The placebo effect in popular culture

This paper gives an overview of the placebo effect in popular culture, especially as it pertains to the work of authors Patrick O’Brian and Sinclair Lewis. The beloved physician as placebo, and the clinician scientist as villain are themes that respectively inform the novels, The Hundred Days and Arrowsmith. Excerpts from the novels, and from film show how the placebo effect, and the randomized clinical trial, have emerged into popular culture, and evolved over time. 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.     

Informed consent and the use of placebo in poland: Ethical and legal aspects

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. 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.     

The Ethics of Type 1 Diabetes Prediction and Prevention Research

There are approximately one million cases oftype 1 diabetes in the US, and the incidenceis increasing worldwide. Given that two-thirdsof cases present in childhood, it is criticalthat prediction and prevention research involvechildren. In this article, I examine whethercurrent research methodologies conform to theethical guidelines enumerated by the NationalCommission for the Protection of Human Subjectsof Biomedical and Behavioral Research, andadopted into the federal regulations thatprotect research subjects. I then offer twopolicy recommendations to help researchersdesign studies that conform to these ethicalrequirements.     

Effects of a meaningful, a discriminative, and a meaningless stimulus on equivalence class formation

Thirty college students attempted to form three 3-node 5-member equivalence classes under the simultaneous protocol. After concurrent training of AB, BC, CD, and DE relations, all probes used to assess the emergence of symmetrical, transitive, and equivalence relations were presented for two test blocks. When the A-E stimuli were all abstract shapes, none of 10 participants formed classes. When the A, B, D, and E stimuli were abstract shapes and the C stimuli were meaningful pictures, 8 of 10 participants formed classes. This high yield may reflect the expansion of existing classes that consist of the associates of the meaningful stimuli, rather than the formation of the ABCDE classes, per se. When the A-E stimuli were abstract shapes and the C stimuli became S(D)s prior to class formation, 5 out of 10 participants formed classes. Thus, the discriminative functions served by the meaningful stimuli can account for some of the enhancement of class formation produced by the inclusion of a meaningful stimulus as a class member. A sorting task, which provided a secondary measure of class formation, indicated the formation of all three classes when the emergent relations probes indicated the same outcome. In contrast, the sorting test indicated "partial" class formation when the emergent relations test indicated no class formation. Finally, the effects of nodal distance on the relatedness of stimuli in the equivalence classes were not influenced by the functions served by the C stimuli in the equivalence classes.     

Group critical incident stress debriefing with emergency services personnel: a randomized controlled trial

Although single-session individual debriefing is contraindicated, the efficacy of group psychological debriefing remains unresolved. We conducted the first randomized controlled trial of critical incident stress debriefing (CISD) with emergency workers (67 volunteer fire-fighters) following shared exposure to an occupational potentially traumatic event (PTE). The goals of group CISD are to prevent post-traumatic stress and promote return to normal functioning following a PTE. To assess both goals we measured four outcomes, before and after the intervention: post-traumatic stress, psychological distress, quality of life, and alcohol use. Fire brigades were randomly assigned to one of three treatment conditions: (1) CISD, (2) Screening (i.e., no-treatment), or (3) stress management Education. Controlling for pre-intervention scores, CISD was associated with significantly less alcohol use post-intervention relative to Screening, and significantly greater post-intervention quality of life relative to Education. There were no significant effects on post-traumatic stress or psychological distress. Overall, CISD may benefit broader functioning following exposure to work-related PTEs. Future research should focus on individual, group, and organizational factors and processes that can promote recovery from operational stressors. Ultimately, an occupational health (rather than victim-based) approach will provide the best framework for understanding and combating potential threats to the health and well-being of workers at high risk for PTE exposure.     

Longitudinal Impact of a Family Critical Time Intervention on Children in High-Risk Families Experiencing Homelessness: A Randomized Trial

A randomized trial compared effects of a Family Critical Time Intervention (FCTI) to usual care for children in 200 newly homeless families in which mothers had diagnosable mental illness or substance problems. Adapted from an evidence‐based practice to prevent chronic homelessness for adults with mental illnesses, FCTI combines housing and structured, time‐limited case management to connect families leaving shelter with community services. Families were followed at five time points over 24 months. Data on 311 children—99 ages 1.5–5 years, 113 ages 6–10 years, and 99 ages 11–16 years—included mother‐, teacher‐, and child‐reports of mental health, school experiences, and psychosocial well‐being. Analyses used hierarchical linear modeling to investigate intervention effects and changes in child functioning over time. Referral to FCTI reduced internalizing and externalizing problems in preschool‐aged children and externalizing for adolescents 11–16. The intervention led to declines in self‐reported school troubles for children 6–10 and 11–16. Both experimental and control children in all age groups showed reductions in symptoms over time. Although experimental results were scattered, they suggest that FCTI has the potential to improve mental health and school outcomes for children experiencing homelessness.     

