Accesibilidad, disponibilidad y asequibilidad de medicamentos para Niños con Enfermedad Renal Crónica en Guatemala / Access, availability and affordability of medications for children with Advanced Chronic Kidney Disease in Guatemala

El artículo tiene como objetivo analizar la disponibilidad, acceso y asequibilidad de los medicamentos para niños con Enfermedad Renal Crónica (ERC) en tratamiento con hemodiálisis (HD) en un país de bajos a medianos ingresos. Se llevó a cabo un estudio transversal para determinar los medicamentos más utilizados en una unidad de hemodiálisis pediátrica, incluyendo el nombre del medicamento, dosis, frecuencia, forma farmacéutica y vía de administración. Dos farmacias dentro del perímetro del hospital, una pública y una privada, fueron consultadas para determinar el costoy disponibilidad de medicamentos genéricos y de marca. De un total de 30 pacientes de la unidad de hemodiálisis, 22 expedientes fueron revisados. En general 94% de marca se encontraban disponibles en las farmacias consultadas en comparación a un 52% de los medicamentos genéricos. En farmacias públicas, 41% de medicamentos de marca y 29% de medicamentos genéricos se encontraban disponibles. El costo promedio para un mes de tratamiento con medicamentos de marca adquiridos en una farmacia privada era de $495.00 vs $299.00 en una farmacia pública. Para medicamentos genéricos, el costo promedio correspondía a $414.00 y $239.00 en farmacias privadas y públicas respectivamente. En promedio, los medicamentos de marca adquiridos en una farmacia privada requieren 41 días de trabajo en un mes a comparación de 25 días si se adquieren en una farmacia pública. Los medicamentos genéricos adquiridos en farmacias privadas corresponden a 34 días de trabajo vs 20 días en farmacias públicas. En general existió un acceso limitado a medicamentos genéricos y los medicamentos poseen un costo general más elevado a comparación de otros países lo que implica un posible impacto en la adherencia terapéutica y los padecimientos secundarios de la ERC en los pacientes pediátricos en Guatemala. Esta realidad se puede aplicar a otros países de bajos a medianos ingresos.

This article aims to analyze the availability, access, and affordability of medications for children with advanced Chronic Kidney Disease (CKD) treated with hemodialysis (HD) in a low to middle income country (LMIC). A cross- sectional chart review was carried out to determine the most common medications used in an HD pediatric unit, including medication name, dose, frequency, dosage form, and route of administration. Two pharmacies within the hospital perimeter, one public and one private, were consulted to determine medication cost and availability for generic and brand-name equivalents. From 30 patients attending the HD unit, 22 records were reviewed. Overall, 94 % of brand name medications were available at pharmacies consulted, versus and 52% of generic medications. In public pharmacies, 41% of brand name, and 29% of generic medications were available. The average cost for a full month´s treatment for brand name drugs in the private pharmacy was 495.00 USD versus 299.00 USD in the public pharmacy. For generic drugs, the average cost was 414.00 USD, and 239.00 USD in private and public pharmacies respectively. On average, brand-name drugs in the private pharmacy cost 41 days' wages versus 25 in the public pharmacy. Generic drugs in the private pharmacy cost 34 days' wages versus 20 in the public pharmacy. Overall, there was limited access to generic medications, medications had an overall high cost compared to other countries both of which have the potential to impact treatment adherence and overall outcomes of CKD5 pediatric patients in Guatemala. This reality can be translated to other LMIC.

A multimedia program for caregivers of pediatric patients with chronic kidney disease in Guatemala.

OBJECTIVES: A multimedia medication training program for parents and legal guardians of children with chronic kidney disease (CKD) aimed to improve comprehension CKD and general information about medications used in pediatric patients attending The Foundation for Children with Kidney Disease (FUNDANIER, Guatemala City). METHODS: A quasi-experimental study was carried out to measure the impact of the educational intervention on medication knowledge, at FUNDANIER from September to October 2019. Means and standard deviations was used to described test results. A Wilcoxon test was performed, to compare scores of pre and post-tests. Odds Ratio (OR) was used to determine if there was an improvement in the knowledge score before and after the intervention. Results There was significant improvement in knowledge scores knowledge before and after the intervention(27/35 versus 33/35, P < 0.005). Mestizo participants had higher odds of improvement before and after the intervention (OR 7, CI: 0.6-78). Parent-guardians with prior education, and who spoke Spanish had higher odds of improved knowledge scores (OR 3.2, CI:0.3-35; OR 1.1 CI: 0.1-14 respectively). CONCLUSION: Caregivers who participated in the educational workshop improved and retained information related to CKD comprehension and medications used. This study provides a model for educational modules that can be used, tested, and applied in other chronic disease settings in low to middle income countries. PRACTICE IMPLICATIONS: A culturally relevant multimedia CKD educational platform was effective in improving medication knowledge among parent/guardians of children with CKD in a low literacy setting.

Addressing Health Inequities and Disparities in Children With Kidney Disease in Disadvantaged Areas: the Latin American and Caribbean Experience.

