Interpreting adverse signals in diabetes drug development programs

Detection and interpretation of adverse signals during preclinical and clinical stages of drug development inform the benefit-risk assessment that determines suitability for use in real-world situations. This review considers some recent signals associated with diabetes therapies, illustrating the difficulties in ascribing causality and evaluating absolute risk, predictability, prevention, and containment. Individual clinical trials are necessarily restricted for patient selection, number, and duration; they can introduce allocation and ascertainment bias and they often rely on biomarkers to estimate long-term clinical outcomes. In diabetes, the risk perspective is inevitably confounded by emergent comorbid conditions and potential interactions that limit therapeutic choice, hence the need for new therapies and better use of existing therapies to address the consequences of protracted glucotoxicity. However, for some therapies, the adverse effects may take several years to emerge, and it is evident that faint initial signals under trial conditions cannot be expected to foretell all eventualities. Thus, as information and experience accumulate with time, it should be accepted that benefit-risk deliberations will be refined, and adjustments to prescribing indications may become appropriate. © 2013 by the American Diabetes Association.

Maternal core beliefs and children's feeding problems

Background: Although maternal mental health problems have been implicated in the exacerbation of childhood feeding difficulties, little research has assessed the contribution of broader maternal cognitions to these problems. The current study examined gender differences in the relationships between mothers' core beliefs and children's feeding problems. Methods: One hundred and three mothers of girls and 93 mothers of boys (age range, 7-64 months) completed the Young Schema Questionnaire and the Child Feeding Assessment Questionnaire. Results: While controlling for child age, a clear link between maternal core beliefs and perceived feeding difficulties emerged for mothers of girls. In particular, abandonment, failure to achieve, dependence and incompetence, enmeshment and defectiveness, and shame beliefs were associated with increased reports of feeding problems in girls. In contrast, emotional deprivation and subjugation beliefs were associated with maternal reports of food fussiness and food refusal in boys. Conclusions: There appears to be a clear role for maternal core beliefs in the reporting of feeding difficulties in children, and the specificity of these links differs depending on the gender of the child. Further research is required to establish the direction of causality and the specificity of these relationships. © 2005 by Wiley Periodicals, Inc.

Material and efficient cause interpretations of the formative model:resolving misunderstandings and clarifying conceptual language

This paper presents a causal explanation of formative variables that unpacks and clarifies the generally accepted idea that formative indicators are ‘causes’ of the focal formative variable. In doing this, we explore the recent paper by Diamantopoulos and Temme (AMS Review, 3(3), 160-171, 2013) and show that the latter misunderstand the stance of Lee, Cadogan, and Chamberlain (AMS Review, 3(1), 3-17, 2013; see also Cadogan, Lee, and Chamberlain, AMS Review, 3(1), 38-49, 2013). By drawing on the multiple ways that one can interpret the idea of causality within the MIMIC model, we then demonstrate how the continued defense of the MIMIC model as a tool to validate formative indicators and to identify formative variables in structural models is misguided. We also present unambiguous recommendations on how formative variables can be modelled in lieu of the formative MIMIC model.

Perceptions of a changing world induce hope and promote peace in intractable conflicts

The importance of hope in promoting conciliatory attitudes has been asserted in the field of conflict resolution. However, little is known about conditions inducing hope, especially in intractable conflicts, where reference to the outgroup may backfire. In the current research, five studies yielded convergent support for the hypothesis that hope for peace stems from a general perception of the world as changing. In Study 1, coders observed associations between belief in a changing world, hope regarding peace, and support for concessions. Study 2 revealed the hypothesized relations using self-reported measures. Studies 3 and 4 established causality by instilling a perception of the world as changing (vs. unchanging) using narrative and drawing manipulations. Study 5 compared the changing world message with a control condition during conflict escalation. Across studies, although the specific context was not referred to, the belief in a changing world increased support for concessions through hope for peace.

Modelling markets

Decision makers in marketing are often faced with rather complicated situations in which decisions have to be made. Let us consider the problem of determining the appropriate advertising budget. A brand manager is asked to determine the optimal budget. He knows that increases in advertising may lead to increased sales, but also lead to increased costs. The advertising expenditures in period t, say 1994, may not only lead to increases in sales in t, but also to increases in t + 1 (1995) and possibly may contribute to the value of the brand for a long time period.2 Increases in sales will result in changes in profit. The decision maker is allowed to spend more advertising money if there is more profit and more sales, thus advertising spending depends on past sales and profit performance. In order to account for these and possibly other relationships it is necessary to formalise these relations. This means that the decision maker has to specify which variables influence which other variables and what the directions of causality between these variables are. To this end a model has to be formalised, data have to be collected and the formalised model has to be calibrated.

