Convalescent Plasma and the US Expanded Access Program: A Personal Narrative.

Between early April 2020 and late August 2020, nearly 100,000 patients hospitalized with SARS-CoV2 infections were treated with COVID-19 convalescent plasma (CCP) in the US under the auspices of an FDA-authorized Expanded Access Program (EAP) housed at the Mayo Clinic. Clinicians wishing to provide CCP to their patients during that 5-month period early in the COVID pandemic had to register their patients and provide clinical information to the EAP program. This program was utilized by some 2,200 US hospitals located in every state ranging from academic medical centers to small rural hospitals and facilitated the treatment of an ethnically and socio-economically diverse cross section of patients. Within 6 weeks of program initiation, the first signals of safety were found in 5,000 recipients of CCP, supported by a later analysis of 20,000 recipients (Joyner et al. in J Clin Invest 130:4791-4797, 2020a; Joyner et al. in Mayo Clin Proc 95:1888-1897, 2020b). By mid-summer of 2020, strong evidence was produced showing that high-titer CCP given early in the course of hospitalization could lower mortality by as much as a third (Joyner et al. in N Engl J Med 384:1015-1027, 2021; Senefeld et al. in PLoS Med 18, 2021a). These data were used by the FDA in its August decision to grant Emergency Use Authorization for CCP use in hospitals. This chapter provides a personal narrative by the principal investigator of the EAP that describes the events leading up to the program, some of its key outcomes, and some lessons learned that may be applicable to the next pandemic. This vast effort was a complete team response to a crisis and included an exceptional level of collaboration both inside and outside of the Mayo Clinic. Writing just 4 years after the initiation of the EAP, this intense professional effort, comprising many moving parts, remains hard to completely understand or fully explain in this brief narrative. As Nelson Mandela said of the perception of time during his decades in prison, "the days seemed like years, and the years seemed like days."

The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards.

Advanced therapy medicinal products (ATMPs) are rapidly evolving to offer new treatment options. The scientific, technical, and clinical complexities subject drug regulatory authorizes to regulatory challenges. To advance the regulatory capacity for ATMPs, the National Medical Products Administration in China made changes to the drug regulatory system and developed regulatory science with the goal of addressing patient needs and encouraging innovation. This study aimed to systematically identify the regulatory evidence on ATMPs in China under the guidance of an overarching framework from the World Health Organization Global Benchmarking Tool. It was found that China's administrative authorities at all levels have issued a number of policy documents to promote the development of ATMPs, covering biopharmaceutical products research and development (n = 14), biopharmaceutical industry development (n = 9), high-quality development of medical institutions (n = 1), specific development plans/projects (n = 6) and specific regional development (n = 4). The legal and regulatory framework of ATMPs in China has been established and is subject to continuous adjustment in various aspects including regulations (n = 3), departmental rules or administrative normative documents (n = 22), and technical guidance (n = 15). As the regulatory reform continues, the drug review processes have been revised, and various technical standards have been launched, which aim to establish a regulatory approach that oversees the full life-cycle development of ATMPs in the country. The limited number of investigational new drug applications and approved ATMPs suggests a lag remains between the translation of advanced therapeutic technologies into clinically available medical products. To accelerate the translational research of ATMP in countries such as China, developing and adopting real-world evidence generated from clinical use in designated healthcare facilities to support scientific decision-making in ATMP regulation is warranted. The enhancement of regulatory capacity building and multi-stakeholder collaborations should also be encouraged to facilitate the timely evaluation of promising ATMPs to meet more patient needs.

How infants predict respect-based power.

Research has shown that infants represent legitimate leadership and predict continued obedience to authority, but which cues they use to do so remains unknown. Across eight pre-registered experiments varying the cue provided, we tested if Norwegian 21-month-olds (N=128) expected three protagonists to obey a character even in her absence. We assessed whether bowing for the character, receiving a tribute from or conferring a benefit to the protagonists, imposing a cost on them (forcefully taking a resource or hitting them), or relative physical size were used as cues to generate the expectation of continued obedience that marks legitimate leadership. Whereas bowing sufficed in generating such an expectation, we found positive Bayesian evidence that all the other cues did not. Norwegian infants unlikely have witnessed bowing in their everyday life. Hence, bowing/prostration as cue for continued obedience may form part of an early-developing capacity to represent leadership built by evolution.

Pharmacist Prescribing Models for HIV Pre-exposure and Post-exposure Prophylaxis.

