The use of placebo in clinical practice has been the topic of extensive debate in the bioethics literature, with much scholarship focusing on concerns regarding deception. While considerations of placebo without deception have largely centred on open-label placebo, this paper considers a different kind of ethical quandary regarding placebo without an intent to deceive—one where the provider believes a treatment is effective due to a direct physiological mechanism, even though that belief may not be supported by rigorous scientific evidence. This (...) is often the case with complementary and alternative medicine (CAM) techniques and also with some mainstream therapies that have not proven to be better than sham. Using one such CAM technique as a case study—electroencephalography (EEG) neurofeedback for attention-deficit/hyperactivity disorder (ADHD)—this paper explores the ethics of providing therapies that may have some beneficial effect, although one that is likely due to placebo effect. First, we provide background on EEG neurofeedback for ADHD and its evidence base, showing how it has proven to be equivalent to—but not better than—sham neurofeedback. Subsequently, we explore whether offering therapies that are claimed to work via specific physical pathways, but may actually work due to the placebo effect, constitute deception. We suggest that this practice may constitute unintentional deception regarding mechanism of action. Ultimately, we argue that providers have increased information provision obligations when offering treatments that diverge from standard of care and we make recommendations for mitigating unintentional deception. (shrink)

Lying to one’s patients is wrong. So obvious as to border on a platitude, this truism is one that bioethicists have heartily endorsed for several decades. Deception, the standard line holds, underc...

Health care providers are expected both to relieve pain and to provide anticipatory guidance regarding how much a procedure is going to hurt. Fulfilling those expectations is complicated by the cognitive modulation of pain perception. Warning people to expect pain or setting expectations for pain relief not only influences their subjective experience, but it also alters how nociceptive stimuli are processed throughout the sensory and discriminative pathways in the brain. In light of this, I reconsider the characterization of placebo analgesia (...) as pharmacologically inert and the use of it as deceptive. I show that placebo analgesia exploits the same physical mechanisms as proven analgesics and argue that it should be utilized to relieve pain. Additionally, I describe factors to help identify situations in which clinicians have the obligation to disclose the potential for pain coupled with ways of mitigating the risk of high-intensity pain by setting positive expectations. (shrink)

In Italy in recent years, an exponential increase in the frequency of medical malpractice claims relating to the issue of informed consent has substantially altered not only medical ethics, but medical practice as well. Total or partial lack of consent has become the cornerstone of many malpractice lawsuits, and continues to be one of the primary cudgels against defendant physicians in Italian courtrooms. Physicians have responded to the rising number of claims with an increase in ‘defensive medicine’ and a prevailing (...) preoccupation with the purely formal aspects of consent. The result is a plethora of consent forms, believed to be a guarantee of ‘informed consent’, as well as a growing reliance on informed consent as a shield against judicial action brought by the patient. Physicians ‘inform’ patients without really sharing information, often delegating the task of communication to other professionals who are not doctors. Italian judges always condemn the physician when information to the patient has been inadequate, thus leading insurance companies to consider the lack of valid informed consent as the total responsibility of the physician and/or the hospital. It is necessary to change tack, to remove this idea of consent which permeates the defensive culture of medical practice. Italian physicians need to be trained, first of all, to become aware that information and consent are two distinct processes, albeit closely connected. Valid communication demands a higher level of professionalism from physicians. (shrink)

