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Nevin Manimala Statistics

Co-Design, Development, and Evaluation of a Mobile Solution to Improve Medication Adherence in Cancer: Design Science Research Approach

JMIR Cancer. 2024 Apr 3;10:e46979. doi: 10.2196/46979.

ABSTRACT

BACKGROUND: Medication nonadherence negatively impacts the health outcomes of people with cancer as well as health care costs. Digital technologies present opportunities to address this health issue. However, there is limited evidence on how to develop digital interventions that meet the needs of people with cancer, are perceived as useful, and are potentially effective in improving medication adherence.

OBJECTIVE: The objective of this study was to co-design, develop, and preliminarily evaluate an innovative mobile health solution called Safety and Adherence to Medication and Self-Care Advice in Oncology (SAMSON) to improve medication adherence among people with cancer.

METHODS: Using the 4 cycles and 6 processes of design science research methodology, we co-designed and developed a medication adherence solution for people with cancer. First, we conducted a literature review on medication adherence in cancer and a systematic review of current interventions to address this issue. Behavioral science research was used to conceptualize the design features of SAMSON. Second, we conducted 2 design phases: prototype design and final feature design. Last, we conducted a mixed methods study on patients with hematological cancer over 6 weeks to evaluate the mobile solution.

RESULTS: The developed mobile solution, consisting of a mobile app, a web portal, and a cloud-based database, includes 5 modules: medication reminder and acknowledgment, symptom assessment and management, reinforcement, patient profile, and reporting. The quantitative study (n=30) showed that SAMSON was easy to use (21/27, 78%). The app was engaging (18/27, 67%), informative, increased user interactions, and well organized (19/27, 70%). Most of the participants (21/27, 78%) commented that SAMSON’s activities could help to improve their adherence to cancer treatments, and more than half of them (17/27, 63%) would recommend the app to their peers. The qualitative study (n=25) revealed that SAMSON was perceived as helpful in terms of reminding, supporting, and informing patients. Possible barriers to using SAMSON include the app glitches and users’ technical inexperience. Further needs to refine the solution were also identified. Technical improvements and design enhancements will be incorporated into the subsequent iteration.

CONCLUSIONS: This study demonstrates the successful application of behavioral science research and design science research methodology to design and develop a mobile solution for patients with cancer to be more adherent. The study also highlights the importance of applying rigorous methodologies in developing effective and patient-centered digital intervention solutions.

PMID:38569178 | DOI:10.2196/46979

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Nevin Manimala Statistics

Postpandemic Sentinel Surveillance of Respiratory Diseases in the Context of the World Health Organization Mosaic Framework: Protocol for a Development and Evaluation Study Involving the English Primary Care Network 2023-2024

JMIR Public Health Surveill. 2024 Apr 3;10:e52047. doi: 10.2196/52047.

ABSTRACT

BACKGROUND: Prepandemic sentinel surveillance focused on improved management of winter pressures, with influenza-like illness (ILI) being the key clinical indicator. The World Health Organization (WHO) global standards for influenza surveillance include monitoring acute respiratory infection (ARI) and ILI. The WHO’s mosaic framework recommends that the surveillance strategies of countries include the virological monitoring of respiratory viruses with pandemic potential such as influenza. The Oxford-Royal College of General Practitioner Research and Surveillance Centre (RSC) in collaboration with the UK Health Security Agency (UKHSA) has provided sentinel surveillance since 1967, including virology since 1993.

OBJECTIVE: We aim to describe the RSC’s plans for sentinel surveillance in the 2023-2024 season and evaluate these plans against the WHO mosaic framework.

METHODS: Our approach, which includes patient and public involvement, contributes to surveillance objectives across all 3 domains of the mosaic framework. We will generate an ARI phenotype to enable reporting of this indicator in addition to ILI. These data will support UKHSA’s sentinel surveillance, including vaccine effectiveness and burden of disease studies. The panel of virology tests analyzed in UKHSA’s reference laboratory will remain unchanged, with additional plans for point-of-care testing, pneumococcus testing, and asymptomatic screening. Our sampling framework for serological surveillance will provide greater representativeness and more samples from younger people. We will create a biomedical resource that enables linkage between clinical data held in the RSC and virology data, including sequencing data, held by the UKHSA. We describe the governance framework for the RSC.

