Patient Selection Bias Research Articles

Outcome of primary ERCP versus primary PTC for biliary drainage in malignant hilar biliary strictures: a systematic review and meta-analysis.

Patients with malignant hilar biliary strictures can suffer from obstructive jaundice. Controversy remains on the optimal approach to obtain preoperative or palliative biliary drainage in these patients. A systematic review and meta-analysis was conducted to compare the two modalities most commonly used in this scenario: endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous transhepatic cholangiography (PTC). MEDLINE via PubMed was searched for relevant articles published from 2005 to April 2019. Following outcome measures were used to compare ERCP and PTC: therapeutic success rate, cholangitis, pancreatitis, bleeding,tube dislocation, reintervention rate, mortality such as 30d mortality and in-hospital death, median survival time, drainage patency, duration until decompression and hospital stay. Risk of bias assessment for the retrospective studies was conducted by NOS. RoB 2 was used for RCT. A meta-analysis was performed by using Review Manager 5.3. The certainty of evidence was appraised using GRADE. Eleven articles of which one RCT and ten retrospective cohort studies fulfilled the inclusion criteria for data-analysis (1417 patients; 784 ERCP, 633 PTC). The combined odds ratio (OR) for therapeutic succes was 3.5 times higher in the PTC group (95% CI 2.05-5.97; high certainty). In terms of cholangitis, ERCP carried a 1.7-fold risk as compared to PTC (95% CI 0.92-3.08; moderate certainty). Patients who underwent ERCP were 11.50 times more likely to undergo a reintervention (95% CI 3.51-37.70; moderate certainty). ERCP was comparable to PTC in terms of pancreatitis (low certainty), bleeding (high certainty) and tube dislocation rate (moderate certainty). Mortality tended to be numerically higher in the PTC group but low patient numbers, selection bias and study heterogeneity did not allow uniform comparative analysis. In patients with malignant hilar biliary strictures, PTC is associated with a better therapeutic success rate, less cholangitis and lower reintervention rate as compared to ERCP.

Should We Rely on AI to Help Avoid Bias in Patient Selection for Major Surgery?

Many regard iatrogenic injuries as consequences of diagnosis or intervention actions. But inaction-not offering indicated major surgery-can also result in iatrogenic injury. This article explores some surgeons' overestimations of operative risk based on patients' race and socioeconomic status as unduly influential in their decisions about whether to perform major cancer or cardiac surgery on some patients with appropriate clinical indications. This article also considers artificial intelligence and machine learning-based clinical decision support systems that might offer more accurate, individualized risk assessment that could make patient selection processes more equitable, thereby mitigating racial and ethnic inequity in cancer and cardiac disease.

Comparison of the Efficacy and Safety of Transarterial Chemoembolization with or without Lenvatinib for Unresectable Hepatocellular Carcinoma: A Retrospective Propensity Score-Matched Analysis.

BackgroundCombination of angiogenesis inhibitor may achieve better therapeutic synergistic efficacy, considering of tumor hypoxia and promoted angiogenesis after transarterial chemoembolization (TACE). This study aimed to compare the safety and efficacy of TACE plus lenvatinib (TACE-lenvatinib) with TACE alone for patients with unresectable hepatocellular carcinoma (HCC).MethodsBetween June 2019 and September 2021, a total of 215 patients diagnosed with unresectable HCC were retrospectively reviewed, including 53 patients who received TACE-lenvatinib and 162 patients who received TACE alone. The patient selection bias between the TACE-lenvatinib group and the TACE group was balanced by propensity score matching analysis at a 1:2 ratio. Progression-free survival (PFS), overall survival (OS) and tumor response were evaluated in the two groups.ResultsAfter propensity score matching analysis, 34 patients receiving TACE-lenvatinib and 68 patients receiving TACE alone were enrolled. The median PFS and OS times in the TACE-lenvatinib group were significantly greater than those in the TACE group (PFS: 8.3 months vs 4.6 months, P = 0.008; OS: 27.7 months vs 18.4 months, P = 0.043). The objective response rate (ORR) in the TACE-lenvatinib group was higher than that in the TACE alone group (64.1% vs 36.5%, P = 0.002). Univariate and multivariate analyses revealed that TACE-lenvatinib treatment was an independent favorable prognostic factor for both PFS and OS.ConclusionFor unresectable HCC patients, the TACE-lenvatinib appeared superior to TACE alone regarding tumor control, PFS, and OS. However, considering the limitations of this study, these results should be interpreted as preliminary and warrant further confirmation.

