Tag: statistics

Health Econ. 2023 Dec 26. doi: 10.1002/hec.4791. Online ahead of print.

ABSTRACT

The cost effectiveness of medical treatments is not precisely known due to the compounding effect of multiple determining factors. Ambulance response time (RT) to emergency calls is exploited to learn more about the effect of the timing of treatment on health outcomes. This causal relation is identified by exploiting rainfall at the time of the ambulance run as a shock to RT. The analysis focuses on patients who have undergone a cardiac event and shows that a one-minute increase in average RT leads to 105 more deaths each year in one Italian region. Finally, the economic value of the lives that would be saved by reducing RT is quantified to facilitate policymaking.

PMID:38148482 | DOI:10.1002/hec.4791

Ther Innov Regul Sci. 2023 Dec 26. doi: 10.1007/s43441-023-00598-y. Online ahead of print.

ABSTRACT

BACKGROUND: In 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use updated its efficacy guideline for good clinical practice and introduced predefined quality tolerance limits (QTLs) as a quality control in clinical trials. QTLs are complementary to Quality by Design (QbD) principles (ICH-E8) and are one of the components of the risk-based clinical trial quality management system.

METHODS: Currently the framework for QTLs process is well established, extensively describing the operational aspects of Defining, Monitoring and Reporting, but a single source of commonly used methods to establish QTLs and secondary limits is lacking. This paper will primarily focus on closing this gap and include applications of statistical process control and Bayesian methods on commonly used study level quality parameters such as premature treatment discontinuation, study discontinuation and significant protocol deviations as examples.

CONCLUSIONS: Application of quality tolerance limits to parameters that correspond to critical to quality factors help identify systematic errors. Some situations pose special challenges to implementing QTLs and not all methods are optimal in every scenario. Early warning signals, in addition to QTL, are necessary to trigger actions to further minimize the possibility of an end-of-study excursion.

PMID:38148473 | DOI:10.1007/s43441-023-00598-y

Odontology. 2023 Dec 26. doi: 10.1007/s10266-023-00875-0. Online ahead of print.

ABSTRACT

AIM: To evaluate the bleaching efficacy and effects on enamel properties of experimental gels with carbamide peroxide (CP; 10%) or hydrogen peroxide (HP; 6%) containing calcium polyphosphate sub-microparticles (CaPPs).

METHODS: A total of 216 bovine tooth specimens were divided for microhardness and color analyses (n = 108) and block randomized into nine groups (n = 12): (G1) commercial CP (Whiteness Perfect, FGM; Brazil); (G2) experimental CP; (G3) CP-0.5%CaPPs; (G4) CP-1.5%CaPPs; (G5) commercial HP (Potenza Bianco, PHS; Brazil); (G6) experimental HP; (G7) HP-0.5%CaPPs; (G8) HP-1.5%CaPPs; (G9) artificial saliva. The gels’ pH values were determined with a bench pH meter. Color (ΔE, ΔE₀₀, ΔWI_D) and microhardness variation were evaluated before and after the therapy. Part of the specimens used for microhardness was submitted to the scanning electron microscopy (SEM) (n = 3) and energy-dispersive X-ray spectroscopy EDX (n = 3) analyses. Statistical analyses were performed in the R statistical software (α = 0.05). Linear mixed models for repeated measures in time were used to analyze microhardness and L* values. Generalized linear models were used to analyze the a*, b*, ΔE, ΔE₀₀, and ΔWI_D, considering a group effect. The EDX data were analyzed using a one-way ANOVA with Tukey’s test.

RESULTS: The gels’ pH remained over 6,0. All gels effectively bleached the specimens and did not differ significantly. When compared to the control group, the hardness was significantly lower in the G1, G2, G6, and G7 groups. The G3, G4, G5, and G8 groups did not differ significantly (p > 0.05).

CONCLUSION: The incorporation of CaPPs in low-concentration whitening gels reduces its negative effects on microhardness without interfering with their bleaching efficacy.

