The future of precision medicine in opioid use disorder: inclusion of patient-important outcomes in clinical trials

Opioid use has reached an epidemic proportion in Canada and the United States that is mostly attributed to excess availability of prescribed opioids for pain. This excess in opioid use led to an increase in the prevalence of opioid use disorder (OUD) requiring treatment. The most common treatment recommendations include medication-assisted treatment (MAT) combined with psychosocial interventions. Clinical trials investigating the effectiveness of MAT, however, have a limited focus on effectiveness measures that overlook patient-important outcomes. Despite MAT, patients with OUD continue to suffer negative consequences of opioid use. Patient goals and personalized medicine are overlooked in clinical trials and guidelines, thus missing an opportunity to improve prognosis of OUD by considering precision medicine in addiction trials. In this mixed-methods study, patients with OUD receiving MAT (n=2,031, mean age 39.1 years [SD 10.7], 44% female) were interviewed to identify patient goals for MAT. The most frequently reported patient-important outcomes were to stop treatment (39%) and to avoid all drugs (25%). These results are inconsistent with treatment recommendations and trial outcome measures. We discuss theses inconsistencies and make recommendations to incorporate these outcomes to achieve patient-centered and personalized treatment strategies.

Red de fracturas por fragilidad: la respuesta ortogeriátrica al desafío global de las fracturas por fragilidad / Fragility fracture network: an orthogeriatric response to the global challenge of fragility fractures

El envejecimiento poblacional ha llevado a los países a vivenciar situaciones epidemiológicas sin precedentes. Entre ellas, la irrupción de algunos síndromes geriátricos como las fracturas por fragilidad. Esto ya ha ocurrido en Europa y, en forma más acelerada, está ocurriendo en América Latina y Asia Pacífico. Tanto por su importancia clínica, social y económica, como por el enorme aumento en su incidencia, estas enfermedades requieren una forma de abordaje acorde con los nuevos tiempos epidemiológicos. De otro modo, harán colapsar los sistemas de salud actuales. Desde los años 60, ha sido la Ortogeriatría la encargada de velar por el manejo general de estas enfermedades, en forma de una alianza clínica, organizacional, docente y científica entre Geriatras y Traumatólogos. En esta revisión, se presenta a la Red de Trabajo en Fracturas por Fragilidad (FFN, Fragility Fracture Network), como una organización global y regionalizada para apoyar y coordinar un esfuerzo mancomunado que favorezca el co-manejo clínico-quirúrgico de las enfermedades óseas por fragilidad, con énfasis en las fracturas de cadera.

Aging populations have led countries to unprecedented epidemiological situations, amongst which are the appearance of geriatric syndromes such as fragility fractures. This has already occurred in Europe and, is now happening at an even faster pace in Latin America and Asia Pacific. Given their clinical, social and economic importance, these illnesses require an approach in line with the new epidemiological reality, otherwise health systems will collapse. Orthogeriatrics has overseen general management of these illnesses since the 60´s using a clinical, organizational, educational and scientific alliance of geriatricians and traumatologists. In this review we present the Fragility Fracture Network, a global and regional organization for the support and coordination of a joint effort to promote clinical -surgical management of fragility associated bone disease, with emphasis on hip fractures.

Integrated community case management (iCCM) of childhood infection saves lives in hard-to-reach communities in Nicaragua / La atención integrada de las infecciones infantiles en la comunidad salva vidas en las comunidades de difícil acceso de Nicaragua / O manejo integrado de casos na comunidade (iCCM) aplicado às infecções infantis salva vidas em comunidades de difícil acesso na Nicarágua

ABSTRACT Objective To describe Nicaragua’s integrated community case management (iCCM) program for hard-to-reach, rural communities and to evaluate its impact using monitoring data, including annual, census-based infant mortality data. Method This observational study measured the strength of iCCM implementation and estimated trends in infant mortality during 2007–2013 in 120 remote Nicaraguan communities where brigadistas (“health brigadiers”) offered iCCM services to children 2–59 months old. The study used program monitoring data from brigadistas’ registers and supervision checklists, and derived mortality data from annual censuses conducted by the Ministry of Health. The mortality ratio (infant deaths over number of children alive in the under-1-year age group) was calculated and point estimates and exact binomial confidence intervals (CIs) were reported. Results Monitoring data revealed strong implementation of iCCM over the study period, with medicine availability, completeness of recording, and correct classification always exceeding 80%. Treatments provided by brigadistas for pneumonia and diarrhea closely tracked expected cases and caregivers consistently sought treatment more frequently from brigadistas than from health facilities. The infant mortality ratio decreased more in iCCM areas compared to the non-iCCM areas. Statistically significant reduction ranged from 52% in 2010 (mortality rate ratio 0.48; 95% CI: 0.25–0.92) to 59% in 2013 (mortality rate ratio 0.41; 95% CI: 0.21–0.81). Conclusions The iCCM has been found to be an effective and feasible strategy to save infant lives in hard-to-reach communities in Nicaragua. The impact was likely mediated by increased use of curative interventions, made accessible and available at the community level, and delivered through high-quality services, by brigadistas.

