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Nevin Manimala Statistics

Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®)

Qual Life Res. 2024 Nov 6. doi: 10.1007/s11136-024-03819-5. Online ahead of print.

ABSTRACT

BACKGROUND: We derived meaningful individual-level change thresholds for worsening in selected patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®) items and their composite scores.

METHODS: We used two data sources, the PRO-TECT trial (Alliance AFT-39) that collected PRO-CTCAE data from adults with advanced cancer at 26 United States (U.S.) community oncology practices and the PRO-CTCAE validation study that collected PRO-CTCAE data from adults undergoing chemotherapy or radiation therapy at nine U.S. cancer centers or community oncology practices. Both studies administered selected PRO-CTCAE items and EORTC QLQ-C30 scales. Conceptually, relevant QLQ-C30 domains were used as anchors to estimate meaningful change thresholds for deterioration in corresponding PRO-CTCAE items and their composite scores. Items or composites with ǀρǀ ≥ 0.30 correlation with QLQ-C30 scales were included. Changes in PRO-CTCAE scores and composites were estimated for patients who met or exceeded a 10-point deterioration on the corresponding QLQ-C30 scale. Change scores were computed between baseline and the 3-month timepoint in PRO-TECT, and in the PRO-CTCAE validation study between baseline and a single follow-up visit that occurred between 1 and 7 weeks later. For each PRO-CTCAE item, change scores could range from – 4 to 4; for a composite, change scores could range from – 3 to 3.

RESULTS: Change scores in QLQ-C30 and PRO-CTCAE were available in 406 and 792 patients in PRO-TECT and the validation study, respectively. Across QLQ-C30 scales, the proportion of patients with a 10-point or greater worsening on QLQ-C30 ranged from 15 to 30% in the PRO-TECT data and 13% to 34% in the validation data. Across PRO-CTCAE items, anchor-based meaningful change estimates for deterioration ranged from 0.05 to 0.30 (mean 0.19) in the PRO-TECT data and from 0.19 to 0.53 (mean 0.36) in the validation data. For composites, they ranged from 0.06 to 0.27 (mean 0.17) in the PRO-TECT data and 0.22 to 0.51 (mean 0.37) in the validation data.

CONCLUSION: In both datasets, the minimal meaningful individual-level change threshold for worsening was one point for all items and composite scores.

CLINICALTRIALS: gov: NCT03249090 (AFT-39), NCT02158637 (MC1091).

PMID:39503942 | DOI:10.1007/s11136-024-03819-5

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Nevin Manimala Statistics

Association between long-term PM2.5 exposure and mortality on Sumatra Island: Indonesian Family Life Survey (IFLS) 2000-2014

Environ Monit Assess. 2024 Nov 6;196(12):1173. doi: 10.1007/s10661-024-13323-5.

ABSTRACT

The concentration of PM2.5 (particulate matter with a diameter < 2.5 µm) on Sumatra Island has increased, mainly because of forest and peatland fires, transportation, and industry. Biomass burning releases partially burned carbon into the atmosphere, resulting in a smoky haze containing PM2.5. Air quality has deteriorated quickly, and PM2.5 has become a major health hazard in Indonesia. Studies on long-term exposure to PM2.5 have indicated its associations with both morbidity and mortality. Here, we measured long-term (2000-2014) exposure to PM2.5 on the basis of satellite-derived aerosol optical depth measurements (1 × 1 km2) used to predict ground-level PM2.5 concentrations. Additionally, population data on Sumatra Island residents from the fourth wave of the Indonesian Family Life Survey (IFLS) were obtained. We investigated the association between long-term PM2.5 exposure and mortality with a retrospective cohort study design. A total of 2409 subjects aged ≥ 40 years participated in the IFLS-3 beginning in November 2000, and we examined mortality outcomes until the IFLS-5 in September 2014. We used Cox regression models to calculate hazard ratios (HRs) of mortality associated with PM2.5 exposure. According to the adjusted model, the mortality HRs per 10 µg/m3 increase in PM2.5 concentration were 1.10 (95% CI 1.03, 1.17) for all natural causes, 1.17 (95% CI 1.05, 1.25) for cardiovascular causes, and 1.19 (95% CI 1.04, 1.36) for respiratory causes. Long-term exposure to PM2.5 was associated with all-natural, cardiovascular, and respiratory mortality on Sumatra Island, where PM2.5 levels exceed the WHO and US-EPA air quality standards.

