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Nevin Manimala Statistics

Randomized Phase II Study to Assess the Role of Single-Agent Nivolumab to Maintain Remission in Acute Myeloid Leukemia

Blood Adv. 2025 Feb 10:bloodadvances.2024015176. doi: 10.1182/bloodadvances.2024015176. Online ahead of print.

ABSTRACT

We conducted a multi-center, open-label, randomized phase II study to assess the efficacy of Nivolumab as maintenance therapy for patients with AML in first complete remission (CR) or CR with incomplete hematologic recovery (CRi) who were not candidates for SCT. Patients were stratified and randomized to Observation (Obs) or Nivolumab (Nivo, 3mg/kg IV every 2 weeks for 46 doses). The primary endpoint was progression-free survival (PFS) defined as time to disease relapse or death due to any reason. Secondary endpoints included overall survival (OS), and evaluation of adverse events following Nivolumab administration. Eighty patients were enrolled with median duration of follow-up of 24 months (33 months among survivors). PFS was 13.2 months in the Nivolumab arm (95% CI: 8.5-21.8) and 10.9 months in the Observation arm (5.4-14.9 months). Overall PFS curves were not statistically significantly different ((Nivo/Obs)= 0.92; 95% CI: 0.54, 1.56; one-sided p = 0.38). The median OS was 53.9 months in the Nivolumab arm and 30.9 months in the Observation arm. Cox regression model HR (Nivo/Obs)= 0.78; 95% CI: 0.40, 1.51; p=0.23 (one-sided). There were more adverse events (AEs) of any type (regardless of attribution) on the Nivolumab arm; 27 (71%) patients on the Nivolumab arm had a grade 3 or higher AE compared to 5 patients (12%) on the Observation arm (p<0.001). Nivolumab maintenance after AML chemotherapy failed to improve the PFS and OS in this randomized Phase II study. There were increased AEs and SAEs with nivolumab, but these AEs and SAEs were expected and manageable. ClinicalTrials.gov ID NCT02275533.

PMID:39928953 | DOI:10.1182/bloodadvances.2024015176

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Validity, Accuracy, and Safety Assessment of an Aerobic Interval Training Using an App-Based Prehabilitation Program (PROTEGO MAXIMA Trial) Before Major Surgery: Prospective, Interventional Pilot Study

JMIR Mhealth Uhealth. 2025 Feb 10;13:e55298. doi: 10.2196/55298.

ABSTRACT

BACKGROUND: Major surgery is associated with significant morbidity and a reduced quality of life, particularly among older adults and individuals with frailty and impaired functional capacity. Multimodal prehabilitation can enhance functional recovery after surgery and reduce postoperative complications. Digital prehabilitation has the potential to be a resource-sparing and patient-empowering tool that improves patients’ preoperative status; however, little remains known regarding their safety and accuracy as medical devices.

OBJECTIVE: This study aims to test the accuracy and validity of a new software in comparison to the gold-standard electrocardiogram (ECG)-based heart rate measurement.

METHODS: The PROTEGO MAXIMA trial was a prospective interventional pilot trial assessing the validity, accuracy, and safety of an app-based exercise program. The Prehab App calculates a personalized, risk-stratified aerobic interval training plan based on individual risk factors and utilizes wearables to monitor heart rate. Healthy students and patients undergoing major surgery were enrolled. A structured risk assessment was conducted, followed by a 6-minute walking test and a 37-minute supervised interval session. During the exercise, patients wore app-linked wearables for heart rate and distance measurements, which were compared with standard ECG and treadmill measurements. Safety, accuracy, and usability assessments included testing alarm signals, while the occurrence of adverse events served as the primary and secondary outcome measures.

RESULTS: A total of 75 participants were included. The mean heart rate differences between wearables and standard ECG were ≤5 bpm (beats per minute) with a mean absolute percentage error of ≤5%. Regression analysis revealed a significant impact of the BMI (odds ratio 0.90, 95% CI 0.82-0.98, P=.02) and Timed Up and Go Test score (odds ratio 0.12, 95% CI 0.03-0.55, P=.006) on the accuracy of heart rate measurement; 29 (39%) patients experienced adverse events: pain (5/12, 42%), ECG electrode-related skin irritations (2/42, 17%), dizziness (2/42, 17%), shortness of breath (2/42, 17%), and fatigue (1/42, 8%). No cardiovascular or serious adverse events were reported, and no serious device deficiency was detected. There were no indications of clinically meaningful overexertion based on laboratory values measured before and after the 6-minute walking test and exercise. The differences in means and ranges were as follows: lactate (mmol/l), mean 0.04 (range -3 to 6; P=.47); creatinine kinase (U/l), mean 12 (range -7 to 43; P<.001); and sodium (mmol/l), mean -2 (range -11 to 12; P<.001).

CONCLUSIONS: The interventional trial demonstrated the high safety of the exercise program and the accuracy of heart rate measurements using commercial wearables in patients before major surgery, paving the way for potential remote implementation in the future.

TRIAL REGISTRATION: German Clinical Trials Register DRKS00026985; https://drks.de/search/en/trial/DRKS00026985 and European Database on Medical Devices (EUDAMED) CIV-21-07-0307311.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2022-069394.

PMID:39928941 | DOI:10.2196/55298

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Assessing the Relationship Between the Type of Internet Use and Internet Addiction in Early and Middle Adolescents: Cross-Sectional Study From Qatar

JMIR Hum Factors. 2025 Feb 10;12:e62955. doi: 10.2196/62955.

ABSTRACT

BACKGROUND: With the increasing prevalence of digital technology, adolescent internet addiction (IA) has become a global concern. Excessive internet use, especially among adolescents, has been linked to various negative outcomes such as poor academic performance, social isolation, and mental health issues. Conducted among adolescents of Arab origin, our study addressed the limitations of the literature, which predominantly focuses on Western, educated, industrialized, rich, and democratic populations.

OBJECTIVE: This study aimed to differentiate between essential and nonessential internet use and how they relate to IA in early and middle adolescents, as well as the relationship between subjective happiness with the amount of time spent on nonessential internet use and IA.

METHODS: A cross-sectional survey was conducted among 377 students from 16 schools in Qatar. The survey measured essential and nonessential internet use, subjective happiness with nonessential use, and IA symptoms using the Internet Addiction Diagnostic Questionnaire, as well as participant demographics. To explore age-specific associations, participants were categorized into early (age 11-13 years) and middle (age 14-17 years) adolescents. Factorial analysis, multiple regression, and logistic regression were used for statistical analysis.

RESULTS: Nonessential internet use significantly predicted IA in both early (P<.001) and middle (P<.001) adolescents, with early adolescents showing a stronger association. Subjective happiness with nonessential internet use negatively predicted IA only in middle adolescents (P<.001) as greater dissatisfaction led to a higher IA risk. Essential internet use did not predict IA in either group.

CONCLUSIONS: Differentiating between essential and nonessential internet use is crucial in understanding IA. This study highlights the importance of developmental differences in shaping IA symptoms. The findings suggest that interventions aimed at addressing IA should be age specific and focus on addressing nonessential use specifically rather than considering internet use and screen time in general as a single entity. Cultural and regional factors also play a role in shaping internet use patterns and IA in the Middle East, necessitating context-specific, culturally sensitive approaches to IA prevention.

PMID:39928940 | DOI:10.2196/62955

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Social Media Use and Oral Health-Related Misconceptions in Saudi Arabia: Cross-Sectional Study

JMIR Form Res. 2025 Feb 10;9:e70071. doi: 10.2196/70071.

ABSTRACT

BACKGROUND: Social media has become a central tool in health communication, offering both opportunities and challenges. In Saudi Arabia, where platforms like WhatsApp, Snapchat, and Instagram are widely used, the quality and credibility of oral health information shared digitally remain critical issues. Misconceptions about oral health can negatively influence individuals’ behaviors and oral health outcomes.

