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Machine Learning (ML) is revolutionizing the functioning of our societies and reshaping much of the economic tissue underlying them. The deep integration of ML into the fabric of our lives has changed to way we work and communicate and how we relate to each other. In this Topical Collection we reflect on the reach and impact of this AI (ML-driven) revolution in our society, critically analyzing some of the most important ethical, epistemological, scientific, and sociological issues underlying it. [ABSTRACT FROM AUTHOR]

PURPOSE We conducted a meta-analysis to evaluate clinically meaningful benefits and harms of monoclonal antibodies targeting amyloid in patients with Alzheimer dementia. METHODS We searched PubMed, Cochrane CENTRAL, and 5 trial registries, as well as the reference lists of identified studies. We included randomized controlled trials comparing a monoclonal antibody with placebo at a dose consistent with that used in phase 3 trials or for Food and Drug Administration approval. Studies had to report at least 1 clinically relevant benefit or harm. Data were extracted independently by at least 2 researchers for random effects meta-analysis. Changes in cognitive and functional scales were compared between groups, and each difference was assessed to determine if it met the minimal clinically important difference (MCID). RESULTS We identified 19 publications with 23,202 total participants that evaluated 8 antiamyloid antibodies. There were small improvements over placebo in the Alzheimer's Disease Assessment Scale (ADAS)-Cog-11 to -14 score (standardized mean difference = -0.07; 95% CI, -0.10 to -0.04), Mini Mental State Examination score (0.32 points; 95% CI, 0.13 to 0.50), and Clinical Dementia Rating-Sum of Boxes scale score (mean difference = -0.18 points; 95% CI, -0.34 to -0.03), and the combined functional scores (standardized mean difference = 0.09; 95% CI, 0.05 to 0.13). None of the changes, including those for lecanemab, aducanumab, and donanemab, exceeded the MCID. Harms included significantly increased risks of amyloid-related imaging abnormalities (ARIA)-edema (relative risk [RR] = 10.29; number needed to harm [NNH] = 9), ARIA-hemorrhage (RR = 1.74; NNH = 13), and symptomatic ARIA-edema (RR = 24.3; NNH = 86). CONCLUSIONS Although monoclonal antibodies targeting amyloid provide small benefits on cognitive and functional scales in patients with Alzheimer dementia, these improvements are far below the MCID for each outcome and are accompanied by clinically meaningful harms. [ABSTRACT FROM AUTHOR]

On June 24, 2022, the US Supreme Court overturned Roe v. Wade, which marked a further restriction on women's abortion rights in the US. It has sparked a wide range of societal reactions around the world. Women in different countries enjoy diverse abortion rights due to conditions in their respective nations and cultures. Abortion protects women's rights to a certain extent, and especially in the event of unintended pregnancy. An inappropriate abortion ban will affect women's health and lives and all aspects of medicine, including the lives of doctors, patient access, and the development of medical technology. This review provides a gynecologist's perspective on the impact of abortion policies on women's health and the medical system. This review also attempts to determine the reason for the government's abortion ban. [ABSTRACT FROM AUTHOR]

A major limiting factor with heart allotransplantation remains the availability of organs from deceased donors. Porcine heart xenotransplantation could serve as an alternative source of organs for patients with terminal heart failure. A first‐in‐human porcine xenotransplantation that occurred in January 2022 at the University of Maryland Medical Center provided an opportunity to examine several ethical issues to guide selection criteria for future xenotransplantation clinical trials. In this article, the authors, who are clinicians at UMMC, discuss the appropriate balancing of risks and benefits and the significance, if any, of clinical equipoise. The authors also review the alleged role of the psychosocial evaluation in identifying patients at an elevated risk of posttransplant noncompliance, and they consider how the evaluation's implementation might enhance inequities among diverse populations. The authors argue that, based on the principle of reciprocity, psychosocial criteria should be used, not to exclude patients, but instead to identify patients who need additional support. Finally, the authors discuss the requirements for and the proper assessment of informed and voluntary consent from patients being considered for xenotransplantation. [ABSTRACT FROM AUTHOR]

Cervical cancer is the second most common female cancer in Nigeria, even though it can be prevented by vaccination and screening. The uptake of these preventive services is extremely low due to lack of spousal support and cost. Human papilloma virus (HPV) vaccines and cervical screening require finance as health services are mostly paid out of pocket. This study explored Nigerian men's willingness to encourage and pay for family member to obtain HPV vaccine and cervical screening. This is a cross-sectional study of 352 men aged 18–65 years living in 12 communities in the 6-geopolitical region. We found poor perception of HPV risk, and believed their family was not susceptible to cervical cancer. However, the majority (>80%) believed HPV vaccine and cervical screenings are important. Additionally, a good number (>58%) would encourage and pay for their family member to receive HPV vaccine and cervical screening. Residency, educational level and monthly income were significantly associated with willingness to encourage their family to receive HPV vaccine and cervical screening. Also, age group, marital status, residency, educational level and monthly income were significantly associated with the willingness to pay for HPV vaccine and cervical cancer screening. Majority were willing to encourage and pay for their family member to get vaccinated and receive cervical screening. This supports the findings that lack of male involvement may be an overlooked obstacle to cervical cancer prevention in developing countries. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV) continues to disproportionately affect gay, bisexual, and other men who have sex with men (GBM) and transgender and nonbinary (trans/NB) individuals. This study investigated attitudes toward participation in HIV survey research, guided by Emanuel's framework for ethical clinical research (e.g., risk–benefit ratio, fair participant selection, respect for participants, social value, and collaborative partnership). GBM (n = 294) and trans/NB (n = 86) persons recruited at a Pride event in Milwaukee completed a survey assessing risks and benefits of participation in, and comfort responding to, sexual health surveys. Participants reported few ethical concerns (e.g., privacy and confidentiality), with notable differences by race, sexual orientation and gender identity, and prior research experiences. Implications for HIV research with GBM and trans/NB individuals are discussed. [ABSTRACT FROM AUTHOR]

