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Nevin Manimala Statistics

Evaluation of the Premier Hb9210 instrument for HbA1c determination

Scand J Clin Lab Invest. 2023 Dec 1:1-7. doi: 10.1080/00365513.2023.2281400. Online ahead of print.

ABSTRACT

Background: Glycated hemoglobin measurements are a valuable tool for long-term blood glucose monitoring and the diagnosis of diabetes. Its widespread use has been made possible due to the development of new analytical methods with improved performances and standardization with reference materials. The aim of the present study was to evaluate the Trinity Biotech Premier Hb9210 analyzer for the measurement of HbA1c.Methods: The precision was assessed using the CLSI EP-15A3 and EP-10A3 protocols. The latter was also used to investigate linearity, carryover, and linear drift. The comparison study was performed between Premier Hb910 and Tosoh HLC-723 G8 through Passing-Bablok regression and the Bland-Altman plot. The Fleiss Kappa index was used to assess the degree of agreement. The interference of Hb variants was investigated using samples with Hb variants S, C, D, E, J, and Seville.Results: Within-run and between-run imprecision fell between 0.37% and 1.16%. No statistically significant nonlinearity, carry-over, and/or drift were observed. The resulting regression line of the Passing-Bablok analysis was y = 0.00 + 1.00x. The Pearson correlation coefficient was 0.997. In the Bland-Altman plot, the relative bias was 0.01%. The overall Fleiss Kappa index was 0.9. No interference from hemoglobin variants was observed.Conclusion: The Premier Hb9210 demonstrated a high degree of automation, reproducibility, good agreement, minimal carry-over effect, and excellent linearity across the wide range of HbA1c levels commonly found in diabetic patients and was not influenced by Hb variants.

PMID:38037903 | DOI:10.1080/00365513.2023.2281400

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Prevalence of pulmonary hypertension in chronic simple silicosis patients and its correlation with smoking history, occupation type, age and duration of silica exposure

Monaldi Arch Chest Dis. 2023 Nov 30. doi: 10.4081/monaldi.2023.2719. Online ahead of print.

ABSTRACT

Silicosis is a preventable occupational health hazard with potential for permanent physical disability and increased socio-economic burden. Pulmonary hypertension (PH) secondary to chronic respiratory diseases signifies poorer prognosis and transthoracic echocardiography (TTE) has proven its usefulness as a screening tool for PH diagnosis. The objectives were to determine PH prevalence in chronic simple silicosis patients through TTE screening and correlate PH prevalence with smoking status, occupation type, age and duration of silica exposure (DSE). We enrolled 104 patients in the study based on occupational exposure to silica dust and radiologic confirmation of chronic simple silicosis. The study sample was divided into significant smokers (SS group) and insignificant smokers (InS group) on the basis of ≥10 pack years smoking history, and into drillers and dressers based on occupation type. TTE examination was performed to measure resting mean pulmonary artery pressure (mPAP) and the patients were classified into: no PH (mPAP≤20 mm Hg), borderline PH (mPAP>20 and <25 mmHg), and PH (mPAP≥25). PH prevalence was 25% in study subjects (26/104); 29.6% (16/54) among SS group versus 20% (10/50) among InS group (.52) ; and 34.2% (14/41) among drillers versus 19.1% (12/63) among dressers (p=.024). Mean age and mean duration of silica exposure among SS and InS groups were comparatively similar, while they had lower values among dressers against dressers with no statistical significance. Logistic regression analysis established a significant association of PH prevalence with higher age in the study sample, SS group and drillers group, while a significant association of PH prevalence with longer DSE was only seen in the study sample. PH prevalence was significantly associated (p=.007) with SS-driller group on comparing TTE findings with combined smoking and occupation type based groups. This study has shown PH prevalence in chronic simple silicosis patients at alarming levels, having associations with driller occupation, older age and longer DSE with varying results among groups and complex interplay with smoking exposure, suggesting the need for large sample-based molecular and genetic studies. Including TTE in the initial work-up of silicosis patients will promote timely intervention and reduce morbidity and mortality with a high benefit-cost ratio.

PMID:38037897 | DOI:10.4081/monaldi.2023.2719

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Effects of medical abortion assisted by traditional Chinese medicine: A network meta-analysis of randomized controlled trials

Int J Gynaecol Obstet. 2023 Dec 1. doi: 10.1002/ijgo.15272. Online ahead of print.

ABSTRACT

BACKGROUND: To what extent traditional Chinese medicine (TCM) combined with mifepristone and misoprostol is beneficial for improving the complete abortion rate and duration of vaginal bleeding has been a subject of debate in the field of medical abortion.

OBJECTIVE: To assess the evidence regarding the complete abortion rate and duration of vaginal bleeding of medical abortion assisted by different kinds of TCM.

