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Nevin Manimala Statistics

Characterization of Baseline Temperature Characteristics Using Thermography in The Clinical Setting

J Surg Res. 2021 Dec 15;272:26-36. doi: 10.1016/j.jss.2021.11.006. Online ahead of print.

ABSTRACT

BACKGROUND: Thermography is a diagnostic method based on the ability to record infrared radiation emitted by the skin and is unique in its ability to accurately show physiological and/or pathological cutaneous temperature changes in a non-invasive way. This method can be used to indirectly assess changes or impairments in cutaneous perfusion. Significant technological advancements have allowed thermography to be more commonly utilized by clinicians, yet a basic consensus of patient characteristics that may affect temperature recordings is not established.

MATERIALS AND METHODS: We evaluated cutaneous temperature in a cohort of outpatients to understand what factors, including tobacco use and other high-risk characteristics, contribute to cutaneous tissue perfusion as measured by thermography. Participants were prospectively enrolled if they were a combustible cigarette smoker, an electronic cigarette (e-cigarette) user, or a never smoker. Standardized thermographic images of the subject’s facial profiles, forearms, and calves were taken and demographic characteristics, medical comorbidities, and tobacco product use were assessed. These variables were statistically tested for associations with temperature at each anatomic site.

RESULTS: We found that gender had a significant effect on thermographic temperature that differed by anatomic site, and we found a lack of significant difference in thermographic temperature by race. Our regression analysis did not support significant differences in thermographic temperatures across smoking groups, while there was a trend for decreased perfusion in smokers relative to non-smokers and e-cigarette users relative to non-smokers.

CONCLUSION: Thermographic imaging is a useful tool for clinical and research use with consideration of sex and other perfusion-affecting characteristics.

PMID:34922267 | DOI:10.1016/j.jss.2021.11.006

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Validation of MiROvaR, a microRNA-based predictor of early relapse in early stage epithelial ovarian cancer as a new strategy to optimise patients’ prognostic assessment

Eur J Cancer. 2021 Dec 15;161:55-63. doi: 10.1016/j.ejca.2021.11.003. Online ahead of print.

ABSTRACT

AIM: Early-stage epithelial ovarian cancer (eEOC) patients have a generally favorable prognosis but unpredictable recurrence. Accurate prediction of risk of relapse is still a major concern, essentially to avoid overtreatment. Our robust tissue-based miRNA signature named MiROvaR, predicting early EOC recurrence in mostly advanced-stage EOC patients, is here challenged in an independent cohort to extend its classifying ability in the early-stage EOC setting.

METHODS: We retrospectively selected patients who underwent comprehensive surgical staging at our institution including stages from IA to IIB. miRNA expression profile was analysed in 89 cases and MiROvaR algorithm was applied using the previously validated cut-off for patients’ classification. The primary endpoint was progression-free survival (PFS) at 5 years. Complete follow-up time (median = 112 months) was also considered as secondary analysis.

RESULTS: MiROvaR was assessable on 87 cases (19 events of disease progression) and classified 68 (78%) low-risk and 19 (22%) high-risk patients. Recurrence rate at primary end-point was 39% for high-risk patients as compared to 9.5% for low-risk ones. Accordingly, their Kaplan-Meier PFS curves were significantly different at both primary and secondary analysis (p = 0.0006 and p = 0.03, respectively). While none of the prominent clinical variables had prognostic relevance, MiROvaR significantly predicted disease recurrence at the 5-year assessment (primary endpoint analysis; HR:5.43, 95%CI:1.82-16.1, p = 0.0024; AUC = 0.78, 95%CI:0.53-0.82) and at complete follow-up time (HR:2.67, 95%CI:1.04-6.8, p = 0.041; AUC:0.68, 95%CI:0.52-0.82).

CONCLUSIONS: We validated MiROvaR performance in identifying at diagnosis eEOC patients’ at higher risk of early relapse thus enabling selection of the most effective therapeutic approach.

PMID:34922264 | DOI:10.1016/j.ejca.2021.11.003

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The effects of SARS-CoV-2 on hearing thresholds in COVID-19 patients with non-hospitalized mild disease

Am J Otolaryngol. 2021 Dec 14;43(2):103320. doi: 10.1016/j.amjoto.2021.103320. Online ahead of print.

ABSTRACT

INTRODUCTION: COVID-19 may have many nonspecific symptoms, such as hearing loss, tinnitus and dizziness. This study aims to investigate the effects of SARS-CoV-2 on the hearing thresholds of patients with COVID-19.

