Tag: nevin manimala

Mult Scler. 2023 Dec 23:13524585231216004. doi: 10.1177/13524585231216004. Online ahead of print.

ABSTRACT

BACKGROUND: As of September 2022, there was no globally recommended set of core data elements for use in multiple sclerosis (MS) healthcare and research. As a result, data harmonisation across observational data sources and scientific collaboration is limited.

OBJECTIVES: To define and agree upon a core dataset for real-world data (RWD) in MS from observational registries and cohorts.

METHODS: A three-phase process approach was conducted combining a landscaping exercise with dedicated discussions within a global multi-stakeholder task force consisting of 20 experts in the field of MS and its RWD to define the Core Dataset.

RESULTS: A core dataset for MS consisting of 44 variables in eight categories was translated into a data dictionary that has been published and disseminated for emerging and existing registries and cohorts to use. Categories include variables on demographics and comorbidities (patient-specific data), disease history, disease status, relapses, magnetic resonance imaging (MRI) and treatment data (disease-specific data).

CONCLUSION: The MS Data Alliance Core Dataset guides emerging registries in their dataset definitions and speeds up and supports harmonisation across registries and initiatives. The straight-forward, time-efficient process using a dedicated global multi-stakeholder task force has proven to be effective to define a concise core dataset.

PMID:38140852 | DOI:10.1177/13524585231216004

Acta Obstet Gynecol Scand. 2023 Dec 23. doi: 10.1111/aogs.14757. Online ahead of print.

ABSTRACT

INTRODUCTION: Obstetric care is a highly active area in the development and application of prognostic prediction models. The development and validation of these models often require the utilization of advanced statistical techniques. However, failure to adhere to rigorous methodological standards could greatly undermine the reliability and trustworthiness of the resultant models. Consequently, the aim of our study was to examine the current statistical practices employed in obstetric care and offer recommendations to enhance the utilization of statistical methods in the development of prognostic prediction models.

MATERIAL AND METHODS: We conducted a cross-sectional survey using a sample of studies developing or validating prognostic prediction models for obstetric care published in a 10-year span (2011-2020). A structured questionnaire was developed to investigate the statistical issues in five domains, including model derivation (predictor selection and algorithm development), model validation (internal and external), model performance, model presentation, and risk threshold setting. On the ground of survey results and existing guidelines, a list of recommendations for statistical methods in prognostic models was developed.

RESULTS: A total of 112 eligible studies were included, with 107 reporting model development and five exclusively reporting external validation. During model development, 58.9% of the studies did not include any form of validation. Of these, 46.4% used stepwise regression in a crude manner for predictor selection, while two-thirds made decisions on retaining or dropping candidate predictors solely based on p-values. Additionally, 26.2% transformed continuous predictors into categorical variables, and 80.4% did not consider nonlinear relationships between predictors and outcomes. Surprisingly, 94.4% of the studies did not examine the correlation between predictors. Moreover, 47.1% of the studies did not compare population characteristics between the development and external validation datasets, and only one-fifth evaluated both discrimination and calibration. Furthermore, 53.6% of the studies did not clearly present the model, and less than half established a risk threshold to define risk categories. In light of these findings, 10 recommendations were formulated to promote the appropriate use of statistical methods.

CONCLUSIONS: The use of statistical methods is not yet optimal. Ten recommendations were offered to assist the statistical methods of prognostic prediction models in obstetric care.

PMID:38140844 | DOI:10.1111/aogs.14757

Acta Paediatr. 2023 Dec 23. doi: 10.1111/apa.17075. Online ahead of print.

ABSTRACT

AIM: We examined the outcomes of using inhaled nitric oxide (iNO) to treat very preterm born (VPT) infants across Europe.

METHODS: This was a sub-study of the Screening to Improve Health in Very Preterm Infants in Europe research. It focused on all infants born between 22 + 0 and 31 + 6 weeks/days of gestation from 2011 to 2012, in 19 regions in 11 European countries. We studied 7268 infants admitted to neonatal care and 5 years later, we followed up the outcomes of 103 who had received iNO treatment. They were compared with 3502 propensity score-matched controls of the same age who did not receive treatment.

