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Nevin Manimala Statistics

Association of the triglyceride-glucose index with severity of coronary stenosis and in-hospital mortality in patients with acute ST elevation myocardial infarction after percutaneous coronary intervention: a multicentre retrospective analysis cohort study

BMJ Open. 2024 Mar 23;14(3):e081727. doi: 10.1136/bmjopen-2023-081727.

ABSTRACT

OBJECTIVES: To explore the impact of the triglyceride-glucose (TyG) index on the severity of coronary stenosis and the risk of in-hospital mortality in patients with acute ST segment elevation myocardial infarction (STEMI) after percutaneous coronary intervention (PCI).

DESIGN: A multicentre retrospective cohort study.

SETTING: Patients with STEMI undergoing PCI from three centres in China from 2015 to 2019.

PARTICIPANTS: A total of 1491 individuals presenting with STEMI were enrolled.

PRIMARY OUTCOME MEASURE: The degree of coronary stenosis was quantified by the Gensini score (GS). The association between the TyG index and the severity of coronary stenosis was explored by using a logistic regression analysis. Cox proportional hazards regression analyses were used to investigate the associations between the variables and in-hospital mortality.

RESULTS: We found a significant correlation between the TyG index and the degree of coronary stenosis in the present study. The TyG index was an independent risk factor for the severity of coronary stenosis (OR 2.003, p<0.001). Using the lowest tertile of the TyG (T1) group as a reference, the adjusted ORs for the T2 group and the T3 group and a high GS were 1.732 (p<0.001), 1.968 (p<0.001), respectively, and all p for trend <0.001. For predicting a high GS, the TyG index’s area under the curve was 0.668 (95% CI 0.635 to 0.700, p<0.001). Additionally, the TyG index was further demonstrated to be an independent predictor of in-hospital mortality in patients with STEMI (HR 1.525, p<0.001).

CONCLUSIONS: The TyG index was associated with the severity of coronary stenosis and all-cause in-hospital mortality in patients with STEMI, which may help physicians precisely risk-stratify patients and implement individualised treatment.

PMID:38521531 | DOI:10.1136/bmjopen-2023-081727

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Nevin Manimala Statistics

Realist evaluation of maternity waiting home intervention models in Inhambane, Mozambique: protocol for a comparative embedded case study, the Mozambique-Canada Maternal Health Project

BMJ Open. 2024 Mar 23;14(3):e075681. doi: 10.1136/bmjopen-2023-075681.

ABSTRACT

INTRODUCTION: This is a study protocol that tests and refines realist theories regarding the uptake and scale-up of the linked maternity waiting home (hereafter MWH) and facility birth intervention in the Mozambican context. The theories were developed through a realist review of MWH-facility birth literature from low-income and middle-income countries. The aim of the proposed study is to contribute to a contextually refined understanding of the causal chains underlying MWH-facility birth adoption by pregnant women and their families, communities, the health system and donors.

METHODS AND ANALYSIS: The overarching methodology is mixed-methods realist evaluation. The study will adopt a comparative embedded case study design comparing three new masonry MWHs built by the Mozambique-Canada Maternal Health Project in Inhambane province with three older MWHs selected based on variation in the built environment. Baseline data on participating MWH-facility birth interventions will be collected through observations, reviews of routine data and analysis of statistics and reports from provincial and district health authorities and the Mozambique-Canada Maternal Health project. Realist interviews will be conducted with MWH users and non-users, companions of MWH users and non-users, partners of MWH users and non-users, and stakeholders within the health system and the non-governmental organisation sector. Realist focus groups will be used to collect data from community-level implementers. The analysis will be retroductive and use the context-mechanism-outcome configuration heuristic tool to represent generative causation. We will analyse data from intervention and comparator MWHs independently and compare the resulting refined programme theories. Data analysis will be done in NVivo 12.

ETHICS AND DISSEMINATION: Ethics approval for the project has been obtained from the Mozambique National Bioethics Committee (CNBS-Comité Nacional de Bioética para a Saúde) and the University of Saskatchewan Bioethical Research Ethics Board. The evaluation will adhere to the International Ethical Guidelines for Biomedical Research Involving Human Subjects and the African adaptation of evaluation ethics and principles. Evaluation results will be disseminated to stakeholders’ practice audiences through peer-reviewed publications, plain-language briefs, theory validation/feedback meetings and conference presentations.

