scholarly journals Nutrition Society Symposium on ‘End points in clinical nutrition trials’ Death, morbidity and economics are the only end points for trials

2005 ◽  
Vol 64 (3) ◽  
pp. 277-284 ◽  
Author(s):  
Ronald L. Koretz
Keyword(s):  
Clinical Outcome ◽  
Clinical Outcomes ◽  
Skin Testing ◽  
Surrogate Marker ◽  
Nutrition Support ◽  
Anthropometric Measures ◽  
End Points ◽  
Nutritional Outcome ◽  
Duration Of Hospitalization ◽  
Better Than

In order to determine whether surrogate markers predict clinical outcome, randomized controlled trials (RCT) of nutrition supportv. no nutrition support that have reported at least one clinical outcome (mortality, infections, total complications, or duration of hospitalization) and at least one nutritional outcome (energy or protein intake, weight gain, N balance, albumin, prealbumin, transferrin, three anthropometric measures, skin testing, lymphocyte count) were assessed for concordance. If changes in nutritional markers predict clinical outcome, changes in both outcomes should go in the same direction. Concordance is defined as both outcomes changing in the same direction or both outcomes showing no difference. Discordance is defined as one outcome changing and the other not (partial) or both outcomes changing in opposite directions (complete). Ninety-nine RCT were identified, of which most were underpowered to see statistically significant changes, especially in clinical outcomes. Thus, the results were analysed only in relation to the direction of the respective changes in outcomes. Forty-eight comparisons (4×12) were made. The rates of concordance were ≤50% in forty-one of forty-eight comparisons; the rate was never >75%. A complete discordance rate of ≥25% was present in forty-three (≥50% in thirteen) of the forty-eight comparisons. The discordance was usually a result of the nutritional outcome being better than the clinical outcome. Changes in nutritional markers do not predict clinical outcomes. Before adopting any surrogate marker as an end point for a clinical trial, it has to be known that improving it will result in patient benefit.

scholarly journals Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials

2020 ◽  
Vol 17 (6) ◽  
pp. 723-728
Author(s):  
Behnood Bikdeli ◽  
César Caraballo ◽  
John Welsh ◽  
Joseph S Ross ◽  
Sanjay Kaul ◽  
...  
Keyword(s):  
England Journal ◽  
Clinical Outcome ◽  
New England ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
European Heart Journal ◽  
Surrogate Marker ◽  
Surrogate Markers ◽  
Primary Endpoints ◽  
Number Of Patients

Background/aims Non-inferiority trials are increasing in cardiovascular medicine, with approval of many drugs and devices on the basis of such studies. Surrogate markers as primary endpoints have been also more frequently used for efficient assessment of cardiovascular interventions. However, there is uncertainty about their concordance with clinical outcomes. Non-inferiority design using a surrogate marker as a primary endpoint may pose particular challenges in clinical interpretation. We sought to explore the publication trends, methodology, and reporting features of non-inferiority cardiovascular trials that used a primary surrogate marker as the primary endpoint. Methods We searched six high-impact journals ( The New England Journal of Medicine, The Journal of the American Medical Association, The Lancet, The Journal of the American College of Cardiology, Circulation, and European Heart Journal) from 1 January 1990 to 31 December 2018 and identified non-inferiority cardiovascular trials that used a surrogate marker as the primary endpoint. We assessed the non-inferiority margin reported in the manuscript and other publicly available platforms (e.g. protocol, clinicaltrials.gov). We also determined whether the included non-inferiority trials with surrogate markers as primary endpoints were followed by clinical outcome trials. Results We screened 15,553 publications and identified 247 cardiovascular trials that used a non-inferiority design. Of these, 37 had a surrogate marker as a primary endpoint (18 drug trials, 13 device trials, 6 others). All of these non-inferiority trials with surrogate outcomes were published after 2000, mostly in cardiology journals (13 in The Journal of the American College of Cardiology, 9 in European Heart Journal, 8 in Circulation, 6 in The Lancet, 1 in The New England Journal of Medicine), and their publication rate increased over time (p < 0.001 for linear trend). The median number of patients in the primary analysis was 300 (interquartile range: 202–465). The study protocol or a methods paper was publicly available for only 13 (35.1%) trials, of which the non-inferiority margin was not reported in 4 trials. In 16 studies (43.2%), the manuscript did not acknowledge the limitations of using a surrogate endpoint or the need for a definitive clinical outcome trial. Thirty-four trials (91.9%) concluded that the tested intervention met non-inferiority criteria. However, only five (13.5%) were followed by clinical outcomes trials the results of which did not always confirm non-inferiority. Conclusion Non-inferiority trials that use a surrogate marker as the primary endpoint are being increasingly performed. However, these trials pose particular challenges with design, reporting, and interpretation, which are not systematically and consistently addressed or reported.

