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    Can shared decision-making interventions increase trust/trustworthiness in the physician-patient encounter? A scoping review

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    Objectives: To summarize the existing literature on the impact of shared decision-making (SDM) interventions on patient trust, with a focus on the specific characteristics that influence the effectiveness of each intervention regarding the outcome of trust. Methods: We conducted a systematic search of the literature with the aid of a research librarian. Data was extracted via Covidence regarding the characteristics of the study including interventions performed, trust scale used, primary and secondary outcomes, and effect size. Results: From 6090 articles, 97 met criteria for full text review and 20 met inclusion criteria. Sixteen of these were original studies while the remaining 4 were secondary analyses. Eight studies reported a statistically significant increase in trust within the intervention group compared to controls while 12 reported no statistically significant changes. None had trust as a primary outcome. Conclusion: Interventions aimed at increasing SDM have the ability to increase trust, but do not always succeed at doing so. Practice implications: The results indicate that increasing SDM can improve trust in the physician-patient relationship, especially when SDM results in improved communication from clinicians. Further studies should look at populations with low baseline trust since a ceiling effect can occur with trust scales. Keywords: Decision aids; Interventions; Scoping review; Shared decision-making; Trust

    Blood Transfusion in Patients With Acute Myocardial Infarction, Anemia, and Heart Failure: Lessons From MINT

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    Background: Blood transfusion may precipitate adverse outcomes, including heart failure (HF), among patients with acute myocardial infarction (MI). This study characterizes the effects of a restrictive or liberal transfusion strategy on outcomes in patients with MI and anemia with and without baseline HF. Methods: In the MINT trial (Myocardial Ischemia and Transfusion), 3504 patients with MI and anemia (hemoglobin \u3c10 g/dL) were randomized to a restrictive (hemoglobin \u3c8 g/dL) or liberal (hemoglobin \u3c10 g/dL) transfusion strategy. We compared the effects of transfusion strategy on outcomes among patients with and without baseline HF. The primary outcome was death or HF at 30 days. Results: Compared with patients without baseline HF (n=1633), those with baseline HF (n=1871) had higher rates of death or HF (18.0% versus 10.0%) at 30 days. Restrictive transfusion resulted in numerically higher rates of death or HF (rate ratio, 1.20 [95% CI, 0.99-1.45] versus 0.94 [95% CI, 0.70-1.26]; Pinteraction=0.18) in patients with than in those without baseline HF. Among secondary outcomes, death or recurrent MI and death were more frequent among those with baseline HF. Restrictive transfusion resulted in numerically higher rates of death or MI and death in patients with than in those without baseline HF. Rates of HF were similar between restrictive and liberal transfusion in patients with baseline HF but lower with restrictive transfusion (rate ratio, 0.51 [95% CI, 0.29-0.92]; Pinteraction=0.02) in patients without baseline HF. Conclusions: A liberal transfusion strategy is safe for patients with MI and anemia, including those with baseline HF. Restrictive transfusion tended to result in worse outcomes, particularly in patients with baseline HF. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02981407. Keywords: anemia; heart failure; hemoglobin; myocardial infarction

    Mineralocorticoid Receptor Antagonist versus Placebo in a Patient With End-Stage Kidney Disease Under Renal Replacement Therapy: A Systematic Review and Meta-Analysis

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    The number of patients living with chronic kidney diseases is increasing, and so are the patients with end-stage renal disease (ESRD) undergoing renal replacement therapy. Although there is a common understanding that these patients face higher risks of fatal or nonfatal cardiovascular and cerebrovascular events, and mineralocorticoid receptor antagonists (MRAs) have been an essential pillar in managing heart failure, their use in this subset of patients has been overshadowed because of concerns of hyperkalemia. Patients with ESRD under renal replacement therapy have often been excluded from landmark trials. This meta-analysis was conducted based on the PRISMA guideline after registering the protocol with PROSPERO (CRD42024499835). A database search included articles until April 2024, and relevant data were extracted from the included studies. Analysis was done using RevMan web (version 5.4). A total of 15 studies among 1086 studies were included in the final analysis. Our meta-analysis revealed MRA significantly reduced all-cause mortality (odds ratio (OR) 0.35, confidence interval (CI), 0.23-0.54) and cardiovascular mortality (OR 0.37, 0.21-0.65). With some possible increase in the risk of hyperkalemia (OR 1.56, CI, 1.01-2.42), with no discernible difference in the occurrence of stroke (OR 0.57, CI, 0.25-1.28) or myocardial infarction (OR 0.63, CI, 0.08-4.72). The utilization of MRA in patients with ESRD under dialysis is linked to improved mortality outcomes, albeit with slight concerns for hyperkalemia. Although current evidence leans toward MRA usage, prospective randomized controlled trials involving a broader patient cohort are essential to establish robust guidance for MRA application in this subset of patients. Keywords: end-stage kidney disease; hyperkalemia; mineralocorticoid receptor antagonist; spironolactone

