Category: Statistics

Eur J Pharm Sci. 2025 Sep 4:107258. doi: 10.1016/j.ejps.2025.107258. Online ahead of print.

ABSTRACT

Lysophosphatidylcholine (LPC) has been the subject of research for many years, but its role in lipid turnover is still not fully understood, neither its role in cancer development and progression. A crucial aspect in LPC research is its efficient and fast extraction from plasma and tissues to use LPC as a biomarker in clinical settings. The extraction methods commonly in use like Bligh & Dyer require the use of toxic halogenated solvents and are time consuming due to multiple extraction steps and subsequent solvent evaporation. In this study, a new, salt-assisted one-step extraction protocol, which avoids halogenated solvents, is presented. Saturated ammonium acetate solution was used as a salt component and acetonitrile:isopropanol (2.5:1 v/v) as eluent. The new extraction is characterized by its simplicity, robustness and short total extraction time of 18 minutes. For validation according to the ICH M10 guideline for bioanalytical method validation, LPC species extracted from plasma were quantified by LC-MS/MS, using LPC 19:0 as internal standard. In addition to these advantages, the new extraction procedure showed a slightly but statistically significant better recovery compared to Bligh & Dyer (93.2% vs. 87.5%; p<0.05; n = 5), as shown by a t-test. The applicability of the new method was demonstrated in a pilot study, in which the plasma of 15 healthy volunteers was analyzed for its content of various LPC types.

PMID:40914465 | DOI:10.1016/j.ejps.2025.107258

Am Heart J. 2025 Sep 4:S0002-8703(25)00320-5. doi: 10.1016/j.ahj.2025.08.020. Online ahead of print.

ABSTRACT

BACKGROUND: Current recommendations for a prophylactic (primary prevention) implantable cardioverter defibrillator (ICD) in patients with both ischemic and non-ischemic heart failure with reduced ejection fraction (HFrEF) originate from clinical trials conducted in selected patients over 20 years ago that showed an overall statistically significant survival benefit associated with a primary prevention ICD in the range of 23%-34%. The recent introduction of angiotensin receptor-neprilysin inhibitors [ARNI] and sodium glucose co-transporter 2 inhibitors [SGLT2i]) was shown to further reduce the risk of sudden cardiac death (SCD) in patients with HFrEF. Thus, there is an unmet need appropriately designed comparative effectiveness clinical trials aimed to reassess the survival benefit of a primary prevention ICD in contemporary patients with HFrEF.

METHODS: The Comparative Effectiveness of ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients at a Low Risk for Arrhythmic Death (CONTEMP-ICD) trial is a prospective, multicenter, open-label, randomized-controlled trial; enrolling 3290 participants with HFrEF who are treated with optimal stable GDMT and are eligible for a primary prevention ICD, but have a lower predicted risk of life-threatening ventricular tachyarrhythmia (VTA) than non-arrhythmic mortality. Enrolled participants will be randomized to Non-ICD vs. ICD treatment arms and will be followed over an average period of 3.5 years. The Specific Aims of the proposed clinical trial are to: 1) Compare the risk of all-cause mortality of Non-ICD vs. ICD in HFrEF patients who have a lower predicted risk of VTA than non-arrhythmic mortality per the MADIT-ICD Benefit Score; 2) Evaluate whether Non-ICD vs. ICD is associated with improved survival free of major CV events in patients with HFrEF who are at a lower predicted arrhythmic risk; 3) Assess healthcare utilization and quality of life implications of Non-ICD vs. ICD management approaches in HFrEF patients who are at a lower predicted arrhythmic risk; and 4) Determine the effect of Non-ICD vs. ICD management on all-cause mortality in prespecified subgroups.

CONCLUSIONS: We hypothesize that, in patients with HFrEF who are at a lower predicted arrhythmic risk, Non-ICD vs. ICD is non-inferior with respect to the primary endpoint of all-cause mortality and superior with respect to the secondary endpoint of survival free of major CV events. NCT06543446; https://contemp-icd.org.

