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Nevin Manimala Statistics

PMart Web Application: Marketplace for Interactive Analysis of Panomics Data

J Proteome Res. 2023 Dec 12. doi: 10.1021/acs.jproteome.3c00512. Online ahead of print.

ABSTRACT

PMart is a web-based tool for reproducible quality control, exploratory data analysis, statistical analysis, and interactive visualization of ‘omics data, based on the functionality of the pmartR R package. The newly improved user interface supports more ‘omics data types, additional statistical capabilities, and enhanced options for creating downloadable graphics. PMart supports the analysis of label-free and isobaric-labeled (e.g., TMT, iTRAQ) proteomics, nuclear magnetic resonance (NMR) and mass-spectrometry (MS)-based metabolomics, MS-based lipidomics, and ribonucleic acid sequencing (RNA-seq) transcriptomics data. At the end of a PMart session, a report is available that summarizes the processing steps performed and includes the pmartR R package functions used to execute the data processing. In addition, built-in safeguards in the backend code prevent users from utilizing methods that are inappropriate based on omics data type. PMart is a user-friendly interface for conducting exploratory data analysis and statistical comparisons of omics data without programming.

PMID:38085827 | DOI:10.1021/acs.jproteome.3c00512

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Development of a radiomics-based model to predict occult liver metastases of pancreatic ductal adenocarcinoma: a multicenter study

Int J Surg. 2023 Dec 4. doi: 10.1097/JS9.0000000000000908. Online ahead of print.

ABSTRACT

BACKGROUND: Undetectable occult liver metastases block the long-term survival of pancreatic ductal adenocarcinoma (PDAC). This study aimed to develop a radiomics-based model to predict occult liver metastases and assess its prognostic capacity for survival.

MATERIALS AND METHODS: Patients who underwent surgical resection and were pathologically proven with PDAC were recruited retrospectively from five tertiary hospitals between January 2015 and December 2020. Radiomics features were extracted from tumors, and the radiomics-based model was developed in the training cohort using LASSO-logistic regression. The model’s performance was assessed in the internal and external validation cohorts using the area under the receiver operating curve (AUC). Subsequently, the association of the model’s risk stratification with progression-free survival (PFS) and overall survival (OS) was then statistically examined using Cox regression analysis and the log-rank test.

RESULTS: A total of 438 patients (mean [standard deviation] age, 62.0 [10.0] years; 255 [58.2%] male) were divided into the training cohort (n = 235), internal validation cohort (n = 100), and external validation cohort (n = 103). The radiomics-based model yielded an AUC of 0.73 (95% confidence interval [CI]: 0.66-0.80), 0.72 (95% CI: 0.62-0.80), and 0.71 (95% CI: 0.61-0.80) in the training, internal validation, and external validation cohorts, respectively, which were higher than the preoperative clinical model. The model’s risk stratification was an independent predictor of PFS (all P < 0.05) and OS (all P < 0.05). Furthermore, patients in the high-risk group stratified by the model consistently had a significantly shorter PFS and OS at each TNM stage (all P < 0.05).

CONCLUSION: The proposed radiomics-based model provided a promising tool to predict occult liver metastases and had great significance in prognosis.

PMID:38085810 | DOI:10.1097/JS9.0000000000000908

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Total versus proximal gastrectomy for proximal gastric cancer after neoadjuvant chemotherapy: a multicenter retrospective propensity score-matched cohort study

Int J Surg. 2023 Dec 4. doi: 10.1097/JS9.0000000000000927. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to analyze and compare the short-term and long-term outcomes of proximal gastrectomy (PG) and total gastrectomy (TG) in patients with locally advanced proximal gastric cancer (GC) following neoadjuvant chemotherapy (NACT).

METHOD: A multicenter retrospective cohort study and propensity score matching (PSM) were employed. We examined 367 patients with proximal GC who received NACT followed by PG (n=164) or TG (n=203) at two Chinese medical institutions between December 2009 and December 2022. Clinical and pathological parameters, postoperative complications, and 5-year overall survival (OS) and recurrence-free survival (RFS) were compared between the two groups. The dissection status and metastasis rate of each lymph node station were assessed.

