Construct Validity and Inter-Rater Reliability of a Tool Designed for Nurses

[Posted 17/Jan/2023]

AUDIENCE: Nursing

KEY FINDINGS: The surgical wound assessment tool was deemed to be acceptable, valid and reliable for monitoring the status of surgical wound healing. However, further modification and testing are needed to strengthen the tool and to determine the applicability of the tool in other populations.

BACKGROUND: Purpose of this study is to validate construct validity and inter-rater reliability of a surgical wound assessment tool. Wound assessment is central to appropriate wound management. However, limited standard surgical wound assessment tools are available to assist nurses in assessing and recording progress in the healing of surgical wounds.

DETAILS: A prospective observational study was utilised to test the validity and reliability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline was used. Convenience sampling was used to recruit 260 patients who underwent elective or emergency surgery at a hospital in Vietnam. Exploratory factor analysis was used to examine the construct validity of the surgical wound assessment tool. Inter-rater reliability was calculated using the intraclass correlation coefficient and Cohen's kappa to determine reliability of the overall scale and identified items. The results of the exploratory factor analysis supported a three-component structure of the surgical wound assessment tool. The intraclass correlation coefficient value of the overall scale was 0.79 (95% CI 0.67-0.89), p < .001, confirming excellent inter-rater reliability. Cohen's kappa value ranged from 0.5 to 1, demonstrating moderate to almost perfect level of agreement for individual items, except for one item on pain.

Copyright © John Wiley & Sons Ltd. All rights reserved.

Source: Do, H. T. T., Edwards, H., Finlayson, K. (2023). Surgical Wound Assessment Tool: Construct Validity and Inter-Rater Reliability of a Tool Designed for Nurses. Journal of Clinical Nursing. 2023; 32: 83-95. Published: January, 2023. DOI: 10.1111/jocn.16476.

Results From Phase 3 Studies of Bempedoic Acid

[Posted 29/Jun/2026]

AUDIENCE: Cardiology, Emergency Medicine, Internal Medicine

KEY FINDINGS: Bempedoic acid was well tolerated in patients aged >=75 years with efficacy and safety comparable with younger subgroups regardless of background statin usage. Bempedoic acid may be considered a viable strategy for managing hypercholesterolemia in adults, regardless of age.

BACKGROUND: Lowering low-density lipoprotein cholesterol (LDL-C) reduces the risk of major vascular events across all age groups. Authors analyzed phase 3 studies of bempedoic acid to characterize the safety and efficacy in patients aged >=75 years with and without a concomitant statin.

DETAILS: Post hoc analysis of bempedoic acid in high-risk patients with cardiovascular disease by age from phase 3 placebo-controlled, randomized clinical trials: two 52-week primary hyperlipidemia studies with maximal background statin ("max-statins pool"), and 1 cardiovascular outcomes trial ("statin-intolerant pool). Efficacy (LDL-C, non–high-density lipoprotein cholesterol, total cholesterol, high-sensitivity C-reactive protein) and safety were evaluated. The max-statins pool included 3009 (2010 bempedoic acid, 999 placebo) patients. The statin-intolerant pool included 13 970 patients (6992 bempedoic acid, 6978 placebo). In total 7022 patients were aged 18 to <65 years; 7372 were aged 65 to <75 years; 2585 were aged >=75 years. Placebo-corrected mean percentage change in LDL-C at week 12 in the max-statin pool with bempedoic acid was -18.4% (95% CI, -21.3 to -15.6) for patients aged 18 to <65 years, -18.6% (95% CI, -21.2 to -16.1) for 65 to <75 years, and -18.3% (95% CI, -22.2 to -14.5) for >=75 years. In the statin-intolerant pool, LDL-C change was -21.9% (95% CI, -23.1 to -20.7) for patients aged 18 to <65 years, -22.9% (95% CI, -24.0 to -21.8) for 65 to <75 years, and -24.5% (95% CI, -26.2 to -22.7) for >=75 years. Frequency of adverse events compared with placebo was similar across the ages, but more frequent among patients >=75 years regardless of background statin. Cardiovascular event reduction was statistically comparable across all ages.