Volumetric Parameters on Interim PET Predict Clinical Outcomes Better Than SUVmax in Patients with Diffuse Large B-Cell Lymphoma

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1519-1519
Author(s):  
Ehsan Malek ◽  
Arun Sendilnatha ◽  
Mahender Yellu ◽  
Andrew Petersen ◽  
Mariano Fernandez-ulloa ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Clinical Outcomes ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Interim Pet ◽  
Large B Cell Lymphoma ◽  
Pet Ct ◽  
Gradient Based ◽  
Large B Cell ◽  
Better Than

Abstract Background: Immunochemotherapy has improved the clinical outcome of patients diagnosed with diffuse large B-cell lymphoma (DLBCL), but only 60% of all DLBCL patients are potentially cured. A response-adaptive imaging strategy that accurately determines the initial response to therapy could improve clinical outcomes. Although there has been an increasing trend to perform interim PET/CT to monitor response, the optimal interpretation method for interim PET analyses remains uncertain. Studies using maximum standard uptake value (SUVmax), have not defined a uniformly applicable SUVmax reduction cutoff that accurately predicts clinical outcome. Here, we hypothesized that a method that maximized the detection of all metabolically active regions within the tumor mass, defined as the metabolic tumor volume (MTV), could serve as a better predictor of clinical outcome than SUVmax measurement. Methods: All patients with DLBCL that were treated from Dec 2006 to Dec 2014 at the University of Cincinnati were studied, retrospectively. Interim PET analysis was performed after 2-4 cycles of chemotherapy. SUVmax and MTV on the initial and interim PET CT for each patient was determined. To evaluate the contribution of metabolic activity within the tumor periphery in assessing clinical outcomes, MTV was measured by two separate methods: fixed-threshold and gradient-segmentation using MIMSoftware, OH, USA. The primary end point of the study was progression free survival (PFS). To identify an optimal threshold cutoff that could predict PFS more accurately, the receiver operating characteristic (ROC) curve analysis was used. Results: A total of 197 patients with pathology confirmed diagnosis of DLBCL were recognized. Of the 197 patients, 167 underwent interim PET analysis. All patients fasted >6 h before intravenous injection of 18F-glucose, had glucose levels >90 and <160 mg/dl at the moment of injection, scans were performed within 90 min after injection and granulocyte-colony stimulating factor was stopped >48 h before imaging. The median follow-up period for patients in the study was 37 months. R-CHOP (Rituximab, Cyclophosphamide, doxorubicin/Hydroxydaunomycin, vincristine/Oncovin and Prednisone) and R-DA-EPOCH (Dose-Adjusted Etoposide, Prednisone, Oncovin, Cyclophosphamide and Hydroxydaunorubicin) were the first line of therapy in 74% and 26% of patients, respectively. On interim PET/CT, 69% of patients achieved complete response with the remaining patients showing partial response based on visual assessment. Dichotomous visual interpretation of interim PET did not correlate with PFS (log-rank P= 0.37). Compared with the threshold-based method, the gradient-based method resulted in a statistically significant greater MTV in pretreatment, as well as interim PET images. However, no significant difference was noted between the reduction in MTV determined by the threshold-based (ΔMTVT) or gradient-based (ΔMTVG) methods (median 34% vs 36%, P =0.29). Thresholds of ΔSUVmax and ΔMTV by ROC curve were 72% and 52%, respectively. ΔMTV predicted PFS better than ΔSUVmax as the AUC for ΔMTV was significantly larger compared with that for ΔSUVmax (Figure 1). All patients who achieved a SUVmax reduction greater than the cutoff value determined by the ROC analysis (ΔSUVmax>72%) were then stratified into two groups based on a ΔMTV cutoff value > or <52%. From a total of 115 patients who achieved a ΔSUVmax >72% on interim PET/CT imaging, 77 (67%) had a ΔMTV >52%. Importantly, patients who achieved a ΔMTV >52% had a statistically significantly greater PFS compared with patients who achieved a ΔMTV <52% (Figure 2). Among 115 patients who achieved a ΔSUVmax >72% on interim PET and those who demonstrated a ΔMTV >52% exhibited greater PFS. Conclusion: Our study highlights the importance of MTV assessment for patients who achieved background SUVmax on the interim PET to better predict the clinical outcome of DLBCL patients. The MTV measurement with the gradient-based method renders a larger volume of tumor than the threshold-based method; however, these two methods report a similar percentage reduction and are interchangeable in terms of interim PET interpretation. Metabolic activity of the peripheral area of the tumor should be incorporated into response-adaptive strategies and prospective trials that evaluate the response to current and novel therapeutic regimens to treat DLBCL patients. Figure 1. Figure 1. Figure 2. Figure 2. Disclosures No relevant conflicts of interest to declare.