RESULTS: After PSM, 80 patients were enrolled in both TG and PG group, and baseline characteristics were comparable between the groups (all P>0.05). The TG group had a higher total number of lymph nodes retrived (P<0.001) and longer operative time (P=0.007) compared to the PG group. The incidence of Clavien-Dindo grade II or higher postoperative complications was similar between the TG group (21.3%, 17/80) and the PG group (23.8%, 19/80) (P=0.850). The 5-year OS rates were 68.4% for the PG group and 66.0% for the TG group (P=0.881), while the 5-year RFS rates were 64.8% and 61.9%, respectively (P=0.571), with no statistically significant differences. Metastasis rates at lymph node stations #4d, #5, #6, and #12a were notably low in the TG group, with values of 2.74%, 0.67%, 1.33%, and 1.74%, respectively.

CONCLUSION: For proximal GC patients following NACT, PG maintains comparable curative potential and oncological efficacy to TG, making it a safe option.

PMID:38085808 | DOI:10.1097/JS9.0000000000000927

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The Relationship Between Care Preparedness and Altruism Levels in Caregivers of Stroke Patients

J Neurosci Nurs. 2023 Dec 12. doi: 10.1097/JNN.0000000000000745. Online ahead of print.

ABSTRACT

BACKGROUND: Stroke care partners and caregivers experience emotional and physical burden, and 80% of stroke patients need support after discharge. This study examines the relationship between caregiver preparedness and altruism levels of stroke patients. METHODS: The population of this descriptive and correlational study consisted of the caregivers of stroke patients who were hospitalized at the stroke center of a hospital between January 2021 and August 2021. The sample was determined as 240 with the known sampling formula. The descriptive information form, the Preparedness for Caregiving Scale, and the Altruism Scale were used to collect the study data. RESULTS: The total mean score of the caregivers’ preparedness to provide care was found to be 25.04 (7.36), and the mean total altruism score was 85.78 (9.20). The mean score of Donation, which is one of the subdimensions of the Altruism Scale, was 26.67 (4.08), and that of Helping Status was 59.10 (6.92). No statistically significant relationships were detected between caregivers’ preparedness to provide care scores, Helping Status scores, Donation scores, and total altruism scores in this study (P = .241, P = .245, and P = .129, respectively). CONCLUSION: No statistically significant relationships were detected between the preparedness and altruism levels of the caregivers of the stroke patients in this study.

PMID:38085795 | DOI:10.1097/JNN.0000000000000745

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Tropical Data: Approach and Methodology as Applied to Trachoma Prevalence Surveys

Ophthalmic Epidemiol. 2023 Dec;30(6):544-560. doi: 10.1080/09286586.2023.2249546. Epub 2023 Dec 12.

ABSTRACT

PURPOSE: Population-based prevalence surveys are essential for decision-making on interventions to achieve trachoma elimination as a public health problem. This paper outlines the methodologies of Tropical Data, which supports work to undertake those surveys.

METHODS: Tropical Data is a consortium of partners that supports health ministries worldwide to conduct globally standardised prevalence surveys that conform to World Health Organization recommendations. Founding principles are health ministry ownership, partnership and collaboration, and quality assurance and quality control at every step of the survey process. Support covers survey planning, survey design, training, electronic data collection and fieldwork, and data management, analysis and dissemination. Methods are adapted to meet local context and needs. Customisations, operational research and integration of other diseases into routine trachoma surveys have also been supported.

RESULTS: Between 29th February 2016 and 24th April 2023, 3373 trachoma surveys across 50 countries have been supported, resulting in 10,818,502 people being examined for trachoma.

CONCLUSION: This health ministry-led, standardised approach, with support from the start to the end of the survey process, has helped all trachoma elimination stakeholders to know where interventions are needed, where interventions can be stopped, and when elimination as a public health problem has been achieved. Flexibility to meet specific country contexts, adaptation to changes in global guidance and adjustments in response to user feedback have facilitated innovation in evidence-based methodologies, and supported health ministries to strive for global disease control targets.

