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Nevin Manimala Statistics

Sample size determination for hypothesis testing on the intraclass correlation coefficient in a two-way analysis of variance model

Br J Math Stat Psychol. 2025 Nov 14. doi: 10.1111/bmsp.70016. Online ahead of print.

ABSTRACT

Reliability evaluation is critical in fields such as psychology and medicine to ensure accurate diagnosis and effective treatment management. When participants are evaluated by the same raters, a two-way ANOVA model is suitable to model the data, with the intraclass correlation coefficient (ICC) serving as the reliability metric. In these domains, the ICC for agreement (ICCa) is commonly used, as the values of the measurements themselves are of interest. Designing such reliability studies requires determining the sample size of participants and raters for the ICCa. Although procedures for sample size determination exist based on the expected width of the confidence interval for the ICCa, there is limited work on hypothesis testing. This paper addresses this gap by proposing procedures to ensure sufficient power to statistically test whether the ICCa exceeds a predetermined value, utilizing confidence intervals for the ICCa. We compared the available confidence interval methods for the ICCa and proposed sample size procedures using the lower confidence limit of the best performing methods. These procedures were evaluated considering the empirical power of the hypothesis test under various parameter configurations. Furthermore, these procedures are implemented in an interactive R shiny app, freely available to researchers for determining sample sizes.

PMID:41239778 | DOI:10.1111/bmsp.70016

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Nevin Manimala Statistics

Improving Aggregation Control of Recombinant Adeno-Associated Virus Serotype 2 (rAAV2) With Small Sugars and Ionic Salts

Biotechnol J. 2025 Nov;20(11):e70157. doi: 10.1002/biot.70157.

ABSTRACT

Two persistent challenges in adeno-associated virus (AAV) manufacturing are AAV particle aggregation and the separation of full and empty AAV capsids in ion-exchange (IEX) chromatography processes, which add to AAV purification, formulation, and quality control challenges. AAV empty capsids and AAV aggregates are both considered product-related impurities by regulatory agencies. AAV full capsids, which contain the genetic payload, is the AAV species that has the therapeutic value. Thus, it is necessary to continuously improve the control of AAV aggregation and the ratio of full to empty capsids during AAV downstream bioprocessing. We investigated a novel approach that significantly improves aggregation control of AAV serotype 2 (AAV2). The novel approach consisted of a systematic study, involving Design of Experiment (DoE), using common formulation excipients (namely, small sugars and ionic salts) to understand the effect of critical process parameters (excipient type, excipient concentration, and pH) on a critical quality attribute (AAV aggregates). With this approach, we observed a statistically significant reduction in AAV2 particle aggregation in solution. Results suggest that this aggregation-control approach could provide insight into potentially being able to create a new strategy for improving the separation of full and empty AAV2 capsids in anion exchange (AEX) chromatography.

PMID:41239772 | DOI:10.1002/biot.70157

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Nevin Manimala Statistics

Prevalence and Predictors of Long Covid in a Cohort of Brazilian Adults 12 Months After Acute Infection: A Cross-Sectional Study

Health Expect. 2025 Dec;28(6):e70467. doi: 10.1111/hex.70467.

ABSTRACT

INTRODUCTION: Since the onset of the pandemic in early 2020, various reports have emerged regarding persistent symptoms associated with Covid-19. Nevertheless, there is insufficient data on the persistence of symptoms over time. This study sought to estimate the prevalence of persistent symptoms 12 months after Covid-19 infection and identify predictors of long Covid in adults living in the State of Paraná, southern Brazil, according to the level of severity of Covid-19 infection.

METHOD: An observational and cross-sectional survey was conducted with Brazilian adults diagnosed with Covid-19, as assessed from data available in two official Covid-19 notification databases in Brazil, using telephone interviews. Descriptive statistics, tests of associations and simple and multiple binary logistic regression analysis were used to identify predictors of long Covid.

RESULTS: In total, 1033 adults participated in the study. The overall prevalence of long Covid was 60.3% (n = 623). Prevalence was higher in women (67.7%), people aged between 50 and 59 years (65.8%) and in individuals who received treatment in an Intensive Care Unit (ICU) during the acute phase of Covid-19 infection (74.4%, n = 241). The risk factors associated with a greater chance of developing long Covid were: female (OR 2.38; 95% CI 1.55; 3.66), living in the Brazilian northwest health macro-region (OR 2.20; 95% CI 1.21; 4.00), presenting multimorbidity (OR 1.86; 95% CI 1.06; 3.28), having an average of six symptoms in the acute phase of Covid-19 (OR 1.22; 95% CI 1.17; 1.28) and having received treatment in an ICU (OR 4.86; 95% CI 2.83; 8.35) and inpatient ward (OR 2.45; 95% CI 1.47; 4.09).