OBJECTIVE: This study aimed to describe the patterns of social media use and estimate the prevalence of oral health-related misconceptions among adults in Saudi Arabia. Additionally, it assessed the associations between engagement with oral health information, self-reported oral health, and the presence and count of these misconceptions.

METHODS: A cross-sectional survey was conducted over 10 weeks, targeting adults aged 15 years and older in Saudi Arabia. Data were collected from a total sample size (n=387) via a questionnaire distributed through targeted advertisements on Instagram, TikTok, Snapchat, and X (Twitter). The prevalence of oral health-related misconceptions was estimated using descriptive statistics, including counts and percentages. Chi-square tests described sociodemographic, social media engagement, and self-reported oral health. Logistic and Poisson regression analyses were used to assess associations between engagement and self-reported oral health with misconceptions. Logistic regression models provided odds ratios and adjusted odds ratios with 95% CI to assess the presence of oral health misconceptions. Poisson regression was used to calculate mean ratios and adjusted mean ratios (AMRs) for the count of misconceptions.

RESULTS: WhatsApp (n=344, 89.8%) and Instagram (n=304, 78.9%) were the most frequently used social media platforms daily. Common oral health misconceptions included beliefs that “Pregnancy causes calcium loss in teeth” (n=337, 87%) and “Dental treatment should be avoided during pregnancy” (n=245, 63.3%). Following dental-specific accounts was significantly associated with lower odds of having any misconceptions (adjusted odds ratio 0.41, 95% CI 0.22-0.78) and a lower count of misconceptions (AMR 0.87, 95% CI 0.77-0.98). Conversely, trust in social media as a source of oral health information was associated with a higher count of misconceptions (AMR 1.16, 95% CI 1.02-1.31).

CONCLUSIONS: Social media platforms are essential yet double-edged tools for oral health information dissemination in Saudi Arabia. Participants who followed dental-specific accounts had significantly lower misconceptions, while trust in social media as a source of information was linked to higher counts of misconceptions. These findings highlight the importance of promoting credible content from verified sources to combat misconceptions. Strategic collaborations with dental professionals are necessary to enhance the dissemination of accurate oral health information and public awareness and reduce the prevalence of oral health-related misconceptions.

PMID:39928937 | DOI:10.2196/70071

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Use of Digital Health Technologies for Dementia Care: Bibliometric Analysis and Report

JMIR Ment Health. 2025 Feb 10;12:e64445. doi: 10.2196/64445.

ABSTRACT

BACKGROUND: Dementia is a syndrome that compromises neurocognitive functions of the individual and that is affecting 55 million individuals globally, as well as global health care systems, national economic systems, and family members.

OBJECTIVE: This study aimed to determine the status quo of scientific production on use of digital health technologies (DHTs) to support (older) people living with dementia, their families, and care partners. In addition, our study aimed to map the current landscape of global research initiatives on DHTs on the prevention, diagnosis, treatment, and support of people living with dementia and their caregivers.

METHODS: A bibliometric analysis was performed as part of a systematic review protocol using MEDLINE, Embase, Scopus, Epistemonikos, the Cochrane Database of Systematic Reviews, and Google Scholar for systematic and scoping reviews on DHTs and dementia up to February 21, 2024. Search terms included various forms of dementia and DHTs. Two independent reviewers conducted a 2-stage screening process with disagreements resolved by a third reviewer. Eligible reviews were then subjected to a bibliometric analysis using VOSviewer to evaluate document types, authorship, countries, institutions, journal sources, references, and keywords, creating social network maps to visualize emergent research trends.

