BNT162b vaccines protect rhesus macaques from SARS-CoV-2.

A safe and effective vaccine against COVID-19 is urgently needed in quantities that are sufficient to immunize large populations. Here we report the preclinical development of two vaccine candidates (BNT162b1 and BNT162b2) that contain nucleoside-modified messenger RNA that encodes immunogens derived from the spike glycoprotein (S) of SARS-CoV-2, formulated in lipid nanoparticles. BNT162b1 encodes a soluble, secreted trimerized receptor-binding domain (known as the RBD-foldon). BNT162b2 encodes the full-length transmembrane S glycoprotein, locked in its prefusion conformation by the substitution of two residues with proline (S(K986P/V987P); hereafter, S(P2) (also known as P2 S)). The flexibly tethered RBDs of the RBD-foldon bind to human ACE2 with high avidity. Approximately 20% of the S(P2) trimers are in the two-RBD 'down', one-RBD 'up' state. In mice, one intramuscular dose of either candidate vaccine elicits a dose-dependent antibody response with high virus-entry inhibition titres and strong T-helper-1 CD4+ and IFNγ+CD8+ T cell responses. Prime-boost vaccination of rhesus macaques (Macaca mulatta) with the BNT162b candidates elicits SARS-CoV-2-neutralizing geometric mean titres that are 8.2-18.2× that of a panel of SARS-CoV-2-convalescent human sera. The vaccine candidates protect macaques against challenge with SARS-CoV-2; in particular, BNT162b2 protects the lower respiratory tract against the presence of viral RNA and shows no evidence of disease enhancement. Both candidates are being evaluated in phase I trials in Germany and the USA1-3, and BNT162b2 is being evaluated in an ongoing global phase II/III trial (NCT04380701 and NCT04368728).

Impacts of Clinical Decision Support Systems on the Relationship, Communication, and Shared Decision-Making Between Health Care Professionals and Patients: Multistakeholder Interview Study.

BACKGROUND: Clinical decision support systems (CDSSs) are increasingly being introduced into various domains of health care. Little is known so far about the impact of such systems on the health care professional-patient relationship, and there is a lack of agreement about whether and how patients should be informed about the use of CDSSs. OBJECTIVE: This study aims to explore, in an empirically informed manner, the potential implications for the health care professional-patient relationship and to underline the importance of this relationship when using CDSSs for both patients and future professionals. METHODS: Using a methodological triangulation, 15 medical students and 12 trainee nurses were interviewed in semistructured interviews and 18 patients were involved in focus groups between April 2021 and April 2022. All participants came from Germany. Three examples of CDSSs covering different areas of health care (ie, surgery, nephrology, and intensive home care) were used as stimuli in the study to identify similarities and differences regarding the use of CDSSs in different fields of application. The interview and focus group transcripts were analyzed using a structured qualitative content analysis. RESULTS: From the interviews and focus groups analyzed, three topics were identified that interdependently address the interactions between patients and health care professionals: (1) CDSSs and their impact on the roles of and requirements for health care professionals, (2) CDSSs and their impact on the relationship between health care professionals and patients (including communication requirements for shared decision-making), and (3) stakeholders' expectations for patient education and information about CDSSs and their use. CONCLUSIONS: The results indicate that using CDSSs could restructure established power and decision-making relationships between (future) health care professionals and patients. In addition, respondents expected that the use of CDSSs would involve more communication, so they anticipated an increased time commitment. The results shed new light on the existing discourse by demonstrating that the anticipated impact of CDSSs on the health care professional-patient relationship appears to stem less from the function of a CDSS and more from its integration in the relationship. Therefore, the anticipated effects on the relationship between health care professionals and patients could be specifically addressed in patient information about the use of CDSSs.

[Supporting medical and nursing activities with AI: recommendations for responsible design and use]. / Unterstützung ärztlicher und pflegerischer Tätigkeit durch KI: Handlungsempfehlungen für eine verantwortbare Gestaltung und Nutzung.

Clinical decision support systems (CDSS) based on artificial intelligence (AI) are complex socio-technical innovations and are increasingly being used in medicine and nursing to improve the overall quality and efficiency of care, while also addressing limited financial and human resources. However, in addition to such intended clinical and organisational effects, far-reaching ethical, social and legal implications of AI-based CDSS on patient care and nursing are to be expected. To date, these normative-social implications have not been sufficiently investigated. The BMBF-funded project DESIREE (DEcision Support In Routine and Emergency HEalth Care: Ethical and Social Implications) has developed recommendations for the responsible design and use of clinical decision support systems. This article focuses primarily on ethical and social aspects of AI-based CDSS that could have a negative impact on patient health. Our recommendations are intended as additions to existing recommendations and are divided into the following action fields with relevance across all stakeholder groups: development, clinical use, information and consent, education and training, and (accompanying) research.

