Enhancing patient safety: detection of in-hospital hazards and effect of training on detection (by training in a low-fidelity simulation Room of Improvement based on hospital-specific CIRS cases).

IMPORTANCE: Adequate situational awareness in patient care increases patient safety and quality of care. To improve situational awareness, an innovative, low-fidelity simulation method referred to as Room of Improvement, has proven effective in various clinical settings. OBJECTIVE: To investigate the impact after 3 months of Room of Improvement training on the ability to detect patient safety hazards during an intensive care unit shift handover, based on critical incident reporting system (CIRS) cases reported in the same hospital. METHODS: In this educational intervention, 130 healthcare professionals observed safety hazards in a Room of Improvement in a 2 (time 1 vs time 2)×2 (alone vs in a team) factorial design. The hazards were divided into immediately critical and non-critical. RESULTS: The results of 130 participants were included in the analysis. At time 1, no statistically significant differences were found between individuals and teams, either overall or for non-critical errors. At time 2, there was an increase in the detection rate of all implemented errors for teams compared with time 1, but not for individuals. The detection rate for critical errors was higher than for non-critical errors at both time points, with individual and group results at time 2 not significantly different from those at time 1. An increase in the perception of safety culture was found in the pre-post test for the questions whether the handling of errors is open and professional and whether errors are discussed in the team. DISCUSSION: Our results indicate a sustained learning effect after 12 weeks, with collaboration in teams leading to a significantly better outcome. The training improved the actual error detection rates, and participants reported improved handling and discussion of errors in their daily work. This indicates a subjectively improved safety culture among healthcare workers as a result of the situational awareness training in the Room of Improvement. As this method promotes a culture of safety, it is a promising tool for a well-functioning CIRS that closes the loop.

Administração de anti-infecciosos em pacientes críticos: gestão proativa de riscos / Administration of anti-infectives in critically ill patients: proactive risk management / Administración de antiinfecciosos en pacientes críticos: gestión proactiva del riesgo

Objetivo: analisar a gestão de riscos proativa do processo de administração de anti-infecciosos em Unidade de Terapia Intensiva. Método: estudo qualitativo, em pesquisa-ação, com observação participante e grupo focal, realizado de 2019 a 2021. Foi mapeado o processo, analisados os riscos, planejadas ações de melhorias e redesenhado o processo. Resultados: a prescrição ocorria em sistema eletrônico e os registros da administração em impressos. O processo de administração de anti-infecciosos possuía 19 atividades, dois subprocessos, 16 modos de falhas e 23 causas potenciais. Os modos de falhas foram relacionados à assepsia e erro de dose no preparo de anti-infecciosos e as causas apontadas foram a falha humana na violação das técnicas e o lapso de memória. Cinco especialistas redesenharam o processo resultando em alterações de atividades e no sistema. Conclusão: a gestão de riscos proativa aplicada ao processo de administração de anti-infecciosos propiciou identificar riscos, suas causas e priorizar ações de melhorias, o que pode viabilizar tomadas de decisões apropriadas(AU)

Objective: to analyze the proactive risk management of the anti-infective administration process in an Intensive Care Unit. Method: qualitative study, in action research, with participant observation and focus group, from 2019 to 2021. The process was mapped, risks analyzed, improvement actions planned and the process redesigned. Results: the prescription occurred in an electronic system and the administration records in printed form. The anti-infective administration process had 19 activities, two sub-processes, 16 failure modes and 23 potential causes. The failure modes were related to asepsis and dose error in the preparation of anti-infectives and the identified causes were human error in violating techniques and memory lapse. Five specialists redesigned the process resulting in changes in activities and in the system. Conclusion: proactive risk management applied to the anti-infective administration process was effective in identifying risks, their causes and prioritizing improvement actions(AU)

Objetivo: analizar la gestión proactiva de riesgos del proceso de administración de antiinfecciosos en una Unidad de Cuidados Intensivos. Método: estudio cualitativo, en investigación-acción, con observación participante y grupo focal, que tuvo lugar del 2019 al 2021. Se mapeó el proceso, se analizaron los riesgos, se planificaron acciones de mejora y se rediseñó el proceso. Resultados: la prescripción ocurrió en sistema electrónico y los registros de administración en forma impresa. El proceso de administración de antiinfecciosos tuvo 19 actividades, dos subprocesos, 16 modos de falla y 23 causas potenciales. Los modos de falla estuvieron relacionados con la asepsia y error de dosis en la preparación de antiinfecciosos y las causas identificadas fueron error humano por violación de técnicas y lapsus de memoria. Cinco especialistas rediseñaron el proceso generando cambios en las actividades y en el sistema. Conclusión: la gestión proactiva de riesgos aplicada al proceso de administración de antiinfecciosos fue efectiva para identificar riesgos, sus causas y priorizar acciones de mejora, lo que puede factibilizar la toma de decisiones adecuadasa(AU)

Guía para la gestión de riesgos de los dispositivos médicos para el diagnóstico / Risk management guidance for diagnostic medical devices

Introducción: Los fabricantes de los dispositivos médicos no siempre disponen de experiencia para realizar un proceso de gestión de riesgos que cumpla con la norma ISO 14971:2019 e incluya los requisitos metrológicos necesarios; por tanto, para un mejor uso de estos equipos, especialmente los de diagnóstico, se debe implementar y mantener un proceso de gestión de riesgos basado en las normativas establecidas. Objetivo: Proponer una guía para la gestión de los riesgos indirectos en pacientes con diagnósticos incorrectos o retrasados. Métodos: Se revisaron las normas internacionales aplicables y se analizaron expedientes de gestión del riesgo de dispositivos médicos, entre ellos reactivos para el diagnóstico in vitro. Resultados: La guía ofrece elementos orientadores para cada etapa del proceso de gestión de riesgos en los dispositivos médicos para el diagnóstico: plan de gestión del riesgo, análisis, valoración y control del riesgo, evaluación del riesgo residual global, revisión de la gestión de riesgo y retroalimentación a partir de la información de producción o posproducción. Conclusiones: Esta guía es una herramienta útil para diseñadores, fabricantes, evaluadores de dispositivos médicos para el diagnóstico, asesores en temas de gestión de riesgos y la calidad de los dispositivos y personal médico(AU)

Introduction: Manufacturers of medical devices do not always have the expertise to perform a risk management process that complies with ISO 14971:2019 and includes the necessary metrological requirements; therefore, for better use of these devices, especially diagnostic devices, a risk management process based on established regulations should be implemented and maintained. Objective: To provide guidance for the management of indirect risks in patients with incorrect or delayed diagnoses. Methods: Applicable international standards were reviewed and risk management dossiers for medical devices, including in-vitro diagnostic reagents, were analyzed. Results: The guidance provides guiding elements for each step of the risk management process for diagnostic medical devices: risk management plan, risk analysis, risk assessment, risk evaluation and control, overall residual risk assessment, risk management review, and feedback from production or post-production information. Conclusions: This guide is a useful tool for designers, manufacturers, evaluators of diagnostic medical devices, risk management and device quality assessors, and medical personnel(AU)

Management of acute exposure to toxic gases in the oil & gas industry -a practical approach.

The objective of this work is to present the key elements in the design of emergency management and response plans in scenarios where there has been loss of containment of chemical agents of acute effect focused in the protection of not routinely exposed in a determined occupational environment. To this purpose, a validation of the current criteria for the management of accidental releases is carried out, taking into account hypothetical risk scenarios. The essential elements of the emergency management system are stated, from a systemic perspective and the corresponding risk control actions; recommendations for their implementation are showed, taking as prototype hydrogen sulfide, a highly toxic gas. Non controlled emissions of toxic gases of acute effect from an occupational standpoint represents a priority because of their human and financial high toll. Design and implementation of an appropriate emergency plan for uncontrollable emissions of toxics chemical agents must be addressed.

The comprehensive complication index (CCI): proposal of a new reporting standard for complications in major urological surgery.

PURPOSE: The comprehensive complication index (CCI) is a new tool for reporting the cumulative burden of postoperative complications on a continuous scale. This study validates the CCI for urological surgery and its benefits over the Clavien-Dindo-Classification (Clavien). MATERIAL AND METHODS: Data from a prospectively maintained data base of all consecutive patients at a university care-center was analyzed. Complications after radical cystectomy (RC), radical prostatectomy (RP), and partial nephrectomy (PN) were classified using the CCI and Clavien system. Differences in complications between the CCI and the Clavien were assessed and correlation analyses performed. Sample size calculations for hypothetical clinical trials were compared between CCI and Clavien to evaluate whether the CCI would reduce the number of required patients in a clinical trial. RESULTS: 682 patients (172 RC, 297 RP, 213 PN) were analyzed. Overall, 9.4-46.6% of patients had > 1 complication cumulatively assessed with the CCI resulting in an upgrading in the Clavien classification for 2.4-32.4% of patients. Therefore, scores between the systems differed for RC: CCI (mean ± standard deviation) 26.3 ± 20.8 vs. Clavien 20.4 ± 16.7, p < 0.001; PN: CCI 8.4 ± 14.7 vs. Clavien 7.0 ± 11.8, p < 0.001 and RP: CCI 5.8 ± 11.7 vs. Clavien 5.3 ± 10.6, p = 0.102. The CCI was more accurate in predicting LOS after RC than Clavien (p < 0.001). Sample size calculations based in the CCI (for future hypothetical trials) resulted in a reduction of required patients for all procedures (- 25% RC, - 74% PN, - 80% RP). CONCLUSION: The CCI is more accurate to assess surgical complications and reduces required sample sizes that will facilitate the conduction of clinical trials.

Gestão de risco e as estratégias do plano de contingência para COVID-19 / COVID-19 contingency plan strategies and risk management / Gestión de riesgos y estratégias del plan de contingencia para COVID-19

Objetivo: analisar o plano de contingência para infecção humana pelo Covid-19 e apresentar um modelo conceitual de gestão de risco para o Covid-19. Método: estudo de avaliação executiva, com análise seguindo os passos: Descrição da política; diagnóstico do problema; desenho da política; implementação; governança; resultados e impactos; que permitiu estabelecer o panorama geral acerca do Plano de Contingência Nacional para Infecção Humana pelo novo Coronavírus. Resultados: foram utilizados os passos metodológicos para apontar pontos positivos e fragilidades do plano de contingência e a construção de um modelo conceitual sobre a gestão de risco para o COVID-19. Conclusão: o cenário nacional enriquecido de condições socioambientais desfavoráveis, expõe o quão é vulnerável a nossa população e o sistema de saúde. Além disso, o estudo apontou para déficits de pessoal, materiais e preparação prévia para situações de risco como fatores a serem tratados dentro do processo de mitigação dos riscos.

Objective: to examine the contingency plan for human infection by Covid-19 and present a conceptual model of risk management for Covid-19. Method: in this executive evaluation study, the analysis followed the steps: policy description; problem diagnosis; policy design; implementation; governance; results and impacts; to establish an overall panorama of the National Human Infection Contingency Plan for the new Coronavirus. Results: the methodological steps were used to highlight the strengths and weaknesses of the contingency plan, and to construct a conceptual model of risk management for COVID-19. Conclusion: the scenario in Brazil, enhanced by unfavorable socio-environmental conditions, exposed how vulnerable its population and the health system are. The study also indicated that deficits in personnel, material and prior preparation for risk situations were factors to be addressed in the risk mitigation process.

Objetivo: examinar el plan de contingencia para la infección humana por Covid-19 y presentar un modelo conceptual de gestión de riesgos para Covid-19. Método: en este estudio de evaluación ejecutiva, el análisis siguió los pasos: descripción de la política; diagnóstico de problemas; diseño de políticas; implementación; gobernancia; resultados e impactos; Establecer un panorama general del Plan Nacional de Contingencia de Infección Humana por el nuevo Coronavirus. Resultados: los pasos metodológicos se utilizaron para resaltar las fortalezas y debilidades del plan de contingencia y para construir un modelo conceptual de gestión de riesgos para COVID-19. Conclusión: el escenario en Brasil, potenciado por condiciones socioambientales desfavorables, expuso la vulnerabilidad de su población y el sistema de salud. El estudio también indicó que los déficits en personal, material y preparación previa para situaciones de riesgo fueron factores a ser abordados en el proceso de mitigación de riesgos.

Leaving Hospital: A Step too Far for Risk-Based Regulation?

Discharges from hospital are internationally recognised as a dangerous time in the care pathway of a patient, posing a risk to both their physical wellbeing and dignity. This article examines the effectiveness of risk-based regulation as a tool to address patient safety incidents linked to the hospital discharge process within the English National Health Service. It examines how the risk of this process is identified, conceptualised, and prioritised amongst the relevant statutory regulators, and argues that the risk is neither uniformly recognised by the statutory regulators within the English NHS, nor sufficiently addressed. Professional regulators in particular appear to have a poor awareness of the risk and their role in addressing it. Until these issues are resolved, patients leaving hospitals will continue to be exposed to patient safety incidents which should be avoidable.

