Pragmatic clinical trials for localized prostate cancer: lessons learned and “three sins”

In “Explanatory and Pragmatic Attitudes in Therapeutic Trials”, Schwatrz and Lelouch describe two approaches to the design of trials, “… the first “explanatory”, the second “pragmatic”. They explained “… the biologist may be interested to know whether the drugs differ in their effects … the explanatory approach”. Biologically endpoints might determine whether it was better to give androgen deprivation therapy (ADT) before or after external beam radiation (EBRT) (i.e., does the sequence of treatments matter). Alternatively, if the arms focus on a clinical endpoint, this is considered … “the pragmatic approach”. An example of a clinically relevant endpoint is overall survival (OS). A real-world example of this are the two randomized controlled trials (RCTs) evaluating the role of prophylactic whole pelvic radiotherapy (WPRT) conducted by the Radiation Therapy Oncology Group (RTOG). RTOG 9413 evaluated possible interactions between the sequence of drugs and volume irradiated, while RTOG/NRG 0924 focuses on OS. There appears to be a common pattern of “what not to do”, or “design errors” made by a number of investigators, that I call the “three sins”. I posit that the prospects for a well-designed pragmatic RCT are likely to be high if these “three sins” are avoided/minimized. The “three sins” alluded to are: 1. You can’t prove something doesn’t work by treating people who don’t need the treatment. 2. You can’t prove something does not work if the treatment is not done properly. 3. You can’t prove something does not work with an underpowered study

The relationship between sociology and cognate disciplines: law

This paper considers the relationship between sociology and law, as a cognate discipline, through a discussion of social research into legal processes and settings, sometimes referred to as empirical socio-legal research. It first addresses the different meanings of research for social scientists and for lawyers, then investigates some particular challenges for cross/inter/multidisciplinary socio-legal research, and identifies the growing demands for empirical analyses of law and legal processes

The Emotional Dimension of Judging: Issues, Evidence, and Insights

Judicial emotions—their display in the courtroom, influence on judicial behavior, and ultimately, their impact on public trust in the judiciary—are under scrutiny as neuro-scientists and social scientists take a fresh look at judicial work and conduct. Emotions and their regulation raise important issues for the exercise of judicial authority, a role in which emotion is formally excised.1 What has been called “emotional labor” is one of several key concepts guiding empirical research and offering insights into how judges undertake their work.2 Other related or overlapping concepts include implicit bias, mindfulness, and procedural fairness. Judges have been introduced to these concepts and associated research through several articles published in the journal Court Review over recent years.3 One of these articles, an American Judges Association white paper titled “Minding the Court: Enhancing the Decision-Making Process,” highlights the degree to which these scientific insights are interrelated in their implications for judicial work.4 For example, consideration of these concepts and research initiatives has implications for judicial performance and the conduct of evaluations.

Hypofractionated SBRT versus conventionally fractionated EBRT for prostate cancer: comparison of PSA slope and nadir.

BackgroundPatients with early stage prostate cancer have a variety of curative radiotherapy options, including conventionally-fractionated external beam radiotherapy (CF-EBRT) and hypofractionated stereotactic body radiotherapy (SBRT). Although results of CF-EBRT are well known, the use of SBRT for prostate cancer is a more recent development, and long-term follow-up is not yet available. However, rapid post-treatment PSA decline and low PSA nadir have been linked to improved clinical outcomes. The purpose of this study was to compare the PSA kinetics between CF-EBRT and SBRT in newly diagnosed localized prostate cancer.Materials/methods75 patients with low to low-intermediate risk prostate cancer (T1-T2; GS 3 + 3, PSA < 20 or 3 + 4, PSA < 15) treated without hormones with CF-EBRT (>70.2 Gy, <76 Gy) to the prostate only, were identified from a prospectively collected cohort of patients treated at the University of California, San Francisco (1997-2012). Patients were excluded if they failed therapy by the Phoenix definition or had less than 1 year of follow-up or <3 PSAs. 43 patients who were treated with SBRT to the prostate to 38 Gy in 4 daily fractions also met the same criteria. PSA nadir and rate of change in PSA over time (slope) were calculated from the completion of RT to 1, 2 and 3 years post-RT.ResultsThe median PSA nadir and slope for CF-EBRT was 1.00, 0.72 and 0.60 ng/ml and -0.09, -0.04, -0.02 ng/ml/month, respectively, for durations of 1, 2 and 3 years post RT. Similarly, for SBRT, the median PSA nadirs and slopes were 0.70, 0.40, 0.24 ng and -0.09, -0.06, -0.05 ng/ml/month, respectively. The PSA slope for SBRT was greater than CF-EBRT (p < 0.05) at 2 and 3 years following RT, although similar during the first year. Similarly, PSA nadir was significantly lower for SBRT when compared to EBRT for years 2 and 3 (p < 0.005).ConclusionPatients treated with SBRT experienced a lower PSA nadir and greater rate of decline in PSA 2 and 3 years following completion of RT than with CF-EBRT, consistent with delivery of a higher bioequivalent dose. Although follow-up for SBRT is limited, the improved PSA kinetics over CF-EBRT are promising for improved biochemical control

