A comparative study of confidence intervals to assess biosimilarity from analytical data

Assessment of analytical similarity of tier 1 quality attributes is based on a set of hypotheses that tests the mean difference of reference and test products against a margin adjusted for standard deviation of the reference product. Thus, proper assessment of the biosimilarity hypothesis requires statistical tests that account for the uncertainty associated with the estimations of the mean differences and the standard deviation of the reference product. Recently, a linear reformulation of the biosimilarity hypothesis has been proposed, which facilitates development and implementation of statistical tests. These statistical tests account for the uncertainty in the estimation process of all the unknown parameters. In this paper, we survey methods for constructing confidence intervals for testing the linearized reformulation of the biosimilarity hypothesis and also compare the performance of the methods. We discuss test procedures using confidence intervals to make possible comparison among recently developed methods as well as other previously developed methods that have not been applied for demonstrating analytical similarity. A computer simulation study was conducted to compare the performance of the methods based on the ability to maintain the test size and power, as well as computational complexity. We demonstrate the methods using two example applications. At the end, we make recommendations concerning the use of the methods.     

Staff and family attitudes to fences as a means of detaining people with dementia in residential aged care settings: The tension between physical and emotional safety

This study investigates staff and family attitudes towards the use of the fences that surround many aged care facilities in Australia, in the context of indefinite detention of people with dementia. This indefinite detention has been described in a report from an Australian Senate Inquiry as “a significant problem within the aged care context”, which “is often informal, unregulated and unlawful”. Five focus groups comprising direct care workers, family members, nurse unit managers and facility managers discussed the reasons for and their attitudes towards fences. The results show a tension between the provision of physical and emotional safety. This is to say that even while it is illegal to detain people with dementia against their will, and even while participants understood the negative impact of fences on the well‐being and emotional safety of people with dementia, they accepted and supported the presence of perimeter fences because they provided the perception that fences kept people with dementia physically safe. This has implications for redressing the balance between physical and emotional safety in policy and practice.     

Rethinking the effectiveness of family planning in Africa

For the past 50 years there has been a near global consensus that the demands of development necessitate that couples reduce their fertility as a critical act which would jump start economic growth. This consensus heralded the era of the One Child policy and over 90% of least developed states continue to run programs which seek to induce lower fertility rates in their populations. However, a growing body of literature is questioning both the validity and utility of these interventions. This article seeks to contribute to the rethinking of family planning programs. Using new data on family planning scores from forty two African states this article shows that rates of fertility are unlikely to be affected by the strength of family planning programs at lower levels of development. However, at moderate levels of development, family planning programs may contribute to accelerating the decline in fertility initiated by exogenous factors. These findings offer a fresh perspective on the wide spread adoption of family planning policy that permeates the developing world.     

Learning in and from projects: the learning modes and a learning capability model

Abstract

The notion of ‘project delivery’ is well embedded in and across the management and organizational sciences literature – generating a narrative that reflects and recognizes the instrumental nature of projects and programmes in strategy execution. Project management, as a distinct and well-established body of research enquiry, has increasingly sought to focus our attention on the impacts of complexity, risk and uncertainty in projects; the corollary being a desideratum to strengthen our theoretical understanding of how insight and learning from projects may influence improvements to organizational efficiency. The wider literature suggests that organizational learning remains a challenging proposition, particularly in the context of organizations operating in environments of high complexity. In this paper, we enhance the conversation on organizational learning through a series of case studies, generating evidence of thirteen ‘learning modes’. The paper proposes that mature organizations tend to exhibit a greater number of learning modes and that there is a tendency to capture and socialize knowledge with a greater emphasis on the context of the learning situation rather than the learning artefact in isolation. The empirical evidence gathered in this paper forms the basis of a capability model, characterized by the thirteen modes of learning. The model intimates that learning occurs, and is more effective, when knowledge and information are enacted in practice through the learning modes which form a nucleus of the organizational learning capability. The research concludes with a 'call to action' that emphasizes the strategic importance of learning practices and routines in project oriented-organizations.     

Two-stage approaches to the analysis of occupancy data I: the homogeneous case (analysis of occupancy data)

Abstract

Occupancy models are used in statistical ecology to estimate species dispersion. The two components of an occupancy model are the detection and occupancy probabilities, with the main interest being in the occupancy probabilities. We show that for the homogeneous occupancy model there is an orthogonal transformation of the parameters that gives a natural two-stage inference procedure based on a conditional likelihood. We then extend this to a partial likelihood that gives explicit estimators of the model parameters. By allowing the separate modeling of the detection and occupancy probabilities, the extension of the two-stage approach to more general models has the potential to simplify the computational routines used there.     

The effect of omitted covariates in marginal and partially conditional recurrent event analyses

There have been many advances in statistical methodology for the analysis of recurrent event data in recent years. Multiplicative semiparametric rate-based models are widely used in clinical trials, as are more general partially conditional rate-based models involving event-based stratification. The partially conditional model provides protection against extra-Poisson variation as well as event-dependent censoring, but conditioning on outcomes post-randomization can induce confounding and compromise causal inference. The purpose of this article is to examine the consequences of model misspecification in semiparametric marginal and partially conditional rate-based analysis through omission of prognostic variables. We do so using estimating function theory and empirical studies.

     

IM Special Section Introduction: Rethinking International Migration in China and India

China and India have the world’s two largest populations and have long been major sources of migrants to other countries. In recent years, movements of Chinese and Indians for study and work overseas have been affected by developments in policies at their chosen destinations as well as at home. The flows of Chinese and Indian students and skilled migrants in the second decade of the 21st century are occurring within quite different political and economic contexts from those that prevailed even as recently as a decade ago. In the first part of this brief editorial introduction, we introduce some features of contemporary Chinese and Indian migration. The four substantive papers in the special section are then introduced, the first two with reference to the changing Asian migration patterns, and the remaining two addressing the changing dynamics of migration.     

Media Disaster Reporting Effects on Public Risk Perception and Response to Escalating Tornado Warnings: A Natural Experiment

Previous research has evaluated public risk perception and response to a natural hazards in various settings; however, most of these studies were conducted either with a single scenario or after a natural disaster struck. To better understand the dynamic relationships among affect, risk perception, and behavioral intentions related to natural disasters, the current study implements a simulation scenario with escalating weather intensity, and includes a natural experiment allowing comparison of public response before and after a severe tornado event with extensive coverage by the national media. The current study also manipulated the display of warning information, and investigated whether the warning system display format influences public response. Results indicate that (1) affect, risk perception, and behavioral intention escalated as weather conditions deteriorated, (2) responses at previous stages predicted responses at subsequent stages of storm progression, and (3) negative affect predicted risk perception. Moreover, risk perception and behavioral intention were heightened after exposure to the media coverage of an actual tornado disaster. However, the display format manipulation did not influence behavioral responses. The current study provides insight regarding public perception of predisaster warnings and the influence of exposure to media coverage of an actual disaster event.