Reducing the risk of bias in health behaviour change trials: Improving trial design,reporting or bias assessment criteria? A review and case study

Objective: It has been suggested that randomised controlled trials (RCTs) of health behaviour change (HBC) interventions are less rigorously designed than – for example– drug trials. This study presents an approach to clarifying whether this is due to poor trial design, incomplete trial reporting and/or the inappropriateness of commonly applied risk of bias assessment criteria.

Design: First, a framework of key sources of bias and common strategies for reducing bias risk is developed based on a literature review. Second, we describe the design of a multi-site RCT evaluating the cost-effectiveness of an HIV-treatment adherence intervention (case study). The choices made by the multidisciplinary team trying to minimise the risk of bias are compared against the risk of bias framework.

Main outcome measures: Implementation of common strategies for reducing the risk of bias in the case study; alternative or additional strategies applied; a justification for each deviation from the risk of bias framework.

Results: Most of the common strategies for reducing the risk of bias could be implemented. Alternative strategies were developed for minimising the risk of performance bias and contamination. Several additional, domain-specific risk of bias strategies were implemented.

Conclusions: The literature provides useful guidance for reducing the risk of bias in HBC trials. Yet, the case study suggests that HBC trial designers may face specific challenges that require alternative/additional measures for reducing the risk of bias. Using the risk of bias justification table (RATIONALE) could lead to better-designed HBC trials, more comprehensive trial reports and the data necessary for evaluating the appropriateness of commonly applied risk of bias assessment criteria to HBC trials.     

The protection of patients’ rights in clinical trials

The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the avoidance of conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients’ rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. This paper was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005. The author is Chairman, Bioethics Committee of the Warsaw Regional Chamber of Physicians and Dentists.     

Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial

Clinician-guided Internet-based cognitive behavioural therapy (iCBT) programs are clinically effective at treating specific anxiety disorders. The present study examined the efficacy of a transdiagnostic Internet-based cognitive behavioural treatment (iCBT) program to treat more than one anxiety disorder within the same program (the Anxiety Program). Eighty six individuals meeting diagnostic criteria for generalized anxiety disorder (GAD), panic disorder, and/or social phobia were randomly assigned to a treatment group, or to a waitlist control group. Treatment consisted of CBT based online educational lessons and homework assignments, weekly email or telephone contact from a clinical psychologist, access to a moderated online discussion forum, and automated emails. An intention-to-treat model using the baseline-observation-carried-forward principle was employed for data analyses. Seventy-five percent of treatment group participants completed all 6 lessons within the 8 week program. Post-treatment data was collected from 38/40 treatment group and 38/38 control group participants, and 3-month follow-up data was collected from 32/40 treatment group participants. Relative to controls, treatment group participants reported significantly reduced symptoms of anxiety as measured by the Generalized Anxiety Disorder - 7 Item, Social Phobia Screening Questionnaire, and the Panic Disorder Severity Rating Scale - Self Report Scale, but not on the Penn State Worry Questionnaire, with corresponding between-groups effect sizes (Cohen’s d) at post-treatment of 0.78, 0.43, 0.43, and 0.20, respectively. The clinician spent a total mean time of 46 min per person over the program, participants rated the procedure as moderately acceptable, and gains were sustained at follow-up. Modifications to the Anxiety program, based on post-treatment feedback from treatment group participants, were associated with improved outcomes in the control group. These results indicate that transdiagnostic programs for anxiety disorders may be successfully administered via the Internet.     

Shaping Medical Students' Attitudes Toward Ethically Important Aspects of Clinical Research: Results of a Randomized,Controlled Educational Intervention

The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants (empathy focused). The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols (analytic focused). Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, desire for information, hopes about participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics.