Statistical approaches for conducting network meta-analysis in drug development

We introduce health technology assessment and evidence synthesis briefly, and then concentrate on the statistical approaches used for conducting network meta-analysis (NMA) in the development and approval of new health technologies. NMA is an extension of standard meta-analysis where indirect as well as direct information is combined and can be seen as similar to the analysis of incomplete-block designs. We illustrate it with an example involving three treatments, using fixed-effects and random-effects models, and using frequentist and Bayesian approaches. As most statisticians in the pharmaceutical industry are familiar with SAS? software for analyzing clinical trials, we provide example code for each of the methods we illustrate. One issue that has been overlooked in the literature is the choice of constraints applied to random effects, and we show how this affects the estimates and standard errors and propose a symmetric set of constraints that is equivalent to most current practice. Finally, we discuss the role of statisticians in planning and carrying out NMAs and the strategy for dealing with important issues such as heterogeneity.     

(Mis)framing Higher Education in South Africa

The question of how to make higher education more inclusive has been a central concern in South Africa and elsewhere over the past two decades. However, in South Africa there remains a disjuncture between policy aimed at promoting inclusivity and the experiences of students and staff in the higher education sector. In this article, the relationship between equity of access and equity of outcomes and the expectations that follow from these policy imperatives are examined from the perspective of Nancy Fraser's normative framework of social justice. In particular, her notion of misframing is used to analyze the current situation in the higher education sector in South Africa. The article concludes that a focus on individual higher education institutions is not sufficient to gain a perspective on the social arrangements required for participatory parity in higher education; and, in fact, such a focus is an instance of misframing and thus a form of injustice.     

Multiplicity: discussion points from the Statisticians in the Pharmaceutical Industry multiplicity expert group

In May 2012, the Committee of Health and Medicinal Products issued a concept paper on the need to review the points to consider document on multiplicity issues in clinical trials. In preparation for the release of the updated guidance document, Statisticians in the Pharmaceutical Industry held a one‐day expert group meeting in January 2013. Topics debated included multiplicity and the drug development process, the usefulness and limitations of newly developed strategies to deal with multiplicity, multiplicity issues arising from interim decisions and multiregional development, and the need for simultaneous confidence intervals (CIs) corresponding to multiple test procedures. A clear message from the meeting was that multiplicity adjustments need to be considered when the intention is to make a formal statement about efficacy or safety based on hypothesis tests. Statisticians have a key role when designing studies to assess what adjustment really means in the context of the research being conducted. More thought during the planning phase needs to be given to multiplicity adjustments for secondary endpoints given these are increasing in importance in differentiating products in the market place. No consensus was reached on the role of simultaneous CIs in the context of superiority trials. It was argued that unadjusted intervals should be employed as the primary purpose of the intervals is estimation, while the purpose of hypothesis testing is to formally establish an effect. The opposing view was that CIs should correspond to the test decision whenever possible. Copyright © 2013 John Wiley & Sons, Ltd.     

But it’s not all about the sex: mothering,normalisation and young learning disabled people

This paper is about mothering, young learning disabled people, their sexualised and relationship lives and normalisation – not through the lens of the disabled person, but via a mothers perspective and theoretical discussion. As a mother who has a learning disabled daughter, a feminist and an academic my own mothering experience, my Ph.D. research and social theory are woven throughout this paper with the intention of opening up debate about sex, intimacy and normalisation, and how these impact upon young learning disabled people. I suggest that the relationship between sex, reproduction, intimacy and intellectual impairment and a project to decipher what it means to be human in all its dirty glory are also part of the discourse that needs to be discussed experientially and theoretically. So much so that the messy world within which we all live can be variously and differently constructed.     

Utility values in health technology assessments: a statistician's perspective

This paper provides an introduction to utilities for statisticians working mainly in clinical research who have not had experience of health technology assessment work. Utility is the numeric valuation applied to a health state based on the preference of being in that state relative to perfect health. Utilities are often combined with survival data in health economic modelling to obtain quality‐adjusted life years. There are several methods available for deriving the preference weights and the health states to which they are applied, and combining them to estimate utilities, and the clinical statistician has valuable skills that can be applied in ensuring the robustness of the trial design, data collection and analyses to obtain and handle this data. In addition to raising awareness of the subject and providing source references, the paper outlines the concepts and approaches around utilities using examples, discusses some of the key issues, and proposes areas where statisticians can collaborate with health economic colleagues to improve the quality of this important element of health technology assessment. Copyright © 2014 John Wiley & Sons, Ltd.     

Drama for Empowerment: the role of Drama in Education with special reference to work in the countries of Central and Eastern Europe

This article deals with the strengths and pitfalls of Drama in Education. I describe two projects that have focused on the empowerment of young people in a civil society and the promotion of intercultural understanding between the countries of Western and Central and Eastern Europe: “Seeding a Network” and “Branching Out”. It is argued that drama is the most inclusive and social of all art forms. Drama in education provides young people with a safe context in which they can tackle major issues, and allows teachers and students alike to radically re‐examine their social and personal relationships. The dangers associated with drama are also discussed.     

Who gives a damn about intellectually disabled people and their families? Care-less spaces personified in the case of LB

On 5 October 2015 the inquest into Connor Sparrowhawk’s death began. A young autistic man, aged 18, died in the bath on 4 July 2013. He had a seizure. The rolling tweets from @LBInquest are harrowing to say the least. Unimaginable torture for Sara and Richard (his mother and step-father), as well as his siblings and others caring. Comments from the inquest such as ‘I felt that Connor should be checked on every 5 or 10 minutes when he was in the bath because of his epilepsy’ and ‘ensuring someone was outside the door when he was bathing was basic nursing care’ sound all the alarm bells for lack of care, because allegedly this did not happen. Clearly there was no one person looking out for him when he needed it the most. On 16 October 2015 the inquest jury found Connor’s death was contributed by neglect. This article will explore the absence of care in a care-less system.