scholarly journals Donor IUI is equally effective for heterosexual couples, single women and lesbians, but autologous IUI does worse

2019 ◽  
Vol 34 (11) ◽  
pp. 2184-2192 ◽  
Author(s):  
Sérgio Reis Soares ◽  
María Cruz ◽  
Vanessa Vergara ◽  
Antonio Requena ◽  
Juan Antonio García-Velasco
Keyword(s):  
Clinical Outcome ◽  
Clinical Outcomes ◽  
Ovarian Reserve ◽  
Single Women ◽  
Good Prognosis ◽  
Heterosexual Couples ◽  
Lesbian Couples ◽  
Mixed Effect ◽  
The Impact ◽  
Better Than

Abstract STUDY QUESTION Are there differences in the clinical outcomes of IUI among different populational groups (heterosexual couples, single women and lesbian couples)? SUMMARY ANSWER The outcome of donor IUI (D-IUI) is similar in all populational groups and better than that seen with autologous insemination. WHAT IS KNOWN ALREADY A vast body of literature on clinical outcome is available for counselling heterosexual couples regarding decisions related to ART. The reproductive potential of single women, lesbian couples and heterosexual couples who need donor semen is assumed to be better, but there is a scarcity of data on their ART performance to actually confirm it. STUDY DESIGN, SIZE, DURATION In this retrospective multicentric cohort study, a total of 7228 IUI treatment cycles performed in 3807 patients between January 2013 and December 2016 in 13 private clinics belonging to the same reproductive medicine group in Spain were included. Patients with previous IUI attempts were excluded from the study. Only 1.9% of cycles were lost to follow-up. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 5318 D-IUI cycles were performed in three different populational groups: heterosexual couples (D-HC, 1167 cycles), single women (SW, 2839 cycles) and lesbian couples (LC, 1312), while a total of 1910 autologous IUI cycles were performed in heterosexual couples (A-HC). This last one was considered the control group and was composed of cycles performed in couples with a male partner with sperm parameters equivalent to those requested from donors. In order to identify factors with an impact on clinical outcome, a multivariate logistic regression analysis was performed. Regarding live birth rate (LBR), mixed effect models were employed to control for the fact that different patients were submitted to different numbers of treatments. MAIN RESULTS AND THE ROLE OF CHANCE Parameters that were significant to the primary outcome (LBR) according to the multivariate analysis were the populational group (D-HC, SW, LC and A-HC) to which the patient belonged, female age and a diagnosis of low ovarian reserve. At the age range of good prognosis (≤37 years), LBR was similar in all groups that underwent D-IUI (18.8% for D-HC, 16.5% for SW and 17.6% for LC) but was significantly lower in the autologous IUI (A-HC) group (11%). For all these significant findings, the strength of the association was confirmed by P values <0.001. From 38 years of age on, no significant differences were observed among the populational groups studied, and for all of them, LBR was below 7% from 40 years of age on. LIMITATIONS, REASONS FOR CAUTION To the best of our knowledge, a smoking habit was the only known factor with a potential effect on ART outcome that could not be controlled for, due to the unavailability of this information in a significant percentage of the clinical files studied. Our study was not capable of precisely quantifying the