On estimands and the analysis of adverse events in the presence of varying follow‐up times within the benefit assessment of therapies

The analysis of adverse events (AEs) is a key component in the assessment of a drug's safety profile. Inappropriate analysis methods may result in misleading conclusions about a therapy's safety and consequently its benefit‐risk ratio. The statistical analysis of AEs is complicated by the fact that the follow‐up times can vary between the patients included in a clinical trial. This paper takes as its focus the analysis of AE data in the presence of varying follow‐up times within the benefit assessment of therapeutic interventions. Instead of approaching this issue directly and solely from an analysis point of view, we first discuss what should be estimated in the context of safety data, leading to the concept of estimands. Although the current discussion on estimands is mainly related to efficacy evaluation, the concept is applicable to safety endpoints as well. Within the framework of estimands, we present statistical methods for analysing AEs with the focus being on the time to the occurrence of the first AE of a specific type. We give recommendations which estimators should be used for the estimands described. Furthermore, we state practical implications of the analysis of AEs in clinical trials and give an overview of examples across different indications. We also provide a review of current practices of health technology assessment (HTA) agencies with respect to the evaluation of safety data. Finally, we describe problems with meta‐analyses of AE data and sketch possible solutions.     

Voluntary Membership and Well-Being of Nonprofit,Government, and Business Employees

While the benefits the volunteers offer nonprofit organizations are substantial, they can also cause problems for these groups. In an environment where people willingly donate their time and energy to a cause that they ostensibly support, why is disruptive behavior so common? This ethnographic study of volunteers at an animal shelter identifies the factors that lead to problematic behavior. The paper argues that disruptions occur when there is a mismatch between the needs of the volunteer and the needs of the organization and because of structural conditions that lead to uncertainty among volunteers. These findings shed light on volunteer behavior broadly and present the opportunity to address disruptive behavior. As a result, the benefits the volunteers provide for an organization can be maximized.     

Data-Informed Ebook Discovery: An Analytical Approach to the User Experience

ABSTRACT

This article reports on an effort to better understand the discoverability of ebook collections at the University of North Carolina at Chapel Hill (UNC-CH). Library staff analyzed titles in nine ebook packages across disciplines and conducted a two-pronged analysis of how discoverable titles in these collections were, both in Summon Discovery Service and the online catalog, and the quality of what could be discovered about the ebooks with these tools. This study revealed that discoverability of ebooks is not equal across collections, and some collections require more work to make them discoverable in Summon and the catalog. Finally, the majority of titles were discovered in Summon, but the catalog still seems to be a better discovery engine for these ebooks.     

Midwifery students’ conceptions of worst imaginable pain

BackgroundThe Visual Analogue Scale (VAS) is one of the most widely used pain assessment scales in clinical practice and research. However, the VAS is used less frequently in midwifery than in other clinical contexts. The issue of how people interpret the meaning of the VAS endpoints (i.e. no pain and worst imaginable pain) has been discussed. The aim of this study was to explore midwifery students’ conceptions of ‘worst imaginable pain’.MethodsA sample of 230 midwifery students at seven universities in Sweden responded to an open-ended question: ‘What is the worst imaginable pain for you?’ This open-ended question is a part of a larger study. Their responses underwent manifest content analysis.ResultsAnalysis of the midwifery students’ responses to the open-ended question revealed five categories with 24 sub-categories. The categories were Overwhelming pain, Condition-related pain, Accidents, Inflicted pain and Psychological suffering.ConclusionsThe midwifery students’ conceptions of ‘worst imaginable pain’ are complex, elusive and diverse.     

Teaching Note—Tweeting Macro Practice: Social Media in the Social Work Classroom

ABSTRACT

Despite its ubiquity, social work educators are just beginning to harness social media in teaching. In this teaching note, we discuss our use of Twitter in a bachelor’s-level macro Human Behavior in the Social Environment course. We present results from a survey of 45 students designed to assess their perceptions of Twitter use in the classroom and, in particular, as a macro social work learning tool. Students appreciated using social media in the course and reported that Twitter was a valuable professional social work tool. We explore how social work educators can provide an innovative classroom experience that incorporates ethical and professional use of social media and demonstrate how we used Twitter to apply macro practice competencies.     

Sensual and sexual marital contentment in parents of small children--a follow-up study when the first child is four years old

This follow-up study explored parents' (N = 452) intimate relationships when their firstborn child was 6 months old and then 4 years later. The measurement used was a modified version of the Dyadic Adjustment Scale, DAS. The present results show that most parents responding were content sensually at 6 months postpartum in 2002 and 4 years later, in 2006. More parents had changed from being sensually content in 2002 to discontent in 2006, than the contrary, however, and the sexual contentment remained low. The average sexual frequency was low both at 6 months and at 4 years for both parents with and without additional children. Experiencing tiredness as a hindrance to having sex was perceived as a greater problem among those parents without additional children. Prospective regression analyses indicated that sexuality was significantly related to both sensual and sexual contentment 4 years later. Sexuality was also one of the most significant covariates in the cross-sectional regression analysis for sensual contentment. Since sexuality plays a central role in partner well-being, it may be an important target for helping parents with small children.