RESULTS: We are co-designing our communication about data sharing and sampling, contextualized by the mosaic framework, with national and general practice patient and public involvement groups. We present our ARI digital phenotype and the key data RSC network members are requested to include in computerized medical records. We will share data with the UKHSA to report vaccine effectiveness for COVID-19 and influenza, assess the disease burden of respiratory syncytial virus, and perform syndromic surveillance. Virological surveillance will include COVID-19, influenza, respiratory syncytial virus, and other common respiratory viruses. We plan to pilot point-of-care testing for group A streptococcus, urine tests for pneumococcus, and asymptomatic testing. We will integrate test requests and results with the laboratory-computerized medical record system. A biomedical resource will enable research linking clinical data to virology data. The legal basis for the RSC’s pseudonymized data extract is The Health Service (Control of Patient Information) Regulations 2002, and all nonsurveillance uses require research ethics approval.

CONCLUSIONS: The RSC extended its surveillance activities to meet more but not all of the mosaic framework’s objectives. We have introduced an ARI indicator. We seek to expand our surveillance scope and could do more around transmissibility and the benefits and risks of nonvaccine therapies.

PMID:38569175 | DOI:10.2196/52047

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Nevin Manimala Statistics

Building Healthy Families: Outcomes of an Adapted Family Healthy Weight Program Among Children in a Rural Mid-Western Community

Child Obes. 2024 Apr 3. doi: 10.1089/chi.2023.0142. Online ahead of print.

ABSTRACT

Background: This study aimed to evaluate the effectiveness of implementing an adapted, evidence-based 12-week Family Healthy Weight Program (FHWP), Building Healthy Families, on reducing BMI metrics and clinical health indicators in a real-world community setting. Methods: Ninety child participants with a BMI percentile greater or equal to the 95th percentile for gender and age and their parents/guardians (n = 137) enrolled in the program. Families attended 12 weekly group-based sessions of nutrition education, family lifestyle physical activity, and behavior modification. A pre-post study design with a 6-month follow-up was used. Results: Nine cohorts of families between 2009 and 2016 completed the program with 82.1% retention at 12 weeks and 53.6% at 6 months. Participants had statistically significant improvements at 12 weeks in BMI z-score, %BMIp95, body mass, body fat, fat mass, fat-free mass, and systolic blood pressure with greater improvement at 6 months in body mass, BMI metrics, body fat, fat mass, fat-free mass, and systolic blood pressure. Parents/guardians of the participants had similar statistically significant body composition and blood pressure improvements (p < 0.05). In addition, children had significant improvements in high-density lipoprotein (HDL) cholesterol and aspartate aminotransferase (AST) liver enzymes at 6 months. Conclusions: Overall, this study demonstrated that an evidence-based FHWP can result in statistically meaningful declines in BMI z-score and accompanied clinically meaningful changes in health risk. Participants lost ∼4% of their body mass in 12 weeks, while their parents/guardians lost closer to 7% of their body mass, which supports previous literature suggesting body mass changes influence health.

PMID:38569168 | DOI:10.1089/chi.2023.0142

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Nevin Manimala Statistics

Study of Correlated Motions to Detect the Conformational Transitions of the Intrinsically Disordered Sheep Prion Peptide

J Chem Inf Model. 2024 Apr 3. doi: 10.1021/acs.jcim.4c00300. Online ahead of print.

ABSTRACT

Intrinsically disordered proteins (IDPs) are known for their random structural changes throughout their sequence based on the environment. The mechanism underlying these structural changes is difficult to explain. All biological processes are known to follow the direction through which they act. A study of the correlated motion can help to understand the direction of the change. Herein, we introduced the multivariate statistical analysis (MSA) technique to study the correlated motion of the peptide. The correlated motion of the sheep prion peptide was studied with the change in the temperature and solvent. These techniques helped to identify the contributing residual motions that helped to form the different secondary structures of the protein and also the triggering factors that drive these sorts of residual motions. The structural details match the experimentally reported data. It was found that the direction of the change of the secondary structure for this peptide shifted from the C-terminal to the N-terminal with an increase in the temperature. It was found that the involvement of the hydrophobic residues present at the C-terminal and the middle residues (residues 12-17) is responsible for forming a β-sheet at the normal temperature. Hydration water was found to play an important role in this change. Insights gained from this study can be used to design strategies for desirable structural changes in the IDPs.

PMID:38569130 | DOI:10.1021/acs.jcim.4c00300

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Nevin Manimala Statistics

Validating Risk Prediction Models for Multiple Primaries and Competing Cancer Outcomes in Families With Li-Fraumeni Syndrome Using Clinically Ascertained Data

J Clin Oncol. 2024 Apr 3:JCO2301926. doi: 10.1200/JCO.23.01926. Online ahead of print.

