A randomized clinical trial on inhaled ciclesonide for managing acute asthma in the emergency room

ABSTRACT BACKGROUND: Use of inhaled corticosteroids for managing acute asthma exacerbations has been tested since the 1990s. OBJECTIVE: To compare high doses of inhaled ciclesonide with systemic hydrocortisone for managing acute asthma exacerbations in the emergency department. DESIGN AND SETTING: Double-blind, randomized clinical trial in the public healthcare system of the city of São Paulo. METHODS: Fifty-eight patients with moderate or severe asthma with peak flow < 50% of predicted were randomized into two groups. Over the course of four hours, one group received 1440 mcg of inhaled ciclesonide plus hydrocortisone-identical placebo (ciclesonide + placebo), while the other received 500 mg of intravenous hydrocortisone plus ciclesonide-identical placebo (hydrocortisone + placebo). Both groups received short-acting bronchodilators (fenoterol hydrobromide and ipratropium bromide). The research protocol included spirometry, clinical evaluation, vital signs and electrocardiogram monitoring. Data were obtained at 30 (baseline), 60, 90, 120, 180, and 240 minutes. We compared data from baseline to hour 4, between and within groups. RESULTS: Overall, 31 patients received ciclesonide + placebo and 27 received hydrocortisone + placebo. Inhaled ciclesonide was as effective as intravenous hydrocortisone for improving clinical parameters (Borg-scored dyspnea, P = 0.95; sternocleidomastoid muscle use, P = 0.55; wheezing, P = 0.55; respiratory effort, P = 0.95); and spirometric parameters (forced vital capacity, P = 0.50; forced expiratory volume in the first second, P = 0.83; peak expiratory flow, P = 0.51). CONCLUSIONS: Inhaled ciclesonide was not inferior to systemic hydrocortisone for managing acute asthma exacerbations, and it improved both clinical and spirometric parameters. TRIAL REGISTRATION: RBR-6XWC26 - Registro Brasileiro de Ensaios Clínicos (http://www.ensaiosclinicos.gov.br/rg/RBR-6xwc26/).

Experiencia en la conducción de ensayos clínicos en Cienfuegos / Experience in conducting clinical trials in Cienfuegos

Fundamento: Cienfuegos se inserta en la Red Nacional de Ensayos Clínicos en la década de los 90. Ha tenido una participación importante en el registro de nuevos fármacos, lo que hasta el momento se ha difundido poco, de ahí la importancia de mostrar el crecimiento alcanzado por la provincia en esta actividad.Objetivo: describir la experiencia adquirida y el desarrollo alcanzado por Cienfuegos en la conducción de ensayos clínicos.Métodos: estudio descriptivo sobre ensayos clínicos realizados en Cienfuegos desde 1992 hasta mayo de 2016. Se analizaron las variables: centro promotor, producto evaluado, fase de desarrollo del ensayo clínico, especialidades médicas y número de pacientes incluidos.Resultados: se ejecutaron 64 ensayos clínicos, procedentes fundamentalmente del Centro de Ingeniería Genética y Biotecnología y el Centro de Inmunología Molecular. Las especialidades médicas con mayor participación fueron oncología y hematología con 15 (23.4%) y 10 (15.6%) ensayos respectivamente. El mayor porcentaje de investigaciones estuvo dirigido a probar la eficacia y seguridad de productos para el tratamiento del cáncer, con la realización de 30 ensayos (46.8 %) en localizaciones como pulmón, sistema hematológico, mama, cabeza y cuello y próstata. Se incluyeron 2420 pacientes. Su ejecución se extendió hasta la Atención Primaria de Salud y se incorporó el Hospital Gustavo Aldereguía Lima al proceso de certificación de sitios clínicos.Conclusiones: existe un trabajo sistemático en Cienfuegos en relación con la ejecución de los ensayos clínico; se ha contribuido al registro sanitario y comercialización de varios productos.

