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Nevin Manimala Statistics

Early In-Bed Cycle Ergometry With Critically Ill, Mechanically Ventilated Patients: Statistical Analysis Plan for CYCLE (Critical Care Cycling to Improve Lower Extremity Strength), an International, Multicenter, Randomized Clinical Trial

JMIR Res Protoc. 2024 Oct 28;13:e54451. doi: 10.2196/54451.

ABSTRACT

BACKGROUND: Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients’ short-term physical function.

OBJECTIVE: Before unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT).

METHODS: CYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female).

RESULTS: CYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024.

CONCLUSIONS: We developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/54451.

PMID:39467285 | DOI:10.2196/54451

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Nevin Manimala Statistics

Using Existing Clinical Data to Measure Older Adult Inpatients’ Frailty at Admission and Discharge: Hospital Patient Register Study

JMIR Aging. 2024 Oct 28;7:e54839. doi: 10.2196/54839.

ABSTRACT

BACKGROUND: Frailty is a widespread geriatric syndrome among older adults, including hospitalized older inpatients. Some countries use electronic frailty measurement tools to identify frailty at the primary care level, but this method has rarely been investigated during hospitalization in acute care hospitals. An electronic frailty measurement instrument based on population-based hospital electronic health records could effectively detect frailty, frailty-related problems, and complications as well be a clinical alert. Identifying frailty among older adults using existing patient health data would greatly aid the management and support of frailty identification and could provide a valuable public health instrument without additional costs.

OBJECTIVE: We aim to explore a data-driven frailty measurement instrument for older adult inpatients using data routinely collected at hospital admission and discharge.

METHODS: A retrospective electronic patient register study included inpatients aged ≥65 years admitted to and discharged from a public hospital between 2015 and 2017. A dataset of 53,690 hospitalizations was used to customize this data-driven frailty measurement instrument inspired by the Edmonton Frailty Scale developed by Rolfson et al. A 2-step hierarchical cluster procedure was applied to compute e-Frail-CH (Switzerland) scores at hospital admission and discharge. Prevalence, central tendency, comparative, and validation statistics were computed.

RESULTS: Mean patient age at admission was 78.4 (SD 7.9) years, with more women admitted (28,018/53,690, 52.18%) than men (25,672/53,690, 47.81%). Our 2-step hierarchical clustering approach computed 46,743 inputs of hospital admissions and 47,361 for discharges. Clustering solutions scored from 0.5 to 0.8 on a scale from 0 to 1. Patients considered frail comprised 42.02% (n=19,643) of admissions and 48.23% (n=22,845) of discharges. Within e-Frail-CH’s 0-12 range, a score ≥6 indicated frailty. We found a statistically significant mean e-Frail-CH score change between hospital admission (5.3, SD 2.6) and discharge (5.75, SD 2.7; P<.001). Sensitivity and specificity cut point values were 0.82 and 0.88, respectively. The area under the receiver operating characteristic curve was 0.85. Comparing the e-Frail-CH instrument to the existing Functional Independence Measure (FIM) instrument, FIM scores indicating severe dependence equated to e-Frail-CH scores of ≥9, with a sensitivity and specificity of 0.97 and 0.88, respectively. The area under the receiver operating characteristic curve was 0.92. There was a strong negative association between e-Frail-CH scores at hospital discharge and FIM scores (rs=-0.844; P<.001).

CONCLUSIONS: An electronic frailty measurement instrument was constructed and validated using patient data routinely collected during hospitalization, especially at admission and discharge. The mean e-Frail-CH score was higher at discharge than at admission. The routine calculation of e-Frail-CH scores during hospitalization could provide very useful clinical alerts on the health trajectories of older adults and help select interventions for preventing or mitigating frailty.

PMID:39467281 | DOI:10.2196/54839

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Nevin Manimala Statistics

Predicting Proximal Humerus Fracture Mechanical Complications: Are Computed Tomography Hounsfield Units the Answer?

J Am Acad Orthop Surg. 2024 Oct 17. doi: 10.5435/JAAOS-D-24-00594. Online ahead of print.

