Determining the non-inferiority margin for patient reported outcomes

One of the cornerstones of any non-inferiority trial is the choice of the non-inferiority margin delta. This threshold of clinical relevance is very difficult to determine, and in practice, delta is often "negotiated" between the sponsor of the trial and the regulatory agencies. However, for patient reported, or more precisely patient observed outcomes, the patients' minimal clinically important difference (MCID) can be determined empirically by relating the treatment effect, for example, a change on a 100-mm visual analogue scale, to the patient's satisfaction with the change. This MCID can then be used to define delta. We used an anchor-based approach with non-parametric discriminant analysis and ROC analysis and a distribution-based approach with Norman's half standard deviation rule to determine delta in three examples endometriosis-related pelvic pain measured on a 100-mm visual analogue scale, facial acne measured by lesion counts, and hot flush counts. For each of these examples, all three methods yielded quite similar results. In two of the cases, the empirically derived MCIDs were smaller or similar of deltas used before in non-inferiority trials, and in the third case, the empirically derived MCID was used to derive a responder definition that was accepted by the FDA. In conclusion, for patient-observed endpoints, the delta can be derived empirically. In our view, this is a better approach than that of asking the clinician for a "nice round number" for delta, such as 10, 50%, π, e, or i.     

1979～2000年中国人口生育趋势:出生数据和教育数据的比较分析

本文研究中国从1979年开始提倡一对夫妇只生育一个孩子至2000年第五次人口普查的生育趋势。为此目的,本文对1979~2001年各生育调查数据与国家统计局每年人口变动调查数据进行比较研究。四普、五普的回推数据,中国国家人口计生委报表中的出生数据和公安部户籍中的出生登记也作为比较对象。鉴于材料中的矛盾,本文就分析教育部部门统计中的各种和出生数据有间接关系的记载、讨论它们内在的口径问题和它们所涉及到的工作程序问题。本文在这一基础上用小学在校学龄儿童年龄分组的数据来估计中国1979~1997年的生育水平和其他资料的可靠性。分析暗示出生数据漏报问题普偏存在,自教育数据算出来的生育数据比许多其他资料高。虽然如此,但自1996年以来比国家统计局的修正数字低。结果同时表明,中国1992年以来确实达到了低生育水平。根据教育统计资料计算的1997年的总和生育率为1·6左右。     

Stuck in the Middle: Maintaining the Organizational Legitimacy of the Regional Environmental Center

Maintenance of legitimacy is central to the survival of any organization and is of particular importance to non-governmental organizations (NGO) reliant on external sources of income. Interaction with the external environment plays an important role in determining organizational legitimacy, shaping actions and determining opportunities. The ability of an organization to effectively respond to and influence the external environment can potentially strengthen its legitimacy. This paper considers the issue of organizational legitimacy by using resource dependence and institutional theories to analyze the development of the Regional Environmental Center for Central and Eastern Europe (REC). The findings indicate that it is possible for an organization to maintain legitimacy through adaptation, responding to the rise and fall of external opportunities and challenges. As predicted by institutional theory, it also argues that external environmental factors place increasing pressure for conformity over time, limiting scope to manoeuvre over the longer-term.     

A presumption to disclose: new laws on the provision of information about child sex offenders to parents in England and Wales

In England and Wales, agencies managing child sex offenders in the community have long had the power to disclose information on those offenders to other agencies and sometimes to individual members of the public; this process has variously been referred to as ‘discretionary disclosure’ or ‘controlled disclosure’. In 2008, new laws were passed to strengthen this process and allow designated members of the public to request such information and imposed a new duty on agencies considering disclosure to conduct those considerations with a ‘presumption to disclose’. This article looks at the background to the new laws and how they might work in practice. Copyright © 2010 John Wiley & Sons, Ltd.     

Sadomasochism and the social sciences: a review of the sociological and social psychological literature

Recent literature about sadomasochism in Sociology and Social Psychology is reviewed. Studies include survey research and questionnaire studies, content analyses, ethnographic research, and critical essays. The current state of our knowledge of sadomasochism, including its defining characteristics, sadomasochistic identities, and sadomasochistic subcultures is briefly summarized.     