Foundation: Cienfuegos is inserted in the National Netork of Clinical Trials of the nineties. Decade. It has an important parrticipation in the registration of new drugs, which up to the moment has not been enough disseminated. This is the reason of the importance of showing the growth achived in the province in this activity.Objective: To describe the experience and development achived in Cienfuegos in conducting clinical trials. Methods: it is a descriptive study on the clinical trials conducted in Cienfuegos from May 1992 to May 2016. Variables such as: promoting center, evaluated product, stage of the clinical trials, medical specialties and number of patients included were analyzed.Results: a number of 64 clinical trials were carried out, basically form Center for Genetic Engineering and Biotechnology and the Center of Molecular Inmunology. The medical specialties with most participation were oncology and hematology with 15 (23.4%) and 10 (15.6%) trials respectively. The highest percentage of research were aimed at confirming the efficacy and safety of product for the treatment of cancer. with the conduction of 30 clinical trials (46.8%) in locations as lungs, hematologic system, breast, head and neck and prostate. A number of 2420 patients were included. There implementation extended to the Primary Health Care System and the Gustavo Aldereguia Lima Provincial Hospital was incorporated to the process of certification.Conclusion: There is a systemtic work in Cienfuegos related to the conduction of clinical trials. There has been a contribution and comercialization of several products.

Adherence to clinical trial registration in countries of Latin America and the Caribbean, 2015 / Cumplimiento del registro de ensayos clínicos en los países de América Latina y el Caribe, 2015 / Adesão ao registro de ensaios clínicos em países da América Latina e Caribe, 2015

ABSTRACT Objective To determine the prevalence of clinical trial registration in the International Clinical Trial Registry Platform (ICTRP) for studies from Latin America and the Caribbean (LAC) and to identify the key characteristics that lead to prospective and retrospective registration. Methods A cross-sectional study identified published, clinical trial studies through a search of PubMed, LILACS (Latin American and Caribbean Center on Health Sciences Information), and the Cochrane Central Register of Controlled Trials. Studies were included if published on 1 January - 31 December 2015, at least one author was affiliated with at least one LAC country, the clinical trial was conducted in at least one LAC site, and the full text of the article was available. A manual search of reference lists was also conducted. ICTRP registration information and key trial characteristics were compared. Results Of 1 502 CT references that met inclusion criteria, 297 were randomly-selected, 90.9% of which were published in English, 65% from Brazil, and 76.8% had a LAC author as the first author. The proportion of CT registered in the ICTRP was 59.9 %, of which 51.7% were registered prospectively. Clinicaltrials.gov was most frequently used registry (84.8%), followed by the Registro Brasileiro de Ensaios Clínicos and the Registro Público Cubano de Ensayos Clínicos. Key characteristics that favored registration were being in study phase 3 or 4 or being a multi-center study. Data was compared to a similar study from 2013 that reported a registration rate of only 19.8%. Conclusions Registration adherence and prospective registration have increased in LAC in recent years, but the proportion of unregistered CT remains high. While there are still many challenges to overcome, the adherence strategies implemented in recent years have proven effective.