Lessons learned: using adverse incident reports to investigate the characteristics and causes of prescribing errors.

INTRODUCTION: Prescribing errors are a principal cause of preventable harm in healthcare. This study aims to establish a systematic approach to analysing prescribing-related adverse incident reports, in order to elucidate the characteristics and contributing factors of common prescribing errors and target multifaceted quality improvement initiatives. METHODS: All prescribing-related adverse incident reports submitted across one NHS board over 12 months were selected. Incidents involving commonly implicated drugs (involved in ≥10 incidents) underwent analysis to establish likely underlying causes using Reason's Model of Accident Causation. RESULTS: 330 prescribing-related adverse incident reports were identified. Commonly implicated drugs were insulin (10% of incidents), gentamicin (7%), co-amoxiclav (5%) and amoxicillin (5%). The most prevalent error types were prescribing amoxicillin when contraindicated due to allergy (5%); prescribing co-amoxiclav when contraindicated due to allergy (5%); prescribing the incorrect type of insulin (3%); and omitting to prescribe insulin (3%). Error-producing factors were identified in 86% of incidents involving commonly implicated drugs. 53% of incidents involved error-producing factors related to the working environment; 38% involved factors related to the healthcare team; and 37% involved factors related to the prescriber. DISCUSSION: This study establishes that systematic analysis of adverse incident reports can efficiently identify the characteristics and contributing factors of common prescribing errors, in a manner useful for targeting quality improvement. Furthermore, this study produced a number of salient findings. First, a narrow range of drugs were implicated in the majority of incidents. Second, a small number of error types were highly recurrent. Lastly, a range of contributing factors were evident, with those related to the working environment contributing to the majority of prescribing errors analysed.

Quality Assessment of Intraoperative Adverse Event Reporting During 29 227 Robotic Partial Nephrectomies: A Systematic Review and Cumulative Analysis.

The definition of intraoperative adverse events (IAEs) still lacks standardization, hampering the assessment of surgical performance in this regard. Over the years, efforts to address this issue have been carried out to improve the reporting of outcomes. In 2019, the European Association of Urology (EAU) proposed a standardized reporting tool for IAEs in urology. The objective of the present study is to distill systematically published data on IAEs in patients undergoing robotic partial nephrectomy (RPN) for renal masses to answer three key questions (KQs). (KQ1) Which system is used to report the IAEs? (KQ2) What is the frequency of IAEs? (KQ3) What types of IAEs are reported? A comprehensive systematic review of all English-language publications on RPN was carried out. We followed the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) guidelines to evaluate PubMed, Scopus, and Web of Science databases (from January 1, 2000 to January 1, 2019). Quality of reporting and grading complications were assessed according to the EAU recommendations. Globally, 59 (35.3%) and 108 (64.7%) studies reported zero and one or more IAEs, respectively. Overall, 761 (2.6%) patients reported at least one IAE. Intraoperative bleeding is reported as the most common IAE (58%). Our analysis showed no improvement in reporting and grading of IAEs over time. PATIENT SUMMARY: Up to now, an agreement regarding the definition and reporting of intraoperative adverse events (IAEs) in the literature has not been achieved. The aim of this study is to evaluate the reporting of IAEs in patients undergoing robotic partial nephrectomy (RPN) after a systematic review of the literature. More rigorous reporting of IAEs during RPN is needed to measure their impact on patients' perioperative care.

ESGE and ESGENA Position Statement on gastrointestinal endoscopy and the COVID-19 pandemic.

We are currently living in the throes of the COVID-19 pandemic that imposes a significant stress on health care providers and facilities. Europe is severely affected with an exponential increase in incident infections and deaths. The clinical manifestations of COVID-19 can be subtle, encompassing a broad spectrum from asymptomatic mild disease to severe respiratory illness. Health care professionals in endoscopy units are at increased risk of infection from COVID-19. Infection prevention and control has been shown to be dramatically effective in assuring the safety of both health care professionals and patients. The European Society of Gastrointestinal Endoscopy (www.esge.com) and the European Society of Gastroenterology and Endoscopy Nurses and Associates (www.esgena.org) are joining forces to provide guidance during this pandemic to help assure the highest level of endoscopy care and protection against COVID-19 for both patients and endoscopy unit personnel. This guidance is based upon the best available evidence regarding assessment of risk during the current status of the pandemic and a consensus on which procedures to perform and the priorities on resumption. We appreciate the gaps in knowledge and evidence, especially on the proper strategy(ies) for the resumption of normal endoscopy practice during the upcoming phases and end of the pandemic and therefore a list of potential research questions is presented. New evidence may result in an updated statement.