Actual prevalence of hypoparathyroidism after total thyroidectomy: a health insurance claims-database study.

Persistent hypoparathyroidism (hypoPT) is a major complication of total thyroidectomy. Nonetheless, previous reports may have underestimated the prevalence of hypoPT due to patient selection bias. We aimed to estimate the actual prevalence of persistent hypoPT after total thyroidectomy and to find predictive factors for postoperative hypoPT. This study retrospectively reviewed data from a health insurance claims-based database provided by the Japan Medical Data Center Co., Ltd. From 2009 to 2019, 2388 patients who underwent total thyroidectomy were identified using the medical procedure codes. Persistent hypoPT was defined as the prescription of active vitamin D supplements for >1 year postoperatively and the assignment of hypoPT codes. The prevalence of persistent hypoPT was estimated at two different levels: minimum and maximum estimations with or without postoperative osteoporosis and/or renal failure codes. Correlates for persistent hypoPT were investigated among several demographic and clinical variables. Of the 2388 patients, 1752 (73.4%) were women with a mean age of 45 years. The types of diseases were: benign thyroid disease (n = 235), malignant thyroid tumors (n = 1570), Graves ' disease (n = 558), and malignancy combined with Graves' disease (n = 25). The minimum and the maximum estimation of the prevalence of persistent hypoPT were 15.0 and 20.3%, respectively. Multivariate logistic regression analysis showed that the malignant tumor (odds ratio, 1.8) independently correlated with persistent hypoPT. The prevalence of persistent hypoPT after total thyroidectomy estimated by the claims-based database was higher than previously recognized. Comprehensive attempts to preserve parathyroid function, especially in malignant diseases, are essential.

Utilization and outcomes of metastatectomy for patients with stage IVB uterine cancer undergoing surgical management (156)

Utilization and outcomes of metastatectomy for patients with stage IVB uterine cancer undergoing surgical management (156)

Comparison of rapid eye movement without atonia quantification methods to diagnose rapid eye movement sleep behavior disorder: a systematic review.

Rapid eye movement (REM) sleep without atonia (RWA) is essential for diagnosing REM sleep behavior disorder (RBD). Manual and automatic quantifications of RWA that use different criteria have been validated. This study compared the RWA quantification methods for diagnosing RBD. The PubMed, EMBASE, Web of Science, and Cochrane Library databases were systemically searched for studies published from inception to December 2021. The inclusion criteria were cohort, cross-sectional, and case-control studies assessing the sensitivity and specificity of RWA quantification methods. Pooled estimates of the sensitivity, specificity, diagnostic odds ratio (DOR), and area under the curve (AUC) were determined. Risk of bias and certainty of evidence was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool and the Grading of Recommendations, Assessment, Development, and Evaluations framework, respectively. Fourteen articles including 402 patients with RBD met the inclusion criteria. Manual methods evaluating any chin and phasic flexor digitorum superficialis (FDS) activity had the highest DOR (138.8, 95% CI = 21.8% to 881.7%) and AUC (0.9686). The automatic REM atonia index (RAI) showed similar or higher sensitivity (89.1%, 95% CI = 84.6% to 92.7%) but a lower specificity (73.5%), DOR (43.1), and AUC (0.9369) than the manual techniques. In this meta-analysis, manual RWA quantification that employed chin or phasic FDS activity had the best RBD diagnostic performance. The automatic RAI method may be useful for screening patients with RBD. The results should be interpreted carefully because of the high risk of bias in patient selection and significant heterogeneity among the studies. CRD42021276445.

Switching from originator infliximab to biosimilar versus continuing on originator in inflammatory bowel disease: results from the observational Project NORTH study

Objective Project NORTH compared real-world clinical and economic outcomes in Swedish patients with inflammatory bowel disease (IBD) who switched from originator infliximab to its biosimilar. Materials and methods Data from electronic medical records and Swedish national registries were linked. Switchers (patients switching from originator infliximab to its biosimilar between 1 April 2014, and 31 December 2017) and non-switchers (patients who received originator infliximab and did not switch to a biosimilar by 31 December 2017) were followed up until 31 October 2019. Results Baseline concomitant medication use, disease duration, and inflammatory markers were lower among switchers than non-switchers. At 6 months, the proportion of patients with stable disease was higher among switchers than non-switchers (71/109 [65%] vs 54/107 [50%]; p = .0385); differences were not significant in subsequent follow-ups. At 6 and 24 months, 98% and 93% of switchers, respectively, used concomitant medications versus 96% and 79% of non-switchers. Throughout the study, all-cause treatment discontinuation occurred in 74 (67%) switchers and 105 (95%) non-switchers. At 36-months, mean (SD) number of IBD-related in-patient care days was higher among non-switchers (2.95 [4.71]) than switchers (1.40 [4.20]), as were total medical costs (€16,740 vs €3,872). Conclusions No substantial differences in clinical outcomes or healthcare resource utilization were observed between switchers and non-switchers. Several analyses indicate that non-switchers might have more poorly controlled/severe disease than switchers at baseline. Overall, numerous difficulties might arise when executing a high-quality, real-world study, including possible selection bias for patients with better disease control for NMS, limiting the generalizability of the results.