RESULTS: All countries used iNO and 292/7268 (4.0%) infants received this treatment, ranging from 1.2% in the UK to 10.5% in France. There were also large regional variations within some countries. Infants treated with iNO faced higher in-hospital mortality than matched controls (odds ratio 2.03, 95% confidence interval 1.33-3.09). The 5-year follow-up analysis of 103 survivors showed no increased risk of neurodevelopmental impairment after iNO treatment.

CONCLUSION: iNO was used for VPT patients in all 11 countries. In-hospital mortality was increased in infants treated with iNO, but long-term neurodevelopmental outcomes were not affected in 103 5-year-old survivors.

PMID:38140833 | DOI:10.1111/apa.17075

Integr Cancer Ther. 2023 Jan-Dec;22:15347354231220608. doi: 10.1177/15347354231220608.

ABSTRACT

OBJECTIVE: evaluate the efficacy of Zingiber Officinale in the management of nausea and vomiting induced by treatment with cisplatin associated with radiotherapy in patients with uterine cervical neoplasms.

METHODS: a triple-blind, randomized, placebo-controlled trial. Interventions: Comparing the effects of ginger with institutional antiemetic therapy (ondansetron with dexamethasone). Patients with cervical cancer who started treatment with cisplatin with an indication of 40 mg/m² associated with radiotherapy, aged over 18 years, and with the ability to tolerate swallowing a capsule were recruited and equally allocated (1:1:1) into 3 groups of 16 patients each (the ginger capsules 250 mg group, ginger capsules 500 mg group, and placebo group). Nausea and vomiting were measured on baseline, 7 days after the first dose of medication and every seven consecutive days during a treatment break.

RESULTS: The 250 mg ginger group had an 8.0% greater chance of experiencing nausea within 24 h after the chemotherapy infusion than the placebo group, although there is no statistical significance (P = .92986). The 500 mg ginger group showed a 63.9% reduction in nausea under the same conditions (P = .40460). No change was detected in the occurrence of nausea episodes during the 6 weeks (P = .8664) or between the groups (P = .2817). No change was detected in acute or late vomiting during the 6 weeks (P = .3510) or between the groups (P = .8500 and P = .5389, respectively).

CONCLUSION: Ginger supplementation does not reduce the intensity of acute and late nausea and vomiting. REBEC (RBR-47yx6p9).

PMID:38140826 | DOI:10.1177/15347354231220608

Phys Rev Lett. 2023 Dec 8;131(23):233601. doi: 10.1103/PhysRevLett.131.233601.

ABSTRACT

The Hong-Ou-Mandel (HOM) effect is crucial for quantum information processing, and its visibility determines the system’s quantum-classical characteristics. In an experimental and theoretical study of the spectral HOM effect between a thermal field and a heralded single-photon state, we demonstrate that the HOM visibility varies dependent on the relative photon statistics of the interacting fields. Our findings reveal that multiphoton components in a heralded state get engaged in quantum interference with a thermal field, resulting in improved visibilities at certain mean photon numbers. We derive a theoretical relationship for the HOM visibility as a function of the mean photon number of the thermal field and the thermal part of the heralded state. We show that the nonclassicality degree of a heralded state is reflected in its HOM visibility with a thermal field; our results establish a lower bound of 41.42% for the peak visibility, indicating the minimum assignable degree of nonclassicality to the heralded state. This research enhances our understanding of the HOM effect and its application to high-speed remote secret key sharing, addressing security concerns due to multiphoton contamination in heralded states.

PMID:38134802 | DOI:10.1103/PhysRevLett.131.233601

Phys Rev Lett. 2023 Dec 8;131(23):231801. doi: 10.1103/PhysRevLett.131.231801.