RESULTS: A total of 704 records met the inclusion criteria for bibliometric analysis. Most reviews were systematic, with a substantial number covering mobile health, telehealth, and computer-based cognitive interventions. Bibliometric analysis revealed that the Journal of Medical Internet Research had the highest number of reviews and citations. Researchers from 66 countries contributed, with the United Kingdom and the United States as the most prolific. Overall, the number of publications covering the intersection of DHTs and dementia has increased steadily over time. However, the diversity of reviews conducted on a single topic has resulted in duplicated scientific efforts. Our assessment of contributions from countries, institutions, and key stakeholders reveals significant trends and knowledge gaps, particularly highlighting the dominance of high-income countries in this research domain. Furthermore, our findings emphasize the critical importance of interdisciplinary, collaborative teams and offer clear directions for future research, especially in underrepresented regions.

CONCLUSIONS: Our study shows a steady increase in dementia- and DHT-related publications, particularly in areas such as mobile health, virtual reality, artificial intelligence, and sensor-based technologies interventions. This increase underscores the importance of systematic approaches and interdisciplinary collaborations, while identifying knowledge gaps, especially in lower-income regions. It is crucial that researchers worldwide adhere to evidence-based medicine principles to avoid duplication of efforts. This analysis offers a valuable foundation for policy makers and academics, emphasizing the need for an international collaborative task force to address knowledge gaps and advance dementia care globally.

TRIAL REGISTRATION: PROSPERO CRD42024511241; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=511241.

PMID:39928936 | DOI:10.2196/64445

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Perceptions in 3.6 Million Web-Based Posts of Online Communities on the Use of Cancer Immunotherapy: Data Mining Using BERTopic

J Med Internet Res. 2025 Feb 10;27:e60948. doi: 10.2196/60948.

ABSTRACT

BACKGROUND: Immunotherapy has become a game changer in cancer treatment. The internet has been used by patients as a platform to share personal experiences and seek medical guidance. Despite the increased utilization of immunotherapy in clinical practice, few studies have investigated the perceptions about its use by analyzing social media data.

OBJECTIVE: This study aims to use BERTopic (a topic modeling technique that is an extension of the Bidirectional Encoder Representation from Transformers machine learning model) to explore the perceptions of online cancer communities regarding immunotherapy.

METHODS: A total of 4.9 million posts were extracted from Facebook, Twitter, Reddit, and 16 online cancer-related forums. The textual data were preprocessed by natural language processing. BERTopic modeling was performed to identify topics from the posts. The effectiveness of isolating topics from the posts was evaluated using 3 metrics: topic diversity, coherence, and quality. Sentiment analysis was performed to determine the polarity of each topic and categorize them as positive or negative. Based on the topics generated through topic modeling, thematic analysis was conducted to identify themes associated with immunotherapy.

RESULTS: After data cleaning, 3.6 million posts remained for modeling. The highest overall topic quality achieved by BERTopic was 70.47% (topic diversity: 87.86%; topic coherence: 80.21%). BERTopic generated 14 topics related to the perceptions of immunotherapy. The sentiment score of around 0.3 across the 14 topics suggested generally positive sentiments toward immunotherapy within the online communities. Six themes were identified, primarily covering (1) hopeful prospects offered by immunotherapy, (2) perceived effectiveness of immunotherapy, (3) complementary therapies or self-treatments, (4) financial and mental impact of undergoing immunotherapy, (5) impact on lifestyle and time schedules, and (6) side effects due to treatment.

CONCLUSIONS: This study provides an overview of the multifaceted considerations essential for the application of immunotherapy as a therapeutic intervention. The topics and themes identified can serve as supporting information to facilitate physician-patient communication and the decision-making process. Furthermore, this study also demonstrates the effectiveness of BERTopic in analyzing large amounts of data to identify perceptions underlying social media and online communities.

PMID:39928933 | DOI:10.2196/60948

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Assessing the Uses, Benefits, and Limitations of Digital Technologies Used by Health Professionals in Supporting Obesity and Mental Health Communication: Scoping Review

J Med Internet Res. 2025 Feb 10;27:e58434. doi: 10.2196/58434.