Engaging Stakeholders Through Corporate Political Activity: Insights From MNE Nonmarket Strategy in an Emerging African Market

As interest increases in the political engagement between multinational enterprises (MNEs) and emerging economy host governments, less is known about wider MNE stakeholder engagement and the development of nonmarket capabilities in institutionally fragile environments. This study investigates how MNEs engage stakeholders through corporate political activity (CPA) during the pro-market reform of Uganda's electricity generation sector. Data is collected through semi-structured interviews, archival materials and fieldwork notes, and is analyzed using an NVivo-supported grounded analytic method. We find both proactive and reactive leveraging of CPA to manage diverse stakeholders. We argue that the host government remains the most important political stakeholder in the early phases of reform, but changes in institutional and political environments necessitate strategic adaptations as the reform process progresses. These adaptations include the need for local engagement and the accommodation of multi-level stakeholder pressures. Our findings contribute to an understanding of corporate political capabilities in Africa's emerging markets, and illustrate how these capabilities can be strategically leveraged to effectively manage diverse stakeholders.     

Leadership behavior and employee well-being: An integrated review and a future research agenda

Leadership behavior has a significant impact on employee behavior, performance and well-being. Extant theory and research on leadership behavior, however, has predominantly focused on employee performance, treating employee well-being (typically measured as job satisfaction) as a secondary outcome variable related to performance, rather than as an important outcome in and of itself. This qualitative state of the science review examines the process by which leadership behavior (i.e., change, relational, task, passive) affects employee well-being. We identify five mediator groupings (social-cognitive, motivational, affective, relational, identification), extend the criterion space for conceptualizing employee well-being (i.e., psychological: hedonic, eudaimonic, negative; and physical), examine the limited evidence for differential processes that underlie the leader behavior-employee well-being relationship and discuss theoretical and methodological problems inherent to the literature. We conclude by proposing a theoretical framework to guide a future research agenda on how, why and when leadership behavior impacts employee well-being.     

Gender Differences in the Consequences of Divorce: A Study of Multiple Outcomes

In this study, I examined gender differences in the consequences of divorce by tracing annual change in 20 outcome measures covering four domains: economic, housing and domestic, health and well-being, and social. I used data from the German Socio-Economic Panel Study (SOEP) and fixed-effects panel regression models on a sample of N = 18,030 individuals initially observed in a marital union, N = 1,220 of whom divorced across the observation period (1984–2015). Three main findings emerged from the analysis. First, men were more vulnerable to short-term consequences of divorce for subjective measures of well-being, but postdivorce adaptation alleviated gender differences in these outcomes. Second, a medium-term view on multiple outcomes showed more similarity than differences between women and men. The medium-term consequences of divorce were similar in terms of subjective economic well-being; mental health, physical health, and psychological well-being; residential moves, homeownership, and satisfaction with housework; and chances of repartnering, social integration with friends and relatives, and feelings of loneliness. Third, the key domain in which large and persistent gender differences emerged were women’s disproportionate losses in household income and associated increases in their risk of poverty and single parenting. Taken together, these findings suggest that men’s disproportionate strain of divorce is transient, whereas women’s is chronic.     

In search for the ideal coopetition partner: an experimental study

Coopetition (collaboration between competitors) has the potential to provide major benefits or losses to participating firms. Entering a partnership with a competitor is a strategic decision with potential long-term consequences rendering the choice of partner of key importance. Existing research has investigated partner’s strategic attributes, but not how the inter-organizational factors between coopetiting firms affect partner selection and on which layers those effects occur. We use a vignette study for reducing this gap, representing the first experimental study on the field of coopetition research. The results from our study from 874 evaluations of potential coopetition partnerships by key informants from Austria, Germany, Liechtenstein and Switzerland offer insights into how the possible partner’s role, resource alignment and the planned activity affect partner selection. The findings suggest that the partner’s role in the markets—i.e. whether it is a direct or an indirect competitor—is critical in partner selection. The planned activity and resource configuration is also found to influence the evaluation of possible coopetition partners. Overall, the results of this first experimental study in coopetition research provide important implications to both theory and practice.