Background: Disclosure of human immunodeficiency virus (HIV)‐positive status in a workplace can be a complex social decision for a person living with HIV. Objective: To design a Decision Guide to support people living with HIV in assessing contexts, risks and benefits of workplace disclosure in choosing whether or not, or to what extent, to disclose. In this report, we review the participatory design of a Decision Guide prototype and focus on its evaluation. Methods: We began with stakeholder input through an environmental scan and community consultation that informed the development of an online Decision Guide prototype. To evaluate the comprehensiveness, acceptability and usability of the prototype, we used qualitative methodology involving individual interviews and the think‐aloud technique. Interviews were transcribed and analysed qualitatively. Results: Fourteen people, including people living with HIV and service providers, participated. We identified benefits of the Decision Guide related to comprehensiveness, acceptability and usability. Additional interview themes focused on disclosure concerns, mitigating risks associated with disclosure and additional considerations for the Decision Guide. Conclusions: The Decision Guide was perceived to be acceptable, comprehensive and useful. The findings endorse the application of a socio‐ecological perspective when designing decision support aids for complex social decisions. Patient or public contribution: People with lived experience of HIV were involved in the prototype design phases as research team members. They, along with community leaders and service providers, also participated in a community forum and were key informants for the evaluation of the Workplace Disclosure Decision Guide prototype. [ABSTRACT FROM AUTHOR]

The relevance of this study is due to the challenges of the global pandemic, which has led to the large-scale development of education digitalization. In this regard, this article is devoted to revealing the features of remote learning in the context of a global pandemic, identifying the risks and benefits of digital learning. The article reveals the discursive content of the counter-pandemic vector of distance learning for University students; defines the classification of risks and advantages of largescale digitalization of students' remote learning. Based on the results of the study, the authors justified the consolidated model of students distance learning, the counter-pandemic vector of which is a large-scale digitalization of the University educational process. The effectiveness of the model is proved by the results of its use in the process of large-scale digitalization of students' remote learning in the context of a global pandemic. The materials of the article have practical application and can be useful in the development and implementation of digital educational complexes. They are recommended to teachers and students of the University, methodologists, curators, Tutors. [ABSTRACT FROM AUTHOR]

One of the defining moments of the 80-year evolution of menopausal hormone therapy (MHT) was the 2002 reveal of the initial results of the combined hormone therapy arm of the Women's Health Initiative (WHI) clinical trial. The exodus from regulatory approved MHT was prompt and profound and accompanied by a rapid acceleration of the compounding pharmacy 'bioidentical' hormone therapy industry. Compounders had recruited prescribers and promoted compounded bioidentical hormone therapy (cBHT) well before the WHI, yet the startling results provided a catalyst that enabled a leap in production of compounded hormones that were variably regulated, basically unstudied, and inconsistently labeled. In this review, the story of the rise of cBHT and the regulatory double standard is eclipsed only by the 2020 findings and recommendations of the US National Academies of Science, Engineering, and Medicine. Their investigation, commissioned by the US Food and Drug Administration, was tasked to: provide an evidence-based summary of the clinical utility of cBHT; evaluate whether the evidence of safety and efficacy supports the use of cBHT; and identify patient populations that might need cBHT in lieu of an approved drug product. Their conclusions are consistent with sound science and their recommendations are in harmony with global menopause societies. [ABSTRACT FROM AUTHOR]

Consumers' potential reactions toward genetically modified (GM) foods affect their commercial feasibility and determine the decisions of economic agents. Inconsistent information on GM foods has created a sense of uncertainty in Chinese consumers' mind. This paper studies how the information about risks and benefits of GM foods from major sources influences Chinese consumer intention to purchase GM soybean oil. This analysis uses data from a survey of 880 residents randomly sampled from 13 cities in Jiangsu province. Using a multinomial logit model, we analyze the effects of information consistency and source credibility. The results show because of new information about 17.36% of consumers increase their intention to purchase GM soybean oil, and 15.10% of consumers decrease purchase intention. Compared to consistent information, inconsistent information can maximize change of purchase intention. The attitude change is greatest when there is a moderate difference between the new information and the initial consumer attitude. Furthermore, trust in biotechnology research institutes, government departments about GM, and GM experts are easier to promote consumers to change their intention to purchase GM soybean oil in a positive direction. Finally, we discuss implications for agencies as to strengthening the regulation and supervision of information sources, and including public-involved policies. Abbreviations: GM, Genetically modified; GMOs, Genetically modified organisms; AGGMO, Center of Agriculture's Genetically Modified Organisms' safety management and policy research organization at Nanjing Agricultural University; MARA, Ministry of Agriculture and Rural Affairs; ¥1 (RMB)≈$6.8 (USD). [ABSTRACT FROM AUTHOR]

Abstract: The purpose of this study was to identify the method of presentation (text, bar graphs, or pictographs) that best enhances the understanding of medical risk information among Japanese adults. We also investigated the effect of graphic format on understanding by differences in numeracy. This is the first study conducted in Japan to clarify understanding the risks and benefits of treatment. Participants were randomized to receive numerical information about the risks and benefits of a hypothetical medical treatment in one of three formats: text, bar graphs, or pictographs. The main outcome variables were adequate verbatim and adequate gist understanding. In total, 1062 individuals (text, 354; bar graphs, 358; and pictographs 350) were included in the analysis. Pictographs and bar graphs did not show significant differences from text in conferring verbatim information. However, pictographs significantly differed from text in conferring gist information (odds ratio [OR] 1.567, 95% confidence interval [CI] 1.097–2.237), but bar graphs did not significantly differ from text (OR 1.390, 95%CI 0.983–1.964). Numeracy was the factor most strongly associated with adequate verbatim and gist understanding. Our results suggest that although pictographs appear to be an effective option, their effectiveness is limited to people with higher numeracy and people with lower numeracy may have little benefit from pictographs. [ABSTRACT FROM AUTHOR]

