Treatment Outcome Studies With Children: Principles of Proper Practice

This article addresses ethical issues in conducting randomized clinical trials (RCTs) with youth. Ethical considerations that occur prior to treatment (matters of research design, the risk–benefit ratio, issues concerning assent/consent, the influence of payment for participation), during treatment (issues of privacy, protocol adherence, premature termination), and following treatment (needs for posttreatment referrals and/or follow-up contacts, archiving of treatment data) are reviewed. Recommendations, based on empirical evidence and clinical experience, are offered for conducting ethical treatment research with youth and future directions for carrying out research on the ethics of conducting RCTs with youth are offered.     

Reasonable People,Double Jeopardy,and Justice

The equipoise requirement in clinical research demands that, if patients are to be randomly assigned to one of two interventions in a clinical trial, there must be genuine doubt about which is better. This reflects the traditional view that physicians must never knowingly compromise the care of their patients, even for the sake of future patients. Equipoise has proven to be deeply problematic, especially in the Third World. Some recent critics have argued against equipoise on the grounds that clinical research is fundamentally distinct from clinical care, and thus should be governed by different norms. I argue against this “difference position,” and instead take issue with the traditional, exclusively patient-centered account of physicians' obligations that equipoise presupposes. In place of this traditional view, I propose a Kantian test for the reasonable partiality that physicians should show their patients, focusing on its application in clinical research and medical education.     

From Standardization to Adaptation: Clinical Trials and the Moral Economy of Anticipation

Hailed as the gold standard, the randomized controlled trial (RCT) occupies a hegemonic position at the top of evidence-based medicine’s hierarchy of knowledge. It is testament to the methodology’s capacity for standardization that it can so readily be spoken of in the singular: the RCT. Under what conditions, then, is it possible to speak of change in the gold standard? Since the 1950s, alternative versions of the RCT have been advocated for under the banner of ‘adaptive design’. Adaptive designs allow investigators to make pre-planned changes to a trial on the basis of accruing information while the experiment is ongoing. Initially a niche topic of methodological debate among biostatisticians, the approach is becoming widespread in mainstream drug development. A genealogical analysis exposes the discursive moves used to justify and popularize adaptation, from a focus on patient well-being and the greater good in the 1960s and 1970s, to efficiency and virtualism in the 1990s and 2000s. Changing discourses of time and patienthood have facilitated a move away from standardization as the singular logic of trials towards an appreciation of flexibility, undergirded by probabilistic methodologies. Adams et al.’s [(2009). Anticipation: Technoscience, life, affect, temporality, Subjectivity, 28, pp. 246–265] conceptual framework of anticipation illuminates this evolving moral economy of medical research, in which modes of knowledge production which claim to know the future are supplanting the traditional certainties of fixed and standardized experimental designs. Predictable uncertainty is the currency of this emerging economy, which capitalizes on computer simulation and ever more sophisticated tools of prediction to leverage credibility.     

Öst's (2008) methodological comparison of clinical trials of acceptance and commitment therapy versus cognitive behavior therapy: Matching Apples with Oranges?

Öst (2008) recently compared the methodological rigor of studies of acceptance and commitment therapy (ACT) and traditional cognitive behavior therapy (CBT). He concluded that the ACT studies had more methodological deficiencies, and thus the treatment did not qualify as an “empirically supported treatment.” Although Öst noted several important limitations that should be carefully considered when evaluating early ACT research, his attempt to devise an empirical matching strategy by creating a comparison sample of CBT studies to bolster his conclusions was itself problematic. The samples were clearly mismatched in terms of the populations being treated, leading to differences in study design and methodology. Furthermore, reanalysis showed clear differences in grant support favoring CBT compared with ACT studies that were not reported in the original article. Given the actual mismatch between the samples, Öst's methodological ratings are difficult to interpret and provide little useful information beyond what could already be gathered by a qualitative review of ACT study limitations. Such limitations are characteristic of the earlier randomized controlled trials of any emerging psychotherapeutic approach.     

Principles and Problems in the Assessment of Quality of Life in Health Care

A remarkable surge in efforts to assess the quality of life of patients has occurred in recent years in medical research. Philosophical discussions of these developments have focused, on the one hand, on epistemological reservations about the plausibility of measuring quality of life and, on the other hand, on moral and ethical qualms about the meaning of life conveyed in such assessments. Whilst providing an important note of caution, such critiques fail to recognise two basic principles of quality of life in medical research. Firstly it is intended to provide understanding about groups and categories of patients rather than individuals. Secondly the purpose of such research is to produce generalisations about the relative costs and benefits of specific health care interventions rather than absolute judgements regarding the quality of life of patients per se. Selecting a good quality of life measure for a clinical trial requires balancing criteria such as validity with practical feasibility. Such measures will play an increasingly central role in providing research evidence to improve health care.     

