Categories
Nevin Manimala Statistics

One-Year Outcomes of Early Therapy With Ticagrelor vs Clopidogrel in CYP2C19 Loss-of-Function Carriers With Stroke or TIA Trial

Neurology. 2024 Feb 13;102(3):e207809. doi: 10.1212/WNL.0000000000207809. Epub 2024 Jan 5.

ABSTRACT

BACKGROUND AND OBJECTIVES: The Ticagrelor or Clopidogrel with Aspirin in High-Risk Patients with Acute Nondisabling Cerebrovascular Events II (CHANCE-2) trial showed that among Chinese patients with minor ischemic stroke or transient ischemic attack (TIA) who were carriers of CYP2C19 loss-of-function alleles, dual-antiplatelet therapy with ticagrelor-aspirin reduced the 90-day risk of stroke without increased severe or moderate bleeding compared with clopidogrel-aspirin. However, whether dual-antiplatelet therapy with ticagrelor was superior to clopidogrel beyond the 90 days of follow-up remained unclear. In this study, we reported 1-year follow-up outcomes of the CHANCE-2 trial.

METHODS: The CHANCE-2 trial is a randomized, double-blind, placebo-controlled trial at 202 centers in China. Patients with a minor stroke or TIA who carried CYP2C19 loss-of-function alleles were randomized within 24 hours after symptom onset, in a 1:1 ratio, to receive ticagrelor and placebo clopidogrel or to receive clopidogrel and placebo ticagrelor for 90 days; both groups received aspirin for the first 21 days. After day 90, treatment was as per the choice of the clinician and the patient.

RESULTS: Among 6,412 patients, the proportion of patients on ticagrelor plus aspirin, clopidogrel plus aspirin, ticagrelor alone, clopidogrel alone, aspirin alone, other antiplatelet, and no antiplatelet beyond month 3 to 1 year was 0.09%, 1.56%, 0.13%, 2.66%, 73.65%, 0.78%, and 21.13% in the ticagrelor-aspirin group and 0.03%, 1.63%, 0.19%, 2.60%, 72.83%, 0.66%, and 22.06% in the clopidogrel-aspirin group, respectively. The primary outcome of new stroke occurred in 252 patients (7.91%) in the ticagrelor-aspirin group and 310 patients (9.73%) in the clopidogrel-aspirin group by 1 year of follow-up (hazard ratio 0.80; 95% CI 0.68-0.95; p = 0.007); new stroke beyond 3 months to 1 year occurred in 61 patients (2.07%) and 67 patients (2.32%) (p = 0.48), respectively. Primary safety outcome of severe or moderate bleeding occurred in 17 patients (0.53%) in the ticagrelor-aspirin group and 20 patients (0.63%) in the clopidogrel-aspirin group (p = 0.61).

DISCUSSION: For CYP2C19 loss-of-function allele carriers, early dual-antiplatelet therapy with ticagrelor is superior to clopidogrel at 1 year in reducing recurrent stroke.

TRIAL REGISTRATION INFORMATION: URL: clinicaltrials.gov. Unique identifier: NCT04078737.

CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with minor stroke or TIA with TIACYP2C19 loss-of-function, ticagrelor plus aspirin for 21 days is superior to clopidogrel plus aspirin in reducing the 1-year risk of recurrent stroke.

PMID:38181311 | DOI:10.1212/WNL.0000000000207809

Categories
Nevin Manimala Statistics

Effectiveness of Immune Checkpoint Inhibitors in Various Tumor Types Treated by Low, Per-Weight, and Conventional Doses at a Tertiary Care Center in Mumbai

JCO Glob Oncol. 2024 Jan;10:e2300312. doi: 10.1200/GO.23.00312.

ABSTRACT

PURPOSE: The cost of immune checkpoint inhibitors (ICIs) limits their accessibility to a small number of patients with cancer in low- and middle-income countries. Early-phase clinical trials have shown target inhibition and high activity at doses lower than those registered and evaluated in clinical trials. Here, we report everyday experience of using ICIs in 100 Indian patients, many of whom received lower doses of ICIs.