Purpose of Review: Compared with high-income countries, healthcare disparities and inequities are more evident in low, lower-middle, and upper-middle-income countries with poorer housing and nutrition conditions. At least 20% of Latin America and the Caribbean are low and lower-middle-income countries. Despite the majority of the other countries being upper-middle income, the United Nations Children's Fund had classified all the regions as "less developed," with limited access to health care for the most vulnerable, the children. Latin America and the Caribbean regions represent an extensive territory with communication limitations and an unstable socio-political and economic environment. After considering the vast population affected by poverty worldwide and the long-term impact of kidney disease starting in childhood, it is crucial to better understand and analyze the multifactorial limiting conditions in accessing specialized care such as pediatric nephrology in disadvantaged areas. Recent Findings: Constraints in accessing basic healthcare in rural areas make it impossible to receive specialized pediatric nephrology care including dialysis and transplantation. Disturbingly, incidence and prevalence figures of acute kidney injury, chronic and end-stage kidney disease in some Latin American and the Caribbean countries are unknown, and these conditions still represent a death sentence for underprivileged populations. However, the monumental efforts of the dedicated healthcare providers and stakeholders that pioneered the actions in the past 50 years have shown remarkable progress in developing pediatric nephology services across the continent. Summary: In this review, we compile some of the latest evidence about the care of children and adolescents with kidney conditions in Latin America and the Caribbean, along with the experiences from the field in the care of these patients facing adverse conditions. We also highlight recommendations to address inequities and disparities.

Community engagement in kidney research: Guatemalan experience.

BACKGROUND: Community engagement is essential for effective research when addressing issues important to both the community and researchers. Despite its effectiveness, there is limited published evidence concerning the evaluation of community engagement in research projects, especially in the area of nephrology. METHODS: We developed a community engagement program in Guatemala to address the role of hydration in chronic kidney disease of unknown origin, using five key engagement principles: 1. Local relevance and determinants of health. 2. Acknowledgment of the community. 3. Dissemination of findings and knowledge gained to all partners. 4. Usage of community partners' input. 5. Involvement of a cyclical and iterative process in the pursuit of goals. The effectiveness of community engagement was measured by a structured questionnaire on a 5-point likert scale. This measure determined how well and how often the research team adhered to the five engagement principles. We assessed internal consistency for each set of the engagement items through Omega coefficient. RESULTS: Sixty-two community leaders completed the questionnaire. Seventy-five percent were female, with a mean age of 37 years. All 5 engagement principles scored highly on the 5-point likert scale. Every item set corresponding to an engagement principles evaluation had a Omega coefficient > 0.80, indicating a firm internal consistency for all question groups on both qualitative and quantitative scales. CONCLUSION: Engagement of the community in the kidney research provides sustainability of the efforts and facilitates the achievements of the goals. Community leaders and researchers became a team and develop a relationship in which commitment and empowerment facilitated the participation in all aspects of the research process. This initiative could be a useful tool for researchers, especially in low-middle income countries, to start research in a community, achieve objectives in a viable form, and open opportunities to further studies.

Implementation challenges to patient safety in Guatemala: a mixed methods evaluation.

BACKGROUND: Little is known about factors affecting implementation of patient safety programmes in low and middle-income countries. The goal of our study was to evaluate the implementation of a patient safety programme for paediatric care in Guatemala. METHODS: We used a mixed methods design to examine the implementation of a patient safety programme across 11 paediatric units at the Roosevelt Hospital in Guatemala. The safety programme included: (1) tools to measure and foster safety culture, (2) education of patient safety, (3) local leadership engagement, (4) safety event reporting systems, and (5) quality improvement interventions. Key informant staff (n=82) participated in qualitative interviews and quantitative surveys to identify implementation challenges early during programme deployment from May to July 2018, with follow-up focus group discussions in two units 1 year later to identify opportunities for programme modification. Data were analysed using thematic analysis, and integrated using triangulation, complementarity and expansion to identify emerging themes using the Consolidated Framework for Implementation Research. Salience levels were reported according to coding frequency, with valence levels measured to characterise the degree to which each construct impacted implementation. RESULTS: We found several facilitators to safety programme implementation, including high staff receptivity, orientation towards patient-centredness and a desire for protocols. Key barriers included competing clinical demands, lack of knowledge about patient safety, limited governance, human factors and poor organisational incentives. Modifications included use of tools for staff recognition, integration of education into error reporting mechanisms and designation of trained champions to lead unit-based safety interventions. CONCLUSION: Implementation of safety programmes in low-resource settings requires recognition of facilitators such as staff receptivity and patient-centredness as well as barriers such as lack of training in patient safety and poor organisational incentives. Embedding an implementation analysis during programme deployment allows for programme modification to enhance successful implementation.

Challenges with pediatric surgical financing and universal health coverage in Guatemala: A qualitative analysis.