SEARCH STRATEGY: We searched electronic databases such as PubMed, Web of Science and Cochrane Library database, China National Knowledge Internet, Wan fang Database, VIP Database, and China Biology Medicine disc from 2000 to February 15, 2023.

SELECTION CRITERIA: The control group was medical abortion with mifepristone and misoprostol, and the experimental group was medical abortion assisted by TCM.

DATA COLLECTION AND ANALYSIS: Major data extraction included sample size, age, medicine used for abortion, outcome measures. RevMan 5.3 and Stata 15.1 software were used to assess the literature quality and perform network meta-analysis, respectively.

MAIN RESULTS: A total of 73 randomized controlled trials (RCTs) with 11 683 patients and nine kinds of TCM were included in this study. Compared with mifepristone and misoprostol, eight kinds of TCM had statistical significance in improving the complete abortion rate. The effect value of Sancao decoction was 5.86 (95% confidence interval [CI] 2.53-13.58). Seven kinds of TCM shortened the duration of vaginal bleeding. The effect value of comfrey and trichosanthin decoction was -8.75 (95% CI -10.86 to -6.64).

CONCLUSIONS: This network meta-analysis showed that Lenge Zhumo decoction and Sancao decoction could have a large beneficial effect on complete abortion rate in medical abortion during early pregnancy, and comfrey and trichosanthin decoction could be the best TCM for shortening the duration of vaginal bleeding.

PMID:38037875 | DOI:10.1002/ijgo.15272

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Measurement properties of Brief-BESTest scores from children, adolescents, and youth with visual impairments

Disabil Rehabil. 2023 Dec 1:1-10. doi: 10.1080/09638288.2023.2288935. Online ahead of print.

ABSTRACT

Purpose: This study aimed to vet the measurement properties of Brief-BESTest scores in children, adolescents, and youth with visual impairment and blindness (YVI). Methods: A cross-sectional sample of YVI (N = 101) completed the Brief-BESTest, a modified version of the Y-Balance Test, the 360-degree turn test, bipedal quiet stance, and Activity-Specific Balance Confidence Scales. Thirty-seven YVI completed test-retest of the Brief-BESTest using a one-year interval. Using classical test theory, various forms of total and item-level Brief-BESTest score reliability and validity were investigated in YVI. Results: All inter-rater reliability coefficients were ≥ .80. When considering the eight items of the Brief-BESTest, 27 of the 28 possible correlations were statistically significant (p<.05). Various internal consistency and item difficulty results were strong. When taking total Brief-BESTest scores and their association with the complementary balance tasks/metrics into account, 11 of 13 associations were statistically significant (p<.05) providing strong convergent validity evidence. Being multimorbid and degree of vision significantly predicted total Brief-BESTest scores (p<.001) suggesting construct (i.e. known groups) validity. Numerous test-retest results (e.g. coefficients, limits of agreement) following the one-year interval were indicative of score stability. Conclusion: Practitioners and researchers should have confidence in, and consider adopting, the Brief-BESTest to examine multidimensional balance in YVI.

PMID:38037853 | DOI:10.1080/09638288.2023.2288935

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Effect of drain placement in short-level spinal surgery on postoperative wound infection: A meta-analysis

Int Wound J. 2023 Dec 1. doi: 10.1111/iwj.14508. Online ahead of print.

ABSTRACT

In the meta-analysis, we evaluated the efficacy of placing drainage channels following single- or double-level spine surgery in order to decrease the incidence of postoperative injury. We conducted the analysis with the help of four databases: PubMed, Embase, Cochrane Library and Web of Science. A review of related studies was carried out after evaluating the quality of the literature against the classification and exclusion criteria set for the trial. Calculation of 95% CI, OR and MD was performed with fixed-effect models. A meta-analysis of the data was carried out with RevMan 5.3. Meta-analyses of randomized controlled trial (RCT) did not indicate that there were a statistically significantly different incidence of postoperative wound infections among those who received drainage compared to those who did not receive drainage (OR, 2.29; 95% CI, 0.50, 10.41 p = 0.28). Moreover, there were no statistically significant differences in post-operation hematoma (OR, 1.20; 95% CI, 0.27, 5.28 p = 0.81) and visual analogue scale score (MD, -0.01; 95% CI, -1.34, 1.33 p = 0.99). Thus, placing drainage in short-levels of spine operation did not significantly influence the outcome of postoperative wound complications. Nevertheless, because of the limited sample size chosen for this meta-analysis, caution should be exercised when treating these data. More high-quality RCT trials with a large number of samples are required to confirm the findings.

PMID:38037852 | DOI:10.1111/iwj.14508

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Intravenous dexamethasone does not prolong the duration of pudendal nerve block in infants and children undergoing hypospadias surgery: A randomized clinical trial

Paediatr Anaesth. 2023 Dec 1. doi: 10.1111/pan.14805. Online ahead of print.

