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Major depressive disorder (MDD), especially in case of suicidal risk, is a psychiatric emergency, associated with high patient burden and healthcare resource utilization. Although active and urgent treatment is crucial, little is known on comprehensive care management of this condition in Italy.
Here we report the ARIANNA study [NCT04463108] interim results to primarily describe the treatment utilization pathways of patients with MDD and active suicidal ideation with intent in the current clinical practice in Italy.
This observational prospective cohort study included adult patients with a moderate-to-severe major depressive episode (MDE) and active suicidality from 24 Italian sites. Real-world data on patient characteristics, treatments, clinical outcomes, and healthcare utilization were collected during a 90-day follow-up. Data collection is still ongoing.
Sixty-four evaluable patients were considered for this interim analysis: 41 (64.1%) females, mean [SD] age 46.0 [15.4] years, a concomitant psychiatric diagnosis in 7 (10.9%), and other comorbidities in 26 (40.6%). The baseline mean [SD] MADRS total score was 37.5 [7.2], with severe MDE and prior suicidal behavior in 30 (46.9%) and 21 (32.8%) patients, respectively. Median [25th;75th percentiles] duration of current MDE was 1.1 [0.3;2.1] months. Acute inpatient hospitalization was provided for 43 (67.2%) patients. Antidepressant augmentation with mood stabilizers and/or antipsychotic drugs and optimization were the most frequent early standard-of-care treatment regimens in 32 (53.3%) and 24 (40.0%) patients with available data (N=60), respectively.
Our preliminary results suggest that initial treatment approaches in this critical population are mostly polypharmacological and delivered as inpatient care, with consequent intensive resource utilization.
The ARIANNA study was sponsored by Janssen-Cilag SpA, Italy. DD and MA are employees of Janssen-Cilag SpA. DA and BR are employees of MediNeos S.U.R.L., a company subject to the direction and coordination of IQVIA Solutions HQ Ltd.
Since the second AI revolution started around 2009, society has witnessed new and steadily more impressive applications of AI. The growth of practical applications has in turn led to a growing body of literature devoted to the liability issues of AI. The present text is an attempt to assess the current state of the law and to advance the discussion.
With the recent proposal of the European Commission for a so-called Artificial Intelligence Act, this technology becomes a regulatory subject in its own right. While the Commission proposal primarily adopts a market-oriented approach, artificial intelligence also plays an increasingly important role in the internal decision-making of corporations. The technology promises increased efficiency, especially for business decisions that are made on the basis of extensive and complex data. Artificial intelligence makes it possible, for instance, to analyse data from customer relationships or production processes on a massive scale, and to prepare it for decision-making processes, such as in the context of algorithmic marketing, algorithmic market research or algorithmic controlling.
Hurricane Katrina uncovered a potential new theory of liability for the health-care industry—failure to plan. Today, the issue remains unresolved: how does a hospital define its duty of preparedness? Research shows there are over 13 definitions for hospital preparedness, multiple types of risk, and arbitrary hospital assessment tools that are not based on empirical data. In the absence of a clear definition for health-care preparedness, this article proposes a “reasonable under the circumstances” test to evaluate alleged liability for failure to plan and similar claims of negligence. In addition, translational science is proposed to aid in the development of a health-care standard of preparedness through a 5-phase evidenced-based, multi-disciplinary process.
To evaluate how key aspects of New York State Ventilator Allocation Guidelines (NYSVAG)—Sequential Organ Failure Assessment score criteria and ventilator time trials —might perform with respect to the frequency of ventilator reallocation and survival to hospital discharge in a simulated cohort of coronavirus disease (COVID-19) patients.
Single center retrospective observational and simulation cohort study of 884 critically ill COVID-19 patients undergoing ventilator allocation per NYSVAG.
In total, 742 patients (83.9%) would have had their ventilator reallocated during the 11-day observation period, 280 (37.7%) of whom would have otherwise survived to hospital discharge if provided with a ventilator. Only 65 (18.1%) of the observed surviving patients would have survived by NYSVAG. Extending ventilator time trials from 2 to 5 days resulted in a 49.2% increase in simulated survival to discharge.
In the setting of a protracted respiratory pandemic, implementation of NYSVAG or similar protocols could lead to a high degree of ventilator reallocation, including withdrawal from patients who might otherwise survive. Longer ventilator time trials might lead to improved survival for COVID-19 patients given their protracted respiratory failure. Further studies are needed to understand the survival of patients receiving reallocated ventilators to determine whether implementation of NYSVAG would improve overall survival.
