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Early Infliximab Trough Levels Predict the Long-term Efficacy of Infliximab in a Randomized Controlled Trial in Patients with Active Crohn's Disease Comparing, between CT-P13 and Originator Infliximab
Get PDFBackground/aims: The clinical efficacy and safety of CT-P13 are comparable to originator infliximab for Crohn's disease in CT-P13 3.4 study (NCT02096861). We performed a multivariate logistic analysis to demonstrate the association between early infliximab trough levels and treatment outcomes of CT-P13 and originator infliximab.
Methods: Early serum infliximab trough levels and anti-drug antibody (ADA) levels were compared between CT-P13 (n=100) and originator infliximab (n=98) groups. Receiver operating characteristic (ROC) analysis and multivariate logistic analysis were conducted to identify optimal cutoffs of serum infliximab trough levels and predictive factors for clinical outcomes.
Results: The median infliximab trough levels were not different between CT-P13 and originator infliximab groups at week 6, week 14, and in median ADA levels at week 14, respectively. ROC analysis found an infliximab concentration threshold of 4.5 μg/mL at week 6 and 4.0 μg/mL at week 14 as the cutoff value with the highest accuracy for the prediction of clinical outcomes. Serum infliximab trough levels at weeks 6 and 14 predicted clinical remission at weeks 30 and 54, and endoscopic remission at week 54. The combinations of clinical remission or C-reactive protein normalization with an early infliximab trough level improved the prediction of long-term clinical or endoscopic remission.
Conclusions: A threshold in serum infliximab trough level at week 6 and week 14 was highly predictive for long-term clinical outcomes. There were no statistical differences in serum infliximab trough levels and ADA levels between CT-P13 and originator infliximab.ope
Radiation pneumonitis following Yttrium-90 radioembolization: A Korean multicenter study
Get PDFObjective: To report the incidence of radiation pneumonitis after radioembolization.
Methods: In this retrospective study, from May 2009 to July 2021, 782 consecutive patients underwent radioembolization in two institutes. Medical internal radiation dose dosimetry and partition dosimetry were used for glass and resin Yttrium-90-labeled microspheres (90Y-microspheres), respectively. Medical records and radiological findings were retrospectively evaluated with emphasis on the symptomatic radiation pneumonitis.
Results: Of the 732 patients with lung shunt study and follow-up, 13 (1.8%) had symptomatic radiation pneumonitis and six patients died due to radiation pneumonitis. Of the 721 patients whose lung doses were calculated, 10 patients who were treated with glass (n = 5) and resin (n = 5) 90Y-microspheres had radiation pneumonitis. No significant statistical difference between glass and resin 90Y-microspheres (p = 0.304) was noted in terms of radiation pneumonitis incidence. Among the patients with radiation pneumonitis, all five patients treated with glass 90Y-microspheres had estimated lung doses > 29 Gy, whereas five patients treated with resin 90Y-microspheres had relatively wide range of lung dose reaching much lower value (13.21Gy).
Conclusion: The present study suggests that radiation pneumonitis after radioembolization may occur even though the manufacturer's instructions are followed.ope
Digital Health Interventions for Adult Patients With Cancer Evaluated in Randomized Controlled Trials: Scoping Review
Get PDFBackground: Digital care has become an essential component of health care. Interventions for patients with cancer need to be effective and safe, and digital health interventions must adhere to the same requirements.
Objective: The purpose of this study was to identify currently available digital health interventions developed and evaluated in randomized controlled trials (RCTs) targeting adult patients with cancer.
Methods: A scoping review using the JBI methodology was conducted. The participants were adult patients with cancer, and the concept was digital health interventions. The context was open, and sources were limited to RCT effectiveness studies. The PubMed, CINAHL, Embase, Cochrane Library, Research Information Sharing Service, and KoreaMed databases were searched. Data were extracted and analyzed to achieve summarized results about the participants, types, functions, and outcomes of digital health interventions.
