Costo-efectividad de las intervenciones de enfermería para el manejo de úlceras por pie diabético: revisión sistemática

Introduction Nursing interventions used for the treatment of diabetic foot ulcers include traditional and advanced healing techniques. Often their choice depends on the nurse's personal judgment, rather than recognition of cost-effectiveness. The objective of this study is to identify the most cost-effective nursing interventions for the management of patients with diabetic foot ulcers. Methodology. A systematic review was conducted at Pubmed, Cochrane and the Virtual Health Library. Randomized and non-randomized studies of any nursing intervention used for diabetic foot ulcer management with reported cost-effectiveness were included. The selection of eligible articles was made by two independent reviewers. The risk of bias was assessed using the following guidelines: Critical Appraisal Skills Programme. Results. Six of the eight included articles were classified at high risk of bias. The two interventions in which a better cost-effectiveness ratio was evidenced compared to the control group were the use of Beta-Glucan gel (compared to placebo) and negative pressure wound therapy (compared to advanced wet wound therapy). Discussion. National and international guidelines for the nursing management of diabetic foot ulcers propose at least 15 different interventions. However, the limited availability of high-quality cost-effectiveness studies makes selection difficult and generates greater variability in nursing practices. Conclusion. Cost-effectiveness studies with direct comparisons of nursing interventions for diabetic foot ulcer management are needed.Introducción. Las intervenciones de enfermería usadas para el tratamiento de las úlceras por pie diabético incluyen técnicas de cura tradicionales y avanzadas. Frecuentemente su elección depende del criterio personal de la enfermera, en lugar del reconocimiento de la relación costo-efectividad. El objetivo de este estudio es identificar las intervenciones de enfermería de mayor costo-efectividad para el manejo de pacientes con úlceras por pie diabético. Metodología. Se realizó una revisión sistemática en Pubmed, Cochrane y la Biblioteca Virtual De La Salud. Se incluyeron estudios aleatorizados y no aleatorizados de cualquier intervención de enfermería usada para el manejo de úlcera por pie diabético con reporte de costo-efectividad. La selección de los artículos elegibles fue realizada por dos evaluadores independientes. El riesgo de sesgos fue evaluado con las guías Critical Appraisal Skills Programme. Resultados. Seis de los ocho artículos incluidos fueron clasificados con alto riesgo de sesgos. Las dos intervenciones en las que se evidenció una mejor relación costo-efectividad en comparación con el grupo control fueron el uso de Beta-Glucan gel (comparado con placebo) y la terapia de presión negativa (comparada con terapia de herida húmeda avanzada). Discusión. Guías nacionales e internacionales para el manejo de enfermería de úlceras por pie diabético proponen al menos 15 diferentes intervenciones. Sin embargo, la escasa disponibilidad de estudios de alta calidad sobre la relación costo-efectividad dificulta la selección y genera mayor variabilidad en las prácticas de enfermería. Conclusión. Es necesario realizar estudios de la relación costo-efectividad con comparaciones directas de las intervenciones de enfermería para el manejo de úlceras por pie diabético

Nifurtimox versus benznidazole or placebo for asymptomatic Trypanosoma cruzi infection (Equivalence of Usual Interventions for Trypanosomiasis - EQUITY): Study protocol for a randomised controlled trial

Background: Either benznidazole (BZN) or nifurtimox (NFX) is recommended as equivalent to treat Trypanosoma cruzi infection. Nonetheless, supportive data from randomised trials is limited to individuals treated with BZN in southern cone countries of Latin America. Methods: The goal of this randomised, concealed, blind, parallel-group trial is to inform the trypanocidal efficacy and safety of NFX and its equivalence to BZN among individuals with T. cruzi positive serology (TC+). Eligible individuals are TC+, 20-65 years old, with no apparent symptoms/signs or uncontrolled risk factors for cardiomyopathy and at negligible risk of re-infection. Consenting individuals (adherent to a 10-day placebo run-in phase) receive a 120-day BID blinded treatment with NFX, BZN or matching placebo (2:2:1 ratio). The four active medication arms include (1) a randomly allocated sequence of 60-day, conventional-dose (60CD) regimes (BZN 300 mg/day or NFX 480 mg/day, ratio 1:1), followed or preceded by a 60-day placebo treatment, or (2) 120-day half-dose (120HD) regimes (BZN 150 mg/day or NFX 240 mg/day, ratio 1:1). The primary efficacy outcome is the proportion of participants testing positive at least once for up to three polymerase chain reaction (PCR) assays (1 + PCR) 12-18 months after randomisation. A composite safety outcome includes moderate to severe adverse reactions, consistent blood marker abnormalities or treatment abandons. The trial outside Colombia (expected to recruit at least 60% of participants) is pragmatic; it may be open-label and not include all treatment groups, but it must adhere to the randomisation and data administration system and guarantee a blinded efficacy outcome evaluation. Our main comparisons include NFX groups with placebo (for superiority), NFX versus BZN groups and 60CD versus 120HD groups (for non-inferiority) and testing for the agent-dose and group-region interactions. Assuming a 1 + PCR ? 75% in the placebo group, up to 25% among BZN-treated and an absolute difference of up to ? 25% with NFX to claim its trypanocidal effect, 60-80 participants per group (at least 300 from Colombia) are needed to test our hypotheses (80-90% power; one-sided alpha level 1%). Discussion: The EQUITY trial will inform the trypanocidal effect and equivalence of nitroderivative agents NFX and BZN, particularly outside southern cone countries. Its results may challenge current recommendations and inform choices for these agents. Trial registration: ClinicalTrials.gov, NCT02369978. Registered on 24 February 2015. © 2019 The Author(s)

