How current law and policy supports providers of NHS healthcare in England to respond to patient harm: A scoping review protocol.

INTRODUCTION: Harm arising from National Health Service (NHS) healthcare results in significant human cost for the patient, those who care for them, and the medical staff involved. Furthermore, patient harm results in substantial financial costs to the public purse. Improving how NHS providers in England respond to patient harm could reduce the number of claims for clinical negligence brought against NHS. Doing so will ensure those affected receive the justice they deserve and protect the public purse. Law and policy are key to supporting providers of NHS healthcare to respond to patient harm but are not necessarily understood and therefore can be challenging to apply to practice. Research exploring how law and policy supports this understanding is limited. The purpose of this scoping review is to address this knowledge gap and improve understanding by critically evaluating how law and policy supports providers of NHS healthcare in England to respond to patient harm. METHODS AND ANALYSIS: The review will use the methodological framework proposed by Arskey and O'Malley, Levac et al and the Joanna Briggs Institute. Search strategies will be developed using selected key words and index terms. MEDLINE, CINAHL, and Westlaw and reference lists of relevant publications will be searched to identify relevant grey literature. Two reviewers will independently assess the extracted data against the eligibility criteria. All studies identified will be charted and the results presented as a narrative synthesis.

Evaluation of Smart Pump Interoperability with an Electronic Medical Record System to Improve Infusion Safety.

Medications administered via intravenous (IV) infusions have high potential for patient harm. Evaluation of the rate of variances between the medication order on the Electronic Medical Record (EMR) and IV infusion details in the smart pump was performed pre and post- implementation of smart pump and EMR interoperability. Introduction of smart pumps with EMR interoperability resulted in a statistically significant reduction in frequency of variances.

Citing Harms, Momentum Grows to Remove Race From Clinical Algorithms.

This Medical News article discusses efforts to evaluate the inclusion of race as a factor in widely used clinical decision-making algorithms.

Gaming Disorder em Minorias Sexuais e de Gênero / Gaming Disorder in sexual and gender minorities / Trastorno de juego en minorías sexuales y de género

ntrodução: Os jogos eletrônicos são agora reconhecidos como um problema de saúde mental, especialmente entre a comunidade LGBTQIA+. Objetivo: explorar os efeitos do transtorno de jogo (gaming disorder) na população LGBTQIA+. Método: A revisão narrativa abordou hábitos de jogo e gaming disorder em minorias sexuais e de gênero, usando PubMed, Google Scholar, Embase e Web of Science. Das 1640 pesquisas, apenas 3 abordaram gaming disorder nessa população. Resultado: consumidores LGBTQ+ gastam mais em jogos digitais. Jogadores LGBTQIA+ consomem mais jogos de exploração de identidade, possivelmente relacionados ao estresse de minoria. Discussão: minorias sexuais têm maior risco de gaming disorder. Para indivíduos LGBTQIA+, os jogos podem servir como escape e plataforma de apoio, mas o uso problemático pode estar associado a desfechos psiquiátricos negativos. Conclusão: Os jogos online têm o potencial de serem ferramentas de apoio para minorias, no entanto, as evidências são limitadas. É necessária mais pesquisa para compreender melhor a relação entre o uso de jogos e a saúde mental da população LGBTQIA+.

ntroduction: Electronic games are now recognized as a mental health issue, especially within the LGBTQIA+ community. Objective: To explore the effects of gaming disorder in the LGBTQIA+ population. Method: The narrative review addressed gaming habits and gaming disorder in sexual and gender minorities, utilizing PubMed, Google Scholar, Embase, and Web of Science. Out of 1640 studies, only 3 focused on gaming disorder in this population. Result: LGBTQ+ consumers spend more on digital games. LGBTQIA+ players engage more in identity exploration games, possibly linked to minority stress. Discussion: Sexual minorities face a higher risk of gaming disorder. For LGBTQIA+ individuals, games can serve as an escape and support platform, but problematic use may be associated with negative psychiatric outcomes. Conclusion: Online games have the potential as support tools for minorities, but evidence is limited. Further research is needed to better understand the relationship between game use and mental health in the LGBTQIA+ population.

