Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro‐research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

The Effects of a Computer Network on Pediatric Pain and Anxiety

SUMMARY

The objective of this study was to test the impact of an enhanced version of STARBRIGHT World (SBW2)-a private computer network for hospitalized children. The impact of SBW2 was assessed with a series of 44 replicated single system designs. Utilizing an ecological momentary assessment approach, self-reports were obtained regarding children's perceptions of their pain intensity, pain aversive-ness and anxiety. The results from the single system designs were aggregated using meta-analysis. Children experienced significantly less pain intensity, pain aversiveness, and anxiety in the SBW2 condition. These findings provide evidence regarding the effectiveness of SBW2 and demonstrate the utility of employing meta-analysis with single system designs.     

Counselor Trainees' Assessment and Diagnosis of Lesbian Clients with Dysthymic Disorder

SUMMARY

Graduate-level counselor trainees completed an Assessment and Diagnostic Inventory consisting of clinical vignettes and a series of questions pertaining to conceptualization of client problem, diagnosis, and assessment of overall level of psychopathology.We hypothesized that participants would assign different diagnoses to clients with lesbian versus heterosexual sexual orientation. Participants responded to vignettes in which clients were identified as either a lesbian or a heterosexual female, with all other content identical. Participants were significantly more likely to perceive lesbian clients' problems to be related to sexual orientation for the vignette corresponding to dysthymic disorder. However, they were not more likely to assign personality disorder diagnoses, nor did they attribute a greater degree of psychopathology to lesbian clients with dysthymic disorder.     

When the Learning Disabled Go to College

Abstract

During the last decade, federal laws have provided for remedial education in elementary and secondary schools for students with learning disabilities, preparing large numbers of them for college. Federal law also mandates helping learning-disabled students with their needs once they matriculate. Declining numbers of high school graduates in the aftermath of the baby boom have made more colleges open their doors to these students. The disabilities, and the accommodations they require, arrive in college with the rest of a student's baggage, demanding attention. Colleges and universities have chosen a variety of approaches, from specific remedial programs and individual accomodations according to need to more general programs. Some colleges pretend these disabilities do not exist and seem oblivious to their presence on campus. Learning disabilities can have an impact in every class and lecture hall and can contribute to unhappiness and the college's attrition rate. On the other hand, responsive and responsible programs provide students with the resources for the same education, honors, and opportunities as their nondisabled peers.     

Differences in Caregiver Self-Efficacy and Satisfaction Related to Sexual Abuse of Offspring

Research suggests parents of sexually abused children may experience negative perceptions of themselves and their parenting abilities following the victimization of their children, which may influence the recovery process in treatment for these families. This study assessed perceived self-efficacy and parenting satisfaction among female caregivers of sexually abused children and female caregivers whose children were not victimized. Results indicated that caregivers of child victims had significantly lower levels of perceived parenting efficacy than their counterparts. There were no significant differences found between groups with regard to parenting satisfaction. The results highlight the importance of evaluating perceived parenting competence in the treatment of nonoffending caregivers in order to facilitate optimal treatment of the child victim and all members of the family system.     

Re-inscribing Gender in New Modes of Medical Expertise: The Investigator-Coordinator Relationship in the Clinical Trials Industry

This article analyses the ways in which research coordinators forge professional identities in the highly gendered organizational context of the clinic. Drawing upon qualitative research on the organization of the clinical trials industry (that is, the private sector, for profit auxiliary companies that support pharmaceutical drug studies), this article explores the relationships between predominantly male physician-investigators and female research coordinators and the constitution of medical expertise in pharmaceutical drug development. One finding is that coordinators actively seek to establish relationships with investigators that mirror traditional doctor-nurse relationships, in which the feminized role is subordinated and devalued. Another finding is that the coordinators do, in fact, have profound research expertise that is frequently greater than that of the investigators. The coordinators develop expertise on pharmaceutical products and diseases through their observations of the patterns that occur in patient-participants' responses to investigational drugs. The article argues, however, that the nature of the relationships between coordinators and investigators renders invisible the coordinators' expertise. In this context, gender acts as a persistent social structure shaping both coordinators' and investigators' perceptions of who can be recognized as having authority and power in the workplace.     

Blinded sample size recalculation for clinical trials with normal data and baseline adjusted analysis

Baseline adjusted analyses are commonly encountered in practice, and regulatory guidelines endorse this practice. Sample size calculations for this kind of analyses require knowledge of the magnitude of nuisance parameters that are usually not given when the results of clinical trials are reported in the literature. It is therefore quite natural to start with a preliminary calculated sample size based on the sparse information available in the planning phase and to re‐estimate the value of the nuisance parameters (and with it the sample size) when a portion of the planned number of patients have completed the study. We investigate the characteristics of this internal pilot study design when an analysis of covariance with normally distributed outcome and one random covariate is applied. For this purpose we first assess the accuracy of four approximate sample size formulae within the fixed sample size design. Then the performance of the recalculation procedure with respect to its actual Type I error rate and power characteristics is examined. The results of simulation studies show that this approach has favorable properties with respect to the Type I error rate and power. Together with its simplicity, these features should make it attractive for practical application. Copyright © 2009 John Wiley & Sons, Ltd.     

Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry‐sponsored clinical trials

In this paper we set out what we consider to be a set of best practices for statisticians in the reporting of pharmaceutical industry‐sponsored clinical trials. We make eight recommendations covering: author responsibilities and recognition; publication timing; conflicts of interest; freedom to act; full author access to data; trial registration and independent review. These recommendations are made in the context of the prominent role played by statisticians in the design, conduct, analysis and reporting of pharmaceutical sponsored trials and the perception of the reporting of these trials in the wider community. Copyright © 2010 John Wiley & Sons, Ltd.     

Generalizing the standardized hazard ratio to multivariate proportional hazards regression,with an application to clinical~genomic studies

The standardized hazard ratio for univariate proportional hazards regression is generalized as a scalar to multivariate proportional hazards regression. Estimators of the standardized log hazard ratio are developed, with corrections for bias and for regression to the mean in high-dimensional analyses. Tests of point and interval null hypotheses and confidence intervals are constructed. Cohort sampling study designs, commonly used in prospective–retrospective clinical genomic studies, are accommodated.