COVID-19 pediatric vaccine authorization, FDA authority, and individual misperception of risk.

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to recommend Emergency Use Authorization ('EUA') of the COVID-19 vaccine for children ages 5-11. The results of the study demonstrate that most comments opposed EUA and these comments were associated with statements that indicated misperceptions of risk. Findings provide interesting insights regarding the role of public comments generally but also suggest that the public participation process in notice and comment can be modified to serve as an intervention to align individual perceptions of risk more closely with evidence-based assessment of risk. In addition, the findings provide opportunities to consider strategies for public health messaging.

Impact of short-notice accreditation assessments on hospitals' patient safety and quality culture-A scoping review: A scoping review of the current literature to understand the impact of short-notice accreditation processes on health service organizations patient safety and quality culture.

AIM: To explore the published evidence describing the impact of short-notice accreditation assessments on hospitals' patient safety and quality culture. DESIGN: Arksey and O'Malley (2005)'s scoping study framework and Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping reviews (PRISMA-ScR). METHODS: A scoping review was conducted to identify papers that provided an evaluation of short-notice accreditation processes. All reviewers independently reviewed included papers and thematic analysis methods were used to understand the data. DATA SOURCES: PubMed/MEDLINE, CINAHL, and ProQuest databases were searched to identify papers published after 2000. RESULTS: Totally, 3317 records were initially identified with 64 full-text studies screened by the reviewers. Five studies were deemed to meet this scoping review's inclusion criteria. All five studies reported variable evidence on the validity of health service or hospital accreditation processes and only three considered the concept of patient safety and quality culture in the context of accreditation. None of the five included studies report the impact of a short-notice accreditation process on a hospital's patient safety and quality culture. CONCLUSIONS: Limited evidence exists to report on the effectiveness of hospital short-notice accreditation models. No study has been undertaken to understand the impact of short-notice accreditation on patient safety and quality cultures within hospital settings. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Understanding this topic will support improved hospital quality, safety, policy, and governance. IMPACT: To provide an understanding of the current knowledge base of short-notice accreditation models and its impact on hospital patient safety and quality culture. REPORTING METHODS: PRISMA reporting guidelines have been adhered to. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

[François Gros (1925-2022)]. / François Gros (1925­2022).

François Gros, a biologist by training, began his research at the Institut Pasteur. In 1961, he discovered the molecular nature of the proposed intermediary between the gene and the protein, a so-called messenger RNA (mRNA), and determined its main characteristics. The author of numerous books, François Gros has helped shape and enlightened the birth of molecular biology and the development of related biotechnologies since the 1970s. He was Professor at the Collège de France and Permanent Secretary of the French Academy of Sciences. Within the Academy, he initiated the creation of a committee for developing countries (COPED). François Gros was a humanist driven by moral rigour and an unfailing sense of commitment.

François Gros, biologiste de formation, a débuté ses travaux de recherche à l'Institut Pasteur. En 1961, il découvre la nature moléculaire de l'intermédiaire proposé entre le gène et la protéine, un ARN dit messager (ARNm) et en détermine les principales caractéristiques. À travers la rédaction de nombreux ouvrages, il a accompagné et éclairé de sa réflexion, la naissance de la biologie moléculaire et le développement des biotechnologies associées, à partir des années 1970. Il a été professeur au Collège de France et secrétaire perpétuel de l'Académie des sciences. Il a initié au sein de l'Académie la création d'un comité pour les pays en voie de développement (COPED). François Gros était un humaniste animé d'une rigueur morale et d'un sens de l'engagement sans faille.

Potential Issues in Mandating a Disclosure of Institutional Investigation in Retraction Notices.

