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Nevin Manimala Statistics

ROBOT-ASSISTED VS. NAVIGATED TRANSPEDICULAR SPINE FUSION

Int J Med Robot. 2023 Jan 17:e2500. doi: 10.1002/rcs.2500. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of this study was to compare intraoperative and postoperative outcome between a robot-assisted vs. a navigated transpedicular fusion technique.

METHODS: This retrospective analysis included patients who underwent transpedicular posterior fusion of the spine due to trauma, pyogenic spondylodiscitis and osteoporosis. Surgery was done either with a robot-assisted or a percutaneous navigated transpedicular fusion technique. The outcome analysis included the duration of surgery, the radiation exposure, the postoperative screw position and complications.

RESULTS: Sixty patients were operated and 491 screws were analysed in total. No statistical difference was seen in the applied cumulative effective radiation dose per patient. Radiological assessment revealed a more accurate screw placement with robot-assistance. A learning curve could be observed in the robot-assisted fusion.

CONCLUSIONS: Robot-assisted and navigated transpedicular fusion techniques are both effective and safe. Robot-assisted transpedicular spine fusion goes along with higher placement accuracy but its implementation needs an adequate learning curve. This article is protected by copyright. All rights reserved.

PMID:36649651 | DOI:10.1002/rcs.2500

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Nevin Manimala Statistics

INSTITUTIONAL OUTCOMES OF BLUNT LIVER & SPLENIC INJURY IN THE ATOMAC ERA

J Trauma Acute Care Surg. 2023 Jan 16. doi: 10.1097/TA.0000000000003870. Online ahead of print.

ABSTRACT

BACKGROUND: The Arizona-Texas-Oklahoma-Memphis-Arkansas Consortium (ATOMAC) practice management guideline was created to standardize management of blunt liver or spleen injury across pediatric trauma centers. We describe our outcomes since guideline adoption at our institution and hypothesize that blunt liver or spleen injury may be managed more expeditiously than currently reported without compromising safety.

METHODS: A retrospective cohort study was conducted on patients <18 years presenting with BLSI from March 2016 to March 2021 at one participating center.

RESULTS: 199 patients were included. There were no clinically relevant differences for age, body mass index (BMI), or sex among the cohort. Isolated splenic injuries (46%, n = 91), and motor vehicle collisions (MVC) (41%, n = 82) were the most common injury and mechanism, respectively. The overall median length of stay (LOS) was 1.2 days (IQR 0.45, 3.3). Intensive Care Unit (ICU) utilization was 23% (n = 46). There was no statistically significant difference in median LOS among patients with isolated solid organ injuries, regardless of injury grade. There were no readmissions associated with non-operative management.

CONCLUSION: The ATOMAC guideline fosters high rates of non-operative management with low ICU utilization and LOS, while demonstrating safety in implementation, irrespective of injury grade.

LEVEL OF EVIDENCE: IV, Therapeutic/Care management.

PMID:36649594 | DOI:10.1097/TA.0000000000003870

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Nevin Manimala Statistics

Lanthony D15 for Occupational Testing: Short-term Repeatability

Optom Vis Sci. 2023 Jan 18. doi: 10.1097/OPX.0000000000001991. Online ahead of print.

ABSTRACT

SIGNIFICANCE: The Lanthony D15 has been reported to have poorer repeatability than the Farnsworth D15. This study found that two trials of the test provide high short-term repeatability and can be administered this way for occupational testing.

PURPOSE: To determine the short-term repeatability of the Lanthony D15 in patients with color vision deficiency. Repeated trials were used to examine if learning effects occur and to determine how many trials would be necessary to ensure the highest short-term repeatability for occupational testing.

METHODS: Twenty male subjects (mean/SD age = 27.2/4.3 years) with congenital color vision deficiency, ranging from mild to severe, participated in this single-visit study. Visual acuity, color vision book screening, Farnsworth D15, and anomaloscope testing were performed for classification purposes. Ten trials of the Lanthony D15 were performed. Color confusion index scores from each trial were determined and a repeated measures ANOVA was used to compare the scores across trials. Orthogonal polynomial analysis was performed to detect any trends across trials through the third order. The intraclass correlation coefficient was calculated.

