Inefficacy interim monitoring procedures in randomized clinical trials: the need to report

If definitive evidence concerning treatment effectiveness becomes available from an ongoing randomized clinical trial, then the trial could be stopped early, with the public release of results benefiting current and future patients. However, stopping an ongoing trial based on accruing outcome data requires methodological rigor to preserve validity of the trial conclusions. This has led to the use of formal interim monitoring procedures, which include inefficacy monitoring that will stop a trial early when the experimental treatment appears not to be working. For participants, inefficacy monitoring is especially important as it ensures that they are not being treated worse than if they had not enrolled on the trial. We discuss the importance of reporting with trial results the formal interim inefficacy monitoring guidelines that were utilized, and, if none were used, the reasons for their absence. A survey of two leading medical journals suggests that this is not current practice.     

The efficacy of systemic therapy with adult patients: a meta-content analysis of 38 randomized controlled trials

Systemic therapy is a widely used psychotherapy approach. Yet there exist few systematic reviews on its efficacy. A meta-content analysis was performed to analyze the efficacy of systemic therapy for the treatment of mental disorders in adulthood. All randomized (or matched) controlled trials (RCT) evaluating systemic/systems oriented therapy in various settings (family, couple, individual, group, multifamily group therapy) with adult index patients suffering from mental disorders were identified by database searches and cross-references in other reviews. Inclusion criteria were: index patient diagnosed with a DSM or ICD listed mental disorder, trial published in any language up to the end of 2008. The RCTs were content analyzed according to their research methodology, interventions applied, and results. Thirty-eight trials published in English, German, Spanish, and Chinese were identified, 34 of them showing systemic therapy to be efficacious for the treatment of mood disorders, eating disorders, substance use disorders, mental and social factors related to medical conditions and physical disorders, and schizophrenia. Systemic therapy may also be efficacious for anxiety disorders. Results were stable across follow-up periods of up to 5 years. There is a sound evidence-base for the efficacy of systemic therapy for adult index patients with mental disorders in at least five diagnostic groups.     

Conceptual framework from the Paris Psychosomatic School: A clinical psychoanalytic approach to oncology1

This article presents further clinical material from the Paris Psychosomatic School ( Aisenstein, 2006 ). The Freudian foundations of psychosomatics are detailed and post-Freudian developments focusing on the contribution of the Paris Psychosomatic School are outlined, in particular, the somatizing process as a result of regression and the somatizing process as a result of drive unbinding. The authors argue that the latter possibly gives rise to progressive and serious illness leading to death. The relationship of classical psychoanalysis to psychotherapeutic treatment from the angle of the Paris school is commented on. The authors then turn to two clinical presentations of women suffering from breast cancer. The method of evaluating the patients’ capacities for undergoing psychotherapeutic treatment and their mental capacity for healing is discussed. The face-to-face psychoanalytic treatment undertaken with the second case is discussed. Finally, the authors recall Freud’s insistence after 1920 on the opposition of the life drives and the death drives, which placed self-destruction at the centre of psychic functioning. They conclude that current research in biology and medicine, notably research concerning programmed cell death, will converge with psychoanalytic psychosomatics to illuminate somatizing processes and demonstrate the relevance of psychoanalytic treatment to patients who are capable of mental reorganization in the course of their illness and medical treatment.     

Effectiveness of peer-led dissonance-based eating disorder prevention groups: Results from two randomized pilot trials

ObjectiveThe present preliminary trials tested whether undergraduate peer leaders can effectively deliver a dissonance-based eating disorder prevention program, which could facilitate broad dissemination of this efficacious intervention.MethodIn Study 1, female undergraduates (N = 171) were randomized to peer-led groups, clinician-led groups, or an educational brochure control condition. In Study 2, which improved a design limitation of Study 1 by using completely parallel outcome measures across conditions, female undergraduates (N = 148) were randomized to either immediate peer-led groups or a waitlist control condition.ResultsIn Study 1, participants in peer- and clinician-led groups showed significantly greater pre–post reductions in risk factors and eating disorder symptoms than controls (M d = .64 and .98 respectively), though clinician- versus peer-led groups had higher attendance and competence ratings, and produced stronger effects at posttest (M d = .32) and at 1-year follow-up (M d = .26). In Study 2, participants in peer-led groups showed greater pre–post reductions in all outcomes than waitlist controls (M d = .75).ConclusionsResults provide novel evidence that dissonance-based eating disorder prevention groups led by undergraduate peers are feasible and produce greater reductions in eating disorder risk factors and symptoms than minimal-intervention control conditions, but indicate that effects are smaller for peer- versus clinician-led groups.     

