Category: Nevin Manimala

AAPS PharmSciTech. 2023 Dec 7;24(8):254. doi: 10.1208/s12249-023-02697-3.

ABSTRACT

Data variations, library changes, and poorly tuned hyperparameters can cause failures in data-driven modelling. In such scenarios, model drift, a gradual shift in model performance, can lead to inaccurate predictions. Monitoring and mitigating drift are vital to maintain model effectiveness. USFDA and ICH regulate pharmaceutical variation with scientific risk-based approaches. In this study, the hyperparameter optimization for the Artificial Neural Network Multilayer Perceptron (ANN-MLP) was investigated using open-source data. The design of experiments (DoE) approach in combination with target drift prediction and statistical process control (SPC) was employed to achieve this objective. First, pre-screening and optimization DoEs were conducted on lab-scale data, serving as internal validation data, to identify the design space and control space. The regression performance metrics were carefully monitored to ensure the right set of hyperparameters was selected, optimizing the modelling time and storage requirements. Before extending the analysis to external validation data, a drift analysis on the target variable was performed. This aimed to determine if the external data fell within the studied range or required retraining of the model. Although a drift was observed, the external data remained well within the range of the internal validation data. Subsequently, trend analysis and process monitoring for the mean absolute error of the active content were conducted. The combined use of DoE, drift analysis, and SPC enabled trend analysis, ensuring that both current and external validation data met acceptance criteria. Out-of-specification and process control limits were determined, providing valuable insights into the model’s performance and overall reliability. This comprehensive approach allowed for robust hyperparameter optimization and effective management of model lifecycle, crucial in achieving accurate and dependable predictions in various real-world applications.

PMID:38062329 | DOI:10.1208/s12249-023-02697-3

Brain Topogr. 2023 Dec 7. doi: 10.1007/s10548-023-01020-4. Online ahead of print.

ABSTRACT

Cognitive reappraisal (CR) is a mechanism for emotion regulation, and the prefrontal cortex (PFC) plays a central role in the regulation of emotions. We tested the hypothesis of an association between CR function and microstructural properties of forceps minor (a commissural bundle within the PFC) in healthy subjects (HS). We analyzed a population of 65 young HS of a public dataset. The diffusion tensor imaging (DTI) sequence of every subject was analyzed to extract the derived shape (diameter and volume) and DTI metrics in terms of fractional anisotropy (FA), mean diffusivity (MD), radial diffusivity (RD), and axial diffusivity (AD) of the forceps minor. The CR subscale of the German version of the Emotion Regulation Questionnaire (ERQ) was used for CR assessment. The Shapiro-Wilk test was applied to test the assumption of normality in all these parameters, adopting a statistical threshold at p < 0.05. Whenever appropriate a non-parametric two-tailed partial correlation analysis was applied to test for correlations between the CR ERQ score and the derived shape and DTI metrics, including age and sex as confounders, adopting a statistical threshold at p < 0.05. The non-parametric two-tailed partial correlation analysis revealed a mildly significant correlation with FA (ρ = 0.303; p = 0.016), a weakly significant negative correlation with MD (ρ = – 0.269; p = 0.033), and a mildly significant negative correlation with RD (ρ = – 0.305; p = 0.015). These findings suggest a correlation between DTI microstructural properties of forceps minor and CR.

PMID:38062326 | DOI:10.1007/s10548-023-01020-4

J Gastrointest Surg. 2023 Dec 7. doi: 10.1007/s11605-022-05539-y. Online ahead of print.

ABSTRACT

BACKGROUND: Sphincter of Oddi dysfunction (SOD) is managed primarily by endoscopic sphincterotomy (ES); however, surgical transduodenal sphincteroplasty (TDS) is a treatment option for select patients. In our high-volume pancreatico-biliary practice, we have observed variable outcomes among TDS patients; therefore, we sought to determine preoperative predictors of durable improvement in quality of life.

METHODS: SOD patients treated by TDS between January 2006 and December 2015 were studied. The primary outcome measure was long-term changes in quality of life after sphincteroplasty. The secondary outcome measure examined postoperative outcomes, including postoperative complications, need for repeat procedures, and readmission rates. Perioperative data were abstracted, and the SF-36 quality-of-life (QoL) survey was administered. Standard statistical analysis included non-parametric methods to examine bivariate associations.