PMID:40914445 | DOI:10.1016/j.ahj.2025.08.020

J Food Prot. 2025 Sep 4:100614. doi: 10.1016/j.jfp.2025.100614. Online ahead of print.

ABSTRACT

Escherichia coli O157:H7 is a significant foodborne pathogen with global public health implications. This study, conducted from December 2022 to July 2023 in Hawassa and Yirgalem, Sidama Region, Ethiopia, assessed the prevalence, molecular identification, and antimicrobial resistance of E. coli O157:H7 in animal-derived foods. A total of 298 samples including beef, raw milk, and fish were analyzed using culture methods, biochemical identification, and PCR. The overall prevalence of E. coli O157:H7 was 3.7%, with isolation rates of 6.25% in fish and 5.6% in beef; no isolates were found in milk samples (p = 0.036). Notably, meat from butcher shops exhibited a higher contamination rate (7.6%) compared to abattoir samples (3.4%), though this difference was not statistically significant (p = 0.445). Among fish samples, Nile Tilapia had a higher isolation rate (8.1%) than African Catfish (3.7%), with fish skin showing greater contamination (8.6%) than muscle tissue (3.4%). All E. coli O157:H7 isolates were susceptible to most tested antibiotics; however, resistance was observed against amoxicillin (81.8%), streptomycin (45.5%), and clindamycin (100%). Additionally, 45.5% of isolates exhibited multidrug resistance with an multidrug resistance (MDR) index of 0.27, though none produced extended-spectrum beta-lactamases (ESBL). These findings underscore the necessity for stringent hygiene practices and effective monitoring of animal-derived foods to mitigate public health risks.

PMID:40914432 | DOI:10.1016/j.jfp.2025.100614

Neurol Ther. 2025 Sep 6. doi: 10.1007/s40120-025-00824-9. Online ahead of print.

ABSTRACT

INTRODUCTION: Migraine headache not only is associated with high levels of suffering but also represents a considerable socioeconomic challenge. It is linked to various psychological and physiological impairments, including sensorimotor and somatosensory dysfunction, like those observed in other persistent pain syndromes. This study aims to determine whether individuals with high-frequency episodic (HFEM) or chronic migraine (CM) exhibit differences in somatosensory perception compared to healthy individuals and to explore potential correlations with neuropsychological features.

METHODS: Using a cross-sectional design, we assessed individuals with HFEM or CM (n = 45) and healthy controls (n = 25) using quantitative sensory testing (QST), conditioned pain modulation testing and neuropsychological questionnaires such as the Central Sensitization Inventory (CSI) and the Toronto Alexithymia Scale (TAS-20).

RESULTS: Data from 45 participants (39 females) with HFEM or CM and a healthy control group of 25 individuals (21 female) were analysed. Median (range) number of monthly headache days of was 12.3 (6) in the migraine group. Statistically significant differences were found only in the assessment of central sensitization (p < 0.0010) but not for QST parameters. Correlations with QST parameters were generally weak, only the wind-up ratio (WUR) showing weak to moderate monotonic associations with both emotion- and somatosensory-associated parameters.

CONCLUSION: Overall, the results provided no evidence of significant differences between the migraine and healthy control groups. The lack of significant differences might be attributed to methodological limitations. However, the comprehensive and standardized implementation of QST strictly following the protocol of the German Research Network on Neuropathic Pain (DFNS), the selection of robust questionnaires, uniform diagnostic criteria and rigorous statistical analysis represent methodological strengths and support the validity of the results. Nevertheless, these findings, which partly contrast with existing literature, may reflect limitations of the sample and methodology and should be interpreted with caution.

PMID:40913749 | DOI:10.1007/s40120-025-00824-9

Eur J Nutr. 2025 Sep 6;64(6):272. doi: 10.1007/s00394-025-03796-6.

