Accidental Communities: Race,Emergency Medicine,and the Problem of PolyHeme®

This article focuses on emergency medical care in black urban populations, suggesting that the classification of a “community” within clinical trial language is problematic. The article references a cultural history of black Americans with pre-hospital emergency medical treatment as relevant to contemporary emergency medicine paradigms. Part I explores a relationship between “autonomy” and “community.” The idea of community emerges as a displacement for the ethical principle of autonomy precisely at the moment that institutionalized medicine focuses on diversity. Part II examines a clinical trial for the blood substitute PolyHeme^® (Northfield Laboratories, Inc., Evanston, IL). It illustrates the ways in which bias in research paradigms and Institutional Review Board decisions attach to the notion and utility of the language of “community.” The conclusion's contemporary anecdote makes apparent the vitality of the issues of prehospital emergency medical care and the ways in which decisions and practices fall too easily into a narrative of culturally biased treatment.     

An open letter to institutional review boards considering Northfield Laboratories' PolyHeme trial

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme and saline in the field and, still without consent, randomized between PolyHeme and blood after arrival at an emergency department. The Federal regulations that govern the waiver of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood-the standard treatment for hemorrhagic shock-is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards.     

An open letter to institutional review boards considering Northfield Laboratories' PolyHeme® trial

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme?, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme? and saline in the field and, still without consent, randomized between PolyHeme? and blood after arrival at an emergency department. The Federal regulations that govern the waiver of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood-the standard treatment for hemorrhagic shock-is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards.     

Getting the ethics right regarding research in the emergency setting: lessons from the PolyHeme study

Research in emergency settings (RES) has become a major public issue with urgent policy implications. Significant attention has focused recently on RES in response to the trial of PolyHeme, a synthetic blood substitute, in trauma victims in hemorrhagic shock. Unfortunately, the discussion of the PolyHeme trial in the popular and scholarly press leaves important questions unanswered. This paper articulates three important lessons from the PolyHeme trial that have significant policy implications. First, the RES regulations should be re-visited, particularly the requirement that existing treatments be unproven or unsatisfactory in order for research to be acceptable without consent. Second, further conceptual and empirical scholarship is needed to accomplish the goal of effectively involving communities. Third, a more subtle analysis is needed regarding how to balance the needs of maintaining public trust and protecting confidential trade information in the context of RES.     

Altruistic Discourse in the Informed Consent Process for Childhood Cancer Clinical Trials

Scholars have debated the role that altruistic considerations play—and should play—in recruitment and decision-making processes for clinical trials. Little empirical data are available to support their various perspectives. We analyzed 140 audiotaped pediatric informed consent sessions, of which 95 (68%) included at least one discussion of how participation in a cancer clinical trial might benefit: 1) the pursuit of scientific knowledge generally; 2) other children with cancer specifically; and 3) “the future” and other vaguely defined recipients. Clinicians initiated most (80%) of these discussions of altruism. The enrollment rate of children in the clinical trial was high (83%) overall, but not higher among children whose parents were involved in an altruism-oriented discussion. These findings suggest that: (1) clinicians invoke a spectrum of altruistic considerations rather than a single monothematic notion of altruism, and (2) the effect of altruistic considerations on subsequent enrollment decisions is marginal. While further research on this topic is warranted, bioethical debate should strive to reflect the diversity of altruistic discourse in clinical research encounters and to place this discourse in the context of other, including nonaltruistic, considerations.     

