RESUMEN
In the summer of 2020, multiple efforts were undertaken to establish safe and effective vaccines to combat the spread of the coronavirus disease (COVID-19). In the United States (U.S.), Operation Warp Speed (OWS) was the program designated to coordinate such efforts. OWS was a partnership between the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector, that aimed to help accelerate control of the COVID-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. The U.S. Department of Veterans Affairs' (VA) was identified as a potential collaborator in several large-scale OWS Phase III clinical trial efforts designed to evaluate the safety and efficacy of various vaccines that were in development. Given the global importance of these trials, it was recognized that there would be a need for a coordinated, centralized effort within VA to ensure that its medical centers (sites) would be ready and able to efficiently initiate, recruit, and enroll into these trials. The manuscript outlines the partnership and start-up activities led by two key divisions of the VA's Office of Research and Development's clinical research enterprise. These efforts focused on site and enterprise-level requirements for multiple trials, with one trial serving as the most prominently featured of these studies within the VA. As a result, several best practices arose that included designating clinical trial facilitators to study sites to support study initiation activities and successful study enrollment at these locations in an efficient and timely fashion.
RESUMEN
Background: The US Department of Veterans Affairs (VA) Office of Research and Development (ORD) supports an extensive clinical trials enterprise. Until recently, external partnerships were limited. The VA's potential value as a partner became more apparent during the COVID-19 pandemic because of its large health care system, diverse patient population, and expertise in conducting clinical trials. Observations: By leveraging its infrastructure, the VA was able to participate in 7 large-scale COVID-19 therapeutic and vaccine trials. A key aspect of this enterprise approach is the ability to provide centralized direction and coordination. The VA's partnerships with external groups offered insights into the challenges associated with conducting important trials, especially when rapidity and coordination were essential. The ORD also developed solutions for reducing study startup time that could be established as best practices. We offer lessons for the challenges VA faced: site infrastructure needs and capabilities; study management roles and responsibilities; educational resources; local review; study design demands; contracting and budgeting; central-level systems; and communication. Conclusions: VA participation in major COVID-19 therapeutic and vaccine trials represented a significant part of its research response to the pandemic. These contributions extended beyond the participants, scientists, and data that helped inform subsequent regulatory approvals. The VA also had an opportunity to directly develop partnerships with non-VA groups. These groups became more familiar with the VA while enabling us to gain more experience in the diverse practices used to conduct multisite clinical studies. Ultimately, these efforts empower the VA to further serve the broader scientific and clinical communities.
RESUMEN
BACKGROUND: Complicated grief is associated with increased suicidal ideation in samples of bereaved individuals; however, suicidal behavior has not been assessed in these patients. Additionally, there are no reports of suicidality among help-seeking individuals with complicated grief. Therefore, we examined suicidal behavior and its correlates in 149 patients who signed informed consent statements to participate in a National Institute of Mental Health-funded treatment study of complicated grief. METHOD: All patients met criteria for complicated grief (Inventory of Complicated Grief score>or=25). Suicidality was assessed using a structured clinical interview administered prior to beginning treatment. Participants also completed self-report questionnaires and interview assessment measures rating the presence or absence of DSM-IV Axis I diagnosis and symptom severity. Data were gathered between April 2001 and April 2004. RESULTS: Thoughts of wanting to die following the death of a loved one were reported by 65% of participants. More than half of this group (38% of the study sample) engaged in self-destructive behavior, including 9% who made a suicide attempt and 29% who engaged in indirect suicidal behavior. In a multiple logistic regression model, only the severity of complicated grief symptoms (p<.0001) and history of a suicide attempt (p<.02) were significantly associated with postloss suicidal behavior. DISCUSSION: Consistent with reports of non-help-seeking bereaved people, a high rate of individuals seeking treatment for complicated grief endorsed a wish to die. Notably, 13% of this group made at least 1 suicide attempt, and 44% engaged in indirect self-destructive behavior. Given its frequency, this behavior should be included in assessment of bereaved people.
Asunto(s)
Pesar , Trastornos Mentales/epidemiología , Conducta Autodestructiva/epidemiología , Suicidio/psicología , Actitud Frente a la Muerte , Aflicción , Trastorno Depresivo Mayor/diagnóstico , Trastorno Depresivo Mayor/epidemiología , Trastorno Depresivo Mayor/psicología , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Femenino , Humanos , Modelos Logísticos , Masculino , Trastornos Mentales/diagnóstico , Trastornos Mentales/psicología , Persona de Mediana Edad , Aceptación de la Atención de Salud/psicología , Inventario de Personalidad/estadística & datos numéricos , Escalas de Valoración Psiquiátrica/estadística & datos numéricos , Conducta Autodestructiva/diagnóstico , Conducta Autodestructiva/psicología , Índice de Severidad de la Enfermedad , Factores Sexuales , Suicidio/estadística & datos numéricos , Intento de Suicidio/psicología , Intento de Suicidio/estadística & datos numéricos , Encuestas y CuestionariosRESUMEN
The aim of the present study was to evaluate severity of sleep disturbances in a group of 105 individuals presenting with complicated grief (CG) accompanied or not by comorbid depression and/or posttraumatic stress disorder (PTSD). A sample of 105 adults meeting criteria for CG was included in this study. All completed the Pittsburgh Sleep Quality Index (PSQI). The total sample presented a mean global PSQI score of 9.44, indicating overall poor sleep quality. Comorbid depression, but not PTSD, further worsened sleep quality. Further studies are required to investigate the potential role of poor sleep quality as a modifiable risk factor of complicated grief response.