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Nevin Manimala Statistics

A regulatory and scientific framework for analytical quality by design in pharmaceutical analysis

J Pharm Pharmacol. 2026 Apr 3;78(4):rgag037. doi: 10.1093/jpp/rgag037.

ABSTRACT

The application of Quality-by-Design approaches in the development of analytical methods has changed the way drugs are manufactured, switching from trial-and-error and one-variable-at-a-time methods to a structured, risk-based scientific framework. The Analytical Target Profile is at the heart of Quality-by-Design. It clearly lays out the criteria for how well the method will perform. The identification of Critical Quality Attributes and Critical Method Parameters through systematic risk assessment tools like the Ishikawa diagram and Failure Mode and Effect Analysis supports this. Statistical methods, particularly Design of Experiments, have been crucial for identifying and optimizing key variables. This leads to the development of a Method Operable Design Region (MODR). The MODR sets the limits for the analytical method’s reliable results, which means that changes can be made after approval without having to go through the whole process again. Box-Behnken and Central Composite are two common designs that are used to determine how various factors interact in order to ensure that methods perform effectively. Quality-by-Design-based control strategies combine lifecycle management and real-time monitoring to make sure that quality continues to improve more effectively. Literature screening and data organization were performed using Microsoft Excel (Microsoft Corporation, Redmond, WA, USA). Reference management and duplicate removal were carried out using EndNote (Clarivate Analytics). Database searches were conducted across PubMed, Web of Science, Elsevier, and Google Scholar using predefined keywords.

PMID:42048548 | DOI:10.1093/jpp/rgag037

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Nevin Manimala Statistics

From DSM-IV to the future: three decades of evolution in psychiatric classification and what lies ahead

Int Rev Psychiatry. 2026 Feb-May;38(1-3):27-36. doi: 10.1080/09540261.2025.2523455. Epub 2025 Jun 30.

ABSTRACT

Psychiatric classification systems have evolved significantly over the past three decades. This article critically examines the transition from DSM-IV and ICD-10 to the more recent DSM-5-TR and ICD-11, analysing key conceptual shifts, including the redefinition of diagnostic criteria, the inclusion of emerging disorders, and the removal of outdated or stigmatizing categories. Particular attention is paid to the growing limitations of categorical models in capturing clinical heterogeneity and comorbidity. In response, dimensional approaches and precision psychiatry have gained prominence, aiming to integrate symptom severity, biomarkers, and neurobiological correlates into diagnostic decision-making. The manuscript explores future trajectories for psychiatric nosology, including the potential role of artificial intelligence, the recognition of novel syndromes such as eco-anxiety and digital addictions, and the need for culturally sensitive frameworks. It also provides stakeholder-specific recommendations-addressed to clinicians, researchers, policymakers, and educators-summarized in a dedicated table. These forward-looking strategies emphasize the importance of ethical, interdisciplinary, and inclusive practices in updating diagnostic systems. Ultimately, the future of psychiatric classification lies in striking a balance between scientific rigor, sociocultural relevance, and individual variability, ensuring that future manuals serve both clinical utility and human dignity.

PMID:42048530 | DOI:10.1080/09540261.2025.2523455

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Nevin Manimala Statistics

Predicting Pediatric Urological Surgery Duration Through Multimodal Patient-Physician Feature Fusion: Deep Learning Framework Incorporating Clinical Text Embedding

JMIR Med Inform. 2026 Apr 28;14:e82329. doi: 10.2196/82329.

ABSTRACT

BACKGROUND: Accurate prediction of surgical duration is critical for optimizing operating room scheduling and resource allocation. Existing models, however, exhibit limited applicability in pediatric urology due to the unique anatomical and developmental characteristics of children.

OBJECTIVE: This study aimed to develop and validate a specialty-tailored prediction framework for estimating the duration of pediatric urological surgeries.