ABSTRACT

BACKGROUND: The UK has a high and increasing prevalence of folate deficiency. The decision to start mandatory folic acid fortification has not yet been implemented. Concern has been raised about the effect of high folate on vitamin B12 status.

METHODS: The prevalence of folate deficiency was assessed based on the serum folate concentrations from 47,240 samples collected between August 2023 and January 2025 (provided to us as anonymised data, measured in a UK-based contract laboratory using an immunochemical analyser). In 39,374 individuals, both serum folate and holotranscobalamin (holoTC) (‘active’ vitamin B12) concentrations were available, and were used to determine if high folate status had a negative impact on active vitamin B12 concentrations.

RESULTS: For women of reproductive age (16-50 y), 72.7% had serum folate concentration lower than 24.3 nM/L for protection against neural tube defects. For young adult women (21-25 y) this percentage was 85.5%. The top decile, across all samples (mean serum folate = 43.9 nM/L, range 38.4- > 45 nM/L, n = 3935), had on average also a high holoTC concentration (119.2 pM/L) and no increased risk of vitamin B12 deficiency.

CONCLUSION: Young women are especially a risk of low folate status. We found no evidence that high folate affects vitamin B12 status.

PMID:40913719 | DOI:10.1007/s00394-025-03796-6

Sports Med. 2025 Sep 6. doi: 10.1007/s40279-025-02304-4. Online ahead of print.

ABSTRACT

BACKGROUND: Physical training influences competitive marathon performance, including training volume and training frequency changes (TFCs) pre-race. Training intensity distribution (i.e., steady-state, quality sessions, interval training) and cross-training contribute to volume and TFCs that may influence performance.

OBJECTIVE: The aim of this study is to assess the relationships among training and TFCs preceding the 2022 Boston Marathon and race performance.

METHODS: Adult 2022 Boston Marathon registrants were contacted via email 1 month pre-race. Athletes reported demographics, training/racing experience, and training pre-race. TFCs were calculated by comparing two timeframes: 12-4 and 4-0 month pre-race training. Official race performance was obtained from chip timing data and demographics. Separate linear regressions were used to assess the effects of training and cross-training in 12-4 and 4-0 months pre-race and TFCs on performance, accounting for experience and demographics.

RESULTS: In total, 917 athletes were included (female: n = 495, 3:53 ± 0:37 h race times, 64.4 ± 24 km/week weekly distance; male: n = 422; 3:35 ± 0:39 h race times, 67.6 ± 26.2 km/week weekly distance). Higher running distance/week, running sessions/week (n), quality sessions/week (“hard sessions”; n), average distance in the 12-4 and 4-0 months pre-race (p ≤ 0.050), and more cross-training (p < 0.001) in the 4-0 months pre-race were associated with faster times and performance. Runners with TFCs of decreased running sessions/week (p = 0.035) had faster times and better performance versus athletes who maintained/increased volume.

CONCLUSION: Habitually higher training exposure 12-4 and 4-0 months, but relatively reduced training frequency 4-0 months pre-race, contributed to better marathon performance.

PMID:40913707 | DOI:10.1007/s40279-025-02304-4

Drug Saf. 2025 Sep 6. doi: 10.1007/s40264-025-01602-0. Online ahead of print.

ABSTRACT

BACKGROUND: Problems with medication management are consistently identified as key concerns for the quality of residential aged care (RAC). Incident reports can provide valuable information on key issues related to medication management; however, few studies have explored medication incidents in RAC settings.

OBJECTIVES: To investigate the characteristics of medication incidents at different stages of medication management and identify the risk factors associated with incidents.

METHODS: A retrospective longitudinal cohort study was conducted using medication incidence data from 25 RAC facilities in New South Wales, Australia. All medication incidents between 1 July 2014 and 31 August 2021 relating to 5709 aged care residents aged ≥ 65 years were included. The outcome measure was the medication incidence rate (IR), quantified as the number of medication incidents per 1000 resident days. A multilevel Poisson regression model was performed to identify risk factors associated with exposure to medication incidents.

