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Nevin Manimala Statistics

Mid-term clinical outcome of arthroscopic surgery on early knee osteoarthritis in middle-old aged patients

Zhongguo Gu Shang. 2023 Jun 25;36(6):502-7. doi: 10.12200/j.issn.1003-0034.2023.06.002.

ABSTRACT

OBJECTIVE: To compare the mid-term clinical effect of arthroscopic surgery versus conservative treatment on the middle aged early knee osteoarthritis (EKOA) patients, with the hope to provide clinical evidence for their individual therapy.

METHODS: A total of 145 middle aged EKOA patients(182 knees) who received arthroscopic surgery or conservative treatment from January 2015 to December 2016 were retrospectively enrolled, including 35 males and 110 females, aged from 47 to 79 years old with an average of (57.6±6.9) years old, and the duration of disease ranged from 6 to 48 months with an average of(14.6±8.9) months. According to treatment method, patients were divided into arthroscopic surgery group (47 patients, 58 knees) and conservative treatment group(98 patients, 124 knees). Before treatment, patients presented with symptoms of knee joint, such as pain, swelling, locking, limited flexion and extension, and weakness, as well as abnormal findings in knee X-ray (without or suspicious joint space narrow, and a few of osteophyte formation) or in knee MRI (injury or degeneration of articular cartilage or meniscus, loose body in the joint cavity and synovial hyperemia edema, etc). Related data were collected, including duration of knee symptoms, presence of meniscus injury, loose body in the joint cavity or mechanical symptoms such as locking, and visual analogue scale (VAS) and Lysholm knee function score before treatment and at the latest follow-up. Statistical analysis was performed to compare the differences in VAS or Lyshilm score before or after treatment between the low groups and within each group.

RESULTS: Patients in the two groups were followed up from 60 to 76 months. In the arthroscopic surgery group, the incision healing was good and no surgical complications occurred. There were no significant differences in age, gender, BMI and follow-up time between the two groups(P>0.05). Before treatment, compared with conservative group, duration of symptoms in the arthroscopic group was longer (P<0.001), comorbidity rates of meniscus injury (P<0.001), free body (P=0.001) and mechanical symptoms (P<0.001) were higher, VAS (P<0.001) and Lysholm score (P<0.001) were worse. At the final follow-up, VAS and Lysholm score in either the conservative group or the arthroscopic group were significantly better than before treatment (P<0.05), while no significant differences between the two groups were found. The VAS was (1.5±1.2) scores in the arthroscopic group and (1.6±1.0)scores in the conservative group(P=0.549), and the Lysholm score was (84.9±12.5) scores in the arthroscopic group and (84.2±9.9) scores in the conservative group (P=0.676).

CONCLUSION: Both arthroscopic surgery and conservative treatment have satisfactory intermediate clinical effect middle- aged patients with EKOA, without statistically differences. However, most of the patients before surgery in the arthroscopic treatment group had mechanical locking symptoms caused by meniscus injury or loose body. Therefore, for the middle-aged EKOA patients with mechanical locking symptoms or without obtaining satisfactory outcome after conservative treatment, arthroscopic surgery may be considered.

PMID:37366090 | DOI:10.12200/j.issn.1003-0034.2023.06.002

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Nevin Manimala Statistics

Machine learning-based classifying of risk-takers and risk-aversive individuals using resting-state EEG data: A pilot feasibility study

Brain Behav. 2023 Jun 27:e3139. doi: 10.1002/brb3.3139. Online ahead of print.

ABSTRACT

BACKGROUND: Decision-making is vital in interpersonal interactions and a country’s economic and political conditions. People, especially managers, have to make decisions in different risky situations. There has been a growing interest in identifying managers’ personality traits (i.e., risk-taking or risk-averse) in recent years. Although there are findings of signal decision-making and brain activity, the implementation of an intelligent brain-based technique to predict risk-averse and risk-taking managers is still in doubt.

METHODS: This study proposes an electroencephalogram (EEG)-based intelligent system to distinguish risk-taking managers from risk-averse ones by recording the EEG signals from 30 managers. In particular, wavelet transform, a time-frequency domain analysis method, was used on resting-state EEG data to extract statistical features. Then, a two-step statistical wrapper algorithm was used to select the appropriate features. The support vector machine classifier, a supervised learning method, was used to classify two groups of managers using chosen features.

RESULTS: Intersubject predictive performance could classify two groups of managers with 74.42% accuracy, 76.16% sensitivity, 72.32% specificity, and 75% F1-measure, indicating that machine learning (ML) models can distinguish between risk-taking and risk-averse managers using the features extracted from the alpha frequency band in 10 s analysis window size.

CONCLUSIONS: The findings of this study demonstrate the potential of using intelligent (ML-based) systems in distinguish between risk-taking and risk-averse managers using biological signals.