The evidence and effectiveness of physiotherapy interventions in treatment of patients with confirmed or suspected coronavirus disease 2019 (COVID-19) is limited. Routinely used interventions in physiotherapy imply a very high risk for physiotherapists because the duration of direct contact with patients is quite long. Physiotherapy may need to be administered by weighing the benefit-risk ratio. Therefore, there is a critical and urgent need to adopt alternatives or modified forms of physiotherapy interventions. As the situation for management of COVID-19 in low-resource contexts could differ from that in high resource context, interventions need to be adapted to the available resources and technology in various settings. Tele-physiotherapy could be a viable option for patients who are in acute care in the hospital, in rehabilitation unit or under quarantine at home due to confirmed or suspected COVID-19. Modification in physiotherapy interventions and adjustment in intervention parameters may serve as an alternative strategy. This article describes alternatives to and/or modification of routinely used physiotherapy interventions for achieving maximum patients' benefits and minimising therapists' exposure in treatment of individuals with confirmed or suspected COVID-19. [ABSTRACT FROM AUTHOR]

It has been proposed that the urgency of having a vaccine as a response to SARS-CoV-2 is so great, given the potential health, economic and social benefits that we should override the established steps in the research development process. In this article I argue that whilst there are some opportunities to expedite the production of a vaccine, it is a mistake to rush the research. We should retain the existing structures represented by clear and separate 'phasing' of trials. I offer three reasons for this view: the existing phases of trials is morally significant; rushing fails to appropriately weigh all of the relevant risks and benefits and consent is not sufficient for the justification of additional risk. Vaccines have played a central role in global health improvements and we should not endanger such achievements for an apparent short-term gain in response to a pandemic such as SARS-CoV-2. [ABSTRACT FROM AUTHOR]

Conducting formative research is a scientific, ethical, and community engagement imperative. This article describes how formative research refined ethical processes for a family-based home-based counseling and testing (FBCT) intervention in KwaZulu-Natal. In-depth interviews were conducted to explore community (n = 20) and key stakeholders' (n = 20) needs, concerns, and perspectives on the FBCT model, including ethical issues for working with children and families. Data were analyzed thematically using NVivo software. Four key ethical considerations emerged, namely, respect for community norms and cultural practices; confidentiality, privacy, and forced disclosure; identifying potential risks and benefits; and voluntariness and capacity to consent. Data were used to refine the intervention and address participants' concerns by engaging the community, providing ethics training for intervention staff, and incorporating independent consent mechanisms for adolescent HIV testing that supported opportunities for family-based testing and disclosure. [ABSTRACT FROM AUTHOR]

Animals access resources such as food and shelter, and acquiring these resources has varying risks and benefits, depending on the suitability of the landscape. Some animals change their patterns of resource selection in space and time to optimize the trade‐off between risks and benefits. We examine the circadian variation in resource selection of swamp wallabies (Wallabia bicolor) within a human‐modified landscape, an environment of varying suitability. We used GPS data from 48 swamp wallabies to compare the use of landscape features such as woodland and scrub, housing estates, farmland, coastal areas, wetlands, waterbodies, and roads to their availability using generalized linear mixed models. We investigated which features were selected by wallabies and determined whether the distance to different landscape features changed, depending on the time of the day. During the day, wallabies were more likely to be found within or near natural landscape features such as woodlands and scrub, wetlands, and coastal vegetation, while avoiding landscape features that may be perceived as more risky (roads, housing, waterbodies, and farmland), but those features were selected more at night. Finally, we mapped our results to predict habitat suitability for swamp wallabies in human‐modified landscapes. We showed that wallabies living in a human‐modified landscape selected different landscape features during day or night. Changing circadian patterns of resource selection might enhance the persistence of species in landscapes where resources are fragmented and disturbed. [ABSTRACT FROM AUTHOR]

Prominent tuberculosis (TB) actors are invoking solidarity to motivate and justify collective action to address TB, including through intensified development and implementation (D&I) of technologies such as drugs and diagnostics. We characterize the ethical challenges associated with D&I of new TB technologies by drawing on stakeholder perspectives from 23 key informant interviews and we articulate the ethical implications of solidarity for TB technology D&I. The fundamental ethical issue facing TB technological D&I is a failure within and beyond the TB community to stand in solidarity with persons with TB in addressing the complex sociopolitical contexts of technological D&I. The failure in solidarity relates to two further ethical challenges raised by respondents: skewed power dynamics that hinder D&I and uncertainties around weighing risks and benefits associated with new technologies. Respondents identified advocacy and participatory research practices as necessary to address such challenges and to motivate sustained collective action to accelerate toward TB elimination. We present the first empirical examination of bioethical accounts of solidarity in public and global health. Our study suggests that solidarity allows us better to understand and address the ethical challenges that arrest the D&I of new TB technologies. Solidarity lends credence to policies and practices that address the relational nature of illness and health through collective action. [ABSTRACT FROM AUTHOR]

