Principles for defining adverse events in behavioral intervention research: lessons from a family-focused adolescent drug abuse trial

Abstract

Background Behavioral intervention research has lagged behind biomedical research in developing principles for defining, categorizing, identifying, reporting, and monitoring adverse events and unanticipated problems. Purpose In this article we present a set of principles for defining adverse events and how they were applied in a large national multi-site family therapy study for substance-using adolescents, The Brief Strategic Family Therapy (BSFT™) Effectiveness Study. Methods The BSFT™ Effectiveness study tested how BSFT™ compares to Treatment as Usual (TAU) for the treatment of drug-abusing adolescents. During protocol development, experts in the BSFT™ intervention, medical safety officers, ethicists and senior investigators defined the procedures for identifying, tracking and reporting adverse events for drug using adolescents as well as their family members. During this process the team identified five key guiding principles. Results The five guiding principles that were used for defining adverse events in this behavioral trial were that that the adverse events should be validated and plausible, and that monitoring systems should assess relatedness, be systematic, and are a shared responsibility. The following non-serious adverse events were identified: arrest, school suspension and drop out, runaway, kicked out of home and violence. The serious adverse events in this study for the identified adolescent participant and all other consented family members were physical or sexual abuse, suicidal behavior, homicidal behavior, hospitalization (drug related or psychiatric related only) and death. The methods used in categorizing, identifying and reporting adverse events in the BSFT™ trial are outlined. More than 50% of the adolescent population (277/481 = 57.5 %) experienced an adverse event during the trial. Family members experienced less adverse events, (61/1338 = 4.5%). The most common event for the adolescent group was arrest (164/277= 59.2%), followed by school suspension/dropout (143/277 = 51.6%), and runaway (79/277= 28.5 %). For the family member group, the most common event was violence (25/61 = 40.9%) followed by arrest (13/61 = 21.3%). There was a significant difference in the presence of adverse events in family members that were randomized to BSFT™ 44/721 (6.1%) when compared to Treatment as Usual 17/617 (2.8%) (p = 0.004). A probable explanation for this is that there were more opportunities to identify adverse events for family members assigned to BSFT™ because family members attended therapy sessions. This difference may also represent the risk for family members that participate in an evidence-based family intervention like BSFT™. Limitations The utility of the principles outside of the BSFT™ trial is unknown. Conclusions Based on the events reported in this trial, the efforts for monitoring and categorizing adverse events appeared justified and appropriate. The strategies and principles described in this paper may be useful for those developing safety plans for behavioral interventio...

Reporting of harms in randomized controlled trials of psychological interventions for mental and behavioral disorders: A review of current practice

“…One reason for this could be that psychological interventions often are considered to be safe, and consequently researchers might not prioritize monitoring of harms. In addition, there is a lack of clear guidelines on how to define, categorize, identify and report harms within this research field [15,16].…”

Human Subjects Protection: An Event Monitoring Committee for Research Studies of Girls From Breast Cancer Families

“…Such systematic tracking and reporting of adverse events in psychosocial, behavioral intervention and observational studies is a more recent phenomenon, with guidelines being less clearly defined and a greater challenge to apply, as they were traditionally developed for biomedical research (3, 4). Consequently, the EMCs for our studies also considered the potential risks, both study-related and incidental to data collection, and provided feedback on the monitoring plans, their conduct and outcomes.…”

“…The NIH also suggests that independent oversight may be indicated for Phase I or II trials, psychosocial, behavioral intervention and observational studies, particularly if vulnerable subjects, e.g., minors, are included or there are other significant risks to study participants (2–4, 6–8). Yet, there is limited guidance for the development and implementation of monitoring plans and oversight committees for psychosocial research (3, 4, 8). Several research groups have reported that the traditional DSMB model is inadequate or impractical in psychosocial, behavioral intervention and observational studies (2–4, 9).…”

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

“…9,10,49 En el tratamiento de las adicciones y de otros trastornos de la salud mental los pacientes tienen un alto riesgo de presentar afecciones renales, cardiacas o respiratorias e infecciones asociadas al consumo; así como accidentes, conductas sexuales de riesgo, comportamiento violento o problemas con la ley debidos al abuso de sustancias; además de una exacerbación de la sintomatología psiquiátrica, o incluso conductas suicidas, causadas por el consumo de alcohol o de drogas 1,5,8,15,50,51 o dificultades en el funcionamiento familiar, laboral o social del sujeto. 52 La conducción de un ECCA debe contemplar un plan acorde para la identificación, evaluación, seguimiento y reporte de posibles eventos adversos. Los mecanismos o herramientas que se utilicen para llevar a cabo este monitoreo de seguridad deberán ser parte del protocolo de investigación.…”

“…Los mecanismos o herramientas que se utilicen para llevar a cabo este monitoreo de seguridad deberán ser parte del protocolo de investigación. 9,52 En el cuadro 9 se muestra una propuesta de las distintas categorías de eventos adversos que deben identificarse en los participantes de un ECCA. 9 Todo conocimiento que tengan los investigadores acerca de los posibles riesgos o eventos adversos que se detecten y que están relacionados con la intervención …”