RESUMEN Objetivo Describir el programa nicaragüense de atención integrada en la comunidad destinado a las comunidades rurales de difícil acceso y evaluar sus efectos a partir de los datos de seguimiento, como los datos censales anuales sobre la mortalidad infantil (menores de 1 año). Método Este estudio de observación tuvo como objetivo valorar la ejecución de la atención integrada en la comunidad y medir las tendencias de la mortalidad infantil (menores de 1 año) entre el 2007 y el 2013 en 120 comunidades nicaragüenses remotas donde los brigadistas brindan servicios de atención integrada en la comunidad a niños de 2 a 59 meses. El estudio se valió de datos programáticos de seguimiento obtenidos de los registros y las listas de verificación utilizadas para la supervisión de los brigadistas, así como datos de mortalidad derivados de los censos anuales realizados por el Ministerio de Salud. Se calculó la razón de mortalidad (defunciones de lactantes por cantidad de menores de un año vivos) y se informaron estimaciones puntuales e intervalos de confianza binomiales exactos. Resultados Los datos de seguimiento mostraron una ejecución sólida del programa de atención integrada en la comunidad en el período del estudio, dado que la disponibilidad de medicamentos, los registros completos y la clasificación correcta siempre superaron el 80%. Como parte del tratamiento proporcionado contra la neumonía y la diarrea, los brigadistas llevaron a cabo un seguimiento minucioso de los casos previstos y los cuidadores solicitaron tratamiento de los brigadistas con más frecuencia que de los establecimientos de salud. La razón de mortalidad infantil (menores de 1 año) disminuyó más en las zonas atendidas por el programa que en aquellas no atendidas. Se observó una disminución estadísticamente significativa del 52% en el 2010 (razón de la tasa de mortalidad 0,48; IC del 95%: 8%-75%) al 59% en el 2013 (razón de la tasa de mortalidad 0,41; IC del 95%: 19%-79%). Conclusiones El programa de atención integrada en la comunidad es una estrategia eficaz y factible para salvar la vida de los lactantes en las comunidades de difícil acceso de Nicaragua. Estos efectos probablemente estuvieron mediados por la mayor prestación de intervenciones curativas, que estuvieron accesibles y disponibles en el ámbito de la comunidad, y fueron brindadas por los brigadistas por medio de servicios de buena calidad.

RESUMO Objetivo Descrever o programa de manejo integrado de casos na comunidade (iCCM) para comunidades rurais e de difícil acesso na Nicarágua e avaliar seu impacto usando dados de monitoramento, inclusive dados censitários anuais de mortalidade infantil. Método Este estudo observacional avaliou o nível de implementação da estratégia iCCM e calculou tendências de mortalidade infantil nos anos 2007-2013 em 120 comunidades remotas da Nicarágua onde “brigadistas de saúde” prestam serviços de iCCM para crianças de 2 a 59 meses de idade. Foram utilizados dados de monitoramento obtidos dos cadastros e checklists de supervisão de brigadistas e dados de mortalidade obtidos dos censos anuais realizados pelo Ministério da Saúde. Foi calculado o coeficiente de mortalidade infantil (número de óbitos infantis dividido pelo número de crianças menores de 1 ano vivas), além de estimativas pontuais e intervalos de confiança (IC) binomiais exatos. Resultados Os dados de monitoramento evidenciaram forte implementação da estratégia iCCM durante o período de estudo; a disponibilidade de medicamentos, a integralidade dos registros e a classificação correta sempre excederam 80%. O tratamento da pneumonia e da diarreia por brigadistas acompanhou de perto o número de casos esperado, e os responsáveis pelas crianças sistematicamente buscaram tratamento com maior frequência junto aos brigadistas do que nos serviços de saúde. O coeficiente de mortalidade infantil diminuiu mais nas áreas com iCCM do que nas áreas sem iCCM. A redução foi estatisticamente significante, variando de 52% em 2010 (razão de taxa de mortalidade: 0,48; IC95%: 8%–75%) a 59% em 2013 (razão de taxa de mortalidade: 0,41; IC95%: 19%–79%). Conclusões Constatou-se que a iCCM é uma estratégia eficaz e viável para salvar vidas de crianças em comunidades de difícil acesso na Nicarágua. O impacto provavelmente foi mediado pelo aumento do uso de intervenções resolutivas, disponibilizadas de maneira acessível no âmbito da comunidade, através do serviço qualificado prestado pelos brigadistas.