Background: An ethical, informed consent process requires that potential participants understand the study, their rights, and the risks and benefits. Yet, despite strategies to improve communication, many participants still lack understanding of potential risks and benefits. Investigating attitudes and practices of research nurses can identify ways to improve the informed consent process. Research question: What are the attitudes, practices, and preparedness of nurses involved in the informed consent process regarding communication of risks and benefits? Research design: A survey was developed and administered online to a national purposive sample of 107 research nurses with experience obtaining informed consent for clinical trials. Survey responses stratified by selected work-related characteristics were analyzed. Ethical considerations: Participants were instructed they need not answer each question and could stop at any time. They consented by clicking "accept" on the email which linked to the survey. The study was approved by the Northeastern University Institutional Review Board, Boston, Massachusetts (NU-IRB Protocol #: 13-06-17). Findings: Most research nurses (87%) used a teach-back method to assess participant comprehension, while 72% relied on their intuition. About one-third did not feel prepared to communicate related statistics. About 20% did not feel prepared to tailor information, and half did not feel competent using supplemental materials to enhance risks and benefits comprehension. Only 70% had received training in the informed consent process which included in-person training (84%), case studies (69%), online courses (57%), feedback during practice sessions (54%), and simulation, such as role playing (49%) and viewing videos (45%). Perceived preparedness was significantly associated with greater informed consent experience and training. Conclusion: Research nurses may have inadequate training to encourage, support, and reinforce communication of risks and benefits during the informed consent process. Relevant purposeful education and training should help to improve and standardize the ethical informed consent process. [ABSTRACT FROM AUTHOR]

Abstract The economic viability of new energy technologies is held as a central tenet to their future deployment; conventional wisdom posits economically rational decision-makers will readily invest in proven low-risk and affordable technologies. But what happens when this is not true. This paper examines the non-financial barriers facing economically viable Combined Heat and Power (CHP) projects. CHP is a mature and lower carbon technology that efficiently uses waste heat from thermal electricity generation; CHP can also provide flexibility services to help integrate variable renewable resources. CHP is low risk and many industrialized countries, particularly those in colder climates in Northern Europe and Russia, generate as much as 50% of their electricity and heat needs from CHP, but United States deployment remains low and investment hurdle rates high. While lower U.S. energy costs make some projects un-economic, many economically-viable CHP projects are stalled or killed by non-financial barriers. To better understand why financially viable CHP projects are not getting built, developers, owners and operators, regulators, and other stakeholders of this technology were interviewed and three major barriers emerged a) the business model of the electrical utility b) negative subjective impressions and c) challenges in allocating the risks and benefits. [ABSTRACT FROM AUTHOR]

We developed measures of benefits and burdens of research participation in cancer clinical trials using a sequential mixed methods design with a qualitative (n = 32) and quantitative sample (n = 110) of cancer clinical trial participants. Benefit–burden items (22 for benefits, 23 for burdens) were subsequently developed and assessed through cognitive interviewing for content, clarity, and meaning. Preliminary psychometric analyses support the internal consistency reliability and construct validity of Benefit (α = .90) and Burden (α = .87) research participation scales. Item response theory models supported the discrimination ability of the items on the scales. Participants who had thoughts of dropping out had lower Benefit scale scores (p < .001) and higher Burden scores (p < .001) than those who had no thoughts of dropping out, supporting construct validity. With further psychometric testing, the scale can be used to develop appropriate interventions to address recruitment and retention of human participants in clinical research. [ABSTRACT FROM AUTHOR]

Known as a dangerous procedure, due to its post-operative evolution in most of the cases, the common carotid ligation was performed first on the 1st November 1805 by Astley Cooper. The article begins with a short introduction in the history of the procedure and the instruments used for the improvement of the results. The main objective of the article is to put in balance the risks and benefits of the common carotid ligation procedure. We need to understand the normal anatomy of the neck arteries which supplies all the head and neck organs and also the sites where we can do the procedure as easiest as it is possible. The study was developed in Prof. Dr. D Hociota" Institute for ENT functional surgery and phonoaudiology from 2010 to 2017 on 5 cases. In all of our cases, we used a gradual closure of the common carotid artery with ligation without using a clamping instrument. Most of the patients died after minimum four months postop. One patient survived after the ligation procedure but with some post-op complications. In all the cases we had a minor stroke complication on the same side with the ligation. In conclusion, the common carotid ligation procedure remains hard to choose method because of the post-op complications and high mortality risk. So we may use it only when we have no other options and if we remain without any treatment resources. [ABSTRACT FROM AUTHOR]

Background:The purpose of this article is to examine the extent to which cancer clinical trial participants assess the benefits and risks of research participation before enrollment.Methods:One hundred and ten oncology research participants enrolled in cancer clinical research in a large Northeastern cancer center responded to a self-administered questionnaire on perceptions about cancer clinical trials.Results:Of the participants, 51.6% reported they did not directly assess the benefits or risks. Educational level, age, employment, treatment options, insurance, and spiritual–religious beliefs were significantly associated with whether participants assessed risk and benefits. Those who felt well informed were more likely to have assessed the benefits and risks at enrollment than those who did not feel well informed (odds ratio [OR] = 3.92,p= .014); of those who did not assess the risks and benefits, 21% did not feel well informed at enrollment (p= .001). Those who agreed that the clinical trial helped pay the costs of the care had nearly three times the odds of not assessing risks and benefits compared to those who disagreed.Conclusion:Our findings have important implications for understanding the role of assessing risks and benefits in the research participation decisions of patients with cancer and call for further understanding of why participants are not assessing information believed to be essential for autonomous informed decisions. [ABSTRACT FROM PUBLISHER]

Non-therapeutic neonatal circumcision, whether for religious or cultural reasons, is generally not available via the NHS. Tragedies can occur with unqualified practitioners, and some health-care Trusts have cooperated with local communities to provide approved services. Unfortunately, these are unevenly distributed throughout the UK and most involve cost. Midwives are well placed to help interested parents understand the procedure and contact an acceptable provider. This article hopes to give midwives some knowledge of infant circumcision, its controversial nature, the pros and cons, the groups for whom it is important and the methods commonly used in the UK. Points are listed for patient discussion and suggestions made for examining websites. As with Scottish guidelines, were midwives to discuss neonatal circumcision with all parents in the antenatal period, it would give them time to consider the procedure and access a safe and reliable service. [ABSTRACT FROM AUTHOR]