RESULTS: Eighty-eight patients had an average follow-up duration of 6.7 (± 2.9) years. Thirty (34%) patients were naïve to endoscopic therapy. Patients with prior endoscopy averaged 2.1 procedures (range 1 to 13) prior to surgery. Perioperative morbidity was 27%; one postoperative death was caused by severe acute pancreatitis. Twenty-nine (33%) patients required subsequent biliary-pancreatic procedures. QoL analysis from available patients showed that 66% were improved or much improved. With multivariable analysis including SOD type and prior endoscopic instrumentation, freedom from surgical complication was the only variable that correlated significantly with a good outcome (p < 0.02).

CONCLUSION: Surgical transduodenal sphincteroplasty provides durable symptom management for select patients with sphincter of Oddi dysfunction. Minimizing surgical complications optimizes long-term outcomes.

PMID:38062321 | DOI:10.1007/s11605-022-05539-y

Neurosurg Rev. 2023 Dec 8;47(1):5. doi: 10.1007/s10143-023-02239-2.

ABSTRACT

While multiple studies exist comparing cervical laminoplasty (CLP) and posterior cervical laminectomy with fusion (PCF), no clear consensus exists on which intervention is better. An umbrella review helps provide an overall assessment by analyzing a given condition’s multiple interventions and outcomes. It integrates all available information on a topic and allows a consensus to be reached on the intervention of choice. A literature search was conducted using specific search criteria in PubMed, Scopus, and Web of Science databases. Titles and abstracts were screened based on inclusion criteria. A full-text review of articles that passed the initial inclusion criteria was performed. Nine meta-analyses were deemed eligible for the umbrella review. Data was extracted on reported variables from these meta-analyses. Subsequent quality assessment using AMSTAR2 and data analysis using the R package metaumbrella were used to determine the significance of postoperative outcomes. When the meta-analyses were pooled, statistically significant differences between CLP and PCF were found for postoperative overall complications rate and postoperative JOA score. PCF was associated with a lower overall complication rate and a higher postoperative JOA score, both supported by a weak level of evidence (class IV). Data regarding all other outcomes were non-significant. Our umbrella review investigates CLP and PCF by providing a comprehensive overview of existing evidence and evaluating inconsistencies within the literature. This umbrella review revealed that PCF had better outcomes for overall complications rate and postoperative JOA than CLP, but they were classified as being of weak significance.

PMID:38062318 | DOI:10.1007/s10143-023-02239-2

Psychon Bull Rev. 2023 Dec 7. doi: 10.3758/s13423-023-02425-9. Online ahead of print.

ABSTRACT

Statistical language-learning, the capacity to extract regularities from a continuous speech stream, arguably involves the ability to segment the stream before the discrete constituents can be stored in memory. According to recent accounts, the segmentation process is reflected in the alignment of neural activity to the statistical structure embedded in the input. However, the degree to which it can predict the subsequent leaning outcome is currently unclear. As this is a relatively new avenue of research on statistical learning, a scoping review approach was adopted to identify and explore the current body of evidence on the use of neural phase entrainment as a measure of online neural statistical language-learning and its relation to the learning outcome, as well as the design characteristics of these studies. All included studies (11) observed entrainment to the underlying statistical pattern with exposure to the structured speech stream. A significant association between entrainment and learning outcome was observed in six of the studies. We discuss these findings in light of what neural entrainment in statistical word-learning experiments might represent, and speculate that it might reflect a general auditory processing mechanism, rather than segmentation of the speech stream per se. Lastly, as we find the current selection of studies to provide inconclusive evidence for neural entrainment’s role in statistical learning, future research avenues are proposed.

PMID:38062317 | DOI:10.3758/s13423-023-02425-9

EJNMMI Phys. 2023 Dec 8;10(1):79. doi: 10.1186/s40658-023-00601-3.

ABSTRACT

BACKGROUND: The aim was to investigate the feasibility of a shortened dynamic whole-body (dWB) FDG-PET/CT protocol and Patlak imaging using a population-based input function (PBIF), instead of an image-derived input function (IDIF) across the 60-min post-injection period, and study its effect on the FDG influx rate (Ki) quantification in patients with metastatic melanoma (MM) undergoing immunotherapy.

