Abstract 345: Non-inferiority Trials With a Primary Surrogate Endpoint: An Increasing Phenotype in Cardiovascular Trials

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Cesar Caraballo ◽  
Behnood Bikdeli ◽  
John Welsh ◽  
Joseph S Ross ◽  
Sanjay Kaul ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Clinical Outcomes ◽  
European Heart Journal ◽  
Linear Trend ◽  
Surrogate Endpoint ◽  
Median Number ◽  
Publication Rate ◽  
Primary Analysis ◽  
Surrogate Outcome ◽  
Number Of Patients

Background: Non-inferiority trials are increasing in cardiovascular medicine, with approval of many drugs and devices on the basis of such studies. Surrogate endpoints have been also increasingly used for efficient assessment of cardiovascular interventions, but there is uncertainty about their concordance with clinical outcomes. Non-inferiority designs using a primary surrogate endpoint in cardiovascular trials may pose particular challenges in clinical interpretation. Methods: We searched six high-impact journals (NEJM, JAMA, Lancet, JACC, Circulation, and EHJ) from 01/01/1990-12/31/2018 and identified non-inferiority cardiovascular trials that used a primary surrogate endpoint. We assessed the non-inferiority margin reported in the manuscript and other publicly available platforms (e.g. protocol, clinicaltrials.gov). We determined whether surrogate outcome non-inferiority trials 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 primary surrogate 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 JACC, 9 in European Heart Journal, 8 in Circulation, 6 in Lancet, 1 in NEJM), and their publication rate increased over time (P<0.001 for linear trend). The median number of patients in the primary analysis was 263 (IQR: 191 - 460). The study protocol or a methods paper was publicly available for only 12 (32.4%) trials, of which the non-inferiority margin was not reported in 4. In 16 (43.2%) studies 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 ocriteria. However, only 3 (9.1%) were followed by clinical outcomes trials the results of which did not always confirm non-inferiority (Figure). Conclusion: Non-inferiority trials with a primary surrogate 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.

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.

Abstract 19637: Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990- 2011

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Behnood Bikdeli ◽  
Natdanai Punnanithinont ◽  
Yasir Akram ◽  
Ike Lee ◽  
Nihar R Desai ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Surrogate Endpoint ◽  
Surrogate Endpoints ◽  
Surrogate Outcome ◽  
Surrogate Outcomes ◽  
Test Strategies ◽  
Outcome Trial ◽  
Primary Hypothesis

Background: Surrogate endpoint trials can test strategies more efficiently, but are accompanied by uncertainty about the relationship between changes in surrogate markers and clinical outcomes. We sought to determine recent trends in the publication of cardiovascular trials with surrogate outcomes. Methods: We identified cardiovascular trials with primary surrogate endpoints published in NEJM, Lancet, and JAMA from January 1990 to December 2011. Trends in publication of surrogate endpoint trials, and the success of the trials in meeting their primary endpoint were evaluated. We also tracked the above three journals for publication of clinical outcome trials on the interventions tested in surrogate trials. Results: We screened 3016 articles and identified 848 primary hypothesis cardiovascular trials, which included 220 surrogate endpoint trials. There was an increase over time in the number of surrogate endpoint trials (P=0.01). From the total of 220 surrogate trials, 157 (71.4 %) were positive for their primary endpoint. Sixty (27.5%) surrogate trials were followed by at least one clinical outcome trial. Among these 60 surrogate trials, in 24 cases the outcomes trial results validated the positive surrogates; whereas in 21 subsequent outcome trials were negative following positive results on a surrogate. However, we identified only 3 examples in which the surrogate trial was negative but a subsequent outcomes trial was conducted and showed benefit (Figure). Conclusions: Cardiovascular surrogate outcomes trials are common, frequently show superiority of the tested intervention and are infrequently followed by a prominent outcomes trial. However, when there was a high profile clinical outcomes study, half of the positive surrogate trials were not validated. Cardiovascular surrogate outcome trials may be more appropriate for excluding benefit from the patient perspective than for identifying it.

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.

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 Late Thrombectomy in Clinical Practice

2021 ◽  
Author(s):  
Moriz Herzberg ◽  
Korbinian Scherling ◽  
Robert Stahl ◽  
Steffen Tiedt ◽  
Frank A. Wollenweber ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Outcome ◽  
Perfusion Imaging ◽  
Time Window ◽  
Ct Perfusion ◽  
Large Trial ◽  
Real World Data ◽  
Baseline Trial ◽  
Good Outcome ◽  
Number Of Patients

Abstract Background and Purpose To provide real-world data on outcome and procedural factors of late thrombectomy patients. Methods We retrospectively analyzed patients from the multicenter German Stroke Registry. The primary endpoint was clinical outcome on the modified Rankin scale (mRS) at 3 months. Trial-eligible patients and the subgroups were compared to the ineligible group. Secondary analyses included multivariate logistic regression to identify predictors of good outcome (mRS ≤ 2). Results Of 1917 patients who underwent thrombectomy, 208 (11%) were treated within a time window ≥ 6–24 h and met the baseline trial criteria. Of these, 27 patients (13%) were eligible for DAWN and 39 (19%) for DEFUSE3 and 156 patients were not eligible for DAWN or DEFUSE3 (75%), mainly because there was no perfusion imaging (62%; n = 129). Good outcome was not significantly higher in trial-ineligible (27%) than in trial-eligible (20%) patients (p = 0.343). Patients with large trial-ineligible CT perfusion imaging (CTP) lesions had significantly more hemorrhagic complications (33%) as well as unfavorable outcomes. Conclusion In clinical practice, the high number of patients with a good clinical outcome after endovascular therapy ≥ 6–24 h as in DAWN/DEFUSE3 could not be achieved. Similar outcomes are seen in patients selected for EVT ≥ 6 h based on factors other than CTP. Patients triaged without CTP showed trends for shorter arrival to reperfusion times and higher rates of independence.

