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Nevin Manimala Statistics

Development & validation of a format for reporting endoscopic colonic biopsies

Indian J Med Res. 2025 Jul;162(1):111-116. doi: 10.25259/IJMR_355_2025.

ABSTRACT

Background & objectives Non-neoplastic diseases make a considerable part of daily workload of gastroenterologist and an endoscopist. As there are only a few endoscopic findings in literature to suggest a large era of colonic diseases, endoscopic biopsy is a must, to reach a definitive diagnosis. This needs a checklist or a similar format that contains all the important histological features to be seen in a colonic biopsy which is currently lacking in published literature. Hence, this study aimed to develop a format for reporting endoscopic colonic biopsies a first of a kind as per our knowledge particularly for non-neoplastic colonic diseases using modified kappa statistics. Methods Seventy one questions were included in this format after searching in various search engines using various phrases. These questions were reviewed by experts and changes were done accordingly. The finalized questionnaire was further shared with 20 subject matter experts. Their feedback was utilized to determine the Content Validity Index (CVI), calculated at both the item level (I-CVI) and the overall scale level (S-CVI), along with the modified kappa coefficient. For studies involving more than six experts, an I-CVI of 0.78 and an S-CVI/average of 0.9 were considered acceptable benchmarks. Results Fourteen out of 20 experts responded. Mean I-CVI for relevance across all items was 0.933, S-CVI/Average (based on proportion data) across all experts was 0.94 and Mean I-CVI was well above 0.78 (0.928). Interpretation & conclusions The scores indicated a strong agreement among experts on various histological features to be seen in an endoscopic colonic biopsy. These findings clearly indicates that the format met the content validity criteria and hence histological sections of endoscopic colonic biopsies can be read using this format.

PMID:40991214 | DOI:10.25259/IJMR_355_2025

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Efficacy of structured exercise & relaxation techniques in managing post-COVID paraspinal myalgia in manual labourers of Belagavi, Karnataka: A quasi-experimental study

Indian J Med Res. 2025 Jul;162(1):117-123. doi: 10.25259/IJMR_827_2024.

ABSTRACT

Background & objectives This study compared the effectiveness of Progressive Muscle relaxation technique (PMRT) and Spinal Muscle Training (SMT) against Standard Neurosurgical Care (SNC) for the management of post-acute-COVID-19 syndrome (PACS)-associated paraspinal myalgia (PM), via changes in serum interleukin (IL)-17 and functional independence measured by Katz index of activities of daily living (ADL). Methods Male manual labourers aged 40-50 yr with PACS-associated PM were enrolled and allocated to the experimental group receiving PMRT and SMT and the control group receiving SNC delivered via telerehabilitation over 12 wk. IL-17 and ADL were measured pre- and post-intervention. Data analysis involved paired and unpaired t-tests, with a P value < 0.05 being statistically significant. Results There was a notable decrease in IL-17 in the experimental and control groups, from (31.13±3.68 pg/mL) to (18.96±2.56 pg/mL) and (31.05±4.24 pg/mL) to (28.89±4.58 pg/mL), respectively. The experimental group’s ADL scores increased from 2.93±0.94 to 5.03±0.85, while the control improved from 2.5±1.13 to 3.53±1.04. The experimental intervention was supported by large effect sizes and statistically significant differences in IL-17 reduction and ADL improvement on inter-group comparisons. Interpretation & conclusions The combination of PMRT and SMT was significantly efficacious than SNC at lowering systemic inflammation and improving functional independence in PACS patients with PM. This study also highlighted the role of telerehabilitation in intervention delivery to socio-demographically limited populations. Future studies should investigate long-term effects and generalizability to larger populations.

PMID:40991213 | DOI:10.25259/IJMR_827_2024

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Pharmacological therapies for alcohol use disorder reduce hepatic decompensation & mortality in alcohol-related liver disease: A GRADE evaluation through a meta-analysis

Indian J Med Res. 2025 Jul;162(1):66-73. doi: 10.25259/IJMR_2086_2024.

