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EFFICACY AND SAFETY OF INTRAVENOUS THROMBOLYTIC THERAPY IN PATIENTS OVER EIGHTY YEARS

Int J Neurosci. 2023 Oct 24:1-8. doi: 10.1080/00207454.2023.2260086. Online ahead of print.

ABSTRACT

Introduction: Intravenous thrombolytic therapy (IVTT) is licensed for patients under 80 years in many countries. In this study, we aimed to demonstrate functional results and complication rates of IVTT in patients over eighty years and whether there is a difference in efficacy and safety between low dose and standard dose recombinant tissue plasminogen activator (rTPA).Methods: A retrospective observational study of patients over eighty who admitted to Suleyman Demirel University Faculty of Medicine Hospital between August 2016 and April 2021 and to Isparta City Hospital between April 2017 and April 2021 and diagnosed with acute ischemic stroke were conducted. Third month modified rankin scores (mRS) and mortality rates of patients and hemorrhagic transformations were determined.Results: There were 29 patients in IVTT group and 25 patients in non-IVTT group. By the third month, it was observed that functional independence (mRS 0-2) ratio was increased more in IVTT group, but it wasn’t statistically significant (p: 0.087). In mortality and symptomatic intracerebral hemorrhage rates, there wasn’t statistically significant diffirence between IVTT and non-IVTT groups and low dose and standard dose rTPA groups by the third month.Conclusion: The efficacy and complication rates of IVTT in patients over 80 years were found similar to not receive IVTT. These results support the safety of IVTT in patients over 80 years. In low or standard dose rTPA preference, we observed that there wasnt’ statistically significance in efficacy and safety. We believe that these results will be supported by studies with larger number of patients.

PMID:37873606 | DOI:10.1080/00207454.2023.2260086

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Early Peanut Introduction in Infants: Improving Guideline Adherence With EMR Standardization

Pediatrics. 2023 Oct 24:e2023062371. doi: 10.1542/peds.2023-062371. Online ahead of print.

ABSTRACT

OBJECTIVES: Peanut allergy in children is a population health problem. Evidence suggests early peanut introduction (EPI) for infants can reduce the development of peanut allergy. Primary care settings have not widely adopted guidelines recommending EPI. Peanut allergy prevention depends on primary care providers incorporating EPI guidelines into well-child check (WCC) encounters. We aimed to improve guideline adherence in a primary care setting by implementing a bundle of clinical decision support (CDS) tools.

METHODS: Using quality improvement methodology, the team developed a standardized work protocol and CDS tools within an electronic medical record (EMR) at 4, 6, and 9-month WCC encounters. The team executed changes and modifications through plan-do-study-act cycles and analyzed results with statistical process control charts.

RESULTS: We collected data from 445 WCC encounters from baseline through sustainability. EMR documentation of EPI guidance at 4, 6, and 9-month WCCs shifted from 13.9% to 83.5% over 12 months. Provider adoption of smart lists and templates increased from 2% to 73%, the distribution of home peanut introduction handouts increased from 5.2% to 54.1%, and caregiver-reported peanut ingestion increased from 0% to 34.6%. Diphtheria-tetanus-acellular pertussis vaccination rates remained at 100% for 6-month visits, and patient in-room time remained at 65 minutes.

CONCLUSIONS: Quality improvement methodology improved documentation of EPI guidance and increased reported peanut ingestion at routine WCC encounters without impacting other measures. Broader use of bundled CDS tools and EMR standardization could further improve guideline adherence and increase early peanut introduction to prevent peanut allergy in infants.

PMID:37873594 | DOI:10.1542/peds.2023-062371

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Treatment of Unstable Sacral Fractures with Robotically-aided Minimally Invasive Triangular Fixation

Orthop Surg. 2023 Oct 24. doi: 10.1111/os.13907. Online ahead of print.

ABSTRACT

OBJECTIVE: The treatment of unstable sacral fractures is huge challenge to surgeons. Robotically-aided minimally invasive triangular fixation (RoboTFX) is the most advanced technique up to now. This study is to evaluate the clinical outcomes of unstable sacral fractures treated with RoboTFX.