Time volunteered on community health activities by brigadistas in Nicaragua / Tiempo de trabajo voluntario dedicado a actividades relacionadas con la salud en la comunidad de los brigadistas en Nicaragua

ABSTRACT Objective To report on how brigadistas (“health brigadiers”) in Nicaragua volunteer their time before the introduction of expanded responsibilities (beyond the scope of integrated community case management (iCCM)) for sick children 2–59 months old. Methods Three complete teams of brigadistas (n = 12 brigadistas total) were selected from remote communities in the department of Matagalpa. Each respondent brigadista was interviewed privately regarding the frequency and duration (i.e., preparation, round-trip travel, and implementation time) of 13 separate activities. The correlation between their overall estimates and summed times of individual activities were measured. Results Brigadista mean density was 1 per 156 total population (range: 120–217). Each team had one encargado/a (“manager”) with an iCCM drug box plus two to four asistentes (“assistants”). All resided in the community they served. Eight reported competing time demands during one to nine months of the year. Brigadistas volunteered an average of 75 hours per month (range: 35–131). Encargados were busier than asistentes (98 versus 68 hours per month). Three activities accounted for 70% of their time: 1) iCCM (30%: treatment (11%), follow-up (19%)); 2) receiving training (21%); and 3) promoting birth planning (19%). Brigadistas’ time was divided among preparation (12%), travel (27%), and implementation (61%). Overall estimates were highly correlated (+0.70) with summed implementation time. Conclusions Brigadistas from these remote Nicaraguan communities were busy with different activities, levels of effort, and patterns of task-sharing. These findings, plus an ongoing job satisfaction survey and a follow-on time study after the introduction of the new interventions, will inform policy for this valuable volunteer cadre.

RESUMEN Objetivo Informar sobre el trabajo voluntario de los brigadistas en Nicaragua antes de la ampliación de sus responsabilidades (más allá del manejo de casos a nivel comunitario) para que se ocuparan también de los niños enfermos de 2 a 59 meses. Métodos Se seleccionaron tres equipos completos de brigadistas (n = 12 brigadistas en total) de comunidades remotas del departamento de Matagalpa. Cada brigadista fue entrevistado en privado sobre la frecuencia y la duración (es decir, preparación, viaje de ida y vuelta, y tiempo de ejecución) de 13 actividades diferentes. Se midió la correlación entre sus cálculos generales y la suma de los tiempos de las actividades individuales. Resultados La densidad promedio de brigadistas era de 1 por 156 habitantes (intervalo: 120-200). Cada equipo tenía un encargado con una caja de medicamentos para el manejo de casos comunitario y de dos a cuatro asistentes. Todos residían en la comunidad que atendían. Ocho informaron exigencias de tiempo conflictivas de uno a nueve meses al año. Los brigadistas trabajaban como voluntarios un promedio de 75 horas por mes (intervalo: 35-131). Los encargados estaban más ocupados que los asistentes (98 horas frente a 68 horas por mes). Tres actividades insumían el 70% de su tiempo: 1) manejo de casos a nivel comunitario (30%: tratamiento [11%], seguimiento [19]); 2) participación en actividades de capacitación (21%), y 3) promoción de la planificación del nacimiento (19%). El tiempo de los brigadistas se repartía entre la preparación (12%), el viaje (27%) y la ejecución (61%). Se observó una elevada correlación (+0,70) entre los cálculos generales y la suma de los tiempos de ejecución. Conclusiones Los brigadistas de estas comunidades remotas nicaragüenses realizaban distintas actividades, con niveles de esfuerzo y esquemas de división de tareas diferentes. Estos resultados, además de una encuesta en curso sobre la satisfacción en el trabajo y un estudio de seguimiento de los tiempos después de la introducción de las nuevas intervenciones, servirán para fundamentar las políticas en relación con este valioso equipo de voluntarios.

