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Nevin Manimala Statistics

Optimizing clinical scientific research: the cohort intervention random sampling study with historical controls

J Comp Eff Res. 2025 Sep 16:e240168. doi: 10.57264/cer-2024-0168. Online ahead of print.

ABSTRACT

Randomized controlled trials (RCTs) are regarded as the highest level of evidence in medical research, but RCTs also have their drawbacks. Over the years, several alternative study designs have been introduced to address these problems. However, many of the alternative designs are often regarded as inferior to RCTs or currently not suitable for widespread implementation due to, for example, ethical or statistical problems. Thus, there is a need for study designs that have the same level of validity as RCTs, but are also suitable for large-scale implementation. The cohort intervention random sampling study (CIRSS) with historical controls meets these requirements, by combining the strengths of abovementioned designs. The CIRSS with historical controls has the potential to optimize implementation of promising new treatments as fluidly and rapidly as possible, representing real-world clinical population. Further research is required to address the range of analyses, implementation, issues, barriers and facilitators and ethical questions related to CIRSS.

PMID:40955624 | DOI:10.57264/cer-2024-0168

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Nevin Manimala Statistics

Evaluating diagnostic accuracy and consistency in applying the 2017 periodontal classification among dental professionals

J Periodontol. 2025 Sep 16. doi: 10.1002/jper.70011. Online ahead of print.

ABSTRACT

BACKGROUND: Accurate periodontal disease diagnosis is essential for optimal treatment planning and patient care. However, variability in applying the 2017 Periodontal Classification may affect diagnostic reliability and treatment outcomes. This study investigated diagnostic accuracy and consistency among periodontists, periodontal residents, and dental interns in Saudi Arabia.

METHODS: Forty-four participants, including 13 periodontists, 14 periodontal residents, and 17 dental interns, independently classified 25 periodontitis cases. Agreement with a gold-standard diagnosis, established by expert periodontists using the 2017 Classification System, was assessed using descriptive statistics. Chi-square tests with Bonferroni-adjusted z-tests were used to compare agreement levels between rater groups. Inter-rater reliability was calculated using Fleiss’ kappa, while Cohen’s kappa was used to assess intra-rater reliability.

RESULTS: Periodontists demonstrated the highest agreement with the gold standard (92.0%) for periodontitis diagnosis. Staging agreement was highest among residents (51.7%) and periodontists (49.1%). Grading accuracy was highest for grade C cases across all groups (60.7%). Underestimation was common across rater groups, with interns exhibiting the highest rates in staging (49.6%) and grading (58.3%). The second assessment demonstrated improved diagnostic accuracy across all groups. Inter-rater reliability ranged from fair to moderate across rater groups (κ = 0.22-0.60). Intra-rater reliability was highest among interns, indicating substantial agreement (κ = 0.63-0.75).

CONCLUSION: Findings highlight considerable variability in the application of the 2017 Periodontal Classification among dental professionals, underscoring the role of clinical experience and training in influencing diagnostic accuracy. Structured calibration and targeted educational strategies are essential to improve diagnostic consistency, minimize misclassification, and support optimal patient care.

PLAIN LANGUAGE SUMMARY: Understanding gum disease correctly is important for providing patients with the right treatments. This study looked at how accurately different groups of dental professionals – specialists in gum disease (periodontists), dentists in training (residents), and recent dental graduates (interns) – could diagnose cases of periodontitis using a new system called the 2017 Periodontal Classification. A group of expert periodontists created a “gold-standard” diagnosis for comparison. We found that periodontists were the most accurate, while interns had more difficulty correctly identifying disease severity. Across all groups, many participants underestimated how serious the cases were. Participants were better at recognizing advanced disease compared to milder forms. When the participants repeated the diagnosis of the cases later, their accuracy improved, suggesting that practice and training help. Our results show that diagnosing gum disease can vary depending on experience and training. The study highlights the need for ongoing education and practice to make sure that all dental professionals can diagnose gum disease reliably, which is important for making treatment decisions and improving patient care.

PMID:40955590 | DOI:10.1002/jper.70011

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Nevin Manimala Statistics

Limitation of Maize Potential Yield by Phosphorus at the Global Scale

Glob Chang Biol. 2025 Sep;31(9):e70485. doi: 10.1111/gcb.70485.