Are the MORECare guidelines on reporting of attrition in palliative care research populations appropriate? A systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Palliative care trials have higher rates of attrition. The MORECare guidance recommends applying classifications of attrition to report attrition to help interpret trial results. The guidance separates attrition into three categories: attrition due to death, illness or at random. The aim of our study is to apply the MORECare classifications on reported attrition rates in trials. METHODS: A systematic review was conducted and attrition classifications retrospectively applied. Four databases, EMBASE; Medline, CINHAL and PsychINFO, were searched for randomised controlled trials of palliative care populations from 01.01.2010 to 08.10.2016. This systematic review is part of a larger review looking at recruitment to randomised controlled trials in palliative care, from January 1990 to early October 2016. We ran random-effect models with and without moderators and descriptive statistics to calculate rates of missing data. RESULTS: One hundred nineteen trials showed a total attrition of 29% (95% CI 28 to 30%). We applied the MORECare classifications of attrition to the 91 papers that contained sufficient information. The main reason for attrition was attrition due to death with a weighted mean of 31.6% (SD 27.4) of attrition cases. Attrition due to illness was cited as the reason for 17.6% (SD 24.5) of participants. In 50.8% (SD 26.5) of cases, the attrition was at random. We did not observe significant differences in missing data between total attrition in non-cancer patients (26%; 95% CI 18-34%) and cancer patients (24%; 95% CI 20-29%). There was significantly more missing data in outpatients (29%; 95% CI 22-36%) than inpatients (16%; 95% CI 10-23%). We noted increased attrition in trials with longer durations. CONCLUSION: Reporting the cause of attrition is useful in helping to understand trial results. Prospective reporting using the MORECare classifications should improve our understanding of future trials.

Ethical leadership, nursing error and error reporting from the nurses' perspective.

BACKGROUND: Nursing errors endanger patient safety, and error reporting helps identify errors and system vulnerabilities. Nursing managers play a key role in preventing nursing errors by using leadership skills. One of the leadership approaches is ethical leadership. AIM: This study determined the level of ethical leadership from the nurses' perspective and its effect on nursing error and error reporting in teaching hospitals affiliated to Shahid Sadoughi University of Medical Sciences, Yazd, Iran. RESEARCH DESIGN: This was a cross-sectional descriptive study. PARTICIPANTS AND RESEARCH CONTEXT: A total of 171 nurses working in medical-surgical wards were selected through random sampling. Data collection was carried out using "ethical leadership in nursing, nursing errors and error reporting" questionnaires. Data were analyzed with SPSS20 using descriptive and analytical statistics. ETHICAL CONSIDERATIONS: This study was approved by the Ethics Committee for Medical Research. Ethical considerations such as completing informed consent form, ensuring confidentiality of information, explaining research objectives, and voluntary participation were observed in the present study. FINDINGS: The results showed that the level of nursing managers' ethical leadership was moderate from the nurses' point of view. The highest and the lowest levels were related to the power-sharing and task-oriented dimensions, respectively. There was a significant relationship between nursing managers' level of ethical leadership with error rates and error reporting. CONCLUSION: The development of ethical leadership approach in nursing managers reduces error rate and increases error reporting. Programs designed to promote such approach in nursing managers at all levels can help reduce the level of error rate and maintain patient safety.

An improved patient safety reporting system increases reports of disruptive behavior in the perioperative setting.

