatments were considered ineffectual, costly and appeared to promote fluid escape. Motivators for clinic attendance were failure of traditional treatments and severe or disabling symptoms. Patients did not report self-treatment with antibiotics. Self-care was hindered by water being unavailable or expensive and patient fatigue. CONCLUSION: A pluralistic approach to podoconiosis self-treatment was discovered. Holy water is widely valued, though some patients prefer holy soil. Priests and traditional healers could help promote self-care and "signpost" patients to clinics. Change in behaviour and improving water access is key to self-care.

Depression and disability in people with podoconiosis: a comparative cross-sectional study in rural Northern Ethiopia.

BACKGROUND: Little is known about depressive symptoms in podoconiosis despite the independent contribution of depression to worse health outcomes and disability in people with other chronic disorders. METHOD: Two-hundred and seventy-one individuals with podoconiosis and 268 healthy neighbours (individuals from the nearest household in any direction) were investigated for depressive symptoms using a validated Amharic version of the Patient Health Questionnaire (PHQ-9). The WHO Disability Assessment Schedule II (WHODAS II) tool was used to measure disability. Logistic regression and zero inflated negative binomial regression were used to identify factors associated with elevated depressive symptoms, and disability, respectively. RESULTS: Among study participants with podoconiosis, 12.6% (34/269) had high levels of depressive symptoms (scoring 5 or more points on the PHQ-9, on two assessments two weeks apart) compared to 0.7% (2/268) of healthy neighbours (p<0.001). Having podoconiosis and being older were significantly associated with increased odds of a high PHQ-9 score (adjusted odds ratios [AOR] 11.42; 95% CI: 2.44-53.44 and AOR 1.04; 95% CI: 1.00-1.08, respectively). Significant predictors of a higher disability score were having podoconiosis (WHODAS II multiplier value: 1.48; 95% CI: 1.39-1.58) and having a high PHQ-9 score (1.07; 95% CI: 1.06-1.08). CONCLUSION: We recommend integrating evidence-based treatments for depression into podoconiosis interventions.

Reasons for loss to follow-up of patients with podoconiosis in the Amhara Region, northern Ethiopia.

BACKGROUND: Podoconiosis is a non-infectious form of tropical lymphoedema characterised by swelling of the feet and lower legs. Treatment is simple and effective yet evidence indicates that a proportion of patients become lost to follow-up. METHODS: This study was a quantitative questionnaire-based study which aimed to identify the most common reasons for loss to follow-up of patients. A total of 191 participants registered with the International Orthodox Christian Charities (IOCC) who had become lost to follow-up were included in a cross-sectional survey based in the Amhara Region, northern Ethiopia. RESULTS: The most common reason was distance, stated by 26.7% (51/191). This was significantly associated with living further from the treatment site (p=0.02). Having had podoconiosis for longer was protective against this (p=0.03). For each additional hour of travel time a patient lived from the treatment centre, the odds of them reporting 'distance' as the main reason for becoming lost to follow-up increased by 1.61 (95% CI: 1.25-2.08). CONCLUSIONS: The consequences of podoconiosis are exacerbated by walking long distances, but in most areas, this is currently required of patients in order to receive treatment. We recommend expansion of services to widen treatment availability, since provision of transport to and from treatment centres is unlikely to be feasible.

Mental distress and podoconiosis in Northern Ethiopia: a comparative cross-sectional study.

BACKGROUND: The stigma, deformity and disability related to most neglected tropical diseases may lead to poor mental health. We aimed to assess the comorbidity of podoconiosis and mental distress. METHODS: A comparative cross-sectional study was conducted in 2012, including 346 people with podoconiosis and 349 healthy neighbourhood controls. Symptoms of mental distress were assessed using the validated Amharic translation of the Kessler-10 scale (K10). A linear regression analysis was conducted to identify factors associated with mental distress. RESULTS: The mean K10 score was 15.92 (95% CI: 15.27 to 16.57) in people with podoconiosis and 14.49 (95% CI: 13.85 to 15.12) in controls (average K10 scores 1.43 points higher [95% CI: 0.52 to 2.34]). In multivariate linear regression of K10 scores, the difference remained significant when adjusted for gender, income, alcohol use, age, place of residence and family history of mental illness. In the adjusted model, people with podoconiosis had K10 scores 1.37 points higher than controls (95% CI: 0.64 to 2.18). Other variables were also associated with high K10 scores: women had K10 scores 1.41 points higher than men (95% CI: 0.63 to 2.18). Those with family history of mental illness had K10 scores 3.56 points higher than those without (95% CI: 0.55 to 6.56). CONCLUSIONS: This study documented a high burden of mental distress among people with podoconiosis compared with healthy controls. Taking this finding in the context of the high stigma and reduced quality of life, we recommend integration of psychosocial care into the current morbidity management of podoconiosis.