A growing number of studies show that a significant proportion of patients, who meet the clinical criteria for the diagnosis of the vegetative state (VS), demonstrate evidence of covert awareness through successful performance of neuroimaging tasks. Despite these important advances, the day-to-day life experiences of any such patient remain unknown. This presents a major challenge for optimizing the patient’s standard of care and quality of life (QoL). We describe a patient who, following emergence from a state of complete behavioral unresponsiveness and a clinical diagnosis of VS, reported rich memories of his experience during this time. This case demonstrates the potential for a sophisticated mental life enabled by preserved memory in a proportion of patients who, similarly, are thought to be unconscious. Therefore, it presents an important opportunity to examine the implications for patient QoL and standard of care, both during the period of presumed unconsciousness and after recovery.
Chapter 1 is devoted to a brief description of the major milestones of contemporary and Jewish/talmudic torts. This description serves as an initial presentation of the place of torts in the private arena of law vis-à-vis other fields. We start with a presentation of Jewish law of torts in general and in Maimonides’ writings. There were attempts to base tort liability in the talmudic legal tradition solely on a fault-based liability theory of peshiah (negligence), but these attempts encountered difficulties. We further present the goals of torts according to contemporary tort theories. We introduce monistic vs. pluralistic approaches, those approaches that focus only on one goal (such as optimal deterrence, distributive justice, and corrective justice) as opposed to mixed-pluralistic approaches that integrate two or more goals. Next, we move on to deal with the standard of care and present the full range of tort liability regimes, starting from strict liability and ending in fault-based liability. We also present the book’s method. The interdisciplinary character of the book requires the use of various methods, such as those of comparative law, legal history, law and religion, Judaic studies, legal theory, and economic analysis of law.
Chapter 7 attempts to define accurately the standard of care adopted by Maimonides in his Code with respect to four categories of damage: (1) damage caused by a person to the property of another, (2) damage caused by a person who injures another, (3) damage caused by property, and (4) murder. In relation to each of these four categories, Maimonides proposed a standard of care that lies on the scale between fault, negligence, and strict liability. A careful examination of Maimonides’ writings reveals that he favored different liability regimes for different categories of damage. We present a scheme that illustrates Maimonides’ differential model and explains its rationale with respect to the hierarchy in the different standards of care applied in different cases. We also describe the historical background, circumstances, and nature of the tortfeasors in Maimonides’ time and in the contemporary era. This is essential for an understanding of the differential liability model in itself and as compared to contemporary models. Maimonides’ tort theory, we argue, is based upon a fundamental distinction between two questions: (1) upon whom should tort liability be imposed and (2) what is the standard of care that should be imposed in each case.
A systematic literature review (SLR) was performed to elucidate the current triage and treatment of an entrapped or mangled extremity in resource scarce environments (RSEs).
A lead researcher followed the search strategy following inclusion and exclusion criteria. A first reviewer (FR) was randomly assigned sources. One of the 2 lead researchers was the second reviewer (SR). Each determined the level of evidence (LOE) and quality of evidence (QE) from each source. Any differing opinions between the FR and SR were discussed between them, and if differing opinions remained, then a third reviewer (the other lead researcher) discussed the article until a consensus was reached. The final opinion of each article was entered for analysis.
Fifty-eight (58) articles were entered into the final study. There was 1 study determined to be LOE 1, 29 LOE 2, and 28 LOE 3, with 15 determined to achieve QE 1, 37 QE 2, and 6 QE 3.
This SLR showed that there is a lack of studies producing strong evidence to support the triage and treatment of the mangled extremity in RSE. Therefore, a Delphi process is suggested to adapt and modify current civilian and military triage and treatment guidelines to the RSE.
This Chapter will focus on one of the main parts of the civil law that is relevant for nurses: the law of negligence. The law of negligence is a part of the civil law that allows a person to bring legal proceedings against another person to correct a wrong or harm that the other person has done to them. Usually the person who has been harmed (the plaintiff) will seek payment of damages in compensation for their injury from the person whose act or omission caused the harm (the defendant). This Chapter will outline the key parts of the law of negligence. The particular focus of the Chapter will be on the special rules that have developed in the law of negligence in relation to health care professionals, including nurses. By understanding how the law will apply to things nurses do that cause people harm, it should be possible for nurses to better avoid acting negligently.
Sixty years have passed since occupiers in England and Wales were placed under a statutory duty to keep visitors to occupied premises reasonably safe. The legislation, however, did not detail the exact operation of this duty of care. The case law, expected to fill in the gaps, has arguably developed without sufficient consistency and/or predictability. This apparent confusion can be remedied through applying a systematic test to the question of whether a breach of duty has occurred. The test follows the verification that the case falls within the field of occupiers’ liability because of the presence of a danger attributable to the state of the premises. It consists of three consecutive stages which ask: (1) whether the risk of injury was foreseeable; (2) whether the occupier could reasonably have been expected to have addressed this very particular risk; and (3) whether any remedial action the occupier actually took was appropriate.
