Tag: statistics

HEC Forum. 2025 Nov 12. doi: 10.1007/s10730-025-09570-9. Online ahead of print.

ABSTRACT

Despite the existence of codified ethical standards in healthcare, their consistent application in clinical decision-making remains underexplored. This study quantitatively evaluates the knowledge, attitudes and practices of Moroccan healthcare professionals regarding medical ethics. Guided by a positivist epistemology and a hypothetico-deductive methodology, a validated questionnaire was administered to 200 practitioners from diverse medical backgrounds. Descriptive statistics revealed that 96% of respondents report disclosing medical errors, yet only 50% had formal exposure to medical ethics, and 51.5% were familiar with the national code of ethics. Correlation analysis indicated weak but positive associations between ethical training and disclosure practices (r ≈ 0.07). Multiple linear regression demonstrated that variables such as knowledge of ethics (β = 0.111) and training (β = 0.022) had modest, non-significant effects on ethical conduct (R² = 1.05%). Attitudinal factors, such as acceptance of placebo use (β = – 0.121, p = 0.094), showed marginal influence, while respect for patient autonomy and additional training did not significantly predict behavior. Sociodemographic variables (age, experience, rank) also lacked predictive power, though the main model constant (β ≈ 1.0, p < 0.001) suggests a generally strong ethical baseline. These findings show the importance of targeted ethics education and institutional reinforcement to strengthen ethical clinical behavior and promote transparency within the Moroccan healthcare system.

PMID:41222799 | DOI:10.1007/s10730-025-09570-9

Adv Ther. 2025 Nov 12. doi: 10.1007/s12325-025-03402-5. Online ahead of print.

ABSTRACT

INTRODUCTION: Immunoglobulin A (IgA) nephropathy is a rare renal condition associated with a high risk of kidney failure. However, conducting phase 3 clinical trials with kidney failure as a primary endpoint is generally not feasible because of sample size and protracted follow-up requirements. Hence, surrogate outcomes are necessary when assessing new treatments in randomized controlled trials. Previous meta-analyses have assessed the validity of early change in proteinuria as a surrogate endpoint, and the present research updates the analysis with additional patient-level data.

METHODS: The same methodology as two previously published individual patient-level meta-analyses was used, with additional data from the PROTECT study included. Early change in proteinuria was defined as change from baseline at 9 months, and the clinical endpoint was defined as the composite of doubling of serum creatinine level, kidney failure or death. The association of treatment effects was ascertained using individual patient data via a Bayesian mixed-effect regression model to relate treatment effects on the clinical outcome to treatment effects on proteinuria with study as the unit of analysis.

RESULTS: The updated individual patient-level meta-analysis including data from PROTECT resulted in an overall slope of 1.03 (95% Bayesian credible interval – 0.40 to 2.34) between treatment effects on early change in proteinuria versus longer-term treatment effects on the clinical outcome, with an R² of 0.80 (95% Bayesian credible interval 0.07 to1.00). This corroborates the use of early proteinuria as a valid surrogate endpoint for a treatment’s effect on progression to kidney failure in studies of IgA nephropathy.

CONCLUSIONS: The FDA and EMA have accepted proteinuria as a valid surrogate outcome for use in clinical trials of new interventions for the treatment of IgA nephropathy, and the present analysis provides further indications that interventions that reduce proteinuria in a short-term trial are likely to improve kidney outcomes over the long term.

PMID:41222790 | DOI:10.1007/s12325-025-03402-5

BJOG. 2025 Nov 12. doi: 10.1111/1471-0528.70080. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess whether Er:YAG laser is superior to sham in treating women with mild/moderate stress urinary incontinence (SUI).

DESIGN: A single blinded, multi-centre RCT comparing Er:YAG laser to sham in women with mild/moderate SUI with patients blinded to allocated treatment.

SETTING: Three urogynaecology departments in United Kingdom, Switzerland and Germany.

POPULATION OR SAMPLE: 79 participants were recruited with mild/moderate SUI.

METHODS: Participants were randomised (2 active: 1 sham) receiving 3 treatment sessions. Participants were assessed at baseline and 6 months post final treatment.

MAIN OUTCOME MEASURES: Primary outcome measure: cure defined as at least 50% reduction in 1 h pad weigh test (PWT) at 6 months compared to baseline (as per FDA guidelines).

SECONDARY OUTCOMES: Change in PWT, (ICIQ-UI SF), (PISQ-12), cough test standing and supine and visual analogue score for pain.

