Risk-benefit Research Articles

Long-term changes in frailty and incident atrial fibrillation: multicenter prospective cohort study

Abstract Background Atrial fibrillation is the most common sustained cardiac arrhythmia and is prevalent among the elderly. Previous findings indicated a higher prevalence of AF in frail adults and frailty prevalent in AF patients. However, the association between dynamic changes of frailty and risk of new-onset AF is unclear. Purpose We aimed to investigate the associations of long-term changes in frailty with incident AF. Its associations with heart failure (HF), coronary heart disease (CHD), and stroke were also evaluated as a secondary aim. Methods Over 50,000 participants from UK Biobank cohort were included, with available frailty index (FI) data and free of AF, HF, CHD or stroke in both baseline and final follow-up assessments. Participants were categorized into nonfrailty, prefrailty and frailty based on their FI scores. Changes of frailty status from baseline to final follow-up assessment included alleviation, maintenance, and aggravation. Thus, transitions of frailty status included 7 categories: nonfrailty maintenance, nonfrailty aggravation (nonfrailty to prefrailty or frailty), prefrailty alleviation (prefrailty to nonfrailty), prefrailty maintenance, prefrailty aggravation (prefrailty to frailty), frailty alleviation (frailty to prefrailty or nonfrailty), and frailty maintenance. FI in baseline and follow-ups are used to calculate the trajectories of frailty (ΔFI). Cox proportional hazard models were used. Results Compared with nonfrailty at baseline, the HRs (95% CI) of AF for prefrailty and frailty were 1.32 (1.29, 1.36) and 1.89 (1.83, 1.96) in the multivariable-adjusted model. During a median of 5.1 years of follow-up from the final assessment, 1729 cases of AF were recorded. Frailty trajectory analysis showed that even a 0.01 point/year increase in ΔFI was associated with 14% (95% CI 1.08-1.20) higher risk of AF, independent of baseline FI and the risk rose to 1.89 (1.45, 2.46) with per 0.05 point/year increase in ΔFI. This association was strengthened in low genetic risk of AF, but sex, age, smoking status, alcohol intake, obesity, hypertension, diabetes and cancer did not materially modify the associations. Moreover, compared with nonfrailty maintenance, sustained frailty had the highest risk of AF (HR 1.95, 1.61-2.36). Alleviation from frailty reduced the risk of AF by 30% (95%CI 0.53-0.94), compared to sustained frailty. These associations were similar in HF and CHD, however, not significant in stroke. Conclusions Middle aged and elderly people, including those with diabetes, obesity and hypertension, may gain substantial benefits in risk of AF, HF and CHD by becoming less frail or maintaining nonfrailty, irrespective of past frailty status and established risk factors, delivering public health implications for the necessity of early identification and timely interventions of frailty in heart health management.

Estimation of individual lifetime cardiovascular disease risk and treatment benefit in patients with established atherosclerotic cardiovascular disease: the updated SMART-REACH2 model

Abstract Background The 2021 ESC Guidelines on Cardiovascular Disease (CVD) Prevention in Clinical Practice recommend using (lifetime) risk to guide preventive treatment intensification. Purpose Updating and systematically recalibrating the SMART-REACH lifetime prediction model for the estimation of lifetime risk of recurrent CVD in patients with established atherosclerotic CVD (ASCVD) to various European and international risk regions. Methods The updated SMART-REACH (i.e., SMART-REACH2) model was derived using data from 9,477 individuals between 40-90 years with coronary artery disease, cerebrovascular disease, peripheral artery disease, or abdominal aortic aneurysms included in the UCC-SMART cohort in whom 2,090 ASCVD events were observed during a median follow-up of 8.9 years (interquartile range 4.5–14.1). Coefficients for type of CVD, estimated glomerular filtration rate, non-high density lipoprotein cholesterol, systolic blood pressure, duration of CVD, C-reactive protein, current smoking, and presence of diabetes were derived using sex-stratified cause-specific Cox models with age as the time axis, adjusted for the competing risk of non-CVD mortality. Lifetables were used to estimate 10-year and lifetime CVD-risk and CVD-free life expectancy. The SMART-REACH2 model was externally validated in 121,701 patients from the NOR-COR, Nor-COAST, HUNT3, SWEDEHEART, Bialystok PLUS/Polaspire, REACH-EU, and REACH non-EU (Asia, Japan, Latin America, North America) covering 43 countries. The model was recalibrated to specific risk regions based on the expected-observed ratios from representative cohorts. Performance was assessed by calibration of predicted and observed risk and Harrel’s C-statistic for discrimination. Results 16,689ASCVD events were observed in the external validation cohorts. The model was visually well calibrated for the various risk regions. The pooled C-statistic across risk regions was 0.665 [95% confidence interval 0.640-0.691], with adequate performance in the separate regions (Figure 1). Using SMART-REACH2 to estimate potential gain in CVD-free life expectancy upon treatment initiation showed varying projections. For example, two comparable 55-year-old males from the low-risk region and very high-risk region would gain an estimated 2.2 and 3.9 CVD-free life years as a result of smoking cessation (Figure 2). Conclusion(s) By using larger and more contemporary data sources, considering geographical differences, and extending the age range, the updated SMART-REACH2 model provides an improved algorithm for the estimation of lifetime risk and CVD-free life expectancy for individuals with established ASCVD, facilitating shared decision-making for cardiovascular prevention as recommended by the 2021 ESC Prevention of CVD guidelines.C-statistics across global risk regionsCase vignette