ABSTRACT

BACKGROUND: The administration of intravenous dexamethasone increases the duration of neuraxial block and improves the quality of analgesia. However, little is known about these effects of dexamethasone on peripheral nerve blocks in children.

AIMS: In this study, we aimed to investigate the benefit of intravenous dexamethasone for enhancing the effect of pudendal block on postoperative analgesia in children who underwent hypospadias surgery.

METHODS: In total, 46 children aged 6-36 months who underwent hypospadias surgery were randomly allocated to either a control group (normal saline, group C) or dexamethasone group (0.5 mg/kg, group D). Pudendal block was performed before the surgery using 0.3 mL/kg of 0.225% ropivacaine on both sides. Parents were instructed to press the patient-controlled analgesia bolus button when their children’s pain score was >4 points. The primary outcome measure was the time at which the first patient-controlled analgesia by proxy bolus dose was administered. The secondary outcome measures were pain score, number of patient-controlled analgesia administration by proxy bolus attempts, number of rescue analgesics required, total amount of fentanyl administered, and overall parental satisfaction.

RESULTS: The time of first patient-controlled analgesia bolus administration by proxy was not different between the control and dexamethasone groups (5.6 [5.2, 8.8] h versus 6.5 [5.4, 8.1] h, hazard ratio 0.8, 95% confidence intervals 0.43 to 1.47, p = .46). There were no statistically significant differences among the secondary outcomes.

CONCLUSIONS: Administration of intravenous dexamethasone did not enhance the duration of pudendal nerve block in infants and children aged 6-36 months who underwent hypospadias surgery.

PMID:38037830 | DOI:10.1111/pan.14805

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Comparative Effectiveness of 2 Chlorhexidine Gluconate-Containing Dressings in Reducing Central Line-Associated Bloodstream Infections, Hospital Stay, and Costs

Inquiry. 2023 Jan-Dec;60:469580231214751. doi: 10.1177/00469580231214751.

ABSTRACT

Chlorhexidine gluconate (CHG)-containing dressings are recommended to prevent central line associated bloodstream infections (CLABSIs) and other catheter-related infections. This study compared the effect of 2 CHG dressings on CLABSI, cost of care, and contact dermatitis. A retrospective analysis was conducted using the Premier Healthcare Database of hospitalized patients (n = 53 149) with central venous catheters (CVCs) and receiving either a transparent CHG gel dressing (n = 14 488) or an opaque CHG sponge dressing (n = 38 661) between January 2019 and September 2020. Two cohorts (n = 14 488 each), CHG-Gel and CHG-Sponge, were matched 1:1 using a propensity score method on 33 patient and facility characteristics. CLABSI and contact dermatitis rates, hospital length of stay (LOS), and hospitalization costs were compared using mixed-effect multiple regression. This approach effectively controlled for random clustering effects across hospitals and patients’ Diagnosis-Related Group (DRG) classifications. CHG gel dressings were associated with a 41% decrease in CLABSI rates (P = .0008) compared to CHG sponge dressings (0.35%vs 0.60%). A 0.4-day shorter LOS (9.53vs 9.90 days, P = .0001) and a cost saving of $3576 per hospital stay ($40 197 vs $43 774, P = .0179) was observed with CHG gel dressing use. There was no statistically significant difference in contact dermatitis rates (P = .7854) between the CHG-Gel and CHG-Sponge cohorts. The findings of this study suggest that the use of CHG gel dressings may be more effective in reducing the risk of CLABSIs and associated clinical costs compared to CHG sponge dressings in hospitalized patients. Moreover, there appears to be no significant discrepancy in contact dermatitis rates between CHG gel and CHG sponge dressings. Healthcare providers may consider using CHG gel dressings as a standard practice for patients with CVCs to reduce the risk of infections and improve patient outcomes.

PMID:38037829 | DOI:10.1177/00469580231214751

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Regional outcome disparities in German head and neck cancer patients: Shorter survival in Eastern Germany

Cancer Med. 2023 Dec 1. doi: 10.1002/cam4.6690. Online ahead of print.

ABSTRACT

INTRODUCTION: Demographics are important prognostic factors in malignant diseases. A nationwide analysis concerning the prognostic impact of demographics in head and neck cancer (HNC) patients (HNCP) has not been performed previously.

METHODS: A retrospective analysis of data from the Center for Cancer Registry Data (ZfKD) and the Federal Statistical Office (Destatis) between 2002 and 2017 was performed. A total of 212’920 HNCP were included. Incidence, tumor stage, age development, sex distribution, age-, residence-, and diagnosis-time-specific survival were examined.