PMID:39503939 | DOI:10.1007/s10661-024-13323-5

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Nevin Manimala Statistics

Enhanced adaptive permutation test with negative binomial distribution in genome-wide omics datasets

Genes Genomics. 2024 Nov 6. doi: 10.1007/s13258-024-01584-w. Online ahead of print.

ABSTRACT

BACKGROUND: The permutation test has been widely used to provide the p-values of statistical tests when the standard test statistics do not follow parametric null distributions. However, the permutation test may require huge numbers of iterations, especially when the detection of very small p-values is required for multiple testing adjustments in the analysis of datasets with a large number of features.

OBJECTIVE: To overcome this computational burden, we suggest a novel enhanced adaptive permutation test that estimates p-values using the negative binomial (NB) distribution. By the method, the number of permutations are differently determined for individual features according to their potential significance.

METHODS: In detail, the permutation procedure stops, when test statistics from the permuted dataset exceed the observed statistics from the original dataset by a predefined number of times. We showed that this procedure reduced the number of permutations especially when there were many insignificant features. For significant features, we enhanced the reduction with Stouffer’s method after splitting datasets.

RESULTS: From the simulation study, we found that the enhanced adaptive permutation test dramatically reduced the number of permutations while keeping the precision of the permutation p-value within a small range, when compared to the ordinary permutation test. In real data analysis, we applied the enhanced adaptive permutation test to a genome-wide single nucleotide polymorphism (SNP) dataset of 327,872 features.

CONCLUSION: We found the analysis with the enhanced adaptive permutation took a feasible time for genome-wide omics datasets, and successfully identified features of highly significant p-values with reasonable confidence intervals.

PMID:39503929 | DOI:10.1007/s13258-024-01584-w

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Nevin Manimala Statistics

Multidimensional Healthcare Access Barriers to Prostate-Specific Antigen Testing: A Nation-Wide Panel Study in the United States From 2006 to 2020

Cancer Med. 2024 Nov;13(21):e70358. doi: 10.1002/cam4.70358.

ABSTRACT

BACKGROUND: Rising metastatic prostate cancer incidence has renewed debate regarding benefits of prostate-specific antigen (PSA) screening. Identifying barriers to accessing screening for individuals at high risk of lethal prostate cancer may slow this rise. We examined associations of access barriers with receipt of PSA testing, stratified by sociodemographic factors.

METHODS: We pooled data from male respondents to Behavior Risk Factor Surveillance Systems (BRFSS) surveys from 2006 to 2020. Questions related to affordability (insurance, cost of visits) and accommodation (regular primary care provider (PCP), physician recommending a PSA test) were considered as individual-level barriers. For availability, we linked provider density from the 2012 Area Health Resource File and estimated driving times to closest health facility within Micropolitan and Metropolitan Statistical Area (MMSA) using Google Earth Engine. These measures were used to compute a spatial accessibility index. We fit survey-weighted, covariate-adjusted logistic regression models to estimate associations of barriers with receipt of PSA within the past 2 years and examined effect modification by sociodemographic factors.

