Categories
Nevin Manimala Statistics

Radiologist Approval for CTPA in the ED: A Single-Centre Pilot Study Did Not Demonstrate a Statistically Significant Difference in Diagnostic Yield

Emerg Med Australas. 2026 Feb;38(1):e70237. doi: 10.1111/1742-6723.70237.

ABSTRACT

OBJECTIVE: Overuse of CT Pulmonary Angiography (CTPA) remains a challenge in emergency medicine. Some institutions resort to radiologist vetting to reduce unnecessary imaging. This is a pilot study that aims to investigate the effect of radiology vetting on the CTPA yield.

METHODS AND RESULTS: This is a retrospective study comparing CTPA yields with and without radiology vetting. The results showed that there was no statistically significant difference in CTPA diagnostic yield, 11.4% (CI 9.2-14.0) versus 10.2% (CI 6.8-14.6), p = 0.60.

CONCLUSION: This study showed that removing radiologist approval for CTPA did not appear to reduce diagnostic yield.

PMID:41705429 | DOI:10.1111/1742-6723.70237

Categories
Nevin Manimala Statistics

Characteristics of patients with abdominal and/or pelvic injuries presenting to Emergency Departments

Pol Przegl Chir. 2025 Dec 3;98(1):1-8. doi: 10.5604/01.3001.0055.4693.

ABSTRACT

<b>Introduction:</b> This study characterizes patients with abdominal and/or pelvic trauma admitted to Emergency Departments (EDs) in Poland, focusing on differentiating stable from unstable cases. The objective is to inform of evidence-based guidelines for managing these injuries in both critical and non-critical trauma patients. <br><br><b>Aim:</b> The study aims to characterize patients admitted to randomly selected Hospital Emergency Departments in Poland after abdominal and/or pelvic injury. It aims to provide evidence-based recommendations for managing abdominal and pelvic trauma. <br><br><b>Materials and methods:</b> A retrospective analysis was conducted using anonymized medical records from three randomly selected EDs in Poland, representing Levels I, II, and III of the Polish Trauma Care System. Patients with abdominal and/ or pelvic trauma were identified and categorised by trauma type, injury mechanism, severity, and stability. Data were summarized using descriptive statistics, and relationships between variables were analyzed using the Chi-square or Fisher’s exact test, with α = 0.05 for significance. <br><br><b>Results:</b> Of 93,714 ED patients, 708 met the study criteria, with 215 confirmed cases of abdominal and/or pelvic trauma. Closed (blunt) injuries were predominant (96.3%), especially low-energy injuries among older adults. Mild trauma was most common (64.65%) according to the CRAMS scale, while severe injuries accounted for only 8.84%. A substantial proportion of patients were stable upon ED admission, with 69.3% of abdominal trauma and 100% of pelvic trauma patients exhibiting no signs of organ failure or peritoneal symptoms. The findings indicate a higher-than-expected prevalence of stable trauma cases, underscoring the need for guidelines to manage stable but potentially vulnerable patients. <br><br><b>Discussion:</b> This study offers insights into the demographic and clinical characteristics of patients with abdominal and/or pelvic trauma in EDs, with a particular focus on differentiating stable from unstable trauma patients and addressing distinct clinical needs. By testing key hypotheses on trauma type, severity, and patient stability, the study brings attention to areas in trauma management that may benefit from revised protocols and resource allocation. Our findings underscore the importance of recognizing stable trauma patients as a significant but underrepresented group in trauma literature. Existing studies are often conducted in EDs located within trauma centres, which influences the patient populations represented in the literature. Additionally, a common inclusion criterion in such studies is trauma team activation or the explicit identification of unstable patients with systolic blood pressure below 90 mmHg. Research focusing on stable patients with abdominal and/ or pelvic trauma is rare and typically addresses aspects other than the specific characteristics of this group. However, in our study, a substantial proportion of patients with abdominal and/or pelvic trauma were clinically stable upon ED arrival. This has implications for ED triage, where prioritization often leans towards critically unstable cases, potentially overlooking the nuanced needs of stable patients who may still benefit from close monitoring to prevent deterioration. <br><br><b>Conclusions:</b> This study reveals a significant proportion of stable, low-severity abdominal and pelvic trauma cases in Polish EDs, challenging the traditional focus on high-risk, unstable trauma. Recognizing stable patients’ specific needs could optimize triage and resource allocation, reducing unnecessary admissions while maintaining quality care. Future guidelines should integrate protocols for stable trauma cases to improve ED efficiency and patient outcomes. <br><br><b>Significance:</b> The findings of this study underscore the need for optimized resource allocation within EDs. Given the high proportion of clinically stable, low-severity trauma cases, current triage protocols may require adaptation to ensure efficient patient management. The current study provides evidence supporting the refinement of trauma protocols, particularly for geriatric trauma patients, whose stable presentations can be misleading. Additionally, research suggests that dedicated monitoring processes for stable trauma patients could reduce preventable complications, particularly in cases involving lowenergy blunt trauma. Expanding on existing assessment tools, including modified early warning scores (MEWS) and geriatric trauma triage criteria, could help differentiate stable but at-risk patients from those who can be safely discharged.