METHODS: Consecutive patients who received at least one dose of an ICI irrespective of tumor type at a tertiary care hospital in Mumbai, India, that was able to access ICIs for its patients were enrolled. The objectives were to study the doses used over a 3-year time period, and the effectiveness of therapy, assessed primarily by the overall response rate (ORR), overall survival (OS), and progression-free survival were secondary end points.

RESULTS: Twenty-five patients were treated with conventional doses of ICIs, 29 patients received lower doses per body weight, and 46 patients received low-dose treatment. The median number of cycles received was 5 (range, 1-28). Seventy-eight patients received ICIs in a palliative setting. The median follow-up time was 10.2, 9.8, and 3.9 months for those receiving fixed approved dosing, per body weight dosing, and low-dose treatment, respectively. There was a trend with time to prescribe lower doses. Response evaluation was available for 92 patients. Twenty-one (five-adjuvant and 16-palliative) patients received ICIs only. The ORR did not differ statistically among different dosing groups, but comparisons are confounded by inclusion of different ICIs, different tumor sites, and concurrent treatments. The median OS was 6.8 (range, 4.6-9.0) months.

CONCLUSION: Adoption of per-body weight and lower dosing of ICIs appears to give acceptable outcomes. Lower dosing can improve access and timely delivery of ICIs in low- and middle-income countries.

PMID:38181308 | DOI:10.1200/GO.23.00312

Categories
Nevin Manimala Statistics

Clinical efficacy of rhGM-CSF gel and medical collagen sponge on deep second-degree burns of infants: A randomized clinical trial

Medicine (Baltimore). 2024 Jan 5;103(1):e36304. doi: 10.1097/MD.0000000000036304.

ABSTRACT

BACKGROUND: This study aimed to observe clinical efficacy of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) gel, medical collagen sponge and rhGM-CSF gel in combination with medical collagen sponge on deep second-degree burns of head, face or neck in infants.

METHODS: A total of 108 infants with deep second-degree burns on head, face or neck were randomly divided into rhGM-CSF group, medical collagen sponge group, and rhGM-CSF + medical collagen sponge group. The scab dissolving time, healing time, bacterial positive rate and Vancouver scar scale were evaluated and analyzed.

RESULTS: The data analysis showed that scab dissolving time and healing time were shorter in rhGM-CSF + medical collagen sponge group than that in rhGM-CSF group and medical collagen sponge group, and the difference was statistically significant (P < .05). Bacterial positive rate was lower in rhGM-CSF + medical collagen sponge group than that in rhGM-CSF group and medical collagen sponge group (P < .05). After 3 months, score of Vancouver scar scale (scar thickness, pliability, pigmentation and vascularity) was less in rhGM-CSF + medical collagen sponge group than that in rhGM-CSF group and medical collagen sponge group (P < .05).

CONCLUSION: rhGM-CSF gel in combination with medical collagen sponge is significantly effective in treating deep second-degree burns of head, face or neck in infants. This combination is beneficial for infection control, acceleration of scab dissolving and wound healing, and reduction of scar hyperplasia and pigmentation, which is worthy of clinical application and promotion.

PMID:38181297 | DOI:10.1097/MD.0000000000036304

Categories
Nevin Manimala Statistics

The effects of mobile technology-based support on young women with depressive symptoms: A block randomized controlled trial

Medicine (Baltimore). 2024 Jan 5;103(1):e36748. doi: 10.1097/MD.0000000000036748.

ABSTRACT

BACKGROUND: The current body of knowledge highlights the potential role of mobile technology as a medium to deliver support for psychological and physical health. This study evaluated the influence of mobile technology support on depressive symptoms and physical activity in female university students.

METHODS: A block randomized controlled trial design with a single site was used. Ninety-nine participants were block-randomized into 3 arms: Experimental Group 1 (emotional and informational support group), Experimental Group 2 (informational support group), and the control group. Interventions were delivered via mobile technology for 2 weeks. Data on depressive symptoms and physical activity were collected from 84 participants at baseline and on Days 8 and 15. Data analyses included descriptive statistics, t tests, one-way analysis of variance, and repeated-measures analysis of variance.