The knowledge, attitude and practice of cardiologists versus other specialists about the safety and efficacy of influenza vaccination in patients with cardiovascular diseases

Abstract Background Influenza vaccination has been shown to reduce the occurrence of cardiovascular events, both in the general population and especially in individuals with cardiovascular disease. However, the extent to which cardiologists and other physicians support and prescribe influenza vaccination for patients with cardiovascular diseases is not known. Purpose To explore cardiologists' and other specialists' opinions on the safety and efficacy of influenza vaccination in preventing cardiovascular events. Methods From September 2023 to February 2024, a survey was conducted among physicians of any specialty, following the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). The survey was available in 5 languages. Participants' opinions were assessed using Likert-type scales. Non-probabilistic convenience sampling was employed, and duplicated responses were prevented using the SurveyMonkey® platform that identifies duplicated IP addresses. Results A total of 2550 physicians from 44 countries answered the survey; the mean age was 46.1±13.1 years, 46.4% were women, and 17.1% were in training. Among respondents 43.6% were cardiologists. While 91.8% of participants considered the influenza vaccine to be very safe, and 90.6% believed that adverse effects of this intervention were rare, a significant proportion did not consider Influenza vaccine to be very beneficial in reducing acute myocardial infarction (54.4% for cardiologists vs 59.3% for other specialists, p=0.013) or stroke (62.2% for cardiologists vs 64.9% for other specialists, p=0.167). summarizes the participants’ opinions regarding the benefits and risks of influenza vaccination. Regarding potential barriers to achieving higher vaccination rates among patients with cardiovascular disease, cardiologists' opinions were similar to those of other specialists (Table 2). Patient beliefs and patients’ fear of vaccine-related adverse effects were identified as major barriers by both cardiologists and other specialists. Only 19.0% of participants reported having some type of checklist system to remind them to recommend the vaccine to their patients. While 73.0% of participants found this topic highly relevant to their daily clinical practice, with no differences between groups (p=0.178), a notable proportion, comprising 48.5% of cardiologists and 47.1% of other specialists, expressed the necessity for additional training to address the risk-benefit ratio of influenza vaccination with their patients (p=0.485). Conclusion Our data suggest that cardiologists and other specialists view the influenza vaccine as safe with a low rate of adverse effects, both in the general population and in individuals with cardiovascular disease. However, a significant proportion of them are unaware of the vaccination's benefit in reducing cardiovascular events. Additionally, about half of the surveyed professionals expressed a need for further education to discuss the benefits of vaccination with their patients.

Life-Threatening Spontaneous Hematoma in Unusual Sites in Patients with COVID-19 on Anticoagulant Therapy: A Case Series

