Category: Nevin Manimala

J Clin Oncol. 2023 Jul 20:JCO2300429. doi: 10.1200/JCO.23.00429. Online ahead of print.

ABSTRACT

PURPOSE: Patients with isolated distal deep vein thrombosis (DVT) have lower rates of adverse outcomes (death, venous thromboembolism [VTE] recurrence or major bleeding) than those with proximal DVT. It is uncertain if such findings are also observed in patients with cancer.

METHODS: Using data from the international Registro Informatizado de la Enfermedad TromboEmbolica venosa registry, we compared the risks of adverse outcomes at 90 days (adjusted odds ratio [aOR]; 95% CI) and 1 year (adjusted hazard ratio [aHR; 95% CI]) in 886 patients with cancer-associated distal DVT versus 5,196 patients with cancer-associated proximal DVT and 5,974 patients with non-cancer-associated distal DVT.

RESULTS: More than 90% of patients in each group were treated with anticoagulants for at least 90 days. At 90 days, the adjusted risks of death, VTE recurrence, or major bleeding were lower in patients with non-cancer-associated distal DVT than in patients with cancer-associated distal DVT (reference): aOR = 0.16 (0.11-0.22), aOR = 0.34 (0.22-0.54), and aOR = 0.47 (0.27-0.80), respectively. The results were similar at 1-year follow-up: aHR = 0.12 (0.09-0.15), aHR = 0.39 (0.28-0.55), and aHR = 0.51 (0.32-0.82), respectively. Risks of death, VTE recurrence, and major bleeding were not statistically different between patients with cancer-associated proximal versus distal DVT, both at 90 days: aOR = 1.11 (0.91-1.36), aOR = 1.10 (0.76-1.62), and aOR = 1.18 (0.76-1.83), respectively, and 1 year: aHR = 1.01 (0.89-1.15), aHR = 1.02 (0.76-1.35), and aHR = 1.10 (0.76-1.61), respectively. However, more patients with cancer-associated proximal DVT, compared with cancer-associated distal DVT, developed fatal pulmonary embolism (PE) during follow-up: The risk difference was 0.40% (95% CI, 0.23 to 0.58).

CONCLUSION: Cancer-associated distal DVT has serious and relatively comparable outcomes compared with cancer-associated proximal DVT. The lower risk of fatal PE from cancer-associated distal DVT needs further investigation.

PMID:37471683 | DOI:10.1200/JCO.23.00429

JMIR Form Res. 2023 Jul 20;7:e47851. doi: 10.2196/47851.

ABSTRACT

BACKGROUND: Breast cancer is the most common cancer in the United States and the second leading cause of death for American Indian women. American Indian women have lower rates of breast cancer screening than other racial groups, and disparities in breast cancer mortality and survival rates persist among them. To address this critical need, a culturally appropriate, accessible, and personalized intervention is necessary to promote breast cancer screening among American Indian women. This study used mobile health principles to develop a mobile web app-based mammogram intervention (wMammogram) for American Indian women in a remote, rural community in the Northern Plains.

OBJECTIVE: This study aimed to assess the feasibility and efficacy of the wMammogram intervention, which was designed to motivate American Indian women to undergo breast cancer screening, as compared with the control group, who received an educational brochure.

METHODS: Using community-based participatory research (CBPR) principles and a multipronged recruitment strategy in a randomized controlled trial design, we developed the wMammogram intervention. This study involved 122 American Indian women aged between 40 and 70 years, who were randomly assigned to either the intervention group (n=62) or the control group (n=60). Those in the intervention group received personalized and culturally appropriate messages through a mobile web app, while those in the control group received an educational brochure. We measured outcomes such as mammogram receipt, intention to receive breast cancer screening after the intervention, and participants’ satisfaction with and acceptance of the intervention.

RESULTS: A significantly higher proportion of women who received the wMammogram intervention (26/62, 42%; P=.009) completed mammograms by the 6-month follow-up than the control group (12/60, 20%). The wMammogram intervention group, compared with the control group, reported significantly higher ratings on perceived effectiveness of the intervention (t₁₂₀=-5.22; P<.001), increase in knowledge (t₁₂₀=-4.75; P<.001), and satisfaction with the intervention (t₁₂₀=-3.61; P<.001). Moreover, compared with the brochure group, the intervention group expressed greater intention to receive a mammogram in the future when it is due (62/62, 100% vs 51/60, 85%) and were more willing to recommend the intervention they received to their friends (61/62, 98.4% vs 54/60, 90%) with statistically significant differences.