RESULTS: This study showed no interaction effect of time and group on depressive symptom scores and physical activity, considering the emotional and informational support from mobile technology. However, Experimental Group 1 exhibited a significant reduction in depressive symptoms during the first week of the study compared to Experimental Group 2 and the control group. While physical activity in Experimental Group 2 and control group increased only during the first week of the study and subsequently decreased, Experimental Group 1 showed an initial increase during the first week that was sustained into the second week.

CONCLUSIONS: Since informational and emotional support showed a strong effect over a short period of time, mobile technology offering emotional support could be used to provide crisis interventions for depression among young women when a short-term impact is required.

PMID:38181292 | DOI:10.1097/MD.0000000000036748

Categories
Nevin Manimala Statistics

Effects of diaphragm electrical stimulation in treating respiratory dysfunction on mechanical ventilation after intracerebral hemorrhage: A single-center retrospective study

Medicine (Baltimore). 2024 Jan 5;103(1):e36767. doi: 10.1097/MD.0000000000036767.

ABSTRACT

Intracerebral hemorrhage (ICH) is a major cause of death and disability worldwide. The benefits of electrical stimulation in the treatment of respiratory dysfunction in patients on mechanical ventilation is unknown. Nevertheless, there is a dearth of evidence-based medical research concerning its clinical efficacy. From January 2019 to January 2023, every enrolled patients experienced respiratory dysfunction after ICH while being supported by mechanical ventilation. A total of 205 eligible patients were enrolled and then allocated into 2 groups: control group and observation group. 133 patients was selected and administered standard treatment as control group. Based on conventional treatment, other 72 patients were administered diaphragm electrical stimulation (DES) treatment. We examined information from current medical records, encompassing all initial data and predictive follow-up data, such as the weaning success rate, occurrence of ventilator-associated pneumonia (VAP), duration of stay in the intensive care unit (ICU) and hospital, expenses related to hospitalization, and mortality within 30 days. The baseline clinical data of the 2 groups did not exhibit any statistically significant disparities (all P > .05). The rate of successful weaning showed a significant increase in the DES group when compared to the control group (P = .025). In patients with respiratory dysfunction due to ICH, treatment with DES resulted in a significant reduction in the duration of invasive ventilation (9.8 ± 2.1 vs 11.2 ± 2.6, P < .01) and total ventilation time (9.8 ± 2.1 vs 11.2 ± 2.6, P < .01). It also led to a decrease in the length of stay in the ICU (15.67 ± 3.76 vs 17.53 ± 4.28, P = .002) and hospitalization cost (11500 vs 13600, P = .001). Additionally, DES treatment resulted in a lower incidence of VAP (73.61% vs 86.46%, P = .022) and improved 30-day mortality (P < .05), without any significant adverse effects. The findings of this research indicate that DESs have a positive impact on enhancing the rate of successful weaning and reducing the incidence of VAP. It decreases the duration of invasive ventilation and total ventilation time while also improving the mortality rate within 30 days. This therapy could offer a fresh alternative for respiratory impairment in patients undergoing mechanical ventilation.

PMID:38181283 | DOI:10.1097/MD.0000000000036767

Categories
Nevin Manimala Statistics

Model of disease severity in alcoholic hepatitis and novel prognostic insights

Rom J Intern Med. 2024 Jan 5. doi: 10.2478/rjim-2024-0001. Online ahead of print.

ABSTRACT

INTRODUCTION: Harmful alcohol consumption is one of the leading risk factors for global disease burden and injury condition, causing death and disability early in life, with over 3 million deaths worldwide every year. Alcoholic hepatitis (AH) is a clinical syndrome characterized by hepatic failure with recent onset of jaundice, consequence of a heavy chronic alcohol drinking. The disease severity ranges from mild to severe cases, with high short-term mortality. Individual variety regarding disease outcome and therapeutic response complicates the prognosis stratification. Thus, novel parameters and continuously sought for a better disease outcome assessment.

AIMS AND OBJECTIVES: To highlight new parameters that accurately assess 30-day mortality (short-term) in patients with AH and to develop a new severity score that uses readily available parameters accessible to any clinician.