RESULTS: No differences in color confusion index (mean/SEM = 3.57/0.04) were found across the ten trials (P = .18). Legendre polynomials showed no statistical significance (all P > .39). The intraclass correlation coefficient was 0.81 (95% CI: 0.70-0.90). Based on the method of Shrout and Fleiss, intraclass correlation coefficients of 0.7, 0.8, and 0.9 could be achieved with an average of 1, 2, and 4 trials of the test, respectively. However, empirically, 0.9 was not achievable.

CONCLUSIONS: The Lanthony D15 test has fairly high short-term repeatability. Thus, while more trials would likely improve clinical certainty, the mean result of two trials appear sufficient for occupational testing.

PMID:36649587 | DOI:10.1097/OPX.0000000000001991

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Nevin Manimala Statistics

Evaluation of the Sensitivity to Endocrine Therapy Index and 21-Gene Breast Recurrence Score in the SWOG S8814 Trial

J Clin Oncol. 2023 Jan 17:JCO2201499. doi: 10.1200/JCO.22.01499. Online ahead of print.

ABSTRACT

PURPOSE: Chemotherapy has not demonstrated benefit over adjuvant endocrine therapy alone for postmenopausal patients with node-positive breast cancer with a 21-gene breast recurrence score (RS) of 25 or below (RS ≤ 25). We tested whether combined results from RS and the sensitivity to endocrine therapy (SET2,3) index of endocrine-related transcription (SETER/PR) adjusted for baseline prognostic index (BPI) improve prognostic assessment, and whether SET2,3 predicted benefit from anthracycline-based chemotherapy.

METHODS: A blinded retrospective clinical validation of SET2,3 in two randomized treatment arms from the SWOG S8814 trial comparing adjuvant anthracycline-based chemotherapy followed by tamoxifen endocrine therapy for 5 years, versus tamoxifen alone. SET2,3 assay was calibrated and measured using whole-transcriptome RNA sequence of tumor samples already tested for RS. The primary end point was disease-free survival (DFS).

RESULTS: There were 106 events in 283 patients over a median follow-up of 8.99 years. Proportional hazards assumptions were met during the first 5 years only. SET2,3 index and RS were not correlated (r = -0.04) and were independently prognostic (SET2,3: hazard ratio [HR], 0.48 per unit; 95% CI, 0.34 to 0.68; P < .001; RS: HR, 1.28 per 10 units; 95% CI, 1.14 to 1.44; P < .001). SET2,3 index did not predict chemotherapy benefit (interaction P = .77). SET2,3 was high in 93/175 (53%) patients with RS ≤ 25 (concordant low-risk), with 5-year DFS 97%. SET2,3 was low in 55/108 (51%) patients with RS > 25 (concordant high-risk), with 5-year DFS 53%. Both components of SET2,3 index were prognostic after adjustment for RS: SETER/PR (HR, 0.65; 95% CI, 0.46 to 0.92) and BPI (HR, 0.45; 95% CI, 0.31 to 0.64).

CONCLUSION: SET2,3 index was not correlated with RS, demonstrated additive prognostic performance, and was not chemopredictive in this subset of patients from S8814. The SETER/PR and BPI components of SET2,3 each added prognostic information to RS.

PMID:36649570 | DOI:10.1200/JCO.22.01499

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Nevin Manimala Statistics

Analysis of the Status of Radiation-generating Medical Devices in Mainland China

Health Phys. 2023 Jan 17. doi: 10.1097/HP.0000000000001669. Online ahead of print.