This study examined female sex workers’ evaluation of ethically relevant experiences of participating in an HPV4 vaccine clinical trial conducted in Lima, Peru (the Sunflower Study). The Sunflower Study provided all participants with HPV testing, treatment for those testing positive, and access to the vaccine for all testing negative. Themes that emerged from content analysis of interviews with 16 former participants included the importance of respectful treatment and access to healthcare not otherwise available and concerns about privacy protections, the potential for HIV stigma, and poststudy abandonment. [ABSTRACT FROM PUBLISHER]

Social media are becoming an important intermediary for interaction between governments, governments and citizens, and governmental agencies and businesses. This is due to the unique characteristics of social media: openness, participation, and sharing. However, despite rapid adoption, a growing concern and skepticism regarding the use of social media exists in the public sector. The purpose of this study is to investigate empirically the risks and benefits of social media use by public agencies. For this purpose, a research model was developed and tested in a survey of 289 government sector employees from six South Korean government research institutes. We found that both risks (i.e., social risk, time, psychological risks, and privacy concern) and benefits (i.e., social connectivity, social involvement, information attainment, and entertainment) significantly affect public sector employees’ satisfaction with and intention to use social media. However, the effect of the benefits on users’ satisfaction was stronger than the risks. The results of the study have important implications for researchers and policy makers. [ABSTRACT FROM AUTHOR]

This paper discusses the ethical issues related to hemicorporectomy surgery, a radical procedure that removes the lower half of the body in order to prolong life. The literature on hemicorporectomy (HC), also called translumbar amputation, has been nearly silent on the ethical considerations relevant to this rare procedure. We explore five aspects of the complex landscape of hemicorporectomy to illustrate the broader ethical questions related to this extraordinary procedure: benefits, risks, informed consent, resource allocation and justice, and loss and the lived body. [ABSTRACT FROM AUTHOR]

This article is based on the British Nutrition Foundation's Annual Lecture 2013, which focused on maternal fish consumption and the effects of methylmercury ( MeHg) on fetal development, with respect to current guidance and policy on fish consumption during pregnancy. Fish makes a valuable contribution to nutrient intakes across the globe and is the primary protein source for many individuals, particularly those in the developing world. Populations with a high fish consumption, such as in the Republic of the Seychelles, have a greater exposure to MeHg, which is present in varying amounts in all fish. MeHg is a toxic pollutant, which is known to impair neurodevelopment. The dose of MeHg from fish consumption, however, needed to impair neurodevelopment is unknown. Current UK and US guidance on fish consumption during pregnancy tend to focus more on avoiding risks rather than highlighting the benefits that can be obtained from eating fish. Such recommendations have been mainly based on data arising from epidemiological studies in the Faroe Islands, where MeHg exposure was largely from pilot whale consumption. Although small adverse effects on child development have been reported in data from the Faroe Islands, data from the ongoing Seychelles Child Development Studies have shown no adverse effects of pre-natal MeHg exposure from high maternal fish consumption (9-12 meals containing fish per week) on developmental outcomes. Instead these data suggest that nutrients, including long-chain polyunsaturated fatty acids ( LC- PUFAs), provided by fish may offer a beneficial effect and attenuate or modify any effects of MeHg on developmental outcomes. Recent expert consultations have concluded that the health benefits of fish consumption outweigh the risks posed by MeHg exposure and have argued the need for improved education and guidance to highlight the importance of consuming nutrients, including LC- PUFAs, from fish for optimal child development and to encourage fish consumption during pregnancy. [ABSTRACT FROM AUTHOR]

Introduction: To evaluate the response to low dose oxybutynin in children with nocturnal enuresis. Materials and Methods: Forty-one neurologically normal enuretic children who were visited in our nephrology clinic in a 3-year period (2007-2009) received low dose oxybutynin (2.5-10 mg/day depending on the weight) to define response to the drug in one and 3- month periods. No, partial, and full response were defined as 0-49%, 50-89% and ⩽90% decrease in bed wetting, respectively. Results: In the first month of treatment, full, partial, and no response were reported in 3 (7.3%), 14 (34.1%), and 24 (58.6%) patients, respectively. In the non-responder patients, 6 (25%) and 5 (20.8 %) patients showed full and partial response in the 3-month period whereas 13 (54.2%) had no response. The side effects of the drug were reported in 5 (12.2%) patients. Children with non-mono symptomatic nocturnal enuresis (NMNE) showed a better response to the drug than those with mono symptomatic nocturnal enuresis (MNE) (75% versus 25%). There was no significant differences in age, gender, family history of enuresis, and the presence or absence of daytime urinary or bowel symptoms between responder and non-responder groups (P>0.05 for all). Conclusions: In this clinical report study, there was 68.3% treatment benefit and 12% risk (side effects of the drug) with low dose oxybutynin. Therefore, it may have a role in treating nocturnal enuresis, especially in patients with NMNE who experience adverse effects of standard treatment (Higher doses of the drug). [ABSTRACT FROM AUTHOR]

Chelation therapy is often used to treat mercury poisoning. Public health personnel are often asked about mercury toxicity and its treatment. This paper provides a public health department response to use of a mercury-containing cosmetic in Minnesota, a perspective on two unpublished cases of chelation treatment for postulated mercury toxicity, and comments on the use of a nonsystemic treatment for removal of mercury following the Iraqi seed coat poisoning incident. Physicians should evaluate sources of exposure, biomarkers, and risks and benefits before recommending chelation therapy for their patients. Potential risks to chelation therapy and its little understood subtle or latent effects are areas of public health concern. [ABSTRACT FROM AUTHOR]

