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Nevin Manimala Statistics

Role of apparent diffusion map in the evaluation of retinoblastoma

Arq Bras Oftalmol. 2024 Feb 23;87(2):e20210435. doi: 10.5935/0004-2749.2021-0435. eCollection 2024.

ABSTRACT

PURPOSE: This study aimed to analyze the association between magnetic resonance imaging apparent diffusion coefficient map value and histopathological differentiation in patients who underwent eye enucleation due to retinoblastomas.

METHODS: An observational chart review study of patients with retinoblastoma that had histopathology of the lesion and orbit magnetic resonance imaging with apparent diffusion coefficient analysis at Hospital de Clínicas de Porto Alegre between November 2013 and November 2016 was performed. The histopathology was reviewed after enucleation. To analyze the difference in apparent diffusion coefficient values between the two major histopathological prognostic groups, Student’s t-test was used for the two groups. All statistical analyses were performed using SPSS version 19.0 for Microsoft Windows (SPSS, Inc., Chicago, IL, USA). Our institutional review board approved this retrospective study without obtaining informed consent.

RESULTS: Thirteen children were evaluated, and only eight underwent eye enucleation and were included in the analysis. The others were treated with photocoagulation, embolization, radiotherapy, and chemotherapy and were excluded due to the lack of histopathological results. When compared with histopathology, magnetic resonance imaging demonstrated 100% accuracy in retinoblastoma diagnosis. Optic nerve invasion detection on magnetic resonance imaging showed a 66.6% sensitivity and 80.0% specificity. Positive and negative predictive values were 66.6% and 80.0%, respectively, with an accuracy of 75%. In addition, the mean apparent diffusion coefficient of the eight eyes was 0.615 × 103 mm2/s. The mean apparent diffusion coefficient value of poorly or undifferentiated retinoblastoma and differentiated tumors were 0.520 × 103 mm2/s and 0.774 × 103 mm2/s, respectively.

CONCLUSION: This study revealed that magnetic resonance imaging is useful in the diagnosis of retinoblastoma and detection of optic nerve infiltration, with a sensitivity of 66.6% and specificity of 80%. Our results also showed lower apparent diffusion coefficient values in poorly differentiated retinoblastomas with a mean of 0.520 × 103 mm2/s, whereas in well and moderately differentiated, the mean was 0.774 × 103 mm2/s.

PMID:38422355 | DOI:10.5935/0004-2749.2021-0435

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Catheter Ablation for Atrial Fibrillation in Patients with Left Ventricular Ejection Fraction ≤ 45%: A Meta-Analysis of Randomized Controlled Trials

Arq Bras Cardiol. 2024 Feb 26;121(1):e20230214. doi: 10.36660/abc.20230214. eCollection 2024.

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) frequently coexist, resulting in adverse outcomes. However, controversies remain regarding the efficacy of catheter ablation (CA) in AF patients with severe left ventricular dysfunction.

OBJECTIVES: The purpose of this study was to perform a meta-analysis of prospective randomized controlled trials to evaluate the efficacy of CA versus medical therapy (MT) in AF patients with left ventricular ejection fraction (LVEF) ≤45%.

METHODS: We searched the literature for studies that compared CA to MT in AF patients with LVEF ≤45%. A meta-analysis of 7 clinical trials was performed, including 1163 patients with AF and HF. Subgroup analysis was performed based on baseline LVEF. All tests were 2-sided; only the p-value <0.05 was considered statistically significant.

RESULTS: We found that CA was associated with lower all-cause mortality (risk ratio: 0.52, 95% CI: 0.37 to 0.72; p<0.01) and greater improvements in LVEF (mean difference: 4.80%, 95% CI: 2.29% to 7.31%; p<0.01) compared to MT. Patients in the CA group had a lower risk of HF hospitalization and AF recurrence and a significantly better quality of life than those in the MT group. The results of subgroup analysis indicated that patients with milder left ventricular dysfunction improved LVEF after AF ablation (mean difference: 6.53%, 95% CI: 6.18% to 6.88%; p<0.01) compared to patients with more severe disease (mean difference: 2.02%, 95% CI: 0.87% to 3.16%; p<0.01).