METHODS: A total of 20 patients aged 20-55 years who were diagnosed with COVID-19 were included in this study. The relationship between the pure-tone thresholds of patients before and after COVID-19 was evaluated.

RESULTS: There was no statistically significant difference between bone conduction pure-tone thresholds in all frequencies before and after COVID-19.

CONCLUSION: SARS-CoV-2 has no effects on the hearing thresholds in patients with non-hospitalized mild COVID-19 disease. Further studies are needed to investigate the possible effects of SARS-CoV-2 on the auditory system.

PMID:34922259 | DOI:10.1016/j.amjoto.2021.103320

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Sensorimotor system changes in adolescent rugby players post-concussion: A prospective investigation from the subacute period through to return-to-sport

Musculoskelet Sci Pract. 2021 Dec 10;57:102492. doi: 10.1016/j.msksp.2021.102492. Online ahead of print.

ABSTRACT

BACKGROUND: The pathophysiology of concussion is complex. Altered sensorimotor function post-concussion may contribute to the wide range of symptoms and impairments reported. There is currently limited evidence documenting changes in sensorimotor function during the recovery period. The aim of this study was to investigate the effect of concussion on the sensorimotor system in adolescents post-concussion using a multifaceted approach.

STUDY DESIGN: Prospective nested case-control study.

METHODS: A total of 285 male adolescent rugby players underwent assessment of sensorimotor function during preseason. Players who sustained a concussion during the season and control players, matched for age and playing position, were assessed in the subacute period (3-5 days) and after return-to-sport (3 weeks). Tests of sensorimotor function included balance, cervical spine and vestibulo-ocular function, and measurement of the size and contraction of lumbopelvic muscles (ultrasound imaging).

RESULTS: Twenty-three players (8%) sustained a concussion. Of these, 20 players were assessed during the subacute period and 17 players following return-to-sport. The prevalence of vestibulo-ocular dysfunction increased from 38.9% to 72.2% during the subacute period and dysfunction was present in 83.3% of players after return-to-sport (p = 0.01). Changes in lumbar multifidus muscle size (p = 0.002) and thickness (p = 0.05) at the L5 vertebral level were observed. No statistically significant changes in balance, cervical spine proprioception, or contraction of lumbopelvic muscles were found (p > 0.05).

CONCLUSION: Changes in sensorimotor function were observed in the subacute period post-concussion, with some persisting after return-to-sport. Using symptom-based criteria for return-to-sport may not adequately reflect the sequelae of concussion on the sensorimotor system.

PMID:34922255 | DOI:10.1016/j.msksp.2021.102492

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Relationship between balance confidence and social engagement in people with multiple sclerosis

Mult Scler Relat Disord. 2021 Dec 3;57:103440. doi: 10.1016/j.msard.2021.103440. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the relationships among patient-reported balance confidence and social satisfaction and social participation in people with multiple sclerosis (pwMS).

METHODS: 75 ambulatory pwMS who had sustained at least two falls or near falls in the prior two months self-reported their balance confidence (Activities-specific Balance Confidence (ABC) questionnaire) and social satisfaction and participation (Patient Reported Outcomes Measurement Information System (PROMIS) measures). Correlations between the ABC and PROMIS measures were examined using Spearman’s rank correlation.

RESULTS: In a cross-sectional analysis, ABC scores and PROMIS scores for social satisfaction and social participation were statistically significantly correlated (ρ 0.37-0.54, p ≤ 0.001). The correlation between balance confidence and social satisfaction was consistently stronger at each time point than between balance confidence and social participation.

CONCLUSION: Self-reported balance confidence is associated with both social satisfaction and social participation in pwMS who fall. The causal direction of this relationship remains uncertain.

PMID:34922250 | DOI:10.1016/j.msard.2021.103440

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The Anti-Depressive Effects of Ultra-High Static Magnetic Field

J Magn Reson Imaging. 2021 Dec 18. doi: 10.1002/jmri.28035. Online ahead of print.

ABSTRACT

BACKGROUND: Ultra-high field magnetic resonance imaging (MRI) has obvious advantages in acquiring high-resolution images. 7 T MRI has been clinically approved and 21.1 T MRI has also been tested on rodents.

PURPOSE: To examine the effects of ultra-high field on mice behavior and neuron activity.

STUDY TYPE: Prospective, animal model.

