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Research is needed to help identify interventions that will improve the capacity or functioning of health systems and thereby contribute to achieving global health goals. Well conducted, randomized controlled trials (RCTs), insofar as they reduce bias and confounding, provide the strongest evidence for identifying which interventions delivered directly to individuals are safe and effective, when ethically feasible, they can also help reduce bias and confounding when assessing interventions targeting entire health systems. However, additional challenges emerge when research focuses on interventions that target the multiple units of organization found within health systems. Hence, one cannot complacently assume that randomization can reduce or eliminate bias and confounding to the same degree in every instance. While others have articulated arguments in favour of alternative designs, this paper is intended to help. people understand why the potential value afforded by RCTs may be threatened. Specifically, it suggests six points to be borne in mind when exploring the challenges entailed in designing or evaluating RCTs on health system interventions: (i) the number of units available for randomization; (ii) the complexity of the organizational unit under study; (iii) the complexity of the intervention; (iv) the complexity of the cause-effect pathway, (v) contamination; and (vi) outcome heterogeneity. The authors suggest that the latter may be informative and that the reasons behind it should be explored and not ignored. Based on improved understanding of the value and possible limitations of RCTs on health system interventions, the authors show why we need broader platforms of research to complement RCTs. Des recherches sont necessaires pour permettre d'identifier les interventions qui amelioreront la capacite ou le fonctionnement des systemes de sante, contribuant ainsi a atteindre les objectifs mondiaux entermes de sante. Des essais controles randomises (ECR) correctement realises, en ce sens qu'ils reduisent les biais et les confusions, offrent la preuve la plus solide pour identifier les interventions sures et efficaces directement realisees sur les personnes. Lorsque l'ethique le permet, ils peuvent egalement permettre de reduire les biais et les confusions lors de l'evaluation d'interventions Ciblant les systemes de sante dans leur integralite. Toutefois, d'autres questions se posent lorsque la recherche est orientee sur les interventions qui ciblent les nombreuses unites d'organisation presentes dans les systemes de sante. Ainsi, il est impossible de presumer avec legerete que la randomisation est en mesure de reduire ou d'eliminer les biais ou les confusions dans la meme mesure dans chaque instance. Alors que certains ont des arguments clairs en faveur de conceptions alternatives, cet article est destine a expliquer pourquoi la valeur potentielle relative aux ECR peut etre menacee. Il suggere en particulier six points a considerer lors de l'etude des questions qui apparaissent dans la conception ou l'evaluation des ECR sur les interventions des systemes de sante: le nombre d'unites disponibles pour la randomisation, la complexite de l'unite d'organisation etudiee, la complexite de l'intervention, la complexite du parcours cause-effet et la contamination. De plus, les auteurs suggerent que l'heterogeneite des resultats peut etre instructive et que les raisons sous-jacentes doivent etre etudiees, et non ignorees. Se basant sur une meilleure comprehension de la valeur et des limitations possibles des ECR sur les interventions des systemes de sante, les auteurs montrent les raisons pour lesquelles nous avons besoin de plateformes de recherche plus vastes afin de completer les ECR. Se necesita realizar investigaciones para facilitar la identificacion de intervenciones que mejoren la capacidad o el funcionamiento de los sistemas sanitarios y, por tanto, contribuir a lograr las metas de salud global. Cuando se los realiza correctamente, los estudios controlados aleatorizados (ECA), siempre que reduzcan el sesgo y la confusion, proporcionan la mas solida evidencia para identificar cuales intervenciones brindadas directamente a las personas son seguras y eficaces. Cuando es factible desde el punto de vista etico, tambien pueden ayudar a reducir el sesgo y la confusion cuando se evaluan las intervenciones centradas en sistemas sanitarios completos. No obstante, surgen desanos adicionales cuando la investigacion se enfoca en intervenciones que se centran en multiples unidades de organizacion encontradas dentro de los sistemas sanitarios. Por tanto, no se puede suponer con complacencia que la aleatorizacion puede reducir o eliminar el sesgo y la confusion en el mismo grado en cada caso. Si bien otros autores tienen argumentos expuestos a favor de disenos alternativos, en este documento el objetivo es ayudar a la gente a entender por que puede verse amenazado el valor potencial de los ECA. Especificamente, propone seis puntos a tener en cuenta al explorar los desafios del diseno o la evaluacion de los ECA en las intervenciones en sistemas sanitarios: el numero de las unidades disponibles para aleatorizacion, la complejidad de la unidad organizativa en estudio, la complejidad de la intervencion, la complejidad de la relacion de causa y erecto, y la contaminacion. Ademas, los autores sugieren que la heterogeneidad de los resultados puede ser informativa y que deben explorarse y no ignorarse las razones detras de dicho fenomeno. Basandose en la mayor comprension del valor y las posibles limitaciones de los ECA en las intervenciones en los sistemas sanitarios, los autores demuestran por que se necesitan plataformas mas amplias de investigacion para complementar los ECA., Introduction Researchers are being urged to provide evidence on how to fix health systems in developing countries. (1-3) These exhortations recognize that health systems play a vital role in achieving [...]