impact of a diagnosis of low ovarian reserve on the LBR of both IUI and D-IUI, due to the number of cycles performed in patients with such diagnosis (n = 231, 3.2% of the total). WIDER IMPLICATIONS OF THE FINDINGS For the first time, a comparison among D-HC, SW, LC and A-HC was performed in a study with a robust sample size and controlling for potential sources of bias. There is now sound evidence that equivalent clinical outcome is seen in the three groups treated with donor semen (D-HC, SW and LC). Specifically, regarding the comparison between SW and LC, our findings rule out differences in LBR proposed by previous publications, with very similar clinical outcomes within the same age ranges. At age ranges of good prognosis (≤37 years), reproductive performance of D-IUI is significantly better than that seen in heterosexual couples undergoing autologous IUI, even when only cases of optimal sperm quality are considered in this last group. This finding is in agreement with the concept that, as a group, A-HC are more prone to have female factor infertility, even when their infertility assessment finds no contraindication to IUI. Age affects all these groups equally, with none of them reaching a 7% LBR after the age of 40 years. Our findings will be useful for the counselling of patients from the different populations studied here about ART strategies. STUDY FUNDING/COMPETING INTEREST(S) None.

Effect of Manipulation under Anesthesia of the First Knee in Staged Bilateral Total Knee Arthroplasty on Clinical Outcome and Satisfaction

2020 ◽  
Author(s):  
Jung-Won Lim ◽  
Yong-Beom Park ◽  
Dong-Hoon Lee ◽  
Han-Jun Lee
Keyword(s):  
Total Knee Arthroplasty ◽  
Patient Satisfaction ◽  
Clinical Outcome ◽  
Clinical Outcomes ◽  
Knee Arthroplasty ◽  
Knee Flexion ◽  
Functional Score ◽  
Manipulation Under Anesthesia ◽  
Total Knee

AbstractThis study aimed to evaluate whether manipulation under anesthesia (MUA) affect clinical outcome including range of motion (ROM) and patient satisfaction after total knee arthroplasty (TKA). It is hypothesized that MUA improves clinical outcomes and patient satisfaction after primary TKA. This retrospective study analyzed 97 patients who underwent staged bilateral primary TKA. MUA of knee flexion more than 120 degrees was performed a week after index surgery just before operation of the opposite site. The first knees with MUA were classified as the MUA group and the second knees without MUA as the control group. ROM, Knee Society Knee Score, Knee Society Functional Score, Western Ontario and McMaster Universities (WOMAC) score, and patient satisfaction were assessed. Postoperative flexion was significantly greater in the MUA group during 6 months follow-up (6 weeks: 111.6 vs. 99.8 degrees, p < 0.001; 3 months: 115.9 vs. 110.2 degrees, p = 0.001; 6 months: 120.2 vs. 117.0 degrees, p = 0.019). Clinical outcomes also showed similar results with knee flexion during 2 years follow-up. Patient satisfaction was significantly high in the MUA group during 12 months (3 months: 80.2 vs. 71.5, p < 0.001; 6 months: 85.8 vs. 79.8, p < 0.001; 12 months: 86.1 vs. 83.9, p < 0.001; 24 months: 86.6 vs. 85.5, p = 0.013). MUA yielded improvement of clinical outcomes including ROM, and patient satisfaction, especially in the early period after TKA. MUA in the first knee could be taken into account to obtain early recovery and to improve patient satisfaction in staged bilateral TKA.