Thromboembolic manifestations are a common phenomenon in patients affected by corona virus (SARS CoV-2). Recent studies have shown that patients with acute renal failure are also at a greater risk of venous and arterial thromboembolism, 15-30% in ICU, and 7% inpatient care. However, frequently unjudicial use of anticoagulants may develop severe life-threatening hematoma. In our hospital settings we had a dedicated COVID Unit with a Hemodialysis facility. Our Nephrology department had managed 381 patients being COVID positive along with renal impairment from March 2020 to January 2022. Among these patients, four patients developed spontaneous non traumatic hematoma in unusual sites. On admission all the patients received treatment according to our national guidelines for COVID-19. Cases: It is a retrospective analysis in a single-centered hospital. Four cases with confirmed COVID-19 with acute kidney injury and on anticoagulant therapy had developed sudden concealed bleeding. These patients had no previous history of anticoagulant therapy before admission. Case 1 developed hemorrhage in Right lower anterior paramedian deep parietal wall of abdomen, Case 2 had hematoma in retroperitoneal space and in lower third of Iliopsoas, Case 3 developed hemorrhage in left cerebral hemisphere, Case 4 had Intramuscular Hematoma in left rectus abdominis. Out of these four patients two of them required Hemodialysis and one of them went into shock. All patients included were male. The mean age was 57±19.64years. All the four patients were initially managed conservatively with keen monitoring and with proper volume resuscitation, blood transfusion and discontinuation of the anticoagulants. Three of the patients survived with conservative management and one patient died due to sudden massive cardiac arrest. The use of therapeutic anticoagulant can increase the risk of bleeding in atypical sites and may exhibit higher patient death with COVID-19 if not identified at early stage. So a risk-benefit ratio of usage of anticoagulants should be kept in mind and further clinical trials needed to justify its random use in COVID-19. J Bangladesh Coll Phys Surg 2024; 42: 393-400

Mild intracerebral bleeding does not adversely affect survival and neurological outcome of surgical therapy for left-sided infective endocarditis

Abstract Background Intracerebral bleeding (IB) is a serious condition that requires increased attention and has implications for treatment options. For patients with infective endocarditis (IE), current guidelines recommend postponing surgery if IB is present. IB can be classified into four relevant groups (following European Cooperative Acute Stroke Study and Heidelberger Bleeding classification): hemorrhagic transformation (HT) 1 and 2, and parenchymal hemorrhage (PH) 1 and 2. PH2 is the only IB with neurological deterioration. These classifications were originally introduced for stroke patients following thrombolysis but without IE. The hypothesis tested in our study is that IB may influence IE treatment and thus outcome. Method Patients were retrospectively identifyied who were operated for left-sided IE, neuroradiologists re-evaluated and classified preoperative cerebral imaging for any IB. Outcome was quantified using the modified Rankin score (mRS), and mRS were extracted from the patients’ hospital chart at admission and by follow-up telephone call (FU), also including mortality. To ensure that the influence of IB was comparable, patients with IB (IB+) were propensity matched (EuroScore 2, Charlson Comorbidity Index, C-reactive protein; nearest neighbor match) to patients without IB (IB-) who also received surgical IE therapy. All IB+ patients underwent a careful risk-benefit analysis before therapy. Results Of 286 consecutive patients (January 2015 - November 2022) operated for left-sided IE, 36 had IB (65±13 years, 26% female): 11 with HT1, 9 with HT2, 8 with PH1, and 8 with PH2. These patients were matched with 36 operated IB- patients. Survival analysis showed no overall effect of IB+ vs. IB- (p = 0.112, 95% CI of hazard ratio was 0.246-1.243 vs. 0.709-3.572). Although there was no effect of IB on survival in the mild IB subgroup (HT1/2, Figure A), there was a difference in patients with severe IB (PH1/2) with less survival in IB+ (Figure B). Neurological outcome (ΔmRS) showed an effect of IB grade in the two-way ANOVA analysis (p = 0.029). Intergroup comparison showed a significantly better outcome for IB- (vs. IB+) in the PH2 subgroup (p = 0.034), but not in other subgroups. For all groups, the mean ΔmRS for IB+ was 1.1±1.6 vs. 0.70±1.4 for IB- (p = 0.256). The mean FU time was 2.6±2.1 years. Conclusion In patients operated for left-sided IE, mild IB did not affect survival or neurological outcome. In the more severe forms of IB, i.e. PH1 and PH2, survival was less favorable compared to matched controls. Furthermore, we observed a difference in neurological outcome in patients with severe IB. Thus, surgical therapy of left-sided IE should be avoided in patients with severe IB, whereas we can add evidence to the safety of surgical therapy in mild IB. Therefore, we recommend regular assessment of the degree of IB in such patients.Figure

Impact of acid blocker therapy on growth, gut microbiome, and lung disease in young children with cystic fibrosis.