MATERIALS AND METHODS: This is a prospective study on patients diagnosed with AH between 2022-2023. We identified 70 patients with AH who met the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for diagnosis after exclusion of patients with severe comorbidities that could influence disease outcome. Clinical and paraclinical parameters were assessed at least on admission and day 7. Mortality at 30-day was considered the endpoint. The database was composed using Microsoft Excel (Microsoft Corporation) and the data was analyzed using SPSS Statistics version 26 (IBM Corporation).

RESULTS: A total of 70 patients were included in the study with a mortality at 30-days of 22.9% (n=16). The independent variables associated with increased short-term mortality identified using the univariate analysis were: fever, infection, esophageal varices, prothrombin time PT, INR, total bilirubin, CRP, LDH and CHI (creatinine height index). Using multivariate regression we determined a novel prognostic score, with criterion for retaining variable being p<0.05. Total bilirubin day 7, CRP, PT, fever and CHI resulted after the analysis and were included into a new mortality score. Our Prognostic Model Score obtained an area under the ROC of 0.950 (95% CI: 0.890-0.980, p<0.001), with a cut-off value of 13.75 (Sn=87.5%, Sp=91%). Regarding the consecrated prognostic scores, MDF and Lille score obtained good AUROCs=0.839 and 0.881, respectively (p<0.000), with cut-off values comparable with literature (MDF=34.35 vs 32) and (Lille=0.475 vs 0.450). The discriminatory power for ABIC (p=0.58), GAHS (p=0.16), MELD-Na (p=0.61) was not significant.

CONCLUSION: We obtained a new prognostic score for the assessment of 30-day mortality in AH that includes markers of inflammation (CRP, fever) and markers of sarcopenia (CHI) along parameters of hepatic disfunction (total bilirubin and PT). Amongst consecrated prognostic models, MDF and Lille scores were representative for our study, while ABIC, GAHS and MELD-Na did not attain statistical significance. Our score is unique by the addition of CRP and this could prove to be a useful tool in AH severity stratification.

PMID:38180800 | DOI:10.2478/rjim-2024-0001

Categories
Nevin Manimala Statistics

Usability of an App for Medical History Taking in General Practice From the Patients’ Perspective: Cross-Sectional Study

JMIR Hum Factors. 2024 Jan 5;11:e47755. doi: 10.2196/47755.

ABSTRACT

BACKGROUND: A future shortage of physicians, especially in general practice, will result in an increasing workload for health care providers as a whole. Therefore, it is important to optimize patient-encounter processes to increase time efficiency related to visits. Utilizing digital tools to record patients’ medical histories prior to a consultation offers great potential to achieve this goal. The collected information can be stored into the practice’s electronic medical record, allowing for the general practitioner to review structured information of the patients’ complaints and related medical history beforehand, thereby saving time during the encounter. However, the low usability of new digital developments in this setting often hinders implementation.

OBJECTIVE: The aim of this study was to evaluate the usability of an app designed for medical history taking in general practice to capture the patients’ perspective.

METHODS: Between November 2021 and January 2022, we recruited 406 patients with acute complaints in one out-of-hour urgent care and seven general practice clinics. These study participants used the app during their waiting time and subsequently assessed its usability by completing the System Usability Scale (SUS), a robust and well-established 10-question survey measuring the perceived usability of products and technologies. Additionally, we collected general participant information, including age, sex, media usage, health literacy, and native language. Descriptive and inferential statistics were applied to identify patient characteristics associated with low or high SUS scores.

RESULTS: We analyzed data from 397 patients (56.7% female, 43.3% male). The mean total SUS score was 77.8 points; 54.4% (216/397) of participants had SUS scores of 80 points or higher, indicating high usability of the app. In a multiple linear regression predicting SUS score, male sex and higher age (65 years or older) were significantly negatively associated with the SUS score. Conversely, a higher health literacy score and German as the native language were significantly positively associated with the SUS score.

CONCLUSIONS: Usability testing based on the SUS anticipates successful implementation of the app. However, not all patients will easily adapt to utilizing the app, as exemplified by the participants of older age in this study who reported lower perceived usability. Further research should examine these groups of people, identify the exact problems in operating such an app, and provide targeted solutions.

