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Nevin Manimala Statistics

Evaluating a Virtual Reality Game to Enhance Teen Distracted Driving Education: Mixed Methods Pilot Study

JMIR Form Res. 2024 Nov 26;8:e60674. doi: 10.2196/60674.

ABSTRACT

BACKGROUND: Inexperienced adolescent drivers are particularly susceptible to engaging in distracted driving behaviors (DDBs) such as texting while driving (TWD). Traditional driver education approaches have shown limited success in reducing motor vehicle crashes among young drivers.

OBJECTIVE: We tested an innovative approach to help address the critical issue of DDB among teenagers. We investigated the effectiveness of using a novel virtual reality (VR) game “Distracted Navigator” to educate novice teenage drivers about DDB.

METHODS: The game consisted of maneuvering a spaceship around asteroids while engaging in simulated DDB (eg, inputting numbers into a keypad). A physician-facilitated discussion, based on the theory of planned behavior, linked gameplay to real-life driving. Teenagers were recruited for the in-person study and randomly assigned at the block level to intervention (VR gameplay or discussion) and control groups (discussion only), approximating a 2:1 ratio. Unblinded, bivariate statistical analyses (all 2-tailed t tests or chi-square tests) and regression analyses measured programming impact on TWD-related beliefs and intentions. Content analysis of focus group interviews identified thematic feedback on the programming.

RESULTS: Of the 24 participants, 15 (63%) were male; their ages ranged from 14 to 17 (mean 15.8, SD 0.92) years, and all owned cell phones. Compared to the control group (n=7, 29%), the intervention group (n=17, 71%) was more likely to report that the programming had positively changed how they felt about texting and driving (?218=-8.3; P=.02). However, specific TWD attitudes and intentions were not different by treatment status. Irrespective of treatment, pre- and postintervention scores indicated reduced confidence in safely TWD (ie, perceived behavioral control; β=-.78; t46=-2.66; P=.01). Thematic analysis revealed the following: (1) the VR gameplay adeptly portrayed real-world consequences of texting and driving, (2) participants highly valued the interactive nature of the VR game and discussion, (3) both the VR game and facilitated discussion were deemed as integral and complementary components, and (4) feedback for improving the VR game and discussion.

CONCLUSIONS: Our findings show that the novel use of immersive VR experiences with interactive discussions can raise awareness of DDB consequences and is a promising method to enhance driving safety education. The widespread accessibility of VR technology allows for scalable integration into driver training programs, warranting a larger, prospective, randomized study.

PMID:39591605 | DOI:10.2196/60674

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Nevin Manimala Statistics

Surgical strategies in Ebstein anomaly: 28 years’ experience in a pediatric hospital

Arch Cardiol Mex. 2024;94(4):403-411. doi: 10.24875/ACM.23000203.

ABSTRACT

OBJECTIVES: Ebstein’s anomaly is a congenital defect characterized by a lack of delamination and apical displacement of the tricuspid valve, tricuspid insufficiency, right atrial enlargement, and ventricular dysfunction. To analyze the results and evolution of the different surgical strategies, data were collected from 45 patients operated on during 1990-2018. Twenty-six patients were included with a median age at initial surgery of 11.3 years (range: 13 days-18.6 years).

METHOD: Procedures were plastic 10 patients (38%), cone technique reconstruction 11 (42%), and replacement 5 (19%). Additional interventions were required in 7 patients: cavo-pulmonary anastomosis 4 and Cox-maze 4. Nine patients (34.6%) required reoperation due to severe tricuspid insufficiency. Six had previous plastic, two bioprothesis, and one, cone.

RESULTS: Overall mortality was 11.5% (3) at a median of 10.1 years post-surgery (range: 5.7-10.12) associated with arrhythmias (p = 0.05), right (p = 0.008), left (p = 0.0001) ventricular dysfunction and reoperations (p = 0.03). None were previous conus. Median follow-up was 6.5 years (range: 1-29.1). Ninety-one-point-six percent were in functional class I/II and 79.2% in sinus rhythm.

CONCLUSIONS: The results of the different classic techniques were similar, although not free of complications and reoperations. Cone reconstruction proved to be effective, with low surgical mortality, less need for reoperations, and durability in the medium term.

PMID:39591595 | DOI:10.24875/ACM.23000203

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Comparing costs and timing of ankle sprain care in two first-tier care systems

Cir Cir. 2024;92(6):751-757. doi: 10.24875/CIRU.23000024.

