Case method and casuistry: The problem of bias

Case methods of reasoning are persuasive, but we need to address problems of bias in order to use them to reach morally justifiable conclusions. A bias is an unwarranted inclination or a special perspective that disposes us to mistaken or one-sided judgments. The potential for bias arises at each stage of a case method of reasoning including in describing, framing, selecting and comparing of cases and paradigms. A problem of bias occurs because to identify the relevant features for such purposes, we must use general views about what is relevant; but some of our general views are biased, both in the sense of being unwarranted inclinations and in the sense that they are one of many viable perspectives. This reliance upon general views to determine relevancy creates additional difficulties for defenders who maintain that case methods of moral reasoning are not only useful, but more basic, reliable or prior to other forms of moral reasoning. If we cannot identify the case's relevant features and issues independently of our general views or biases, we need further explanation about why a case method or casuistry should be viewed as prior to or more basic or reliable than other forms of moral reasoning. Problems of bias also arise for other methods of reasoning. In medical science, case reviews are regarded as an unreliable way to form generalizations, and methods such as clinical trials are used to address bias.     

Sudden Gains in Internet-Based Cognitive Behavior Therapy for Body Dysmorphic Disorder

Sudden gains have been associated with better short- and long-term treatment outcomes in a number of psychiatric disorders. However, no studies to date have evaluated sudden gains in body dysmorphic disorder (BDD). We used data from a previous randomized controlled trial evaluating the efficacy of an Internet-based cognitive-behavior treatment (CBT) for BDD. The sample consisted of 47 adults diagnosed with BDD. We compared the treatment outcomes of sudden gainers vs. gradual gainers (i.e., treatment responders with no sudden gains) and non-sudden gainers (i.e., gradual gainers plus nonresponders) at posttreatment and 3, 12, and 24 months after the end of the treatment. Twelve (25.5%) participants experienced a sudden gain. Compared to non-sudden gainers and to gradual gainers, sudden gainers showed significantly larger improvements on the Yale-Brown Obsessive-Compulsive Scale modified for BDD at posttreatment (g = 1.23 and g = .91, respectively), and at 3-month (g = 1.23 and g = 1.00, respectively), 12-month (g = 1.12 and g = .91, respectively), and 24-month follow-up (g = 1.11 and g = .97, respectively). This translated into higher rates of treatment responders and remitters in the sudden gainers across all time points. The occurrence of sudden gains in Internet-based CBT for BDD is associated with favorable short- and long-term treatment outcomes. This suggests that a sudden improvement during the treatment could be a marker of good prognosis, while non-sudden—including gradual—gainers are more likely to need continued support or booster sessions. Early identification of patients who are not progressing as expected and subsequent tailoring of the delivered intervention has the potential to improve treatment outcomes in this group.     

Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments

The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 ± 31.7 (range: 0–131) projects of clinical trials and 71.1 ± 139.8 (range: 0–638) projects of other types of medical research. During one BC meeting an average of 10.3 ± 14.7 (range: 0–71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary.

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.     

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.

The Inducement of Meaningful Work: A Response to Anderson and Weijer

James A. Anderson and Charles Weijer take the wage payment model proposed by Neil Dickert and Christine Grady and extend the analogy of research participation to unskilled wage labor to include just working conditions. Although noble in its intentions, this moral extension generates unsavory outcomes. Most notably, Anderson and Weijer distinguish between two types of research subjects: occasional and professional. The latter, in this case, receives benefits beyond the moral minima in the form of “the right to meaningful work.” The problem is that meaningful work can itself be a form of inducement, and consequently, may in fact increase the incidence of inducement contrary to the intentions of the wage payment model.     

A randomized controlled comparison of guided self-help cognitive behavioral therapy and behavioral weight loss for binge eating disorder

We performed a randomized controlled study to test the relative efficacy of guided self-help (gsh) cognitive-behavioral therapy (CBTgsh) and behavioral weight loss treatment (BWLgsh) treatments for binge eating disorder (BED). To provide an additional partial control for non-specific influences of attention, a third control (CON) treatment condition was included. We tested the treatments using a guided self-help approach given the promising results from initial studies using minimal therapist guidance. Ninety consecutive overweight patients (19 males, 71 females) with BED were randomly assigned (5:5:2 ratio) to one of three treatments: CBTgsh (N=37), BWLgsh (N=38), or CON (N=15). The three 12-week treatment conditions were administered individually following guided self-help protocols. Overall, 70 (78%) completed treatments; CBTgsh (87%) and CON (87%) had significantly higher completion rates than BWLgsh (67%). Intent-to-treat analyses revealed that CBTgsh had significantly higher remission rates (46%) than either BWLgsh (18%) or CON (13%). Weight loss was minimal and differed little across treatments. The findings suggest that CBT, administered via guided self-help, demonstrates efficacy for BED, but not for obesity. The findings support CBT administered via guided self-help as a first step in the treatment of BED and provide evidence for its specific effects.     

A review of the worst performance rule: Evidence, theory, and alternative hypotheses

This paper reviews evidence, theory, and alternative hypotheses for the worst performance rule (WPR), which states that on multitrial cognitive tasks, worst performance trials predict general intelligence (g) better than best performance trials. A review of the relevant evidence indicates that the WPR has been found for a variety of participants, tasks, and measures. A review of relevant theories reveals that the WPR appears to be related to cognitive factors (e.g., lapses in working memory) as well as biological factors (e.g., individual differences in neural oscillations). A review of alternative hypotheses shows that the WPR cannot be attributed to statistical or data artifacts such as outliers, unreliable measurement, or variance compression. The preponderance of evidence supports the hypothesis that the WPR holds for cognitive tasks high in g saturation but not for cognitive tasks low in g saturation. The paper ends with a call for research on the causes of the WPR and for research on the correlates of best performance.     

Using empirical data to inform the ethical evaluation of placebo controlled trials

There has been considerable debate about the ethical acceptability of using placebo-controls in clinical research. Although this debate has been rich in rhetoric, considering that much of this research is predicated upon the assumption that data from this research is vital to clinical decision-making, it is ironic that researchers have introduced little data into these discussions. Using some published research concerning the use of placebo-controls in clinical research in hypertension and psychiatric drug trials, I suggest some ways that such data might be incorporated into the ethical analysis concerning placebo use in clinical trials. This approach promises to be important for enhancing conceptual and scientific understanding as well as public policy decision-making. An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.