BACKGROUND: Patient safety event reporting systems are a mainstay in non-punitive reporting of near misses and adverse events. We hypothesized that an upgraded reporting system that included the ability to report positive behaviors would increase behavioral reports in the perioperative environment. METHODS: We performed a retrospective assessment of prospectively collected reports from the Patient Safety Net (PSN) event reporting system (2/2010-2/2015) and the RL Solutions RL6 system (8/2015-4/2018). RESULTS: Under the PSN system, 0.8 behavioral events per quarter were submitted, compared to 7.4 behavioral events per quarter with the RL6 system. The average length of reports increased from 61 to 185 words. Reports were most often submitted by nursing staff (66%), and about attending physicians (36%). 22% of reports under the RL6 system were positive; 46% of these positive reports were about physicians. CONCLUSION: After implementation of an upgraded reporting system that includes an option for positive reporting, the number and length of reports increased. We believe that a robust reporting system has contributed to a culture of safety at our institution.

Patient-Reported Outcome Measures may optimize shared decision-making for cancer risk management in BRCA mutation carriers.

PURPOSE: The aim of this study was to compare patient-reported outcomes (PROs) of BRCA1/2 mutation carriers, either after bilateral prophylactic mastectomy (BPM) or during breast surveillance, to improve shared decision-making in their cancer risk management. METHODS: Unaffected BRCA1/2 mutation carriers at least one year after BPM followed by immediate breast reconstruction (BPM-IBR) or one year under surveillance were eligible. After informed consent, the Hospital Anxiety and Depression Scale (HADS) and BREAST-Q were administered and compared between the different strategies. PROs were also compared to available normative data. RESULTS: Ninety-six participants were analyzed in this study and showed significant differences between strategies in age, age at genetic testing, and time since BPM or starting breast surveillance. All HADS scores were below 8 suggesting no signs of anxiety or depression in both groups. Higher mean 'Q-physical well-being' scores were reported by the surveillance group (81.78 [CI 76.99-86.57]) than the BPM group (76.96 [CI 73.16 - 80.75]; p = 0.011). Overall, for both questionnaires better scores were seen when compared to age-matched normative data. CONCLUSIONS: No signs of anxiety or depression were seen in the surveillance or BPM-IBR group. Slightly better mean BREAST-Q scores were seen for the surveillance group in comparison to BPM-IBR, except for 'Q-psychological well-being'. The difference in 'Q-physical well-being' was significantly worse for BPM-IBR. Approaches to obtain longitudinal PROs and reference values should be explored in the future, which could add value to shared decision-making in regards to breast cancer risk management in this specific patient population.

Safety of patients with mental disorders: a collective construction of strategies / Seguridad del paciente con trastornos mentales: construcción colectiva de estrategias / Segurança do paciente com transtorno mental: construção coletiva de estratégias

ABSTRACT Objective: to describe risk management implementation in the safety of patients with mental disorders through action research. Method: an action research carried out with a multidisciplinary team from a reference hospital in mental health in Southeast Brazil. Results: three strategies considered as managerial technologies for the mentally ill patient were developed: risk management diagram for patient safety; patient safety protocols; and textual proposal of software for internal management of incident notifications. Final considerations: this action research allowed a collective discussion by the whole multidisciplinary team, enabling strategy drafting for risk management implementation and improvement of care quality in the safety of patients with mental disorders at the study site.

RESUMEN Objetivo: describir la implementación de la gestión de riesgos en la seguridad de los pacientes con trastornos mentales a través de la investigación de acción. Método: investigación de acción realizada con un equipo multidisciplinario de un hospital de referencia en salud mental en el sureste de Brasil. Resultados: se desarrollaron tres estrategias consideradas como tecnologías de gestión para el paciente mentalmente enfermo: diagrama de gestión de riesgos para la seguridad del paciente; protocolos de seguridad del paciente; y propuesta textual de software para la gestión interna de notificaciones de incidencias. Consideraciones finales: la investigación de acción permitió una discusión colectiva por parte de todo el equipo multiprofesional, lo que permitió la elaboración de estrategias para la implementación de la gestión de riesgos y la mejora de la calidad de la atención en la seguridad de los pacientes con trastornos mentales en el lugar de estudio.

RESUMO Objetivo: descrever a implantação da gestão de risco para a segurança do paciente com transtorno mental por meio da pesquisa-ação. Método: pesquisa-ação realizada com equipe multidisciplinar de um hospital referência em Saúde Mental na região Sudeste do Brasil. Resultados: foram elaboradas três estratégias consideradas tecnologias gerenciais para o paciente com transtorno mental: diagrama da gestão de risco na segurança do paciente; protocolos de segurança do paciente; e proposta textual de software para gestão interna de notificações de incidentes. Considerações finais: a pesquisa-ação permitiu uma discussão coletiva por toda a equipe multiprofissional, possibilitando a elaboração de estratégias para a implantação da gestão de risco e a melhoria da qualidade da assistência na segurança do paciente com transtorno mental no local do estudo.