ABSTRACT

OBJECTIVE: To compare the costs of care and the opportunity of care for the management of grade I-II ankle sprain in two Family Medicine Units, one with rehabilitation service (FMU 13) and one without rehabilitation service (FMU 41).

METHOD: Observational analytical study, records with diagnosis of grade I-II ankle sprain attended at the FMU were included January-November 2021. Consultations were recorded in the emergency department, family medicine, rehabilitation, cabinet studies and time to grant the appointment in the rehabilitation service (opportunity of care), the Mann-Whitney U test was used to compare costs of care and timeliness of care.

RESULTS: In FMU 41, care costs were higher compared to FMU 13 ($13,990 vs $8,063); however, this difference was not significant, as was the cost of care in family medicine, rehabilitation, and opportunity of care.

CONCLUSIONS: The costs of care and the opportunity of care were similar in both models of care (FMU 13-FMU 41) of grade I-II ankle sprain.

PMID:39591581 | DOI:10.24875/CIRU.23000024

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Nevin Manimala Statistics

Extranodal Rosai-Dorfman disease in the breast: a literature review from 1969 to 2023

Cir Cir. 2024;92(6):741-750. doi: 10.24875/CIRU.24000184.

ABSTRACT

OBJECTIVE: Reviewing available literature regarding extranodal Rosai-Dorfman disease in the breast to explore the clinical characteristics of this disease, the described therapeutic options, and their outcomes.

METHOD: In January 2024, the PubMed, SpringerOpen, and Scopus databases were searched with the keywords “Rosai,” “Dorfman,” and “Breast.” Forty-two studies were included in the final analysis, obtaining a total of 70 reported cases of extranodal Rosai-Dorfman disease affecting the breast. Patient characteristics, mammogram descriptions, therapeutic management, and outcomes were reviewed for statistical analysis.

RESULTS: The main population consisted of females in their sixth decade of life (93%), presenting with a firm, non-tender nodule (65.7%), generally localized to one breast (72%). About 18.6% of patients had nodal or extranodal disease in other areas. Excisional biopsy was the main treatment strategy (63%) and surgical excision showed a lesser association with recurrence than incisional biopsy (p = 0.049). Most instances of disease recurrence or progression were diagnosed within the first 2 years.

CONCLUSIONS: This study revealed that surgical excision showed less association with disease recurrence or progression than expectant management. Follow-up can be conducted with a mammogram and physical examination since recurrence tends to occur locally within 2 years.

PMID:39591578 | DOI:10.24875/CIRU.24000184

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Visual and refractive outcomes after SMILE versus FS-LASIK: a paired-eye study

Cir Cir. 2024;92(6):758-768. doi: 10.24875/CIRU.23000261.

ABSTRACT

OBJECTIVE: To compare visual acuity, refraction, Schirmer test, tear break-up time (TBUT), esthesiometry, optical quality, higher order aberrations and posterior corneal elevation measurements before and after small-incision lenticule extraction (SMILE) and femtosecond laser-assisted in situ keratomileusis (FS-LASIK).

METHOD: Paired eye, randomized, cohort study. Follow-up was performed at days 1 and 7, and at months 1, 3, 6 and 12.

RESULTS: Forty-two eyes were enrolled in the study. Over time, a difference in posterior corneal elevation was statistically significant (p < 0.01) with a greater change in patients treated with SMILE. There was no difference in corrected distance visual acuity and uncorrected distance visual acuity and cylinder between the two techniques; however, there was a statistical significant difference in spherical error and spherical equivalent (p < 0.01). There was no difference between the eyes with FS-LASIK and SMILE in the assessment regarding the TBUT, the Schirmer test and esthesiometry.

CONCLUSIONS: SMILE showed more changes in the posterior elevation with a progressive backward shift throughout time during follow-up. SMILE and FS-LASIK provides similar results in myopic patients regarding visual acuity, refraction, Schirmer test, TBUT and esthesiometry.

PMID:39591576 | DOI:10.24875/CIRU.23000261

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Comparative analysis of operative treatment of fractures of the proximal humerus using two different surgical techniques

Cir Cir. 2024;92(6):702-708. doi: 10.24875/CIRU.23000414.

ABSTRACT

OBJECTIVE: The purpose of this study was to examine the surgical treatment of two-part and three-part proximal humerus fractures utilizing two approaches.