Emotion Beliefs and Cognitive Behavioural Therapy for Social Anxiety Disorder

Despite strong support for the efficacy of cognitive behavioural therapy (CBT) for social anxiety disorder (SAD), little is known about mechanisms of change in treatment. Within the context of a randomized controlled trial of CBT, this study examined patients' beliefs about the fixed versus malleable nature of anxiety—their ‘implicit theories’—as a key variable in CBT for SAD. Compared to waitlist (n = 29; 58% female), CBT (n = 24; 52% female) led to significantly lower levels of fixed beliefs about anxiety (M_baseline = 11.70 vs. M_Post = 7.08, d = 1.27). These implicit beliefs indirectly explained CBT-related changes in social anxiety symptoms (κ² = .28, [95% CI = 0.12, 0.46]). Implicit beliefs also uniquely predicted treatment outcomes when controlling for baseline social anxiety and other kinds of maladaptive beliefs (perceived social costs, perceived social self-efficacy, and maladaptive interpersonal beliefs). Finally, implicit beliefs continued to predict social anxiety symptoms at 12 months post-treatment. These findings suggest that changes in patients' beliefs about their emotions may play an important role in CBT for SAD.     

The intricacies of verbalizations,gestures, and game outcome using sequential analysis

ObjectivesThe purpose of the present study was to identify the intricacies of verbalizations, gestures, and game outcome during competition.DesignThe behavioral research software Observer XT^® using sequential analysis was used to analyze our data.MethodParticipants were 34 junior tennis players with a mean age of 13.68 (SD = 1.8). Youth players were observed during 17 matches using the Self-Talk and Gestures Rating Scale and were examined by a built-in application (Observer XT^®) of mapping of verbalizations, gestures, and performance.ResultsSequences indicated negative verbalizations were the most frequently exhibited form of overt verbalizations, followed by positive and instructional verbalizations. Furthermore negative verbalizations for either the server or the receiver decreased the probability of winning a game and showed verbalizations from the server related to the receiver's verbalizations and game outcome, and vice versa.ConclusionsThe results shed light on how verbalizations and gestures interact differently according to the context, which may have important implications for research that has focused on verbalizations and has neglected gestures and contextualized performance in sport.     

Effects of the medical resonance therapy music® on haemodynamic parameter in children with autonomic nervous system disturbances

The present investigation is dedicated to the effects of the Medical Resonance Therapy Music^® (MRT-Music) on basic haemodynamic parameter in children with transient arterial hypertension due to disturbances of the autonomic nervous system with different degrees of initial sympatheticotonia. After the nuclear accident at Chernobyl many children developed blood pressure too high for their age norm. Having already observed a decrease in high blood pressure in pregnant women during Medical Resonance Therapy Music (Gerasimovich, Einysh, 1999; Gerasimovich, Sidorenko, 1995; Sidorenko, Tetiorkina, Korotkov, 1997) we studied the effects of the Medical Resonance Therapy Music^® (MRT-Music) on such children—with very positive results: the treatment with the music preparations demonstrated a clear sympatholythic effect and led the disturbed haemodynamic state back to its healthy age norm.     

Using a CBT Approach to Teach Social Skills to Adolescents with Autism Spectrum Disorder and Other Social Challenges: The PEERS® Method

Deficits in social functioning are one of the hallmark features of autism spectrum disorder (ASD), yet very few evidence-based social skills programs exist for adolescents with ASD and other social challenges. The purpose of this paper is to provide an overview of one of the only empirically supported social skills programs for youth with ASD: The Program for the Education and Enrichment of Relational Skills (PEERS ^®). Developed at the UCLA Semel Institute for Neuroscience and Human Behavior, PEERS^® utilizes the principles of cognitive behavior therapy (CBT) to improve social functioning for youth with ASD and other social difficulties. One of the only empirically-supported social skills programs to disseminate published treatment manuals for mental health professionals and educators, the PEERS^® approach applies CBT methods of instruction including: didactic lessons (psychoeducation), role-play demonstrations, cognitive strategies, behavioral rehearsal exercises, performance feedback, homework assignments and review, and parent involvement within a small group treatment format. Results from four randomized controlled trials and one quasi-experimental study reveal significant improvements in overt social skills, frequency of peer interactions, and social responsiveness following this treatment protocol.     