RESULTS: A total of 5708 medication incidents were analysed. The overall medication IR was 1.81 per 1000 resident days (95% CI 1.76, 1.86). Of 5709 residents, 35% (n = 2016) had at least one recorded medication incident, of which 1095 (> 50%) had more than one. The majority of the incidents were associated with medication administration (3023 incidents, 53%), followed by supply (n = 1546, 27%) and monitoring the response to the medication (n = 548, 9.6%). The outcome of the incident on residents was reported in 5165 (90%) incidents, with 724 (14%) requiring the resident to be monitored by the hospital, general practitioner (GP), or staff. Respite admissions were associated with a higher risk of medication incidents including potentially harmful incidents, compared with permanent admissions (rate ratio (RR) = 1.908, 95% CI 1.646, 2.211, p < 0.01). Residents with Parkinson’s disease had a 1.5-fold greater risk of a medication incident (RR = 1.586, 95% CI 1.318, 1.908) compared with residents without Parkinson’s. The administration of more than five medications (polypharmacy) was associated with an increased risk of medication incidents (RR = 2.019, 95% CI 1.930, 2.111).

CONCLUSIONS: Medication incidents affected more than one-third of older adults in RAC facilities. Improvement strategies should focus on medication administration, supply and monitoring, with particular attention given to respite residents and those with multimorbidity and polypharmacy.

PMID:40913687 | DOI:10.1007/s40264-025-01602-0

J Endocrinol Invest. 2025 Sep 6. doi: 10.1007/s40618-025-02654-w. Online ahead of print.

ABSTRACT

PURPOSES: Controversy has emerged regarding the impact of non-nutritive sweeteners (NNS) on body weight. This systematic review and meta-analysis of randomized controlled trials aims to assess the effect of NNS intake on body weight change.

RESULTS: Of the 3327 studies retrieved, 19 met the eligibility criteria for inclusion in the meta-analysis. Compared to the control group, the experimental group that replaced daily caloric sugars with NNS showed significant weight change (MD = -0.79 kg; 95% CI: [-1.55, -0.04]; P = 0.04; I² = 84) When grouped by study duration, the effect of NNS intervention on weight change was significant in studies lasting less than 18 weeks (MD = -0.91 kg; 95% CI: [-1.70, -0.12]; P = 0.02), but minimal in studies longer than 18 weeks (P = 0.51). According to the weight status of the participants, the effect of NNS on body weight was statistically significant only in the normal weight group (MD = -0.97 kg; 95% CI: [-1.40, -0.54]; P < 0.01) and the mixed weight group (comprising normal and overweight individuals) (MD= -1.59 kg, 95% CI: [-2.62, -0.57]; P < 0.01), not in the obese group (MD = -0.646 kg; 95% CI: [-1.839, 0.546]; P = 0.29). In the comparator group, NNS had a greater effect only when compared with caloric sugars (MD= -0.94 kg, P = 0.04). Significant weight differences were also observed in the population with diabetes (MD = -1.56 kg, P < 0.01), but not in the nondiabetic population.

CONCLUSION: Our study indicates that replacing sugar with NNS leads to weight loss, particularly in normal-weight participants who received the intervention for less than 18 weeks and those with diabetes. For the overweight, it is still advisable to focus on active weight intervention strategies, using NNS only as an auxiliary measure to replace the caloric sugars in the daily diet during weight intervention. This information can inform evidence-based clinical decision-making.

PMID:40913681 | DOI:10.1007/s40618-025-02654-w

Rheumatol Int. 2025 Sep 6;45(9):220. doi: 10.1007/s00296-025-05977-2.