ABSTRACT

Background & objectives The role of behavioural therapies for alcohol use disorder (AUD) has been reported in patients with alcohol-related liver disease (ALD); however, that of pharmacological treatments is yet to be established. We conducted a systematic review and meta-analysis to study the use of these pharmacological interventions in ALD for liver-related and patient-important outcomes, including abstinence. Methods We conducted a systematic search of four major databases. Title and abstract screening, full-text review, risk of bias assessment, and data extraction were performed independently by two reviewers. Random-effects meta-analysis was used to calculate pooled effect estimates with 95 per cent confidence intervals (CI). The certainty of the evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) tool and categorised as high, moderate, low, or very low. Results Altogether, eleven studies (1 RCT and 10 cohort studies) were included in the systematic review and eight studies in the meta-analyses. Meta-analysis of two cohort studies (44813 participants) showed significantly lower odds of all-cause mortality with the use of AUD pharmacotherapy with acceptable statistical heterogeneity [Odds Ratio (OR) 0.86; 95% CI 0.79-0.93; I2 = 0%]. Meta-analysis of one RCT and three cohort studies (303 participants) for the outcome of abstinence revealed a pooled proportion of 47.5 per cent (95% CI, 42.1-52.9; I2 = 11.7%). The certainty in estimates was very low. Interpretation & conclusions The present systematic review and meta-analysis suggest that pharmacological therapies in ALD may reduce overall mortality and the incidence of hepatic decompensation. However, given the very low certainty of evidence, these findings should be interpreted with caution and underscore the need for well-designed trials.

PMID:40991211 | DOI:10.25259/IJMR_2086_2024

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Hope, Mindfulness, and Anxiety in the Context of Racial Discrimination Among Black Young Adults

J Racial Ethn Health Disparities. 2025 Sep 24. doi: 10.1007/s40615-025-02655-8. Online ahead of print.

ABSTRACT

OBJECTIVES: Anxiety disorders have a chronic, more severe course among Black individuals. Racial and ethnic discrimination exacerbates anxiety among Black adults. Hope and mindfulness are positive resilience traits that correlate with lower anxiety levels. Protective factors against anxiety must be examined in culturally informed contexts. This study evaluates the unique associations of hope, mindfulness, discrimination, anxiety, and social anxiety among Black adults.

METHODS: Participants were 635 (133 men, 502 women) adults from a large southwestern United States university who identified as African American or Black. Ages ranged from 18 to 52 (Mage = 21.66 years). Participants completed a battery of self-report questionnaires on hope, mindfulness, anxiety, social anxiety, and discrimination.

RESULTS: Structural equation modeling analyses demonstrated that hope is associated with lower social fear when accounting for mindfulness and discrimination (β = – 0.14, C.I = – 0.24: – 0.03). Mindfulness is associated with lower anxiety (β = – 0.31, C.I = – 0.41: – 0.21), social fear (β = – 0.18, C.I = – 0.29: – 0.07), and social avoidance (β = – 0.22, C.I = – 0.34: – 0.10) when accounting for hope and discrimination. Discrimination is associated with higher anxiety (β = 0.28, C.I = 0.20:0.36), social fear (β = 0.31, C.I = 0.22:0.39), and social avoidance (β = 0.29, C.I = 0.20:0.37) when accounting for mindfulness and hope.

CONCLUSIONS: Mindfulness had more robust protective qualities in the context of discrimination for anxiety and social anxiety than hope. The maladaptive relationships between discrimination and anxiety remained despite the presence of hope and mindfulness. Additional research is needed to identify strength-based approaches to protecting against and healing from experiences with discrimination among Black adults.

