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Nevin Manimala Statistics

Statistical Fragility of Endoscopic Lumbar Decompression Outcomes: A Systematic Review of Randomized Controlled Trials

Global Spine J. 2025 Sep 27:21925682251383882. doi: 10.1177/21925682251383882. Online ahead of print.

ABSTRACT

Study DesignSystematic Review.IntroductionRandomized controlled trials (RCTs) on lumbar endoscopic decompression inform treatment decisions for disk disease, radiculopathy, and lumbar spinal stenosis. This study assessed the fragility of statistical outcomes in these RCTs.MethodsPubMed, Embase, and MEDLINE were queried for RCTs reporting dichotomous outcomes with at least 1 endoscopic decompression arm. The fragility index (FI) and reverse FI (rFI) represented the number of event reversals needed to change significance for significant and nonsignificant outcomes, respectively. The fragility quotient (FQ) was calculated by dividing FI by sample size. Subgroup analysis was performed by outcome type.Results37 RCTs met the inclusion criteria for analysis. A total of 160 outcomes were analyzed. The median FI was 4 (IQR: 3-5) and FQ 0.038 (IQR: 0.017-0.067). Significant outcomes (n = 23) had a median FI of 7 (IQR: 2-13), FQ 0.024 (IQR: 0.012-0.056); nonsignificant outcomes (n = 137) had FI 4 (IQR: 3-5), FQ 0.041 (IQR: 0.020-0.068). Revisions/reoperations were most robust (FI: 5, FQ: 0.037); microscopic outcomes most fragile (FI: 4, FQ: 0.022). Pain outcomes had FI 4 (FQ: 0.051); complications FI 4 (FQ: 0.038). In 47.5% of outcomes, patients lost to follow-up exceeded FI.ConclusionsFindings from RCTs on lumbar endoscopic decompression are vulnerable to small changes in outcome events. In nearly half of outcomes, patients lost to follow-up outnumbered the FI. Reporting FI and FQ with P-values may improve interpretation and reliability of trial results.

PMID:41014588 | DOI:10.1177/21925682251383882

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Machine Learning using MR İmaging Radiomics can Predict the Response of Large Hepatocellular Carcinoma to Transarterial Radioembolization

Niger J Clin Pract. 2025 Sep 1;28(9):1111-1120. doi: 10.4103/njcp.njcp_305_25. Epub 2025 Sep 27.

ABSTRACT

BACKGROUND: Large tumor size is associated with poor outcomes in patients with hepatocellular carcinoma (HCC). Although some studies have evaluated the treatment response of HCC to transarterial radioembolization (TARE), none of them used radiomics features with machine learning (ML) models in large tumors.

AIM: To assess the performance of ML models using radiomics to predict the treatment response of TARE in large HCC lesions.

METHODS: This study included 49 patients with a large (>5 cm) HCC who underwent TARE. Treatment response was determined according to modified response evaluation criteria in solid tumors (mRECIST) criteria from the 3-month follow-up MR examinations. Complete or partial response was categorized as the responder group, while stable or progressive disease was classified as the non-responder group. Segmentation was performed on axial T2-weighted (T2W) and contrast-enhanced (CE) T1-weighted images. Classification learning models were used to create prediction models for TARE response.

RESULTS: Forty-nine patients (9 female, 40 male; mean age 63.58 ± 8.77) were included. None of the clinical, laboratory, and radiologic characteristics except the neutrophil counts showed statistical significance. Radiomics models obtained from CE-T1 and T2W images demonstrated an accuracy rate of 79.6%, while the area under the curve (AUC) rates were 0.92 and 0.77, respectively. The clinical model showed an accuracy rate of 77.6% and an AUC of 0.65. No statistically significant difference was found among all the models (P = 0.092).

CONCLUSION: ML-based models constructed with radiomics features obtained from MR images before the TARE procedure might predict response in large HCC lesions.

PMID:41014537 | DOI:10.4103/njcp.njcp_305_25

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Comparison of Early versus Late Exposure Methods of Dressing in the Healing of Split-Thickness Skin Graft Donor Sites in a Tertiary Hospital, Southeast, Nigeria

Niger J Clin Pract. 2025 Sep 1;28(9):1085-1089. doi: 10.4103/njcp.njcp_250_25. Epub 2025 Sep 27.