Gender Differences in Cardiogenic Shock Patients: Clinical Features, Risk Prediction, and Outcomes in a Hub Center.

IntroductionThere is scarce knowledge about gender differences in clinical presentation, management, use of risk stratification tools and prognosis in cardiogenic shock (CS) patients.PurposeThe primary endpoint was to investigate the differences in characteristics, management, and in-hospital mortality according to gender in a cohort of CS patients admitted to a tertiary hub center. The secondary endpoint was to evaluate the prognostic performance of the Society of Cardiovascular Angiography and Interventions (SCAI) classification in predicting in-hospital mortality according to sex.MethodsThis is a retrospective single-Center cohort study of CS patients treated by a multidisciplinary shock team between September 2014 and December 2020. Baseline characteristics and clinical outcomes according to gender were registered. Discrimination of SCAI classification was assessed using the area under the receiver operating characteristic curve (AUC).ResultsOverall, 163 patients were included, 39 of them female (24%). Mean age of the overall cohort was 55 years (44–62), similar between groups. Compared with men, women were less likely to be smokers and the prevalence of COPD and diabetes mellitus was significantly lower in this group (p < 0.05). Postcardiotomy (44 vs. 31%) and fulminant myocarditis (13 vs. 2%) were more frequent etiologies in females than in males (p = 0.01), whereas acute myocardial infarction was less common among females (13 vs. 33%). Regarding management, the use of temporary mechanical circulatory support, mechanical ventilation, or renal replacement therapy was frequent and no different between the groups (88, 87, and 49%, respectively, in females vs. 42, 91, and 41% in males, p > 0.05). In-hospital survival in the overall cohort was 53%, without differences between groups (52% in females vs. 55% in males, p = 0.76). Most of the patients (60.7%) were in SCAIE at presentation without differences between sexes. The SCAI classification showed a moderate ability for predicting in-hospital mortality (overall, AUC: 0.653, 95% CI 0.582–0.725). The AUC was 0.636 for women (95% CI 0.491–0.780) and 0.658 for men (95% CI 0.575–0.740).ConclusionsOnly one in four of patients treated at a dedicated CS team were female. This may reflect differences in prevalence of severe heart disease at young (<65) ages, although a patient-selection bias cannot be ruled out. In this very high-risk CS population of multiple etiologies, overall, in-hospital survival was slightly above 50% and showed no differences between sexes. Treatment approaches, procedures, and SCAI risk stratification performance did not show gender disparities among treated patients.

Surgical Management of Type II Displaced Dens Fractures Improves One-year Mortality in Elderly Patients.

Retrospective cross-sectional analysis of US national data collected by PearlDiver Inc. database. To determine the rates of surgical/nonsurgical treatments and associated one-year mortality for displaced type II dens fractures without neurological deficit. Existing literature on dens fractures includes small series of patients with highly variable surgical rates. These studies contain insufficient data to determine the benefits of surgical or nonsurgical treatment as surgeon bias in treatment and selection of patients have significant effects on the results. Displaced type II dens fractures and upper cervical surgeries were identified using their respective International Classification of Diseases, 10th Revision (ICD-10) diagnosis and Current Procedural Terminology (CPT) codes. Inclusion criteria included patients older than 65, diagnosed with a displaced type II dens fracture, absent neurological damage, during the years 2015 to 2018. Age, sex, ICD-10 diagnosis codes, CPT codes, displacement type, and Elixhauser Comorbidity Index scores were obtained through the PearlDiver database. Patient-related variables and one-year mortality associated with surgical versus nonsurgical treatment were compared using univariate χ 2 analysis, odds ratios, and multivariate logistic regression analysis. Among the 5300 patients who met our inclusion criteria, 59% (n=3108) were female, the mean age was 76.6 (±3.9) years old, and the average Elixhauser Comorbidity Index was 7.1 (±4.0). Only 8.3% (n=437) had surgical treatment for the displaced dens fracture. Multivariate logistic regression analysis for one-year mortality showed surgery was associated with decreased one-year mortality in all patients ( z =-6.26; P <0.001), patients between the ages of 65 and 74 ( z =-2.53; P =0.012), and patients over the age of 75 ( z =-5.81; P <0.001). Despite surgery improving survival in elderly patients with type II dens fractures, surgical management is rarely pursued. Factors that independently increase the likelihood of surgery include younger age, male sex, and posterior displacement. 4.