PMID:38085791 | DOI:10.1080/09286586.2023.2249546

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Cochlear Implant Outcomes: Quality of Life in Prelingually Deafened, Late-Implanted Patients

Otol Neurotol. 2024 Jan 1;45(1):e24-e27. doi: 10.1097/MAO.0000000000004052. Epub 2023 Nov 26.

ABSTRACT

AIMS: Reevaluating and expanding cochlear implantation’s (CI) indication while measuring the quality of life (QoL) outcomes regarding the parent’s point of view of prelingually deafened, late-implanted patients, which are widely known to showcases a limited improvement in speech recognition.

MATERIALS AND METHODS: A retrospective descriptive and analytic study to assess QoL outcomes from CI in 64 early deafened, late-implanted patients, according to their parent’s perspective, between January 2009 and December 2019, using the Nottingham Pediatric Cochlear Implant Program (Nottingham University Hospital, Nottingham, United Kingdom) “Children with cochlear implantation: parents perspective.”

RESULTS: The most represented age interval is the 5 and 7 interval and the mean age is 10.09 years. There was no sex predominance, with rural origin and high school academicals level preponderance. Fourteen children had experienced neonatal icterus, eight had meningitis, and seven were the result of related marriage. The age of the first consultation was typically over 2 years old, with only 45 schooled children. Age had a significantly statistic correlation between Self-reliance and Well-being and happiness subscales. History of receiving aid and speech therapy has a clear correlation with Self-reliance, Well-being and happiness, and Communication and Education. Schooling statuses, sex, age of appearance, and communication mode were not correlated to any subscale score, and with the exception of Effect of implantation, all the other “Children with cochlear implantation: parent’s perspective” subscales were intercorrelated.

CONCLUSION: Properly validated QoL assessments for CI are a must, as outcomes of CI expand beyond audiometric performances to include the improvement of QoL.

PMID:38085762 | DOI:10.1097/MAO.0000000000004052

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An Investigation of the Impact of Expanding High-Deductible Health Plans on Patient Decision for Cochlear Implant Surgery and Postoperative Outcomes

Otol Neurotol. 2024 Jan 1;45(1):46-51. doi: 10.1097/MAO.0000000000004063. Epub 2023 Nov 26.

ABSTRACT

HYPOTHESIS: After the expansion of high deductibles, patients will delay cochlear implant (CI) surgery to the end of the year, and the risk of postoperative known risks will increase.

BACKGROUND: The Affordable Care Act was associated with increased enrollment in high-deductible health plans (HDHPs), which resulted in rising health insurance deductibles. Health insurance plans can cover a patient’s cost of healthcare once the deductible is met. Patients have been shown to be economic rational decision makers and make decisions based on cost rather than health. They wait for their deductible to be met, typically at the end of the year, then proceed to have costly care. The goal of this study was to evaluate the impact of rising health insurance deductibles on the rate and postoperative outcomes of cochlear implantation and to assess changes by the Tax Cuts and Jobs Act.

METHODS: TriNetX was used to accumulate summary data on patients who obtained a CI between 2005 and 2022 at the beginning (quarter 1) and the end of the year (quarter 4) from the electronic medical records of 75 healthcare organizations. The trends in average rate of cochlear implantation and resultant postoperative known risks or complications were statistically evaluated.

RESULTS: After expansion of HDHPs, the rate of cochlear implantation between quarter 4 (19 cases per year) and quarter 1 (17 cases/year) was similar (p = 0.18). For all patient groups, the case volume significantly increased. Between quarter 4 and quarter 1, postoperative tinnitus was more common in the beginning of the year (risk ratio, 0.68; 95% confidence interval, 0.46-0.99).

CONCLUSIONS: The number of patients receiving CIs significantly increased despite the expansion of HDHPs. Tinnitus was a rare postoperative known risk in the beginning of the year. Patients are less likely concerned about cost of CI surgery because of the impact of hearing loss on quality of life.

