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Nevin Manimala Statistics

Retrograde intrarenal surgery versus miniaturized percutaneous nephrolithotomy for renal calculi: a grade-assessed meta-analysis of randomized controlled trials with trial sequential analysis

World J Urol. 2026 May 24;44(1):380. doi: 10.1007/s00345-026-06500-3.

ABSTRACT

BACKGROUND: The optimal management of medium-sized (1-3 cm) renal stones remains a clinical dilemma, with retrograde intrarenal surgery (RIRS) and miniaturized percutaneous nephrolithotomy (mPCNL) serving as competing minimally invasive options. To overcome the selection bias inherent in previous meta-analyses that included observational data, we aimed to compare the efficacy and safety of both techniques by exclusively analyzing randomized controlled trials (RCTs).

METHODS: A systematic literature search of five databases was conducted up to February 2026. Only RCTs comparing RIRS and mPCNL were included. The primary outcomes were the single session stone-free rate (SFR) and overall complication rate. Secondary outcomes included stone clearance-related outcomes, operative performance outcomes, and recovery-related outcomes. Data were pooled using a random-effects model, and trial sequential analysis (TSA) was applied.

RESULTS: Thirty RCTs encompassing 4173 patients were included. mPCNL demonstrated a significantly higher single-session SFR compared to RIRS (R.R: 0.92, 95% C.I: 0.88-0.96, p < 0.001). RIRS showed a trend toward a lower overall complication rate although the difference did not reach statistical significance (RR = 0.79, 95% CI: 0.63-1.01; p = 0.057), reduced blood transfusion requirements, smaller hemoglobin drops, and shorter hospitalization times. However, RIRS required significantly more postoperative auxiliary procedures. Operative times and high-grade Clavien-Dindo III-V complication rates were comparable between both techniques. TSA confirmed that the cumulative evidence for single-session SFR was sufficient and conclusive, whereas TSA findings for overall complication rate should be interpreted cautiously.

CONCLUSIONS: mPCNL achieves significantly higher SFR than RIRS in the management of 1-3 cm renal calculi. However, RIRS was associated with lower bleeding-related morbidity and shorter hospitalization, although no statistically significant difference was observed in the overall complication rate. Therefore, the choice between RIRS and mPCNL should be individualized, balancing maximal SFR against procedural invasiveness according to patient characteristics and stone complexity.

PMID:42177692 | DOI:10.1007/s00345-026-06500-3

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Nevin Manimala Statistics

Periodontal changes in patients with skeletal Class III malocclusion with and without prophylactic gingival grafting during presurgical orthodontic treatment

Am J Orthod Dentofacial Orthop. 2026 May 23:S0889-5406(26)00190-3. doi: 10.1016/j.ajodo.2026.03.012. Online ahead of print.

ABSTRACT

INTRODUCTION: This study aimed to evaluate periodontal tissue changes after prophylactic gingival grafting in patients with skeletal Class III malocclusion undergoing presurgical orthodontic treatment involving mandibular incisor proclination.

METHODS: A total of 28 patients with skeletal Class III malocclusion scheduled for orthognathic surgery were included. Thirteen received subepithelial connective tissue grafts before orthodontic treatment (graft group), whereas 15 did not (nongraft group). Lateral cephalograms and cone-beam computed tomography images were taken before and after treatment to perform cephalometric and periodontal measurements. The primary outcomes were supracrestal gingival area (GA) and gingival thickness (GT) 1-5. Secondary outcomes included alveolar bone thickness (BT) 1-5, vertical bone height, and clinical crown length. Statistical analyses included intragroup changes, intergroup comparisons, and regression analyses.

RESULTS: In the graft group, GA and GT significantly increased. In contrast, BT2 and BT3 decreased, and vertical bone height increased, indicating vertical bone loss. No gingival recession was observed in either group. In exploratory analyses, increases in GA, GT1, and GT2 were negatively associated with a change in the incisor mandibular plane angle, whereas increases in GT3-5 were negatively associated with age.

CONCLUSIONS: Prophylactic gingival grafting before presurgical orthodontic treatment increased GT and GA in patients with skeletal Class III malocclusion, even in the presence of alveolar bone loss.

