Lessons learnt on patient safety in dentistry through a 5-year nationwide database study on iatrogenic harm.

Safe delivery of care is a priority in dentistry, while basic epidemiological knowledge of patient safety incidents is still lacking. The objectives of this study were to (1) classify patient safety incidents related to primary dental care in Denmark in the period 2016-2020 and study the distribution of different types of dental treatment categories where harm occurred, (2) clarify treatment categories leading to "nerve injury" and "tooth loss" and (3) assess the financial cost of patient-harm claims. Data from the Danish Dental Compensation Act (DDCA) database was retrieved from all filed cases from 1st January 2016 until 31st December 2020 pertaining to: (1) The reason why the patient applied for treatment-related harm compensation, (2) the event that led to the alleged harm (treatment category), (3) the type of patient-harm, and (4) the financial cost of all harm compensations. A total of 9069 claims were retrieved, of which 5079 (56%) were found eligible for compensation. The three most frequent categories leading to compensation were "Root canal treatment and post preparation"(n = 2461, 48% of all approved claims), "lack of timely diagnosis and initiation of treatment" (n = 905, 18%) and "surgery" (n = 878, 17%). Damage to the root of the tooth accounted for more than half of all approved claims (54.36%), which was most frequently a result of either parietal perforation during endodontic treatment (18.54%) or instrument fracture (18.89%). Nerve injury accounted for 16.81% of the approved claims. Total cost of all compensation payments was €16,309,310, 41.1% of which was related to surgery (€6,707,430) and 20.4% (€3,322,927) to endodontic treatment. This comprehensive analysis documents that harm permeates all aspects of dentistry, especially in endodontics and surgery. Neglect or diagnostic delays contribute to 18% of claims, indicating that harm does not solely result from direct treatment. Treatment harm inflicts considerable societal costs.

Drug-Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation.

INTRODUCTION: Drug-drug interactions (DDIs) have potential to cause patient harm, including lowering therapeutic efficacy. This study aimed to (i) determine the prevalence of potential DDIs (pDDIs); clinically relevant DDIs (cDDIs), that is, DDIs that could lead to patient harm, taking into account a patient's individual clinical profile, drug effects and severity of potential harmful outcome; and subsequent actual harm among hospitalized patients and (ii) examine the impact of transitioning from paper-based medication charts to electronic medication management (eMM) on DDIs and patient harms. METHODS: This was a secondary analysis of the control arm of a controlled pre-post study. Patients were randomly selected from three Australian hospitals. Retrospective chart review was conducted before and after the implementation of an eMM system, without accompanying clinical decision support alerts for DDIs. Harm was assessed by an expert panel. RESULTS: Of 1186 patient admissions, 70.1% (n = 831) experienced a pDDI, 42.6% (n = 505) a cDDI and 0.9% (n = 11) an actual harm in hospital. Of 15,860 pDDIs identified, 27.0% (n = 4285) were classified as cDDIs. The median number of pDDIs and cDDIs per 10 drugs were 6 [interquartile range (IQR) 2-13] and 0 (IQR 0-2), respectively. In cases where a cDDI was identified, both drugs were 44% less likely to be co-administered following eMM (adjusted odds ratio 0.56, 95% confidence interval 0.46-0.73). CONCLUSION: Although most patients experienced a pDDI during their hospital stay, less than one-third of pDDIs were clinically relevant. The low prevalence of harm identified raises questions about the value of incorporating DDI decision support into systems given the potential negative impacts of DDI alerts.

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.

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.

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.

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+.

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.

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.

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.

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.

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.

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.

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)