Nanotechnology has been touted as the next ‘industrial revolution’ of our modern age. In order for successful research, development, and social discourses to take place in this field, education research is needed to inform the development of standards, course development, and workforce preparation. In addition, there is a growing need to educate citizens and students about risks, benefits, and social and ethical issues related to nanotechnology. This position paper describes the advancements that have been made in nanoscale science and nanotechnology, and the challenges that exist to educate students and the public about critical nanoscience concepts. This paper reviews the current research on nanotechnology education including curricula, educational programs, informal education, and teacher education. Furthermore, the unique risks, benefits and ethics of these unusual technological applications are described in relation to nanoeducation goals. Finally, we outline needed future research in the areas of nanoscience content, standards and curricula, nanoscience pedagogy, teacher education, and the risks, benefits, and social and ethical dimensions for education in this emerging field. [ABSTRACT FROM PUBLISHER]

Purpose: Many cancer patients use complementary and alternative medicine (CAM). However, data in hematological cancers are lacking on which types of CAM are being used, what information sources on CAM patients use and to what extent CAM is being addressed in the consultation with the hematologist. Methods: We developed a standardized questionnaire on CAM which was provided online to the representatives of the worldwide Chronic Myeloid Leukemia Advocates Network. Results: A total of 53 leaders of patients' advocacy groups for chronic myeloid leukemia (CML) patients from 35 countries responded to the survey. In almost all countries, CAM is important for CML patients and is widely used in addition to conventional leukemia treatment. Mostly, patients have to pay by themselves. General practitioners, herbalists, healers and naturopaths are the main sources for CAM treatments. Information on CAM is derived most frequently from the Internet, and family and friends, but rarely provided by the oncologist. Disclosure of CAM use to the oncologist is low, but increases if oncologists offer CAM. Conclusions: In spite of very different health care systems, the features of CAM usage are similar in the different countries. We suggest extending the cooperation of self-help and scientists in order to provide training of oncologists on CAM and quality-controlled, evidence-based information on CAM on the Internet both for patients as well as health professionals as a promising strategy to increase safe use of CAM in patients with CML. [ABSTRACT FROM AUTHOR]

A major misperception concerning postmenopausal hormone replacement therapy ( HRT) is that the associated risks are large in magnitude and unique to HRT, but over the past 10 years, sufficient data have accumulated so that the magnitude and perspective of risks associated with the primary coronary heart disease prevention therapies of statins, aspirin, and postmenopausal HRT have become more fully defined. Review of randomized controlled trials indicates that the risks of primary prevention therapies and other medications commonly used in women's health are of similar type and magnitude, with the majority of these risks categorized as rare to infrequent (<1 event per 100 treated women). Evidence-based data show that the risks of postmenopausal HRT are predominantly rare (<1 event per 1,000 treated women) and certainly no greater than other commonly used medications in women's health, including statins and aspirin. These risks, including breast cancer, stroke, and venous thromboembolism are common across medications and are rare, and even rarer when HRT is initiated in women younger than 60 or who are less than 10 years since menopause. In Part 1 of this series, the sex-specificity of statins and aspirin and timing of initiation of HRT as modifiers of efficacy in women were reviewed. Herein, the comparative risks of primary prevention therapies in women are discussed. [ABSTRACT FROM AUTHOR]

Abstract: Background: Although acceptability of combined oral contraceptives (COCs) is widespread, patients are often unaware of the noncontraceptive benefits. Study Design: An opinion survey through telephone interview was conducted to evaluate the knowledge of 500 Brazilian women 15–45 years of age who were current users or had recently used COCs. Data were obtained on their knowledge of adverse events, the effects of COCs on health- and menstrual-related symptoms, noncontraceptive benefits and aspects related to sexual response. Results: Most of the women interviewed learned about the pill from doctors or the Internet. Other than the pill, the best-known contraceptive methods were the condom and intrauterine device. The majority of women believe that COCs do not change the risk of gynecological cancers. Most believed that they had no significant effect on sexual response. Conclusions: COCs users in Brazil lack precise information on aspects related to general health, particularly menstrual-related symptoms and noncontraceptive health benefits. [Copyright &y& Elsevier]

Undergoing oronasopharyngeal suction is an unpleasant experience, but the intervention may prevent the deterioration of children who cannot clear their secretions. A successful procedure requires a practitioner with appropriate knowledge, dexterity and communication skills. Thorough training should be provided and a careful risk-benefit assessment is important before suction is performed. [ABSTRACT FROM AUTHOR]

Objective: Most patients with non-small cell lung cancer (NSCLC) present with an incurable, advanced disease, and treatment decisions may be hard. This study explored the factors that influence patients' choice of treatment during the oncologist-patient consultation. Design: Semi-structured interviews conducted within 1 month of a consultation with an oncologist. Participants: Five patients newly diagnosed with incurable NSCLC and facing a treatment decision following a consultation with an oncologist. Setting: A regional oncology unit in the UK. Results: Some of the participants who opted for chemotherapy had made a decision before seeing the oncologist, presented with fewer symptoms, had been more active in seeking information before the consultation, and were willing to accept the risk of side effects. Participants opting for radiotherapy were not willing to accept the risk of side effects for the possibility of a small survival gain and instead focused on symptom relief. Conclusion: Some participants sought information before the consultation from various formal and informal sources. This may undermine the oncologist-patient consultation as the information may be incomplete or inaccurate. Patients vary in their willingness to accept risks for small potential gains. More research is required into methods to communicate the extent of the risks of treatment. The Clinical Nurse Specialist performed a valuable role for the patients and was seen as a trusted source of information. [ABSTRACT FROM AUTHOR]