STUDY ON THRIVE SCORE IN THE PROGNOSIS OF ISCHEMIC STROKE

2017 ◽  
pp. 22-24
Author(s):  
Thi Thao Nhi Tran ◽  
Dinh Toan Nguyen
Keyword(s):  
Ischemic Stroke ◽  
Clinical Outcome ◽  
Regression Models ◽  
Cross Sectional Study ◽  
High Rate ◽  
Vascular Events ◽  
Cross Sectional ◽  
Key Words Ischemic Stroke ◽  
Outcome Mortality ◽  
Better Than

Background and Purpose: Stroke is the second cause of mortality and the leading cause of disability. Using the clinical scale to predict the outcome of the patient play an important role in clinical practice. The Totaled Health Risks in Vascular Events (THRIVE) score has shown broad utility, allowing prediction of clinical outcome and death. Methods: A cross-sectional study conducting on 102 patients with acute ischemic stroke using THRIVE score. The outcome of patient was assessed by mRankin in the day of 30 after stroke. Statistic analysis using SPSS 15.0. Results: There was 60.4% patient in the group with THRIVE score 0 – 2 points having a good outcome (mRS 0 - 2), patient group with THRIVE score 6 - 9 having a high rate of bad outcome and mortality. Having a positive correlation between THRIVE score on admission and mRankin score at the day 30 after stroke with r = 0.712. THRIVE score strongly predicts clinical outcome with ROC-AUC was 0.814 (95% CI 0.735 - 0.893, p<0.001), Se 69%, Sp 84% and the cut-off was 2. THRIVE score strongly predicts mortality with ROC-AUC was 0.856 (95% CI 0.756 - 0.956, p<0.01), Se 86%, Sp 77% and the cut-off was 3. Analysis of prognostic factors by multivariate regression models showed that THRIVE score was only independent prognostic factor for the outcome of post stroke patients. Conclusions: The THRIVE score is a simple-to-use tool to predict clinical outcome, mortality in patients with ischemic stroke. Despite its simplicity, the THRIVE score performs better than several other outcome prediction tools. Key words: Ischemic stroke, THRIVE, prognosis, outcome, mortality

Clinicopathological and Imaging Features Predictive of Clinical Outcome in Metaplastic Breast Cancer

2020 ◽  
Vol 16 (6) ◽  
pp. 729-738
Author(s):  
Ga Young Yoon ◽  
Joo Hee Cha ◽  
Hak Hee Kim ◽  
Hee Jung Shin ◽  
Eun Young Chae ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Outcome ◽  
Clinical Outcomes ◽  
Tumor Size ◽  
Multivariable Analysis ◽  
Disease Free Survival ◽  
Imaging Features ◽  
Peritumoral Edema ◽  
Imaging Findings ◽  
Metaplastic Breast Cancer

Background: Metaplastic breast cancer (MC) is a rare disease, thus it is difficult to study its clinical outcomes. Objective: To investigate whether any clinicopathological or imaging features were associated with clinical outcome in MC. Methods: We retrospectively evaluated the clinicopathological and imaging findings, and the clinical outcomes of seventy-two pathologically confirmed MCs. We then compared these parameters between triple-negative (TNMC) and non-TNMCs (NTNMC). Results: Oval or round shape, and not-circumscribed margin were the most common findings on mammography, ultrasound (US), and magnetic resonance imaging (MRI). It was mostly a mass without calcification on mammography, and revealed complex or hypoechoic echotexture, and posterior acoustic enhancement on US, and rim enhancement, wash-out kinetics, peritumoral edema, and intratumoral necrosis on MRI. Of all 72, 64 were TNMCs, and eight were NTNMCs. Clinicopathological and imaging findings were similar between the two groups, except that MRI showed peritumoral edema more frequently in TNMCs than NTNMCs (p=0.045). There were 21 recurrences and 13 deaths. Multivariable analysis showed that larger tumor size and co-existing DCIS were significantly predictive of Disease free survival (DFS), and larger tumor size and neoadjuvant chemotherapy were significantly predictive of overall survival (OS). Conclusion: MC showed characteristic imaging findings, and some variables associated with survival outcome may help to predict prognosis.