ABSTRACT

INTRODUCTION: The purpose was to determine whether computed tomography (CT) Hounsfield units (HU) as a proxy for bone quality can predict postoperative complications following surgical treatment of proximal humerus fractures.

METHODS: Sixty-six patients with 2-, 3-, or 4-part proximal humerus fractures who underwent surgical fixation at single institution and had complete radiographic data available were included. Radiographic measurements included the deltoid tuberosity index (DTI) on preoperative anterior-posterior shoulder radiographs, and the HU value from the surgical proximal humerus was determined by measuring the humeral head at the midaxial/coronal/sagittal CT image using a circle-type region of interest (≥35 mm2). Postoperative complications recorded were implant failure, development of osteonecrosis, nonunion, and acute periprosthetic fracture. Patients with and without complications were statistically compared, and binary logistic regression was performed to determine whether preoperative proximal humerus CT HU were predictive of complications.

RESULTS: Eight patients (12.1%) developed 11 overall complications, with three patients experiencing multiple complications each. Complications included osteonecrosis (4), implant failure (5), nonunion (1), and acute periprosthetic fracture (1). No difference was observed in demographics or Neer or AO/OTA classification between those with and without complications. Patients with complications had markedly lower DTI and overall HU as well as HU in the coronal and sagittal planes. Regression analysis for average DTI demonstrated a higher DTI and had a 10 times decreased risk of complication (P = 0.040, odds ratio = -10.5, 95% confidence interval, 0.000 to 0.616). Regression analysis for average total HU also found a higher HU associated with a decreased risk of complications (P = 0.034, odds ratio = -0.020, 95% confidence interval, 0.980 to 0.962). Logistic regression analysis, including age, age-adjusted Charlson Comorbidity Index, mean DTI, and mean total HU, only found mean total HU to be notable within the model.

DISCUSSION: CT HU may identify patients with poorer bone quality and thus help predict postoperative complications.

LEVEL OF EVIDENCE: Diagnostic Level III.

PMID:39467278 | DOI:10.5435/JAAOS-D-24-00594

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The association of schooling, sibling life situation, and dietary habits with the estimated 24-h urinary salt excretion and sodium-to-potassium ratio in 3-year-old children

Clin Exp Hypertens. 2024 Dec 31;46(1):2421003. doi: 10.1080/10641963.2024.2421003. Epub 2024 Oct 28.

ABSTRACT

OBJECTIVES: We examined the association of schooling, sibling life situation, and dietary habits with the estimated 24-h urinary salt excretion and the urinary sodium-to-potassium (Na/K) ratio in 3-year-old children.

METHODS: The subjects were 639 children who underwent a health checkup in four cities and towns in Kyoto Prefecture from January to November 2019. The children’s parents answered questionnaires about weekday childcare places, the birth order, and the awareness of reducing the salt intake. The questions on food intake frequency included 10 items. The estimated 24-h salt excretion and Na/K ratio were calculated from the participants’ first voiding urine in the morning.

RESULTS: Data were available for 294 children. The median (interquartile range (IQR)) of salt excretion (g/day) was 2.6 (1.7-3.4), and urinary Na/K ratio (mmol ratio) was 2.6 (1.6-4.1). Multinomial logistic regression analysis showed that the group with older siblings was significantly associated with high salt (odds ratio 1.89 (95% confidence interval 1.04 to 3.46)). In the urinary Na/K ratio, the nursery group had a significantly lower Na/K (odds ratio 0.32 (0.17 to 0.60)). High processed meat products intake was associated with a higher Na/K (odds ratio 1.96 (1.05-3.66)), whereas high vegetable intake was associated with a lower Na/K (odds ratio 0.45 (0.23-0.87)). Other factors showed no significant associations.

CONCLUSIONS: In Japanese 3-year-old children, the estimated 24-h urinary salt excretion was associated with older siblings, and the urinary Na/K ratios were associated with schooling situation and the intake of processed meat products and vegetables.

PMID:39467276 | DOI:10.1080/10641963.2024.2421003

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Nevin Manimala Statistics

Prevalence of hepatitis A and B antibodies among enlisted accessions, Joint Base San Antonio-Lackland, 2023

MSMR. 2024 Oct 20;31(10):17-18.