The financing of surgical care for children in low- and middle-income countries (LMICs) remains challenging and may restrict adherence to universal health coverage (UHC) frameworks. Our aims were to describe Guatemala's national pediatric surgical financing structure, to identify financing challenges, and to develop recommendations to improve the financing of surgical care for children. We conducted a qualitative study of the financing of surgical care for children in Guatemala's public health system with key informant interviews (n = 20) with experts in the medical, financial, and political health sectors. We used this data to generate recommendations to improve surgical care financing for children. We identified several systemic challenges to the financing of surgical care for children, including passive purchasing structures, complex political contexts, health system fragmentation, widespread use of informal fees for surgical services, and lack of earmarked funding for surgical care. Patient and provider challenges include lack of provider input in non-personnel funding decisions, and patients functioning as both financing agents and beneficiaries in the same financing stream. Key recommendations include reducing health finance system fragmentation through resource pooling, increasing earmarked funding for surgical care with quantifiable outcome measures, engagement with clinical providers in non-personnel budgetary decision-making, and use of innovative financing instruments such as resource pooling. Surgical financing for children in Guatemala requires substantial remodeling to increase access to timely, affordable, and safe surgical care and improve alignment with Guatemala's UHC scheme.

Mesoamerican Endemic Nephropathy (MeN): A Disease Reported in Adults That May Start Since Childhood?

Mesoamerican endemic nephropathy (MeN) is a type of chronic kidney disease (CKD) of uncertain etiology that occurs along the Pacific coast of the southern part of Mexico and Central America. During the past 20 years MeN has become a leading cause of death in the region, clamming close to 50,000 lives, with 40% of these deaths occurring in young people. The cause remains unknown, but most researchers believe in a multifactorial etiology that includes social determinants of poverty. Existing evidence suggests that subclinical kidney injury begins early in life and leads to a higher than expected prevalence of CKD among children in Central America. Access to health services in the region, specifically kidney replacement therapy, remains limited. We proposed a strategy to address the perceived needs and urge coordinated efforts of governments, academic organizations, and international bodies to develop a comprehensive plan of action to mitigate this situation among the vulnerable and economically disadvantaged population.

Factors associated with chronic kidney disease of non-traditional causes among children in Guatemala.

OBJECTIVE: To identify factors associated with chronic kidney disease of non-traditional causes among children in Guatemala. METHODS: A cross-sectional survey was conducted. The study population was all pediatric patients with stage 5 chronic kidney disease active in FUNDANIER's pediatric nephrology unit (N = 156). Simple random sampling led to a total of 100 participants. Data collection consisted of a questionnaire addressing individual and household characteristics, access and utilization of health care, and place of residence when the disease began. Chronic kidney disease etiology was obtained from medical records. Municipality-level secondary data were collected. Descriptive statistics were estimated. Logistic regression was used for bivariate and multivariate analysis. RESULTS: The odds ratio (OR) for almost all variables approached 1. Notable exceptions in household characteristics were mother's education level up to primary school (OR 2.2727) and living in an urban setting when symptoms began (OR 0.4035). Exceptions in municipal characteristics are zones with intensive small-scale agriculture (OR 3.8923) and those with intensive large-scale agriculture (OR 0.3338). P-values and confidence intervals show that the sample was not big enough to capture statistically significant associations between variables. CONCLUSIONS: Study findings suggest that factors associated with chronic kidney disease of non-traditional causes among children in Guatemala are intensive agricultural practices in their municipality of residence, and mother's level of education. Future research in children could use case-control designs or population-based studies in agricultural communities. Public health interventions that involve kidney function screening among children are recommended.

Factors associated with chronic kidney disease of non-traditional causes among children in Guatemala

[ABSTRACT]. Objective. To identify factors associated with chronic kidney disease of non-traditional causes among children in Guatemala. Methods. A cross-sectional survey was conducted. The study population was all pediatric patients with stage 5 chronic kidney disease active in FUNDANIER’s pediatric nephrology unit (N = 156). Simple random sampling led to a total of 100 participants. Data collection consisted of a questionnaire addressing individual and household characteristics, access and utilization of health care, and place of residence when the disease began. Chronic kidney disease etiology was obtained from medical records. Municipality-level secondary data were collected. Descriptive statistics were estimated. Logistic regression was used for bivariate and multivariate analysis. Results. The odds ratio (OR) for almost all variables approached 1. Notable exceptions in household characteristics were mother’s education level up to primary school (OR 2.2727) and living in an urban setting when symptoms began (OR 0.4035). Exceptions in municipal characteristics are zones with intensive small-scale agriculture (OR 3.8923) and those with intensive large-scale agriculture (OR 0.3338). P-values and confidence intervals show that the sample was not big enough to capture statistically significant associations between variables. Conclusions. Study findings suggest that factors associated with chronic kidney disease of non-traditional causes among children in Guatemala are intensive agricultural practices in their municipality of residence, and mother’s level of education. Future research in children could use case-control designs or population-based studies in agricultural communities. Public health interventions that involve kidney function screening among children are recommended.