Copyright © American Heart Association, Inc. All rights reserved.

Source:John Mancini, G. B., Lincoff, A. M., Goldberg, A. C., et al. Efficacy and Safety of Bempedoic Acid in Patients Aged >=75 Years Stratified by Varying Statin Exposure: Results From Phase 3 Studies of Bempedoic Acid. Journal of the American Heart Association. Published: June 23, 2026. DOI: 10.1161/JAHA.125.04789

A Phase 3, Multicentre, Randomised, Double-Blind, Placebo-Controlled Tria.

[Posted 23/Jun/2026]

AUDIENCE: Oncology, Internal Medicine

KEY FINDINGS: The addition of aglatimagene plus valacyclovir to standard radiotherapy improved disease-free survival in patients with localised prostate cancer without increasing clinically significant toxicity compared to placebo.

BACKGROUND: Approximately 30% of men with localised prostate cancer who undergo radiotherapy with curative intent experience disease recurrence, which often leads to the need for salvage therapies that carry significant toxicity. Previous research indicated that aglatimagene besadenovec (CAN-2409) demonstrates synergy with radiation and induces immune-mediated cytotoxicity in prostate cancer patients. This study evaluated whether adding aglatimagene plus the prodrug valacyclovir to standard-of-care external beam radiotherapy (EBRT) could improve disease-free survival.

This was a phase 3, randomised, double-blind, placebo-controlled study conducted at 51 centres in the USA and Puerto Rico. Eligible patients (aged >=18 years, ECOG score 0-2) with intermediate- or high-risk prostate cancer were randomised (2:1) to receive either intraprostatic aglatimagene (5 x 10¹¹} viral particles) plus valacyclovir or a placebo plus valacyclovir, alongside standard-of-care EBRT. The primary endpoint was disease-free survival in the intent-to-treat population. Safety was assessed in all patients who received at least one injection. Between Feb 21, 2012, and Sept 9, 2021, 745 men were randomly assigned to the aglatimagene group (n=496) or the placebo group (n=249). After a median follow-up of 50.3 months, median disease-free survival was not reached in the aglatimagene group, while it was 86.1 months in the placebo group (hazard ratio 0.70, 95% CI 0.52–0.94; P=0.016). Grade 3 or worse treatment-emergent adverse events (TEAEs) occurred in 40 (8%) of 479 patients in the aglatimagene group and 17 (7%) of 232 in the placebo group, with acute kidney injury being the most common grade 3 or worse TEAE in both cohorts (2%). No treatment-related deaths were reported. DETAILS:

Copyright © Skyscape Editorial Team. All rights reserved.

Source:DeWeese, T., Manzanera, A., Sylvester, J. et al. Aglatimagene Besadenovec (CAN-2409) With Radiotherapy for Patients With Localised Prostate Cancer: A Phase 3, Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial. The Lancet Oncology. 2026; 27(6): 673-685. Published: June 22, 2026. DOI: XXXX

[Posted 22/Jun/2026]

AUDIENCE: Emergency Medicine, Internal Medicine

KEY FINDINGS:

• Retrospective cohort study of 262 patients with acute respiratory failure.
• ROX and ROX-HR indexes were associated with outcomes of conventional oxygen therapy.
• Higher index values correlated with successful treatment response.
• ROX-HR demonstrated the strongest early predictive performance.
• ROX-HR-0 independently predicted treatment success and may support early bedside risk stratification.
• Findings support further validation in larger prospective populations before broad implementation.

BACKGROUND: Conventional oxygen therapy remains the initial respiratory support strategy for many patients presenting with acute respiratory failure (ARF). However, delayed recognition of treatment failure may lead to prolonged hypoxemia, escalation delays, and poorer clinical outcomes. Noninvasive bedside tools that identify patients at risk for oxygen therapy failure could improve early decision-making. This retrospective study evaluated the respiratory rate oxygenation (ROX) index and the respiratory rate oxygenation–heart rate (ROX-HR) index as predictors of conventional oxygen therapy outcomes in ARF.

