Improving health system responses when patients are harmed: a protocol for a multistage mixed-methods study.

INTRODUCTION: At least 10% of hospital admissions in high-income countries, including Australia, are associated with patient safety incidents, which contribute to patient harm ('adverse events'). When a patient is seriously harmed, an investigation or review is undertaken to reduce the risk of further incidents occurring. Despite 20 years of investigations into adverse events in healthcare, few evaluations provide evidence of their quality and effectiveness in reducing preventable harm.This study aims to develop consistent, informed and robust best practice guidance, at state and national levels, that will improve the response, learning and health system improvements arising from adverse events. METHODS AND ANALYSIS: The setting will be healthcare organisations in Australian public health systems in the states of New South Wales, Queensland, Victoria and the Australian Capital Territory. We will apply a multistage mixed-methods research design with evaluation and in-situ feasibility testing. This will include literature reviews (stage 1), an assessment of the quality of 300 adverse event investigation reports from participating hospitals (stage 2), and a policy/procedure document review from participating hospitals (stage 3) as well as focus groups and interviews on perspectives and experiences of investigations with healthcare staff and consumers (stage 4). After triangulating results from stages 1-4, we will then codesign tools and guidance for the conduct of investigations with staff and consumers (stage 5) and conduct feasibility testing on the guidance (stage 6). Participants will include healthcare safety systems policymakers and staff (n=120-255) who commission, undertake or review investigations and consumers (n=20-32) who have been impacted by adverse events. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Northern Sydney Local Health District Human Research Ethics Committee (2023/ETH02007 and 2023/ETH02341).The research findings will be incorporated into best practice guidance, published in international and national journals and disseminated through conferences.

Detecting Algorithmic Errors and Patient Harms for AI-Enabled Medical Devices in Randomized Controlled Trials: Protocol for a Systematic Review.

BACKGROUND: Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report. OBJECTIVE: This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes. METHODS: This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate. RESULTS: The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024. CONCLUSIONS: Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance. TRIAL REGISTRATION: PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51614.

Development of the Harm Prevention Partners Clinical Model: An Academic-Practice Partnership for Prevention of Patient Harm Events.

This innovative academic-practice partnership applied user-centered design, resulting in a new clinical model, the "Harm Prevention Partners Program." The model engaged students working as teams with faculty to intervene on nurse-sensitive indicators by documenting care on a novel smartphone tool and generating an intervention dashboard to visualize impact. Faculty utilized the dashboard to guide postclinical debriefing and highlight students' impact on patient outcomes.

Real or fake? Sourcing and marketing of non-prescribed benzodiazepines amongst two samples of people who regularly use illicit drugs in Australia.

INTRODUCTION: There is concern around non-prescribed benzodiazepine use, particularly with increasing detections of counterfeit products containing high-risk novel compounds. The aims of this study were to investigate how and which non-prescribed benzodiazepines are being sourced; forms, appearance and packaging; and awareness of risks associated with non-prescribed benzodiazepines. METHODS: Data were collected from a sample of Australians who inject drugs or use ecstasy and/or other illicit stimulants on a monthly or more frequent basis, and who reported past 6-month use of non-prescribed benzodiazepines (n = 235 and n = 250, respectively). Data were collected on source, diversion from a known/trusted prescription, product name and aesthetic characteristics for the last non-prescribed benzodiazepine obtained. RESULTS: Amongst participants who injected drugs, 71% reported that their last non-prescribed benzodiazepines were diverted from a known/trusted prescription, compared to 59% of participants who used ecstasy/other stimulants. Sourcing via cryptomarkets was rare. Across both samples, the majority reported last obtaining substances sold/marketed as diazepam or alprazolam. Participants sourcing via non-diverted means were twice as likely to obtain alprazolam. Known sourcing of novel compounds was rare. Amongst participants who used ecstasy/other stimulants, 36% reported confidence in the content/dose of non-prescribed benzodiazepines even when the source is unknown. DISCUSSION AND CONCLUSIONS: Most participants obtained substances sold as classic/registered benzodiazepines, mostly via diverted prescriptions, with a substantial minority potentially unaware of counterfeits circulating. While diverted use undeniably presents risks, tightening of prescriptions in Australia could inadvertently lead to greater supply of novel benzodiazepines as seen internationally, reinforcing prioritisation of demand and harm reduction strategies.