ABSTRACT

BACKGROUND: Split-thickness skin grafting (STSG) is a veritable reconstructive option for covering skin and soft tissue defects but donor site management remains a challenge. Attempts to improve STSG donor site care have been made using different methods and various dressing agents; however, there is no consensus on the standard method of donor site care.

AIM: This study aims to compare STSG healing rate using early versus late exposure of donor site dressing methods.

METHODS: This study was conducted in Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Ebonyi State, Southeast, Nigeria. Forty patients were recruited for the study and assigned to two groups of 20 patients each by a simple random sampling method. Group A had late exposure of the donor site dressing, whereas Group B had early exposure of the donor site dressing. The percentage re-epithelialization rate on the 14th day and the duration for complete re-epithelialization for both groups were calculated. The results were analyzed using International Business Machine Corporation, Statistical Package for the Social Sciences, Chicago Illinois, USA. (IBM SPSS) Statistics for Windows version 26.

RESULTS: The early exposure dressing method showed a faster re-epithelialization rate with a mean value of 98.15 (±4.92) compared with late exposure dressing methods with a mean rate of 70.95 (±13.22), which was statistically significant with a P value of 0.001. The duration for complete re-epithelialization was 13.80 (±4.63) days for the early exposure method and 29.40 (±6.25) days for the late exposure method. This is statistically significant with P < 0.001.

CONCLUSION: Management of STSG donor site by early exposure of the donor site dressing is associated with increased re-epithelialization rate and shortened duration for complete donor site healing.

PMID:41014534 | DOI:10.4103/njcp.njcp_250_25

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Influence of Surface Treatment on the Color Stability and Microhardness of Two Nanohybrid Enamel Shade Resin Composites: An In-Vitro Study

Niger J Clin Pract. 2025 Sep 1;28(9):1076-1084. doi: 10.4103/njcp.njcp_818_24. Epub 2025 Sep 27.

ABSTRACT

BACKGROUND: Oxygen-inhibited layer (OIL) is formed due to inadequate polymerization of resin composite (RC), which compromises its physical and mechanical properties.

AIM: This study focuses on analyzing the impact of different OIL control surface treatments on the color stability and microhardness of enamel shade RC.

METHODS: Discs (n = 240) were prepared out of two different types of nanohybrid enamel shade RCs, G-aenial A’CHORD (group AC) and Beautifil II Enamel (group BT). After allotting 60 samples each for the two experiments on color stability using spectrophotometer and surface microhardness using Vickers microhardness tester, they were further divided into four subgroups of 15 each based on the OIL control surface treatments: glycerin (G), mylar strip (M), finishing and polishing (FP), and no treatment (NT).

RESULTS: Group AC showed the least ∆E (color difference) values in subgroup M with statistical significance (one-way ANOVA; P = 0.001). However, group BT showed lesser ∆E in subgroups M and G (one-way ANOVA; P = 0.001). Between groups, AC showed significantly lower ∆ E and a higher mean hardness value (HV) than BT. The subgroup FP of both groups exhibited relatively high values (Tukey post-hoc; P = 0.001). The subgroup M showed the least ∆ E, and the subgroup FP showed the highest HV in both groups.

CONCLUSION: G-aenial A’CHORD showed relatively superior color stability and microhardness than that of Beautifil II Enamel. Finishing and polishing improved the microhardness of both the enamel shade RCs.

PMID:41014533 | DOI:10.4103/njcp.njcp_818_24

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Judicial and Ethical Dimensions of Sexual Harassment Allegations Against Physicians: A Content Analysis of Supreme Court Decisions in Turkey

Niger J Clin Pract. 2025 Sep 1;28(9):1032-1038. doi: 10.4103/njcp.njcp_356_25. Epub 2025 Sep 27.

ABSTRACT

BACKGROUND: Sexual harassment allegations against physicians undermine trust in healthcare and present significant ethical and legal challenges. While such issues are widely discussed in the context of professional conduct, systematic analyses of judicial decisions-particularly in non-Western settings-remain limited.

AIM: This study aims to analyze Turkish Supreme Court decisions involving sexual harassment allegations by physicians toward their patients, focusing on identifying patterns, associated risk factors, and ethical implications.

METHODS: A total of 46 Supreme Court judgments (2009-2024) were identified using the Lexpera database, employing keywords such as “harassment by physician” and “harassment during medical examination.” Each case was evaluated according to physician specialty, nature of the act (penetrative vs nonpenetrative), examination context, witness presence, and judicial outcomes (conviction, acquittal, or reversal).

