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Although informed consent for clinical treatment has become a vital part of contemporary medical practice, it means different things in different contexts, is variably practised and rarely achieves the theoretical ideal. In this review, we focus on the clinical practice of informed consent. We first describe what we know about informed consent: what it is, where it came from and what purposes it serves. We then describe several limitations that complicate the practice of informed consent. Finally, we make several practical suggestions as to how clinicians might optimally approach the informed consent process. 79 references

Purpose To evaluate the independent effect of frailty, as measured by the Risk Analysis Index-Administrative (RAI-A) for postoperative complications and discharge outcomes following brain tumor resection (BTR) in a large multi-center analysis. Methods Patients undergoing BTR were queried from the National Surgical Quality Improvement Program (NSIQP) for the years 2015 to 2019. Multivariable logistic regression was performed to evaluate the independent associations between frailty tools (age, 5-factor modified frailty score [mFI-5], and RAI-A) on postoperative complications and discharge outcomes. Results We identified 30,951 patients who underwent craniotomy for BTR; the median age of our study sample was 59 (IQR 47–68) years old and 47.8% of patients were male. Overall, increasing RAI-A score, in an overall stepwise fashion, was associated with increasing risk of adverse outcomes including in-hospital mortality, non-routine discharge, major complications, Clavien-Dindo Grade IV complication, and extended length of stay. Multivariable regression analysis (adjusting for age, sex, BMI, non-elective surgery status, race, and ethnicity) demonstrated that RAI-A was an independent predictor for worse BTR outcomes. The RAI-A tiers 41–45 (1.2% cohort) and > 45 (0.3% cohort) were ~ 4 (Odds Ratio [OR]: 4.3, 95% CI: 2.1–8.9) and ~ 9 (OR: 9.5, 95% CI: 3.9–22.9) times more likely to have in-hospital mortality compared to RAI-A 0–20 (34% cohort). Conclusions and Relevance Increasing preoperative frailty as measured by the RAI-A score is independently associated with increased risk of complications and adverse discharge outcomes after BTR. The RAI-A may help providers present better preoperative risk assessment for patients and families weighing the risks and benefits of potential BTR.

Processes for transferring patients to higher acuity facilities lack a standardized approach to prognostication, increasing the risk for low value care that imposes significant burdens on patients and their families with unclear benefits. We sought to develop a rapid and feasible tool for predicting mortality using variables readily available at the time of hospital transfer. All work was carried out at a single, large, multi-hospital integrated healthcare system. We used a retrospective cohort for model development consisting of patients aged 18 years or older transferred into the healthcare system from another hospital, hospice, skilled nursing or other healthcare facility with an admission priority of direct emergency admit. The cohort was randomly divided into training and test sets to develop first a 54-variable, and then a 14-variable gradient boosting model to predict the primary outcome of all cause in-hospital mortality. Secondary outcomes included 30-day and 90-day mortality and transition to comfort measures only or hospice care. For model validation, we used a prospective cohort consisting of all patients transferred to a single, tertiary care hospital from one of the 3 referring hospitals, excluding patients transferred for myocardial infarction or maternal labor and delivery. Prospective validation was performed by using a web-based tool to calculate the risk of mortality at the time of transfer. Observed outcomes were compared to predicted outcomes to assess model performance. The development cohort included 20,985 patients with 1,937 (9.2%) in-hospital mortalities, 2,884 (13.7%) 30-day mortalities, and 3,899 (18.6%) 90-day mortalities. The 14-variable gradient boosting model effectively predicted in-hospital, 30-day and 90-day mortality (c = 0.903 [95% CI:0.891-0.916]), c = 0.877 [95% CI:0.864-0.890]), and c = 0.869 [95% CI:0.857-0.881], respectively). The tool was proven feasible and valid for bedside implementation in a prospective cohort of 679 sequentially transferred patients for whom the bedside nurse calculated a SafeNET score at the time of transfer, taking only 4-5 minutes per patient with discrimination consistent with the development sample for in-hospital, 30-day and 90-day mortality (c = 0.836 [95%CI: 0.751-0.921], 0.815 [95% CI: 0.730-0.900], and 0.794 [95% CI: 0.725-0.864], respectively). The SafeNET algorithm is feasible and valid for real-time, bedside mortality risk prediction at the time of hospital transfer. Work is ongoing to build pathways triggered by this score that direct needed resources to the patients at greatest risk of poor outcomes.

