Balancing Patient Safety Research Articles

Evaluating the Risk of Traumatic Brain Injury in Adults Following a Fall With Concomitant Use of Anti-Coagulation: A Retrospective Cohort Study.

Introduction Falls and fractures are major health challenges for older adults in England. Despite the advantages of anticoagulants, their use in the elderly is often restricted due to concerns about fall-related injuries. However, there is a lack of clear data on the risk of discontinuing anticoagulation therapy solely due to fall risk. NICE guidelines (2021) advise that anticoagulation should not be withheld solely based on age or fall risk. This study aims to assess the incidence of significant brain injuries or intracranial haemorrhages in patients on anticoagulant therapy, also comparing the independent risk factors for traumatic brain injury. Objective This study aims to assess the incidence of TBI following falls in patients on anticoagulant therapy, comparing outcomes between those using DOACs and Vitamin K antagonists. Methods A retrospective cohort study was conducted at Queen Alexandra Hospital, University Hospitals Portsmouth NHS Trust, from November 2023 to May 2024. Data were collected from 3,468 CT head scans performed on patients with a history of falls, including 801 on anticoagulation therapy. Results Of the 801 patients on anticoagulation, 763 (95.2%) were aged 65 or older, with a mean age of 83.1 years. Acute hemorrhage was detected in 3.1% (25/801) of patients. Patients on Warfarin and Dabigatran had significantly higher TBI risk compared to those on Apixaban (6.7%, p=0.02; and 7.6%, p=0.01, respectively), while Edoxaban and Rivaroxaban showed no significant difference. Also, older age (≥65 years) and higher frailty scores (CFS 6 and 7) were associated with increased TBI risk (p<0.05). All patients with acute hemorrhage received conservative management, and two patients experienced mortality within six months. Discussion The study indicates that the risk of TBI following falls in anticoagulated patients is 3.1% relatively low, aligning with existing literature. This underscores the need for careful consideration before discontinuing anticoagulation therapy solely based on fall risk. Hence, discontinuation of anticoagulation should be a patient-specific decision that carefully considers the balance between the risk of traumatic brain injury (TBI) and the benefits of anticoagulation therapy. Factors such as age, frailty, and the type of anticoagulant should all be taken into account. Clinical judgment and selective CT imaging can help balance patient safety with healthcare costs. Conclusion The incidence of adverse outcomes following head injury in patients on anticoagulant therapy is 3.1% and relatively low. Careful decision-making regarding the discontinuation of anticoagulation therapy, informed by patient background and presentation and selective CT imaging, is essential to manage risks effectively and optimize healthcare resource utilization.

Quality of Care and Quality of Life: Balancing Patient Safety and Physician Burnout.

Since the publication of the Institute of Medicine's landmark report on medical errors in 2000, a large number of safety programs have been implemented in American hospitals. Concurrently, there has been a dramatic increase in the rate of burnout among physicians. Although there are many unrelated causes of burnout (eg, loss of autonomy), and multiple safety programs that are applauded by physicians (eg, The Safe Motherhood Initiative), other programs created in the name of safety improvements may be contributing to physician distress. In this piece, we review several of those programs, describe their limitations and costs to physician well-being, and discuss the manner in which they might be modified to retain their benefits while mitigating the burdens they place on physicians.

Postoperative Recovery in the Youngest: Beyond Technology.

Measuring and interpreting vital signs in pediatric patients recovering from anaesthesia, particularly those up to 36 months old, is challenging. Nurses' decision-making regarding the level of monitoring must balance patient safety with individualized care. This study aimed to explore the perceptions of critical care nurses and registered nurse anesthetists regarding their experiences and actions when making decisions about vital sign monitoring for children in post-anesthesia care units (PACUs). A qualitative study utilizing the critical incident technique was conducted. Interviews were performed with a purposeful sample of 17 critical care nurses and registered nurse anaesthetists from two hospitals. Nurses reported that the rationale for decisions concerning the need for vital sign monitoring in children was both adequate and inadequate. Actions were taken to adjust the monitoring of vital signs, optimizing conditions for assessment and ensuring the child's safe recovery. The complexity of accurately monitoring children makes it challenging for nurses in the PACU to adhere to guidelines. Evidence-based care and safety are compromised when technology has limitations and is not adapted for paediatric use, leading to a greater reliance on experience and clinical assessment. This reliance on experience is crucial for reliable assessment but also entails accepting greater risks.