METHODS: From March 2017 to October 2021, 48 consecutive patients with unstable sacral fractures were included in the study. All patients received surgical treatment with triangular fixation (TFX). Patients were divided into four groups according to the number of fractures (uni- or bilateral) and surgical method employed (RoboTFX or traditional open TFX). Between these four groups, clinical data on operation time, intraoperative bleeding, intraoperative fluoroscopy time, infection rate, fracture healing rates, insertion accuracy, Majeed pelvic outcome score, Mears’ criterion, and Gibbons score were compared. Quantitative data were expressed as mean ± standard deviation and compared using Student’s t-test. Categorical variable were compared using the Pearson’s χ2 test.

RESULTS: Comparing unilateral RoboTFX versus open TFX, neither fracture healing rate, infection rate, Majeed pelvic outcome score, Mears’ radiological evaluation criterion, nor Gibbons score of the two groups were statistically significantly different (p > 0.05). However, operation time, intraoperative bleeding, intraoperative fluoroscopy time, and insertion accuracy in the RoboTFX group were all significantly better than those of the traditional open group (p < 0.05). Likewise, operation time, intraoperative bleeding, intraoperative fluoroscopy time, and accuracy of fixation insertion of the bilateral RoboTFX group were significantly better than those of the bilateral open group (p < 0.05). Meanwhile infection rate, fracture healing rate, Majeed score, Mears’ criterion, and Gibbons score of two groups were not significantly different (p > 0.05).

CONCLUSION: RoboTFX has the advantages of less operation time, less intraoperative bleeding and fluoroscopy, more accurate fixation insertion, and a higher healing rate compared to traditional open methods in the treatment of unstable sacral fractures. However, RoboTFX requires a few critical considerations, and the indications of its operation should be strictly evaluated.

PMID:37873590 | DOI:10.1111/os.13907

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Effect of physical exercise in real-world settings on executive function of atypical children: A systematic review and meta-analysis

Child Care Health Dev. 2023 Oct 24. doi: 10.1111/cch.13182. Online ahead of print.

ABSTRACT

BACKGROUND: Impaired executive function is a core symptom of cognitive impairment in atypical children. The purpose of this systematic review and meta-analysis is to explore the effectiveness of interventions for exercise in real-life settings on executive function in atypical children.

METHODS: This study searched the CNKI, Wan-Fang, VIP, WOS, PubMed, Scopus and EBSCO databases. Two researchers independently selected articles, extracted data and assessed the risk of bias for the included studies. Exercise activities were categorized into open and closed skills based on the unpredictability of the environmental context and into sequential and continuous skills based on the complexity of the movement structure. Based on these two classifications, motor skills were categorized into open-sequential (e.g. basketball), open-continuous (e.g. obstacle running), closed-sequential (e.g. martial arts) and closed-continuous (e.g. swimming) skills. The SPSS 25.0 and Stata 16.0 software were used for statistical analysis.

RESULTS: A total of 19 articles (23 studies) were included in the systematic review and meta-analysis. The participants were 990 atypical children with neurodevelopmental disorders. Physical exercise in real-world settings had significant intervention effects on inhibitory control (SMD = -0.592, P = 0.033), working memory (SMD = -0.473, P = 0.034) and cognitive flexibility (SMD = -0.793, P = 0.014) in atypical children. Quantitative intervention characteristics and motor skill types moderated the effect of exercise on promoting executive function in atypical children. Overall, exercise for 30-50 min, three to seven times a week for less than 10 weeks is effective in improving executive function in atypical children. Open skills and sequential skills have a positive intervention effect on more dimensions of executive function in atypical children.

CONCLUSIONS: Physical exercise in real-world settings has a positive intervention effect on executive function in atypical children. We should design interventions based on the personality traits of the subject and the type of exercise they are interested in to better promote improved executive function in atypical children.

PMID:37873578 | DOI:10.1111/cch.13182

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Metaphyseal Metal Sleeves for Reconstruction of Severe Knee Bone Defects: Excellent Survival Rate at a Mean Follow-Up of 6.4 Years

Orthop Surg. 2023 Oct 24. doi: 10.1111/os.13905. Online ahead of print.