ABSTRACT

PURPOSE: There exists a barrier between developing and disseminating risk prediction models in clinical settings. We hypothesize that this barrier may be lifted by demonstrating the utility of these models using incomplete data that are collected in real clinical sessions, as compared with the commonly used research cohorts that are meticulously collected.

MATERIALS AND METHODS: Genetic counselors (GCs) collect family history when patients (ie, probands) come to MD Anderson Cancer Center for risk assessment of Li-Fraumeni syndrome, a genetic disorder characterized by deleterious germline mutations in the TP53 gene. Our clinical counseling-based (CCB) cohort consists of 3,297 individuals across 124 families (522 cases of single primary cancer and 125 cases of multiple primary cancers). We applied our software suite LFSPRO to make risk predictions and assessed performance in discrimination using AUC and in calibration using observed/expected (O/E) ratio.

RESULTS: For prediction of deleterious TP53 mutations, we achieved an AUC of 0.78 (95% CI, 0.71 to 0.85) and an O/E ratio of 1.66 (95% CI, 1.53 to 1.80). Using the LFSPRO.MPC model to predict the onset of the second cancer, we obtained an AUC of 0.70 (95% CI, 0.58 to 0.82). Using the LFSPRO.CS model to predict the onset of different cancer types as the first primary, we achieved AUCs between 0.70 and 0.83 for sarcoma, breast cancer, or other cancers combined.

CONCLUSION: We describe a study that fills in the critical gap in knowledge for the utility of risk prediction models. Using a CCB cohort, our previously validated models have demonstrated good performance and outperformed the standard clinical criteria. Our study suggests that better risk counseling may be achieved by GCs using these already-developed mathematical models.

PMID:38569124 | DOI:10.1200/JCO.23.01926

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Nevin Manimala Statistics

N-Heterocyclic Carbene to Actinide d-Based π-bonding Correlates with Observed Metal-Carbene Bond Length Shortening Versus Lanthanide Congeners

J Am Chem Soc. 2024 Apr 3. doi: 10.1021/jacs.3c12721. Online ahead of print.

ABSTRACT

Comparison of bonding and electronic structural features between trivalent lanthanide (Ln) and actinide (An) complexes across homologous series’ of molecules can provide insights into subtle and overt periodic trends. Of keen interest and debate is the extent to which the valence f- and d-orbitals of trivalent Ln/An ions engage in covalent interactions with different ligand donor functionalities and, crucially, how bonding differences change as both the Ln and An series are traversed. Synthesis and characterization (SC-XRD, NMR, UV-vis-NIR, and computational modeling) of the homologous lanthanide and actinide N-heterocyclic carbene (NHC) complexes [M(C5Me5)2(X)(IMe4)] {X = I, M = La, Ce, Pr, Nd, U, Np, Pu; X = Cl, M = Nd; X = I/Cl, M = Nd, Am; and IMe4 = [C(NMeCMe)2]} reveals consistently shorter An-C vs Ln-C distances that do not substantially converge upon reaching Am3+/Nd3+ comparison. Specifically, the difference of 0.064(6) Å observed in the La/U pair is comparable to the 0.062(4) Å difference observed in the Nd/Am pair. Computational analyses suggest that the cause of this unusual observation is rooted in the presence of π-bonding with the valence d-orbital manifold in actinide complexes that is not present in the lanthanide congeners. This is in contrast to other documented cases of shorter An-ligand vs Ln-ligand distances, which are often attributed to increased 5f vs 4f radial diffusivity leading to differences in 4f and 5f orbital bonding involvement. Moreover, in these traditional observations, as the 5f series is traversed, the 5f manifold contracts such that by americium structural studies often find no statistically significant Am3+vs Nd3+ metal-ligand bond length differences.

PMID:38569081 | DOI:10.1021/jacs.3c12721

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Nevin Manimala Statistics

Assessing the sensitivity and suitability of a range of detectors for SIMT PSQA

J Appl Clin Med Phys. 2024 Apr 3:e14343. doi: 10.1002/acm2.14343. Online ahead of print.

ABSTRACT

PURPOSE: Single-isocenter multi-target intracranial stereotactic radiotherapy (SIMT) is an effective treatment for brain metastases with complex treatment plans and delivery optimization necessitating rigorous quality assurance. This work aims to assess five methods for quality assurance of SIMT treatment plans in terms of their suitability and sensitivity to delivery errors.