ABSTRACT

The purpose of this paper is to describe the status of radiation-generating medical devices in mainland China. The number of diagnostic radiology and interventional radiology devices was collected from the national medical radiation protection monitoring information system, while the number of radiation therapy and nuclear medicine devices was from the published articles. Statistical analysis of the correlation was used to assess the relationship between the number of high technology medical devices and GDP per capita. A total of 143,064 radiation-generating medical devices were identified in mainland China, and diagnostic radiology devices accounted for 94% of those. The number of CTs was 14.84 per million, an increase by a factor of 1.45 compared to 2009. But the distribution of CTs was imbalanced among different areas: the highest number of CT per million population was 27.70 in Tibet, and the lowest was 8.55 per million population in Guangxi province. Statistical analysis of the correlation showed that the number of PET scanners per million population was positively correlated with GDP per capita, and similarly for medical accelerators. The number of mammographic devices per million population was much lower than that in other countries. The investment of radiation-generating medical devices in China was far from enough, especially for mammographic devices. More efforts should be taken to bring medical resources to regions with greater population areas in the future.Health Phys. 124(0):000-000; 2023.

PMID:36649541 | DOI:10.1097/HP.0000000000001669

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Nevin Manimala Statistics

Investigation of Obesity-Related HAdV-36 in NAFLD Patients: a Case-Control Study

Clin Lab. 2023 Jan 1;69(1). doi: 10.7754/Clin.Lab.2022.221031.

ABSTRACT

BACKGROUND: HAdV-36 leads to adipocyte proliferation of adipose tissue through E4orf1 gene, leading to the development of obesity and related diseases. We aimed to investigate the presence and any association of HAdV-36 in non-alcoholic fatty liver disease (NAFLD) patients Methods: The patient group was composed of 116 patients; 30 obese patients with NAFLD (BMI > 30 kg/m2), 30 patients with Diabetes Mellitus (DM)+NAFLD (BMI > 30 kg/m2), 16 patients with NAFLD (BMI < 30 kg/m2), and operated obese group with NAFLD (BMI > 30 kg/m2). The control group comprised 81 non-obese healthy adults. Liver adipose tissue samples were obtained in 30 operated NAFLD patients. HAdV-36-DNA, HAdV-36 neutralizing antibodies, serum lipid, and adipokine levels were analyzed.

RESULTS: HAdV-36 neutralizing antibodies (HAdV-36 Ab-positive) were detected in 10/116 and 2/81 participants in the study and control groups, respectively; the difference was statistically significant (p < 0.005). LDL, total cholesterol but not adipokine levels were found to be significantly higher in HadV-36 Ab-positive patients (p < 0.05). While HAdV-36 was identified as a risk factor with OR = 4.11 in univariate analyses, there was no significant difference in binary logistic regression analysis. HAdV-36-DNA was detected in the adipose tissue samples of two patients.

CONCLUSIONS: We suggest that the presence of HAdV-36 may lead to the development of obesity with the increase in adipose tissue, and diseases such as hyperlipidemia, NAFLD, DM, and metabolic syndrome may develop on the basis of chronic inflammation caused by obesity. Thus, HAdV-36 may be a plausible risk factor for the development of NAFLD.

PMID:36649529 | DOI:10.7754/Clin.Lab.2022.221031

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Nevin Manimala Statistics

Procalcitonin (PCT) Improves the Accuracy and Sensitivity of CURB-65 Score in Predicting CAP Patients Admission to ICU

Clin Lab. 2023 Jan 1;69(1). doi: 10.7754/Clin.Lab.2022.220342.

ABSTRACT

BACKGROUND: The CURB-65 scoring system is a simple tool for assessment and prognosis prediction for community-acquired pneumonia (CAP) patients. However, the variations in the performance of CURB-65 in young and elderly patients, underestimation, or overestimation of the severity have often been reported. It is worth noting that the application of biomarkers is helpful for improving the accuracy of the scoring system. In recent years, more and more reports and studies paid attention to procalcitonin (PCT) in respiratory infectious diseases, and its clinical value has attracted increasing attention. The study aimed at investigating the effectiveness of the CURB-65 score combined with PCT in predicting admission of CAP patients to intensive care units (ICU).