PMID:42177665 | DOI:10.1016/j.ajodo.2026.03.012

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Nevin Manimala Statistics

Reviving Living Donor Kidney Transplantation in Australia

Med J Aust. 2026 May;224(5):e70202. doi: 10.5694/mja2.70202.

ABSTRACT

Australia’s rate of living donor kidney transplantation has stagnated. In 2024, there were 253 living donor kidney transplants, down from 354 in 2008, with the living donor rate falling to 9.5 donors per million population-well below peer nations. Despite growth in deceased donation, waiting list times continue to lengthen and can now reach 6-7 years for some groups, reflecting the rising numbers of Australians living with kidney failure. Access is unequal: First Nations people receive few living donor transplants; women are more likely to donate than men but are less likely to receive a living donor transplant; and people from lower socio-economic groups are disadvantaged. Barriers include information gaps, limited multilingual resources, time-intensive workups and financial disincentives. A coordinated reset, supported by national leadership, contemporary guidance, better data and streamlined, culturally safe pathways can restore growth.

PMID:42177664 | DOI:10.5694/mja2.70202

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Nevin Manimala Statistics

Kidney Failure After Living Kidney Donation in Australia: A National Registry Linkage Study, 2004-2024

Med J Aust. 2026 May;224(5):e70206. doi: 10.5694/mja2.70206.

ABSTRACT

National linkage of the Australia and New Zealand Living Kidney Donor Registry and the Australia and New Zealand Dialysis and Transplant Registry provides the first Australian estimates of kidney failure treated with kidney replacement therapy (KRT) after living kidney donation (2004-2024). Out of 5291 donors (56,962 person-years; median follow-up, 10.96 years), three donors underwent KRT (0.53 per 10,000 person-years). No events occurred within 10 years of donation. Australian clinicians can now counsel and guide potential donors using local data: risk of kidney failure requiring KRT is very low, but late events warrant lifelong follow-up.

PMID:42177660 | DOI:10.5694/mja2.70206

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Nevin Manimala Statistics

Effect of Feldenkrais Method in Enhancing Postural Control for Patients With Diabetic Polyneuropathy

Physiother Res Int. 2026 Jul;31(3):e70233. doi: 10.1002/pri.70233.

ABSTRACT

BACKGROUND: Diabetic polyneuropathy (DPN) contributes to impaired postural control and increases the risk of falls due to sensory and motor deficits. The Feldenkrais Method (FM), a sensorimotor approach that enhances body awareness and coordination, may offer therapeutic benefits in addressing these challenges.

OBJECTIVE: To evaluate the effectiveness of the Feldenkrais Method in improving dynamic balance, postural control, fear of falling, and quality of life in adults with DPN.

METHODS: Twenty-six participants aged 45-60 years with DPN were randomized into a study group receiving FM-based training or a control group receiving conventional balance training. Both interventions were administered twice weekly for 24 weeks. Primary outcomes included Timed Up and Go (TUG), limits of stability (LoS), Falls Efficacy Scale (FES), and Diabetes-39 Questionnaire for quality of life (QoL). Data were analyzed using repeated-measures ANOVA and post hoc Bonferroni tests.

RESULTS: Significant post-intervention improvements were observed in the FM group across all outcomes: TUG (p = 0.0001), LoS (p = 0.0001), FES (p = 0.0001), and QoL (p = 0.0001). Furthermore, the FM group demonstrated statistically significant superiority over the control group in all primary and secondary measures (p < 0.05). The control group showed no statistically significant changes.

CONCLUSION: The Feldenkrais Method appears effective in enhancing balance, postural control, and quality of life in individuals with DPN. These results support its integration into neurorehabilitation programs.

PMID:42177654 | DOI:10.1002/pri.70233

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Nevin Manimala Statistics

An exploratory application of modern statistical methodology and machine learning techniques in assessment of crystallinity monitoring and control strategy development for high-risk drug manufacturing

J Biopharm Stat. 2026 May 24:1-14. doi: 10.1080/10543406.2026.2670525. Online ahead of print.

