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Setting up a pragmatic clinical trial in a low-resource setting: A qualitative assessment of GoLBeT, a trial of podoconiosis management in Northern Ethiopia.

ABSTRACT:

Background

Clinical trials are often perceived as being expensive, difficult and beyond the capacity of healthcare workers in low-resource settings. However, in order to improve healthcare coverage, the World Health Organization (WHO) World Health Report 2013 stated that all countries need to become generators as well as recipients of data. This study is a methodological examination of the steps and processes involved in setting up the Gojjam Lymphoedema Best Practice Trial (GoLBeT; ISRCTN67805210), a highly pragmatic clinical trial conducted in northern Ethiopia. Challenges to the trial and strategies used to deal with them were explored, together with the reasons for delays.

Methodology and principal findings

Qualitative research methods were used to analyse emails and reports from the period between trial inception and recruitment. This analysis was complemented by interviews with key informants from the trial operational team. The Global Health Research Process Map was used as a framework against which to compare the steps involved in setting up the trial. A mini-group discussion was conducted with the trial operational team after study completion for reflection and further recommendations. This study showed that the key areas of difficulty in setting up and planning this trial were: the study design, that is, deciding on the study endpoint, where and how best to measure it, and assuring statistical power; recruitment and appropriate training of staff; planning for data quality; and gaining regulatory approvals. Collaboration, for example with statisticians, the trial steering committee, the study monitors, and members of the local community was essential to successfully setting up the trial.

Conclusions and significance

Lessons learnt from this trial might guide others planning pragmatic trials in settings where research is not common, allowing them to anticipate possible challenges and address them through trial design, planning and operational delivery. We also hope that this example might encourage similar pragmatic studies to be undertaken. Such studies are rarely undertaken or locally led, but are an accessible and efficient way to drive improved outcomes in public health.

SUBMITTER: Erber AC

PROVIDER: S-EPMC8370641 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPodoconiosis (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.MethodsWe 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.FindingsBetween 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.InterpretationA 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.FundingJoint Global Health Trials scheme (from the Wellcome Trust, the UK Medical Research Council, and UK Aid).

Project description: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.

Project description:BackgroundPodoconiosis is a non-filarial elephantiasis caused by long-term barefoot exposure to volcanic soils in endemic areas. Irritant silicate particles penetrate the skin, causing a progressive, debilitating lymphoedema of the lower leg, often starting in the second decade of life. A simple patient-led treatment approach appropriate for resource poor settings has been developed, comprising (1) education on aetiology and prevention of podoconiosis, (2) foot hygiene (daily washing with soap, water and an antiseptic), (3) the regular use of emollient, (4) elevation of the limb at night, and (5) emphasis on the consistent use of shoes and socks.Methodology/principal findingsWe did a 12-month, non-comparative, longitudinal evaluation of 33 patients newly presenting to one clinic site of a non-government organization (the Mossy Foot Treatment & Prevention Association, MFTPA) in southern Ethiopia. Outcome measures used for the monitoring of disease progress were (1) the clinical staging system for podoconiosis, and (2) the Amharic Dermatology Life Quality Index (DLQI), both of which have been recently validated for use in this setting. Digital photographs were also taken at each visit. Twenty-seven patients completed follow up. Characteristics of patients completing follow-up were not significantly different to those not. Mean clinical stage and lower leg circumference decreased significantly (mean difference -0.67 (95% CI -0.38 to -0.96) and -2.00 (95% CI -1.26 to -2.74), respectively, p<0.001 for both changes). Mean DLQI diminished from 21 (out of a maximum of 30) to 6 (p<0.001). There was a non-significant change in proportion of patients with mossy lesions (p = 0.375).Conclusions/significanceThis simple, resource-appropriate regimen has a considerable impact both on clinical progression and self-reported quality of life of affected individuals. The regimen appears ideal for scaling up to other endemic regions in Ethiopia and internationally. We recommend that further research in the area include analysis of cost-effectiveness of the regimen.

Project description:BackgroundRural populations in low-income countries commonly suffer from the co-morbidity of neglected tropical diseases (NTDs). Podoconiosis, trachomatous trichiasis (both NTDs) and cataract are common causes of morbidity among subsistence farmers in the highlands of northern Ethiopia. We explored whether podoconiosis was associated with cataract or trachomatous trichiasis (TT) among this population.MethodsA comparative cross-sectional study was conducted in East Gojam region, Amhara, Ethiopia in May 2016. Data were collected from patients previously identified as having podoconiosis and from matched healthy neighbourhood controls. Information on socio-demographic factors, clinical factors and past medical history were collected by an interview-administered questionnaire. Clinical examination involved grading of podoconiosis by examination of both legs, measurement of visual acuity, direct ophthalmoscopy of dilated pupils to grade cataract, and eyelid and corneal examination to grade trachoma. Multiple logistic regression was conducted to estimate independent association and correlates of podoconiosis, TT and cataract.FindingsA total of 700 participants were included in this study; 350 podoconiosis patients and 350 healthy neighbourhood controls. The prevalence of TT was higher among podoconiosis patients than controls (65 (18.6%) vs 43 (12.3%)) with an adjusted odds ratio OR 1.57 (95% CI 1.02-2.40), p = 0.04. There was no significant difference in prevalence of cataract between the two populations with an adjusted OR 0.83 (95% CI 0.55-1.25), p = 0.36. Mean best visual acuity was 0.59 (SD 0.06) in podoconiosis cases compared to 0.44 (SD 0.04) in controls, p<0.001. The proportion of patients classified as blind was higher in podoconiosis cases compared with healthy controls; 5.6% vs 2.0%; adjusted OR 2.63 (1.08-6.39), P = 0.03.ConclusionsIndividuals with podoconiosis have a higher burden of TT and worse visual acuity than their matched healthy neighbourhood controls. Further research into the environmental and biological reasons for this co-morbidity is required. A shared approach to managing these two NTDs within the same population could be beneficial.