Prediction of true test scores from observed item scores and ancillary data

In many educational tests which involve constructed responses, a traditional test score is obtained by adding together item scores obtained through holistic scoring by trained human raters. For example, this practice was used until 2008 in the case of GRE^®General Analytical Writing and until 2009 in the case of TOEFL^® iBT Writing. With use of natural language processing, it is possible to obtain additional information concerning item responses from computer programs such as e‐rater^®. In addition, available information relevant to examinee performance may include scores on related tests. We suggest application of standard results from classical test theory to the available data to obtain best linear predictors of true traditional test scores. In performing such analysis, we require estimation of variances and covariances of measurement errors, a task which can be quite difficult in the case of tests with limited numbers of items and with multiple measurements per item. As a consequence, a new estimation method is suggested based on samples of examinees who have taken an assessment more than once. Such samples are typically not random samples of the general population of examinees, so that we apply statistical adjustment methods to obtain the needed estimated variances and covariances of measurement errors. To examine practical implications of the suggested methods of analysis, applications are made to GRE General Analytical Writing and TOEFL iBT Writing. Results obtained indicate that substantial improvements are possible both in terms of reliability of scoring and in terms of assessment reliability.     

Diverse multi-week physical activity programs reduce ADHD symptoms: A systematic review and meta-analysis

ObjectivePhysical activity (PA) has been proposed as an adjunct treatment and secondary prevention intervention for attention-deficit hyperactivity/impulsivity disorder (ADHD) and oppositional defiant disorder (ODD). However, meta-analyses testing effects on symptoms and functional impairment have yielded conflicting results.MethodsA systematic search of eight databases yielded 15 randomized controlled trial and 2 quasi-experimental design studies—including N = 881 youth (M = 9.75 years, 71% male)—that tested the effects of multi-week PA programs on symptoms and impairment of children with [or at-risk for] ADHD and/or ODD.ResultsRandom effects meta-analyses favored PA groups on omnibus ADHD measures (g = −0.42, 95%CI[-0.62;-0.21]), combined ADHD symptoms (g = −0.50, 95%CI[-0.82;-0.17]), inattention (g = −0.41,95%CI[-0.82; 0.00]), and hyperactivity/impulsivity (g = −0.30, 95%CI[-0.56;-0.04]). Heterogeneity was moderate across studies (I² = 49%, 95%CI[12%-to-70%]). Significant differences favored PA programs whether inclusion required diagnosis, programs augmented frontline treatments, and active or passive comparison groups were utilized.ConclusionDiverse PA programs can reduce ADHD symptoms, especially where they intentionally pursue this end.     

Obsessive-compulsive symptoms and cigarette smoking: an initial cross-sectional test of mechanisms of co-occurrence

ABSTRACT

Tobacco addiction and obsessive-compulsive symptoms (OCS; intrusive thoughts or impulses that cause distress and rituals) are both mediated by compulsivity and negative reinforcement. Little evidence exists to guide theory, research, treatment, and population-based prevention of this co-occurrence. We propose a conceptual model of OCS-smoking co-occurrence in which smokers with elevated OCS capitalize on smoking to assuage OCS. This secondary analysis examined associations between OCS levels and self-reported smoking motives that are model-concordant: i) negative reinforcement—smoking for relief; ii) sensorimotor—benefits of behaviors and sensations of the tobacco self-administration ritual; and iii) habitual—smoking without conscious control. A community sample of cigarette smokers enrolled in a cessation trial (N = 458; 47.2% female; M _age = 36.9; SD = 13.6) completed pre-quit self-report measures of OCS levels and smoking motives. Regression models adjusted for sociodemographic covariates and non-OCS psychopathologies indicated that OCS level was positively associated with each model-concordant motive. OCS level was also correlated with tobacco dependence severity and greater withdrawal symptom severity experienced during previous quit attempts. Those with higher OCS report greater motivation to smoke for negative reinforcement, sensorimotor behavioral-ritualistic, habit/automaticity, and stimulation reasons. Further examination of the proposed model of OCS-smoking co-occurrence is warranted to guide theory and intervention for this population.     