CONCLUSIONS: The results highlight the high prevalence of long Covid and support the formulation of health policies capable of minimising the consequences on the population, on the services offered by professionals and on health systems.

PATIENT OR PUBLIC CONTRIBUTION: The study topic’s importance was based on the patients’ experiences in the author’s previous research and the need to develop patient-centred care.

PMID:41239762 | DOI:10.1111/hex.70467

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Nevin Manimala Statistics

Risk of re-operation after incision and drainage for acute, abscess-forming pilonidal sinus disease: A Danish population-based cohort study

Colorectal Dis. 2025 Nov;27(11):e70307. doi: 10.1111/codi.70307.

ABSTRACT

BACKGROUND: Acute abscess-forming pilonidal sinus disease (PSD) is treated surgically, with lateral incision and drainage (I&D) considered the gold standard; however, the risk of re-operation is unknown.

AIM: To evaluate re-operation rates following abscess-forming PSD treatment with lateral I&D, and to identify factors influencing re-operation rates.

METHODS: Using data from nationwide Danish databases covering 2010-2021, we identified patients diagnosed with abscess-forming PSD undergoing lateral I&D as the initial treatment for PSD. Patients were followed up until re-operation, death, emigration, or the end of the study period. Stratified by sex, the risk of re-operation was reported as a cumulative incidence function (CIF). To explore risks, we used Cox regression analysis to calculate crude and age-adjusted hazard ratios (aHR).

RESULTS: Of 8251 (62% male) patients included, 2455 underwent re-operation for PSD. The overall five-year CIF was 32% for males and 33% for females. In males, the five-year CIF decreased from 47% among 0- to 16-year-olds to 14% among 50+ year-olds. In females, the corresponding numbers were 37% and 13%, respectively. A family history of PSD was found to increase re-operation risk, especially among female patients (aHR: 1.64 (95% confidence interval [95% CI]: 1.39-1.93)). The risk increases following the second and third consecutive I&D procedures to 52% and 69% in males, and to 57% and 64% in females, respectively.

CONCLUSION: As roughly two-thirds of patients do not require additional surgery, our findings do not support mandatory follow-up with definitive surgery for all PSD patients undergoing I&D. For certain high-risk subgroups, however, subsequent definitive surgery may be appropriate.

PMID:41239746 | DOI:10.1111/codi.70307

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Nevin Manimala Statistics

Concerns on the statistical methodology and incomplete reporting of patient information in the long-term outcomes of biologic therapy for prepouch ileitis

Colorectal Dis. 2025 Nov;27(11):e70309. doi: 10.1111/codi.70309.

NO ABSTRACT

PMID:41239745 | DOI:10.1111/codi.70309

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Nevin Manimala Statistics

Efficacy of individual increment on house dust mite sublingual immunotherapy in low-response patients with allergic rhinitis

Medicine (Baltimore). 2025 Nov 14;104(46):e45738. doi: 10.1097/MD.0000000000045738.

ABSTRACT

This study aimed to investigate the clinical improvement of the incremental dosage regimen in allergic rhinitis (AR) patients with low response to sublingual immunotherapy (SLIT). This retrospective study included 65 AR patients with low response to dust mite SLIT after 6-month treatment. Patients were divided into regular-dose (RD) group (n = 23) and high-dose (HD) group (n = 42). The RD group maintained the previous standard dose, while the HD group received the higher tolerated dose and further categorized into 2 subgroups based on increased doses. Total nasal symptoms score (TNSS), total medication score (TMS), combined symptom and medication score (CSMS), and visual analog scale were compared at baseline, 6 months, and 1 year. Safety was assessed by reported adverse events (AEs).There were no significant differences between RD and HD groups at baseline and 6 months. However, patients in the HD group showed significantly lower TNSS, TMS, CSMS, and visual analog scale at 1 year compared to the RD group (all P <.01). Continued improvements in TNSS, TMS, and CSMS were only found in the HD group from 6-month to 1-year treatment (all P <.01). Moreover, there was no statistical difference between HD subgroups at any follow-up points. In addition, a higher proportion of patients in the HD group discontinued medication. No difference was observed in AEs between RD and HD groups. Dose increment after 6-month SLIT treatment could significantly enhance efficacy in low-response AR patients over a 1-year course without raising the risk of AEs.