THE EFFECTS OF A SELF-INSTRUCTIONAL PACKAGE ON OVERACTIVE PRESCHOOL BOYS

The effects of a self-instructional package on three overactive preschool boys were investigated using a multiple-baseline design across subjects. Behavioral observations of the three target subjects indicated transfer of training effects from the experimental tasks to the classroom. On-task behaviors increased dramatically concomitant with the introduction of the self-instructional package, and treatment gains were maintained 22.5 weeks after baseline was initiated. In addition, the use of an observer-expectancy control condition gave further credibility to the demonstration of a causal relationship.     

Uncertainty and the Ethics of Clinical Trials

A probabilistic explication is offered of equipoise and uncertainty in clinical trials. In order to be useful in the justification of clinical trials, equipoise has to be interpreted in terms of overlapping probability distributions of possible treatment outcomes, rather than point estimates representing expectation values. Uncertainty about treatment outcomes is shown to be a necessary but insufficient condition for the ethical defensibility of clinical trials. Additional requirements are proposed for the nature of that uncertainty. The indecisiveness of our criteria for cautious decision-making under uncertainty creates the leeway that makes clinical trials defensible.     

Massed Cognitive Processing Therapy in Active-Duty Military: A Case Series

Despite consistent evidence that Cognitive Processing Therapy (CPT) is an efficacious treatment for posttraumatic stress disorder (PTSD), the effects among active-duty service members and veterans have been smaller than for civilians. Modifications to standard delivery may be needed to increase treatment engagement and completion, which could improve outcomes in this population. Delivering CPT in a massed format may reduce barriers to care and enable more rapid symptom reduction, yet clinicians and patients may have concerns about the tolerability and practicality of such interventions. This case series describes a course of CPT delivered in 5 days in a mixed group and individual format among 4 active-duty military service members as part of a larger randomized clinical trial. Although the pattern of symptom change differed between patients, most demonstrated clinically significant reductions in PTSD and depression symptoms during the 5-day treatment. Patients reported that the pace was tolerable and that the mixed group and individual format was beneficial. Although further research is needed to understand the longer-term outcomes of massed CPT, this therapy format has important implications for the future delivery of treatments for PTSD.     

Effects of Peer-Mediated Accountability on Opportunities to Respond and Correct Skill Performance by Elementary School Children in Physical Education

We investigated the effects of group instruction, peer-dyads, and peer-mediated accountability on the number of trials performed and the number of correct trials during one-minute timed trials of volleyball skills. Peer-mediated accountability consisted of teacher goal setting, peer recording of performance, public posting of performance, and special content-related activities that served as public recognition of achievement. Twenty-four students in a Grade 4 physical education class participated. A reversal A-B-A-C design was used to assess the effects of each condition. Results indicated that students performed more trials and were more successful in the peer-mediated accountability condition than during either group instruction of peer dyads conditions. Findings are discussed in terms of the contingent relation between performance and consequences created by the peer-mediated accountability variable.     

Effects of sequential 1-minute time trials with and without inter-trial feedback and self-correction on general and special education students' fluency with math facts

We measured the effects of two procedures for implementing 1-min time trials on the rate and accuracy with which elementary students wrote answers to single-digit math facts in two concurrent experiments in a first grade classroom and a special education classroom. On-task behavior of three students in each class was also measured. Baseline was a 10-min work period in which students were told to answer as many problems as you can. The two time trial conditions, each of which was also conducted within a 10-min period, consisted of: (1) a series of seven 1-min time trials with a 20-s rest period following each timing; and (2) two 1-min timings, each followed by a teacher-directed feedback and self-correction activity. Students in both classrooms answered correctly more problems per minute during both time trial conditions than they did during the 10-min work period, with the highest levels of fluency occurring during the two time trials with self-correction. The emphasis on going fast did not impair students' accuracy of performance. In both classrooms the percentage of attempted problems answered correctly was high during the initial baseline and increased slightly over the course of the study. On-task behavior was higher during both time trial conditions than during the 10-min work period. When asked at the study's conclusion which of the three methods for practicing math facts (1) helped you learn the most and (2) would you like to do again, the majority of the students in both classrooms chose the time trials followed by feedback and self-correction.