Effective case management is an important strategy to reduce pneumonia-related morbidity and mortality in children. Guidelines based on sound evidence are avallable but are used variably. This review outlines current guidelines for childhood pneumonia management in the setting where most child pneumonia deaths occur and identifies challenges for improved management in a variety of settings and different "at-risk" groups. These include appropriate choice of antibiotic, clinical overlap with other conditions, prompt and appropriate referral for inpatient care, and management of treatment failure. Management of neonates, and of HIV-infected or severely malnourished children is more complicated. The influence of co-morbidities on pneumonia outcome means that pneumonia case management must be integrated within strategies to improve overall paediatric care. The greatest potential for reducing pneumonia-related deaths in health facilities is wider implementation of the current guidelines built around a few core activities: training, antibiotics and oxygen. This requires investment in human resources and in equipment for the optimal management of hypoxaemia. It is important to provide data from a variety of epidemiological settings for formal cost-effectiveness analyses. Improvements in the quality of case management of pneumonia can be a vehicle for overall improvements in child healthcare practices. La prise en charge efficace des cas joue un role important dans la reduction de la morbidite et de la mortalite dues a la pneumonie. Des recommandations reposant sur des elements factuels solides sont disponibles, mais sont appliquees diversement. Le present article expose dans leurs grandes lignes les recommandations actuelles pour la prise en charge de la pneumonie chez l&apos;enfant dans les pays ou interviennent la plupart des deces d&apos;enfants par pneumonie et identifie les difficultes pour ameliorer cette prise en charge dans divers pays et chez differents groupes << a risque >>. Ces recommandations concernent notamment le choix d&apos;un antibiotique adapte, le recouvrement clinique avec d&apos;autres pathologies, l&apos;orientation rapide et appropriee vers des soins hospitaliers et la prise en charge des echecs therapeutiques. La prise en charge des nouveau-nes et des enfants infectes par le VIH ou gravement denutris est plus complexe. L&apos;influence des comorbidites sur l&apos;issue de la pneumonie implique que la prise en charge de cette maladie doit s&apos;integrer dans des strategies d&apos;amelioration des soins pediatriques en general. Le plus fort potentiel de reduction de la mortalite par pneumonie dans les etablissements de soins reside dans l&apos;elargissement de l&apos;application des recommandations actuelles, elaborees autour de quelques interventions centrales : formation, antibiotiques et oxygene. Cet elargissement necessite des investissements en ressources humaines et en equipements pour une prise en charge optimale de l&apos;hypoxemie. Il est important de fournir des donnees provenant de divers contextes epidemiologiques pour etablir des analyses cout/efficacite formelles. L&apos;amelioration en termes de qualite de la prise en charge de la pneumonie pourrait servir de moteur a des ameliorations globales des pratiques de soins pediatriques. Un manejo de casos eficaz constituye una estrategia importante para reducir la morbilidad y la mortalidad por neumonia en la ninez. Las directrices basadas en la evidencia de que se dispone se utilizan en diversa medida. En el presente analisis se describen las directrices actuales para el tratamiento de la neumonia en la ninez en las circunstancias que rodean la mayoria de las muertes por neumonia en la infancia y se senalan les retos que deben superarse para mejorar el tratamiento en diversos contextos y diferentes grupos en riesgo. Entre ellos cabe citar la eleccion apropiada del antibiotico, el solapamiento clinico con otras dolencias, la derivacion rapida y apropiada para dispensar atencion hospitalaria, y el manejo de les casos de fracaso terapeutico. El tratamiento de les recien nacidos y de les ninos infectados por el VIH o malnutridos es mis complicado. Dada la influencia de posibles comorbilidades en la evolucion de la neumonia, el tratamiento de les casos de esa enfermedad debe integrarse en estrategias orientadas a mejorar la atencion pediatrica en general. Las mayores posibilidades de reducir las defunciones relacionadas con la neumonia en les centros de salud son las que se derivan de una mis amplia aplicacion de las directrices actuales centradas en unas cuantas actividades basicas: capacitacion, antibioticos y oxigeno. Eso exige invertir en recursos humanos y en equipo para manejar optimamente la hipoxemia. Es importante aportar datos procedentes de diverses entornos epidemiologicos para poder realizar analisis formales de costo-eficacia. Las mejoras de la calidad del tratamiento de casos de neumonia pueden brindar la ocasion para introducir otras mejoras mas generales en las practicas de salud infantil. [TEXT NOT REPRODUCIBLE IN ASCII], Introduction Pneumonia is the leading cause of death in children worldwide and the great majority of these deaths occur in resource-limited settings. (1) WHO developed a case-management strategy in the [...]

