Periprocedural Management and Multidisciplinary Care Pathways for Patients With Cardiac Implantable Electronic Devices: A Scientific Statement From the American Heart Association.

The rapid technological advancements in cardiac implantable electronic devices such as pacemakers, implantable cardioverter defibrillators, and loop recorders, coupled with a rise in the number of patients with these devices, necessitate an updated clinical framework for periprocedural management. The introduction of leadless pacemakers, subcutaneous and extravascular defibrillators, and novel device communication protocols underscores the imperative for clinical updates. This scientific statement provides an inclusive framework for the periprocedural management of patients with these devices, encompassing the planning phase, procedure, and subsequent care coordinated with the primary device managing clinic. Expert contributions from anesthesiologists, cardiac electrophysiologists, and cardiac nurses are consolidated to appraise current evidence, offer patient and health system management strategies, and highlight key areas for future research. The statement, pertinent to a wide range of health care professionals, underscores the importance of quality care pathways for patient safety, optimal device function, and minimization of hemodynamic disturbances or arrhythmias during procedures. Our primary objective is to deliver quality care to the expanding patient cohort with cardiac implanted electronic devices, offering direction in the era of evolving technologies and laying a foundation for sustained education and practice enhancement.

Funding and Resourcing Quality Improvement Effort in Infectious Diseases.

Infectious diseases physicians are frequently called on to perform quality improvement and patient safety (QIPS) work. We describe a newly created faculty position at our institution that allows a faculty member with graduate training in quality and safety methodologies to address QIPS priorities at both the division and hospital levels.

Decolonization and Pathogen Reduction Approaches to Prevent Antimicrobial Resistance and Healthcare-Associated Infections.

Antimicrobial resistance in healthcare-associated bacterial pathogens and the infections they cause are major public health threats affecting nearly all healthcare facilities. Antimicrobial-resistant bacterial infections can occur when colonizing pathogenic bacteria that normally make up a small fraction of the human microbiota increase in number in response to clinical perturbations. Such infections are especially likely when pathogens are resistant to the collateral effects of antimicrobial agents that disrupt the human microbiome, resulting in loss of colonization resistance, a key host defense. Pathogen reduction is an emerging strategy to prevent transmission of, and infection with, antimicrobial-resistant healthcare-associated pathogens. We describe the basis for pathogen reduction as an overall prevention strategy, the evidence for its effectiveness, and the role of the human microbiome in colonization resistance that also reduces the risk for infection once colonized. In addition, we explore ideal attributes of current and future pathogen-reducing approaches.

Comparing the clinical practice and prescribing safety of locum and permanent doctors: observational study of primary care consultations in England.

BACKGROUND: Temporary doctors, known as locums, are a key component of the medical workforce in the NHS but evidence on differences in quality and safety between locum and permanent doctors is limited. We aimed to examine differences in the clinical practice, and prescribing safety for locum and permanent doctors working in primary care in England. METHODS: We accessed electronic health care records (EHRs) for 3.5 million patients from the CPRD GOLD database with linkage to Hospital Episode Statistics from 1st April 2010 to 31st March 2022. We used multi-level mixed effects logistic regression to compare consultations with locum and permanent GPs for several patient outcomes including general practice revisits; prescribing of antibiotics; strong opioids; hypnotics; A&E visits; emergency hospital admissions; admissions for ambulatory care sensitive conditions; test ordering; referrals; and prescribing safety indicators while controlling for patient and practice characteristics. RESULTS: Consultations with locum GPs were 22% more likely to involve a prescription for an antibiotic (OR = 1.22 (1.21 to 1.22)), 8% more likely to involve a prescription for a strong opioid (OR = 1.08 (1.06 to 1.09)), 4% more likely to be followed by an A&E visit on the same day (OR = 1.04 (1.01 to 1.08)) and 5% more likely to be followed by an A&E visit within 1 to 7 days (OR = 1.05 (1.02 to 1.08)). Consultations with a locum were 12% less likely to lead to a practice revisit within 7 days (OR = 0.88 (0.87 to 0.88)), 4% less likely to involve a prescription for a hypnotic (OR = 0.96 (0.94 to 0.98)), 15% less likely to involve a referral (OR = 0.85 (0.84 to 0.86)) and 19% less likely to involve a test (OR = 0.81 (0.80 to 0.82)). We found no evidence that emergency admissions, ACSC admissions and eight out of the eleven prescribing safety indicators were different if patients were seen by a locum or a permanent GP. CONCLUSIONS: Despite existing concerns, the clinical practice and performance of locum GPs did not appear to be systematically different from that of permanent GPs. The practice and performance of both locum and permanent GPs is likely shaped by the organisational setting and systems within which they work.