PMID:37366037 | DOI:10.1002/brb3.3139

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Nevin Manimala Statistics

Biostatistics for gastroenterologists. Part II ̶ Rethinking sample size

Rev Esp Enferm Dig. 2023 Jun 27;115. doi: 10.17235/reed.2023.9784/2023. Online ahead of print.

ABSTRACT

Sample size determination is a critical aspect of medical studies, influencing the reliability and generalizability of research findings. This article explores the importance of sample size in both basic and clinical research. The considerations for sample size differ based on the type of research, whether it is involving humans, animals, or cells. In basic research, a larger sample size is necessary to ensure statistical power and reliable results, enhancing the precision and generalizability of findings. In clinical research, determining an appropriate sample size is crucial for obtaining valid and clinically relevant results, ensuring sufficient statistical power to detect differences between treatment groups or validate intervention efficacy. Reporting sample size calculations accurately and complying with reporting guidelines, such as the CONSORT Statement, is essential for transparent and comprehensive research publications. Consulting a statistician is highly recommended to ensure appropriate sample size determination, enhance scientific rigor, and obtain reliable and clinically relevant findings in medical research.

PMID:37366033 | DOI:10.17235/reed.2023.9784/2023

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Nevin Manimala Statistics

Rural-urban disparities in pregestational and gestational diabetes in pregnancy: Serial, cross-sectional analysis of over 12 million pregnancies

BJOG. 2023 Jun 27. doi: 10.1111/1471-0528.17587. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare trends in pregestational (DM) and gestational diabetes (GDM) in pregnancy in rural and urban areas in the USA, because pregnant women living in rural areas face unique challenges that contribute to rural-urban disparities in adverse pregnancy outcomes.

DESIGN: Serial, cross-sectional analysis.

SETTING: US National Center for Health Statistics (NCHS) Natality Files from 2011 to 2019.

POPULATION: A total of 12 401 888 singleton live births to nulliparous women aged 15-44 years.

METHODS: We calculated the frequency (95% confidence interval [CI]) per 1000 live births, the mean annual percentage change (APC), and unadjusted and age-adjusted rate ratios (aRR) of DM and GDM in rural compared with urban maternal residence (reference) per the NCHS Urban-Rural Classification Scheme overall, and by delivery year, reported race and ethnicity, and US region (effect measure modification).

MAIN OUTCOME MEASURES: The outcomes (modelled separately) were diagnoses of DM and GDM.

RESULTS: From 2011 to 2019, there were increases in both the frequency (per 1000 live births; mean APC, 95% CI per year) of DM and GDM in rural areas (DM: 7.6 to 10.4 per 1000 live births; APC 2.8%, 95% CI 2.2%-3.4%; and GDM: 41.4 to 58.7 per 1000 live births; APC 3.1%, 95% CI 2.6%-3.6%) and urban areas (DM: 6.1 to 8.4 per 1000 live births; APC 3.3%, 95% CI 2.2%-4.4%; and GDM: 40.8 to 61.2 per 1000 live births; APC 3.9%, 95% CI 3.3%-4.6%). Individuals living in rural areas were at higher risk of DM (aRR 1.48, 95% CI 1.45%-1.51%) and GDM versus those in urban areas (aRR 1.17, 95% CI 1.16%-1.18%). The increased risk was similar each year for DM (interaction p = 0.8), but widened over time for GDM (interaction p < 0.01). The rural-urban disparity for DM was wider for individuals who identified as Hispanic race/ethnicity and in the South and West (interaction p < 0.01 for all); and for GDM the rural-urban disparity was generally wider for similar factors (i.e. Hispanic race/ethnicity, and in the South; interaction p < 0.05 for all).

CONCLUSIONS: The frequency of DM and GDM increased in both rural and urban areas of the USA from 2011 to 2019 among nulliparous pregnant women. Significant rural-urban disparities existed for DM and GDM, and increased over time for GDM. These rural-urban disparities were generally worse among those of Hispanic race/ethnicity and in women who lived in the South. These findings have implications for delivering equitable diabetes care in pregnancy in rural US communities.

PMID:37366023 | DOI:10.1111/1471-0528.17587

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Nevin Manimala Statistics

Clinical and histopathological correlations in symptomatic patients with salpingectomy for Essure® implant removal: a cross-sectional study

Eur J Contracept Reprod Health Care. 2023 Jun 27:1-7. doi: 10.1080/13625187.2023.2218953. Online ahead of print.

ABSTRACT

PURPOSE: Many concerns have been raised about adverse effects related to Essure® device. Several pathophysiological hypotheses have been proposed including allergic reactions, Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants, galvanic corrosion with release of heavy metals and inflammation. In the present study, we aimed to focus on inflammation process by performing a histopathological evaluation of Fallopian tubes in symptomatic patients with Essure® removal.