The Safety of Inpatient Health Care.

BACKGROUND: Adverse events during hospitalization are a major cause of patient harm, as documented in the 1991 Harvard Medical Practice Study. Patient safety has changed substantially in the decades since that study was conducted, and a more current assessment of harm during hospitalization is warranted. METHODS: We conducted a retrospective cohort study to assess the frequency, preventability, and severity of patient harm in a random sample of admissions from 11 Massachusetts hospitals during the 2018 calendar year. The occurrence of adverse events was assessed with the use of a trigger method (identification of information in a medical record that was previously shown to be associated with adverse events) and from review of medical records. Trained nurses reviewed records and identified admissions with possible adverse events that were then adjudicated by physicians, who confirmed the presence and characteristics of the adverse events. RESULTS: In a random sample of 2809 admissions, we identified at least one adverse event in 23.6%. Among 978 adverse events, 222 (22.7%) were judged to be preventable and 316 (32.3%) had a severity level of serious (i.e., caused harm that resulted in substantial intervention or prolonged recovery) or higher. A preventable adverse event occurred in 191 (6.8%) of all admissions, and a preventable adverse event with a severity level of serious or higher occurred in 29 (1.0%). There were seven deaths, one of which was deemed to be preventable. Adverse drug events were the most common adverse events (accounting for 39.0% of all events), followed by surgical or other procedural events (30.4%), patient-care events (which were defined as events associated with nursing care, including falls and pressure ulcers) (15.0%), and health care-associated infections (11.9%). CONCLUSIONS: Adverse events were identified in nearly one in four admissions, and approximately one fourth of the events were preventable. These findings underscore the importance of patient safety and the need for continuing improvement. (Funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.).

Medical Student Elective to Improve Diagnosis in Health Care: Developing Solutions to Reduce Patient Harm.

RATIONALE AND OBJECTIVES: At our institution, a new medical student elective was designed and implemented by the department of radiology to teach medical students about diagnostic error. The purpose of this article is to describe the diagnostic error elective structure and implementation, present objective and subjective evaluations of the elective, and provide a model for other radiology departments to run their own electives. MATERIALS AND METHODS: Starting in January 2018, a 2-week in-person career exploration session elective was offered for third year medical students. In 2020 due to the COVID pandemic, the elective was expanded to fourth year medical students. All students were required to complete a project that addressed diagnostic error. Subjective comments were recorded, and objective measurements obtained from student evaluations. RESULTS: A total of 11 sessions were held, consisting of 3 fourth year and 26 third year students. A total of 12 projects (11 groups) were completed, seven of which have been accepted for presentation at national meetings. On a 1 to 5 scale (5 highest), students rated their educational experience at a mean score of 4.61. Subjective comments focused on the benefit of exposure to new topics, mentorship by radiologists, and ability to complete a project in such a short time. CONCLUSION: Diagnostic errors and solutions are vague, new concepts to medical students and even facilitator faculty. This course allowed students to gain awareness of diagnostic error and could easily be replicated at other institutions with interested faculty and medical school support.

Core Competency Self-Assessment Enhances Critical Review of Complications and Entrustable Activities.