Full-Endoscopic versus Minimally Invasive Lumbar Interbody Fusion for Lumbar Degenerative Diseases : A Systematic Review and Meta-Analysis.

ObjectiveAlthough full-endoscopic lumbar interbody fusion (Endo-LIF) has been tried as the latest alternative technique to minimally invasive transforaminal lumbar interobody fusion (MIS-TLIF) since mid-2010, the evidence is still lacking. We compared the clinical outcome and safety of Endo-LIF to MIS-TLIF for lumbar degenerative disease. MethodsWe systematically searched electronic databases, including PubMed, EMBASE, and Cochrane Library to find literature comparing Endo-LIF to MIS-TLIF. The results retrieved were last updated on December 11, 2020. The perioperative outcome included the operation time, blood loss, complication, and hospital stay. The clinical outcomes included Visual analog scale (VAS) of low back pain and leg pain and Oswestry disability index (ODI), and the radiological outcome included pseudoarthosis rate with 12-month minimum follow-up. ResultsFour retrospective observational studies and one prospective observational study comprising 423 patients (183 Endo-LIF and 241 MIS-TLIF) were included, and the pooled data analysis revealed low heterogeneity between studies in our review. Baseline characteristics including age and sex were not different between the two groups. Operation time was significantly longer in Endo-LIF (mean difference [MD], 23.220 minutes; 95% confidence interval [CI], 10.669–35.771; p=0.001). However, Endo-LIF resulted in less perioperative blood loss (MD, -144.710 mL; 95% CI, 247.941–41.478; p=0.023). Although VAS back pain at final (MD, -0.120; p=0.586), leg pain within 2 weeks (MD, 0.005; p=0.293), VAS leg pain at final (MD, 0.099; p=0.099), ODI at final (MD, 0.141; p=0.093) were not different, VAS back pain within 2 weeks was more favorable in the Endo-LIF (MD, -1.538; 95% CI, -2.044 to -1.032; p<0.001). On the other hand, no statistically significant group difference in complication rate (relative risk [RR], 0.709; p=0.774), hospital stay (MD, -2.399; p=0.151), and pseudoarthrosis rate (RR, 1.284; p=0.736) were found. ConclusionRelative to MIS-TLIF, immediate outcomes were favorable in Endo-LIF in terms of blood loss and immediate VAS back pain, although complication rate, mid-term clinical outcomes, and fusion rate were not different. However, the challenges for Endo-LIF include longer operation time which means a difficult learning curve and limited surgical indication which means patient selection bias. Larger-scale, well-designed study with long-term follow-up and randomized controlled trials are needed to confirm and update the results of this systematic review.

Clinical characteristics and outcomes of adult alveolar rhabdomyosarcoma (ARMS) patients on front-line therapies: An MD Anderson Cancer Center (MDACC) case series.