CONCLUSIONS: Our meta-analysis demonstrated that CA was associated with significant improvements in outcomes of AF patients with LVEF ≤45%. Additionally, AF patients with milder left ventricular dysfunction could benefit more from CA.

PMID:38422349 | DOI:10.36660/abc.20230214

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Algorithmic bias evaluation in 30-day hospital readmission models: A retrospective analysis of hospital discharges

J Med Internet Res. 2024 Feb 27. doi: 10.2196/47125. Online ahead of print.

ABSTRACT

BACKGROUND: The adoption of predictive algorithms in healthcare comes with the potential for algorithmic bias, which could exacerbate existing disparities. Fairness metrics were proposed to measure algorithmic bias, but the application to real-world tasks is limited.

OBJECTIVE: This study aims to evaluate the algorithmic bias between racial and income groups associated with the application of common 30-day hospital readmission models and assesses the usefulness and interpretability of selected fairness metrics.

METHODS: This retrospective study used 10.6 million adult inpatient discharges from Maryland and Florida from 2016-2019. Models predicting 30-day hospital readmissions were evaluated: LACE Index, modified HOSPITAL score, and modified CMS readmission measure, which was applied “as-is” (using existing coefficients) and “retrained” (recalibrated with 50% of the data). Predictive performances and bias measures were evaluated for all population, and between Black and white populations and between low- and other-income groups. Bias measures included the parity of false negative rate (FNR), false positive rate (FPR), zero-one-loss, and generalized entropy index. Racial bias represented by FNR and FPR differences were stratified by individual hospital and population composition to explore shifts of algorithmic bias in different populations.

RESULTS: The retrained CMS model demonstrated the best predictive performance (AUC: 0.74 in Maryland and 0.68-0.70 in Florida) and modified HOSPITAL score demonstrated the best calibration (Brier score: 0.16-0.19 in Maryland and 0.19-0.21 in Florida) across subpopulations in both states. Calibration was better in white (compared to Black) and other-income (compared to low income) populations; and AUC was higher or similar in Black population (compared to white). Retrained CMS and modified HOSPITAL score had the lowest racial and income bias in Maryland. In Florida, modified HOSPITAL score showed the lowest racial bias; and modified HOSPITAL score and retrained CMS overall had the lowest income bias. In both states, white and higher income patient groups showed a higher FNR while Black and low-income patient groups resulted in a higher FPR and higher zero-one-loss. When stratified by hospital and population composition, these models demonstrated heterogenous algorithmic bias in different context and populations.

CONCLUSIONS: Caution must be taken when interpreting fairness measures’ face value. A higher FNR or FPR could potentially reflect missed opportunities or wasted resources, but these measures could also reflect healthcare utilization patterns and gaps in care. Simply relying on the statistical notions of bias could obscure or underplay the causes of health disparity. The imperfections of health data, analytic frameworks, and the underlying health systems must be carefully considered. Fairness measures can serve as a useful routine assessment to detect disparate model performances but are insufficient to inform mechanisms or policy changes. Such assessment, however, is an important first step toward data-driven improvement to address existing health disparities.

PMID:38422347 | DOI:10.2196/47125

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Feasibility of Guided Internet-Based Cognitive Behavioral Therapy for Panic Disorder and Social Anxiety Disorder in Japan: Pilot Single-Arm Trial

JMIR Form Res. 2024 Feb 29;8:e53659. doi: 10.2196/53659.

ABSTRACT

BACKGROUND: Cognitive behavioral therapy (CBT) is effective in treating anxiety disorders. Accessibility to CBT has been limited in Japan due to the shortage of therapists. While an open-source e-learning system can be used to create a simple internet-based cognitive behavioral therapy (ICBT) program, the safety and outpatient acceptance of this treatment approach have not been explored in Japan.