ABSTRACT

Phosphorus (P) is known as a major limiting factor of crop yields at the global scale. Previous estimates of the global P limitation are either based on statistical approaches or on complex global gridded crop models. Both failed to distinguish between P and the other limiting factors. Global gridded crop models, despite their complexities, omitted key mechanisms such as soil P dynamics or plant adjustments to P limitation (e.g., change in root:shoot ratio or in shoot P concentration). Thus, current approaches fail to quantify the contribution of P limitation to the global yield gap. Here, we developed a simple but mechanistic model (called GPCROP) that simulates the interactions between plant growth and soil P at a daily time step, all other factors being assumed non-limiting. The model explicitly represents key mechanisms such as the replenishment of the soil P solution by more stable soil P pools, the diffusion of P in soil, and plant adjustments to P limitation. We found that soil available P greatly limits the global maize potential production, even when that limitation was strongly alleviated by plant adjustment mechanisms. With and without these adjustments, maize global production would decrease by 78.9% (std = 17.3) and 92.7% (std = 7.4), respectively, compared to its potential production. We also found that the beginning of the growing season is a key period for P limitation as roots, not yet developed, cannot sustain the plant P demand. This suggests that earlier studies based on a comparison between annual averages of soil supply versus plant demand are not appropriate for assessing P limitation. Considerable uncertainties remain in our approach, and we especially stress the need to use global datasets of soil iron and aluminum (hydr)oxides, currently in development, to constrain the spatial variation of some key parameters driving the P concentration of the soil solution.

PMID:40955582 | DOI:10.1111/gcb.70485

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Nevin Manimala Statistics

Two-sample empirical likelihood method for right censored data

Int J Biostat. 2025 Sep 5. doi: 10.1515/ijb-2024-0120. Online ahead of print.

ABSTRACT

In this paper, a two-sample empirical likelihood method for right censored data is established. This method allows for comparisons between various functionals of survival distributions, such as mean lifetimes, survival probabilities at a fixed time, restricted mean survival times, and other parameters of interest. It is demonstrated that under some regularity conditions, the scaled empirical likelihood statistic converges to a chi-squared distributed random variable with one degree of freedom. A consistent estimator for the scaling constant is proposed, involving the jackknife estimator of the asymptotic variance of the Kaplan-Meier integral. A simulation study is carried out to investigate the coverage accuracy of confidence intervals. Finally, two real datasets are analyzed to illustrate the application of the proposed method.

PMID:40955545 | DOI:10.1515/ijb-2024-0120

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Nevin Manimala Statistics

The Cost-Effectiveness of the Cancer Home-Life Intervention: An Economic Evaluation Alongside a Randomized Clinical Trial with a Six-Month Time Frame

J Palliat Med. 2025 Sep 16. doi: 10.1177/10966218251374527. Online ahead of print.

ABSTRACT

Background: People with advanced cancer often face significant challenges in everyday activities, especially within their home environments, where they spend most of their time. The Cancer Home-Life Intervention is an occupational therapy-based program supporting everyday activities in people with advanced cancer living at home. Aim: To examine the cost-utility and cost-effectiveness of the Cancer Home-Life Intervention compared to usual care over six months. Methods: This economic evaluation with a societal perspective was conducted alongside a randomized controlled trial (ClinicalTrials.gov: NCT02356627). Quality-adjusted life years (QALYs) and activities of daily living motor ability accounted for the outcome. Costs included primary and secondary health care, domestic care, assistive devices, and participants’ out-of-pocket costs. A total of 242 adults with advanced cancer were included from two Danish University Hospitals and randomized 1:1 to the Cancer Home-Life Intervention or usual care. Primary analysis included 172 participants alive at six months follow-up. Results: The intervention showed no statistically significant improvement in either QALYs or activities of daily living motor ability compared to usual care. However, the cost-utility analysis revealed a 72% probability of the intervention being cost-effective, regardless of the willingness-to-pay threshold per QALY gained. The probability of cost-effectiveness for activities of daily living motor ability started at 26% and increased to 58%. Sensitivity analyses supported these findings. Conclusion: The Cancer Home-Life Intervention showed limited potential for cost-effectiveness compared to usual practice. The cost-utility analysis revealed a 72% probability of cost-effectiveness. However, these findings should be interpreted cautiously due to small, nonstatistically significant improvements in QALYs.