Responsibility and decision-making authority in using clinical decision support systems: an empirical-ethical exploration of German prospective professionals' preferences and concerns.

Machine learning-driven clinical decision support systems (ML-CDSSs) seem impressively promising for future routine and emergency care. However, reflection on their clinical implementation reveals a wide array of ethical challenges. The preferences, concerns and expectations of professional stakeholders remain largely unexplored. Empirical research, however, may help to clarify the conceptual debate and its aspects in terms of their relevance for clinical practice. This study explores, from an ethical point of view, future healthcare professionals' attitudes to potential changes of responsibility and decision-making authority when using ML-CDSS. Twenty-seven semistructured interviews were conducted with German medical students and nursing trainees. The data were analysed based on qualitative content analysis according to Kuckartz. Interviewees' reflections are presented under three themes the interviewees describe as closely related: (self-)attribution of responsibility, decision-making authority and need of (professional) experience. The results illustrate the conceptual interconnectedness of professional responsibility and its structural and epistemic preconditions to be able to fulfil clinicians' responsibility in a meaningful manner. The study also sheds light on the four relata of responsibility understood as a relational concept. The article closes with concrete suggestions for the ethically sound clinical implementation of ML-CDSS.

Ensuring Privacy and Confidentiality in Social Work Through Intentional Omissions of Information in Client Information Systems: a Qualitative Study of Available and Non-available Data.

There is intensive debate about the use of AI-based systems in social work, although the degree of digitalization is low in many jurisdictions. In this article, the findings of research about the process of case recording in client information systems for social work are presented. Between January and June 2020, 20 guideline-based interviews were conducted with experts working for funding agencies or service providers. A significant finding was that there are intentional omissions of information within digital client records, despite being relevant for further case processing. This finding and the reasons for omission are highly relevant to the current debate on AI, because it extends consideration beyond the ethics of design to include the ethics of usage.

Elder abuse forensic centers.

Elder abuse forensic centers present a new model of multidisciplinary collaboration on elder abuse cases. The "clients" of a forensic center are Adult Protective Services (APS), law enforcement, and the Long-term Care Ombudsman. Centers take the basic multidisciplinary team model and add a geriatrician and a psychologist. Additionally, forensic center team members make home visits with APS and others for the purposes of conducting psychological or medical evaluations, lessening the burden of multiple interviews for the alleged abuse victims, and gathering evidence for possible prosecution. The challenges and successes of the four California forensic center teams are discussed.

Geriatricians and psychologists: essential ingredients in the evaluation of elder abuse and neglect.

This article describes the clinical work that three sets of geriatricians and psychologists provided in three elder abuse forensic centers in California. After a brief history of how the clinical services in each program developed, the contributions of geriatricians and psychologists within these elder abuse teams are detailed through the use of several case anecdotes. Beyond providing physical and psychological evaluations, geriatricians and psychologists provide consultations and education to other professionals and to elder abuse victims and their caregivers. These clinical teams emphasize the importance of conducting home visits and functional assessments, working with interdisciplinary team members, and providing expert testimony.

Tuberculosis control among people in U.S. Immigration and Customs Enforcement custody.

BACKGROUND: People detained by United States Immigration and Customs Enforcement (ICE) are a high-risk population for tuberculosis (TB). Detainees are screened for TB upon intake, and TB patients are reported to the Division of Immigration Health Services (DIHS). METHODS: TB case reports were reviewed for ICE detainees reported to DIHS during 2004-2005. Case counts and frequency distributions are presented. Case counts are stratified by demographic characteristics, release status, laboratory and clinical findings, HIV/AIDS status, and drug resistance. Case rates were calculated for patients housed at facilities with DIHS staffing. Duration of treatment and of ICE custody is provided. Analyses were conducted in 2006. RESULTS: During 2004 and 2005, 76 and 142 TB patients were reported, respectively. The TB case rate was 82.6/100,000 in 2004 and 121.5/100,000 in 2005. The culture-confirmed case rate of 55.8/100,000 in 2005 was 2.5 times higher than the case rate in the U.S. foreign-born population. Of 218 patients, 127 (58.3%) had Mycobacterium tuberculosis-positive sputum cultures, 70 (32.1%) had acid-fast bacilli-positive sputum smears, and 36 (16.5%) were symptomatic at diagnosis. Patients from Mexico, Honduras, Guatemala, and El Salvador accounted for 184 cases (84.4%) and 184 patients (84.4%) were repatriated. TB patients spent an average 82.6 days in treatment before release or repatriation. CONCLUSIONS: Screening at intake to ICE custody has helped DIHS staff in diagnosing TB and starting patients on treatment, but patients are usually deported before completing therapy. Because of deportation, and sometimes re-entry into the United States, unique collaborations are required to support completion of treatment.