PMID:38521527 | DOI:10.1136/bmjopen-2023-075681

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Nevin Manimala Statistics

Development and validation of a novel score for predicting perioperative major adverse cardiovascular events in patients with stable coronary artery disease undergoing noncardiac surgery

Int J Cardiol. 2024 Mar 21:131982. doi: 10.1016/j.ijcard.2024.131982. Online ahead of print.

ABSTRACT

BACKGROUND: A model developed specifically for stable coronary artery disease (SCAD) patients to predict perioperative major adverse cardiovascular events (MACE) has not been previously reported.

METHODS: The derivation cohort consisted of 5780 patients with SCAD undergoing noncardiac surgery at the First Affiliated Hospital of Zhejiang University School of Medicine, from January 1, 2013 until May 31, 2021. The validation cohort consisted of 2677 similar patients from June 1, 2021 to May 31, 2023. The primary outcome was a composite of MACEs (death, resuscitated cardiac arrest, myocardial infarction, heart failure, and stroke) intraoperatively or during hospitalization postoperatively.

RESULTS: Six predictors, including Creatinine >90 μmol/L, Hemoglobin <110 g/L, Albumin <40 g/L, Leukocyte >10 ×109/L, high-risk Surgery (general abdominal or vascular), and American Society of Anesthesiologists (ASA) class (III or IV), were selected in the final model (CHALSA score). Each patient was assigned a CHALSA score of 0, 1, 2, 3, or > 3 according to the number of predictors present. The incidence of perioperative MACEs increased steadily across the CHALSA score groups in both the derivation (0.5%, 1.4%, 2.9%, 6.8%, and 23.4%, respectively; p < 0.001) and validation (0.3%, 1.5%, 4.1%, 9.2%, and 29.2%, respectively; p < 0.001) cohorts. The CHALSA score had a higher discriminatory ability than the revised cardiac risk index (C statistic: 0.827 vs. 0.695 in the validation dataset; p < 0.001).

CONCLUSIONS: The CHALSA score showed good validity in an external dataset and will be a valuable bedside tool to guide the perioperative management of patients with SCAD undergoing noncardiac surgery.

PMID:38521511 | DOI:10.1016/j.ijcard.2024.131982

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Nevin Manimala Statistics

Combined polygenic scores for ischemic stroke risk factors aid risk assessment of ischemic stroke

Int J Cardiol. 2024 Mar 21:131990. doi: 10.1016/j.ijcard.2024.131990. Online ahead of print.

ABSTRACT

BACKGROUND: Current risk assessment for ischemic stroke (IS) is limited to clinical variables. We hypothesize that polygenic scores (PGS) of IS (PGSIS) and IS-associated diseases such as atrial fibrillation (AF), venous thromboembolism (VTE), coronary artery disease (CAD), hypertension (HTN), and Type 2 diabetes (T2D) may improve the performance of IS risk assessment.

METHODS: Incident IS was followed for 479,476 participants in the UK Biobank who did not have an IS diagnosis prior to the recruitment. Lifestyle variables (obesity, smoking and alcohol) at the time of study recruitment, clinical diagnoses of IS-associated diseases, PGSIS, and five PGSs for IS-associated diseases were tested using the Cox proportional-hazards model. Predictive performance was assessed using the C-statistic and net reclassification index (NRI).

RESULTS: During a median average 12.5-year follow-up, 8374 subjects were diagnosed with IS. Known clinical variables (age, gender, clinical diagnoses of IS-associated diseases, obesity, and smoking) and PGSIS were all independently associated with IS (P < 0.001). In addition, PGSIS and each PGS for IS-associated diseases was also independently associated with IS (P < 0.001). Compared to the clinical model, a joint clinical/PGS model improved the C-statistic for predicting IS from 0.71 to 0.73 (P < 0.001) and significantly reclassified IS risk (NRI = 0.017, P < 0.001), and 6.48% of subjects were upgraded from low to high risk.

CONCLUSIONS: Adding PGSs of IS and IS-associated diseases to known clinical risk factors statistically improved risk assessment for IS, demonstrating the supplementary value of inherited susceptibility measurement . However, its clinical utility is likely limited due to modest improvements in predictive values.

