Prediction of accrual closure date in multi-center clinical trials with discrete-time Poisson process models

In a phase III multi‐center cancer clinical trial or a large public health study, sample size is predetermined to achieve desired power, and study participants are enrolled from tens or hundreds of participating institutions. As the accrual is closing to the target size, the coordinating data center needs to project the accrual closure date on the basis of the observed accrual pattern and notify the participating sites several weeks in advance. In the past, projections were simply based on some crude assessment, and conservative measures were incorporated in order to achieve the target accrual size. This approach often resulted in excessive accrual size and subsequently unnecessary financial burden on the study sponsors. Here we proposed a discrete‐time Poisson process‐based method to estimate the accrual rate at time of projection and subsequently the trial closure date. To ensure that target size would be reached with high confidence, we also proposed a conservative method for the closure date projection. The proposed method was illustrated through the analysis of the accrual data of the National Surgical Adjuvant Breast and Bowel Project trial B‐38. The results showed that application of the proposed method could help to save considerable amount of expenditure in patient management without compromising the accrual goal in multi‐center clinical trials. Copyright © 2012 John Wiley & Sons, Ltd.     

Testing bioequivalence for multiple formulations with power and sample size calculations

Bioequivalence (BE) trials play an important role in drug development for demonstrating the BE between test and reference formulations. The key statistical analysis for BE trials is the use of two one‐sided tests (TOST), which is equivalent to showing that the 90% confidence interval of the relative bioavailability is within a given range. Power and sample size calculations for the comparison between one test formulation and the reference formulation has been intensively investigated, and tables and software are available for practical use. From a statistical and logistical perspective, it might be more efficient to test more than one formulation in a single trial. However, approaches for controlling the overall type I error may be required. We propose a method called multiplicity‐adjusted TOST (MATOST) combining multiple comparison adjustment approaches, such as Hochberg's or Dunnett's method, with TOST. Because power and sample size calculations become more complex and are difficult to solve analytically, efficient simulation‐based procedures for this purpose have been developed and implemented in an R package. Some numerical results for a range of scenarios are presented in the paper. We show that given the same overall type I error and power, a BE crossover trial designed to test multiple formulations simultaneously only requires a small increase in the total sample size compared with a simple 2 × 2 crossover design evaluating only one test formulation. Hence, we conclude that testing multiple formulations in a single study is generally an efficient approach. The R package MATOST is available at https://sites.google.com/site/matostbe/ . Copyright © 2012 John Wiley & Sons, Ltd.     

Seven useful designs

When designing a clinical trial there is a need to design a study that achieves the objectives of a trial both efficiently and with minimum resources. This paper describes seven trial designs that could possibly be used in clinical development and highlights how a design although not optimal for an individual study may be optimal for a wider clinical program.     

White Privilege and Clinical Social Work Practice: Reflections and Recommendations

This exploratory study examined how seasoned White social workers grappled with the presence and effects of White privilege on their clinical practice. Data were collected in focus groups; findings were surfaced through thematic analysis. Five themes emerged: the role of engaging in continuous self-awareness in clinical practice; the complexity of using intersectionality to inform our work; the necessity of addressing White privilege in clinical conversations; the importance of creating strategies for use of power; and the process of engaging in life-long growth. These workers demonstrated awareness of, and accountability for, White privilege. Implications for progressive social work practice are discussed.     

临床医生自我和谐现状及影响因素探究

采用自我和谐量表、临床医生工作压力源问卷和中文版医患关系问卷,调查了湖南省22所医院的363名临床医生。结果表明,临床医生在自我和谐量表各维度的得分均低于常模(P<0.01),其自我和谐现状不容乐观,且在年龄、性别、学历、职称、医院级别等人口学变量上存在差异(P<0.05);临床医生的工作压力源及医患关系均与自我和谐水平有高相关(P<0.001)。文章从工作压力和医患关系两角度探讨了影响临床医生自我和谐的主要因素。     

留学生临床实习质量保障体系的研究与实践

通过总结南京医科大学历年留学生实习管理经验,对刚刚完成实习的2007级来华留学生进行问卷调查,了解实习准入制度、实习带教方法和实习前强化培训等方面存在的问题,以此为基础,探讨适合学校实际情况的临床实习质量保障体系.     

How Psychological Telehealth Can Alleviate Society's Mental Health Burden: A Literature Review

Mental health professionals must establish new means to reach those in need that face obstacles related to geographical location, time limitations, and health. With the high incidence of mental illness, as well as the hypothesized increase in coming years, telehealth modalities propose a novel and far-reaching alternative to traditional therapy. This article outlines the positive aspects and interdisciplinary possibilities when telehealth is incorporated into mental health practice. Novel outlets including mHealth and the utilization of computer tablets as mental health facilitators are outlined. Considerations for practice including training are discussed, as well as potential future directions for the field. Available data supports telehealth as an effective mode for the treatment of clients who are unable to pursue mental health services in their current form. However, careful consideration and training for the mental health professional is needed if telehealth is to be effectively used to alleviate the mental health burden.     

Literary clinical practice: desire,depression and toxic masculinity in Hamlet

ABSTRACT

This essay introduces the notion of a literary clinical practice for which it remains essential to continue to consider those texts that open up a place for a readership, or audience, or even a civilization to consider the endlessly generative failure of its literature to write mental health. Concerned with mental illness that is an effect of language on the subject, the body, and of the enigma of the truth as cause, psychoanalysis is the crucial interlocutor for any literary clinical concern with the maladies of literature and society. In order to re-assess the utility of Shakespeare’s Hamlet to contemporary problems such as depression – perhaps the dominant symptom of our time – this essay attempts a reconsideration of Jacques Lacan’s famous seminar on Hamlet from the perspective of the contemporary clinic of the Lacanian orientation in psychoanalysis led by Jacques-Alain Miller.     

Development and Utilization of a Practice-Based,Adolescent Intake Questionnaire (Adquest)

Summary

This article describes an intake questionnaire (Adquest) that was designed, tested, and implemented, and later employed in clinical data-mining studies, by practitioners in an adolescent mental health program. The instrument is primarily a practice-based, clinical information-gathering and client engagement device. Consequently, it differs in significant ways from more research-driven Rapid Assessment Instruments (RAIs). Despite these differences, when aggregated and analyzed, Adquest data provides valuable psychosocial information about hundreds of vulnerable urban youth seeking mental health services.