Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy

Competing risk methods are time‐to‐event analyses that account for fatal and/or nonfatal events that may potentially alter or prevent a subject from experiencing the primary endpoint. Competing risk methods may provide a more accurate and less biased estimate of the incidence of an outcome but are rarely applied in cardiology trials. APEX investigated the efficacy of extended‐duration betrixaban versus standard‐duration enoxaparin to prevent a composite of symptomatic deep‐vein thrombosis (proximal or distal), nonfatal pulmonary embolism, or venous thromboembolism (VTE)–related death in acute medically ill patients (n = 7513). The aim of the current analysis was to determine the efficacy of betrixaban vs standard‐duration enoxaparin accounting for non‐VTE–related deaths using the Fine and Gray method for competing risks. The proportion of non‐VTE–related death was similar in both the betrixaban (133, 3.6%) and enoxaparin (136, 3.7%) arms, P = .85. Both the traditional Kaplan‐Meier method and the Fine and Gray method accounting for non‐VTE–related death as a competing risk showed equal reduction of VTE events when comparing betrixaban to enoxaparin (HR/SHR = 0.65, 95% 0.42‐0.99, P = 0.046). Due to the similar proportion of non‐VTE–related deaths in both treatment arms and the use of a univariate model, the Fine and Gray method provided identical results to the traditional Cox model. Using the Fine and Gray method in addition to the traditional Cox proportional hazards method can indicate whether the presence of a competing risk, which is dependent of the outcome, altered the risk estimate.     

A comparison of multi‐disciplinary groups in the UK and New Jersey

During the past 30 years in both the United Kingdom and the United States there has been an increasing emphasis on the need for the agencies, disciplines and professions who are involved in investigating child abuse allegations and in protecting children from abuse to work together, to cooperate with each other and to coordinate their responses. (See Besharov, 1990; British Paediatric Association, 1966; Kempe and Helfer, 1972; London Borough of Brent, 1985; London Borough of Greenwich, 1987). One way of achieving this has been through the use of multi‐disciplinary groups. This paper will describe the initial findings from a study which aimed to examine and compare the working of two such groups, namely, case conferences in the UK and multi‐disciplinary teams in one state in the United States, New Jersey. The findings from the study show that while there are some similarities between the two types of multi‐disciplinary groups, there are also significant differences in functions, membership, structure of meetings and chairing. However, the major difference that emerges is the more prominent role of representatives from the legal system in New Jersey's multi‐disciplinary teams compared with UK case conferences. Copyright © 1999 John Wiley & Sons, Ltd.     

How Runaway and Homeless Youth Navigate Troubled Waters: The Role of Formal and Informal Helpers

Most adolescents navigate the transition from adolescence to young adulthood with relative success. However, runaway and homeless youth experience formidable obstacles in their paths and engage in dangerous behaviors that threaten their well being and long-term prospects. This study is part of a larger exploratory research effort aimed at understanding how runaway and homeless adolescents navigate the troubled waters of their adolescence to make successful developmental transitions into young adulthood. The focus of this paper is to report findings related to the formal and informal helping resources that enable runaway and homeless youth to resolve difficulties, deal with hazards, and achieve some level of self-defined success in young adulthood. This study utilized a qualitative research design, and the primary data collection method was in-depth interviews with 12 formerly runaway and homeless young people. The constant comparative method was used to analyze the data. Evidence emerged regarding who provided help, the types of help provided, conditions that facilitated acceptance of help, and advice to helping professionals. The findings illustrate the experiences youth had with helpers that they found valuable and experiences they perceived as detrimental.     

How Runaway and Homeless Youth Navigate Troubled Waters: Personal Strengths and Resources

Little attention has been paid to how runaway or homeless adolescents are able to make successful transitions into adulthood. This article reports on partial findings from an exploratory study of the research question, “How do formerly runaway and homeless adolescents navigate the troubled waters of leaving home, living in high-risk environments, and engaging in dangerous behaviors, to make successful developmental transitions into young adulthood?” This qualitative study involved interviews with 12 formerly runaway or homeless youth. Data were analyzed using the constant comparative method. This paper reports on findings related to the personal strengths and resources that enabled youth to make successful transitions: learning new attitudes and behaviors, personal attributes, and spirituality. Recommendations for program development and intervention with homeless or at-risk youth are discussed.     

