Selecting the Right Tool For the Job

There are competing ethical concerns when it comes to designing any clinical research study. Clinical trials of possible treatments for Ebola virus are no exception. If anything, the competing ethical concerns are exacerbated in trying to find answers to a deadly, rapidly spreading, infectious disease. The primary goal of current research is to identify experimental therapies that can cure Ebola or cure it with reasonable probability in infected individuals. Pursuit of that goal must be methodologically sound, practical and consistent with prevailing norms governing human subjects research. Some maintain that only randomized controlled trials (RCTs) with a placebo or standard-of-care arm can meet these conditions. We maintain that there are alternative trial designs that can do so as well and that sometimes these are preferable to RCTs.     

Handling Missing Covariates in Conditional Mixture Models Under Missing at Random Assumptions

Mixture modeling is a popular method that accounts for unobserved population heterogeneity using multiple latent classes that differ in response patterns. Psychologists use conditional mixture models to incorporate covariates into between-class and/or within-class regressions. Although psychologists often have missing covariate data, conditional mixtures are currently fit with a conditional likelihood, treating covariates as fixed and fully observed. Under this exogenous-x approach, missing covariates are handled primarily via listwise deletion. This sacrifices efficiency and does not allow missingness to depend on observed outcomes. Here we describe a modified joint likelihood approach that (a) allows inference about parameters of the exogenous-x conditional mixture even with nonnormal covariates, unlike a conventional multivariate mixture; (b) retains all cases under missing at random assumptions; (c) yields lower bias and higher efficiency than the exogenous-x approach under a variety of conditions with missing covariates; and (d) is straightforward to implement in available commercial software. The proposed approach is illustrated with an empirical analysis predicting membership in latent classes of conduct problems. Recommendations for practice are discussed.     

药物临床试验设计的伦理思考

目前广泛采用的药物临床试验设计中,由于不能使受试者最大限度的受益而在伦理学方面存在弊端。自适应设计方法的出现,为克服这一弊端提供了现实途径,可使药物临床试验的受试者能够最大程度的受益。本文从传统临床试验引发的伦理问题入手,阐述了自适应设计以人为本的特点,探讨了其在解决伦理与疗效冲突问题中的重要作用。     

Evaluation of a Peer-Led Mutual Support Group for Chinese Families of People with Schizophrenia

Family interventions in schizophrenia have shown positive effects on patients but little attention has been paid to their effects on family members, particularly those in non-Western countries. This randomized controlled trial evaluated the effectiveness of a bi-weekly, 12-session, family-led mutual support group for Chinese caregivers of schizophrenia sufferers over 6 months compared with standard psychiatric care. It was conducted with 76 families of outpatients with schizophrenia in Hong Kong of whom 38 were assigned randomly to either a mutual support group or standard care. Families' psychosocial health status and patients' symptom severity and length of re-hospitalizations at recruitment, one-week and 12-month post-intervention were compared between groups. Results of repeated-measures mixed model indicated that the mutual support group experienced significantly greater improvements in families' burden, functioning and number of support persons and length of patients' re-hospitalizations at two post-tests. The findings provide evidence that mutual support groups can be an effective family-initiated, community-based intervention for Chinese schizophrenia sufferers.     

The relationship between psychoanalysis and schizophrenia-A response to the commentary by Robert Michels

In this section, the author responds to Dr Michels's commentary. In contrast to the situation in the United States, there are far fewer psychoanalysts in the UK and very few indeed working in general psychiatry to influence its practice. It is argued that psychoanalysis differs from all other psychological approaches with its recognition of the inner world and its unconscious influence on the individual's everyday life. Michels invites one to focus on outcome studies to judge the effectiveness of psychoanalysis in schizophrenia. There is a danger of throwing the baby out with the bathwater in that psychoanalysis helps in understanding presenting clinical material and in risk assessment in everyday general psychiatry.     

Introduction to the Special Section: Advances in psychological prevention and treatment interventions to promote children's mental health

This paper introduces the Special Section on Advances in Psychological Prevention and Treatment Interventions to Promote Children's Mental Health. The three articles in the Special Section provide perspectives on the adaptation, evaluation, and implementation of evidence‐based psychological interventions for children in countries in Northern and Eastern Europe, and Latin America. The articles highlight disparate methodologies for the examination of intervention data, including addressing causal inference in the absence of availability of true experiment data (i.e., randomised controlled trial data), randomised trial data from a school‐based prevention programme, and predictors of change in an evidence‐based treatment programme. Together, the articles highlight the movement of evidence‐based practices into routine care settings and emerging strategies for settings in which randomised trial data are not yet available. They demonstrate the contribution of psychological research to the advancement of practices for improving children's mental health.     

Critical Time Intervention for Homeless People Making the Transition to Community Living: A Randomized Controlled Trial

To help create an evidence base in Europe for effective interventions that improve the well‐being of homeless people, we tested whether critical time intervention (CTI), a time‐limited intervention developed to support vulnerable people during times of transition, is effective outside the United States. For this multicenter, parallel‐group randomized controlled trial, 183 adults who were moving from shelters in the Netherlands to supported or independent housing were allocated to CTI or care‐as‐usual. The primary outcome was number of days rehoused, which was assessed by interviewing participants four times during a 9‐month follow‐up. Outcomes were analyzed with three‐level mixed‐effects models. The primary outcome did not differ between groups. CTI had a significant effect on family support and, for people experiencing less social support, psychological distress. Groups did not differ significantly on social support, fulfillment of care needs, quality of life, self‐esteem, excessive alcohol use, or cannabis use. Because few participants were homeless at 9 months, more research is needed to establish whether CTI can prevent long‐term recurrent homelessness. Given recent emphasis on informal support in public services and positive effects of CTI on family support and psychological distress, CTI is a fitting intervention for Dutch shelter services.     

部分中文医药杂志伦理保护措施的报告情况

对2002年之前和之后(2000年7月~2001年12月和2003年1月~2004年6月)对6种中文医药杂志发表的临床研究类文章进行比较,并对文中报告知情同意和伦理委员会批准情况的比例给予评价。