    Individual- vs Neighborhood-Level Measures of Social Risk

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    Efficacy of paclitaxel-coated versus uncoated balloon angioplasty for revascularization of coronary in-stent restenosis: a meta-analysis and metaregression

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    Background: Treatment of in-stent restenosis (ISR) accounts for 10% of percutaneous coronary interventions in the USA. Paclitaxel-coated balloons (PCBs) are an alternative to uncoated balloons (UCBs) for ISR. Methods: We systematically searched PubMed, Scopus, and Cochrane Central for studies comparing PCB with UCB in treating ISR. Outcomes included late lumen loss, binary restenosis, target lesion revascularization (TLR), and major adverse cardiovascular events (MACE). Results: Eight trials including 1410 patients [PCB in 865 (61%), follow-up 6 months to 10 years) were identified. Angiographic outcomes of late lumen loss [mean difference: -0.50 mm; 95% confidence interval (CI): -0.66 to -0.33; P \u3c 0.01] and binary restenosis [relative risk (RR): 0.22; 95% CI: 0.13-0.40; P \u3c 0.01] at 6-8 months were lower with PCB. TLR at 6 months (RR: 0.16; 95% CI: 0.06-0.40; P \u3c 0.001) and 1 year (RR: 0.45; 95% CI: 0.31-0.66; P \u3c 0.001), MACE at 6 months (RR: 0.25; 95% CI: 0.16-0.38; P \u3c 0.001), MACE at 3-5 years (RR: 0.54; 95% CI: 0.37-0.80; P = 0.002), and TLR at 3-5 years (RR: 0.51; 95% CI: 0.29-0.90; P = 0.021) were lower with PCB. Meta-regression revealed that ISR lesions in the left anterior descending artery were associated with lower rates of binary restenosis while the opposite was observed for left circumflex lesions. Conclusion: Revascularization of coronary ISR with PCB is associated with reduced late lumen loss, binary restenosis, TLR, CCE, and MACE. PCB may be a preferred strategy for coronary ISR. Keywords: balloon angioplasty; coronary artery disease; drug-coated balloon; in-stent restenosis; paclitaxel-coated balloon

    Breast cancer screening for transgender individuals with breast cancer susceptibility genes

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    Transgender individuals represent a growing and very heterogeneous population, yet there are no precise estimates of their breast cancer risk and equitable breast cancer screening guidelines. They have lower rates of healthcare utilization and face disproportionate discrimination in comparison to cisgender individuals. Unfortunately, most national databases continue to report binary gender. Gender affirming hormone therapy (GAHT), surgical history, and psychosocial factors may complicate risk stratification and breast cancer screening decisions. Those with genetic predisposition to cancer, specifically breast cancer susceptibility genes like BRCA1 and BRCA2, face yet another challenge in terms of counselling and screening, given they constitute a rare subgroup. While BRCA pathogenic variants significantly elevate lifetime breast cancer risk in cisgender individuals, evidence-based guidelines for transgender people-specifically those undergoing GAHT or surgical interventions-remain limited. Hence, transgender individuals need to consider a cancer risk assessment before proceeding with gender affirming medical and surgical treatments if they also harbor a breast cancer susceptibility gene. This review article highlights the role of gender affirming treatment and its implications for breast cancer and the recommended optimal screening in transgender individuals with breast cancer susceptibility genes. We emphasize the need for individualized, culturally competent care and advocate for inclusive clinical guidelines accounting for genetic risk as well as gender identity. Keywords: BRCA1; BRCA2; Transgender; breast cancer; breast cancer susceptibility genes

    Long-term Efficacy of Pediatric Anti-reflux Surgery in Reduction of Acid-reducing Medication

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    Introduction: Revision of anti-reflux procedures (ARPs) has contributed to a shift away from surgical management of pediatric gastroesophageal reflux disease. Long-term proton-pump inhibitor and H2 antagonist use, however, is associated with infection and micronutrient malabsorption. This study investigates long-term ARP efficacy in decreasing acid-reduction medication (ARMs) usage. Methods: A retrospective cohort study of pediatric patients undergoing ARP at a single institution was conducted from January 1, 2000 to December 31, 2017, allowing for at least a 6-y follow-up. Eligibility included patients less than 18 y undergoing index ARP. Age, weight, comorbidities, and ARM use were collected. Operative information included procedure type and hospital course. Postoperative information included complications, reoperation, postoperative symptoms, and postoperative ARMs. t-Tests compared continuous outcomes, while chi-square test compared frequency of categorical outcomes. Results: In total, 305 patients were included with a mean (standard deviation) age of 7.2 (6.5) y. In total, 54.7% of patients were male; 70.7% were White, 23% Hispanic, and 5.7% Black. The procedure was laparoscopic for 99.3% and open for 0.7% (n = 2). The most common preoperative symptoms were regurgitation (53.4%) and retrosternal pain (9.2%). Postoperatively, regurgitation remained the most common at 30.8% (n = 94). The most common comorbidities were neurodevelopmental delay (42%, n = 128) and asthma (35.7%, n = 109). 11.8% (n = 33) underwent reoperation. Subsequently, 2.4% (n = 7) of the patients were within 90 d of operation, most commonly for wrap slippage (n = 11) or hiatal hernia (n = 9). AMRs were discontinued in 39.8% (n = 80) of the patients within 30 d and 57.4% (n = 156) at most recent follow-up. It appeared most efficacious for neurodevelopmental delay patients. The mean follow-up was 10 y. Conclusions: More than half of the patients discontinued ARMs following ARP suggesting that surgery remains beneficial in reducing long-term medication use. Keywords: Anti-reflux surgery; Fundoplication; Gastroesophageal reflux; Histamine antagonist; Laparoscopic surgery; Pediatric; Proton pump inhibitor