OBJECTIVE: The aim of this study was to investigate whether outpatients with anxiety disorders could accept and successfully complete the ICBT program with guidance by CBT therapists when implementing therapeutic modules and CBT tasks. Due to being in the initial phase of a novel treatment in Japan, this study was intended for verification with a small sample size.

METHODS: In total, 6 adults, including 4 male participants and 2 female participants, were enrolled in a single-arm trial. The intervention involved guided ICBT comprising 12 sessions, including CBT text, comprehension confirmation tests, and explanatory videos about cognitive behavioral models, accessible through a website. The therapist guided the participants in accessing the ICBT program and answering their questions using a chat tool. The primary outcome was anxiety severity assessed using the State-Trait Anxiety Inventory-Trait. Secondary outcomes included the Panic Disorder Severity Scale, Liebowitz Social Anxiety Scale (LSAS), Beck Anxiety Inventory (BAI), Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and Working Alliance Inventory-Short Form (WAI-SF). Statistical analyses were performed using paired 2-tailed t tests to assess the changes in clinical symptoms. The total WAI-SF score at the final session was used to evaluate the therapeutic alliance. For statistical analyses, mean changes for total State-Trait Anxiety Inventory-Trait, BAI, Panic Disorder Severity Scale, LSAS, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7 scores were analyzed using the paired 2-tailed t test. The 2-sided significance level for hypothesis testing was set at 5%, and 2-sided 95% CIs were calculated.

RESULTS: Most participants diligently engaged with the ICBT program. No adverse events were reported. The mean total scores for the primary outcome decreased by 11.0 (SD 9.6) points (95% CI -22.2 to 0.20; Hedges g=0.95), but it was not statistically significant. The mean total scores for the secondary outcomes that assess clinical symptoms decreased, with a significant reduction observed in the BAI of 15.7 (SD 12.1) points (95% CI -28.4 to -3.0; P=.03; Hedges g=1.24). The mean total scores for PDSS and LSAS decreased significantly, by 12.0 (SD 4.24) points (95% CI -50.1 to 26.1; P=.16; Hedges g=1.79) and 32.4 (SD 11.1) points (95% CI -59.7 to -4.3; P=.04; Hedges g=1.38), respectively. Of the participants, 67% (n=4) showed treatment response, and 50% (n=3) achieved remission after the intervention. The therapeutic alliance, measured using the WAI-SF, was moderate.

CONCLUSIONS: Guided ICBT may be feasible for the treatment of outpatients with panic disorder and social anxiety disorder in Japan.

TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry UMIN0000038118; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043439.

PMID:38421717 | DOI:10.2196/53659

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Prognostic Factors for Survival Using a Clinical Severity Staging System Among Patients With Acute Invasive Fungal Sinusitis

JAMA Otolaryngol Head Neck Surg. 2024 Feb 29. doi: 10.1001/jamaoto.2024.0042. Online ahead of print.

ABSTRACT

IMPORTANCE: Despite the aggressive progression of fulminant acute invasive fungal sinusitis (AIFS), data on prognostic factors have been disparate, hindering the development of a staging system. A composite staging system may improve prognostication for patient counseling and conduct of clinical research.

OBJECTIVE: To identify prognostically important factors in AIFS and to incorporate the factors into a comprehensive Functional Severity Staging System and Clinical Severity Staging System.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included adult patients diagnosed with pathology-proven AIFS from June 1, 1992, to December 31, 2022, at Washington University Medical Center and Barnes-Jewish Hospital, a tertiary care center in St Louis, Missouri. Data were analyzed from April to July 2023.

MAIN OUTCOME AND MEASURES: Sequential sequestration and conjunctive consolidation was used to develop a composite staging system to predict 6-month overall survival.