RESUMEN Objetivo Determinar la prevalencia del registro de ensayos clínicos de América Latina y el Caribe en la Plataforma de Registros Internacionales de Ensayos Clínicos (ICTRP, por su sigla en inglés) y definir los elementos clave que fomentan el registro prospectivo y retrospectivo de estudios. Métodos Se realizó un estudio transversal para encontrar los ensayos clínicos publicados mediante una búsqueda en PubMed, LILACS (Centro Latinoamericano y del Caribe para Información en Ciencias de la Salud) y el Registro Central Cochrane de Ensayos Clínicos Controlados. Se incluyeron los estudios que habían sido publicados entre el 1 de enero y el 31 de diciembre del 2015, que tenían cuando menos un autor afiliado a uno o más países de América Latina y el Caribe, que se habían realizado al menos en un centro de América Latina y el Caribe, y que tenían el texto completo del artículo disponible. También se llevó a cabo una búsqueda manual en listas de referencia. Se comparó la información sobre registros de la ICTRP y las características clave de los ensayos clínicos. Resultados De las 1 502 referencias que cumplieron los criterios de inclusión, se seleccionaron 297 aleatoriamente. De estas, 90,9% se habían publicado en inglés, 65% eran de Brasil y 76,8% tenían como primer autor un investigador de América Latina y el Caribe. La proporción de ensayos clínicos registrados en la ICTRP fue de 59,9%, de los cuales 51,7% se habían registrado prospectivamente. Clinicaltrials.gov fue el registro usado con mayor frecuencia (84,8%), seguido por el Registro Brasileiro de Ensaios Clínicos y el Registro Público Cubano de Ensayos Clínicos. Se determinó que las características clave que favorecían el registro eran que fuese un estudio de fase 3 o 4 o un estudio multicéntrico. Se compararon los datos con un estudio similar del 2013 en el que se había informado que la tasa de registro era de apenas 19,8%. Conclusiones En América Latina y el Caribe se ha observado en los últimos años un aumento en el cumplimiento del registro y del registro prospectivo de ensayos clínicos, pero la proporción de estudios sin registrar sigue siendo alta. Sin embargo, aunque persisten muchos retos que se deben superar, las estrategias adoptadas en los últimos años para que se cumpla este requisito han sido eficaces.

RESUMO Objetivo Determinar a prevalência do registro de estudos clínicos na Plataforma Internacional de Registro de Ensaios Clínicos (ICTRP) para estudos realizados na América Latina e Caribe (ALC) e identificar as principais características que conduzem ao registro prospectivo e retrospectivo. Métodos Em um estudo transversal, foram identificados os estudos clínicos publicados através de uma busca nas bases de dados PubMed, LILACS (Centro Latino-Americano e do Caribe de Informação em Ciências da Saúde) e Cochrane Central Register of Controlled Trials (CENTRAL). Foram incluídos estudos publicados de 1o. de janeiro a 31 de dezembro de 2015, em que pelo menos um dos autores provinha de um país da ALC, realizados em um ou mais centros na ALC e que apresentavam o texto completo disponível. Foi também feita uma busca manual das listas de referências. Foram comparados os dados sobre o registro na ICTRP e as principais características dos estudos. Resultados Das 1.502 referências de estudos clínicos que atenderam os critérios de inclusão, 297 foram selecionadas aleatoriamente. Verificou-se que 90,9% dos estudos foram publicados em inglês, 65% eram provenientes do Brasil e 76,8% tinham como primeiro autor um pesquisador da ALC. O percentual de registro dos estudos clínicos na ICTRP foi de 59,9%, sendo 51,7% registrado de forma prospectiva. Clinicaltrials.gov foi o registro mais usado (84,8%), seguido do Registro Brasileiro de Ensaios Clínicos e do Registro Público Cubano de Ensayos Clínicos. As principais características que contribuíram para o registro foram ser estudo de fase 3 ou 4 ou multicêntrico. Os dados foram comparados com um estudo semelhante realizado em 2013 que verificou uma taxa de registro de apenas 19,8%. Conclusões Houve um aumento na adesão ao registro e no registro prospectivo na ALC nos últimos anos, porém o percentual de estudos clínicos não registrados continua alto. Embora ainda existam muitos desafios a serem vencidos, as estratégias de adesão implementadas nos últimos anos têm sido eficazes.