Background Peripheral artery disease (PAD) affects over 230 million people worldwide and is due to systemic atherosclerosis with etiology linked to chronic inflammation, hypertension, and smoking status. PAD is associated with walking impairment and mobility loss as well as a high prevalence of coronary and cerebrovascular disease. Intermittent claudication (IC) is the classic presenting symptom for PAD, although many patients are asymptomatic or have atypical presentations. Few effective medical therapies are available, while surgical and exercise therapies lack durability. Metformin, the most frequently prescribed oral medication for Type 2 diabetes, has salient anti-inflammatory and promitochondrial properties. We hypothesize that metformin will improve function, retard the progression of PAD, and improve systemic inflammation and mitochondrial function in non-diabetic patients with IC. Methods 200 non-diabetic Veterans with IC will be randomized 1:1 to 180-day treatment with metformin extended release (1000 mg/day) or placebo to evaluate the effect of metformin on functional status, PAD progression, cardiovascular disease events, and systemic inflammation. The primary outcome is 180-day maximum walking distance on the 6-min walk test (6MWT). Secondary outcomes include additional assessments of functional status (cardiopulmonary exercise testing, grip strength, Walking Impairment Questionnaires), health related quality of life (SF-36, VascuQoL), macro- and micro-vascular assessment of lower extremity blood flow (ankle brachial indices, pulse volume recording, EndoPAT), cardiovascular events (amputations, interventions, major adverse cardiac events, all-cause mortality), and measures of systemic inflammation. All outcomes will be assessed at baseline, 90 and 180 days of study drug exposure, and 180 days following cessation of study drug. We will evaluate the primary outcome with linear mixed-effects model analysis with covariate adjustment for baseline 6MWT, age, baseline ankle brachial indices, and smoking status following an intention to treat protocol. Discussion MOBILE IC is uniquely suited to evaluate the use of metformin to improve both systematic inflammatory responses, cellular energetics, and functional outcomes in patients with PAD and IC. Trial Registration : The prospective MOBILE IC trial was publicly registered (NCT05132439) November 24, 2021.

Background There are many approaches in implementation science research and practice to prospectively and pragmatically measure the amount of effort required to implement a particular evidence-based practice (EBP). We sought to 1) demonstrate how to prospectively and pragmatically document implementation activities in a real-world implementation trial; 2) quantify implementation dose (frequency and time spent) across the implementation of four EBPs; and 3) explore potential drivers of variation in implementation dose across EBP, sites, implementation progress, and wave. Methods We built on the existing literature to develop a prospective and pragmatic way to track implementation activities during a type III hybrid effectiveness-implementation stepped wedge trial. We then quantified both total implementation dose (defined as total time spent by the implementer team) and how much of this dose was synchronous (defined as time spent working directly with local implementers at the sites receiving the intervention). We used multiple linear regression to understand what factors may influence differences in total implementation dose delivered (such as which evidence-based practice was being implemented, in which wave of the stepped wedge, at which medical centers), as well as how dose was related to implementation progress, categorized by 1) decision to participate, 2) training, 3) implementation with support, and 4) independent implementation. Results From 2022 to 2023, we prospectively captured implementation dose across 25 implementation instances related to four EBPs that were implemented at seven VA medical centers. We implemented Surgical Pause seven times, TAP six times, CAPABLE six times, and EMPOWER six times. We captured and categorized 1,271 h of implementation activities. Asynchronous administrative activities were most common across implementation phases. Other common synchronous activities include engaging collaborators, problem solving, providing updates, and ongoing action/implementation planning. The EBP was the largest driver of variation in implementation dose overall. Site, implementation progress, and wave did not independently explain variations in implementation dose. Conclusions The EBP being implemented was a much stronger predictor of the implementation dose required than were other factors, such as experience implementing the EBP or characteristics of the medical center where the intervention was being implemented.

Background Unmet care needs among older adults accelerate cognitive and functional decline and increase medical harms, leading to poorer quality of life, more frequent hospitalizations, and premature nursing home admission. The Department of Veterans Affairs (VA) is invested in becoming an “Age-Friendly Health System” to better address four tenets associated with reduced harm and improved outcomes among the 4 million Veterans aged 65 and over receiving VA care. These four tenets focus on “4Ms” that are fundamental to the care of older adults, including (1) what M atters (ensuring that care is consistent with each person’s goals and preferences); (2) M edications (only using necessary medications and ensuring that they do not interfere with what matters, mobility, or mentation); (3) M entation (preventing, identifying, treating, and managing dementia, depression, and delirium); and (4) M obility (promoting safe movement to maintain function and independence). The Safer Aging through Geriatrics-Informed Evidence-Based Practices (SAGE) Quality Enhancement Research Initiative (QUERI) seeks to implement four evidence-based practices (EBPs) that have shown efficacy in addressing these core tenets of an “Age-Friendly Health System,” leading to reduced harm and improved outcomes in older adults. Methods We will implement four EBPs in 9 VA medical centers and associated outpatient clinics using a type III hybrid effectiveness-implementation stepped-wedge trial design. We selected four EBPs that align with Age-Friendly Health System principles: Surgical Pause, EMPOWER (Eliminating Medications Through Patient Ownership of End Results), TAP (Tailored Activities Program), and CAPABLE (Community Aging in Place – Advancing Better Living for Elders). Guided by the Pragmatic Robust Implementation and Sustainability Model (PRISM), we are comparing implementation as usual vs. active facilitation. Reach is our primary implementation outcome, while “facility-free days” is our primary effectiveness outcome across evidence-based practice interventions. Discussion To our knowledge, this is the first large-scale randomized effort to implement “Age-Friendly” aligned evidence-based practices. Understanding the barriers and facilitators to implementing these evidence-based practices is essential to successfully help shift current healthcare systems to become Age-Friendly. Effective implementation of this project will improve the care and outcomes of older Veterans and help them age safely within their communities. Trial registration Registered 05 May 2021, at ISRCTN #60,657,985. Reporting guidelines Standards for Reporting Implementation Studies (see attached).