METHODS: We integrated multisource heterogeneous data, encompassing patient demographics, surgical details, surgeon-specific features, and electronic medical record narratives, to develop a customized prediction system. Large language model techniques were used to extract semantic representations from unstructured clinical text, while a multihead perceptron architecture enabled the efficient fusion of structured and unstructured features. Pediatric-specific clinical variables, such as developmental stage and the severity of urinary tract malformations, were explicitly modeled to capture their impact on surgical duration.

RESULTS: The proposed approach achieved a mean absolute error of 11.39 minutes and a root mean square error of 15.58 minutes, markedly outperforming existing methods. Comparative analyses demonstrated that the Qwen-based structured preprocessing with text embeddings provided superior feature representation, surpassing both traditional long short-term memory and direct Embedding-3 approaches. Feature importance analysis identified the primary surgical procedure, surgical plan, and preoperative diagnosis as dominant predictive factors.

CONCLUSIONS: By combining innovative feature engineering with a tailored model architecture, the proposed framework substantially improves the accuracy of surgical duration prediction in pediatric urology. These findings offer robust technical support for precision operating room scheduling and hold significant clinical value in enhancing the efficiency of surgical resource utilization.

PMID:42048521 | DOI:10.2196/82329

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Nevin Manimala Statistics

Restoring Engagement in Digital Self-Control Tools Using Nudge Reconfiguration Prompts: Quasi-Experimental Study

JMIR Form Res. 2026 Apr 28;10:e85349. doi: 10.2196/85349.

ABSTRACT

BACKGROUND: Digital self-control tools (DSCTs) have emerged as technological interventions to address excessive smartphone usage and promote digital well-being. However, these tools face persistent challenges with user attrition and sustained engagement, compromising their long-term effectiveness. Current literature lacks an understanding of how observable behavioral indicators, as opposed to self-reported measures, are associated with user engagement and readiness to change in DSCTs.

OBJECTIVE: This study addresses three research questions (RQs): (RQ1) whether prompting passive DSCT users to reconfigure nudges increases subsequent user-nudge interaction, (RQ2) how engagement evolves over time and what behavioral divergence emerges between accepting and rejecting users, and (RQ3) whether observable in-app behavioral indicators are more strongly associated with intervention acceptance than traditional self-reported measures.

METHODS: We conducted a quasi-experimental study (N=252) targeting users who had disabled nudges. Participants were randomly assigned to receive a prompt to reconfigure their nudge settings during daily check-ins (n=138, experimental group) or to a control condition (n=114, no intervention). The experimental group was further classified into acceptance and rejection subgroups based on their response to the intervention. Data collection included DSCT configuration logs, usage-triggered nudge logs, and self-reported questionnaire responses. We analyzed user-nudge interaction ratios using difference-in-differences with permutation tests (RQ1) and nudge configuration parameters and manual app blocking using independent-samples t tests with Cohen d (RQ2) and compared behavioral indicators against self-reported measures using t tests and chi-square tests (RQ3).

RESULTS: Of the experimental participants, 46% (63/138) accepted the nudge reconfiguration prompt. Post intervention, the acceptance subgroup’s 7-day average user-nudge interaction ratio increased from 29.7% to 58.5% (peak of 65% on day 1), a significant increase even after controlling for the temporal decline observed in the control group (difference-in-differences=+36.3 percentage points, P<.001). The rejection subgroup’s decline was not significantly different from the control group’s decline (P=.82). The acceptance subgroup showed preexisting behavioral indicators of higher readiness to change, including 21.53% shorter consecutive usage thresholds (P=.03) compared to the rejection subgroup, with a directionally consistent but nonsignificant difference in cooldown length (+20.56%). Behavioral divergence in consecutive usage thresholds widened post intervention, with Cohen d increasing from -0.47 to -0.67 (P=.002). Acceptance subgroup participants demonstrated a significantly lower tendency to select leisure-oriented daily goals (15.6% vs 26.2%; chi-square P=.001, Cramer V=0.13). Self-reported measures of screen time goals and scrolling regret were not significantly associated with intervention acceptance (P>.10).