Objective Haemophilus influenzae type b (Hib) vaccine was introduced into routine immunization services in Kenya in 2001. We aimed to estimate the cost-effectiveness of Hib vaccine delivery. Methods A model was developed to follow the Kenyan 2004 birth cohort until death, with and without Hib vaccine. Incidence of invasive Hib disease was estimated at Kilifi District Hospital and in the surrounding demographic surveillance system in coastal Kenya. National Hib disease incidence was estimated by adjusting incidence observed by passive hospital surveillance using assumptions about access to care. Case fatality rates were also assumed dependent on access to care. A price of US$ 3.65 per dose of pentavalent diphtheria-tetanus-pertussis-hep B-Hib vaccine was used. Multivariate Monte Carlo simulations were performed in order to assess the impact on the cost-effectiveness ratios of uncertainty in parameter values. Findings The introduction of Hib vaccine reduced the estimated incidence of Hib meningitis per 100 000 children aged < 5 years from 71 to 8; of Hib non-meningitic invasive disease from 61 to 7; and of non-bacteraemic Hib pneumonia from 296 to 34. The costs per discounted disability adjusted life year (DALY) and per discounted death averted were US$ 38 (95% confidence interval, CI: 26-63) and US$1197 (95% CI: 814-2021) respectively. Most of the uncertainty in the results was due to uncertain access to care parameters. The break-even pentavalent vaccine price--where incremental Hib vaccination costs equal treatment costs averted from Hib disease--was US$1.82 per dose. Conclusion Hib vaccine is a highly cost-effective intervention in Kenya. It would be cost-saving if the vaccine price was below half of its present level. Objectit La vaccination contre Haemophilus intluenzae type b (Hib) a ete integree au programme de vaccinations systematiques kenyan en 2001. Nous nous sommes efforces d&apos;estimer le rapport cout/efficacite de la delivrance de ce vaccin. Methodes Un modele a ete mis au point pour sume jusqu&apos;a leur mort une cohorte d&apos;enfants nes en 2004, vaccines ou non contre le virus Hib. L&apos;incidence des infections a Hib invasives a ete estimee l&apos;hopital de district de Kilifi et par le biais du systeme de surveillance demographique environnante de la region cotiere du Kenya. L&apos;incidence nationale des affections a Hib a ete estimee a partir d&apos;ajustements sur l&apos;incidence observee par la surveillance passive dans les hopitaux et d&apos;hypotheses concernant l&apos;acces aux soins. Les taux de letalite ont egalement ete supposes comme dependants de l&apos;acces aux soins. L&apos;etude s&apos;est basee sur un prix d&apos;US$ 3,65 par dose pour le vaccin pentavalent DTCP + Hib. L&apos;influence sur les rapports cout/efficacite des incertitudes sur les parametres a ete evaluee par des simulations multivariees de type Monte Carlo. Resultats Chez les enfants de moins de 5 ans, l&apos;introduction du vaccin anti-Hib a permis de reduire l&apos;incidence de la meningite Hib de 71 a 8 cas pour 100 000, celle des affections invasives non meningees de 61 a 7 cas pour 100 000 et celle des pneumonies a Hib non bacteriennes de 296 a 34 cas pour 100 000. Les economies realisees grace au nombre d&apos;annees de vie corrigees de l&apos;incapacite (DALY) epargnees et aux deces evites s&apos;elevent respectivement a US$ 38 [intervalle de confiance a 95% (IC) : 26-63] et a US$ 1197 [intervalle de confiance a 95% (IC) : 814-2021]. La plus grande part de l&apos;incertitude sur les resultats est imputable aux difficultes d&apos;evaluation des parametres relatifs aux soins. Le seuil de rentabilite du vaccin pentavalent (prix pour lequel l&apos;economie sur les depenses entrainees par les infections a Hib compense l&apos;augmentation des couts de vaccination) est d&apos;US$ 1,82 par dose. Conclusion La vaccination contre le virus Hib constitue une intervention hautement efficace dans le cas du Kenya. Elle permettrait une economie si le prix du vaccin etait inferieur de 50% au moins a son niveau actuel. Objetivo Estimar la costoeficacia de la administracion de la vacuna contra Haemophilus influenzae tipo b (Hib), que se introdujo en los servicios de inmunizacion sistematica de Kenya en 2001. Metodos Se elaboro un modelo para seguir la evolucion de la cohorte de nacimiento