实施临床试验报告规范,提高临床试验透明度

临床试验是指以人为对象的前瞻性研究,预先将受试者或受试人群分配至接受一种或多种医疗干预,以评价医疗干预对健康结局的影响。其中"医疗干预"包括但不仅限于药物,也包括细胞及其他生物制品、外科治疗、放射治疗、医疗器械、行为疗法、治疗过程的改变和预防保健等[1-2]。     

Widening the social context of disablement among married older adults: Considering the role of nonmarital relationships for loneliness

Utilizing the stress process and life course perspectives, we investigated the influence of non-spousal social support on the associations between marital quality, physical disability, and loneliness among married older adults. Using data from the National Social Life, Health, and Aging Project (NSHAP), we found that the association between physical disability and loneliness was partially accounted for by the fact that physical disability was associated with less supportive nonmarital relationships. While physically-disabled older adults in higher-quality marriages were buffered from loneliness, supportive non-martial relationships did not offset elevated loneliness among those in low-quality marriages. These associations were largely similar for men and women. Thus, although both marital and nonmarital relationships are important for loneliness, when confronted with a stressor such as disablement it is the marital relationship alone that matters.     

A Comparative Pharmacokinetic Estimate of Mercury in U.S. Infants Following Yearly Exposures to Inactivated Influenza Vaccines Containing Thimerosal

The use of thimerosal preservative in childhood vaccines has been largely eliminated over the past decade in the United States because vaccines have been reformulated in single‐dose vials that do not require preservative. An exception is the inactivated influenza vaccines, which are formulated in both multidose vials requiring preservative and preservative‐free single‐dose vials. As part of an ongoing evaluation by USFDA of the safety of biologics throughout their lifecycle, the infant body burden of mercury following scheduled exposures to thimerosal preservative in inactivated influenza vaccines in the United States was estimated and compared to the infant body burden of mercury following daily exposures to dietary methylmercury at the reference dose established by the USEPA. Body burdens were estimated using kinetic parameters derived from experiments conducted in infant monkeys that were exposed episodically to thimerosal or MeHg at identical doses. We found that the body burden of mercury (AUC) in infants (including low birth weight) over the first 4.5 years of life following yearly exposures to thimerosal was two orders of magnitude lower than that estimated for exposures to the lowest regulatory threshold for MeHg over the same time period. In addition, peak body burdens of mercury following episodic exposures to thimerosal in this worst‐case analysis did not exceed the corresponding safe body burden of mercury from methylmercury at any time, even for low‐birth‐weight infants. Our pharmacokinetic analysis supports the acknowledged safety of thimerosal when used as a preservative at current levels in certain multidose infant vaccines in the United States.     

Impact of an Overt Response System on Staff Performance and Maintenance of Computer-Based Instruction

Interactive Computer Based Instruction (CBI) systems involve teaching strategies to facilitate greater response opportunities during training in an effort to improve learner performance. The current study investigated the effect of online staff training videos with and without overt response requirements on posttest and maintenance test scores across six block-randomized instructional modules for four employees of a university located in the southeastern region of the United States. The overt response consisted of multiple-choice questions administered throughout select teaching modules using an alternating treatment design. Findings suggest that learning occurred as a result of the CBI training; however, the effectiveness of the overt response system varied across individuals, with no discernible differentiation between learning gains associated with response requirements. Other areas of research for expanding the efficacy of CBI and overt response systems are highlighted.     

Enacting reflective and deliberative practices in action research

ABSTRACT

We consider action research as a form of deliberative policy analysis. This analysis explores a “reconstruction clinic” in which stakeholders and public officials engaged memories, hopes and obligations as they sought to resolve controversies over details of policy implementation. We ask how institutional design shaped participants’ reflective and deliberative progress. Reflection in action can prompt not only changes in cognitive frames, but new behavioural capacities for action. Deliberative practices can shape new relationships between parties through the work of apology, recognition, appreciation, and emergent collaboration.     