RESULTS: 32/51 patients (62.7%) of patients were defined as cured (per FDA guidelines) in the laser group compared with 4/23 (18.2%) cure in the sham group, p < 0.001, (OR 7.6, 2.2-25.8 95% CI). There was a statistically and clinically significant improvement in patients treated with laser in PWT, ICIQ-UI SF and PISQ-12 at 6 months (3 g, p = 0.002, 5 points, p < 0.001 and 6 points, p < 0.001, respectively). There was no evidence of statistically significant differences in the sham group.

CONCLUSIONS: This RCT demonstrates a beneficial effect of Er:YAG laser in women with mild/moderate SUI compared with sham.

TRIAL REGISTRATION: www.

CLINICALTRIALS: gov (NCT03996070).

PMID:41221700 | DOI:10.1111/1471-0528.70080

Am J Hum Biol. 2025 Nov;37(11):e70168. doi: 10.1002/ajhb.70168.

ABSTRACT

OBJECTIVES: This study investigates how marital and maternal statuses influenced female mortality in the Tang Dynasty (618-907 ce), China. It challenges the focus on reproductive risks by exploring both biological and social factors affecting female mortality in reproductive and post-reproductive years.

MATERIALS AND METHODS: Epitaph data were analyzed from four female groups: bureaucrats’ wives (married, reproductive), eunuchs’ wives (married, nonreproductive due to husband’s castration), never-married religious women (never married, nonreproductive), and widowed religious women (reproductive, later left marriage). Ages at death were illustrated using summary statistics and kernel density plots, analyzed using bootstrapped polynomial regression, pairwise comparisons with 9999 replicates, and Kaplan-Meier survival curves. Male bureaucrats and eunuchs were also included for contextual comparison.

RESULTS: Bureaucrats’ wives had a significantly lower adjusted mean age at death than nonreproductive groups, eunuchs’ wives (-7.43 years; p = 0.006), and never-married religious women (-7.07 years; p = 0.006). Survival curves support that reproductive risks shaped mortality. Among post-reproductive women, those who remained in marital roles had a significantly lower mean age at death than those who joined a religious order (-3.9 years; p = 0.003). The negative effects of remaining in marriage in later life were supported.

DISCUSSION: Female mortality resulted from a complex interplay of biological and social factors. Reproductive risks primarily affected females during younger ages. During post-reproductive years, remaining in marriage and widowhood negatively affected survival, while entering religious orders was protective.

PMID:41221699 | DOI:10.1002/ajhb.70168

J Pharm Pract. 2025 Nov 12:8971900251395191. doi: 10.1177/08971900251395191. Online ahead of print.

ABSTRACT

Background: Several strategies described in the literature regarding the role of pharmacist-led educational interventions to healthcare providers, however, evidence available on the role of education in the Emergency Department (ED) setting on discharge prescriptions is limited. The purpose of this study was to evaluate the impact of pharmacist-led education on antimicrobial prescribing at discharge from the ED. Objective: To determine whether pharmacist-led provider education improves patient outcomes by reducing medication-related errors in the ED when prescribing antimicrobials at discharge for skin and soft tissue infections (SSTIs), urinary tract infections (UTIs), and community-acquired pneumonia (CAP). Methods: This was a retrospective pre-vs post-intervention cohort study at Maimonides Medical Center (MMC). A total of 192 patients in the pre-intervention period and 181 patients in the post-intervention period were included. The primary endpoint was appropriateness of antimicrobial discharge prescriptions pre- and post-intervention. Results: In the pre-intervention period, 17.7% of patients had an SSTI, 47.4% had a UTI, and 34.9% had CAP. In the post-intervention period, 15.5% of patients had an SSTI, 51.4% had a UTI, and 33.1% had CAP. After implementation of pharmacist-led provider education, there was a statistically significant increase in the number of appropriate antimicrobial discharge prescriptions in the post-intervention period, 86.7% vs 75.5% respectively (P = .008). While there was no statistically significant difference in recurrent infections, there was a trend towards improvement in post-intervention period, 3.9% vs 5.7% respectively (P = .473). Conclusion: Pharmacist-led provider education significantly improved prescribing patterns for antimicrobial discharge prescriptions.

PMID:41221665 | DOI:10.1177/08971900251395191

Popul Stud (Camb). 2025 Nov 12:1-23. doi: 10.1080/00324728.2025.2573925. Online ahead of print.