de 2004 hasta el momento de la defuncion, con y sin vacuna anti-Hib. Se estimo la incidencia de la enfermedad invasiva por Hib en el Hospital de Distrito de Kilifi y en el sistema circundante de vigilancia demografica de la costa de Kenya. La incidencia nacional de enfermedad por Hib se estimo ajustando la incidencia observada mediante vigilancia pasiva en los hospitales, asumiendo algunas premisas sobre el acceso a la atencion. Se asumio que las tasas de letalidad tambien dependian del acceso a la asistencia. Fijando en US$ 3,65 el precio de la dosis de vacuna pentavalente contra difteria-tetanos-tos ferina-hep B-Hib, se realizaron simulaciones multifactoriales con el metodo de Monte Carlo para determinar el impacto de la incertidumbre de los parametros en los valores de la costo-eficacia. Resultados La introduccion de la vacuna anti-Hib redujo la incidencia estimada de meningitis por Hib por 100 000 ninos menores de 5 anos de 71 a 8; de enfermedad invasiva no meningitica por Hib, de 61 a 7; y de neumonia por Hib no bacteriemica, de 296 a 34. Los costos por AVAD (ano de vida ajustado en funcion de la discapacidad) descontado evitado y por muerte descontada evitada fueron de US$ 38 (intervalo de confianza (IC) del 95%: 26-63) y US$1197 (IC95%: 814-2021), respectivamente. La mayor parte de la incertidumbre de los resultados se debio a la incertidumbre de los parametros relativos al acceso a la atencion. El umbral de rentabilidad de la vacuna pentavalente -punto de equivalencia del incremento de los costos de la vacunacion anti-Hib y de los costos evitados en concepto de tratamiento de la enfermedad por Hib- fue de US$1,82 por dosis. Conclusion La vacunacion contra Hib es una intervencion altamente costoeficaz en Kenya, y permitiria hacer economias si la vacuna costara menos de la mitad de lo que cuesta ahora., Introduction Haemophilus influenzae type b (Hib) vaccine has been licensed for use in infants since 1991. Most industrialized countries introduced the vaccine quickly into routine infant immunization services, This was [...]

Objective Little data has been published on the presenting symptoms and signs among ill infants aged Methods Standardized assessment tools were designed to record clinical symptoms and signs. Data were collected prospectively on all infants aged Findings Data on 467 outpatient consultations and 769 inpatient episodes were available for analysis. These data highlighted the importance of findings in the history, particularly breathing difficulties, abnormal feeding, and abnormal behaviour, as well as clinical signs in the evaluation of young infants. They indicated possible important differences in the panel of signs useful for detecting severe illness in infants aged 0-6 days and those aged 7-59 days. They also showed that some simplification of current guidelines that still preserved the sensitivity and specificity for detecting very severe disease might be possible. Conclusion Simple clinical features may allow distinction between severe and non-severe illness to be made with reasonable confidence. Prospective studies on an adequate scale are needed urgently to provide current integrated management of childhood illness guidelines for young infants with an adequate evidence base. Keywords Critical illness; Infant, Newborn, Diseases/diagnosis; Severity of illness index; Infant, Newborn; Infant care/methods; Delivery of health care, Integrated; Practice guidelines; Sensitivity and specificity; Prospective studies; Kenya (source: MeSH, NLM). Mots cles Maladie grave; Nouveau-ne, Maladies/diagnostic; Indice de gravite; Nouveau-ne; Soins nourrisson/methodes; Distribution integree soins; Ligne directrice pratique medicale; Sensibilite et specificite (Epidemiologie); Etude prospective; Kenya (source: MeSH, INSERM). Palabras clave Enfermedad critica; Enfermedades del recien nacido/diagnostico; Indice de gravedad; Recien nacido; Cuidado del lactante/metodos; Entrega integrada de atencion de salud; Entrega integrada de atencion de salud; Pautas practicas; Sensibilidad y especificidad; Estudios prospectivos; Kenya (fuente: DeCS, BIREME)., Introduction Many developing countries have adopted the integrated management of childhood illness (IMCI) approach to the care of ill children at primary care level (1). For assessment, classification, and treatment [...]