Acid blocker therapy (ABT) has become common in cystic fibrosis (CF), despite insufficient evidence for benefits and studies showing potentially negative effects. We examined associations between ABT usage and growth, gut microbiome (GM), and early-onset lung disease in young children with CF. One hundred forty-five infants with CF born during 2012-2017, diagnosed through newborn screening by age 3 months and followed to 36 months of age at six CF centers were evaluated. Longitudinal data on growth, pancreatic functional status, pulmonary symptoms, and acid blocker medications were prospectively collected. Early-onset lung disease severity was evaluated by a clinical scoring system. GM composition was assessed by 16S rRNA methodology. ABT use before age 3 years was frequent, with 81 (56%) of patients on H2 receptor antagonist (H2RA) or proton pump inhibitor (PPI), and higher among pancreatic insufficient (60%) versus pancreatic sufficient (26%) children. H2RA was commonly prescribed in infancy before transitioning to PPI. Growth improvements were not significantly greater, while GM α-diversity at 3 years of age was significantly lower and early-onset lung disease more severe, in persistent ABT users compared to nonusers of ABT. In our cohort of young children with CF, early and persistent ABT use was not associated with significant growth benefits and instead showed associations with reduced GM diversity and negative effects on early-onset lung disease. Consequentially, there is a critical need for systematic evaluation and comprehensive risk-benefit analysis of ABT to ensure proper guidelines for children with CF.

Proton pump inhibitors and cardiovascular risk: a critical review.

Proton pump inhibitors (PPI) are widely used medications for gastrointestinal disorders. Recent research suggests a potential association between long-term PPI use and increased cardiovascular (CV) risk, creating a complex clinical dilemma. This review critically evaluates the current evidence for this association, considering the limitations of observational studies and the lack of definitive confirmation from randomized controlled trials.This review delves into the reported association between PPIs and adverse CV events, examining proposed mechanisms such as drug interactions, electrolyte imbalances induced by PPIs and their potential impact on cardiac and vascular function. Evidence suggests these mechanisms converge, with varying influence depending on patient populations.Clinicians require a risk-benefit analysis for each patient considering their CV risk profile. Alternative gastrointestinal therapies should be explored for high-bleeding risk patients. Medications with lower cytochrome-P450 interaction potential may be preferable among essential PPI users. Elucidating the specific mechanisms by which PPIs might influence CV health, assessing long-term vascular effects and investigating interactions with newer anticoagulant medications are crucial for future research.

End-of-Life Decision Making in Patients with Advanced Dementia: The Perspectives of the Korean General Population and Clinicians.

Korea's transition into a super-aged society brings to the forefront the escalating dementia prevalence and the consequent rise in mortality, highlighting the need for effective end-of-life (EOL) care strategies. Despite legislative advancements, gaps remain in addressing the medical and ethical challenges of EOL care for patients with advanced dementia, particularly in evaluating treatment options like nasogastric tube (NGT) use and mechanical ventilation (MV). This study investigates the attitudes of the general population (GP) and clinicians in Korea towards EOL treatment decisions. A cross-sectional, web-based survey was conducted among 500 members of the GP and 200 clinicians from a university hospital. Case vignettes were used to assess attitudes towards EOL treatment decisions, specifically focusing on NGT and MV use, and to explore the influencing factors. There was a notable difference in favorable attitudes toward NGT withdrawal between the GP (62.2%) and clinicians (39.0%). Otherwise, both groups showed higher acceptance of MV withholding (82.2% [GPs] and 82.5% [clinicians]) when informed of the patient's verbal intention regarding life-sustaining treatment (LST), and attitudes were more positive with written advance directives. Also, it was decreased when patient intentions were unclear. The results suggested the need to consider NGT as a medical intervention requiring a risk-benefit analysis. Although LST decision-making in patients with advanced dementia is still limited in Korea, this study showed the shared recognition among the GP and clinicians of the importance of EOL treatment decisions that consider patient wishes and quality of life for patients with advanced dementia.

Risk of major adverse cerebro-cardiovascular events following BNT162b2, CoronaVac, and ChAdOx1 vaccination and SARS-CoV-2 infection: A self-controlled case-series study

ObjectiveTo assess the potential risk of major adverse cerebro-cardiovascular events (MACCE) associated with COVID-19 vaccination and SARS-CoV-2 infection. MethodsThis self-controlled case series study used nationwide health database from Malaysia. The study included individuals aged ≥18 years who were hospitalised between 24 February 2021 and 30 June 2022. Outcomes were composite of MACCE: stroke, acute ischaemic heart disease, and cardiovascular death. Exposures were COVID-19 vaccination and SARS-CoV-2 infection. The risk period was day 1 to day 21 following exposure. Conditional Poisson regression model was used to estimate the incidence rate ratios (IRRs) and 95 % confidence interval (CI) comparing the outcomes in the risk and control periods. ResultsThe risk of MACCE within 21 days after vaccination per 100,000 doses administered were 12.0 (95% CI 11.9–12.1) (BNT162b2), 9.2 (95% CI 9.1–9.3) (CoronaVac), and 6.8 (95% CI 6.6–7.0) (ChAdOx1). The incidence rate ratios showed no increased risk of MACCE associated with the first, second, or third doses of BNT162b2, CoronaVac, and ChAdOx1 vaccines for individuals without prior cardiovascular disease (CVD). This finding was consistent for individuals with CVD. Vaccine booster dose, whether in a homologous or heterologous schedule, did not show increased risk of MACCE. Analysis by ethnic groups detected a slightly elevated risk of MACCE in Indian after the first dose of ChAdOx1 (IRR 1.64; 95% CI 1.08–2.48) in those without CVD. No significant association were observed in other subgroup analyses. SARS-CoV-2 infection was associated with significantly increased risk of MACCE in individuals without CVD (IRR 3.54; 95% CI 3.32–3.76) and with CVD (IRR 1.98; 95% CI 1.61–2.34). ConclusionsOur findings support the favourable safety profile of these COVID-19 vaccines and indicate that the overall benefit-risk ratio of the COVID-19 vaccines remains positive.