DETAILS: Investigators conducted a retrospective cohort analysis of patients admitted through the emergency department of a tertiary general hospital between June 2021 and May 2023. Patients receiving standard oxygen therapy for ARF were included and categorized according to treatment outcome into Success and Failure groups. Among 1,086 screened patients, exclusions included patients with SpO2 >93% on room air, incomplete data, refusal of treatment, immediate mechanical ventilation requirement, and death within 24 hours. A final cohort of 262 patients was analyzed, including 153 patients in the Success group and 109 in the Failure group. ROX and ROX-HR indexes were measured at baseline (0 h) and again at 1 h after oxygen therapy initiation. Predictive performance was evaluated using receiver operating characteristic (ROC) analysis, area under the ROC curve (AUROC), and multivariable logistic regression.

Patients with successful conventional oxygen therapy demonstrated significantly higher ROX and ROX-HR values at both 0 h and 1 h compared with patients who failed treatment (all p < 0.001).

At baseline, the ROX-HR index demonstrated slightly greater predictive discrimination than the ROX index:

• ROX-HR AUROC: 0.76 (95% CI 0.70–0.81)
• ROX AUROC: 0.75 (95% CI 0.69–0.81)

Multivariable logistic regression identified the baseline ROX-HR value (ROX-HR-0) as an independent predictor of successful conventional oxygen therapy:

• Odds ratio (OR): 0.48
• 95% CI: 0.27–0.86
• p = 0.013

Copyright © Elsevier B.V., its licensors, and contributors. All rights are reserved.

Source: Shen, J., Fang, Y., You, H., et al. A Retrospective Study of the Respiratory Rate Oxygenation and Respiratory Rate Oxygenation-Heart Rate Indexes in Predicting the Results of Conventional Oxygen Therapy in Patients with Acute Respiratory Failure. The Journal of Emergency Medicine. 2026; 86: 82-91. Published: July, 2026. DOI: 10.1016/j.jemermed.2026.03.017.

Clinical Characteristics and Neurodevelopmental Outcomes in 30 Patients

[Posted 19/Jun/2026]

AUDIENCE: Neurology, Neonatology

KEY FINDINGS: KCNQ2-related neonatal epilepsy shows robust, topology-dependent genotype-phenotype correlations with prognostic utility: early EEG patterns flag risk; transmembrane missense variants are associated with DEE, whereas single-allele truncating/NMD variants are associated with SeL(F)NE. Apparent benefits of oxcarbazepine reflect associations in an observational cohort and should not be interpreted as causal; prospective, phenotype-stratified studies are warranted. Long-term developmental surveillance remains essential, particularly for individuals with DEE and those with severe early EEG patterns or variants in transmembrane/pore regions.

BACKGROUND: The aim of this study was to characterize clinical features, genetic architecture, treatment responses, and neurodevelopmental outcomes in neonatal epilepsy associated with KCNQ2 variants and to delineate genotype-phenotype correlations.

DETAILS: Authors conducted a retrospective, two-center study of 30 neonates from 2019 to 2024. All patients underwent whole-exome sequencing with Sanger confirmation and, at last follow-up, were classified, according to International League Against Epilepsy criteria as having self-limited (familial) neonatal epilepsy (SeL[F]NE) or developmental and epileptic encephalopathy (DEE). Primary outcomes were seizure freedom by 6 months and milestone-based three-level neurodevelopment (normal/mild/severe). Clinical/EEG/MRI features and variant class/topology were compared across phenotypes. Most infants presented in the first week of life (median 3 days), typically with focal tonic seizures. EEG abnormalities were common (90%); burst-suppression/profound discontinuity consistently signaled adverse neurodevelopment. MRI was often normal (53%) or nonspecific. Authors identified 29 distinct variants (32 occurrences) across 30 patients. Twenty-eight carried a single heterozygous variant, and 2 carried 2 heterozygous variants (phase not determined); missense variants predominated (21/30, 70%). Clear topology-phenotype patterns emerged: transmembrane missense variants—especially S5-pore-S6—were enriched in DEE, whereas C-terminal/nontransmembrane variants were associated with SeL(F)NE and benign outcomes. At the last follow-up, SeL(F)NE accounted for 63% and DEE 37%. Seizure freedom reached 93%. Oxcarbazepine was often associated with seizure control after phenobarbital nonresponse, but this observational signal should not be interpreted as causal. Neurodevelopment was normal in 63%; delays occurred only within the DEE cohort. All 5 single-allele truncating/NMD lesions (CNV deletion, canonical splice-site, 2 nonsense, 1 frameshift) aligned with SeL(F)NE, whereas the 2 individuals with 2 heterozygous variants were classified as DEE with marked impairment; however, phase was not determined and 1 recurrent variant (p.E515D) was classified as likely benign, precluding inference of 2 pathogenic alleles.

