Monoclonal Anti-PCSK9 Antibodies: Real-World Data.

Background: Real-world data on the use of lipid-lowering therapy (LLT) in clinical practice show that about 80% of (very) high-cardiovascular (CV)-risk patients disregard the 2019 European Society of Cardiology (ESC) Guidelines' recommendations on dyslipidemias. The availability of proprotein convertase subtilisin/kexin type 9 monoclonal antibodies (PCSK9mAb) should reduce this gap. Our aim was to provide data on PCSK9mAb use in clinical practice, investigating the achievement of the ESC Guidelines' recommendations in the real world. Methods: Between April 2018 and December 2022, patients who started on PCSK9mAb therapy (140 mg of evolocumab or 75 mg or 150 mg of alirocumab, subcutaneous injection every 2 weeks) were included in a prospective registry. Our cohort consisted of 256 patients: 95 (37.1%) were women (mean age: 65.43 ± 11.12 yrs), 53 (20.7%) were at high CV risk, and 203 (79.3%) were at very high CV risk. Results: After one year of PCSK9mAb treatment, nearly 60% of patients demonstrated full adherence to the ESC Guidelines' recommendations, defined as achieving at least a 50% reduction in low-density lipoprotein cholesterol (LDL-C) levels along with reaching LDL-C target levels (≤55 and ≤70 mg/dL for very high and high risk, respectively). Concomitant high-dose statin therapy emerged as the primary predictor of LDL-C target attainment. Heterozygous familial hypercholesterolemia (HeFH), statin intolerance, and female gender were associated with a significant lower probability of achieving LDL-C target levels. Conclusions: Our analysis confirms that PCSK9mAb treatment is safe and effective, enabling 60% of our cohort to fully achieve the LDL-C guideline recommendations. The use of high-intensity statins emerged as a significant predictor of efficacy. Conversely, familial hypercholesterolemia and female gender were identified as predictors of therapeutic failure. Hence, it is crucial to address disparities in cardiovascular disease prevention between genders and to enhance strategies for managing elevated LDL-C in HeFH patients.

General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections-a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial).

BACKGROUND: The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. METHODS: We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3-4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2-3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. DISCUSSION: In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. TRIAL REGISTRATION: ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. PROTOCOL VERSION: 2 (5 December 2022).

Effectiveness of R-CHOP versus R-CHOEP for treatment of young patients with high-risk diffuse large B-cell lymphoma: A Danish observational population-based study.

PURPOSE: Etoposide to standard R-CHOP is used for high-risk diffuse large B-cell lymphoma (DLBCL) in some countries. Due to the lack of randomized trials, a real-world data study using matching methods was used to test the potential effectiveness of R-CHOEP over R-CHOP. PATIENTS AND METHODS: This study included patients from the Danish Lymphoma Register diagnosed between 2006 and 2020 at the age of 18-60 years with de novo DLBCL and age-adjusted IPI ≥2. R-CHOEP treated patients were matched 1:1 without replacement to R-CHOP treated patients using a hybrid exact and genetic matching technique. Primary endpoints were progression-free survival (PFS) and overall survival (OS). RESULTS: In total, 396 patients were included; 213 received R-CHOEP and 183 received R-CHOP. Unadjusted 5-year PFS and OS for R-CHOEP were 69% (95% Confidence intervals [CI]; 63%-76%) and 79% (CI;73%-85%) versus 62% (CI;55%-70%) and 76% (CI;69%-82%) for R-CHOP (log-rank test, PFS p = .25 and OS p = .31). A total of 127 patients treated with R-CHOEP were matched to 127 patients treated with R-CHOP. Matching-adjusted 5-year PFS and OS were 65% (CI; 57%-74%) and 79% (CI; 72%-84%) for R-CHOEP versus 63% (CI; 55%-73%) and 79% (CI;72%-87%) for R-CHOP (log-rank test, PFS p = .90 and OS p = .63). CONCLUSION: The present study did not confirm superiority of R-CHOEP over R-CHOP for young patients with high-risk DLBCL.

Oral Cancer Risk and Screening Prevalence Among Hospitalized Women.