PMID:41239732 | DOI:10.1097/MD.0000000000045738

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Nevin Manimala Statistics

Evaluation of ChatGPT as a supplementary tool for pituitary adenomas: An observational study based on simulated consultations

Medicine (Baltimore). 2025 Nov 14;104(46):e45928. doi: 10.1097/MD.0000000000045928.

ABSTRACT

Chat Generative Pretrained Transformer (ChatGPT), a large language model developed by OpenAI, has shown potential in healthcare communication and patient education. However, its performance in specialized medical domains, such as pituitary adenomas (PAs), remains unclear. Therefore, this study aimed to evaluate the reliability and consistency of ChatGPT in answering PA-related questions. We hypothesized that ChatGPT would demonstrate high reliability in responding to general patient-oriented queries but lower reliability for specialized clinical questions. A total of 256 PA-related questions were collected from patients and families, clinical practice guidelines, and medical question banks. Each question was input into ChatGPT (GPT-4, March 2025 version), and the generated responses were independently reviewed by 2 senior neurosurgeons. Any discrepancies in their assessments were resolved by a third neurosurgeon with over 30 years of clinical experience. Responses were categorized as completely correct, partially correct but usable, partially correct, or incorrect. Responses rated as completely correct or partially correct but usable were considered reliable. Consistency was assessed based on the stability of response quality across similar question types. Comparisons were made by question type (general vs professional) and source using univariate analysis. Among the 256 responses, 143 (55.8%) were completely correct, 68 (26.6%) were partially correct but usable, 19 (7.4%) were partially correct, and 26 (10.2%) were incorrect. Overall, 82.4% of the responses were considered reliable, and 68.4% demonstrated consistency. Reliability was significantly higher for general questions than for professional ones (95.0% vs 78.6%, OR = 5.182, 95% CI: 1.545-17.378, P = .003), and for guideline-derived questions compared to question bank-derived ones (100.0% vs 75.7%, OR = 1.321, 95% CI: 1.214-1.437, P = .017). Differences in consistency across subgroups were not statistically significant. ChatGPT exhibits high reliability and moderate consistency in answering PA-related questions, especially for general and guideline-based content. It may serve as a supplementary source of patient information but should not replace professional medical consultation, particularly in complex or surgical contexts. As this study was conducted in an artificial testing environment without validation in real patient consultations, the generalizability of the findings remains limited.

PMID:41239728 | DOI:10.1097/MD.0000000000045928

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Nevin Manimala Statistics

Body mass index and depressive symptoms among Chinese nurses: A cross-sectional study

Medicine (Baltimore). 2025 Nov 14;104(46):e45886. doi: 10.1097/MD.0000000000045886.

ABSTRACT

Depressive symptoms are common in the nursing profession. A normal body mass index (BMI) is an important indicator of individuals’ health. However, few studies have examined the relationship between depressive symptoms and BMI in nurses. The aim of the present study was to investigate the association between them in Chinese nurses. A total of 1866 nurses from 12 tertiary hospitals participated in a survey conducted in Shandong, China. BMI was calculated by measuring participants’ height and weight. Depressive symptoms were assessed using the 10-item Center for Epidemiologic Studies Depression Scale. The relationship between BMI and depressive symptoms was analyzed using a multivariate logistic regression analysis. The depressive symptom prevalence in Chinese nurses was 47.8%. The results of the multivariate logistic regression analysis revealed that compared with participants whose BMI was in the normal range, those who were underweight (odds ratio = 1.670, 95% confidence interval: 1.161-2.403) or obese (odds ratio = 1.540, 95% confidence interval: 1.003-2.365) were positively associated with depressive symptoms, and those who were overweight were not significantly associated with depressive symptoms. Our findings indicated a high depressive symptom prevalence in Chinese nurses. Nurses who were obese or underweight were more likely to have depressive symptoms than those with a normal BMI. Age, educational background, professional title, monthly income, and department were factors that influenced depressive symptoms. Hospital administrators should take effective measures to encourage nurses to maintain a normal BMI status or be overweight and focus on the role of influencing factors that are conducive to improving nurses’ depressive symptoms.

