Ancillary Study

Abstract: OBJECTIVE: To review and revise the 1987 pediatric brain death guidelines. METHODS: Relevant literature was reviewed. Recommendations were developed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) system. CONCLUSIONS AND RECOMMENDATIONS: (1) Determination of brain death in term newborns, infants, and children is a clinical diagnosis based on the absence of neurologic function with a known irreversible cause of coma. Because of insufficient data in the literature, recommendations for preterm infants 30 days to 18 years) is recommended. The first examination determines the child has met the accepted neurologic examination criteria for brain death. The second examination confirms brain death based on an unchanged and irreversible condition. Assessment of neurologic function after cardiopulmonary resuscitation or other severe acute brain injuries should be deferred for 24 hours or longer if there are concerns or inconsistencies in the examination. (4) Apnea testing to support the diagnosis of brain death must be performed safely and requires documentation of an arterial PaCO(2) 20mmHg above the baseline and ≥60mmHg with no respiratory effort during the testing period. If the apnea test cannot be safely completed, an ancillary study should be performed. (5) Ancillary studies (electroencephalogram and radionuclide cerebral blood flow) are not required to establish brain death and are not a substitute for the neurologic examination. Ancillary studies may be used to assist the clinician in making the diagnosis of brain death (a) when components of the examination or apnea testing cannot be completed safely due to the underlying medical condition of the patient; (b) if there is uncertainty about the results of the neurologic examination; (c) if a medication effect may be present; or (d) to reduce the interexamination observation period. When ancillary studies are used, a second clinical examination and apnea test should be performed, and components that can be completed must remain consistent with brain death. In this instance, the observation interval may be shortened, and the second neurologic examination and apnea test (or all components that are able to be completed safely) can be performed at any time thereafter. (6) Death is declared when these above criteria are fulfilled. ANN NEUROL 2012; Language: en

Abstract: Objectives: The Hispanic Community Health Study/Study of Latinos (HCHS/SOL) Sociocultural Ancillary Study aims to examine associations between sociocultural and psychosocial factors and cardiovascular disease (CVD) and metabolic syndrome prevalence in Hispanics/Latinos The conceptual framework is based on the Reserve Capacity and Lifespan Biopsychosocial Models, which emphasize multiple risk and protective pathways underlying socioeconomic and ethnic influences in health This study describes the rationale, participants, and procedures for the HCHS/SOL Sociocultural Ancillary Study Design and Setting: The Sociocultural Ancillary Study to the HCHS/SOL is a crosssectional cohort study with future opportunities for prospective investigation Participants: Participants were 5,313 adults, aged 18–74 years, of self-identified Hispanic/Latino descent and representing multiple Hispanic/Latino background groups, recruited from the Bronx, NY, Chicago, Ill, Miami, Fla, and San Diego, Calif Intervention: Participants completed an interview-administered sociocultural assessment battery within 9 months of their HCHS/SOL clinical baseline exam Outcome Measures: The primary outcomes are CVD and metabolic syndrome and its component risk factors Results: The Sociocultural Ancillary Study sample is broadly representative of the HCHS/SOL cohort Weighted demographics are: 55% male, 56% 18–44 years, 44% ≥45 years, and 37% Mexican, 20% Cuban, 16% Puerto Rican, 12% Dominican, 8% Central American, and 5% South American descent Conclusions: By testing theoretically driven hypotheses concerning sociocultural and psychosocial factors in CVD, the Sociocultural Ancillary Study seeks to inform future prevention and intervention efforts for US Hispanic/ Latinos (Ethn Dis 2014;24[1]:77–83)

Abstract: Objectives To summarize the ongoing Prevention of Alzheimer’s Disease (AD) by Vitamin E and Selenium (PREADViSE) trial as an ancillary study to SELECT (a large prostate cancer prevention trial) and to present the blinded results of the first year as an exposure study.