ABSTRACT

BACKGROUND: Obesity and mental health issues present interconnected public health challenges that impair physical, social, and mental well-being. Digital technologies offer potential for enhancing health care communication between health professionals (HPs) and individuals living with obesity and mental health issues, but their effectiveness is not fully understood.

OBJECTIVE: This scoping review aims to identify and understand the different types of technologies used by HPs in supporting obesity and mental health communication.

METHODS: A comprehensive scoping review, which followed a validated methodology, analyzed studies published between 2013 and 2023 across 8 databases. The data extraction focused on HPs’ use of communication technologies, intervention types, biopsychosocial considerations, and perceptions of technology use. The review was guided by the following research question: “What are the uses, benefits, and limitations of digital technologies in supporting communication between HPs and persons living with obesity and mental health issues?”

RESULTS: In total, 8 studies-featuring web-based platforms, social media, synchronous video calls, telephone calls, automated SMS text messaging, and email-met the inclusion criteria. Technologies such as virtual learning collaborative dashboards and videoconferencing, supported by automated SMS text messaging and social media (Facebook and WhatsApp groups), were commonly used. Psychologists, dietitians, social workers, and health coaches used digital tools to facilitate virtual appointments, diet and mental health monitoring, and motivational and educational support through group therapy, 1-on-1 sessions, and hybrid models. Benefits included enhanced access to care and engagement, personalized digital cognitive behavioral therapy, perceived stigma reduction, privacy, and improved physical health outcomes in weight reduction. However, improvements in mental health outcomes were not statistically significant in studies reporting P values (P≥.05). The limitations included engagement difficulties due to conflicting personal family and work commitments; variable communication mode preferences, with some preferring in-person sessions; and misinterpretations of SMS text messaging prompts. Conflicts arose from cultural and individual differences, weight stigma, and confusion over HP roles in obesity and mental health care.

CONCLUSIONS: Digital technologies have diversified the approaches HPs can take in delivering education, counseling, and motivation to individuals with obesity and mental health issues, facilitating private, stigma-reduced environments for personalized care. While the interventions were effective in obesity management, the review revealed a shortfall in addressing mental health needs. This highlights an urgent need for digital tools to serve as media for a deeper engagement with individuals’ complex biopsychosocial needs. The integration of data science and technological advancements offers promising avenues for tailored digital solutions. The findings advocate the importance of continued innovation and adaptation in digital health care communication strategies, with clearer HP roles and an interdisciplinary, empathetic approach focused on individual needs.

PMID:39928923 | DOI:10.2196/58434

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Impact of Mobile Phone Usage on Sleep Quality Among Medical Students Across Latin America: Multicenter Cross-Sectional Study

J Med Internet Res. 2025 Feb 10;27:e60630. doi: 10.2196/60630.

ABSTRACT

BACKGROUND: The ubiquitous use of mobile phones among medical students has been linked to potential health consequences, including poor sleep quality.

OBJECTIVE: This study investigates the prevalence of mobile phone addiction and its association with sleep quality among medical students across 6 Latin American countries.

METHODS: A descriptive, cross-sectional, multicenter study was conducted between December 2023 and March 2024 using a self-administered online survey. The survey incorporated the Mobile Phone Addiction Scale and the Pittsburgh Sleep Quality Index to evaluate mobile phone addiction and sleep quality among 1677 medical students. A multiple regression model was applied to analyze the relationship between mobile phone addiction and poor sleep quality, adjusting for sex, age, and educational level to ensure robust results.

RESULTS: Mobile phone addiction was identified in 32.5% (545/1677) of participants, with significant differences across countries. The overall mean Pittsburgh Sleep Quality Index score was 7.26, indicating poor sleep quality. Multiple regression analysis revealed a strong association between mobile phone addiction and poor sleep, controlled for demographic variables (β=1.4, 95% CI 1.05-1.74).