Objective To investigate whether the outpatient, syndrome-based approach of the Integrated Management of Childhood Illness (IMCI) protocol could be extended to the inpatient arena to give clear and simple minimum standards of care for poorly resourced facilities. Methods A prospective, one-year admission cohort retrospectively compared hypothetical performance of syndrome-based management with paediatrician-defined final diagnosis. Admission syndrome definitions were based on local adaptations to the IMCI protocol that encompassed 20 clinical features, measurement of oxygen saturation, and malaria microscopy. Findings After 315 children with clinically obvious diagnoses (e.g. sickle cell disease and burns) were excluded, 3705 admission episodes were studied. Of these, 2334 (63%) met criteria for at least one severe syndrome (mortality 8% vs 95%) for severe pneumonia, severe malaria, and diarrhoea with severe dehydration, and probably for severe malnutrition (sensitivity 71%). Syndrome-directed treatment suggested the use of broad-spectrum antibiotics in 75/133 (56% sensitivity) children with bacteraemic and 63/71 (89% sensitivity) children with meningitis. Conclusions Twenty clinical features, oxygen saturation measurements, and results of malaria blood slides could be used for inpatient, syndrome-based management of acute paediatric admissions. The addition of microscopy of the cerebrospinal fluid and haemoglobin measurements would improve syndrome-directed treatment considerably. This approach might rationalize admission policy and standardize inpatient paediatric care in resource-poor countries, although the clinical detection of bacteraemia remains a problem. Keywords Acute disease/therapy; Critical illness/therapy; Syndrome; Pneumonia/diagnosis/drug therapy; Malaria/diagnosis/drug therapy; Diarrhea/diagnosis/drug therapy; Child nutrition disorders/diagnosis/therapy; Meningitis/diagnosis/drug therapy; Bacteremia/ diagnosis/drug therapy; Infant; Child, Preschool; Models, Theoretical; Prospective studies; Kenya (source: MeSH, NLM). Mots cles Maladie aigue/therapeutique; Maladie grave/therapeutique; Syndrome; Pneumonie/diagnostic/chimiotherapie; Paludisme/diagnostic/chimiotherapie; Diarrhee/diagnostic/chimiotherapie; Troubles nutrition enfant/diagnostic/therapeutique; Meningite/diagnostic/chimiotherapie; Bacteriemie/diagnostic/chimiotherapie; Nourrisson; Enfant age pre-scolaire; Modele theorique; Kenya (source: MeSH, INSERM). Palabras clave Enfermedad aguda/terapia; Enfermedad critica/terapia; Sindrome; Estudio prospectivo Neumonia/diagnostico/quimioterapia; Paludismo/diagnostico/quimioterapia; Diarrea/diagnostico/quimioterapia; Trastornos de la nutricion del nino/diagnostico/terapia/quimioterapia; Meningitis/diagnostico/quimioterapia; Bacteremia/diagnostico/quimioterapia; Lactante; Infante; Modelos teoricos; Estudios prospectivos; Kenya (fuente: DeCS, BIREME)., Introduction Over the last ten years, considerable effort has been put into developing the Integrated Management of Childhood Illness (IMCI) initiative, a generic, but adaptable, approach to the assessment and [...]

WHO regularly gathers, evaluates, and cites evidence to support its recommendations. How this is done varies between departments, but highly centralized processes, complex methods and expert consultations are often used. [...]