Recommendations on the statistical analysis of the Comet assay

In 2010, the Statisticians in the Pharmaceutical Industry (PSI) Toxicology Special Interest Group met to discuss the design and analysis of the Comet assay. The Comet assay is one potential component of the package of safety studies required by regulatory bodies. As these studies usually involve a three-way nested experimental design and as the distribution of the measured response is usually either lognormal or lognormal plus a point mass at zero, the analysis is not straightforward. This has led to many different types of analysis being proposed in the literature, with several different methods applied within the pharmaceutical industry itself. This article summarises the PSI Toxicology Group's discussions and recommendations around these issues.     

HIV and family therapists' duty to warn: a legal and ethical analysis

In the absence of definitive legal precedents, family therapists must decide whether to warn sexual partners of HIV-positive clients when clients themselves refuse to do so. Deciding whether to break confidentiality reaises both legal and ethical issues. Legally, the Tarasoff ruling requires therapists to warn potential victims of illegal dangers posed by clients but does not require therapists to warn potential victims of dangers posed by their clients' legally permissible actions. unless the behavior of the seropositive client is proscribed by state law, warning the clients' partners does not fall within the scope of the Tarasoff ruling. Ethically, therapists must negotiate and adhere to a disclosure policy that balances considerations of respecting autonomy, maintaining integrity (avoiding fraud and betrayal), benefiting clients, and fostering responsibility. Some therapeutic and ethical aspects of these considerations are discussed.     

‘Kids who Smoke Think that They Can Be Adults as Well’: Children's Smoking and Transitions to Adulthood

This article aims to explore the ways in which preadolescents associate smoking with transitions to adulthood, in the context of sociological theories of childhood, using data from the Liverpool Longitudinal Study of Smoking. The research found that at age 9 many of the cohort argued that smoking was more acceptable for adults because they had bigger bodies than children. Some children also suggested that smoking was appropriate for adults because adults were competent to make important decisions and to balance risks. By age 11, when several of the cohort had actually tried smoking, children's views about the risks smoking posed to their bodies had altered, and many children were aware of smoking‐related disease among adults. The cohort also suggested that some children might take up smoking to demonstrate that they are ‘grown up’ too. In the UK, legal restrictions on the age of tobacco purchase are reinforced by social norms that construct smoking as an activity that is only suitable for adults. The goal of legal restrictions that ban the sale of cigarettes to children is to protect their health. The unintended outcome, however, is that for many young people smoking is a way of demonstrating maturity and adult status.     

Indigenous land and sea management programs: Can they promote regional development and help “close the (income) gap”?

Throughout the world, there is growing recognition of the important role Indigenous people play in natural resource management and conservation. Indigenous Land and Sea Management Programs (ILSMPs; which provide funds to Indigenous people to support Indigenous land management activities) are also known to generate social and economic benefits, although relative few of these co‐benefits have been quantified. Using northern Australia as a case study, we analysed data on ILSMP expenditure within three regional input–output tables, learning more about the size and distribution of their associated regional economic benefits. We found ILSMPs make a significant contribution to regional economies—with multipliers commonly exceeding that of other key regional industries such as agriculture and mining. We also found ILSMP expenditures make a larger contribution to Indigenous household incomes than they do to non‐Indigenous incomes—thus helping to close the (income) gap. They will continue to do so, provided the proportion of ILSMP money spent on Indigenous (compared to non‐Indigenous) incomes does not fall below a threshold amount. Rather than finding evidence of a trade‐off between socio‐ecological and financial/economic goals, our results suggest ILSMPs, known for their ecological importance, can also make a vitally important contribution to economic development in rural areas.