Intraoperative Hypotension Prediction: Current Methods, Controversies, and Research Outlook.

Intraoperative hypotension prediction has been increasingly emphasized due to its potential clinical value in reducing organ injury and the broad availability of large-scale patient datasets and powerful machine learning tools. Hypotension prediction methods can mitigate low blood pressure exposure time. However, they have yet to be convincingly demonstrated to improve objective outcomes; furthermore, they have recently become controversial. This review presents the current state of intraoperative hypotension prediction and makes recommendations on future research. We begin by overviewing the current hypotension prediction methods, which generally rely on the prevailing mean arterial pressure as one of the important input variables and typically show good sensitivity and specificity but low positive predictive value in forecasting near-term acute hypotensive events. We make specific suggestions on improving the definition of acute hypotensive events and evaluating hypotension prediction methods, along with general proposals on extending the methods to predict reduced blood flow and treatment effects. We present a start of a risk-benefit analysis of hypotension prediction methods in clinical practice. We conclude by coalescing this analysis with the current evidence to offer an outlook on prediction methods for intraoperative hypotension. A shift in research toward tailoring hypotension prediction methods to individual patients and pursuing methods to predict appropriate treatment in response to hypotension appear most promising to improve outcomes.

Case report: use of pleural dialysis as an alternate means of renal replacement therapy in three cats

ObjectiveThe objective of this case series is to describe the indications, methodology, and short-term outcomes of three cats with severe azotemia managed with pleural dialysis.Case summaryThree cats were presented separately to the emergency room (ER) on referral for severe azotemia of varying etiologies. Despite aggressive medical and/or surgical management, none of the cats showed improvement in their blood urea nitrogen (BUN) or creatinine values. Renal replacement therapy was recommended, but for varying reasons, the patients were unable to undergo a traditional extracorporeal method, such as intermittent hemodialysis (IDH). Instead, pleural dialysis was performed, and all three cats showed improvement in their renal values during and after their treatment. No significant complications were documented as a result of pleural dialysis. Two of the three cats were discharged from the hospital and the third cat was humanely euthanized due to poor prognosis.New or unique information providedPleural dialysis is a novel therapeutic procedure that is not documented in veterinary or human literature. This method of renal replacement therapy was well-tolerated and had no reported complications. Careful case selection and risk-benefit analysis should be considered before attempting this procedure. Further studies are necessary to further define the utility of this therapeutic intervention, evaluate the incidence of complications, and determine long term outcomes following the procedure.

An Integrated Framework for Scientific and Ethical Review of Research Proposals

Research proposals must adhere to both scientific and ethical standards to ensure the integrity and impact of research endeavours. However, existing guidelines often fall short in providing comprehensive guidance for non-medical disciplines, requiring separate documents for scientific and ethical reviews, and lacking detailed instructions for specific steps such as risk-benefit analysis and the use of secondary data. This study addresses these challenges by developing a detailed, step-by-step guideline for preparing research proposals that seamlessly integrate scientific and ethical reviews. Through a qualitative research design, involving focus group discussions with ethics review committee members and key informant interviews with experts, combined with a comprehensive literature review, this study identified best practices and challenges in the current review process. The proposed guideline offers a structured approach to preparing research proposals, emphasizing clarity in research objectives, methodology, data analysis, and expected outcomes for scientific review. For ethical review, it provides detailed instructions on risk-benefit analysis, informed consent processes, privacy and confidentiality measures, and the ethical use of secondary or archival data. The guidelines were pilot-tested with researchers to ensure their usability and effectiveness, resulting in a refined tool that can standardize the proposal preparation process and improve the quality and integrity of research across various disciplines.

