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Nevin Manimala Statistics

A staged use of tourniquet does not influence the fast-track recovery after total knee arthroplasty: a prospective randomized study

Arch Orthop Trauma Surg. 2024 Apr 3. doi: 10.1007/s00402-024-05300-x. Online ahead of print.

ABSTRACT

INTRODUCTION: Upper-tight tourniquet is widely used in Total Knee Arthroplasty in different modalities. However, it has been associated with a negative impact on post-operative muscle strength end pain. This study aimed to investigate the effect of tourniquet on post-operative pain and recovery in enhanced recovery joint surgery.

MATERIALS AND METHODS: In this prospective randomized study, we included 116 patients undergoing to TKA. Surgery was performed with a staged use of tourniquet in Group A (58 patients) and without tourniquet in Group B. In the former group a low-pressure tourniquet was deflated after bone cuts to allow hemostasis of posterior recess and re-inflated for cementation. For all patients a multimodal fast-track recovery protocol was used. Time to reach rehabilitation milestones was recorded as primary endpoint. Range of motion, pain, hemarthrosis, total blood loss, surgical field visualization, Knee Score (KS) and Oxford Knee Score (OKS) were considered as secondary outcomes.

RESULTS: . No statistically significant differences were found (group B: average 1.3 ± 0.6 day; group A: average 1.2 ± 0.5 day). Group A had a shorter mean surgical time and a clearer surgical field visualization. Group B had a larger estimated blood loss and hemoglobin drop without a statistically significant difference in the transfusion rate. No differences between the groups were seen in the KS, OKS and range of motion (ROM) and post-operative joint swelling. Pain score was similar between cohorts and recorded thigh pain was surprisingly greater in group B.

DISCUSSION: The use of tourniquet in TKA surgery helps to minimize intraoperative blood loss and improves surgical field visualization. Its application with a modern and staged protocol does not affect the functional outcomes (OKS, KSS, ROM) of the early post operative period without compromising the fast-track recovery.

PMID:38568385 | DOI:10.1007/s00402-024-05300-x

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Nevin Manimala Statistics

A practical guide to the appropriate analysis of eGFR data over time: A simulation study

Pharm Stat. 2024 Apr 3. doi: 10.1002/pst.2381. Online ahead of print.

ABSTRACT

In several therapeutic areas, including chronic kidney disease (CKD) and immunoglobulin A nephropathy (IgAN), there is a growing interest in how best to analyze estimated glomerular filtration rate (eGFR) data over time in randomized clinical trials including how to best accommodate situations where the rate of change is not anticipated to be linear over time, often due to possible short term hemodynamic effects of certain classes of interventions. In such situations, concerns have been expressed by regulatory authorities that the common application of single slope analysis models may induce Type I error inflation. This article aims to offer practical advice and guidance, including SAS codes, on the statistical methodology to be employed in an eGFR rate of change analysis and offers guidance on trial design considerations for eGFR endpoints. A two-slope statistical model for eGFR data over time is proposed allowing for an analysis to simultaneously evaluate short term acute effects and long term chronic effects. A simulation study was conducted under a range of credible null and alternative hypotheses to evaluate the performance of the two-slope model in comparison to commonly used single slope random coefficients models as well as to non-slope based analyses of change from baseline or time normalized area under the curve (TAUC). Importantly, and contrary to preexisting concerns, these simulations demonstrate the absence of alpha inflation associated with the use of single or two-slope random coefficient models, even when such models are misspecified, and highlight that any concern regarding model misspecification relates to power and not to lack of Type I error control.

PMID:38568372 | DOI:10.1002/pst.2381

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Nevin Manimala Statistics

K-12 Life Skills Education, Independence, and Employment of Autistic Individuals: Giving Voice to Autistic Adults

J Autism Dev Disord. 2024 Apr 3. doi: 10.1007/s10803-024-06304-7. Online ahead of print.