METHODS: Sun Nuclear ArcCHECK and SRS MapCHECK, GafChromic EBT Radiochromic Film, machine log files, and Varian Portal Dosimetry were all used to measure 15 variations of a single SIMT plan. Variations of the original plan were created with Python. They comprised various degrees of systematic MLC offsets per leaf up to 2 mm, random per-leaf variations with differing minimum and maximum magnitudes, simulated collimator, and dose miscalibrations (MU scaling). The erroneous plans were re-imported into Eclipse and plan-quality degradation was assessed by comparing each plan variation to the original clinical plan in terms of the percentage of clinical goals passing relative to the original plan. Each erroneous plan could be then ranked by the plan-quality degradation percentage following recalculation in the TPS so that the effects of each variation could be correlated with γ pass rates and detector suitability.

RESULTS & CONCLUSIONS: It was found that 2%/1 mm is a good starting point for the ArcCHECK, Portal Dosimetry, and the SRS MapCHECK methods, respectively, and provides clinically relevant error detection sensitivity. Looser dose criteria of 5%/1 mm or 5%/1.5 mm are suitable for film dosimetry and log-file-based methods. The statistical methods explored can be expanded to other areas of patient-specific QA and detector assessment.

PMID:38569013 | DOI:10.1002/acm2.14343

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Nevin Manimala Statistics

Predictors of delayed initiation of breast milk and exclusive breastfeeding in Ethiopia: A multi-level mixed-effect analysis

PLoS One. 2024 Apr 3;19(4):e0301042. doi: 10.1371/journal.pone.0301042. eCollection 2024.

ABSTRACT

BACKGROUND: Despite the well-established benefits of early initiation of breastfeeding and exclusive breastfeeding for the first six months to promote optimal neonatal and child health, evidence indicates that in Ethiopia, a significant number of newborns initiate breastfeeding late, do not adhere to exclusive breastfeeding (EBF) for the recommended duration, and instead are fed with bottles.

OBJECTIVE: To determine the proportion of delayed initiation of breast milk, exclusive breastfeeding, and its individual and community-level predictors among mothers in Ethiopia.

METHODS: A secondary data analysis was done using the 2019 Ethiopian Mini Demographic Health Survey data. We examined a weighted sample of 2,012 children born within the past 24 months and 623 children aged 0-5 months at the time of the survey. The data analysis was done using STATA version 15. To understand the variation in delayed initiation and exclusive breastfeeding, statistical measures such as the Intraclass correlation coefficient, median odds ratio, and proportional change in variance were calculated. We employed a multilevel mixed-effects logistic regression model to identify predictors for each outcome variable. Statistical significance was determined with a p-value < 0.05.

RESULTS: The proportion of delayed initiation of breast milk and exclusive breastfeeding were 24.56 and 84.5%, respectively. Women aged 34-49 years old (AOR = 0.33: 95% CI; 0.15-0.72), having a television in the house (AOR = 0.74: 95%CI; 0.33-0.97), delivered by cesarean section (AOR = 3.83: 95% CI; 1.57-9.32), and resided in the Afar regional state (AOR = 1.43: 95%CI; 1.03-12.7) were significantly associated with delayed initiation of breast milk. On the other hand, attended primary education (AOR = 0.67: 95%CI; 0.35-0.99), secondary education (AOR = 0.34: 95%CI; 0.19-0.53), women whose household headed by male (AOR = 0.68; 95% CI; 0.34-0.97), and rural residents (AOR = 1.98: 95%CI; 1.09-3.43) were significantly associated with exclusive breastfeeding practice.

CONCLUSION: Health promotion efforts that encourage timely initation of breast milk and promote EBF, focused on young mothers, those who gave birth through cesarean section, and those residing in urban and the Afar regional state. Furthermore, government health policymakers and relevant stakeholders should consider these identified predictors when revising existing strategies or formulating new policies.

PMID:38568996 | DOI:10.1371/journal.pone.0301042

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Nevin Manimala Statistics

Dietary fat intake with risk of gestational diabetes mellitus and preeclampsia: a systematic review and meta-analysis of prospective cohort studies

Nutr Rev. 2024 Apr 3:nuae033. doi: 10.1093/nutrit/nuae033. Online ahead of print.

ABSTRACT

CONTEXT: Gestational diabetes mellitus (GDM) and preeclampsia (PE) are commonly observed medical complications in pregnancy. Dietary total fat and fatty acids associated with GDM and PE risk have been examined in several epidemiological studies. In some instances, systematic reviews and meta-analyses might provide more accurate dietary recommendations.

OBJECTIVES: This systematic review and dose-response meta-analysis was conducted to investigate the association between dietary total fat and fatty acids and the risk of GDM and PE.