RESULTS: Most incidents occurred in public hospitals, and the majority of patients were female. Physicians most frequently accused belonged to family medicine, obstetrics and gynecology, and radiology specialties. Documentation of informed consent and the presence of witnesses was rare. Allegations often involved genital examinations performed without explicit consent. While 69.7% of local court decisions resulted in convictions, only 39.4% were upheld by the Supreme Court.

CONCLUSION: Clear communication, standardized informed consent procedures, and the presence of witnesses during sensitive examinations are essential in preventing both misconduct and false accusations. These findings underscore the ethical importance of transparency and institutional safeguards and highlight the need for proactive policies to protect both patients and physicians.

PMID:41014528 | DOI:10.4103/njcp.njcp_356_25

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Evaluation of Cranial Computed Tomography use and Guideline Compliance in Head Trauma Patients Presenting to the Emergency Department

Niger J Clin Pract. 2025 Sep 1;28(9):1027-1031. doi: 10.4103/njcp.njcp_472_25. Epub 2025 Sep 27.

ABSTRACT

BACKGROUND: Head trauma was the significant public health issue and a common cause of emergency department visits. Cranial computed tomography (CT) was widely used in its evaluation; however, overuse-particularly in mild cases-raises concerns about patient safety and healthcare efficiency.

AIM: This study aimed to evaluate the appropriateness of cranial CT use in head trauma patients, its relationship with Glasgow Coma Scale (GCS) scores, and the prevalence of potentially avoidable imaging.

METHODS: This retrospective study included 1,000 patients presenting with head trauma, who underwent cranial CT. Data collected included demographics, trauma mechanism, GCS score, CT findings, and indication for imaging. CT necessity was assessed using the Canadian CT Head Rule and New Orleans Criteria. CTs performed in patients with GCS 13-15, normal findings, and no guideline-based indications were classified as potentially avoidable.

RESULTS: Of all patients, 65% were male, with a mean age of 42.1 ± 20.7 years. Mild trauma (GCS 13-15) was present in 77.5% of cases. Intracranial pathology was detected in 35.9% overall, with higher rates in patients with moderate and severe trauma. Unnecessary CT imaging was found in 57% of all cases, and in 80.2% of mild trauma cases. A statistically significant association was found between lower GCS scores and intracranial findings (P < 0.001).

CONCLUSION: Cranial CT was often overused in mild head trauma without adherence to clinical guidelines. Promoting the use of decision support tools and raising awareness among clinicians and patients are crucial for reducing potentially avoidable imaging, radiation exposure, and healthcare burden.

PMID:41014527 | DOI:10.4103/njcp.njcp_472_25

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Correlation between Chronic Urinary Retention, Retained Urine Volume, and Renal Function in Men with Urinary Retention from Bladder Outlet Obstruction in Southeast Nigeria

Niger J Clin Pract. 2025 Sep 1;28(9):1020-1026. doi: 10.4103/njcp.njcp_354_25. Epub 2025 Sep 27.

ABSTRACT

BACKGROUND: Urinary retention (UR) can lead to both anatomical and functional derangement in the urinary system. Chronic kidney disease occurs when there is renal damage.

AIM: This study aims to determine the relationship between chronic UR (CUR), retained urine volume, and renal function among men with chronic and acute-on-chronic UR.

METHODS: The study was a hospital-based prospective study of Nigerian men presenting with chronic or acute-on-chronic UR. Diagnosis of UR was made based on history and physical examination. The estimated glomerular filtration rate (eGFR) was calculated using the serum creatinine level. Retained urine volume was measured after an aseptic urethral catheterization. Spearman’s rank correlation test was used for correlation analysis between CUR, retained urine volume, and renal function. A P value of < 0.05 was accepted as statistically significant.

RESULTS: Fifty-six men met the inclusion criteria. Most of the patients were in the age range of 80-89 years. A total of 20 (35.7%) had acute-on-chronic UR, while 36 (64.3%) had CUR. The mean retained urine volume was 1500 ± 748.0 mL and 1100 ± 515.0 mL for the chronic and acute-on-chronic UR groups, respectively. Obstructive nephropathy occurred in 88.6% of the participants with CUR. There was a significant negative relationship between the eGFR and the volume of retained urine (r = -0.397, P = 0.002).