ABSTRACT

The Department of the Air Force performs universal antibody serology testing for hepatitis B surface antibody (anti-HBs) and hepatitis A immunoglobulin G (IgG anti-HAV) among enlisted recruits presenting to basic military training (BMT) at Joint Base San Antonio (JBSA)-Lackland. These results, along with previous vaccination records, if available at the time of accession, guide HBV and HAV vaccination during BMT. Data from January 1, 2023, through December 31, 2023, in the electronic health record, MHS-GENESIS, was used for this analysis. This analysis shows a much higher prevalence of HAV antibodies compared to HBV in the trainee population at JBSA-Lackland during 2023.

PMID:39467271

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Guest editorial: health policy analysis on improving HIV PrEP implementation to help end the HIV epidemic in the U.S. military

MSMR. 2024 Oct 20;31(10):11-16.

ABSTRACT

Use of HIV pre-exposure prophylaxis (PrEP) among U.S. military service members at high risk for HIV infection remains suboptimal, resulting in preventable new HIV infections and decreased medical readiness among service members. PrEP coverage should be increased to the greatest extent possible to prevent HIV infection and support the Military Health System (MHS) quadruple aim. This policy analysis employed the Centers for Disease Control and Prevention (CDC)’s Policy Analytical Framework to develop several policy options based upon the evidence summary and interventions described. Evaluation criteria based on the CDC’s Policy Analytical Framework incorporated all elements of the Military Health System (MHS)’s quadruple aim, including impact on population health and readiness, impact on the experience of care, and value in terms of cost-effectiveness. An additional criterion of feasibility was also added to account for cultural, societal, and political factors influencing this policy decision. This policy analysis suggests that HIV PrEP coverage in the MHS remains suboptimal, while several available interventions could result in substantial increases in PrEP coverage that would, in turn, result in further reductions in new service member HIV infections and increased medical readiness.

PMID:39467270

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Nevin Manimala Statistics

Routine screening for antibodies to human immunodeficiency virus in the U.S. Armed Forces, active and reserve components, January 2019-June 2024

MSMR. 2024 Oct 20;31(10):2-10.

ABSTRACT

Summaries of HIV seropositivity for members of the U.S. military have been published with MSMR since 1995. The current report summarizes numbers and trends of newly identified HIV-antibody seropositivity from January 1, 2019 through June 30, 2024 among military members of 5 services under the active and reserve components of the U.S. Armed Forces, in addition to the Army and Air Force National Guard. From January 2023 through June 2024, approximately 1.8 million service members (active component, Guard, and reserve) were tested for antibodies to HIV, and 403 (0.22 per 1,000 tested) were identified as HIV-antibody positive. Of the 403 new HIV infections that were identified during this period, only 10 (2.5%) were among female service members. The HIV-antibody seropositivity rates first reported in MSMR 3 decades ago remain comparable to rates presented in 2023, under scoring a continued value of HIV testing programs. The cost-effectiveness of HIV testing strategies, differentiated by universal or indications-based testing following military accession, may be instructive to further understand the value of current screening efforts in different clinical settings.

PMID:39467267

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3D Vortex-Energetics in the Left Pulmonary Artery for Differentiating Pulmonary Arterial Hypertension and Pulmonary Venous Hypertension Groups Using 4D Flow MRI

J Magn Reson Imaging. 2024 Oct 28. doi: 10.1002/jmri.29635. Online ahead of print.

ABSTRACT

BACKGROUND: Pulmonary hypertension (PH) is a life-threatening. Differentiation pulmonary arterial hypertension (PAH) from pulmonary venous hypertension (PVH) is important due to distinct treatment protocols. Invasive right heart catheterization (RHC) remains the reference standard but noninvasive alternatives are needed.

PURPOSE/HYPOTHESIS: To evaluate 4D Flow MRI-derived 3D vortex energetics in the left pulmonary artery (LPA) for distinguishing PAH from PVH.

STUDY TYPE: Prospective case-control.