Introducción: Los videojuegos electrónicos son reconocidos actualmente como un problema de salud mental, especialmente dentro de la comunidad LGBTQIA+. Objetivo: Explorar los efectos del trastorno de juego (gaming disorder) en la población LGBTQIA+. Método: La revisión narrativa abordó los hábitos de juego y el gaming disorder en minorías sexuales y de género, utilizando PubMed, Google Scholar, Embase y Web of Science. De las 1640 investigaciones, solo 3 se centraron en el gaming disorder en esta población. Resultado: Los consumidores LGBTQ+ gastan más en juegos digitales. Los jugadores LGBTQIA+ consumen más juegos de exploración de identidad, posiblemente relacionados con el estrés de minoría. Discusión: Las minorías sexuales enfrentan un mayor riesgo de gaming disorder. Para los individuos LGBTQIA+, los juegos pueden servir como un escape y plataforma de apoyo, pero el uso problemático puede estar asociado con resultados psiquiátricos negativos. Conclusión: Los juegos en línea tienen el potencial como herramientas de apoyo para las minorías, pero la evidencia es limitada. Se requiere más investigación para comprender mejor la relación entre el uso de juegos y la salud mental en la población LGBTQIA+.

Uncovering the Risks of Anticancer Therapy Through Incident Report Analysis Using a Newly Developed Medical Oncology Incident Taxonomy.

BACKGROUND: Incident reporting systems were developed to identify possible and actual harm in healthcare facilities. They have the potential to capture important safety trends and to enable improvements that can mitigate the risk of future patient harm and suffering. We recently developed and validated a taxonomy specific for medical oncology designed to enhance the identification, tracking, and trending of incidents that may lead to patient harm. The current project was designed to test the ability of such a taxonomy to be applied across different organizations delivering medical oncology care and to identify specific risks that could result in future harm. METHODS: We analyzed 309 randomly selected medical oncology-related incident reports from 3 different cancer centers that had been posted between January 2019 and December 2020. Each report was assigned up to 2 incident categories. We used a 2-step process to reconcile reviewer discrepancies. In a secondary analysis, each of the incidents was reviewed and recoded to identify events which may result in major or catastrophic harm. RESULTS: Three hundred four incidents met criteria for inclusion. Three hundred incidents (98.7%) were successfully coded. Sixty-seven percent of incidents were encompassed by the following 4 of 21 categories: prescriber ordering (22%), nursing care (15%), pharmacy (14%), and relational/communication issues (15%). Of 297 evaluable incidents, 47% did not reach the patient, 44.7% reached the patient without harm, 7.7% caused minor injury, and 0.7% caused severe injury or death. Submission rates by physicians varied between the 3 sites accounting for 1.7%, 10.7%, and 16.1% of reports. Secondary analysis identified 9 distinct scenarios that may result in major or catastrophic patient harm. CONCLUSIONS: A medical oncology-specific incident reporting taxonomy has the potential to increase our understanding of inherent risks and may lead to process improvements that improve patient safety.

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model.

