Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than “minimal risk” (§ 45CFR46.404); or 2) no more than a “minor increase over minimal risk” if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1977. Report and recommendations: Research involving children, Washington, DC: U.S. Government Printing Office.  [Google Scholar] report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria.     

微创技术的发展:历史、现实和未来

根据"看"的技术不同,微创技术可以分为两类和三种.目前,微创技术正处于以内镜、腔镜、介入X-线、介入超声以及微创化外科技术为主的技术发展阶段.展望未来,微创技术可能出现三种发展趋势:(1)现有技术的进一步完善、提高;(2)现有不同技术的相互融合;(3)微创新技术的发明.     

Living in the Past,Present, and Future: Measuring Temporal Orientation With Language

Temporal orientation refers to individual differences in the relative emphasis one places on the past, present, or future, and it is related to academic, financial, and health outcomes. We propose and evaluate a method for automatically measuring temporal orientation through language expressed on social media. Judges rated the temporal orientation of 4,302 social media messages. We trained a classifier based on these ratings, which could accurately predict the temporal orientation of new messages in a separate validation set (accuracy/mean sensitivity = .72; mean specificity = .77). We used the classifier to automatically classify 1.3 million messages written by 5,372 participants (50% female; ages 13–48). Finally, we tested whether individual differences in past, present, and future orientation differentially related to gender, age, Big Five personality, satisfaction with life, and depressive symptoms. Temporal orientations exhibit several expected correlations with age, gender, and Big Five personality. More future‐oriented people were older, more likely to be female, more conscientious, less impulsive, less depressed, and more satisfied with life; present orientation showed the opposite pattern. Language‐based assessments can complement and extend existing measures of temporal orientation, providing an alternative approach and additional insights into language and personality relationships.     

“I Was a Muslim,But Now I Am a Christian”: Preaching,Legitimation, and Identity Management in a Southern Evangelical Church

Established in 2005, “Life” is a suburban, nondenominational, evangelical church in Charlotte, North Carolina, with an almost entirely white membership, yet the lead pastor is an immigrant from the Middle East. As an ex‐Muslim ethnic Pakistani who was born and raised in Kuwait, Pastor Sameer Khalid does not “fit” into southern culture, and he did not convert to Christianity until he was enrolled in college in the United States. Ethnographic data from 14 months of fieldwork reveal how Pastor Sameer uses weekly sermons to negotiate racialized stigmas, emphasize his common religious identity with the congregation, and make his immigrant background a distinctive religious resource for the church. More specifically, while all pastors require legitimation of their charismatic authority, this research focuses on the dynamics of performance through preaching within the Sunday morning services of this congregation, a performance that negotiates this lead pastor's ethnic and religious identities and accentuates his strategic use of institutionalized evangelical narratives to subvert Islamophobic threats and buttress legitimation of his pastoral identity.     

A Novel Approach to the Assessment of Fidelity to a Cognitive Behavioral Therapy for PTSD Using Clinical Worksheets: A Proof of Concept With Cognitive Processing Therapy

Fidelity monitoring is a critical indicator of psychotherapy quality and is central to successful implementation. A major barrier to fidelity in routine care is the lack of feasible, scalable, and valid measurement strategies. A reliable, low-burden fidelity assessment would promote sustained implementation of cognitive behavioral therapies (CBTs). The current study examined fidelity measurement for cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) using clinical worksheets. External raters evaluated patient worksheets done as a part of treatment, both guided by the therapist and completed independently as homework. Results demonstrated that fidelity ratings from CPT session worksheets were feasible and efficient. Notably, they were strongly correlated with observer ratings of the fidelity of CPT strategies that were present on the worksheets. Agreement among ratings conducted by individuals with a range of experience with CPT was acceptable to high. There was not a main effect of therapist-guided, in-session worksheet ratings on PTSD symptom change. However, patient competence in completing worksheets independently was associated with greater PTSD symptom decline and in-session, therapist-guided worksheet completion was associated with larger symptom decreases among patients with high levels of competence. With further research and refinement, rating of worksheets may be an efficient way to examine therapist and patient skill in key CPT elements, and their interactions, compared to the gold standard of observer ratings of therapy video-recordings. Additional research is needed to determine if worksheets are an accurate and scalable alternative to gold standard observer ratings in settings in which time and resources are limited.     

Predictors of Improvement in Pediatric Chronic Migraine: Results from the Cognitive-Behavioral Therapy and Amitriptyline Trial

Explore predictors of improvement in headache days and migraine-related disability through a secondary analysis of the cognitive-behavioral therapy plus amitriptyline trial in children and adolescents (Clinical Trials Registration Number: NCT00389038). Participants were 135 youth aged 10–17 years old diagnosed with chronic migraine. Predictor variables included group assignment (treatment or control), baseline scores from depression and quality of life measures, and demographic variables. Criterion variables included headache days and migraine-related disability. Higher baseline depression scores were indicative of more days with headache post-treatment regardless of group assignment. Family income at the higher-end of the low-income range was significantly associated with less migraine-related disability regardless of group assignment (Household Income: HINC-01 in The United States Census Bureau. Bureau, U, 2020). Results from this secondary analysis identify depression symptoms and family income as predictors that can impact headache frequency and migraine-related disability. Self-reported symptoms of depression and family income are important factors to consider as part of the biopsychosocial model of care.