Hierarchies of evidence are an important and influential tool for appraising evidence in medicine. In recent years, hierarchies have been formally adopted by organizations including the Cochrane Collaboration [1], NICE [2,3], the WHO [4], the US Preventive Services Task Force [5], and the Australian NHMRC [6,7]. The development of such hierarchies has been regarded as a central part of Evidence-Based Medicine, a movement within healthcare which prioritises the use of epidemiological evidence such as that provided by Randomised Controlled Trials. Philosophical (...) work on the methodology of medicine has so far mostly focused on claims about the superiority of RCTs, and hence has largely neglected the questions of what hierarchies are, what assumptions they require, and how they affect clinical practice. This thesis shows that there is great variation in the hierarchies defended and in the interpretations they are, and can be, given. The interpretative assumptions made in using hierarchies are crucial to the content and defensibility of the underlying philosophical commitments concerning evidence and medical practice. Once this variation is been identified, it becomes clear that the little philosophical work that has been done so far affects only some hierarchies, under some interpretations. Modest interpretations offered by La Caze [11], conditional hierarchies like GRADE [12-14], and heuristic approaches such as that defended by Howick et al. [15,16] all survive previous philosophical criticism. This thesis extends previous criticisms by arguing that modest interpretations are so weak as to be unhelpful for clinical practice; that GRADE and similar conditional models omit clinically relevant information, such as information about variation in treatments’ effects and the causes of different responses to therapy; and that heuristic approaches lack the necessary empirical support. The conclusion is that hierarchies in general embed untenable philosophical assumptions: principally that information about average treatment effects backed by high-quality evidence can justify strong recommendations, and that the impact of evidence from individual studies can and should be appraised in isolation. Hierarchies are a poor basis for the application of evidence in clinical practice. The Evidence-Based Medicine movement should move beyond them and explore alternative tools for appraising the overall evidence for therapeutic claims. (shrink)

Warning research participants and patients about potential risks associated with participation/treatment is a fundamental part of consent. However, such risk warnings might cause negative expectations and subsequent nocebo effects (i.e., negative expectations cause negative outcomes) in participants. Because no existing review documents how past research has quantitatively examined nocebo effects – and negative expectations – arising from consent risk warnings, we conducted a pre-registered scoping review (N = 9). We identified several methodological issues across these studies, which in addition to (...) mixed findings, limit conclusions about whether risk warnings cause nocebo effects. (shrink)

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. (...) To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply. (shrink)

The informed consent process presents challenges for psychological trauma research (e.g. Institutional Review Board [IRB] apprehension). While previous research documents researcher and IRB-member perspectives on these challenges, participant views remain absent. Thus, using a mixed-methods approach, we investigated participant views on consent guidelines in two convenience samples: crowdsourced (N = 268) and undergraduate (N = 265) participants. We also examined whether trauma-exposure influenced participant views. Overall, participants were satisfied with current guidelines, providing minor feedback and ethical reminders for researchers. Moreover, (...) participant views for consent were similar irrespective of trauma-exposure. Our study has implications for IRBs and psychological researchers. (shrink)

Pains are subject to obvious, well-documented, and striking top-down influences. This is in stark contrast to visual perception, where the debate over cognitive penetrability tends to revolve around fairly subtle experimental effects. Several authors have recently taken up the question of whether top-down effects on pain count as cognitive penetrability, and what that might show us about traditional debates. I review some of the known mechanisms for top-down modulation of pain, and suggest that it reveals an issue with a relatively (...) neglected part of the cognitive penetrability literature. Much of the debate inherits Pylyshyn’s stark contrast between transducers and cognition proper. His distinction grew out of his running fight with Gibson, and is far too strong to be defensible. I suggest that we might therefore view top-down influences on pain as a species of transducer calibration. This provides a novel but principled way to distinguish between several varieties of top-down effect according to their architectural features. (shrink)

The American Journal of Bioethics, Volume 12, Issue 3, Page 31-33, March 2012.

The American Journal of Bioethics, Volume 12, Issue 3, Page 37-39, March 2012.

Background Thorough information of the patient is an integral part of the process of shared decision making. We aimed to investigate if detailed information about medication may induce nocebo effects. Methods We conducted a randomized, single-blind, pilot-study including n = 51 psychiatric in-patients aged between 18 and 80 years with a depressive disorder and accompanying sleeping disorders. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. In both groups, (...) patients received an open-label placebo pill instead of their sleeping medication. Results No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter. Conclusion In this study, we were not able detect an effect of informed consent vs. simple consent on the emergence of placebo or nocebo effects. This finding is contrary to most assumptions and publications about this topic. Trial registration Trial registration number: DRKS00017653, registered August 30th 2018. Retrosprectively registered. (shrink)