e23548 Background: Rhabdomyosarcomas are the most common soft tissue sarcoma in children, and the prognosis of pediatric ARMS has improved with the use of multi-modality therapies. However, ARMS in adults is rare, and long-term outcomes continue to be poor. This study aimed to evaluate clinical outcomes of an adult ARMS population on different front-line systemic chemotherapies, particularly the vincristine/doxorubicin/ifosfamide (VDI) regimen. Methods: Adult fusion-positive confirmed ARMS patients over the age of 18 years (y) treated at MDACC from 2004 to 2018 were identified in our patient registry. Descriptive clinical statistics including staging, front-line chemotherapy, multimodal therapy usage, and survival analyses were performed. Results: 49 patients were identified, with mean age of 34.9 y (range 18y - 67y), and 53% were male. Most patients were white (53%, 26 pts), and the most common primary tumor site was the parameningeal space (63%; 31 pts). Patients were either intermediate (67%) or high clinical risk (33%). Most patients were IRSG clinical group IIIa (36%), IIIb (20%) or IV (33%) and were classified clinical stage 3 (49%) or 4 (33%). Of all patients at diagnosis, 71% had nodal disease and 32% were metastatic. Radiotherapy and surgery were given with upfront chemotherapy in 33 pts (67%) and 24 pts (49%) respectively, with 19 patients receiving both. Median OS for the entire cohort was 3.6 years. Doxorubicin containing chemotherapy regimens trended to worse OS than non-doxorubicin containing regimens (2.3 yrs vs 4.0 yrs, p = 0.355). Comparing patients who received VDI (19 pts) vs non-VDI (30 pts; 13 received Actinomycin D, 12 received doxorubicin in different regimens, and 5 received neither), median OS was 1.8 yrs vs 3.8 yrs (p = 0.283) respectively. There were similar number of front-line chemotherapy cycles (8.5 vs 9.5 cycles), high clinical risk (26% vs 37%) and metastatic disease (21% vs 36%) in the VDI vs non-VDI cohorts. Patients receiving upfront radiation had improved survival (3.7 vs 1.5 yr, p = 0.01), but this is likely confounded by those with metastases being less likely to receive upfront radiation. Conclusions: In this single center retrospective analysis of adult ARMS patients, survival outcomes continue to be similar to historical outcomes. There was no statistically significant OS difference in patients who did or did not receive doxorubicin containing front-line chemotherapy regimens, or in particular VDI therapy, although there was a trend to decreased OS. However, limitations to this study include limited sample size, non-randomization to treatment selection, and possible biases in patient selection for different chemo regimens. Based on these observations, randomized prospective studies are necessary to delineate which frontline chemotherapy regimen is most beneficial in this rare tumor in adults.

A systematic review and meta-analysis of circulating cell-free DNA as a diagnostic biomarker for non-small cell lung cancer.

BackgroundEarly diagnosis of non-small cell lung cancer (NSCLC) is crucial for treatment. Circulating cell-free DNA (cfDNA) is an extracellular nucleic acid found in serum, and tumor cfDNA circulating in the blood may be used as a biomarker for early diagnosis. The purpose of this study was to evaluate the application value of cfDNA as a biomarker for the diagnosis of NSCLC through meta-analysis.MethodsWe searched the China National Knowledge Infrastructure (CNKI), Wanfang, VIP, PubMed, Cochrane Central Register of Controlled Trials, Embase, and Web of Science databases using the following search terms: lung cancer, NSCLC, biomarkers, circulating cfDNA, cfDNA, circulating tumor DNA (ctDNA), circulating cell-free tumor DNA, and diagnosis. The retrieval period was set until September 2021. According to PICOS (patients, intervention, comparison, outcomes, and study design) principles the inclusion criteria were: aged ≥18 years; at least 10 NSCLC cases; NSCLC patients diagnosed by histopathology or cytology; circulating cfDNA was detected; outcome data could be completely extracted. Bias risk assessment was conducted according to the QUADAS (Quality Assessment of Diagnostic Accuracy Studies). RevMan 5.3 was used for meta-analysis.ResultsEight studies met the inclusion criteria, including a total of 618 NSCLC patients and 635 healthy subjects. The overall sensitivity and specificity were 0.79 [95% confidence interval (CI): 0.75–0.82] and 0.81 (95% CI: 0.78–0.84), respectively. The area under the curve (AUC) of the summary receiving operating characteristic (SROC) curve was 0.8941. The pooled positive likelihood ratio, pooled negative likelihood ratio, and pooled diagnostic odds ratio were 5.37 (95% CI: 2.67–10.81), 0.24 (95% CI: 0.15–0.38), and 24.68 (95% CI: 8.85–68.84), respectively. The patient selection bias was high in two articles was high, unclear in one article, and low in the remaining five ones. The risk of bias in the research index test was unclear in one article, and low in the remaining seven articles. The reference standard bias, and flow and time bias of all articles was low.ConclusionsCirculating cfDNA is an efficacy biomarker in diagnosis of NSCLC. Its clinical application technology is worthy of further research.

Clinical application of deep learning and radiomics in hepatic disease imaging: a systematic scoping review.

