Tag: statistics

Am J Clin Dermatol. 2025 Jul 29. doi: 10.1007/s40257-025-00964-6. Online ahead of print.

ABSTRACT

BACKGROUND: Psoriasis is a chronic, inflammatory disease requiring long-term therapy. Risankizumab, an anti-interleukin-23 monoclonal antibody, is approved to treat moderate-to-severe plaque psoriasis in adults.

OBJECTIVE: The aim was to assess the long-term safety and efficacy of continuous risankizumab treatment through 6 years in adults with moderate-to-severe plaque psoriasis.

METHODS: LIMMitless, a phase 3, open-label extension study, evaluated the long-term safety and efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis following multiple phase 2/3 base studies. Patients randomized to risankizumab 150 mg at baseline of the base studies (≤ 52 weeks) were eligible to enroll in the LIMMitless study, in which they received risankizumab 150 mg subcutaneously every 12 weeks for an additional 252 weeks. This final analysis assessed safety (treatment-emergent adverse events [TEAEs]) through 324 weeks and efficacy (including proportions of patients who achieved ≥ 90%/100% improvement from baseline in Psoriasis Area and Severity Index [PASI 90/PASI 100], static Physician’s Global Assessment of clear or almost clear [sPGA 0/1], or Dermatology Life Quality Index of no effect on patient’s quality of life [DLQI 0/1]) through 304 weeks.

RESULTS: Of 897 patients enrolled in the LIMMitless study, 661 completed the study for a total of 4921.2 patient years of exposure to risankizumab. Rates of TEAEs, TEAEs leading to discontinuation, and TEAEs of safety interest were low and consistent with rates observed in previous studies. During the base studies, risankizumab treatment demonstrated high rates of rapid and durable efficacy through 52 weeks; risankizumab treatment also maintained or further improved efficacy and quality-of-life outcomes in the LIMMitless study. At week 304, 86.0% of patients achieved PASI 90, 54.2% achieved PASI 100, 84.7% achieved sPGA 0/1, and 76.3% achieved DLQI 0/1 (using modified nonresponder imputation).

CONCLUSIONS: Long-term risankizumab was well tolerated and demonstrated high and durable efficacy through 6 years of continuous treatment.

CLINICAL TRIAL REGISTRATION: NCT03047395.

PMID:40728772 | DOI:10.1007/s40257-025-00964-6

J Clin Monit Comput. 2025 Jul 29. doi: 10.1007/s10877-025-01311-0. Online ahead of print.

ABSTRACT

In critical care settings, continuous vital sign monitoring is crucial to ensure patient safety and timely intervention. While traditional patient monitor threshold alarm systems have been life-saving, they often generate numerous non-actionable alarms, which can overwhelm caregivers and lead to ineffective patient monitoring. We still have these numerous false alarms because we have a gap in understanding the importance of age-specific threshold settings, delay, and critical illness events inclusion in understanding the specificity and sensitivity of the threshold alarms. This study investigated the effect of age-specific thresholds, delay, and critical illness events on the number of threshold alarms to balance their specificity and sensitivity. Secondary data from 772 pediatric patients was extracted from the IMPALA Project conducted in the High Dependency Unit (HDU) at Queen Elizabeth and Zomba Central Hospitals in Malawi. Threshold crossing detector algorithms and age-defining functions were used to generate alarms and impute age-specific thresholds. Z-test was used to determine differences between normal threshold alarms and age-specific threshold alarms. Threshold alarms were categorized into different delays based on their durations to identify an adaptive delay that would minimize the threshold alarms to manageable alarms. Time series analysis was leveraged to extract and compare threshold alarms around patients with and without critical illness events per hour. Additionally, we investigated the variability of threshold alarms during the hour time windows before and after each critical illness event, considering factors such as delay and age. A multi-regression model was used to determine the effects of critical illness events on the number of threshold alarms, with a significance level set at p < 0.05, indicating statistical significance. The age-specific threshold had a positive influence on the threshold alarms by reducing the total number of threshold alarms [31.14% for ECGHR, 17.54% ECGRR and 54.79% for SPO2]. There was a greater significant difference between normal and age-specific threshold alarms (p < 0.00001). A 15-s delay reduced the total number of threshold alarms by 45%. We had more threshold alarms being generated 1 h before critical illness events occurrence, and applying delay and age-specific threshold had more impact on threshold alarms 3 h after the occurrence of critical illness events [Respiratory support (Total threshold alarms (232), 15 s delay (77), 15 s and age-specific threshold (17)] and most threshold alarms 1 h before critical illness events had longer durations. Critical illness [Convulsion (p < 0.0001), Malaria treatment (p < 0.0001), Death (p = 0.053), Respiratory support (p = 0.046), and Sepsis (p = 0.051)] had positive effects on the threshold alarm. There was a drop and increase in the vital sign values during the occurrence of these critical illness events [Bronchodilator support (β = – 0.0030), Death (β = – 0.0374), Malaria treatment (β = – 0.0056), and Inotropic support (β = – 0.0063)] indicating that more threshold alarms were produced during the occurrence of these critical illness events. Age-specific threshold, delay, and critical illness events can be used to strike a balance between the sensitivity and specificity of threshold alarms. In this way, we can reduce the number of non-actionable (false alarms) alarms and increase the number of actionable alarms around critical illness events. It is necessary to look into critical illness event alarm forecasting further.

