Group Intervention Studies in the Cognitive Rehabilitation of Individuals with Traumatic Brain Injury: Challenges Faced by Researchers

There are many factors to consider in designing and interpreting group studies. These include both analytic considerations, such as the selection of valid and reliable outcome measures, and subjective considerations, such as the selection of outcomes that are perceived to be important to participants and researchers. In this paper, we review key issues to consider in the design of group studies in neurorehabilitation, using problem-solving studies in traumatic brain injury as an example.     

Conflict or harmony? Clinical research and the medical press in Russia

The author relates conditions for conducting clinical trials in Russia, current experiences of ethics committees, areas where conflicts of interest can occur regarding publishing the results of clinical trials in medical journals and the state of medical journalism in Russia today. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002. The author is a science editor of Meditsynskaya Gazeta.     

Conflict of interest in medical research in Estonia

An area where conflicts of interest can take place in Estonia is in the conduct of clinical trials. The paper lists the main areas where such conflicts of interest can occur. The author also briefly discusses Estonia’s current position with regard to regulating genetic information and the commencement of the Estonian Genome Project. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Applying Behavioral Momentum Theory to Increase Compliance

ABSTRACT

Behavioral momentum has been used as a theory to create effective interventions to increase compliance with requests, including student compliance in schools. These interventions are based on delivering a series of high probability compliance request-response-reinforcement (RRR) trials at high rates just prior to providing a request for a response that has often resulted in noncompliance. In this article, a real example of a substitute teacher leading her class through the Hokey-Pokey is used to describe and clarify interventions based on behavioral momentum. Analysis of specific procedural variables that may impact the effectiveness of interventions based on behavioral momentum theory is provided to assist practitioners with development and implementation of these proce dures within educational contexts. Recommendations for future research on this innovative technology areprovided.     

Response to commentaries on discussion paper Gene–environment interdependence

There is a high measure of agreement on the key issues concerning gene–environment interdependence. Contrary to arguments on the need for direct exact replication of findings, it is suggested that “robust” replication using the same constructs is needed. RCTs have an important role for testing for environmental mediation but cannot be used for environmental risks in childhood that show G×E in relation to adult outcomes. Instead, greater use needs to be made of natural experiments. Experimental methods are needed to study biological mediating mechanisms and these should include both animal models and human brain imaging studies. In addition to further research on G×E, further studies of gene–environment correlations are required. Many challenges remain but the future for gene–environment interdependence is bright.     

Analysis of Recruitment Strategies: Enrolling Veterans With PTSD Into a Clinical Trial

This analysis evaluated the efficacy of a variety of recruitment methods employed in a medication trial in a veteran population. Recruitment and demographic data were collected over the course of a randomized controlled trial (RCT) assessing the efficacy of an experimental medication for posttraumatic stress disorder (PTSD). Multivariate logistic regression was used to identify demographic and recruitment variables predictive of consenting to participation in the trial. Data were collected for 1,050 potential study participants. As compared with individuals contacted by mail based on chart review, potential participants who were referred by a clinician were 3 times more likely to consent to participate, and individuals who responded to an advertisement were 5 times more likely to consent to participate. Females were more likely to respond to advertisements, whereas males were more likely to be referred. Those who were referred were significantly older than potential participants identified via the directed mailing. Clinician referral was the method most likely to lead to identifying an eligible and willing participant. When designing a recruitment plan for a clinical trial, factors such as the target sample and available staff should be carefully considered.     

The effect of message framing and the nature of the targeted illness on individuals’ intention to participate in clinical trials

IntroductionClinical trials are considered as the most useful methods to evaluate the efficacy of new medical treatments, but the participation of healthy individuals is often too small, which limits the statistical power of the trial and hence its effectiveness.ObjectiveThe goal of the present research is to assess, for the first time, the effects of message framing (gain versus loss) and of the nature of the illness targeted by a clinical trial (highly- versus mildly-contagious) on individuals’ intention to enter it.MethodsThe experimental manipulation is carried out within a scenario promoting a clinical trial, in a 2 (framing: gain vs loss) × 2 (nature of the illness: highly- vs mildly-contagious) between-participants design. After reading the scenario, participants were asked to rate their intention to enter the trial and their perception of its utility.ResultsStatistical analyses validated a causal model explaining that a gain-framed message describing a highly-contagious illness increases the perception of the utility of the clinical trial, which in turn enhances the intention to participate.ConclusionThe discussion mainly focuses on the contributions of these findings at a theoretical level, considering the limits and potential of their possible application.     

Is Measurement Noninvariance a Threat to Inferences Drawn from Randomized Control Trials? Evidence From Empirical and Simulation Studies

Randomized control trials (RCTs) are considered the gold standard when evaluating the impact of psychological interventions, educational programs, and other treatments on outcomes of interest. However, few studies consider whether forms of measurement bias like noninvariance might impact estimated treatment effects from RCTs. Such bias may be more likely to occur when survey scales are utilized in studies and evaluations in ways not supported by validation evidence, which occurs in practice. This study consists of simulation and empirical studies examining whether measurement noninvariance impacts treatment effects from RCTs. Simulation study results demonstrate that bias in treatment effect estimates is mild when the noninvariance occurs between subgroups (e.g., male and female participants), but can be quite substantial when being assigned to control or treatment induces the noninvariance. Results from the empirical study show that surveys used in two federally funded evaluations of educational programs were noninvariant across student age groups.     

USING A BLOCKED-TRIALS PROCEDURE TO TEACH IDENTITY MATCHING TO A CHILD WITH AUTISM

Children with autism may struggle in developing conditional discrimination repertoires. Saunders and Spradlin (1989 , 1990 , 1993 ) arranged “blocked” teaching trials in which they presented the same sample stimulus repeatedly across trials (in lieu of randomly alternating targets across trials) and then faded the number of trials in each block. We replicated the effects of this blocked‐trials procedure in teaching identity matching to a child with autism and evaluated the necessity of fading. Arranging blocked trials facilitated the acquisition of identity matching, but fading the block size was not necessary to maintain discriminated performance.