ABSTRACT

OBJECTIVE: Management of bone loss in complex primary and revision total knee arthroplasty is key to the surgeries. Metaphyseal metal sleeves have been increasingly used recently to reconstruct severe knee metaphyseal bone defects. This study aimed to investigate the outcomes of the metaphyseal sleeve reconstructing Anderson Orthopedic Research Institute (AORI) type II and type III bone defects of knee joint.

METHODS: From 2014 to 2019, a total of 44 knees were enrolled in this clinical retrospective study after the screening, including seven cases of primary TKA and 37 cases of revision TKA. The types of bone defects involved in this study were AORI types II and III, and did not involve AORI type I bone defects. Patients’ knee function preoperatively and postoperatively as well as quality of life were recorded and analyzed. Analysis included the American Knee Society Score (KSS), hospital for special surgery knee score (HSS), the Western Ontario and McMaster Universities (WOMAC) index, the Short Form 12 (SF-12) health survey, visual analogue scale score, and radiographic assessment with a mean follow-up of 6.4 years. Paired t-tests were used to determine the significance of changes in clinical scores and knee mobility.

RESULTS: A mean follow-up of 77.2 (±17.6, standard deviation [SD]) months was performed, and none of the patients underwent knee revision for infection or aseptic loosening. At the last follow-up, the KSS knee score changed statistically from 37.1 (±19.7) preoperatively to 86.5 (±13.6, SD, p < 0.001) postoperatively and the KSS function score from 32.7 (±24.0) preoperatively to 78.3 (±15.6, SD, p < 0.001) postoperatively. The knee mobility improved from a mean of preoperative 72.61° (±33.42°, SD) to 108.52° (±24.15°, SD, p < 0.001). Postoperative radiographs showed that the host bone was tightly integrated with the metaphyseal metal sleeve, and there was no obvious translucent line formation around the sleeve. Of the patients, 86.4% had a postoperative satisfaction score ≥8 (10-point scale).

CONCLUSION: At the mean follow-up of 6.4 years, the survival rate of the metaphyseal sleeves was 100%. Metaphyseal sleeves combined with cementless stems is an excellent and viable option for reconstruction of AORI type II and type III bone defects of the knee.

PMID:37873568 | DOI:10.1111/os.13905

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Increasing illness severity of skilled nursing facility patients over time: Implications for readmission penalties

J Am Geriatr Soc. 2023 Oct 24. doi: 10.1111/jgs.18629. Online ahead of print.

ABSTRACT

BACKGROUND: Current financial penalties for rehospitalization of skilled nursing facilities (SNFs) patients are based in part on the studies by Ouslander et al., 2011, and Mor et al., 2010, demonstrating that many SNF hospitalizations were avoidable. With increasing age, complex illness severity, and use of SNFs for subacute rehabilitation, readmission metrics and financial penalties based on previous data may be due for reevaluation.

METHODS: Retrospective electronic medical record (EMR) review of 21,591 admissions and discharges between 2010 and 2019 inclusive. Data extracted included demographics, LACE, Charlson comorbidity index (CCI), and simplified HOSPITAL score parameters. The scores were calculated for the study years from the extracted data. Patients readmitted to the hospital within 30 days were identified.

RESULTS: Mean yearly score of all three indices rose steadily: LACE score 10.76-12.04 (0.43 estimated annual increase, 95% CI [0.39, 0.46]), CCI 4.26-5.05 (0.31 estimated annual increase, 95% CI [0.27, 0.34]), and simplified HOSPITAL score 3.46-4.03 (0.21 estimated annual increase, 95% CI [0.18, 0.24]). The estimated probability of readmission across observed CCI scores ranged from 15.4% to 15.9%, 95% CI bounds (10.8%, 22.7%). The estimated probability of readmission across observed LACE scores ranged from 4.7% to 36.3%, 95% CI bounds (3.4%, 54.7%). The estimated probability of readmission across observed HOSPITAL scores ranged from 5.8% to 54.1%, 95% CI bounds (6.2%, 66.0%).

CONCLUSIONS AND IMPLICATIONS: The study confirms anecdotal experience that the illness acuity of patients admitted to SNFs increased progressively over time and was associated with an increased risk of 30-day readmissions to the hospital. Our study suggests that the use of clinically validated readmission risk assessment tools instead of the Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP) current risk adjustors may be a more accurate reflection of the current illness severity of a facility’s patient population at the time of payment adjustment.