Acceptance of insects as food in Germany: risk–benefit perceptions and the role of risk preferences

PurposeWith a growing world population and climate crises, edible insects are a promising alternative to conventional livestock. However, Western consumers are largely opposed to eating insects. The aim of this study is to investigate the acceptance of insects in a German sample with a specific focus on risk–benefit perceptions and risk preferences.Design/methodology/approachData were collected via an online survey (N = 569). Established scales for food neophobia (FN), risk perception, risk preference and acceptance were used. The statistical analyses included mean comparisons regarding acceptance and risk–benefit perceptions of unprocessed and processed insects. We further examined the role of perceived benefits and risks as well as risk preferences as determinants of acceptance via hierarchical multiple regressions.FindingsRespondents indicated lower perceived risks, and higher perceived benefits and thus higher acceptance for processed insect products as compared to whole insects. Risk perception was the strongest predictor of acceptance of unprocessed as well as processed insect food. Respondents who reported to have already eaten insects before exhibited higher risk preferences than those who had not.Originality/valueThis study specifically considered the role of risk preferences, which has been so far largely overlooked in consumer research on insect foods. The findings indicate that acceptance of insect food is mainly driven by risk perception rather than individual risk preferences. However, risk preferences should not be totally overlooked as they seem to play a role especially for unprocessed insects and the decision to try insects for the first time.

Challenging antibiotic stewardship: antibiotic use in the management of acute pancreatitis without waiting for a CT scan or CRP marker

Madam, Acute pancreatitis is an acute inflammation of the pancreas presenting as severe abdominal pain and elevated pancreatic enzymes. The global burden of Acute pancreatitis has increased by 3.07% per year, for the last 56 years.1 Gallstones, chronic alcohol, and hypertriglyceridemia are the main risk factors involved in the pathogenesis of Acute pancreatitis worldwide.2 However, in Pakistan gall stones impacting the common bile duct and hypertriglyceridemia are the main culprits. There has been an extensive debate regarding the use of prophylactic antibiotics and the outcome of acute pancreatitis. The cumulative evidence suggests that the prompt use of antibiotics, before obtaining serum markers, is not associated with a significant decrease in secondary pancreatic infection.3 Multiple studies have shown that the use of antibiotics, deviating from the recent guidelines, boosts antibiotic resistance and the risk of invasive fungal infections. A 2020 study conducted by Soulountsi has also rendered this practice unjustified.4 In studies supporting the use of prophylactic antibiotics in improving outcomes, the quality of evidence is low suggesting that the approach should be more tailored to individual patient conditions while adhering to the guidelines. Despite the sterile nature of the early stages of acute pancreatitis, some clinicians continue to opt for prophylactic use, however, it is strictly against the international consensus. Unfortunately, in Pakistan, there is a common practice of using antibiotics in acute pancreatitis within 72hrs, without waiting for the CT scan results and inflammatory markers screening. Antimicrobial resistance is an anticipated outcome of such practice. The prevalence of antimicrobial resistance to commonly prescribed antibiotics is already very high.5 Not weighing the risk-benefit ratio will not only contribute to increasing resistance but also predispose to avoidable and potentially fatal fungal infections. The appropriate approach to management of Acute pancreatitis should be based on a thorough knowledge of recent guidelines, carrying out proper investigations, and making an individualized plan for the patient based on clinical findings. This will not only minimize the burden of complications but also provide more room for improvements in the management of acute pancreatitis.