Barriers to access and re-attendance for treatment of podoconiosis: a qualitative study in northern Ethiopia.

BACKGROUND: Podoconiosis is a chronic non-infectious lymphoedema affecting individuals exposed to red clay soil in endemic areas. Evidence from International Orthodox Christian Charities (IOCC) treatment centers' registers suggests that a significant proportion of registered patients with podoconiosis fail to re-attend for treatment, putting them at risk of worsening disability associated with the lymphoedema and attacks of acute adenolymphangitis. The aim of this study was to explore barriers to access and re-attendance of patients with podoconiosis in northern Ethiopia. METHODS: A cross-sectional qualitative study was conducted at three IOCC treatment sites from February to April 2013. Twenty-eight patients and three project leaders took part in in-depth interviews. Three focus group discussions were undertaken with 22 patients, patient association leaders and project staff members. RESULTS: Barriers to access and to continued attendance at treatment centers were recognized by all participant groups. The following reasons were reported: lay beliefs about the disease's causation and presentation, occupational, geographic and financial barriers, stigma and conflicting expectations of treatment services. CONCLUSIONS: This study illustrates the multiple, step-wise barriers to accessing treatment faced by podoconiosis patients. These factors are dynamic, frequently interact and result from competing social and economic priorities.

Podoconiosis patients' willingness to pay for treatment services in Northwest Ethiopia: potential for cost recovery.

BACKGROUND: Podoconiosis is non-filarial elephantiasis of the lower legs. It is more commonly found in tropical Africa, Central and South America, and northwest India. In Ethiopia, a few non-governmental organizations provide free treatment to podoconiosis patients, but sustainability of free treatment and scale-up of services to reach the huge unmet need is challenged by resource limitations. We aimed to determine podoconiosis patient's willingness to pay (WTP) for a treatment package (composed of deep cleaning of limbs with diluted antiseptic solution, soap, and water, bandaging, application of emollient on the skin, and provision of shoes), and factors associated with WTP in northwestern Ethiopia. METHODS: A cross-sectional study was conducted among randomly selected untreated podoconiosis patients (n=393) in Baso Liben woreda, northwestern Ethiopia. The contingent valuation method was used with a pre-tested interviewer-administered questionnaire. RESULTS: The majority of podoconiosis patients (72.8%) were willing to pay for treatment services. The median WTP amount was 64 Birr (US$ 3.28) per person per year. More than one-third of patients (36.7%) were willing to pay at least half of the full treatment cost and 76.2% were willing to pay at least half of the cost of shoes. A multivariate analysis showed that having a higher monthly income, being a woman, older age, being aware of the role of shoes to prevent podoconiosis, and possession of a functional radio were significantly associated with higher odds of WTP. CONCLUSIONS: The considerable WTP estimates showed that podoconiosis treatment could improve sustainability and service utilization. A subsidized cost recovery scheme could reduce treatment costs and more feasibility integrate podoconiosis treatment service with other NTDs and the government's primary health care system.

Stigma towards a neglected tropical disease: felt and enacted stigma scores among podoconiosis patients in Northern Ethiopia.