MATERIALS AND METHODS: A cross-sectional study with identification of the type of inflammatory response and characterisation of inflammatory cells in the surrounding tubal tissue around the Essure® (STTE) and at distance from the implant. Histopathological and clinical correlations were also investigated.

RESULTS: In the STTE from 47 cases, acute inflammation was observed in 3/47 (6.4%) cases. Chronic inflammation with lymphocytes (42.5%, 20/47) was associated with a significant higher pre-operative pain score (p = .03). Fibrosis was noted in 43/47 (91.5%) cases. Fibrosis without lymphocytes (51.1%, 24/47) was statistically associated with significant reduced pain (p = .04). At distance from the Essure® implant, only chronic inflammation with lymphocytes was present in 10/47 (21.7%) cases.

CONCLUSIONS: Inflammation response do not seem to be enough to explain all the Essure-related adverse outcomes, suggesting the involvement of other biological mechanisms.

CLINICALTRIALS.GOV IDENTIFIER: NCT03281564.

PMID:37365993 | DOI:10.1080/13625187.2023.2218953

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Nevin Manimala Statistics

Diagnostic accuracy of hand-held colposcope (Gynocular) in comparison with standard colposcope in patients with abnormal cervical cytology or visual inspection with acetic acid positivity: a cross over randomized controlled study

Obstet Gynecol Sci. 2023 Jun 27. doi: 10.5468/ogs.23089. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the diagnostic accuracy of a handheld colposcope (Gynocular) versus a standard colposcope in women with abnormal cervical cytology or visual Inspection with acetic acid positivity.

METHODS: This crossover randomized clinical trial was conducted in Pondicherry, India, and included 230 women who were referred for colposcopy. Swede scores were calculated using both colposcopes, and a cervical biopsy was performed from the most visually abnormal areas. Swede scores were compared with the histopathological diagnosis, which was used as the reference standard. The level of agreement between the two colposcopes was calculated using Kappa (ᴋ) statistics.

RESULTS: The level of agreement of Swede scores between the standard and Gynocular colposcopes was 62.56%, and the κ statistic was 0.43 (P<0.001). Cervical intraepithelial neoplasia (CIN) 2+ (CIN 2, CIN 3, CIN 3+) was diagnosed in 40 (17.4%) women. There were no significant differences between the two colposcopes in terms of sensitivity, specificity, or predictive value for detecting CIN 2+ lesions.

CONCLUSION: The diagnostic accuracy of Gynocular colposcopy was similar to that of standard colposcopy for detecting CIN 2+ lesions. Gynocular colposcopes showed a good level of agreement with standard colposcopes when the Swede score was used.

PMID:37365989 | DOI:10.5468/ogs.23089

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Nevin Manimala Statistics

Bayesian model selection for generalized linear mixed models

Biometrics. 2023 Jun 27. doi: 10.1111/biom.13896. Online ahead of print.

ABSTRACT

We propose a Bayesian model selection approach for generalized linear mixed models (GLMMs). We consider covariance structures for the random effects that are widely used in areas such as longitudinal studies, genome-wide association studies, and spatial statistics. Since the random effects cannot be integrated out of GLMMs analytically, we approximate the integrated likelihood function using a pseudo-likelihood approach. Our Bayesian approach assumes a flat prior for the fixed effects and includes both approximate reference prior and half-Cauchy prior choices for the variances of random effects. Since the flat prior on the fixed effects is improper, we develop a fractional Bayes factor approach to obtain posterior probabilities of the several competing models. Simulation studies with Poisson GLMMs with spatial random effects and overdispersion random effects show that our approach performs favorably when compared to widely used competing Bayesian methods including deviance information criterion and Watanabe-Akaike information criterion. We illustrate the usefulness and flexibility of our approach with three case studies including a Poisson longitudinal model, a Poisson spatial model, and a logistic mixed model. Our proposed approach is implemented in the R package GLMMselect that is available on CRAN.

PMID:37365985 | DOI:10.1111/biom.13896

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Nevin Manimala Statistics

Sex-based differences in safety and efficacy of catheter ablation for atrial fibrillation

J Cardiovasc Electrophysiol. 2023 Jun 27. doi: 10.1111/jce.15975. Online ahead of print.

ABSTRACT

BACKGROUND: Studies have identified significant sex-based differences and disparities in the clinical presentation and treatment of atrial fibrillation (AF). Studies have shown women are less likely to be referred for catheter ablation, are older at the time of ablation, and are more likely to have recurrence after ablation. However, in most studies investigating AF ablation outcomes, the female cohorts were relatively small. The impact of sex on the outcome and safety of ablation procedures is still unclear.