Background Oral cancer screenings are often on the back burner in the face of other cancer screenings. In high-risk individuals, early detection of oral cancer has a better prognosis and survival. Hospitalization may offer an opportunity to target high-risk populations. This study evaluates the prevalence of women at high risk for oral cancer among hospitalized women and their preference for oral cancer screening. Design and participants Five hundred and ten cancer-free women admitted to the hospital under the internal medicine service at an academic center were enrolled to participate in the study. Three hundred and seventy women were at high risk for developing oral cancer, defined by smoking status, alcohol use, or both. High-risk women received bedside smoking cessation counseling and oral cancer informational handouts and were offered oral screening examinations during hospitalization. Six months after discharge, study participants received a follow-up phone call to determine if these women discussed oral cancer screening with their primary care physicians at the follow-up visit. Results Seventy-three percent of the hospitalized women were at high risk for developing oral cancer. Fifty-seven percent of high-risk women reported having no primary dentist. High-risk women were more likely to be younger, reported a disability, and had a lower comorbidity burden than the average-risk group. Only 41% of high-risk hospitalized women received oral cancer screening examinations during the hospital stay. Post-hospitalization, 66% of high-risk patients discussed oral cancer screening with their primary care. Conclusion Almost three-fourths of hospitalized women are at high risk for developing oral cancer. Hospitalization provides an opportunity to educate and screen high-risk populations.

Assessing the Feasibility and Effectiveness of Screening for Indoor Tanning in the Primary Care Setting: A Report of Preliminary Findings.

Introduction: Indoor tanning is a major modifiable risk factor in the development of both melanoma and nonmelanoma skin cancers. Investigation of behavior-altering interventions is an area of active research. As with other preventive measures, screening of high-risk populations can be an important aspect of a multimodality public health intervention. This study sought to further the limited understanding of indoor tanning screening practices in the primary care setting. Methods: Physicians practicing within the scope of primary care in the northeast were surveyed in 2022 on practice patterns around the frequency of indoor tanning screening, barriers encountered with implementing screening, and actions taken with a positive screen. Research methodology adhered to the Joanna Briggs Institute critical appraisal checklist. Results: Of 26 primary care physicians, only 7.7% routinely screened for indoor tanning. Barriers identified included time limitations (76.9%) and prioritization of other health concerns (96.2%). All primary care physicians (100%) reacted to reports of indoor tanning with an intervention, most commonly counseling on the risks of indoor tanning (92.6%). Conclusions: This data suggest that screening for indoor tanning use could be improved. The authors recommend the incorporation of a standardized screening question regarding indoor tanning in intake forms.

Early laparoscopic cholecystectomy in severely comorbid patients with acute cholecystitis: results of a monocentric study.

Aim: The aim is to evaluate laparoscopic cholecystectomy safety based on American Society of Anesthesiologists score for acute cholecystitis in patients with comorbidities. Patients & methods: This is retrospective study of patients who underwent laparoscopic cholecystectomy for acute cholecystitis between 2003 and 2021. According to their respective ASA-score, patients were divided into group 1: ASA1-2 and group 2: ASA3-4. Results: We collected 578 patients. Even though the gangrenous forms were more frequent and the operative time was longer in group 2, laparoscopic cholecystectomy seems safe and effective. We didn't observe any differences in terms of intraoperative incidents, open conversion rate, or postoperative complications compared with other patients. Conclusion: ASA3-4 patients with acute cholecystitis don't face elevated risks of complications or mortality during laparoscopic cholecystectomy.

This study, involving 578 patients with acute cholecystitis, assessed the safety of early laparoscopic cholecystectomy based on their health scores. Despite longer operative times and more gangrenous forms in higher-scored patients, laparoscopic cholecystectomy was found to be safe and effective. No significant differences in complications or mortality were observed compared with lower-scored patients. In conclusion, early laparoscopic cholecystectomy is considered a safe option for patients with higher health scores facing acute cholecystitis.

Study assessed laparoscopic cholecystectomy safety in high-risk patients with acute cholecystitis based on ASA scores. Despite longer operative times, it's a safe and effective option. #CholecystectomySafety.