PMID:38148447 | DOI:10.1007/s10266-023-00875-0

Behav Res Methods. 2023 Dec 26. doi: 10.3758/s13428-023-02242-x. Online ahead of print.

ABSTRACT

Semantic feature production norms have several desirable characteristics that have supported models of representation and processing in adults. However, several key challenges have limited the use of semantic feature norms in studies of early language acquisition. First, existing norms provide uneven and inconsistent coverage of early-acquired concepts that are typically produced and assessed in children under the age of three, which is a time of tremendous growth of early vocabulary skills. Second, it is difficult to assess the degree to which young children may be familiar with normed features derived from these adult-generated datasets. Third, it has been difficult to adopt standard methods to generate semantic network models of early noun learning. Here, we introduce Feats-a tool that was designed to make headway on these challenges by providing a database, the Language Learning and Meaning Acquisition (LLaMA) lab Noun Norms that extends a widely used set of feature norms McRae et al. Behavior Research Methods 37, 547-559, (2005) to include full coverage of noun concepts on a commonly used early vocabulary assessment. Feats includes several tools to facilitate exploration of features comprising early-acquired nouns, assess the developmental appropriateness of individual features using toddler-accessibility norms, and extract semantic network statistics for individual vocabulary profiles. We provide a tutorial overview of Feats. We additionally validate our approach by presenting an analysis of an overlapping set of concepts collected across prior and new data collection methods. Furthermore, using network graph analyses, we show that the extended set of norms provides novel, reliable results given their enhanced coverage.

PMID:38148439 | DOI:10.3758/s13428-023-02242-x

Hernia. 2023 Dec 26. doi: 10.1007/s10029-023-02925-6. Online ahead of print.

ABSTRACT

PURPOSE: As the global population continues to age, there is a noticeable yearly rise in the incidence of hernias. Simultaneously, smoking, a widespread addictive behavior and a significant contributor to mortality, has evolved into a pervasive public health concern. Existing literature has already established a connection between smoking and an increased risk of postoperative recurrence and postoperative infections following hernia surgery. However, there remains a dearth of research exploring the association between smoking and hernia morbidity. In this study, our objective is to systematically evaluate the causal relationship between cigarette smoking behaviors and hernia morbidity using a Mendelian randomization (MR) approach.

METHODS: Hernia-related data were sourced from the FinnGen Biobank database, while cigarette smoking behavior data were gathered from the GWAS and Sequencing Consortium of Alcohol and Nicotine Use. To assess the causal relationship, we employed five methods: the weighted median, the weighted mode the inverse variance weighted (IVW), MR-Egger, and the simple mode. Sensitivity analysis was conducted, incorporating Cochran’s Q test, the MR-Egger intercept test, leave-one-out analysis, and funnel plot. The presentation of the causal relationship is expressed as an odds ratio (OR) along with their corresponding 95% confidence intervals (CI).

RESULTS: Employing the IVW method as the reference standard, we found that smoking intensity is associated with an increased risk of diaphragmatic hernia (OR = 1.21, 95% CI 1.00-1.46, P = 0.047). These consistent findings were further corroborated by the weighted median and weighted mode methods (OR = 1.26, 95% CI 1.03-1.54, P = 0.026; OR = 1.25, 95% CI 1.02-1.52, P = 0.045). Conversely, when applying the IVW method, we identified no statistically significant causal relationship between smoking age, smoking initiation status, smoking cessation status, and the incidence of hernia.

CONCLUSIONS: Our MR study has uncovered genetic evidence linking smoking intensity and the occurrence of diaphragmatic hernia. The risk of developing diaphragmatic hernia rises in tandem with the intensity of smoking. This emphasizes the crucial role of regularly advising patients to cease smoking in clinical settings.

PMID:38148419 | DOI:10.1007/s10029-023-02925-6

Med Biol Eng Comput. 2023 Dec 27. doi: 10.1007/s11517-023-02989-7. Online ahead of print.

