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Artemisinin-based combination therapies (ACTs) were introduced as the standard of care for uncomplicated malaria in Africa almost two decades ago. Recent studies in East Africa have reported a gradual increase in kelch13 (k13) mutant parasites associated with reduced artesunate efficacy. As part of the Community Access to Rectal Artesunate for Malaria project, we collected blood samples from 697 children with signs of severe malaria in northern Uganda between 2018 and 2020, before and after the introduction of rectal artesunate (RAS) in 2019. K13 polymorphisms were assessed, and parasite editing and phenotyping were performed to assess the impact of mutations on parasite resistance. Whole-genome sequencing was performed, and haplotype networks were constructed to determine the geographic origin of k13 mutations. Of the 697 children, 540 were positive for Plasmodium falciparum malaria by PCR and were treated with either RAS or injectable artesunate monotherapy followed in most cases by ACT. The most common k13 mutation was C469Y (6.7%), which was detected more frequently in samples collected after RAS introduction. Genome editing confirmed reduced in vitro susceptibility to artemisinin in C469Y-harboring parasites compared to wild-type controls (P < 0.001). The haplotypic network showed that flanking regions of the C469Y mutation shared the same African genetic background, suggesting a single and indigenous origin of the mutation. Our data provide evidence of selection for the artemisinin-resistant C469Y mutation. The realistic threat of multiresistant parasites emerging in Africa should encourage careful monitoring of the efficacy of artemisinin derivatives and strict adherence to ACT treatment regimens.
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Antimaláricos , Artemisininas , Resistência a Medicamentos , Malária Falciparum , Plasmodium falciparum , Proteínas de Protozoários , Plasmodium falciparum/efeitos dos fármacos , Plasmodium falciparum/genética , Uganda , Artemisininas/uso terapêutico , Artemisininas/farmacologia , Humanos , Antimaláricos/uso terapêutico , Antimaláricos/farmacologia , Malária Falciparum/tratamento farmacológico , Malária Falciparum/parasitologia , Resistência a Medicamentos/genética , Proteínas de Protozoários/genética , Mutação , Artesunato/uso terapêutico , Artesunato/farmacologia , Pré-Escolar , Criança , Masculino , FemininoRESUMO
Research on social innovations in health has increased in recent years. However, little training is geared toward enhancing social innovation research capacity. Most health training for low- and middle-income countries (LMICs) is developed by individuals in high-income countries, disregarding LMIC researchers' wisdom and insights and the communities' needs. Our team organized a multi-phase investigation involving a series of surveys and co-creation group discussions to assess individuals' training needs that directly informed a subsequent co-created training workshop series. We conducted a Hennessy-Hicks Training Needs Assessment among the Social Innovation in Health Initiative (SIHI) network and formed a co-creation group comprising SIHI fellows to design related training workshops. We ran a final evaluation survey and analyzed the workshop series' strengths, weaknesses and threats. Descriptive and thematic analysis were employed to analyze survey data and open-ended responses. The final evaluation survey captured data from 165 learners in 35 countries, including 26 LMICs. Most participants (67.3%, 111/165) rated the training workshop series as excellent, and 30.3% (50/165) rated it as good on a five-point scale. The need for writing research grants and manuscripts was rated the highest priority. Learners were interested in community-engaged research and diversity, equity and inclusion. This workshop illustrated how co-creation could be an effective tool for developing training materials tailored for LMIC researchers. We also offer a template for conducting a needs assessment and subsequent training workshops for LMICs. The ground-up, locally developed courses may be more effective than externally developed training programs intended for LMICs.