BACKGROUND: Podoconiosis, or non-filarial elephantiasis, is a neglected tropical disease (NTD) characterised by swelling of the lower legs. When left untreated, this disfiguring condition has a significant social impact. This study aimed to describe the stigma experience among podoconiosis patients in Dembecha, Northern Ethiopia and assess potential associations between stigma and sociodemographic determinants. METHODS: The study was conducted in May 2012 in Northern Ethiopia. A questionnaire-based cross-sectional study design was used and stigma was assessed using a validated podoconiosis stigma scale including 'felt' and 'enacted' stigma domains. Enacted stigma includes the experience of discrimination such as abuse, loss of employment or prejudicial attitudes, while felt stigma is the perceived fear of enacted stigma. A multivariable linear regression model was used to explore determinants that may be associated with stigma. RESULTS: A total of 346 clinically confirmed podoconiosis patients participated in the study. The total mean score of all stigma scale items was 30.7 (Range = 0 to 96). There was a higher mean score of scale items in domains of felt stigma (21.7; Range = 0 to 45) as compared to enacted stigma (9.0; Range = 0 to 51). The total mean score of all stigma scale items appeared to increase with disease stage. A final adjusted linear regression model found an association between stigma and factors including monthly income, duration lived in the current residence, and disease stage, after controlling for confounders. CONCLUSION: Podoconiosis is a stigmatized disease with a clear social impact. This paper documented the burden of podoconiosis-related stigma and identified associated factors. Programs aimed at preventing and treating podoconiosis should incorporate interventions to mitigate both felt and enacted stigma. Interventions targeting patients should prioritize those with advanced disease.

The impact of podoconiosis on quality of life in Northern Ethiopia.

BACKGROUND: Podoconiosis is one of the most neglected tropical diseases, which untreated, causes considerable physical disability and stigma for affected individuals. Little is known about the quality of life (QoL) of patients with podoconiosis. This study aimed to assess the QoL of patients with podoconiosis in comparison with healthy controls in Ethiopia. METHODS: A comparative cross-sectional study was conducted in May 2012, among 346 clinically confirmed adult patients with podoconiosis, and 349 healthy adult neighbourhood controls in Dembecha woreda (district) in northern Ethiopia. QoL was assessed using the validated Amharic version of the World Health Organisation Quality of Life questionnaire (WHOQoL-BREF) scale; in addition, mental health and stigma were assessed by the Kessler-10 scale and podoconiosis stigma scale respectively. Logistic regression analysis was done to identify factors associated with QoL. RESULTS: Patients with podoconiosis had significantly lower mean overall QoL than the controls (52.05 versus 64.39), and this was also true in all four sub domains (physical, psychological, social and environmental). Controls were 7 times more likely to have high (above median) QoL (Odds Ratio = 6.74, 95% Confidence Interval 4.62 to 9.84) than cases. Factors associated with lower QoL were: experiencing high levels of stigma, living in an urban area, being illiterate, having additional co-morbidities, and being unmarried. Mental illness was associated with lower scores in psychological and physical domains. CONCLUSIONS: Programs targeting podoconiosis interventions should include QoL as an indicator for monitoring progress. Interventions targeting improvement of QoL among patients with podoconiosis should address depression, stigma and other co-morbidities.

Patients' perceptions of podoconiosis causes, prevention and consequences in East and West Gojam, Northern Ethiopia.

BACKGROUND: Podoconiosis is a form of non-filarial elephantiasis that affects barefoot individuals in highland tropical areas. The disease presents with bilateral, asymmetric swelling of the legs, usually confined to below the knee. This study aimed to assess podoconiosis patients' perceptions of prevention, control, causes and familial clustering of the disease, and to document physical, social and economic impairments associated with the disease, with the ultimate aim of enabling development of tailored interventions in this region. METHODS: This descriptive study is part of the largest cross-sectional community-based household survey yet conducted on podoconiosis. It was completed in November and December, 2011, in Debre Eliyas and Dembecha Woredas of East and West Gojam Zones, northern Ethiopia, and consisted of a house-to-house census by community health workers followed by interviews of identified patients using a structured questionnaire. RESULTS: In the 17,553 households surveyed, 1,319 patients were identified. More male as compared to female patients were married (84.6% vs. 53.6%, χ(2) = 157.1, p < 0.0001) while more female as compared to male patients were divorced (22.5% vs. 3.6%, χ(2) = 102.3, p < 0.0001). Less than half of the study subjects believed podoconiosis could be prevented (37.5%) or controlled (40.4%) and many (41.3%) did not know the cause of podoconiosis. Two-fifths of the study subjects had a relative affected with podoconiosis. Approximately 13% of the respondents had experienced one or more forms of social stigmatization. The coping strategies adopted by patients to mitigate the physical impairments caused by podoconiosis were: working only occasionally (44.9%), avoiding physically demanding tasks (32.4%), working fewer hours (21.9%) or completely stopping work (8%). Most study subjects (96.4%) had noticed a decline in their income following the development of podoconiosis, and 78% said they were poorer than their healthy neighbours. CONCLUSION: This study shows that podoconiosis has strong psychosocial, physical and economic impacts on patients in East and West Gojam Zones of northern Ethiopia. Concerns related to familial clustering, poor understanding of the causes and prevention of podoconiosis all add to the physical burden imposed by the disease. Strategies that may ease the impact of podoconiosis include delivery of tailored health education on the causes and prevention of disease, involving patients in intervention activities, and development of alternative income-generating activities for treated patients.