SINGLE INSTITUTION RETROSPECTIVE ANALYSIS OF COMPLICATIONS ASSOCIATED WITH SURGICAL DEBULKING OF BRAIN METASTASIS

Abstract AIMS Surgical resection of brain metastasis is associated with complications, which worsen patient’s quality of life, results in oncological treatment delays and death. Surgical complication data aids decision making, leads to objective risk benefit analysis and informed consent. The aim of this study is to quantify rates, types and risk factors for complications related to surgical debulking of brain metastasis. METHOD Retrospective analysis on adult patients with brain metastasis, who underwent surgical debulking between 2017 and 2023 at Royal Preston Hospital. Data collected included demographics, diagnosis, 30-days post-operative complications, 30-days mortality, 30-days post-operative palliation, primary tumour, Karnofsky-Performance Score (KPS), first vs. repeat resection, use of drain and type of suture materials etc. Univariate analysis was carried out using Graphpad software. RESULTS Two-hundred and twenty-seven patients qualified. The most common primaries were lung (n=93, 41%), breast (n=43, 18.9%), and skin (n=31, 13.7%). The most common complications were Hospital-acquired pneumonia (HAP) (n=27, 11.9%), surgical site infection (SSI) (n=19, 8.4%), wound dehiscence (n=14, 6.2%), thromboembolic events (n=12, 5.3%) and CSF leak (n=8, 3.5%). Thirty days mortality and post-operative palliation (due to surgical complications) were both 3.5% each (n=8). Two-hundred and six (93.2%) had KPS ³70 whilst 15 (6.8%) had KPS < 70 [range 30-60 pre-operatively (median 60)). KPS < 70 was statistically significant for post-operative palliation (p=0.01), HAP (0=0.02) and urine infection (p=0.002), but not for 30-day mortality. Twenty-five (11.1%) patients undergoing repeat resections, experienced higher wound infections (p=0.002). CONCLUSION Surgical debulking is associated with significant post-operative complications, with 7% either dying or not receiving any further treatment, 18.1% percent developing serious wound complications (SSI, CSF leak, Wound dehiscence) and 19.4% experiencing significant medical complications (HAP/UTI/Thromboembolism). Pre- operative KPS < 70 and repeat resections are associated with statistically increased risk of complications.

Fertility Preservation in Surviving Women Following Cancer Treatment

For the afflicted female, Diminished Ovarian Reserve (DOR) has disastrous effects on her quality of life, fertility, fecundity, and general well-being. Gynecological operations and chemotherapy can also make DOR worse. By evaluating the gonadotoxicity and effectiveness of current chemotherapy regimens as well as the techniques used in gynecological procedures, the best regimen or technique can be chosen after a risk-benefit ratio study. This ought to be carried out in concert with methods for preserving fertility, such as cryopreservation, ovarian transposition and suppression, and medication. To meet the demand for oncofertility, novel strategies utilizing fertoprotective agents must be assessed. This guarantees the greatest protection of the follicular pool and the least amount of harm to the ovarian environment and function. KYAMC Journal Volume: 15, No: 01, April 2024: 50-55.

Diffusion of ERP in the Construction Industry: An ERP Modules Approach: Case Study of Developing Countries

The risk–benefit analysis of ERP implementation is worth investigating to optimize the efficiency of ERP deployment in the construction sector. This study investigates the factors affecting the dissipation of ERP through diffusion models in developing countries. Moreover, it suggests a strategy to adopt ERP modules that optimize process integration and project efficiency through the priority factors method. According to the study, the internal model best describes the studied modules, and it suggests that imitative behavior and word of mouth significantly influence ERP adoption in the Africa and Middle East regions. This research concludes with an optimized order for deploying ERP modules based on the importance, urgency, and ease of implementation of each module. It is as follows: work progress (500), budgeting (405), procurement (343), site operations (280), planning and scheduling (270), accounting (252), inventory management (126), document control (90), and tendering (6). Therefore, it can be concluded that this study fills the research gap of ERP module adoption using diffusion models and priority factors within the construction industry, specifically in the specified regions. However, considering dynamic influence factors might provide more precise predictions, while involving a greater number of companies’ owners might highlight a greater importance of external factors.

Development and assessment of algorithms for predicting brain amyloid positivity in a population without dementia

BackgroundThe accumulation of amyloid-β (Aβ) peptide in the brain is a hallmark of Alzheimer’s disease (AD), occurring years before symptom onset. Current methods for quantifying in vivo amyloid load involve invasive or costly procedures, limiting accessibility. Early detection of amyloid positivity in non-demented individuals is crucial for aiding early AD diagnosis and for initiating anti-amyloid immunotherapies at early stages. This study aimed to develop and validate predictive models to identify brain amyloid positivity in non-demented patients, using routinely collected clinical data.MethodsPredictive models for amyloid positivity were developed using data from 853 non-demented participants in the MEMENTO cohort. Amyloid levels were measured potentially repeatedly during study course through Positron Emision Tomography or CerebroSpinal Fluid analysis.The probability of amyloid positivity was modelled using mixed-effects logistic regression. Predictors included demographic information, cognitive assessments, visual brain MRI evaluations of hippocampal atrophy and lobar microbleeds, AD-related blood biomarkers (Aβ42/40 and P-tau181), and ApoE4 status. Models were subjected to internal cross-validation and external validation using data from the Amsterdam Dementia Cohort. Performance also was evaluated in a subsample that met the main criteria of the Appropriate Use Recommendations (AUR) for lecanemab.ResultsThe most effective model incorporated demographic data, cognitive assessments, ApoE status, and AD-related blood biomarkers, achieving AUCs of 0.82 [95%CI 0.81-0.82] in MEMENTO sample and 0.90 [95%CI 0.86-0.94] in the external validation sample. This model significantly outperformed a reference model based solely on demographic and cognitive data, with an AUC difference in MEMENTO of 0.10 [95%CI 0.10-0.11]. A similar model without ApoE genotype achieved comparable discriminatory performance. MRI markers did not improve model performance. Performances in AUR of lecanemab subsample were comparable.ConclusionA predictive model integrating demographic, cognitive, and blood biomarker data offers a promising method to help identify amyloid status in non-demented patients. ApoE genotype and brain MRI data were not necessary for strong discriminatory ability, suggesting that ApoE genotyping may be deferred when assessing the risk-benefit ratio of immunotherapies in amyloid-positive patients who desire treatment. The integration of this model into clinical practice could reduce the need for lumbar puncture or PET examinations to confirm amyloid status.