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Países em Desenvolvimento , Renda , Humanos , Avaliação das Necessidades , Inquéritos e Questionários , PesquisadoresRESUMO
Community health workers (CHW) usually refer children with suspected severe malaria to the nearest public health facility or a designated public referral health facility (RHF). Caregivers do not always follow this recommendation. This study aimed at identifying post-referral treatment-seeking pathways that lead to appropriate antimalarial treatment for children less than five years with suspected severe malaria. An observational study in Uganda enrolled children below five years presenting to CHWs with signs of severe malaria. Children were followed up 28 days after enrolment to assess their condition and treatment-seeking history, including referral advice and provision of antimalarial treatment from visited providers. Of 2211 children included in the analysis, 96% visited a second provider after attending a CHW. The majority of CHWs recommended caregivers to take their child to a designated RHF (65%); however, only 59% followed this recommendation. Many children were brought to a private clinic (33%), even though CHWs rarely recommended this type of provider (3%). Children who were brought to a private clinic were more likely to receive an injection than children brought to a RHF (78% vs 51%, p<0.001) and more likely to receive the second or third-line injectable antimalarial (artemether: 22% vs. 2%, p<0.001, quinine: 12% vs. 3%, p<0.001). Children who only went to non-RHF providers were less likely to receive an artemisinin-based combination therapy (ACT) than children who attended a RHF (odds ratio [OR] = 0.64, 95% CI 0.51-0.79, p<0.001). Children who did not go to any provider after seeing a CHW were the least likely to receive an ACT (OR = 0.21, 95% CI 0.14-0.34, p<0.001). Health policies should recognise local treatment-seeking practices and ensure adequate quality of care at the various public and private sector providers where caregivers of children with suspected severe malaria actually seek care.
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BACKGROUND: Increasing trends of antimicrobial resistance are observed around the world, driven in part by excessive use of antimicrobials. Limited access to diagnostics, particularly in low- and middle-income countries, contributes to diagnostic uncertainty, which may promote unnecessary antibiotic use. We investigated whether introducing a package of diagnostic tools, clinical algorithm, and training-and-communication messages could safely reduce antibiotic prescribing compared with current standard-of-care for febrile patients presenting to outpatient clinics in Uganda. METHODS: This was an open-label, multicenter, 2-arm randomized controlled trial conducted at 3 public health facilities (Aduku, Nagongera, and Kihihi health center IVs) comparing the proportions of antibiotic prescriptions and clinical outcomes for febrile outpatients aged ≥1 year. The intervention arm included a package of point-of-care tests, a diagnostic and treatment algorithm, and training-and-communication messages. Standard-of-care was provided to patients in the control arm. RESULTS: A total of 2400 patients were enrolled, with 49.5% in the intervention arm. Overall, there was no significant difference in antibiotic prescriptions between the study arms (relative risk [RR]: 1.03; 95% CI: .96-1.11). In the intervention arm, patients with positive malaria test results (313/500 [62.6%] vs 170/473 [35.9%]) had a higher RR of being prescribed antibiotics (1.74; 1.52-2.00), while those with negative malaria results (348/688 [50.6%] vs 376/508 [74.0%]) had a lower RR (.68; .63-.75). There was no significant difference in clinical outcomes. CONCLUSIONS: This study found that a diagnostic intervention for management of febrile outpatients did not achieve the desired impact on antibiotic prescribing at 3 diverse and representative health facility sites in Uganda.
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Administração de Caso , Malária , Humanos , Uganda , Pacientes Ambulatoriais , Malária/tratamento farmacológico , Febre/diagnóstico , Febre/tratamento farmacológico , Antibacterianos/uso terapêutico , Instituições de Assistência Ambulatorial , Comunicação , AlgoritmosRESUMO
[This corrects the article DOI: 10.1371/journal.pmed.1004189.].
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Severe malaria is a potentially fatal condition that requires urgent treatment. In a clinical trial, a sub-group of children treated with rectal artesunate (RAS) before being referred to a health facility had an increased chance of survival. We recently published in BMC Medicine results of the CARAMAL Project that did not find the same protective effect of pre-referral RAS implemented at scale under real-world conditions in three African countries. Instead, CARAMAL identified serious health system shortfalls that impacted the entire continuum of care, constraining the effectiveness of RAS. Correspondence to the article criticized the observational study design and the alleged interpretation and consequences of our findings.Here, we clarify that we do not dispute the life-saving potential of RAS, and discuss the methodological criticism. We acknowledge the potential for confounding in observational studies. Nevertheless, the totality of CARAMAL evidence is in full support of our conclusion that the conditions under which RAS can be beneficial were not met in our settings, as children often failed to complete referral and post-referral treatment was inadequate.The criticism did not appear to acknowledge the realities of highly malarious settings documented in detail in the CARAMAL project. Suggesting that trial-demonstrated efficacy is sufficient to warrant large-scale deployment of pre-referral RAS ignores the paramount importance of functioning health systems for its delivery, for completing post-referral treatment, and for achieving complete cure. Presenting RAS as a "magic bullet" distracts from the most urgent priority: fixing health systems so they can provide a functioning continuum of care and save the lives of sick children.The data underlying our publication is freely accessible on Zenodo.