BACKGROUND: In the United States, osteopathic manipulative treatment (OMT), is a popular complementary physical health approach for the treatment of neuromusculoskeletal disorders. However, post-OMT adverse events (AEs) are poorly defined in terms of frequency, severity, and temporal evolution. To date, no benchmark for patient safety exists. To improve understanding in this field, we set out to model the landscape of patient harm after OMT. METHODS: We conducted a comprehensive search of all available primary clinical research studies reporting on the occurrence of post-OMT AEs in nonpregnant, adult outpatients treated by an osteopathic physician in the United States. The methodology of eligible studies was then reviewed to select those containing the minimum required dataset to model the post-OMT AEs. The minimum required dataset consisted of four model parameters: 'post-OMT interval', 'OMT encounters with post-OMT interval assessment', 'AEs preceded by an OMT encounter', and 'AE severity.' We used the dataset extracted from selected studies to calculate a patient safety benchmark defined as the incidence rate of AEs per 100 post-OMT interval-days. RESULTS: From 212 manuscripts that we identified, 118 primary clinical research studies were assessed for eligibility. A total of 23 studies met inclusion criteria for methodological review, of which 13 studies passed and were selected for modeling. Mild AEs were the most frequent, accounting for n = 161/165 (98%) of total AEs observed in the literature. The cumulative incidence of mild AEs was also significantly greater (P = 0.01) than both moderate and severe grades. The benchmark incidence rate was 1.0 AEs per 100 post-OMT interval-days. CONCLUSIONS: The majority of post-OMT AEs observed in the primary clinical literature were of mild severity. Modeling of the combined dataset on post-OMT AEs allowed for the derivation of a patient safety benchmark that, to date, has not been established in the field of osteopathic manipulative medicine. Additional research is needed to improve model resolution during the post-OMT period. This work conceptualized a model for identifying and grading post-OMT AEs, which should facilitate future comparisons between institutions in order to continually improve patient safety standards in the field of osteopathic manipulative medicine.

Diagnostic Errors: A Stronger Role for Nursing Could Help Reduce Patient Harm.

Institutional support and better nurse training are key.

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.

Preventing Potential Patient Harm Through Clinical Content Interventions During Oncology Clinical Trial Implementation.

OBJECTIVES: Clinical trial documents are complex and may have inconsistencies, leading to potential site implementation errors and may compromise participant safety. This study characterizes the frequency and type of administrative and potential patient safety interventions (PPSIs) made during the review of oncology trial documents for clinical trial implementation by centralized clinical content specialists. METHODS: A dedicated group of centralized clinical content specialists reviewed trial documents, including the protocol, laboratory manual, and pharmacy/cellular therapy manual, and collected intervention data over a 1-year period. Each trial was categorized by study phase and sponsor type, and multiple interventions could be identified per trial. Interventions were deemed administrative or PPSIs, with PPSIs further subcategorized as medication, laboratory, procedure related, or other. RESULTS: Of 585 clinical trials reviewed, 269 (46%) required intervention(s). Among 1001 interventions, 171 (17.1%) were PPSIs. Most PPSIs were medication related (45.6%), with drug dosing interventions most frequently identified (53.8%). Phase 1 trials had the highest proportion of PPSIs (0.35:1) and administrative interventions (2:1) per trial compared with all other phases. Investigator-initiated trials saw the highest proportion of PPSIs per trial (0.44:1) of all sponsor types. CONCLUSIONS: This study demonstrates a gap in patient safety when assessing trial documents for clinical trial implementation. One solution to address this gap is the utilization of a centralized team of clinical specialists to preemptively review trial documents, thereby enhancing patient safety during clinical trial conduct.

Identifying the patient harms to include in an in silico clinical trial.

BACKGROUND AND OBJECTIVE: Clinical trials represent a crucial step in the development and approval of medical devices. These trials involve evaluating the safety and efficacy of the device in a controlled setting with human subjects. However, traditional clinical trials can be expensive, time-consuming, and ethically challenging. Augmenting clinical trials with data from computer simulations, so called in silico clinical trials (ISCT), has the potential to address these challenges while satisfying regulatory requirements. However, determination of the patient harms in scope of an ISCT is necessary to ensure all harms are sufficiently addressed while maximizing the utility of the ISCT. This topic is currently lacking guidance. The objective of this work is to propose a general method to determine which patient harms should be included in an ISCT for a regulatory submission. METHODS: The proposed method considers the risk associated with the harm, the impact of the device on the likelihood of occurrence of the harm and the technical feasibility of evaluating the harm via ISCT. Consideration of the risk associated with the harm provides maximum clinical impact of the ISCT, in terms of focusing on those failure modes which are most relevant to the patient population. Consideration of the impact of the device on a particular harm, and the technical feasibility of modeling a particular harm supports that the technical effort is devoted to a problem that (1) is relevant to the device in question, and (2) can be solved with contemporary modeling techniques. RESULTS AND CONCLUSIONS: As a case study, the proposed method is applied to a total shoulder replacement humeral system. With this framework, it is hoped that a consistent approach to scoping an ISCT can be adopted, supporting investment in ISCT by the industry, enabling consistent review of the ISCT approach across device disciplines by regulators, and providing maximum impact of modeling technologies in support of devices to improve patient outcomes.

