Clinical Competence and Perception of Medical Students after Early Clinical Exposure through Pre-clerckship Education at an Ethiopian Medical School: A Cross-sectional Study

BACKGROUND: Conventional medical curriculum is the mainstay in the long history of modern medical education. Innovative integrated medical curriculum attracted significant attention in improving conventional curriculum. In the integrated curriculum, basic sciences are incorporated horizontally with each other, and students are exposed early to clinical settings. This is expected to improve students' knowledge and skills in clinical medicine by the time they start their clerkship rotation. METHOD: the study aims to make a baseline assessment on the overall knowledge and skills of medical students towards clinical medicine. An institution-based cross-sectional study was conducted from March to April of 2020 using 91 third year medical students (convenience sampling). A threesection selfadministered survey instrument, short written MCQ exam, and practical (OSCE) students' examination were used for this survey. RESULT: participants tend to exhibit better knowledge on basics of history taking and physical examination with an average score of 79%. Comparatively, the score for average physical examination skill was low (56.3%). Students' perception on ECE showed, over 50% of participants believe ECE increases burden on their overall workload. Even then, the majority (92.3%) still think that ECE has positive impact on their clerkship education. Taken together, it appears more hands-on interventions is needed to further improve skills of medical students in physical examination with particular emphasis on the clinical examination of breast, thyroid, musculoskeletal, and neurologic systems

Ensayos clínicos con análisis secuencial y su interrupción precoz ¿cómo interpretarlos? / How to interpret clinical trials with sequential analysis that were stopped early

El análisis secuencial de ensayos clínicos permite el monitoreo continuo de los datos emergentes para el investigador, así como una mayor seguridad para evitar someter a los participantes a una terapia inferior o fútil en términos de eficacia o seguridad, antes que esta sea evidente, mientras se controla la tasa de error general. Si bien ha sido extensamente empleado desde su desarrollo, no está exento de problemas. Entre ellos se puede mencionar el balance entre seguridad y eficacia, el sesgo condicional y la sobrestimación del tamaño del efecto de las intervenciones. En esta revisión se desarrollan distintos aspectos de esta metodología y el impacto que tiene la inclusión de ensayos clínicos precozmente interrumpidos en las revisiones sistemáticas con metanálisis.

Sequential analysis of clinical trials allows researchers a continuous monitoring of emerging data and greater security to avoid subjecting the trial participants to a less effective therapy before the inferiority is evident, while controlling the overall error rate. Although it has been widely used since its development, sequential analysis is not problem-free. Among them main issues to be mentioned are the balance between safety and efficacy, overestimation of the effect size of interventions and conditional bias. In this review, we develop different aspects of this methodology and the impact of including early-stopped clinical trials in systematic reviews with meta-analysis.

Ensayo quirúrgico aleatorio controlado de dos procedimientos para hallux valgus: fracaso en el reclutamiento / Surgical randomized controlled trial of two procedures for hallux valgus: recruitment failure

Antecedentes: Los ensayos quirúrgicos aleatorizados controlados (EQAC) son la mejor manera de validar los nuevos tratamientos quirúrgicos; sin embargo, comprenden una fracción muy pequeña de los artículos publicados en la literatura. Una de las razones de la falta de éxito es el hecho de no reclutar un número adecuado de pacientes. Métodos: Se presentan los resultados de 14 meses de reclutamiento de un EQAC que compara dos procedimientos quirúrgicos para el tratamiento del hallux valgus doloroso. El estudio es no ciego, de no inferioridad y paralelo con una meta de inclusión de 100 sujetos en 24 meses. Resultados: En los primeros 14 meses de reclutamiento, 94 pacientes fueron evaluados para su elegibilidad, de los cuales 54 fueron excluidos y 40 cumplían con criterios según protocolo. De estos 40, 13 fueron incluidos en el proceso de aleatorización pero sólo 11 fueron sometidos a los procedimientos quirúrgicos, ya que dos se rehusaron a dicho proceso el día de la cirugía. De los 27 pacientes elegibles restantes, en 22 no hubo más contacto después de completar la evaluación de elegibilidad y siete se negaron al procedimiento aleatorio. Los resultados indican que el estudio no recluta un número suficiente de sujetos. Conclusiones: Los datos muestran que los investigadores que planean realizar un EQAC deben ser conscientes de la gran cantidad de esfuerzo y recursos financieros necesarios para alcanzar las metas de reclutamiento de pacientes.

Background: Randomized controlled surgical trials (RCST) are the optimal way to validate new surgical treatments, yet RCSTs comprise a very small fraction of published articles in the surgical literature. One of most frequent reasons for lack of success in RCSTs is the failure to recruit an adequate number of patients. Methods: We report the results of 14 months of recruitment for an RCST comparing two different surgical procedures for the treatment of painful hallux valgus. The study is an open-label non-inferiority parallel trial, with an accrual goal of 100 subjects in 24 months. Results: In the first 14 months of recruitment, 94 patients were assessed for eligibility, of which 54 were excluded and 40 were protocol-eligible. Of these 40 only 13 enrolled in the trial. Eleven patients were randomized and treated according to the protocol, the other two withdrew prior to randomization. Of the 27 eligible patients who did not enroll and the 2 eligible patients who withdrew prior to ramdomization, 22 declined to participate in the study and 7 elected to have surgical treatment but refused randomization. Conclusions: The data show that investigators planning RCST's in surgery should be aware of the large amount of effort and significant financial resources needed to achieve patient recruitment goals.

Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil

Introduction Parenteral antimony-based compounds are still the standard of care for cutaneous leishmaniasis (CL) treatment in many countries, despite their high toxicity. Previous studies showed that oral azithromycin could be an option for CL treatment. The aim of this study was to evaluate efficacy and safety of oral azithromycin (AZ) for CL treatment compared with injectable meglumine antimoniate (MA). Methods This was a randomized, open-label, 2-arm, non-inferiority clinical trial. Treatment-naïve patients with localized CL were treated with MA (15mg/kg/day up to 1,215mg) or AZ (500mg/day) during 20 consecutive days. The primary efficacy end point was a CL cure 90 days after treatment completion. The analysis was performed with intention-to-treat (ITT) and per protocol (PP) analyses. After an anticipated interim analysis, the study was interrupted due to the high failure rate in the azithromycin group. Results Twenty-four volunteers were included in each group. The MA group had a higher cure rate than the AZ group with the ITT and PP analyses, which were 54.2% versus 20.8% [relative risk (RR) 1.97; 95% confidence intervals (95%CI) 1.13-3.42] and 72.2% versus 23.8% (RR 3.03; 95%CI 1.34-6.87), respectively. No unexpected adverse events were observed. Conclusions ...

Manual de procedimientos para la realización de ensayos clínicos en el Perú / Manual of procedures for conducting clinical testing in Peru

En la publicación identifican nuevas disposiciones legales y procedimientos técnico administrativos en el marco de los requisitos y dispositivos del Reglamento de ensayos clínicos en el Perú y normatividad conexa, primando el respeto a los postulados y principios éticos enmarcados en la justicia y equidad como principal función del Estado; además de utilizar estándares de calidad técnica y legal

Estudios clinicos controlados aleatoreos, en la pediatria de Latino America ( 1996-2005) / Randomized controlled trials in pediatric Latin America (1996-2005)

Los estudios controlados aleatoreos (ECR) están entre los métodos más adecuados para evaluar la efectividadde intervenciones en Salud, pero hay grandes dificultades para efectuar este tipo de investigaciones en Latino América. Objetivo: Analizar la producción de ECR en países de Latino América en niños o adolescentes, en el período 1996-2005.