Factors that Determine or Influence Managerial Innovation in Public Contexts: The Case of Local Performance Management

The use of Performance-Based Management (PBM) by French public organizations has sharply accelerated over the last few years. Moreover, very few studies have analyzed this change. The object of this article is thus to conduct an in-depth analysis of the dynamics of managerial innovation in three French local authorities via the study of the factors that foster the adoption and implementation of PBM by this type of organization. We demonstrate a tendency to overestimate the explanatory power of the neo-institutionalist theories. Indeed, our analysis illustrates a balanced vision of the human, technical and contextual factors at the origin of this type of managerial innovation.     

Model averaging inconcentration–QT analyses

This article describes how a frequentist model averaging approach can be used for concentration–QT analyses in the context of thorough QTc studies. Based on simulations, we have concluded that starting from three candidate model families (linear, exponential, and Emax) the model averaging approach leads to treatment effect estimates that are quite robust with respect to the control of the type I error in nearly all simulated scenarios; in particular, with the model averaging approach, the type I error appears less sensitive to model misspecification than the widely used linear model. We noticed also few differences in terms of performance between the model averaging approach and the more classical model selection approach, but we believe that, despite both can be recommended in practice, the model averaging approach can be more appealing because of some deficiencies of model selection approach pointed out in the literature. We think that a model averaging or model selection approach should be systematically considered for conducting concentration–QT analyses. Copyright © 2016 John Wiley & Sons, Ltd.     

Association of sexual abstinence in adolescence with mental health in adulthood

We examined whether adolescent sexual abstinence predicts better adult mental health. 1,917 adolescents, recruited from middle schools at age 13, were surveyed at ages 13, 18, 23, and 29. In bivariate analyses, adolescent sexual abstinence was associated with better mental health at age 29 for females, but not males; three adolescent factors, educational prospects, family bonding, and unconventionality were investigated as explanatory variables of this relationship. The abstinence-mental health relationship was nonsignificant when educational prospects was included in multivariate models, and marginally significant when family bonding and unconventionality were included; all three explanatory factors accounted for significant proportions of the variance in adult mental health. Girls who are uninvolved in school, have weak family backgrounds, and exhibit unconventionality may have poor adult mental health, whether or not they abstain from sex in adolescence. Interventions that strengthen adolescents' connections to families and schools may reduce risk for long-term mental health problems.     

Effects of a single-lesson tobacco prevention curriculum on knowledge, skill identification and smoking intention

One in five students report experimenting with tobacco before the age of 13 and most prevention efforts take place in the school setting. This study measures the effect of a single-lesson tobacco prevention curriculum, conducted by a health education center, focusing on knowledge of tobacco, ability to identify refusal techniques, and intent not to smoke. Data were collected, via electronic keypads, from students visiting a non-school, health education center in Michigan (n = 704 intervention and 85 comparison). Contingency table Chi-squared tests and t-tests demonstrated that a single lesson can improve general knowledge and ability to identify appropriate refusal techniques. Improvement in intent not to smoke was not significant because both groups had very high intent prior to implementation. Similar to results from other programs, multivariate logistic regression of gender, general knowledge, and skill identification revealed that only the skill variable was associated with intent not to smoke at pretest. Recommendations are given for further research and for designing more effective curricula or programs.     

Response Order Effects in Dichotomous Categorical Questions Presented Orally: The Impact of Question and Respondent Attributes

Using data from 548 experiments in telephone surveys conductedby the Gallup Organization, we explored how attributes of questionsand respondents moderate response order effects in dichotomouscategorical questions. These effects were predominantly recencyeffects and occurred most in questions that were more difficultto comprehend (especially among respondents with the least education),with response choices that were more difficult to comprehend(because they were complete sentences instead of words or phrasesand because they were not mutually exclusive), and that wereasked after many prior questions. Recency effects were alsomore common in questions that explicitly or implicitly encouragedrespondents to wait until they had heard all the answer choicesbefore formulating a judgment than in questions that inducedrespondents to begin formulating a judgment before all the answerchoices had been read (especially among the least educated respondents).A study of interviewer behavior revealed patterns of pausingbetween and within sentences that help to explain why some typesof questions are especially prone to recency effects and othersare not.