The aim of this study was to assist organizations seeking to develop or improve their medical disaster relief effort by identifying fundamental elements and processes that permeate high-quality, international, medical disaster relief organizations and the teams they deploy.
A qualitative descriptive design was used. Data were gathered from interviews with key personnel at five international medical response organizations, as well as during field observations conducted at multiple sites in Jordan and Greece, including three refugee camps. Data were then reviewed by the research team and coded to identify patterns, categories, and themes.
The results from this qualitative, descriptive design identified three themes which were key characteristics of success found in effective, well-established, international medical disaster relief organizations. These characteristics were first, ensuring an official invitation had been extended and the need for assistance had been identified. Second, the response to that need was done in an effective and sustainable manner. Third, effective organizations strived to obtain high-quality volunteers.
By following the three key characteristics outlined in this research, organizations are more likely to improve the efficiency and quality of their work. In addition, they will be less likely to impede the overall recovery process.
BrobyN, LassetterJH, WilliamsM, WintersBA. Effective International Medical Disaster Relief: A Qualitative Descriptive Study. Prehosp Disaster Med. 2018;33(2):119–126.
Health agencies working with the homebound play a vital role in bolstering a community’s resiliency by improving the preparedness of this vulnerable population. Nevertheless, this role is one for which agencies lack training and resources, which leaves many homebound at heightened risk. This study examined the utility of an evidence-based Disaster Preparedness Toolkit in Veterans Health Administration (VHA) Home-Based Primary Care (HBPC) programs.
We conducted an online survey of all VHA HBPC program managers (N=77/146; 53% response rate).
Respondents with fewer years with the HBPC program rated the toolkit as being more helpful (P<0.05). Of those who implemented their program’s disaster protocol most frequently, two-thirds strongly agreed that the toolkit was relevant. Conversely, of those who implemented their disaster protocols very infrequently or never, 23% strongly agreed that the topics covered in the toolkit were relevant to their work (P<0.05).
This toolkit helps support programs as they fulfill their preparedness requirements, especially practitioners who are new to their position in HBPC. Programs that implement disaster protocols infrequently may require additional efforts to increase understanding of the toolkit’s utility. Engaging all members of the team with their diverse clinical expertise could strengthen a patient’s personal preparedness plan. (Disaster Med Public Health Preparedness. 2017;11:56–63)
Many forensic psychiatric settings serve unique populations who have, in addition to traditional psychiatric symptoms, diverse legal and criminogenic needs. A lack of clear treatment standards that address all aspects of forensic care can lead to inefficient or inappropriate interventions and contribute to institutional violence.
A model of psychosocial care specific for patients with multiple myeloma and their caregivers has not yet been proposed. We sought to develop a model of care that considers the specific profile of this disease.
The authors, representing a multidisciplinary care team, met in December of 2012 to identify a model of psychosocial care for patients with multiple myeloma and their caregivers. This model was determined by consensus during the meeting and via total agreement following the meeting. The meeting was sponsored by Onyx Pharmaceuticals.
The need for targeted psychosocial care for the multiple myeloma patient and caregiver throughout the disease process is essential to ensure quality of life and optimal treatment outcomes. We propose herein the first known model of care for the treatment of multiple myeloma that engages both the patient and their caregivers.
Significance of results:
Innovative partnerships between psychosocial providers and other entities such as pharmaceutical companies can maximize resources for comprehensive program development. This manuscript proposes a model of care that promotes active engagement in therapies for multiple myeloma while engaging the individual patient and their family caregivers. This treatment approach must be evidence based in terms of distress screening tools, comprehensive psychosocial assessments, and, most importantly, in the interventions and measurements of response that clinicians apply to this population.
This article explores the variation of the standard of care in negligence to favour defendants, an issue of considerable practical significance which has not previously been the subject of systematic analysis. By shining a spotlight on this issue I hope to show that varying the standard of care in this way is a useful technique, which is and could be used in a number of types of case to achieve an appropriate balance between liability and non-liability. I also hope to show that if this technique is employed there are some ways of varying the standard of care which are preferable to others. The structure of the analysis is centred around three core questions. First, to what extent has English negligence law already varied the standard of care to favour defendants? Secondly, if the standard of care is to be varied, how should this be done? And thirdly, when and why might the use of a modified standard of care be desirable?