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Antimaláricos , Artemisininas , Malária , Criança , Humanos , Pré-Escolar , Artesunato/uso terapêutico , Antimaláricos/uso terapêutico , Artemisininas/uso terapêutico , Administração Retal , Malária/tratamento farmacológico , Encaminhamento e Consulta , Bisacodil/uso terapêuticoRESUMO
BACKGROUND: For a full treatment course of severe malaria, community-administered pre-referral rectal artesunate (RAS) should be completed by post-referral treatment consisting of an injectable antimalarial and oral artemisinin-based combination therapy (ACT). This study aimed to assess compliance with this treatment recommendation in children under 5 years. METHODS AND FINDINGS: This observational study accompanied the implementation of RAS in the Democratic Republic of the Congo (DRC), Nigeria, and Uganda between 2018 and 2020. Antimalarial treatment was assessed during admission in included referral health facilities (RHFs) in children under 5 with a diagnosis of severe malaria. Children were either referred from a community-based provider or directly attending the RHF. RHF data of 7,983 children was analysed for appropriateness of antimalarials; a subsample of 3,449 children was assessed additionally for dosage and method of ACT provision (treatment compliance). A parenteral antimalarial and an ACT were administered to 2.7% (28/1,051) of admitted children in Nigeria, 44.5% (1,211/2,724) in Uganda, and 50.3% (2,117/4,208) in DRC. Children receiving RAS from a community-based provider were more likely to be administered post-referral medication according to the guidelines in DRC (adjusted odds ratio (aOR) = 2.13, 95% CI 1.55 to 2.92, P < 0.001), but less likely in Uganda (aOR = 0.37, 95% CI 0.14 to 0.96, P = 0.04) adjusting for patient, provider, caregiver, and other contextual factors. While in DRC, inpatient ACT administration was common, ACTs were often prescribed at discharge in Nigeria (54.4%, 229/421) and Uganda (53.0%, 715/1,349). Study limitations include the unfeasibility to independently confirm the diagnosis of severe malaria due to the observational nature of the study. CONCLUSIONS: Directly observed treatment was often incomplete, bearing a high risk for partial parasite clearance and disease recrudescence. Parenteral artesunate not followed up with oral ACT constitutes an artemisinin monotherapy and may favour the selection of resistant parasites. In connection with the finding that pre-referral RAS had no beneficial effect on child survival in the 3 study countries, concerns about an effective continuum of care for children with severe malaria seem justified. Stricter compliance with the WHO severe malaria treatment guidelines is critical to effectively manage this disease and further reduce child mortality. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03568344).
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Antimaláricos , Malária , Criança , Humanos , Pré-Escolar , Artesunato/uso terapêutico , Antimaláricos/uso terapêutico , República Democrática do Congo/epidemiologia , Uganda , Nigéria/epidemiologia , Malária/tratamento farmacológico , Malária/epidemiologia , Malária/diagnóstico , Encaminhamento e ConsultaRESUMO
BACKGROUND: Rectal artesunate, an efficacious pre-referral treatment for severe malaria in children, was deployed at scale in Uganda, Nigeria, and DR Congo. In addition to distributing rectal artesunate, implementation required additional investments in crucial but neglected components in the care for severe malaria. We examined the real-world costs and constraints to rectal artesunate implementation. METHODS: We collected primary data on baseline health system constraints and subsequent rectal artesunate implementation expenditures. We calculated the equivalent annual cost of rectal artesunate implementation per child younger than 5 years at risk of severe malaria, from a health system perspective, separating neglected routine health system components from incremental costs of rectal artesunate introduction. FINDINGS: The largest baseline constraints were irregular health worker supervisions, inadequate referral facility worker training, and inadequate malaria commodity supplies. Health worker training and behaviour change campaigns were the largest startup costs, while supervision and supply chain management accounted for most annual routine costs. The equivalent annual costs of preparing the health system for managing severe malaria with rectal artesunate were US$2·63, $2·20, and $4·19 per child at risk and $322, $219, and $464 per child treated in Uganda, Nigeria, and DR Congo, respectively. Strengthening the neglected, routine health system components accounted for the majority of these costs at 71·5%, 65·4%, and 76·4% of per-child costs, respectively. Incremental rectal artesunate costs accounted for the minority remainder. INTERPRETATION: Although rectal artesunate has been touted as a cost-effective pre-referral treatment for severe malaria in children, its real-world potential is limited by weak and under-financed health system components. Scaling up rectal artesunate or other interventions relying on community health-care providers only makes sense alongside additional, essential health system investments sustained over the long term. FUNDING: Unitaid. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.