Contaminant Organism Growth in Febrile Infants at Low Risk for Invasive Bacterial Infection.

In this multicenter, cross-sectional, secondary analysis of 4042 low-risk febrile infants, nearly 10% had a contaminated culture obtained during their evaluation (4.9% of blood cultures, 5.0% of urine cultures, and 1.8% of cerebrospinal fluid cultures). Our findings have important implications for improving sterile technique and reducing unnecessary cultures.

Consistency of ablations with trainee and increasing independence during fellowship training-Analysis of ablation data by CARTONET.

INTRODUCTION: Training in clinical cardiac electrophysiology (CCEP) involves the development of catheter handling skills to safely deliver effective treatment. Objective data from analysis of ablation data for evaluating trainee of CCEP procedures has not previously been possible. Using the artificial intelligence cloud-based system (CARTONET), we assessed the impact of trainee progress through ablation procedural quality. METHODS: Lesion- and procedure-level data from all de novo atrial fibrillation (AF) and cavotricuspid isthmus (CTI) ablations involving first-year (Y1) or second-year (Y2) fellows across a full year of fellowship was curated within Cartonet. Lesions were automatically assigned to anatomic locations. RESULTS: Lesion characteristics, including contact force, catheter stability, impedance drop, ablation index value, and interlesion time/distance were similar over each training year. Anatomic location and supervising operator significantly affected catheter stability. The proportion of lesion sets delivered independently and of lesions delivered by the trainee increased steadily from the first quartile of Y1 to the last quartile of Y2. Trainee perception of difficult regions did not correspond to objective measures. CONCLUSION: Objective ablation data from Cartonet showed that the progression of trainees through CCEP training does not impact lesion-level measures of treatment efficacy (i.e., catheter stability, impedance drop). Data demonstrates increasing independence over a training fellowship. Analyses like these could be useful to inform individualized training programs and to track trainee's progress. It may also be a useful quality assurance tool for ensuring ongoing consistency of treatment delivered within training institutions.

US businesses engaged in direct-to-consumer marketing of perinatal stem cell interventions following the Food and Drug Administration's enforcement discretion era.

BACKGROUND AIMS: The goal of this study was to analyze online marketing representations made by 300 US businesses selling allogeneic perinatal stem cell products. The study was conducted after a period of enforcement discretion by the US Food and Drug Administration (FDA). METHODS: Data mining and content analysis were used to identify, analyze and categorize marketing claims made on the websites of 300 businesses selling perinatal stem cell interventions. RESULTS: The study identified types of perinatal interventions companies advertised, geographic locations of clinics selling such products, types of companies operating in this space, diseases and injuries such businesses claim to treat, prices companies charge for such interventions, brand names of advertised perinatal cell products and identities of suppliers. CONCLUSIONS: A substantial number of US businesses market unapproved perinatal stem cell products for various indications. This widespread commercial activity occurred following the conclusion of a period of enforcement discretion by the FDA and suggests the need for more robust and comprehensive regulatory responses to businesses selling unapproved perinatal stem cell products.

Reducing Overuse of 3-Day Repeat Type and Screen Testing across an 11-Hospital Safety Net System.

BACKGROUND: According to the American Association of Blood Banks, a Type and Screen (T&S) is valid for up to three calendar days. Beyond a limited number of clinical indications such as a transfusion reaction, repeat T&S testing within 3 days is not warranted. Inappropriate repeat T&S testing is a costly medical waste and can lead to patient harm. OBJECTIVE: To reduce inappropriate duplicate T&S testing across a large, multihospital setting. SETTING: The largest urban safety net health system in the USA, with 11 acute care hospitals. INTERVENTIONS: Our first intervention involved adding the time elapsed since the last T&S order into the order and the process instructions that described when a T&S was indicated. The second intervention was a best practice advisory that triggered when T&S was ordered before the expiration of an active T&S. MAIN MEASURES: The primary outcome measure was the number of duplicate inpatient T&S per 1000 patient days. KEY RESULTS: Across all hospitals, the weekly average rate of duplicate T&S ordering decreased from 8.42 to 7.37 per 1000 patient days (12.5% reduction, p < 0.001) after the first intervention and to 4.32 per 1000 patient days (48.7% reduction, p < 0.001) after the second intervention. Using linear regression to compare pre-intervention to post-intervention 1, the level difference was - 2.46 (9.17 to 6.70, p < 0.001) and slope difference was 0.0001 (0.0282 to 0.0283, p = 1). For post-intervention 1 to post-intervention 2, the level difference was - 3.49 (8.06 to 4.58, p < 0.001) and slope difference was - 0.0428 (0.0283 to - 0.0145, p < 0.05). CONCLUSIONS: Our intervention successfully reduced duplicate T&S testing using a two-pronged electronic health record intervention. The success of this low effort intervention across a diverse health system provides a framework for similar interventions in various clinical settings.

