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Nevin Manimala Statistics

Real-world evidence for regulatory purposes: The example of DARWIN EU®

Farm Hosp. 2025 Mar 17:S1130-6343(25)00018-2. doi: 10.1016/j.farma.2025.02.011. Online ahead of print.

NO ABSTRACT

PMID:40102084 | DOI:10.1016/j.farma.2025.02.011

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Nevin Manimala Statistics

Effect of environmental conditions on wear resistance of lithium silicate glass-ceramic materials

Dent Mater. 2025 Mar 18:S0109-5641(25)00287-8. doi: 10.1016/j.dental.2025.03.004. Online ahead of print.

ABSTRACT

OBJECTIVES: To compare the impact of neutral and acidic environments on wear resistance of lithium silicate glass-ceramics (LSGCs), with and without crystallization firing after manufacturing.

MATERIALS AND METHODS: Fifty-six specimens were tested in a two-body wear simulator and divided into seven groups. Four groups consisted of commercially available LSGC materials, each opposed to steatite antagonists. A fifth group included an LSGC material tested additionally in its fired state. A sixth group involved another LSGC material opposed to zirconia antagonists. A seventh group comprised zirconia specimens, opposed to steatite antagonists. All specimens underwent a two-body wear test with 250,000 cycles, a 5 kg load, and 1 mm lateral movement, while immersed in either neutral (pH 7) or acidic (pH 3) buffer solutions. Laser scanning microscopy, optical profilometry, and scanning electron microscopy were used to quantify and/or investigate the wear. Data were analyzed using one-way ANOVA.

RESULTS: LSGC materials exhibited significantly higher wear at pH 7 compared to pH 3 (p < 0.001). The greatest volume loss was observed in an unfired LSGC material (0.138 ± 0.039 mm³ at pH 3 vs. 0.495 ± 0.092 mm³ at pH 7). Steatite antagonists also suffered significantly greater wear at pH 7, with the highest antagonist wear recorded at 1.718 ± 0.068 mm³ . The wear mechanism caused by steatite antagonists differed from zirconia antagonists.

SIGNIFICANCE: Environmental conditions play a major role in the wear performance of LSGCs. Fully crystallized LSGC materials show similar susceptibility to environmental changes compared to LSGC materials requiring crystallization firing.

PMID:40102078 | DOI:10.1016/j.dental.2025.03.004

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Nevin Manimala Statistics

Title X Provider Experiences With and Perceptions of Contraception Guidelines Implementation in Georgia: A Qualitative Study

Womens Health Issues. 2025 Mar 17:S1049-3867(25)00029-5. doi: 10.1016/j.whi.2025.02.004. Online ahead of print.

ABSTRACT

OBJECTIVES: Georgia Title X sites serve over 160,000 patients per year, providing critical contraceptive access. The U.S. Medical Eligibility Criteria and Selected Practice Recommendations for Contraceptive Use (U.S. MEC SPR) are meant to increase contraception access, but few studies have explored U.S. MEC SPR implementation. This qualitative study aimed to understand Georgia Title X providers’ experiences with and attitudes toward U.S. MEC SPR implementation.

STUDY DESIGN: From March 2023 to December 2023, we conducted semi-structured interviews with 20 Georgia Title X providers. Participants also completed a short demographic survey. Transcripts were first assessed using rapid analysis techniques in Google Sheets, then analyzed more thoroughly with a thematic analysis approach in Dedoose. We calculated demographic descriptive statistics using SAS.

RESULTS: The sample was diverse in race but not gender; all participants identified as cisgender women. Interviews revealed that most participants learned about the guidelines in medical or nursing school. Notable benefits of using the U.S. MEC SPR included facilitating patient contraceptive education and building providers’ confidence in their prescribing skills. The only reported challenges were limited user-friendliness and limited information about certain medical conditions in the U.S. MEC. Participants had mixed experiences with clinic leadership prioritizing U.S. MEC SPR use but reported similar perceived patient barriers to care.

CONCLUSIONS: This study suggests that the U.S. MEC SPR can help Title X providers serve clients seeking contraception, but barriers to widespread implementation remain. Efforts to increase guidelines use should consider providers’ needs and preferences along with factors impacting patient access to contraceptive care.

PMID:40102077 | DOI:10.1016/j.whi.2025.02.004

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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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Nevin Manimala Statistics

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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Nevin Manimala Statistics

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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Nevin Manimala Statistics

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