Bayes shrinkage estimator for consistency assessment of treatment effects in multi-regional clinical trials

The primary objective of a multi-regional clinical trial is to investigate the overall efficacy of the drug across regions and evaluate the possibility of applying the overall trial result to some specific region. A challenge arises when there is not enough regional sample size. We focus on the problem of evaluating applicability of a drug to a specific region of interest under the criterion of preserving a certain proportion of the overall treatment effect in the region. We propose a variant of James-Stein shrinkage estimator in the empirical Bayes context for the region-specific treatment effect. The estimator has the features of accommodating the between-region variation and finiteness correction of bias. We also propose a truncated version of the proposed shrinkage estimator to further protect risk in the presence of extreme value of regional treatment effect. Based on the proposed estimator, we provide the consistency assessment criterion and sample size calculation for the region of interest. Simulations are conducted to demonstrate the performance of the proposed estimators in comparison with some existing methods. A hypothetical example is presented to illustrate the application of the proposed method.     

The precision of regression-type estimator for incremental cost–effectiveness ratio

The estimation of incremental cost–effectiveness ratio (ICER) has received increasing attention recently. It is expressed in terms of the ratio of the change in costs of a therapeutic intervention to the change in the effects of the intervention. Despite the intuitive interpretation of ICER as an additional cost per additional benefit unit, it is a challenge to estimate the distribution of a ratio of two stochastically dependent distributions. A vast literature regarding the statistical methods of ICER has developed in the past two decades, but none of these methods provide an unbiased estimator. Here, to obtain the unbiased estimator of the cost–effectiveness ratio (CER), the zero intercept of the bivariate normal regression is assumed. In equal sample sizes, the Iman–Conover algorithm is applied to construct the desired variance–covariance matrix of two random bivariate samples, and the estimation then follows the same approach as CER to obtain the unbiased estimator of ICER. The bootstrapping method with the Iman–Conover algorithm is employed for unequal sample sizes. Simulation experiments are conducted to evaluate the proposed method. The regression-type estimator performs overwhelmingly better than the sample mean estimator in terms of mean squared error in all cases.     

Generalizing the standardized hazard ratio to multivariate proportional hazards regression,with an application to clinical~genomic studies

The standardized hazard ratio for univariate proportional hazards regression is generalized as a scalar to multivariate proportional hazards regression. Estimators of the standardized log hazard ratio are developed, with corrections for bias and for regression to the mean in high-dimensional analyses. Tests of point and interval null hypotheses and confidence intervals are constructed. Cohort sampling study designs, commonly used in prospective–retrospective clinical genomic studies, are accommodated.     

Utilizing Bayesian predictive power in clinical trial design

The Bayesian paradigm provides an ideal platform to update uncertainties and carry them over into the future in the presence of data. Bayesian predictive power (BPP) reflects our belief in the eventual success of a clinical trial to meet its goals. In this paper we derive mathematical expressions for the most common types of outcomes, to make the BPP accessible to practitioners, facilitate fast computations in adaptive trial design simulations that use interim futility monitoring, and propose an organized BPP-based phase II-to-phase III design framework.     

Social work and pastoral counseling: Empowering each other

ABSTRACT

This article addresses the divergent outcomes which can result from counseling services offered pastorally versus clinically. As faith leaders often have greater direct access than social workers to supporting religious populations, it is important to explore the intersection between religious pastoral support and clinical social work. Presenting six scenarios from the author’s own experiences as both a rabbi and social worker, this article processes each scenario first through the pastoral lens of an Orthodox rabbi, followed by the clinical lens of a social worker or other mental health professional. The client outcomes which are produced from each modality are radically different. This contrast demonstrates the distinction between the goals, values, and training of each profession, and highlights importance for future work to be done in linking religious and pastoral training to mental health services, as well as broadening the scope of cultural competence for social workers and therapists who may engage with tight-knit religious populations.     

Response‐adaptive designs for binary responses: How to offer patient benefit while being robust to time trends?