A retraction notice is a formal announcement for the removal of a paper from the literature, which is a weighty matter. Xu et al. (Science and Engineering Ethics, 29(4), 25 2023) reported that 73.7% of retraction notices indexed by the Web of Science (1927-2019) provided no information about institutional investigations that may have led to the retractions, and recommended that Committee on Publication Ethics (COPE) retraction guidelines should make it mandatory to disclose institutional investigations leading to retractions in such notices. While this recommendation would add to the transparency of the retraction process, a blanket mandate as such could be potentially problematic. For research misconduct (RM)-positive cases, a mandatory investigative disclosure may be abused by some to deflect responsibility. More importantly, a mandatory disclosure could harm authors and institutions in RM-negative cases (i.e. those stemming from honest errors with no misconduct). I illustrate with case vignettes the potential epistemic injustice and confusion that a mandate for investigation disclosure in retraction notices could incur, and suggest a more nuanced approach to its implementation.

What do Retraction Notices Reveal About Institutional Investigations into Allegations Underlying Retractions?

Academic journal publications may be retracted following institutional investigations that confirm allegations of research misconduct. Retraction notices can provide insight into the role institutional investigations play in the decision to retract a publication. Through a content analysis of 7,318 retraction notices published between 1927 and 2019 and indexed by the Web of Science, we found that most retraction notices (73.7%) provided no information about institutional investigations that may have led to retractions. A minority of the retraction notices (26.3%) mentioned an institutional investigation either by journal authorities (12.1%), research performing organizations (10.3%), joint institutions (1.9%), research integrity and ethics governing bodies (1.0%), third-party institutions (0.5%), unspecified institutions (0.4%), or research funding organizations (0.1%). Comparing retraction notices issued before and after the introduction of retraction guidelines by the Committee on Publication Ethics (COPE) in 2009 revealed that those published after the guidelines' publication were more likely to report investigations by journal authorities. Comparing retraction notices from different disciplines revealed that those from social sciences and the humanities were more likely to disclose investigations by research performing organizations than those from biomedical and natural sciences. Based on these findings, we suggest that the COPE retraction guidelines in the future make it mandatory to disclose in retraction notices institutional investigations leading to retractions.

The savings associated with decriminalization of drug use in New South Wales, Australia: A comparison of four drug policies.

INTRODUCTION: Most Australian states and territories have established some form of scheme to divert minor drug offenders from court. However, the number charged with drug possession continues to rise. We examine the costs of four alternatives to existing policy in relation to people apprehended by police using or in possession of a prohibited drug. METHODS: We construct a Markov micro-simulation model to examine four policies: (1) current policy; (2) expanding the existing cannabis cautioning scheme to all drug use/possession offences; (3) issuing an infringement notice to all those found using or in possession of a prohibited drug; (4) prosecuting all drug use/possession offences in the courts. The cycle length is one month. Since our aim is to examine the cost to the government, all costs are taken from the Government perspective and are in 2020 Australian dollars. RESULTS: The current estimated annual cost per offence is $977 (SD: $293). Policy 2 costs $507 per offence per year (SD: $106). Policy 3 turns into a net revenue gain of $225 (SD: $68) per offence per annum. Policy 4 lifts the current cost of processing from $977 to $1282 per offence per year (SD: $321). CONCLUSIONS: Extending the cannabis cautioning scheme to all drugs would reduce the cost of current policy by more than 50 %. A policy of issuing infringement notices or cautions for drug use/possession would save costs and generate income for the government.

Do patron bans affect subsequent behaviour? An examination of pre- and post-ban offending for barring notice and prohibition order recipients in Western Australia.

INTRODUCTION: To explore whether receipt of either of two patron banning provisions currently used in Western Australia-in response to alcohol-related disorderly and anti-social behaviour-is associated with changes to subsequent offending. METHOD: Western Australia Police de-identified the offender records and associated data for 3440 individuals who had received one or more police-imposed barring notice/s between 2011 and 2020, and 319 individuals who had received one or more prohibition orders between 2013 and 2020. The number of offences recorded for each recipient before and after the first notice/order were examined to understand the potential effect of both provisions upon subsequent offending. RESULTS: The low number of repeat barring notices (5% of the total) and prohibition orders (1% of the total) points to their general success. Analysis of offending records before and after receipt/expiry of either provision indicates that both have a generally positive effect on subsequent behaviours. For all barring notice recipients, 52% recorded no further offences and for all prohibition order recipients, 58% recorded no further offences. There was a less positive effect for the sub-set of multiple ban recipients and prolific offenders. DISCUSSION AND CONCLUSIONS: Barring notices and prohibition orders appear to have a generally positive effect on subsequent behaviours for the majority of recipients. More targeted interventions are recommended for repeat offenders, for whom patron banning provisions have a more limited effect.