RESULTS: There were 185,643 participants, of whom 73% were White, 11% were Black, 4% were Asian, and 11% were Hispanic. Physician recommendation was the strongest predictor of having a PSA test (aOR: 14.5, 95% CI: 13.6, 15.6). Not having a regular PCP (aOR: 0.29, 95% CI: 0.27, 0.31), insurance (aOR: 0.64, 95% CI: 0.58, 0.71), and prohibitive cost of care (aOR: 0.82, 95% CI: 0.75, 0.90) were associated with lower PSA testing. Access barriers were stronger predictors of PSA testing for Asian and White participants compared to other groups (Phet < 0.004 for insurance and regular PCP) and for those with college education compared to those without (Phet < 0.05 for insurance, perceived unaffordability).

DISCUSSION: Physician recommendation was the strongest predictor of receipt of PSA testing, regardless of sociodemographic grouping. Future studies should consider access barriers jointly and across sociodemographic strata.

PMID:39503193 | DOI:10.1002/cam4.70358

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Nevin Manimala Statistics

The effect of the endothelin receptor antagonist atrasentan on insulin resistance in phenotypic clusters of patients with type 2 diabetes and chronic kidney disease

Diabetes Obes Metab. 2024 Nov 6. doi: 10.1111/dom.16041. Online ahead of print.

ABSTRACT

AIMS: Type 2 diabetes (T2D) patients with a clinical phenotype characterized by a high degree of insulin resistance are at increased risk of chronic kidney disease (CKD). We previously demonstrated that the endothelin receptor antagonist (ERA) atrasentan reduced insulin resistance in T2D. In this study, we compared the effect of atrasentan on insulin resistance across different phenotypic clusters of patients with T2D.

MATERIALS AND METHODS: We performed a post hoc analysis of the SONAR trial, a randomized, placebo-controlled trial of the ERA atrasentan in patients with T2D and CKD. Patients were stratified into four previously identified phenotypic clusters: severe insulin-deficient diabetes (SIDD), severe insulin-resistant diabetes (SIRD), mild obesity-related diabetes (MOD) and mild age-related diabetes (MARD). Changes in insulin resistance, assessed by HOMA-IR, were compared between the phenotypic clusters using a mixed effects model.

RESULTS: In total, 931 patients were included in the analysis. In the overall population, atrasentan compared to placebo reduced HOMA-IR by 12.9% [95%CI 3.5,21.4]. This effect of atrasentan was more pronounced in clusters characterized by insulin resistance or deficiency: (SIRD cluster 26.2% [95% CI 3.8,43.3] and SIDD cluster 18.5% [95%CI -3.8,35.9]), although the latter did not reach statistical significance. The effect of atrasentan compared to placebo was less pronounced in the other two clusters (MARD 12.2% [95% CI -1.7,24.12] and MOD -5.3% [95% CI -28.9,13.9]).

CONCLUSIONS: Atrasentan significantly improved insulin sensitivity in patients with T2D and CKD, especially in those characterized by high insulin resistance (SIRD cluster). Further studies are warranted to investigate the long-term clinical outcomes of atrasentan treatment in these distinct phenotypic clusters.

PMID:39503150 | DOI:10.1111/dom.16041

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Nevin Manimala Statistics

Identification and Management of Dental Anxiety by New Zealand Dentists

Anesth Prog. 2024 Sep 9;71(3):115-122. doi: 10.2344/201833.

ABSTRACT

OBJECTIVE: More than 1 in 8 New Zealand (NZ) adults are dentally anxious, which can lead to avoiding dental care and a higher risk of poor oral health. However, little is known about how dentally anxious patients are identified and managed by NZ general dentists. This survey aimed to investigate how NZ dentists identify and manage dentally anxious patients.

METHODS: We conducted an email survey of NZ dentists in 2022, obtaining 212 responses. Along with demographic information, respondents were queried about whether they ask patients about past/current dental fears and their likely origin, how they assessed those fears, their usual management of dentally anxious patients, and how the management of dentally anxious patients could be improved.

RESULTS: Almost three-quarters reported personally asking patients about past and/or current dental fears, and half enquired about bad life experiences that had led to those fears. Only 6 respondents (2.8%) reported using a formal dental anxiety/phobia assessment tool prior to treatment. For managing severely anxious adult dental patients, all dentists used at least 1 pharmacologic or psychological technique or referral to a colleague.

