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.

Problem-solving training via videoconferencing for family caregivers of persons with spinal cord injuries: a randomized controlled trial

Objective

To examine the effectiveness of an individualized problem-solving intervention delivered in videoconferencing sessions with family caregivers of persons living with a spinal cord injury (SCI) and possible contagion effects on care recipients.

Design

Family caregivers were randomly assigned to an education-only control group or an intervention group in which participants received problem-solving training (PST) in monthly videoconference session for a year.

Participants

Sixty-one caregivers (54 women, 7 men) and their care recipients (40 men, 21 women) consented to participate.

Main outcome measures

The Social Problem-Solving Inventory-Revised was administered to caregivers. Caregivers and care recipients completed the Inventory to Diagnose Depression, the SF-36 and the Satisfaction with Life scale at pre-treatment, 6 months and 12 months.

Results

Twenty-eight caregivers discontinued the study and their follow-up data were unavailable at the final assessment. Older caregivers were more likely than younger caregivers to remain in the study. Intent-to-treat analyses projected a significant decrease in depression among caregivers receiving PST; efficacy analyses indicated this effect was pronounced at the 6th month assessment. ITT analyses and efficacy analyses revealed that care recipients of caregivers receiving PST reported gains in social functioning over time.

Conclusions

Community-based, telehealth interventions may benefit family caregivers and their care recipients, but the mechanisms of these effects are unclear. Attrition and sample issues should be considered in future studies with these populations.     

Testing a new cognitive behavioural treatment for obesity: A randomized controlled trial with three-year follow-up

It is remarkably difficult for people with obesity to maintain a new lower weight following weight loss. The aim of the present study was to examine the immediate and longer-term effects of a new cognitive behavioural treatment that was explicitly designed to minimise this post-treatment weight regain. One hundred and fifty female participants with obesity were randomized to the new treatment, behaviour therapy (the leading alternative psychological treatment) or guided self-help (a minimal intervention). Both of the main treatments resulted in an average weight loss of about ten percent of initial weight whereas weight loss was more modest with guided self-help. The participants were subsequently followed-up for three years post-treatment. The great majority regained almost all the weight that they had lost with the new treatment being no better than the behavioural treatment in preventing weight regain. These findings lend further support to the notion that obesity is resistant to psychological methods of treatment, if anything other than a short-term perspective is taken. It is suggested that it is ethically questionable to claim that psychological treatments for obesity “work” in the absence of data on their longer-term effects.     

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.     

Healthy Children As Subjects in Pharmaceutical Research

Recruitment of healthy children for drugresearch has emerged due in part to several newAmerican laws and policies that have led to asurge in pharmaceutical research involvingchildren-subjects. In this paper, I review theethical and scientific issues and the argumentsin favor and against this new practice.     

Standardized Web-Based Cognitive Behavioural Therapy of Mild to Moderate Depression: A Randomized Controlled Trial with a Long-Term Follow-Up

Depression is common but undertreated. Web-based self-help provides a widely accessible treatment alternative for mild to moderate depression. However, the lack of therapist guidance may limit its efficacy. The authors assess the efficacy of therapist-guided web-based cognitive behavioural treatment (web-CBT) of mild to moderate depression. Fifty-four individuals with chronic, moderate depression participated in a randomized wait-list controlled trial, with an 18-month follow-up (immediate treatment: n = 36, wait-list control: n = 18). Primary outcome measures were the Beck Depression Inventory (BDI-IA) and the Depression scale of the Symptom Checklist-90-Revised (SCL-90-R. DEP). Secondary outcome measures were the Depression Anxiety Stress Scales and the Well-Being Questionnaire. Five participants (9%) dropped out. Intention-to-treat analyses of covariance revealed that participants in the treatment condition improved significantly more than those in the wait-list control condition (.011 < p < .015). With regard to the primary measures, between-group effects (d) were 0.7 for the BDI-IA and 1.1 for the SCL-90-R DEP. Posttest SCL-90- R DEP scores indicated recovery of 49% of the participants in the treatment group compared with 6% in the control group (odds ratio = 14.5; p < .004). On average, the effects were stable up to 18 months (n = 39), although medication was a strong predictor of relapse. The results demonstrate the efficacy of web-CBT for mild to moderate depression and the importance of therapist guidance in psychological interventions.     

Clinical specificity and the non-generalities of science

Theoretical Medicine and Bioethics - How to improve clinical practice and, in particular, that of physical therapy? Currently, several strategies are used which all fit the label...     

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.     

Autoshaped responding: A baseline for studying stimulus preference

In an autoshaping procedure with pigeons, trials consisted of the illumination of two keys, each with a different color, and then a response-independent feeder operation. Over successive conditions, all key-color pairs were arranged from the set of amber, red, green, and blue lamps. During sessions with a given pair, the left-right configuration of the colors varied irregularly, and the two colors alternated in illuminating the feeder. With one red and one green key, for example, red appeared sometimes on the left and sometimes on the right, and the feeder was alternately lit red or green on successive trials. Both total pecks and proportion of trials with at least one peck on a key of a given color were generally greater for red and amber than for green and blue, and relations among preferences were generally transitive across different color pairs. Repeating the procedure with decreased red and amber intensities and increased green and blue intensities reduced red and amber pecking relative to green and blue pecking, implying that differences in responding were determined more strongly by intensive than by chromatic properties of the stimuli.     

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。