[RESUMEN]. Objetivo. Determinar los factores asociados a la enfermedad renal crónica por causas no tradicionales en niños en Guatemala. Métodos. Se realizó una encuesta transversal. La población de estudio fue la totalidad de pacientes pediátricos con enfermedad renal crónica en fase 5 ingresados en la unidad de nefrología pediátrica de Fundanier (N = 156). Mediante el muestreo aleatorio simple se dispuso de un total de 100 participantes. La recopilación de datos consistió en un cuestionario que abordaba las características individuales y del hogar, el acceso y el uso de la atención de salud y el lugar de residencia al inicio de la enfermedad. La etiología de la enfermedad renal crónica se obtuvo a partir de los expedientes médicos y los datos secundarios se recopilaron a nivel municipal. Se calcularon las estadísticas descriptivas y se empleó el método de regresión logística para el análisis bifactorial y multifactorial. Resultados. La razón de posibilidades (OR) se aproximó a 1 en casi todas las variables. Dos excepciones destacables en lo relativo a las características domésticas fueron el nivel de escolaridad de la madre hasta la educación primaria (OR 2,2727) y el lugar de residencia en un entorno urbano en la aparición de los síntomas (OR 0,4035). Las excepciones con respecto a las características municipales fueron las zonas de agricultura intensiva a pequeña escala (OR 3,8923) y las zonas de agricultura intensiva a gran escala (OR 0,3338). Los valores P y los intervalos de confianza indican que la muestra no fue lo suficientemente amplia para recoger las asociaciones estadísticamente significativas entre variables. Conclusiones. Los resultados del estudio sugieren que los factores asociados a la enfermedad renal crónica por causas no tradicionales en niños en Guatemala son las prácticas agrícolas intensivas en el municipio de residencia y el nivel de escolaridad de la madre. Las futuras investigaciones con niños podrían incluir el diseño de casos o los estudios poblacionales en comunidades agrícolas. Se recomiendan intervenciones de salud pública que incorporen el tamizaje de la función renal en niños.

[RESUMO]. Objetivo. Identificar os fatores associados a doença renal crônica de etiologia não tradicional em crianças na Guatemala. Métodos. Foi realizado um estudo transversal em uma população que consistiu de todos os pacientes pediátricos com doença renal crônica ativa em estágio 5 atendidos na unidade de nefrologia pediátrica da Fundación para el Niño Enfermo Renal (FUNDANIER) (N = 156). O processo de amostragem aleatória simples determinou a obtenção de uma amostra com 100 participantes. Um questionário foi usado para a coleta de dados sobre as características pessoais e familiares dos participantes, acesso à assistência de saúde e utilização de serviços e local de residência ao início da doença. Informação sobre a etiologia da doença renal crônica foi obtida dos prontuários médicos. Também foram coletados dados secundários ao nível da localidade. Estatísticas descritivas foram estimadas e um modelo de regressão logística foi usado nas análises bivariada e multivariada. Resultados. As razões de chance (odds ratio, OR) de quase todas as variáveis se aproximaram de 1. As exceções nas variáveis relativas às características familiares foram escolaridade da mãe de nível fundamental (OR 2,2727) e residir em área urbana ao início dos sintomas (OR 0,4035). As exceções nas variáveis ao nível municipal foram áreas de agricultura intensiva em pequena escala (OR 3,8923) e em grande escala (OR 0,3338). Os valores de p e os intervalos de confiança indicam que o tamanho da amostra não foi grande o suficiente para detectar associações estatisticamente significativas entre as variáveis. Conclusões. O estudo demonstrou que práticas agrícolas intensivas na localidade de residência e nível de escolaridade da mãe são fatores associados a doença renal crônica de etiologia não tradicional em crianças na Guatemala. Outros estudos em crianças devem ser realizados como estudos de caso-controle ou estudos populacionais em comunidades agrícolas. Recomendam-se também intervenções de saúde pública com a avaliação preventiva da função renal em crianças.

Factors associated with chronic kidney disease of non-traditional causes among children in Guatemala / Factores asociados a la enfermedad renal crónica por causas no tradicionales en niños en Guatemala / Fatores associados a doença renal crônica de etiologia não tradicional em crianças na Guatemala

ABSTRACT Objective. To identify factors associated with chronic kidney disease of non-traditional causes among children in Guatemala. Methods. A cross-sectional survey was conducted. The study population was all pediatric patients with stage 5 chronic kidney disease active in FUNDANIER's pediatric nephrology unit (N = 156). Simple random sampling led to a total of 100 participants. Data collection consisted of a questionnaire addressing individual and household characteristics, access and utilization of health care, and place of residence when the disease began. Chronic kidney disease etiology was obtained from medical records. Municipality-level secondary data were collected. Descriptive statistics were estimated. Logistic regression was used for bivariate and multivariate analysis. Results. The odds ratio (OR) for almost all variables approached 1. Notable exceptions in household characteristics were mother's education level up to primary school (OR 2.2727) and living in an urban setting when symptoms began (OR 0.4035). Exceptions in municipal characteristics are zones with intensive small-scale agriculture (OR 3.8923) and those with intensive large-scale agriculture (OR 0.3338). P-values and confidence intervals show that the sample was not big enough to capture statistically significant associations between variables. Conclusions. Study findings suggest that factors associated with chronic kidney disease of non-traditional causes among children in Guatemala are intensive agricultural practices in their municipality of residence, and mother's level of education. Future research in children could use case-control designs or population-based studies in agricultural communities. Public health interventions that involve kidney function screening among children are recommended.

