Tag: nevin manimala

J Biopharm Stat. 2026 Feb 18:1-17. doi: 10.1080/10543406.2026.2626058. Online ahead of print.

ABSTRACT

The win ratio, along with its stratified variant known as the stratified win ratio, has been widely utilized in many disease areas for both design and analysis of clinical trials. It is applied most prominently in cardiovascular diseases, followed by respiratory disease, diabetes, oncology, neurology, and other areas. Additionally, the win odds, which incorporates ties in its calculation, has also garnered attention in both prospective and retrospective analyses, alongside their utilization in study design. Researchers have invested considerable effort in the statistical inference of the win statistics (win ratio, win odds, and net benefit). However, despite their significance, the issue of noncollapsibility, highlighted as critical in the FDA’s covariate adjustment guidance in 2023, has not been thoroughly investigated for these win statistics. In this article, we investigate the noncollapsibility of win statistics in three typical types of clinical trial data: binary, continuous, and time-to-event data. We demonstrate that (1) the win ratio is noncollapsible for all of these three types of data; (2) both win odds and net benefit exhibit collapsibility for binary data but are noncollapsible for continuous and time-to-event data. Therefore, win statistics are generally noncollapsible. In light of these findings, we propose the use of stratified win statistics as a standardization approach for analyzing prioritized multiple outcomes, particularly in scenarios where noncollapsibility is a concern.

PMID:41705365 | DOI:10.1080/10543406.2026.2626058

J Biopharm Stat. 2026 Feb 18:1-21. doi: 10.1080/10543406.2026.2627389. Online ahead of print.

ABSTRACT

Regulatory decision-making on the marketing authorisation of Advanced Therapy Medicinal Products (ATMP) is challenging, in particular since the evidence that is provided in the marketing authorization application is frequently not from randomized controlled clinical trials, but based on single-arm trials (SAT). Additionally, if a conditional marketing authorisation is applied, cross-trial comparisons are often necessary against other authorised treatments in the same indication. While various biostatistical solutions to these problems have been proposed recently, a comprehensive overview of the available methods is missing. Therefore, our aim is to provide a general overview of statistical methods that have been proposed to support efficacy claims in marketing authorization applications mainly based on non-randomised evidence. We carefully developed a systematic search strategy, which initially yielded 63,671 results. Finally, following predefined in- and exclusion criteria, the methodologies from 120 papers were summarized in this review, followed by a discussion of their potential relevance for regulatory decision making, as well as promising future directions of biostatistical research. There is indeed a broad range of different methodological approaches available, but hardly any systematic empirical comparisons of these methods exist. Therefore, biostatisticians should be encouraged to systematically generate such comparative evidence, in order to allow for subsequently formulating recommendations regarding which methods are appropriate for supporting efficacy claims in the approval of medicines for ATMPs.

PMID:41705354 | DOI:10.1080/10543406.2026.2627389

Prim Health Care Res Dev. 2026 Feb 18;27:e22. doi: 10.1017/S146342362610098X.

ABSTRACT

OBJECTIVES: This study evaluates the psychological factors influencing vaccination attitudes and behaviors among individuals visiting family health centers. Using the 5C model, the study identifies key determinants affecting vaccination intention and hesitancy, providing insights into strategies to enhance vaccine acceptance.

METHODS: A cross-sectional study was conducted among 1712 adults aged 18 and over in Ankara, Turkey. Data were collected through face-to-face interviews, covering socio-demographic characteristics, vaccination attitudes, and internet usage. The Turkish version of the ‘Psychological Antecedents of Vaccination (5C) Scale’ was used to assess participants’ responses. Multivariate logistic regression analysis was performed to determine factors influencing vaccination intention.

RESULTS: Individuals whose income exceeds their expenses (OR: 1.532, 95% CI: 1.107-2.119), those who received the COVID-19 vaccine (OR: 2.362, 95% CI: 1.429-3.906), and those who are not active social media users (OR: 1.417, 95% CI: 1.096-1.833) were more likely to get vaccinated without hesitation. Higher confidence (OR: 1.268, 95% CI: 1.231-1.306) and collective responsibility (OR: 1.083, 95% CI: 1.046-1.122) scores were associated with increased willingness to vaccinate, while higher calculation scores (OR: 0.932, 95% CI: 0.899-0.965) were linked to hesitancy.

CONCLUSIONS: The findings suggest that fostering confidence and collective responsibility is crucial for improving vaccine acceptance. Communication strategies should be tailored to reduce hesitancy among active social media users. Future research should explore the underlying risk factors contributing to vaccine hesitancy in different populations.