Alternativas para o estabelecimento de via aérea cirúrgica durante a pandemia de COVID-19 / Alternatives for establishing a surgical airway during the COVID-19 pandemic

RESUMO Atualmente médicos e profissionais da saúde encontram-se frente a uma pandemia desafiadora causada por uma nova cepa denominada 2019 Novel Coronavírus (COVID-19). A infecção humana pelo COVID-19 ainda não tem o espectro clínico completamente descrito, bem como não se sabe com precisão o padrão de letalidade, mortalidade, infectividade e transmissibilidade. Não há vacina ou medicamento específico disponível. O tratamento é de suporte e inespecífico. No Brasil, assim como no restante do mundo o número de casos de COVID-19 tem crescido de maneira alarmante levando a um aumento do número de internações assim como da mortalidade pela doença. Atualmente os estados com maior número de casos são, respectivamente, São Paulo, Rio de Janeiro, Distrito Federal e Ceará. O objetivo deste trabalho é oferecer alternativas a fim de orientar cirurgiões quanto ao manejo cirúrgico das vias aéreas em pacientes com suspeita e/ou confirmação para infecção pelo COVID-19.

ABSTRACT Currently doctors and health professionals are facing a challenging pandemic caused by a new strain called 2019 Novel Coronavirus (COVID-19). Human infection with COVID-19 does not yet have the clinical spectrum fully described, and the pattern of lethality, mortality, infectivity and transmissibility is not known with precision. There is no specific vaccine or medication available. Treatment is supportive and nonspecific. In Brazil, as in the rest of the world, the number of COVID-19 cases has grown alarmingly, leading to an increase in the number of hospitalizations as well as in mortality from the disease. Currently, the states with the highest number of cases are, respectively, São Paulo, Rio de Janeiro, Distrito Federal and Ceará. The objective of this work is to offer alternatives in order to guide surgeons regarding the surgical management of the airways in patients with suspicion and / or confirmation for COVID-19 infection.

Agrass questionnaire: Assessment of risk management in health care / Questionário agrass: Avaliação da gestão de riscos assistenciais em serviços de saúde

ABSTRACT OBJECTIVE This study aims to assess the development and the validity analysis of the Assessment of Risk Management in Health Care Questionnaire (AGRASS). METHODS This is a validation study of a measurement instrument following the stages: 1) Development of conceptual model and items; 2) Formal multidisciplinary assessment; 3) Nominal group for validity analysis with national specialists; 4) Development of software and national pilot study in 62 Brazilian hospitals 5) Delphi for validity analysis with the users of the questionnaire. In stages 3 and 5, the items were judged based on face validity, content validity, and utility and viability, by a 1-7 Likert scale (cut-off point: median < 6). Accuracy and reliability of the questionnaire were analyzed with the Confirmatory Factor Analysis and the Cronbach's alpha. RESULTS The initial version of the instrument (98 items) was adapted during stages 1 to 3 for the final version with 40 items, which were considered relevant, of adequate content, useful, and viable. The instrument has 2 dimensions and 9 subdimensions, and the items have closed-ended questions (yes or no). The software for the automatic collection and analysis generates indicators, tables, and automatic graphs for the assessed institution and aggregated data. The adjustment indices confirmed a bi-dimensional model composed of structure and process (X2/gl = 1.070, RMSEA ≤ 0.05 = 0.847, TLI = 0.972), with high reliability for the AGRASS Questionnaire (α = 0.94) and process dimension (α = 0.93), and adequate for the structural dimension (α = 0.70). CONCLUSIONS The AGRASS Questionnaire is a potentially useful instrument for the surveillance and monitoring of the risk management and patient safety in health services.