scholarly journals Deep phenotyping classical galactosemia: clinical outcomes and biochemical markers

2020 ◽  
Vol 2 (1) ◽  
Author(s):  
Mendy M Welsink-Karssies ◽  
Sacha Ferdinandusse ◽  
Gert J Geurtsen ◽  
Carla E M Hollak ◽  
Hidde H Huidekoper ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Newborn Screening ◽  
Clinical Outcomes ◽  
Movement Disorders ◽  
Brain Mri ◽  
Primary Ovarian Insufficiency ◽  
Ovarian Insufficiency ◽  
Classical Galactosemia ◽  
Intellectual Outcome

Abstract Early diagnosis and dietary treatment do not prevent long-term complications, which mostly affect the central nervous system in classical galactosemia patients. The clinical outcome of patients is highly variable, and there is an urgent need for prognostic biomarkers. The aim of this study was first to increase knowledge on the natural history of classical galactosemia by studying a cohort of patients with varying geno- and phenotypes and second to study the association between clinical outcomes and two possible prognostic biomarkers. In addition, the association between abnormalities on brain MRI and clinical outcomes was investigated. Classical galactosemia patients visiting the galactosemia expertise outpatient clinic of the Amsterdam University Medical Centre were evaluated according to the International Classical Galactosemia guideline with the addition of an examination by a neurologist, serum immunoglobulin G N-glycan profiling and a brain MRI. The biomarkers of interest were galactose-1-phosphate levels and N-glycan profiles, and the clinical outcomes studied were intellectual outcome and the presence or absence of movement disorders and/or primary ovarian insufficiency. Data of 56 classical galactosemia patients are reported. The intellectual outcome ranged from 45 to 103 (mean 77 ± 14) and was &lt;85 in 62%. Movement disorders were found in 17 (47%) of the 36 tested patients. In females aged 12 years and older, primary ovarian insufficiency was diagnosed in 12 (71%) of the 17 patients. Significant differences in N-glycan peaks were found between controls and patients. However, no significant differences in either N-glycans or galactose-1-phosphate levels were found between patients with a poor (intellectual outcome &lt; 85) and normal intellectual outcome (intellectual outcome ≥ 85), and with or without movement disorders or primary ovarian insufficiency. The variant patients detected by newborn screening, with previously unknown geno- and phenotypes and currently no long-term complications, demonstrated significantly lower galactose-1-phospate levels than classical patients (P &lt; 0.0005). Qualitative analysis of the MRI’s demonstrated brain abnormalities in 18 of the 21 patients, more severely in patients with a lower intellectual outcome and/or with movement disorders. This study demonstrates a large variability in clinical outcome, which varies from a below average intelligence, movement disorders and in females primary ovarian insufficiency to a normal clinical outcome. In our cohort of classical galactosemia patients, galactose-1-phosphate levels and N-glycan variations were not associated with clinical outcomes, but galactose-1-phosphate levels did differentiate between classical and variant patients detected by newborn screening. The correlation between brain abnormalities and clinical outcome should be further investigated by quantitative analysis of the MR images. The variability in clinical outcome necessitates individual and standardized evaluation of all classical galactosemia patients.

scholarly journals 688 Pediatric Obstructive Sleep Apnea (OSA) and COVID-19-Related Adverse Clinical Outcomes