Safety of high-risk diabetic patients during Ramadan at a tertiary care hospital in Pakistan, practicing updated IDF DAR guidelines.

Objective: To determine trend of following medical advice and safety of high-risk diabetic patients during Ramadan practicing updated IDF DAR guidelines. Methods: The cross-sectional study was conducted at Outpatient Department of Diabetes, Endocrinology and Metabolic Disorders Hayatabad Medical Complex Peshawar, Pakistan from April to June 2022, and comprised of high-risk diabetic patients (>6.0) based on updated IDF-DAR guidelines 2022 intending to fast. A questionnaire was designed to document patient risk factors score, type and duration of diabetes, HbA1c, comorbidities and complications developed during Ramadan. Data was analyzed using SPSS 20. Results: Among all 130 participants, 78(60%) followed medical advice and did not fast and 52(40%) patients fasted against medical advice during month of Ramadan. Out of 130 participants, 89.2% were having type-2 diabetes Mellitus, 55.4% were female and mean age of participants was 52+14.6.40%. In fasting group, 57.7% were in the age range of 16 to 50 years while in non-fasting group 69.2% participants were more than 50 years old (P-value 0.031). There were 80.8% female participants in fasting group versus 38.5% in non-fasting group (P-value 0.001). Hypoglycemia occurred in 58.3% patients in fasting group and 29.3% non-fasting group. (P-value 0.021). On the other hand, 27.8% patients in fasting group and 55.2% of non-fasting group had hyperglycemia (P-value 0.025). Conclusion: Despite advised against fasting in these high-risk patients as per IDF DAR guidelines, almost half of patients fasted considering fasting a religious obligation. Those who fasted had significant hypoglycemia despite adjustment of medications as in guidelines. There is need of more intensive education before fasting, especially in high-risk diabetic patients.

Topical tacrolimus for high-risk corneal transplantation: a randomized, clinical trial.

BACKGROUND: The prevalence of rejection is 10-30% in penetrating keratoplasty (PKP) case, and the rate is higher in cases of high-risk patients. Although using topical corticosteroids is a standard method for management the rejection of post-PKP patients, it may not be sufficiently potent in high-risk patients. Topical administration of tacrolimus (TAC) may be effective in suppression rejection after corneal transplantation. This study aimed to investigate the efficacy and safety of topical TAC in high-risk PKP patients in Japan. METHODS: This study was a single centre, single-blinded, randomized controlled trial. Patients with a history of PKP, graft rejection, atopic dermatitis, or deep corneal neovascularisation who underwent PKP were enrolled. They were randomly assigned to receive 0.1% TAC ophthalmic suspension or artificial tear (AT) up to week 52 after surgery. All participants received 0.1% betamethasone up to week 13 after surgery then they received 0.1% fluorometholone up to week 52. The incidence of immunological rejection during the observation period was the main outcome measure in this study. RESULTS: Thirty patients were enrolled in this study, and 12 eyes in the TAC group and 13 eyes in the AT group completed the study, respectively. Five out of 30 patients discontinued participation after providing informed consent. No serious adverse effects were developed in patients who received 0.1% TAC ophthalmic suspension. No rejection episodes occurred in the TAC group, while one eye in the AT group had rejection. Graft clarity, best spectacle-corrected visual acuity, intraocular pressure, and corneal endothelial cell density were not significantly different between the TAC and AT groups. CONCLUSION: Our results demonstrated that good tolerability of 0.1% TAC ophthalmic suspension. However, we failed to demonstrate its efficacy in preventing immunological rejection in high-risk patients undergoing PKP. TRIAL REGISTRATION: This study was first registered in the University Hospital Medical Information Network (UMIN000029669, Date of registration: November 1, 2017). With the enforcement of the Clinical Trial Act in Japan, the study re-registered in the Japan Registry of Clinical Trials (jRCTs031180342, Date of registration: March 18, 2019).

Understanding early deaths after major emergency abdominal surgery: An observational study of 754 patients.