Comparative Study of General Notices in Pharmacopoeias in Japan, the United States, and Europe.

Globalization of pharmaceutical supply chains has expanded and manufacturers are required to manufacture products in compliance with the pharmacopoeial standards used in all exporting countries/regions to ensure product quality. International harmonization has been facilitated by the Pharmacopoeial Discussion Group consisting of the Japanese Pharmacopoeia, the United States Pharmacopeia, and the European Pharmacopoeia. However, since the pharmacopoeias have been developed individually under the regulatory framework of each country/region, differences exist between these pharmacopoeias. When using pharmacopoeias, an understanding of common pharmacopoeial rules is essential. Clarifying the similarities and differences in the General Notices of the pharmacopoeias widely referenced worldwide is considered valuable for those already using one or two of them to access the remaining pharmacopoeias. In this study, we compared the existence of items and the contents described in the General Notices of the three pharmacopoeias to clarify the differences. Investigation of the existence of items revealed that more than 70% of the 105 items in General Notices in the three pharmacopoeias were in the entire pharmacopoeias (for Japan, including Japanese laws and notifications). Furthermore, investigating contents revealed that approximately 20% of the 105 items have some differences such as numerical values and test conditions. However, it was shown that most of the items did not have major differences. It is expected that the three pharmacopoeias will be utilized simultaneously by understanding the similarities and differences shown in this study.

A Value-centered Exploration of Data Privacy and Personalized Privacy Assistants.

In the current post-GDPR landscape, privacy notices have become ever more prevalent on our phones and online. However, these notices are not well suited to their purpose of helping users make informed decisions. I suggest that instead of utilizing notice to elicit informed consent, we could repurpose privacy notices to create the space for more meaningful, value-centered user decisions. Value-centered privacy decisions, or those that accurately reflect who we are and what we value, encapsulate the intuitive role of personal values in data privacy decisions. To explore how we could design for such decisions, I utilize Suzy Killmister's Four-Dimensional Theory of Autonomy (4DT) to operationalize value-centered privacy decisions. I then utilize 4DT to help design a system-called a value-centered privacy assistant (VcPA)-that could help create the space for value-centered data privacy decisions using privacy notices. Using this 4DT lens, I further assess the degree that an existing technology, personalized privacy assistants (PPAs), use notices in a manner that allows for value-centered decision-making. I lastly utilize insights from the PPA assessment to inform the design of a VcPA, concluding that a VcPA could utilize notices to assist users in value-centered app selection and in other data privacy decisions.

The need for standards and certification for investigative genetic genealogy, and a notice of action.

As investigative genetic genealogy (IGG) becomes a more common tool for investigating agencies to resolve cold cases and provide names to unidentified human remains, there is an urgent need for standards and a certification process for IGG practitioners. There are four broad concerns that give rise to this need: data privacy, public trust, proficiency (and agency trust), and accountability. Yet, while the need is clear, the few discussions of standards and certification thus far have been plagued by misunderstandings of IGG and poor analogs for the profession. Thus, in addition to describing the need, this article analyzes three relevant analogs for IGG standards and certification and describes the strengths and weaknesses of each. Finally, this article announces the creation of a non-profit Board of Certification for Investigative Genetic Genealogy and a framework for standards and a certification process for IGG.

How do HTA agencies perceive conditional approval of medicines? Evidence from England, Scotland, France and Canada.