Lifestyle interventions in the treatment of childhood overweight: a meta-analytic review of randomized controlled trials.

CONTEXT: Evaluating the efficacy of pediatric weight loss treatments is critical. OBJECTIVE: This is the first meta-analysis of the efficacy of RCTs comparing pediatric lifestyle interventions to no-treatment or information/education-only controls. DATA SOURCES: Medline, PsycINFO, and Cochrane Controlled Trials Register. STUDY SELECTION: Fourteen RCTs targetting change in weight status were eligible, yielding 19 effect sizes. DATA EXTRACTION: Standardized coding was used to extract information on design, participant characteristics, interventions, and results. DATA SYNTHESIS: For trials with no-treatment controls, the mean effect size was 0.75 (k = 9, 95% confidence interval [CI] = 0.52-0.98) at end of treatment and 0.60 (k = 4, CI = 0.27-0.94) at follow-up. For trials with information/education-only controls, the mean ES was 0.48 (k = 4, CI = 0.13-0.82) at end of treatment and 0.91 (k = 2, CI = 0.32-1.50) at follow-up. No moderator effects were identified. CONCLUSIONS: Lifestyle interventions for pediatric overweight are efficacious in the short term with some evidence for extended persistence. Future research is required to identify moderators and mediators and to determine the optimal length and intensity of treatment required to produce enduring changes in weight status.     

Early stopping of clinical trials: charting the ethical terrain

The decision to terminate a clinical trial earlier than planned is often described as ethically problematic, but it is rarely systematically analyzed as an ethical issue in its own right. This paper provides an overview of the main ethical considerations at stake in such decisions and of the main tensions between these considerations. Arguments about informed consent and the impact of early stopping on research and society are explored. We devote particular attention to a familiar conflict that arises with special urgency when early data suggest that the experimental treatment is superior. Should the trial be stopped so that participants in the control group will not be allocated a seemingly inferior treatment, or should it continue in pursuit of evidence conclusive enough to improve the care of future patients? We scrutinize three ways to address this problem. Rather than dissolving the tension, they represent different trade-offs between the respective welfare interests of subjects and future patients.     

Procedural misconceptions and informed consent: insights from empirical research on the clinical trials industry

This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function as root causes of therapeutic misconceptions.     

A randomized controlled trial of self-directed versus therapist-directed cognitive-behavioral therapy for obsessive-compulsive disorder patients with prior medication trials

Cognitive-behavioral therapy incorporating exposure and response prevention (ERP) is widely considered a first-line psychosocial treatment for patients with obsessive-compulsive disorder (OCD). However, a number of obstacles prevent many patients from receiving this treatment, and self-administered ERP may be a useful alternative or adjunct. Forty-one adult outpatients with a primary diagnosis of OCD, who reported at least 1 current or previous adequate medication trial, were randomly assigned to self-administered or therapist-administered ERP. Patients in both treatment conditions showed statistically and clinically significant symptom reduction. However, patients receiving therapist-administered ERP showed a superior response in terms of OCD symptoms and self-reported functional impairment. We discuss several potential reasons for the superiority of therapist-administered treatment, and propose a stepped-care integration of self-administered and therapist-administered interventions for OCD.     

The need to reform our assessment of evidence from clinical trials: A commentary

The ideology of evidence-base medicine (EBM) has dramatically altered the way we think, conceptualize, philosophize and practice medicine. One of its major pillars is the appraisal and classification of evidence. Although important and beneficial, this process currently lacks detail and is in need of reform. In particular, it largely focuses on three key dimensions (design, [type I] alpha error and beta [type II] error) to grade the quality of evidence and often omits other crucial aspects of evidence such as biological plausibility, reproducibility, generalizability, temporality, consistency and coherence. It also over-values the randomized trial and meta-analytical techniques, discounts the biasing effect of single centre execution and gives insufficient weight to large and detailed observational studies. Unless these aspects are progressively included into systems for grading, evaluating and classifying evidence and duly empirically assessed (according to the EBM paradigm), the EBM process and movement will remain open to criticism of being more evidence-biased than evidence-based.     