Inhalational anaesthetic agent consumption within a multidisciplinary veterinary teaching hospital: an environmental audit

Inhalational anaesthetic agents are routinely used in veterinary anaesthesia practices, yet their consumption contributes significantly to greenhouse gas emissions and environmental impact. We conducted a 55-day observational study at a veterinary teaching hospital in Switzerland, monitoring isoflurane and sevoflurane consumption across small, equine and farm animal clinics and analysed the resulting environmental impact. Results revealed that in total, 9.36 L of isoflurane and 1.27 L of sevoflurane were used to anaesthetise 409 animals across 1,489 h. Consumption rates varied among species, with small and farm animals ranging between 8.7 and 13 mL/h, while equine anaesthesia exhibited a higher rate, 41.2 mL/h. Corresponding to 7.36 tonnes of carbon dioxide equivalent in total environmental emissions or between 2.4 and 31.3 kg of carbon dioxide equivalent per hour. Comparison to human anaesthesia settings showed comparable consumption rates to small animals, suggesting shared environmental implications, albeit on a smaller scale. This research highlights the importance of continued evaluation of veterinary anaesthesia practices to balance patient safety with environmental stewardship; potential mitigation strategies are explored and discussed.

Perspectives and Awareness of Environmental Sustainability in the Infection Prevention and Control Community Nationally

Background: Healthcare contributes significantly to waste production and greenhouse gas emissions. This became especially apparent during the COVID-19 pandemic. Yet there is modest recognition of this issue, particularly within decision-making in Infection Prevention and Control (IPC). The aim of our study was to gauge general knowledge and attitudes of hospital epidemiologists (HEs) and infection preventionists (IPs) around the intersection of environmental sustainability and IPC, and to identify related institutional practices. Methods: An online survey, composed of ten questions related to environmental sustainability in IPC, was created and emailed to members of the SHEA Research Network (SRN), a national consortium of healthcare facilities collaborating on IPC research, from August - October 2023. Survey answers were collated via Redcap© and descriptive results were obtained. Results: Forty-two individuals (33 HEs, 7 directors of IPC, and 2 IPs) from unique institutions completed the survey. Thirty (71.4%) were from academic medical centers, 5 (11.9%) were from VA medical centers and 7 (16.7%) were from community hospitals. Over half of participants correctly estimated the amount of waste and carbon emissions produced annually by the US healthcare system (6 million tons and 8.5% of national emissions, respectively). However, only 42.9% considered environmental sustainability concerns important or very important when making IPC decisions. Fifteen (34.9%) had an environmental sustainability committee at their institution and of these, 8 had an established relationship with the IPC department. The most common techniques to promote sustainability amongst institutions were water/energy conservation (59.5%), reusable personal protective equipment (52.4%) and Leadership in Energy and Environmental Design (LEED) certification (47.6%). When asked which efforts they would support at their institution, 28.6% would eliminate the use of single-use endoscopes and one third would avoid use of ethylene oxide for sterilization. In deciding whether to support environmental sustainability measures, key considerations participants articulated were patient safety concerns, knowledge about effectiveness and costs, and administrative support. Conclusion: Although there is growing awareness around the contribution of the healthcare industry to carbon emissions and waste production, IPC professionals have not yet universally adopted measures to promote environmental sustainability. In our survey, many participants acknowledged the importance of balancing patient safety and sustainability concerns. Our study demonstrates the need for more research and education to inform decisions around environmentally sustainable efforts in IPC that also preserve patient safety. Additionally, professional and regulatory bodies must acknowledge and promote the importance of environmental sustainability in IPC decision-making.

Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety.

Surface the urgent dilemma that healthcare delivery organizations (HDOs) face navigating the US Food and Drug Administration (FDA) final guidance on the use of clinical decision support (CDS) software. We use sepsis as a case study to highlight the patient safety and regulatory compliance tradeoffs that 6129 hospitals in the United States must navigate. Sepsis CDS remains in broad, routine use. There is no commercially available sepsis CDS system that is FDA cleared as a medical device. There is no public disclosure of an HDO turning off sepsis CDS due to regulatory compliance concerns. And there is no public disclosure of FDA enforcement action against an HDO for using sepsis CDS that is not cleared as a medical device. We present multiple policy interventions that would relieve the current tension to enable HDOs to utilize artificial intelligence to improve patient care while also addressing FDA concerns about product safety, efficacy, and equity.

How Do Women Vote: What Women Post About Home Birth Versus Hospital Birth on Popular Social Media Platforms.

The rates of home birth have been increasing; reliance on social media as a source of medical advice and support for patients has also been increasing. This is the first study that directly evaluates birthing people's perceptions, attitudes, and advice about planned home births expressed in public posts and comments on two popular social media platforms - Reddit and TikTok. Posts on each platform were searched from January 2017 through July 2022 using the terms "home birth" and "home vs. hospital birth". Included posts were from the United States written in English, with at least 10 comments and 10 upvotes or likes. Up to five themes were collected per post or comment and were categorized as supportive, opposing, or neutral. The Institutional Review Board (IRB) determined that the project did not include human subjects. Collectively, 777 posts and 47,452 comments wereevaluated for inclusion; 257 posts and 2,408 comments met the inclusion criteria for analysis. In posts, 69% supported, 20% opposed, and 11% were neutral toward home birth (n = 257). Similarly, in comments, 53% supported, 28% opposed, and 19% were neutral (n = 2,408). Supportive themes included concerns about the safety of hospital delivery and reassurance about home birth safety, enhanced patient control with home deliveries, positive personal stories reinforcing home birth, concerns about excessive interventions in hospital birth, and advice about preparing for home birth. Opposing themes included concerns about risks of home birth, negligence of those attempting it, reassurance that hospital birth does offer women control, greater financial costs of home birth and that medical interventions can be lifesaving. These results can help physicians recognize some of the women's concerns about hospital births and what information they may find on social media guiding them as they formulate their birth plans. Overall, this information helps with the goal of balancing patient safety with the need to respect patient autonomy.

Scope of practice regulation in medicine: balancing patient safety, access to care and professional autonomy.

Scope of practice regulation in medicine is crucial for ensuring patient safety, access to care and professional autonomy. This paper explores the impact of scope of practice regulation on healthcare delivery, professional responsibilities and patient outcomes. It discusses the variability in standards for safe practice, the challenges in defining boundaries between medical specialties and the recent controversies in cosmetic surgery practice. The paper also examines the potential benefits and drawbacks of rigorous scope of practice regulations, including their impact on clinical innovation, flexibility and access to care. Furthermore, it delves into the implications of defensive medicine and the consequences of restrictive regulations on patient care. The author proposes implementing a proactive, national, artificial intelligence-powered, real-time outcome monitoring system to address these challenges. This system aims to cover every patient undergoing a surgical procedure and could be gradually extended to non-surgical conditions, benefiting all key stakeholders in the health system. The paper emphasises the need for a balanced approach to scope of practice regulation to avoid stifling clinical innovation and professional autonomy, while ensuring patient safety and professional accountability.