BACKGROUND: Major emergency abdominal surgery is associated with severe postoperative complications and high short- and long-term mortality. Despite recent advancements in standardizing multidisciplinary care bundles, a subgroup of patients continues to face a heightened risk of short-term mortality. This study aimed to identify and describe the high-risk surgical patients and risk factors for short-term postoperative mortality. METHODS: In this study, we included all patients undergoing major emergency abdominal surgery over 2 years and collected data on demographics, intraoperative variables, and short-term outcomes. The primary outcome measure was short-term mortality and secondary outcome measures were pre, intra, and postoperative risk factors for premature death. Multivariable binary regression analysis was performed to determine possible risk factors for short-term mortality. RESULTS: Short-term mortality within 14 days of surgery in this cohort of 754 consecutive patients was 8%. Multivariable analysis identified various independent risk factors for short-term mortality throughout different phases of patient care. These factors included advanced age, preoperative history of myocardial infarction or ischemic heart disease, chronic obstructive pulmonary disease, liver cirrhosis, chronic kidney disease, and vascular bowel ischemia or perforation of the stomach or duodenum during the primary surgery. CONCLUSION: Patients at high risk of early mortality following major emergency abdominal surgery exhibited distinct perioperative risk factors. This study underscores the importance of clinicians identifying and managing these factors in high-risk patients to ensure optimal care.

Noninvasive respiratory support in the perioperative setting: a narrative review.

The application of preoperative noninvasive respiratory support (NRS) has been expanding with increasing recognition of its potential role in this setting as a physiological optimization for patients with a high risk of developing atelectasis and postoperative pulmonary complications (PPC). The increased availability of high-performance anesthesia ventilator machines providing an easy way for NRS support in patients with reduced lung function should not be under-evaluated. This support can reduce hypoxia, restore lung volumes and theoretically reduce atelectasis formation after general anesthesia. Therapeutic purposes should also be considered in the perioperative setting, such as preoperative NRS to optimize treatment of patients' pre-existing diseases, e.g., sleep-disordered breathing. Finally, the recent guidelines for airway management suggest preoperative NRS application before anesthesia induction in difficult airway management to prolong the time needed to secure the airway with an orotracheal tube. This narrative review aims to revise all these aspects and to provide some practical notes to maximize the efficacy of perioperative noninvasive respiratory support.

Combined Lumbar Plexus-Sciatic Nerve Block for Urgent Lower Limb Surgery: A Good Alternative in Patients With High Anesthetic Risk.

The use of peripheral nerve blocks has grown significantly in recent years not only because of the progress and availability of the materials necessary for its realization but also for enhancing patient safety. Anesthesia in the elderly or individuals with high anesthetic risk is always a challenge for the practitioner. Hence, the importance of peripheral nerve blocks in avoiding the side effects associated with general or spinal anesthesia. In this report, we present a case series of five patients with high anesthetic risk (classified American Society of Anesthesiologists (ASA) III or IV) who underwent different lower limb surgeries under a combined lumbar plexus-sciatic nerve block. The goal of this case series was to evaluate the effectiveness of this technique as an anesthetic alternative for these different types of surgical procedures.

Routine Functional Testing or Standard Care in High-Risk Patients after Percutaneous Coronary Intervention.

PURPOSE OF REVIEW: This review aimed to collate the available evidence on outcomes following routine functional stress testing vs standard of care (i.e. symptom-guided stress testing) in high-risk patients following percutaneous coronary intervention (PCI). RECENT FINDINGS: The most recent pragmatic POST-PCI trial provided randomized evidence showing that routine functional stress testing post-PCI did not lead to a reduction in 2-year ischemic cardiovascular events or all-cause mortality, as compared to a symptom-guided standard-of-care approach. This was also true for sub-analyses including multivessel or left main disease, diabetics, as well as following imaging or physiology guided PCI. In the absence of a change in their clinical or functional status suggestive of stent failure, post-PCI routine periodic stress testing in stable patients on guideline-directed medical therapy is currently not recommended by American clinical practice guidelines. While evidence on the cost-effectiveness of routine stress testing strategy is scarce, physician, payer, and policy-level interventions to reduce inappropriate use of routine functional testing need to be addressed.