Toward an Understanding of the Connections in Creating Lasting Family Connections

Abstract

The Creating Lasting Family Connections^® (CLFC) program is designed to help improve relationship skills and reduce antisocial behaviors. Strader and colleagues propose that prosocial connectedness is responsible for program outcomes. We propose that the intersection of high agreeableness and low impulsivity represent an operational definition. We examined this definition in the context of a RCT with 246 men in prison reentry. CLFCFP increased the number of connected individuals. Being connected and the program independently impacted relationship skills, but no evidence was found to support the hypothesis that the program impacts would be more pronounced among those who were connected.     

A combination of Raspberry Pi and SoftEther VPN for controlling research devices via the Internet

Remote control over devices for experiments may increase the efficiency of operant research and expand the area where behavior can be studied. This article introduces a combination of Raspberry Pi^® (Pi) and SoftEther VPN^® that allows for such remote control via the Internet. The Pi is a small Linux computer with a great degree of flexibility for customization. Test results indicate that a Pi‐based interface meets the requirement for conducting operant research. SoftEther VPN^® allows for establishing an extensive private network on the Internet using a single private Wi‐Fi router. Step‐by‐step instructions are provided in the present article for setting up the Pi along with SoftEther VPN^®. Their potential for improving the way of conducting research is discussed.     

Effects of soundtrack music on the video game experience

ABSTRACT

Aesthetic elements such as soundtrack music have been neglected in game entertainment research. Based on previous work in games research and the psychology of film soundtracks (Cohen, 2001), we test the hypotheses that soundtrack music contributes to players‘ enjoyment via intensification of emotions (affective route) and via amplification of the sense of spatial presence and identification with the game character (cognitive routes). Study 1 tested these assumptions with N = 68 young male players of an episode of Assassin’s Creed: Black Flag^®, either with the original soundtrack music present or absent, and reported game enjoyment, as well as scores of the assumed mediator variables afterward. In Study 2, N = 59 young males played an episode of Alien: Isolation^® with soundtrack music present or absent and reported their horror experience, as well as the experiential facets as in study 1. Findings clearly show an indirect effect of soundtrack music on enjoyment through positive emotions (study 1) and an impact of (shocking) music on players’ horror experience (study 2). However, a mediation of the effect of soundtrack music on game enjoyment via spatial presence or identification was not established. We discuss implications for future research in game entertainment.     

Legal and Ethical Considerations for Requiring Consent for Apnea Testing in Brain Death Determination

Abstract

The past decade has witnessed escalating legal and ethical challenges to the diagnosis of death by neurologic criteria (DNC). The legal tactic of demanding consent for the apnea test, if successful, can halt the DNC. However, US law is currently unsettled and inconsistent in this matter. Consent has been required in several trial cases in Montana and Kansas but not in Virginia and Nevada. In this paper, we analyze and evaluate the legal and ethical bases for requiring consent before apnea testing and defend such a requirement by appealing to ethical and legal principles of informed consent and battery and the right to refuse medical treatment. We conclude by considering and rebutting two major objections to a consent requirement for apnea testing: (1) a justice-based objection to allocate scarce resources fairly and (2) a social utility objection that halting the diagnosis of brain death will reduce the number of organ donors.     

The role of therapist support on effectiveness of an internet-based modular self-help intervention for adjustment disorder: a randomized controlled trial

Background: Adjustment disorder is among the most often diagnosed mental health disorders. Still, there is a lack of specific interventions available for adjustment disorder.

Objectives: The aim of this study was to test if an internet-based self-help intervention for adjustment disorder could be effective without therapist involvement.

Design: A parallel group randomized controlled trial design was used to test the effectiveness of the Brief Adjustment Disorder Intervention (BADI) – an internet-based intervention for adjustment disorder.

Methods: In total 1077 participants were randomized into two conditions: BADI intervention and BADI intervention with therapist support. The main outcome measures were symptoms of adjustment disorder and well-being.

