Article
Public, Environmental & Occupational Health
Elizabeth R. Brassfield, Mara Buchbinder
Summary: The implementation of medical aid-in-dying (MAID) poses new challenges for clinical communication and counseling. Health care providers must balance potential harms and the obligation to inform eligible patients about MAID, as norms and policies vary across jurisdictions.
PATIENT EDUCATION AND COUNSELING
(2021)
Article
Ethics
Daniel A. Wilkenfeld, Grace Campbell
Summary: This study argues that there are serious deficits in the process of obtaining informed consent in medical interventions, with the proposal that the responsibility of obtaining informed consent should be shifted from physicians to nurses in order to address issues related to patient's lack of appropriate cognitive state during interventions.
Article
Emergency Medicine
Krista L. L. Snyder, Jon F. F. Merz
Summary: We conducted a census of trials conducted under the U.S. FDA's EFIC rule and found that 30 out of 69 completed trials were terminated early, mainly due to futility (15 trials) and poor recruitment (10 trials). The rate of trial conduct has remained relatively constant since 2001, with approximately 18 trials started in each 5-year period.
ACADEMIC EMERGENCY MEDICINE
(2023)
Article
Psychology, Multidisciplinary
Edward Jacobs
Summary: As psychedelic-assisted psychotherapy (PAP) becomes more widely used, there is a need to adapt clinical ethics to accommodate its unique features. The long-term effects of psychedelic drugs and the transformative experiences they induce challenge the traditional understanding required for informed consent. This article explores the ethical implications and consequences for prospective patients.
FRONTIERS IN PSYCHOLOGY
(2023)
Review
Multidisciplinary Sciences
Benjamin R. Freedman, Charles Hwang, Simon Talbot, Brian Hibler, Simon Matoori, David J. Mooney
Summary: Skin injuries cause significant disruptions to patients' lives and lead to prolonged hospital stays, infection, and death. Advances in wound healing devices have primarily focused on treating macroscopic healing rather than the underlying microscopic pathophysiology. There is no consensus on the optimal treatment strategies using different wound healing products, prompting the development of new therapies. This article summarizes the progress in the development of novel drug, biologic products, and biomaterial therapies for wound healing, including both approved therapies and those undergoing clinical trials. Perspectives on successful and accelerated translation of these integrated therapies are also discussed.
Article
Public, Environmental & Occupational Health
Rafael Dal-Re, Teck Chuan Voo, Soren Holm
Summary: The study investigated whether any changes were made to the original participant's information sheet/informed consent form (PIS/ICF) provided by the WHO Solidarity Plus team when transferred to participating countries. The results showed that no edits were made in 8 countries, some elements were added in 8 countries, and 3 countries did not participate. The conclusion suggests that WHO should consider adding three omitted elements in the PIS/ICFs of future similar trials.
JOURNAL OF GLOBAL HEALTH
(2023)
Article
Medicine, General & Internal
Claudia Neumann, Grigorij Schleifer, Nadine Strassberger-Nerschbach, Johannes Kamp, Gregor Massoth, Alexandra Gortzen-Patin, Dishalen Cudian, Markus Velten, Mark Coburn, Ehrenfried Schindler, Maria Wittmann
Summary: The use of digital online pre-operative patient information or evaluation in Europe varies widely and is not currently implemented as standard practice, particularly in the pediatric population. However, telemedicine may provide benefits in terms of reduced contact and exposure to health risks for high-risk patients in the future.
JOURNAL OF CLINICAL MEDICINE
(2022)
Article
Nursing
Georgina Morley, Caroline Bradbury-Jones, Jonathan Ives
Summary: This study aims to explore moral distress in nursing practice empirically and conceptually, identifying factors that exacerbate and mitigate it, and constructing a model to represent its constituent parts. Using feminist empirical bioethics and interpretive phenomenology, data from critical care nurses in the UK was collected and analysed, leading to the development of the Moral Distress Model. The model highlights five compounding factors that influence nurses' moral distress experiences, providing insights for interventions to address moral distress.