ABSTRACT

Pharmaceutical polymorphism and crystallinity changes may have significant impact on drug’s quality, efficacy, and safety. The risk mitigation strategies include pharmaceutical development, monitoring and control strategy establishment during manufacturing, and stability monitoring program during storage. All of those are resources intensive. During data mining and analysis of risk mitigation strategies of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) which may involve polymorphism and crystallinity change, one of the challenges is data heterogeneity encountered in submissions. This data heterogeneity may result in data not readily available for automated analysis which is called missing data. Modern statistical methodologies are available to handle this missing data and associated data analyses; however, very limited deployment of these methods to pharmaceutical chemistry, manufacturing, and controls (CMC) regulatory domain being reported. In big data era, consideration of statistical methodologies in this field will become continuously more important as the amount of available data in regulatory submissions increases. In this study, through data mining of approved NDAs and ANDAs by the FDA during the years 2017-2022 which had polymorphism and/or crystallinity keywords, we established a dataset which contained 148 approved NDAs and ANDAs and involved crystallinity monitoring and control strategy development of high-risk drug product manufacturing processes. Then, we applied several advanced machine learning techniques for exploratory pattern recognition and risk classification in the pharmaceutical manufacturing CMC domain. Furthermore, we conducted Monte Carlo simulations to demonstrate the feasibility of risk classification with generated synthetic outcomes using supervised machine learning techniques to the dataset established.

PMID:42177643 | DOI:10.1080/10543406.2026.2670525

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Nevin Manimala Statistics

A survey of parallelism testing methods for bioassays

J Biopharm Stat. 2026 May 24:1-7. doi: 10.1080/10543406.2026.2670518. Online ahead of print.

ABSTRACT

Parallelism is the prerequisite assumption that the test product behaves like a dilution or concentration of the reference product. It is the basis for defining the relative potency of a test product to the reference standard. Once parallelism between the test and reference curves is established, the relative potency will be constant at any effective response levels. This paper presents a review of most proposals for parallelism testing via significance, equivalence, and similarity testing approaches. The pros and cons of each proposal with equivalence margin determination are discussed. Recent approaches for testing parallelism are introduced in the paper.

PMID:42177641 | DOI:10.1080/10543406.2026.2670518

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Nevin Manimala Statistics

A response to Pek et al.’s commentary on Z-curve: clarifying the assumptions of selection models

Cogn Emot. 2026 May 24:1-5. doi: 10.1080/02699931.2026.2678998. Online ahead of print.

ABSTRACT

Pek et al. (2026. What does a Z-curve analysis tell us? Cognition & Emotion, 1-16) comment on Soto and Schimmack (2025. Credibility of results in emotion science: A z-curve analysis of results in the journals Cognition & Emotion and Emotion. Cognition & Emotion) and raise concerns about the use of z-curve to evaluate the credibility of emotion research. Their central criticism is based on simulations showing that z-curve can overestimate the expected discovery rate when selection operates not only at the level of statistical significance but also within the set of significant results as a function of effect size. This point is correct: if researchers selectively publish larger significant effects while suppressing smaller significant ones, selection models that assume threshold-based filtering can be biased. However, this limitation is not unique to z-curve and applies equally to other selection models used in meta-analysis. More importantly, there is currently little empirical evidence for effect-size bias, while there is ample evidence of selection based on significance. Under these more realistic conditions, z-curve provides informative estimates of (a) selection bias, (b) the expected replication rate, and (c) the false positive risk. Our results also demonstrate substantial inflation of effect size estimates in traditional meta-analyses that ignore selection processes. For these reasons, we reject the recommendation to rely solely on standard meta-analytic approaches and advocate for the use of selection models to obtain more realistic estimates.

PMID:42177632 | DOI:10.1080/02699931.2026.2678998

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Nevin Manimala Statistics

Real-World Safety and Retention of Tofacitinib in Elderly Versus Non-elderly Patients With Rheumatoid Arthritis: A Retrospective Cohort Study in Taiwan

Int J Rheum Dis. 2026 May;29(5):e70683. doi: 10.1111/1756-185x.70683.

