A meta-analytic framework to adjust for bias in external control studies

While randomized controlled trials (RCTs) are the gold standard for estimating treatment effects in medical research, there is increasing use of and interest in using real-world data for drug development. One such use case is the construction of external control arms for evaluation of efficacy in single-arm trials, particularly in cases where randomization is either infeasible or unethical. However, it is well known that treated patients in non-randomized studies may not be comparable to control patients—on either measured or unmeasured variables—and that the underlying population differences between the two groups may result in biased treatment effect estimates as well as increased variability in estimation. To address these challenges for analyses of time-to-event outcomes, we developed a meta-analytic framework that uses historical reference studies to adjust a log hazard ratio estimate in a new external control study for its additional bias and variability. The set of historical studies is formed by constructing external control arms for historical RCTs, and a meta-analysis compares the trial controls to the external control arms. Importantly, a prospective external control study can be performed independently of the meta-analysis using standard causal inference techniques for observational data. We illustrate our approach with a simulation study and an empirical example based on reference studies for advanced non-small cell lung cancer. In our empirical analysis, external control patients had lower survival than trial controls (hazard ratio: 0.907), but our methodology is able to correct for this bias. An implementation of our approach is available in the R package ecmeta .     

Semi-parametric estimation of ROC curves based on binomial regression modelling

This paper presents a method of estimating a receiver operating characteristic (ROC) curve when the underlying diagnostic variable X is continuous and fully observed. The new method is based on modelling the probability of response given X , rather than the distribution of X given response. The method offers advantages in modelling flexibility and computational simplicity. The resulting ROC curve estimates are semi-parametric and can, in principle, take an infinite variety of shapes. Moreover, model selection can be based on standard methods within the binomial regression framework. Statistical accuracy of the curve estimate is provided by a simply implemented bootstrap approach.     

How many Australians have slept rough?

How many Australians have experienced homelessness during their lifetime and how many people have slept rough? This paper draws on evidence from a random sample of the Australian population to answer these questions (N=1349). First, we explain the methodology for the research. Then we focus on the number of people who have experienced homelessness and the different experiences of men and women. Next, we investigate how many people have slept rough. We conclude that about 2.35 million people have experienced homelessness during their lifetime, and that 59 per cent of them (about 1.4 million people) have slept rough.     

Can a Self-Regulation Skills and Cultural Arts Program Promote Positive Outcomes in Mental Health Symptoms and Academic Achievement for At-Risk Youth?

ABSTRACT

Self-regulation skills programs focusing on emotional regulation and executive functioning and arts programs have separately demonstrated reductions in internalizing and externalizing disorders and academic difficulties and have shown improvement in self-regulation skills. This study sought to evaluate participants in Prodigy (a program synthesizing arts and self-regulation skills) regarding changes in mental health symptoms and academic performance. A quasi-experimental pretest–posttest was conducted with 108 at-risk adolescents and their parents. Significant reductions in internalizing and externalizing mental health symptoms and increases in academic self-efficacy with positive trends in improved academic achievement were noted. Future research regarding the potential of these two modalities is discussed.     

Telling a Good Story: Using Narratives in Vocational Rehabilitation With Veterans

Because of the high chronicity of work-related problems in a Veterans Administration Medical Center population, many of the traditional methods of career assessment, counseling, and placement have proven ineffectual. In this article the authors detail the development of an intervention based on narrative or storytelling principles. They describe efforts to introduce this model to patients as well as to relate patients' stories to vocational outcomes. The usefulness of stories as an organizing principle for counselors and clients is discussed, and suggestions are offered for further uses of storytelling interventions.     

Access to justice for Aboriginal People in the Northern Territory

This article discusses research in the Northern Territory on Aboriginal civil and family law needs. It is based on focus group discussions and interviews with legal services providers and other associated organisations. The article argues that key areas of legal need involve discrimination, housing, child protection, social security, credit/debt and consumer law problems. It further argues that welfare conditionality, particularly as embodied in the NT Intervention and subsequent Stronger Futures policies, has exacerbated the need for legal assistance and advocacy for Aboriginal people.     

Voices From the Front Line: State Social Workers and New Labour

Summary The article explores the condition of state social work in Englandtoday. It is based on interviews with experienced social workersemployed by local authority social services departments acrossthe north of England. These front line state social workersprovide a penetrating insight into the diverse ways in whichtheir work has been transformed and degraded and the mannerin which the needs of clients have been largely ignored. Fromtheir perspective, the election of a Labour government in 1997proved to be a massive disappointment and many social workersreported that it has further undermined state social work practice,workers and clients. The paper seeks to offer an explanationby noting the neo-liberalism of Labour's social policy and thedire consequences which flow from New Labour's fixation withwaged work as the principal solution to social exclusion andpoverty. Above all, it seeks to provide an opportunity for theviews of front-line state social workers to be heard.