PMID:40991199 | DOI:10.1007/s40615-025-02655-8

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Impact of continuous positive airway pressure therapy on metabolic and renal parameters in patients with obstructive sleep apnea, type 2 diabetes mellitus, and chronic kidney disease: a prospective cohort study

Int Urol Nephrol. 2025 Sep 24. doi: 10.1007/s11255-025-04777-8. Online ahead of print.

ABSTRACT

BACKGROUND: Continuous positive airway pressure (CPAP) therapy is the gold standard treatment for obstructive sleep apnea (OSA), but its impact on type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD), remains unclear. This study aimed to evaluate the effects of CPAP therapy on metabolic and renal parameters in patients with OSA, T2DM, and CKD for over 18 months.

MATERIAL AND METHODS: This prospective, non-randomized, single-centre cohort study enrolled 60 patients with moderate-to-severe OSA (AHI > 15 episodes/hour), CKD (eGFR 15-60 mL/min/1.73m2), and T2DM. The patients were divided into a CPAP therapy group (n = 30) and a usual care group (n = 30). CPAP adherence was defined as ≥ 4 h/night for at least 70% of monitored nights. The primary outcomes included changes in the urinary albumin-to-creatinine ratio (UACR) Secondary outcomes included changes in serum creatinine, estimated glomerular filtration rate (eGFR), HbA1c, homeostasis model assessment of insulin resistance (HOMA-IR), apnea-hypopnea index (AHI), and oxygen desaturation index (ODI). Statistical analyses included independent test, repeated measures of analysis of variance, and analysis of covariance (ANCOVA).

RESULTS: 8 (13%) patients were lost to follow-up, and therefore 52 patients (27 patients in CPAP group and 25 patients in usual care group) were included in per-protocol analysis. After 18 months, CPAP therapy significantly improved AHI (mean change: 8.96 ± 4.94, p = 0.001), HbA1c (mean change: 1.44 ± 0.46, p = 0.001), HOMA-IR (mean change: 1.85 ± 0.14, p = 0.001), UACR (mean change: 139.08 ± 85.27 mg/g, p = 0.015), and serum creatinine (mean change: 1.02 ± 0.34 mg/dL, p = 0.011). No significant changes were observed in eGFR (p = 0.513) levels.

CONCLUSION: CPAP therapy significantly improved metabolic and renal parameters, particularly albuminuria and insulin resistance, in patients with OSA, T2DM, and CKD. However, it did not significantly impact the eGFR over 18 months.

PMID:40991192 | DOI:10.1007/s11255-025-04777-8

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The mediating role of pain in the relationship between sleep and recovery

Ir J Med Sci. 2025 Sep 24. doi: 10.1007/s11845-025-04097-x. Online ahead of print.

ABSTRACT

BACKGRAUND: Sleep disturbances and pain are common in the early postoperative period and can significantly impact recovery. Poor sleep quality may increase pain perception, while unmanaged pain can further disrupt sleep, creating a negative cycle that impairs healing. Understanding how these factors interact is essential to improving postoperative outcomes.

AIM: This study aims to examine the mediating role of pain in the relationship between sleep quality on the first postoperative night and the level of recovery.

METHODS: This descriptive and cross-sectional study was conducted with 250 patients who underwent laparoscopic cholecystectomy in the general surgery clinic of a university hospital. Data were collected using the Patient Information Form, the Richards-Campbell Sleep Questionnaire, the Quality of Recovery-40 Questionnaire, and the Visual Analogue Scale. For statistical analysis, Pearson correlation, regression, hierarchical regression, and bootstrap mediation analysis were performed.

RESULTS: Sleep quality was found to be a significant and positive predictor of recovery (β = 0.415, p < .001). However, when pain was included in the model, the effect of sleep quality decreased but remained significant (β = 0.130, p = .035). The results of the bootstrap mediation analysis confirmed that pain was a significant mediator in this relationship.

CONCLUSION: Sleep quality influences postoperative recovery both directly and indirectly through pain levels. The findings suggest that holistic approaches to sleep and pain management in postoperative care processes may optimise recovery.