RESUMEN Objetivo. Determinar los factores asociados a la enfermedad renal crónica por causas no tradicionales en niños en Guatemala. Métodos. Se realizó una encuesta transversal. La población de estudio fue la totalidad de pacientes pediátricos con enfermedad renal crónica en fase 5 ingresados en la unidad de nefrología pediátrica de Fundanier (N = 156). Mediante el muestreo aleatorio simple se dispuso de un total de 100 participantes. La recopilación de datos consistió en un cuestionario que abordaba las características individuales y del hogar, el acceso y el uso de la atención de salud y el lugar de residencia al inicio de la enfermedad. La etiología de la enfermedad renal crónica se obtuvo a partir de los expedientes médicos y los datos secundarios se recopilaron a nivel municipal. Se calcularon las estadísticas descriptivas y se empleó el método de regresión logística para el análisis bifactorial y multifactorial. Resultados. La razón de posibilidades (OR) se aproximó a 1 en casi todas las variables. Dos excepciones destacables en lo relativo a las características domésticas fueron el nivel de escolaridad de la madre hasta la educación primaria (OR 2,2727) y el lugar de residencia en un entorno urbano en la aparición de los síntomas (OR 0,4035). Las excepciones con respecto a las características municipales fueron las zonas de agricultura intensiva a pequeña escala (OR 3,8923) y las zonas de agricultura intensiva a gran escala (OR 0,3338). Los valores P y los intervalos de confianza indican que la muestra no fue lo suficientemente amplia para recoger las asociaciones estadísticamente significativas entre variables. Conclusiones. Los resultados del estudio sugieren que los factores asociados a la enfermedad renal crónica por causas no tradicionales en niños en Guatemala son las prácticas agrícolas intensivas en el municipio de residencia y el nivel de escolaridad de la madre. Las futuras investigaciones con niños podrían incluir el diseño de casos o los estudios poblacionales en comunidades agrícolas. Se recomiendan intervenciones de salud pública que incorporen el tamizaje de la función renal en niños.

RESUMO Objetivo. Identificar os fatores associados a doença renal crônica de etiologia não tradicional em crianças na Guatemala. Métodos. Foi realizado um estudo transversal em uma população que consistiu de todos os pacientes pediátricos com doença renal crônica ativa em estágio 5 atendidos na unidade de nefrologia pediátrica da Fundación para el Niño Enfermo Renal (FUNDANIER) (N = 156). O processo de amostragem aleatória simples determinou a obtenção de uma amostra com 100 participantes. Um questionário foi usado para a coleta de dados sobre as características pessoais e familiares dos participantes, acesso à assistência de saúde e utilização de serviços e local de residência ao início da doença. Informação sobre a etiologia da doença renal crônica foi obtida dos prontuários médicos. Também foram coletados dados secundários ao nível da localidade. Estatísticas descritivas foram estimadas e um modelo de regressão logística foi usado nas análises bivariada e multivariada. Resultados. As razões de chance (odds ratio, OR) de quase todas as variáveis se aproximaram de 1. As exceções nas variáveis relativas às características familiares foram escolaridade da mãe de nível fundamental (OR 2,2727) e residir em área urbana ao início dos sintomas (OR 0,4035). As exceções nas variáveis ao nível municipal foram áreas de agricultura intensiva em pequena escala (OR 3,8923) e em grande escala (OR 0,3338). Os valores de p e os intervalos de confiança indicam que o tamanho da amostra não foi grande o suficiente para detectar associações estatisticamente significativas entre as variáveis. Conclusões. O estudo demonstrou que práticas agrícolas intensivas na localidade de residência e nível de escolaridade da mãe são fatores associados a doença renal crônica de etiologia não tradicional em crianças na Guatemala. Outros estudos em crianças devem ser realizados como estudos de caso-controle ou estudos populacionais em comunidades agrícolas. Recomendam-se também intervenções de saúde pública com a avaliação preventiva da função renal em crianças.

Exploring the safety and efficacy of adding ketoconazole to tacrolimus in pediatric renal transplant immunosuppression.

BACKGROUND: Guatemala is a developing country in Central America with limited health resources. In order to expand successful renal transplant care to children and adolescents at the lowest possible cost, our pediatric renal transplant clinic uses a post-transplant tacrolimus-sparing strategy via inhibition of CYP3A4. AIM: To study the safety, efficacy and the associated cost reduction of ketoconazole in combination with tacrolimus in this pediatric population. METHODS: A retrospective chart review was carried out among the cohort of pediatric renal transplant recipients treated at the Foundation for pediatric renal patients (Fundación para el Niño Enfermo Renal - FUNDANIER), a pediatric tertiary care renal transplant center in Guatemala City, Guatemala. Patient charts were reviewed to ascertain the number of transplant recipients who were transitioned from tacrolimus based immunosuppression to combination therapy with ketoconazole and tacrolimus. Twenty-five post-transplant patients that used ketoconazole combined with tacrolimus were identified. Anthropometric, clinical and laboratory data was collected from patient charts before and after the transition. RESULTS: Of the 25 patient charts reviewed 12 (48%) patients were male and the average patient age was 13 years. Twenty-four (96%) transplants were from living donors. There was a non-significant difference between the mean tacrolimus doses six months and two months prior to ketoconazole: -0.10 ± 0.04 (95%CI: 0.007, -0.029), P = 0.23. However, the difference between the mean tacrolimus doses six months prior to ketoconazole initiation and six months after ketoconazole addition was significant: 0.06 ± 0.05 (95%CI: -0.034, -0.086) P < 0.001. All tacrolimus doses were reduced by 45% after the addition of ketoconazole. Therapeutic levels of tacrolimus ranged between 6.8-8.8 ng/mL during the study period and patients demonstrated an increase in estimated glomerular filtration rate. The combination of tacrolimus and ketoconazole resulted in a 21% reduction in cost. CONCLUSION: Patients experienced an effective dose-reduction of tacrolimus with the administration of ketoconazole. There was no relevant variations in tacrolimus serum levels, number of rejections, or significant liver toxicity. The strategy allowed a cost reduction in pediatric immunosuppressive therapy.