State strategies for pharmacist prescribing exist on a continuum from most restrictive to least restrictive. Using human immunodeficiency virus (HIV) pre-exposure prophylaxis and post-exposure prophylaxis as a case study, there are 3 viable pharmacist prescribing models: (1) population-based collaborative practice agreements; (2) government protocols; and (3) standard of care prescribing. The advantages and disadvantages of these 3 models are reviewed.

Towards the understanding of the core of general personality disorder factor: g-PD and its relation to hostile attributions.

There is a general consensus that personality disorders (PDs) share a general factor (g-PD) overlapping with the general factor of psychopathology (p-factor). The general psychopathology factor is related to many social dysfunctions, but its nature still remains to some extent ambiguous. We posit that hostile attributions may be explanatory for the factor common for all PDs, i.e., interpersonal problems and difficulty in building long-lasting and satisfying relationships of all kinds. Thus, the main objective of the current project was to expand the existing knowledge about underlying factors of g-PD with regard to hostile attributions. We performed a cross-sectional study on a representative, community sample of Poles (N = 1031). Our hypotheses were primarily confirmed as hostile attributions predicted p-factor. However, the relation was positive only for hostile attributions related to ambiguous situations involving relational harm and physical harm done by female authorities and negative in case of hostile attributions in situations involving physical harm done by peers. Additionally, paranoia-like thoughts strongly related to hostile attributions and independently predicted g-PD. The results contribute to the current discussion on the nature of the g-PD, confirm that hostile attributions and paranoia are a crucial aspect of personality pathology, and indicate the importance of working on these cognitions in the course of therapeutic work.

Impact of decentralized management on sickness absence in hospitals: a two-wave cohort study of frontline managers in Danish hospital wards.

BACKGROUND: This study explores the impact of decentralized management on the sickness absence among healthcare professionals. Sickness absence is a reliable indicator of employees' wellbeing and it is linked to management quality. However, the influence of decentralized management on sickness absence has not been adequately studied. METHODS: The research design combined a two-wave, web-survey of frontline managers in two Danish university hospitals with administrative data on sickness absence at the ward-level. The first and second wave included data from 163165 and 137 frontline managers linked to 121 wards and 108 wards. Data was analysed using an ordinal logistic regression model. RESULTS: Wards where frontline managers had the highest level of decentralised decision authority compared to none showed lower odds of ward-level sickness absence (ORcrude: 0.20, 95% CI: 0.05-0.87). A very high extent of cross-functional decision authority showed lower odds of sickness absence (ORcrude: 0.08, 95% CI: 0.01-0.49). Overall, the results showed a clear data trend, although not all results were statistically significant. CONCLUSION: Higher levels of decentralized management in wards were positively associated with lower risks of sickness absence in hospital wards. The study supports future research on how to empower decision autonomy at the frontline level of management.

Opt-out vaccination in school and daycare: Reconciling parental authority and obligations.

An increasing vaccine hesitancy among parents, which has resulted in insufficient rates of immunization, provides reason to reconsider childhood vaccination practices. Studies suggest that parents' decision-making process concerning whether to vaccinate their child is highly influenced by cognitive biases. These biases can be utilized to increase vaccination uptake via changes in the choice context. This article considers childhood vaccination programmes, which involve children being vaccinated in school or daycare unless their parents actively 'opt out'. We suggest that such programmes reconcile parents' decisional authority and vaccination duties. First, opt-out childhood vaccination based in schools or daycare centres are not disrespectful of parental authority. Second, the programme aligns the default setting with a moral obligation to vaccinate one's child that most parents have.

AI-driven decision support systems and epistemic reliance: a qualitative study on obstetricians' and midwives' perspectives on integrating AI-driven CTG into clinical decision making.