DATA SOURCES: Research on dietary fat intake and the risk of GDM and PE was conducted through systematic searches of the PubMed, Scopus, and Web of Science databases for articles published up to August 19, 2023. An investigation of associations between dietary intake of total fat and fatty acids and the risk of GDM and PE was performed using prospective cohort study designs.

RESULTS: Twenty-one prospective cohort studies were considered eligible. Findings indicated that higher intakes of total fat (relative risk [RR], 1.08; 95% confidence interval [CI], 1.02-1.14), animal fat (RR, 1.56; 95%CI, 1.34-1.89), vegetable fat (RR, 1.23; 95%CI, 1.05-1.45), dietary cholesterol (RR, 1.48; 95%CI, 1.10-2.00), and omega-3 fatty acid (RR, 1.11; 95%CI, 1.02-1.20) are associated with a greater risk of GDM. However, no significant association was found between dietary total fat and fatty acids and the risk of PE. Dose-response meta-analyses suggested every 10% increment in total energy intake from total fat, 5% from animal fat, 5% from vegetable fat, and 100 mg from cholesterol was related to 15%, 12%, 7%, 14%, and 20% higher GDM risk, respectively.

CONCLUSIONS: Overall, total fat, animal fat, vegetable fat, dietary cholesterol, and omega-3 fatty acid consumption are associated with a small but statistically significant increase in GDM risk.

PROTOCOL REGISTRATION: PROSPERO (CRD42023466844).

PMID:38568994 | DOI:10.1093/nutrit/nuae033

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Nevin Manimala Statistics

Toxoplasma gondii infection and testosterone alteration: A systematic review and meta-analyses

PLoS One. 2024 Apr 3;19(4):e0297362. doi: 10.1371/journal.pone.0297362. eCollection 2024.

ABSTRACT

BACKGROUND: Toxoplasma gondii (T. gondii) is a worldwide distributed protozoan parasite which has infected a wide range of warm-blooded animals and humans. The most common form of T. gondii infection is asymptomatic (latent); nevertheless, latent toxoplasmosis can induce various alterations of sex hormones, especially testosterone, in infected humans and animals. On the other hand, testosterone is involved in behavioral traits and reproductive functions in both sexes. Hence, the purpose of this systematic review is to summarize the available evidence regarding the association between T. gondii infection and testosterone alteration.

METHODS: In the setting of a systematic review, an electronic search (any date to 10 January 2023) without language restrictions was performed using Science Direct, Web of Science, PubMed, Scopus, and Google Scholar. The PRISMA guidelines were followed. Following the initial search, a total of 12,306 titles and abstracts were screened initially; 12,281 were excluded due to the lack of eligibility criteria or duplication. Finally, 24 articles met the included criteria. A mean±standard deviation (SD) was calculated to assess the difference of testosterone between T. gondii positive and T. gondii negative humans. The possibility of publication bias was assessed using Egger’s regression. P-value < 0.05 was considered statistically significant.

RESULTS: This systematic review identified 24 articles (18 studies in humans and six studies in animals). Most human studies (13 out of 19) reported an increased level of testosterone following latent toxoplasmosis in males, while three studies reported decreased levels and two studies reported an insignificant change. Eleven articles (seven datasets in males and seven datasets in females) were eligible to be included in the data synthesis. Based on the random-effects model, the pooled mean± SD of testosterone in T. gondii positive than T. gondii negative was increased by 0.73 and 0.55 units in males and females, respectively. The Egger’s regression did not detect a statistically significant publication bias in males and females (p = value = 0.95 and 0.71), respectively. Three studies in male animals (rats, mice, and spotted hyenas) and two studies in female animals (mice and spotted hyenas) reported a decline in testosterone in infected compared with non-infected animals. While, one study in female rats reported no significant changes of testosterone in infected than non-infected animals. Moreover, two studies in male rats reported an increased level of testosterone in infected than non-infected animals.

CONCLUSIONS: This study provides new insights about the association between T. gondii infection and testosterone alteration and identifies relevant data gaps that can inform and encourage further studies. The consequence of increased testosterone levels following T. gondii infection could partly be associated with increased sexual behavior and sexual transmission of the parasite. On the other hand, declining testosterone levels following T. gondii infection may be associated with male reproductive impairments, which were observed in T. gondii-infected humans and animals. Furthermore, these findings suggest the great need for more epidemiological and experimental investigations in depth to understand the relationship between T. gondii infection and testosterone alteration alongside with future consequences of testosterone alteration.

PMID:38568993 | DOI:10.1371/journal.pone.0297362