CONCLUSIONS: Observable in-app behavioral indicators, rather than self-reported measures, effectively differentiate intervention receptiveness. Study results suggest that effective DSCT design should incorporate adaptive strategies that recognize and respond to users’ readiness to change, as evidenced by their in-app behaviors, while preserving autonomy. Such systems are likely to outperform static interventions or designs that rely solely on self-reported preferences.

PMID:42048520 | DOI:10.2196/85349

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Nevin Manimala Statistics

Comparative effectiveness of atorvastatin monotherapy vs. atorvastatin plus bempedoic acid combination in patients with coronary artery disease: a multicenter observational study

Pol Merkur Lekarski. 2026;54(2):190-197. doi: 10.36740/Merkur202602114.

ABSTRACT

OBJECTIVE: Aim: To evaluate the impact of adding bempedoic acid to atorvastatin therapy on cardiovascular outcomes, including major adverse cardiovascular events (MACE), cardiac arrest, all-cause hospitalization, and myopathy, in patients with established coronary artery disease.

PATIENTS AND METHODS: Materials and methods: We conducted a retrospective cohort study using the TriNetX global health research network. Patients with established CAD were categorized based on their antilipemic therapy into two cohorts: atorvastatin monotherapy and atorvastatin plus bempedoic acid. Propensity score matching was employed to balance baseline characteristics between the cohorts. The primary outcome was the occurrence of MACE, while secondary outcomes included cardiac arrest events, all-cause hospitalization, and incidence of myopathy.

RESULTS: Results: After matching, 6,549 patients were included in each cohort. MACE occurred more frequently in the atorvastatin group (5.7%) compared to the combination therapy group (3.2%), with a hazard ratio of 1.606 (95% CI: 1.302-1.980, P<0.001). Cardiac arrest and all-cause hospitalizations were also higher in the atorvastatin group, with hazard ratios of 1.628 (95% CI: 1.041-2.544, P<0.001) and 1.418 (95% CI: 1.177-1.710, P<0.001), respectively. No significant difference in myopathy was observed (HR 0.915, 95% CI: 0.741-1.129).

CONCLUSION: Conclusions: Adding bempedoic acid to atorvastatin therapy appears to confer a protective effect in CAD patients by significantly reducing MACE, cardiac arrest, and hospitalizations without increasing myopathy risk. Prospective studies are warranted to confirm these findings.

PMID:42048509 | DOI:10.36740/Merkur202602114

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Nevin Manimala Statistics

Variants of the structure of the urinary system organs in human fetuses

Pol Merkur Lekarski. 2026;54(2):183-189. doi: 10.36740/Merkur202602113.

ABSTRACT

OBJECTIVE: Aim: To find out the features of individual anatomical variability of the urinary system organs in the fetal period of human ontogenesis.

PATIENTS AND METHODS: Materials and Methods: 102 human fetuses with a parieto-calcaneal length (PCL) of 160.0-480.0 mm (4-10 months of gestation) were studied. A complex of morphological research methods was applied, which included anthropometry, morphometry, injection of blood vessels with dyes for visualization of blood vessels of macrospecimens, preparation of macrospecimens, and statistical analysis.

RESULTS: Results: Our material revealed a number of variants of the shape and structure of the ureters, in particular, doubling of the renal pelvis and ureters – 4 observations. The reasons for this may be impaired morphogenesis of the metanephros at the end of the 6th – beginning of the 7th week of intrauterine development. Bends of the proximal part of the ureter, megaureter were observed in 2 cases, polymegacolix, megacolix – in 2 cases. Aberrant renal vessels were detected in 8 specimens. The reasons for their occurrence may be impaired angiogenesis at the end of the 6th week of prenatal development.

CONCLUSION: Conclusions: 1. Variants of the structure and topography, as well as malformations of the upper urinary tract, were detected in 15.7% of 102 studied fetal specimens. 2. The ratio of detected variants and anomalies of the structure and topography in female fetuses prevailed over those in male fetuses in the ratio of 5:3. 3. Extreme forms of anatomical variability of the structure of renal vessels and their syntopy with the renal pelvis and ureter in all observations were a potential danger of vasorenal conflicts, which would subsequently lead to hydronephrotic transformation of the kidney.