METHOD: Study involved a total of 40 individuals. Twenty patients were treated with plates and screws and 20 with intramedullary locking nail osteosynthesis. We created 10 pairs of patients that were matched in age, gender, and fracture type, with the sole difference being the osteosynthetic material used. The mean follow-up was 4 years (1-9 years). We evaluated the results of treatment using Constant’s scoring scale.

RESULTS: The mean value of Constant’s scoring scale was 78.05 for patients treated with plates and screws and 67.55 for those treated with intramedullary stabilization. There was no statistically significant difference between the groups nor were there statistically significant differences in post-operative range of motion (ROM).

CONCLUSIONS: The results of Constant’s scoring scale were higher for patients whose fractures were stabilized with a plate and screws. The same group of patients had a higher degree of mobility and better ROM. Even while there was a general tendency toward better outcomes when using plates and screws for fixation, there was no indication as to which surgical technique offers the best results.

PMID:39591575 | DOI:10.24875/CIRU.23000414

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Interobserver variation in the Parkland scale. Are we seeing the same thing?

Cir Cir. 2024;92(6):709-714. doi: 10.24875/CIRU.23000362.

ABSTRACT

OBJECTIVE: The aim of this study was to analyze the reliability of agreement between surgeons when using the Parkland Grading Scale for Acute Cholecystitis (PGS-AC).

METHODS: A total of 43 images taken out of videos of laparoscopic cholecystectomies (LCs) were collected, they were used to frame an online questionnaire that was sent to 18 surgeons and resident doctors who classified the images according to the Parkland scale criteria, followed by the evaluation of concordance between observers applying the Fleiss κ test.

RESULTS: A global Fleiss’ κ value of 0.213 was obtained, which corresponds to a low interobserver concordance. Factors such as being a surgical resident, having more than 10 years of experience performing this type of procedure, or performing more than 2 LCs per week, were related to greater concordance in diagnosis.

CONCLUSIONS: The low concordance found when using the Parkland grading scale, translates into a high interobserver variation related to multiple variables, which is why, we are not seeing the same.

PMID:39591568 | DOI:10.24875/CIRU.23000362

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Characteristics and mortality in patients with cancer and COVID-19

Cir Cir. 2024;92(6):769-775. doi: 10.24875/CIRU.23000379.

ABSTRACT

OBJECTIVE: Throughout the COVID-19 pandemic, care protocols were created to apply in hospital units and care for the vulnerable populationin. The objetive was to describe clini- cal manifestations, comorbidity and mortality in cancer patients with SARS CoV-2 infection, as well as sanitary measures carried out in COVID centers.

METHOD: Retrospective study of 1752 patients admitted to a respiratory care unit.

RESULTS: 5% of the population studied had a previous diagnosis of cancer; 59.1% were solid neoplasms and 40.9% hematologic neoplasms. Patients with cancer showed lower rates of admission to the intensive care unit (ICU) compared to patients without cancer (8% vs. 17.4%), with no differences in survival.

CONCLUSIONS: Oncology patients hospitalized with COVID-19 did not have different survival rates and were less likely to require ICU care compared to non-cancer patients, this is likely due to multidisciplinary teamwork during the pandemic.

PMID:39591561 | DOI:10.24875/CIRU.23000379

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Functional Outcome Measures to Optimize Drug Development in Spinal and Bulbar Muscular Atrophy: Results From a Meta-Analysis of the Global SBMA Dataset

Neurology. 2024 Dec 24;103(12):e210088. doi: 10.1212/WNL.0000000000210088. Epub 2024 Nov 26.

ABSTRACT

BACKGROUND AND OBJECTIVES: Spinal and bulbar muscular atrophy (SBMA) is a rare, slowly progressive, and debilitating disease without effective treatments available. Lack of reliable biomarkers and sensitive outcome measures makes clinical research conduct challenging. The primary objective of this study was to identify clinically meaningful and statistically sensitive outcome measures enabling the evaluation of therapeutic interventions in late-stage clinical trials.

METHODS: This study was a meta-analysis of SBMA patient-level data from 6 observational studies conducted in Italy, South Korea, Denmark, United Kingdom, Japan, and United States. Patients with confirmed SBMA genetic diagnosis and differing severity were enrolled following individual site protocols. Routine assessments were performed longitudinally for approximately 3 years, including one or more clinical outcomes, such as SBMA functional rating scale (SBMAFRS), 6-minute walk test (6MWT), quantitative muscle testing (QMT), and Adult Myopathy Assessment Tool (AMAT). A modified scale, m-SBMAFRS, was derived by including only lower limb and trunk subscales having lower variability and larger effect size compared with the others. Changes from baseline at follow-up time points were calculated for all measures, and percent changes using random slope models were calculated to compare clinical measure performances. A survey conducted on 196 patients by the Coordination of Rare Diseases at Sanford (CoRDS), elucidating the impact of specific disease aspects on patients’ lives, was also evaluated to corroborate these research outcomes.

