Issues in applying recent CPMP ‘Points to Consider’ and FDA guidance documents with biostatistical implications

The International Conference on Harmonisation guideline ‘Statistical Principles for Clinical Trials’ was adopted by the Committee for Proprietary Medicinal Products (CPMP) in March 1998, and consequently is operational in Europe. Since then more detailed guidance on selected topics has been issued by the CPMP in the form of ‘Points to Consider’ documents. The intent of these was to give guidance particularly to non‐statistical reviewers within regulatory authorities, although of course they also provide a good source of information for pharmaceutical industry statisticians. In addition, the Food and Drug Administration has recently issued a draft guideline on data monitoring committees. In November 2002 a one‐day discussion forum was held in London by Statisticians in the Pharmaceutical Industry (PSI). The aim of the meeting was to discuss how statisticians were responding to some of the issues covered in these new guidelines, and to document consensus views where they existed. The forum was attended by industry, academic and regulatory statisticians. This paper outlines the questions raised, resulting discussions and consensus views reached. It is clear from the guidelines and discussions at the workshop that the statistical analysis strategy must be planned during the design phase of a clinical trial and carefully documented. Once the study is complete the analysis strategy should be thoughtfully executed and the findings reported. Copyright © 2003 John Wiley & Sons, Ltd.     

Mobilizing ethnic competition

Ethnic competition theory provides a powerful explanation for ethnic conflict, by demonstrating how variation in ethnic mobilization relates to intergroup struggles over scarce resources. However, the tendency to capture such relationships at the aggregate level, through macro-level proxies of intergroup competition, offers little insight into the processes through which ethnic grievances mobilize into contentious action. This article integrates insights from the social movements literature to address how competitive contexts crystallize into broader conflicts. Drawing on data from the civil rights-era Ku Klux Klan??perhaps the quintessential case of contentious ethnic organization in the United States??the analysis focuses on the ways in which meso-level arrangements mediate the relationship between overarching competitive contexts and ethnic conflict. Results of a paired comparative analysis of KKK mobilization in Greensboro and Charlotte demonstrate that social and spatial relations within each city shaped the contours of perceived competition and subsequent ethnic organization in ways that were not always predictable through observation of conventional proxies of competition.     

Self-Directed Gambling Changes: Trajectory of Problem Gambling Severity in Absence of Treatment

Most problem gamblers do not seek formal treatment, recovering on their own through cognitive re-appraisal or self-help strategies. Although barriers to treatment have been extensively studied, there is a paucity of research on self-directed changes in problem gambling and very few studies have examined these changes prospectively. The aim of this study was to examine the trajectory of gambling severity and behavior change over an 18-month period, among a sample of non-treatment seeking/attending problem gamblers recruited from the community (N?=?204) interested in quitting or reducing gambling. Separate mixed effects models revealed that in absence of formal treatment, significant reductions in gambling severity, frequency, and amount gambled could be observed over the course of a 6 to 9-month period and that changes experienced within the first 12 months were maintained for an extended 6 months. Problem gambling severity at baseline was significantly associated with changes in severity over time, such that participants with more severe gambling problems demonstrated greater reductions in their gambling severity over time. A total of 11.1% of participants gambled within a low-risk threshold at 18 months, although 28.7% of the sample reported consecutive gambling severity scores below problem levels for the duration of 1 year or longer. The findings suggest that among problem gamblers motivated to quit or reduce their gambling, significant self-directed changes in gambling severity can occur over a relatively short time. Additional prospective studies are needed to document the role of specific self-help tools or thought processes in exacting gambling changes.     

Ambivalence and Control: State Action Against the Civil Rights-Era Ku Klux Klan

Models that purport to explain the interplay between dissidents and the state generally assert, either explicitly or implicitly, that the path from state interests to action to outcomes is a linear one. Using the case of the United Klans of America (UKA) in North Carolina, I argue that state efforts to exert social control upon a perceived threat are shaped by a range of internal and external contingencies. In particular, I undertake a comparative analysis of two state agencies to demonstrate how a particular mechanism—ambivalence, here conceptualized as the relational consequence of a mismatch between organizational culture and organizational goals—leads to distinct, and sometimes heterogeneous, actions and outcomes not directly traceable to organizational mandates. Findings lend insight into how endogenous organizational processes shape contentious political outcomes in potentially divergent ways.     