Response‐adaptive randomisation (RAR) can considerably improve the chances of a successful treatment outcome for patients in a clinical trial by skewing the allocation probability towards better performing treatments as data accumulates. There is considerable interest in using RAR designs in drug development for rare diseases, where traditional designs are not either feasible or ethically questionable. In this paper, we discuss and address a major criticism levelled at RAR: namely, type I error inflation due to an unknown time trend over the course of the trial. The most common cause of this phenomenon is changes in the characteristics of recruited patients—referred to as patient drift. This is a realistic concern for clinical trials in rare diseases due to their lengthly accrual rate. We compute the type I error inflation as a function of the time trend magnitude to determine in which contexts the problem is most exacerbated. We then assess the ability of different correction methods to preserve type I error in these contexts and their performance in terms of other operating characteristics, including patient benefit and power. We make recommendations as to which correction methods are most suitable in the rare disease context for several RAR rules, differentiating between the 2‐armed and the multi‐armed case. We further propose a RAR design for multi‐armed clinical trials, which is computationally efficient and robust to several time trends considered.     

Enacting reflective and deliberative practices in action research

ABSTRACT

We consider action research as a form of deliberative policy analysis. This analysis explores a “reconstruction clinic” in which stakeholders and public officials engaged memories, hopes and obligations as they sought to resolve controversies over details of policy implementation. We ask how institutional design shaped participants’ reflective and deliberative progress. Reflection in action can prompt not only changes in cognitive frames, but new behavioural capacities for action. Deliberative practices can shape new relationships between parties through the work of apology, recognition, appreciation, and emergent collaboration.     

A Study of Clinical Change in Individual Career Counseling

This study examined the clinical significance of career counseling effects. Participants were 111 university students (83% women) who participated in individual career counseling sessions at their university. All participants completed the French version of the Outcome Questionnaire–30.2 (OQ‐30.2; Lambert, Finch, Okiishi, & Burlingame, 2005) immediately before the 1st session (pretest) and at the beginning of the last session (posttest). The OQ‐30.2 assesses 3 client life domains: subjective discomfort, problems in interpersonal relationships, and problems in social role satisfaction. Using Jacobson and Truax’s (1991) statistical approach to assessing clinical change, the authors compared clients’ pretest OQ‐30.2 scores with their posttest scores. Among clients with a “dysfunctional” score (n = 59) at the study’s inception, 34% recovered and 14% improved, whereas 41% of clients with functional scores (n = 52) at the study’s inception improved. The results suggest that individual career counseling can make a difference in the lives of many clients; they also highlight the importance of further outcome research that accounts for possible variability in clients’ responses to career counseling.     

Integrating self-care into clinical practice with trauma clients

ABSTRACT

Self-care is recognized as an important aspect of social work practice. Beginning in educational settings, developing social workers are encouraged to learn about and practice self-care. However, self-care is typically promoted through strategies and approaches outside of the practice context. Social workers are oftentimes encouraged to use individualized self-care plans, which often feature a variety of relaxation and secondary techniques; focus on self-awareness and self-reflection; and have proper use of supervision. Although these strategies are invaluable, they do little to directly benefit the social worker during direct practice or while in session with a client which is a time period when clinicians are particularly vulnerable to distress or burnout. The importance of real-time self-care strategies is particularly critical for clinicians, especially those who engage in trauma work, given the sensitivity of topics that clients may have endured or benefit from assistance in processing. Further, little information has been published on the use of self-care techniques during a session with a client or in a clinical context. The purpose of the present paper is to discuss self-care strategies that can be useful both outside of and within a clinical setting and present a model of such strategies that focus on integrating self-care in clinical practice particularly for those engaging in trauma work. The paper will conclude by discussing the relevancy of the developed model in practice.     

Dialogical Research in Supervision: Practical Guidelines from Experienced Supervisors in Family Therapy,Child Protection,and Specialty Mental Health Services

This two‐year qualitative participatory research project examines practical guidelines for supervision. Sixteen experienced supervisors across professional settings of family therapy, child protection, and specialty mental health services in the geographical regions of Northern Norway and Northern Sweden outline four main practical guidelines in supervision based on their supervisory practices: (1) elaborating an agreed‐upon contract; (2) exploring potential formats; (3) exploring contents; (4) acknowledging responsibility for process and dilemmas. Participants summarised how they generated mutual growth in supervisory relationships, while being respectful of the first‐person perspective of supervisees. The study challenges pre‐dominating guidelines about deficit‐ or developmental stage‐oriented supervision. It illustrates reflecting processes and a polyphonic orientation in supervision by welcoming diversity, wondering, and tolerance for the not‐yet‐decided among involved persons in a mutual exploration and calibration of relevant knowledge. It outlines a dialogical research for sharing, exploring, and questioning knowledge as beneficial for whom, told by whom, and evaluated by whom.