POPULATION/SUBJECTS: Fourteen PAH patients (11 female) and 18 PVH patients (9 female) diagnosed from RHC, 23 healthy controls (9 female).

FIELD STRENGTH/SEQUENCE: 1.5 T; gradient recalled echo 4D flow and balanced steady-state free precession (bSSFP) cardiac cine sequences.

ASSESSMENT: LPA 3D vortex cores were identified using the lambda2 method. Peak vortex-contained kinetic energy (vortex-KE) and viscous energy loss (vortex-EL) were computed from 4D flow MRI. Left and right ventricular (LV, RV) stroke volume (LVSV, RVSV) and ejection fraction (LVEF, RVEF) were computed from bSSFP. In PH patients, mean pulmonary artery pressure (mPAP), pulmonary capillary wedge pressure (PCWR) and pulmonary vascular resistance (PVR) were determined from RHC.

STATISTICAL TESTS: Mann-Whitney U test for group comparisons, Spearman’s rho for correlations, logistic regression for identifying predictors of PAH vs. PVH and develop models, area under the receiver operating characteristic curve (AUC) for model performance. Significance was set at P < 0.05.

RESULTS: PAH patients showed significantly lower vortex-KE (37.14 [14.68-78.52] vs. 76.48 [51.07-120.51]) and vortex-EL (9.93 [5.69-25.70] vs. 24.22 [12.20-32.01]) than PVH patients. The combined vortex-KE and LVEF model achieved an AUC of 0.89 for differentiating PAH from PVH. Vortex-EL showed significant negative correlations with mPAP (rho = -0.43), PCWP (rho = 0.37), PVR (rho = -0.64). In the PAH group, PVR was significantly negatively correlated with LPA vortex-KE (rho = -0.73) and vortex-EL (rho = -0.71), and vortex-KE significantly correlated with RVEF (rho = 0.69), RVSV, (rho = 0.70). In the PVH group, vortex-KE (rho = 0.52), vortex-EL significantly correlated with RVSV (rho = 0.58).

DATA CONCLUSION: These preliminary findings suggest that 4D flow MRI-derived LPA vortex energetics have potential to noninvasively differentiate PAH from PVH and correlate with invasive hemodynamic parameters.

EVIDENCE LEVEL: 1 TECHNICAL EFFICACY: Stage 3.

PMID:39467263 | DOI:10.1002/jmri.29635

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Polymorphism of RAAS genes in patients with COVID-19: comparison with frequency in population and relationship with severity of course

Ter Arkh. 2024 Oct 10;96(9):872-878. doi: 10.26442/00403660.2024.09.202849.

ABSTRACT

AIM: Evaluation of genes polymorphisms frequencies of angiotensinogen (AGT), angiotensin converting enzyme type 1 (ACE1) and angiotensin II receptors type 1 (AGTR1) and type 2 (AGTR2) in patients admitted with coronavirus disease (COVID-19) and its association the severity of severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2).

MATERIALS AND METHODS: The study included 100 patients admitted to the hospital with a laboratory-confirmed diagnosis of COVID-19. All patients were identified with alleles and genotypes of polymorphic markers rs4762 of the AGT gene, rs1799752 of the ACE1 gene, rs5186 of the AGTR1 gene and rs1403543 of the AGTR2 gene. The frequencies of each polymorphisms were compared with population. Statistical processing was performed using the Statistica 8.0 software package.

RESULTS: In evaluated cohort there was higher frequency of D-allele ACE1 rs1799752 compared to population. Depending on the availability of criteria for the severity of coronavirus infection, 44 (44%) patients were diagnosed with severe, 56 (56%) with moderate course. The groups did not significantly differ in age, gender, cardiovascular risk factors and comorbid pathology. In the groups with severe and moderate course, the same distribution of genotypes and alleles of AGT rs4762, AGTR2 rs1403543 and ACE1 rs1799752 was revealed. For the I/D alleles of the ACE1 rs1799752 gene, a significant deviation from the papulation was found in both the group of severe and moderate COVID-19. In the group with a severe course of the disease, a higher frequency of the mutant C-allele of the AGTR1 rs5186 gene was detected. In the same group, a deviation in the frequency ratio of A and C of the AGTR1 rs5186 alleles from Hardy-Weinberg Equilibrium was found. When calculating the risk of severe COVID-19 in the presence of the C-allele compared with the A-allele, an odds ratio 2.092 (95% confidence interval 1.066-4.108) was obtained.