PMID:40991188 | DOI:10.1007/s11845-025-04097-x

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Estimating QALYs in adults with cerebral palsy: mapping the San Martin scale to the EQ-5D-5L for economic evaluation

Eur J Health Econ. 2025 Sep 24. doi: 10.1007/s10198-025-01831-1. Online ahead of print.

ABSTRACT

BACKGROUND: Responses on health-related quality of life measured by disease-specific instruments can be mapped onto the EQ-5D to estimate utility values for economic evaluation. San Martin´s Quality of Life Scale (St. MQoL-S) is a preferred measure to obtain health outcomes in adults with cerebral palsy. Nevertheless, it lacks a preference-based health utility score for estimating quality-adjusted life years (QALYs).

OBJECTIVE: To develop algorithms for mapping from the St. MQoL-S to allow future prediction of the EQ-5D-5L, in adults with cerebral palsy, when utility data have not been collected.

METHODS: Direct mapping models were developed using ordinary least squares, a generalized linear model, and Tobit regression analysis to estimate EQ-5D-5L utilities, with St. MQoL-S total and domain scores as explanatory variables, in a cross-sectional study of adults with cerebral palsy in Spain. Goodness-of-fit was assessed using mean absolute error (MAE) and root mean square error (RMSE). Repeated k-fold cross-validation was employed to select the optimal mapping model demonstrating superior predictive performance.

RESULTS: The best-performing model for predicting EQ-5D-5L utilities, includes the St. MQoL-S total scores, age, gender, and types of cerebral palsy as explanatory variables in a stepwise ordinary least squares regression, making it the most robust model for use as a mapping algorithm with external data.

CONCLUSION: This is the first study to present mapping algorithms between the St. MQoL-S and EQ-5D-5L. The mapping functions preferred in this study seem adequate for estimating the utilities of the EQ-5D-5L for economic evaluation and to obtain QALYs in adults with cerebral palsy.

PMID:40991164 | DOI:10.1007/s10198-025-01831-1

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Efficacy of platelet concentrates on vital pulp treatment of fully developed and immature permanent teeth: a systematic review and network meta-analysis of human clinical trials

Odontology. 2025 Sep 24. doi: 10.1007/s10266-025-01193-3. Online ahead of print.

ABSTRACT

This systematic review and network meta-analysis compared the efficacy of platelet concentrates with traditional bioactive capping materials on vital pulp treatment (VPT) healing outcomes in permanent human teeth. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) checklist and a registered protocol (CRD42024614771), a search was conducted across PubMed, Web of Science, Scopus, ClinicalTrials.gov, and the Cochrane Library for studies published until March 31, 2025. Controlled clinical trials evaluating VPT success rates using platelet concentrates versus bioceramics in permanent teeth, with at least 6 months’ follow-up, were included. Data from the selected studies were analyzed using the MetaInsight tool to assess multiple comparisons, and the risk of bias was evaluated using the Cochrane RoB2 and ROBINS-I tools. Evidence quality was graded using the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE). The search identified 1097 studies, with ten meeting the inclusion criteria, encompassing 437 patients and three treatment modalities. At 6 months, success rates for mature teeth showed no statistically significant differences: LPC (RR = 1.00; 95% CI: 0.96-1.04) and PRF (RR = 1.04; 95% CI: 0.96-1.12). For immature teeth, PRF demonstrated no significant effect (RR = 0.99; 95% CI: 0.92-1.06). At 12 months, outcomes remained non-significant for mature teeth with LPC (RR = 1.02; 95% CI: 0.90-1.15) and PRF (RR = 1.10; 95% CI: 0.94-1.28), and for immature teeth treated with PRF (RR = 1.00; 95% CI: 0.94-1.06). These findings suggest that while platelet concentrates may offer comparable outcomes, bioceramics should be considered the preferred option based on probabilistic analysis.PROSPERO registration number: CRD42024614771.