PMID:42048508 | DOI:10.36740/Merkur202602113

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Nevin Manimala Statistics

Enhancing cognitive engagement in medical students through problem-based histology instruction: implications for competency-oriented physician training

Pol Merkur Lekarski. 2026;54(2):176-182. doi: 10.36740/Merkur202602112.

ABSTRACT

OBJECTIVE: Aim: This study aimed to verify experimentally the effectiveness of a problem-search approach for teaching Histology in enhancing the level of cognitive engagement among first-year medical students enrolled in specialty I2 “Medicine,” as well as to substantiate the feasibility of its implementation in the educational process of future physician training.

PATIENTS AND METHODS: Materials and Methods: The study was conducted during the 2024-2025 academic year and consisted of three stages (summative, formative, and final) using a pedagogical quasi-experimental design. A total of 756 undergraduate students enrolled in specialty I2 “Medicine” participated and were divided into a control group (n=352) and an experimental group (n=354). The level of cognitive engagement was assessed before and after the formative stage using B. K. Pashnev’s questionnaire. The experimental group was taught using a combination of problem-based learning, the case method, heuristic dialogue, smallgroup work, project-based learning, and digital interactive technologies.

RESULTS: Results: At the summative stage, no statistically significant differences between the groups were identified. After the implementation of the problem-inquiry teaching methodology, the experimental group demonstrated a significant increase in the proportion of medical students with an advanced level of cognitive engagement (from 32.5% to 70.1%) compared with the control group (χ2=38.369; p<0.05).

CONCLUSION: Conclusions: The proposed methodology for teaching Histology to future physicians, grounded in a problem-search approach, is an effective means of enhancing medical students’ cognitive engagement and may be recommended for implementation in higher medical education practice.

PMID:42048507 | DOI:10.36740/Merkur202602112

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Nevin Manimala Statistics

Impact of sarcoidosis on clinical outcomes in patients with dilated cardiomyopathy: A propensity-matched analysis from the TriNetX network

Pol Merkur Lekarski. 2026;54(2):169-175. doi: 10.36740/Merkur202602111.

ABSTRACT

OBJECTIVE: Aim: Our study aims to compare the outcomes in patients with dilated cardiomyopathy (DCM) who have sarcoidosis and who do not have sarcoidosis.

PATIENTS AND METHODS: Materials and Methods: We used data from the TriNetX US collaborative network database, including DCM patients with and without sarcoidosis between Aug 1, 2015 and Aug 1, 2025. Propensity score matching was done to minimize differences in baseline characteristics. A total of 4,514 patients in each cohort (sarcoidosis vs. non-sarcoidosis) were studied after propensity score matching. The primary outcome was ventricular assist device (VAD) placement, and the secondary outcomes were ventricular arrhythmia, hospitalization or ED visits, acute kidney injury, and stroke.

RESULTS: Results: The incidence of VAD insertion was more frequent in the sarcoidosis group (2.2% vs. 1.3%; OR: 1.676, 95% CI: 1.210-2.321; P<0.001). Secondary outcomes also showed significant differences, with higher rates of ventricular arrhythmia (OR: 2.082, 95% CI: 1.833-2.364; P<0.001), acute kidney injury (OR: 1.305, 95% CI: 1.157-1.473; P<0.001), and hospitalization/ED visits (OR: 1.159, 95% CI: 1.003-1.340; P<0.001) in the sarcoidosis cohort. Other arrhythmia events were more frequent (OR: 2.517, 95% CI: 2.425-2.613; P<0.001). The risk of composite stroke did not differ significantly between groups (OR: 1.132, 95% CI: 0.957-1.339; P=0.146).