There is a growing disconnect between regulatory agencies that are promoting expedited approval to medicines based on early phase clinical evidence and health technology assessment (HTA) agencies that require robust clinical evidence to inform coverage decisions. This paper provides an assessment of the evidence gap between regulatory and HTA agencies on medicines receiving conditional marketing authorisation (CMA) and examines how HTA agencies in France, England, Scotland, and Canada interpret and appraise evidence for these medicines. A mixed methods research design was used to identify the types and frequency of parameters raised in the context of HTA decision-making for all conditional approvals in Europe and Canada between 2010 and 2017. Significant heterogeneity was found across the HTA agencies in England, Scotland, France, and Canada in the assessment of medicines receiving CMA, with the highest likelihood of rejection present in Quebec (50%) and Scotland (25%). Rejected medicines were more likely to have unresolved uncertainties related to the magnitude of clinical benefit, study design, and issues in economic modelling. More systematic use of joint early dialogue and conditional reimbursement pathways would help clarify evidence requirements and avoid delays in patient access to innovative medicines.

Immigration Law, Public Health, and the Future of Public Charge Policymaking.

U.S. immigration law has excluded noncitizens likely to become a "public charge" since 1882. When the Trump administration proposed a new Rule expanding the interpretation of that exclusion in 2018, over 55,000 people wrote public comments. These comments, overwhelmingly opposed to the change, are the subject of Rachel Fabi and Lauren Zahn's insightful article in this issue of The Journal of Law, Medicine, and Ethics. The themes they identify resonate with the history of the public charge exclusion, which has always reflected a tension between two aims of American governance - to provide for those in need of assistance, and to shape the nation's citizenry according to ideals of self-sufficiency.

The collaborative development through multidisciplinary and advocate consensus of an accessible notice of rights for people with intellectual disabilities in police custody.

Background People with intellectual disabilities are over-represented in the criminal justice system. The United Nations' Convention on the Rights of Persons with Disabilities (UNCRPD) enshrines a right to equal access to justice for persons with disabilities (Article 13, UNCRPD). Accessible information is a key aspect of exercising this right. Yet, many jurisdictions, including Ireland, are yet to develop accessible information for disabled people who may be arrested. Aims This paper describes the collaborative development through multidisciplinary and advocate consensus of an accessible (Easy -to- Read) Notice of Rights (ERNR) for people with intellectual disabilities in police custody in Ireland. Methods Guidelines developed by Ireland's representative organisation for people with intellectual disabilities and examples of international practice were used to develop a draft ERNR by the primary researcher in partnership with an expert from a representative organisation for people with intellectual disabilities. The ERNR was developed thereafter through two focus groups with a view to achieving consensus with a focus on accessibility, accuracy and layout. This included a multidisciplinary focus group with participants from a representative organisation for people with intellectual disabilities, psychology, speech and language therapy, the police force, public health, forensic psychiatry, mental health, law and, subsequently, a focus group of people with lived experience of intellectual disability. Results Progressive development of the ERNR resulted in incremental improvements in textual accuracy as well as the inclusion of more accessible language and imagery. Originality/value This is the first attempt at developing an easy-to-read document relating to the legal rights of suspects in police custody in Ireland and, accordingly, this procedural innovation promises to assist, not just persons with intellectual disabilities, but also those with limited literacy at the point of arrest. The methodology used in the preparation of the document, employing a focus group to achieve consensus with participation from both multiple disciplines and persons with an intellectual disability, is in harmony with the ethos of the UNCPRD. This methodology may usefully be employed by other member states that have ratified the Convention but have yet to develop accessible version of the legal rights and entitlements that extend to arrested persons under their domestic law.

Short-notice cancellations of laparoscopic permanent contraception.