ANIMAL MODEL: Ninety-eight healthy C57BL/6 mice and 18 depression model mice.

FIELD STRENGTH: 11.1-33.0 T SMF (static magnetic field) for 1 hour and 7 T for 8 hours. Gradients were not on and no imaging sequence was used.

ASSESSMENT: Open field test, elevated plus maze, three-chambered social test, Morris water maze, tail suspension test, sucrose preference test, blood routine, biochemistry examinations, enzyme-linked immunosorbent assay, immunofluorescent assay.

STATISTICAL TESTS: The normality of the data was assessed by Shapiro-Wilk test, followed by Student’s t test or the Mann-Whitney U test for statistical significance. The statistical cut-off line is P < 0.05.

RESULTS: Compared to the sham group, healthy C57/6 mice spent more time in the center area (35.12 ± 4.034, increased by 47.19%) in open field test and improved novel index (0.6201 ± 0.02522, increased by 16.76%) in three-chambered social test a few weeks after 1 hour 11.1-33.0 T SMF exposure. 7 T SMF exposure for 8 hours alleviated the depression state of depression mice, including less immobile time in tail suspension test (58.32% reduction) and higher sucrose preference (increased by 8.80%). Brain tissue analysis shows that 11.1-33.0 T and 7 T SMFs can increase oxytocin by 164.65% and 36.03%, respectively. Moreover, the c-Fos level in hippocampus region was increased by 14.79%.

DATA CONCLUSION: 11.1-33.0 T SMFs exposure for 1 hour or 7 T SMF exposure for 8 hours did not have detrimental effects on healthy or depressed mice. Instead, these ultra-high field SMFs have anti-depressive potentials.

EVIDENCE LEVEL: 1 TECHNICAL EFFICACY: Stage 1.

PMID:34921571 | DOI:10.1002/jmri.28035

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Feasibility of Machine Learning and Logistic Regression Algorithms to Predict Outcome in Orthopaedic Trauma Surgery

J Bone Joint Surg Am. 2021 Dec 17. doi: 10.2106/JBJS.21.00341. Online ahead of print.

ABSTRACT

BACKGROUND: Statistical models using machine learning (ML) have the potential for more accurate estimates of the probability of binary events than logistic regression. The present study used existing data sets from large musculoskeletal trauma trials to address the following study questions: (1) Do ML models produce better probability estimates than logistic regression models? (2) Are ML models influenced by different variables than logistic regression models?

METHODS: We created ML and logistic regression models that estimated the probability of a specific fracture (posterior malleolar involvement in distal spiral tibial shaft and ankle fractures, scaphoid fracture, and distal radial fracture) or adverse event (subsequent surgery [after distal biceps repair or tibial shaft fracture], surgical site infection, and postoperative delirium) using 9 data sets from published musculoskeletal trauma studies. Each data set was split into training (80%) and test (20%) subsets. Fivefold cross-validation of the training set was used to develop the ML models. The best-performing model was then assessed in the independent testing data. Performance was assessed by (1) discrimination (c-statistic), (2) calibration (slope and intercept), and (3) overall performance (Brier score).

RESULTS: The mean c-statistic was 0.01 higher for the logistic regression models compared with the best ML models for each data set (range, -0.01 to 0.06). There were fewer variables strongly associated with variation in the ML models, and many were dissimilar from those in the logistic regression models.

CONCLUSIONS: The observation that ML models produce probability estimates comparable with logistic regression models for binary events in musculoskeletal trauma suggests that their benefit may be limited in this context.

PMID:34921550 | DOI:10.2106/JBJS.21.00341

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Inter-observer agreement in the Paprosky classification in a hospital in a country of an emerging economy

Acta Ortop Mex. 2021 May-Jun;35(3):257-260.

ABSTRACT

INTRODUCTION: The evaluation and management of acetabular bone loss in total hip arthroplasty is a challenge for orthopedic surgeons, we wish in this study to determine the inter-observer concordance in the Paprosky classification for acetabular defects.

MATERIAL AND METHODS: Observational, descriptive, longitudinal, prospective study. It was performed using anteroposterior hip radiographs of patients scheduled for primary total hip arthroplasty or revision with acetabular bone defect, Sinapse local X-ray system, 20 X-rays were assessed per observer taken randomly (doctors assigned to the joint replacement service with minimum experience of five years) using the Paprosky classification spontaneously, (without previous classes) for acetabular defects, inter-observer concordance was assessed using Cohen’s Kappa coefficient.