ABSTRACT

Thermography, as a harmless modality, thanks to its low equipment complexity in parallel with quick and cheap access, has been able to come up as a method with significant potential in the diagnosis of some cancers in recent years. However, the complexity of the images resulting from this method has caused the use of deep learning to interpret thermograms. A limiting factor in this process is the strong dependence of deep learning methods on the number of training data, which is a serious challenge in thermography due to the young age of this technology and the lack of available images. In this paper, an attempt is made to reduce the above challenge by utilizing the concept of statistical learning in such a way that the statistical distribution of the original data is estimated by using generative adversarial networks (i.e., GAN). Then, several fake images are reconstructed based on the estimated distribution in order to increase the training thermograms. Since the fake images are reconstructed based on similar statistics of real thermograms in each class, the effective features of each class are preserved to a significant extent in the reconstruction process. The use of this method indicates a significant improvement in the separation of healthy and cancerous thermograms compared to the benchmark method which does not use the concept of GAN in such a way that characteristics of sensitivity and accuracy are improved in ranges of 3-9% and 3-7%, respectively. In terms of specificity, although we have seen an improvement of up to 9%, in some cases, small drops of up to 2% have also been observed, which can still be justified due to the significant improvement in sensitivity and accuracy.

PMID:38148414 | DOI:10.1007/s11517-023-02989-7

Int J Stroke. 2023 Dec 26:17474930231225568. doi: 10.1177/17474930231225568. Online ahead of print.

ABSTRACT

BACKGROUND.: In stroke patients with insulin resistance (IR), post-stroke cognitive impairment (PSCI) is associated with higher risk of recurrent stroke, but the effect of pioglitazone on that risk has not been explored. The goal of this study was to compare the secondary stroke prevention effect of pioglitazone against placebo in patients with versus without PSCI.

METHODS.: We studied patients enrolled in the Insulin Resistance Intervention after Stroke (IRIS) trial with a post-stroke Modified Mini-Mental State Examination (3MS) cognitive assessment (mean time of assessment: 79 days post-stroke). We considered a baseline score of ≤ 88 on the 3MS to indicate global PSCI, and domain-specific summary scores in the lowest quartile to indicate attention, language, memory, orientation, and visuospatial impairments.

RESULTS.: In n=3338 patients with IR, the effect of pioglitazone vs. placebo on secondary stroke significantly differed by initial post-stroke global (interaction p = 0.0127) and memory impairment status (interaction p = 0.0003). Hazard ratios (HRs) were time-dependent such that, among those with either global or memory impairment, pioglitazone has an increasingly stronger protective effect at later timepoints. There was no statistically significant effect of pioglitazone among those without either global or memory impairment. The effect of pioglitazone vs. placebo on myocardial infarction (MI) also significantly differed by global impairment status (interaction p = 0.030). Pioglitazone was protective among those with global impairment (HR = 0.23; 95% CI: 0.08, 0.71)) but not among those without (HR = 0.88; 95% CI: 0.59, 1.31).

CONCLUSIONS.: These data indicate that pioglitazone treatment may be more effective at reducing risk of recurrent stroke and MI in stroke patients with PSCI. Simple cognitive testing 2 to 3 months post-stroke may identify patients for whom treatment would be most beneficial.

PMID:38148372 | DOI:10.1177/17474930231225568

J Expo Sci Environ Epidemiol. 2023 Dec 26. doi: 10.1038/s41370-023-00636-9. Online ahead of print.

ABSTRACT

BACKGROUND: Residential mobility can introduce exposure misclassification in pediatric epidemiology studies using birth address only.

OBJECTIVE: We examined whether residential mobility varies by sociodemographic factors and urbanicity/rurality among children with cancer.