PMID:40955537 | DOI:10.1177/10966218251374527

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Nevin Manimala Statistics

The effect of non-surgical periodontal treatment on Dickkopf-1 and secreted Frizzled-Related Protein 5 levels

J Periodontol. 2025 Sep 16. doi: 10.1002/jper.70005. Online ahead of print.

ABSTRACT

BACKGROUND: Recent advancements in bone tissue biomarker research have identified 2 promising molecules: Dickkopf-1 and secreted Frizzled-Related Protein 5. This study aims to evaluate the levels of these biomarkers in gingival crevicular fluid in periodontal health, gingivitis, and periodontitis and to assess the effects of non-surgical periodontal treatment on these biomarkers.

METHODS: A total of 99 adult subjects were included in this study, divided into 3 groups: 33 periodontally healthy individuals, 33 with gingivitis, and 33 with periodontitis. Patients in the gingivitis and periodontitis groups received non-surgical periodontal treatment. Periodontal clinical parameters were recorded, and gingival crevicular fluid levels of biomarkers were analyzed by enzyme-linked immunosorbent assay at baseline and 6-8 weeks post-treatment.

RESULTS: Pre-treatment Dickkopf-1 levels were found to be highest in the periodontitis group (p < 0.001). Conversely, secreted Frizzled-Related Protein 5 levels were highest in the healthy group (p < 0.001). Post-treatment, a statistically significant reduction in Dickkopf-1 levels was observed in the gingivitis (p = 0.015) and periodontitis (p < 0.001) groups, while secreted Frizzled-Related Protein 5 levels significantly increased (respectively, p = 0.008 and p < 0.001). A statistically significant weak negative correlation was identified between total Dickkopf-1 and secreted Frizzled-Related Protein 5 levels (τ = -0.117, p = 0.027). Receiver operating characteristic curve analysis to assess diagnostic performance between periodontal health and periodontitis revealed an area under the curve of 0.938 for Dickkopf-1 and 0.803 for secreted Frizzled-Related Protein 5.

CONCLUSIONS: These biomarkers could serve as valuable biomarkers in the pathogenesis of periodontal disease. Non-surgical periodontal treatment significantly affects the levels of these biomarkers, indicating their potential utility in monitoring therapeutic outcomes.

PLAIN LANGUAGE SUMMARY: In the human body, bone tissue is in a state of constant balance of production and destruction. This balance supports the maintenance of the mechanical integrity of the skeleton and the regulation of calcium and phosphorus levels. Bone markers have been developed to monitor various bone diseases and the effect of treatments without any interventional procedures. Dickkopf-1 (Dkk-1) and secreted Frizzled-Related Protein 5 (sFRP5) are two of the current bone markers that play a role in the balance of bone formation and destruction in the human body. The presence of these molecules in periodontal diseases, which cause inflammation and bone destruction in the gingiva surrounding the teeth, is not yet clear. In this study, Dkk-1 and sFRP5 levels were investigated in periodontal diseases, and the effect of treatment of periodontal diseases on these molecules was evaluated. In the transition from periodontal disease to health, Dkk-1 levels decreased while sFRP5 levels increased. Consistent with these results, Dkk-1 levels decreased in all groups after treatment, while sFRP5 levels increased. In conclusion, Dkk-1 and sFRP5 may serve as valuable markers for the early diagnosis of periodontal disease, and non-surgical periodontal treatment may significantly affect the levels of these markers, demonstrating their potential utility in monitoring treatment outcomes.

PMID:40955531 | DOI:10.1002/jper.70005

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Nevin Manimala Statistics

Peri-operative outcomes of open, laparoscopic and robotic simple prostatectomy

BJU Int. 2025 Sep 16. doi: 10.1111/bju.16928. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare peri-operative outcomes and trends in open (OSP), laparoscopic (LSP) and robot-assisted simple prostatectomy (RASP).

MATERIALS AND METHODS: We used German Nationwide Inpatient Data (GRAND), provided by the Research Data Centre of the Federal Bureau of Statistics, and performed multiple patient-level analyses.