Results: A total of 231 studies were reviewed. Digital health interventions were used mostly at home (187/231, 81%), and the web-based intervention was the most frequently used intervention modality (116/231, 50.2%). Interventions consisting of multiple functional components were most frequently identified (69/231, 29.9%), followed by those with the self-manage function (67/231, 29%). Web-based interventions targeting symptoms with the self-manage and multiple functions and web-based interventions to treat cognitive function and fear of cancer recurrence consistently achieved positive outcomes. More studies supported the positive effects of web-based interventions to inform decision-making and knowledge. The effectiveness of digital health interventions targeting anxiety, depression, distress, fatigue, health-related quality of life or quality of life, pain, physical activity, and sleep was subject to their type and function. A relatively small number of digital health interventions specifically targeted older adults (6/231, 2.6%) or patients with advanced or metastatic cancer (22/231, 9.5%).
Conclusions: This scoping review summarized digital health interventions developed and evaluated in RCTs involving adult patients with cancer. Systematic reviews of the identified digital interventions are strongly recommended to integrate digital health interventions into clinical practice. The identified gaps in digital health interventions for cancer care need to be reflected in future digital health research.ope
Family-centered interventions for children and adolescents with type 1 diabetes mellitus: an integrative review
Get PDFPurpose: The purpose of this study was to investigate the effect of family-centered interventions on improving health outcomes in children and adolescents with type 1 diabetes mellitus (T1DM).
Methods: A literature search was conducted according to the PRISMA guidelines, using six electronic databases: EMBASE, CINAHL, Medline, CENTRAL, Scopus, and Web of Science. The inclusion criteria encompassed studies with populations of children and adolescents (age <18 years) and at least one parent/caregiver, or only parents/caregivers if the children were very young, and studies that investigated the health outcomes of children and parents/caregivers diagnosed with T1DM.
Results: From 2,746 published studies, only nine studies met the inclusion criteria. The key interventions were non-technology-based interventions (n=4), technology-based interventions (n=2), and combined technology- and non-technologybased interventions (n=3). The interventions had effects on glycated hemoglobin, adherence to diabetes management, diabetes self-management behaviors, and parentchild teamwork in diabetes management. Other essential effects were children's quality of life, children's problem-solving skills, parents' quality of life, and parents' coping and depression.
Conclusion: Family-centered interventions can effectively improve health outcomes in children and adolescents with T1DM. In the future, family-centered interventions integrated with other approaches, theories, and models should be developed to achieve the best possible outcomes.ope
Patterns and risk factors of cognitive decline among community-dwelling older adults in South Korea
Get PDFDementia prevalence is increasing worldwide. Thus, the global impact of cognitive impairment and dementia have become significant public health issues. This study assessed the patterns of and investigated risk factors associated with cognitive decline over time in community-dwelling Korean adults (age ≥65 years). We enrolled 1,369 older adult respondents without cognitive decline in the baseline survey of the Korean Longitudinal Study of Aging (2006-2016) in South Korea. The risk of first-ever mild-to-moderate or severe cognitive decline during the 10-year follow-up (2006-2016) was comparatively evaluated between the cognitive decline group (comprising participants with mild-to-moderate or severe cognitive decline; n = 728) and the normal cognition group (participants without a cognitive decline event; n = 641). The cognitive decline-free survival rates for up to ten years were measured using Kaplan-Meier analysis. The generalized estimation equations model was used to analyze changes in K-MMSE over time from 2006 to 2016. The adjusted Cox proportional hazards model revealed that increased age, female, lower education level, no religious status, and living in a small city were factors that were associated with a higher risk of cognitive decline, as were health-related factors, including lower handgrip strength, a higher number of chronic diseases, and depressive symptoms. Regular exercise, non-drinking status, and active social engagements reduced the risk of cognitive decline. The identified risk factors could facilitate the development of cognitive decline-prevention programs incorporating individualized risk-modification interventions to prevent cognitive decline in older adults.ope
Interlaboratory Comparison Study (Ring Test) of Next-Generation Sequencing-Based NTRK Fusion Detection in South Korea
Get PDFPurpose: Tropomyosin receptor kinase (TRK) inhibitors are approved for the treatment of neurotrophic receptor tyrosine kinase (NTRK) fusion-positive tumors. The detection of NTRK fusion using a validated method is required before therapeutic application. An interlaboratory comparison study of next-generation sequencing (NGS)-based NTRK gene fusion detection with validated clinical samples was conducted at six major hospitals in South Korea.
