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Nevin Manimala Statistics

Causal mediation analysis with mediator values below an assay limit

Stat Med. 2024 Mar 31. doi: 10.1002/sim.10065. Online ahead of print.

ABSTRACT

Causal indirect and direct effects provide an interpretable method for decomposing the total effect of an exposure on an outcome into the indirect effect through a mediator and the direct effect through all other pathways. A natural choice for a mediator in a randomized clinical trial is the treatment’s targeted biomarker. However, when the mediator is a biomarker, values can be subject to an assay lower limit. The mediator is affected by the treatment and is a putative cause of the outcome, so the assay lower limit presents a compounded problem in mediation analysis. We propose two approaches to estimate indirect and direct effects with a mediator subject to an assay limit: (1) extrapolation and (2) numerical optimization and integration of the observed likelihood. Since these estimation methods solely rely on the so-called Mediation Formula, they apply to most approaches to causal mediation analysis: natural, separable, and organic indirect, and direct effects. A simulation study compares the two estimation approaches to imputing with half the assay limit. Using HIV interruption study data from the AIDS Clinical Trials Group described in Li et al 2016, AIDS; Lok and Bosch 2021, Epidemiology, we illustrate our methods by estimating the organic/pure indirect effect of a hypothetical HIV curative treatment on viral suppression mediated by two HIV persistence measures: cell-associated HIV-RNA and single-copy plasma HIV-RNA.

PMID:38556761 | DOI:10.1002/sim.10065

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Nevin Manimala Statistics

Evaluation of a pathway to address take own leave events for First Nations peoples presenting for emergency care: The Deadly RED project

Emerg Med Australas. 2024 Mar 31. doi: 10.1111/1742-6723.14397. Online ahead of print.

ABSTRACT

OBJECTIVE: The ‘Deadly RED’ project primarily aimed to improve culturally competent care to reduce the number of First Nations patients presenting to a Queensland ED who ‘Take own leave’ (TOL). The secondary aim was to evaluate the implementation project.

METHODS: A pre/post-test quasi experimental study design using mixed methods was co-designed with adherence to Indigenous research considerations. Quantitative analysis of First Nations presentations before and after Deadly RED implementation was performed using SPSS. Qualitative analysis of transcribed research yarns in NVIVO was coded and themed for analysis. Staff experiences and perspectives were collated using electronically distributed surveys and process audits were performed.

RESULTS: A total of 1096 First Nations presentations June to August 2021 and 1167 in the matched 2022 post-implementation period were analysed. Significantly more patients were recorded as TOL post-implementation (13.0% pre vs 21.3% post) and representations rates were unchanged. Forty-six staff surveyed identified improvements in all parameters including cultural appropriateness and quality of care. Qualitative analysis of 85 research yarns revealed themes migrated to increasingly acceptable, accessible, and usable care. Notably, 45% of the First Nation’s patients recorded as TOL self-reported that their treatment was complete. The study was feasible as 80% of packs distributed and 73% follow-up screening after TOL.

CONCLUSIONS: The Deadly RED evaluation revealed significant discrepancies in the reported data points of TOL and the ‘story’ of the First Nations persons experience of appropriate and completed care. Staff awareness and cultural capability improved significantly, and yarning allowed knowledge translation and improvements in communication which contributed to a better healthcare experience for First Nations patients attending our ED.

PMID:38556708 | DOI:10.1111/1742-6723.14397

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Nevin Manimala Statistics

Replacing the Scalpel With a Computer Mouse: An Evaluation of Time Spent on Electronic Health Record for Plastic Surgery Residents and Its Impact on Resident Training

Ann Plast Surg. 2024 Apr 1;92(4S Suppl 2):S271-S274. doi: 10.1097/SAP.0000000000003863.

ABSTRACT

BACKGROUND: Following the integration of the electronic health record (EHR) into the healthcare system, concern has grown regarding EHR use on physician well-being. For surgical residents, time spent on the EHR increases the burden of a demanding, hourly restricted schedule and detracts from time spent honing surgical skills. To better characterize these burdens, we sought to describe EHR utilization patterns for plastic surgery residents.