ABSTRACT

Extending the Higgs sector of the standard model (SM) by just one additional Higgs doublet field leads to the two-Higgs-doublet model (2HDM). In the type-I Z_{2}-symmetric limit of the 2HDM, all the five new physical Higgs states can be fairly light, O(100) GeV or less, without being in conflict with current data from the direct Higgs boson searches and the B-physics measurements. In this Letter, we establish that the new neutral as well as the charged Higgs bosons in this model can all be simultaneously observable in the multi-b final state. The statistical significance of the signature for each of these Higgs states, resulting from the electroweak (EW) production of their pairs, can exceed 5σ at the 13 TeV high-luminosity Large Hadron collider (HL-LHC). Since the parameter space configurations where this is achievable are precluded in the other, more extensively pursued, 2HDM types, an experimental validation of our findings would be a clear indication that the true underlying Higgs sector in nature is the type-I 2HDM.

PMID:38134801 | DOI:10.1103/PhysRevLett.131.231801

Phys Rev Lett. 2023 Dec 8;131(23):237101. doi: 10.1103/PhysRevLett.131.237101.

ABSTRACT

We derive general bounds on the probability that the empirical first-passage time τ[over ¯]_{n}≡∑_{i=1}^{n}τ_{i}/n of a reversible ergodic Markov process inferred from a sample of n independent realizations deviates from the true mean first-passage time by more than any given amount in either direction. We construct nonasymptotic confidence intervals that hold in the elusive small-sample regime and thus fill the gap between asymptotic methods and the Bayesian approach that is known to be sensitive to prior belief and tends to underestimate uncertainty in the small-sample setting. We prove sharp bounds on extreme first-passage times that control uncertainty even in cases where the mean alone does not sufficiently characterize the statistics. Our concentration-of-measure-based results allow for model-free error control and reliable error estimation in kinetic inference, and are thus important for the analysis of experimental and simulation data in the presence of limited sampling.

PMID:38134782 | DOI:10.1103/PhysRevLett.131.237101

Gynecol Oncol. 2023 Dec 21;181:54-59. doi: 10.1016/j.ygyno.2023.12.009. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine clinical significance of preoperative and pre-chemotherapy CA-125 in high-risk early-stage epithelial ovarian cancer patients.

METHODS: All patients with stage IA/IB and grade 3, stage IC, clear cell, or completed resected stage II cancer were enrolled in a phase III trial and treated with chemotherapy. Kaplan-Meier method and Cox proportional hazards model were used for statistical analyses.

RESULTS: 427 patients with high-risk early-stage ovarian cancer were enrolled. Of 213 patients with preoperative CA-125 data, 79% had elevated CA-125. Median preoperative CA-125 level was 103 U/mL. Patients with ≤10, 11-15, and > 15 cm tumors had median preoperative CA-125 levels of 62, 131 and 158 U/mL, respectively (p = 0.002). For the 350 patients with data for pre-chemotherapy CA-125 level, 69% had elevated pre-chemotherapy CA-125 above 35 U/mL with median value of 65 U/mL. However, age, race, stage, cell type and grade of disease were not correlated with CA-125 levels before and after surgery. On multivariate analysis, elevated pre-chemotherapy CA-125 independently predicted worse recurrence-free survival (HR = 2.13, 95% CI: 1.23-3.69; p = 0.007) and overall survival (HR = 1.99, 95% CI: 1.10-3.59; p = 0.022) after adjusting for age, stage, cell type and grade of disease. Compared to those with normal CA-125, patients with elevated pre-chemotherapy CA-125 had lower recurrence-free survival (RFS, 87% vs. 75%; p = 0.007) and overall survival (OS, 88% vs. 82%; p = 0.02). However, preoperative CA-125 was not prognostic of RFS (p = 0.699) or OS (p = 0.701).

CONCLUSIONS: Preoperative CA-125 was elevated in nearly 80% of high-risk early-stage ovarian cancer patients. Pre-chemotherapy CA-125 was associated with recurrence-free and overall survival; however, preoperative CA-125 was not prognostic.

PMID:38134754 | DOI:10.1016/j.ygyno.2023.12.009

Neuroimage Clin. 2023 Dec 15;41:103553. doi: 10.1016/j.nicl.2023.103553. Online ahead of print.