    A phase 3 study of ravulizumab to protect patients with chronic kidney disease from cardiac surgery-associated acute kidney injury and major adverse kidney events (ARTEMIS)

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    Background: Cardiac procedures, particularly those requiring cardiopulmonary bypass (CPB), are associated with the development of cardiac surgery-associated acute kidney injury (CSA-AKI). Development of CSA-AKI occurs as a result of inflammation, uncontrolled complement activation, and kidney cell damage. In patients with preoperative renal impairment, such as those with chronic kidney disease (CKD), there is an increased risk of both CSA-AKI and poorer clinical outcomes. Currently, there are limited effective, targeted pharmacological interventions for the prevention or treatment of CSA-AKI, although emerging therapies are being investigated, particularly in patients with existing CKD. The ARTEMIS (RAvulizumab to PRotect PaTients with Chronic Kidney DisEase froM CSA-AKI and Subsequent Major Adverse Kidney Events) trial will assess the efficacy and safety of ravulizumab (a complement C5 inhibitor) in reducing the risk of major adverse kidney events (MAKE) in patients with preoperative CKD undergoing non-emergent cardiac surgery with CPB. Methods: This trial is currently recruiting patients with CKD who have planned cardiac surgery requiring CPB including coronary artery bypass grafting, valve replacement or repair, or combined procedures. This is a phase 3, randomized, double-blind, placebo-controlled, global study assessing the efficacy and safety of a single preoperative dose of ravulizumab. These outcomes will be assessed using the occurrence of MAKE and its components, as well as the occurrence and severity of CSA-AKI throughout the study period. Discussion: Complement activation is known to occur during and after cardiac procedures as a result of CPB and ischemia-reperfusion injury, leading to a cycle of cell damage and death. Therefore, it is hypothesized that preoperative administration of ravulizumab will provide immediate and complete complement inhibition, which will be sustained throughout the surgical period, preventing the uncontrolled complement activation associated with the development of CSA-AKI, thus minimizing poor outcomes for patients. Trial registration: ClinicalTrials.gov NCT05746559. Registered on February 27, 2023. Keywords: Cardiac surgery-associated acute kidney injury; Cardiopulmonary bypass; Chronic kidney disease; Complement activation; Interventional study; Ischemia–reperfusion injury; Ravulizumab

    The Association of Prenatal Dietary Factors with Child Autism Diagnosis and Autism-Related Traits Using a Mixtures Approach: Results from the Environmental Influences on Child Health Outcomes Cohort

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    Background: Previous research on the role of maternal diet in relation to autism has focused on examining individual nutrient associations. Few studies have examined associations with multiple nutrients using mixtures approaches, which may better reflect true exposure scenarios. Objectives: This study aims to examine associations of nutrient mixtures with children\u27s autism diagnosis and trait scores within a large, diverse population. Methods: Participants were drawn from the United States Environmental influences on Child Health Outcomes (ECHO) consortium. Maternal prenatal diet was reported via validated food frequency questionnaires. Children\u27s autism-related traits were measured using the Social Responsiveness Scale (SRS) and autism diagnoses were from parent reports of physician diagnosis. Bayesian kernel machine regression was used to examine the overall mixture effect and interactions between a set of 5 primary nutrients (folate, vitamin D, omega 3 and omega 6 fatty acids, and iron), adjusted for potential confounders, in relationship to child outcomes. Secondary analyses were conducted in a subset of cohorts with an expanded set of 14 nutrients. Traditional linear and logistic regression models were also analyzed for comparison of results to mixture models. Results: A total of 2614 participants drawn from 7 ECHO cohorts were included in primary analysis. Mixture analyses suggested that increasing the overall 5-nutrient mixture was associated with lower SRS scores. Individual U-shaped associations and bivariate interactions between folate and omega 3 fatty acids were suggested. In the subset included in the secondary analyses of the 14-nutrient mixture, a modest inverse trend remained, but individual nutrient associations were altered, with vitamin D demonstrating higher relative importance than other nutrients. Strong associations with autism diagnosis were not observed. Conclusions: In this large sample, we found evidence for combined nutrient effects with broader autism-related traits. Because results for individual nutrients were sensitive to mixture components, replication of combined associations between nutrients and autism-related outcomes is needed. Keywords: autism; epidemiology; neurodevelopment; nutrients; statistical mixtures methods

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