JOURNAL OF CLINICAL NURSING
(2022)
Article
Medicine, General & Internal
Ezekiel J. Emanuel, Connor W. Boyle
Summary: The study found that current informed consent documents for COVID-19 vaccine trials are too long and complex, making them difficult to understand. By shortening the length and simplifying the language, the accessibility for participants can be improved.
Article
Neurosciences
Tobias Haeusermann, Winston Chiong
Summary: New treatment modalities such as psychedelics, ketamine, and neuromodulatory technologies are being welcomed as potential therapeutic agents for mental illness. However, their use also raises ethical questions related to informed consent, clinical response expectancy, and distributive justice. This overview discusses and introduces these issues.
NEUROPSYCHOPHARMACOLOGY
(2023)
Article
Health Care Sciences & Services
Claudia Neumann, Nadine Strassberger-Nerschbach, Achilles Delis, Johannes Kamp, Alexandra Goertzen-Patin, Dishalen Cudian, Andreas Fleischer, Goetz Wietasch, Mark Coburn, Ehrenfried Schindler, Grigorij Schleifer, Maria Wittmann
Summary: Digitalization is becoming increasingly important in the medical field, opening up new possibilities for optimizing patient education in the context of anesthesia. However, the implementation of remote consent in Europe is limited, reflecting the inconsistent legal situation and medical technical structures across the continent.
Article
Obstetrics & Gynecology
Summary: Informed consent is a process that involves supporting patients to understand medical options and make voluntary and autonomous decisions, considering the risks, benefits, and alternatives.
FERTILITY AND STERILITY
(2023)
Article
Biochemistry & Molecular Biology
Carolina Seybert, Goncalo Cotovio, Luis Madeira, Miguel Ricou, Ana Matos Pires, Albino J. Oliveira-Maia
Summary: Enhanced informed consent procedures are necessary for patients undergoing psychedelic treatments, like psilocybin and MDMA, as they can induce altered states of consciousness and susceptibility to suggestion.
Article
Computer Science, Theory & Methods
Chehara Pathmabandu, John Grundy, Mohan Baruwal Chhetri, Zubair Baig
Summary: Smart Buildings (SBs) use IoT technologies to automate operations and services, aiming to increase efficiency, maximize comfort, and minimize environmental impact. However, these cloud-based smart devices can capture and share sensitive data about occupants, exposing them to privacy threats. Users often lack awareness and fail to protect their privacy due to the convenience offered by IoT devices, resulting in a privacy paradox. To address this, a novel solution for informed consent management in shared smart spaces is proposed. This solution increases user awareness, provides visibility into privacy conformance, and enables informed decision-making. A reference architecture and proof-of-concept prototype are provided, and the proposed solution is validated through expert interviews.
FUTURE GENERATION COMPUTER SYSTEMS-THE INTERNATIONAL JOURNAL OF ESCIENCE
(2023)
Article
Health Care Sciences & Services
Kelly E. Ormond, Maia J. Borensztein, Miranda L. G. Hallquist, Adam H. Buchanan, William Andrew Faucett, Holly L. Peay, Maureen E. Smith, Eric P. Tricou, Wendy R. Uhlmann, Karen E. Wain, Curtis R. Coughlin
Summary: The research identified core concepts essential for informed consent for genetic testing through an expert consensus process, including the voluntary nature of testing, test recommendations and results, family impact, and potential risks.
JOURNAL OF PERSONALIZED MEDICINE
(2021)
Article
Psychology, Multidisciplinary
Andrew L. Geers, Kelly S. Clemens, Ben Colagiuri, Emily Jason, Luana Colloca, Rebecca Webster, Lene Vase, Mette Seig, Kate Faasse
Summary: The aim of this study was to examine whether side effects of the primary COVID-19 vaccine are associated with a decrease in intentions to receive a COVID-19 booster, as well as to identify psychological and demographic factors that predict booster intentions. The results showed that intentions for a booster vaccination were high and not correlated with the side effects of the primary vaccine. Positive vaccination attitudes, trust in vaccine development, worry about the COVID-19 pandemic, low concern over vaccine side effects, and affiliation with the democratic political party were predictors of booster intentions.