CONCLUSIONS: This study shows the feasibility and efficacy of the wMammogram intervention to promote breast cancer screening for American Indian women in a remote, rural community-based setting. Findings suggest that, with advancements in technology and the ubiquity of mobile devices, mobile web apps could serve as a valuable health intervention tool that builds upon low-cost technology and enhances accessibility and sustainability of preventive care to help reduce breast health disparities experienced in hard-to-reach American Indian populations.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05530603; https://clinicaltrials.gov/ct2/show/NCT05530603.

PMID:37471115 | DOI:10.2196/47851

Clin J Am Soc Nephrol. 2023 Jul 20. doi: 10.2215/CJN.0000000000000237. Online ahead of print.

ABSTRACT

BACKGROUND: The 2021 KDIGO guidelines recommend following anti-PLA2R antibody levels as a marker of treatment response in membranous nephropathy, however the optimal timing to evaluate antibody levels and how to combine them with other clinical variables are currently unknown.

METHODS: We used a cohort of 85 patients from the MENTOR trial with anti-PLA2R antibodies ≥14 RU/ml to identify risk factors for not experiencing proteinuria remission after 12 months of treatment with cyclosporine or rituximab. Three landmark times were considered: at baseline, and after 3 and 6 months of treatment. Logistic regression model performance was evaluated using C-statistics and model fit (Akaike Information Criterion (AIC), R2).

RESULTS: The model at baseline that best predicted no remission included anti-PLA2R antibodies >323 RU/ml and creatinine clearance; the best model after 3 months included the change from baseline in both antibody and albumin levels; and the best model after 6 months included antibody levels >14 RU/ml, creatinine clearance, and the change from baseline in albumin. Compared to the model at baseline, the model at 3 months had better model fit (AIC 70.9 vs 96.4, R2 51.8% vs 30.1%) and higher C-statistic (0.93 vs 0.83, p=0.008). The model at 6 months had no difference in performance compared to the model at 3 months (AIC 68.6, R2 53.0%, C-statistic 0.94 p=0.67).

CONCLUSIONS: Using the MENTOR clinical trial cohort of patients with membranous nephropathy treated with standardized cyclosporine or rituximab, we found that the optimal method to evaluate risk factors for the probability of treatment response was to use anti-PLA2R antibody levels combined with albumin levels after 3 months of treatment, which was significantly better than using antibody levels alone or risk factor evaluation at baseline, with no added benefit of waiting until 6 months of treatment.

PMID:37471101 | DOI:10.2215/CJN.0000000000000237

JAMA Netw Open. 2023 Jul 3;6(7):e2324522. doi: 10.1001/jamanetworkopen.2023.24522.

ABSTRACT

IMPORTANCE: Chronic total occlusion percutaneous coronary intervention (CTO-PCI) is not usually offered because of skepticism about long-term clinical benefits.

OBJECTIVE: To assess the association of successful CTO-PCI with quality of life by analyzing the relevant domains of the Seattle Angina Questionnaire (SAQ).

DATA SOURCES: PubMed, EMBASE, Web of Science, Google Scholar, and Cochrane databases were searched to identify randomized trials and observational studies specifically addressing quality of life domains of SAQ from January 2010 to June 2022.

STUDY SELECTION: Studies included reporting SAQ metrics such as angina frequency, physical limitation, and quality of life, before and after CTO-PCI.

DATA EXTRACTION AND SYNTHESIS: The present study was performed according to the Cochrane Collaboration and Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements, in which fixed-effect or random-effect models with generic inverse-variance weighting depending on statistical homogeneity were applied. Data were extracted by 3 independent reviewers.

OUTCOMES AND MEASURES: The primary outcome was angina frequency; physical limitation and quality of life were assessed as secondary outcomes.