ABSTRACT

BACKGROUND: Social anhedonia is common within major depressive disorder (MDD) and associated with worse treatment outcomes. The orbitofrontal cortex (OFC) is implicated in both reward (medial OFC) and punishment (lateral OFC) in social decision making. Therefore, to understand the biology of social anhedonia in MDD, medial/lateral OFC metabolism, volume, and thickness, as well as structural connectivity to the striatum, amygdala, and ventral tegmental area/nucleus accumbens were examined. A positive relationship between social anhedonia and these neurobiological outcomes in the lateral OFC was hypothesized, whereas an inverse relationship was hypothesized for the medial OFC. The association between treatment-induced changes in OFC neurobiology and depression improvement were also examined.

METHODS: 85 medication-free participants diagnosed with MDD were assessed with Wisconsin Schizotypy Scales to assess social anhedonia and received pretreatment simultaneous fluorodeoxyglucose positron emission tomography (FDG-PET) and magnetic resonance imaging (MRI), including structural and diffusion. Participants were then treated in an 8-week randomized placebo-controlled double-blind course of escitalopram. PET/MRI were repeated following treatment. Metabolic rate of glucose uptake was quantified from dynamic FDG-PET frames using Patlak graphical analysis. Structure (volume and cortical thickness) was quantified from structural MRI using Freesurfer. To assess structural connectivity, probabilistic tractography was performed on diffusion MRI and average FA was calculated within the derived tracts. Linear mixed models with Bonferroni correction were used to examine the relationships between variables.

RESULTS: A significantly negative linear relationship between pretreatment social anhedonia score and structural connectivity between the medial OFC and the amygdala (estimated coefficient: -0.006, 95 % CI: -0.0108 – -0.0012, p-value = 0.0154) was observed. However, this finding would not survive multiple comparisons correction. No strong evidence existed to show a significant linear relationship between pretreatment social anhedonia score and metabolism, volume, thickness, or structural connectivity to any of the regions examined. There was also no strong evidence to suggest significant linear relationships between improvement in depression and percent change in these variables.

CONCLUSIONS: Based on these multimodal findings, the OFC likely does not underlie social anhedonia in isolation and therefore should not be the sole target of treatment for social anhedonia. This is consistent with previous reports that other areas of the brain such as the amygdala and the striatum are highly involved in this behavior. Relatedly, amygdala-medial OFC structural connectivity could be a future target. The results of this study are crucial as, to our knowledge, they are the first to relate structure/function of the OFC with social anhedonia severity in MDD. Future work may need to involve a whole brain approach in order to develop therapeutics for social anhedonia.

PMID:38134743 | DOI:10.1016/j.nicl.2023.103553

Best Pract Res Clin Obstet Gynaecol. 2023 Dec 10;92:102434. doi: 10.1016/j.bpobgyn.2023.102434. Online ahead of print.

ABSTRACT

Laparoscopy and robotics are recommended for managing gynecological cancer, as they are associated with lower morbidity and comparable outcomes to open surgery. However, in the case of early cervical cancer, new evidence suggests worse oncological outcomes with these approaches compared to open surgery, though the limited number of robotic cases makes it challenging to draw definitive conclusions for this particular approach. The prior conization has been proposed as a strategy to reduce the risk of tumor spillage and contamination during minimally invasive (MIS) radical hysterectomy (RH). Retrospective studies have indicated that undergoing conization before RH is linked to a reduced risk of recurrences, especially in cervical tumors measuring less than 2 cm. Nevertheless, these studies lack the statistical power needed to definitively establish conization as a recommended step before RH. Furthermore, these studies do not have enough cases utilizing the robotic approach and specific conclusions cannot be drawn from this technique. The question of whether a subset of cases would benefit from preoperative conization and whether conization should be performed to recommend MIS over open surgery remains unanswered. Prospective clinical trials involving women diagnosed with early-stage cervical cancer <2 cm, randomized between undergoing conization before robotic RH or without prior conization are mandatory to assess the role of conization before robotic RH in cervical cancer.

PMID:38134716 | DOI:10.1016/j.bpobgyn.2023.102434