Tag: statistics

Gut Microbes. 2025 Dec;17(1):2479772. doi: 10.1080/19490976.2025.2479772. Epub 2025 Mar 18.

ABSTRACT

Socioeconomic position (SEP) in childhood and beyond may influence the gut microbiome, with implications for disease risk. Studies evaluating the relationship between life-course SEP and the gut microbiome are sparse, particularly among Hispanic/Latino individuals, who have a high prevalence of low SEP. We use the Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a population-based cohort study conducted in four field centers in the United States (U.S.), to evaluate the association between life-course SEP and gut microbiome composition. Life-course SEP indicators included parental education (proxy of childhood SEP), current SEP (n = 2174), and childhood (n = 988) and current economic hardship (n = 994). Shotgun sequencing was performed on stool samples. Analysis of Compositions of Microbiomes was used to identify associations of life-course SEP indicators with gut microbiome species and functions. Parental education and current SEP were associated with the overall gut microbiome composition; however, parental education and current education explained more the gut microbiome variance than the current SEP. A lower parental education and current SEP were associated with a lower abundance of species from genus Bacteroides. In stratified analysis by nativity, we found similar findings mainly among foreign-born participants. Early-life SEP may have long-term effects on gut microbiome composition underscoring another biological mechanism linking early childhood factors to adult disease.

PMID:40102030 | DOI:10.1080/19490976.2025.2479772

BMJ Paediatr Open. 2025 Mar 18;9(1):e003267. doi: 10.1136/bmjpo-2024-003267.

ABSTRACT

BACKGROUND: Despite evidence demonstrating clinical and cost benefits of transanastomotic tubes (TATs), following repair of congenital duodenal obstruction they are used in a minority of infants in the UK. Most infants are fed using parenteral nutrition (PN) (sometimes in combination with a TAT). This variation is unexplained by clinical or demographic factors. We aimed to understand why this is and the barriers to practice change.

METHODS: UK-based clinicians (surgeons, neonatologists, dietitians and specialist nurses) completed an online mixed methods survey. Open-ended replies were summarised thematically. Data were analysed using descriptive and inferential statistics.

RESULTS: 109 clinicians (24 neonatologists, 7 nurses, 3 dietitians, 75 surgeons) from all 25 UK neonatal surgical units completed the survey. 88% (n=96/109) stated TAT use was decided solely by surgeons, driven primarily by considerations of providing appropriate nutrition and risks; 36% of surgeons felt TATs should always be used where possible. Decisions about central venous catheters (CVCs) were made by neonatologists (28%, n=31/109), surgeons (17%, n=18/109), jointly (48%, n=52/109) or ‘other’ (7%, n=8/109). Neonatologists and surgeons prioritised providing appropriate nutrition and risks when deciding whether to use CVCs/PN; surgeons rated a lack of supporting research and TATs’ risks as key barriers to TAT usage. Costs and parents’ preferences had limited influence on TAT and PN usage.

CONCLUSIONS: Increased TAT usage requires surgeons to be persuaded of TATs’ efficacy and safety, and neonatologist recognition that exclusive TAT feeding (ie, without CVCs/PN) can provide adequate nutrition. Further work is required to appreciate how best to achieve this.

PMID:40102024 | DOI:10.1136/bmjpo-2024-003267

Dtsch Arztebl Int. 2025 May 16;(Forthcoming):arztebl.m2025.0035. doi: 10.3238/arztebl.m2025.0035. Online ahead of print.

ABSTRACT

BACKGROUND: The analysis of a study with Bayesian statistics makes use of additional information to supplement the new study data. In this review, we explain the principles of the application of this method in clinical research.

METHODS: The concept of Bayesian statistics is introduced and explained with the aid of an illustrative example from a drug approval study. Its major aspects are discussed. The existing prior knowledge is formulated as a probability distribution of an odds ratio. Multiple scenarios are shown to demonstrate how a suitable prior distribution is determined and how it can affect the final result.

RESULTS: Bayesian statistics makes use of prior knowledge, e.g., the findings of earlier clinical trials, and combines the prior probability distribution with the findings of the current study for statistical analysis. The suitability and applicability of the prior knowledge in question must be assessed and the prior knowledge weighted accordingly, and any uncertainties must be taken into account in the analysis. The result that is derived is called the posterior distribution of the parameters of interest and is summarized in terms of point estimators and credibility intervals. In contrast to classical statistics, results of this type permit direct quantitative statements on the probability of parameter values and on the probabilities of the null and alternative hypotheses (in one-sided statistical tests).