The obstetrical emergency department: need, rationale, and guide to implementation.

The past 2 decades have seen dramatic growth in the number of obstetrics and gynecology hospitalists, and many hospitals have created obstetrical-specific emergency departments. The goals of an obstetrics emergency department are to provide safe and efficient care to the pregnant dyad and postpartum patient, while generating revenue for emergency services provided. In an obstetrics emergency department, all patients must be evaluated in person by a licensed practitioner, whereas historically they may have been evaluated in person by nursing staff or a trainee. We make the argument that formation of an obstetrics emergency department has the potential to improve the safety and quality of patient care. In addition, the financial benefits to institutions are substantial and can subsidize the cost of maintaining obstetrician presence all the time in the hospital. There are various regulatory requirements to become certified, accredited, and licensed as an emergency department. In addition, there are many operational and systems issues that institutions should consider before implementation. We provide a guide for healthcare systems considering creating an obstetrics emergency department.

Society for Maternal-Fetal Medicine Special Statement: Emergency checklist, planning worksheet, and system preparedness bundle for placenta accreta spectrum.

Placenta accreta spectrum is a life-threatening complication of pregnancy that is underdiagnosed and can result in massive hemorrhage, disseminated intravascular coagulation, massive transfusion, surgical injury, multisystem organ failure, and even death. Given the rarity and complexity, most obstetrical hospitals and providers do not have comprehensive expertise in the diagnosis and management of placenta accreta spectrum. Emergency management, antenatal interdisciplinary planning, and system preparedness are key pillars of care for this life-threatening disorder. We present an updated sample checklist for emergent and unplanned cases, an antenatal planning worksheet for known or suspected cases, and a bundle of activities to improve system and team preparedness for placenta accreta spectrum.

Infringement of clinical pharmacist's authority.

Clinical pharmacists are healthcare practitioners who have advanced education and training in comprehensive medication management. Clinical pharmacists work with other members of the healthcare team to manage particular medications or disease states. Even though clinical pharmacists are members of healthcare teams, there are still many cases of challenge in the interprofessional relationship with other healthcare team members, especially related to drug management. Increasing interprofessional communication between physicians and clinical pharmacists within the healthcare system could enhance the role of clinical pharmacists. Earlier studies reported that physicians were comfortable with pharmacists detecting and preventing prescription errors, but were uncomfortable with them recommending drug therapy to patients. Acceptance of pharmacists' suggestions by prescribers is a necessary component of the evaluation of clinical pharmacy services. The role of clinical pharmacists could be improved by increasing interprofessional communication between doctors and clinical pharmacists in the healthcare system.

Opioid-related deaths and their counterpart by occurrence era, age group and coimplicated drugs: Scotland vs. England and Wales.

AIMS: Compare by occurrence era and age group how opioid-related deaths (ORDs) and their counterpart evolved in Scotland vs. England and Wales during 2006-2020. For Scotland, compare coimplication rates between ORDs and non-ORDs for any benzodiazepine, cocaine or gabapentin/pregabalin, and consider whether coimplication in ORDs depended on opioid-specificity. METHODS: Cross-tabulations of drug misuse deaths (DMDs) obtained by 3 yearly occurrence era (2006-2008 to 2018-2020) and age group (under 25, 25-34, 35-44, 45-54, 55+ years) for England and Wales and subdivided by whether at least 1 opiate was mentioned on death certificate (DMD-Os or not); and of Scotland's opioid-related deaths (ORDs vs. non-ORDs) together with (i) coimplication by any benzodiazepine, cocaine or gabapentin/pregabalin; and (ii) opioid-specificity of ORDs. ORD is defined by heroin/morphine, methadone or buprenorphine being implicated in DMD. RESULTS: Per era between 2012-2014 and 2018-2020, Scotland's ORDs increased by 54% and non-ORDs by 34%. Increase in DMD-Os in England and Wales was more modest. Cocaine was implicated in 83% of Scotland's 2690 non-ORDs during 2006-2020; and any benzodiazepine in 53% of 8409 ORDs. However, in 2018-2020, coimplication rates in 2926 ORDs (880 non-ORDs) were 81% (33%) for any benzodiazepine, 30% (74%) for cocaine and 38% (22%) for gabapentin/pregabalin. Coimplication rate in 2018-2020 for any benzodiazepine was lowest at 70% (616/877) for heroin/morphine ORDs; and, by age group, at 66% (160/241) for ORDs aged 55+ years. CONCLUSIONS: Drug testing to inform users, shared intelligence between police and public health for earlier detection of changes in supply and monitoring of prescribed daily-dose of methadone are urgent.

