The role of the minimum clinically important difference and its impact on designing a trial

The minimum clinically important difference (MCID) between treatments is recognized as a key concept in the design and interpretation of results from a clinical trial. Yet even assuming such a difference can be derived, it is not necessarily clear how it should be used. In this paper, we consider three possible roles for the MCID. They are: (1) using the MCID to determine the required sample size so that the trial has a pre-specified statistical power to conclude a significant treatment effect when the treatment effect is equal to the MCID; (2) requiring with high probability, the observed treatment effect in a trial, in addition to being statistically significant, to be at least as large as the MCID; (3) demonstrating via hypothesis testing that the effect of the new treatment is at least as large as the MCID. We will examine the implications of the three different possible roles of the MCID on sample size, expectations of a new treatment, and the chance for a successful trial. We also give our opinion on how the MCID should generally be used in the design and interpretation of results from a clinical trial.     

Fitting E(max) models to clinical trial dose-response data

We consider fitting Emax models to the primary endpoint for a parallel group dose–response clinical trial. Such models can be difficult to fit using Maximum Likelihood if the data give little information about the maximum possible response. Consequently, we consider alternative models that can be derived as limiting cases, which can usually be fitted. Furthermore we propose two model selection procedures for choosing between the different models. These model selection procedures are compared with two model selection procedures which have previously been used. In a simulation study we find that the model selection procedure that performs best depends on the underlying true situation. One of the new model selection procedures gives what may be regarded as the most robust of the procedures.     

Dimensions of child neglect: an exploration of parental neglect and its relationship with delinquency

While neglect is generally associated with poor developmental outcomes, it remains poorly defined. Factor analysis was applied to 39 parental behavior variables on data from the Cambridge Study in Delinquent Development (CSDD) to explore underlying dimensions of parental behavior that were consistent with the concept of neglect. Logistic regression assessed associations between the dimensions of neglect recovered from the CSDD and future adult delinquency. Factor analysis revealed four dimensions; logistic regression revealed significant associations between two of these dimensions--poor supervision and a disorganized, chaotic home environment--and future adult delinquency. Neglect is a viable construct that can summarize aspects of parental behavior and predict future adult delinquency.     

Rethinking the changing structures of rural local government – State power,rural politics and local political strategies?

There is a notable absence in contemporary rural studies – of both a theoretical and empirical nature – concerning the changing nature of rural local government. Despite the scale and significance of successive rounds of local government reorganisation in the UK, very little has been written on this topic from a rural perspective. Instead research on local political change has tended to concentrate on local governance and local partnerships – on the extra-governmental aspects of the governance system – rather than on local government itself. In contrast, this paper draws upon strategic-relational state theory to explore the changing structures and institutions of rural local government, and analyse how these can be related to the changing state strategies of those groups which are politically powerful in rural areas. In this respect, the paper draws on current and previous rounds of local government reorganisation to illustrate how new objects of governance, new state strategies and new hegemonic projects are emerging as a consequence of such restructuring processes.     

Retrospective accounts of first exposure to minoritized sexual and gender identities

Although there has been considerable research about attitudes towards LGBTQ+ people, there has been little research into how people first come to be aware of minoritized sexual and gender minority (SGM) identities. This study sought to address this gap. A sample of sexual minority (n = 150) and heterosexual (n = 802) young adults (N = 952; M_age = 18.88 years, SD = 1.75; 949 were cisgender, three were transgender), primarily recruited from a large southern university, were asked retrospectively to recount their first exposure to or awareness of SGM identities. Responses between SGM and heterosexual participants were compared through a variety of analytical approaches, including analyzing themes about the source from which participants first recalled encountering these identities, and whether understanding about these identities came through a personal connection to someone with these identities. SGM participants reported encountering minoritized sexual identities a year earlier than did heterosexual participants, with both groups encountering these concepts in middle childhood, on average. SGM participants were more likely than heterosexual participants to report learning about minoritized gender identities from someone with a minoritized gender identity, while heterosexual participants more often reported learning about these identities from media or celebrities. Heterosexual (vs. SGM) participants were also more likely to imply that minoritized gender identities were adopted to be popular, rather than being authentic identities in themselves. Framed by developmental intergroup theory (DIT), we discuss implications of these findings, especially potential interrelationships with the development of prejudiced attitudes about SGM identities.