FREADMAN, AnneThe Livres-Souvenirs of Colette Genre and the Telling of Time Oxford: Legenda, August 2012200 pp., £40.00, ISBN: 978-1-906540-93-7

Full text: The title of the book gives us a major clue on the innovative approach developed by Anne Freadman in her analysis of a particular Colette corpus, the one devoted to auto-biographical writing: Les Vrilles de la vigne, Mes apprentissages, La Maison de Claudine, Sido ,L’E ́toile Vesper and Le Fanal bleu. Freadman follows the powerful lure of Rimbaldianvieilles vieilleries and its echoes with Colette’s fondness for collecting objects, people and memories. To this must be added a technical aspect, that of the study of the genre of Colette’s writing. Freadman argues that, by largely avoiding the autobiographical form, the writer achieves a new way of ‘telling time’, collecting anecdotes and detail taken from the quotidian and setting them within an all-encompassing preoccupation with time. This provides the second part of the title.The sonata form directs the sequence of the book, orchestrated into five parts,from ‘exposition’ to ‘first subject’ to‘bridge’ to ‘second subject’ to ‘recapitulation’. This has the advantage of enabling Freadman to move and progress between distinct themes—autobiography first,then alternative forms—with grace,whilst preserving within her own writing what she sees as the essence of Colette’s relationship to time in her ‘Livres-Souvenirs’, the telling of time. This‘telling of time’ is itself therefore cleverly subjected to the time constraints and freedoms of musical composition. Freadman’s ‘Exposition’ takes us through a discussion of the autobiographical genre, analysing the texts against anumber of theorists, from Lejeune to Benjamin and Ricoeur, before launching into ‘Colette and Autobiography’. It argues pertinently that Colette did not write a ‘sustained’ autobiography, even inthe most autobiographical of her writings, Mes apprentissages. Measured against Goodwin’s three sources for autobiography, confession, apologia and memoirs, Colette’s autobiographical writings appear to be at odds with all of them. Freadman then goes on in Part II of her argument, to persuasively uncover a project that rejects self-scrutiny and with no autobiographical strategy. In ‘Collecting Time’, despite claims of continuity, narrative logic and causality areabandoned in favour of a collection offragments, family stories that are built up generation after generation into familylegends. A close and fruitful analysis of Sidoleads us to a study of ‘The Art of Ending’, concentrating on L’E ́toile Vesperandle Fanal Bleu. The closing chapter gives a fascinating reading of La Naissance du jouras an exemplar of the way in which the two subjects developed in Freadman’s volume are cast together:Colette’s own working through the autobiographical genre, and her refusal to write memoirs, in favour of collecting memories, and the strategies she uses for her purpose. In ‘Recapitulation’, her concluding chapter, Freadman adroitlyen capsulates her analysis in a fetching title: ‘Fables of Time’. Indeed, the wholepremise of her book is to move away from autobiographical genre, having acknowledged the links and debt the corpus owes to it, and into a study of the multiple and fruitful ways in which Colette tells time.The rich and varied readings of thematerial, competently informed by theoretical input, together with acute sensitivity to the corpus, mark out this study as incontournable for Colette scholars.

Hope in the Middle East:malleability beliefs, hope, and the willingness to compromise for peace

The importance of hope has long been asserted in the field of conflict resolution. However, little is actually known about either how to induce hope or what effects hope has on conciliatory attitudes. In the current research, we tested whether (1) hope is based upon beliefs regarding conflict malleability and (2) hope predicts support for concessions for peace. Study 1, a correlational study conducted among Israeli Jews, revealed that malleability beliefs regarding conflicts in general are associated with hope regarding the Israeli–Palestinian conflict as well as with support for concessions. In Study 2, we established causality using an experimental manipulation of beliefs regarding conflicts being malleable (vs. fixed). Findings have both theoretical and practical implications regarding inducing hope in intractable conflicts, thus promoting the attitudes so critical for peacemaking.

The meaning, antecedents and outcomes of employee engagement:a narrative synthesis

The claim that high levels of engagement can enhance organizational performance and individual well-being has not previously been tested through a systematic review of the evidence. To bring coherence to the diffuse body of literature on engagement, the authors conducted a systematic synthesis of narrative evidence involving 214 studies focused on the meaning, antecedents and outcomes of engagement. The authors identified six distinct conceptualizations of engagement, with the field dominated by the Utrecht Group's ‘work engagement’ construct and measure, and by the theorization of engagement within the ‘job demands–resources’ framework. Five groups of factors served as antecedents to engagement: psychological states; job design; leadership; organizational and team factors; and organizational interventions. Engagement was found to be positively associated with individual morale, task performance, extra-role performance and organizational performance, and the evidence was most robust in relation to task performance. However, there was an over-reliance on quantitative, cross-sectional and self-report studies within the field, which limited claims of causality. To address controversies over the commonly used measures and concepts in the field and gaps in the evidence-base, the authors set out an agenda for future research that integrates emerging critical sociological perspectives on engagement with the psychological perspectives that currently dominate the field.

Detecting expressions of blame or praise in text

The growth of social networking platforms has drawn a lot of attentions to the need for social computing. Social computing utilises human insights for computational tasks as well as design of systems that support social behaviours and interactions. One of the key aspects of social computing is the ability to attribute responsibility such as blame or praise to social events. This ability helps an intelligent entity account and understand other intelligent entities’ social behaviours, and enriches both the social functionalities and cognitive aspects of intelligent agents. In this paper, we present an approach with a model for blame and praise detection in text. We build our model based on various theories of blame and include in our model features used by humans determining judgment such as moral agent causality, foreknowledge, intentionality and coercion. An annotated corpus has been created for the task of blame and praise detection from text. The experimental results show that while our model gives similar results compared to supervised classifiers on classifying text as blame, praise or others, it outperforms supervised classifiers on more finer-grained classification of determining the direction of blame and praise, i.e., self-blame, blame-others, self-praise or praise-others, despite not using labelled training data.