Copyright © American Academy of Neurology. All Rights Reserved.

Source: Li, Y., Li, J., Li, L., et al. KCNQ2 Variants in Neonatal Epilepsy: Clinical Characteristics and Neurodevelopmental Outcomes in 30 Patients. Neuro Genetics. 2026; 12(3): e200380. Published: June, 2026. 12(3): e200380. DOI: 10.1212/NXG.0000000000200380.

ISUOG vs Delphi Diagnostic Criteria

[Posted 18/Jun/2026]

AUDIENCE: Ob/Gyn, Neonatology

KEY FINDINGS: While the detection rate of sFGR was higher using the Delphi criteria compared with the ISUOG criteria, the additional cases identified solely using the Delphi definition had significantly lower perinatal morbidity and mortality compared with those meeting the ISUOG definition for sFGR. Nonetheless, each constituent criterion within the Delphi definition was independently associated with adverse outcome in sFGR twin pregnancy. Further research is needed to elucidate the most appropriate tools for diagnosing and classifying MCDA twin pregnancies complicated by sFGR.

BACKGROUND: Purpose of this study is to evaluate the diagnostic performance of the Delphi consensus definition for selective fetal growth restriction (sFGR), compared with the traditional definition recommended by the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG), in predicting adverse perinatal outcome in monochorionic diamniotic (MCDA) twin pregnancy.

DETAILS: This was a retrospective cohort study of MCDA twin pregnancies followed at a tertiary fetal medicine unit between January 2000 and January 2024. Cases diagnosed with twin-to-twin transfusion syndrome or twin anemia–polycythemia sequence before or at the time of sFGR diagnosis and those with fetal structural or genetic anomaly were excluded. Fetal growth was assessed using chorionicity-specific twin reference charts and sFGR was diagnosed using the ISUOG or Delphi definition. Logistic regression analysis was used to evaluate the performance of each constituent criterion of the Delphi definition in identifying cases at risk of adverse outcome. The diagnostic performance of the ISUOG and Delphi criteria was assessed using receiver-operating-characteristics (ROC)-curve analysis. The final analysis included 363 MCDA twin pregnancies, of which 110 (30.3%) were diagnosed with sFGR using the Delphi consensus definition. The ISUOG criteria identified only 53/363 (14.6%) cases as sFGR. The rate of intact survival of both twins was significantly lower among the 53 cases diagnosed using ISUOG criteria compared with the 57 cases diagnosed solely using Delphi criteria (26.4% vs 63.2%), with significantly lower neonatal morbidity in the latter group. Logistic regression analysis showed that each constituent criterion of the Delphi definition was associated independently with significantly reduced intact survival of both twins. All combinations of Delphi criteria showed low-to-moderate discriminative ability in predicting the demise of the smaller and/or larger twin (all areas under the ROC curve > 0.6). The Delphi criteria had slightly higher sensitivity (0.840 vs 0.789) but lower specificity (0.743 vs 0.877) compared with the ISUOG criteria for predicting the demise of the smaller twin. Similar results were obtained for the prediction of larger twin demise and double fetal demise.

Copyright © John Wiley & Sons, Inc. All rights reserved

Source: Sorrenti, S., Yaghi, O., Prasad, S., et al. Perinatal Outcome of Monochorionic Twin Pregnancy Complicated by Selective Fetal Growth Restriction: ISUOG vs Delphi Diagnostic Criteria. Ultrasound in Obstetrics and Gynecology. 2026; 67(6): 774-782. Published: June, 2026. DOI: 10.1002/uog.70239.