ANNALS OF BEHAVIORAL MEDICINE
(2022)
Article
Anesthesiology
Sharon Thomas, Yang Wang, Rachel Cundiff-O'Sullivan, Rachel Massalee, Luana Colloca
Summary: This study examined the role of jaw function, psychological factors, and chronic overlapping pain conditions (COPCs) on pain-related disability in patients with temporomandibular disorders (TMD). The results suggest that improving joint function, providing psychosocial support, and managing pain conditions can improve pain-related disability in TMD patients.
EUROPEAN JOURNAL OF PAIN
(2023)
Review
Clinical Neurology
Robert R. Edwards, Kristin L. Schreiber, Robert H. Dworkin, Dennis C. Turk, Ralf Baron, Roy Freeman, Troels S. Jensen, Alban Latremoliere, John D. Markman, Andrew S. C. Rice, Michael Rowbotham, Roland Staud, Simon Tate, Clifford J. Woolf, Nick A. Andrews, Daniel B. Carr, Luana Colloca, Doina Cosma-Roman, Penney Cowan, Luda Diatchenko, John Farrar, Jennifer S. Gewandter, Ian Gilron, Robert D. Kerns, Serge Marchand, Gwendolyn Niebler, Kushang V. Patel, Lee S. Simon, Tina Tockarshewsky, Geertrui F. Vanhove, Daniel Vardeh, Gary A. Walco, Ajay D. Wasan, Ursula Wesselmann
Summary: There is a large variability in individual response to pain treatments, even those that are highly effective, which has led to calls for personalized approaches to treating patients with pain. Precision pain medicine aims to determine the optimal treatments for specific patients by using empirically based algorithms. This review surveys the current state of precision pain medicine and presents evidence-based recommendations for its application in chronic pain research.
Article
Pharmacology & Pharmacy
Luana Colloca, Robert H. Dworkin, John T. Farrar, Leslie Tive, Jiyue Yang, Lars Viktrup, Gorana Dasic, Christine R. West, Ed Whalen, Mark T. Brown, Steven A. Gilbert, Kenneth M. Verburg
Summary: This study conducted secondary analyses on data from two clinical trials to identify patient-based variables that predicted responses to placebo or tanezumab. The findings will inform the design of future clinical trials and advance clinical pharmacology and translational science.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Clinical Neurology
Dale J. Langford, Raissa Lou, Soun Sheen, Dagmar Amtmann, Luana Colloca, Robert R. Edwards, John T. Farrar, Nathaniel P. Katz, Michael P. McDermott, Bryce B. Reeve, Ajay D. Wasan, Dennis C. Turk, Robert H. Dworkin, Jennifer S. Gewandter
Summary: Variability in pain outcomes can hinder the sensitivity of chronic pain clinical trials. Participants' expectations may contribute to this variability and impede the development of new pain treatments. Measurement and management of expectations in clinical trials need to be optimized and standardized. This article provides an overview of research findings on the relationship between baseline expectations and pain outcomes, emphasizing the potential benefit of adjusting for participants' expectations in trial analyses.
Article
Psychiatry
Kelly S. Clemens, Kate Faasse, Winston Tan, Ben Colagiuri, Luana Colloca, Rebecca Webster, Lene Vase, Emily Jason, Andrew L. Geers
Summary: This study investigates the influence of social communication on vaccine side-effect experiences, particularly focusing on personal acquaintances and social media. The results show that both sources of social communication can predict pre-vaccination side-effect expectations and post-vaccination side-effect experiences. Moreover, pre-vaccination expectations mediate the relationships between social communication and experienced side-effects. This study provides evidence for the importance of modifying side-effect expectations through personal and online channels.