METHODS: Thirty-seven patients were enrolled, including a PBIF modeling group (n = 17) and an independent validation cohort (n = 20) of MM from the ongoing prospective IMMUNOPET2 trial. All dWB-PET data were acquired on Vision 600 PET/CT systems. The PBIF was fitted using a Feng’s 4-compartments model and scaled to the individual IDIF tail’s section within the shortened acquisition time. The area under the curve (AUC) of PBIFs was compared to respective IDIFs AUC within 9 shortened time windows (TW) in terms of linear correlation (R²) and Bland-Altman tests. Ki metrics calculated with PBIF vs IDIF on 8 organs with physiological tracer uptake, 44 tumoral lesions of MM and 11 immune-induced inflammatory sites of pseudo-progression disease were also compared (Mann-Whitney test).

RESULTS: The mean ± SD relative AUC bias was calculated at 0.5 ± 3.8% (R² = 0.961, AUC_PBIF = 1.007 × AUC_IDIF). In terms of optimal use in routine practice and statistical results, the 5th-7th pass (R² = 0.999 for both Ki mean and Ki max) and 5th-8th pass (mean ± SD bias = – 4.9 ± 6.5% for Ki mean and – 4.8% ± 5.6% for Ki max) windows were selected. There was no significant difference in Ki values from PBIF_{5_7} vs IDIF_{5_7} for physiological uptakes (p > 0.05) as well as for tumor lesions (mean ± SD Ki IDIF_{5_7} 3.07 ± 3.27 vs Ki PBIF_{5_7} 2.86 ± 2.96 100ml/ml/min, p = 0.586) and for inflammatory sites (mean ± SD Ki IDIF_{5_7} 1.13 ± 0.59 vs Ki PBIF_{5_7} 1.13 ± 0.55 100ml/ml/min, p = 0.98).

CONCLUSION: Our study showed the feasibility of a shortened dWB-PET imaging protocol with a PBIF approach, allowing to reduce acquisition duration from 70 to 20 min with reasonable bias. These findings open perspectives for its clinical use in routine practice such as treatment response assessment in oncology.

PMID:38062278 | DOI:10.1186/s40658-023-00601-3

Eur J Trauma Emerg Surg. 2023 Dec 8. doi: 10.1007/s00068-023-02399-2. Online ahead of print.

ABSTRACT

PURPOSE: The current study was undertaken to describe the independent contribution of chronic obstructive pulmonary disease (COPD) to the risk of postoperative morbidity and in-hospital mortality among patients undergoing surgery for an acute abdominal diagnosis.

METHODS: Patients who underwent emergency abdominal procedures were identified from the electronic database of the Department of Visceral, Transplantation, Thoracic and Vascular Surgery of our institution. To evaluate differences in surgical risk associated with COPD, patients with COPD were matched for age, sex, and type of surgery with an equal number of controls who did not have COPD. Logistic regression was performed to evaluate the univariate and multivariate associations between the independent variables, including COPD and outcome variables.

RESULTS: Between January 2012 and December 2022, 3519 patients undergoing abdominal emergency surgery were identified in our abdominal surgical department. After removing ineligible cases, 201 COPD cases with an equal number of matched controls remained for analysis. The prevalence of COPD after the exclusion of ineligible cases was 5.7%. There were statistically significant differences in the rate of postoperative pulmonary complications (PPCs [57.7% vs. 35.8%; P < 0.001]), ventilator dependence (VD [63.2% vs. 46.3%; P < 0.001]), thromboembolic events (TEEs [22.9% vs. 12.9%; P = 0.009]), and in-hospital mortality (41.3% vs. 30.8%; P = 029) for patients with and without COPD. Independent of other covariates, the presence of COPD was not associated with a significantly increased risk of in-hospital mortality (OR, 1.16; 95% CI 0.70-1.97; P = 0.591) but was associated with an increased risk of PPCs (OR, 2.49; 95% CI 1.41-4.14; P = 0.002) and VD (OR, 2.26; 95% CI 1.22-4.17; P = 0.009).

CONCLUSIONS: Preexisting COPD may alter a patient’s risk of PPCs and VD. However, it was not associated with an increased risk of in-hospital mortality.

PMID:38062271 | DOI:10.1007/s00068-023-02399-2

J Womens Health (Larchmt). 2023 Dec 8. doi: 10.1089/jwh.2023.0429. Online ahead of print.