Meeting the needs of people with primary progressive multiple sclerosis, their families, and the health-care community.

Although major advances have been made in delaying or preventing progression for the relapsing forms of multiple sclerosis (MS), little progress has been made to date in disease management for primary progressive MS (PPMS). Treatment strategies are largely focused on managing the symptoms of the disease and providing counseling and other forms of psychosocial support. The nurse plays a major role in managing these patients. This article summarizes a collaborative effort by the National Multiple Sclerosis Society and the Multiple Sclerosis Association of America to analyze the needs of this patient population and respond with programs that will meet those needs. This approach to developing a needs assessment is broadly applicable to other patient populations.

Bruising as a marker of physical elder abuse.

OBJECTIVES: To describe bruising as a marker of physical elder abuse. DESIGN: Consenting older adults were examined to document location and size of bruises and assess whether they were inflicted during physical abuse. An expert panel confirmed physical abuse. Findings were compared with results of an earlier study of accidental bruising in older adults. SETTING: Residences of participants. PARTICIPANTS: Sixty-seven adults aged 65 and older reported to Adult Protective Services (APS) for suspected physical elder abuse. MEASUREMENTS: Age, sex, ethnicity, race, functional status, medical conditions, cognitive status, history of falls, bruise size and location, recall of cause, and responses to Revised Conflicts Tactics Scale and Elder Abuse Inventory. RESULTS: Seventy-two percent (n=48) of older adults who had been physically abused within 30 days before examination had bruises. The physically abused older adults had significantly larger bruises; more of them knew the cause of their bruises (43 (89.6%) vs 16 (23.5%) of the comparison group); and they were significantly more likely to have bruises on the face, lateral aspect of the right arm and the posterior torso (including back, chest, lumbar, and gluteal regions) than older adults from an earlier study who had not been abused (n=68). CONCLUSION: Bruises that occur as a result of physical elder mistreatment are often large (>5 cm) and on the face, lateral right arm, or posterior torso. Older adults with bruises should be asked about the cause of the bruises to help ascertain whether physical abuse occurred.

Human cargo: health conditions of Chinese migrants interdicted offshore by U.S. authorities.

During the eight month period between April and December 1999, the United States Coast Guard intercepted seven boats carrying migrants from the People's Republic of China destined for the United States. These migrants were processed by the United States Immigration and Naturalization Service in three locations: Tinian Island, Midway Island, and Guatemala. Emergency Medical Response Teams from the United States Public Health Service, Division of Immigration Health Services, were deployed to conduct initial health screenings of the 913 migrants on board these ships and provide on-going health care until the individuals were repatriated or relocated. The distributions of demographic characteristics of the population and the health conditions observed are presented. Differences in health conditions observed by temporary detention location, sex, and age group were assessed. The majority of migrants were males younger than age 30. Few serious illnesses were observed. The most prevalent conditions included skin rashes, fungal rashes, upper respiratory infections, abdominal discomfort, scabies, abrasions, skin lesions, headache, pain and/or injuries, dental problems, and ear problems. For many health conditions, statistically significant differences were observed by location. For nearly all conditions for which differences were observed by sex, these differences were accounted for by a greater proportion of females presenting with the condition.

Can cervicography be improved? An evaluation with arbitrated cervicography interpretations.

OBJECTIVE: The purpose of this study was to estimate the optimal performance of cervicography. We compared an arbitrated cervigram classification with an arbitrated referent diagnosis of cervical neoplasia. STUDY DESIGN: From an initial group of 8460 women, a stratified sample of cervigrams from 3645 women and histologic information from 414 women underwent arbitration. Interobserver agreement was assessed for cervicography and the referent diagnosis. Sensitivity, specificity, and predictive values were estimated for initial and arbitrated cervicography results, compared with the initial and arbitrated referent diagnoses. RESULTS: For the detection of arbitrated high-grade lesions or cancer, arbitrated cervicography yielded an overall sensitivity of 63.9% and a specificity of 93.7%. Significantly higher sensitivity was associated with younger age and age-related visual characteristics. CONCLUSION: Optimization of the cervigram classification improved performance over a single interpretation in this population but suggested the limits of static visual screening.