Performance of Ethiopia's Health System in Delivering Integrated Community-Based Case Management

Background. Analyzing complex health programs by their components and subcomponents serves design; documentation; evaluation; research; and gap identification and prioritization. In 2012; we developed a rapid methodology to characterize integrated community case management (iCCM) programs by assessing benchmarks for eight health system components in three program phases. Objective. To assess iCCM benchmarks in Ethiopia three years after scale-up commenced; and to compare the benchmarks across the geographical region. Methods. Six national iCCM experts scored each of 70 benchmarks (no; partial; or yes) and then were facilitated to reach consensus. Results. Overall; iCCM benchmark achievement in Ethiopia was high (87.3); highest for pre-introduction (93.0); followed by introduction (87.9) and scale-up (78.1) phases. Achievement bysystem component was highest for coordination and policy (94.2) and lowest for costing and finance (70.3). Six regional countries' benchmark assessments; including two from Ethiopia 14 months apart; were highly correlated with program duration at scale (correlation coefficient: +0.88). Conclusion. Ethiopia has a mature; broad-based iCCM program. Despite limitations; the method described here rapidly; systematically; and validly characterized a complex program and highlighted areas for attention through government or partners

Utilization of Integrated Community Case Management Services in Three Regions in Ethiopia after Two Years of Implementation

Background: The integrated community case management (iCCM) strategy has brought fully integrated treatment for sick children to the community in Ethiopia since 2010. Objectives: To describe patterns of use of iCCM services in 31 woredas (districts) in three regions of Ethiopia. Methods: We analyzed all 60;452 encounters (58;341 [98.2] for children 2-59 months of age and 2079 [1.8] for children2 months of age) recorded in iCCM registration books from December 24; 2012 to January 15; 2013 in 622 randomly sampled health posts. Results: Children 2-23 months constituted more than half (58.9) of the total children treated; and about half of the registered infants 2 months (1000/2079 [48.1]) were not sick since some Health Extension Workers (HEWs) were recording well-infant visits. On average; sick children had 1.3 symptoms; more among children 2-59 months than among young infants (1.4 vs. 1.04; respectively). The main classifications for children 2-59 months were diarrhea with some or no dehydration (29.8); pneumonia (20.7); severe uncomplicated malnutrition (18.5); malaria (11.2); and other severe diseases (4.0). More than half the sick children 2 months (52.7) had very severe disease. Treatment rates (per 1000 children per year) were low for all classifications: 11.9 for malaria (in malarious kebeles only); 20.3 for malnutrition; 21.2 for pneumonia; and 29.2 for diarrhea with wide regional variations; except for pneumonia. Nearly two-thirds of health posts (64) treated 5 cases/month; but one treated 40. Health Extension Workers saw 60 more sick children 2-59 months in the third quarter of 2012 than in the third quarter of 2011. Conclusion: The use of iCCM services is low and increasing slowly; and the few busy health posts deserve further study. Recording healthy young infants in sick registers complicates tracking this vulnerable group

A positive deviance-based antenatal nutrition project improves birth-weight in Upper Egypt.

The positive deviance approach identifies and promotes existing uncommon healthy behaviours. A positive deviance-informed antenatal project was pilot-tested in Al-Minia Governorate, Upper Egypt, during 2003-2004, after a positive deviance study in 2000 found that successful pregnancies had increased consumption of meat and vegetables, daytime rest, and antenatal care; less second-hand smoke exposure; and symptoms of no urinary tract infection. Accordingly, health facilities were upgraded in target and comparison areas to provide quality antenatal care, including treatment of urinary tract infection. Additionally, in the target villages, women at-risk of delivering low-birth-weight infants were enrolled in weekly 'IMPRESS' (improved pregnancy through education and supplementation) sessions with counselling and supplemental food. In total, 519 women (344 target, 175 comparison) were enrolled in the third or fourth month of pregnancy and were followed through delivery. Birth-weights of the target mothers increased 2.2 times more than birth-weights of the comparison mothers over baseline (mean increase: 0.58 vs 0.26 g respectively, p<0.01). Similarly, the decrease in prevalence of low birth-weight from baseline was greater in the target villages than in the comparison mothers (% of decrease: 26.9 vs 11.9 respectively, p<0.01). The target at-risk women were far more likely than their counterparts to report eating more food (54.9% vs 10.6%), more meat (57.1% vs 4.2%), more vegetables (66.9% vs 5.3%), increasing daytime rest (64.1% vs 11.7%), and avoiding second-hand smoke (91.3% vs 51.6%) during pregnancy. The cost per 100 g of improvement in birth-weight was US$ 3.98. The Government of Egypt and partners are scaling up the elements of the project.