PMID:41705346 | DOI:10.1017/S146342362610098X

Neurourol Urodyn. 2026 Feb 18. doi: 10.1002/nau.70240. Online ahead of print.

ABSTRACT

INTRODUCTION: Primary bladder neck obstruction (BNO) occurs when the bladder neck fails to open during voiding. The cause of BNO is not fully understood but may be related to smooth muscle hypertrophy, increased collagen deposition, or sympathetically mediated high-tone smooth muscle of the urethra. As there is symptom overlap with other urinary pathology, diagnosis is challenging, and there are limited treatments with a paucity of data. Onabotulinum toxin A (BoNT-A) to the bladder neck has shown improvement in symptoms caused by BNO in women in a small retrospective study. We aimed to prospectively analyze the therapeutic efficacy of BoNT-A to the bladder neck as a treatment option for women with BNO.

MATERIALS AND METHODS: We performed a pilot study recruiting female patients with pelvic pain and BNO from September 2023 to July 2024. Patients were diagnosed with BNO using the urodynamic Nitti Criteria, patient symptoms of hesitancy, straining, and/or dysuria, and cystoscopic evidence suggesting BNO. Patients were assessed prior to BoNT-A injection to the bladder neck and 4-6 weeks post-procedure. The procedure consisted of 100 units of BoNT-A reconstituted to 2 mL of Marcaine or saline with 0.5 mL injected cystoscopically at 10, 2, 5, and 7 o’clock in the bladder neck. The primary outcome was the change in the Female Genitourinary Pain Index Scale (Female GUPI, scores range from 0 to 44, lower scores are better). Secondary outcomes pre-procedure versus post-procedure included the Pelvic Floor Distress Index-20 (PFDI-20, scores range from 0 to 300, lower scores are better), a pain visual analogue scale (VAS, ranging from 0-no pain to 10-worst pain), and post-void residual (PVR) volumes. The Global Response Assessment (GRA, -3 to +3, +3 better) was included post-procedure. Data were analyzed using descriptive statistics, and outcomes were compared using the Wilcoxon signed-rank test.

RESULTS: Twenty-two female patients with BNO were recruited to our study. Patients had significant improvement in the Female GUPI with a decrease in scores from a median of 34.5 (IQR 31-36) pre-bladder neck BoNT-A to 26 (20.3-29.8) post-procedure (p = 0.002). The Pain, Urination, and Quality of Life subscales of the Female GUPI all demonstrated significant improvement (all p < 0.05). Median improvement on the GRA was 1.4 (SD 1.4). Compared to baseline, there was improvement in the Urinary Distress Index-6 (UDI-6) subscale (p = 0.012) but not in overall PFDI-20 total scores, which includes prolapse and bowel symptoms in addition to the UDI-6 (p = 0.161). The median PVR prior to treatment was 126 mL (IQR 50-193), and after treatment decreased to 28 (14-59) (p = < 0.001).

CONCLUSIONS: BNO in women encounters limited therapeutic options. BoNT-A to the bladder neck may be considered. BoNT-A to the bladder neck demonstrated improvement in pain, lower urinary tract symptoms (LUTS), and PVR volumes in those with refractory BNO.

PMID:41705318 | DOI:10.1002/nau.70240

Pediatr Pulmonol. 2026 Feb;61(2):e71509. doi: 10.1002/ppul.71509.

ABSTRACT

BACKGROUND: Poor indoor air quality (IAQ) contributes to asthma morbidity, particularly affecting children and young people (CYP) from socioeconomically deprived backgrounds. Air purification devices may improve IAQ and asthma symptoms, but real-world evidence remains limited.

AIM: To assess the feasibility, acceptability, and potential clinical impact of installing an air purifier in the homes of CYP with severe asthma.

METHODS: An unblinded feasibility study recruiting children ≤ 15 years with a confirmed diagnosis of asthma attending a regional severe asthma service. Participants selected by computer-generated random allocation. An air purifier (manufactured by Rensair Ltd.) was installed in each home, with instructions to operate continuously on “quiet mode” for 1-year, and operating costs covered. Data on asthma management and symptoms, quality of life, and qualitative feedback were collected and analysed using thematic analysis.