The joint contribution of experiencing and witnessing violence during childhood on child abuse in the parent role

This article examines adult respondents' abuse of children as a consequence of their own childhood experiences of abuse, both direct experiences of childhood violence (hitting) and exposure to interparental violence (witnessing). In particular, the study examines the extent to which these factors function interactively: Are both experience and exposure necessary or is either sufficient to increase disproportionately the probability of child abuse? Using data from the Second National Family Violence Survey, results of a logistic regression analysis show that either or both factors produced higher than average and relatively similar rates of child abuse. Only respondents with neither form of family violence reported lower than average rates of abuse of their own children. The analysis controlled for gender, race, family income, and family structure; race was the only control variable to be significantly associated with child abuse. Finally, no control variable modified the interaction between the family violence variables.     

Risk of Disclosure, Perceptions of Risk, and Concerns about Privacy and Confidentiality as Factors in Survey Participation

This article reports on a web-based vignette experiment investigating how likely subjects would be to participate in surveys varying in topic sensitivity and risk of disclosure. A total of 3,672 participants each responded to a series of eight vignettes, along with a variety of background questions, concerns about confidentiality, trust in various institutions, and the like.Vignettes were randomly assigned to respondents, such that each respondent was exposed to four levels of disclosure risk for each level of topic sensitivity (high versus low). Half the sample was assigned to receive a confidentiality statement for all eight vignettes, while the other half received no mention of confidentiality in the vignettes. The order of presentation of vignettes was randomized for each respondent.Respondents were also asked for their subjective perceptions of risk, harm, and social as well as personal benefits for one of the eight vignettes. Adding these questions permits us to examine how objective risk information presented by the researcher relates to the subjective perception of risk by the participant, and to assess the importance of both for their willingness to participate in the surveys described.Under conditions resembling those of real surveys, objective risk information does not affect willingness to participate. On the other hand, topic sensitivity does have such effects, as do general attitudes toward privacy and survey organizations as well as subjective perceptions of risk, harm, and benefits. We discuss the limitations and implications of these findings.     

Motivators for Seeking Gambling-Related Treatment Among Ontario Problem Gamblers

A random digit dialing telephone survey was used to interview 8,467 adults in Ontario, Canada. The NODS-CLiP was used to identify a representative sample of 730 gamblers (54.3% male, mean age 45.3 years) with possible past year gambling problems in order to explore factors that might affect disordered gamblers’ motivators for seeking gambling-related help. A final sample of 526 gamblers provided useable data on possible reasons for and barriers to seeking help, awareness of services, self-perception of gambling problems and experience with help-seeking. Financial and relationship issues were the most frequently volunteered motivators. However, over two-thirds of the respondents could not think of a reason for seeking help. Gamblers who had self-admitted or more severe problems, who knew how to get help, who were employed and had more education, and who identified possible barriers to seeking help were more likely to suggest motivators, especially financial ones. More research is recommended on gamblers’ trajectory towards recognition of a gambling problem, the process of overcoming specific barriers to treatment, and the role of social advantage (e.g., education and employment), in order to devise educational campaigns that will encourage earlier help-seeking among disordered gamblers.     

Motivators for Resolving or Seeking Help for Gambling Problems: A Review of the Empirical Literature

This literature review summarizes recent empirical research on the reasons disordered gamblers try, through treatment or otherwise, to resolve or reduce their gambling problems. Relevant databases and bibliographies were searched for English-language studies, published since 1998, that asked gamblers themselves about motivators for action. Found were ten studies addressing reasons for trying to resolve or reduce gambling problems, five addressing reasons for seeking help and four addressing reasons for requesting self-exclusion from casinos. Help-seeking occurred largely in response to gambling-related harms (especially financial problems, relationship issues and negative emotions) that had already happened or that were imminent. Resolution was often motivated by the same kinds of harms but evaluation/decision-making and changes in lifestyle or environment played a more prominent role. Self-exclusion was motivated by harms, evaluation/decision-making and a wish to regain control. Awareness and educational materials could incorporate messages that might encourage heavy gamblers to make changes before harms became too great. Intervention development could also benefit from more research on the motivators leading to successful (vs. failed) resolution, as well as on the ways in which disordered gamblers are able to overcome specific barriers to seeking help or reaching resolution.     

The Impact of Sexual Abuse Treatment on the Social Work Clinician

A growing body of literature exists on the prevalence and psychological sequelae of sexual abuse and its treatment. However, less attention has been focused on the experience of clinicians who treat these clients. This article uses the concept of vicarious traumatization (McCann and Pearlman, 1990a) to describe the impact this work may have on the social work clinician. The issues addressed include the impact of the work on the clinician's world-view and the possibility that there is a grief process as clinicians come to terms with their exposure to traumatic material. Implications of this reaction and suggestions to alleviate the detrimental effects arc addressed.