Contributory factors and patient harm including deaths associated direct acting oral anticoagulants (DOACs) medication incidents: evaluation of real world data reported to the National Reporting and Learning System.

INTRODUCTION: Direct oral anticoagulants (DOACs) are considered high risk medicines and are frequently associated with medication errors. The nature of incidents and associated outcomes of such incidents are poorly understood. AREAS COVERED: Using a national patient safety reporting database, the National Reporting and Learning System (NRLS), this study aimed to report the contributory factors and outcomes including severe harm and deaths related to all safety incidents involving DOACs reported in England and Wales between 2017-2019. Reason's accident causation model was used to classify the incidents. EXPERT OPINION: A total of 15,730 incident reports were analyzed. A total of 25 deaths were reported with a further 270 and 55 incidents leading to moderate and severe harm, respectively. A further 8.8% (n = 1381) of incidents were associated with low degree of harm. The majority of the incidents involved active failures (n = 13776; 87.58) including duplication of anticoagulant therapies, patients being discharged without DOACs, non-consideration of renal function, and lack of commencement of DOACs post-surgery suggesting preventability of such reported incidents. This study shows that medication incidents involving DOACs have the potential to cause severe harm and deaths, and there is a need to promote guideline adherence through education, training, and decision support technologies.

Eventos adversos na atençãoprimária à saúde / Adverse events in primary health care / Eventos adversos en la atención primaria a la salud

Objetivo: Identificar na literatura os principais fatores contribuintes para ocorrência de Eventos Adversos na Atenção Primária à Saúde. Métodos: Trata-se de uma revisão integrativa. A partir da formação da questão norteadora, foi realizada uma pesquisa nas bases de dados: MEDLINE, PubMed, BDENF, SciELO e LILACS. Ao final, foram incluídos 15 artigos. Resultados: 7 dos artigos traziam fatores ligados a medicação como principal, 3 traziam prática e procedimentos, 2 organização e gestão, 1 comunicação e 2 outros fatores. Conclusão: Percebeu-se que erros relacionados a medicação e diagnóstico são os mais comuns nas instâncias de saúde. A falha na comunicação entre funcionários e entre os serviços de saúde, além de fatores organizacionais e diagnósticos tardios também foram apontadas, sendo boa parte, evitável. A subnotificação foi comumente relatada nos artigos, revelando que os dados existentes possam não estar condizentes com a realidade. (AU)

Objective: To identify in the literature the main contributing factors for the occurrence of Adverse Events in Primary Health Care. Methods: This is an integrative review. Based on the formation of the guiding question, a research was carried out in the databases: MEDLINE, PubMed, BDENF, SciELO and LILACS. At the end, 15 articles were included. Results: 7 of the articles included factors related to medication as main, 3 had practice and procedures, 2 organization and management, 1 communication and 2 other factors. Conclusion: Errors related to medication and diagnosis are the most common in health instances. The failure to communicate between employees and between health services, in addition to organizational factors and late diagnoses were also pointed out, being mostly avoidable. Underreporting was commonly reported in the articles, revealing that existing data may not be consistent with reality. (AU)

