Human papillomavirus (HPV) vaccination: a call for action in Italy.

Human papillomavirus (HPV) is the most common sexually transmitted infection. The implementation of primary prevention aims to reduce the burden of HPV infection and HPV-related disease. However, HPV-related diseases are still a concern, even in high-income countries. Approximately 570 000 new cervical cancer cases are diagnosed in Italy every year. Prophylactic HPV vaccines have been developed to minimize the spread of HPV. Growing evidence supports the administration of HPV vaccines (even just one dose) in reducing the prevalence of HPV infection and HPV-related disease including cancers. HPV vaccines are characterized by a high level of efficacy (>95%) in women who are naïve to HPV; however, they do not increase clearance in patients with ongoing HPV infection. With more than 200 million doses administered to date, HPV vaccines are considered to be safe and effective at preventing HPV-related infections and cancers. In this review we aim to review the current evidence regarding HPV vaccination and to describe trends in HPV vaccination coverage in Italy. In Italy, vaccination against HPV has been included in the National Immunization Plan (NIP) since 2007-2008. Using data abstracted from the Italian Ministry of Health, we analyzed changes in HPV vaccination coverage. We observed that HPV vaccines are underutilized and coverage rates are decreasing. Looking at the target population (females and males aged 11-12 years) in Italy, a decrease in coverage rates was observed. A call for action, improved HPV awareness, and education are the key elements to enhance the widespread adoption of HPV vaccination.

Implications of Placebo and Nocebo Effects for Clinical Practice: Expert Consensus.

BACKGROUND: Placebo and nocebo effects occur in clinical or laboratory medical contexts after administration of an inert treatment or as part of active treatments and are due to psychobiological mechanisms such as expectancies of the patient. Placebo and nocebo studies have evolved from predominantly methodological research into a far-reaching interdisciplinary field that is unravelling the neurobiological, behavioural and clinical underpinnings of these phenomena in a broad variety of medical conditions. As a consequence, there is an increasing demand from health professionals to develop expert recommendations about evidence-based and ethical use of placebo and nocebo effects for clinical practice. METHODS: A survey and interdisciplinary expert meeting by invitation was organized as part of the 1st Society for Interdisciplinary Placebo Studies (SIPS) conference in 2017. Twenty-nine internationally recognized placebo researchers participated. RESULTS: There was consensus that maximizing placebo effects and minimizing nocebo effects should lead to better treatment outcomes with fewer side effects. Experts particularly agreed on the importance of informing patients about placebo and nocebo effects and training health professionals in patient-clinician communication to maximize placebo and minimize nocebo effects. CONCLUSIONS: The current paper forms a first step towards developing evidence-based and ethical recommendations about the implications of placebo and nocebo research for medical practice, based on the current state of evidence and the consensus of experts. Future research might focus on how to implement these recommendations, including how to optimize conditions for educating patients about placebo and nocebo effects and providing training for the implementation in clinical practice.

A Critical (and Cautiously Optimistic) Appraisal of Moerman's "Meaning Response".

In this article we propose a critical reassessment of Daniel Moerman's "meaning response." First, we reconstruct and criticize Moerman's original proposal of introducing the "meaning response" as a way of clarifying some terminological and conceptual issues in the placebo debate. Next we evaluate the criticisms that Moerman's proposal is epistemically moot since other existing and more empirically grounded models already account for all the phenomena that fall under the concept of the "meaning response." We conclude that Moerman's original proposal is inherently problematic and that, in order to be instrumentally useful in the future, the meaning response must be reconceived so that it may finally support, rather than oppose, other theoretical and empirical lines of research currently ongoing in the field of placebo studies.

Placebo Effects and the Ethics of Therapeutic Communication: A Pragmatic Perspective.

In this article we explore the ethics of manipulating verbal information for the sake of influencing health outcomes through placebo and nocebo responses. Recent scientific research on placebo and nocebo effects has drawn attention to the ways in which communication by health professionals may modulate the symptoms of patients across an array of highly prevalent conditions such as pain, depression, anxiety, insomnia, irritable bowel syndrome, migraine, and Parkinson's disease. The positive and negative effects of clinicians' communication on patient outcomes pose important ethical issues, which we describe in this article under the label of "the ethics of therapeutic communication" (TC). We begin by reviewing available evidence supporting the claim that doctor-patient communication has therapeutic effects. We then identify in truthfulness, helpfulness, and pragmatism three morally relevant considerations that can guide clinicians in therapeutic communication with their patients. Finally, we examine the ethics of using TC to enhance the effectiveness of proven medical interventions and open-label placebos.

Machine Learning in Clinical Psychology and Psychotherapy Education: A Mixed Methods Pilot Survey of Postgraduate Students at a Swiss University.

Background: There is increasing use of psychotherapy apps in mental health care. Objective: This mixed methods pilot study aimed to explore postgraduate clinical psychology students' familiarity and formal exposure to topics related to artificial intelligence and machine learning (AI/ML) during their studies. Methods: In April-June 2020, we conducted a mixed-methods online survey using a convenience sample of 120 clinical psychology students enrolled in a two-year Masters' program at a Swiss University. Results: In total 37 students responded (response rate: 37/120, 31%). Among respondents, 73% (n = 27) intended to enter a mental health profession, and 97% reported that they had heard of the term "machine learning." Students estimated 0.52% of their program would be spent on AI/ML education. Around half (46%) reported that they intended to learn about AI/ML as it pertained to mental health care. On 5-point Likert scale, students "moderately agreed" (median = 4) that AI/M should be part of clinical psychology/psychotherapy education. Qualitative analysis of students' comments resulted in four major themes on the impact of AI/ML on mental healthcare: (1) Changes in the quality and understanding of psychotherapy care; (2) Impact on patient-therapist interactions; (3) Impact on the psychotherapy profession; (4) Data management and ethical issues. Conclusions: This pilot study found that postgraduate clinical psychology students held a wide range of opinions but had limited formal education on how AI/ML-enabled tools might impact psychotherapy. The survey raises questions about how curricula could be enhanced to educate clinical psychology/psychotherapy trainees about the scope of AI/ML in mental healthcare.