Project description:Background: Despite the fact that the burden, risk factors, and clinical characteristics of acute coronary syndrome (ACS) have been studied widely in developed countries, limited data are available from sub-Saharan Africa. Therefore, this study aimed at evaluating the clinical characteristics, treatment, and 30-day mortality of patients with ACS admitted to tertiary hospitals in Ethiopia. Methods: A total of 181 ACS patients admitted to tertiary care hospitals in Ethiopia were enrolled from March 15 to November 15, 2018. The clinical characteristics, management, and 30-day mortality were evaluated by ACS subtype. The Cox proportional hazards model was used to determine the predictors of 30-day all-cause mortality. A p-value < 0.05 was considered statistically significant. Results: The majority (61%) of ACS patients were admitted with ST-segment elevation myocardial infarction (STEMI). The mean age was 56 years, with male predominance (62.4%). More than two-thirds (67.4%) of patients presented to hospital after 12 h of symptom onset. Dyslipidemia (48%) and hypertension (44%) were the most common risk factors identified. In-hospital dual antiplatelet and statin use was high (>90%), followed by beta-blockers (81%) and angiotensin-converting enzyme inhibitors (ACEIs; 72%). Late reperfusion with percutaneous coronary intervention (PCI) was done for only 13 (7.2%), and none of the patients received early reperfusion therapy. The 30-day all-cause mortality rate was 25.4%. On multivariate Cox proportional hazards model analysis, older age [hazard ratio (HR) = 1.03, 95% CI = 1.003-1.057], systolic blood pressure (HR = 0.99, 95% CI = 0.975-1.000), serum creatinine (HR = 1.32, 95% CI = 1.056-1.643), Killip class > II (HR = 4.62, 95% CI = 2.502-8.523), ejection fraction <40% (HR = 2.75, 95% CI = 1.463-5.162), and STEMI (HR = 2.72, 95% CI = 1.006-4.261) were independent predictors of 30-day mortality. Conclusions: The 30-day all-cause mortality rate was unacceptably high, which implies an urgent need to establish a nationwide program to reduce pre-hospital delay, promoting the use of guideline-directed medications, and increasing access to reperfusion therapy.

Project description:BACKGROUND:Several studies have shown that leprosy, podoconiosis and lymphatic filariasis impact individual quality of life. In contrast, family quality of life has not received as much attention despite evidence that families are also affected. This is especially relevant given the crucial role of the family in most societies around the world. This study looks at the impact of leprosy, podoconiosis and lymphatic filariasis on family quality of life. METHODOLOGY:The study used a cross-sectional design with a qualitative approach. Both semi-structured interviews and focus group discussions were conducted. Participants, persons affected and their family members, were selected by purposive sampling. Data were collected between August and November 2017 in Awi zone, Northwest Ethiopia and analysed by three independent researchers using open, inductive coding and content analysis. RESULTS:A total of 86 participants were included in this study: 56 participants in the in-depth interviews and 30 participants in the focus group discussions. We found that participation restrictions, reduced productivity and marginalisation were common. In addition, discrimination in the communities occurred often, often extending to family members of persons affected. Divorce and difficulties in finding a spouse were common for persons affected and their family members. Many persons affected reported mental health problems. While most people got social and physical support from their families, there were a few exceptions. In particular, persons with younger children seemed to lack social support. Having to provide for their affected family member sometimes caused stress, school dropouts and an additional workload. Financial problems and loss of livelihood were reported by almost all participants. CONCLUSION:This study revealed that leprosy, lymphatic filariasis and podoconiosis have an effect on several dimensions of family quality of life. Many problems reported related to stigma and poverty.

Project description:Community pharmacy professionals are being widely accepted as sources of treatment and advice for managing minor ailments, largely owing to their location at the heart of the community. The aim of the present study was, therefore, to document the involvement of community pharmacy professionals in the management of minor ailments and perceived barriers that limit their provision of such services. Simulated patient (SP) visits combined with a qualitative study using in-depth interviews was conducted among community pharmacy professionals in Gondar town, Northwest Ethiopia. Scenarios of three different minor ailments (uncomplicated upper respiratory tract infection, back pain and acute diarrhea) were selected and results were reported as percentages. Pharmacy professionals were also interviewed about the barriers in the management of minor ailments. Out of 66 simulated visits, 61 cases (92.4%) provided one or more medications to the SPs. Pharmacy professionals in 16 visits asked SPs information on details of symptoms and past medical and medication history. Ibuprofen alone or in combination with paracetamol was the most commonly dispensed analgesics for back pain. Oral rehydration fluid (ORS) with zinc was the most frequently dispensed medication (33.3%) for the management of acute diarrhea followed by mebendazole (23.9%). Moreover, amoxicillin-clavulanic acid capsule (35%) followed by Amoxicillin (25%) were the most commonly dispensed antibiotics for uncomplicated upper respiratory tract infection. Lack of clinical training and poor community awareness towards the role of community pharmacists in the management of minor ailments were the main barriers for the provision of minor ailment management by community pharmacy professionals. Overall, community pharmacists provided inadequate therapy for the simulated minor ailments. Lack of access to clinical training and poor community awareness were the most commonly cited barriers for providing such services. So as to improve community pharmacists' involvement in managing minor ailments and optimize the contribution of pharmacists, interventions should focus on overcoming the identified barriers.