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A269-A269
Author(s):  
Vaishal Shah ◽  
Nancy Foldvary-Schaefer ◽  
Lu Wang ◽  
Lara Jehi ◽  
Cynthia Pena Obrea ◽  
...  
Keyword(s):  
High Risk ◽  
Clinical Outcome ◽  
Clinical Outcomes ◽  
Pediatric Patients ◽  
Control Design ◽  
Supplemental Oxygen ◽  
Case Control ◽  
World Health ◽  
Invasive Ventilation ◽  
High Flow Oxygen

Abstract Introduction The relationship of OSA and human coronavirus (COVID-19) in the pediatric population is unknown. We postulate that OSA is associated with SARS-CoV-2 positivity and with adverse COVID-19 outcomes in children. Methods A retrospective review of 120 consecutive patients (&lt;18 years) with prior polysomnogram (PSG) and COVID-19 testing from the Cleveland Clinic COVID-19 registry was conducted. Using a case control design of SARS-CoV-2 positive and negative pediatric patients, we examined COVID-19 and pre-existing OSA (dichotomized AHI≥1) using logistic (OR,95%CI) regression and as continuous measures: AHI, oxygen(SpO2) nadir, %time SpO2&lt;90%) using linear regression(beta+/-SE). In those positive for SARS-CoV-2(cases only), we assessed the association of OSA and World Health Organization(WHO) COVID-19 clinical outcome composite score (hospitalization, requiring supplemental oxygen, non-invasive ventilation/high-flow oxygen, invasive ventilation/ECMO or death) using Wilcoxon rank sum test for ordinal data. Results Cases (n=36) were 11.8±4.4 years, 61% male, 27.8% black and 88.9% with OSA, while 85.7% of controls (n=84) had OSA. OSA was not associated with increased SARS-CoV-2 positivity: OR=1.33(0.40, 4.45,p=0.64). No significant difference between cases and controls for mean AHI 3.7(1.5,6.0) vs 3.5(1.5,7.1),p=0.91,SpO2 nadir 88.6±5.4 vs 89.1±4.4,p=0.58,%time SpO2&lt;90% 0.05[0.00,1.00) vs 0.10 (0.00,1.00, p=0.65) respectively was noted. WHO-7 COVID-19 clinical outcome did not meet statistical significance in relation to OSA due to the low event frequency (p=0.49). Of note, those with OSA vs without OSA had a higher WHO-7 outcome score of 2 vs 0 and prevalence of hospitalization: 12.5 vs 0% respectively. Of hospitalized patients, the following was observed: 23% had moderate/severe OSA vs 4.3% mild OSA, 50% required supplemental oxygen and 25% required intubation/invasive ventilation. No deaths or readmissions were reported. High risk conditions included: 75% obesity, 50% asthma, 25% sickle cell disease and 25% hypoplastic left heart. Conclusion In this first report of which we are aware focused on COVID-19 in pediatric OSA, we use a case control design leveraging COVID-19 and sleep laboratory registries. Albeit not statistically significant, pediatric patients with OSA had a higher percentage of worse clinical outcomes. Larger network studies are needed to clarify whether poorer COVID-19 outcomes may be attributable to OSA or modulated via high risk health conditions. Support (if any):

Discharge heart rate and clinical outcomes in hospitalized heart failure patients with coexisted atrial fibrillation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Xing ◽  
X Bai ◽  
J Li
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Heart Rate ◽  
Clinical Outcome ◽  
Confidence Interval ◽  
Clinical Outcomes ◽  
Beta Blockers ◽  
Funding Source ◽  
Proportional Hazard ◽  
Cox Proportional Hazard