METHODS: We conducted a retrospective study. We analyzed data from 520 non-immune individuals over the age of 18 in this study. All patients received blood indicators measurement and CURB-65 score calculation on admission. The primary outcome used to assess the probability of a CAP patient was who would get a bed in general ward or ICU. Receiver operating characteristic curves (ROC) were used to evaluate the sensitivity and specificity of the CURB-65 model and PCT combined CURB-65 augmented model in predicting the main outcomes.

RESULTS: After analyzing the data from 520 patients, we found that the probability of entering the ICU was 22.1% (115/520). The AUC of Combination 1 (PCT&CURB-65 scores), Combination 2 (WBC&CURB-65 scores), Combination 3 (hs-CRP&CURB-65 scores) and Combination 4 (D-dimer&CURB-65 scores) for predicting CAP patients entering the ICU was 0.92 (95% CI 0.88 – 0.95), 0.91 (95% CI 0.87 – 0.94), 0.89 (95% CI 0.85 – 0.92), and 0.90 (95% CI 0.87 – 0.94), respectively, with statistically significant differences (p = 0.00); the sensitivities were 0.83, 0.82, 0.77 and 0.77, respectively, and the specificities were 0.92, 0.84, 0.90 and 0.91, respectively. PCT was superior to other indexes to improve the sensitivity and specificity of the CURB-65 score.

CONCLUSIONS: Procalcitonin improves the accuracy and sensitivity of the CURB-65 score in predicting the probability of CAP patients entering the ICU, and PCT was superior to other indexes to improve the sensitivity and specificity of the CURB-65 score.

PMID:36649520 | DOI:10.7754/Clin.Lab.2022.220342

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Nevin Manimala Statistics

Changes of Plasma Blood Ammonia Levels of Chinese Healthy People and the Establishment of Reference Intervals

Clin Lab. 2023 Jan 1;69(1). doi: 10.7754/Clin.Lab.2022.220105.

ABSTRACT

BACKGROUND: Blood ammonia detection is used for the diagnosis or differential diagnosis of various hepatitis virus infections, severe liver cirrhosis, and hepatic encephalopathy. It is also one of the important indexes reflecting liver coma, Reyes syndrome, and other diseases. However, blood ammonia changes rapidly with time. If samples are not sent and detected in time, the results will be wrong, resulting in clinical misdiagnosis and life danger to patients. The purpose of this paper is to explore the change of blood ammonia with time and establish its reference interval.

METHODS: For this study, 228 healthy patients (111 males and 117 females) were selected who underwent physical examination at the Health Management Center of the Second Xiangya Hospital of Central South University from April to May 2021. The blood ammonia detection kit (colorimetric method) produced by Roche Diagnostics GmbH of Germany was used for detection on the Roche cobas c702 automatic biochemical analyzer. After eliminating outliers from the obtained test results, they were grouped according to gender and age, and SPSS 26.0 software was employed to statistically analyze the blood ammonia test results.

RESULTS: The differences in blood ammonia levels at each detection time were statistically significant (p < 0.05). The differences in blood ammonia levels between male and female subjects at 1 hour, 2 hours, and 3 hours were statistically significant (p < 0.05), but all ages saw no statistically significant difference in blood ammonia levels between segments (p > 0.05). The blood ammonia levels of each detection time and different genders showed a normal distribution. Therefore, it is necessary to take the 95% (X ± 1.96S) results of both sides as the reference interval according to the detection time and gender, and establish the reference intervals. The 1-hour blood ammonia reference interval for healthy men in Changsha is 15.8 – 47.5 μmol/L, for healthy women it is 12.4 – 39.6 μmol/L; the 2-hour blood ammonia reference interval for healthy men is 22.3 – 56.5 μmol/L, and for healthy women it is 19.1 – 48.0 μmol/L; the reference interval of 3-hours blood ammonia for healthy men is 27.9 – 65.7 μmol/L, and for healthy women it is 24.6 – 56.7 μmol/L.