PMID:38521508 | DOI:10.1016/j.ijcard.2024.131990

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Judicious use of corticosteroid injections prior to shoulder arthroplasty does not compromise outcomes at a minimum of 2-year following surgery

J Shoulder Elbow Surg. 2024 Mar 21:S1058-2746(24)00192-7. doi: 10.1016/j.jse.2024.03.006. Online ahead of print.

ABSTRACT

BACKGROUND: The use of total shoulder arthroplasty is continuing to rise with its expanding indications. For patients with chronic conditions, such as glenohumeral arthritis and rotator cuff arthropathy, nonoperative treatment is typically done prior to arthroplasty and often includes corticosteroid injections. Recent studies in the shoulder arthroplasty literature as well as applied from the hip and knee literature have focused on the risk of periprosthetic infection. Literature is lacking as to whether the judicious use of corticosteroids in the year prior to arthroplasty influences patient reported outcomes. The purpose of this study was to determine if preoperative corticosteroid injections prior to shoulder arthroplasty affected two-year patient-reported outcomes.

METHODS: Retrospective review of anatomic and reverse total shoulder arthroplasty patients (n=230) was performed at a single institution including multiple surgeons. Patients were included if they had preoperative and a minimum of 2-year postoperative patient reported outcomes, including: ASES, VAS, SANE, VR12-PCS, and VR12-MCS. Patients were included in the injection group if they had received an injection, either glenohumeral or subacromial, within twelve months prior to arthroplasty (inject=134). Subgroup analysis included anatomic (TSA=92) and reverse total shoulder arthroplasty (RSA=138) as well as those with no injection within 12 months prior to surgery. An ANOVA was used to compare outcomes between patients who received an injection and those who did not prior to TSA and RSA.

RESULTS: There were 230 patients included with 134 patients in the injection group and 96 in the no injection group. Patients who received an injection in the year prior to arthroplasty displayed a significantly higher ASES [82 (16.23SD) vs. 76 (19.43SD), p < .01] and SANE [70 (24.49SD) vs. 63 (29.22SD), p < .01] scores versus those who had not received injection. There was no difference when comparing preoperative injection versus no injection in patients undergoing TSA. Those patients undergoing RSA displayed significantly higher ASES scores (p<.01). There were no significant differences in VAS, VR12-PCS, and VR12-MCS among any analysis (P>0.05), and the MCID in ASES was not different between groups (p.09).

CONCLUSION: Corticosteroid injections within twelve months prior to anatomic and reverse total shoulder arthroplasty do not compromise patient reported outcomes during a minimum of two-year follow-up. Although more complications occurred in the injection group, it did not reach statistical significance and warrants further study in a larger population.

PMID:38521485 | DOI:10.1016/j.jse.2024.03.006

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Nevin Manimala Statistics

Tranexamic Acid Reduces Perioperative Blood Loss and Postoperative Hemoglobin Loss during Total Ankle Arthroplasty: A Systematic Review and Meta-Analysis of Clinical Comparative Studies

J ISAKOS. 2024 Mar 21:S2059-7754(24)00054-3. doi: 10.1016/j.jisako.2024.03.009. Online ahead of print.

ABSTRACT

IMPORTANCE: Peri-operative blood loss during joint replacement procedures is a modifiable risk factor that impacts wound complications, hospital stay and total costs. Tranexamic acid (TXA) is an anti-fibrinolytic that has been widely used in orthopedic surgery, but its efficacy in the setting of total ankle arthroplasty (TAA) has not been quantified to date.

AIM: The purpose of this systematic review and meta-analysis was to evaluate the efficacy and safety of administering TXA in patients undergoing TAA.

EVIDENCE REVIEW: The Medline, Embase and Cochrane library databases were systematically reviewed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Five comparative studies examining blood loss following administration of TXA for patients undergoing TAA were included. The outcome measures of interest were blood loss, reduction in hemoglobin concentration, transfusion requirements, total complications and wound complications.

FINDINGS: In total, 194 patients received TXA and 187 patients did not receive TXA while undergoing TAA. Based on the common-effects model for total blood loss for the TXA group versus control, the standardized mean difference (SMD) was -0.7832 (95% CI, -1.1544, -0.4120; P<.0001), in favor of lower total blood loss for TXA. Based on the random-effects model for reduction in hemoglobin for the TXA group versus control, the SMD was -0.9548 (95% CI, -1.7850, -0.1246; P=.0242) in favor of lower hemoglobin loss for TXA. Based on the random-effects model for total complications for the TXA group versus control, the risk ratio was 0.512 (95% CI, 0.1588, 1.6512; P=.1876), in favor of lower total complications for TXA but this was not statistically significant.