CONCLUSION: The data obtained suggest that the genes polymorphisms of the components of renin-angiotensin-aldosterone system, namely D-allele of ACE1 rs1799752 and C-allele of AGTR1 rs5186, may make it possible to identify groups of patients predisposed to the development of more severe COVID-19.

PMID:39467241 | DOI:10.26442/00403660.2024.09.202849

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Antihypertensive therapy in patients with arterial hypertension and concomitant diseases in real clinical practice (according to the National Registry of Arterial Hypertension, 2019-2022)

Ter Arkh. 2024 Oct 10;96(9):860-871. doi: 10.26442/00403660.2024.09.202848.

ABSTRACT

BACKGROUND: Arterial hypertension (AH) remains the leading risk factor associated with cardiovascular diseases (CVDs), cerebrovascular disease and chronic kidney disease. About 70% of patients with AH who are on monotherapy cannot achieve blood pressure (BP) targets, and therefore all quidelines for the management of AH have recently recommended prescribing combination therapy (PCT). In real clinical practice (RCP), there remains significant uncertainty in the effectiveness and rationality of therapy, despite the wide availability of antihypertensive drugs (AHD) and the presence of recommendations for a stepwise approach to prescribing combinations of specific groups of AHD in different clinical situations.

AIM: Analyze the real ongoing antihypertensive therapy, including the PCT; international nonproprietary names of drugs and their dosages in RCP; compliance of therapy with clinical recommendations; changing trends in the PCT.

MATERIALS AND METHODS: An analysis was carried out of the data from the register of AH, the compliance of treatment in different clinical groups of patients and the achievement of BP and low-density lipoprotein cholesterol targets in the sample of 2019-2022 (n=5012). The prescription of AHD and achievement of targets values were assessed in accordance with current clinical guidelines for the management of AH and hypercholesterolemia. Data from 2010 (n=7782) and 2020 (n=3061) were analyzed to assess the dynamics of prescription of monotherapy and PCT.

RESULTS: The greatest increase in the number of AHD was observed in patients with hypertension in combination with coronary heart disease, heart failure, and atrial fibrillation. In a small group of patients with hypertension without other CVDs, the recommended combinations of AHD were not prescribed; preference was given to angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and β-adrenoblocker (β-AB). PCT mainly differed from the recommended combinations by the wider use of drugs from the β-AB group. The PCT of recommended drugs was highest in patients with hypertension and coronary artery disease – more than 90%, hypertension and heart failure in 56.2%, hypertension and atrial fibrillation – 33.3%, hypertension and chronic kidney desease – 19.6%. Achievement of BP and low-density lipoprotein cholesterol targets was insufficient in all analyzed groups. Among the international nonproprietary names of drugs, the most frequently prescribed are the following: bisoprolol, metoprolol, lisinopril, perindopril, losartan, spironolactone, amlodipine, torasemide, indapamide, hypochlorothiazide, moxonidine. The prescribed daily dosages were closer to the initial recommended ones. By 2020, the prescription of PCT with β-AB and a more uniform prescription of various combinations will come to the fore, while PCT in 2010 is characterized by the presence of one or two leaders combinations.

CONCLUSION: The described features of prescribing AHD partially reproduce clinical recommendations for the management of AH. Differences in therapy provided in RCP may be associated with an attempt to intensify the treatment of hypertension in patients with other concomitant CVDs. At the same time, analysis of combinations and dosages of prescribed drugs suggests the presence of wide opportunities for further escalation of therapy. The presented data can provide insight into current patterns of antihypertensive therapy prescription in patients in RCP and lay the foundation for optimizing therapy in different categories hypertensive patients.

PMID:39467240 | DOI:10.26442/00403660.2024.09.202848