Dexmedetomidine and Fentanyl in Endotracheal Intubation: A Comparative Analysis of Hemodynamic and Intubation Responses

Aim: Endotracheal intubation, a critical procedure in anaesthesia, can induce significant hemodynamic fluctuations, posing risks, especially to patients with cardiovascular concerns. This study compares the effects of dexmedetomidine and fentanyl, two agents commonly used to mitigate these responses, on endotracheal intubation conditions and associated hemodynamic changes.&#x0D; Material and Method: Conducted at tertiary care training and research hospital, this study involved 60 patients aged 40-60, all classified American Society of Anesthesiologists (ASA) I-II, undergoing elective upper and lower extremity surgeries. Excluding patients with contraindicating conditions, the subjects were divided into two groups to receive either dexmedetomidine or fentanyl, along with propofol and vecuronium, for induction. Hemodynamic parameters were continuously monitored, and intubation conditions were assessed using the Cooper scoring system.&#x0D; Results: The study found that both dexmedetomidine and fentanyl effectively stabilised hemodynamic parameters during intubation. However, the fentanyl group displayed significantly higher total scores on the Cooper intubation conditions scale, indicating more favourable conditions for endotracheal intubation in terms of ease and patient comfort.&#x0D; Conclusion: While both dexmedetomidine and fentanyl are effective in maintaining hemodynamic stability during endotracheal intubation, fentanyl demonstrates a slight advantage in optimising intubation conditions. This distinction offers valuable insight for anesthesiologists in tailoring anaesthetic strategies and balancing patient safety with procedural efficiency in surgical settings.

Balancing Patient Safety and Early Postoperative Discharge: An American College of Surgeons National Surgical Quality Improvement Program Analysis of Postoperative Complications After Minimally Invasive Urologic Surgery.

Balancing Patient Safety and Early Postoperative Discharge: An American College of Surgeons National Surgical Quality Improvement Program Analysis of Postoperative Complications After Minimally Invasive Urologic Surgery.

The Glasgow declaration on sustainability in Anaesthesiology and Intensive Care.

The Glasgow declaration on sustainability in Anaesthesiology and Intensive Care.

Balancing autonomy of thought and action in the context of patient safety: resident perspectives on intraoperative autonomy

PurposeThe goal of surgical residency is to produce technically competent surgeons who can safely operate autonomously. This study aimed to explore residents’ perception of intraoperative autonomy across post-graduate years (PGY).MethodsGeneral surgery residents at a single academic institution were invited to participate in focus groups divided by PGY to explore their opinions on operative autonomy. Focus groups were audio recorded, transcribed, and analyzed using constant comparative technique. Thematic analysis was performed using an inductive approach.ResultsThirty-nine residents participated in five focus groups. Five themes emerged from the data. Residents distinguished between autonomy of thought representing graduated decision-making and autonomy of action representing technical maneuvers in the operating room. Residents vocalized a respect for the balance of autonomy and patient safety and stated a desire to have clear expectations to minimize the impact of external factors on autonomy.ConclusionsResidents differentiated autonomy as a parallel of autonomy of thought and autonomy of action and were empathetic to the responsibility of faculty to balance patient safety and autonomy. Surgical educators can improve resident autonomy by clearly managing expectations and minimizing external factors negatively affecting intraoperative autonomy.

Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database.

Cross-Sectional Analysis. To summarize medical device reports (MDRs) between August 1, 2017 and November 30, 2021 relating to robot-assisted spine systems within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). The MAUDE database was abstract for all MDRs relating to each FDA-approved robot-assisted spine system. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific robot-assisted spine systems and reported events as detailed by the MDRs. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). There were 263 MDRs consisting of 265 reported events. Misplaced screws represented 61.5% (n = 163) of reported events. Of the 163 reported events, 57.1% (n = 93) described greater than 1 misplaced screw, 15.3% (n = 25) required return to the operating room, 8.6% (n = 14) resulted in neurologic injury, 4.3% (n = 7) resulted in dural tear, and 1.2% (n = 2) resulted in hemorrhage or bleeding. Reported events other than misplaced screws included system imprecision detected prior to screw placement (58/265, 21.9%), mechanical failure (23/265, 8.7%), and software failure (18/265, 6.8%). As more robot-assisted spine systems gain FDA approval and the adoption of these systems continues to grow, documenting and understanding the range of reported events associated with each "tool" is imperative to balancing patient safety with surgical innovation. This study of the MAUDE database provides a unique summary of reported events associated with robot-assisted spine systems that is not directly linked to a research setting.