Brief strategic therapy in first myocardial infarction patients with increased levels of stress: a randomized clinical trial

Background: Little is known about the impact of interventions targeting chronic stress levels on clinical outcomes among myocardial infarction (MI) patients with increased levels of stress. Objectives: To examine the impact of the addition of brief strategic therapy (BST) to usual care (UC) on clinical outcomes in first MI patients with increased levels of stress. Design: Eighty-one patients were randomly assigned to BST in conjunction with UC (medical treatment, risk factor information, and guidance on unhealthy behavior change) or to UC. Methods: The outcome measures were scores on the Perceived Stress Scale, reinfarction and cardiac mortality rates, and scores on the Health Survey. Measures were taken before, post-treatment, and at two follow-ups. Results: Patients subjected to BST showed reduced perceived stress at post-treatment and maintained decreased levels at follow-ups. At 1-year follow-up, they had a lower rate of non-fatal reinfarction, and at 2.5-year follow-up, they had a lower rate of fatal reinfarction. Their mental and physical health was improved at post-treatment and this was sustained at follow-ups. Conclusion: The addition of BST to UC favorably influences the disease course after MI in patients with increased levels of stress.     

Ethical and social dilemmas in community-based controlled trials in situations of poverty: a view from a South African project

All psychological and social research presents ethical dilemmas, many of which centre around the difficulties which flow from the power imbalances between those conducting the research and the research respondents or participants. Issues of power are magnified in research undertaken in contexts of poverty, and there is a burgeoning literature on ethical issues in research in developing countries. In this article, we augment the existing literature by focusing on the experiences of an assessor working in a controlled trial of a mother-infant intervention in a poor South African community. We consider issues of community expectations, the presentation to our project of physical health problems, the issue of HIV/AIDS, cultural beliefs which impact on the research, child protection issues, and the tensions between research assessment and ubuntu--a cultural norm which requires helpful engagement with others. We suggest that our experiences may assist with the development of further research.     

Psychological adjustment among African American breast cancer patients: one-year follow-up results of a randomized psychoeducational group intervention.

The effectiveness of support group interventions for cancer patients has been established among White patients but has been virtually unstudied among minority patients. The current study represents the 1st randomized support group intervention targeted to African American women with breast cancer. Participants (N = 73) with nonmetastatic breast cancer were randomly assigned to an 8-week group intervention or an assessment-only control condition At 12 months, the intervention resulted in improved mood as well as improved general and cancer-specific psychological functioning among women with greater baseline distress or lower income. Subsequent research is needed to address effective methods of enrolling and following women with fewer psychosocial and financial resources, as they were the most likely to benefit from this particular intervention.     

Six approaches to the explication of facet-level traits: examples from conscientiousness

Proponents of the Five-Factor Model (FFM) of personality have argued for somewhat different conceptualizations of the factors. Ultimately, the factors are best understood by a specification of the traits (or facets) that define them, and these facets in turn must be clearly conceptualized. Using as examples the Conscientiousness facet scales of the Revised NEO Personality Inventory, we discuss six approaches to understanding facet-level traits: (i) rational analysis of item content; (ii) characterization of the low pole, the psychological opposite; (iii) interpretation of external correlates; (iv) examination of secondary and tertiary factor loadings; (v) translation into the specialized languages of applied psychology; and (vi) case studies. © 1998 John Wiley & Sons, Ltd.     

以象解筮的探索——论尚秉和先生对《左传》《国语》筮例的阐解

《左传》《国语》中的筮例,是对《易》学研究极具价值的材料,历代学者对此进行过许多研究考辨、阐释解说。近代《易》学大师尚秉和先生既以《左传》《国语》筮例作为创立“尚氏学”的最重要的佐证材料之一,又将“以象解《易》”的方法用以阐解《左传》《国语》的筮例,颇具特色。本文考察了尚先生以象解筮的具体内容,辨析了“尚氏说”的自洽性,并就“尚氏说”中“观象”与“用象”、“易理”与“义理”等问题进行追问与思考。