Adaptive and repeated cumulative meta‐analyses of safety data during a new drug development process

During a new drug development process, it is desirable to timely detect potential safety signals. For this purpose, repeated meta‐analyses may be performed sequentially on accumulating safety data. Moreover, if the amount of safety data from the originally planned program is not enough to ensure adequate power to test a specific hypothesis (e.g., the noninferiority hypothesis of an event of interest), the total sample size may be increased by adding new studies to the program. Without appropriate adjustment, it is well known that the type I error rate will be inflated because of repeated analyses and sample size adjustment. In this paper, we discuss potential issues associated with adaptive and repeated cumulative meta‐analyses of safety data conducted during a drug development process. We consider both frequentist and Bayesian approaches. A new drug development example is used to demonstrate the application of the methods. Copyright © 2015 John Wiley & Sons, Ltd.     

Pathways and transitions of gamblers over two years

Moderate-risk and problem gamblers represent 1.4% and 0.4% of the Québec population, respectively. Research on gamblers’ trajectories has been hampered by methodological shortcomings leading to heterogeneous results. The present research was conducted in the Province of Québec with a representative sample of adult gamblers and aims to explore how gamblers change over time according to the severity of their gambling problems. Using a 2-year follow-up prospective design (3 waves), 179 gamblers selected from a representative survey were divided into the 4 PGSI (Problem Gambling Severity Index) categories. Beyond the decreasing trend in PGSI scores detected within the overall sample using a linear growth model, our analyses revealed that moderate-risk gamblers are heterogeneous in their composition and evolution, comprising stable moderate-risk, recent cases and former problem gamblers. Over three waves, one-third of moderate-risk gamblers improved, one-third remained stable and one-third became problem gamblers. The subgroups transitioning in and out of the moderate-risk category differed in terms of reported changes in gambling behaviours and consequences. Problem gamblers remain vulnerable over time, being at risk of experiencing chronic problems. Results highlight the necessity of subgroup-specific prevention programmes and treatment services that address both the non-linearity of risky gambling and the chronicity of problem gambling.     

INFORMING RETIREMENT SAVINGS DECISIONS: A FIELD EXPERIMENT ON SUPPLEMENTAL PLANS

Although supplemental saving plans can be an important part of an individual's financial security in retirement, contribution rates remain low, particularly among those with lower salaries and less education. We report findings from an intervention that provided information on key aspects of the employer‐provided supplemental saving plans to older public employees in North Carolina. Among workers participating in a supplemental plan, individuals who received an informational flyer increased their contributions in the months following the intervention relative to the control group. In contrast, individuals who were not enrolled in a retirement saving plan were not moved to begin contributing to a supplemental plan. The results suggest that informational interventions can induce workers who are already engaged in the saving process to reassess their level of retirement preparedness. (JEL C93, D14, D9)     

Attachements indésirables, attachements acceptables : autour d’un échange de seringues en prison

To inquire into innovation in public policy, attention is focused on the work done by a group that proposed an innovative project for “preventing” drug-use in a prison in Luxembourg. After several events and reversals, the final arrangements, which brought together disparate interests, was grounded in the contingent attachment of various persons to the leading role played by a general practitioner and the “permanent attachment” of authorized needles distributed in a case. In a situation where attempts to work out a theory in terms of “positions”, “power” and “control” would have difficulty coming up with a convincing explanation of this surprising process, preference is given to describing this innovation in terms of “passages” and “attachments”.     

Do Infants Recognize Engagement in Social Interactions? The Case of Face‐to‐Face Conversation