ABSTRACT

Familial Mediterranean Fever (FMF) is frequently diagnosed during reproductive ages, but its impact on pregnancy remains unclear. We aimed to evaluate maternal and neonatal outcomes in FMF pregnancies by comparing before and after diagnosis periods as well as with healthy controls, and to identify predictors of adverse outcomes. This retrospective, cross-sectional study included 215 pregnancies (129 before and 86 after FMF diagnosis) from 81 women with FMF and 94 pregnancies from 42 healthy controls. Demographic data, disease characteristics, medications, and genetic mutations were recorded. Maternal and neonatal outcomes were compared, and multivariate logistic regression was used to identify predictors of adverse maternal outcomes. After FMF diagnosis, live birth occurred in 69 cases (80.2%), miscarriage in 15 (17.4%), and stillbirth in 2 (2.3%). In contrast, before diagnosis, live birth occurred in 104 cases (80.6%), miscarriage in 17 (13.4%), and stillbirth in 7 (5.4%). Among pregnancies after diagnosis, cesarean section was more frequent (38 cases, 53.5% vs. 29 cases, 25.9%, p < 0.001), as well as adverse maternal outcomes (58 cases, 67.4% vs. 63 cases, 48.8%, p = 0.007), compared to before diagnosis. Compared with controls, FMF patients showed no significant differences in maternal or neonatal outcomes. Among 86 pregnancies after diagnosis, colchicine was used in 66 (76.7%), and FMF flares were reported in 22 cases (31.9%) among pregnancies resulting in live birth, most commonly during the second trimester. Logistic regression identified older maternal age (OR 1.12, 95% CI: 1.02-1.25, p = 0.02) and disease flares before pregnancy (OR 6.96, 95% CI: 1.40-34.58, p = 0.02) as independent predictors of adverse maternal outcomes. Maternal and neonatal outcomes in FMF pregnancies were comparable to those in controls. Advanced maternal age and disease activity before conception were identified as independent predictors of adverse maternal outcomes.

PMID:40913658 | DOI:10.1007/s00296-025-05977-2

Arch Gynecol Obstet. 2025 Sep 6. doi: 10.1007/s00404-025-08159-4. Online ahead of print.

ABSTRACT

BACKGROUND: Polycystic ovary syndrome (PCOS) is characterized by reproductive and endocrine abnormalities.

OBJECTIVE: The present study aimed to assess the effect of oral contraceptive pills (OCPs) and vitamin D3 on sexual dysfunction in women with PCOS and vitamin D3 deficiency.

MATERIALS AND METHODS: This randomized double-blind placebo-controlled clinical trial was conducted in Iran between January and April 2019. The Female Sexual Function Index (FSFI) and Beck Depression Inventory (BDI) questionnaires were filled out for all participants and their serum levels of vitamin D3 were measured. Women with PCOS and vitamin D3 deficiency were divided into 2 equal groups (A and B) with a table of random numbers (n = 35/ each). Both groups were given vitamin D3 (50,000 IU/w) for 12 week. The case group was given low-dose OCP for 3 months and a similar placebo was given to the control group. Vitamin D3 level and sexual function were assessed in both groups at 3 and 6 months after taking OCP.

RESULTS: There was no statistically significant difference between the two groups in demographic characteristic such as weight (69.54 ± 10.34 vs 70.17 ± 10.60, P = 0.803). Both groups treated with vitamin D3 exhibited increased sexual function scores at the beginning of the study (P = 0.03) and 3 months (P = 0.01) after taking OCP. Examination of sexual function variables showed that sexual desire in the control group was greater than in the OCP-treated group at 3 (P = 0.009) and 6 (P = 0.01) months after entering the study.

CONCLUSION: The results of the study showed that the score of women’s sexual performance increased in all areas, especially in the area of sexual desire, with the use of vitamin D3. The simultaneous use of OCP with vitamin D3 to improve sexual performance in these women had no significant difference with the use of vitamin D3 alone. According to the research findings, it is recommended that vitamin D3 supplementation can be used to increase the quality of life and improve sexual function in PCOS women.

PMID:40913650 | DOI:10.1007/s00404-025-08159-4