BACKGROUND: The Accreditation Council for Graduate Medical Education has defined six core competencies (CCs) that every successful physician should possess. However, the assessment of CC achievement among trainees is difficult. This project was designed to prospectively evaluate the impact of resident identification of CC as a component of morbidity review on error identification and standard of care (SOC) assessments. The platform was assessed for its reliability as a measure of resident critical analysis of complication causality across postgraduate year (PGY). MATERIALS AND METHODS: A total of 1945 general surgery cases with complications were assessed for error identification and SOC management between January 1, 2016, and December 31, 2018. CC identification was additionally assessed between January 1, 2019, and December 31, 2019, and included 708 general surgery cases. Data were evaluated for error assessments and overall SOC management. PGY4 and 5 residents were compared for number of cases and complications reviewed, severity, error causation, and CC relevance. RESULTS: Study groups were equivalent by Clavien-Dindo scores. Error identification significantly increased in all categories: diagnostic (P < 0.001), technical (P < 0.05), judgment (P < 0.001), system (P < 0.001), and communication (P < 0.001). Overall SOC assessments validated by a supervising surgical quality officer were unchanged. An increased exposure to cases with severe complications, error causation, and CC relevance was noted across PGY. CONCLUSIONS: The addition of CC assessment into morbidity review appears to improve the critical thinking of evaluating residents by increasing the identification of management errors. Used as an element of prospective self-assessment, teaching residents to identify CC principles in cases with complications may assist in learner progression toward clinical competence and critical thinking.

Control de daños ortopédicos en pacientes politraumatizados pediátricos. Hospital Pediátrico "Eliseo Noel Caamaño" / Control of orthopedic damages in pediatric politraumatized patients. Pediatric Hospital "Eliseo Noel Caamaño"

RESUMEN Introducción: el control de daños en Ortopedia es aplazar la reparación definitiva de lesiones traumáticas, con el objetivo de la recuperación fisiológica deteriorada por lesiones y/o complicaciones que pueden poner en peligro la vida, realizando entonces procedimientos quirúrgicos sencillos, como una estabilización quirúrgica externa de las fracturas. Objetivo: determinar el comportamiento del control de daños ortopédicos en politraumatizados pediátricos. Materiales y método: se realizó un estudio observacional, descriptivo, prospectivo, de corte transversal, de enero del 2015 a diciembre del 2018. El universo estuvo constituido por 22 pacientes menores de 19 años de edad, politraumatizados en el período; la muestra por 15 pacientes, a los que se les aplicó control de daños ortopédicos, según criterios de selección. Resultados: se aplicó control de daños ortopédicos a 15 infantes. El más afectado fue el sexo masculino con el 73,3 %. Prevalecieron los traumatismos de los miembros inferiores con el 58,3 % y las fracturas cerradas con un 53,8 %. La osteomielitis crónica fue la complicación que predominó, en el 20 % de la muestra. En el 73,3 % de los casos se evaluó como satisfactoria la aplicación del control de daños ortopédicos en los politraumatizados. Conclusiones: a la totalidad de los traumatizados se le aplicó control de daños ortopédicos. Predominó el sexo masculino y el grupo de edad de 9 -14 años. Los miembros inferiores aportan la mayor cantidad con el fémur y la tibia. El control de daños ortopédicos se evaluó satisfactoriamente en la mayoría de los pacientes estudiados (AU).

ABSTRAC Introduction: the control of damages in Orthopedics is to postpone the definitive repair of traumatic lesions, with the objective of the physiologic recovery deteriorated by lesions and/or complications that can put in danger the life, carrying out simple surgical procedures, like an external surgical stabilization of the fractures at that time. . Objective: to determine the behavior of the orthopedic damage control in pediatric politraumatized patients. Material and method: a cross-sectional, prospective, descriptive, observational study was carried out from January 2015 to December 2018. The universe was formed by 22 patients younger than 19 years politraumatized in the period and the sample formed 15 patients; they underwent orthopedic damage control, according to the selection criteria. Results: the orthopedic damage control, was applied to 15 children. Male sex was the most affected one. Trauma in the lower limbs with 58.3 % and closed fractures with 53.8 prevailed. The predominating complication was chronic poliomyelitis in 20 % of the sample. The orthopedic damage control in politraumatized patients was assessed as successful in 73.3 % of the cases. Conclusions: the orthopedic damage control was applied to the total of traumatized patients. The male sex and the 9-14 years-old age group predominated. Lower limbs contributed with the biggest quantity of trauma, in femur and tibia. The orthopedic damage control was assessed as successful in most of studied patients (AU).