CONCLUSION: Combining the current study findings with prior knowledge can enable the more precise estimation of a treatment effect, or else lessen the number of subjects needed for a clinical trial. Central elements of Bayesian statistics are the selection and weighting of prior knowledge; subjective judgements must be made. Bayesian techniques require a precise description of the methods applied, meticulous study of the available literature, and experience in the mathematical representation of the results.

PMID:40101264 | DOI:10.3238/arztebl.m2025.0035

Blood Adv. 2025 Mar 18:bloodadvances.2025015793. doi: 10.1182/bloodadvances.2025015793. Online ahead of print.

ABSTRACT

Allogeneic hematopoietic cell transplantation (allo-HCT) is potentially curative for older adults with hematologic malignancies. Concerns about non-relapse mortality (NRM) in older adults limit allo-HCT utilization. We executed a prospective, observational study (BMT-CTN 1704) enrolling allo-HCT recipients aged ≥60 years from 49 centers in the U.S. We analyzed associations between 13 measurements of older adult health and NRM within 1-year to construct a comprehensive health assessment risk model (primary-CHARM) using amultivariate Fine-Gray model and grouped penalized variable selection. Two (Cox and pseudovalue Boosting) Machine-Learning (ML) models were also explored. Models’ performances were compared using area under the receiver operating curve (AUC), with bootstrap and crossvalidation sampling to correct for optimism, decision-curve analysis (DCA), calibration, and Brierscores. Among 1105 patients with median age of 67 years (range 60-82) who received alloHCT, NRM was 14.4% and overall survival (OS), 71.7% at 1-year. Factors statistically selected for inclusion in primary-CHARM were: higher comorbidity-burden, lower albumin, higher Creactive protein, older age, higher weight loss percentage, lower patient-reported performance score, and cognitive impairment. Primary-CHARM scores were independently associated with higher NRM (hazard ratio [HR]:2.72, p<0.0001) and worse OS (HR:2.09, p<0.0001). Bootstrap bias-corrected AUC for primary-CHARM was 0.591. Comparing primary-CHARM to HCTcomorbidity index and 2 ML-CHARM models, calibration, Brier score, and DCA analysis favored primary-CHARM. The primary-CHARM, comprised of mostly simple and readily available parameters, risk-stratifies older adults for allo-HCT. Adopting primary-CHARM in practice maypromote broader use of HCT by quantifying risk and enhance the design of strategies to improve outcomes. Clinicaltrials.gov number: (NCT03992352).

PMID:40101246 | DOI:10.1182/bloodadvances.2025015793

JMIR Public Health Surveill. 2025 Mar 18;11:e62828. doi: 10.2196/62828.

ABSTRACT

BACKGROUND: Well-designed public health messages can help people make informed choices, while poorly designed messages or persuasive messages can confuse, lead to poorly informed decisions, and diminish trust in health authorities and research. Communicating uncertainties to the public about the results of health research is challenging, necessitating research on effective ways to disseminate this important aspect of randomized trials.

OBJECTIVE: This study aimed to evaluate people’s understanding of overall and statistical uncertainty when presented with alternative ways of expressing randomized trial results.

METHODS: Two parallel, web-based, individually randomized trials (3×2 factorial designs) were conducted in the United States and Norway. Participants were randomized to 1 of 6 versions of a text (summary) communicating results from a study examining the effects of wearing glasses to prevent COVID-19 infection. The summaries varied in how overall uncertainty (“Grading of Recommendations Assessment, Development and Evaluation [GRADE] language,” “plain language,” or “no explicit language”) and statistical uncertainty (whether a margin of error was shown or not) were presented. Participants completed a web-based questionnaire exploring 4 coprimary outcomes: 3 to measure understanding of overall uncertainty (benefits, harms, and sufficiency of evidence), and one to measure statistical uncertainty. Participants were adults who do not wear glasses recruited from web-based research panels in the United States and Norway. Results of the trials were analyzed separately and combined in a meta-analysis.

RESULTS: In the US and Norwegian trials, 730 and 497 individuals were randomized, respectively; data for 543 (74.4%) and 452 (90.9%) were analyzed. More participants had a correct understanding of uncertainty when presented with plain language (United States: 37/99, 37% and Norway: 40/76, 53%) than no explicit language (United States: 18/86, 21% and Norway: 34/80, 42%). Similar positive effect was seen for the GRADE language in the United States (26/79, 33%) but not in Norway (30/71, 42%). There were only small differences between groups for understanding the uncertainty of harms. Plain language improved correct understanding of evidence sufficiency (odds ratio 2.05, 95% CI 1.17-3.57), compared to no explicit language. The effect of GRADE language was inconclusive (odds ratio 1.34, 95% CI 0.79-2.28). The understanding of statistical uncertainty was improved when the participants were shown the margin of error compared to not being shown: Norway: 16/75, 21% to 24/71, 34% vs 1/71, 1% to 2/76, 3% and the United States: 21/101, 21% to 32/90, 36% vs 0/86, 0% to 3/79, 4%).