Artificial intelligence (AI) has begun to play a pivotal role in hepatic imaging. This systematic scoping review summarizes the latest progress of AI in evaluating hepatic diseases based on computed tomography (CT) and magnetic resonance (MR) imaging. We searched PubMed and Web of Science for publications, using terms related to deep learning, radiomics, imaging methods (CT or MR), and the liver. Two reviewers independently selected articles and extracted data from each eligible article. The Quality Assessment of Diagnostic Accuracy Studies-AI (QUADAS-AI) tool was used to assess the risk of bias and concerns regarding applicability. The screening identified 45 high-quality publications from 235 candidates, including 8 on diffuse liver diseases and 37 on focal liver lesions. Nine studies used deep learning and 36 studies used radiomics. All 45 studies were rated as low risk of bias in patient selection and workflow, but 36 (80%) were rated as high risk of bias in the index test because they lacked external validation. In terms of concerns regarding applicability, all 45 studies were rated as low concerns. These studies demonstrated that deep learning and radiomics can evaluate liver fibrosis, cirrhosis, portal hypertension, and a series of complications caused by cirrhosis, predict the prognosis of malignant hepatic tumors, and differentiate focal hepatic lesions. The latest studies have shown that deep learning and radiomics based on hepatic CT and MR imaging have potential application value in the diagnosis, treatment evaluation, and prognosis prediction of common liver diseases. The AI methods may become useful tools to support clinical decision-making in the future. Deep learning and radiomics have shown their potential in the diagnosis, treatment evaluation, and prognosis prediction of a series of common diffuse liver diseases and focal liver lesions.

The benefits of adding a defibrillator to cardiac resynchronization therapy - Systematic review and meta-analysis

Abstract Funding Acknowledgements Type of funding sources: Other. Main funding source(s): The research presented here, carried out by Semmelweis University was supported by Semmelweis 250+ Excellence Scholarship (EFOP-3.6.3-VEKOP-16-2017-00009)as well as the Centre for Translational Medicine, Semmelweis University. This work was financed by the Thematic Excellence Programme (2020-4.1.1.-TKP2020) of the Ministry for Innovation and Technology in Hungary, within the framework of the Therapeutic Development and Bioimaging thematic programmes of the Semmelweis University. Background There is an enduring controversy whether cardiac resynchronisation therapy-defibrillation (CRT-D) is preferred over CRT-pacemaker (CRT-P). No head-to-head randomised controlled trials have been designed to compare the treatments. However, several observational studies were performed during previous years, but they got controversial results. Methods PubMed, CENTRAL and Embase until October 2021 were screened for studies comparing CRT-P and CRT-D, focusing on all-cause mortality, cardiovascular mortality, sudden cardiac death, and non-cardiac death. Both interventional and observational studies comparing CRT-D and CRT-P patients were included. Studies only available as conference abstracts were excluded. Odds ratio with 95% confidence interval (CI) was calculated, data from the selected studies were pooled using a random effect model (Mantel-Haenszel method, where more than 5 studies with Hartung-Knapp adjustment). τ2 was estimated by Paule-Mandel method with CI calculated by Q profile method. Statistical heterogeneity was assessed by Cochrane Q test and I2 test. Results were summarized by Forest and drapery plots. Results: 16 observational studies(57,337 patients) were included(CRT-P: 32 591, CRT-D: 24 746). CRT-D was superior to CRT-P regarding all-cause mortality in univariate analysis(HR:0.73; 95% CI:0.64-0.83; p &amp;lt;0.01). The between-study heterogeneity (I2) value was not significant. The random-effects τ2 value was 0.02 (95% CI:0-0.06). Three studies(47,846 patients, CRT-P: 27,344, CRT-D: 20,502) compared cardiovascular mortality between CRT-D and CRT-P. Univariate analysis showed a significantly lower rate of cardiovascular mortality in patients implanted with a CRT-D device compared to patients with a CRT-P device.(HR:0.61; 95% CI:0.50-0.73; p=0.002) Five studies (6,434 patients. CRT-P:3,475, CRT-D:2,959) were analyzed for sudden cardiac death, CRT-D was superior in univariate analysis(HR:0.33; 95% CI:0.28-0.89; p=0.03). Three studies (4,623 patients. CRT-P:2,518, CRT-D:2,105) reported on heart failure death, CRT-D was associated with decreased heart failure mortality compared to CRT-P(HR:0.68; 95% CI: 0.41-0.95; p=0.008). Three studies(48,770 patients ,CRT-P:28,398, CRT-D: 20,372) reported on non-cardiac death, CRT-D showed significantly better survival than CRT-P(HR:0.58; 95% CI:0.55-0.60; p&amp;lt;0.0001). Conclusion: Our work demonstrates an association between CRT-D and lower all-cause mortality, cardiovascular and heart failure mortality, sudden cardiac death, and non-cardiac death. However, due to the heterogeneity of the articles coming from the selection bias of patients for CRT-D/CRT-P implantation, this question requires further analysis.