RESULTS: This global SBMA dataset analyzed data from 278 men (mean age = 59.7 ± 10.8 years, mean disease duration = 17.7 ± 11.9 years). Patients progressed on SBMAFRS (-4.7 ± 6.2 points after 38 months with 1-year standard response mean [SRM] = 0.6) and 6MWT (distance walked decreased by -53.2 ± 87.0 meters after 26 months with 1-year SRM = 0.5). These measures showed lower variability and larger effect size than AMAT and QMT (1-year SRM = 0.1 and -0.2, respectively) and confirmed SBMA linear progression across a range of disease stages. The m-SBMAFRS also showed a significant yearly decline of 0.9 ± 1.5 points (SRM = 0.6) and more consistent performance with less variability across clinical sites. The CoRDS survey confirmed the relevance of lower limb strength and mobility, which correlated with higher quality-of-life metrics and were reported by patients as predominant disease issues.

DISCUSSION: We generated a comprehensive global SBMA dataset, enabling the identification of sensitive functional end points for clinical trials. Possible limitations relate to data collection nuances across sites that a single study protocol could override.

PMID:39591556 | DOI:10.1212/WNL.0000000000210088

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First-Line Lenvatinib Plus Pembrolizumab Versus Chemotherapy for Advanced Endometrial Cancer: A Randomized, Open-Label, Phase III Trial

J Clin Oncol. 2024 Nov 26:JCO2401326. doi: 10.1200/JCO-24-01326. Online ahead of print.

ABSTRACT

PURPOSE: Lenvatinib plus pembrolizumab (len + pembro) significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in previously treated advanced or recurrent endometrial cancer (aEC) in the phase III Study 309/KEYNOTE-775. We report results from the phase III, randomized, open-label European Network of Gynaecological Oncological Trial-en9/LEAP-001 study (ClinicalTrials.gov identifier: NCT03884101) that evaluated len + pembro versus chemotherapy in first-line aEC.

METHODS: Patients with stage III to IV or recurrent, radiographically apparent EC and no previous chemotherapy or disease progression ≥6 months after neo/adjuvant platinum-based chemotherapy were randomly assigned 1:1 to lenvatinib 20 mg once daily plus pembrolizumab 200 mg once every 3 weeks or paclitaxel 175 mg/m2 plus carboplatin AUC 6 mg/mL/min once every 3 weeks. Primary end points were PFS and OS, evaluated in the mismatch repair-proficient (pMMR) and all-comers populations. Noninferiority was assessed for OS at final analysis (FA) for len + pembro versus chemotherapy (multiplicity-adjusted, one-sided nominal alpha, .0159; null hypothesis-tested hazard ratio [HR], 1.1).

RESULTS: Eight hundred forty-two patients were randomly assigned (len + pembro, n = 420 [pMMR population, n = 320]; chemotherapy, n = 422 [pMMR population, n = 322]). At FA (data cutoff, October 2, 2023), median PFS (95% CI) in the pMMR population was 9.6 (8.2 to 11.9) versus 10.2 (8.4 to 10.5) months with len + pembro versus chemotherapy (hazard ratio [HR], 0.99 [95% CI, 0.82 to 1.21]) and among all-comers was 12.5 (10.3 to 15.1) versus 10.2 (8.4 to 10.4) months (HR, 0.91 [95% CI, 0.76 to 1.09]; descriptive analyses). Median OS (95% CI) in the pMMR population was 30.9 (25.4 to 37.7) versus 29.4 (26.2 to 35.4) months with len + pembro versus chemotherapy (HR, 1.02 [95% CI, 0.83 to 1.26]; noninferiority P = .246, not statistically significant per multiplicity control strategy) and among all-comers was 37.7 (32.2 to 43.6) versus 32.1 (27.2 to 35.7) months (HR, 0.93 [95% CI, 0.77 to 1.12]). Grade ≥3 treatment-related adverse events occurred in 331/420 (79%) versus 274/411 (67%) treated patients.

CONCLUSION: First-line len + pembro did not meet prespecified statistical criteria for PFS or OS versus chemotherapy in pMMR aEC.

PMID:39591551 | DOI:10.1200/JCO-24-01326