RESULTS: Twenty CYP were recruited (mean age: 11.2 (SD: 2.68), 60% boys). Thematic analysis of feedback from CYP and families indicated high acceptability and perceived improvements in night-time symptoms and IAQ. Over this 12-month study period, the mean annual number of systemic corticosteroid courses decreased from 4.2 to 2.15 (p = 0.006) from the previous year, and unscheduled primary care visits fell from 4.0 to 1.8 (p = 0.02). Trends towards marginal improvements in asthma control test mean scores (13.3 to.14.2 for < 12 years (p = 0.2), 15.5 to 16.8 for ≥12 years (p = 0.6) and quality of life scores were observed (54.6 to 62.4 for total score (p = 0.08), 17.2 to 19.8 for emotional domain (p = 0.07) and 13.6 to 13.9 for activity domain (p = 0.7)), with a statistically significant increase in the symptom domain of the Mini-PAQLQ (23.8 to 28.8 p = 0.04).

CONCLUSIONS: Air purifiers may offer a feasible, acceptable, and potentially beneficial intervention for children with severe asthma, particularly in settings with poor IAQ. Larger controlled trials are warranted to confirm these findings and inform implementation.

TRIAL REGISTRATION: NCT05817357.

PMID:41705315 | DOI:10.1002/ppul.71509

Thromb J. 2026 Jan 5;24(1):1. doi: 10.1186/s12959-025-00774-0.

ABSTRACT

Despite the recently reported real-world evidence of the signals between echinocandins and coagulation dysfunction events, there are some concerns that may impact the robustness and implications of these findings. For the study design, combining hypercoagulation and hypocoagulation into a single category, “coagulation dysfunction events,” may introduce data heterogeneity and complicate interpretation. Possible misclassification of thrombocytopenia and platelet count decreases in spontaneous reports could influence the results and their implications for surveillance activities. For the statistical methods, the analysis reported only crude signal estimates without adjustments for potential confounders. In some comparisons, using Pearson’s Chi-square test was inappropriate to investigate the strength or direction of the signals. For the data interpretation, the use of “time to onset” could be misleading without confirmation of temporality (e.g., events detected on day 0 could have occurred before antifungal initiation). Translating pharmacovigilance signals into predictability without evidence of stronger association was also inappropriate. Addressing these issues could strengthen the insights into echinocandins-induced coagulation dysfunctions and expedite further investigation into these adverse events.

PMID:41703561 | DOI:10.1186/s12959-025-00774-0

BMC Oral Health. 2026 Feb 17. doi: 10.1186/s12903-026-07858-x. Online ahead of print.

ABSTRACT

BACKGROUND: Ankylosis complicates the management of impacted maxillary canines (IMCs), yet its prevalence and extent, and associated bone characteristics remain understudied, limiting confident clinical decision-making. This study aims to determine the prevalence and extent of radiographic ankylosis in IMCs and investigate the associated surrounding bone density characteristics using cone beam computed tomography (CBCT), providing parameters to improve diagnosis and treatment planning.

METHODS: Ethics committee approval was obtained for this single center, cross-sectional retrospective study. Fifty-six IMCs CBCT images from the radiology unit database between 2017 and 2022 were assessed for radiographic ankylosis. They were categorized as having clear signs, possible signs or no signs of radiographic ankylosis. The prevalence, extent and sites of radiographic signs suggestive of ankylosis were recorded. Bone density was quantified using CBCT grey values (relative values, not Hounsfield units) and measured using Materialise Mimics software (version 20). Data were analysed using descriptive statistics and paired t-tests.

RESULTS: Radiographic signs of ankylosis were found in 26.8% of IMCs (8.9% clear signs; 17.9% possible signs), occurring primarily on palatal (73.3%) and cervical (60.0%) root surfaces. Three (20.0%) IMCs had the largest extent of four affected sites. Bone density was significantly higher at the sites suggestive of ankylosis (p < 0.001), with a mean grey value difference of 259.533 (SD 141.506).

CONCLUSION: The prevalence of radiographic ankylosis in IMCs was low, mainly affecting the palatal and cervical root surfaces. Increased grey value on CBCT can serve as an indicator for radiographic ankylosis.

PMID:41703552 | DOI:10.1186/s12903-026-07858-x

BMC Oral Health. 2026 Feb 17. doi: 10.1186/s12903-026-07919-1. Online ahead of print.

ABSTRACT

BACKGROUND: Molar-incisor hypomineralization (MIH) is a prevalent developmental enamel defect that frequently affects permanent molars and is associated with increased dentin permeability, hypersensitivity, and a higher risk of pulpal inflammation. These clinical features may necessitate endodontic treatment at an early age; however, information regarding potential variations in root canal morphology in MIH-affected molars remains limited. This study aimed to investigate the root canal morphology of hypomineralized permanent molars and compare it with that of healthy molars via microcomputed tomography (µCT).