CONCLUSION: The study identified several weaknesses among NZ dentists in identifying and managing dental anxiety patients. The use of formal dental anxiety/phobia assessment tools prior to treatment needs improvement. Addressing dental anxiety is a complex issue that requires a multipronged approach involving improved education, the development and implementation of better assessment tools, and a greater understanding of how dentists’ current assessment and management of dental anxiety can be improved.

PMID:39503143 | DOI:10.2344/201833

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Nevin Manimala Statistics

Efficacy of Midazolam/Meperidine vs Midazolam/Hydromorphone for Enteral Moderate Sedation in the Pediatric Dental Patient

Anesth Prog. 2024 May 3;71(1):15-18. doi: 10.2344/22-00037.

ABSTRACT

OBJECTIVE: The goal of this study was to compare the efficacy of midazolam/meperidine (M/M) vs midazolam/hydromorphone (M/H) for enteral moderate sedation along with inhalational sedation in pediatric dental patients.

METHODS: This retrospective chart review analyzed the charts of pediatric patients who received dental treatment under enteral moderate sedation with either M/M or M/H in combination with inhalational sedation (nitrous oxide/oxygen) at El Rio Community Health Centers (affiliated with NYU Langone) in Tucson, Arizona, from July 2014 to December 2020. Included subjects were between 2 and 5 years of age, less than 20 kg, and otherwise healthy. In addition to demographic and drug-dosing data, treatment completion, sedation level, behavioral score, overall effectiveness, and sedation duration data were collected and analyzed from each patient’s chart.

RESULTS: No statistically significant differences were observed when comparing the 2 drug regimens in treatment completion (P = .89), sedation level (P = .74), and overall effectiveness (P = .70). There was a statistically significant difference in behavior scoring, with the M/H group demonstrating higher scores (P = .04) than the M/M group.

CONCLUSION: The combination of midazolam and hydromorphone may provide an effective alternative to midazolam and meperidine when used with inhalational sedation (nitrous oxide/oxygen) for the moderate sedation of pediatric dental patients.

PMID:39503125 | DOI:10.2344/22-00037

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Nevin Manimala Statistics

Efficacy of Maxillary Buccal Infiltration of Articaine for Palatal Anesthesia: A Prospective, Randomized, Crossover Study

Anesth Prog. 2024 May 3;71(1):8-14. doi: 10.2344/23-00023.

ABSTRACT

OBJECTIVE: Although there are conflicting data, several authors have proposed that articaine’s molecular properties suggest improved perfusion capabilities over other amide anesthetics. The purpose of this prospective, randomized, crossover study was to evaluate the anesthetic efficacy of palatal soft-tissue anesthesia following a buccal infiltration of 1.8 and 3.6 mL of 4% articaine with 1:100,000 epinephrine.

METHODS: One hundred eighteen adults received 1.8 or 3.6 mL of 4% articaine with 1:100,000 epinephrine as a buccal infiltration of the maxillary first molar at 2 separate appointments. Palatal soft-tissue anesthesia was evaluated with a dental explorer. Anesthetic success was defined as the absence of pain with an explorer stick. For the subjects who achieved palatal anesthesia, mapping was conducted over 70 minutes, and the overall area of palatal anesthesia was calculated. The data were analyzed using chi-square tests.

RESULTS: The highest percentage of palatal anesthetic success was 20% for the 1.8-mL volume and 32% for the 3.6-mL volume both at 30 minutes. A statistically significant difference between the 1.8- and 3.6-mL volumes was seen at 40 minutes. There was high variability in area measurements for subjects who achieved palatal anesthesia. The highest area measurements were 92 mm2 for the 1.8-mL volume at 20 minutes and 113 mm2 for the 3.6-mL volume at 10 minutes.