RESULTS: Seven prospective randomized or observational studies (2500 patients) were included, with a mean (SD) participant age of 61.2 (2.1) years. CTO-PCI was associated with significantly improved quality-of-life metrics during a mean (SD) follow-up of 14.8 (16.3) months. In patients with successful procedures, angina episodes became less frequent (mean [SD] difference for SAQ angina frequency of 12.9 [3.1] survey points [95% CI, 7.1-19.8 survey points]; standardized mean difference was 0.54 [95% CI, 0.21-0.92]; P = .002; I2 = 86.4%) and they experienced less physical activity limitation (mean [SD] difference for SAQ physical limitation of 9.7 [6.2] survey points [95% CI, 3.5-16.2 survey points]; standardized mean difference was 0.42 [95% CI, 0.24-0.55]; P < .001; I2 = 20.9%), and greater quality-of-life domain (mean [SD] difference for SAQ quality of life of 14.9 [3.5] survey points [95% CI, 7.7-22.5 survey points]; standardized mean difference was 0.41 [95% CI, 0.25-0.61]; P < .001; I2 = 58.8%) compared with patients with optimal medical therapy or failed procedure. Furthermore, follow-up duration (point estimate, 0.03; 95% CI, 0.01-0.04; P = .01) was associated with a significant decrease in angina frequency in meta-regression analysis.

CONCLUSIONS AND RELEVANCE: In this systematic review and meta-analysis examining quality of life following CTO-PCI, successful procedures were associated with improved quality-of-life parameters compared with patients on optimal medical therapy or after failed CTO-PCI. These findings suggest support for using PCI to treat CTOs in symptomatic patients unresponsive to medical treatment.

PMID:37471086 | DOI:10.1001/jamanetworkopen.2023.24522

JAMA Netw Open. 2023 Jul 3;6(7):e2324539. doi: 10.1001/jamanetworkopen.2023.24539.

ABSTRACT

IMPORTANCE: Patients with decompensated cirrhosis are hospitalized for acute management with temporizing and lifesaving procedures. Published data to inform intervention development in this area are more than a decade old, and it is not clear whether there have been improvements in disparities in the receipt of these procedures over time.

OBJECTIVE: To evaluate the associations of race and ethnicity with receipt of procedures to treat decompensated cirrhosis over time in the US.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cross-sectional study analyzed National Inpatient Sample data on cirrhosis admissions among patients with portal hypertension-related complications from 2009 to 2018. All hospital discharges for individuals aged 18 years and older from 2009 to 2018 were assessed for inclusion. Admissions were included if they contained at least 1 cirrhosis-related International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) or International Statistical Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code and at least 1 cirrhosis-related complication ICD-9-CM or ICD-10-CM code (ie, ascites, hepatic encephalopathy, variceal hemorrhage [VH], and hepatorenal syndrome [HRS]). Data were analyzed from January to June 2022.

EXPOSURE: Hospitalization for decompensated cirrhosis.

MAIN OUTCOMES AND MEASURES: The outcomes of interest were trends in the odds ratios (ORs) for receiving procedures (upper endoscopy, transjugular portosystemic shunt [TIPS], hemodialysis, and liver transplantation [LT]) for decompensated cirrhosis and mortality by race and ethnicity, modeled over time. Multivariable logistic regression was used to assess these outcomes.

RESULTS: Among 717 580 admissions (median [IQR] age, 58 [52-67] years), 345 644 patients (9.8%) were Black, 623 991 patients (17.6%) were Hispanic, and 2 340 031 patients (47.4%) were White. Based on the modeled trends, by 2018, there were no significant differences by race or ethnicity in the odds of receiving upper endoscopy for VH. However, Black patients remained less likely than White patients to undergo TIPS for VH (OR, 0.54; 95% CI, 0.47-0.62) and ascites (OR, 0.34; 95% CI, 0.31-0.38). The disparity in receipt of LT improved for Black and Hispanic patients over the study period; however, by 2018, both groups remained less likely to undergo LT than their White counterparts (Black: OR, 0.66; 95% CI, 0.61-0.70; Hispanic: OR, 0.74; 95% CI, 0.70-0.78). The odds of death in Black and Hispanic patients declined over the study period but remained higher in Black patients than White patients in 2018 (OR, 1.08; 95% CI, 1.05-1.11).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of individuals hospitalized with decompensated cirrhosis, there were racial and ethnic disparities in receipt of complex lifesaving procedures and in mortality that persisted over time.