PMID:40728767 | DOI:10.1007/s10877-025-01311-0

EJNMMI Phys. 2025 Jul 29;12(1):73. doi: 10.1186/s40658-025-00788-7.

ABSTRACT

In clinical nuclear medicine, reconstruction methods incorporating regularization terms have been widely investigated. However, searching for optimal hyperparameters for the entire examination is time-consuming and arduous because the optimal hyperparameters need to be determined experimentally and vary depending on factors, including the acquisition condition, reconstruction condition, and so on. In this study, we propose a row-action type automatic regularized expectation maximization method (RAREM). This method considers the acquisition conditions and object structure for determining the hyperparameters and does not require the user to set the hyperparameters experimentally. This study was conducted using numerical simulations and a real SPECT system METHODS: Total variation-expectation maximization (TV-EM) and modified-block sequential regularized EM (BSREM) were compared with RAREM, with the optimal hyperparameters of the two conventional reconstruction methods determined in advance from normalized root mean square error (NRMSE) results. This simulation examination utilized three types of phantoms with the number of counts and projections being examined in six ways each, resulting in a total of 108 conditions. The NRMSE and structural similarity index measure (SSIM) were used to evaluate of the simulation examination, and the Mann-Whitney U test was used for statistical analysis. In the real examination, two types of phantoms were used, and the number of projections was examined in three ways, for a total of six conditions. Contrast recovery coefficient (CRC) and specific binding ratio (SBR) were used to evaluate the real examination RESULTS: The NRMSE, CRC, and SBR of RAREM were equivalent to those of the conventional methods, and the SSIM of RAREM was equivalent to or better than that of the conventional methods, with significant differences in some cases. The results indicated that RAREM worked well with the evaluated object structure and considered the acquisition conditions CONCLUSION: In this study, an automatically controlled regularization reconstruction method was proposed. The proposed method does not require the user to set hyperparameters experimentally and can avoid the investigation of optimal hyperparameters; it is an alternative to conventional regularized methods in clinical.

PMID:40728756 | DOI:10.1186/s40658-025-00788-7

Eur Radiol. 2025 Jul 29. doi: 10.1007/s00330-025-11913-6. Online ahead of print.

NO ABSTRACT

PMID:40728754 | DOI:10.1007/s00330-025-11913-6

Eur Radiol. 2025 Jul 29. doi: 10.1007/s00330-025-11868-8. Online ahead of print.

ABSTRACT

Unrecognized and untreated injuries of the posteromedial and posterolateral corners of the knee are more common than previously thought and have been linked to poor outcomes after anterior cruciate ligament reconstruction. Amongst imaging modalities, magnetic resonance is currently referred to as the gold standard for the evaluation of these regions, but has several limitations, in particular in the identification of subacute and chronic lesions. Recent technological advancements and the progressive refinement of linear probes have expanded the potential of High-resolution ultrasound in demonstrating the stabilizers of the posteromedial and posterolateral corners in both normal and pathological cases, and now this modality may be considered as a useful complementary tool for the evaluation of these structures. The aim of this work is twofold: (i) to review, also with the support of dedicated dissections and schematic drawings, the normal anatomy and the biomechanical role of the clinically relevant stabilizers of the posteromedial and posterolateral knee, including the distal expansion of the semimembranosus tendon, the popliteus muscle-tendon unit, and the posterior oblique ligament; (ii) to illustrate the normal ultrasound appearance of these structures and the spectrum of pathological findings that this modality may disclose in patients with anterior cruciate ligament tear. KEY POINTS: Question Injuries of the posteromedial and posterolateral knee worsen the outcome after anterior cruciate ligament reconstruction but are often underdiagnosed on imaging. Findings Ultrasound has potential in diagnosing tears of stabilizers of the posteromedial and posterolateral knee and provides complementary information to MRI about ligament status and continuity. Clinical relevance In subacute and chronic injuries, ultrasound has some advantages over MRI as it can disclose subtle abnormalities that might otherwise be unrecognized, thereby improving diagnostic confidence and patient counselling.

