Research ethics and clinical trials: Fostering collaboration with research participants

Accountability in research is a concept that applies to researchers and study participants alike. Human subjects play an active part in the success or failure of a clinical trial by virtue of their understanding of a study's goals expectations of personal gain, and adherence to study design. Trials must be designed to address patient concerns, offer an improved consent process, and move beyond our narrow conception of “patient rights.”; Problems with protocol adherence may be reduced by conceptualizing clinical research as an endeavor with mutual accountability within a relational ethic.     

Family systems functioning,family health roles,and utilization of physical health services

The purpose of the study reported here is to determine the relationship between family systems functioning, family health role, and family utilization of health services. The research is based in the Circumplex Model of Marital and Family Systems (Olson, Sprenkle, & Russel, 1979). Family functioning variables include family level of cohesion, family adaptability, and family type, as measured by FACES II. Family health role (i.e., leadership role and acceptance of sick role) and utilization of health services are measured by scales of the investigator-developed Family Health Questionnaire. The sample consists of 140 parents of 70 families, composed of two parents with children under 25 years of age living at home. Analysis reveals significant relationships between the family level of adaptability and acceptance of the sick role, in conjunction with significant gender and gender interaction effects. There are no significant differences between family cohesion levels or family typologies with the health variables.Su An Arnn Phipps is an Assistant Professor at the University of Oklahoma College of Nursing Graduate Program, Tulsa, 700 N. Greenwood, Tulsa, OK 74106. Her research interests include family systems functioning and family physical health, couples' infertility experience, and fathers' role(s) in family health. She received her Ph.D. from Oklahoma State University in Family Relations and Child Development.     

Functional Neurological Symptom Disorder (Conversion Disorder) from an Interactional Approach: A Composite Case Study

Functional neurological symptom disorder, alternatively termed conversion disorder (FNSD-CD) (Although the DSM-5 utilises the term 'conversion disorder', practitioners and consumers consider this to be an outdated, unsubstantiated and often stigmatising term. In accordance with this, the current terminology used in the field is 'functional neurological symptom disorder'), involves symptoms of altered voluntary motor or sensory functions without identifiable nervous system disease or pathology. It is considered a psychiatric disorder and is, thus, listed in the Diagnostic and Statistical Manual of Mental Disorders (5th Ed.; DSM-5). As per the nosology of the DSM-5, the discrete behavioural or psychological syndrome or pattern observed in FNSD-CD is assumed to be a function of a problem of, or a disorder within, the individual. Accordingly, the psychiatric approach to FNSD-CD, as set out in the DSM-5, invokes an assumption common to the medical model which is that of lineal (i.e., straight-line) causality, namely, causal events are arranged in a lineal sequence. The interactional approach, however, which is a development of general system theory in the field of family therapy, offers an alternative approach to understanding psychiatric disorders. Specifically, this approach places the emphasis on the relationships between individuals and their reciprocal influences on – including their psychological and emotional wellbeing with – one another. It draws on the assumption of nonlineal (i.e., circular) causality, namely, causal events are arranged in a circular sequence. From an interactional approach, therefore, FNSD-CD is thought to be a function of a problem of, or a deficit within, the individuals’ relationship/s, rather than within an individual, per se. This article utilises a composite case study to investigate FNSD-CD from an interactional approach.     

Under the skin: Exploring 2-month-olds' thermal reactions in different social interactions with mother and stranger

Physiological adaptations to external stressors can reveal socio-cognitive health in infancy. With the use of thermal imaging and behavioural analyses, the current study examined the arousal markers accompanying infants’ interactions with a familiar and an unfamiliar person. To address the current research question, the mother and a complete stranger interacted with 2 to 3 month-old infants (N= 10, 2 boys)in three different conditions: Neutral, Play, and Compliment. Behavioral analyses showed that overall gaze was longer to the Stranger compared to the Mother independent of condition. Physiological findings showed that skin temperature was significantly higher with the stranger independent of condition. The regions of the face that passed the significance threshold included the maxillary area, the nose, and the forehead. Both behavioral and physiological findings emphasize the ability of the infant to distinguish between a familiar and an unfamiliar person. Most importantly, however thermal imaging has proven to be a promising tool in physiologically differentiating between variable social conditions in very young infants opening up a new experimental portal for identifying healthy physiological development.     

Corporate governance and the market reaction to stock repurchase announcement

This paper investigates the effect of corporate governance on market reaction around of a stock repurchase announcement. We argue that corporate governance affects the ability of a stock repurchase to alleviate agency costs related to free cash flows, and the credibility of the undervaluation signal sent by the announcement of buyback programs. We find a higher 3-day cumulative abnormal return to programs announced by firms with better corporate governance practices than those with bad governance (1.6% and 0.85% respectively), and the market reaction is significantly higher following the successive scandals in year 2001 (Enron, Arthur Anderson, WorldCom??) and the resulting Sarbanes?COxley Act of 2002. Further investigations indicate that firms with a lower Free Cash Flow to Asset ratio have a higher market reaction, which is consistent with the information signaling hypothesis, and this is more significant in firms with good governance practices, and following post Sarbanes?COxley Act.     

From waterfall plots to spaghetti plots in early oncology clinical development

Waterfall plots are used to describe changes in tumor size observed in clinical studies. They are frequently used to illustrate the overall drug response in oncology clinical trials because of its simple representation of results. Unfortunately, this visual display suffers a number of limitations including (1) potential misguidance by masking the time dynamics of tumor size, (2) ambiguous labelling of the y‐axis, and (3) low data‐to‐ink ratio. We offer some alternatives to address these shortcomings and recommend moving away from waterfall plots to the benefit of plots showing the individual time profiles of sum of lesion diameters (according to RECIST). The spider plot presents the individual changes in tumor measurements over time relative to baseline tumor burden. Baseline tumor size is a well‐known confounding factor of drug effect which has to be accounted for when analyzing data in early clinical trials. While spider plots are conveniently correct for baseline tumor size, they cannot be presented in isolation. Indeed, percentage change from baseline has suboptimal statistical properties (including skewed distribution) and can be overly optimistic in favor of drug efficacy. We argued that plots of raw data (referred to as spaghetti plots) should always accompany spider plots to provide an equipoised illustration of the drug effect on lesion diameters.     

Women and homelessness,a complex multidimensional issue: findings from a scoping review

Homelessness is an increasingly prevalent issue worldwide. Women represent the fastest growing segment of the homeless population and have differing needs to men. These differences need to be considered by service providers and other stakeholders working with homeless women. A scoping review was conducted to address the question “What is known about issues relating to homeless women in the existing literature?” PubMed, PsycInfo, Embase, CINAHL, Scopus and Web of Science were searched up until March 2018 with no date limits. The final sample of articles included in this scoping study was 232 from which six themes were extracted: (1) pathways into homelessness, (2) trauma, victimization and adverse childhood experiences, (3) mental and physical health issues, (4) barriers to accessing treatment and experiences with service providers, (5) social support and life satisfaction and (6) strengths, hopes and leaving homelessness. This review suggests a strengths-based approach to addressing women’s homelessness. This approach emphasizes people’s self-determination and strengths and views clients as resilient to problems they encounter in their lives. Future research and service provision should take into account the complexities in the lives of homeless women and recognize the autonomy of women to move out of homelessness.