PurposeIn this paper, patient information is approached from a Heideggerian perspective with the intention to gather an understanding about the personal nature of the information. The purpose of this paper is to analyse the ownership of patient information and then present Datenherrschaft as a suitable model for patient ownership of patient information.Design/methodology/approachThis paper is theoretical in approach. It is based on arguments derived from Heidegger’s work in the Being and Time.FindingsBased on this Heideggerian approcah, a proposal for using the special (...) definition of ownership of patient information – Datenherrschaft – given to a patient is suggested. From a Heideggerian perspective, it can be stated that the patient has the strongest rights towards patient information because this information is crucial for a patient to have an understanding about their Dasein.Research limitations/implicationsDatenherrschaft is used as an example of an ethically justified way of regulating the patient information ownership and should be analysed further. Especially the practical implications of implementing Datenherrschaft need more research.Originality/valuePatient information ownership is an issue that is neither unambiguously solved in many countries, nor has it, in our view, been ethically justified. The potential solution – Datenherrschaft – presented in this paper is clear and has strong philosophical justifications. (shrink)

Nocebo effects occur when an adverse effect on the patient arises from the patient's own negative expectations. In accordance with informed consent, providers often disclose information that results in unintended adverse outcomes for the patient. While this may adhere to the principle of autonomy, it violates the doctrine of “primum non nocere,” given that side-effect disclosure may cause those side effects. In this article we build off previous work, particularly by Wells and Kaptchuk and by Cohen :3–11.[Taylor & Francis Online], (...) [Web of Science ®] [Google Scholar]), to suggest ethical guidelines that permit nondisclosure in the case when a nocebo effect is likely to occur on of the basis of nonmaleficence. We accept that that autonomy vis-à-vis informed consent must be forestalled, but salvage much of its role by elaborating a practical clinical approach to postencounter follow-up. In doing so, we reconcile a clinically practicable process of determining conditions of disclosure with long-standing ethical commitments to patients. (shrink)

Fortunato and colleagues' target article extends both the ethical analysis and the clinical practice of nondisclosure by focusing on nocebo effects (Fortunato, Wasserman, and Menkes 2017). Instance...

Introduction:The effects of specific suggestions are usually studied by measuring parameters that are directly addressed by these suggestions. We recently proposed the use of a uniform, unrelated, and objective measure like maximal muscle strength that allows comparison of suggestions to avoid nocebo effects and thus to improve communication. Since reduced breathing strength might impair respiration and increase the risk of post-operative pulmonary complications, the aim of the present study was to evaluate the effects of the suggestions on respiratory muscle power. (...) Both the identification and neutralization of negative suggestions in the clinical context and stimulating suggestions could improve breathing force, a predictor of physical fitness and convalescence.MethodsIn 50 healthy, adult volunteers, respiratory muscle strength was measured by maximal inspiratory and expiratory pressures, as well as by maximal inspiratory and expiratory flows. Baseline was compared to values after application of eleven suggestions, five out of clinical context, including memory of negative or positive past, risk information for informed consent, and a non-verbal suggestion. Six stimulating suggestions included self-affirmation, empowering words, a heroic mirror image, and an imagination.ResultsAll suggestions showed an impact on respiratory muscle strength, indicating placebo and nocebo effects. No single parameter could represent the breathing force in its complexity, however, trends and different specific aspects of it were measured. The strongest reaction was observed with the recall of a previous negative situation resulting in a reduction in expiratory flow to 96.1% of baseline. After risk information, a decrease was observed in three of the parameters, with the highest extend in expiratory pressure by 4.4%. This nocebo effect was neutralized by adding positive aspects to the risk information. Every intended strengthening suggestion resulted in statistically significant increases of at least one parameter, with changes of up to 10%, indicating placebo effects. Here, expiration was more affected than inspiration. Sex was the only influencing factor reaching statistical significance, with stronger reactions in women.ConclusionRespiratory muscle strength proved to be sensitive to suggestions with clinical context, as well as suggestions intended for stimulation. With this objective measurement, evaluation, and comparison of different suggestions is possible to help avoid nocebo effects. The demonstrated effect of supporting suggestions can be followed up and used in clinical practice. (shrink)

The Italian code of medical deontology recently approved stipulates that physicians have the duty to inform the patient of each unwanted event and its causes, and to identify, report and evaluate adverse events and errors. Thus the obligation to supply information continues to widen, in some way extending beyond the doctor-patient relationship to become an essential tool for improving the quality of professional services.