PMID:38085761 | DOI:10.1097/MAO.0000000000004063

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Ocular Adverse Events After Influenza Vaccination in Older Adults: Self-Controlled Case Series Using a Large Database in Japan

Ophthalmic Epidemiol. 2023 Dec 12:1-6. doi: 10.1080/09286586.2023.2289990. Online ahead of print.

ABSTRACT

BACKGROUND: To clarify the risk of adverse ocular events following influenza vaccination.

METHODS: This self-controlled case series study used a claims database linked to vaccination records of a large city in Japan between April 2014 and September 2021. Individuals aged ≥ 65 years who developed adverse ocular events during the follow-up period were included. The exposure was influenza vaccination. The primary outcome was defined as the occurrence of at least one of the following five eye diseases: uveitis, scleritis, retinal vein occlusion, retinal artery occlusion, or optic neuritis. Conditional Poisson regression was used to estimate the within-subject incidence rate ratio of ocular adverse events during the risk period (0-56 days after vaccination) compared to the control period.

RESULTS: A total of 4,527 cases were eligible for the study (median age, 74 years; male, 42%). The incidence rate ratio for the outcome during the risk period was 0.99 (95% confidence interval, 0.87 to 1.14). No increased risk was observed for individual components of the outcome either; the incidence rate ratio was 0.94 (0.78 to 1.13) for uveitis, 1.17 (0.86 to 1.59) for scleritis, 0.98 (0.76 to 1.27) for retinal vein occlusion, 0.89 (0.42 to 1.87) for retinal artery occlusion, and 0.87 (0.44 to 1.70) for optic neuritis.

CONCLUSIONS: This self-controlled case series showed no apparent increase in the risk of adverse ocular events after influenza vaccination among older adults. These results mitigate the concerns of older adults who may hesitate to receive influenza vaccination for fear of adverse ocular events.

ABBREVIATION: HR = hazard ratio; CI = confidence interval; RVO = retinal vein occlusion; SCCS = self-controlled case series.

PMID:38085757 | DOI:10.1080/09286586.2023.2289990

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A Model of Immediate Implant Placement to Evaluate Early Osseointegration in 129/Sv Diabetic Mice

Int J Oral Maxillofac Implants. 2023 Dec 12;38(6):1200-1210. doi: 10.11607/jomi.10335.

ABSTRACT

PURPOSE: To analyze the process of early oral osseointegration of titanium (Ti) implants in diabetic 129/Sv mice through microCT and histologic and immunohistochemical analysis.

MATERIALS AND METHODS: A group of 30 male 129/Sv mice was equally subdivided into two groups: (1) nondiabetic (ND), in which mice did not undergo systemic alterations and received a standard diet, and (2) diabetic (D), in which mice were provided a high-fat diet from the age of 6 weeks until the conclusion of the study and received two intraperitoneal (IP) injections of streptozotocin (STZ) at a concentration of 100 mg/Kg each. Each mouse underwent extraction of a maxillary first molar, and customized Ti screws (0.50 mm diameter, 1.5 mm length) were placed in the residual alveolar sockets of the palatal roots. At 7 and 21 days after implant placement, the animals were euthanized for maxilla and pancreas collection. Maxillae containing Ti implants were analyzed with microCT, histology, and immunohistochemistry for cells that were positive for F4/80, CD146, runt-related transcription factor 2 (Runx2), and proliferating cell nuclear antigen (PCNA). Pancreata were histologically analyzed. Quantitative data were statistically analyzed with a significance level at 5% (P < .05).

RESULTS: ND mice presented successful healing and osseointegration, with a significantly higher fraction of bone volume compared to D mice, both at the alveolar sockets (53.39 ± 5.93 and 46.08 ± 3.18, respectively) and at the implant sites (68.88 ± 7.07 and 44.40 ± 6.98, respectively) 21 days after implant placement. Histologic evaluation revealed that the ND mice showed a significant decrease in inflammatory infiltrate and a significant increase in newly formed bone matrix at 21 days, whereas peri-implant sites in the D mice were predominantly encapsulated by fibrous tissue and chronic inflammatory infiltrate. Immunohistochemical characterization revealed higher Runx2 osteoblast differentiation and higher cell proliferation activity in the ND mice at 7 days, while higher amounts of macrophages were present in D mice at 7 and 21 days. Interestingly, no differences were found in CD146-positive cells when comparing ND and D mice.