CKD Care and Research in Guatemala: Overview and Meeting Report.

On October 14-15, 2019, the 1st Symposium to Promote Chronic Kidney Disease (CKD) Research in Guatemala was held in Guatemala City, Guatemala. The Symposium hosted more than 50 attendees, including health care professionals, policy makers, researchers, and leaders of nongovernmental organizations. The meeting's objectives were to (1) share clinical and health delivery experiences, (2) disseminate local research, and (3) establish consensus priorities for future research. In this report, we review the state of CKD nephrology in Guatemala, summarize experiences shared during the meeting from representatives of the clinical settings in Guatemala where CKD care is provided, and describe consensus priorities for future research.

Implementation Analysis of a Perioperative Patient Safety Program in Guatemala.

BACKGROUND: The implementation of programs to improve patient safety remains challenging in low- and middle-income countries. The goal of our study was to define the barriers and facilitators to implementation of a perioperative patient safety program in Guatemala. MATERIAL AND METHODS: We conducted semi-structured interviews with 16 staff pre-intervention and a follow-up focus group discussion 1 year later in the perioperative department at the Roosevelt Hospital in Guatemala. We performed qualitative thematic analysis to identify barriers and facilitators to the implementation process, with analysis guided by the Consolidated Framework for Implementation Research. RESULTS: We found several dominant themes affecting implementation of a patient safety program. Implementation facilitators included strong prioritization of patient needs, program compatibility with existing workflow, and staff attributes. Barriers included a lack of knowledge about patient safety, limited resources, limited leadership engagement, and lack of formal implementation leaders. Several program modifications were made to enhance successful implementation iteratively during the implementation process. DISCUSSION: Our analysis highlights several dominant themes which affect the implementation of a perioperative safety program in Guatemala. Understanding the barriers and facilitators to implementation during program deployment allows for program modification and improvement of the implementation process itself.

Challenges in the provision of kidney care at the largest public nephrology center in Guatemala: a qualitative study with health professionals.

BACKGROUND: Chronic kidney disease (CKD) is increasing worldwide, and the majority of the CKD burden is in low- and middle-income countries (LMICs). However, there is wide variability in global access to kidney care therapies such as dialysis and kidney transplantation. The challenges health professionals experience while providing kidney care in LMICs have not been well described. The goal of this study is to elicit health professionals' perceptions of providing kidney care in a resource-constrained environment, strategies for dealing with resource limitations, and suggestions for improving kidney care in Guatemala. METHODS: Semi-structured interviews were performed with 21 health professionals recruited through convenience sampling at the largest public nephrology center in Guatemala. Health professionals included administrators, physicians, nurses, technicians, nutritionists, psychologists, laboratory personnel, and social workers. Interviews were recorded and transcribed in Spanish. Qualitative data from interviews were analyzed in NVivo using an inductive approach, allowing dominant themes to emerge from interview transcriptions. RESULTS: Health professionals most frequently described challenges in providing high-quality care due to resource limitations. Reducing the frequency of hemodialysis, encouraging patients to opt for peritoneal dialysis rather than hemodialysis, and allocating resources based on clinical acuity were common strategies for reconciling high demand and limited resources. Providers experienced significant emotional challenges related to high patient volume and difficult decisions on resource allocation, leading to burnout and moral distress. To improve care, respondents suggested increased budgets for equipment and personnel, investments in preventative services, and decentralization of services. CONCLUSIONS: Health professionals at the largest public nephrology center in Guatemala described multiple strategies to meet the rising demand for renal replacement therapy. Due to systems-level limitations, health professionals faced difficult choices on the stewardship of resources that are linked to sentiments of burnout and moral distress. This study offers important lessons in Guatemala and other countries seeking to build capacity to scale-up kidney care.

Epidemiologic and socioeconomic profile of Guatemalan hemodialysis patients: Assessment and dissemination via a free-access information system.

There is wide variation in the presence of renal replacement therapy (RRT) registries throughout the world, which is a major obstacle to designing and implementing coordinated strategies for chronic kidney disease care and resource planning. Guatemala does not have a national registry of patients on RRT. We describe the result of a cross-sectional study at a national level on epidemiologic and socioeconomic characteristics of hemodialysis patients in Guatemala: most patients were male (57%), above the age of 20 (90%), unemployed (60%), married or in a civil union (53%), had an elementary school education (47%), and living in the geographical clusters in the south of the country. We also describe a free-access website created with the results of the study. Given that Guatemala is still years away from a complete national registry, this information can be used by interested parties in the meantime to promote rational use of limited resources and to inform data-driven health policies.

Developing a national patient safety plan in Guatemala.