Caseload Allocation and Special Judicial Skills: Finding the \u27Right Judge\u27

Australian courts, as with those in most common law systems, value judicial officers who are generalists. Appointment to a court indicates that the appointee is capable of dealing impartially with all types of cases that come before it. However, caseload allocation processes within courts also recognize and value different skills or expertise that may be applied to particular types of cases or to particular judicial tasks. Our research investigates ways magistrates courts in Australia (first instance courts of general criminal and civil jurisdiction) manage caseload allocation processes to match magistrates’ skills and abilities to specific work demands within their general jurisdictions as well as to the demands of specialist lists and courts. The research draws on interview data collected from judicial officers and court staff involved in caseload allocation in four Australian jurisdictions. This research finds that these courts place a high value on the principle that ‘everyone should be able to do everything’ and the entitlement of individual judicial officers to a caseload that is balanced and fair in relation to their colleagues. However, this preference for generalist judicial officers can create tensions in relation to the need to staff specialist lists, and to sometimes use particular skills in the general lists. Despite the presumption of competence, those allocating generalist and specialist caseload take into account different skills and expertise in the judicial workforce in the allocation decisions. Preferences of judicial officers for particular types of work can also play a role. However, the process by which assessments are made about expertise is also less than transparent in many cases, and draws largely on informal sources of knowledge. Magistrates and court users may benefit from a more clearly defined and transparent process to identify and develop skills and expertise, and allocate caseload accordingly. Such a process must preserve the flexibility that these high-volume courts need to deal with their caseload efficiently and appropriately and to match judicial skills to the needs of particular types of cases

Judging and Emotion Work: Discipline Processes as Guidance

What constitutes good judging has long been a matter of discussion.1 Models of good judging contain norms about judicial demeanor and emotion, especially in court, though typically not expressed in those terms.2 The conventional model of the impartial judge characterises emotion as incompatible with, and potentially undermining, impartiality and so threatening the legitimacy of judicial authority and the rule of law.3 However, judicial work necessarily engages a wide range of emotions and requires considerable emotion capacities, which can (appear to) conflict with this expectation of dispassionate, impersonal, and detached judging.4 Performing judicial authority can entail considerable emotion work5 on the part of the judicial officer, managing the judicial officer’s own felt and displayed emotion, as well as those of other courtroom participants.

Observing judicial work and emotions: using two researchers

Author version made available in accordance with publisher policy.Observation is an important component of research to examine complex social settings and is well-established for studying courtroom dynamics and judicial behaviour. However, the many activities occurring at once and the multiple participants, lay and professional, make it impossible for a sole researcher to observe and understand everything occurring in the courtroom. This article reports on the use of two researchers to undertake court observations, in two different studies, each nested in a different research design. The social nature of data collection and the value of dialogue between the two researchers in interpreting observed events, especially when studying emotion, are readily apparent in both studiesFunding for the Australian research includes: a 2001 University–Industry Research Collaborative Grant with Flinders University and the Association of Australian Magistrates (AAM) and financial support from the Australasian Institute of Judicial Administration (AIJA); an Australian Research Council (ARC) Linkage Project Grant (LP0210306) with AAM and all magistrates courts; and two ARC Discovery Project Grants (DP0665198, DP1096888). The Swedish Research is funded by the Swedish Research Council (2011-1553) and the Swedish Research Council for Health, Working Life and Welfare (2011-0671)

Locating the Judge within Sentencing Research

Research into sentencing is undertaken from a range of theoretical, disciplinary and methodological perspectives. Each approach offers valuable insights, including a conception of the judge, sometimes explicit, often implicit. Little scholarly attention has been paid to directly interrogating the ways in which different research traditions construct the judge in the sentencing process. By investigating how different research approaches locate the judge as an actor in sentencing, theoretically and empirically, this article addresses that gap. It considers key examples of socio-legal scholarship which emphasise the judge as operating within experiential, emotional and social, as well as legal dimensions. This growing body of research offers a more social, relational and interactive understanding of the judge in sentencing, extending and complementing the valuable, but necessarily limited, insights of other research approaches about the place of the judge in sentencing

Feminist Judging in Lower Courts

Much of the literature on feminist judging concentrates on judges and judging in appellate and superior courts. This article extends that literature by investigating whether and how feminist judging manifests in lower courts, which deal with the vast bulk of criminal offences and civil claims. It does so through analysis of transcripts of non-trial criminal proceedings in Australian magistrates courts, focusing on judicial practices rather than gender or other known characteristics of the magistrates. Clear instances of feminist judging are relatively rare. Where they occur, they are often in the form of isolated feminist ‘moments’ rather than a magistrate exhibiting a distinct feminist orientation. The article reflects on what these finding suggest about the nature of judging in lower courts and the possibilities for feminist judging in that context

Locating the Judge within Sentencing Research

Research into sentencing is undertaken from a range of theoretical, disciplinary and methodological perspectives. Each approach offers valuable insights, including a conception of the judge, sometimes explicit, often implicit. Little scholarly attention has been paid to directly interrogating the ways in which different research traditions construct the judge in the sentencing process. By investigating how different research approaches locate the judge as an actor in sentencing, theoretically and empirically, this article addresses that gap. It considers key examples of socio-legal scholarship which emphasise the judge as operating within experiential, emotional and social, as well as legal dimensions. This growing body of research offers a more social, relational and interactive understanding of the judge in sentencing, extending and complementing the valuable, but necessarily limited, insights of other research approaches about the place of the judge in sentencing