RESULTS: Of 71 patients with pathology-proven AIFS over the 30-year period, the median (range) age of the cohort was 56 (19-63) years, and there were 47 (66%) male patients. The median (range) follow-up time was 2 (0-251) months. There were 28 patients alive within 6 months, for a 39% survival rate. Symptoms, comorbidity burden, and presence and duration of severe neutropenia were associated with 6-month survival and were consolidated into a 3-category Clinical Severity Staging System with 6-month survival of 75% for stage A (n = 16), 41% for stage B (n = 27), and 18% for stage C (n = 28). The discriminative power of the composite staging system was moderate (C statistic, 0.63).

CONCLUSION AND RELEVANCE: This cohort study supports the clinical importance of symptomatology, comorbidity burden, and prolonged severe neutropenia at the time of AIFS presentation. The composite clinical staging system may be useful for clinicians when counseling patients with AIFS and conducting clinical research.

PMID:38421674 | DOI:10.1001/jamaoto.2024.0042

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Progression-Free Survival Analysis With a Graphical Estimand Approach in the Phase 2 SAMCO-PRODIGE 54 Trial

JAMA Oncol. 2024 Feb 29. doi: 10.1001/jamaoncol.2024.0002. Online ahead of print.

NO ABSTRACT

PMID:38421658 | DOI:10.1001/jamaoncol.2024.0002

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Telemedicine vs Telephone Consultations and Medication Prescribing Errors Among Referring Physicians: A Cluster Randomized Crossover Trial

JAMA Netw Open. 2024 Feb 5;7(2):e240275. doi: 10.1001/jamanetworkopen.2024.0275.

ABSTRACT

IMPORTANCE: Critically ill children presenting to emergency departments (EDs) in non-children’s hospitals are at high risk for experiencing medical errors, including medication errors. Video telemedicine consultations with pediatric specialists have the potential to reduce the risk of medication errors beyond the current standard of care, telephone consultations.

OBJECTIVE: To compare the rates of ED physician-related medication errors among critically ill children randomized to receive either video telemedicine or telephone consultations.

DESIGN, SETTING, AND PARTICIPANTS: This cluster randomized, unbalanced crossover trial was conducted at 15 community EDs in northern California between September 2014 and March 2018. Analyses were conducted from May 2022 to January 2023. Participants included acutely ill children younger than 15 years presenting to a participating ED.

INTERVENTIONS: Participating EDs were randomized to use video telemedicine or telephone for consultations with pediatric critical care physicians according to 1 of 4 unbalanced (3 telemedicine to 1 telephone) crossover treatment assignment sequences.

MAIN OUTCOMES AND MEASURES: Pharmacists reviewed medical records to document physician-related medication errors using a previously validated instrument. Multilevel logistic regression analyses were performed to create models with the medication order as the unit of analysis and adjusting for age, the log-transformed Revised Pediatric Emergency Assessment Tool score, and hospital study period.

RESULTS: A total of 696 patient encounters were included in the trial (mean [SD] age, 4.2 [4.6] years; median [IQR] age, 2.1 [0.5-2.1] years; 304 female [43.7%]), with 537 patient encounters (77.2%) assigned to video telemedicine and 159 patient encounters (22.8%) assigned to telephone. At least 1 physician-related medication error occurred for 87 patients (12.5%), including 20 of 159 patients (12.6%) in the telephone cohort and 67 of 537 patients (12.5%) in the telemedicine cohort. Of the 2414 medication orders, errors occurred in 124 cases (5.1%), including 26 of 513 orders (5.1%) in the telephone cohort and 98 of 1901 orders (5.2%) in the telemedicine cohort. In the multivariable analysis, the adjusted odds ratio of experiencing a medication error among those assigned to telemedicine was 0.86 (95% CI, 0.49-1.52; P = .61).

CONCLUSIONS AND RELEVANCE: This cluster randomized crossover trial found no statistically significant differences in physician-related medication errors between critically ill children assigned to receive telephone consultations vs video telemedicine consultations.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02877810.

