Properties of the weighted log‐rank test in the design of confirmatory studies with delayed effects

Proportional hazards are a common assumption when designing confirmatory clinical trials in oncology. This assumption not only affects the analysis part but also the sample size calculation. The presence of delayed effects causes a change in the hazard ratio while the trial is ongoing since at the beginning we do not observe any difference between treatment arms, and after some unknown time point, the differences between treatment arms will start to appear. Hence, the proportional hazards assumption no longer holds, and both sample size calculation and analysis methods to be used should be reconsidered. The weighted log‐rank test allows a weighting for early, middle, and late differences through the Fleming and Harrington class of weights and is proven to be more efficient when the proportional hazards assumption does not hold. The Fleming and Harrington class of weights, along with the estimated delay, can be incorporated into the sample size calculation in order to maintain the desired power once the treatment arm differences start to appear. In this article, we explore the impact of delayed effects in group sequential and adaptive group sequential designs and make an empirical evaluation in terms of power and type‐I error rate of the of the weighted log‐rank test in a simulated scenario with fixed values of the Fleming and Harrington class of weights. We also give some practical recommendations regarding which methodology should be used in the presence of delayed effects depending on certain characteristics of the trial.     

Transnational policy entrepreneurs and the cultivation of influence: individuals,organizations and their networks

ABSTRACT

The ‘policy entrepreneur’ concept arises from the Multiple Streams’ theory of agenda setting in Policy Studies. Through conceptual stretching’, the concept is extended to global policy dynamics. Unlike ‘advocacy networks’ and ‘norm entrepreneurs’, the discussion addresses the strategies of ‘insider’ or ‘near-governmental’ non-state actors. The analysis advances the policy entrepreneur concept in three directions. First, the discussion develops the transnational dimensions of this activity through a case study of International Crisis Group. Second, rather than focusing on charismatic individuals, the discussion emphasizes the importance of organizational resources and reputations for policy entrepreneurship and access into international policy communities. Organizations maintain momentum behind policy solutions and pressures for change over the long term when individuals retire or depart for other positions. Third, the discussion outlines four distinct entrepreneur strategies and techniques that both individuals and organizations cultivate and deploy to enhance their power and persuasion in global policy processes and politics.     

Wage and Non-Wage Compensation Among Young Alcoholic and Heavy Drinking Women: A Preliminary Analysis

The association between drinking and selected job characteristics among women aged 24 to 31 is examined. Using the 1989 NLSY, women are classified as alcohol abusers or dependent based on DSM-III-R criteria or as heavy drinkers based on reported frequency of six or more drinks. Heavy drinking is negatively associated with wage and non-wage compensation. These effects diminish when human capital measures are controlled. Current alcoholism and current and past heavy drinking are strongly negatively associated with years of schooling. The association between alcoholism and job compensation and characteristics is not as strong as that seen for heavy drinking. It is not known if this is a consequence of errors in identifying alcoholic women in population-based surveys.     

Volume 30

Theory and Society -     

A NOTE ON EVANESCENT PROCESSES

This note examines the connection between μ-invariant measures for the transition function of a continuous-time Markov chain and those of its q-matrix, Q. The major result establishes a necessary and aufficient condition for a convergent μ-invariant measure for Q to be μ-inhant for the minimal transition function, P, under the assumption that P is honest. This corrects Theorem 6 of Vere-Jones (1969) and the first part of Corollary 1 of Pollett (1986), both of which assert that the above conclusion holds in the absence of this condition. The error was pointed out by E.A. van Doom (1991) and the counterexample which be presented provides the basis for the present arguments. In determining where the error occurred in the original proof, we are able to identify a simple sufficient condition for μ-invariance.     

Spatial variation in soil inorganic nitrogen across an arid urban ecosystem

We explored variations in inorganic soil nitrogen (N) concentrations across metropolitan Phoenix, Arizona, and the surrounding desert using a probability-based synoptic survey. Data were examined using spatial statistics on the entire region, as well as for the desert and urban sites separately. Concentrations of both NO₃-N and NH₄-N were markedly higher and more heterogeneous amongst urban compared to desert soils. Regional variation in soil NO₃-N concentration was best explained by latitude, land use history, population density, along with percent cover of impervious surfaces and lawn, whereas soil NH₄-N concentrations were related to only latitude and population density. Within the urban area, patterns in both soil NO₃-N and NH₄-N were best predicted by elevation, population density and type of irrigation in the surrounding neighborhood. Spatial autocorrelation of soil NO₃-N concentrations explained 49% of variation among desert sites but was absent between urban sites. We suggest that inorganic soil N concentrations are controlled by a number of ‘local’ or ‘neighborhood’ human-related drivers in the city, rather than factors related to an urban-rural gradient.     

Don't mention Stonehenge!

It rises massive and magnificent above Salisbury Plain. The extraordinary monoliths of Stonehenge leave us as impressed today as ever—and as baffled. Archaeologists argue about how it was made. Can statisticians tell the answer? Chris Jones thinks they can be of considerable assistance.     

Projective Identification as a Contributor to Domestic Violence

Many explanations have been given as to why men batter. Rarely are deep unconscious intrapsychic processes identified as contributing reasons. One way that violent men may use their partner to fill emotional needs is through the primitive defense of projective identification. Projective identification may be invoked by men to induce the other partner to carry split off threatening parts of the self that are too anxiety provoking to retain. The occurrence of projective identification could therefore be an important intrapsychic and interpersonal dynamic that contributes to the escalation of tension prior to the violent episode.     

WOMEN ATHLETES AS FALSELY ACCUSED DEVIANTS: Managing the Lesbian Stigma

As the behavior of women athletes is often interpreted to violate gender norms, women athletes are frequently devalued and stigmatized. The present study examines the manner in which such devaluation and stigmatization impact on women athletes and how these athletes manage the lesbian label attached to their sport participation. In-depth telephone interviews were conducted with 24 intercollegiate athletes from three Division I universities. Processes underlying athletes' responses parallel Becker's construction of the "falsely accused deviant" and Goffman's conceptualization of "stigma management." Factors leading to false accusation of lesbianism are discussed, as well as the various mechanisms utilized by athletes to manage the lesbian label.