PMID:37471085 | DOI:10.1001/jamanetworkopen.2023.24539

JAMA Oncol. 2023 Jul 20. doi: 10.1001/jamaoncol.2023.2535. Online ahead of print.

ABSTRACT

IMPORTANCE: Personalized treatment approaches for patients with oligometastatic colorectal liver metastases are critically needed. We previously defined 3 biologically distinct molecular subtypes of colorectal liver metastases: (1) canonical, (2) immune, and (3) stromal.

OBJECTIVE: To independently validate these molecular subtypes in the phase 3 New EPOC randomized clinical trial.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective secondary analysis of the phase 3 New EPOC randomized clinical trial included a bi-institutional discovery cohort and multi-institutional validation cohort. The discovery cohort comprised patients who underwent hepatic resection for limited colorectal liver metastases (98% received perioperative chemotherapy) from May 31, 1994, to August 14, 2012. The validation cohort comprised patients who underwent hepatic resection for liver metastases with perioperative chemotherapy (fluorouracil, oxaliplatin, and irinotecan based) with or without cetuximab from February 26, 2007, to November 1, 2012. Data were analyzed from January 18 to December 10, 2021.

INTERVENTIONS: Resected metastases underwent RNA sequencing and microRNA (miRNA) profiling in the discovery cohort and messenger RNA and miRNA profiling with microarray in the validation cohort.

MAIN OUTCOMES AND MEASURES: A 31-feature (24 messenger RNAs and 7 miRNAs) neural network classifier was trained to predict molecular subtypes in the discovery cohort and applied to the validation cohort. Integrated clinical-molecular risk groups were designated based on molecular subtypes and the clinical risk score. The unique biological phenotype of each molecular subtype was validated using gene set enrichment analyses and immune deconvolution. The primary clinical end points were progression-free survival (PFS) and overall survival (OS).

RESULTS: A total of 240 patients were included (mean [range] age, 63.0 [56.3-68.0] years; 151 [63%] male), with 93 in the discovery cohort and 147 in the validation cohort. In the validation cohort, 73 (50%), 28 (19%), and 46 (31%) patients were classified as having canonical, immune, and stromal metastases, respectively. The biological phenotype of each subtype was concordant with the discovery cohort. The immune subtype (best prognosis) demonstrated 5-year PFS of 43% (95% CI, 25%-60%; hazard ratio [HR], 0.37; 95% CI, 0.20-0.68) and OS of 63% (95% CI, 40%-79%; HR, 0.38; 95% CI, 0.17-0.86), which was statistically significantly higher than the canonical subtype (worst prognosis) at 14% (95% CI, 7%-23%) and 43% (95% CI, 32%-55%), respectively. Adding molecular subtypes to the clinical risk score improved prediction (the Gönen and Heller K for discrimination) from 0.55 (95% CI, 0.49-0.61) to 0.62 (95% CI, 0.57-0.67) for PFS and 0.59 (95% CI, 0.52-0.66) to 0.63 (95% CI, 0.56-0.70) for OS. The low-risk integrated group demonstrated 5-year PFS of 44% (95% CI, 20%-66%; HR, 0.38; 95% CI, 0.19-0.76) and OS of 78% (95% CI, 44%-93%; HR, 0.26; 95% CI, 0.08-0.84), superior to the high-risk group at 16% (95% CI, 10%-24%) and 43% (95% CI, 32%-52%), respectively.

CONCLUSIONS AND RELEVANCE: In this prognostic study, biologically derived colorectal liver metastasis molecular subtypes and integrated clinical-molecular risk groups were highly prognostic. This novel molecular classification warrants further study as a possible predictive biomarker for personalized systemic treatment for colorectal liver metastases.

TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN22944367.

PMID:37471075 | DOI:10.1001/jamaoncol.2023.2535

Psychol Methods. 2023 Jul 20. doi: 10.1037/met0000599. Online ahead of print.