CONCLUSIONS: This current review demonstrated that administration of TXA led to a reduction in blood loss and hemoglobin loss without an increased risk of the development of venous thromboembolism in patients undergoing TAA. No difference was observed with respect to total complication rates between the TXA cohort and the control group. TXA appears to be an effective hemostatic agent in the setting of TAA, but further studies are necessary to identify the optimal timing, dosage and route of TXA during TAA.

LEVEL OF EVIDENCE: III.

PMID:38521460 | DOI:10.1016/j.jisako.2024.03.009

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Universal antifungal prophylaxis effectively prevents fungal bloodstream infection in pediatric liver transplant recipients: a retrospective real-world study

Int J Infect Dis. 2024 Mar 21:107003. doi: 10.1016/j.ijid.2024.107003. Online ahead of print.

ABSTRACT

BACKGROUND: Fungal bloodstream infection (fBSI) following pediatric liver transplantation present a significant challenge; however, there remains a paucity of guidance regarding antifungal prophylaxis in this population. This study aimed to evaluate the effectiveness of universal antifungal prophylaxis and propose a desirable strategy.

METHODS: We enrolled 604 pediatric patients who underwent liver transplantation between 2020 and 2023, including 242 patients with empirical prophylaxis and 362 patients with universal prophylaxis. Univariate and multivariate logistic regression analyses were performed to identify independent factors for fBSI.

RESULTS: Eight (2.2%) pediatric recipients in the universal prophylaxis group and 13 (5.4%) in the empirical group developed fBSI (P = 0.038). Universal prophylaxis was a protective factor (P = 0.044), while high-volume intraoperative plasma transfusion and deceased donor liver transplantation were independent risk factors for fBSI (P = 0.035 and 0.008, respectively). Universal antifungal strategy showed an increased OS trend after liver transplantation although without significant statistical difference (P = 0.217). Patients with fBSI had poorer survival than those without fBSI (P < 0.001).

CONCLUSION: Universal prophylaxis strategy for fBSI in pediatric after liver transplantation is desirable as it could markedly decrease the occurrence of fBSI. Pediatric patients with deceased donor and high-volume intraoperative transfusion should be paid more attention to preventing fBSI.

PMID:38521451 | DOI:10.1016/j.ijid.2024.107003

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Joint analysis of vaccination effectiveness and antiviral drug effectiveness for COVID-19: a causal inference approach

Int J Infect Dis. 2024 Mar 21:107012. doi: 10.1016/j.ijid.2024.107012. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aims to estimate the causal effects of oral antivirals and vaccinations in prevention against all-cause mortality and progression to severe COVID-19 in an integrative setting with both antivirals and vaccinations considered as interventions.

METHODS: We identified hospitalized adult patients (i.e., aged 18 or above) in Hong Kong with confirmed SARS-CoV-2 infection between March 16th, 2022 and December 31st, 2022. An inverse probability weighted (IPW) Andersen-Gill model with time-dependent predictors was used to address immortal time bias and produce causal estimates for the protection effects of oral antivirals and vaccinations against severe COVID-19.

RESULTS: Given prescription is made within five days of confirmed infection, nirmatrelvir-ritonavir is more effective in providing protection against all-cause mortality and development into severe COVID-19 than molnupiravir. There was no significant difference between CoronaVac and Comirnaty in the effectiveness of reducing all-cause mortality and progression to severe COVID-19.

CONCLUSIONS: The use of oral antivirals and vaccinations causes lower risks of all-cause mortality and progression to severe COVID-19 for hospitalized SARS-CoV-2 patients.

FUNDING: Health and Medical Research Fund, Hong Kong.

PMID:38521448 | DOI:10.1016/j.ijid.2024.107012

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Nevin Manimala Statistics

Promoting healthful food purchases through in-store interventions: Empirical evidence from rural food deserts

Appetite. 2024 Mar 21:107305. doi: 10.1016/j.appet.2024.107305. Online ahead of print.