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Antimaláricos , Artemisininas , Malária , Humanos , Artesunato/uso terapêutico , Antimaláricos/uso terapêutico , Artemisininas/uso terapêutico , Malária/tratamento farmacológico , África SubsaarianaRESUMO
Pre-referral rectal artesunate suppositories can save the lives of children with severe malaria if patients receive adequate post-referral care. A multi-country randomised controlled trial reporting on the efficacy of rectal artesunate informed the current WHO guidelines. In October, 2022, we reported on the findings of the Community Access to Rectal Artesunate for Malaria (CARAMAL) project, a carefully monitored roll-out of quality-assured rectal artesunate into established community-based health-care systems in DR Congo, Nigeria, and Uganda. The aim of the project was to understand the challenges involved in the successful real-world implementation of pre-referral rectal artesunate and to inform subsequent scale-up in endemic countries. In our study, we found that children treated with pre-referral rectal artesunate in routine clinical practice did not have an increased chance of survival, most likely explained by shortfalls along the continuum of care. A substantial proportion of the more than 6200 severely ill children that were followed up 28 days after treatment initiation did not receive comprehensive severe malaria care, either due to an incomplete referral to a secondary facility, or due to incomplete post-referral treatment. The observational study design allowed for a realistic assessment of the obstacles involved in implementing pre-referral rectal artesunate in settings where malaria mortality remains high. Without improving the entire continuum of care, children will continue to die from severe malaria and promising interventions will fail to meet their full potential.
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Antimaláricos , Artemisininas , Malária , Criança , Humanos , Artesunato/uso terapêutico , Antimaláricos/uso terapêutico , Artemisininas/uso terapêutico , Malária/tratamento farmacológico , Malária/epidemiologia , Encaminhamento e Consulta , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Observacionais como AssuntoRESUMO
BACKGROUND: For children below 6 years with suspected severe malaria attending a health care provider unable to provide parenteral malaria treatment, pre-referral rectal artesunate (RAS) is recommended by the World Health Organization to prevent death and disability. A number of African countries are in the process of rolling out quality-assured RAS for pre-referral treatment of severe malaria at community-level. The success of RAS depends, among other factors, on the acceptability of RAS in the communities where it is being rolled-out. Yet to date, there is limited literature on RAS acceptability. This study aimed to determine the acceptability of RAS by health care providers and child caregivers in communities where quality assured RAS was rolled out. This study was nested within the comprehensive multi-country observational research project Community Access to Rectal Artesunate for Malaria (CARAMAL), implemented in the Democratic Republic of the Congo (DRC), Nigeria, and Uganda between 2018 and 2020. Data from three different sources were analysed to understand RAS acceptability: interviews with health workers during three health care provider surveys (N = 341 community health workers and 467 primary health facility workers), with caregivers of children < 5 years of age during three household surveys (N = 9332 caregivers), and with caregivers of children < 5 years of age who were treated with RAS and enrolled in the CARAMAL Patient Surveillance System (N = 3645 caregivers). RESULTS: RAS acceptability was high among all interviewed stakeholders in the three countries. After the roll-out of RAS, 97-100% heath care providers in DRC, 98-100% in Nigeria and 93-100% in Uganda considered RAS as very good or good. Majority of caregivers whose children had received RAS for pre-referral management of severe malaria indicated that they would want to get the medication again, if their child had the same illness (99.8% of caregivers in DRC, 100% in Nigeria and 99.9% in Uganda). In three household surveys, 67-80% of caregivers whose children had not previously received RAS considered the medication as useful. CONCLUSION: RAS was well accepted by health workers and child caregivers in DRC, Nigeria and Uganda. Acceptability is unlikely to be an obstacle to the large-scale roll-out of RAS in the studied settings.