Informed consent is an essential step in helping patients be aware of consequences of their treatment decisions. With surgery, it is vitally important for patients to understand the risks and benefits of the procedure and decide accordingly. We explored whether a written IC form was provided to patients; whether they read and signed it; whether they communicated orally with the physician; whether these communications influenced patient decisions. Adult postsurgical patients in nine general hospitals of Italy’s Campania Region were interviewed via (...) a structured questionnaire between the second and seventh day after the surgery at the end of the first surgical follow up visit. Physicians who were independent from the surgical team administered the questionnaire. The written IC form was given to 84.5% of those interviewed. All recipients of the form signed it, either personally or through a delegate; however, 13.9% did not know/remember having done so; 51.8% said that they read it thoroughly. Of those who reported to have read it, 90.9% judged it to be clear. Of those receiving the written consent form, 52.0% had gotten it the day before the surgery at the earliest 41.1% received it some hours or immediately before the procedure. The written IC form was explained to 65.6% of the patients, and 93.9% of them received further oral information that deemed understandable. Most attention was given to the diagnosis and the type of surgical procedure, which was communicated respectively to 92.8 and 88.2% of the patients. Almost one in two patients believed that the information provided some emotional relief, while 23.2% experienced increased anxiety. Younger patients and patients with higher levels of education were more likely to read the written IC form. The written IC form is not sufficient in assuring patients and making them fully aware of choices they made for their health; pre-operative information that was delivered orally better served the patients’ needs. To improve the quality of communication we suggest enhancing physicians’ communication skills and for them to use structured conversation to ensure that individuals are completely informed before undergoing their procedures. (shrink)

The American Journal of Bioethics, Volume 12, Issue 3, Page 30-31, March 2012.

The nocebo effect, a phenomenon whereby learning about the possible side effects of a medical treatment increases the likelihood that one will suffer these side effects, continues to challenge physicians and ethicists. If a physician fully informs her patient as to the potential side effects of a medicine that may produce nocebogenic effects, which is usually conceived of as being a requirement associated with the duty to respect autonomy, she risks increasing the likelihood that her patient will experience these side (...) effects and therefore suffer (unnecessary) harm, a violation of the duty of nonmaleficence. If, on the other hand, she intentionally withholds side effect information in an effort to protect her patient from suffering unnecessary harm from side effects, which is consistent with the duty of nonmaleficence, she violates the duty to respect patient autonomy. In this paper, the author discusses several previous attempts to deal with the nocebo effect and explains their weaknesses. He then proposes a means of managing the nocebo effect and argues that it does not share the weaknesses found in previous approaches. He concludes with a discussion of a simple, yet practical tool that might help clinicians manage the tension resulting from the nocebo effect. (shrink)

The American Journal of Bioethics, Volume 12, Issue 3, Page 33-34, March 2012.

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. (...) To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply. (shrink)

IntroductionIn the context of giving risk information for obtaining informed consent, it is not easy to comply with the ethical principle of “primum nihil nocere.” Carelessness, ignorance of nocebo effects and a misunderstood striving for legal certainty can lead doctors to comprehensive and brutal risk information. It is known that talking about risks and side effects can even trigger those and result in distress and nonadherence to medication or therapy.MethodsRecently, we have reported on significant clinically relevant effects of verbal and (...) non-verbal suggestions on maximal muscular arm strength in healthy volunteers and in patients at two time points before surgery. Maximal strength during arm abduction was measured by dynamometry of the deltoid muscle group. Suggestions from clinical everyday life were formulated as presumed negative and neutral versions.ResultsHere, we report on the effects of two versions of risk information in 45 patients. After sole mentioning risks of a puncture for the placement of a pain catheter, the maximal arm muscle strength was significantly reduced to 83% of baseline several days, and to 84% the evening before surgery. Strength was not significantly decreased and close to baseline at T1 and T2 when risks and benefits of a pain catheter were combined in one sentence. The difference between both versions was significant. With persistent normal distribution of values, the effect was due to uniform reactions of many patients, not to strong reactions of a few. High suggestibility and increase of anxiety with approaching surgery were identified as influencing factors for the neutralizing effect of modified wording.ConclusionWe not only suggest an alternative formulation for risk information to avoid nocebo effects but present an objective method to quantify and compare effects of different wordings. Thereby, we provide evidence that concurrently given positive aspects can neutralize negative effects during medical interview. (shrink)