BACKGROUND: Given that AI-driven decision support systems (AI-DSS) are intended to assist in medical decision making, it is essential that clinicians are willing to incorporate AI-DSS into their practice. This study takes as a case study the use of AI-driven cardiotography (CTG), a type of AI-DSS, in the context of intrapartum care. Focusing on the perspectives of obstetricians and midwives regarding the ethical and trust-related issues of incorporating AI-driven tools in their practice, this paper explores the conditions that AI-driven CTG must fulfill for clinicians to feel justified in incorporating this assistive technology into their decision-making processes regarding interventions in labor. METHODS: This study is based on semi-structured interviews conducted online with eight obstetricians and five midwives based in England. Participants were asked about their current decision-making processes about when to intervene in labor, how AI-driven CTG might enhance or disrupt this process, and what it would take for them to trust this kind of technology. Interviews were transcribed verbatim and analyzed with thematic analysis. NVivo software was used to organize thematic codes that recurred in interviews to identify the issues that mattered most to participants. Topics and themes that were repeated across interviews were identified to form the basis of the analysis and conclusions of this paper. RESULTS: There were four major themes that emerged from our interviews with obstetricians and midwives regarding the conditions that AI-driven CTG must fulfill: (1) the importance of accurate and efficient risk assessments; (2) the capacity for personalization and individualized medicine; (3) the lack of significance regarding the type of institution that develops technology; and (4) the need for transparency in the development process. CONCLUSIONS: Accuracy, efficiency, personalization abilities, transparency, and clear evidence that it can improve outcomes are conditions that clinicians deem necessary for AI-DSS to meet in order to be considered reliable and therefore worthy of being incorporated into the decision-making process. Importantly, healthcare professionals considered themselves as the epistemic authorities in the clinical context and the bearers of responsibility for delivering appropriate care. Therefore, what mattered to them was being able to evaluate the reliability of AI-DSS on their own terms, and have confidence in implementing them in their practice.

Invited review: An evaluation of EFSA opinion on calf welfare from a nutritional and management perspective.

In March 2023, the European Food Safety Authority published a Scientific Opinion on Calf Welfare. This opinion was prepared in response to a request from the European Commission to provide an independent view on the welfare of calves that reflected the most recent scientific knowledge. Data sources used to develop their recommendations included peer-reviewed studies, expert knowledge, and gray literature. The opinion considered specific scenarios and welfare consequences of specific management practices, including feeding fiber to calves raised for white veal and amount of cow-calf contact. The opinion suggested that calves should be fed specific quantities of forage NDF during the rearing cycle. Regarding separation of calves, the committee recommended that the calf should remain with the cow for a minimum of 24 h and then be housed with another calf. The committee further suggested that prolonged cow-calf contact should increasingly be implemented, due to benefits to both cow and calf to minimize stress of separation. The objective of this review is to assess the veracity of these recommendations and the scientific data that underpins them. This review will present literature to support the contention that, from a nutritional and management perspective, these recommendations may impair calf welfare by exposing calves to innutritious rations containing excess fiber and increasing their risk of morbidity and mortality due to poor colostrum intake and exposure to disease-causing pathogens. Alternative recommendations are made that may further the goal of calf welfare in the context of nutrition and housing.

Mother-child dynamics: Examining reciprocal relations between parental knowledge, child disclosure, parental legitimacy beliefs, and adolescent alcohol use.

Early adolescent alcohol use is associated with adverse developmental and health outcomes. Parental knowledge can prevent or delay substance use, while youth behaviors may concurrently influence parenting. More research is needed to examine the role of youth's perceptions of legitimacy of parental authority. This multi-informant study examined prospective bidirectional effects between parental knowledge and child disclosure alongside youth-reported alcohol use and perceived legitimacy of parental authority. Data were analyzed across three waves in a community sample of 304 mother-child dyads. A cross-lagged panel model was estimated using repeated measures of adolescent alcohol use, perceived legitimacy of parental authority, parental knowledge, and child disclosure. Positive reciprocal associations were found in early adolescence between child disclosure and both parental knowledge and perceived legitimacy of parental authority. Legitimacy of parental authority negatively predicted alcohol use across adolescence. Child alcohol use also negatively predicted parental knowledge among mothers in later adolescence. Effects were not reciprocated nor sustained. Novel findings demonstrate that the parental legitimacy beliefs predict reduced alcohol use and have a reciprocal association with child disclosure. Clinical implications to mitigate youth alcohol use initiation, by enhancing parental self-efficacy and positive parenting, are discussed.

The role of ethnicity in the admission process of male juvenile released offenders: Examining risk and readiness to change in the Israeli Shushan centers.