Os pais como pilares para a segurança do paciente em unidade neonatal / Parents as pillars for patient safety in a neonatal unit / Padres como pilares para la seguridad del paciente em una unidad neonatal

Objetivo: conhecer a experiência dos pais como estratégia de avaliação da qualidade da assistência de enfermagem. Método: pesquisa descritiva com abordagem qualitativa, desenvolvida na Unidade Neonatal de um Hospital do sul do Brasil. A coleta de dados foi realizada através de entrevistas, utilizando a técnica do incidente crítico (TIC), com 18 pais que estavam com seus filhos internados por 20 dias ou mais e que tinham previsão e plano de alta hospitalar. Após, os dados foram submetidos à análise de conteúdo. Resultados: a análise revelou fragilidades no cuidado prestado pela equipe de enfermagem em relação à administração de medicamentos, ao uso de equipamentos, à monitorização e ao posicionamento dos bebês, aos cuidados com a pele e à higiene de mãos. Conclusão: a experiência dos pais revelou elementos que integram a avaliação da assistência em enfermagem, destacando-os como pilares para a segurança do paciente.

Objective: to learn the parents' experience as a strategy for assessing the quality of nursing care. Method: in this qualitative, descriptive study at the Neonatal Unit of a hospital in southern Brazil, data were collected by critical incident (CI) interviews of 18 parents whose children had been hospitalized for 20 days or more, and whose discharge was scheduled and planned for. The data subsequently underwent content analysis. Results: data analysis revealed weaknesses in the care provided by the nursing staff as regards administration of medication, use of equipment, monitoring and positioning of babies, skin care and hand hygiene. Conclusion: The parents' experience revealed elements that enter into evaluation of nursing care, revealing parents to be mainstays of patient safety.

Objetivo: conocer la experiencia de los padres como estrategia para evaluar la calidad de la atención de enfermería. Método: en este estudio cualitativo y descriptivo en la Unidad Neonatal de un hospital en el sur de Brasil, los datos fueron recolectados por entrevistas de incidentes críticos (IC) de 18 padres cuyos hijos habían estado hospitalizados durante 20 días o más, y cuyo alta fue programada y planificada para. Los datos posteriormente se sometieron a análisis de contenido. Resultados: el análisis de datos reveló debilidades en la atención brindada por el personal de enfermería en lo que respecta a la administración de medicamentos, uso de equipos, monitoreo y posicionamiento de bebés, cuidado de la piel e higiene de manos. Conclusión: la experiencia de los padres reveló elementos que entran en la evaluación de la atención de enfermería, revelando que los padres son pilares de la seguridad del paciente.

Análisis de la cultura de seguridad del paciente en un hospital universitario / Analysis of the patient safety culture in a university hospital

OBJETIVO: 1) Determinar la percepción de seguridad que tienen los/las profesionales sanitarios/as y no sanitarios/as en un hospital universitario; 2) describir el clima de seguridad con sus fortalezas y debilidades; y 3) evaluar las dimensiones valoradas negativamente y establecer áreas de mejoras. MÉTODO: Estudio transversal y descriptivo realizado en el Hospital Universitario San Juan de Alicante en el que se recogen los resultados de la valoración del nivel de cultura de seguridad utilizando como instrumento de medición la encuesta Hospital Survey on Patient Safety Culture de la Agency for Healthcare Research and Quality adaptada al español. RESULTADOS: La tasa de respuesta fue del 35,36%. El colectivo con mayor participación fue el médico (32,3%), y el servicio más implicado, el de urgencias (9%). El 86,4% tuvo contacto con el paciente. El 50% de los/las trabajadores/as calificó el clima de seguridad entre 6 y 8 puntos. El 82,8% no notificó ningún evento adverso en el último año. Los profesionales con mayor cultura de seguridad fueron los farmacéuticos, y los que tuvieron peor cultura, los celadores. No se identificó ninguna fortaleza de manera global. Hubo dos dimensiones que se comportaron como una debilidad: la 9 (dotación de personal) y la 10 (apoyo de la gerencia a la seguridad del paciente). CONCLUSIONES: La percepción sobre seguridad del paciente es buena, aunque mejorable. No se han identificado fortalezas. Las debilidades identificadas son dotación de personal, apoyo de la gerencia a la seguridad del paciente, cambios de turno y transición entre servicios, y percepción de seguridad