RESULTS: Mean age of HNCP increased more rapidly than in the general population (slope coefficient: 0.29 vs. 0.20; p < 0.0001). Higher age and male sex were associated with a worse prognosis. Whereas overall survival (OS) increased from the early to the later observation period for HNCP <70 years, no OS improvement for HNCP >70 years was found. Furthermore, an OS disadvantage was observed for East Germany compared to West Germany (median 47 vs. 60 months; p < 0.0001). This disparity was associated with a disproportionately high ratio of men in East Germany (men/women: 4.4 vs. 3.1; p < 0.0001) and a lower mean age (61 vs. 63 years; p < 0.0001). In addition to stage, age and sex, residence in East Germany were confirmed as an independent factor for OS in a multivariate analysis.

CONCLUSION: Finally, three decades after the German reunion, a survival disadvantage for patients in East Germany still exists. This discrepancy may be a result of socioeconomic disparities.

PMID:38037808 | DOI:10.1002/cam4.6690

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Incidence of type 1 diabetes mellitus in children and adolescents under 20 years of age across 55 countries from 2000 to 2022: A systematic review with meta-analysis

Diabetes Metab Res Rev. 2023 Dec 1:e3749. doi: 10.1002/dmrr.3749. Online ahead of print.

ABSTRACT

AIMS: The aim of this study was to determine the global incidence of type 1 diabetes mellitus (T1DM) in children and adolescents under 20 years of age from 2000 to 2022.

MATERIALS AND METHODS: Two reviewers searched three electronic databases (PubMed, Web of Science, and CINAHL) for studies published between January 2000 and November 2022. Pooled estimates of T1DM incidence with a 95% confidence interval (CI) per 100,000 person-years were calculated by country/region, sex, age, and COVID-19 pandemic period (pre-COVID-19 and pandemic).

RESULTS: The study included 126 studies from 55 countries and 18 regions. The incidence rate (IR) of T1DM from 2000 to 2022 was 14.07 (95%CI, 12.15-16.29) per 100,000 person-years. Finland and high-income North America had the highest IR, with 56.81 (95%CI, 55.91-57.73) and 28.77 (95%CI, 26.59-31.13) per 100,000 person-years, respectively. The IR was 13.37 (95%CI, 10.60-16.88) per 100,000 person-years in boys and 13.87 (95%CI, 11.51-16.70) per 100,000 person-years in girls. There were statistically significant differences among different age ranges: 0-4 versus 5-9 and 10-14 years old (p < 0.001); 5-9 versus 15-19 (p < 0.001) and 10-14 versus 15-19 years old (p = 0.003). Finally, during the pandemic period (2020-2022), the IR was 24.84 (95%CI, 17.16-35.96) per 100,000 person-years, which was higher but not significant compared with the prepandemic period (2017-2019) of 13.56 (95%CI, 7.49-24.56) per 100,000 person-years (p = 0.090).

CONCLUSIONS: The IR of T1DM in children and adolescents under 20 years of age is substantial, especially during the pandemic period, although it varies across regions. More reliable data from additional countries are needed to determine the worldwide incidence of T1DM.

PMID:38037806 | DOI:10.1002/dmrr.3749

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Anesthesia via peripheral nerve blocks during total knee replacement has no effect on postoperative inflammation in elderly patients

J Orthop Surg (Hong Kong). 2023 Sep-Dec;31(3):10225536231217539. doi: 10.1177/10225536231217539.

ABSTRACT

BACKGROUND: We have previously shown that, compared with general anesthesia (GA), the procedure of peripheral nerve blocks (PNB) facilitates faster recovery of elderly patients from total knee replacement (TKR). Here, we investigated whether the faster recovery is associated with decreased perioperative stress and inflammation and decreased incidences of postoperative complications.

METHODS: After randomization, 165 patients aged ≥65 years underwent TKR under GA or PNB. The primary outcomes were the perioperative inflammation and stress levels, based on the serum C-reactive protein and interleukin-6 levels, erythrocyte sedimentation rate, white-blood cell and neutrophil counts, and blood-sugar level. The secondary outcomes were the postoperative complications, including cardiovascular, respiratory, and hepatic or renal complications, insomnia, delirium, electrolyte disturbances, and nausea and vomiting.

RESULTS: The two groups were not significantly demographically different (p > .05). Of the cytokines related to stress and inflammation, the differences of time points were statistically significant between the two groups (p < .01), but two-way ANOVA revealed no interaction between the time points and groups. Incidences of postoperative complications were far lower in PNB group than in GA group (p = .006). Incidences of postoperative respiratory complications (p = .005) and postoperative nausea and vomiting (p = .040) were significantly lower in PNB group than in GA group. There were no significant differences in other complications between the two groups (p > .05).

CONCLUSIONS: PNB does not alleviate the stress and inflammation in elderly patients post TKR but significantly reduces the incidences of postoperative complications, especially respiratory complications, and nausea and vomiting. (ClinicalTrials.gov Identifier: NCT01871012).

PMID:38037804 | DOI:10.1177/10225536231217539