ABSTRACT

Autistic adults are often challenged to engage in and complete life skill tasks independently and are underrepresented in employment. No prior study has explored the perceptions of autistic individuals regarding K-12 life skills experiences and postsecondary employment. As such, the purposes of this study were to explore the association between components of life skills instruction and employment for 12 autistic individuals, and to elicit the perspectives of and experiences in K-12 education and employment of six autistic adults. As this was a mixed methods study, surveys and semi-structured interviews were conducted. Results of Fisher’s test indicated no statistically significant associations between employment and instructional components; however, the associations between employment and household chores [Cramer’s V = .60]; cooking [Cramer’s V = .66]; one-on-one instruction [Cramer’s V = .63]; and field trips [Cramer’s V = .41]) were large. The associations between employment and job site training [Cramer’s V = .33] and token boards [Cramer’s V = .33]) were moderate. Three themes and 10 subthemes emerged. Specifically, participants remembered Memorable Components from K-12 instruction: (a) job site training, (b) field trips, and (c) household chores. Participants perceived Beneficial Practices as: (a) job site training and (b) skills learned. Participants described shortcomings of K-12 instruction as need (a) for more skills training, (c) for social skills training, (d) to eliminate unnecessary instruction and (e) to carefully consider student placement. In conclusion, participants described experiences that helped them gain and attain post-secondary employment. More specific individualized programming in K-12 instruction would be beneficial to develop independence and post-secondary employment.

PMID:38568366 | DOI:10.1007/s10803-024-06304-7

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Comparison of the efficacy, safety and postoperative quality of life between modified side overlap anastomosis and double-tract anastomosis after laparoscopic proximal gastrectomy

Updates Surg. 2024 Apr 3. doi: 10.1007/s13304-024-01830-6. Online ahead of print.

ABSTRACT

PURPOSE: To compare the surgical safety and postoperative quality of life (QOL) between side overlap anastomosis (SOA) and double-tract anastomosis (DTA) after laparoscopic proximal gastrectomy (LPG).

METHODS: This retrospective cohort study included 43 patients with proximal gastric cancer (PGC) who underwent LPG and were admitted to the Second Affiliated Hospital of Fujian Medical University between August 2020 and December 2022 were in. Their clinical and follow-up data were collected. The patients were divided into the modified SOA (mSOA) (n = 20) and DTA (n = 23) groups based on the anastomosis methods used. The main outcome measures included the QOL of patients 1 year after surgery, and the evaluation criteria were based on the postgastrectomy syndrome assessment scale. Secondary outcome measures included intraoperative and postoperative conditions, postoperative long-term complications and nutritional status 3, 6 and 12 months after surgery.

RESULTS: No significant differences were observed in intraoperative and postoperative conditions (P > 0.05) between the mSOA and DTA groups. The mSOA group showed a decreased incidence of reflux esophagitis 1 year after surgery compared with the DTA group (P < 0.05), and no statistically significant differences were noticed between the two groups in terms of other postoperative complications (P > 0.05). The mSOA group showed better QOL when compared with the DTA group (P < 0.05). No significant differences were recorded in postoperative nutritional status between the two groups (P > 0.05).

CONCLUSION: The efficacy and safety of LPG with mSOA for PGC were comparable. When compared with the DTA group, the mSOA group seems to show reduced incidence of gastroesophageal reflux and improved QOL, which makes mSOA one of the ideal surgical methods for PGC.

PMID:38568357 | DOI:10.1007/s13304-024-01830-6

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An overview of detecting gene-trait associations by integrating GWAS summary statistics and eQTLs

Sci China Life Sci. 2024 Mar 29. doi: 10.1007/s11427-023-2522-8. Online ahead of print.

ABSTRACT

Detecting genes that affect specific traits (such as human diseases and crop yields) is important for treating complex diseases and improving crop quality. A genome-wide association study (GWAS) provides new insights and directions for understanding complex traits by identifying important single nucleotide polymorphisms. Many GWAS summary statistics data related to various complex traits have been gathered recently. Studies have shown that GWAS risk loci and expression quantitative trait loci (eQTLs) often have a lot of overlaps, which makes gene expression gradually become an important intermediary to reveal the regulatory role of GWAS. In this review, we review three types of gene-trait association detection methods of integrating GWAS summary statistics and eQTLs data, namely colocalization methods, transcriptome-wide association study-oriented approaches, and Mendelian randomization-related methods. At the theoretical level, we discussed the differences, relationships, advantages, and disadvantages of various algorithms in the three kinds of gene-trait association detection methods. To further discuss the performance of various methods, we summarize the significant gene sets that influence high-density lipoprotein, low-density lipoprotein, total cholesterol, and triglyceride reported in 16 studies. We discuss the performance of various algorithms using the datasets of the four lipid traits. The advantages and limitations of various algorithms are analyzed based on experimental results, and we suggest directions for follow-up studies on detecting gene-trait associations.

PMID:38568343 | DOI:10.1007/s11427-023-2522-8

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Outcomes of robot-assisted radical prostatectomy in men after trans-urethral resection of the prostate: a matched-pair analysis

J Robot Surg. 2024 Apr 3;18(1):158. doi: 10.1007/s11701-024-01935-5.