PMID:38421649 | DOI:10.1001/jamanetworkopen.2024.0275

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Growth Hormone Mediators and Glycemic Control in Youths With Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial

JAMA Netw Open. 2024 Feb 5;7(2):e240447. doi: 10.1001/jamanetworkopen.2024.0447.

ABSTRACT

IMPORTANCE: Youth-onset type 2 diabetes (T2D) has a more aggressive phenotype than adult-onset T2D, including rapid loss of glycemic control and increased complication risk.

OBJECTIVE: To identify associations of growth hormone mediators with glycemic failure, beta cell function, and insulin sensitivity in youth-onset T2D.

DESIGN, SETTING, AND PARTICIPANTS: This post hoc secondary analysis of the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) randomized clinical trial, which enrolled participants from July 2004 to February 2009, included 398 participants from 15 university-affiliated medical centers with available plasma samples from baseline and 36 months. Participants were youths aged 10 to 17 years with a duration of T2D of less than 2 years who were randomized to metformin, metformin plus lifestyle intervention, or metformin plus rosiglitazone. Participants were followed up for a mean (SD) of 3.9 (1.5) years during the trial, ending in 2011. Statistical analysis was performed from August 2022 to November 2023.

EXPOSURE: Plasma insulin-like growth factor-1 (IGF-1), growth hormone receptor (GHR), and insulin-like growth factor binding protein 1 (IGFBP-1).

MAIN OUTCOMES AND MEASURES: Main outcomes were (1) loss of glycemic control during the TODAY study, defined as hemoglobin A1c (HbA1c) level of 8% or more for 6 months or inability to wean from insulin therapy, and (2) baseline and 36-month measures of glycemia (fasting glucose, HbA1c), insulin sensitivity (1/fasting C-peptide), high-molecular-weight adiponectin, and beta cell function (C-peptide index, C-peptide oral disposition index).

RESULTS: This analysis included 398 participants (mean [SD] age, 13.9 [2.0] years; 248 girls [62%]; 166 Hispanic participants [42%]; 134 non-Hispanic Black participants [34%], and 84 non-Hispanic White participants [21%]). A greater increase in IGF-1 level between baseline and 36 months was associated with lower odds of glycemic failure (odds ratio [OR], 0.995 [95% CI, 0.991-0.997]; P < .001) and higher C-peptide index per 100-ng/mL increase in IGF-1 (β [SE], 0.015 [0.003]; P < .001). A greater increase in log2 GHR level between baseline and 36 months was associated with higher odds of glycemic failure (OR, 1.75 [95% CI, 1.05-2.99]; P = .04) and lower C-peptide index (β [SE], -0.02 [0.006]; P < .001). A greater increase in log2 IGFBP-1 level between baseline and 36 months was associated with higher odds of glycemic failure (OR, 1.37 [95% CI, 1.09-1.74]; P = .007) and higher high-molecular-weight adiponectin (β [SE], 431 [156]; P = .007).

CONCLUSIONS AND RELEVANCE: This study suggests that changes in plasma growth hormone mediators are associated with loss of glycemic control in youth-onset T2D, with IGF-1 associated with lower risk and GHR and IGFBP-1 associated with increased risk.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00081328.

PMID:38421647 | DOI:10.1001/jamanetworkopen.2024.0447

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Heterogeneity in Systematic Reviews of Medical Imaging Diagnostic Test Accuracy Studies: A Systematic Review

JAMA Netw Open. 2024 Feb 5;7(2):e240649. doi: 10.1001/jamanetworkopen.2024.0649.

ABSTRACT

IMPORTANCE: Systematic reviews of medical imaging diagnostic test accuracy (DTA) studies are affected by between-study heterogeneity due to a range of factors. Failure to appropriately assess the extent and causes of heterogeneity compromises the interpretability of systematic review findings.

OBJECTIVE: To assess how heterogeneity has been examined in medical imaging DTA studies.