Using team science in vascularized composite allotransplantation to improve team and patient outcomes.

Reconstructive allografts using Vascularized Composite Allotransplantation (VCA) are providing individuals living with upper limb loss and facial disfigurement with new opportunities for a sensate, esthetically acceptable, and functional alternative to current treatment strategies. Important research attention is being paid to how best to assess and screen candidates for VCA, measure optimal patient outcomes, and support patient adherence to lifelong behaviors and medical regimens. Far less attention, however, has been dedicated to the team science required for these complex VCA teams to form, prepare, and provide the highest quality clinical and psychosocial care to those receiving VCA. VCA teams are unique in that they require specialized team members whose scope of practice may not otherwise overlap. The team also needs to constantly negotiate balancing patient safety with multiple risks throughout the transplant process. This study aimed to elucidate the team science needed for this highly innovative and complex area of medicine. Using in-depth qualitative interviews with 14 VCA team members and observations at team meetings, we found that careful consideration of team composition, team structure, and organizational commitment (e.g., local culture and team values; investment of resources) influences team performance and patient outcomes, but that to be efficient and truly effective, teams need to commit to developing processes that foster collaboration. These processes are action-oriented (e.g., communication, leadership), strategic (e.g., planning, training) and interpersonal (e.g., conflict management, trust building). Dedication and commitment to team science allows teams to manage conflict under stress and exercise ways to leverage strengths to provide optimal performance or patient psychosocial and clinical outcomes. This study can provide insight into quality improvement efforts for VCA teams and guidance for other transplant programs that wish to consider expansion into VCA.

Assessment of surgical autonomy: in support of aspirational goals

Drawing on key principles of adult learning theory, a number of surgical autonomy assessment scales have been developed for use in resident evaluation. These assessment scales allow graded autonomy in resident surgical education, balancing patient safety with the need for achieving resident competency during training. The main scales used, the Zwisch scale and the Dreyfus scale, differ only in the inclusion of an “expert” level, and there is controversy in surgical education on whether inclusion of these types of aspirational goals is appropriate. This clinical opinion article reviews key aspects of adult learning theory that pertain to surgical skill acquisition and use of aspirational goals in education, and situates existing surgical autonomy assessment scales within this context. Existing evidence argues for the continued inclusion of aspirational goals in surgical education, but with a concomitant update to the surgical autonomy assessment scales to more closely align with the typical progression of surgical skills during residency. The current process for milestone evaluation put forth by the Accreditation Council for Graduate Medical Education provides an example of a potential framework that could be adapted for use in surgical skill assessment.

Management of breast cancer patients during the first coronavirus pandemic: Lessons learned and future directions

Introduction: The coronavirus (COVID-19) pandemic presented significant challenges to the management of breast cancer patients. Immunosuppression from chemotherapy increases risk of COVID-19 related complications and mortality. Balancing patient safety and service provision required careful assessment. ABS released guidelines on how services should adapt. This audit aimed to assess how well guidelines were adhered to and evaluate patient outcomes.