METHODS: Our study included 400 children born in Pennsylvania during 2002-2015 and diagnosed with leukemia at ages 2-7 years. Addresses were obtained from state registries at birth and diagnosis. We considered three aspects of mobility between birth and diagnosis: whether a child moved, whether a mover changed census tract, and distance moved. We evaluated predictors of these aspects in urban- and rural-born children using chi-square, t-tests, and regression analyses.

RESULTS: Overall, 58% of children moved between birth and diagnosis; suburban/rural-born children were more likely to move than urban-born children (67% versus 57%). The mean distance moved was 16.7 km in suburban/rural-born and 14.8 km in urban-born movers. In urban-born children, moving between birth and diagnosis was associated with race, education, participation in the Nutrition Program for Women, Infants and Children (WIC), and census tract-level income (all χ² p < 0.01). Urban-born movers tended to be born in a census tract with a higher Social Vulnerability Index than non-movers (t-test p < 0.01). No factors were statistically significantly associated with any of the residential mobility metrics in suburban/rural-born children, although the sample size was small.

IMPACT STATEMENT: In this study of a vulnerable population of children with cancer, we found that rural-born children were more likely to move than urban-born children, however, the frequency of movers changing census tracts was equivalent. Mobility in urban-born children, but not rural-born, was associated with several social factors, although the sample size for rural-born children was small. Mobility could be an important source of misclassification depending on the spatial heterogeneity and resolution of the exposure data and whether the social factors are related to exposures or health outcomes. Our results highlight the importance of considering differences in mobility between urban and rural populations in spatial research.

PMID:38148338 | DOI:10.1038/s41370-023-00636-9

Nat Commun. 2023 Dec 26;14(1):8504. doi: 10.1038/s41467-023-43967-9.

ABSTRACT

Forward genetic screens of mutated variants are a versatile strategy for protein engineering and investigation, which has been successfully applied to various studies like directed evolution (DE) and deep mutational scanning (DMS). While next-generation sequencing can track millions of variants during the screening rounds, the vast and noisy nature of the sequencing data impedes the estimation of the performance of individual variants. Here, we propose ACIDES that combines statistical inference and in-silico simulations to improve performance estimation in the library selection process by attributing accurate statistical scores to individual variants. We tested ACIDES first on a random-peptide-insertion experiment and then on multiple public datasets from DE and DMS studies. ACIDES allows experimentalists to reliably estimate variant performance on the fly and can aid protein engineering and research pipelines in a range of applications, including gene therapy.

PMID:38148337 | DOI:10.1038/s41467-023-43967-9

J Obstet Gynaecol Res. 2023 Dec 26. doi: 10.1111/jog.15869. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to determine the effect of progressive relaxation exercises (PRE) and transcutaneous electrical nerve stimulation administered to women delivering via cesarean delivery on acute pain, breastfeeding success, and comfort levels.

METHODS: This is a single-blind, randomized controlled study. This study was carried out in the obstetrics and gynecology clinic of a university hospital affiliated with the Ministry of Health in Turkey between August 20, 2018 and April 15, 2019. A total of 120 participants were randomly assigned to one of four groups, which included a transcutaneous electrical neural stimulation (TENS) group, a PRE group, a combined intervention group, and a control group. Data were collected with a Data Collection Form, The Visual Analogue Scale, The LATCH Breastfeeding Diagnostic Tool, and The Postpartum Comfort Scale.

RESULTS: According to the findings of the study, it was determined that pain significantly decreased and comfort increased after having a cesarean delivery in all three intervention groups compared to the control group (p < 0.05). Regarding the breastfeeding success, while there was no statistically significant change in this behavior in the TENS group, it was significantly better in the PRE group and the combined intervention group, where TENS and PRE were administered together (p < 0.05).

CONCLUSIONS: According to our study results, we recommend that TENS and PRE should be employed together after a cesarean delivery as safe non-pharmacological methods in pain management, eliminating breastfeeding problems, and increasing comfort.

PMID:38148300 | DOI:10.1111/jog.15869