Estimand framework: Are we asking the right questions? A case study in the solid tumor setting

The estimand framework requires a precise definition of the clinical question of interest (the estimand) as different ways of accounting for “intercurrent” events post randomization may result in different scientific questions. The initiation of subsequent therapy is common in oncology clinical trials and is considered an intercurrent event if the start of such therapy occurs prior to a recurrence or progression event. Three possible ways to account for this intercurrent event in the analysis are to censor at initiation, consider recurrence or progression events (including death) that occur before and after the initiation of subsequent therapy, or consider the start of subsequent therapy as an event in and of itself. The new estimand framework clarifies that these analyses address different questions (“does the drug delay recurrence if no patient had received subsequent therapy?” vs “does the drug delay recurrence with or without subsequent therapy?” vs “does the drug delay recurrence or start of subsequent therapy?”). The framework facilitates discussions during clinical trial planning and design to ensure alignment between the key question of interest, the analysis, and interpretation. This article is a result of a cross-industry collaboration to connect the International Council for Harmonisation E9 addendum concepts to applications. Data from previously reported randomized phase 3 studies in the renal cell carcinoma setting are used to consider common intercurrent events in solid tumor studies, and to illustrate different scientific questions and the consequences of the estimand choice for study design, data collection, analysis, and interpretation.     

Embracing Change

The Internet, Google, e-journals, packages, e-books and patron driven acquisitions have all been perceived as “a threat to libraries as we know them.” Yet, in spite of these developments and under the weight of chronic budget pressures, the typical academic library now offers more users better access to more content and services than ever before. In this session we will look at how librarians and the vendors that serve them have responded to these “threats” to their future to create new and improved services.     

Trust in Government Actions During the COVID-19 Crisis

The worldwide COVID-19 pandemic puts countries and their governments in an unprecedented situation. Strong countermeasures have been implemented in most places, but how much do people trust their governments in handling this crisis? Using data from a worldwide survey, conducted between March 20th and April 22nd, 2020, with more than 100,000 participants, we study people’s perceptions of government reactions in 57 countries. We find that media freedom reduces government trust directly as well as indirectly via a more negative assessment of government reactions as either insufficient or too strict. Higher level of education is associated with higher government trust and lower tendency to judge government reactions as too extreme. We also find different predictors of perceived insufficient reactions vs. too-extreme reactions. In particular, number of COVID-19 deaths significantly predicts perceived insufficient reactions but is not related to perceived too-extreme reactions. Further survey evidence suggests that conspiracy theory believers tend to perceive government countermeasures as too strict.

     

A New Model for Long-Term Care: Balancing Palliative and Restorative Care Delivery

ABSTRACT

Nursing homes have been mandated to maintain or promote the physical and psychological functioning of residents since the enactment of the 1987 Omnibus Reconciliation Act. Although this restorative approach to care has improved outcomes for some residents (Institute of Medicine, 2001 Institute of Medicine. 2001. Improving the quality of long term care, Washington, DC: National Academy Press.  [Google Scholar]), it ignores the reality that all permanently placed residents will die. A new model for long-term care, one that includes a simultaneous restorative and palliative approach to care delivery, is proposed. Palliative care principles provide a guiding framework for changing care delivery. Basic tenets, such as resident and family viewed as a unit of care, interdisciplinary teamwork, and interdisciplinary plans of care, provide a basis for specific operational suggestions. Operational strategies, such as psychosocial and spiritual support for family, resident decision making and participation in goal setting, expertise in aggressive pain and symptom control, and bereavement services following resident death, are described.     

Language Barriers

Different people use language in different ways. We capture this by making language competence—the set of messages an agent can use and understand—private information. Our primary focus is on common‐interest games. Communication generally remains possible; it may be severely impaired even with common knowledge that language competence is adequate; and, indeterminacy of meaning, the confounding of payoff‐relevant information with information about language competence, is optimal.     

Demographic Correlates and Judicial Determinations of Child Sexual Abuse Offenses

This study involved an in-depth evaluation of court records and various investigation reports of 532 alleged child sex offenders as well as their interactions with the typical societal intervention mechanism. The major results indicated that offenders significantly differed from the general population in various background characteristics. Generally, alleged offenders were more likely to be from certain demographic groups such as male, minorities, the poorly educated, labor workers, and the unemployed. Comparisons between subgroups defined by prior mental health, substance abuse, and childhood experiences indicated that negative background characteristics were further associated with the severity and judicial outcome of the charges. These results suggest the complexity of determining the etiology, correlates, and criminal and judicial dispositions of child sexual victimization. Finally, this study questions the sufficiency of the current “quarantine” approach, which “segregates” perpetrators through the mandatory registration and general distribution of the identities of convicted offenders. Implications were made regarding the need for integrating various academic disciplines and for coordinating the services of societal intervention units.     

The state of qualitative research in health and social science literature: a focused mapping review and synthesis

Abstract

Pluralism and creativity are inherent and important parts of the qualitative endeavour. The multiplicity of approaches and methods can, however, be confusing. We undertook a focused mapping review and synthesis to obtain a snap-shot profile of the state of qualitative research in health and social science literature. We retrieved 102 qualitative articles published between January and March 2015 from six leading health and social science journals. Articles were scrutinised for alignment between researchers’ reported orientation (methodological or philosophical positioning) and the techniques used (methods). In the sampled articles level of alignment was generally high, with considerable mastery of qualitative approaches evident. However, the complexity of the qualitative landscape highlighted in our review, led us to develop a diagrammatic representation: The Qualitative Research Level of Alignment Wheel?. This educational resource/teaching aid is designed to assist qualitative researchers (particularly those more novice) and research students to locate the orientation and techniques of their studies. As an important contribution to the international field of qualitative inquiry, it will assist in understanding and accounting for points at which techniques are melded and orientations blended. In turn this will lead to the individual and collective qualitative endeavour as being a coherent one.     

TEACHING STATISTICS: A TALK ABOUT TIME SERIES

When presenting research results to a mixed audience, it is common for seminar speakers either to address the specialists or the uninitiated (thus alienating the other, uncatered-for group of listeners), or to risk falling between these two stools (and so satisfy no one). We suggest a way that the lecturer's dilemma might often be more optimally resolved; and, in so doing, present material which could provide useful ideas for wider application in enlivening formal class-room instruction in time-series analysis. Finally, we pre-empt some of the predicted response that the content of this paper may trigger from certain experts; and discuss the general lack of emphasis on assumptions in statistical teaching.     

The Politics of Disability: A New Approach

This paper will argue that the politics of disability has, so far, been narrowly conceived as part of the processes of party and pressure group activity. These approaches will be examined critically and it will be suggested that they are unlikely to produce substantial political gains in terms of ensuring the full participation of disabled people in society or contribute significantly to improving the quality of their lives. Finally, it will be argued that the politics of disability can only be properly understood as part of the newly emergent social movements of all kinds and it is only within this context that their real significance can be grasped.