ABSTRACT

OBJECTIVES: Tofacitinib, the first approved oral small-molecule Janus kinase inhibitor (JAKi), is widely used for treating rheumatoid arthritis (RA). This study aims to compare the drug retention rates of tofacitinib between elderly (≥ 65 years) and nonelderly (< 65 years) RA patients in a real-world clinical setting in Taiwan and to identify clinical factors associated with treatment discontinuation.

METHODS: We conducted a retrospective cohort study of RA patients receiving tofacitinib between 2015 and 2020, with follow-up until December 31, 2021. Patients were categorized into an elderly group (≥ 65 years, n = 82) and a nonelderly group (< 65 years, n = 224). Drug discontinuation was defined as the cessation of tofacitinib during follow-up. Primary outcomes included retention rates, reasons for discontinuation, and the incidence of adverse events. Kaplan-Meier analysis and multivariate Cox proportional hazards models were used to identify independent factors for discontinuation.

RESULTS: A total of 306 RA patients were included (mean age: 56.97 ± 12.44 years). The elderly group had a significantly higher prevalence of comorbidities, including hypertension, diabetes, hyperlipidemia, and osteoporosis. There was no significant difference in mean treatment duration (2.70 ± 1.73 vs. 2.61 ± 1.69 years, p = 0.7049). Kaplan-Meier analysis showed no statistically significant difference in retention rates (Log-rank test, p = 0.425). Multivariate analysis revealed that age was not an independent risk factor for discontinuation (adjusted HR = 1.086, 95% CI: 0.729-1.618, p = 0.685). Among 40 patients who discontinued due to adverse events, serious infection was the leading cause (35.0%), comprising 10 non-fatal serious infection events and 4 infection-related deaths. Major adverse cardiovascular events (MACE) occurred only in the elderly group (15.8%).

CONCLUSIONS: In real-world practice, the drug retention of tofacitinib in elderly RA patients is comparable to that in nonelderly patients. Despite a higher comorbidity burden, age itself is not an independent risk factor for treatment discontinuation. However, the risk of MACE is higher in elderly patients, necessitating careful cardiovascular assessment and monitoring before tofacitinib treatment. These findings suggest that tofacitinib is a viable option for elderly RA patients, provided individualized risk assessment is performed. Notably, discontinuation due to adverse events was substantially less frequent than discontinuation due to lack of efficacy, supporting the overall favorable tolerability of tofacitinib in this population.

PMID:42177625 | DOI:10.1111/1756-185x.70683

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Nevin Manimala Statistics

Association of the red cell distribution width to total serum calcium ratio with severe AKI in patients undergoing cardiac surgery: a retrospective cohort study using the MIMIC-IV database

J Cardiothorac Surg. 2026 May 23. doi: 10.1186/s13019-026-04255-x. Online ahead of print.

ABSTRACT

BACKGROUND: Acute kidney injury (AKI) is a common complication following cardiac surgery. The RCR (ratio of RDW to total serum calcium (TSC)), which exhibits high predictive value for various perioperative diseases, may also be associated with kidney injury. Therefore, we tested the hypothesis that the postoperative RCR index is associated with kidney injury following major cardiac surgery.

METHODS: This was a retrospective observational cohort study. We included 7,872 patients who underwent cardiac surgery from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database. The exposure was the first postoperative measurements of red blood cell distribution width (RDW) and Total serum calcium (TSC). The primary outcome was severe AKI, defined as stage 3 AKI or new-onset dialysis. Secondary outcomes included AKI of any stage, length of hospital stay, and length of intensive care unit (ICU) stay.

RESULTS: A total of 5,992 patients (76.1%) developed postoperative AKI, among whom 3,348 (42.5%) had stage 2 AKI, 654 (8.3%) had stage 3 AKI, and 160 (2.0%) required new-onset dialysis. In the multivariate regression model, the RCR index (categorical variable) was significantly associated with severe AKI (adjusted odds ratio [OR], 2.02 [95% CI, 1.54-2.68]) and AKI of any stage (OR, 1.26 [95% CI, 1.05-1.50]). When the RCR index was treated as a continuous variable, this association remained statistically significant.

CONCLUSIONS: Elevated postoperative RCR index is associated with postoperative AKI in patients who undergo cardiac surgery.

PMID:42177596 | DOI:10.1186/s13019-026-04255-x