Results: Pre-intervention to post-intervention adjustment disorder effect size for the BADI intervention group was d?=?0.64, and for the BADI with therapist support group the effect size was d?=?0.53.

Conclusions: The present study supported the effectiveness of the BADI intervention. Our findings also indicated that adding therapist support to the standard BADI intervention did not significantly improve the outcomes.     

Assessing the Ethics of Medical Research in Emergency Settings: How Do International Regulations Work in Practice?

Different ethical principles conflict in research conducted in emergency research. Clinical care and its development should be based on research. Patients in critical clinical condition are in the greatest need of better medicines. The critical condition of the patient and the absence of a patient representative at the critical time period make it difficult and sometimes impossible to request an informed consent before the beginning of the trial. In an emergency, care decisions must be made in a short period of time, and the more time is wasted, the more the risk of death or severe tissue damage and incapacity increases. Consent requests take time, and so the time period before treatment might put the patient’s life in jeopardy. Not requesting consent before a trial is also contradictory. A person should not be forced to participate in a trial against his or her will. Due to the dark history of medical research previously, international declarations and conventions have set up ethical principles for medical research. They emphasize the autonomy of the research participant—or his or her legal representative—to give a free and informed consent prior to the initiation of research. In the case of a critical emergency, the unconscious state of the patient, the emotional stress of family members or the lack of time to start life-sustaining measures may often restrict the possibilities of communicating with the patient or his/her representative. Therefore, written informed consent is difficult to achieve, and its voluntariness in emergency situations is, at best, open to question. The mortality of patients is high without clinical interventions in emergency research. Random selection of patients is difficult and requires extra work from personnel in the emergency rooms. Recruitment, information and asking for consent may also take time, postpone the initiation of treatment and increase the risk of death and irreversible tissue and organ damage, and therefore be risky for the patient. It is therefore essential that the health care professionals recruiting suitable research participants are well motivated and well trained. Medical research in an emergency setting should always be regarded as an exceptional situation requiring special provisions. Only such research should be done as cannot be done in other conditions. An independent body must approve the research protocol and the ways in which the consent of the participant or proxy are to be sought. In addition, the trial must be expected to result in direct and significant benefit for the research participants. If research without prior consent is not approved, the development of emergency care is threatened. On the other hand, if prior consent is not required, a person could be recruited into a clinical trial against his or her will. Doing good and avoiding harm, and respecting the autonomy of the patient are in conflict in the context of emergency medical research. To develop better medicines for patients experiencing acute medical emergencies, research into such conditions should be allowed. Research participants should have the possibility to participate or refuse to participate in research that may benefit them and other patients. The risk of irreversible damage occurring as the consequence of time delays for seeking consent is unacceptable. A prior wish about participation in clinical trials should be respected, if known. The conditions under which medical research in emergencies can be considered acceptable can be determined and agreed upon nationally and internationally. An earlier version of this paper was presented at The 7th International Conference on Bioethics on “The Ethics of Research in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland.     

Tracing the size,reach, impact,and breadth of positive psychology

This study quantitatively assessed the size, disciplinary reach, impact, and topic breadth of positive psychology (PP), in order to provide a comprehensive evaluation of the growth and significance of the field. Over 1.7?million documents in 700 PsycINFO ^® journals covering the fields of psychology, psychiatry, neuroscience, management, business, public health, and sport science were analyzed using semantic and bibliographic methods. Results indicate that PP covers many different research topics from a diverse range of disciplines, and that PP literature has been growing rapidly in significance. Over 18,000 documents were identified as belonging to PP, with 2300 published in 2011. These documents represent over 4% of PsycINFO ^® documents within the data-set published that year, and make PP close to the median size of all disciplines listed in the Thomson Reuters Journal Citation Reports ^®, Social Sciences Edition. The aggregate impact factor for PP in 2011 was 2.64.