Abstract Background Whether discharge heart rate for hospitalized heart failure (HF) patients with coexisted atrial fibrillation (AF) is associated with long-term clinical outcomes and whether this association differs between patients with and without beta-blockers have not been well studied. Purpose We investigated the associations between discharge heart rate and clinical outcomes in hospitalized HF patients with coexisted AF, while stratified to beta-blockers at discharge. Methods The study cohort included 1631 HF patients hospitalized primarily with AF, which was from the China PEACE Prospective Heart Failure Study. Clinical outcome was 1-year combined all-cause mortality and HF hospitalization after discharge. We analyzed association between outcome and heart rate at discharge with restricted cubic spline and Cox proportional hazard ratios (HR). Results The median age was 68 (IQR: 60- 77) years, 41.9% were women, discharge heart rate was (median (IQR)) 75 (69- 84) beats per minute (bpm), and 60.2% received beta-blockers at discharge. According to the result of restricted cubic spline plot, the relationship between discharge heart rate and clinical outcome may be nonlinear (P&lt;0.01). Based on above result, these patients were divided into 3 groups: lowest &lt;65 bpm, middle 65–86 bpm and highest ≥87 bpm, clinical outcomes occurred in 128 (64.32%), 624 (53.42%) and 156 (59.32%) patients in the lowest, middle, and highest groups respectively. In the Cox proportional hazard analysis, the lowest and highest groups were associated with increased risks of clinical outcome compared with the middle group (HR: 1.289, 95% confidence interval (CI): 1.056 - 1.573, p=0.013; HR: 1.276, 95% CI: 1.06 - 1.537, p=0.01, respectively). And a significant interaction between discharge heart rate and beta-blocker use was observed (P&lt;0.001 for interaction). Stratified analysis showed the lowest group was associated with increased risks of clinical outcomes in patients with beta-blockers (HR: 1.584, 95% confidence interval (CI): 1.215–2.066, p=0.001). Conclusion There may be a U-curve relationship between discharge heart rate and clinical outcomes in hospitalized HF patients with coexisted AF. They may have the best clinical outcomes with heart rates of 65 - 86 bpm. And strict heart rate control (&lt;65 bpm) may be avoided for patients who discharge with beta-blockers. Figure 1 Funding Acknowledgement Type of funding source: Other. Main funding source(s): This work was supported by the National Key Research and Development Program (2017YFC1310803) from the Ministry of Science and Technology of China; the CAMS Innovation Fund for Medical Science (2017-I2M-B&R-02); the 111 Project from the Ministry of Education of China (B16005).

scholarly journals Efficacy of Mechanical Thrombectomy using Penumbra ACETM Aspiration Catheter Compared to Stent Retriever SolitaireTM FR in Patients with Acute Ischemic Stroke

2021 ◽  
Vol 11 (4) ◽  
pp. 504
Author(s):  
Dalibor Sila ◽  
Markus Lenski ◽  
Maria Vojtková ◽  
Mustafa Elgharbawy ◽  
František Charvát ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Clinical Outcome ◽  
Acute Ischemic Stroke ◽  
Clinical Outcomes ◽  
Mechanical Thrombectomy ◽  
Binary Logistic Regression ◽  
Stent Retriever ◽  
Good Clinical Outcome ◽  
Significant Difference ◽  
Aspiration Technique

Background: Mechanical thrombectomy is the standard therapy in patients with acute ischemic stroke (AIS). The primary aim of our study was to compare the procedural efficacy of the direct aspiration technique, using Penumbra ACETM aspiration catheter, and the stent retriever technique, with a SolitaireTM FR stent. Secondarily, we investigated treatment-dependent and treatment-independent factors that predict a good clinical outcome. Methods: We analyzed our series of mechanical thrombectomies using a SolitaireTM FR stent and a Penumbra ACETM catheter. The clinical and radiographic data of 76 patients were retrospectively reviewed. Using binary logistic regression, we looked for the predictors of a good clinical outcome. Results: In the Penumbra ACETM group we achieved significantly higher rates of complete vessel recanalization with lower device passage counts, shorter recanalization times, shorter procedure times and shorter fluoroscopy times (p < 0.001) compared to the SolitaireTM FR group. We observed no significant difference in good clinical outcomes (52.4% vs. 56.4%, p = 0.756). Predictors of a good clinical outcome were lower initial NIHSS scores, pial arterial collateralization on admission head CT angiography scan, shorter recanalization times and device passage counts. Conclusions: The aspiration technique using Penumbra ACETM catheter is comparable to the stent retriever technique with SolitaireTM FR regarding clinical outcomes.

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