OBJECTIVE: Permanent contraception through tubal sterilization is the preferred contraceptive method for 25% of women in the United States. Laparoscopic permanent contraception has an anecdotally high cancellation rate. Cancellations affect operating room utilization and may reflect barriers to care. We aimed to identify the short-notice cancellation (≤7 days from scheduled surgery) rate for laparoscopic permanent contraception, reasons for cancellation, and postcancellation outcomes. STUDY DESIGN: We performed a retrospective chart review of patients aged 18 to 50 who canceled or no-showed a scheduled laparoscopic permanent contraception surgery between May 2016 and May 2019 at an academic tertiary care hospital and academic county hospital in Denver, Colorado. We reviewed electronic health records to determine the time between cancellation and surgery date and documented reasons for cancellation. We evaluated contraceptive methods used and pregnancies within a year after the canceled surgery. RESULTS: The overall surgery cancellation rate for scheduled laparoscopic permanent contraception was 22% (123 of 558). Short-notice cancellation occurred for 71.5% of patients and 32.5% (40 of 123) canceled same day. The most common reason for cancellation was patient choice (74%) followed by financial/insurance issues (11.4%). In the year after their canceled surgery, 22% (27 of 123) of patients obtained permanent contraception and 5.7% (7 of 123) had a subsequent pregnancy. CONCLUSIONS: Among patients who canceled their laparoscopic permanent contraception, the vast majority canceled their surgery a week or less from their scheduled date. These short-notice cancellations may adversely affect both patients and the health care system. More research is needed on institutional policies to reduce laparoscopic permanent contraception cancellations while helping patients who want effective contraception find an option that works best for them. IMPLICATIONS: Our retrospective cohort study found that laparoscopic permanent contraception surgeries have an overall high cancellation rate at both an academic tertiary and an academic county hospital, with most cancellations occurring less than 7 days prior to surgery. Future research will be used to reduce barriers to permanent contraception while developing clinical tools to reduce surgery cancellation rates.

Effects of advance notice on transition-related pausing in pigeons.

Transitions between tasks can produce behavioral disruptions that are characterized as problematic. Advance notice, a procedure designed to reduce disruptions, involves presenting a stimulus to warn of the end of the ongoing activity and the nature of the upcoming activity. Clinical evaluations of advance notice have produced mixed results. We studied advance notice in a controlled laboratory setting. Pigeons' keypecking was maintained on a multiple schedule with 2 fixed-ratio components. In the lean component, completing the ratio produced brief access to food; in the rich component, completing the ratio produced longer access. Disruptions in operant behavior, measured as pauses in pecking, were reliably produced in the transition from a rich component to a lean one. Advance notice was provided by flashing the houselight before transitions to lean components. Advance notice did not reduce pausing in the rich-lean transition; instead, it tended to increase it. When the flashing houselight warned of a transition but was equally likely to be followed by the rich component as the lean one, the stimulus had no reliable effect on pausing. Despite its limitations as a translational model of clinical settings, this experiment suggests that clinical use of advance notice should be approached with caution.

Confidencialidad de datos en un hospital-escuela dedicado a la investigación / Data Confidentiality in a Hospital-School Dedicated to Research / Confidencialidade de dados em um hospital-escola dedicado à pesquisa

Resumen: La información clínica que deriva de la atención médica es almacenada en los expedientes clínicos que se encuentran en archivos físicos o electrónicos en las distintas instituciones hospitalarias que se dedican a la enseñanza. Esta valiosa información constituye una herramienta fundamental en la investigación clínica, por lo tanto, debe de ser considerada confidencial desde que el paciente la remite hasta después de finalizar su tratamiento. Cuando los miembros de un hospital-escuela realizan actividades de investigación, utilizan la información contenida en los expedientes clínicos. La confidencialidad de estos registros es protegida por la ley, por esta razón es necesario fundamentar y desarrollar un método que ayude a los investigadores a conocer estos datos clínicos sin violar su privacidad y confidencialidad. Es necesario cuestionarnos si un aviso de privacidad que indique a los pacientes que la información derivada de sus padecimientos puede utilizarse posteriormente para fines de investigación será suficiente para resolver los conflictos relacionados con la obtención de datos. Un aviso de privacidad es un documento legal que se utiliza para la protección de datos de las personas, aplicarlo en las instituciones hospitalarias dedicadas a la enseñanza y a la investigación facilitará el uso de la información derivada de las consultas y mantendrá la confianza de que los datos utilizados en la investigación respetarán, la confidencialidad y la privacidad, a través del anonimato.