RESULTS: Between 2013 and 2023, 46 234 simple prostatectomies were performed in Germany for benign prostatic hyperplasia without concomitant bladder stones. Of these, 44 194 (96%) were performed with an open, 724 (1%) with a laparoscopic, and 1335 (3%) with a robotic approach. Among patients undergoing OSP, 11 755 (27%) cases were performed with a transcapsular and 32 439 (73%) with a transvesical approach. We compared transcapsular OSP vs RASP and LSP. The adoption of RASP increased exponentially during the period studied, while the use of OSP gradually declined, and that of LSP remained stable. In multivariable regression analyses, in-hospital transfusions were lower for LSP (6.5%; odds ratio [OR] 0.46, 95% confidence interval [CI] 0.34-0.62, P < 0.001) and RASP (7.3%; OR 0.58, 95% CI 0.47-0.72, P < 0.001) compared to OSP (13%). In-hospital urinary retention was significantly less frequent after LSP (4.6%; OR 0.46, 95% CI 0.32-0.65, P < 0.001) and RASP (6.4%; OR 0.68, 95% CI 0.54-0.85, P < 0.001) compared to OSP (9.3%). The median (interquartile range) hospital stay was 9 (8-12) days for OSP, 7 (6-9) days for RASP (P < 0.001) and 4 (4-7) days for LSP (P < 0.001). Transcapsular OSP was associated with a lower risk of intensive care unit admission (P < 0.001) and shorter hospital stay (P < 0.001) compared to transvesical OSP.

CONCLUSION: Our results showed that RASP is rapidly growing and offers better peri-operative outcomes compared to OSP.

PMID:40955513 | DOI:10.1111/bju.16928

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Nevin Manimala Statistics

Medial and Lateral Column Load Distribution After In Situ Subtalar/Talonavicular Fusion With and Without Calcaneocuboid Fusion: A Cadaveric Study

Foot Ankle Int. 2025 Sep;46(9):1025-1029. doi: 10.1177/10711007251344916. Epub 2025 Sep 16.

ABSTRACT

BACKGROUND: Previous investigations have speculated that stiffening the lateral column of the hindfoot in triple arthrodesis can increase lateral plantar pressure with resulting lateral column pain. It is unclear whether sparing of the calcaneocuboid joint in hindfoot arthrodesis yields lower lateral column plantar forefoot pressures vs triple arthrodesis including the calcaneocuboid joint.

METHODS: Tendon loading and axial pressure were applied to 9 cadaveric legs according to standard cadaveric models. Medial and lateral forefoot pressures were recorded using a pressure-sensitive plate. Specimens were tested in native state, after sequential subtalar and talonavicular fixation, and after added calcaneocuboid fixation. All fixation was performed in situ in a neutral foot position. Testing was performed both on a neutral sensor plate and on a plate with 10 degrees of lateral slope.

RESULTS: In neutral position, pressure under the fifth metatarsal increased significantly from 31.0 ± 22.4 kPa in the native state to 63.1 ± 33.0 kPa (P = .018) after CC-sparing fusion and to 54.7 ± 27.9 kPa (P = .023) after triple arthrodesis. In the everted position, there was no significant difference in pressure under the fifth metatarsal from 56.8 ± 31.8 kPa in the native state to 89.7 ± 55.4 kPa (P = .134) after CC-sparing fusion and to 78.9 ± 42.9 kPa (P = .111) after triple fusion. No statistically significant pressure differences under the fifth metatarsal were found between the arthrodesis groups with loading on a neutral (P = .687) or sloped (P = .393) surface.

CONCLUSION: In our in situ fusion cadaveric model, both traditional triple arthrodesis and the calcaneocuboid-sparing procedure resulted in significantly higher lateral forefoot plantar pressure compared with the native state, but there was no significant difference in lateral pressure between the procedures on both a flat and a laterally inclined surface. These findings should be interpreted in light of limitations including small sample size, static loading conditions, intact cartilage, and lack of formal radiographic assessment of hindfoot alignment.

CLINICAL RELEVANCE: Although other considerations may warrant sparing the calcaneocuboid joint during hindfoot fusion, its preservation did not reduce lateral column overload in this model.

PMID:40955505 | DOI:10.1177/10711007251344916

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Nevin Manimala Statistics

Impact of Extended Lens-Induced Myopia on Retinal Structure and Function in Mice

Curr Eye Res. 2025 Sep 16:1-9. doi: 10.1080/02713683.2025.2557590. Online ahead of print.

ABSTRACT

PURPOSE: To investigate time-dependent structural and functional retinal alterations in a mouse model of prolonged lens-induced myopia.