OBJECTIVE: 1) To determine the perception of safety of health professionals and non-health professionals in a university hospital; 2) describe the climate of safety with its strengths and weaknesses; 3) evaluate the negatively valued dimensions and establish areas of improvement. METHOD: A cross-sectional and descriptive study carried out at the San Juan University Hospital in Alicante, where the results of the assessment of the safety culture level are collected using Hospital Survey On Patient Safety survey of the Agency for Healthcare Research and Quality adapted to Spanish language. RESULTS: The response rate was 35.36%. The group with the greatest participation was the physician (32.3%) and the service most involved, urgencies (9%). 86.4% had contact with the patient. 50% of workers rated the safety climate between 6 and 8 points. 82.8% did not report any adverse events in the last year. The professionals with the greatest security culture were the pharmacists and with the worst culture, the guards. No strength was identified globally. There were two dimensions that behaved like a weakness: 9 (staffing) and 10 (management support for patient safety). CONCLUSIONS: The patient's perception of safety is good, although it can be improved. No strengths have been identified. The weaknesses identified are staffing, management support for patient safety, handoffs and transitions, and safety perception

La seguridad de las cosas sencillas / The security of simple things

No disponible

Testing a Model of Speaking up in Nursing.

BACKGROUND: Speaking up is using one's voice to alert those in authority of concerns. Failure to speak up leads to moral distress; speaking up leads to moral courage. OBJECTIVE: The purpose of this study was to explore the influences of organizational culture, personal culture, and workforce generation on speaking-up behaviors among RNs. METHODS: We distributed a cross-sectional electronic survey to several thousand RNs, resulting in 303 usable surveys. RESULTS: Organizational culture was a strong predictor of speaking-up behaviors; speaking up partially mediated the relationship between organizational culture and moral distress but was not a mediator between organizational culture and moral courage. Workforce generation did not explain speaking up. CONCLUSIONS: The role of organizational culture supports efforts toward healthy work environments. Because not speaking up is related to moral distress, efforts must be escalated to empower nurses to use their voices.

Patient-related factors associated with an increased risk of being a reported case of preventable harm in first-line health care: a case-control study.

BACKGROUND: Patient safety issues in primary health care and in emergency departments have not been as thoroughly explored as patient safety issues in the hospital setting. Knowledge is particularly sparse regarding which patients have a higher risk of harm in these settings. The objective was to evaluate which patient-related factors were associated with risk of harm in patients with reports of safety incidents. METHODS: A case-control study performed in primary health care and emergency departments in Sweden. In total, 4536 patients (cases) and 44,949 controls were included in this study. Cases included patients with reported preventable harm in primary health care and emergency departments from January 1st, 2011 until December 31st, 2016. RESULTS: Psychiatric disease, including all psychiatric diagnoses regardless of severity, nearly doubled the risk of being a reported case of preventable harm (odds ratio, 1.96; p < 0.001). Adjusted for income and education there was still an increased risk (odds ratio, 1.69; p < 0.001). The preventable harm in this group was to 46% diagnostic errors of somatic disease. CONCLUSION: Patients with psychiatric illness are at higher risk of preventable harm in primary care and the emergency department. Therefore, this group needs extra attention to prevent harm.