JOURNAL OF PSYCHOSOMATIC RESEARCH
(2023)
Article
Anesthesiology
Margaret Yin, Salim A. Muhammed, Yang Wang, Luana Colloca
Summary: This study found that the use of physically oriented mind-body practices, such as yoga and massage, was associated with reduced placebo effects in chronic pain patients with Temporomandibular Disorders. The use of psychologically oriented practices and natural products was not associated with placebo effects. This finding provides insights into the relationship between complementary and integrative approaches and placebo effects, and the potential therapeutic perspective of endogenous pain modulation in chronic pain management.
EUROPEAN JOURNAL OF PAIN
(2023)
Article
Clinical Neurology
Rachel L. Cundiff-O'Sullivan, Yang Wang, Sharon Thomas, Shijun Zhu, Claudia M. Campbell, Luana Colloca
Summary: This study utilized structural equation modeling to analyze the impact of psychological and sociodemographic factors on pain severity, interference, and jaw limitation in temporomandibular disorder (TMD) patients, and found that the dimensions of pain catastrophizing do not mediate these relationships.
Article
Multidisciplinary Sciences
Roni Shafir, Maya Israel, Luana Colloca
Summary: The placebo effect demonstrates how positive expectancies shape the effectiveness of various treatments. This study shows that placebo-induced expectancies can improve individuals' internal emotion regulation attempts. The placebo distraction was effective in reducing fear of pain and was preferred by the participants.
SCIENTIFIC REPORTS
(2023)
Review
Rheumatology
Tuhina Neogi, Luana Colloca
Summary: Osteoarthritis (OA) is a common form of arthritis that affects millions of people worldwide, but there are currently no effective treatments to stop its progression. The development of drugs for OA is hindered by the gradual nature of the disease and the requirement to demonstrate improvements in both structure and symptoms. Clinical trials for OA are also hampered by high placebo responses, which make it difficult to identify new effective treatments. Understanding placebo responses and effects in OA trials can help improve clinical practice and enhance symptom management.
NATURE REVIEWS RHEUMATOLOGY
(2023)
Article
Medicine, General & Internal
Danielle R. Trakimas, Luana Colloca, Carole Fakhry, Marietta Tan, Zubair Khan, Peter S. Vosler
Summary: Patients with head and neck cancer are at risk of chronic opioid dependence after surgery. This study aims to examine whether the addition of conditioned open-label placebos (COLPs) to standard multimodal analgesia can reduce opioid consumption within 5 days after surgery in these patients. The study will use a randomized controlled trial design to assess the effectiveness of COLPs as adjunctive pain management in patients with head and neck cancer.
Editorial Material
Psychiatry
Luana Colloca, Sina Nikayin, Gerard Sanacora
Article
Psychology, Multidisciplinary
Chad E. Cook, Antoine Bailliard, Jennifer A. Bent, Joel E. Bialosky, Elisa Carlino, Luana Colloca, Jorge E. Esteves, Dave Newell, Alvisa Palese, William R. Reed, Jennifer Plumb Vilardaga, Giacomo Rossettini
Summary: The objective of this study was to create a consensus definition of contextual factors to better refine this concept for clinicians and researchers. Using a multi-stage virtual Nominal Group Technique, the study resulted in the creation and ranking of 12 final definitions of contextual factors.
FRONTIERS IN PSYCHOLOGY
(2023)
Article
Health Care Sciences & Services
Susan Persky, Luana Colloca
Summary: The rapid development of medical extended reality (MXR) in healthcare and medicine shows great promise. However, there is a lack of rigorous clinical trials to establish its efficacy. The paper proposes a framework for designing controls and sham conditions in MXR trials to improve research findings and develop generalizable knowledge.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2023)
Article
Communication
Jessica Cornell, Ariana Taj, John Sivinski, Margaret Yin, Parth Bhatia, Desai Oula, Sophia Fatschel, Patricia Franklin, Jason Noel, Luana Colloca, Chamindi Seneviratne
Summary: This article reports on the methods used to design and analyze a virtual scientific conference and the findings suggest that the virtual platform allowed for virtual attendance, produced moderate engagement, and the majority of attendees were satisfied with the quality of the conference.
FRONTIERS IN COMMUNICATION
(2022)
