Outside any therapeutic trial prescription of hydroxychloroquine for hospitalized patients with covid-19 during the first wave of the pandemic: A national inquiry of prescription patterns among French hospitalists.

INTRODUCTION: During the first wave of the coronavirus-disease 2019 (covid-19) pandemic in early 2020, hydroxychloroquine (HCQ) was widely prescribed in light of in vitro activity against severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). Our objective was to evaluate in early 2020 the rate of French hospitalists declaring having prescribed HCQ to treat covid-19 patients outside any therapeutic trial, compare the reasons and the determinants for having prescribed HCQ or not. MATERIAL AND METHODS: A national inquiry submitted by email from May 7 to 25, 2020, to a sample of French hospitalists: doctors managing patients hospitalized for covid-19 in a French department of internal medicine or infectious diseases and identified in the directories of French hospitals or as a member of the French Infectious Diseases Society (SPILF). Primary outcome was the percentage of hospitalists declaring having prescribed HCQ to covid-19 patients. Secondary outcomes were reasons and determinants of HCQ prescription. RESULTS: Among 400 (22.8%) responding hospitalists, 45.3% (95% CI, 40.4 to 50.1%) declared having prescribed HCQ to covid-19 patients. Two main profiles were discerned: HCQ prescribers who did not raise its efficacy as a motive, and non-prescribers who based their decision on evidence-based medicine. Multivariate analysis retained the following prescription determinants (adjusted odds ratio; 95% confidence interval): a departmental procedure for HCQ prescription (8.25; 4.79 to 14.20), having prescribed other treatments outside a therapeutic trial (3.21; 1.81 to 5.71), prior HCQ prescription (2.75; 1.5 to 5.03) and HCQ prescribed within the framework of a therapeutic trial (0.56; 0.33 to 0.95). CONCLUSION: Almost half of the hospitalists prescribed HCQ. The physician's personality (questioning or not evidence-based-medicine principles in the context of the pandemic) and departmental therapeutic procedures were the main factors influencing HCQ prescription. Establishment of "therapeutic" procedures represents a potential means to improve the quality of therapeutic decision-making during a pandemic.

Protected adults' voting rights: an interdisciplinary study of medical assessment and jurisprudence in France.

OBJECTIVES: The study's objective was to describe the decision-making about voting rights of protected adults, which includes the medical assessment and the magistrate's decision to maintain voting rights or not. DESIGN: This work explores using an interdisciplinary approach: first, magistrate's decision-making with a systematic review of jurisprudence and second medical assessment with semistructured questionnaires sent to physicians assessing adults under guardianship. SETTING: France. PARTICIPANTS: For jurisprudence's analysis, all guardianship decisions found on the Legifrance.gouv.fr website and that specified the protected person's voting rights were analysed. For the survey about medical civic assessment, an 18-item questionnaire was sent to all physicians drawing up medical certificates prior to placement under guardianship in one urban (Paris and the three surrounding departments) and one rural area of France (the 10 most rural French administrative departments). MAIN OUTCOME MEASURES: The analysis of jurisprudence explores the situation concerning protected adults' voting rights and the reasons for magistrates' decision. The survey about medical civic assessment explores the means of medical assessment (persons consulted, information collected), the content of the medical certificate, the physicians' opinions regarding their role. RESULTS: The analysis of the jurisprudence demonstrates that 30% (51/171) of protected adults kept the right to vote. The survey shows that medical assessment varied according to the physician's gender, specialty and geographical location. Voting capacity was the main criterion common to both physicians and magistrates in the decision whether to maintain voting rights. 27% (34/124) of physicians would like the official texts to be more precise, and one-third (41/133) wished to have tools to facilitate assessment of civic capacity. CONCLUSIONS: Official guides need to be drawn up to detail the criteria for and means of medical assessment of the civil capacity of protected adults, with a view to ensuring transparency and homogeneity in the exercise of justice.

Assessing capacity to consent for research in cognitively impaired older patients.

BACKGROUND: The number of clinical trials including older patients, and particularly patients with cognitive impairment, is increasing. While statutory provisions exist to make sure that the capacity to consent is assessed systematically for each patient, many gray areas remain with regard to how this assessment is made or should be made in the routine practice of clinical research. OBJECTIVES: The aim of this review was to draw up an inventory of assessment tools evaluating older patients' capacity to consent specifically applicable to clinical research, which could be used in routine practice. METHODS: Two authors independently searched PubMed, Cochrane, and Google Scholar data-bases between November 2015 and January 2016. The search was actualized in April 2017. We used keywords (MeSH terms and text words) referring to informed consent, capacity to consent, consent for research, research ethics, cognitive impairment, vulnerable older patients, and assessment tools. Existing reviews were also considered. RESULTS: Among the numerous existing tools for assessing capacity to consent, 14 seemed potentially suited for clinical research and six were evaluated in older patients. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) was the most frequently cited. CONCLUSION: The MacCAT-CR is currently the most used and the best validated questionnaire. However, it appears difficult to use and time-consuming. A more recent tool, the University of California Brief Assessment of Capacity to Consent (UBACC), seems interesting for routine practice because of its simplicity, relevance, and applicability in older patients.

Conditions for exercising residents' voting rights in long-term care residences: a prospective multicenter study.