CONCLUSION: Because of the low success rates (20%-32%) and the high variability of the area anesthetized for the subjects who achieved palatal anesthesia, the clinical efficacy of 1.8 or 3.6 mL of articaine via buccal infiltration for palatal anesthesia is of questionable value.

PMID:39503116 | DOI:10.2344/23-00023

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Nevin Manimala Statistics

Transcranial direct current stimulation combined with cognitive training improves two executive functions: Cognitive flexibility and information updating after traumatic brain injury

Acta Psychol (Amst). 2024 Oct 26;250:104553. doi: 10.1016/j.actpsy.2024.104553. Online ahead of print.

ABSTRACT

Traumatic brain injury (TBI) often causes persistent deficits in cognitive flexibility and information updating. Cognitive flexibility refers to the brain’s ability to adjust its thinking and behavior in response to changing circumstances, whereas information updating is the process of incorporating new facts into current knowledge. Both cognitive flexibility and information updating are critical components of executive function, and their impairment can have a major influence on a person’s capacity to operate independently and adjust to life’s problems following a TBI. Understanding and addressing these specific cognitive processes is therefore critical in designing successful therapies for TBI patients. Previous studies have examined the effects of non-invasive brain stimulation and cognitive training separately. This study investigated the effects of combining transcranial direct current stimulation (tDCS) with computer-based cognitive training, comparing this combined intervention against a control group with no treatment, to assess improvements in two executive functions in TBI patients: cognitive flexibility and information updating. Thirty TBI patients, 2-12 weeks post-injury with impaired executive dysfunction, were randomized to an experimental or control group. The experimental group received ten 30-minute sessions over 2 weeks of anodal (A-tDCS), 2.0 mA to the prefrontal cortex while performing cognitive training tasks from the RehaCom software. The control group received no intervention during this period. Cognitive flexibility and information updating were assessed before and after the intervention period using the n-back working memory task, Wisconsin Sorting Card Test, and quantitative electroencephalography (qEEG) during eyes-closed state. Statistically significant differences in theta, alpha, beta, and gamma band power were observed between groups (p < .05, 4 < f < 6). Secondary outcomes indicated significant improvements in cognitive flexibility within Wisconsin Card Sorting Test and information updating performance within n-back task (p < .05, 7 < f < 20). The combination of tDCS and cognitive training may improve cognitive flexibility and information updating in TBI patients by enhancing plasticity and connectivity in prefrontal regions involved in these complex cognitive processes.

PMID:39503106 | DOI:10.1016/j.actpsy.2024.104553

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Nevin Manimala Statistics

Exploring multisensory home office design in virtual reality: Effects on task performance, heart rate, and emotion

Acta Psychol (Amst). 2024 Oct 26;250:104536. doi: 10.1016/j.actpsy.2024.104536. Online ahead of print.

ABSTRACT

The integration of virtual reality (VR) and multisensory experiences offers a novel approach to enhancing workspace design, particularly for home office environments. This preliminary study examines the effects of visual and olfactory stimuli in a VR-simulated smart home environment on presence, task performance, heart rate, and mood. Sensory conditions, including visual, olfactory, and combined stimuli, were controlled in an experiment with 60 participants to assess both physiological and psychological responses. Task performance was measured through cognitive tests, while heart rate and mood states were monitored using a heart rate sensor and the Positive and Negative Affect Schedule (PANAS), respectively. Statistical results showed that the sense of presence provided by VR and specific conditions-such as visual stimuli (e.g., intelligent lighting systems)-effectively enhanced work efficiency, with task performance under visual stimuli significantly outperforming that under olfactory stimuli (e.g., peppermint scent). However, these sensory stimuli did not significantly affect heart rate or emotions. Our findings underscore the potential of sensory design to improve task performance and highlight the importance of the sensory environment in designing home offices, suggesting that sensory stimuli can enhance work efficiency in remote or virtual work settings.

PMID:39503105 | DOI:10.1016/j.actpsy.2024.104536