Better than nothing: A historical account of placebos and placebo effects from modern to contemporary medicine.

Throughout the history of medicine, multiple conceptions of "placebo" and "placebo effect" have often co-existed across different domains, and today the meaning of these concepts is still disputed. Against this background, this chapter provides a succinct account of the key events in the history of the concepts of "placebo," "placebo control," and "placebo effect." The first section reconstructs the etymology of the term "placebo" and its first introduction in medicine. The next sections provide an account of how placebos have been employed in both medical practice and scientific research in modern medicine. Later sections trace the emergence of the concepts of "placebo control" and "placebo effect" in the first half of the 20th century, from the first empirical studies investigating the effects of placebos up to the publication of Beecher's landmark article "The Powerful Placebo." Finally, the last two sections review the varieties of randomized, placebo-controlled trials (RCTs) in the second half of the 20th century, and the subsequent wave of empirical studies that, starting from the 1970s, have investigated the psychological, pharmacological and neurobiological mechanisms of placebo effects.

The Ethics of Placebo Effects in Clinical Practice and Research.

This chapter provides a synthetic overview of the contemporary debate over the ethics of placebos and placebo effects in both clinical and research contexts. Section 1 briefly reconstructs how ethical attitudes toward the use of placebos have changed during the last century following the emergence of autonomy in medical ethics. Next, Sections 2-4 chart the main ethical issues concerning the use of placebos in clinical settings, examining: the ethics of deceptive placebos; the ethics of placebos without deception; and the ethics of modulating placebo and nocebo effects without placebos. Finally, Section 5 outlines the role of placebos in research, discussing the ethics of placebos as controls in clinical experiments.

Highlights from the 2013 Science of Placebo thematic workshop.

In the last 30 years, a converging series of laboratory experiments, clinical trials, and neurocognitive studies have identified several key mechanisms of placebo effects. These studies suggest not only that placebo responses may be ubiquitous across research and clinical settings, but also that they can significantly modulate symptoms across a wide spectrum of highly prevalent conditions such as acute pain, chronic pain, anxiety, depression, Parkinson's disease, and nausea, just to name a few. In order to inform the medical community about the most recent advances in the field of placebo studies, a thematic workshop entitled "The Science of Placebo" was held at the Beth Israel Deaconesses Medical Center (BIDMC), Harvard Medical School, in Boston (MA), on the 19-20 of June 2013. The workshop, sponsored by The Robert Wood Johnson Foundation, was organised by the Program in Placebo Studies and the Therapeutic Encounter, a Harvard-wide network of researchers dedicated to the study of the placebo phenomenon hosted by the BIDMC. The event was structured as a series of four public lectures, each delivered by a leading investigator in the field of placebo studies. The four keynote speakers were Fabrizio Benedetti, professor of neurophysiology and human physiology at the University of Turin Medical School and at the National Institute of Neuroscience in Italy; Tor Wager, director of the Cognitive and Affective Control Laboratory and associate professor of psychology and neuroscience at the University of Colorado; Predrag Petrovic, psychiatrist and researcher in the Department of Clinical Neuroscience at the Karolinska Institute in Stockholm; and Ted Kaptchuk, director of the Program in Placebo Studies and associate professor of medicine at Harvard Medical School.

Mechanistic understanding in clinical practice: complementing evidence-based medicine with personalized medicine.

In the last century, medicine has undergone an unprecedented wave of radical changes. From the implementation of surgery up to the development of single gene-targeted therapies, clinical decision making has become increasingly complex to handle. Today, this complexity needs to be rethought in the light of two emerging paradigms: evidence-based medicine (EBM) and personalized medicine (P-Med). The new availability of diverse sources of scientific evidence raises significant issues concerning how clinicians will compare, evaluate and orient their decisions in front of a rapidly growing plethora of therapies, procedures, medical technologies and drugs. In this paper, we compare the background visions behind these two paradigms, evaluating their respective relevance for present and future clinical decision making. In particular, we argue that EBM and P-Med are driven by two diverse modes of reasoning about 'evidence making' in medicine. EBM is grounded on statistical notions and epidemiological data, generally gathered through systematic meta-reviews of randomized controlled trials; P-Med, instead, is grounded on mechanistic explanations of molecular interactions, metabolic pathways and biomarkers. While both paradigms are epistemically sound, we argue that they cannot, and should not, be hybridized into a unique model. Rather, they ought to represent two compatible, but alternative ways of informing the clinical practice. Hence, we conclude that clinicians may expect to see their responsibility increasing as they will deal with diverse, but equally compelling, ways of reasoning and deciding about which intervention will qualify as the 'best one' in each individual case.

Constructing the Medical Humanities gaze.

In the last few decades genomics has completely reshaped the way in which patients and physicians experience and make sense of illness. In this paper we build upon a real case - namely that of breast cancer genetic testing - in order to point to the shortcomings of the paradigm currently driving healthcare delivery. In particular, we put forward a viable analytical model for the construction of a proper decisional process broadening the scope of medical gaze onto human experience of illness. This model revolves around four main conceptual axes: (i) communicating information; (ii) informing decisions; (iii) respecting narratives; (iv) empowering decision-making. These four kernels, we argue, map precisely onto the main pitfalls of the model presently dealing with genetic testing provision. Medical Humanities, we conclude, ought to play a pivotal role in constructing the environment for competent decision-making, autonomous self-determination and respectful narritivization of one's own life.