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Antimaláricos , Artemisininas , Malária , Criança , Humanos , Pré-Escolar , Artesunato/uso terapêutico , Nigéria/epidemiologia , República Democrática do Congo , Antimaláricos/uso terapêutico , Artemisininas/uso terapêutico , Cuidadores , Uganda/epidemiologia , Malária/tratamento farmacológico , Malária/epidemiologia , Encaminhamento e Consulta , Agentes Comunitários de SaúdeRESUMO
BACKGROUND: To prevent child deaths from severe malaria, early parenteral treatment is essential. Yet, in remote rural areas, accessing facilities offering parenteral antimalarials may be difficult. A randomised controlled trial found pre-referral treatment with rectal artesunate (RAS) to reduce deaths and disability in children who arrived at a referral facility with delay. This study examined the effectiveness of pre-referral RAS treatment implemented through routine procedures of established community-based health care systems. METHODS: An observational study accompanied the roll-out of RAS in the Democratic Republic of the Congo (DRC), Nigeria and Uganda. Children <5 years of age presenting to a community-based health provider with a positive malaria test and signs of severe malaria were enrolled and followed up during admission and after 28 days to assess their health status and treatment history. The primary outcome was death; covariates of interest included RAS use, referral completion, and post-referral treatment. RESULTS: Post-roll-out, RAS was administered to 88% of patients in DRC, 52% in Nigeria, and 70% in Uganda. The overall case fatality rate (CFR) was 6.7% (135/2011) in DRC, 11.7% (69/589) in Nigeria, and 0.5% (19/3686) in Uganda; 13.8% (865/6286) of patients were sick on day 28. The CFR was higher after RAS roll-out in Nigeria (16.1 vs. 4.2%) and stable in DRC (6.7 vs. 6.6%) and Uganda (0.7 vs. 0.3%). In DRC and Nigeria, children receiving RAS were more likely to die than those not receiving RAS (aOR=3.06, 95% CI 1.35-6.92 and aOR=2.16, 95% CI 1.11-4.21, respectively). Only in Uganda, RAS users were less likely to be dead or sick at follow-up (aOR=0.60, 95% CI 0.45-0.79). Post-referral parenteral antimalarials plus oral artemisinin-based combination therapy (ACT), a proxy for appropriate post-referral treatment, was protective. However, in referral health facilities, ACT was not consistently administered after parenteral treatment (DRC 68.4%, Nigeria 0%, Uganda 70.9%). CONCLUSIONS: Implemented at scale to the recommended target group, pre-referral RAS had no beneficial effect on child survival in three highly malaria-endemic settings. RAS is unlikely to reduce malaria deaths unless health system issues such as referral and quality of care at all levels are addressed. TRIAL REGISTRATION: The study is registered on ClinicalTrials.gov : NCT03568344.
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Antimaláricos , Artemisininas , Malária , Antimaláricos/uso terapêutico , Artemisininas/uso terapêutico , Artesunato/uso terapêutico , Criança , Pré-Escolar , Humanos , Recém-Nascido , Malária/diagnóstico , Malária/tratamento farmacológico , Encaminhamento e ConsultaRESUMO
Identification, stabilization, and prompt referral of children with signs of severe febrile disease (danger signs) in rural communities are crucial for preventing complications and death from severe malaria, pneumonia, and diarrhea. We set out to determine the treatment-seeking practices and treatment patterns for children < 5 years of age with an acute febrile illness, with or without danger signs of severe disease, in a highly malaria-endemic area of northern Uganda. Three household surveys were conducted from November through December each year in 2018, 2019, and 2020. Overall, 30% of the children in the study were reported to have had a WHO-classified danger sign including convulsions, unconsciousness/unusually sleepy, inability to feed or drink, and vomiting everything. Only half of the children in this study sought care from a health provider. However, significantly more children with danger signs of severe disease sought and received treatment and diagnostics from a health provider, compared with those without danger signs (adjusted odds ratio: 1.6, 95% confidence interval: 1.2-2.0; P < 0.01). In the total population studied, care seeking in the public sector was 26% and similar to care seeking in the private sector (24%). Community health workers were used as the first source of care by 12% of the children. Approximately 38% of the children who were reported to have danger signs of severe disease requiring prompt referral and treatment did not seek care from a health provider. Understanding and addressing barriers to accessing healthcare could contribute to better treatment seeking practices.