ABSTRACT

Effective ways to promote healthful food intake in rural areas are understudied. The paper evaluated whether a two-component, in-store intervention designed to encourage healthy food purchases was associated with improved healthfulness scores of food items purchased by shoppers in rural food deserts. One component introduced a point-of-sales label that assigned a single numerical score to each food item facilitating direct comparisons of the product’s nutrition with those of other products shelved around it. The other component was a one-day nutrition education workshop promoted within the store. Interventions took place in 2015 at two stores in rural counties in the U.S. Midwest. Four stores in similar communities were selected as the control group. We applied a difference-in-difference model to estimate changes in the healthfulness of food items purchased attributable to the intervention among shoppers at the treatment stores (n = 486) and control stores (n = 10,759) using store transaction data. Healthfulness of food items was measured in terms of food scores published by the Environmental Working Group on a 1-10 scale. Both components had minimal impacts on the scores, although 0.2 and 0.1 points increases in the score per item and score per dollar were statistically significant at the 1% level respectively. A year after the intervention, these small effects of the intervention further diminished compared to the immediately after implementation. Results suggest the average effects of intervention across the study communities had limited practical significance but benefited some rural residents who were exposed to the intervention.

PMID:38521414 | DOI:10.1016/j.appet.2024.107305

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Use of eculizumab in pediatric patients with high-risk transplant-associated thrombotic microangiopathy: outcomes and risk factors associated with response and survival. A retrospective study on behalf of the Spanish Group for Hematopoietic Transplantation and Cellular Therapy (GETH-TC)

Transplant Cell Ther. 2024 Mar 21:S2666-6367(24)00292-6. doi: 10.1016/j.jtct.2024.03.019. Online ahead of print.

ABSTRACT

INTRODUCTION: Transplant-associated thrombotic microangiopathy (TA-TMA) is associated with high morbidity and mortality. Although with the introduction of eculizumab the survival has significantly improved, there is still a need for improvement, especially in high-risk patients.

OBJECTIVES: This study aims to describe the results obtained with eculizumab in a pediatric cohort with the attempt to define which risk factors could determine the response to treatment.

METHODS: We designed a national multicentre retrospective study, where children treated with eculizumab for high-risk TA-TMA were included.

RESULTS: Twenty-nine patients were included after a first (n=28) or a second allogeneic hematopoietic stem cell transplantation (HSCT) (n=1) for malignant (n=17) or non-malignant diseases (n=12). Median time from HSCT to TA-TMA diagnosis was 154 days (IQR 103-263). Eleven patients (38%) were initially diagnosed of low – intermediate risk TA-TMA and progressed to high-risk TA-TMA (hrTA-TMA), with a median time of 4 days (IQR 1 – 33). SC5b-9 was increased in 90% of 20 patients where measured. Renal (n=12), pulmonary (n=1) and intestinal (n=1) biopsy confirmed the diagnosis in 12/14 patients (85%). Seventeen patients (58%) presented extrarenal involvement with serositis (n=13, 44,8%), pulmonary (n=12, 41,4%), gastrointestinal (n=8, 27,6%), cardiovascular (n=7, 24,1%) or central nervous system (CNS) (n=2, 6,9%) involvement. Median time from hrTA-TMA diagnosis to the initiation of eculizumab was 7 days (IQR 1-18). Overall, 19 patients (65.5%) responded to eculizumab of whom 17 (58,6%) presented complete response and 2 (6.9%) achieved partial response. The remaining 10 patients (34.5%) did not present any type of response. The TA-TMA ORR was 27.59 % (95% CI 14.87 – 47.66), 55.17% (95% CI 38.43 – 73.48) and 62.07% (95% CI 45.10 – 79.13%) at 1, 3 and 6 months post eculizumab initiation, respectively. In the multivariate analysis the pulmonary involvement decreased the probability of response (HR 0.18, p-value 0.0298). The 1-year OS was 55.2% (95% CI: 35.6-71.0) for the whole cohort and 83.3% (95% CI: 56.7-94.3) for patients who responded to eculizumab. The presence of pulmonary (HR 14.93, p-value 0.0043) and CNS involvement (HR 8.63, p-value 0.0497) presented a statistically significant decrease in survival.

CONCLUSION: We found that patients diagnosed of hrTA-TMA with pulmonary involvement presented a poor response to eculizumab and patients with pulmonary and CNS involvement a significant decreased in survival. With these results, we hypothesize that using eculizumab at an early stage of the disease and before organ damage is established, the response and therefore the survival might significantly improve.

PMID:38521410 | DOI:10.1016/j.jtct.2024.03.019