Naturalistic effectiveness trials of atypical antipsychotics are needed to provide broader information on efficacy, safety, and tolerability in patients with schizophrenia treated in a community practice setting.
in this 26-week, open-label, multicentre study, patients with schizophrenia requiring a switch in antipsychotic medication because current medication was not well tolerated and/or clinical symptoms were not well controlled were randomized to receive aripiprazole or an atypical antipsychotic standard of care (SOC) treatment (i.e., olanzapine, quetiapine, or risperidone based on the investigator's judgment of the optimal treatment for the individual patient and the patient's prior response to antipsychotic medication). The primary objective was to compare the effectiveness of a 26-week treatment of aripiprazole versus SOC, as measured by the investigator Assessment Questionnaire (IAQ) total score at Week 26 last observation carried forward (LOCF) (primary endpoint), a validated measure that monitors relief or worsening of 10 key symptoms associated with the psychopathology of schizophrenia and side effects of antipsychotic treatment. Secondary objectives were to further assess effectiveness using the Clinical Global Impression – Global Improvement (CGI-I) and Clinical Global Impression – Severity of Illness scale, to assess time to treatment discontinuation, patient preference of medication, quality of life, and the tolerability of aripiprazole compared with SOC.
Aripiprazole treatment (n = 268) resulted in significantly better effectiveness than SOC treatment (n = 254; P < 0.001; Week 26 LOCF) as evidenced by the IAQ total score beginning at Week 4 (the first assessment point) and sustained through Week 26. A similar relationship was demonstrated among patients who completed the study (observed cases analysis); aripiprazole was associated with significantly better effectiveness at all time points with a greater differential effect from SOC over time. Patients treated with aripiprazole also demonstrated significantly greater improvements on the CGI-I scale (responder rate, P = 0.009 at Week 26 LOCF), as well as on quality of life (Quality of Life scale total score; P < 0.001 at Week 26). Furthermore, a significantly higher proportion of patients receiving aripiprazole rated their study medication as “much better” on the Preference of Medication Questionnaire (POM) scale than their pre-study medication compared with SOC patients (P < 0.001; Week 26). Time to treatment discontinuation and rates of discontinuation due to adverse events were similar in both treatment groups. The incidence of patients with one or more extrapyramidal symptom (e.g., akathisia, dystonia, parkinsonian events, and residual events) was higher in patients receiving aripiprazole compared with patients treated with SOC (13.5% vs. 5.6%); however, a higher proportion of patients in the SOC-treated group had clinically significant weight gain (21.2% vs. 7.3% for aripiprazole) and potentially clinically relevant elevated fasting levels of total cholesterol, low-density lipoprotein cholesterol, triglycerides, and serum prolactin compared with patients receiving aripiprazole.
Aripiprazole is an effective atypical antipsychotic for the treatment of schizophrenia, demonstrating better effectiveness than SOC agents used in this study in patients for whom a switch in antipsychotic medication was warranted.
The prehospital 12-lead electrocardiogram (ECG) has become a standard of care. For the prehospital 12-lead ECG to be useful clinically, however, cardiologists and emergency physicians (EP) must view the test as useful. This study measured physician attitudes about the prehospital 12-lead ECG.
This study tested the hypothesis that physicians had “no opinion” regarding the prehospital 12-lead ECG.
An anonymous survey was conducted to measure EP and cardiologist attitudes toward prehospital 12-lead ECGs. Hypothesis tests against “no opinion” (VAS = 50 mm) were made with 95% confidence intervals (CIs), and intergroup comparisons were made with the Student-t-test.
Seventy-one of 87 (81.6%) surveys were returned. Twenty-five (67.6%) cardiologists responded and 45 (90%) EPs responded. Both groups of physicians viewed prehospital 12-lead ECGs as beneficial (mean = 69 mm; 95% CI = 65–74mm). All physicians perceived that ECGs positively influence preparation of staff (mean = 63 mm; 95% CI = 60–72mm) and that ECGs transmitted to hospitals would be beneficial (mean = 66 mm; 95% CI = 60–72mm). Cardiologists had more favorable opinions than did EPs. The ability of paramedics to interpret ECGs was not seen as important (mean = 50 mm; 95% CI = 43–56mm). The justifiable increase in field time was perceived to be 3.2 minutes (95% CI = 2.7–3.8 minutes), with 23 (32.8%) preferring that it be done on scene, 46 (65.7%) during transport, and one (1.4%) not at all.
Prehospital 12-lead ECGs generally are perceived as worthwhile by cardiologists and EPs. Cardiologists have a higher opinion of the value and utility of field ECGs. Since the reduction in mortality from the 12-lead ECG is small, it is likely that positive physician attitudes are attributable to other factors.
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