Tag: pubmed

Ther Innov Regul Sci. 2024 Dec 17. doi: 10.1007/s43441-024-00720-8. Online ahead of print.

ABSTRACT

A data monitoring committee (DMC) can have an extremely challenging job. Stop a trial too soon, and results are inconclusive and the trial fails to obtain answers to important questions that could inform future clinical practice. Stop a trial too late, and trial participants are exposed to potentially harmful or ineffective interventions longer than necessary. Securing convincing and conclusive evidence and the ethical responsibility to current and future patients are weighed carefully during DMC deliberations. The ability to interpret complex information, and appreciation of issues affecting scientific integrity, are critical for the DMC to protect trial participants and public trust. Challenges faced by and issues of prudence faced by DMCs are discussed including interim analysis issues, assessing the totality of information with statistical boundaries as guidelines, interpretation of composite and surrogate outcomes, reactions to early trends, benefit:risk assessment, landscape changes, subgroup analyses, composing information for a comprehensive understanding of patient-centric effects, and evaluating the value of additional data. Case studies illustrate how DMCs addressed the challenges.

PMID:39688768 | DOI:10.1007/s43441-024-00720-8

J Math Biol. 2024 Dec 17;90(1):8. doi: 10.1007/s00285-024-02172-y.

ABSTRACT

We propose an integral model describing an epidemic of an infectious disease. The model is behavioural in the sense that the force of infection includes the information index that describes the opinion-driven human behavioural changes. The information index contains a memory kernel to mimic how the individuals maintain memory of the past values of the infection. We obtain sufficient conditions for the endemic equilibrium to be locally stable. In particular, we show that when the infectivity function is represented by an exponential distribution, stability is guaranteed by the weak Erlang memory kernel. However, through numerical simulations, we show that oscillations, possibly self-sustained, may arise when the memory is more focused in the disease’s past history, as exemplified by the strong Erlang kernel. We also show the model solutions in cases of different infectivity functions taken from studies where specific diseases like Influenza and SARS are considered.

PMID:39688746 | DOI:10.1007/s00285-024-02172-y

J Robot Surg. 2024 Dec 17;19(1):28. doi: 10.1007/s11701-024-02175-3.

ABSTRACT

The adoption of robot-assisted microsurgery (RAMS) is a cutting-edge advancement in the realm of microsurgery. The Symani Surgical System is CE approved and has recently gained FDA approval. It provides tremor elimination, motion scaling and improved ergonomics. This study reports on the first 100 consecutive cases of RAMS at a high-volume academic center, representing the largest series to date, and assesses its clinical application and efficacy. A prospective database captured all RAMS cases at a single institution between February 2023 and April 2024. Parameters recorded included patient demographics, surgical details, and outcomes. Surgeons completed a comprehensive 12 h training program to ensure adept use of the system. One-hundred patients with a mean age of 54 yrs were identified, predominantly male (66%). RAMS was performed in a wide range of procedures, notably free flaps (73%), nerve surgery (20%), and lymphovenous anastomoses (LVA) (6%). 159 anastomoses and coaptations were performed. Major complications occurred in 12 cases (12%). There were two complete free flap losses (2.7% of free flaps) and one partial free flap loss (1.4%). LVAs had significantly longer times per stitch than other types of anastomoses (p < 0.01). RAMS presents a viable alternative to traditional microsurgery with a commendable safety profile, marked by a 3% conversion rate to conventional techniques and complication rates that align with current literature. While challenges such as longer anastomosis times and higher costs exist, the results affirm the feasibility of RAMS in a high-volume microsurgical center.

PMID:39688744 | DOI:10.1007/s11701-024-02175-3

Eur Radiol. 2024 Dec;34(12):7645-7646. doi: 10.1007/s00330-024-11070-2. Epub 2024 Sep 13.

NO ABSTRACT

PMID:39688724 | DOI:10.1007/s00330-024-11070-2

Eur Radiol. 2024 Dec;34(12):7647-7649. doi: 10.1007/s00330-024-11071-1. Epub 2024 Sep 12.

NO ABSTRACT

PMID:39688723 | DOI:10.1007/s00330-024-11071-1

J Racial Ethn Health Disparities. 2024 Dec 17. doi: 10.1007/s40615-024-02248-x. Online ahead of print.