PMID:40728753 | DOI:10.1007/s00330-025-11868-8

Nervenarzt. 2025 Jul 29. doi: 10.1007/s00115-025-01842-6. Online ahead of print.

ABSTRACT

With the introduction of the 11th revision of the World Health Organization International Statistical Classification of Diseases and Related Health Problems (ICD-11), structural and content-related adjustments to the diagnostic guidelines for anxiety disorders were made, which are presented in this review article. Previously classified as “phobic disorders” and “other anxiety disorders” within the group “neurotic, stress-related, and somatoform disorders”, in ICD-11 “anxiety- or fear-related disorders” now constitute a separate group. The core diagnoses of agoraphobia, social anxiety disorder, specific phobia, panic disorder and generalized anxiety disorder are retained, with the modification that agoraphobia and panic disorder can now be diagnosed separately and comorbidly. Within the framework of the lifespan perspective, separation anxiety disorder and selective mutism have been moved to the group “anxiety- or fear-related disorders”. The diagnosis “mixed anxiety and depressive disorder” is now classified as “mixed depressive and anxiety disorder” in the group “affective disorders”. In accordance with the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM‑5), it is possible to code isolated panic attacks in addition to other mental or somatic disorders. Overall, ICD-11 follows the DSM‑5 classification of anxiety- and fear-related disorders in many respects. Furthermore, the omission of subcategorizations and a precise minimum number of required symptoms simplify the diagnostic criteria. Future studies will need to address questions regarding the diagnostic accuracy, clinical practicability and further operationalization of the ICD-11 diagnostic criteria for anxiety- or fear-related disorders.

PMID:40728738 | DOI:10.1007/s00115-025-01842-6

J Gambl Stud. 2025 Jul 29. doi: 10.1007/s10899-025-10418-7. Online ahead of print.

ABSTRACT

In literature, there is a lack of multidimensional analyses that examine the co-occurrence of multiple addiction-related behaviors within households. This study aims to fill that gap by identifying the demographic and socioeconomic factors associated with Turkish households in which tobacco use, alcohol consumption, and gambling occur simultaneously, thereby contributing both to academic understanding and to informed policymaking. The study utilizes micro data from the Household Budget Survey conducted by the Turkish Statistical Institute between 2015 and 2019. The probabilities of households engaging in tobacco use, alcohol consumption and gambling behaviors are estimated simultaneously with the Multivariate Probit Model, which also considers correlations among unobservable factors. It has been determined that demographic and socioeconomic factors have separate significant effects on harmful habits. By focusing on the social and cultural dynamics in Türkiye, this study provides insights into harmful habits in households, contains guiding results especially for developing local policies. It has been identified that in Türkiye, deterrent policies for tobacco use should prioritize targeting young, low-educated, high-income males; for alcohol consumption, the focus should be on middle-aged, highly educated, high-income, single males; and for gambling, priority should be given to unemployed, middle-aged, highly educated, high-income, single males.

PMID:40728712 | DOI:10.1007/s10899-025-10418-7

J Endocrinol Invest. 2025 Jul 29. doi: 10.1007/s40618-025-02661-x. Online ahead of print.

ABSTRACT

PURPOSE: Thyroid surgery is performed for various indications, including goiter, suspected or diagnosed malignancy, and hyperthyroidism. While previous studies have focused on postoperative quality of life (QoL) improvements, limited data exist on preoperative QoL in different patient groups. This study aimed to assess the preoperative QoL of patients undergoing thyroid surgery and identify risk factors associated with poor QoL. Additionally, we compared the QoL of patients with thyroid cancer or suspected malignancy to those undergoing surgery for non-cancer-related indications.