METHODS: Myopia was induced in male C57BL/6J mice by fitting -30 D lenses on both eyes starting at postnatal week 3. Mice were assigned to either a long-term induction group (3-9 weeks of age) or a short-term induction group (3-6 weeks of age). Separate groups fitted with 0 D lenses served as controls. Ocular parameters, including refraction, axial length, choroidal thickness, and retinal thickness were measured at weeks 3, 6, and 9 using an infrared photorefractor and spectral-domain optical coherence tomography. Retinal function was assessed by dark-adapted electroretinography at week 9 for the long-term group and at week 6 for the short-term group. Statistical analyses included two-way repeated-measures ANOVA followed by Bonferroni’s post hoc test for comparisons across groups and time points, and two-tailed unpaired t-test or one-way ANOVA with Fisher’s LSD post hoc test for group comparisons at individual time points.

RESULTS: After 6 weeks of myopia induction, the long-term myopia group exhibited significant reduction in refraction, axial length elongation, and choroidal thickness thinning. Inner retinal thickness was markedly reduced, and electroretinography revealed attenuated amplitudes and delayed implicit times of the oscillatory potentials.

CONCLUSION: Prolonged lens-induced myopia in mice induces time-dependent structural and functional retinal alterations, particularly in the inner layers. This model underscores the significance of early retinal monitoring under long-term myopic conditions and serves as a platform for investigating retinal vulnerability and developing preservation strategies over time.

PMID:40955491 | DOI:10.1080/02713683.2025.2557590

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Nevin Manimala Statistics

Analysis of the body composition of patients with impaired carbohydrate metabolism

Vopr Pitan. 2025;94(4):76-85. doi: 10.33029/0042-8833-2025-94-4-76-85. Epub 2025 Jul 21.

ABSTRACT

The prevalence of carbohydrate metabolism disorders, such as type 2 diabetes mellitus and insulin resistance, associated with the global obesity pandemic, makes modern healthcare necessary to improve diagnostic tools aimed at early detection and further evaluation of the effectiveness of therapeutic measures. Bioimpedance is a modern diagnostic tool in dietetics and endocrinology. Differences in body composition, as well as the accumulation of fat mass in patients with impaired carbohydrate metabolism, become an urgent issue to study. The purpose of the study was to conduct a comparative analysis of the body composition of patients with type 2 diabetes mellitus (DM2) and insulin resistance (IR).

MATERIAL AND METHODS: The analysis of medical records of 1003 patients who received individual consultations from a dietitian and an endocrinologist at the bases of medical, preventive and diagnostic organizations in Samara has been carried out. The patients were divided into three groups depending on the disease history: with diagnosed DM2 (288 people); with clinically established IR (319 people) and without carbohydrate metabolism disorders (396 people). The data of the morbidity history and the results of bioimpedance have been analyzed.

RESULTS: A significant difference in the component composition between patients with DM2, insulin resistance and without impaired carbohydrate metabolism was revealed in all parameters, except for active cellular and musculo-skeletal mass in kilograms and basal metabolism in women and except for the percentage of fat mass in men. DM2 patients were found to have the highest median values of body weight and body mass index (BMI), fat mass, total body water, and the lowest values of active cellular and skeletal muscle mass relative to lean body mass, as well as the current metabolic rate (specific basal metabolic rate and phase angle). The results of the component composition in patients of different sexes had a statistically significant difference (p<0.001) in patients with IR and DM2 for all indicators except body fat mass in kilograms and BMI. At the same time, in the group of patients without carbohydrate metabolism disorders, statistically significant differences were not found for any of the indicators, except for the phase angle and fat mass in kilograms, which may indicate the presence of certain gender-specific characteristics of the influence of carbohydrate metabolism disorders on the component composition of the body. Significant differences in fat mass and proportion of fat mass were found for patients with and without carbohydrate metabolism disorders depending on the body mass index. There were also significant differences in fat mass and the fat mass available for patients with and without impaired carbohydrate metabolism, depending on BMI.

CONCLUSION: Bioelectrical impedance analysis as a method of analyzing the body structure and nutritional status of patients is an effective and easy-to-use tool capable of detecting abnormalities in the accumulation of adipose tissue and metabolic processes in patients with impaired carbohydrate metabolism. Differences in the fat component of body composition in individuals with excess body weight and obesity in the presence and absence of DM2 and IR confirm the need to assess the body composition in patients of dietary and endocrinological profiles for early detection of these disorders and their control in view of the diabetogenic effect of adipose tissue.

PMID:40955487 | DOI:10.33029/0042-8833-2025-94-4-76-85