To assess voting conditions in long-term care settings, we conducted a multicenter survey after the 2009 European elections in France. A questionnaire about voting procedures and European elections was proposed in 146 out of 884 randomized facilities. Sixty-four percent of facilities answered the questionnaire. Four percent of residents voted (national turnout: 40%), by proxy (58%) or at polling places (42%). Abstention related to procedural issues was reported in 32% of facilities. Sixty-seven percent of establishments had voting procedures, and 53% declared that they assessed residents' capacity to vote. Assistance was proposed to residents for voter registration, for proxy voting, and for voting at polling places, respectively, in 33%, 87%, and 80% of facilities. This survey suggests that residents may be disenfranchised and that more progress should be made to protect the voting rights of residents in long-term care facilities.

[Voting by cognitively impaired persons: legal and ethical issues]. / Le vote des sujets ayant des altérations des fonctions cognitives : aspects législatifs et éthiques.

In democratic countries, cognitively impaired persons are a substantial and growing group of citizens. Most of them are citizens with dementia. In dementia, cognitive impairment induces a loss of some capacities, resulting in vulnerability and increased need for assistance. Voting by cognitively impaired persons raises any questions about the integrity of the electoral process, the risk of fraud and the respect of their citizenship. In France, the law is not definite about the voting of cognitively impaired persons. An objective assessment for voting capacity may be useful both for professionals in charge of voting organisation and for guardianship judge in order to help him in his decision to remove or keep the voting right of persons placed under guardianship. Assessing the reality of voting by cognitively impaired citizens is necessary to advance respect for their right to vote.

The vote of acute medical inpatients: a prospective study.

OBJECTIVE: There may be ethical issues associated with allowing certain inpatients to vote as some may be cognitively impaired. During the 2007 elections in France, we conducted a prospective observational study on voting among hospitalized patients. METHOD: Patients hospitalized in an Internal Medicine and Geriatric Department on election day were included. The primary outcome was the turnout among registered inpatients, and secondary outcomes were Mini-Mental State Examination (MMSE) scores and reasons for abstention. RESULTS: Of 142 inpatients (mean age 73 years), 84 were eligible to vote, and 22 actually voted (turnout 25.2%). Among the voters, 23% had an MMSE score of less than 12; 58% of abstentions were procedure-related. DISCUSSION: In our study, some inpatients did not vote as a result of procedural issues. When patients with severe cognitive impairment vote, there is a potential risk of vote diversion. Voting procedures should be improved to give inpatients easier access to the ballot while protecting them from the risk of fraud.

[Treatment trial methodology in internal medicine]. / Méthodologie des essais thérapeutiques: les règles de base sont-elles applicables aux essais en médecine interne?

Clinical trials are the foundation of therapeutic evaluation. Their interpretation and usefulness depend on their compliance with strict methodological rules. Departments of internal medicine admit patients with many different diseases, a variety that makes it difficult to organize and conduct clinical trials in their standard form. This article reviews the rules of clinical trials that are essential to their validity and reliability. The prospective randomized double-blinded clinical trial is the most scientifically rigorous method for assessing treatment. Rare diseases and those involving several specialties can and should be performed in accordance with the standard methodological rules, despite their particular aspects. This article considers ways to improve the participation of departments of internal medicine to future clinical trials.

Defective costimulatory function is a striking feature of antigen-presenting cells in an HLA-B27-transgenic rat model of spondylarthropathy.

OBJECTIVE: A disease resembling the human spondylarthropathies develops in HLA-B27-transgenic rats. This disease in rats is mediated by CD4+ T cells, but antigen-presenting cells (APCs) may also play a role. Dendritic cells (DCs) have been reported to be defective in allogeneic mixed lymphocyte culture in this model. Here, we further investigated the functional defect of APCs. METHODS: DCs and B cells from nontransgenic, HLA-B27 (33-3)-transgenic, and HLA-B7 (120-4)-transgenic rats were used to stimulate T cells. Surface expression of HLA-B transgene and rat molecules on APCs and the formation of conjugates between DCs and T cells were monitored by flow cytometry. RESULTS: We observed a strikingly defective stimulation of allogeneic and syngeneic T lymphocytes by APCs from HLA-B27 but not HLA-B7 rats, even if stimulation was driven in the presence of anti-T cell receptor (TCR) antibody. We found no evidence that HLA-B27 DCs were immature, lacked production of some diffusible factor, or produced an inhibitory factor for T cells. When comparing the levels of expression of class II major histocompatibility complex, CD2, intercellular adhesion molecule 1, lymphocyte function-associated antigen 1, B7, and CD40 molecules at the surface of DCs from 33-3, 120-4, and nontransgenic rats, we found little difference. However, HLA-B27-transgenic DCs formed fewer conjugates with T cells than did nontransgenic DCs. Furthermore, the proportion of conjugates formed between DCs and T cells, as well as the difference between nontransgenic and HLA-B27-transgenic DCs, were in large part reduced by blocking CD86 on DCs. CONCLUSION: We confirmed defective stimulation of T cells by APCs in HLA-B27 rats, the mechanism of which appears to implicate APC/T cell contact, independent of TCR engagement. In addition, decreased use of the CD86 costimulatory molecule by B27 DCs was observed. Impaired costimulatory function could result in a loss of tolerance toward microbial flora in this model.