Materials and methods: A total of 18 samples, including a positive standard reference and eight positive and nine negative clinical samples, were validated using the VENTANA pan-TRK (EPR17341) and TruSight Oncology 500 assays. These samples were then tested using four different NGS panels currently being used at the six participating institutions.
Results: NTRK fusions were not detected in any of the nine negative clinical samples, demonstrating 100% specificity in all six participating institutions. All assays showed 100% analytical sensitivity to identify the NTRK fusion status in formalin-fixed paraffin-embedded (FFPE) samples, although with variable clinical sensitivity. False-negative results were due to low tumor purity, poor RNA quality, and DNA-based sequencing panel. The RNA-based targeted NGS assay showed an overall high success rate of identifying NTRK fusion status in FFPE samples.
Conclusion: This study is the first to test the proficiency of NGS-based NTRK detection in South Korea with the largest participating institutions. RNA-based NGS assays to detect NTRK fusions can accurately characterize fusion transcripts if sufficient RNA of adequate quality is available. The comparative performance data will support the implementation of targeted NGS-based sequencing assays for NTRK fusion detection in routine diagnostics.ope
Albumin, filamin-A and cytokeratin 19 help distinguish intrahepatic cholangiocarcinoma from extrahepatic adenocarcinoma
No full textBackground: The differential diagnosis of intrahepatic cholangiocarcinomas (iCCAs) from metastatic adenocarcinomas from organs adjacent to the liver (gallbladder, pancreas, and stomach) is difficult due to histopathological similarity and a lack of specific markers. This study aimed to develop a method to differentiate iCCA and adenocarcinomas originated from extrahepatic organs adjacent to the liver.
Methods: We retrospectively enrolled surgically resected iCCA (n = 181) and adenocarcinomas from extrahepatic organs (n = 30, n = 28, and n = 38 from gallbladder, pancreas, and stomach, respectively) between 2007 and 2013. The albumin mRNA in situ hybridization (ISH) and immunohistochemistry (IHC) of filamin-A and cytokeratin 19 (CK19) were performed using tissue microarray. Using logistic regression analysis of three markers, iCCA-score was developed, and its diagnostic performance was evaluated.
Results: The iCCAs were more frequently positive for albumin ISH (23.2% vs. 0%), filamin-A IHC (47.5% vs. 12.5%) and CK19 (68.5% vs. 40.6%) than extrahepatic adenocarcinomas (p < 0.001 for all). The iCCA-score consisting of these three markers was developed, and it showed higher diagnostic performance (area under the curve [AUC], 0.798 vs. 0.616, p < 0.001). Taking an iCCA-score of 2 or higher as the threshold for iCCA, the sensitivity was substantially higher than albumin ISH alone (45.9% and 23.2%, respectively; p < 0.001), but maintained high specificity (94.8% and 100%, respectively).
Conclusion: Albumin ISH and IHC staining for filamin-A and CK19 showed distinct expression patterns between iCCA and extrahepatic adenocarcinomas from gallbladder, pancreas, and stomach. We developed iCCA-score that consisted of those three markers, and it showed better diagnostic performance than albumin ISH alone.restrictio
Prophylactic intraoperative wound irrigation with antibiotic solution for the prevention of surgical incisional wound infections: Systematic literature review and meta-analysis
No full textBackground: There is no consensus on the use of prophylactic intraoperative wound irrigation (pIOWI) for reducing surgical-site infections (SSIs), particularly surgical incisional wounds, and opinions are divided on whether an antibiotic should be mixed with the solution used for incisional wound irrigation. No large, reliable cohort studies or meta-analyses of pIOWI for surgical incisional wounds were found in PubMed or Embase.