Xpert MTB/XDR for detection of pulmonary tuberculosis and resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin.

Xpert MTB/XDR for detection of pulmonary tuberculosis and resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin.

MO560: Adherence to Nutritional Recommendations as Expressed by Patients on Hemodialysis, Their Informal Carers and Healthcare Professionals—the Goodrenal Project

Abstract BACKGROUND AND AIMS Low adherence to nutritional recommendations is common in patients on hemodialysis (HD), but the reasons are not well known. We explored the main needs, barriers and facilitators affecting nutritional adherence as experienced by patients on HD, their informal carers and their healthcare professionals (HCPs) at the dialysis centre. METHOD This study is part of the GoodRENal project—funded by the European Community, Erasmus + program that comprises four countries: Spain, Sweden, Belgium and Greece. As part of this project, exploratory questionnaires were constructed and answered by the patients, their carers and their HCPs. The questionnaire comprised three sections consisting of statements exploring the needs, barriers and facilitators affecting adherence to nutritional recommendations for patients on HD. Each statement could be rated from 1 (strongly disagree), 2 (disagree), 3 (neither agree or disagree), 4 (agree) to 5 (strongly agree). In addition, there was a section for free text. To avoid bias in patient selection, 10 patients were randomized from the first dialysis shift of the week in the four participating countries. RESULTS In total, 40 patients, 40 informal carers and 40 HCPs HealthCP accepted to participate, out of whom 38 patients (68% male, 62 ± 15 years), 33 informal carers (21% male, age 54 ± 12 years, of whom 68% were spouses) and 37 HCPs (22% male, age 42 ± 10 years, 60% were nurses) answered the questionnaires. Two of the four centres had a dedicated dietitian at the dialysis unit, who worked there on average 18 ± 8 hours per week. At the dialysis units without a dietitian, the nurses and doctors were responsible for nutritional care. To simplify the analysis, answers rated as 4 and 5 were grouped as agree. The main findings are presented below: CONCLUSION These descriptive findings show that patients, informal carers and HCPs identified different needs, barriers, and facilitators to increase adherence to nutritional recommendations. These results can be used to build and tailor strategies aimed at patients, informal carers and HCPs.

Comparison of Vaccine Effectiveness Against the Omicron (B.1.1.529) Variant in Hemodialysis Patients

Comparison of Vaccine Effectiveness Against the Omicron (B.1.1.529) Variant in Hemodialysis Patients

Distribution of FFRCT in single obstructive coronary stenosis and predictors for major adverse cardiac events: a propensity score matching study

BackgroundFractional flow reserve derived from computed tomography (FFRCT) has been demonstrated to improve identification of lesion-specific ischemia significantly compared with coronary computed tomography angiography (CCTA). It remains unclear whether the distribution of FFRCT values in obstructive stenosis between patients who received percutaneous coronary intervention (PCI) or not in routine clinical practice, as well as its association with clinical outcome. This study aims to reveal the distribution of FFRCT value in patients with single obstructive coronary artery stenosis and explored the independent factors for predicting major adverse cardiac events (MACE).MethodsThis was a retrospective study of adults with non-ST-segment elevation acute coronary syndrome undergoing FFRCT assessment by using CCTA data from January 1, 2016 to December 31, 2020. Propensity score matching (PSM) method was used to account for patient selection bias. The risk factors for predicting MACE were evaluated by a Cox proportional hazards regression analysis.ResultsOverall, 655 patients with single obstructive (≥ 50%) stenosis shown on CCTA were enrolled and divided into PCI group (279 cases) and conservative group (376 cases) according to treatment strategy. The PSM cohort analysis demonstrated that the difference in history of unstable angina, Canadian Cardiovascular Society Class (CCSC) and FFRCT between PCI group (188 cases) and conservative group (315 cases) was statistically significant, with all P values < 0.05, while the median follow-up time between them was not statistically significant (24 months vs. 22.5 months, P = 0.912). The incidence of MACE in PCI group and conservative group were 14.9% (28/188) and 23.5% (74/315) respectively, P = 0.020. Multivariate analysis of Cox proportional hazards regression revealed that history of unstable angina (adjusted odds ratio (adjOR), 3.165; 95% confidence interval (CI), 2.087–4.800; P < 0.001), FFRCT ≤ 0.8 (OR, 1.632;95% CI 1.095–2.431; P = 0.016), and PCI therapy (OR 0.481; 95% CI 0.305–0.758) were the independent factors for MACE.ConclusionsHistory of unstable angina and FFRCT value of ≤ 0.8 were the independent risk factors for MACE, while PCI therapy was the independent protective factor for MACE.