TRIAL REGISTRATION: German Clinical Trials Register World Health Organization Trial Registration Data Set DRKS00026659; https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00026659.

PMID:38180798 | DOI:10.2196/47755

Categories
Nevin Manimala Statistics

Key Factors Influencing the Operationalization and Effectiveness of Telemedicine Services in Henan Province, China: Cross-Sectional Analysis

J Med Internet Res. 2024 Jan 5;26:e45020. doi: 10.2196/45020.

ABSTRACT

BACKGROUND: Telemedicine has demonstrated its potential in alleviating the unbalanced distribution of medical resources across different regions. Henan, a province in China with a population of approximately 100 million, is especially affected by a health care divide. The province has taken a proactive step by establishing a regional collaborative platform for telemedicine services provided by top-tier provincial hospitals.

OBJECTIVE: We aim to identify the key factors that influence the current operationalization and effectiveness of telemedicine services in Henan province. The insights gained from this study will serve as valuable references for enhancing the efficient operation of telemedicine platforms in low- and middle-income regions.

METHODS: We analyzed service reports from the performance management system of telemedicine services in Henan province throughout 2020. Using descriptive statistics and graphical methods, we examined key influencing factors, such as management competency; device configuration; and hospital capability, capacity, and service efficacy, across hospitals at 2 different tiers. In addition, we used generalized linear models and multiple linear regression models to identify key operational factors that significantly affect the service volume and efficacy of 2 major telemedicine services, namely teleconsultation and tele-education.

RESULTS: Among the 89 tier 3 hospitals and 97 tier 2 hospitals connected to the collaborative telemedicine platform, 65 (73%) and 55 (57%), respectively, have established standardized management procedures for telemedicine services. As the primary delivery method for telemedicine services, 90% (80/89) of the tier 3 hospitals and 94% (91/97) of the tier 2 hospitals host videoconferencing consultations through professional hardware terminals rather than generic computers. Teleconsultation is the dominant service type, with an average annual service volume per institution of 173 (IQR 37-372) and 60 (IQR 14-271) teleconsultations for tier 3 and tier 2 hospitals, respectively. Key factors influencing the service volume at each hospital include available funding, management competency, the number of connected upper tiers, and the number of professional staff. After receiving teleconsultations from tier 3 (65/89, 73%) and tier 2 (61/97, 63%) hospitals, patients reported significant improvements in their medical conditions. In addition, we observed that service efficacy is positively influenced by management competency, financial incentives, the number of connected upper or lower tiers, and the involvement of participating medical professionals.

CONCLUSIONS: Telemedicine has become increasingly popular in Henan province, with a notable focus on teleconsultation and tele-education services. Despite its popularity, many medical institutions, especially tier 2 hospitals, face challenges related to management competency. In addition to enhancing the effectiveness of existing telemedicine services, health care decision-makers in Henan province and other low- and middle-income regions should consider expanding the service categories, such as including remote emergency care and telesurgery, which have promise in addressing crucial health care needs in these regions.

PMID:38180795 | DOI:10.2196/45020

Categories
Nevin Manimala Statistics

Artificial Intelligence in Medicine: Cross-Sectional Study Among Medical Students on Application, Education, and Ethical Aspects

JMIR Med Educ. 2024 Jan 5;10:e51247. doi: 10.2196/51247.

ABSTRACT

BACKGROUND: The use of artificial intelligence (AI) in medicine not only directly impacts the medical profession but is also increasingly associated with various potential ethical aspects. In addition, the expanding use of AI and AI-based applications such as ChatGPT demands a corresponding shift in medical education to adequately prepare future practitioners for the effective use of these tools and address the associated ethical challenges they present.

OBJECTIVE: This study aims to explore how medical students from Germany, Austria, and Switzerland perceive the use of AI in medicine and the teaching of AI and AI ethics in medical education in accordance with their use of AI-based chat applications, such as ChatGPT.

