The likelihood of a favorable outcome with intensive care can be better estimated by consideration of four factors in addition to gestational age: sex, exposure or nonexposure to antenatal corticosteroids, whether single or multiple birth, and birth weight. (ClinicalTrials.gov numbers, NCT00063063 [ClinicalTrials.gov] and NCT00009633 [ClinicalTrials.gov].).
BACKGROUND We previously reported early results of a randomized trial of whole-body hypothermia for neonatal hypoxic–ischemic encephalopathy showing a significant reduction in the rate of death or moderate or severe disability at 18 to 22 months of age. Long-term outcomes are now available. METHODS In the original trial, we assigned infants with moderate or severe encephalopathy to usual care (the control group) or whole-body cooling to an esophageal temperature of 33.5°C for 72 hours, followed by slow rewarming (the hypothermia group). We evaluated cognitive, attention and executive, and visuospatial function; neurologic outcomes; and physical and psychosocial health among participants at 6 to 7 years of age. The primary outcome of the present analyses was death or an IQ score below 70. RESULTS Of the 208 trial participants, primary outcome data were available for 190. Of the 97 children in the hypothermia group and the 93 children in the control group, death or an IQ score below 70 occurred in 46 (47%) and 58 (62%), respectively (P = 0.06); death occurred in 27 (28%) and 41 (44%) (P = 0.04); and death or severe disability occurred in 38 (41%) and 53 (60%) (P = 0.03). Other outcome data were available for the 122 surviving children, 70 in the hypothermia group and 52 in the control group. Moderate or severe disability occurred in 24 of 69 children (35%) and 19 of 50 children (38%), respectively (P = 0.87). Attention–executive dysfunction occurred in 4% and 13%, respectively, of children receiving hypothermia and those receiving usual care (P = 0.19), and visuospatial dysfunction occurred in 4% and 3% (P = 0.80). CONCLUSIONS The rate of the combined end point of death or an IQ score of less than 70 at 6 to 7 years of age was lower among children undergoing whole-body hypothermia than among those undergoing usual care, but the differences were not significant. However, hypothermia resulted in lower death rates and did not increase rates of severe disability among survivors. (Funded by the National Institutes of Health and the Eunice Kennedy Shriver NICHD Neonatal Research Network; ClinicalTrials.gov number, NCT00005772.)
This randomized clinical trial (N = 253) evaluated the efficacy of a theory-based intervention designed to reduce both alcohol use and incidence of unprotected sexual behaviors among HIV-positive men who have sex with men with alcohol use disorders. An integrated, manualized intervention, using both individual counseling and peer group education/support, was compared with a control condition in which participants received resource referrals. The intervention was based on the transtheoretical model’s stages and processes of change, and motivational interviewing was used to enhance client readiness for change. Major findings include treatment effects for reduction in number of drinks per 30-day period, number of heavy drinking days per 30-day period, and number of days on which both heavy drinking and unprotected sex occurred. Practitioners employing this intervention may achieve enhanced client outcomes in reduction of both alcohol use and risky sexual behavior.
This paper reviews trends in higher education, characterizing both the current learning environments in pharmacy education as well as a vision for future learning environments, and outlines a strategy for successful implementation of innovations in educational delivery. The following 3 areas of focus are addressed: (1) rejecting the use of the majority of classroom time for the simple transmission of factual information to students; (2) challenging students to think critically, communicate lucidly, and synthesize broadly in order to solve problems; and (3) adopting a philosophy of ''evidence-based education'' as a core construct of instructional innovation and reform.Keywords: blended learning, distance education, e-learning, learning environment, online learning INTRODUCTIONAlthough many of our colleagues in the academy might protest vociferously, we contend that higher education has focused for far too long and much too closely on the wrong metric of student performance, and that this misguided focus, however practical and well-intentioned, has influenced virtually all aspects of the educational enterprise. The raison d'être for higher education is simple and straightforward: to prepare students, predominantly young adults, for future success. Success, of course, can be defined in many ways: the ability to pursue and advance in the career of one's choice; the ability to contribute meaningfully to one's community; the ability to pursue an ''intellectual life.'' The challenge to higher education, and where we contend that the academy has failed, is in measuring, in a meaningful way, the success of our students. This failing is particularly problematic for programs that prepare students to pursue a specific profession, such as pharmacy, as compared to those that provide a broader liberal arts experience.Instead of attempting to assess the true impact on students, educational programs at all levels have focused on easier, and arguably more objective, metrics: course grades, aggregate grade point averages, and scores on standardized examinations. These short-term endpoints have resulted predictably in short-term thinking by all parties associated with the educational enterprise. Students, for example, often focus on what is required to achieve a particular grade in a given course. How many times have we listened to our faculty colleagues complain about students asking the question: ''Will this material be on our exam?'' (In contrast, how frequently do we hear our students ask the more intellectually satisfying question, ''How will I be able to use this material once I am in practice?'') Similarly, classroom instructors focus predominantly on content or technical aspects of application. While this is viewed as providing the necessary foundation upon which students can build in a discrete discipline, valuable opportunities to help students learn how to think, rather than simply what to remember, are lost. Moreover, entire educational systems focus on end-of-course, endof-grade, or end-of-program performance measures ...
Aims We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence. Methods This 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine metabolites thrice weekly as the main outcome. Results The 300 subjects (76% male, 72% African-American, mean age 46 years) had smoked cocaine on average for 13 days monthly at baseline. We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of ≥ 42 μg/mL (high IgG), which was attained by 67% of the 130 vaccine subjects receiving five vaccinations. Almost 3-times fewer high than low IgG subjects dropped out (7% vs 20%). Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), after week 8, more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial (24% vs 18%), and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment (OR=3.02), but neither were significant. Injection site reactions of induration and tenderness differed between placebo and active vaccine, and the 29 serious adverse events did not lead to treatment related withdrawals, or deaths. Conclusions The vaccine was safe, but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence.
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