ABSTRACT

BACKGROUND: The burden of obesity falls disproportionately on some racial and ethnic minority groups.

OBJECTIVE: To assess for racial and ethnic differences in the utilization of obesity-management medications among clinically eligible individuals.

DESIGN: Medical Expenditure Panel Survey (2011-2016, 2018 and 2020) data and a cross-sectional study design was used to assess for racial and ethnic differences in obesity-management medication utilization. Descriptive statistics and multivariable logistic regression models were used to identify the association of race and ethnicity with obesity-management medication utilization. Adjusted models controlled for demographics, socioeconomic status, obesity class, diabetes status, number of chronic conditions, insurance status, and geographic region.

PARTICIPANTS: Adults with a BMI ≥ 30 kg/m² and individuals with a BMI ≥ 27 kg/m² with ≥ 1 weight-related condition.

MAIN MEASURES: The primary outcome measure was utilization of an FDA-approved medication for obesity-management during the study period. The primary independent predictor was race and ethnicity. Separate indicator variables were created for each racial and ethnic group (Non-Hispanic Asian, Non-Hispanic Black, Hispanic, and Non-Hispanic White (reference group)).

KEY RESULTS: In adjusted analyses, Asian (aOR, 0.36; 95% CI, 0.16 to 0.77; P < 0.01), Black (aOR, 0.51; 95% CI, 0.39 to 0.68; P < 0.001) and Hispanic individuals (aOR, 0.70; 95% CI, 0.49 to 0.98; P = 0.04) had significantly lower odds of utilizing obesity-management medications compared to White individuals.

CONCLUSIONS: The results of this study suggest that there are racial and ethnic disparities in the use of obesity-management medications.

PMID:39688718 | DOI:10.1007/s40615-024-02248-x

Brain Struct Funct. 2024 Dec 17;230(1):8. doi: 10.1007/s00429-024-02884-3.

ABSTRACT

To investigate the microstructural integrity, tract volume analysis, and functional connectivity (FC) alterations of the left uncinate fasciculus (UF) in patients with amyotrophic lateral sclerosis (ALS) compared to healthy controls (HCs). Fourteen limb-onset ALS patients were recruited at baseline and ten at follow-up, along with 14 HCs. All participants underwent 3D T1-weighted, diffusion tensor imaging and kurtosis imaging (DTI/DKI), and resting-state functional MRI (rs-fMRI) using a 3 Tesla scanner with 64-channel coils. Eight metrics of diffusion, rs-FC of the left UF, and graph theory analyses were extracted. Statistical group comparisons and correlation analysis for significant diffusion metrics were also conducted. Significantly lower radial kurtosis (RK), mean kurtosis (MK), and higher DTI diffusivity metrics were observed in the left UF of ALS patients than in HCs. RK and MK were correlated with various cognitive scores, particularly executive function and visuospatial ability. The volume of the left UF was positively correlated only with RK and MK at follow-up. While rs-FC analysis did not reveal group differences, a negative functional link between the left UF and cerebellum was observed in HCs but not in patients. Graph theory analysis suggested decreased connectivity in baseline patients and potential compensatory effects during the follow-up. Our study reveals microstructural abnormalities and potential network changes in left UF. DKI metrics, especially RK and MK, may be more sensitive biomarkers than DTI metrics, particularly longitudinally. Diffusion changes appear to precede volume and functional connectivity alterations, suggesting diffusion as a potential early biomarker.

PMID:39688717 | DOI:10.1007/s00429-024-02884-3

J Math Biol. 2024 Dec 17;90(1):7. doi: 10.1007/s00285-024-02173-x.

ABSTRACT

We propose a general framework for the study of the genealogy of neutral discrete-time populations. We remove the standard assumption of exchangeability of offspring distributions appearing in Cannings models, and replace it by a less restrictive condition of non-heritability of reproductive success. We provide a general criterion for the weak convergence of their genealogies to $\Xi$ -coalescents, and apply it to a simple parametrization of our scenario (which, under mild conditions, we also prove to essentially include the general case). We provide examples for such populations, including models with highly-asymmetric offspring distributions and populations undergoing random but recurrent bottlenecks. Finally we study the limit genealogy of a new exponential model which, as previously shown for related models and in spite of its built-in (fitness) inheritance mechanism, can be brought into our setting.