CONCLUSION: Conclusions: Sarcoidosis in DCM was associated with higher risk of VAD insertion and most secondary outcomes, except stroke, indicating worse prognosis and need for closer monitoring and targeted management.

PMID:42048506 | DOI:10.36740/Merkur202602111

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Nevin Manimala Statistics

Adaptive swimming as a means of physical and sports rehabilitation for people with musculoskeletal disorders

Pol Merkur Lekarski. 2026;54(2):163-168. doi: 10.36740/Merkur202602110.

ABSTRACT

OBJECTIVE: Aim: To investigate the impact of adaptive swimming training sessions on the psycho-emotional and functional state of individuals with musculoskeletal disorders.

PATIENTS AND METHODS: Materials and Methods: The research was conducted in 2025, with 32 male service members aged 26-58 who underwent rehabilitation for musculoskeletal injuries over 6 weeks. The research used a combination of theoretical, empirical, and mathematical statistical methods. The psycho-emotional state was assessed using the Wessman-Ricks technique, and the functional state was assessed using a 100 m swimming test and the duration of heart rate recovery after exercise.

RESULTS: Results: Data analysis showed that adaptive swimming training sessions have a pronounced rehabilitative effect: they normalize the psycho-emotional state, reduce stress levels, and increase the body’s adaptive capabilities. The integral indicator of emotional state after 6 weeks of training increased by 1.15 points (p≤0.001) and reached a good level, reflecting the restoration of emotional balance. Functional indicators also improved: the time to cover a distance of 100 meters was reduced by 51 seconds (p≤0.001); the duration of heart rate recovery was reduced by 3.65 beats per minute (p≤0.001).

CONCLUSION: Conclusions: It has been established that adaptive swimming training sessions contribute to improving the psycho-emotional state and functional capabilities of individuals with musculoskeletal disorders. A significant improvement in the integral indicators of the cardiovascular system’s emotional and functional states has been observed.

PMID:42048505 | DOI:10.36740/Merkur202602110

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Nevin Manimala Statistics

Immunohistochemical analysis and distribution of lymphocytes and Kupffer cells in the liver of rats with long-term experimental use of hemp seed oil

Pol Merkur Lekarski. 2026;54(2):137-143. doi: 10.36740/Merkur202602106.

ABSTRACT

OBJECTIVE: Aim: To conduct histological and immunohistochemical analysis and distribution of lymphocytes and Kupffer cells in the liver of rats with long-term experimental use of hemp seed oil (HSO).

PATIENTS AND METHODS: Materials and Methods: 26 sexually mature male rats (180-230 g, 5-7 months old) were divided into three groups: experimental (n=14, 0.5 ml/kg/day HSO orally for 10 weeks), control (n=6, 0.1 ml/kg/day HSO orally for 10 weeks), and intact (n=6). Histological and immunohistochemical (CD3, CD20, CD56, CD68) studies, alongside quantitative analysis of lymphocyte and macrophage distribution in hepatic lobules, were performed. Statistical significance was assessed using Mann-Whitney and Pearson tests, with p<0.05 considered significant.

RESULTS: Results: After 10 weeks of 0.5 ml/kg/day HSO, 71.43% of experimental rats developed mild fatty liver disease (Kleiner grade S1 steatosis), a significant difference from the control group (p<0.0001). No histological inflammation or necrotic changes in hepatocytes were observed. Small numbers of CD3 lymphocytes were present in portal tracts, without extending into or damaging the adjacent parenchyma. CD20 and NK resident lymphocytes were sparse. Aggregates of CD68-positive Kupffer cells were most common near liver lobule triads. The average number of Kupffer cells (5.79±0.06 per 0.01 mm2) in the experimental group significantly (p<0.001) exceeded the control by 1.49 times, suggesting hyperplasia of specialized macrophages and their increased role in liver immune function.

CONCLUSION: Conclusions: Ten weeks of experimental use indicates that hemp seed oil is safe to consume at a dose of 0.5 ml/kg/day.

PMID:42048501 | DOI:10.36740/Merkur202602106