CONCLUSIONS: Plain language, but not GRADE language, was better than no explicit language in helping people understand overall uncertainty of benefits and harms. Reporting margin of error improved understanding of statistical uncertainty around the effect of wearing glasses, but only for a minority of participants.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05642754; https://tinyurl.com/4mhjsm7s.

PMID:40101228 | DOI:10.2196/62828

Braz J Cardiovasc Surg. 2025 Mar 18;40(2):e20240049. doi: 10.21470/1678-9741-2024-0049.

ABSTRACT

INTRODUCTION: Penetrating cardiac injury, though infrequent, is associated with substantial mortality. In 2005, our research team conducted a comprehensive retrospective analysis of penetrating cardiac injuries managed at our facility from 1990 to 2003. Now, two decades later, we conducted the present study on penetrating cardiac injuries attended in our hospital over the last 20 years.

METHODS: This is a retrospective analysis of medical records and trauma database data, with a focus on survivors of penetrating cardiac trauma, excluding those deceased upon arrival.

RESULTS: Out of 1,093 cases, 25 had penetrating cardiac injuries with an overall mortality rate of 36%. Hemorrhage was the leading cause of death, and survival was correlated with higher systolic blood pressure upon admission and the level of consciousness.

CONCLUSION: The study highlights the need for rapid intervention and emphasizes the importance of managing bleeding and supporting hemodynamics. It also points to areas for improvement in emergency care and the benefits of interdisciplinary collaboration.

PMID:40101197 | DOI:10.21470/1678-9741-2024-0049

Braz J Cardiovasc Surg. 2025 Mar 18;40(2):e20230503. doi: 10.21470/1678-9741-2023-0503.

ABSTRACT

INTRODUCTION: Cardiopulmonary bypass is known to be a cause of systemic inflammatory response. The systemic inflammatory response affects albumin and lymphocyte levels and is associated with the development of complications. Serum albumin and lymphocyte concentrations have been used to create inflammation-based risk scores, which predict prognosis in different patient groups. One of these risk scores is called the Prognostic Nutritional Index (PNI). In this study, our objective was to examine how changes in PNI values, measured at different times before and after surgery, impact clinical outcomes and hospital mortality.

METHODS: One hundred and sixty-four patients were retrospectively scanned and included in the study. Patients were divided into aortic valve replacement (AVR) and mitral valve replacement (MVR) groups. The patient’s preoperative and postoperative PNI values were examined. Duration of cross-clamping, cardiopulmonary bypass time, length of hospital and intensive care unit stay, postoperative mortality, atrial fibrillation, and acute kidney injury (AKI) development were evaluated.

RESULTS: Preoperative and second PNI values were lower in the patients that developed AKI and non-survivors. The PNI cutoff value was ≤ 28.01 in non-survivors (P=0.001). In the MVR group, the decrease in PNI value over time was statistically significant (P<0.001). There was a negative correlation between preoperative PNI value and length of stay in intensive care unit, cross-clamping, and cardiopulmonary bypass duration (P<0.05, P<0.01).

CONCLUSION: A correlation was determined between the PNI value and development of postoperative AKI and mortality. PNI value, an easy method to use, can be used in the follow-up of these patients.

PMID:40101188 | DOI:10.21470/1678-9741-2023-0503

Braz J Cardiovasc Surg. 2025 Mar 18;40(2):e20230469. doi: 10.21470/1678-9741-2023-0469.

ABSTRACT

OBJECTIVE: To assess the technical feasibility and functional, metabolic, and structural myocardial integrity of the donor heart after four hours of direct coronary oxygen persufflation (COP).

METHODS: This research was carried out on three-month-old minipig siblings weighing 23-36 kg. Cardiac arrest was achieved by administrating two liters of Bretschneider’s cardioplegic solution (histidine-tryptophan-ketoglutarate [HTK]) (Custodiol®, Germany) into the aortic root. Orthotopic heart transplantation was performed after three hours of cardiac arrest.

RESULTS: A statistically significant decrease in cardiac output was observed in both groups (from 3.36 ± 0.36 l/min and 3.72 ± 0.52 l/min in the HTK group and modified HTK + COP to 2.35 ± 0.52 l/min and 2.15 ± 0.34 l/min, respectively) (Р<0.05). Differences between both groups were insignificant (P>0.05). Cardiac output was 2.99 ± 0.45 l/min and 2.48 ± 0.58 l/min (Р>0.05) in both groups after 120 min of cardiac recovery. Lactate dehydrogenase, creatine phosphokinase-MB, and troponin I changes in coronary sinus blood were significantly higher in the early reperfusion period. Statistical insignificance was observed between both groups (P>0.05). Myocardial oxygen consumption was 8.2 [7.35; 9.35] ml-О2/min/100 g and 7.7 [6.75; 10.12] ml-О2/min/100g in both groups (P>0.05). Histological examinations demonstrate no significant myocardial ischemic injury in the persufflation group.