This study explores 12‐month‐olds' understanding of face‐to‐face conversation, a key contextual structure associated with engagement in a social interaction. Using a violation‐of‐expectations paradigm, we habituated infants to a “face‐to‐face” conversation, and in a test phase compared their looking times between “back‐to‐back” (conceptually novel) and “face‐to‐face” (conceptually familiar) conversations, while simultaneously manipulating perceptual familiarity in a 2 × 2 factorial design. We also analyzed dynamic changes in pupil dilation, which are considered a reliable measure of cognitive load that may index processing of social interactions. Infants looked relatively longer at perceptual changes (new speaker positions) but not at conceptual change (back‐to‐back conversation), suggesting that face‐to‐face conversation may not elicit particular expectations, and so may not carry any particular conceptual significance. Moreover, on the first test trial, larger pupil dilation was observed for familiar conditions, suggesting that familiarity with perceptual features could enhance processing of conversations. Thus, this study undermines assertions regarding infants' conceptual understanding of the social signals underlying engagement. Infants may rather recognize such signals through their perceptual familiarity and associated positive feelings. This may then increase their engagement when observing and participating in others' collaborative activities, in turn allowing for the development of knowledge regarding others' intentions.     

An Empirical Analysis of Life Jacket Effectiveness in Recreational Boating

This article gives a measure of life jacket (LJ) effectiveness in U.S. recreational boating. Using the U.S. Coast Guard's Boating Accident Report Database from 2008 to 2011, we find that LJ wear is one of the most important determinants influencing the number of recreational boating fatalities, together with the number of vessels involved, and the type and engine of the vessel(s). We estimate a decrease in the number of deceased per vessel of about 80% when the operator wears their LJs compared to when they do not. The odds of dying are 86% higher than average if the accident involves a canoe or kayak, but 80% lower than average when more than one vessel is involved in the accident and 34% lower than average when the operator involved in the accident has more than 100 hours of boating experience. Interestingly, we find that LJ effectiveness decreases significantly as the length of the boat increases and decreases slightly as water temperature increases. However, it increases slightly as the operator's age increases. We find that between 2008 and 2011, an LJ regulation that requires all operators to wear their LJs—representing a 20% increase in wear rate—would have saved 1,721 (out of 3,047) boaters or 1,234 out of 2,185 drowning victims. The same policy restricted to boats 16–30 feet in length would have saved approximately 778 victims. Finally, we find that such a policy would reduce the percentage of drowning victims compared to other causes of death.     

Design for Usability; practice-oriented research for user-centered product design

The Design for Usability project aims at improving the usability of electronic professional and consumer products by creating new methodology and methods for user-centred product development, which are feasible to apply in practice. The project was focused on 5 key areas: (i) design methodology, expanding the existing approach of scenario-based design to incorporate the interaction between product design, user characteristics, and user behaviour; (ii) company processes, barriers and enablers for usability in practice; (iii) user characteristics in relation to types of products and use-situations; (iv) usability decision-making; and (v) product impact on user behaviour. The project team developed methods and techniques in each of these areas to support the design of products with a high level of usability. This paper brings together and summarizes the findings.     

Union Formation and Partner Choice in a Transnational Context: The Case of Descendants of Turkish Immigrants in France1

This paper examines the transition to a first union of descendants of Turkish immigrants in France. We use data from the project The Integration of the European Second Generation, 2007, and apply event-history techniques. We find that descendants of Turkish immigrants who grew up in France enter a first union earlier and more often in a direct marriage than do young adults without an immigrant background. We then describe the type of union in more detail and estimate the likelihood of a transnational partner choice, that is, between a young adult born in France of Turkish immigrant parentage and an immigrant from Turkey. We pay attention to social factors such as education, city of residence, and to cultural factors such as the rules of affinity in Turkey and the attachment to the norm of virginity at marriage as factors that orient partner choice. Finally, we discuss what anthropological methods could contribute to this research.     

An Ex-Post View of Inequality of Opportunity in France and its Regions

This paper proposes an ex-post measure of inequality of opportunity in France and its regions by assessing the inequality between individuals exerting the same effort. To this end, we define a fair income that fulfils ex-post equality of opportunity requirements. Unfairness is measured by an unfair Gini based on the distance between the actual income and the fair income. Our findings reveal that the measures of ex-post inequality of opportunity largely vary across regions, and that this is due to differences in reward schemes and in the impact of the non responsibility factors of income. We find that most regions have actual incomes closer to fair incomes than to average income, excepted Ile de France where the actual income looks poorly related to effort variables. Finally, we find that income inequality and inequality of opportunity are positively correlated among regions.