Summary: Clinical information derived from medical care is registered in clinical records in physical or electronic files in different hospital institutions dedicated to teaching. This valuable information is a fundamental tool for clinical research; therefore, it should be considered confidential from the moment the patient transfers it, until after the end of their treatment. When members of a hospital-school carry out research activities, they use information contained in clinical records. Confidentiality of these records is protected by law, for this reason, it is necessary to underpin and develop a method to help researchers to learn this clinical data without violating privacy and confidentiality. It is necessary to question ourselves whether a privacy notice indicating patients that the information derived from their conditions may subsequently be used for research purposes will be enough to resolve disputes related to data collection; in this regard, a privacy notice is a legal document used for the protection of people's data; using it in teaching and research hospital institutions will facilitate the use of information derived from consultations and maintain confidence that the data used in research will respect, first and foremost, confidentiality and privacy, through anonymity.

Resumo: As informações clínicas derivadas dos cuidados médicos são armazenadas nos prontuários médicos encontrados em arquivos físicos ou eletrônicos de diversos hospitais que se dedicam ao ensino. Essas informações valiosas são uma ferramenta fundamental na pesquisa clínica, portanto, devem ser consideradas conidenciais desde o momento em que o paciente as envia até o final do tratamento. Quando os membros de um hospital-escola realizam atividades de pesquisa, eles usam as informações contidas nos registros médicos. A conidencialidade desses registros é protegida por lei, por isso é necessário fundamentar e desenvolver um método que ajude os pesquisadores a conhecer esses dados clínicos sem violar sua privacidade e confidencialidade. É necessário questionar se um aviso de privacidade que informe aos pacientes que as informações derivadas de suas condições podem ser usadas posteriormente para fins de pesquisa será suficiente para resolver disputas relacionadas à coleta de dados. Um aviso de privacidade é um documento legal usado para a proteção de dados de indivíduos. Aplicá-lo em hospitais envolvidos em ensino e pesquisa facilitará o uso de informações derivadas das consultas e manterá a coniança de que os dados usados na pesquisa respeitarão, em primeiro lugar, a conidencialidade e a privacidade, por meio do anonimato.

A comparison of the Food and Drug Administration's and Health Canada's regulatory decisions about failed confirmatory trials for oncology drugs: an observational study.

BACKGROUND: Oncology drugs are frequently approved on the basis of surrogate outcomes that require further trials to confirm the benefits, but at times these trials fail and regulators need to decide whether to withdraw approval for the indication and/or to remove the drug from the market. This study compares decisions by the Food and Drug Administration and Health Canada about oncology drugs that were approved using either Accelerated Approval (FDA) or Notice of Compliance with conditions (NOC/c, Health Canada) and that failed confirmatory trials. METHODS: Drug/indications approved by the FDA through its Accelerated Approval Pathway and that later failed confirmatory studies were identified from a published study and additional information on these drugs was collected from Drugs@FDA. Health Canada websites were searched on September 11, 2021 for the same group of drugs to determine if they were approved in Canada under the NOC/c pathway for the same indication as in the US. Information from both the FDA and Health Canada about these products was entered into an Excel spreadsheet. Decisions about whether to withdraw the drugs or remove the failed indication for the drug and requirements for confirmatory studies were compared. In addition, the dates of decisions by the two agencies were compared. RESULTS: Ten drug/indications were available for comparison. Regulatory decisions were similar in 4 cases, different in 1 case and could not be determined in the remaining 5, in 1 case because decisions were pending in both countries and in the other 4, because the NOC/c had not been fulfilled in Canada. The requirements for the confirmatory studies were similar in both countries. Decisions were made earlier in the United States. CONCLUSIONS: This study shows that decisions made by Health Canada and the FDA about whether to withdraw a drug or remove a failed indication when drug/indications fail a confirmatory trial are usually similar, although the sample size on which this conclusion is made is small. The clinical implications of these similarities and differences should be explored.