ABSTRACT

In the absence of complete civil registration and vital statistics, Health and Demographic Surveillance Systems (HDSSs) are important sources of population-based data throughout sub-Saharan Africa. However, HDSS data on the vital status of newborns are often unreliable due to omission of those who were born and died between two rounds of data collection and are therefore never enumerated. This study investigates whether pregnancy registration improves estimation of under-five mortality (U5M) in three HDSSs in The Gambia, Kenya, and South Africa. We find that mortality is higher for children whose mother’s pregnancy was observed than for children who were first registered after birth. Cox proportional hazards models with inverse probability weights further suggest that this difference is probably due to improved ascertainment of deaths in pregnancy cohorts and unlikely to be driven by a selection effect. These results highlight the importance of pregnancy registration in HDSSs for the estimation of U5M.

PMID:41221637 | DOI:10.1080/00324728.2025.2573925

Int J Gynaecol Obstet. 2025 Nov 12. doi: 10.1002/ijgo.70620. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the association between the first-trimester aggregate index of systemic inflammation (AISI) and the risk of gestational diabetes mellitus (GDM) in women with twin pregnancies, and to evaluate the predictive value of this novel index.

METHODS: A prospective cohort study was conducted in Maternal and Child Health Hospital of Hunan Province from January 2019 to December 2024, enrolling 335 women with twin pregnancies during their first trimester of pregnancy (7-14 weeks) after exclusions. Multivariable logistic regression, restricted cubic spline (RCS) models, receiver operating characteristic (ROC) curves, subgroup analyses, and sensitivity analyses were used to evaluate associations, diagnostic effects, and consistency of the study.

RESULTS: AISI was significantly and positively associated with the risk of GDM. After fully adjusted, the risk of GDM was significantly higher in the highest quartile compared with the lowest of AISI (odds ratio [OR]: 2.11, 95% confidence interval [CI]: 2.11 [1.07-4.19]; P = 0.032). A non-linear dose-response relationship was identified (P for nonlinear = 0.020). ROC analysis demonstrated a diagnostic accuracy with an area under the curve (AUC) of 0.61 (95% CI: 0.54-0.69, cutoff point = 610.65). The associations remained consistent in sensitivity analyses and most of the subgroup analyses (P for interaction >0.05).

CONCLUSION: Elevated first-trimester AISI levels are independently associated with an increased risk of GDM in twin pregnancies. AISI may serve as a potential indicator for early prediction of GDM in this unique population.

PMID:41221622 | DOI:10.1002/ijgo.70620

Analyst. 2025 Nov 12. doi: 10.1039/d5an00937e. Online ahead of print.

ABSTRACT

Global metabolic profiles of dried blood microsamples (BμS) were studied in comparison to conventional plasma and blood samples using Gas Chromatography-Mass Spectrometry (GC-MS). Venous blood from 10 healthy, overnight-fasted individuals was collected and used to produce dried microsamples on Whatman cards, Capitainer and Mitra devices. In parallel paired plasma samples were collected. The metabolite extraction protocol was optimized and methanol was selected as the extraction solvent. Twenty µL of the venous BμS and plasma were analyzed using the Fiehn GC-MS protocol which includes methoximation and trimethylsilylation derivatization steps. In an additional study, three paired finger capillary BµS (Mitra), liquid venous blood, and plasma metabolic profiles were evaluated. BµS devices, mainly the Mitra, provided equivalent or greater information than plasma, considering it had the highest mean abundance of features and most annotated metabolites (37) with highest abundance. Additionally, in the last study, 14 metabolites had statistically higher abundance in the capillary blood Mitra BμS compared to liquid venous blood and plasma. Overall, the results suggest that BμS is a viable alternative for untargeted blood metabolomics, providing comparable information. Since the different BμS devices capture different metabolic profiles, the choice of device for a research study should be carefully considered depending on one’s goals.

PMID:41221588 | DOI:10.1039/d5an00937e

Med Decis Making. 2025 Nov 12:272989X251388633. doi: 10.1177/0272989X251388633. Online ahead of print.