PMID:41239726 | DOI:10.1097/MD.0000000000045886

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Nevin Manimala Statistics

Effect of early shoulder functional exercise timing on drainage duration and subcutaneous seroma formation in overweight women undergoing modified radical mastectomy for breast cancer

Medicine (Baltimore). 2025 Nov 14;104(46):e45808. doi: 10.1097/MD.0000000000045808.

ABSTRACT

This retrospective study investigates the impact of early postoperative shoulder functional exercise timing on drainage duration and subcutaneous seroma formation in overweight women undergoing modified radical mastectomy (MRM) for breast cancer. A total of 194 overweight breast cancer patients (BMI > 24) who underwent MRM between January 2023 and December 2024 were included. Patients were divided into a study group (n = 101, shoulder exercise initiated on postoperative day 7) and a control group (n = 93, exercise started on day 3). Key outcomes included postoperative drainage volume, drainage tube retention duration, and incidence of subcutaneous seroma. Additional visual analyses and subgroup analyses by BMI were performed. A multivariable logistic regression model was constructed to identify independent predictors of seroma formation. The study group exhibited significantly lower postoperative drainage volume (229.5 ± 82.2 vs 581.3 ± 115.7 mL, P < .001), shorter drainage tube retention duration (6.8 ± 0.8 vs 8.3 ± 0.7 days, P < .001), and a lower incidence of subcutaneous seroma (11.9% vs 30.1%, χ2 = 8.850, P = .003). Visual comparisons confirmed more favorable distribution patterns in the study group. BMI subgroup analysis revealed that patients with BMI ≥ 27.0 kg/m2 had worse outcomes, and benefited more from delayed exercise. Multivariate analysis identified early exercise initiation (odds ratio (OR) = 4.14, P = .004), higher BMI (OR = 1.20, P = .031), and advanced tumor stage (OR = 1.92, P = .015) as independent risk factors for seroma. Delaying shoulder functional exercise initiation to postoperative day 7 significantly reduces drainage volume, shortens drainage tube retention, and lowers the risk of seroma in overweight women following mastectomy. These benefits are particularly pronounced in patients with higher BMI. Adjusting rehabilitation protocols based on body habitus may improve postoperative recovery and warrants broader clinical adoption.

PMID:41239724 | DOI:10.1097/MD.0000000000045808

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Nevin Manimala Statistics

Cervical strain elastography to predict response to labor induction at late-term pregnancy in nulliparous women: A prospective cohort study

Medicine (Baltimore). 2025 Nov 14;104(46):e45821. doi: 10.1097/MD.0000000000045821.

ABSTRACT

Cervical tension elastography represents a novel noninvasive approach for assessing cervical stiffness and predicting the outcomes of labor induction. However, its additive value along with cervical length (CL) measurement is unknown. This study aimed to evaluate the predictive value of cervical tension elastography, particularly stiffness ratio and CL, for successful labor induction in nulliparous women during late pregnancy. This prospective study was conducted at 2 healthcare centers, Eskişehir City Hospital and Hitit University Erol Olçok Education and Research Hospital, from May 2024 to June 2024. A total of 50 nulliparous women were included in the study, of whom 43 had vaginal delivery and 7 underwent cesarean section. Cervical stiffness ratio and CL were measured using cervical tension elastography before induction. The statistical analysis was performed using IBM SPSS (Chicago) version 24.0. Continuous variables were analyzed using t-tests or nonparametric tests, and chi-square tests were used for categorical variables. Receiver operating characteristic analysis was also conducted to assess predictive values. Among the participants, 14% (7/50) experienced induction of labor failure, which aligned with global rates (17.3%-36.8%). CL and stiffness ratio, assessed via strain elastography, showed no significant predictive value for induction of labor success (P > .05). Receiver operating characteristic analysis demonstrated poor discrimination, with area under the curve values of 0.58 for CL and 0.55 for stiffness ratio. When measured in conjunction with CL, the cervical stiffness ratio was not found to improve the predictability of labor induction. Larger studies are required to validate these preliminary findings in more diverse populations.

PMID:41239722 | DOI:10.1097/MD.0000000000045821