The Management of Patients at High Risk of Serious COVID-19 Disease: Optimising the Patient Pathway in the Middle East, Africa, and Eastern Europe.

Introduction For patients at high risk of severe COVID-19 disease, antiviral therapeutic options are available to reduce the risk of hospitalization or death. Although many countries have developed national guidelines for COVID-19 management that include use of antiviral agents, it is unclear how these guidelines are used in daily clinical practice. This study aims to assess the management of high-risk COVID-19 patients in the Middle East, Africa, and Eastern Europe, with a focus on understanding current practices, challenges, and potential strategies for improvement. Methods Healthcare professionals (HCPs) from the Middle East, Africa, and Eastern Europe came together at a regional summit in February 2023 to share perspectives on the therapeutic management of patients at high risk of serious COVID-19 disease in the community. Summit participants represented diverse medical specialties, geographical regions, and healthcare settings. Key insights gathered during the summit were supplemented with evidence from the published literature via a non-systematic literature search of MEDLINE and online sources such as government reports since the start of 2020 to identify articles on disease burden, unmet needs, treatment access, antiviral therapy, guidelines related to individuals with COVID-19 at high-risk for poor outcomes in low- and middle-income countries (LMICs). Together, these sources were used by the authors to generate their recommendations for future priorities and optimal care pathways globally. Results Specific insights gathered from the summit were that participants reported that primary care is the first point of contact for high-risk patients, but the role of primary care physicians (PCPs) in treatment is uncertain. Additionally, participants highlighted that between-country differences in the care pathway for high-risk patients are due to variations in local treatment practices, healthcare system structures, and resourcing. In line with the published literature, participants agreed that HCP education is needed to support the identification, counseling, and appropriate management of high-risk patients and that pharmacists have a critical role to play in identifying clinically important potential interactions with antiviral treatment and recommending appropriate adjustments. Furthermore, patient hesitancy can result in late presentation, delayed treatment, and potential progression of symptoms. HCPs should proactively counsel high-risk patients, so they are aware of their risk and its implications and understand what to do if they experience symptoms of COVID-19. Targeted educational initiatives for patients are needed to mitigate reluctance to undergo COVID-19 testing and counter COVID-19 misinformation. Conclusion Collaboration among stakeholders is essential to optimize COVID-19 management for high-risk patients globally, ensuring effective implementation of guidelines and improving outcomes.

Uric acid and acute kidney injury in high-risk patients for developing acute kidney injury undergoing cardiac surgery: A prospective multicenter study.

PURPOSE: It is unclear whether preoperative serum uric acid (SUA) elevation may play a role in the development of acute kidney injury (AKI) associated with cardiac surgery (CSA-AKI). We conducted a cohort study to evaluate the influence of preoperative hyperuricemia on AKI in patients at high risk for developing SC-AKI. DESIGN: Multicenter prospective international cohort study. SETTING: Fourteen university hospitals in Spain and the United Kingdom. PARTICIPANTS: We studied 261 consecutive patients at high risk of developing CSA-AKI, according to a Cleveland score ≥ 4 points, from July to December 2017. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: AKIN criteria were used for the definition of AKI. Multivariable logistic regression models and propensity score-matched pairwise analysis were used to determine the adjusted association between preoperative hyperuricemia (≥7 mg/dL) and AKI. Elevated preoperative AUS (≥7 mg/dL) was present in 190 patients (72.8%), whereas CSA-AKI occurred in 145 patients (55.5%). In multivariable logistic regression models, hyperuricemia was not associated with a significantly increased risk of AKI (adjusted Odds Ratio [OR]: 1.58; 95% confidence interval [CI]: 0.81-3; P = .17). In propensity score-matched analysis of 140 patients, the hyperuricemia group experienced similar adjusted odds of AKI (OR 1.05, 95%CI 0.93-1.19, P = .37). CONCLUSIONS: Hyperuricemia was not associated with an increased risk of AKI in this cohort of patients undergoing cardiac surgery at high risk of developing CSA-AKI.