METHODS: Integrated plastic surgery resident EHR utilization from March 2019 to March 2020 was extracted via Cerner Analytics at a tertiary academic medical center. Time spent in the EHR on-duty (0600-1759) and off-duty (1800-0559) in the form of chart review, orders, documentation, and patient discovery was analyzed. Statistical analysis was performed in the form of independent t tests and Analysis of Variance (ANOVA).

RESULTS: Twelve plastic surgery residents spent a daily average of 94 ± 84 minutes on the EHR, one-third of which was spent off-duty. Juniors (postgraduate years 1-3) spent 123 ± 99 minutes versus seniors (postgraduate years 4-6) who spent 61 ± 49 minutes (P < 0.01). Seniors spent 19% of time on the EHR off-duty, compared with 37% for juniors (P < 0.01). Chart review comprised the majority (42%) of EHR usage, followed by patient discovery (22%), orders (14%), documentation (12%), other (6%), and messaging (1%). Seniors spent more time on patient discovery (25% vs 21%, P < 0.001), while juniors spent more time performing chart review (48% vs 36%, P = 0.19).

CONCLUSION: Integrated plastic surgery residents average 1.5 hours on the EHR daily. Junior residents spend 1 hour more per day on the EHR, including more time off-duty and more time performing chart review. These added hours may play a role in duty hour violations and detract from obtaining operative skill sets.

PMID:38556688 | DOI:10.1097/SAP.0000000000003863

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Nevin Manimala Statistics

Alternative Lymphatic Drainage Pathways in the Trunk Following Oncologic Therapy

Ann Plast Surg. 2024 Apr 1;92(4S Suppl 2):S258-S261. doi: 10.1097/SAP.0000000000003861.

ABSTRACT

BACKGROUND: Anatomic and functional descriptions of trunk and breast lymphedema following breast cancer treatment are emerging as indicators of lymphatic dysfunction. Indocyanine green-lymphangiography has been instrumental in characterizing this dysfunction in the extremity and can be applied to other regions. Previous work has established a validated Pittsburgh Trunk Lymphedema Staging System to characterize such affected areas. This study aims to identify risk and protective factors for the development of truncal and upper extremity lymphedema using alternative lymphatic drainage, providing implications for medical and surgical treatment.

METHODS: Patients undergoing revisional breast surgery with suspicion of upper extremity lymphedema between 12/2014 and 3/2020 were offered lymphangiography. The breast and lateral/anterior trunks were visualized and blindly evaluated for axillary and inguinal lymphatic flow. A linear-weighted Cohen’s kappa statistic was calculated comparing alternative drainage evaluation. Binomial regression was used to compute relative risks (RRs). Significance was assessed at alpha = 0.05.

RESULTS: Eighty-six sides (46 patients) were included. Twelve sides underwent no treatment and were considered controls. Eighty-eight percent of the noncontrols had alternative lymphatic flow to the ipsilateral axillae (64%), ipsilateral groins (57%), contralateral axillae (20.3%), and contralateral groins (9.3%). Cohen’s kappa for alternative drainage was 0.631 ± 0.043. Ipsilateral axillary and contralateral inguinal drainage were associated with reduced risk of developing truncal lymphedema [RR 0.78, confidence interval (CI) 0.63-0.97, P = 0.04; RR 0.32, CI 0.13-0.79, P = 0.01, respectively]. Radiation therapy increased risk of truncal and upper extremity lymphedema (RR 3.69, CI 0.96-14.15, P = 0.02; RR 1.92, CI 1.09-3.39, P = 0.03, respectively). Contralateral axillary drainage and axillary lymph node dissection were associated with increased risk of upper extremity lymphedema (RR 4.25, CI 1.09-16.61, P = 0.01; RR 2.83, CI 1.23-6.52, P = 0.01, respectively).

CONCLUSIONS: Building upon previous work, this study shows risk and protective factors for the development of truncal and upper extremity lymphedema. Most prevalent alternative channels drain to the ipsilateral axilla and groin. Ipsilateral axillary and contralateral inguinal drainage were associated with reduced risk of truncal lymphedema. Patients with radiation, axillary dissection, and contralateral axillary drainage were associated with increased risk of upper extremity lymphedema. These findings have important clinical implications for postoperative manual lymphatic drainage and for determining eligibility for lymphovenous bypass surgery.