PMID:40991160 | DOI:10.1007/s10266-025-01193-3

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Predictive Factors of Suboptimal Response to Topical 0.1% Cyclosporine A Cationic Emulsion in Pediatric Vernal Keratoconjunctivitis: A Real-World Retrospective Study

Ophthalmol Ther. 2025 Sep 24. doi: 10.1007/s40123-025-01244-6. Online ahead of print.

ABSTRACT

INTRODUCTION: Vernal keratoconjunctivitis (VKC) is a chronic, recurrent ocular surface disease of childhood that often requires long-term anti-inflammatory therapy beyond topical corticosteroids. This study aimed to identify the clinical predictors of suboptimal treatment response with 0.1% cyclosporine A cationic emulsion (CsA CE) in a real-world pediatric cohort.

METHODS: This was a retrospective, single-center study including patients aged 4-18 years with moderate or severe VKC, evaluated at a multidisciplinary ophthalmology clinic between January 2021 and December 2024. All patients received 0.1% CsA CE (administered four times daily). Demographic, clinical, and anamnestic data were collected. Disease severity was assessed using the Bonini grading scale, which provides a semiquantitative evaluation of ocular signs and symptoms. Statistical analysis was performed using univariate and multivariate Cox regression. For significant parameters, ROC curves were generated and optimal cut-off values were identified using the Youden’s Index.

RESULTS: A total of 101 patients were included (mean age 8.86 ± 3.31 years; 27 females). Over a mean follow-up period of 1.44 ± 1.13 years, 18 patients (17.8%) required escalation to 1% CsA galenic eye drops, of whom seven were further switched to 0.1% tacrolimus galenic eye drops. On multivariate analysis, the baseline composite clinical score was the strongest predictor of suboptimal treatment response. Notably, the clinical signs score alone demonstrated superior discriminative ability (AUC 0.732) compared to the total score (AUC 0.714). Optimal cut-off values were identified as 7 for clinical signs and 15 for the overall score.

CONCLUSIONS: Baseline disease severity, particularly the score for clinical signs, is a reliable predictor of response to 0.1% CsA CE. In patients exceeding the identified thresholds, early therapeutic escalation may be warranted to improve disease control and prevent structural complications.

PMID:40991157 | DOI:10.1007/s40123-025-01244-6

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Analysis of whole genome sequence data shows association of Alzheimer’s disease with rare coding variants in ABCA7, PSEN1, SORL1 and TREM2

J Neurogenet. 2025 Sep 24:1-10. doi: 10.1080/01677063.2025.2561589. Online ahead of print.

ABSTRACT

Previous studies have reported associations between risk of Alzheimer’s disease (AD) or dementia and rare coding variants in a number of genes. A two-stage strategy was used in which a previously released whole exome sequenced sample was used to prioritise 100 genes showing the strongest evidence for association with AD. These genes were then analysed in a newly released whole genome sequenced sample to identify those which showed statistically significant evidence for rare coding variant association. Association analysis of loss of function (LOF) and nonsynonymous variants was carried out in 18,998 protein-coding genes using 11,188 controls and 5,808 cases, with nonsynonymous variants being annotated using 45 different pathogenicity predictors. The 100 genes showing strongest evidence for association were then analysed in a new sample of 27,749 controls and 13,234 cases using only the pathogenicity predictor which had performed best in the first sample. Four genes were statistically significant after correction for multiple testing: ABCA7, PSEN1, SORL1 and TREM2. The association of different categories of variant with AD was characterised and the pattern was seen to vary between genes. This study quantifies the contribution of different types of variant within each gene to AD risk. In general, these variants are probably too rare to be clinically useful for assessing individual risk of AD. Further research into the mechanisms whereby the products of these genes affect AD pathogenesis may aid development of novel therapeutic strategies.

PMID:40990081 | DOI:10.1080/01677063.2025.2561589