CONCLUSIONS: There are differences in blood ammonia levels between men and women at different detection times in Changsha. A reference interval suitable for blood ammonia in healthy individuals in the region should be established according to the detection time and gender, so as to provide better relevant evidence for clinical diagnosis.

PMID:36649513 | DOI:10.7754/Clin.Lab.2022.220105

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Molecular Biomarker Exploration of Rituximab plus CHOP Therapy in Real-World Diffuse Large B-Cell Lymphoma Patients

Clin Lab. 2023 Jan 1;69(1). doi: 10.7754/Clin.Lab.2022.211124.

ABSTRACT

BACKGROUND: Presently, several classification methods are based on diffuse large B-cell lymphoma (DLBCL), but its clinical application has not yet been testified in Asian populations.

METHODS: Twenty-five DLBCL patients were subjected to second-generation gene sequencing (NGS), and retrospective analysis of clinical features of the patients was to explore genotyping and survival prognosis biomarkers.

RESULTS: The prevalent mutant genes in DLBCL patients cover myeloid differentiation factor 88 (MyD88) (40%), TP53 (32%), B-cell translocation gene 2 (BTG2) (28%), PIM1 (28%), and CREB-binding protein (CREBBP) (24%) in this study. The classical International Prognostic Index (IPI) scores were associated with progression-free survival (PFS) (HR: 7.52, 95% CI 1.51 – 37.6, p = 0.00393) via univariate analysis. Furthermore, patients with ETS-variant gene 6 (ETV6) (HR: 5.1, 95% CI 0.927 – 28.1, p = 0.0371), platelet-derived growth factor receptor A (PDGFRA) (HR: 4.29, 95% CI 0.824 – 22.3, p = 0.0594), platelet-derived growth factor receptor B (PDGFRB) (HR: 10.8, 95% CI 0.979 – 119, p = 0.0149) was distinctively correlated with poor PFS except for the IPI score. Nevertheless, the mutation of PDGFRA/B gene was not distinct in further multivariate analysis (PFS: HR: 2.72, 95% CI 0.52 – 14.23, p = 0.2369). Additionally, better survival prognosis was in DLBCL patients who did not progress within 12 months (POD12). Ultimately, caspase recruitment domain 11 (CARD11) gene mutations were enriched in patients with primary intranodal tumors, but the prognostic relevance was not discovered.

CONCLUSIONS: ETV6 and platelet-derived growth factor receptor (PDGFR)A/B gene mutations are supposed to be potential biomarkers for the prognosis of DLBCL patients via the statistical analysis of this small sample, and POD12 is also expected to be an effective endpoint for efficacy assessment.

PMID:36649512 | DOI:10.7754/Clin.Lab.2022.211124

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Nevin Manimala Statistics

Is D-dimer Test Cost Effective and Time Sensitive for Diagnosis of Venous Thromboembolism in Emergency Department?

Clin Lab. 2023 Jan 1;69(1). doi: 10.7754/Clin.Lab.2022.220304.

ABSTRACT

BACKGROUND: A D-dimer assay can be used to reduce unnecessary imaging when ruling out venous thromboembolism (VTE) in the Emergency Department (ED), thus potentially reducing patient visit times and costs.

METHODS: This was a cross-sectional retrospective data analysis of an academic medical center ED visits between January 1 and June 30, 2019. ED visit length and VTE diagnostic cost were compared for visits with and without a D-dimer assay. The total sample size was 106 adult ED patients who were not at high risk of VTE and, of these, 27 encounters included D-dimer testing and 79 encounters did not. Outcomes were measured using independent samples t-tests to compare ED visit length and VTE diagnostic cost for ED visits with and without D-dimer tests.

RESULTS: D-dimer testing had a moderate effect upon ED visit length, but it did not correspond to differences in ED visit length or VTE diagnostic cost.

CONCLUSIONS: D-dimer testing was not statistically significant in improving the ED visit length or the VTE diagnostic cost compared to imaging studies for suspected VTE cases in the ED.

PMID:36649503 | DOI:10.7754/Clin.Lab.2022.220304