Role of Carotid Ultrasonography Combined with Monocyte/HDL Ratio in Internal Carotid Artery Stenosis.

BACKGROUND: Carotid duplex ultrasonography (DUS) is the primary screening tool for carotid artery stenosis, but has low reliability. MHR, which is the ratio of monocytes to high-density lipoprotein cholesterol (HDL-C), can be a marker for the degree and distribution of extracranial and intracranial atherosclerotic stenosis. OBJECTIVE: We determined the diagnostic value of DUS+MHR for internal carotid artery (ICA) stenosis. METHODS: We divided 273 hospitalized patients into non-stenosis (<50%) and ICA stenosis (≥50%) groups based on Digital Subtraction Angiography (DSA). We determined the peak systolic velocity (PSV) in the ICA on DUS, calculated the MHR, and investigated their relationship with ICA stenosis. RESULTS: On DSA, 34.1% (93/273) patients had moderate-to-severe ICA stenosis. DUS and DSA showed low concordance for detecting ICA stenosis (kappa = 0.390). With increasing age, the incidence of moderate-to-severe ICA stenosis increased. PSV, monocyte count, and MHR were significantly greater in the stenosis group than in the non-stenosis group (P < 0.001), while the HDL-C level was significantly lower (P = 0.001). PSV (OR: 1.020, 95% CI: 1.011-1.029, P < 0.001) and MHR (OR: 5.662, 95% CI: 1.945-16.482, P = 0.002) were independent risk factors for ICA stenosis. The area under the receiver operating characteristic curve of PSV+MHR (0.819) was significantly higher than that of PSV or MHR alone (77.42% sensitivity, P = 0.0207; 73.89% specificity, P = 0.0032). CONCLUSION: The combination of ICA PSV on DUS and MHR is better than PSV alone at identifying ICA stenosis and is well-suited to screen high-risk patients.

Safety profile of recombinant adjuvanted anti-herpes zoster vaccine (RZV) in high-risk groups: Data from active surveillance program. Puglia (Italy), 2021-23.

BACKGROUND: Since 2021 a recombinant adjuvanted anti-Herpes Zoster vaccine(Recombinant Zoster Vaccine, RZV) is offered in Italy to high-risk patients. Few real-life data about RZV safety are available in target populations. OBJECTIVES: This study investigates Adverse Events Following Immunization(AEFIs), baseline disease flare-ups, and Herpes Zoster (HZ) episodes occurring after RZV administration in a heterogeneous population of fragile patients to design its safety profile. METHODS: This is a retrospective population-based study. RZV-vaccinated patients at Bari Policlinico General Hospital vaccination clinic from October 1st, 2021, to March 31st, 2023, were enrolled. Subjects were screened for reason of RZV eligibility and baseline chronic pathologies. AEFIs occurred in the first 7-days post-vaccination period were collected, and baseline disease flare-ups and post-vaccination HZ episodes were assessed via a 3-month follow-up. RESULTS: Five-hundred-thirty-eight patients were included and total of 1,031 doses were administered. Most patients were vaccinated due to ongoing immunosuppressive therapy(54.65 %); onco-hematological and cardiovascular conditions were the most common chronic baseline pathologies. Out of 1,031 follow-ups, 441 AEFI cases were reported(42.7/100). The most common symptoms were injection site pain/itching(35.60/100), asthenia/malaise(11.44/100), and fever (10.09/100). Four serious AEFIs occurred(0.38/100). Older age, male sex, and history of cardiovascular diseases(OR:0.71; 95CI:0.52-0.98; p-value <0.05) were found to decrease AEFIs risk, while endocrine-metabolic illnesses(OR:1.61; 95CI:1.15-2.26; p-value <0.05) increased it. Twelve patients(2.23 %) reported a flare-up/worsening of their baseline chronic condition within the first three months after vaccination(mean interval 31.75 days, range 0-68 days). Patients with rheumatological illnesses had a higher risk of relapse(OR:16.56; 95CI:3.58-76.56; p-value <0.001), while male sex behaved as a protective factor. Twelve patients who completed the vaccination cycle(2.43%) had at least one HZ episode by the long-term follow-up. CONCLUSIONS: The study demonstrates RZV safety in a significant number of high-risk patients. Hence, RZV should be actively offered as part of tailored vaccination programs to decrease the burden of HZ in fragile populations.