Evaluación de un estudio clínico sobre el efecto de la oración intercesora remota en pacientes críticamente enfermos / Critical appraisal of a clinical study on the effect of remote intercessory prayer in severely ill patients

Introducción. Las medicinas alternativas y complementarias son un recurso de salud de amplia difusión en la población general, sin embargo su eficacia clínica es materia de discusión. Algunas instituciones reconocidas en este campo sugieren que las investigaciones sobre los diversos tratamientos deben seguir los mismos requisitos de calidad y de evaluación de la evidencia que las de cualquier intervención médica alopática y someterse a los mismos criterios de verificación de cualquier innovación científica en salud. Objetivo. Evaluar críticamente un ensayo clínico publicado sobre el efecto de la oración intercesora remota (OIR), en pacientes críticos hospitalizados en la unidad de cuidados intensivos. Metodología. Se revisó el estado del arte de la investigación sobre el efecto de la OIR y se describieron puntos de controversia. Se analizó la argumentación que ofrece el estudio y se evaluaron críticamente los aspectos relacionados con el diseño, la recolección de información y la interpretación de resultados. Se utilizó la guía de evaluación elaborada por el National Collaborating Centre of Methods and Tools de McMaster University, del Canadá, que se fundamenta en los criterios compilados por Gordon Guyatt y Drummond Rennie (2002). Resultados. Se observa ausencia de un marco teórico que fundamente el fenómeno de investigación y fallas metodológicas en la distribución aleatoria, el enmascaramiento, la estandarización de la intervención y la valoración e interpretación de los resultados. Conclusión. El estudio no cumple los criterios de calidad de los ensayos clínicos y la evidencia aportada no puede aplicarse a ninguna población. En la literatura científica revisada se menciona que este tipo de problemas son frecuentes en estudios sobre medicinas alternativas.

Introduction. Complementary and alternative medicines are a health resource widespread in the general population, but its clinical efficacy is a matter of discussion. Some recognized institutions in this field suggest that research on complementary therapies should follow the same quality requirements and evaluation of the evidence than any allopathic medical intervention and undergo the same quality standards. Objective. To critically evaluate one published clinical trial on the effect of remote intercessory prayer in critically ill patients hospitalized in an intensive care unit. Methodology. It was done a review of the research on the effect of remote intercessory prayer and a description of the points of dispute. It was made an analysis of the backgrownd and the argument, the methodological issues and the interpretation of results. A guide designed by the National Collaborating Centre of Methods and Tools of McMaster University was used. Results. It was observed an absence of a theoretical framework of research phenomenon and methodological flaws in randomization, blinding, standardization of intervention, outcomes assessment and interpretation of results. Conclusion. The study does not meet the quality criteria of clinical trials and the evidence provided could not be applied to any population. The revised literature mentions that such problems are common in research on alternative and complementary therapies.

Avaliação da utilidade clínica de novos testes diagnósticos em tuberculose: o papel dos ensaios clínicos pragmáticos / Evaluation of the clinical utility of new diagnostic tests for tuberculosis: the role of pragmatic clinical trials

A tuberculose é uma das principais doenças infecciosas em países em desenvolvimento, e o tempo durante o qual a cadeia de transmissibilidade é mantida tem sido apontado como um dos principais fatores de perpetuação da doença. Nesse contexto, novas ferramentas para o diagnóstico têm sido aprovadas pelas agências regulamentadoras nesses países, e sua incorporação é quase imediatamente implementada pelos programas governamentais de controle da tuberculose. As intervenções na área da saúde têm sido cada vez mais investigadas em ensaios clínicos explanatórios (que avaliam seus efeitos benéficos) e em ensaios clínicos pragmáticos (que auxiliam na tomada de decisão). Nós argumentamos que a avaliação de novas técnicas diagnósticas para a detecção da tuberculose não deveria escapar dessa mesma lógica de escrutínio.

Tuberculosis is one of the major infectious diseases in developing countries, and the length of time for which the chain of transmission is maintained has been implicated as a major factor in the perpetuation of the disease. In this context, regulatory agencies in such countries have approved new diagnostic tools, which have been almost immediately incorporated into the national tuberculosis control programs. Health interventions have been increasingly investigated in clinical trials, including explanatory trials (in order to evaluate the beneficial effects of such interventions) and pragmatic trials (in order to aid in the decision-making process). We argue that the evaluation of new diagnostic techniques for the detection of tuberculosis should not escape this same logic of evaluation.