OBJECTIVE: Patient safety is challenging for health systems around the world, particularly in low-and middleincome countries such as Guatemala. The goal of this report is to summarize a strategic planning process for a national patient safety plan in Guatemala. METHODS: This strategic planning process involved multiple stakeholders, including representatives of the Guatemala Ministry of Health and Social Assistance, medical leadership from across the public health system, and academic experts from Guatemala and the United States of America. We used mixed methods (quantitative and qualitative surveys) and a nominal group technique at a national symposium to prioritize patient safety challenges across Guatemala, and subsequent meetings to develop a national patient safety plan. RESULTS: This national patient safety plan outlines four domains to advance patient safety across the public hospital system over a five-year period in Guatemala: leadership and governance, training and awareness, safety culture, and outcome metrics. For each domain, we developed a set of goals, activities, outputs, and benchmarks to be overseen by the Ministry of Health. CONCLUSIONS: With this national patient safety plan, Guatemala has made a long-term commitment to improving patient safety across the public hospital system of Guatemala. Future efforts will require its extension to all levels of the Guatemalan health system.

Developing a national patient safety plan in Guatemala

[ABSTRACT]. Objective. Patient safety is challenging for health systems around the world, particularly in low- and middleincome countries such as Guatemala. The goal of this report is to summarize a strategic planning process for a national patient safety plan in Guatemala. Methods. This strategic planning process involved multiple stakeholders, including representatives of the Guatemala Ministry of Health and Social Assistance, medical leadership from across the public health system, and academic experts from Guatemala and the United States of America. We used mixed methods (quantitative and qualitative surveys) and a nominal group technique at a national symposium to prioritize patient safety challenges across Guatemala, and subsequent meetings to develop a national patient safety plan. Results. This national patient safety plan outlines four domains to advance patient safety across the public hospital system over a five-year period in Guatemala: leadership and governance, training and awareness, safety culture, and outcome metrics. For each domain, we developed a set of goals, activities, outputs, and benchmarks to be overseen by the Ministry of Health. Conclusions. With this national patient safety plan, Guatemala has made a long-term commitment to improving patient safety across the public hospital system of Guatemala. Future efforts will require its extension to all levels of the Guatemalan health system.

[RESUMEN]. Objetivo. La seguridad del paciente constituye un reto para los sistemas de salud de todo el mundo, particularmente en los países de ingresos medianos y bajos como Guatemala. El objetivo del presente informe es resumir el proceso de planificación estratégica para elaborar un plan nacional sobre seguridad del paciente en Guatemala. Métodos. En el proceso de planificación estratégica participaron varios interesados directos, entre los cuales se encontraron representantes del Ministerio de Salud Pública y Asistencia Social de Guatemala, autoridades médicas de todo el sistema de salud pública, así como expertos académicos de Guatemala y Estados Unidos de América. Para establecer las prioridades en cuanto a los retos que deben abordarse en Guatemala en materia de seguridad del paciente se utilizó un método mixto (encuestas cuantitativas y cualitativas) y la técnica de grupo nominal en un simposio nacional, y posteriormente se realizaron reuniones para elaborar un plan nacional sobre la seguridad del paciente. Resultados. En el plan nacional sobre la seguridad del paciente se presentan cuatro ámbitos en los cuales se puede impulsar la seguridad del paciente en todos los hospitales públicos de Guatemala en un período de cinco años: liderazgo y gobernanza, capacitación y concientización, cultura de seguridad y métodos para medir los resultados. Se creó un conjunto de metas, actividades, resultados y puntos de referencia para cada ámbito, que estarán bajo la supervisión del Ministerio de Salud. Conclusiones. Con este plan nacional sobre la seguridad del paciente, Guatemala ha adquirido el compromiso a largo plazo de mejorar la seguridad del paciente en los hospitales públicos del país. Las iniciativas que se emprendan en el futuro requerirán que se extienda a todos los niveles del sistema de salud guatemalteco.

[RESUMO]. Objetivo. A segurança do paciente representa um desafio aos sistemas de saúde em todo o mundo, sobretudo nos países de baixa e média renda como a Guatemala. O presente tem o objetivo de descrever sucintamente o processo de planejamento estratégico para um plano nacional de segurança do paciente na Guatemala. Métodos. Este processo de planejamento estratégico contou com a participação de diversos interessados diretos, como representantes do Ministério da Saúde e Assistência Social da Guatemala, autoridades médicas da área de saúde pública e especialistas acadêmicos da Guatemala e dos Estados Unidos. Métodos combinados (pesquisas quantitativas e qualitativas) e técnica de grupo nominal foram usados em um simpósio nacional para priorizar os desafios em segurança do paciente na Guatemala e reuniões subsequentes foram realizadas para elaborar o plano nacional de segurança do paciente. Resultados. No plano nacional de segurança do paciente, são definidos quatro domínios para fazer avançar o processo de segurança do paciente no sistema hospitalar público em um período de cinco anos: liderança e governança; capacitação e conscientização; cultura de segurança e métricas para mensuração dos resultados. Um conjunto de metas, atividades, resultados e parâmetros de referência foi elaborado para cada domínio, a ser supervisado pelo Ministério da Saúde. Conclusões. Com este plano nacional de segurança do paciente, a Guatemala assumiu um compromisso de longo prazo de melhorar a segurança do paciente no sistema hospitalar público. Esforços devem ser empreendidos para expandir o plano a todos os níveis do sistema de saúde da Guatemala.