     

The Therapeutic Alliance in Couple Therapy for Depression: Predicting Therapy Progress and Outcome from Assessments of the Alliance by the Patient, the Spouse, and the Therapists

This study examined Couple Therapy (CT) for depression in a naturalistic setting. It looked at the associations between the therapeutic alliance and subjective distress, and between the alliance and depression outcome. Twenty-nine depressive patients and their spouses were treated via CT. Treatments were adapted in accordance with the patient’s need. The couples assessed the alliance and their subjective distress at every session. In addition, the therapists assessed the alliance at every session. The patient’s depression outcome was assessed at baseline and at 6, 12, 18, and 24 months post-baseline. The Outcome Rating Scale, The Session Rating Scale, and the Beck Depression Inventory were used. At any given session, the patients’ and spouses’ deviations from their average subjective distress ratings predicted their deviations from their average alliance ratings in the same session. At any given session, the patients’ and spouses’ deviations from their average alliance ratings predicted their deviations from their average subjective distress in the next session. The therapy-system alliance was significantly associated with the patients’ depression outcome, explaining 19.4 % of the variance in the patients’ depression change. The results indicate the importance of taking into account the association between the alliance and subjective distress during the treatment, and confirm the usefulness of routine evaluation of the therapeutic process as an indicator of the association between alliance and therapy outcome in everyday CT for depression.     

Counseling in the Philippines: Past,Present, and Future

The history of colonization and persistent attempts at self‐governance in the Philippines parallel the beginnings of counseling in the country, which were largely influenced by the United States. Because of the Guidance and Counseling Act of 2004 and the Psychology Act of 2009, counseling is on its way to professionalization and regulation. Counseling is growing in depth and credibility, as evidenced by applications in practice that are not only indigenous but powerfully relevant.     

Effect of Transcranial Direct Current Stimulation Combined With Virtual Reality Training on Balance in Children With Cerebral Palsy: A Randomized,Controlled, Double-Blind,Clinical Trial

The authors' aim was to investigate the effects of continuous transcranial direct current stimulation (tDCS) combined with virtual reality training on static and functional balance in children with cerebral palsy (CP). Twenty children with CP (6 girls and 14 boys; M age = 7 years 6 months ± 2 years) were randomly allocated to two groups. The experimental group received active tDCS and the control group received sham stimulation during the 10 sessions of virtual reality mobility training protocols. The children were evaluated on 3 occasions (preintervention, postintervention, and 1-month follow-up). Static balance was evaluated using a force plate under 4 conditions: feet on force plate with (a) eyes open and (b) with eyes closed, and feet on foam mat with (c) eyes open and (d) with eyes closed. Functional balance was evaluated using the Pediatric Balance Scale and the Timed Up and Go Test. The analyses demonstrated statistically significant postintervention and follow-up effects favoring the experimental group over the control group with regard to the Pediatric Balance Scale, Timed Up and Go Test, and area of oscillation of the center of pressure when standing on the force plate with eyes open. The present findings suggest that tDCS can potentiate the effects of virtual reality training on static and functional balance among children with CP.     

Potential Perils of the Demonstration-Consultation Interview in Family Therapy: A Case Study of Contextual Confusion

This article focuses on a specific aspect of consultation in contemporary family therapy, namely, problems that arise in the context of a consultation that simultaneously serves as a demonstration of a particular model of therapy. The demonstration-consultation interview is used widely in family therapy, but has received little attention in the literature. We use a case example of the apparent persistent deterioration in the clinical state of a patient following such a family interview with a visiting expert, and examine the possible contribution to the patient's deterioration that the demonstration-consultation context creates for the various participants. We offer provisional guidelines to minimize the risk of negative effects of the demonstration-consultation interview, pending empirical research into this phenomenon.     

Women Are On, But Not In, the News: Gender Roles in Local Television News

This investigation examined 580 news stories in the top three local television news programs in a Northeastern U.S. television market for a two-week period. Content analysis was used to determine whether or not there were gender differences in the prevalence of reporters and anchors and in the type of stories they reported. Analysis of newscasts revealed that female reporters were more likely to present human interest and health related stories, while males were more likely to present political stories. Analysis of news sources revealed that male experts were used significantly more often than were female experts as news sources. There was no relationship between time news stories were presented and gender of the reporters or anchors.     

A Review of Scientific Progress in Flow in Sport and Exercise: Normal Science,Crisis, and a Progressive Shift

Flow is highly relevant and desirable in sport and exercise. Drawing on ideas from iconic philosophers of science—Thomas Kuhn, Karl Popper, and Imre Lakatos—we argue that research in this field has followed a pattern of “normal science.” With a series of accumulating criticisms and “anomalies,” we propose flow research is approaching a “crisis point.” We highlight problems with research based on the traditional nine-dimensions conceptualization of flow. Then, drawing on the work of Popper and Lakatos, we offer theoretical and methodological suggestions for developing a more progressive and practically useful theory for researchers and practitioners.     

Counseling in the Czech Republic: History,Status, and Future

This article reviews the history and current status of counseling in the Czech Republic. Recommendations for advancement of the profession in a postcommunist era are offered, including the incorporation of social justice principals for the benefit of Gypsies and immigrants, collaboration between Czech and non‐Czech counselors, and counseling research with the Czech people.