Can blood and salivary biomarkers replace biopsy as a diagnostic tool?

Data sources The online databases of Medline, Web of Science, Embase and Cochrane Library were systematically searched to identify articles published (up to October 2021) on the accuracy of microRNAs (miRNAs) in the diagnosis of oral squamous cell carcinoma (OSCC).Study selection Primary research studies involving human participants with the presence of healthy controls and sufficient data for statistical analysis were included. Exclusion criteria included review articles, letters, case reports and non-human trials. Two reviewers independently assessed the studies, and any conflicts were resolved by consulting a third reviewer. From 326 initially identified articles, 20 articles (all case-control studies) were included in the meta-analysis involving 1,106 cases and 732 controls.Data extraction and synthesis Data extracted included sensitivity, specificity, likelihood ratios and diagnostic odds ratios for blood and salivary miRNAs. A combined category of body fluid miRNAs was also synthesised. Heterogeneity between studies was evaluated using Cochran's Q test and I2 statistic. Quality assessment of the studies was performed using the Quality Assessment of Diagnostic Accuracy Studies criteria (QUADAS-2). Meta-analysis was performed based on a random-effects model. A comparison of the diagnostic accuracies between blood and salivary miRNAs was carried out using the summary receiver operator characteristic curve (SUROC) including the area under the curve (AUC). P <0.05 was considered as statistically significant.Results Risk of bias was deemed to be moderate; however, patient selection bias was high due to 15 studies lacking randomisation. Heterogeneity between studies was high. Meta-analysis revealed that for body fluid miRNAs, sensitivity was 0.78 (95% CI: 0.73-0.83), specificity was 0.82 (95% CI: 0.77-0.86), AUC value was 0.87 (95% CI: 0.84-0.90), and positive and negative likelihood ratios were 4.3 (95% CI: 3.4-5.4) and 0.27 (95% CI: 0.22-0.34), respectively. The diagnostic odds ratio was 16 (95% CI: 11-23).Conclusions Body fluid miRNAs may provide moderate accuracy in diagnosing OSCC; however, the significant heterogeneity between studies and the lack of large-scale high-quality studies limits their diagnostic value.

Comparison of DEB-TACE and cTACE for the initial treatment of unresectable hepatocellular carcinoma beyond up-to-seven criteria: A single-center propensity score matching analysis

PurposeTo evaluate clinical outcomes of drug-eluting beads transarterial chemoembolization (DEB-TACE) with CalliSpheres microspheres and conventional TACE (cTACE) as the initial treatment in patients with unresectable hepatocellular carcinoma (HCC) beyond up-to-seven criteria. MethodsThe study retrospectively assessed the medical records of HCC patients beyond up-to-seven criteria who received the initial treatment of DEB-TACE or cTACE from June 2016 to December 2019 in our institution. To reduce the patient selection bias, propensity score matching (PSM) analysis was used. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and adverse events (AEs) were compared between the two groups. In addition, prognostic factors affecting PFS and OS were analyzed by univariate and multivariate methods. ResultsA total of 312 eligible HCC patients were included in the study, including 140 patients in the DEB-TACE group and 172 patients in the cTACE group. 110 patients were chosen in each group after PSM analysis and there were no significant differences in baseline characteristics (P > 0.05). Before PSM analysis, DEB-TACE had better ORR and DCR compared to cTACE group (P < 0.05). After PSM analysis, the ORR for DEB-TACE group was still higher than that for cTACE group, while no significant difference in the DCR between the two groups. In addition, DEB-TACE group had better survival benefits than cTACE group before PSM analysis (mPFS: 11.5 months vs 9.0 months, P < 0.001; mOS: 24.0 months vs 19.2 months, P = 0.045). Similarly, after PSM analysis, the median PFS and OS in the DEB-TACE group were still higher than that in the cTACE group (mPFS: 11.1 months vs 9.0 months, P = 0.015; mOS: 25.0 months vs 19.0 months, P = 0.030). Further, the univariate and multivariate analysis indicated that DEB-TACE treatment was a positive prognostic factor for PFS and OS. ConclusionDEB-TACE with CalliSpheres microspheres might be an effective and safe treatment for patients with unresectable HCC beyond up-to-seven criteria.