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Malária , Criança , Agentes Comunitários de Saúde , Febre , Humanos , Lactente , Malária/diagnóstico , Malária/tratamento farmacológico , Malária/epidemiologia , Aceitação pelo Paciente de Cuidados de Saúde , Uganda/epidemiologiaRESUMO
INTRODUCTION: Almost all sub-Saharan African countries have adopted some form of integrated community case management (iCCM) to reduce child mortality, a strategy targeting common childhood diseases in hard-to-reach communities. These programs are complex, maintain diverse implementation typologies and involve many components that can influence the potential success of a program or its ability to effectively perform at scale. While tools and methods exist to support the design and implementation of iCCM and measure its progress, these may not holistically consider some of its key components, which can include program structure, setting context and the interplay between community, human resources, program inputs and health system processes. METHODS: We propose a Global South-driven, systems-based framework that aims to capture these different elements and expand on the fundamental domains of iCCM program implementation. We conducted a content analysis developing a code frame based on iCCM literature, a review of policy documents and discussions with key informants. The framework development was guided by a combination of health systems conceptual frameworks and iCCM indices. RESULTS: The resulting framework yielded 10 thematic domains comprising 106 categories. These are complemented by a catalogue of critical questions that program designers, implementers and evaluators can ask at various stages of program development to stimulate meaningful discussion and explore the potential implications of implementation in decentralised settings. CONCLUSION: The iCCM Systems Framework proposed here aims to complement existing intervention benchmarks and indicators by expanding the scope and depth of the thematic components that comprise it. Its elements can also be adapted for other complex community interventions. While not exhaustive, the framework is intended to highlight the many forces involved in iCCM to help managers better harmonise the organisation and evaluation of their programs and examine their interactions within the larger health system.
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Administração de Caso , Planejamento em Saúde Comunitária , Criança , Mortalidade da Criança , Serviços de Saúde Comunitária , Programas Governamentais , HumanosRESUMO
OBJECTIVES: Despite progress made to expand access to health service in Ghana, inequities still exist. Social innovations have been developed as community-engaged solutions to decrease inequities. METHODS: In partnership with a multistakeholder group, our social innovation team organised a crowdsourcing contest to identify health innovations in Ghana. Informed by a WHO-Special Programme for Research and Training in Tropical Diseases framework, we organised a six-stage crowdsourcing challenge. RESULTS: In all, 13 innovations were received in the contest, while 2 innovations were rejected after initial screening. The 11 innovations were reviewed by a panel of four independent expert judges. Inter-rated reliability index (kappa) was 0.86. Following the review of the average score, five top innovations were recognised. These submissions can be put into three main themes: technology and strengthening (eg, mHealth for cervical cancer screening, video directly observed therapy), inclusiveness and reaching the marginalised (people with disability and infertility) and data utilisation for project improvement (seasonal calendar to reduce morbidity and mortality of children under 5 for malaria, diarrhoea and pneumonia). CONCLUSION: In conclusion, this study shows that solutions to local problems exist. Therefore, policymakers, the government and development partners should support the scale-up of such innovations.
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Crowdsourcing , Neoplasias do Colo do Útero , Criança , Detecção Precoce de Câncer , Feminino , Gana , Humanos , Reprodutibilidade dos Testes , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/prevenção & controleRESUMO
INTRODUCTION: Children who receive prereferral rectal artesunate (RAS) require urgent referral to a health facility where appropriate treatment for severe malaria can be provided. However, the rapid improvement of a child's condition after RAS administration may influence a caregiver's decision to follow this recommendation. Currently, the evidence on the effect of RAS on referral completion is limited. METHODS: An observational study accompanied the roll-out of RAS in three malaria endemic settings in the Democratic Republic of the Congo (DRC), Nigeria and Uganda. Community health workers and primary health centres enrolled children under 5 years with suspected severe malaria before and after the roll-out of RAS. All children were followed up 28 days after enrolment to assess their treatment-seeking pathways. RESULTS: Referral completion was 67% (1408/2104) in DRC, 48% (287/600) in Nigeria and 58% (2170/3745) in Uganda. In DRC and Uganda, RAS users were less likely to complete referral than RAS non-users in the pre-roll-out phase (adjusted OR (aOR)=0.48, 95% CI 0.30 to 0.77 and aOR=0.72, 95% CI 0.58 to 0.88, respectively). Among children seeking care from a primary health centre in Nigeria, RAS users were less likely to complete referral compared with RAS non-users in the post-roll-out phase (aOR=0.18, 95% CI 0.05 to 0.71). In Uganda, among children who completed referral, RAS users were significantly more likely to complete referral on time than RAS non-users enrolled in the pre-roll-out phase (aOR=1.81, 95% CI 1.17 to 2.79). CONCLUSIONS: The findings of this study raise legitimate concerns that the roll-out of RAS may lead to lower referral completion in children who were administered prereferral RAS. To ensure that community-based programmes are effectively implemented, barriers to referral completion need to be addressed at all levels. Alternative effective treatment options should be provided to children unable to complete referral. TRIAL REGISTRSTION NUMBER: NCT03568344; ClinicalTrials.gov.