CONCLUSION: A high prevalence of obstructive nephropathy was observed among men with chronic and acute-on-chronic UR in this study.

PMID:41014526 | DOI:10.4103/njcp.njcp_354_25

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Predictive Value of the CRP/Albumin Ratio for Acute Kidney Injury and Renal Replacement Therapy in Critically Ill Patients: A Retrospective Observational Study

Niger J Clin Pract. 2025 Sep 1;28(9):995-1003. doi: 10.4103/njcp.njcp_254_25. Epub 2025 Sep 27.

ABSTRACT

BACKGROUND: Acute kidney injury (AKI) and the need for renal replacement therapy (RRT) are major complications in critically ill patients. The C-reactive protein (CRP)/albumin ratio (CAR) is a readily available biomarker reflecting systemic inflammation and nutritional status, but its predictive value for renal outcomes in the intensive care unit (ICU) remains uncertain.

AIMS: To assess whether the CAR measured within the first 12 hours of ICU admission can predict the development of AKI and the need for RRT in critically ill patients.

METHODS: This retrospective observational study was conducted in a tertiary intensive care unit and included 204 ICU patients without acute or chronic kidney failure at admission. CRP and albumin levels were measured within 12 hours of ICU admission. Patients with conditions affecting albumin levels were excluded. AKI and RRT development during ICU stay were recorded. Statistical analyses included the Mann-Whitney U test, Chi-square test, receiver operating characteristic (ROC) analysis for diagnostic performance, and multivariate logistic regression for independent predictors.

RESULTS: AKI occurred in 55.9% and RRT was required in 21.6% of patients. Patients requiring RRT had lower albumin levels and higher acute physiology and chronic health evaluation II (APACHE II) and sequential organ failure assessment (SOFA) scores. Although CAR was slightly elevated in patients with AKI or RRT, it was not independently associated with these outcomes (RRT: OR 0.97, AUC 0.575; AKI: OR 1.03, AUC 0.643).

CONCLUSIONS: The CRP/albumin ratio was not an independent predictor of AKI or RRT. Its clinical usefulness may improve, when combined with established illness severity scores for renal risk stratification in ICU patients.

PMID:41014523 | DOI:10.4103/njcp.njcp_254_25

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Effectiveness of surgical interventions in patients with severe pressure ulcers: the SIPS mixed-methods exploratory study

Health Technol Assess. 2025 Sep;29(47):1-150. doi: 10.3310/DWKT1327.

ABSTRACT

BACKGROUND: Surgical reconstruction to close a severe pressure ulcer has not been evaluated.

AIM AND OBJECTIVES: We aimed to investigate the feasibility of research to evaluate surgical reconstruction for severe pressure ulcers by: systematically reviewing evidence about: the effectiveness of surgical reconstruction for severe pressure ulcers; the impact of pressure ulceration on health-related quality-of-life (review 2) surveying primary and secondary care healthcare professionals about surgical referrals of patients with severe pressure ulcers and severe pressure ulcer management, including surgical reconstruction describing patients with incident pressure ulcers and with severe pressure ulcers having surgical reconstruction comparing outcomes in patients with severe pressure ulcers having/not having surgical reconstruction seeking consensus about treatments and management strategies for severe pressure ulcers.

DESIGN: Systematic reviews; surveys; binary choice experiment; retrospective cohort studies using routine data; consensus meeting.

PARTICIPANTS: General practitioners; nurses; and surgeons managing pressure ulcers; people with incident pressure ulcers and hospitalised with severe pressure ulcers.

INTERVENTION: Surgical reconstruction.

COMPARATOR: No surgical reconstruction.

OUTCOMES: Surgical reconstruction, time to next admission with a severe pressure ulcer time to next admission, hospital stay, all-cause mortality, surgical reconstruction after discharge.