“Pesquisa de sáudes cardiovascular e colaborcao para evaliar os marcadores e os resultados da foeca da Chagas”: coceito, metordos e características de grupo de doadores de sagre em Bucaramanga, Colombia

Colombia está expuesta simultáneamente a las enfermedades transmitidas por vectores como la Enfermedad de Chagas (ECHA), asÍ como a la carga creciente de la enfermedad cardiovascular de origen aterosclerótico (ECV). Objetivo: Estudiar a través del ensamblaje de un estudio de cohorte de adultos jóvenes de Bucaramanga, el desarrollo de la ECHA y la ECV. MetodologÍa: Se diseñó un estudio a partir de donantes de sangre con tamización serológica para T. cruzi. Se construyó una base de datos de donantes consecutivos con estatus positivo (T[+]) apareada (en relación 1:4, estratificada por banco y mes de donación) con donantes T[-]. Los participantes fueron clasificados por estado serológico y electrocardiograma y evaluados clÍnicamente (realizando pruebas adicionales de función cardiovascular a los T[+] y a una muestra aleatoria de T[-]). En los siguientes años se iniciaron ensayos clÍnicos en los participantes T[+] y mediciones repetidas en los T[-] para estudios de riesgo de ECV. Resultados: De 6,228 donantes (18 a 50 años de edad) registrados en la base (1997-2003), 2,130 donantes de sangre (edad media 36.4 [DE 8.4] años, 64.0% hombres, 73.4% residentes en los estratos 1-3, 486 T[+]) consintieron participar. El protocolo de contacto, seguimiento y recuperación de participantes ha logrado que se obtengan mediciones repetidas en al menos el 80% de los participantes. Conclusiones: CHICAMOCHA constituye un activo de valor social que aumenta las capacidades locales de investigación. Se requieren esfuerzos continuados para ensanchar sus posibilidades de formación de investigadores, g e n e r a c i ó n d e p r o d u c t o s d e c o n o c i m i e n t o y recomendaciones para el sistema de salud.[Villar JC, Herrera VM, Cháves-Neira AM, MartÍnez-Contreras LX, Villar-Centeno LA, Ardila E, Marcell-Vásquez S, Vásquez SM. "Cardiovascular Health Investigation and Collaboration to Assess the Markers and Outcomes of Chagas disease " (CHICAMOCHA): Concepto, métodos y caracterÍsticas de una cohorte de donantes de sangre en Bucaramanga, Colombia. MedUNAB 2015; 18 (1): 14-26]Geographical and socio-demographic conditions expose Colombian population to the threat of vector-borne diseases (such as Chagas’ [CHAD]) and cardiovascular disease of atherosclerotic origin (CVD). Objective: To assemble a cohort study of young adults, to promote understanding of CHAD and CVD in Bucaramanga, Colombia. Methodology: A study of blood donors with serological screening for T.cruzi was designed. A database of consecutive donors with positive results (T[+]) was built. This group was compared with a random sample of T[-] individuals (1:4 ratio, within strata of bank and month of donation). Participants classified by serology and electrocardiography status underwent clinical interviews (additional cardiovascular tests to T[+] and a random sample to T[-] were performed. In the following years, T[+] individuals participated in randomized trials whereas those whereas those T[-] participated in repeated measurements to test CVD risk factors. Results: From 6,228 donors in the database (18 to 50 years old) registered in the database (1997-2203), 2,130 blood donors (mean age 36.4 (SD 8.4) years, 64% males, 73.4% living in low socioeconomic strata, 486 T[+]) agreed to participate. Our contact protocol, and follow-up procedure with participants allowed us to obtain repeatedly measurements of at least 80% of the participants. Conclusions: CHICAMOCHA represents a social asset that builds local research capacity. Continued efforts are required to enhance its potential for research training, scholarly work and health care guidance. [Villar JC, Herrera VM, Cháves-Neira AM, MartÍnez-Contreras LX, Villar-Centeno LA, Ardila E, Marcell-Vásquez S, Vásquez SM. "Cardiovascular Health Investigation and Collaboration to Assess the Markers and Outcomes of Chagas disease " (CHICAMOCHA): Concept, methods and characteristics of a cohort of blood donors in Bucaramanga, Colombia. MedUNAB 2015; 18 (1): 14-26