ABSTRACT

The generally small but touted as “statistically significant” correlation coefficients in the social sciences jeopardize theory testing and prediction. To investigate these small coefficients’ underlying causes, traditional equations such as Spearman’s (1904) classic attenuation formula, Cronbach’s (1951) alpha, and Guilford and Fruchter’s (1973) equation for the effect of additional items on a scale’s predictive power are considered. These equations’ implications differ regarding large interitem correlations enhancing or diminishing predictive power. Contrary to conventional practice, such correlations decrease predictive power when treating items as multi-item scale components but can increase predictive power when treating items separately. The implications are wide-ranging. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

PMID:37471016 | DOI:10.1037/met0000599

Psychol Methods. 2023 Jul 20. doi: 10.1037/met0000581. Online ahead of print.

ABSTRACT

Omega squared (ω^2) is a measure of effect size for analysis of variance (ANOVA) designs. It is less biased than eta squared, but reported less often. This is in part due to lack of clear guidance on how to calculate it. In this paper, we discuss the logic behind effect size measures, the problem with eta squared, the history of omega squared, and why it has been underused. We then provide a user-friendly guide to omega squared and partial omega squared for ANOVA designs with fixed factors, including one-way, two-way, and three-way designs, using within-subjects factors and/or between-subjects factors. We show how to calculate omega squared using output from SPSS. We provide information on the calculation of confidence intervals. We examine the problems of nonadditivity, and intrinsic versus extrinsic factors. We argue that statistical package developers could play an important role in making the calculation of omega squared easier. Finally, we recommend that researchers report the formulas used in calculating effect sizes, include confidence intervals if possible, and include ANOVA tables in the online supplemental materials of their work. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

PMID:37471015 | DOI:10.1037/met0000581

J Exp Psychol Hum Percept Perform. 2023 Jul 20. doi: 10.1037/xhp0001147. Online ahead of print.

ABSTRACT

Handling imperfect information problems is fundamental to perception, learning, and decision-making. Ensemble perception may partially overcome imperfect information by providing global clues. However, if not all cluster elements are readily accessible, the observations required for computing statistics are incomplete. In this case, these elements’ internal correlations (i.e., regularity) could serve as clues to elucidate the missing pieces. We thus investigated spatial regularity’s role in ensemble perception under imperfect information situations created using partially occluded stimuli. In two experiments, we manipulated circle size (Experiment 1) and line orientation (Experiment 2) to linearly vary with its location; spatial regularity thus supplied clues for inferring information of the invisible parts. Participants estimated the mean of the targeted feature of the entire cluster, including visible and invisible parts. We observed robust biases toward the overall cluster in the estimations, implying the invisible parts were considered during ensemble perception. We proposed this effect could be understood as assessing evidence from visible parts to construct the missing parts. Experiment 3 employed a periodicity regularity to deter participants from using specific strategies, and consistent results were found. We then developed a generative model, the Regularity-Based Model, to simulate the inference process, which better captured the pattern of human outcomes than the comparative model. These findings indicate the visual system could use high-level structural information to infer scenes with incomplete information, thus producing more accurate ensemble representations. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

PMID:37471003 | DOI:10.1037/xhp0001147

Psychol Assess. 2023 Aug;35(8):715-720. doi: 10.1037/pas0001251.

ABSTRACT

In a previous study, it was reported that the typically replicable factor structure of the Personality Inventory for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (PID-5) was noninvariant across samples of Black American and White American university students. The investigators of that study attributed this noninvariance across these two racial groups to Black American racialization, defined as Black individuals living in a predominantly non-Black society. In the current investigation, we examined further the effects of Black racialization by examining PID-5 factor structure invariance using a sample of nonracialized Black (Nigerian) university students (i.e., Black people living in a primarily Black society) and a sample of White American students. The factor structure of the PID-5 across the samples indicated overall configural invariance, suggesting that the same PID-5 facet traits, for the most part, load on the same factors for the nonracialized Black people and White Americans. This result is consistent with the view that Black racialization likely contributes to PID-5 factor structure noninvariance across White and Black Americans. There were some differences, however, between the Nigerian and White American students with respect to metric invariance and scalar invariance, suggesting the facet-to-factor loadings have different magnitudes of association across groups and that domain scale score elevations in Nigerian and White American students are not comparable; this was particularly prominent for the disinhibition domain. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

PMID:37470995 | DOI:10.1037/pas0001251