RESUMO OBJETIVO O estudo objetiva descrever a construção e análise da validade do Questionário Avaliação da Gestão de Riscos Assistenciais em Serviços de Saúde (AGRASS). MÉTODOS Trata-se de estudo de validação de um instrumento de medida nas etapas: 1. construção do modelo conceitual e itens; 2. apreciação formal multidisciplinar; 3. grupo nominal para análise da validade com especialistas da esfera nacional; 4. desenvolvimento de softwares e estudo-piloto nacional em 62 hospitais do Brasil; 5. Delphi para análise da validade com utilizadores do questionário. Nas etapas 3 e 5, os itens foram julgados quanto à validade de face e conteúdo, utilidade e viabilidade, em uma escala Likert de 1 a 7 (ponto de corte: mediana < 6). A validade de construto e a confiabilidade foram analisadas com análise fatorial confirmatória e coeficientes α de Cronbach. RESULTADOS A versão inicial do instrumento (98 itens) foi adaptada durante as etapas 1 a 3 para a versão com 40 itens considerados relevantes, de conteúdo adequado, úteis e viáveis. O instrumento tem duas dimensões e nove subdimensões, e os itens têm opção de resposta fechada (sim ou não). Os softwares para coleta e análise automática geram indicadores, tabelas e gráficos automáticos para a instituição avaliada e conjuntos agregados. Os índices de ajuste confirmaram o modelo bidimensional de estrutura e processo (X2/gl = 1,070, RMSEA ≤ 0,05 = 0,847; TLI = 0,972), havendo confiabilidade alta para o Questionário AGRASS (α = 0,94) e a dimensão processo (α = 0,93) e aceitável para a dimensão estrutura (α = 0,70). CONCLUSÃO O Questionário AGRASS é um instrumento potencialmente útil para a vigilância e monitoramento da gestão de riscos e segurança do paciente em serviços de saúde.

When risk becomes illness: The personal and social consequences of cervical intraepithelial neoplasia medical surveillance.

BACKGROUND: After the early detection of cervical intraepithelial neoplasia (CIN), medical surveillance of the precancerous lesions is carried out to control risk factors to avoid the development of cervical cancer. OBJECTIVE: To explore the effects of medical surveillance on the personal and social lives of women undergoing CIN follow-up and treatment. METHODOLOGY: A generic qualitative study using a poststructuralist perspective of risk management was carried out in a gynecology clinic in a public hospital of the Galician Health Care System (Spain). Participants were selected through purposive sampling. The sample consisted of 21 women with a confirmed diagnosis of CIN. Semistructured interviews were recorded and transcribed, and a thematic analysis was carried out, including researcher triangulation to verify the results of the analysis. FINDINGS: Two main themes emerged from the participants' experiences: CIN medical surveillance encounters and risk management strategies are shaped by the biomedical discourse, and the effects of "risk treatment" for patients include (a) profound changes expected of patients, (b) increased patient risk management, and (c) resistance to risk management. While doctors' surveillance aimed to prevent the development of cervical cancer, women felt they were sick because they had to follow strict recommendations over an unspecified period of time and live with the possibility of a life-threatening disease. Clinical risk management resulted in the medicalization of women's personal and social lives and produced great uncertainty. CONCLUSIONS: This study is the first to conceptualize CIN medical surveillance as an illness experience for patients. It also problematizes the effects of preventative practices in women's lives. Patients deal with great uncertainty, as CIN medical surveillance performed by gynecologists simultaneously trivializes the changes expected of patients and underestimates the effects of medical recommendations on patients' personal wellbeing and social relations.

Otorhinolaryngology litigations in Japan.

PURPOSE: The purpose of this study was to examine the malpractice litigations pertaining to otorhinolaryngology in Japan. METHODS: A retrospective review was undertaken of cases tried in the Japanese civil court system during the 26-year period from 1990 to 2015 as identified in a computerized legal database. Data including patient demographics, disease, chief allegations, court's decisions, and the year decision was made were collected and analyzed. Patients' chief allegations were assigned to one of the five categories: delayed diagnosis, complication during diagnostic procedure, inappropriate treatment, complication during treatment procedure, or lack of informed consent. RESULTS: Thirty-one malpractice litigations were identified. Eight (26%) malpractice litigations pertained to tumors, 1 (3%) to a tumor-like lesion, 14 (45%) to inflammation, and 8 (26%) to others. Among the patients' chief allegations, inappropriate treatment and complication during treatment procedure were the most frequent [11 (36%) for each], followed by delayed diagnosis [6 (19%)], complication during diagnostic procedure [2 (6%)], and lack of informed consent [1 (3%)]. CONCLUSION: These data may aid in the design of risk-prevention strategies to be used by otorhinolaryngologists.