Methods: We searched the PubMed, Embase, Cochrane Library, Insight, Scopus, and Web of Science databases for primary research articles investigating the relevance of pIOWI with antibiotics for SSIs. The initial search was limited to human studies published before January 2022, which were indexed as randomized controlled trials (RCTs); clinical trials; or observational, cross-sectional, or cohort studies. We used R statistical software version 4.1.2 for this meta-analysis.
Results: The odds ratio of the random-effects model was 0.519 [95% confidence interval (CI); 0.311, 0.864, P-value < 0.0117], indicating that the intervention had a statistically significant effect on surgical complications. To examine the heterogeneity of the entire study, we performed statistical analysis (τ2 (tau square) = 0.4175 [0.0732; 2.8178]; τ (tau) = 0.6461 [0.2706; 1.6786]; Higgins' I2 = 64.0% [34.8%; 80.1%]; and H = 1.67 [1.24; 2.24]).
Conclusions: Many studies have shown that inclusion of antibiotics in the irrigation solution significantly lowers the rate of soft-tissue-related SSIs, but those studies contain both heterogeneity and many biases. Further large, prospective RCTs only limited to incisional SSIs and excluding other variables and biases in the field of plastic surgery are needed.restrictio
Vaccine Effect on Household Transmission of Omicron and Delta SARS-CoV-2 Variants
Get PDFBackground: We evaluated the household secondary attack rate (SAR) of the omicron and delta severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, according to the vaccination status of the index case and household contacts; further, in vaccinated index cases, we evaluated the effect of the antibody levels on household transmission.
Methods: A prospective cross-sectional study of 92 index cases and 197 quarantined household contacts was performed. Tests for SARS-CoV-2 variant type and antibody level were conducted in index cases, and results of polymerase chain reaction tests (during the quarantine period) were collected from contacts. Association of antibody levels in vaccinated index cases and SAR was evaluated by multivariate regression analysis.
Results: The SAR was higher in households exposed to omicron variant (42%) than in those exposed to delta variant (27%) (P = 0.040). SAR was 35% and 23% for unvaccinated and vaccinated delta variant exposed contacts, respectively. SAR was 44% and 41% for unvaccinated and vaccinated omicron exposed contacts, respectively. Booster dose immunisation of contacts or vaccination of index cases reduced SAR of vaccinated omicron variant exposed contacts. In a model with adjustment, anti-receptor-binding domain antibody levels in vaccinated index cases were inversely correlated with household transmission of both delta and omicron variants. Neutralising antibody levels had a similar relationship.
Conclusion: Immunisation of household members may help to mitigate the current pandemic.ope
Impact of the Duration of Postoperative Antibiotics on the Prognosis of Patients with Infective Endocarditis
Get PDFAppropriate postoperative antibiotic treatment in patients with infective endocarditis (IE) reduces the risks of recurrence and mortality. However, concerns about adverse drug reactions arise due to prolonged antibiotic usage. Therefore, we compared the recurrence and mortality rates according to the duration of postoperative antibiotic therapy in patients with IE. From 2005 to 2017, we retrospectively reviewed 416 patients with IE treated at a tertiary hospital in South Korea; among these, 216 patients who underwent heart valve surgery and received appropriate antibiotics were enrolled. The patients were divided into two groups based on the duration of usage of postoperative antibiotic therapy; the duration of postoperative antibiotic therapy was more than two weeks in 156 patients (72.2%) and two weeks or less in 60 patients (27.8%). The primary endpoint was IE relapse. The secondary endpoints were 1-year IE recurrence, 1-year mortality, and postoperative complication rates. The median age was 53 (interquartile range: 38-62) years. The relapse rate of IE was 0.9% (2/216). There was no statistical difference in relapse (0.0% vs. 1.3%, p = 0.379), 1-year recurrence (1.7% vs. 1.3%, p = 0.829), or 1-year mortality (10.0% vs. 5.8%, p = 0.274) between patients with postoperative antibiotic administration of two weeks or less versus more than two weeks. The duration of postoperative antibiotic therapy did not affect the 1-year mortality rate (log-rank test, p = 0.393). In conclusion, there was no statistically significant difference in recurrence, mortality, or postoperative complications according to the duration of postoperative antibiotic therapy.ope