RESULTS: An interobserver agreement was obtained on average for the Paprosky classification of acetabular defects using the Cohen’s Kappa coefficient, the concordance analysis was done using the statistical program statistical package for the social sciences of 0.237.

CONCLUSIONS: Both the null hypothesis (Kappa greater than 0.80 value considered optimal) and the alternative hypothesis (Kappa from 0.41 to 0.80 value equal to moderate to good) did not agree with our study (Kappa equal to 0.237) value equal to mild, in addition , it was shown that the greater the acetabular defect, the lower the interobserver agreement in surgeons in our institution.

PMID:34921534

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Comparative analysis of three models of reverse shoulder prosthesis based on the new angles of distalization and lateralization

Acta Ortop Mex. 2021 May-Jun;35(3):245-251.

ABSTRACT

PURPOSE: Compare functional and radiological outcomes of three different designs of reverse shoulder arthroplasty according to distalization and lateralization shoulder angle, in heterogenic diagnostics (fracture, cuff arthropathy, fracture sequela and osteoarthritis).

MATERIAL AND METHODS: Prospective cohort of 33 patients of reverse shoulder arthroplasty (RSA) between December 2014 and July 2017 with a minimum one year of follow-up. We defined three groups, G: 10 patients with Grammont (155o, Medialized Glena), B: 9 patients with Bio-RSA (155º, lateralized bone glena) and A: 14 patients with Arrow (135o, lateralized metallic glena). We analyze demographic, clinical, functional and radiological outcomes (lateralization shoulder angle (LSA) and distalization shoulder angle (DSA)). For the statistical analysis, ANOVA, T-tests and linear regression tests were used, with a statistical significance of 5%.

RESULTS: The LSA was significantly higher in group A (98o A, 79o G, 80o B) (p < 0.05). In DSA, group B was significantly higher than A (52o B, 39o A) (p < 0.05) and not significant to G (48o G) (p = 0.06). There was no correlation of LSA and DSA with external rotation (p = 0.51) and active elevation (p = 0.41), respectively. There was no significant clinical (anterior elevation, external rotation, internal rotation) and functional outcomes (adjusted Constant score and subjective shoulder evaluation) differences between the different RSA models (p > 0.05).

CONCLUSIONS: The LSA was higher in the Arrow and the DSA was higher in Bio-RSA. We did not find Clinical – Radiological correlation in this heterogeneous series of patients.

PMID:34921532

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What if the future of HER2-positive breast cancer patients was written in miRNAs? An exploratory analysis from NeoALTTO study

Cancer Med. 2021 Dec 17. doi: 10.1002/cam4.4449. Online ahead of print.

ABSTRACT

BACKGROUND: Neoadjuvant therapy with dual HER2 blockade improved pathological complete response (pCR) rate in HER2-positive breast cancer patients. Nevertheless, it would be desirable to identify patients exquisitely responsive to single agent trastuzumab to minimize or avoid overtreatment. Herein, we evaluated the predictive and prognostic value of basal primary tumor miRNA expression profile within the trastuzumab arm of NeoALTTO study (ClinicalTrials.gov Identifier: NCT00553358).

METHODS: RNA samples from baseline biopsies were randomized into training (n = 45) and testing (n = 47) sets. After normalization, miRNAs associated with Event-free survival (EFS) and pCR were identified by univariate analysis. Multivariate models were implemented to generate specific signatures which were first confirmed, and then analyzed together with other clinical and pathological variables.

RESULTS: We identified a prognostic signature including hsa-miR-153-3p (HR 1.831, 95% CI: 1.34-2.50) and hsa-miR-219a-5p (HR 0.629, 95% CI: 0.50-0.78). For two additional miRNAs (miR-215-5p and miR-30c-2-3p), we found a statistically significant interaction term with pCR (p.interaction: 0.017 and 0.038, respectively). Besides, a two-miRNA signature was predictive of pCR (hsa-miR-31-3p, OR 0.70, 95% CI: 0.53-0.92, and hsa-miR-382-3p, OR: 1.39, 95% CI: 1.01-1.91). Notably, the performance of this predictive miRNA signature resembled that of the genomic classifiers PAM50 and TRAR, and did not improve when the extended models were fitted.

CONCLUSION: Analyses of primary tumor tissue miRNAs hold the potential of a parsimonious tool to identify patients with differential clinical outcomes after trastuzumab based neoadjuvant therapy.

PMID:34921525 | DOI:10.1002/cam4.4449