PMID:38556685 | DOI:10.1097/SAP.0000000000003861

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Nevin Manimala Statistics

Racial Diversity of Patient Population Represented on United States Plastic Surgeons’ Webpages

Ann Plast Surg. 2024 Apr 1;92(4S Suppl 2):S210-S217. doi: 10.1097/SAP.0000000000003855.

ABSTRACT

Current literature demonstrates a lack of racial diversity in plastic surgery media. However, to our knowledge, no study has yet examined the racial diversity of Webpage content as if from a patient-search perspective. The objective of this study is to determine if there is a racial discrepancy between the US Census, American Society of Plastic Surgeons (ASPS) statistics, and the media featuring implied patients on US plastic surgeons’ Webpages from a patient-focused approach. A Google search was completed using the term “(state) plastic surgeon.” The first 10 relevant Web sites were collected for each state, and homepages were analyzed. In line with previous studies, the implied patients in media were classified into 1 of 6 skin tone categories: I, ivory; II, beige; III, light brown; IV, olive; V, brown; and VI, dark brown. These correlate to Fitzpatrick phototypes; however, the Fitzpatrick scale measures skin’s response to UV exposure. Skin tone was used as a guide to measure racial representation in the media, with the caveat that skin tone does not absolutely correlate to racial identity. Categories I-III were further classified as “white” and IV-VI as “nonwhite.” These data were compared with the 2020 ASPS demographics report and US Census. Four thousand eighty individuals were analyzed from 504 Webpages, the majority of which were those of private practice physicians. A total of 91.62% of individuals were classified as “white” and 8.38% “nonwhite.” The distribution by category was as follows: I = 265, II = 847, III = 2626, IV = 266, V = 71, and VI = 5. Using χ2 analyses, a statistically significant difference was found between the racial representation within this sample and that of the 2020 US Census nationally (P < 0.001), regionally (P < 0.001), and subregionally (P < 0.001); the 2020 ASPS Cosmetic Summary Data (P < 0.001); and the 2020 ASPS Reconstructive Summary Data (P < 0.001). This study highlights the significant difference between racial representation on plastic surgeons’ Webpages and the demographics of patients they serve. Further analyses should identify the impact of these representational disparities on patient care and clinical outcomes, as well as examine how best to measure racial diversity and disparities in patient-oriented media.

PMID:38556676 | DOI:10.1097/SAP.0000000000003855

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Nevin Manimala Statistics

Minimizing Nipple-Areolar Complex Complications in Prepectoral Breast Reconstruction After Nipple-Sparing Mastectomy

Ann Plast Surg. 2024 Apr 1;92(4S Suppl 2):S179-S184. doi: 10.1097/SAP.0000000000003906.

ABSTRACT

PURPOSE: Nipple-areolar complex (NAC) viability remains a significant concern following prepectoral tissue expander (TE) reconstruction after nipple-sparing mastectomy (NSM). This study assesses the impact of intraoperative TE fill on NAC necrosis and identifies strategies for mitigating this risk.

METHODS: A chart review of all consecutive, prepectoral TEs placed immediately after NSM was performed between March 2017 and December 2022 at a single center. Demographics, mastectomy weight, intraoperative TE fill, and complications were extracted for all patients. Partial NAC necrosis was defined as any thickness of skin loss including part of the NAC, whereas total NAC necrosis was defined as full-thickness skin loss involving the entirety of the NAC. P < 0.05 was considered statistically significant.

RESULTS: Forty-six patients (83 breasts) with an average follow-up of 22 months were included. Women were on average 46 years old, nonsmoker (98%), and nondiabetic (100%) and had a body mass index of 23 kg/m2. All reconstructions were performed immediately following prophylactic mastectomies in 49% and therapeutic mastectomies in 51% of cases. Three breasts (4%) were radiated, and 15 patients (33%) received chemotherapy. Mean mastectomy weight was 346 ± 274 g, median intraoperative TE fill was 150 ± 225 mL, and median final TE fill was 350 ± 170 mL. Partial NAC necrosis occurred in 7 breasts (8%), and there were zero instances of complete NAC necrosis. On univariate analysis, partial NAC necrosis was not associated with any patient demographic or operative characteristics, including intraoperative TE fill. In multivariable models controlling for age, body mass index, mastectomy weight, prior breast surgery, and intraoperative TE fill, partial NAC necrosis was associated with lower body mass index (odds ratio, 0.53; confidence interval [CI], 0.29-0.98; P < 0.05) and higher mastectomy weight (odds ratio, 1.1; CI, 1.01-1.20; P < 0.05). Prior breast surgery approached significance, as those breasts had a 19.4 times higher odds of partial NAC necrosis (95% CI, 0.88-427.6; P = 0.06).

