Modelling and simulation to improve decision‐making in clinical development

Modelling and simulation are buzz words in clinical drug development. But is clinical trial simulation (CTS) really a revolutionary technique? There is not much more to CTS than applying standard methods of modelling, statistics and decision theory. However, doing this in a systematic way can mean a significant improvement in pharmaceutical research. This paper describes in simple examples how modelling could be used in clinical development. Four steps are identified: gathering relevant information about a drug and the disease; building a mathematical model; predicting the results of potential future trials; and optimizing clinical trials and the entire clinical programme. We discuss these steps and give a number of examples of model components, demonstrating that relatively unsophisticated models may also prove useful. We stress that modelling and simulation are decision tools and point out the benefits of integrating them with decision analysis. Copyright © 2005 John Wiley & Sons, Ltd.     

Who suspects and reports child maltreatment to Social Services in Sweden? Is there a reliable mandatory reporting process?

This article deals with the mandatory report process in Sweden. The components that are analysed are who makes the reports, what is reported and the outcome for the reports. Data were collected in a Swedish county in the year 2000 by means of locating every report made to the Social Services during one year (1998). The net sample consisted of 1,570 reports regarding 1,051 children. A follow-up study was carried out in 2003 of all the children for whom a report in 1998 did not lead to an investigation being initiated. We found in these study indicators that the process might not be secure. The professionals reported 1% of the children in the municipality; 22% of the reports from professionals were not investigated. The five-year follow-up study shows that 53% of the children that these reports concerned had been the subject of an investigation. This could be an indicator that children continue to be maltreated after being reported since the assessments are not accurate. In this study, 67% of ‘crime reports’ were ‘not indicating’ child maltreatment. There should be a questioning of ‘crime reports’ automatically entering the mandated report process as, if registered nationally, this could lead to a deflation of mandatory reports. Administration needs to change introducing a national form for filing reports.     

GamTest: Psychometric Evaluation and the Role of Emotions in an Online Self-Test for Gambling Behavior

Recent increases in the number of online gambling sites have made gambling more available, which may contribute to an increase in gambling problems. At the same time, online gambling provides opportunities to introduce measures intended to prevent problem gambling. GamTest is an online test of gambling behavior that provides information that can be used to give players individualized feedback and recommendations for action. The aim of this study is to explore the dimensionality of GamTest and validate it against the Problem Gambling Severity Index (PGSI) and the gambler’s own perceived problems. A recent psychometric approach, exploratory structural equation modeling (ESEM) is used. Well-defined constructs are identified in a two-step procedure fitting a traditional exploratory factor analysis model as well as a so-called bifactor model. Using data collected at four Nordic gambling sites in the autumn of 2009 (n = 10,402), the GamTest ESEM analyses indicate high correspondence with the players’ own understanding of their problems and with the PGSI, a validated measure of problem gambling. We conclude that GamTest captures five dimensions of problematic gambling (i.e., overconsumption of money and time, and monetary, social and emotional negative consequences) with high reliability, and that the bifactor approach, composed of a general factor and specific residual factors, reproduces all these factors except one, the negative consequences emotional factor, which contributes to the dominant part of the general factor. The results underscore the importance of tailoring feedback and support to online gamblers with a particular focus on how to handle emotions in relation to their gambling behavior.     

Health and living conditions of Samis compared with other citizens based on representative surveys in three Swedish regions

This is the first general health survey of Samis compared with other Swedes to be based on randomised samples. In three regions, Samis were compared with respondents to the Public Health Investigation (n = 613 Samis and 6,309 respondents). Samis were also compared as to gender and membership in reindeer‐herding Sami villages (SVs). The survey shows that Samis of today have better education, work situation and health, and a healthier lifestyle than other Swedish citizens living in the same regions. There are, however, great differences among the Samis themselves. Members of SVs have weaker finances, and they report having less societal trust and worse health than non‐members do. Male members have lower education, are less involved in social activities and report worse overall health, but do not have a higher incidence of psychiatric problems, than other Samis. Samis, in general, have similar or better health and social situation than non‐Samis, but male SV‐members face greater problems and higher risks than other Samis. Key Practitioner Message: ? Health and welfare authorities in cooperation with the Sami parliament and the Sami villages should develop special strategies to assist the herding communities in culturally sensitive ways.     

Passive Support: No Support at All?

Several scholars have pointed out a shift from classic secondary associations to tertiary organizations based on passive support in Western countries. This development necessitates a better understanding of passive support within social science and voluntary sector management, on which strong opinions are expressed in the literature. This article attempts to contribute to the empirical basis for such opinions. We suggest that the current anxieties concerning the future of democracy if activity rates drop may be exaggerated.     

Inference for outcome probabilities in multi-state models

In bone marrow transplantation studies, patients are followed over time and a number of events may be observed. These include both ultimate events like death and relapse and transient events like graft versus host disease and graft recovery. Such studies, therefore, lend themselves for using an analytic approach based on multi-state models. We will give a review of such methods with emphasis on regression models for both transition intensities and transition- and state occupation probabilities. Both semi-parametric models, like the Cox regression model, and parametric models based on piecewise constant intensities will be discussed.     

Ergonomics and sustainability--challenges from global supply chains

The development of globalised supply chains is a major challenge for sustainability. For several years, there has been discussion within the profession whether and how ergonomics and human factors can play a role. Based on our research, we have identified five major challenges from global supply chains especially related to the social aspects of sustainability: (1) criteria for social sustainability, (2) the role of key performance indicators in the management of supply chains, (3) the constant changes in supply chains, (4) the challenge in establishing participation, and (5) the development of agency and regulatory mechanisms. There are obviously no clear and simple solutions to these challenges. One possible avenue for progress might lie in acquiring a greater understanding of the challenges from global supply chains and developing a strategy which combines social and long-term business sustainability. Starting from such a basis, the next step would be to find ways for the ergonomics and human factors community to create international collaboration which can impact specific global supply chains.