Adverse drug events caused by three high-risk drug-drug interactions in patients admitted to intensive care units: A multicentre retrospective observational study.

AIMS: Knowledge about adverse drug events caused by drug-drug interactions (DDI-ADEs) is limited. We aimed to provide detailed insights about DDI-ADEs related to three frequent, high-risk potential DDIs (pDDIs) in the critical care setting: pDDIs with international normalized ratio increase (INR+ ) potential, pDDIs with acute kidney injury (AKI) potential, and pDDIs with QTc prolongation potential. METHODS: We extracted routinely collected retrospective data from electronic health records of intensive care units (ICUs) patients (≥18 years), admitted to ten hospitals in the Netherlands between January 2010 and September 2019. We used computerized triggers (e-triggers) to preselect patients with potential DDI-ADEs. Between September 2020 and October 2021, clinical experts conducted a retrospective manual patient chart review on a subset of preselected patients, and assessed causality, severity, preventability, and contribution to ICU length of stay of DDI-ADEs using internationally prevailing standards. RESULTS: In total 85 422 patients with ≥1 pDDI were included. Of these patients, 32 820 (38.4%) have been exposed to one of the three pDDIs. In the exposed group, 1141 (3.5%) patients were preselected using e-triggers. Of 237 patients (21%) assessed, 155 (65.4%) experienced an actual DDI-ADE; 52.9% had severity level of serious or higher, 75.5% were preventable, and 19.3% contributed to a longer ICU length of stay. The positive predictive value was the highest for DDI-INR+ e-trigger (0.76), followed by DDI-AKI e-trigger (0.57). CONCLUSION: The highly preventable nature and severity of DDI-ADEs, calls for action to optimize ICU patient safety. Use of e-triggers proved to be a promising preselection strategy.

Advanced prescription of injectable anticancer drugs: Safety assessment in a European Comprehensive Cancer Centre using the risk matrix approach.

AIMS: The purpose of this work was to assess failures in the advanced prescription of parenteral anticancer agents in an adult day oncology care unit with more than 100 patients per day. METHODS: An a priori descriptive analysis was carried out by using the risk matrix approach. After defining the scope in a multidisciplinary meeting, we determined at each step the failure modes (FMs), their effects (E) and their associated causes (C). A severity score (S) was assigned to all effects and a probability of occurrence (O) to all causes. These S and O indicators, were used to obtain a criticality index (CI) matrix. We assessed the risk control (RC) of each failure in order to define a residual criticality index (rCI) matrix. RESULTS: During risk analysis, 14 FMs were detected, and 61 scenarios were identified considering all possible effects and causes. Nine situations (15%) were highlighted with the maximum CI, 18 (30%) with a medium CI, and 34 (55%) with a negligible CI. Nevertheless, among all these critical situations, only three (5%) had an rCI to process (i.e., missed dose adjustment, multiple prescriptions and abnormal biology data); the others required monitoring only. Clinicians' and pharmacists' knowledge of these critical situations enables them to manage the associated risks. CONCLUSIONS: Advanced prescription of injectable anticancer drugs appears to be a safe practice for patients when combined with risk management. The major risks identified concerned missed dose adjustment, prescription duplication and lack of consideration for abnormal biology data.

National Analysis of Outcomes for Adult Trauma Patients With Isolated Severe Blunt Traumatic Brain Injury Following Venous Thromboembolism Prophylaxis.