Evaluación de conocimientos para el manejo no farmacológico del dolor

Interventions for pain relief are classified as pharmacological and non-pharmacological; the first include the administration of analgesic drugs and the second are complementary therapies. The objective of this study was to design and to validate a measurement instrument called "Knowledge about non-pharmacological interventions for pain relief”, to assess the level of knowledge about non-pharmacological pain management in a group of professional nurses and nursing assistants of a health institution in Bucaramanga, Colombia. Methods: The instrument was developed in two phases; the first phase consisted of the bibliographic search for the design, facial and content validation by experts. In the second phase was evaluated test/re-test reliability. Results: The final version of the questionnaire includes six dimensions proposed by the National Institute of Alternative Medicine of the United States with 30 items. The reliability of this instrument was low (Kappa-Cohen Index <0.60) in 80% of the items. Conclusion: This is the first instrument designed to measure the knowledge about non-pharmacological pain management in nurses and nursing assistants in our country, however, it is necessary to continue with processes that allow to improve their reliability and to evaluate their validity.As intervenções para o alivio da dor classificam-se em farmacológicas e não farmacológicas; as primeiras, consideram a administração de analgésicos, as segundas, empregam-se terapias complementarias. Objetivo: desenvolver e validar um questionário para à avaliação do nível de conhecimentos sob intervenções não farmacológicas para o tratamento da dor num grupo de enfermeiras padrão e auxiliares de enfermagem numa instituição de saúde de Bucaramanga, Colômbia. Materiais e métodos: O instrumento desenvolveu-se em duas fases: a primeira constou da busca de literatura, o desenho, a validação facial e de conteúdo por expertos. Na segunda fase, o questionário aplicou-se duas vezes a 30 enfermeiras e auxiliares de enfermagem com um intervalo de 30 dias para avaliar a confiabilidade. Calculou-se a pontuação total do instrumento e o índice Kappa-Cohen. Resultados: A versão final do questionário tem 30 questões avaliando seis dimensões propostas pelo Instituto Nacional de Medicina Alternativa dos Estados Unidos. Mais do 80% dos participantes teve o 70% das perguntas acertadas, entretanto, a confiabilidade do instrumento foi baixa (Kappa-Cohen <0,60) no 80% dos itens. Conclusão: Este é o primeiro instrumento desenvolvido para aferir conhecimentos sobre terapia não farmacológica para o alivio da dor em enfermeiras e auxiliares de enfermagem na Colômbia, entretanto requer continuar aprimorando a sua confiabilidade e a avaliação da sua validez.      Las intervenciones para el alivio del dolor se clasifican en farmacológicas y no farmacológicas; las primeras incluyen la administración de fármacos analgésicos y las segundas utilizan terapias complementarias. El objetivo de este estudio fue diseñar y validar un instrumento de medición denominado “Conocimiento sobre intervenciones no farmacológicas para el alivio del dolor” para evaluar el nivel de conocimientos sobre intervenciones no farmacológicas para el manejo del dolor en un grupo de enfermeras profesionales y auxiliares de enfermería de una institución de salud de Bucaramanga, Colombia. Métodos:  El instrumento se desarrolló en dos fases; la primera fase consistió en la búsqueda bibliográfica para el diseño, la validación facial y de contenido por expertos. En la segunda fase se evalúo la confiabilidad prueba- reprueba de la versión final del cuestionario. Resultados:  La versión final del cuestionario contempla seis dimensiones propuestas por el Instituto Nacional de Medicina Alternativa de Estados Unidos con un total de 30 ítems. La confiabilidad de este instrumento fue baja (Índice Kappa-Cohen <0.60) en el 80% de los ítems. Conclusión:  Este es el primer instrumento diseñado para medir los conocimientos sobre intervenciones no farmacológicas para el alivio del dolor en enfermeras y auxiliares de enfermería en nuestro país, sin embargo, se requiere continuar con procesos que permitan mejorar su confiabilidad y evaluar su validez.