INTRODUCTION: Disparities in evaluating readiness to change and recidivism risk across diverse cultural groups can profoundly affect rehabilitation program efficacy. This study examines readiness to change and recidivism risk disparities between Israeli-Arabs and Israeli-Jews entering a re-entry program by the Prisoner Rehabilitation Authority postrelease. METHOD: The University of Rhode Island Change Assessment Scale questionnaire gauged readiness to change, whereas the Ohio Youth Assessment System-Residential tool assessed recidivism risk. The sample included 151 participants: 98 Israeli-Arabs and 53 Israeli-Jews. Mean differences in change readiness and recidivism risk were statistically assessed through t tests. RESULTS: Significant differences emerged in change readiness levels between Israeli-Arabs and Jews upon rehabilitation program entry, with Israeli-Jews exhibiting higher readiness. Additionally, a noteworthy divergence in recidivism risk was noted, indicating elevated average risk for Israeli-Jews. CONCLUSIONS: Findings underscore the vital need for cultural sensitivity during admission. Bias potential in assessing risk for Arab participants emphasizes the necessity of a comprehensive culturally sensitive approach. While focusing on admission, the Risk-Need-Responsivity model application could enhance risk evaluation and guide culturally tailored treatments.

Weighted Attribute-Based Proxy Re-Encryption Scheme with Distributed Multi-Authority Attributes.

Existing attribute-based proxy re-encryption schemes suffer from issues like complex access policies, large ciphertext storage space consumption, and an excessive authority of the authorization center, leading to weak security and controllability of data sharing in cloud storage. This study proposes a Weighted Attribute Authority Multi-Authority Proxy Re-Encryption (WAMA-PRE) scheme that introduces attribute weights to elevate the expression of access policies from binary to multi-valued, simplifying policies and reducing ciphertext storage space. Simultaneously, the multiple attribute authorities and the authorization center construct a joint key, reducing reliance on a single authorization center. The proposed distributed attribute authority network enhances the anti-attack capability of cloud storage. Experimental results show that introducing attribute weights can reduce ciphertext storage space by 50%, proxy re-encryption saves 63% time compared to repeated encryption, and the joint key construction time is only 1% of the benchmark scheme. Security analysis proves that WAMA-PRE achieves CPA security under the decisional q-parallel BDHE assumption in the random oracle model. This study provides an effective solution for secure data sharing in cloud storage.

The impact of a nutrition course on self-epistemic authority, professional meaning as mediating factors on professional identity among nursing students.

BACKGROUND: The professional competence of nursing personnel is integral to the efficacy of nursing procedures. Educational endeavors, especially those encompassing professional training programs, are critical in fostering a professional identity among nurses. The role of nurses within a multi-disciplinary nutrition team has the potential to enhance professional identity and improve the quality of care provided. OBJECTIVE: This study aimed to explore the potential impact of knowledge acquisition and practical nutrition education on the development of professional identity among nursing school students. Furthermore, we hypothesize that professional autonomy and self-epistemic authority mediated the relationship between a sense of meaning, professional mission, and professional identity. DESIGN: A cross-sectional survey compared nursing students who had completed a practical nutrition course with those who had not. The study measured professional identity, professional autonomy, self-epistemic authority, and sense of meaning. Data collection was conducted using validated questionnaires, with questions tailored to suit the study demographic. Mediation analysis was conducted on the combined sample of both groups. PARTICIPANTS: The study included 98 nursing students, divided into a study group (57 students who completed a nutrition course) and a control group (41 students who did not complete the course). RESULTS: Significant differences were found between the groups in measures of professional identity (t = 3.42, p < .001), professional autonomy (t = 2.93, p < .005), and self-epistemic authority (t = 2.78, p < .007). There was no significant difference in the sense of meaning (t = 1.45, p = .150). Mediation analysis on the combined sample revealed that self-epistemic authority mediated the relationship between professional meaning and professional identity, while professional autonomy did not. CONCLUSION: The findings suggest that practical nutrition education enhances nursing students' professional identity, autonomy, and self-epistemic authority. Future studies should include larger and more diverse samples to further explore these relationships.

Patient Expertise and Medical Authority: Epistemic Implications for the Provider-Patient Relationship.

The provider-patient relationship is typically regarded as an expert-to-novice relationship, and with good reason. Providers have extensive education and experience that have developed in them the competence to treat conditions better and with fewer harms than anyone else. However, some researchers argue that many patients with long-term conditions (LTCs), such as arthritis and chronic pain, have become "experts" at managing their LTC. Unfortunately, there is no generally agreed-upon conception of "patient expertise" or what it implies for the provider-patient relationship. I review three prominent accounts of patient expertise and argue that all face serious objections. I contend, however, that a plausible account of patient expertise is available and that it provides a framework both for further empirical studies and for enhancing the provider-patient relationship.

King of the castle: organisational influences on authority gradients between network controllers and other team members.