CONCLUSIONS: Nipple-areolar complex necrosis following prepectoral TE reconstruction is a rare but serious complication. In this study of 83 breasts, 7 (8%) developed partial NAC necrosis, and all but one were able to be salvaged.

PMID:38556670 | DOI:10.1097/SAP.0000000000003906

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Nevin Manimala Statistics

A population-based urinary and plasma metabolomics study of environmental exposure to cadmium

Environ Health Prev Med. 2024;29:22. doi: 10.1265/ehpm.23-00218.

ABSTRACT

BACKGROUND: The application of metabolomics-based profiles in environmental epidemiological studies is a promising approach to refine the process of health risk assessment. We aimed to identify potential metabolomics-based profiles in urine and plasma for the detection of relatively low-level cadmium (Cd) exposure in large population-based studies.

METHOD: We analyzed 123 urinary metabolites and 94 plasma metabolites detected in fasting urine and plasma samples collected from 1,412 men and 2,022 women involved in the Tsuruoka Metabolomics Cohort Study. Regression analysis was performed for urinary N-acetyl-beta-D-glucosaminidase (NAG), plasma, and urinary metabolites as dependent variables, and urinary Cd (U-Cd, quartile) as an independent variable. The multivariable regression model included age, gender, systolic blood pressure, smoking, rice intake, BMI, glycated hemoglobin, low-density lipoprotein cholesterol, alcohol consumption, physical activity, educational history, dietary energy intake, urinary Na/K ratio, and uric acid. Pathway-network analysis was carried out to visualize the metabolite networks linked to Cd exposure.

RESULT: Urinary NAG was positively associated with U-Cd, but not at lower concentrations (Q2). Among urinary metabolites in the total population, 45 metabolites showed associations with U-Cd in the unadjusted and adjusted models after adjusting for the multiplicity of comparison with FDR. There were 12 urinary metabolites which showed consistent associations between Cd exposure from Q2 to Q4. Among plasma metabolites, six cations and one anion were positively associated with U-Cd, whereas alanine, creatinine, and isoleucine were negatively associated with U-Cd. Our results were robust by statistical adjustment of various confounders. Pathway-network analysis revealed metabolites and upstream regulator changes associated with mitochondria (ACACB, UCP2, and metabolites related to the TCA cycle).

CONCLUSION: These results suggested that U-Cd was associated with metabolites related to upstream mitochondrial dysfunction in a dose-dependent manner. Our data will help develop environmental Cd exposure profiles for human populations.

PMID:38556356 | DOI:10.1265/ehpm.23-00218

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Nevin Manimala Statistics

U-Shaped Association between Serum Chloride Levels and In-Hospital Mortality in Patients with Congestive Heart Failure in Intensive Care Units

Int Heart J. 2024;65(2):237-245. doi: 10.1536/ihj.23-331.