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Antimaláricos , Malária , Antimaláricos/uso terapêutico , Artesunato/uso terapêutico , Criança , Pré-Escolar , República Democrática do Congo/epidemiologia , Humanos , Malária/tratamento farmacológico , Malária/epidemiologia , Nigéria/epidemiologia , Encaminhamento e Consulta , Uganda/epidemiologiaRESUMO
The key to reducing malaria deaths in highly endemic areas is prompt access to quality case management. Given that many severe cases occur at peripheral level, rectal artesunate (RAS) in the form of suppositories was developed in the 1990s, allowing for rapid initiation of life-saving antimalarial treatment before referral to a health facility with full case management capabilities. One randomized controlled trial published in 2009 showed a protective effect of RAS pre-referral treatment against overall mortality of 26%, but with significant differences according to study sites and length of referral. Two important issues remained unaddressed: (1) whether the mortality impact of RAS observed under controlled trial conditions could be replicated under real-world circumstances; and (2) clear operational guidance for the wide-scale implementation of RAS, including essential health system determinants for optimal impact. From 2018 to 2020, the Community Access to Rectal Artesunate for Malaria (CARAMAL) project was conducted as a large-scale observational implementation study in the Democratic Republic of the Congo (DRC), Nigeria, and Uganda (registered on ClinicalTrials.gov as NCT03568344). CARAMAL aimed to provide high-quality field evidence on the two issues above, in three remote settings with high malaria endemicity. A number of complementary study components were implemented. The core of the CARAMAL study was the Patient Surveillance System (PSS), which allowed tracking of cases of severe febrile illness from first contact at the periphery to a referral health facility, and then on to a Day 28 visit at the home of the patient. Community and provider cross-sectional surveys complemented the PSS. Here we describe in some detail RAS implementation, as well as the key CARAMAL study components and basic implementation experience. This manuscript does not intend to present key study results, but provides an extensive reference document for the companion papers describing the impact, referral process, post-referral treatment and costing of the RAS intervention.
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BACKGROUND: Integrated Community Case Management (iCCM) of malaria, pneumonia and diarrhoea is an equity focused strategy, to increase access to care for febrile illness in children under-5 years of age, in rural communities. Lay community members are trained to diagnose and treat malaria, pneumonia and diarrhoea in children, and to identify and refer very ill children. Today, many low-income countries including Uganda, have a policy for iCCM which is being rolled out through public sector community health workers (CHWs). Ten years after the introduction of the iCCM strategy in Uganda, it is important to take stock and understand the barriers and facilitators affecting implementation of the iCCM policy. METHODS: We conducted an iCCM policy analysis in order to identify the challenges, enablers and priorities for scale-up of the iCCM strategy in Uganda. This was a qualitative case study research which included a document review (n=52) and key informant interviews (n=15) with Ugandan stakeholders. Interviews were conducted in 2017 and the desk review included literature up to 2019. RESULTS: This paper highlights the iCCM policy trajectory since 2010 in Uganda and includes a policy timeline. The iCCM policy process was mainly led by international agencies from inception, with little ownership of the government. Many implementation challenges including low government funding, weak coordination and contradicting policies were identified, which could contribute to the slow scale up of the iCCM program. Despite the challenges, many enablers and opportunities also exist within the health system, which should be further harnessed to scale up iCCM in Uganda. These enabling factors include strong community commitment, existing policy instruments and the potential of utilizing also the private sector for iCCM implementation. CONCLUSION: The iCCM program in Uganda needs to be strengthen through increased domestic funding, strong coordination and a focus on monitoring, evaluation and operational research.