Creating arteriovenous fistulas for children in Guatemala.

OBJECTIVE: The Guatemalan Foundation for Children with Kidney Diseases was established in 2003 as the first and only comprehensive pediatric nephrology program and hemodialysis unit in Guatemala. Bridge of Life (BOL) is a not-for-profit charitable organization focused on chronic kidney disease and supplied equipment, training and support during formation of the hemodialysis unit. Pediatric permanent vascular access (VA) expertise had not been established and noncuffed dialysis catheters provided almost all VA, many through subclavian vein access sites. BOL assistance was requested for establishing a VA surgical program, resulting in recurring BOL surgical missions to create arteriovenous fistulas (AVF) in these children. This study analyzes the BOL pediatric VA missions to Guatemala. METHODS: Three surgical pediatric VA missions were conducted in Guatemala from 2015 to 2017. Each mission was led by two or three surgeons. All supplies and equipment (including ultrasound units) were taken as part of each mission. The BOL surgical VA mission teams work with local pediatric surgeons, pediatric nephrologists, and dialysis nurses to establish collegial relationships and foster teaching interactions. We retrospectively reviewed the patient demographic data, procedures, and outcomes for these missions. RESULTS: AVFs were created in 54 new pediatric patients. Ages were 8 to 19 years (13.4 ± 2.8 years) and 29 patients (54%) were male. Patient weights were 28 to 50 kg (30.8 ± 8.3 kg) with body mass indexes of 12 to 25 kg/m2 (17.9 ± 2.9 kg/m2). Radiocephalic AVFs were created in 21 children (39%), proximal radial artery AVFs in 12 (22%). and brachial artery inflow AVFs in 5 (9%). Sixteen patients (30%) required transpositions and one a translocation; two of these were femoral procedures. Primary and cumulative patency rates were 83% and 85% at 12 months and 62% and 85% at 36 months, respectively. The median follow-up was 17 months. Interventions with fistulagram and balloon angioplasty options were not available for AVF dysfunction or access salvage during the study period. However, six patients underwent an AVF revision and salvage during subsequent missions or by one of the Guatemalan surgeons (R.S.). Four individuals underwent successful transplantation during the study period. There were no operative deaths or major complications. CONCLUSIONS: Pediatric VA missions to Guatemala created safe and functional AVFs in concert with local pediatric surgeons and pediatric nephrologists. Three surgical missions included access operations in 54 new patients. Cumulative AVF patency was 85% at 36 months.

Teaching patient safety in global health: lessons from the Duke Global Health Patient Safety Fellowship.

Health systems in low-income and middle-income countries (LMICs) have a high burden of medical errors and complications, and the training of local experts in patient safety is critical to improve the quality of global healthcare. This analysis explores our experience with the Duke Global Health Patient Safety Fellowship, which is designed to train clinicians from LMICs in patient safety, quality improvement and infection control. This intensive fellowship of 3-4 weeks includes (1) didactic training in patient safety and quality improvement, (2) experiential training in patient safety operations, and (3) mentorship of fellows in their home institution as they lead local safety programmes. We have learnt several lessons from this programme, including the need to contextualise training to local needs and resources, and to focus training on building interdisciplinary patient safety teams. Implementation challenges include a lack of resources and data collection systems, and limited recognition of the role of safety in global health contexts. This report can serve as an operational guide for intensive training in patient safety that is contextualised to global health challenges.

Long-term safety and tolerability of valsartan in children aged 6 to 17 years with hypertension.

OBJECTIVE: The present study aimed to assess the long-term safety and tolerability of valsartan in hypertensive children aged 6-17 years, with or without chronic kidney disease (CKD). METHODS: This was an 18-month, open-label, multicentre, prospective study conducted in 150 patients with history of hypertension with or without CKD. The primary endpoint was long-term safety and tolerability of valsartan and valsartan-based treatments, assessed in terms of adverse events (AEs), serious AEs, laboratory measurements, estimated glomerular filtration rate (eGFR), urinalysis and electrocardiogram. RESULTS: Of 150 enrolled patients, 117 (78%) completed the study. At week 78, a clinically and statistically significant reduction in mean sitting systolic and diastolic blood pressures was observed in all patients (- 14.9 mmHg and - 10.6 mmHg, respectively). Within the first 3 months of treatment, mean urine albumin creatinine ratio decreased in CKD population, which was sustained. A higher percentage of CKD patients had at least one AE compared to non-CKD patients (85.3% vs. 73.3%, respectively). The majority of AEs were mild (50.7%) or moderate (18.7%) in severity. As expected, in patients with underlying CKD, increases in serum potassium, creatinine and blood urea nitrogen were more commonly reported compared to non-CKD patients. A > 25% decrease in Schwartz eGFR was observed in 28.4% of CKD patients and 13.5% of non-CKD patients. CONCLUSIONS: Valsartan was generally well tolerated, with an AE profile consistent with angiotensin receptor blockers in the overall population and in patients with underlying CKD. Long-term efficacy was maintained and a beneficial effect on proteinuria was observed.