Podoconiosis in East and West Gojam Zones, northern Ethiopia.

BACKGROUND: Podoconiosis is a neglected tropical disease (NTD) that is prevalent in red clay soil-covered highlands of tropical Africa, Central and South America, and northern India. It is estimated that up to one million cases exist in Ethiopia. This study aimed to estimate the prevalence of podoconiosis in East and West Gojam Zones of Amhara Region in northern Ethiopia. METHODOLOGY/PRINCIPAL FINDINGS: A cross-sectional household survey was conducted in Debre Eliyas and Dembecha woredas (districts) in East and West Gojam Zones, respectively. The survey covered all 17,553 households in 20 kebeles (administrative subunits) randomly selected from the two woredas. A detailed structured interview was conducted on 1,704 cases of podoconiosis identified in the survey. RESULTS: The prevalence of podoconiosis in the population aged 15 years and above was found to be 3.3% (95% CI, 3.2% to 3.6%). 87% of cases were in the economically active age group (15-64 years). On average, patients sought treatment five years after the start of the leg swelling. Most subjects had second (42.7%) or third (36.1%) clinical stage disease, 97.9% had mossy lesions, and 53% had open wounds. On average, patients had five episodes of acute adenolymphangitis (ALA) per year and spent a total of 90 days per year with ALA. The median age of first use of shoes and socks were 22 and 23 years, respectively. More men than women owned more than one pair of shoes (61.1% vs. 50.5%; χ(2) = 11.6 p = 0.001). At the time of interview, 23.6% of the respondents were barefoot, of whom about two-thirds were women. CONCLUSIONS: This study showed high prevalence of podoconiosis and associated morbidities such as ALA, mossy lesions and open wounds in northern Ethiopia. Predominance of cases at early clinical stage of podoconiosis indicates the potential for reversing the swelling and calls for disease prevention interventions.

Addressing the neglected tropical disease podoconiosis in Northern Ethiopia: lessons learned from a new community podoconiosis program.

BACKGROUND: Despite its great public health importance, few control initiatives addressing podoconiosis (non-filarial elephantiasis, a geochemical neglected tropical disease) exist. In June 2010, the first podoconiosis program in Northern Ethiopia, consisting of prevention, awareness, and care and support activities, began in Debre Markos, Northern Ethiopia. This study aims to document and disseminate the lessons learned from a new community podoconiosis program in Debre Markos. METHODS/PRINCIPAL FINDINGS: We used a content analysis approach to examine and evaluate data from a series of sources. These sources include conducted interview transcripts, a focus group discussion transcript and secondary sources including monitoring and evaluation field reports, observation notes, and research obtained from a literature review. Themes were identified and grouped into matrix tables. Overall, sixteen program steps were identified and grouped into 6 domains: Initial preparation, training and sensitization, foundation building, treatment activity implementation, awareness, and follow-up. Emphasis is placed on the need for baseline data, effective training, local leadership, experience-sharing, mass-awareness, cross-cutting sector issues (i.e., water and waste management), and integration with government health systems. Related successes and challenges are also described, as are stakeholder roles and misconceptions and socio-cultural challenges affecting the program start-up. Many of the identified successes and challenges are relevant to the aim of the podoconiosis program to be sustainable and community-led. CONCLUSIONS/SIGNIFICANCE: Much of this information has already been used to improve the Debre Markos program. We also anticipate that the domains and steps identified will be useful in guiding new programs in other settings where podoconiosis is highly prevalent. We hope to encourage partnerships and collaboration among podoconiosis stakeholders in future growth and disease control expansion.