Notes on testing carry-over effects in continuous data under an incomplete block crossover design

We consider hypothesis testing and estimation of carry-over effects in continuous data under an incomplete block crossover design when comparing two experimental treatments with a placebo. We develop procedures for testing differential carry-over effects based on the weighted-least-squares (WLS) method. We apply Monte Carlo simulations to evaluate the performance of these test procedures in a variety of situations. We use the data regarding the forced expiratory volume in one second (FEV₁) readings taken from a double-blind crossover trial comparing two different doses of formoterol with a placebo to illustrate the use of test procedures proposed here.     

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.     

Predictive Hierarchic Modeling of Operational Characteristics in Clinical Trials

An analytic methodology for patient enrollment modeling using a Poisson-gamma model is developed by Anisimov & Fedorov (2005–2007). For modeling hierarchic processes associated with enrollment, a new methodology using evolving stochastic processes is proposed. This provides rather general and unified framework to describe various operational processes associated with enrollment. The technique for calculating predictive distributions, mean, and credibility bounds for evolving processes is developed. Some applications to modeling operational characteristics in clinical trials are considered with focus to modeling events associated with incoming and follow-up patients in different settings. For these models, predictive characteristics are derived in a closed form.     

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.     

Adaptive designs for single‐arm phase II trials in oncology

Clinical phase II trials in oncology are conducted to determine whether the activity of a new anticancer treatment is promising enough to merit further investigation. Two‐stage designs are commonly used for this situation to allow for early termination. Designs proposed in the literature so far have the common drawback that the sample sizes for the two stages have to be specified in the protocol and have to be adhered to strictly during the course of the trial. As a consequence, designs that allow a higher extent of flexibility are desirable. In this article, we propose a new adaptive method that allows an arbitrary modification of the sample size of the second stage using the results of the interim analysis or external information while controlling the type I error rate. If the sample size is not changed during the trial, the proposed design shows very similar characteristics to the optimal two‐stage design proposed by Chang et al. (Biometrics 1987; 43:865–874). However, the new design allows the use of mid‐course information for the planning of the second stage, thus meeting practical requirements when performing clinical phase II trials in oncology. Copyright © 2012 John Wiley & Sons, Ltd.     

A simulation study of methods for selecting subgroup‐specific doses in phase 1 trials

Patient heterogeneity may complicate dose‐finding in phase 1 clinical trials if the dose‐toxicity curves differ between subgroups. Conducting separate trials within subgroups may lead to infeasibly small sample sizes in subgroups having low prevalence. Alternatively,it is not obvious how to conduct a single trial while accounting for heterogeneity. To address this problem,we consider a generalization of the continual reassessment method on the basis of a hierarchical Bayesian dose‐toxicity model that borrows strength between subgroups under the assumption that the subgroups are exchangeable. We evaluate a design using this model that includes subgroup‐specific dose selection and safety rules. A simulation study is presented that includes comparison of this method to 3 alternative approaches,on the basis of nonhierarchical models,that make different types of assumptions about within‐subgroup dose‐toxicity curves. The simulations show that the hierarchical model‐based method is recommended in settings where the dose‐toxicity curves are exchangeable between subgroups. We present practical guidelines for application and provide computer programs for trial simulation and conduct.