Methodological Strategies in Child Clinical Trials: Advancing the Efficacy and Effectiveness of Psychosocial Treatments

The present paper reviews issues of treatment efficacy (i.e., potency) and effectiveness (i.e., clinical utility) in applied clinical child research. Threats to treatment evaluation are reviewed in the context of these two dimensions. It is proposed that treatment outcome research faces new challenges stemming from the ever increasing emphasis on generalization of gains and dissemination of interventions outside of clinical research settings. Issues and approaches proposed as warranting further development and attention include development, flexibility, acceptability, and disseminability of psychosocial assessment and treatment methods. A research emphasis is promoted that balances experimental control with the need for treatment generalization and delivery outside of the research setting, in order to maximize the utility of clinical research.     

Evidence based practice: A guide for counsellors and psychotherapists

There has been an increasing tendency for healthcare policy makers and managers to require that all forms of therapy are supported by rigorous research evidence. This paper, which has also been distributed as an Information Sheet to all members of the British Association for Counselling and Psychotherapy (BACP), provides a practitioner‐oriented introduction to evidence‐based practice, with suggestions for further reading on this topic.     

随机控制实验:助推脱贫的现场干预研究

消除贫困是全世界新千年的首要目标。行为经济学家和发展经济学家正借助随机控制实验和助推技术在全球范围内帮助贫困者摆脱贫困。当前采用随机控制实验帮助贫困者克服行为偏差的助推行动主要表现在帮助贫困者改善当前物质条件和提升未来保障两个方面。随机控制实验和助推技术在国内的研究和实践也有效地帮助国内贫困农民提高了身心健康水平和经济收入。未来还需加强关于随机控制实验和助推技术的外部效度检验及两者的异同点方面的研究, 并结合脱贫的内生动力制定更加简单、高效、严谨的扶贫政策和项目。     

Sudden Gains in Internet-Based Cognitive Behavior Therapy for Body Dysmorphic Disorder

Sudden gains have been associated with better short- and long-term treatment outcomes in a number of psychiatric disorders. However, no studies to date have evaluated sudden gains in body dysmorphic disorder (BDD). We used data from a previous randomized controlled trial evaluating the efficacy of an Internet-based cognitive-behavior treatment (CBT) for BDD. The sample consisted of 47 adults diagnosed with BDD. We compared the treatment outcomes of sudden gainers vs. gradual gainers (i.e., treatment responders with no sudden gains) and non-sudden gainers (i.e., gradual gainers plus nonresponders) at posttreatment and 3, 12, and 24 months after the end of the treatment. Twelve (25.5%) participants experienced a sudden gain. Compared to non-sudden gainers and to gradual gainers, sudden gainers showed significantly larger improvements on the Yale-Brown Obsessive-Compulsive Scale modified for BDD at posttreatment (g = 1.23 and g = .91, respectively), and at 3-month (g = 1.23 and g = 1.00, respectively), 12-month (g = 1.12 and g = .91, respectively), and 24-month follow-up (g = 1.11 and g = .97, respectively). This translated into higher rates of treatment responders and remitters in the sudden gainers across all time points. The occurrence of sudden gains in Internet-based CBT for BDD is associated with favorable short- and long-term treatment outcomes. This suggests that a sudden improvement during the treatment could be a marker of good prognosis, while non-sudden—including gradual—gainers are more likely to need continued support or booster sessions. Early identification of patients who are not progressing as expected and subsequent tailoring of the delivered intervention has the potential to improve treatment outcomes in this group.     

Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments

The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 ± 31.7 (range: 0–131) projects of clinical trials and 71.1 ± 139.8 (range: 0–638) projects of other types of medical research. During one BC meeting an average of 10.3 ± 14.7 (range: 0–71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary.

COMPARISON OF DATA‐COLLECTION METHODS IN A BEHAVIORAL INTERVENTION PROGRAM FOR CHILDREN WITH PERVASIVE DEVELOPMENTAL DISORDERS: A REPLICATION

Cummings and Carr (2009) compared two methods of data collection in a behavioral intervention program for children with pervasive developmental disorders: collecting data on all trials versus only the first trial in a session. Results showed that basing a child's progress on first‐trial data resulted in identifying mastery‐level responding slightly sooner, whereas determining mastery based on all trials resulted in slightly better skill maintenance. In the current replication, no such differences in indication of mastery or maintenance were observed when data were collected on all trials or the first trial.     

Has Emergency Medicine Research Benefited Patients? An Ethical Question

From an ethical standpoint, the goal of clinical research is to benefit patients. While individual investigations may not yield results that directly improve patients’ evaluation or treatment, the corpus of the research should lead in that direction. Without the goal of ultimate benefit to patients, such research fails as a moral enterprise. While this may seem obvious, the need to protect and benefit patients can get lost in the milieu of clinical research.Many advances in emergency medicine have been based upon the results of research studies conducted both within the specialty and by others outside of the field. But has this research benefited patients? Has it followed the Hippocratic commitment “to do good or at least do no harm”? The answer is: yes, and no. This paper attempts to demonstrate this: first by citing advances from applied research that have benefited emergency department patients over the past three decades, and follows with some aspects of emergency medicine research that makes one question both its safety and its efficacy. While enormous gains have been made in patient care as a result of emergency medical research, ethical considerations complicate this rosy picture, and point to future areas of concern for researchers.Some aspects of clinical research and research oversight fall short of meeting the ethical standards of safety and patient benefit. Research agendas are still driven largely by the availability of funds, both from private industry and from government agencies. Many vital patient groups are harmed by omitting or sorely under-representing them as research subjects, most notably those that are critically ill and injured. Finally, questions still arise about clinical researchers’ fiduciary responsibility to their subject-patients. Even more important than the institutional safeguards, such as the Institutional Review Boards, is the individual researcher’s moral compass, which must serve to protect the subject-patients of clinical research.Overall, emergency medicine research has been and continues to be a moral endeavor. Perhaps the greatest moral lapse has been the lack of attention to key populations within emergency medicine research, and the patients most needing acute intervention are the ones who suffer.     

A review of the worst performance rule: Evidence, theory, and alternative hypotheses

This paper reviews evidence, theory, and alternative hypotheses for the worst performance rule (WPR), which states that on multitrial cognitive tasks, worst performance trials predict general intelligence (g) better than best performance trials. A review of the relevant evidence indicates that the WPR has been found for a variety of participants, tasks, and measures. A review of relevant theories reveals that the WPR appears to be related to cognitive factors (e.g., lapses in working memory) as well as biological factors (e.g., individual differences in neural oscillations). A review of alternative hypotheses shows that the WPR cannot be attributed to statistical or data artifacts such as outliers, unreliable measurement, or variance compression. The preponderance of evidence supports the hypothesis that the WPR holds for cognitive tasks high in g saturation but not for cognitive tasks low in g saturation. The paper ends with a call for research on the causes of the WPR and for research on the correlates of best performance.     

A problem for achieving informed choice

Most agree that, if all else is equal, patients should be provided with enough information about proposed medical therapies to allow them to make an informed decision about what, if anything, they wish to receive. This is the principle of informed choice; it is closely related to the notion of informed consent. Contemporary clinical trials are analysed according to classical statistics. This paper puts forward the argument that classical statistics does not provide the right sort of information for informing choice. The notion of probability used by classical statistics is complex and difficult to communicate. Therapeutic decisions are best informed by statistical approaches that assign probabilities to hypotheses about the benefits and harms of therapies. Bayesian approaches to statistical inference provide such probabilities.