Strict coordination of proliferation and programmed cell death (apoptosis) is essential for normal physiology. An imbalance in these two opposing processes results in various diseases including AIDS, neurodegenerative disorders, myelodysplastic syndromes, ischemia/reperfusion injury, cancer, autoimmune disease, among others. Objective and quantitative noninvasive imaging of apoptosis would be a significant advance for rapid and dynamic screening as well as validation of experimental therapeutic agents. Here, we report the development of a recombinant luciferase reporter molecule that when expressed in mammalian cells has attenuated levels of reporter activity. In cells undergoing apoptosis, a caspase-3-specific cleavage of the recombinant product occurs, resulting in the restoration of luciferase activity that can be detected in living animals with bioluminescence imaging. The ability to image apoptosis noninvasively and dynamically over time provides an opportunity for high-throughput screening of proapoptotic and antiapoptotic compounds and for target validation in vivo in both cell lines and transgenic animals.

From his perspective as a general surgeon, Episcopal priest and Medical Director for High Risk Populations and Outcomes at a large health-care system, the author identifies an unrecognized problem that clergy were banned from visiting parishioners in most hospitals across the country during the height of the Covid-19 pandemic—a situation that persists in many contexts. The author explains why pastoral visitation should be considered essential care—especially at a time of crisis—and encourages hospital administrators across the country to clarify policies to welcome community clergy as essential personnel, but to do so with prudent procedures that mitigate risk to the community and to the visiting clergy. Given the fact that most hospitals in this country were founded by religious organizations and still carry the imprint of that founding in their names, it would be tragic for these very same hospitals to cut patients off from their religious communities precisely at the time they need them most.

Abstract BACKGROUND With an aging population, elderly patients with multiple comorbidities are more frequently undergoing spine surgery and may be at increased risk for complications. Objective measurement of frailty may predict the incidence of postoperative adverse events. OBJECTIVE To investigate the associations between preoperative frailty and postoperative spine surgery outcomes including mortality, length of stay, readmission, surgical site infection, and venous thromboembolic disease. METHODS As part of a system-wide quality improvement initiative, frailty assessment was added to the routine assessment of patients considering spine surgery beginning in July 2016. Frailty was assessed with the Risk Analysis Index (RAI), and patients were categorized as nonfrail (RAI 0-29) or prefrail/frail (RAI ≥ 30). Comparisons between nonfrail and prefrail/frail patients were analyzed using Fisher's exact test for categorical data or by Wilcoxon rank sum tests for continuous data. RESULTS From August 2016 through September 2018, 668 patients (age of 59.5 ± 13.3 yr) had a preoperative RAI score recorded and underwent scheduled spine surgery. Prefrail and frail patients suffered comparatively higher rates of mortality at 90 d (1.9% vs 0.2%, P < .05) and 1 yr (5.1% vs 1.2%, P < .01) from the procedure date. They also had longer in-hospital length of stay (LOS) (3.9 d ± 3.6 vs 3.1 d ± 2.8, P < .001) and higher rates of 60 d (14.6% vs 8.2%, P < .05) and 90 d (15.8% vs 9.8%, P < .05) readmissions. CONCLUSION Preoperative frailty, as measured by the RAI, was associated with an increased risk of readmission and 90-d and 1-yr mortality following spine surgery. The RAI can be used to stratify spine patients and inform preoperative surgical decision making. Graphical Abstract Graphical Abstract

Professionalism and ethics are Accreditation Council for Graduate Medical Education (ACGME) core competencies, but there is little evidence regarding the effectiveness of ethics education. General surgery residents at the University of Pittsburgh completed questionnaires measuring attitudes and knowledge about surgical ethics before and after four 60-minute, faculty-facilitated seminars implementing the American College of Surgeons ethics curriculum. Most residents experienced ethical challenges at least once every rotation: competition of interests (75%), professional obligations (75%), confidentiality (83%), truth telling (88%), surrogate decision making (91%), and end-of-life issues (100%). The educational intervention increased both knowledge about surgical ethics (P = .013) and confidence in dealing with competition of interests (P = .001), professional obligations (P = .011), truth telling (P = .013), confidentiality (P = .011), end-of-life issues (P = .007), and surrogate decision making (P = .052). Most residents recommended the American College of Surgeons text for future use (84%), considering ethics education a “standard” part of residency training (70%). Focused instruction using the American College of Surgeons ethics curriculum can effectively improve both knowledge and confidence about surgical ethics.