OBJECTIVE: To investigate sex-based differences in outcomes and complications after AF catheter ablation, with a significant female cohort METHOD: In this retrospective study, patients undergoing AF ablation from January 1, 2014, to March 31, 2021, were included. We investigated clinical characteristics, duration and progression of AF, number of EP appointments from diagnosis to ablation, procedural data, and procedure complications.

RESULTS: Total of 1346 patients underwent first catheter ablation for AF during this period, including 896 (66.5%) male and 450 (33.4%) female patients. Female patients were older at the time of ablation (66.2 vs. 62.4 years; p < .001). Women had higher CHA2 DS2 -VASc (congestive heart failure, hypertension, age, diabetes, stroke, vascular disease, sex category) scores (3 vs. 2; p < .001) than men, expectedly, as the female sex warrants an additional point. 25.3% female patients had PersAF at the time of diagnosis versus 35.3% male patients (p < .001). At the time of ablation, 31.8% female patients had PersAF as compared to 43.1% male patients (p < .001), indicating progression of PAF to PersAF in both sexes. Women tried more AADs than men before ablation (1.13 vs. 0.98; p = .002). Male and female patients had no statistically significant difference in (a) arrhythmia recurrence at 1-year post ablation (27.7% vs. 30%; p = .38) or (b) procedural complication rate (1.8% vs. 3.1%; p = .56).

CONCLUSION: Female patients were older and had higher CHA2 DS2 -VASc scores compared to males at the time of AF ablation. Women tried more AADs than men before ablation. One-year arrhythmia recurrence rates and procedural complications were similar in both sexes. No sex-based differences were observed in safety and efficacy of ablation.

PMID:37365926 | DOI:10.1111/jce.15975

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Nevin Manimala Statistics

Plasma Thioredoxin Reductase as a Potential Biomarker for Gynecologic Cancer

Technol Cancer Res Treat. 2023 Jan-Dec;22:15330338231184995. doi: 10.1177/15330338231184995.

ABSTRACT

BACKGROUND: According to previous literatures, plasma thioredoxin reductase (TrxR) level was significantly elevated in various malignant tumors and serve as a potential biomarker for diagnosis and prognostic prediction. However, there is little awareness of the clinical value of plasma TrxR in gynecologic malignancies. In the present study, we aim to evaluate the diagnostic accuracy of plasma TrxR in gynecologic cancer and explore its role in treatment surveillance.

METHODS: We retrospectively enrolled 134 patients with gynecologic cancer and 79 patients with benign gynecologic disease. The difference of plasma TrxR activity and tumor markers level between two groups was compared using Mann-Whitney U test. By detecting pretreatment and post-treatment level of TrxR and conventional tumor markers, we further assessed the change trend of them with the Wilcoxon signed-ranks test.

RESULTS: Compared with benign control [5.7 (5, 6.6) U/mL], statistically significant increase of TrxR activity was observed in gynecologic cancer group [8.4 (7.25, 9.825) U/mL] (P < .0001), regardless of age and stage. On the basis of receiver operating characteristic (ROC) curves, we found plasma TrxR shows the highest diagnostic efficacy for distinguishing malignancy with benign disease, with an area under the curve (AUC) of 0.823 (95% confidence interval [CI] = 0.767-0.878), in the whole cohort. Besides, patients receiving treatment previously [8 (6.5, 9) U/mL] had a decreased TrxR level relative to treatment-native patients [9.9 (8.6, 10.85) U/mL]. Furthermore, follow-up data showed that plasma TrxR level would be evidently decreased after two courses of antitumor therapy (P < .0001), which is consistent with the downward trend of conventional tumor markers.

CONCLUSION: Collectively, all these results demonstrated plasma TrxR is an effective parameter for gynecologic cancer diagnosis and concurrently acts as a promising biomarker for treatment response assessment.

PMID:37365925 | DOI:10.1177/15330338231184995

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Nevin Manimala Statistics

Varying-coefficients for regional quantile via KNN-based LASSO with applications to health outcome study

Stat Med. 2023 Jun 27. doi: 10.1002/sim.9839. Online ahead of print.

ABSTRACT

Health outcomes, such as body mass index and cholesterol levels, are known to be dependent on age and exhibit varying effects with their associated risk factors. In this paper, we propose a novel framework for dynamic modeling of the associations between health outcomes and risk factors using varying-coefficients (VC) regional quantile regression via K-nearest neighbors (KNN) fused Lasso, which captures the time-varying effects of age. The proposed method has strong theoretical properties, including a tight estimation error bound and the ability to detect exact clustered patterns under certain regularity conditions. To efficiently solve the resulting optimization problem, we develop an alternating direction method of multipliers (ADMM) algorithm. Our empirical results demonstrate the efficacy of the proposed method in capturing the complex age-dependent associations between health outcomes and their risk factors.

PMID:37365909 | DOI:10.1002/sim.9839