Randall Collins,Ideas and Ritual Solidarity

Sociological Forum -     

Where local and national evaluators meet: unintended threats to ethical evaluation practice

The ethical work of program evaluators is based on a covenant of honesty and transparency among stakeholders. Yet even under the most favorable evaluation conditions, threats to ethical standards exist and muddle that covenant. Unfortunately, ethical issues associated with different evaluation structures and contracting arrangements have received little attention in the evaluation research literature. This article focuses on the unintended ethical threats associated with multitiered evaluation contexts. After briefly reviewing the various frames through which evaluation theory and ethics are commonly viewed, we discuss ethical challenges associated with multitiered evaluation designs including examples drawn from our evaluation projects. The article concludes with specific findings and recommendations for evaluators, grantors, grantees, and researchers.     

Sociology: After the linguistic and multicultural turns

This paper offers an analysis of the continuing crisis in sociology that is different from those that have appeared in the literature. In contrast to the ideological and technical readings, it suggests that the origins of the crisis are to be found in the hermeneutic challenge that has resulted from the linguistic and multicultural turns. Both of these developments have given rise to new discourses within the academy that are competing with subfields such as the sociology of the arts and race/ethnic relations. The nature and impact of this new competition is examined in greater detail through the case of the sociology of race. The analysis reveals that these competitive challenges are hermeneutic in nature and not primarily technical or ideological. The paper concludes with some suggestions for crisis resolution.     

A Relational Gompertz Model of Male Fertility: Development and Assessment

Brass has proposed a relational Gompertz model of female fertility which, in combination with the standard fertility distribution developed by Booth, has proved useful in a range of applications, such as indirect estimation, demographic modelling, and population projections. This paper develops a standard distribution of male fertility for use in conjunction with the relational Gompertz model. The derivation of the standard takes advantage of the similarity between the shape of male and female fertility distributions. It entails ‘stretching’ the female standard, so that it extends to age 80, and then transforming it, using the Gompertz model into a pattern which is more typical of male fertility distributions in the developing world. An assessment of this new standard by fitting the relational Gompertz model based on it to a series of male fertility distributions from diverse populations, suggests that it performs very well.     

Subgroup analyses of clinical effectiveness to support health technology assessments

Subgroup analysis is an integral part of access and reimbursement dossiers, in particular health technology assessment (HTA), and their HTA recommendations are often limited to subpopulations. HTA recommendations for subpopulations are not always clear and without controversies. In this paper, we review several HTA guidelines regarding subgroup analyses. We describe good statistical principles for subgroup analyses of clinical effectiveness to support HTAs and include case examples where HTA recommendations were given to subpopulations only. Unlike regulatory submissions, pharmaceutical statisticians in most companies have had limited involvement in the planning, design and preparation of HTA/payers submissions. We hope to change this by highlighting how pharmaceutical statisticians should contribute to payers' submissions. This includes early engagement in reimbursement strategy discussions to influence the design, analysis and interpretation of phase III randomized clinical trials as well as meta-analyses/network meta-analyses. The focus on this paper is on subgroup analyses relating to clinical effectiveness as we believe this is the first key step of statistical involvement and influence in the preparation of HTA and reimbursement submissions.     

Subgroup analyses in cost‐effectiveness analyses to support health technology assessments

‘Success’ in drug development is bringing to patients a new medicine that has an acceptable benefit–risk profile and that is also cost‐effective. Cost‐effectiveness means that the incremental clinical benefit is deemed worth paying for by a healthcare system, and it has an important role in enabling manufacturers to obtain new medicines to patients as soon as possible following regulatory approval. Subgroup analyses are increasingly being utilised by decision‐makers in the determination of the cost‐effectiveness of new medicines when making recommendations. This paper highlights the statistical considerations when using subgroup analyses to support cost‐effectiveness for a health technology assessment. The key principles recommended for subgroup analyses supporting clinical effectiveness published by Paget et al. are evaluated with respect to subgroup analyses supporting cost‐effectiveness. A health technology assessment case study is included to highlight the importance of subgroup analyses when incorporated into cost‐effectiveness analyses. In summary, we recommend planning subgroup analyses for cost‐effectiveness analyses early in the drug development process and adhering to good statistical principles when using subgroup analyses in this context. In particular, we consider it important to provide transparency in how subgroups are defined, be able to demonstrate the robustness of the subgroup results and be able to quantify the uncertainty in the subgroup analyses of cost‐effectiveness. Copyright © 2014 John Wiley & Sons, Ltd.