ABSTRACT

ObjectivesBayesian multiparameter evidence synthesis (B-MPES) can improve the reliability of long-term survival extrapolations by leveraging registry data. We extended the B-MPES framework to also incorporate historical trial data and examined the impact of alternative external information sources on predictions from early data cuts for a trial in metastatic non-small-cell lung cancer (mNSCLC).MethodsB-MPES models were fitted to survival data from the phase III CheckMate 9LA study of nivolumab plus ipilimumab plus 2 cycles of chemotherapy (NIVO+IPI+CHEMO, v. 4 cycles of CHEMO) in first-line mNSCLC, with 1 y of minimum follow-up. Trial observations were supplemented by registry data from the Surveillance, Epidemiology, and End Results program, general population data, and, optionally, historical trial data with extended follow-up for first-line NIVO+IPI (v. CHEMO) and/or second-line NIVO monotherapy in advanced NSCLC, via estimated 1-y conditional survival. Predictions from the 3 alternative B-MPES models were compared with those from standard parametric models (SPMs).ResultsB-MPES models better anticipated the emergent survival plateau with NIVO+IPI+CHEMO that was apparent in the 4-y data cut compared with SPMs, for which short-term extrapolations in both treatment arms were overly conservative. However, the B-MPES model incorporating NIVO+IPI data slightly overestimated 4-y NIVO+IPI+CHEMO survival owing to a confounding effect on estimated hazards that could not be accounted for a priori until later data cuts of CheckMate 9LA. Extrapolations were relatively robust to the choice of external data sources provided that the prior data had been adjusted to attenuate confounding.ConclusionsIncorporating historical trial data into survival models can improve the plausibility and interpretability of lifetime extrapolations for studies of novel therapies in metastatic cancers when data are immature, and B-MPES provides an appealing method for this purpose.HighlightsLeveraging historical trial data with extended follow-up to extrapolate survival from early study data cuts in a Bayesian evidence synthesis framework can realize anticipated longer-term effects that are characteristic of a novel therapy or class thereof.Using moderately confounded external data sources can improve the reliability of survival extrapolations from B-MPES models provided that the prior information is adjusted and rescaled appropriately, but it is essential to rationalize the implicit assumptions surrounding longer-term treatment effects in the current study.B-MPES models are an attractive option to conduct informed lifetime survival extrapolations based on transparent clinical assumptions via leveraging multiple external data sources, but model flexibility and a priori confidence in external data must be specified carefully to avoid overfitting.

PMID:41221583 | DOI:10.1177/0272989X251388633

Int J Gynaecol Obstet. 2025 Nov 12. doi: 10.1002/ijgo.70652. Online ahead of print.

ABSTRACT

OBJECTIVE: Selective reporting of research results based on statistical significance compromises research validity, potentially misleading clinical decision-making and future research. In obstetrics, the extent of this issue remains unclear. This study aimed to characterize the frequency, patterns, and temporal trends in the reporting of P-values, effect sizes, and statistically significant results in abstracts of obstetric studies from 2013 to 2023.

METHODS: We retrieved abstracts in the field of obstetrics between January 1, 2013, and December 31, 2023, from Medline, Embase and Cochrane CENTRAL. Automated text-mining was performed to detect and extract reporting of statistical inference, including P-values, effect sizes, Bayesian-related statistics, confidence intervals, and textual descriptions. The extracted statistical inferences were analyzed to assess trends over time and overall distribution, as well as specific patterns across different study designs.

RESULTS: A total of 23 167 eligible obstetric studies were identified from 46 788 abstracts. The proportion of abstracts reporting only P-values remained relatively stable over time, from 28.5% (95% confidence interval [CI]: 26.5%-30.5%) in 2013 to 27.6% (95% CI: 25.7%-29.5%) in 2023. There was a consistent rise in the proportion of abstracts reporting effect sizes, whether alone or alongside P-values, increasing from 22.1% (95% CI: 20.3%-24.0%) in 2013 to 39.5% (95% CI: 37.4%-41.7%) in 2023. Abstracts that reported neither P-values nor effect sizes decreased from 49.4% (95% CI: 47.2%-51.6%) in 2013 to 32.9% (95% CI: 30.8%-34.9%) in 2023. Most reported P-values clustered around common cut-offs, with 30.7% at 0.001 and 31.5% at 0.05. Among abstracts that reported statistical significance, 89.0% (95% CI: 87.4%-90.5%) reported a statistically significant difference, and the trend has remained stable over the past decade. Randomized controlled trials reported a lower proportion of statistically significant statements (82.4%, 95% CI: 75.9%-88.8%) than other study types.

CONCLUSION: Although the reporting of effect sizes has gradually increased over time, the use of standalone P-values remains common. The consistently high proportion of abstracts presenting at least one statistically significant result might reflect entrenched reporting practices in the field.

PMID:41221575 | DOI:10.1002/ijgo.70652