ABSTRACT

Prior history of transurethral resection of the prostate (TURP) can complicate Robot-assisted radical prostatectomy (RARP). Very few studies analyse the outcomes of RARP in men with a prior history of TURP. We analysed the oncological and functional outcomes of RARP in post-TURP men from our prospectively maintained database. We included the RARP data from January 2016 to January 2022. Thirty men who had RARP with a prior history of TURP were identified (Group 2). They were matched using R software and propensity score matching to 90 men with no previous TURP (Group-1). The groups were matched for age, body mass index (BMI), Gleason score, stage, PSA and D’Amico risk category in a 1:3 ratio. The two-year oncological and functional outcomes were compared. Overall, the study found no significant difference between the groups in the preoperative parameters, such as BMI, age, Gleason grade, clinical stage, PSA, prostate volume, and D’amico risk grouping. There was no difference in the estimated blood loss. The TURP group had a lower chance of having a nerve spare (p = 0.03). The median console time was longer in the TURP group (140 min (120,180) versus 168 (129,190) p = 0.058). The postoperative complications (Clavien-Dindo 3a 2% versus 6.7%) and hospital stay (median of 2 days), positive surgical margins, continence, and biochemical recurrence rates at 3, 12, and 24 months were not statistically different between the groups. In high-volume centres, the oncological and continence outcomes of RARP post-TURP are not inferior to that of men without prior TURP.

PMID:38568342 | DOI:10.1007/s11701-024-01935-5

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Nevin Manimala Statistics

Blood Lead Levels and Their Association with Iron Deficiency and Anemia in Children

Biol Trace Elem Res. 2024 Apr 3. doi: 10.1007/s12011-024-04163-y. Online ahead of print.

ABSTRACT

Lead is a ubiquitous and neurotoxic heavy metal particularly harmful to children, who are more susceptible than adults to its toxic effects. The prevalence of lead poisoning and iron deficiency (ID) is high in socioeconomically vulnerable child populations, negatively affecting neurocognitive development in children. Although numerous studies have shown the association between blood lead levels (BLL) and ID, the issue remains controversial. Here, we aimed to identify the association between BLL and iron nutritional status in children. We conducted an analytical cross-sectional study of healthy children aged 1-6 y attending periodic health checks in primary healthcare units from La Plata and its surroundings, Buenos Aires, Argentina, between 2012 and 2017. We performed anthropometric evaluations and determined BLL, hemoglobin (Hb) and serum ferritin levels. Blood lead levels ≥ 5 µg/dL were defined as elevated BLL; ferritin levels < 12 ng/ml were considered ID; Hb levels < 11 g/dL (< 11.5 g/dL for children ≥ 5 y) were defined as anemia. Data were analysed using Mann Whitney test, Student´s t-test, chi-square test and logistic regression. The R package (v. 4.2.2.) was used for the statistical analysis of data. The sample included 392 children (mean age, 2.4 ± 1.4 y; 44.6% females). The prevalence of elevated BLL, ID and anemia was 8.7%, 26.3% and 31.8%, respectively. We found a significant association between elevated BLL and ID (odds ratio [OR], 95% confidence interval [CI]: 3.16 (1.50, 6.63)). The prevalence of elevated BLL was 16.2% and 5.8% in children with and without ID, respectively (p = 0.003). We also found association between elevated BLL and anemia (OR 95% CI: 3.03 (1.49, 6.29)). In conclusion, blood lead levels ≥ 5 µg/dL were significantly associated with ID and anemia in children aged 1-6 years.

PMID:38568334 | DOI:10.1007/s12011-024-04163-y

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Detecting DSM-5 Opioid and Methamphetamine Use Disorders With the UNCOPE Screen

Subst Use Addctn J. 2024 Apr 3:29767342241245300. doi: 10.1177/29767342241245300. Online ahead of print.

ABSTRACT

BACKGROUND: The most recent wave of the opioid epidemic has contributed to record number of drug overdoses. Most fatal outcomes are associated with opioids and methamphetamine; two substances that tend to be used at high rates among criminal justice populations. Despite the steady rise in the number of overdoses in local detention centers, many correctional facilities do not conduct routine screens for opioid and methamphetamine use disorders. This study examines the utility of the UNCOPE, a 6-item brief screen, to detect probable Diagnostic and Statistical Manual for Mental Disorders, fifth edition (DSM-5) diagnoses for these 2 specific substance use disorders (SUDs). The study also examines key indicators of these specific SUDs.