Content Analysis of 2012-2019 FDA Warning Letters and Notices of Violations using the Economic, Clinical, and Humanistic Outcomes (ECHO) Model.

OBJECTIVE: The study purpose was to critically review FDA-issued warning letters (WLs) and notice of violation (NOV) letters against drug companies' from 2012-2019 for economic, clinical, and humanistic (ECHO) claims made in pharmaceutical promotional materials. Specific objectives were to assess the, (1) number of WLs and NOV issued; (2) frequency of WLs and NOV by therapeutic areas; (3) type of communication media cited in WLs or NOV; (4) intended audience for the claims in promotional materials for which the WLs and NOV were issued; and (5) number of WLs and NOV for ECHO claims. METHODS: The quantitative content analysis approach was employed to review WLs and NOVs, obtained from the FDA website, from January 2012-December 2019. A data abstraction form was created based on the published literature on this topic and assessment of the content of WLs and NOVs for 2010. This form was pilot tested on letters issued in 2011. The researchers discussed any unclear question or information presented in the letters. The letters were reviewed three researchers. If there was disagreement between the reviewers, either a fourth reviewer arbitrated on the disagreement or the letter(s) were discussed by the researchers to determine a final classification. ICD-10 codes were used for therapeutic categories in the data collected form. Descriptive statistics, Kappa statistics for interrater reliability, and Cochrane-Armitage test were performed using IBM SPSS Statistics version 24.0. RESULTS: A total of 102 letters were analyzed. Of these, 19 (19%) were WLs and 83 (81%) were NOVs. Majority of these letters were issued to manufacturers of therapeutic agents for diseases of the nervous system (n=15; 14.7%) and neoplasms (n=15; 14.7%). The most commonly cited media for violation was online website (n=29; 27.1%). Out of the 153 violations in 102 letters, 92 (60.1%) were clinical; 13 (8.5%) humanistic; 2 (1.3%) were economic; and 46 (30%) were categorized as 'Others'. CONCLUSION: The study found misleading claims of the clinical effectiveness and risk information included in the promotional materials targeted to consumers as well as healthcare providers. Promoting reliable, evidence-based information is important for the health of the public as inadequate information could lead to irrational decision making both on consumer as well as on prescriber side.

Custos com recursos humanos em hemodiálise: análise do regime de sobre aviso e horas extras / Human resources costs in hemodialysis: analysis of the warning and overtime regimen / Costos de recursos humanos en hemodiálisis: análisis del régimen de advertencia y horas extras

Objetivo: avaliar o custo e a viabilidade financeira do regime de sobreaviso e horas extras dos profissionais de enfermagem do setor de Hemodiálise e propor intervenções que favoreçam a racionalização dos recursos financeiros nesta unidade. Método: levantamento da literatura pertinente em bases de dados acadêmicas; identificação da realidade através de análise de documentos como folha de ponto, escala de sobre aviso, descrição de horas extras, comprovantes de pagamento de táxi e reembolso quilometragem; e construção do Diagrama de Ishikawa para evidenciar o problema e suas causas. Resultados: o custo com o regime de sobre aviso e horas extras no setor de hemodiálise em um período de 18 meses foi de R$ 198.996,59 (média mensal R$ 11.005,39), verificou-se que 70% deste valor deve-se ao pagamento de sobre aviso. Foi proposto duas intervenções distintas, as quais economizaram em 18 meses aproximadamente R$ 73.730,99 (média mensal RS 4.096,16) e 82.814,40 (média mensal R$ 4.600,80), tais propostas aguardam avaliação dos gestores responsáveis para possível implantação. Conclusão: a construção deste estudo contribuiu de maneira a aprimorar e desenvolver o conhecimento teórico-prático sobre a gestão financeira e otimização de recursos, podendo servir também como incentivo/modelo para outras unidades iniciarem ações visando a racionalização de recursos financeiros.