ABSTRACT

Background: Physicians are less likely to discuss lung cancer screening (LCS) with women, and women have lower awareness of LCS availability. The objective of this qualitative study was to determine information needs, patient-provider communication barriers, and preferences for LCS education among women. Materials and Methods: Eight semistructured qualitative focus groups were conducted with 28 self-identified women meeting LCS eligibility criteria. Participants were recruited through a large health system, from a community-based LCS program, and through a national online database between October 2020 and March 2021. Focus groups were led by a trained moderator via Zoom. Audio recordings were transcribed and analyzed using thematic analysis by investigators. Results: LCS decision-making influences included: (1) Health care provider recommendation; (2) Self-advocacy; (3) Insurance coverage and cost; (4) Family; and (5) Interest in early detection. Participants preferred video and print materials, available at physician’s office or shared by physician, without scare tactics or shaming about smoking, use clear language, with diverse participants and images. Preferred content focused on: (1) Benefits of early detection; (2) Lung cancer definition, statistics, and risk factors; (3) Benefits of quitting smoking; (4) Demonstration or explanation of how LCS is done; and (5) Availability of other tests and potential harms of screening. Conclusion: Women in our study had limited awareness of LCS and their eligibility and wanted recommendation and support for LCS from their health care providers. We identified addressable information needs about lung cancer and the screening process that can be used to improve LCS uptake in women and shared decision-making processes.

PMID:38061051 | DOI:10.1089/jwh.2023.0429

J Womens Health (Larchmt). 2023 Dec 8. doi: 10.1089/jwh.2023.0326. Online ahead of print.

ABSTRACT

Objective: To compare gender compositions in the leadership of the top 25 medical schools in North America with the leadership of their affiliated university senior leadership and other faculties. Materials and Methods: This retrospective cross-sectional observational study used publicly available gender data from 2018 to 2019 of universities drawn from the U.S. News Best Global Universities for Clinical Medicine Ranking report. Gender compositions in eight leadership tiers from senior leadership to medical school department directors were analyzed. Data analysis included gender compositions by leadership tier and faculty. Results: Male representation is greater at higher leadership tiers, with the largest imbalance being at the level of medical school department heads. The faculty of medicine has more men in leadership positions than the average of the other faculties (p = 0.02), though similar to schools of engineering, business, dentistry, and pharmacy. Across the eight leadership tiers, a significant trend exists between tier and proportions, indicating that male representation was greater at higher tiers (p < 0.001). No correlation was found between a university’s leadership gender composition and its ranking. Conclusion: The under-representation of women is greater in medical school leadership than the leadership of their affiliated universities. The faculty of medicine has greater male over-representation than the average of the other faculties.

PMID:38061046 | DOI:10.1089/jwh.2023.0326

J Womens Health (Larchmt). 2023 Dec 8. doi: 10.1089/jwh.2023.0032. Online ahead of print.

ABSTRACT

Background: Cardiovascular risk is increased by a history of adverse pregnancy outcomes (APOs). Efforts to understand and prevent these adverse outcomes may improve both fetal and birthing persons’ outcomes in the peripartum period, and over the patient’s lifetime. This study aims to assess the association of clinical, sociodemographic, and economic neighbor-hood factors with preterm birth (PTB) and APOs (the composite of stillbirth, small for gestation age, and low birthweight). Materials and Methods: This is a cross-sectional study using the electronic medical records of deliveries from seven Northwell Health hospitals between January 1, 2018 and July 31, 2020. There were 62,787 deliveries reviewed in this study. Deliveries that were not the first for the patient during the study period and multiple gestational pregnancies were excluded. Patients with incomplete data on outcome were also excluded. Main outcomes were PTB and composite APOs. Measures included history of PTB, hypertension, diabetes, body mass index, race/ethnicity, age, preferred language, marital status, parity, health insurance, and median income, percent unemployment, and mean household size by zip code. Results: Of the 62,787 deliveries, 43.3% were from white, Non-Hispanic, and Non-Latino patients. There were 4,552 (7.2%) PTBs and 8,634 (13.8%) APOs. Patients enrolled in public insurance had higher odds of PTB (odds ratio [OR] 1.15, 95% CI 1.06-1.24) and APOs (OR 1.19, 95% CI 1.12-1.25). There was a statistically significant association of both PTB (p = 0.037) and APOs (p = 0.005) when comparing patients that live in a zip code with a median income over 100k to those with an income <100k. In addition, living in a zip code within the second quintile of unemployment was associated with lower odds of APOs (OR 0.92, 95% CI 0.84-0.99). Conclusions: Numerous sociodemographic and clinical factors are associated with both PTB and APOs. Tailored programs addressing these disparities may improve outcomes in pregnant persons.

PMID:38061042 | DOI:10.1089/jwh.2023.0032