Academic Detailing as a Health Information Technology Implementation Method: Supporting the Design and Implementation of an Emergency Department-Based Clinical Decision Support Tool to Prevent Future Falls.

BACKGROUND: Clinical decision support (CDS) tools that incorporate machine learning-derived content have the potential to transform clinical care by augmenting clinicians' expertise. To realize this potential, such tools must be designed to fit the dynamic work systems of the clinicians who use them. We propose the use of academic detailing-personal visits to clinicians by an expert in a specific health IT tool-as a method for both ensuring the correct understanding of that tool and its evidence base and identifying factors influencing the tool's implementation. OBJECTIVE: This study aimed to assess academic detailing as a method for simultaneously ensuring the correct understanding of an emergency department-based CDS tool to prevent future falls and identifying factors impacting clinicians' use of the tool through an analysis of the resultant qualitative data. METHODS: Previously, our team designed a CDS tool to identify patients aged 65 years and older who are at the highest risk of future falls and prompt an interruptive alert to clinicians, suggesting the patient be referred to a mobility and falls clinic for an evidence-based preventative intervention. We conducted 10-minute academic detailing interviews (n=16) with resident emergency medicine physicians and advanced practice providers who had encountered our CDS tool in practice. We conducted an inductive, team-based content analysis to identify factors that influenced clinicians' use of the CDS tool. RESULTS: The following categories of factors that impacted clinicians' use of the CDS were identified: (1) aspects of the CDS tool's design (2) clinicians' understanding (or misunderstanding) of the CDS or referral process, (3) the busy nature of the emergency department environment, (4) clinicians' perceptions of the patient and their associated fall risk, and (5) the opacity of the referral process. Additionally, clinician education was done to address any misconceptions about the CDS tool or referral process, for example, demonstrating how simple it is to place a referral via the CDS and clarifying which clinic the referral goes to. CONCLUSIONS: Our study demonstrates the use of academic detailing for supporting the implementation of health information technologies, allowing us to identify factors that impacted clinicians' use of the CDS while concurrently educating clinicians to ensure the correct understanding of the CDS tool and intervention. Thus, academic detailing can inform both real-time adjustments of a tool's implementation, for example, refinement of the language used to introduce the tool, and larger scale redesign of the CDS tool to better fit the dynamic work environment of clinicians.

Effect of remimazolam vs propofol in high-risk patients undergoing upper gastrointestinal endoscopy: a non-inferiority randomized controlled trial.

BACKGROUND: Procedural sedation is essential for optimizing upper gastrointestinal endoscopy, particularly in high-risk patients with multiple underlying diseases. Respiratory and circulatory complications present significant challenges for procedural sedation in this population. This non-inferiority randomized controlled trial aims to investigate the safety and comfort of remimazolam compared to propofol for procedural sedation during upper gastrointestinal endoscopy in high-risk patients. METHODS: A total of 576 high-risk patients scheduled to undergo upper gastrointestinal endoscopy are planned to be enrolled in this study and randomly allocated to either the remimazolam or propofol group. The primary outcome measure is a composite endpoint, which includes (1) achieving a Modified Observer's Alertness/Sedation scale (MOAA/S) score ≤ 3 before endoscope insertion, (2) successful completion of the endoscopic procedure, (3) the absence of significant respiratory instability during the endoscopy and treatment, and (4) the absence of significant circulatory instability during the examination. The noninferiority margin was 10%. Any adverse events (AEs) that occur will be reported. DISCUSSION: This trial aims to determine whether remimazolam is non-inferior to propofol for procedural sedation during upper gastrointestinal endoscopy in high-risk patients, regarding success rate, complication incidence, patient comfort, and satisfaction. TRIAL REGISTRATION {2A AND 2B}: Chinese Clinical Trial Registry ClinicalTrials.gov ChiCTR2200066527. Registered on 7 December 2022.