METHODS: This cross-sectional study, conducted from June 15 to July 15, 2023, surveyed medical students across Germany, Austria, and Switzerland using a web-based survey. This study aimed to assess students’ perceptions of AI in medicine and the integration of AI and AI ethics into medical education. The survey, which included 53 items across 6 sections, was developed and pretested. Data analysis used descriptive statistics (median, mode, IQR, total number, and percentages) and either the chi-square or Mann-Whitney U tests, as appropriate.

RESULTS: Surveying 487 medical students across Germany, Austria, and Switzerland revealed limited formal education on AI or AI ethics within medical curricula, although 38.8% (189/487) had prior experience with AI-based chat applications, such as ChatGPT. Despite varied prior exposures, 71.7% (349/487) anticipated a positive impact of AI on medicine. There was widespread consensus (385/487, 74.9%) on the need for AI and AI ethics instruction in medical education, although the current offerings were deemed inadequate. Regarding the AI ethics education content, all proposed topics were rated as highly relevant.

CONCLUSIONS: This study revealed a pronounced discrepancy between the use of AI-based (chat) applications, such as ChatGPT, among medical students in Germany, Austria, and Switzerland and the teaching of AI in medical education. To adequately prepare future medical professionals, there is an urgent need to integrate the teaching of AI and AI ethics into the medical curricula.

PMID:38180787 | DOI:10.2196/51247

Categories
Nevin Manimala Statistics

Pure Wisdom or Potemkin Villages? A Comparison of ChatGPT 3.5 and ChatGPT 4 on USMLE Step 3 Style Questions: Quantitative Analysis

JMIR Med Educ. 2024 Jan 5;10:e51148. doi: 10.2196/51148.

ABSTRACT

BACKGROUND: The United States Medical Licensing Examination (USMLE) has been critical in medical education since 1992, testing various aspects of a medical student’s knowledge and skills through different steps, based on their training level. Artificial intelligence (AI) tools, including chatbots like ChatGPT, are emerging technologies with potential applications in medicine. However, comprehensive studies analyzing ChatGPT’s performance on USMLE Step 3 in large-scale scenarios and comparing different versions of ChatGPT are limited.

OBJECTIVE: This paper aimed to analyze ChatGPT’s performance on USMLE Step 3 practice test questions to better elucidate the strengths and weaknesses of AI use in medical education and deduce evidence-based strategies to counteract AI cheating.

METHODS: A total of 2069 USMLE Step 3 practice questions were extracted from the AMBOSS study platform. After including 229 image-based questions, a total of 1840 text-based questions were further categorized and entered into ChatGPT 3.5, while a subset of 229 questions were entered into ChatGPT 4. Responses were recorded, and the accuracy of ChatGPT answers as well as its performance in different test question categories and for different difficulty levels were compared between both versions.

RESULTS: Overall, ChatGPT 4 demonstrated a statistically significant superior performance compared to ChatGPT 3.5, achieving an accuracy of 84.7% (194/229) and 56.9% (1047/1840), respectively. A noteworthy correlation was observed between the length of test questions and the performance of ChatGPT 3.5 (ρ=-0.069; P=.003), which was absent in ChatGPT 4 (P=.87). Additionally, the difficulty of test questions, as categorized by AMBOSS hammer ratings, showed a statistically significant correlation with performance for both ChatGPT versions, with ρ=-0.289 for ChatGPT 3.5 and ρ=-0.344 for ChatGPT 4. ChatGPT 4 surpassed ChatGPT 3.5 in all levels of test question difficulty, except for the 2 highest difficulty tiers (4 and 5 hammers), where statistical significance was not reached.

CONCLUSIONS: In this study, ChatGPT 4 demonstrated remarkable proficiency in taking the USMLE Step 3, with an accuracy rate of 84.7% (194/229), outshining ChatGPT 3.5 with an accuracy rate of 56.9% (1047/1840). Although ChatGPT 4 performed exceptionally, it encountered difficulties in questions requiring the application of theoretical concepts, particularly in cardiology and neurology. These insights are pivotal for the development of examination strategies that are resilient to AI and underline the promising role of AI in the realm of medical education and diagnostics.

PMID:38180782 | DOI:10.2196/51148