PMID:39688711 | DOI:10.1007/s00285-024-02173-x

Theor Appl Genet. 2024 Dec 17;138(1):9. doi: 10.1007/s00122-024-04798-4.

ABSTRACT

The dQTG.seq model was utilized to investigate the genetic underpinnings of phenotypic plasticity in soybean isoflavone content, leading to the identification of 100 marker sites associated with phenotypic plasticity, including 27 transcription factors. Overexpression of Glyma.18G091600 (GmERF7) hairy roots under low temperature, salt, and drought stress confirmed the regulatory role of GmERF7 in the phenotypic plasticity of soybean isoflavone content. Phenotypic plasticity is characteristic of organisms that undergo phenotypic changes in response to environmental fluctuations. This phenomenon is pivotal in evolutionary processes and the emergence of new traits. Isoflavones, significant secondary metabolites found in soybeans, have garnered considerable attention owing to their beneficial physiological effects on human health. The variation in isoflavone content among different soybean varieties is influenced by diverse environmental factors, thereby influencing the evaluation of high and low isoflavone varieties. In this study, we measured the phenotypic plasticity of isoflavone content in recombinant inbred lines Hefeng 25 and L-28 in three different environments over two years. Utilizing the dQTG.seq model, 100 statistically significant markers were identified, and 101 potential genes, including 27 transcription factors, were screened. Through qRT-PCR analysis, elevated expression levels of Glyma.18G091600, Glyma.09G196200, and Glyma.05G229500 were observed in various parts of soybean plants. Under low temperature, drought or salt stress conditions, the related enzymes involved in the isoflavone synthesis pathway were notably upregulated in Glyma.18G091600 (GmERF7) overexpressed hairy roots compared to wild-type controls, resulting to higher phenotypic plasticity values for DZ, GC, GT, and TI. These results suggest that GmERF7 influences the phenotypic plasticity of soybean isoflavone content, enhancing adaptation to adverse environments, while also promoting the synthesis and accumulation of soybean isoflavones.

PMID:39688708 | DOI:10.1007/s00122-024-04798-4

J Foot Ankle Res. 2024 Dec;17(4):e70021. doi: 10.1002/jfa2.70021.

ABSTRACT

BACKGROUND: The visual analogue scale (VAS) and the Foot Health Status Questionnaire (FHSQ) are patient-reported outcome measures that are frequently used to evaluate the management of plantar heel pain. This study aimed to re-calculate (i.e. revise) the minimal important differences (MIDs) of the VAS and the FHSQ when used for plantar heel pain to enhance the validity and precision of previous estimates.

METHODS: This study used an anchor-based method to calculate MIDs and incorporated best-practice analyses to ensure credibility of the estimates. Data from 369 participants previously recruited from the community into four randomised controlled trials that evaluated interventions for plantar heel pain were used. VAS and FHSQ data from these participants at baseline and follow-up were pooled to calculate the MIDs (95% confidence intervals). A 15-point global rating of change Likert scale was used at follow-up as the transition scale, which was anchored to baseline. For the VAS, MIDs for two distinct types of pain were calculated: average pain and first-step pain. For the FHSQ, MIDs for two domains were calculated: foot pain and foot function.

RESULTS: The revised MIDs for the 100 mm VAS were -8.5 mm (95% CI: -12.2 to -4.7) for average pain and -19.2 mm (95% CI: -24.7 to -13.8) for first-step pain, which represent improvements in pain. The MIDs for the FHSQ were 12.4 points (95% CI: 6.9 to 18.0) for foot pain and 6.4 points (95% CI: 0.9 to 11.9) for foot function, which represent improvements in foot health status.

CONCLUSIONS: The revised MIDs from this study for the VAS and the FHSQ when used for plantar heel pain have enhanced validity and precision compared to previous estimates. This is important for clinicians and researchers as it provides a better understanding of how much improvement is required by an individual before an important change is experienced. The revised MIDs will also assist researchers with prospective sample size calculations, so future clinical trials are appropriately powered from a statistical standpoint.

PMID:39682003 | DOI:10.1002/jfa2.70021