ABSTRACT

Serum chloride level has clinical significance in the prognosis of heart failure. Little is known regarding the association between serum chloride levels and in-hospital mortality in patients with heart failure.This retrospective study used clinical data obtained from the Medical Information Mart for Intensive Care Database. The study cohort comprised patients who were categorized on the basis of their serum chloride levels, and the primary endpoint was in-hospital mortality. To assess the impact of serum chloride levels at the time of intensive care unit admission on in-hospital mortality, we used various statistical approaches, including multivariable logistic regression models, a generalized additive model, and a two-piecewise linear regression model. In addition, subgroup analysis was conducted to examine the robustness of the main findings.This study comprised 15,983 participants. When compared with the reference group (Q5), the groups with the highest (Q7) and lowest (Q1) blood chloride levels exhibited increased in-hospital mortality, with fully adjusted odds ratios (ORs) of 1.36 [95% confidence interval (CI): 1.08-1.71] and 1.25 (95% CI: 1-1.56), respectively. A U-shaped relationship was observed between blood chloride levels and in-hospital mortality, with the lowest risk observed at a threshold of 105.017 mmol/L. The effect sizes and corresponding CIs below and above the threshold were 0.969 (95% CI: 0.957-0.982) and 1.039 (95% CI: 1.002-1.076), respectively. Stratified analyses demonstrated the robustness of this correlation.The relationship between serum chloride levels and in-hospital mortality in patients with heart failure was U-shaped, with an inflection point of 105.017 mmol/L.

PMID:38556334 | DOI:10.1536/ihj.23-331

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Nevin Manimala Statistics

Ionic Distribution of an Unequal Electrolyte Near an Air/Water Surface

J Oleo Sci. 2024;73(4):619-623. doi: 10.5650/jos.ess23140.

ABSTRACT

The distribution of electrolytes near the air/water surface plays an essential role in many processes. While the general distribution is governed by classic Poisson-Boltzmann statistics, the analytical solution is only available for symmetric electrolytes. From the recent studies in the literature, it is evident that surface adsorption is dependent on specific ions as well as the H-bond structure at the surface. Experimental data can capture the macro properties of the surface, such as surface tension and surface potential. Yet, the underpinning mechanisms behind this experimental macro-observation remain unclear. To address the challenge, we developed a framework combining experimental studies and numerical calculations. The model was developed for electrolytes with unequal cationic and anionic charges. The asymmetric model was successfully applied to describe the surface charge of MgCl 2 aqueous solution. The results can be explained by the role of cationic size and charge on the surface layer.

PMID:38556295 | DOI:10.5650/jos.ess23140

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Nevin Manimala Statistics

Evaluation of a Community-based Pharmacy Resident-led Continuous Glucose Monitoring Program within a Family Medicine Clinic

J Am Pharm Assoc (2003). 2024 Mar 29:102078. doi: 10.1016/j.japh.2024.102078. Online ahead of print.

ABSTRACT

BACKGROUND: Pharmacist-driven continuous glucose monitoring (CGM) is associated with reduced hemoglobin A1c (HbA1c) and achievement of daily glycemic goals. Community-based pharmacists are well positioned to improve CGM uptake among patients with diabetes due to their accessibility and expertise. However, little data exists evaluating outcomes of CGM services led by a community-based pharmacist.

OBJECTIVE: To evaluate the impact of a community-based pharmacy resident-driven CGM service on HbA1c, revenue, and patient satisfaction.

PRACTICE DESCRIPTION: Independent community pharmacy sharing a clinical services agreement with a primary care clinic for Postgraduate Year One (PGY1) Community-based Pharmacy Residents to provide patient care under general supervision of the physician.

PRACTICE INNOVATION: Patients were offered CGM services if they were 18+ years with a HbA1c >7.0% and insurance coverage for CGM. Enrolled patients engaged in three months of pharmacist-led appointments for CGM application, data interpretation, diabetes education, and lifestyle management. Current Procedural Terminology (CPT) codes 99211, 95250, or 95251 were billed based on each encounter. HbA1c values were collected at program enrollment and conclusion. Patients completed a satisfaction survey at program conclusion.

EVALUATION METHODS: Demographics and billed CPT codes were collected from the electronic health record. Descriptive statistics were used to analyze survey data.

RESULTS: Eighteen patients were included. A mean reduction of 1.2% occurred in HbA1c (n=12; 9.7% to 8.5%). Forty CPT codes were billed, generating $3,671.40 of revenue. Satisfaction surveys were collected for 50% of participants (n=9). Most were satisfied with the CGM service and its individual components (n=8, 89%). Most were willing to continue using CGM devices and receive diabetes education from a pharmacist (n=8, 89%).

CONCLUSION: A community-based pharmacist led CGM service demonstrated a reduction in HbA1c and generated revenue for the clinic. Patients reported satisfaction and willingness to continue the service.

PMID:38556247 | DOI:10.1016/j.japh.2024.102078