The rail system relies on the effective coordination of multiple disciplines and teams situated within an operational hierarchy to meet a single operational objective-the safe and timely movement of rail traffic. Power and status dispersals across these teams and the various roles within them impact interaction and communication. This study drew on the perceptions of network controllers, to identify organisational factors influencing power imbalances that generate authority gradients between network controllers and other team members. Network controllers (N = 55) across eight Australasian organisations engaged in interviews using the Scenario Invention Task Technique to explore perceptions of risk. Thematic analysis revealed relationships between teams were affected by: (1) the accountability mechanisms adopted by organisations; (2) the way power was vested in roles; and (3) the status attached to roles. This insight into organisational power hierarchies and the generation of authority gradients provides opportunities for understanding teamwork error.Practitioner summary: Communication is impaired by authority gradients across teams in rail and is a contributing factor in incidents occurring on the network. This paper explores the organisational influences on power hierarchies across teams from the perspective of the network controller, pointing to an adversarial culture, resulting in tribalism impeding team interactions.

Chronicling the pursuit for full practice authority in Tennessee: Recommendations for a path forward.

BACKGROUND: The quest for full practice authority (FPA) for Tennessee Advanced Practice Registered Nurses (APRNs) began with promise in the late 1960s. However, progress has stalled in the ensuing time, and prospects for advancing FPA do not look promising. PURPOSE: The purpose of this article is to chronicle the pursuit of FPA in Tennessee, offer reflections on what has transpired to date, and suggest a path forward. METHODS: Various data from various sources were used to chronicle the history of FPA in Tennessee, make the case for its need, and identify better approaches for success. DISCUSSION: As one of a dwindling number of states without FPA, access to primary care health services and the economic vitality of Tennessee communities are of concern. CONCLUSION: The path forward for achieving FPA in Tennessee necessitates changes in approach and players. Specific recommendations are offered.

Confronting Medical Diploma Mills: State Licensing Boards, Legislatures, and the Limits of Medical Authority in the 1920s.

In the standard story of the rise of professional authority in medicine in the 1920s, state medical licensing boards were partners in a coalition, led by the American Medical Association, to radically improve medical education. Boards obtained state laws that limited admission to licensing examinations to graduates of schools approved by the AMA, thus bringing about the rapid demise of low-quality schools by about 1925. The reality at the state level was quite different, however. Medical examining boards containing homeopaths, eclectics, and sometimes osteopaths could be far from reliable partners. Passing laws to benefit the medical profession was exceedingly difficult and dependent on local medical politics. Through the lens of a major medical diploma mill scandal revealed by a journalist in 1923, this paper examines reform efforts in three states greatly affected by the scandal: Missouri, where the scandal originated, Connecticut, and Massachusetts. In each of these states, graduates of low-quality schools as well as fake doctors from diploma mills were able to take a state examination and practice. This paper argues that the AMA, far from being the major player in the elimination of inadequate schools, could set standards but had to stay on the sidelines.

Introduction to Special Issue: Geneses, organizations and transformations of psychiatric epidemiology.

Recent historiography has revealed a growing interest in the developments of psychiatric epidemiology. This volume aims to explicitly tackle the problem of transforming a diversity of knowledge into a structured scientific unit. Furthermore, it aims to answer this by bringing together historical studies that demonstrate how epistemic authority has led to the hierarchization of knowledge and the institutionalization of psychiatric epidemiology. Interdisciplinary research teams are traced back in history, and their organization is interrogated. Tracing the history of psychiatric epidemiology involves an exploration of disciplinary divisions of labour, such as how survey methods are based on theoretical frameworks, how research programmes are regulated with political and moral ideals, and how the wider public recognizes public health expertise.

[At the heart of care management, the relationship]. / Au cœur du management du soin, la relation.

The prevalence of management concerns in hospitals and a highly normative conception of health care are converging today in a standardization of care. The latter is undoubtedly at the root of the current malaise among caregivers. Indeed, the New Public Management approach is encouraging them, despite themselves, to carry out their missions to the detriment of the values of care. A more appropriate form of management would, on the contrary, be based on a continuity to be sought between care values and management values, around the notion of support. This would mean reinstating concern for interpersonal relationships at the heart of care management missions.

[A framework for the practice of peer support]. / Pour un cadre d'exercice de la pair-aidance.

The concept of peer support is now firmly established in the psychiatric landscape. While taking into account the benefits that this approach brings to patients and teams, it is essential to consider the need to define a framework for the practice of peer support. This framework, which is essential for the development of the practice, will help to avoid overly fragile exposure, which is synonymous with difficulties for peer helpers and their teams.