PMID:37873563 | DOI:10.1111/jgs.18629

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Pediatric model-based dose optimization using a pooled exposure-response safety analysis for nivolumab and nivolumab plus ipilimumab combination in melanoma

CPT Pharmacometrics Syst Pharmacol. 2023 Oct 23. doi: 10.1002/psp4.13070. Online ahead of print.

ABSTRACT

An exposure-response (E-R) safety analysis was conducted across adult and pediatric (<18 years) studies to evaluate the potential impact of higher nivolumab and/or ipilimumab exposures in adolescents (≥12 to <18 years ) versus adults with melanoma using the approved adult dosing regimens for nivolumab alone or in combination with ipilimumab. Data from 3507 patients across 15 studies were used to examine the relationship between nivolumab-ipilimumab daily average exposure (Cavg ) and time to grade 2+ immune-mediated adverse events (gr2+ IMAEs). Results from the E-R safety model showed ipilimumab, but not nivolumab, exposure to be a statistically significant predictor of gr2+ IMAEs. Significant covariates included sex (41% higher risk for women than men), line of therapy (19% higher for first-line than later-line), and treatment setting (26% lower for adjuvant than advanced melanoma). Younger age and lower body weight (BW) were each associated with a lower risk of gr2+ IMAEs (hazard ratio, 0.830 for 15-year-olds versus 60-year-olds and 0.84 for BW 52 kg versus 75 kg). For adolescents with melanoma treated with nivolumab in the advanced or adjuvant settings, these results are supportive of nivolumab flat dosing regimens for adolescents ≥40 kg and BW-based dosing for adolescents <40 kg. These results also support adult weight-based dosing regimens for nivolumab plus ipilimumab in adolescents with advanced melanoma. This analysis suggests that although higher exposures are predicted in adolescents with lower weight compared with adults, there is no predicted immune-mediated safety risk when treated with the approved adult dosing of nivolumab with/without ipilimumab.

PMID:37873561 | DOI:10.1002/psp4.13070

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Association between optic atrophy 1 polymorphisms and primary open angle glaucoma risk: Based on a meta-analysis

Eur J Ophthalmol. 2023 Oct 23:11206721231208244. doi: 10.1177/11206721231208244. Online ahead of print.

ABSTRACT

BACKGROUND: Emerging evidence suggested a significant association between optic atrophy 1 (OPA1) polymorphisms and primary open angle glaucoma (POAG) risk. However, the current data are inconsistent or even contradictory. Given these, we conducted a meta-analysis to examine the precise association between OPA1 polymorphisms and POAG risk.

MATERIALS AND METHODS: Online databases were retrieved, and the related studies were reviewed from inception to December 1, 2022. Odds ratios (ORs) and corresponding 95% confidence intervals (CIs) were calculated to examine the statistical power of each genetic model. In addition, heterogeneity, sensitivity, cumulative analysis, and publication bias were analyzed to guarantee statistical power.

RESULT: Overall, 14 studies within 11 publications (involving 2,413 POAG patients and 1,904 controls) were included and some significant association between OPA1 rs166850 C/T (T vs. C: OR = 1.24, 95%CI = 1.06-1.45, P = 0.01, I2 = 39.0%; CT vs. CC: OR = 1.37, 95%CI = 1.05-1.79, P = 0.02, I2 = 41.6%; CT + TT vs. CC: 1.37, 95%CI = 1.06-1.77, P = 0.02, I2 = 41.6%), rs10451941T/C (TC + CC vs. TT: OR = 1.79, 95%CI = 1.41-2.28, P < 0.01, I2 = 71.9%) polymorphisms and POAG susceptibility. In addition, further significant associations were also observed in the stratified analysis, especially in normal tension glaucoma groups and Caucasian descendants.

CONCLUSION: The observed evidences suggest that OPA1 polymorphisms may be associate with POAG susceptibility significantly.

PMID:37872653 | DOI:10.1177/11206721231208244

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Predictors of cervical tumour size for outpatients with cervical cancer at the University of Gondar referral hospital: a retrospective study design

Eur J Med Res. 2023 Oct 24;28(1):453. doi: 10.1186/s40001-023-01296-z.