Objetivo: Identificar en la literatura los principales factores contribuyentes para la ocurrencia de Eventos Adversos en la Atención Primaria a la Salud. Métodos: Se trata de una revisión integrativa. A partir de la formación de la cuestión orientadora, se realizó una investigación en las bases de datos: MEDLINE, PubMed, BDENF, SciELO y LILACS. Al final, se incluyeron 15 artículos. Resultados: 7 de los artículos traían factores ligados à la medicación como principal, 3 traían práctica y procedimientos, 2 orgnización y gestión, 1 comunicación y 2 otros factores. Conclusión: Se dio cuenta que errores relacionados con la medicación y el diagnóstico son los más comunes en las instancias de salud. La falla en la comunicación entre funcionarios y entre los servicios de salud, además de factores organizacionales y diagnósticos tardío también fueron señalados, siendo buena parte, evitable. La subnotificación fue comúnmente relatada en los artículos, revelando que los datos existentes pueden no estar en concordancia con la realidad. (AU)

Factors influencing in-hospital prescribing errors: A systematic review.

AIM: In-hospital prescribing errors (PEs) may result in patient harm, prolonged hospitalization and hospital (re)admission. These events are associated with pressure on healthcare services and significant healthcare costs. To develop targeted interventions to prevent or reduce in-hospital PEs, identification and understanding of facilitating and protective factors influencing in-hospital PEs in current daily practice is necessary, adopting a Safety-II perspective. The aim of this systematic review was to create an overview of all factors reported in the literature, both protective and facilitating, as influencing in-hospital PEs. METHODS: PubMed, EMBASE.com and the Cochrane Library (via Wiley) were searched, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement, for studies that identified factors influencing in-hospital PEs. Both qualitative and quantitative study designs were included. RESULTS: Overall, 19 articles (6 qualitative and 13 quantitative studies) were included and 40 unique factors influencing in-hospital PEs were identified. These factors were categorized into five domains according to the Eindhoven classification ('organization-related', 'prescriber-related', 'prescription-related', 'technology-related' and 'unclassified') and visualized in an Ishikawa (Fishbone) diagram. Most of the identified factors (87.5%; n = 40) facilitated in-hospital PEs. The most frequently identified facilitating factor (39.6%; n = 19) was 'insufficient (drug) knowledge, prescribing skills and/or experience of prescribers'. CONCLUSION: The findings of this review could be used to identify points of engagement for future intervention studies and help hospitals determine how to optimize prescribing. A multifaceted intervention, targeting multiple factors might help to circumvent the complex challenge of in-hospital PEs.

Automated Detection of Patient Harm: Implementation and Prospective Evaluation of a Real-Time Broad-Spectrum Surveillance Application in a Hospital With Limited Resources.

OBJECTIVES: This study aimed to prospectively validate an application that automates the detection of broad categories of hospital adverse events (AEs) extracted from a basic hospital information system, and to efficiently mobilize resources to reduce the level of acquired patient harm. METHODS: Data were collected from an internally designed software, extracting results from 14 triggers indicative of patient harm, querying clinical and administrative databases including all inpatient admissions (n = 8760) from October 2019 to June 2020. Representative samples of the triggered cases were clinically validated using chart review by a consensus expert panel. The positive predictive value (PPV) of each trigger was evaluated, and the detection sensitivity of the surveillance system was estimated relative to incidence ranges in the literature. RESULTS: The system identified 394 AEs among 946 triggered cases, associated with 291 patients, yielding an overall PPV of 42%. Variability was observed among the trigger PPVs and among the estimated detection sensitivities across the harm categories, the highest being for the healthcare-associated infections. The median length of stay of patients with an AE showed to be significantly higher than the median for the overall patient population. CONCLUSIONS: This application was able to identify AEs across a broad spectrum of harm categories, in a real-time manner, while reducing the use of resources required by other harm detection methods. Such a system could serve as a promising patient safety tool for AE surveillance, allowing for timely, targeted, and resource-efficient interventions, even for hospitals with limited resources.

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.).