METHODS: A total of sixty extracted permanent molars were included in this study, comprising thirty hypomineralized teeth and thirty healthy control teeth. All samples were scanned using a SkyScan 1172 µCT system. Root canal configurations were classified according to the Sert and Bayırlı classification system, and isthmus types were assessed according to the system described by Hsu and Kim. The numbers of major and minor apical foramina were recorded. Morphometric analyses included measurements of canal area, cervical width, and cervical thickness. All the data were statistically analyzed via independent t tests, with the level of significance set at p < 0.05.

RESULTS: The most common root canal configuration in both groups was Type I, defined as the presence of two canals without noticeable communication. Hypomineralized teeth exhibited a significantly greater number of minor apical foramina in the middle third of the root (p = 0.016) as well as a greater total number of minor apical foramina compared with healthy teeth (p = 0.047). The cervical width was significantly greater in the hypomineralized molars (p = 0.02), whereas no significant differences were observed in the cervical thickness, canal area, or isthmus distribution between the two groups.

CONCLUSIONS: µCT analysis demonstrated distinct morphological differences between hypomineralized and healthy permanent molars, particularly regarding the number of minor apical foramina and cervical width. These findings underscore the need to consider potential root canal variations during endodontic assessment and treatment planning in MIH-affected molars.

PMID:41703541 | DOI:10.1186/s12903-026-07919-1

BMC Oral Health. 2026 Feb 17. doi: 10.1186/s12903-026-07925-3. Online ahead of print.

ABSTRACT

BACKGROUND: Pain perception during dental procedures is a common cause of patient anxiety. The aim of this study was to compare the pain perception during anesthetic injection and patient preference between a conventional local anesthesia technique and a computer-controlled local anesthesia delivery (CCLAD) system.

METHODS: A randomized, crossover clinical trial was conducted with 40 patients who received both conventional and computerized local anesthesia using the SOGA Smart II device. A 2% lidocaine with epinephrine (1.8 ml, 1:100,000) was used for both techniques. In maxilla, infiltration technique was used and in mandible, Inferior Alveolar Nerve Block was administered. The pain during injection was assessed using a Visual Analogue Scale (VAS). Statistical analysis was performed using paired t-tests.

RESULTS: The mean VAS score for conventional anesthesia was 4.20 ± 1.16, and for the CCLAD system was 2.23 ± 1.23. The difference was statistically significant (p < 0.001). No gender-based differences in VAS scores were observed. The majority of patients expressed a preference for the computerized system.

CONCLUSION: The SOGA Smart II CCLAD system significantly reduces pain perception compared to conventional techniques. Most patients favored the electronic delivery method, suggesting its potential role as a patient-centered approach to reducing injection-related discomfort in selected clinical settings.

TRIAL REGISTRATION: Trial was registered retrospectively with the registration number: TCTR20250517004, dated 17th May, 2025.

PMID:41703537 | DOI:10.1186/s12903-026-07925-3

BMC Pediatr. 2026 Feb 17. doi: 10.1186/s12887-025-06379-w. Online ahead of print.

ABSTRACT

BACKGROUND: Because the respiratory system of extremely/very preterm infants is immature, respiratory support is essential to their care; however, the effects of invasive and non-invasive ventilation modes on prognosis and complications remain controversial. The efficacy and safety of invasive mechanical ventilation (IMV), nasal continuous positive airway pressure (NCPAP), and non-invasive high-frequency oscillatory ventilation (NHFOV) were to be compared in extremely/very preterm infants. METHODS: Clinical data from 220 extremely/very preterm infants admitted between January 2024 and March 2025 were retrospectively analyzed. Infants were stratified by initial ventilation modality into the invasive group (AG, n = 87), the non-invasive NCPAP group (BG, n = 82), and the non-invasive NHFOV group (CG, n = 51); treatment outcomes and complications were compared. RESULTS: The CG had the shortest total ventilation time (8.5 ± 2.8 days), the lowest rate of reintubation (17.6%), and the highest weaning success rate (88.2%), all of which were superior to the other groups (P < 0.05); the AG had the highest incidence of bronchopulmonary dysplasia (37.9%) and intracranial hemorrhage (13.8%) (P < 0.05). Mortality, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), and sepsis incidence not statistically significant among the three groups (P > 0.05).

CONCLUSION: Non-invasive ventilation, especially NHFOV, was found to optimize treatment outcomes and reduce complications in extremely/very preterm infants; its preferential use was recommended.

PMID:41703503 | DOI:10.1186/s12887-025-06379-w