PMID:41705379 | DOI:10.5604/01.3001.0055.4693

Categories
Nevin Manimala Statistics

Multiple magnetic abdominal foreign bodies as a near-fatal type of home trauma requiring surgical interventions – a 5-year single-center observation

Pol Przegl Chir. 2025 Oct 16;98(1):1-5. doi: 10.5604/01.3001.0055.3182.

ABSTRACT

<b>Introduction:</b> Ingestion of magnetic foreign bodies (MFBs), especially high-powered neodymium magnets, is an increasing cause of paediatric emergency visits. These magnets can lead to severe gastrointestinal injuries requiring surgical intervention.<b>Aim:</b> This study presents own experience of children admitted with multiple MFB ingestions and evaluates their long-term outcomes, including quality of life (QoL).<b>Material and methods:</b> We retrospectively analysed cases of children admitted for multiple MFB ingestion to the University Children’s Hospital in Cracow from 2020 to 2024. Patients with single MFBs were excluded. QoL was assessed using a modified version of the RAND SF-36 questionnaire. Results were compared between patients treated endoscopically and surgically. Additionally, the impact of a media awareness campaign initiated in 2021 was evaluated.<b>Results:</b> Fifteen children met the inclusion criteria; ten required surgical intervention, while five were treated successfully via endoscopy. Following the 2021 media campaign, the number of admissions decreased. QoL analysis showed better outcomes in the endoscopy group, particularly in physical and social functioning and pain. Statistically significant differences were found in emotional well-being between groups. One patient died due to unrelated causes and was excluded from the QoL survey.<b>Conclusions:</b> Prompt removal of multiple MFBs seems essential to prevent serious complications. Public education is key to early recognition and safer outcomes. Minimally invasive methods improve QoL and should be used when possible.<b>Significance for the field:</b> Rising admissions of patients with MFB ingestions need direct prevention actions and more awareness from the carekeepers.

PMID:41705375 | DOI:10.5604/01.3001.0055.3182

Categories
Nevin Manimala Statistics

Reproductive and Neurobehavioral Effects of Combined Exposure to Dinotefuran and Piperonyl Butoxide in an F1 Generation of Mice

Birth Defects Res. 2026 Feb;118(2):e70035. doi: 10.1002/bdr2.70035.

ABSTRACT

BACKGROUND: Few published studies are reported for reproductive and neurobehavioral toxicity of combined exposure to neonicotinoid insecticides and synergists in mammals. This study aimed to evaluate the reproductive and neurobehavioral effects of combined dinotefuran (DIN) and piperonyl butoxide (PBO) in an F1-generation toxicity study in mice.

METHODS: DIN and PBO were given in the diet to provide levels of 0% (control), PBO 0.03%, DIN 0.012% + PBO 0.03%, and DIN 0.024% + PBO 0.03% from 5 weeks of age of the F0 generation to 11 weeks of age of the F1 generation in mice. Selected reproductive and neurobehavioral parameters were measured in the F1 generation.

RESULTS: For exploratory behavior in the F0 generation, the number of horizontal activities increased with a statistically significant dose-related response in adult males. For exploratory behavior in the F1 generation, the total distance, movement time, average speed, and average time of movement increased with statistically significant dose-related responses in adult males. In the spontaneous behavior of males in the F1 generation, the parallel lines during the control and treatment groups indicated significant distances in the total distance, average speed, and average time of movement.

CONCLUSIONS: The dose levels of DIN with PBO in the present study affected exploratory and spontaneous behavior at lower dose levels than those observed in previous studies with the single administration of DIN and PBO. Therefore, the dose level of PBO (0.03%, approximately 44-116 mg/kg body weight/day) is estimated to have a synergistic effect on DIN exposure.

PMID:41705366 | DOI:10.1002/bdr2.70035

Categories
Nevin Manimala Statistics

Win statistics (win ratio, win odds, and net benefit): Noncollapsibility and standardization for randomized clinical trials

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

Categories
Nevin Manimala Statistics

Statistical methodologies for absolute and relative efficacy assessment based on single-arm trials: a scoping review

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

Categories
Nevin Manimala Statistics

Assessing psychological antecedents of vaccination in family health center visitors

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

Categories
Nevin Manimala Statistics

Onabotulinum Toxin A Is a Viable Intervention for Bladder Neck Obstruction in Women: A Prospective Pilot Study of Patient Reported Outcomes

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

Categories
Nevin Manimala Statistics

Installing Air Purifiers in the Homes of Children With Severe Asthma: Outcomes and Family Perspectives From a Feasibility Study

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

Categories
Nevin Manimala Statistics

Echinocandins and coagulation dysfunction events

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