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Malária , Pneumonia , Criança , Humanos , Uganda , Administração de Caso , Diarreia/terapia , Diarreia/diagnóstico , Malária/diagnóstico , Malária/terapia , Políticas , Pneumonia/diagnósticoRESUMO
OBJECTIVES: To develop a consensus statement to provide advice on designing, implementing and evaluating crowdsourcing challenge contests in public health and medical contexts. DESIGN: Modified Delphi using three rounds of survey questionnaires and one consensus workshop. SETTING: Uganda for face-to-face consensus activities, global for online survey questionnaires. PARTICIPANTS: A multidisciplinary expert panel was convened at a consensus-development conference in Uganda and included 21 researchers with experience leading challenge contests, five public health sector workers, and nine Ugandan end users. An online survey was sent to 140 corresponding authors of previously published articles that had used crowdsourcing methods. RESULTS: A subgroup of expert panel members developed the initial statement and survey. We received responses from 120 (85.7%) survey participants, which were presented at an in-person workshop of all 21 panel members. Panelists discussed each of the sections, revised the statement, and participated in a second round of the survey questionnaire. Based on this second survey round, we held detailed discussions of each subsection with workshop participants and further revised the consensus statement. We then conducted the third round of the questionnaire among the 21 expert panelists and used the results to finalize the statement. This iterative process resulted in 23 final statement items, all with greater than 80% consensus. Statement items are organised into the seven stages of a challenge contest, including the following: considering the appropriateness, organising a community steering committee, promoting the contest, assessing contributions, recognising contributors, sharing ideas and evaluating the contest (COPARSE). CONCLUSIONS: There is high agreement among crowdsourcing experts and stakeholders on the design and implementation of crowdsourcing challenge contests. The COPARSE consensus statement can be used to organise crowdsourcing challenge contests, improve the rigour and reproducibility of crowdsourcing research and enable large-scale collaboration.
Assuntos
Crowdsourcing , Medicina , Consenso , Técnica Delphi , Humanos , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
Objectives: Understanding treatment seeking for severe febrile illness (SFI) is methodologically challenging. In this scoping review, we investigate definitions of severe febrile illness in treatment seeking studies on children under 5 years of age in low and middle income countries. We analyze the association of SFI definitions with different concepts of treatment seeking and identify related research gaps. Methods: We searched Pubmed, Scopus and WHOLIS, and screened references of included publications for eligibility. Results: Definitions of SFI had either a biomedical perspective (predominantly in quantitative studies) or a caregiver perspective (predominantly in qualitative studies). In quantitative analyses of treatment seeking, severity was more often conceptualized as a determinant rather than an outcome of a treatment seeking process. The majority of quantitative analyses only included surviving children or did not explicitly mention dead children. Conclusion: Different research questions lead to diverse definitions and concepts of severity and treatment seeking outcomes, which limits the comparability of the available evidence. Systematic exclusion of dead children is likely to bias inferences on the association of treatment seeking and health outcomes of children with SFI in low and middle income countries.
Assuntos
Países em Desenvolvimento , Febre , Aceitação pelo Paciente de Cuidados de Saúde , Índice de Gravidade de Doença , Pré-Escolar , Febre/terapia , Humanos , Lactente , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricosRESUMO
BACKGROUND: Social innovations in health are inclusive solutions to address the healthcare delivery gap that meet the needs of end users through a multi-stakeholder, community-engaged process. While social innovations for health have shown promise in closing the healthcare delivery gap, more research is needed to evaluate, scale up, and sustain social innovation. Research checklists can standardize and improve reporting of research findings, promote transparency, and increase replicability of study results and findings. METHODS AND FINDINGS: The research checklist was developed through a 3-step community-engaged process, including a global open call for ideas, a scoping review, and a 3-round modified Delphi process. The call for entries solicited checklists and related items and was open between November 27, 2019 and February 1, 2020. In addition to the open call submissions and scoping review findings, a 17-item Social Innovation For Health Research (SIFHR) Checklist was developed based on the Template for Intervention Description and Replication (TIDieR) Checklist. The checklist was then refined during 3 rounds of Delphi surveys conducted between May and June 2020. The resulting checklist will facilitate more complete and transparent reporting, increase end-user engagement, and help assess social innovation projects. A limitation of the open call was requiring internet access, which likely discouraged participation of some subgroups. CONCLUSIONS: The SIFHR Checklist will strengthen the reporting of social innovation for health research studies. More research is needed on social innovation for health.