Apheresis at the National Institutes of Health: A unique nursing experience

The National Institutes of Health (NIH) Clinical Center (CC) is the largest hospital in the world dedicated entirely to clinical research. For over 50 years, NIH scientists have been involved in the development and refinement of apheresis technology that is essential for new and emerging clinical applications of immunotherapy and personalized medicine. NIH investigators have studied the structure and function of blood cells, looking for characteristics that can be exploited to create these new and innovative therapies. Since the very beginning, NIH apheresis nurses have played a pivotal role in providing the raw materials needed for these innovations. The NIH CC Department of Transfusion Medicine (DTM) provides essential services to support investigators and patients when apheresis nurses collect Hematopoietic Progenitor Cells (HPCs), lymphocytes, platelets, plasma and granulocytes from patients and donors enrolled in clinical research protocols at NIH. While balancing patient safety needs, regulatory requirements and research protocol integrity, DTM apheresis nurses face unique challenges.

A review of documents assessing capacity and treatment needs to safeguard adults with incapacity

AimsTo audit the completion of Adults with Incapacity (AWI) documents (Assessment of Capacity, Section 47 Certificate of Incapacity and Treatment Plan) to ensure they met the legal standards required. We hypothesised that the forms were not all completed comprehensively, particularly with regards to the Treatment Plans.MethodIn addition to being legal documents, AWI documents provide an important framework to guide clinicians when giving treatment and balancing patient safety with patient autonomy. Correctly completed documents help provide vulnerable patients with ethical and lawful treatment that allows them to be treated with respect and dignity.An audit was conducted across two Old Age Psychiatry wards at Ayrshire Central Hospital during October 2020. We assessed all AWI documents available on the wards (n = 20) using criteria based on the standards set by the Mental Welfare Commission for Scotland to ensure legal competence.Result95% of the forms were signed and dated, and the nature of the incapacity was given in 100% of the documents. On the other hand, 35% of the forms gave no indication of the presence or absence of a guardian. Only one of those identified as having a guardian was consulted with regards to the treatment plan. Another member of staff was consulted on the Treatment Plan in 45% of cases. 30% of the Treatment Plans were not precisely worded enough to be considered justifiable for treatment. In the Certificate of Incapacity, two out-of-date certificates were found, and staff were notified immediately. 45% of certificates were considered over-generalised with regards to the description under medical treatment.ConclusionOverall, the forms were mostly signed and dated, with the nature of incapacity given. The two areas that appeared to be the most problematic were the issue of identifying and discussing plans with a guardian, and the specification of treatment covered by both the Certificate of Incapacity and the Treatment Plan.Discussion with members of the healthcare team found some confusion over how to complete the forms and many cited a lack of formal training as the main reason for their uncertainty. In addition, accessing clear information online or on the wards on how to complete the forms was challenging. We intend to improve the completion of these documents by implementing teaching and a guidance poster, based on the areas that we identified as being problematic, and completing the audit cycle.

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group.

Performance status (PS) is one of the most common eligibility criteria. Many trials are limited to patients with high-functioning PS, resulting in important differences between trial participants and patient populations with the disease. In addition, existing PS measures are subjective and susceptible to investigator bias. A multidisciplinary working group of the American Society of Clinical Oncology and Friends of Cancer Research evaluated how PS eligibility criteria could be more inclusive. The working group recommendations are based on a literature search, review of trials, simulation study, and multistakeholder consensus. The working group prioritized inclusiveness and access to investigational therapies, while balancing patient safety and study integrity. Broadening PS eligibility criteria may increase the number of potentially eligible patients for a given clinical trial, thus shortening accrual time. It may also result in greater participant diversity, potentially reduce trial participant and patient disparities, and enable clinicians to more readily translate trial results to patients with low-functioning PS. Potential impact on outcomes was explored through a simulation trial demonstrating that when the number of Eastern Cooperative Oncology Group PS2 participants was relatively small, the effect on the estimated HR and power was modest, even when PS2 patients did not derive a treatment benefit. Expanding PS eligibility criteria to be more inclusive may be justified in many cases and could result in faster accrual rates and more representative trial populations.See related commentary by Giantonio, p. 2369.

Balancing Patient Safety, Clinical Efficacy, and Cybersecurity with Clinician Partners.

Balancing Patient Safety, Clinical Efficacy, and Cybersecurity with Clinician Partners.