Risk-benefit analysis of a multi-site radiographer comment model for emergency departments.

Critical/urgent X-ray findings are not always communicated in an appropriate time frame to ED physicians. The practice of radiographers alerting referrers to clinically significant image findings (verbally, via image flags or written comment) is noted internationally but risk assessment data is unavailable in the literature. A hybrid radiographer comment and alert model was piloted in New South Wales and a risk-benefit assessment conducted for timely and safe communication of abnormal X-ray appearances to ED physicians. Radiographer comments (n = 1102) were provided to five New South Wales EDs by 69 radiographers for a period of 3-12 months. Site auditors classified comments as true positive (TP), false positive (FP) or indeterminate (ID) with respect to the radiology report. FP comments were investigated with ED referrers and a low-medium-high-risk assessment was provided by two independent reviewers. A total of 42 FP (3.9%; 95% confidence interval [CI] 2.9-5.3) comments were analysed for any adverse outcomes. Risk assessments demonstrated 37 low, 5 low-moderate and no high-risk cases. A total of 282 direct or potential patient benefits were identified (26.4%; 95% CI 23.8-29.1). A total of 42 radiology report discrepancies were incidentally found: (3.9%; 95% CI 2.9-5.3). Audit results demonstrated areas where the radiographer comment could mitigate risk. The provision of radiographer alerts with a written comment for ED was found to be low risk to patients in the pilot study. Radiographers communicating directly with the emergency team when abnormal image appearances are detected can reduce diagnostic error and improve patient safety and health outcomes.

Apixaban dosing in hemodialysis - can drug level monitoring mitigate controversies?

BackgroundInconsistent study results and contradictory recommendations from health authorities regarding the use of apixaban in patients on hemodialysis have generated considerable uncertainty among clinicians, making investigations of appropriate dosing an unmet need.MethodsWe analyzed pre-dialysis apixaban drug levels from a tertiary care dialysis unit, comparing 2.5 mg once versus twice daily dosing. We applied mixed-effects models including dialysis modality, adjusted standard Kt/V, ultrafiltration, and dialyzer characteristics. We included an exploratory analysis of bleeding events and compared the drug levels of our dialysis patients to those from non-CKD reference populations taking the standard dose of 5 mg twice daily.ResultsWe analyzed 143 drug levels from 24 patients. Mean (SD) age at first drug level measurement was 64.7 (15.9) years (50 % female), median (IQR) follow-up was 12.5 (5.5 – 21) months. For the apixaban 2.5 mg once and twice daily groups, median (IQR) drug levels were 54.4 (< 40 – 72.1) and 71.3 (48.8 – 104.1) ng/mL respectively (P < 0.001). Levels were below the detection limit in 30 % (with 2.5 mg once daily) and 14 % (with 2.5 mg twice daily) respectively. Only dosing group (twice versus once daily) was independently associated with higher drug levels (P = 0.002). Follow-up did not suggest accumulation. The 95th percentile of drug levels did not exceed those of non-CKD populations taking 5 mg twice daily. Median (IQR) drug levels before a bleeding (8 episodes) were higher than those without a subsequent bleeding: 111.6 (83.1 – 129.3) versus 54.8 (< 40 – 77.1) ng/mL (P < 0.001). Concomitant antiplatelet therapy was used in 86% of those with bleeding events versus 6% without bleeding events (P < 0.001).ConclusionsDrug monitoring may be a contributory tool to increase patient safety. Despite non-existing target ranges, drug levels on both edges of the spectrum (e.g. below detectability or beyond the 95th percentiles of reference populations) may improve decision-making in highly individualized risk-benefit analyses.