Psychotropic drug prescribing for children and adolescents is frequently off-label and has increased over time and can be controversial. Psychotropic prescribing in two large UK medium secure units for young people has been studied. A total of 89 patients were included, 64% being aged less than 18 years. A total of 137 of 202 (67.8%) of prescriptions were off-label. The most common reasons for a prescription being off-label were the indication (N = 103) and the patient’s age (N = 41). The main classes of drugs involved were antipsychotics (N = 59), antiepileptics as mood stabilisers (N = 22), anticholinergics and hyoscine (N = 15) and antidepressants (N = 11). Aggression (N = 48) and post-traumatic stress disorder (N = 30) were the most common off-label indications. Some antidepressant prescriptions were contrary to advice of the Committee on Safety of Medicines (CSM). Meta-analyses or randomised controlled trials supported 27% of off-label prescriptions, with lesser quality studies supporting a further 29.2% and expert opinion 38.7%, whereas for 5.1% no evidence could be found. Prescribers tended to over-estimate the level of evidence from clinical trials or extrapolated from findings in adults. They often quoted their own experience rather than expert sources to justify their prescribing practice. It is important that prescribers are fully aware of the quality of experimental data and the risk-benefit ratio when prescribing off-label for young persons. If the evidence base is limited, it is particularly important to provide information about the risks and benefits of the treatment to the patient/relatives. A second opinion may be helpful. Both target symptoms and side effects should be monitored and regularly reviewed. [ABSTRACT FROM PUBLISHER]

Studies have investigated perceived own risk as a predictor of behavioural change, but only few have investigated perceived risk to others. However, many risks are distributed, affecting other people as much as the 'agents' of the behaviour in question. Further, research on health perceptions has focussed more on risk than benefit even though people generally choose to engage in behaviours because of benefits not risks. The present study investigated the acceptance of smoking restrictions in Germany, a country that at the time of conducting the research had few restrictions on smoking. Smokers (N = 147) rated the benefits and risks of smoking for themselves and others, and their attitudes towards smoking restrictions. We replicated comparative optimism and reality constraints concerning smoking risks. Additionally, we found that participants overestimated their own benefits compared to other smokers ('comparative utility'). Importantly, own benefits but risks to others best predicted the acceptance of smoking regulations. Moreover, smokers who intended to quit differed from those who did not intend to quit. These findings are potentially important for policy makers aiming to broaden acceptance of regulations for risky behaviours: It may be more effective to remind people they are putting others at risk rather than themselves. [ABSTRACT FROM AUTHOR]

There has been debate in the literature as to whether: (1) the risks and benefits of genetically-modified (GM) food and agriculture are considered and determined by individuals separately or whether they are jointly determined by attitudes; (2) consumer acceptance is determined by individuals weighing up their risk and benefit perceptions in a rational, even-handed manner, or if benefit perceptions are more important than risk perceptions, and (3) certain types of risk and benefit are more important than others. Against this background, this paper assesses the categories of risks and benefits and their relative importance in determining willingness to consume. A survey was carried out to collect data on the categories of risks and benefits in the US, UK and France, and the relative importance of selected perceived risk and benefit dimensions was estimated. The findings show: risk and benefit perceptions are negatively correlated, but not perfectly and, given that regressions we performed support the proposition that benefits are more important than risks in determining willingness to consume, a strong case can be made for measuring risks and benefits separately. Almost 2/3 of consumers perceive medium to high potential benefits from GM, though the proportion is slightly lower in the UK and down to 40% in France. Nevertheless, this suggests a much higher level of support for the technology than is normally assumed. From the study, benefits are more important for consumers’ willingness to consume than perceived risks, and slightly more interviewees scored above than below the mean on willingness to consume GM food. [ABSTRACT FROM AUTHOR]

United States law requires that immunization providers use Centers for Disease Control Vaccine Information Statements (VISs) and inform parents about vaccine risks and benefits prior to every childhood immunization. A recent national survey found that public health clinics (PHCs) reported high compliance with this law. To further investigate these findings, we conducted an immunization time-motion study in two PHCs in Kansas and Louisiana. Research assistants observed a convenience sample of 246 child immunization visits to record distribution of the VISs and content and time of vaccine communication. Thirty percent of parents read below a ninth grade level, 53% had Medicaid insurance, and 56% were Black. VISs were given with every dose of vaccine administered in 89% of visits. Public health nurses (PHNs) frequently discussed potential vaccine side effects (91%), treatment of side effects (91%), and the vaccine schedule (93%). Contraindications were screened in 71% of visits. Benefits were discussed in 48% of visits and severe risks in 29%. The national Vaccine Injury Compensation Program (VICP) was never discussed. The immunization visits lasted for a mean of 20 min. Vaccine communication of side effects, risks, benefits, screening for contraindications, and the next visit lasted for an average of 16 s for all vaccines. PHC compliance with mandated VIS distribution and practical vaccine communication was high. Room for improvement exists in discussion of benefits, serious risks, and the VICP. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to compare adults with and without dementia on capacities to consent to treatment as assessed by three instruments. Design and Methods: Eighty-eight older adults with mild to moderate dementia were compared with 88 matched controls on four indices of legal competency to consent to medical treatment as assessed with three capacity instruments. Results: Mean performance of adults with dementia on a legal standard of understanding treatment information was impaired relative to controls on all instruments, and it was also impaired for an appreciation standard on one instrument and a reasoning standard on two instruments. However, in categorical ratings, most adults with dementia were within the normal range on all decisional capacities. Legal standards were operationalized differently across the three instruments for the capacities of appreciation and reasoning. Implications: Most adults with mild dementia can participate in medical decision making as defined by legal standards, although memory impairments may limit demonstration of understanding of diagnostic and treatment information. In dementia, assessments of reasoning about treatment options should focus on whether a person can describe salient reasons for a specific choice, whereas assessments of appreciation of the meaning of diagnostic and treatment information should focus on whether a person can describe the implications of various choices for future states. More research is needed to establish the reliability and validity of assessment tools and of capacity constructs. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to explore women's decision-making about the balance of risks and benefits of taking hormone replacement therapy (HRT) based on the latest evidence from the Women's Health Initiative (WHI) trial of combined HRT.Methods: Women aged 50-69 years, who were eligible for the Women's International Study of long Duration Oestrogen after Menopause (WISDOM) trial, were invited to participate in one of eight focus groups. Participants were asked to discuss their views about taking HRT based on the latest international evidence.Results and Conclusions: Eighty-two women participated overall. Qualitative content analysis was applied to the discussion transcripts. Women regarded the decisions they make about taking HRT as highly personal, and, for women currently taking HRT, the overwhelming reason for continuation was perceived improvement in quality of life regardless of either the risks or the benefits in the longer term. [ABSTRACT FROM AUTHOR]