METHODS: This prospective study included 204 patients who underwent thyroidectomy or lobectomy at Oulu University Hospital, Finland, between September 2021 and December 2022. Patients completed preoperative QoL assessments using the RAND-36, ThyPRO-39, Beck Depression Inventory (BDI), and Voice Handicap Index (VHI) questionnaires. Patient characteristics and clinical data were collected from medical records. Statistical analyses included Mann-Whitney U tests, Pearson Chi-square tests, and logistic regression to evaluate differences between patient groups and identify factors associated with poor QoL.

RESULTS: Patients undergoing thyroid surgery, regardless of indication, reported lower QoL compared to the general Finnish population. No significant differences were found between cancer and non-cancer patients in overall QoL scores. Poor QoL was significantly associated with younger age (< 65 years), higher BDI and VHI scores, elevated BMI, and frequent dyspnea.

CONCLUSION: Preoperative QoL is significantly lower in patients undergoing thyroid surgery compared to the general population, independent of diagnosis. Contrary to our hypothesis, patients with thyroid cancer did not report worse QoL than those with non-malignant thyroid diseases.

PMID:40728709 | DOI:10.1007/s40618-025-02661-x

J Endocrinol Invest. 2025 Jul 29. doi: 10.1007/s40618-025-02664-8. Online ahead of print.

ABSTRACT

INTRODUCTION: Growth hormone (GH) deficiency (GHD) elevates high-sensitivity C-reactive protein (hs-CRP) levels, an inflammatory marker. While daily GH replacement has been shown to reduce hs-CRP levels, the effects of long-acting GH therapyon hs-CRP remain unclear.

PURPOSE: This pilot study aimed to investigate the association between a once-weekly GH derivative, somapacitan, and hs-CRP in adult patients with GHD.

METHODS: This study prospectively evaluated serum hs-CRP levels and metabolic parameters in adult patients with untreated GHD during a 6-month course of weekly somapacitan therapy.

RESULTS: Among 13 adult patients with GHD (9 men; 10 with adult-onset GHD), serum hs-CRP levels significantly decreased following somapacitan therapy (0.24 [0.07-0.51] to 0.07 [0.06-0.25] mg/dL, P <.001), whereas serum insulin-like growth factor (IGF)-1 levels (80 ± 53 to 148 ± 74 ng/mL, P <.001) and IGF-1 SD scores (- 2.8 ± 2.3 to – 0.4 ± 1.7, P <.001) significantly increased. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels showed slight but statistically insignificant decreases after the treatment. Changes in hs-CRP levels correlated significantly with changes in IGF-1 SD scores (r = -.66, P =.01), AST (r =.67, P =.01), and ALT (r =.74, P =.004). In partial correlation analyses, changes in hs-CRP levels remained significantly associated with ALT changes (r =.59, P =.04), independent of IGF-1 SD score changes.

CONCLUSION: The reduction in hs-CRP levels after somapacitan therapy for GHD suggests that somapacitan has a protective role against inflammation, possibly mediated by the liver.

PMID:40728708 | DOI:10.1007/s40618-025-02664-8

Environ Sci Pollut Res Int. 2025 Jul 29. doi: 10.1007/s11356-025-36759-9. Online ahead of print.

ABSTRACT

Glass waste is generated in large quantities worldwide, yet only a small portion is recycled or reused. To support the circular economy, it is essential to explore alternatives that incorporate this waste into new production chains, such as in civil construction. This study investigates the technical feasibility of replacing sand with glass powder in the production of dry concrete blocks. Four mixtures were tested, with sand replaced by 0%, 25%, 50%, and 75% glass powder (particle size < 600 μm). The obtained blocks were characterized by water absorption and compressive strength. All mixtures met the standard requirement for water absorption (< 10%), with values ranging from 6.0 to 7.5%. In terms of compressive strength, the replacement of sand with glass powder led to a statistically significant improvement (p ≤ 0.05) in all substitution levels. The average compressive strength increased by 32 to 35% compared to the control mix (3.11 MPa at 28 days), with the highest value reaching 4.35 MPa at 56 days for the 50% replacement. Furthermore, only the 50% mix achieved the minimum characteristic compressive strength required by Brazilian standards (fbk ≥ 3 MPa), with 3.62 MPa. The results support the industrial use of glass powder as a sustainable alternative to natural sand, promoting the reuse of long-neck glass bottles and reducing environmental impact.

PMID:40728706 | DOI:10.1007/s11356-025-36759-9