INTRODUCTION: We aim to evaluate the association of early versus late venous thromboembolism (VTE) prophylaxis on in-hospital mortality among patients with severe blunt isolated traumatic brain injuries. METHODS: Data from the American College of Surgeons Trauma Quality Program Participant Use File for 2017-2021 were analyzed. The target population included adult trauma patients with severe isolated traumatic brain injury (TBI). VTE prophylaxis types (low molecular weight heparin and unfractionated heparin) and their administration timing were analyzed in relation to in-hospital complications and mortality. RESULTS: The study comprised 3609 patients, predominantly Caucasian males, with an average age of 48.5 y. Early VTE prophylaxis recipients were younger (P < 0.01) and more likely to receive unfractionated heparin (P < 0.01). VTE prophylaxis later than 24 h was associated with a higher average injury severity score and longer intensive care unit stays (P < 0.01). Logistic regression revealed that VTE prophylaxis later than 24 h was associated with significant reduction of in-hospital mortality by 38% (odds ratio 0.62, 95% confidence interval 0.40-0.94, P = 0.02). Additionally, low molecular weight heparin use was associated with decreased mortality odds by 30% (odds ratio 0.70, 95% confidence interval 0.55-0.89, P < 0.01). CONCLUSIONS: VTE prophylaxis later than 24 h is associated with a reduced risk of in-hospital mortality in patients with severe isolated blunt TBI, as opposed to VTE prophylaxis within 24 h. These findings suggest the need for timely and appropriate VTE prophylaxis in TBI care, highlighting the critical need for a comprehensive assessment and further research concerning the safety and effectiveness of VTE prophylaxis in these patient populations.

Telemedicine Could Reduce the Role of Family Physicians to Case Managers.

The COVID-19 pandemic led to the widespread and continuing use of telemedicine in primary care. Despite telemedicine's benefits, it threatens to reduce the role of family physician to that of gatekeeper and case manager, nullifying decades of experience and medical intuition that is more difficult to develop and apply virtually. Additionally, many values of family medicine have eroded during this global process. The narrative presents 3 vignettes that illustrate different ways in which we contend with this complex issue. The challenges presented by telemedicine require us to re-examine our professional and personal values such as maintaining the centrality of the therapeutic relationship with patients. The greatest concern, however, relates to the future of the profession and the ability of new family doctors to overcome the challenges of telemedicine in an increasingly digital world.

An improved implementation of metrological traceability concepts is needed to benefit from standardization of laboratory results.

Non-harmonization of laboratory results represents a concrete risk for patient safety. To avoid harms, it is agreed that measurements by in vitro diagnostic medical devices (IVD-MD) on clinical samples should be traceable to higher-order references and adjusted to give the same result. However, metrological traceability is not a formal claim and has to be correctly implemented, which in practice does not happen for a non-negligible number of measurands. Stakeholders, such as higher-order reference providers, IVD manufacturers, and External Quality Assessment organizers, have major responsibilities and should improve their contribution by unambiguously and rigorously applying what is described in the International Organization for Standardization 17511:2020 standard and other documents provided by the international scientific bodies, such as Joint Committee on Traceability in Laboratory Medicine and IFCC. For their part, laboratory professionals should take responsibility to abandon non-selective methods and move to IVD-MDs displaying proper selectivity, which is one of the indispensable prerequisites for the correct implementation of metrological traceability. The practicality of metrological traceability concepts is not impossible but relevant education and appropriate training of all involved stakeholders are essential to obtain the expected benefits in terms of standardization.

Cognitive Bias in the Patient Encounter: Part I. Background and significance.

Cognitive bias may lead to diagnostic error in the patient encounter. There are hundreds of different cognitive biases, but certain biases are more likely to affect patient diagnosis and management. As during morbidity and mortality rounds, retrospective evaluation of a given case, with comparison to an optimal diagnosis, can pinpoint errors in judgment and decision-making. The study of cognitive bias also illuminates how we might improve the diagnostic process. In Part 1 of this series, cognitive bias is defined and placed within the background of dual process theory, emotion, heuristics, and the more neutral term judgment and decision-making bias.

Cognitive Bias in the Patient Encounter: Part II. Debiasing using an adaptive toolbox.

Cognitive bias may lead to medical error, and awareness of cognitive pitfalls is a potential first step to addressing the negative consequences of cognitive bias (see Part 1). For decision-making processes that occur under uncertainty, which encompass most physician decisions, a so-called "adaptive toolbox" is beneficial for good decisions. The adaptive toolbox is inclusive of broad strategies like cultural humility, emotional intelligence, and self-care that help combat implicit bias, negative consequences of affective bias, and optimize cognition. Additionally, the adaptive toolbox includes situational-specific tools such as heuristics, narratives, cognitive forcing functions, and fast and frugal trees. Such tools may mitigate against errors due to cultural, affective, and cognitive bias. Part 2 of this two-part series covers metacognition and cognitive bias in relation to broad and specific strategies aimed at better decision-making.

Psychology in the operating theatre: the importance of colour and cognition in the redesign of clinical systems for medication safety.

Medication errors in anaesthesia remain a leading cause of patient harm. Compared with conventional methods, use of the international colour-code standard on syringes and medication trays allows significantly more errors to be detected, and does so under conditions of cognitive load. Testing methods from experimental psychology provide important new insights for human factors research in anaesthesia and health care.