ABSTRACT

BACKGROUND: Cervical cancer is one of the most serious threats to women’s lives. Modelling the change in tumour size over time for outpatients with cervical cancer was the study’s main goal.

METHODS: A hospital conducted a retrospective cohort study with outpatients who had cervical cancer. The information about the tumour size was taken from the patient’s chart and all patient data records between May 20, 2017, and May 20, 2021. The data cover 322 cervical cancer outpatients’ basic demographic and medical information. When analysing longitudinal data, the linear mixed effect model and the connection between tumour sizes in outpatients were taken into consideration. A linear mixed model, a random intercept model, and a slope model were used to fit the data.

RESULT: A sample of 322 cervical cancer outpatients was examined, and 148 (or 46% of the outpatients) tested positive for HIV. The linear mixed model with a first-order autoregressive covariance structure revealed that a change in time of one month led to a 0.009 cm2 reduction in tumour size. For every kilogramme more in weight, the tumour size change in cervical cancer patients decreased considerably by 0.0098 cm2. The tumour size change in the cervical cancer patient who was HIV-positive was 0.4360 cm squared greater than that in the HIV-negative outpatients.

CONCLUSION: As a consequence, there was a significant association between the longitudinal change in tumour size and the predictor variables visit time, therapy, patient weight, cancer stage, HIV, oral contraceptive use, history of abortion, and smoking status.

PMID:37872641 | DOI:10.1186/s40001-023-01296-z

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Concentration levels of selected hormones in judokas and the extent of their changes during a special performance test at different ambient temperatures

BMC Sports Sci Med Rehabil. 2023 Oct 23;15(1):140. doi: 10.1186/s13102-023-00751-y.

ABSTRACT

BACKGROUND: There is little scientific literature available on the diversity of physiological responses of judokas to anaerobic interval exercises in warm environments. Understanding the dynamics of changes in the concentration of selected hormones during a special endurance test at different ambient temperatures may have significant practical value, as it provides an opportunity for optimal programming and monitoring of the training process. So, the main aim of the research was to survey interval anaerobic exercises in different ambient temperatures on Concentration levels of selected hormones in judokas.

METHODS: 15 judokas athletes (age: 20.65 ± 2.03 years; body height: 178.00 ± 6.31 cm; body mass: 76.26 ± 12.57 kg; training experience: 12.1 ± 1.57 years) volunteered for the study. The judokas performed five sequences (each lasting 7.20 min) of pulsatile exercises on a cycle ergometer and hand ergometer in a thermoclimatic chamber at temperatures of 21 ± 0.5 °C and 31 ± 0.5 °C. The exercises were different from typical interval exercises, with varying times, upper and lower limb loads, and were followed by a 15-minute break after each sequence. Total duration of the experiment, including the five sequences of pulsating exercise and four 15-minute rest breaks between each exercise sequence, amounted to 96 min and 20 s. The workload was increased by 20 W for the lower limb tests and 12 W for the upper limb tests every 2 min. Biochemical measurements of testosterone (T), cortisol (C), growth hormone (HGH), adrenocorticotropic hormone (ACTH), follicle-stimulating hormone (FSH), adrenaline (E), noradrenaline (NE), and β-endorphin (β-end)were performed using the enzyme-linked immunosorbent assay (ELISA) method on blood samples taken before and after five series of pulsatile exercises, at 1, 24, and 48 h.

RESULTS: Pulsatile exercise at ambient temperatures of 21 and 31 °C resulted in a decrease in body weight of the studied athletes (p < 0.05) and significantly reduced body volume and plasma volume after training (p < 0.05). The concentration of HGH, testosterone, cortisol and NE showed a statistically significant difference after the end of the series of pulsating exercises at both temperatures (p < 0.05) and did not significantly affect the concentration of ACTH, FSH and adrenaline concentration.

CONCLUSIONS: An increase in the concentration of growth hormone, cortisol and NE was observed after doing the work at both 21 and 31 °C ambient temperature. Physical exertion in both ambient temperatures contributed to a statistically significant decrease in testosterone concentration. Based on the obtained research results, it can be concluded that physical activity in various thermal conditions of the external environment activates the hormonal response to varying degrees, with the direction of changes depending on the external thermal factor.

PMID:37872638 | DOI:10.1186/s13102-023-00751-y