Objective: to evaluate the cost and financial viability of the overwarning and overtime regime of nursing professionals in the Hemodialysis sector and to propose interventions that favor the rationalization of financial resources in this unit. Method: survey of the pertinent literature in academic databases; identification of reality through analysis of documents such as timesheet, scale over notice, description of overtime, vouchers of payment of taxi and mileage refund; and construction of the Ishikawa Diagram to highlight the problem and its causes. Results: the cost with the warning and overtime regime in the hemodialysis sector in an 18-month period was R$ 198,996.59 (monthly average R$ 11,005.39), it was found that 70% of this amount is due to the payment of on notice. Two distinct interventions were proposed, which saved approximately R$ 73,730.99 (monthly average RS 4,096.16) and 82,814.40 (monthly average R$ 4,600.80) in 18 months, such proposals await evaluation from managers responsible for possible implementation. Conclusion: the construction of this study contributed in order to improve and develop theoretical and practical knowledge about financial management and resource optimization, and may also serve as an incentive/model for other units to initiate actions aimed at rationalizing financial resources.

Objetivo: evaluar el coste y la viabilidad financiera del régimen de sobrecalentamiento y horas extras de los profesionales de enfermería del sector de la Hemodiálisis y proponer intervenciones que favorezcan la racionalización de los recursos financieros en esta unidad. Método: encuesta de la literatura pertinente en bases de datos académicas; identificación de la realidad a través del análisis de documentos tales como hoja de horas, escala sobre aviso, descripción de horas extras, vales de pago de taxi y reembolso de kilometraje; y la construcción del Diagrama de Ishikawa para resaltar el problema y sus causas. Resultados: el costo con el régimen de advertencia y horas extras en el sector de la hemodiálisis en un período de 18 meses fue de R$ 198,996.59 (promedio mensual R$ 11,005.39), se encontró que el 70% de esta cantidad se debe al pago de previo aviso. Se propusieron dos intervenciones distintas, que ahorraron aproximadamente R$ 73,730.99 (promedio mensual RS 4,096.16) y 82,814.40 (promedio mensual R$ 4,600.80) en 18 meses, tales propuestas esperan la evaluación de los gerentes responsables de una posible implementación. Conclusión: la construcción de este estudio contribuyó con el fin de mejorar y desarrollar conocimientos teóricos y prácticos sobre gestión financiera y optimización de recursos, y también puede servir como incentivo/modelo para que otras unidades inicien acciones destinadas a racionalizar los recursos financieros.

Retraction of papers authored by Yuhji Saitoh - Beyond the Fujii phenomenon.

BACKGROUND AND AIMS: Various aspects of retracted articles authored by Yoshitaka Fujii and their retraction notices have been examined. Yuhji Saitoh has coauthored many articles with Yoshitaka Fujii which were subsequently retracted. Japanese Society of Anesthesiology (JSA) recommends retraction of various articles by Yuhji Saitoh, but various attributes of those and their retraction notices have not been examined. METHODS: A list of retracted articles was retrieved from PubMed, Retraction Watch Database and relevant journals. Their retraction notices were obtained from the journal's webpage. Predefined characteristics of the retracted articles and their retraction notices were evaluated against those proposed by Committee on Publication Ethics (COPE). RESULTS: Fifteen such articles were retracted. Two of them were not identified as retracted in the journal webpage. Half of the papers mentioned by JSA are yet to be retracted. Among those retracted, only 13.3% retraction notices were in line with the guidelines published by the COPE. Two retracted articles are yet to be flagged as retracted in PubMed. The median (interquartile range) time required for retraction from the date of declaration of being eligible for retraction is 14 (3) months. Data were analysed with Microsoft Excel™ (2007). CONCLUSION: Even after more than 1 year of recommendation, many articles containing evidence of scientific misconduct are yet to be retracted. Among those retracted, the relevant authority failed to follow the prevalent and well-regarded standards of ethics in scholarly publication.