: ObjectivesTo evaluate Canadian women'' s knowledge of the risks, benefits and side effects of oral contraceptives (OCs) and the effect of counseling.: Study designSix-hundred and forty-nine Canadian women filling an OC prescription at Shopper''s Drug Mart stores completed the survey. Respondents recorded whether or not they had discussed 12 separate issues about OC use with their healthcare provider. Optimal responses to multiple-choice questions were compared between those reporting counseling to those reporting no counseling, using Fisher''s Exact Tests. Women were also questioned on what they were told about associated cancer risks.: ResultsEighty percent or more of the women selected the optimal response for the questions relating to dysmenorrhea, leg pain and co-medication. Less than half of survey respondents identified the optimal response for nausea, breakthrough bleeding, breast tenderness, acne, headaches and weight change. Counseling made a significant impact on selection of the optimal response for 7 of the 12 questions (p < 0.004, adjusted significance level). Fifty-two percent indicated that they did not know what they were told about the risk of uterine and ovarian cancer when on the pill. A significant proportion of women said they would phone their physician for relatively minor problems such as breakthrough bleeding (65%), breast tenderness (55%) and acne (54%).: ConclusionsThe knowledge level of Canadian women on the pill regarding risks, benefits and side effects of the pill remains deficient in several key areas. Adequate counseling by healthcare providers can help women recognize the pill''s positive health benefits, and may result in fewer unnecessary physician contacts and unwanted pregnancies. [Copyright &y& Elsevier]

Although combined oral hormonal contraceptives have been described as the most significant medical advance of the 20th century, the usage rate in the People’s Republic of China is considerably lower than in developed countries. This survey aimed to explore the acceptability of combined oral hormonal contraceptives (COC) amongst women aged 18–35 years who attended the family planning clinic in the International Peace Maternity and Child Health Hospital in Shanghai, as well as amongst gynecologists who worked in the same hospital. In total, 500 clients and 89 gynecologists were recruited. Only 12% of the clients had ever used COC. Women with a lower educational level or parous women were more likely to use COC (p < 0.05). COC was the third most popular method recommended by the gynecologists (85.4%). Both groups were concerned about the risks and side effects of COC, especially younger doctors and doctors with fewer years of experience (p < 0.01). The results of the survey suggest that it is necessary to provide improved training about COC to reproductive-aged women and professionals to dispel misunderstandings of the pill. [Copyright &y& Elsevier]

La Vaque and Rossiter made a strong, supported argument that it is unethical to use a “no treatment” control group in a research study if a known, effective treatment is available. Their argument is based on the supposition that the Declaration of Helsinki is the ethical world standard for research with humans. Their argument appears to be straightforward, but is not simple to apply. The issues are very complex, include issues not discussed in their argument, and can lead to a different conclusion as pointed out in this paper. The World Medical Association developed the Declaration of Helsinki as one of their official policies. The Declaration of Helsinki, however, is not accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations or even by the United States Federal Government. Perhaps it is not mentioned because its ethical provisions are aspirational rather than mandatory as implied by La Vaque and Rossiter. Researchers and clinicians should also be aware of other ethical issues not directly discussed in the La Vaque and Rossiter paper. The Belmont Report is the basis for the ethical protection of human research subjects for at least 17 federal agencies and does not mention the Declaration of Helsinki. The Belmont Report mentions several ethical principles that form the basis for informed consent, risk/benefit assessment, confidentiality of data, subject selection, Institutional Review Boards, and other protections needed when doing research with human subjects. At least 2 of these core principles have direct implications to the discussion related to the use of placebo controls. The ethical principle of fidelity is also important in guiding research activities with human subjects. Researchers should be familiar with the La Vaque and Rossiter argument, the Belmont Report, and the federal policies developed to implement the provisions of that report, for example, Regulation 45 CFR 46. [ABSTRACT FROM AUTHOR]

A recent Cochrane review on water fluoridation found that the initiation of water fluoridation resulted in reductions in dmft of 1.81 (35%) and in DMFT of 1.16 (26%). There were also increases in the percentage of caries-free children (deciduous dentition: 15%, permanent dentition: 14%). However, the majority of the studies were conducted prior to 1975, and the widespread use of fluoride toothpaste, and the authors found very little contemporary evidence on the efficacy of water fluoridation. They estimated that for a fluoride level of 0.7 ppm the percentage of participants with some degree of fluorosis was 40% and that in 12.5% this was of aesthetic concern. In the following editorial in Fluoride, this editor noted that the ability of fluoride to adversely cellular metabolism in cariogenic bacteria was its Achilles' heel for being a useful systemic therapeutic agent as it could also disrupt the ultrastructure of mitochondria and endoplasmic reticulum, and alter enzyme and gene expression levels in humans. The Fluoride editorial noted that, as well as contributing to dental fluorosis, systemic fluoride intake may be a possible aetiological factor in a number of significant health problems and concluded that an objective assessment of the risks and benefits of water fluoridation, together with taking account of the precautionary principle, indicated that systemic fluoride ingestion for preventing dental caries was a flawed concept. [ABSTRACT FROM AUTHOR]

'No decision about me without me' describes the Department of Health's latest vision for the health service where patients are active participants in their treatment decisions. This article argues that for 'no decision about me without me' to be a reality, nurses must be required to obtain a truly informed consent from their patients by ensuring that information about the benefits and risks of treatment are properly explained to all patients regardless of their ability to question the treatment decision. [ABSTRACT FROM AUTHOR]