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.     

Case Reading as a Practice and Training Intervention in Domestic Violence and Child Protection

This article explores the role of a case-reading tool, developed by the Safe and Together Institute, deployed across five Australian states, and which engaged workers from child protection (CP) and specialist domestic and family violence (DFV) services. It aimed to assess the extent to which DFV is identified in CP case files and to assess the quality of case practice from a DFV-informed perspective, as documented in the case file. The Safe and Together approach to child welfare provides a robust foundation upon which practitioners from statutory and nonstatutory backgrounds can work collaboratively and reach consensus about how best to ensure the safety and wellbeing of children living with DFV. The case reading is both a process of transformative working for practitioners and an analytical tool through which their agencies can affect systemic change.

IMPLICATIONS

• A national audit of 20 child protection case files using the Safe and Together case-reading process indicated that documented child protection practice sits at the lower end of a domestic and family violence-informed Continuum of Practice.

• Analysis indicates a need to improve: child protection engagement with fathers who use DFV, assessments of their parenting role and its impact on children and family functioning; identification of adult survivors’ protective capacities and their impact on children.

• Research in this area may have broader implications for other professions and government policy both nationally and internationally.

     

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.     

The Pastor in the Basement: Discourses of Authenticity in the Networked Public Sphere

Applying Altheide's method of ethnographic content analysis, this article tracks competing discourses of authenticity in media coverage of Jeremiah Wright and Sarah Palin. The “pastor problems” of the last election demonstrate a bias toward issues of sincerity and authenticity in the networked public sphere. Pundits and bloggers use viral videos to construct rival representations of candidates’ backstage identities. Such debates favor “flat” notions of authenticity, however, and decontextualization tends to thwart the critical gatekeeping functions of journalism. Religion serves as a proxy for issues of race, prophetic critique is demonized, and apocalyptic thinking is normalized.     

Eye-Tracking Data: New Insights on Response Order Effects and Other Cognitive Shortcuts in Survey Responding

Survey researchers since Cannell have worried that respondents may take various shortcuts to reduce the effort needed to complete a survey. The evidence for such shortcuts is often indirect. For instance, preferences for earlier versus later response options have been interpreted as evidence that respondents do not read beyond the first few options. This is really only a hypothesis, however, that is not supported by direct evidence regarding the allocation of respondent attention. In the current study, we used a new method to more directly observe what respondents do and do not look at by recording their eye movements while they answered questions in a Web survey. The eye-tracking data indicate that respondents do in fact spend more time looking at the first few options in a list of response options than those at the end of the list; this helps explain their tendency to select the options presented first regardless of their content. In addition, the eye-tracking data reveal that respondents are reluctant to invest effort in reading definitions of survey concepts that are only a mouse click away or paying attention to initially hidden response options. It is clear from the eye-tracking data that some respondents are more prone to these and other cognitive shortcuts than others, providing relatively direct evidence for what had been suspected based on more conventional measures.     

Children in self-care: An examination of research confounds

Families using self-care, in-home, and out-of-home child care arrangements were compared on a number of demographic variables. Certain variables (e.g., family income; marital status) were, as expected, related to the type of child care in use. However, one unexpected trend also was identified: regardless of the type of child care arrangement reported by parents, as the age of children increased across the out-of-home, in-home, and self-care family groups so too did the number of hours children spent at home alone. This trend is discussed in relation to two confounding areas of which researchers should be aware when conducting school-age child care needs assessment surveys and conducting self-care studies: (a) the context within which the self-care decision is made; and (b) the reasoning that goes into making the self-care decision.