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Nevin Manimala Statistics

Evaluating the implementation of a rapid access atrial fibrillation clinic utilising a pharmacist-physician model of care

Res Social Adm Pharm. 2025 Mar 6:S1551-7411(25)00072-5. doi: 10.1016/j.sapharm.2025.03.005. Online ahead of print.

ABSTRACT

BACKGROUND: Time to assessment and treatment of atrial fibrillation (AF) is critical for reducing stroke risk. However, Australian data have shown low uptake of timely anticoagulation, with people in regional areas having a greater risk of low uptake compared to people in metropolitan areas.

OBJECTIVE: To conduct a retrospective, mixed methods evaluation of a pharmacist-physician model of care for a rapid access atrial fibrillation (RAAF) clinic in a large regional centre in Victoria, Australia.

METHODS: The RAAF clinic involved telehealth pharmacist appointments and face-to-face physician consults and aimed to see patients within 14 days of referral. A retrospective mixed-methods evaluation was adopted. Quantitative methods included time-based analysis of appointment statistics, analyses of the proportion of patients meeting known quality indicators for risk assessment and treatment for AF. Qualitative analysis included conventional content analysis of patient feedback and net promoter scoring to understand patient acceptability.

RESULTS: There were 312 patients referred to the service during 2022-2023, 274 (88 %) patients participated in 268 pharmacist and 421 physician appointments. Median days from referral to first clinic consultation were 14 (inter quartile range 9-20). Proportion of high-risk patients (CHADSVA >1) who received anticoagulation for stroke prevention increased from 88 % pre-clinic to 97 % post-clinic. Anti-arrhythmic therapies were used by 76 % of patient’s pre-clinic and 73 % post-clinic, with changes to therapy occurring in 35 % of patients. Patients were highly accepting of the service, with a mean patient acceptability score of 9 out of 10. Qualitative analysis illustrated that positive patient experience was linked to clinician performance, as well as the organisational structure and workflow of the clinic itself.

CONCLUSIONS: A pharmacist-physician model of care was successfully implemented in a regional health setting, leading to improved access and medication management, with high levels of patient acceptance.

PMID:40102069 | DOI:10.1016/j.sapharm.2025.03.005

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Assessing the clinical efficacy of neoadjuvant intravesical Mitomycin C in naïve non-muscle invasive urinary bladder cancer: A systematic review and meta-analysis

Curr Probl Cancer. 2025 Mar 17:101198. doi: 10.1016/j.currproblcancer.2025.101198. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Naïve non-muscle invasive bladder cancer (NMIBC) is commonly treated with transurethral resection (TURBT), but recurrence and progression remain concerns. This meta-analysis, the first we have conducted on this topic, compared recurrence and progression rates between patients treated with neoadjuvant Mitomycin C (MMC) and the control group (TURBT alone).

METHODS: Relevant articles were identified and appraised through a structured literature assessment. Databases searched included PubMed, Medline, Scopus, and Science Direct. Duplicate publications, book sections, conference papers, encyclopedias, case reports, magazine articles, presentations, theses, protocols, systematic reviews, and meta-analyses were excluded. Heterogeneity was assessed using the I2.

KEY FINDINGS AND LIMITATIONS: The meta-analysis evaluated recurrence rates, progression rates, and adverse events. No heterogeneity was observed (I2=0 %). The pooled odd ratio (OR) for recurrence was 2.554 (95 % CI: 1.637-3.986), indicating a significant decrease in recurrence for the MMC group (P < 0.001). For progression rates, the overall pooled OR was 1.508 (95 % CI: 0.832-2.734), suggesting that the MMC group showed a lower progression rate. However, this difference was not statistically significant (P = 0.176).Adverse events varied, with the MMC group showing fewer cases of hematuria (8.4 % vs. 34 %) but more irritative bladder symptoms.

CONCLUSIONS AND CLINICAL IMPLICATIONS: The meta-analysis suggests lower recurrence and progression rates in the neoadjuvant MMC group compared to the control group. Both groups experienced a comparable range of adverse events, suggesting that both treatment approaches exhibit a similar safety profile. Larger and more randomized controlled trials (RCT) are needed to confirm MMC’s effectiveness in NIMBC treatment and establish its role in clinical practice.

PMID:40102068 | DOI:10.1016/j.currproblcancer.2025.101198

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Monday’s feel calmer when creative practitioners are here’: a quality improvement project exploring whether creative-practitioner sessions on adult inpatient mental-health wards reduce levels of violence and aggression

BMJ Open Qual. 2025 Mar 18;14(1):e003122. doi: 10.1136/bmjoq-2024-003122.

ABSTRACT

BACKGROUND: Violence and aggression (V&A) are commonplace on mental-health wards and may lead to restrictive practice interventions (RPI), having a detrimental impact on patients and staff. In the 12 months preceding this quality improvement (QI) project, there was a mean V&A incidence of 52.7±113.0 and RPI of 37.6±84.1 per 1000 bed days.

METHODS: Using QI methodology, a project involving creative practitioners was codeveloped to provide a range of activities delivered via a 7-day service, across 13 inpatient mental-health wards in five hospital settings, using levels of V&A and RPI as outcome measures. The creative practices used drew on successful projects arising from a linked charity, Creative Minds. Three plan-do-study-act cycles were completed. (1) Coproduction with ward staff, patients and creative practitioners of 4-week session plans, including an induction training package for creative practitioners. (2) Streamlined and centralised communication between creative practitioners and participating wards using a project coordinator. (3) Implementation of a creative-practitioner Rota to better support ward activity planning, staff and patient expectation setting.

RESULTS: During the 12-month project wards with creative practitioners experienced statistically significant reduction in V&A levels (F (1, 168)=5.72, p=0.017) and RPI (F (1, 168)=8.40, p=0.0042). Wards not involved in the project, V&A levels (F (1, 142) =3.34, p<0.069) and RPI (F (132, 142)=0.99, p=0.52) remained unchanged. Ward length-of-stay was used as a balancing measure with no difference pre 45.0±4.9 days and post 46.9±5.0 days intervention (p=0.18). At the project peak, creative practitioners delivered around 300 hours per week of creative activity, which appears to be associated with reduced number of V&A/RPI incidents.

CONCLUSIONS: Recommendations for the project’s next steps are to secure sustained funding for creative practitioners to further enhance patients/staff well-being, as well as the coproduction of a creative-practitioner implementation guide to be tested in other mental-health inpatient settings as a part of a research study to better understand the impact of the type/timing of activities (ie, day/evening/weekends) on important patient outcomes and staff well-being.

PMID:40102040 | DOI:10.1136/bmjoq-2024-003122

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Life-course socioeconomic position and the gut microbiome in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL)

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

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Exploring the current usage of and attitudes towards transanastomotic tube (TAT) feeding in infants born with duodenal atresia: a survey of practice in the UK

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

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Introduction to Bayesian Statistics: Part 36 of a Series on the Evaluation of Scientific Publications

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

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Novel Composite Health Assessment Risk Model for Older Allogeneic Transplant Recipients: BMT-CTN 1704

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

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Alternative Presentations of Overall and Statistical Uncertainty for Adults’ Understanding of the Results of a Randomized Trial of a Public Health Intervention: Parallel Web-Based Randomized Trials

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

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Penetrating Cardiac Injury: A 20-Year Retrospective Analysis at a High-Complexity University Center

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

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The Effect of Prognostic Nutritional Index in Predicting Clinical Outcomes in Valve Replacement Patients

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