CONCLUSION: The study demonstrated technical feasibility and safety of direct coronary persufflation for four hours during ex vivo donor heart conditioning. However, no significant advantages of direct COP were observed over the standard cold preservation protocol.

PMID:40101187 | DOI:10.21470/1678-9741-2023-0469

Urol Pract. 2025 Mar 18:101097UPJ0000000000000814. doi: 10.1097/UPJ.0000000000000814. Online ahead of print.

ABSTRACT

PURPOSE: This study aims to characterize payments by drug and medical device manufacturers to current program directors (PD) of the Society of Urologic Oncology (SUO)-accredited fellowship programs in the United States (US).

METHODS: PDs were identified from SUO fellowship websites as of February 2024. Demographic data, educational background, and scholarly metrics were collected via an online search. Industry payments SUO PDs from 2014 to 2023 were extracted from the Open Payments database. Descriptive statistics were used to summarize PD characteristics and industry payment details. Univariable linear regression was used to assess the association of PD characteristics or scholarly metrics with payments.

RESULTS: Fifty-one PDs from 37 SUO fellowship programs were identified. PDs were predominantly men (94%) and mid-career. In aggregate, over the study period, PDs received $USD 18,963,555 in industry payments over ten years. Most payments were for associated research funding ($15,490,525, 81.6%; median [IQR] per PD recipient, $126,584 [$36,565-$706,516]; 1,262 payments). General payments accounted for a total of $3,473,030 (18.3%) (median [IQR] per PD, $10,345 [$2,196-$49,180]). SUO PDs received $120,763 (0.6%) for education fees. No association was found between PD characteristics or research metrics and industry payments.

CONCLUSIONS: PDs of SUO fellowships receive significant industry payments, surpassing those received by the average urologist. Most of these payments are allocated to research, with smaller proportions directed to general support and educational initiatives.

PMID:40101162 | DOI:10.1097/UPJ.0000000000000814

Med Sci Sports Exerc. 2025 Mar 18. doi: 10.1249/MSS.0000000000003706. Online ahead of print.

ABSTRACT

PURPOSE: This study compared the physiological effects of a moderate-intensity interval training (MIT) microcycle followed by an active recovery period (collectively termed MITblock) with a time-matched regular training period (REG) during the general preparation phase in well-trained cyclists.

METHODS: Using a randomized crossover design, 30 well-trained male cyclists (maximal oxygen consumption (VO2max), 70.5 (4.6) mL·min-1·kg-1) completed both MITblock and REG. The MIT microcycle involved six interval sessions over seven days with 5-7 × 10-14 min work intervals at a perceived exertion (RPE) of 14-15 on the Borg 6-20 scale. A six-day active recovery period followed before physiological testing. During REG, cyclists performed their regular preparatory-phase training routine, which primarily involved low-intensity exercise. Specific guidelines included completing either two MIT sessions or one MIT session and one high-intensity interval session per week. Endurance performance indicators assessed included changes in 15 min maximal average power output (PO15min), power output at 4 mmol·L-1 [blood lactate] (PO4mmol), 1 min peak power output during incremental testing (POVO2max), and VO2max.

RESULTS: Although the Training Impulse (TRIMP) score was not different between MITblock and REG (1944 (436) vs. 1800 (232), respectively; p = 0.27), MITblock resulted in significantly greater improvements than REG in PO4mmol (4.0 (4.4)% vs. -1.3 (3.7)%, p < 0.01), POVO2max (2.5 (4.5)% vs. -0.7 (3.9)%, p < 0.01) and VO2max (2.0 (3.9)% vs. 0.0 (3.5)%, p = 0.05). Changes in PO15min were not statistically different between MITblock and REG (3.9 (8.3)% vs. 0.2 (6.8)%, p = 0.14). During MIT intervals, RPE was 14.4 (0.3), corresponding to 66 (5)% of POVO2max, 85 (3)% of maximal heart rate, and 2.8 (1.1) mmol·L-1 [blood lactate].

CONCLUSIONS: Six moderate-intensity interval sessions over seven days, followed by a six-day active recovery period, induce improvements in endurance performance indicators compared to a time-matched regular training period in well-trained cyclists.

PMID:40101160 | DOI:10.1249/MSS.0000000000003706