RESULTS: Review 1 included three studies comparing different surgical reconstruction techniques. None reported wound-free time. Recurrence occurred in ≈ 20%. Review 2 included three randomised controlled trials measuring health-related quality of life, but none observed benefits of interventions evaluated. Among primary care survey respondents, 54% did not know surgical reconstruction can treat severe pressure ulcers; > 50% had never referred a patient to a surgeon. Among nurses, 72% had considered surgical reconstruction for a severe pressure ulcer; 54% believed surgical reconstruction should be more available. Among surgeons, 39% had never offered surgical reconstruction and 52% offered surgical reconstruction to < 50%; 68% believed surgical reconstruction should be more available. Routine data recorded 367,884 admissions with severe pressure ulcer diagnoses in England over 7.5 years; surgical reconstructions were performed in at least 404 and at most 1018 admissions. Twenty English hospitals performed > 70% of the surgical reconstructions. Comparing surgical reconstruction (n = 325) versus no surgical reconstruction (n = 1474) patients, time to next admission with a severe pressure ulcer was longer in patients having surgical reconstruction (hazard ratio = 0.79, 95% confidence interval 0.61 to 1.03; p = 0.07). Estimated pressure ulcer incidence in primary care was ≈ 5/10,000, but the true incidence was believed to be ≈ 7 times higher. Episodes of pressure ulcer care could not be identified. There was consensus about a referral pathway for severe pressure ulcer patients wanting surgical reconstruction, including both community-led and surgically led multidisciplinary team meetings, and about the influence of several patient and severe pressure ulcer characteristics on suitability for surgical reconstruction.

LIMITATIONS: Surveys only considered factors one by one. Analyses of the Hospital Episode Statistics cohort depended on coding accuracy. For the comparison of surgical reconstruction and no surgical reconstruction, the no surgical reconstruction group had to be admitted. Routine data do not record wound healing outcomes. Primary care data underestimated pressure ulcer incidence; pressure ulcer care episodes could not be identified. The consensus meeting did not include surgeons. The COVID-19 pandemic caused delays, made team members unavailable and restricted face-to-face meetings.

CONCLUSIONS: There is insufficient evidence to determine the effectiveness of surgical reconstruction on health-related quality of life or wound healing for severe pressure ulcers. Too few procedures are carried out to enable a randomised controlled trial to be feasible.

FUTURE WORK: We identified three areas: qualitative research on the acceptability of surgical reconstruction and the impact of a SPU on a patient’s quality-of-life; a core outcome set for interventions to treat pressure ulcers; and economic modelling of surgical reconstruction cost-effectiveness.

STUDY REGISTRATION: This study is registered as PROSPERO 2019 CRD42019156436, 2019 CRD42019156450; ISRCTN13292620.

FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127850) and is published in full in Health Technology Assessment; Vol. 29, No. 47. See the NIHR Funding and Awards website for further award information.

PMID:41014516 | DOI:10.3310/DWKT1327

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Impact of pre-existing frailty on all-cause mortality in stroke survivors: a systematic review and dose-response meta-analysis

Age Ageing. 2025 Aug 29;54(9):afaf273. doi: 10.1093/ageing/afaf273.

ABSTRACT

BACKGROUND: The association between pre-existing frailty and increased mortality in stroke survivors remains unclear, with prior studies reporting inconsistent findings. This meta-analysis aimed to evaluate the impact of pre-stroke frailty on all-cause mortality in this population.

METHODS: We systematically searched PubMed, Embase, Web of Science, Cochrane Library, CINAHL, PsycINFO, CNKI, Wanfang, VIP, and SinoMed databases up to November 12, 2024. Study selection and data extraction were independently performed by two investigators. Studies using validated frailty assessment tools and reporting adjusted hazard ratios (HRs) or odds ratios (ORs) with 95% confidence intervals (CIs) were included.

RESULTS: Sixteen studies involving 55,897 patients met the inclusion criteria. The prevalence of frailty among stroke survivors ranged from 11.2% to 75.3%. Meta-analysis showed that pre-stroke frailty was significantly associated with increased all-cause mortality (pooled HR = 2.19, 95% CI: 1.44-3.34; pooled OR for continuous frailty scores = 1.26, 95% CI: 1.14-1.38). Dose-response analysis revealed a linear relationship, with each one-point increase in frailty score associated with a 6.4% higher risk of death (HR = 1.064, 95% CI: 1.031-1.098). Subgroup analyses indicated that the association was particularly strong in acute ischemic stroke populations (OR = 3.43, 95% CI: 1.81-6.51). The type of frailty assessment tool and study sample size were identified as potential sources of heterogeneity.

CONCLUSION: Pre-stroke frailty independently predicts all-cause mortality in stroke survivors. Even mild increases in frailty burden are associated with worse outcomes, highlighting the clinical importance of incorporating frailty assessment into prognostic evaluation.

PMID:41014508 | DOI:10.1093/ageing/afaf273