CONCLUSIONS: This study underscores a significant prevalence of mobile phone addiction among medical students and its detrimental association with sleep quality in Latin America. The findings advocate for the need to address mobile phone usage to mitigate its negative implications on student health and academic performance. Strategies to enhance digital literacy and promote healthier usage habits could benefit medical education and student well-being.

PMID:39928921 | DOI:10.2196/60630

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Involvement of the Nigrostriatal Pathway in Patients With Idiopathic Normal Pressure Hydrocephalus and Parkinsonism

Neurology. 2025 Mar 11;104(5):e213352. doi: 10.1212/WNL.0000000000213352. Epub 2025 Feb 10.

ABSTRACT

BACKGROUND AND OBJECTIVES: Idiopathic normal pressure hydrocephalus (iNPH) is characterized by gait disturbance, cognitive decline, and urinary incontinence and may include parkinsonism. The underlying mechanism of parkinsonism in iNPH-whether neurodegenerative or mechanical-remains unclear. This study aimed to assess nigrostriatal integrity in iNPH patients with parkinsonism using dopaminergic transporter imaging (DAT-SPECT) and nigrosome MRI.

METHODS: This prospective study was conducted at the Movement Disorders Clinic, Santa Chiara Hospital, Pisa University, from 2021 to 2023. Inclusion criteria for the iNPH group included the following: (1) clinical diagnosis of probable iNPH per the 2021 Japanese Society Guidelines and (2) parkinsonism per United Kingdom Parkinson’s Disease Society Brain Bank criteria. An equal number of patients with Parkinson disease (PD), matched for age and sex, served as a comparison group. All participants underwent DAT-SPECT and 3T MRI within 1 month. Statistical analyses included the Student t test or Fisher-Pitman permutation tests for continuous variables and χ2 tests for categorical variables. Multiple linear regression (adjusted for age and sex) compared DAT binding between groups. Pearson correlation assessed relationships between striatal DAT binding and parkinsonism in patients with iNPH evaluated using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part III.

RESULTS: A total of 20 patients with iNPH (mean age 75.4 ± 5.1 years, 65% female) and 20 patients with PD (mean age 74 ± 3.7 years, 55% female) were included. Reduced striatal DAT binding was observed in 45% of patients with iNPH, with none exhibiting nigrosome loss. Conversely, all patients with PD showed both reduced DAT binding and nigrosome loss (p < 0.001). After adjusting for age and sex, patients with iNPH exhibited significantly higher putaminal and caudate DAT binding than patients with PD (right putamen: β = -0.644, p < 0.001; left putamen: β = -0.659, p < 0.001; right caudate: β = -0.429, p = 0.006; left caudate: β = -0.391, p = 0.016), with an elevated putaminal/caudate ratio (p = 0.012). In patients with iNPH, striatal DAT binding negatively correlated with motor severity (left: r = -0.626, p = 0.004; right: r = -0.425, p = 0.07).

DISCUSSION: Findings suggest that parkinsonism in iNPH may stem from mechanical disruption of the nigrostriatal pathway rather than neurodegeneration, as indicated by preserved nigrosome integrity despite reduced DAT binding. Limitations include the small sample size and lack of postsurgical follow-up data.

PMID:39928907 | DOI:10.1212/WNL.0000000000213352

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Principal Component Analysis in Dental Research

Int J Oral Maxillofac Implants. 2025 Feb 7;40(1):13-20. doi: 10.11607/jomi.10940.

ABSTRACT

Principal component analysis (PCA) is a statistical tool that condenses the information contained in a large group of independent variables to a more manageable number of variables. This is useful when performing an analysis on data sets with a large number of variables. PCA restructures the original independent variables into new variables called principal components that maximize the information present in the data. The principal components then act as a substitute for the independent variables in an analysis. The purpose of this article is to present PCA in an understandable way for researchers without advanced statistical and mathematical backgrounds. To solidify the comprehension of the process and provide a template for researchers, we present an extended step-by-step example of PCA in use on a fictitious peri-implantitis data set.

PMID:39928897 | DOI:10.11607/jomi.10940