Consideraciones metodológicas y éticas para la conducción de ensayos clínicos controlados aleatorizados (ECCA) sobre intervenciones para las adicciones

Abstract

SUMMARYAccording to epidemiologic reports, the harmful use of alcohol and illicit drugs has increased among the Mexican population. This use is associated to several risks and issues that affect public health and the public well-being of the country. In this article it is acknowledged the need for development of treatment models and interventions whose therapeutic value is demonstrated by scientific evidence, that respond to the attention needs of the population affected by substance use in our country and that can be generalized in community clinical practice.In clinical research, randomized controlled clinical trials (RCT's) are the "gold standard" to demonstrate the effect of a therapeutic intervention. A randomized controlled clinical trial is a prospective study in which the effect, value and safety of one or various experimental interventions are tested against a "control" intervention in human subjects.Acknowledging that in Mexico there is a lack of research on addiction treatment that is compliant with all the requirements to be considered as an RCT, this article presents some methodological and ethical considerations that are neccesary for their design and conduction. These considerations include from the establishment of a relevant research question and objectives, adequate study design, development of strategies for data management, statistical analysis, monitoring of interventions, safety monitoring and research quality assurance and protection of human subjects.Key words: Substance use disorders, treatment, controlled clinical trials, randomized clinical trials, methodology, ethical aspects. RESUMENSegún reportes epidemiológicos, el consumo nocivo de alcohol y drogas ilegales dentro de la población mexicana ha ido en aumento, lo que se asocia a varios riesgos o problemáticas que afectan la salud y bienestar públicos del país. Se reconoce la necesidad de desarrollar modelos de tratamiento e intervenciones cuyo valor terapéutico esté respaldado por la evidencia científica, que respondan a las necesidades de atención de la población afectada por el consumo de sustancias en nuestro país y que puedan generalizarse en la práctica clínica comunitaria.Dentro de la investigación clínica, el "estándar de oro" para demostrar el efecto de una intervención terapéutica son los ensayos clínicos controlados aleatorizados (ECCA). Un ECCA es un estudio prospectivo en el cual se prueba el efecto, valor y seguridad de una o varias intervenciones experimentales contra una intervención "control" en sujetos humanos.Reconociendo que en México hay una falta de investigaciones sobre tratamientos para las adicciones que cumplan con todos los requisitos para ser considerados ECCA, en este artículo se presentan distintas consideraciones metodológicas y éticas que deben tomarse en cuenta para su diseño y conducción en la materia; abarcando aspectos que parten desde el establecimiento de una pregunta y objetivos relevantes hasta el diseño adecuado del estudio y el desarrollo de estrategias para la administración de datos, análisi...

A systematic narrative review of subjective well‐being promotion intervention programmes in the school setting

“…The results obtained by the reviewed experimental studies are favourable to the field of well-being promotion in that they report positive outcomes for subjective well-being, showing that more than half of the results were statistically significant. This shows us the potential for progress on research with highly rigorous standards in the field of well-being promotion, above all considering the strengths and advantages of disseminating this type of design among the population (Marín-Navarrete et al, 2013). This outcome is even more relevant when we consider the fact that experimental designs are used less often by the social sciences due to the requirements for procedural controls to achieve the methodological rigour they entail (Concha et al, 2011).…”

Estilo Personal del Terapeuta: comparación entre profesionales que trabajan en instituciones de adicciones y profesionales del área clínica general/Therapist Personal Styles: A Comparison Between Professionals Working in Drug Addiction Institutions and Professionals Working in the General Clinical Area

“…Las adicciones constituyen un problema de salud pública que demanda grandes cantidades de dinero al sistema sanitario (Marín-Navarrete et al, 2013), por lo que es importante avanzar en el conocimiento de variables del tratamiento que pueden influir sobre los resultados (Blonigen, Finney, Wilbourne, & Moos, 2015).…”