CONCLUSIONS: This study evaluated the effects of immediate dental implant placement in 129/Sv diabetic mice by using specific healing markers to identify changes in cellular events involved in early oral osseointegration. This approach may serve as tool to evaluate new materials and surface coatings to improve osseointegration in diabetic patients.

PMID:38085752 | DOI:10.11607/jomi.10335

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Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials

JMIR Form Res. 2023 Dec 12;7:e44768. doi: 10.2196/44768.

ABSTRACT

BACKGROUND: Wearable sensors in digital health may pose a risk for skin irritation through the use of wearable patches. Little is known about how patient- and product-related factors impact the risk of skin irritation. Aripiprazole tablets with sensor (AS, Abilify MyCite; Otsuka America Pharmaceutical, Inc) is a digital medicine system indicated for the treatment of patients with schizophrenia, bipolar I disorder, and major depressive disorder. AS includes aripiprazole tablets with an embedded ingestible event marker, a wearable sensor attached to the skin through a wearable patch, a smartphone app, and a web-based portal. To continuously improve the final product, successive iterations of wearable patches were developed, including raisin patch version 4 (RP4), followed by disposable wearable sensor version 5 (DW5), and then reusable wearable sensor version 2 (RW2).

OBJECTIVE: This analysis pooled safety data from clinical studies in adult participants using the RP4, DW5, and RW2 wearable patches of AS and evaluated adverse events related to the use of wearable patches.

METHODS: Safety data from 12 studies in adults aged 18-65 years from May 2010 to August 2020 were analyzed. All studies evaluated safety, with studies less than 2 weeks also specifically examining human factors associated with the use of the components of AS. Healthy volunteers or patients with schizophrenia, bipolar I disorder, or major depressive disorder were enrolled; those who were exposed to at least 1 wearable patch were included in the safety analysis. Adverse events related to the use of a wearable patch were evaluated. Abrasions, blisters, dermatitis, discoloration, erythema, irritation, pain, pruritus, rash, and skin reactions were grouped as skin irritation events (SIEs). All statistical analyses were descriptive.

RESULTS: The analysis included 763 participants (mean [SD] age 42.6 [12.9] years; White: n=359, 47.1%; and male: n=420, 55%). Participants were healthy volunteers (n=269, 35.3%) or patients with schizophrenia (n=402, 52.7%), bipolar I disorder (n=57, 7.5%), or major depressive disorder (n=35, 4.6%). Overall, 13.6% (104/763) of the participants reported at least 1 SIE, all of which were localized to the wearable patch site. Incidence of ≥1 patch-related SIEs was seen in 18.1% (28/155), 14.2% (55/387), and 9.2% (28/306) of participants who used RP4, DW5, and RW2, respectively. Incidence of SIE-related treatment discontinuation was low, which is reported by 1.9% (3/155), 3.1% (12/387), and 1.3% (4/306) of participants who used RP4, DW5, and RW2, respectively.

CONCLUSIONS: The incidence rates of SIEs reported as the wearable patch versions evolved from RP4 through RW2 suggest that information derived from reported adverse events may have informed product design and development, which could have improved both tolerability and wearability of successive products.

TRIAL REGISTRATION: Clinicaltrials.gov NCT02091882, https://clinicaltrials.gov/study/NCT02091882; Clinicaltrials.gov NCT02404532, https://clinicaltrials.gov/study/NCT02404532; Clinicaltrials.gov NCT02722967, https://clinicaltrials.gov/study/NCT02722967; Clinicaltrials.gov NCT02219009, https://clinicaltrials.gov/study/NCT02219009; Clinicaltrials.gov NCT03568500, https://clinicaltrials.gov/study/NCT03568500; Clinicaltrials.gov NCT03892889, https://clinicaltrials.gov/study/NCT03892889.

PMID:38085556 | DOI:10.2196/44768