METHODS: Data were collected from comprehensive substance use assessments conducted with 717 adults who were recently admitted to 4 county jails.

RESULTS: Findings indicate that 3 positive UNCOPE responses accurately detected 99.8% of opioid use disorder diagnoses and 98.7% of methamphetamine use disorder diagnoses. Receiver operating characteristic curve results generate an area under the curve at 0.99 for severe opioid use cases and 0.98 for severe methamphetamine use cases. Subsequent analyses indicate 2 of the 6 items on the UNCOPE function to accurately identify 100% of cases classified with opioid use disorder and 99.6% of cases classified with methamphetamine use disorder.

CONCLUSIONS: Evidence suggests that UNCOPE is a practical and efficient approach to identifying opioid and methamphetamine use disorders. In addition, 2 items can serve as an ultra-brief method to detecting these conditions at the time of admission to detention centers.

PMID:38567634 | DOI:10.1177/29767342241245300

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Evaluation of vaccine effectiveness of mRNA COVID-19 vaccines in children: a systematic review and meta-analysis

Eur Rev Med Pharmacol Sci. 2024 Mar;28(6):2584-2592. doi: 10.26355/eurrev_202403_35764.

ABSTRACT

OBJECTIVE: To evaluate the vaccine effectiveness (VE) of mRNA COVID-19 vaccines in children using a meta-analysis approach.

MATERIALS AND METHODS: Relevant studies on the use of mRNA COVID-19 vaccines in children were identified through computerized searches. VE-related indicators were extracted, and data analysis was performed using the R software with the meta-package.

RESULTS: This study included a total of 12 relevant articles involving 9,963,732 participants from multiple centers in different countries, including the United States, Canada, Singapore, Israel, South Korea, and Qatar. The administered vaccine types included BNT162b2 and mRNA-1273. Participants were categorized into partially immunized (one dose of vaccine) and fully immunized (two doses of vaccine). Four articles reported VE after one dose of vaccine, while 12 reported VE after two doses. Heterogeneity analysis indicated significant heterogeneity among the studies, warranting the use of a random-effects model for analysis. Meta-analysis results revealed that the VE of partial immunization ranged from 16.61 (95% CI: 6.32-25.77) to 34.30 (95% CI: 24.21-43.04), with a pooled VE of 22.80 (95% CI: 15.68-29.32). The VE after full immunization ranged from 16.14 (95% CI: 14.42-17.83) to 90.47 (95% CI: 67.42-97.21), with a pooled VE of 56.17 (95% CI: 41.12-67.37). Meta-regression analysis showed no statistically significant correlation between VE and time (p>0.05).

CONCLUSIONS: Both partial and full immunization of the BNT162b2 mRNA vaccine provide benefits in reducing infection rates. VE varies over time and is closely associated with viral mutations and waning immunity. The specific mechanisms require further investigation.

PMID:38567617 | DOI:10.26355/eurrev_202403_35764

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Zonulin: can it be used as a marker for preterm labor?

Eur Rev Med Pharmacol Sci. 2024 Mar;28(6):2403-2408. doi: 10.26355/eurrev_202403_35747.

ABSTRACT

OBJECTIVE: Inflammation has been reported to increase zonulin levels, a protein that regulates intestinal permeability. The aim of this study was to investigate the association of serum zonulin levels with preterm labor in pregnant women.

PATIENTS AND METHODS: A total of 180 pregnant women between 32-42 weeks of gestation were included in the study. Among those whose gestational week is less than 37, preterm labor (group 1), normal course pregnant (group 2), and gestational weeks between 37-42 pregnant women with normal course (group 3), term labor (group 4) groups were formed.

RESULTS: Zonulin levels were not statistically different between groups. Among the inflammation markers, only C-reactive protein levels were significantly higher in group 1 compared to groups 2 and 3. There were a total of 18/90 (20%) pregnant women with premature rupture of membranes (PROM) in the delivery groups. The mean zonulin level was higher in those with PROM (155.3±50.2 ng/ml) than those without PROM (128.8±59 ng/ml). However, there was no statistically significant difference between them.

CONCLUSIONS: In conclusion, serum zonulin levels were not useful as a marker for predicting preterm labor. However, examining large-scale studies about the relationship between PROM and zonulin is still needed.

PMID:38567603 | DOI:10.26355/eurrev_202403_35747