EVIDENCE REVIEW: The PubMed database was searched for systematic reviews of medical imaging DTA studies that performed a meta-analysis. The search was limited to the 40 journals with highest impact factor in the radiology, nuclear medicine, and medical imaging category in the InCites Journal Citation Reports of 2021 to reach a sample size of 200 to 300 included studies. Descriptive analysis was performed to characterize the imaging modality, target condition, type of meta-analysis model used, strategies for evaluating heterogeneity, and sources of heterogeneity identified. Multivariable logistic regression was performed to assess whether any factors were associated with at least 1 source of heterogeneity being identified in the included meta-analyses. Methodological quality evaluation was not performed. Data analysis occurred from October to December 2022.

FINDINGS: A total of 242 meta-analyses involving a median (range) of 987 (119-441 510) patients across a diverse range of disease categories and imaging modalities were included. The extent of heterogeneity was adequately described (ie, whether it was absent, low, moderate, or high) in 220 studies (91%) and was most commonly assessed using the I2 statistic (185 studies [76%]) and forest plots (181 studies [75%]). Heterogeneity was rated as moderate to high in 191 studies (79%). Of all included meta-analyses, 122 (50%) performed subgroup analysis and 87 (36%) performed meta-regression. Of the 242 studies assessed, 189 (78%) included 10 or more primary studies. Of these 189 studies, 60 (32%) did not perform meta-regression or subgroup analysis. Reasons for being unable to investigate sources of heterogeneity included inadequate reporting of primary study characteristics and a low number of included primary studies. Use of meta-regression was associated with identification of at least 1 source of variability (odds ratio, 1.90; 95% CI, 1.11-3.23; P = .02).

CONCLUSIONS AND RELEVANCE: In this systematic review of assessment of heterogeneity in medical imaging DTA meta-analyses, most meta-analyses were impacted by a moderate to high level of heterogeneity, presenting interpretive challenges. These findings suggest that, despite the development and availability of more rigorous statistical models, heterogeneity appeared to be incomplete, inconsistently evaluated, or methodologically questionable in many cases, which lessened the interpretability of the analyses performed; comprehensive heterogeneity assessment should be addressed at the author level by improving personal familiarity with appropriate statistical methodology for assessing heterogeneity and involving biostatisticians and epidemiologists in study design, as well as at the editorial level, by mandating adherence to methodologic standards in primary DTA studies and DTA meta-analyses.

PMID:38421646 | DOI:10.1001/jamanetworkopen.2024.0649

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Assessment of current water, sanitation, and hygiene (WASH) practices in the third and ninth districts of N’Djamena, Chad

J Water Health. 2024 Feb;22(2):414-435. doi: 10.2166/wh.2024.324.

ABSTRACT

Access to safe drinking water, sanitation, and hygiene in Chad’s cities, especially N’Djamena, is a persistent and significant challenge. This study aimed to assess current practices in water, sanitation, and hygiene in N’Djamena’s third and ninth districts. We surveyed 395 households, conducted water source identification, and analyzed seven water samples at the National Water Laboratory. Temperature, ammonium, total coliforms, and aerobic flora values exceeded World Health Organization (WHO) guidelines. Ammonium and temperature averaged 0.7 mg/L and 30.1-31.93 °C, respectively. Bacterial contamination (>100 MPN/100 mL) exceeded the WHO’s 0 MPN/100 mL guidelines, rendering the water unfit for consumption. Survey results indicate that 78.7% use hand pumps, 21.1% have tap water access, and 0.2% rely on rivers for water. Regarding toilets, 92.8% have traditional models, 2.9% have modern facilities, and 4.3% practice open defecation. 95% dispose of untreated wastewater into nature, with only 5% using septic tanks. For solid waste, 72% use illegal dumpsites, 18% rely on public services, and 10% burn waste. Finally, 95.5% of households wash their hands with clean water and soap after using the toilet. It is crucial to treat drinking water and implement proper hygiene and sanitation measures to safeguard the population’s health in the studied area.

PMID:38421634 | DOI:10.2166/wh.2024.324