scholarly journals 288. Follow-Up Blood Cultures in Gram-Negative Bacteremia: How Do They Impact Outcomes

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S144-S144
Author(s):  
Azza Elamin ◽  
Faisal Khan ◽  
Ali Abunayla ◽  
Rajasekhar Jagarlamudi ◽  
aditee Dash
Keyword(s):  
Clinical Outcomes ◽  
Antibiotic Treatment ◽  
Readmission Rate ◽  
Blood Cultures ◽  
Categorical Variables ◽  
Gram Negative ◽  
Number Of Patients ◽  
Significant Difference ◽  
The Impact

Abstract Background As opposed to Staphylococcus. aureus bacteremia, there are no guidelines to recommend repeating blood cultures in Gram-negative bacilli bacteremia (GNB). Several studies have questioned the utility of follow-up blood cultures (FUBCs) in GNB, but the impact of this practice on clinical outcomes is not fully understood. Our aim was to study the practice of obtaining FUBCs in GNB at our institution and to assess it’s impact on clinical outcomes. Methods We conducted a retrospective, single-center study of adult patients, ≥ 18 years of age admitted with GNB between January 2017 and December 2018. We aimed to compare clinical outcomes in those with and without FUBCs. Data collected included demographics, comorbidities, presumed source of bacteremia and need for intensive care unit (ICU) admission. Presence of fever, hypotension /shock and white blood cell (WBC) count on the day of FUBC was recorded. The primary objective was to compare 30-day mortality between the two groups. Secondary objectives were to compare differences in 30-day readmission rate, hospital length of stay (LOS) and duration of antibiotic treatment. Mean and standard deviation were used for continuous variables, frequency and proportion were used for categorical variables. P-value &lt; 0.05 was defined as statistically significant. Results 482 patients were included, and of these, 321 (67%) had FUBCs. 96% of FUBCs were negative and 2.8% had persistent bacteremia. There was no significant difference in 30-day mortality between those with and without FUBCs (2.9% and 2.7% respectively), or in 30-day readmission rate (21.4% and 23.4% respectively). In patients with FUBCs compared to those without FUBCs, hospital LOS was longer (7 days vs 5 days, P &lt; 0.001), and mean duration of antibiotic treatment was longer (14 days vs 11 days, P &lt; 0.001). A higher number of patients with FUBCs needed ICU care compared to those without FUBCs (41.4% and 25.5% respectively, P &lt; 0.001) Microbiology of index blood culture in those with and without FUBCs Outcomes in those with and without FUBCs FUBCs characteristics Conclusion Obtaining FUBCs in GNB had no impact on 30-day mortality or 30-day readmission rate. It was associated with longer LOS and antibiotic duration. Our findings suggest that FUBCs in GNB are low yield and may not be recommended in all patients. Prospective studies are needed to further examine the utility of this practice in GNB. Disclosures All Authors: No reported disclosures

scholarly journals Polypharmacy-associated potential contraindications of drug prescriptions in patients with primary angle closure disease in a real-world setting

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Fumiaki Tanaka ◽  
Naoki Shibatani ◽  
Kazumi Fujita ◽  
Hiroaki Ikesue ◽  
Satoru Yoshimizu ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Anterior Chamber ◽  
Anterior Chamber Depth ◽  
Japanese Patients ◽  
Median Number ◽  
Angle Closure ◽  
Primary Angle Closure ◽  
Primary Angle Closure Glaucoma ◽  
Number Of Patients ◽  
Multiple Drugs

Abstract Background Primary angle closure disease (PACD) is a type of glaucoma in which the intraocular pressure (IOP) is increased because of the blockage of the anterior chamber angle. Medications contraindicated for patients with PACD, such as anticholinergics, cause mydriasis, and can elevate IOP. However, anticholinergics are currently contraindicated only for primary angle closure glaucoma (PACG) in Japanese package inserts. In this study, we investigated the prescription status of medications contraindicated for PACD, such as anticholinergics, in patients with PACD scheduled for eye surgeries. Methods Forty-three Japanese patients diagnosed with PACD at Kobe City Eye Hospital, Japan, and scheduled hospitalization for eye surgeries between December 2017 and July 2018, were included. Data, including sex, age, diagnosis, IOP, anterior chamber depth, and patients’ regular medications prior to hospitalization, were collected for each patient from the electronic medical records. Results The number of patients with chronic primary angle closure (CPAC) and acute primary angle closure (APAC) was 35 (81.4%) and 8 (18.6%), respectively. Among all the 43 patients with PACD, 8 (18.6%) received 15 medications that are potentially contraindicated for PACD by non-ophthalmologist. According to medication categories, benzodiazepine hypnotics were the most commonly prescribed. Among the 8 patients with APAC, 2 (25.0%) had routinely received medications contraindicated for PACD. The median number of all kinds of prescriptions on the day of hospitalization was significantly higher for patients who received medications contraindicated for PACD than for those who did not receive them (p = 0.010). Conclusions About 20% of patients with PACD received medications potentially contraindicated for PACD, such as anticholinergics. Attention should be paid to patients prescribed multiple drugs for adverse events, such as increase in intraocular pressure.

scholarly journals Carbapenemase-Producing, Carbapenem-Resistant Acinetobacter baumannii: Summary of CDC Consultations, 2017–2019

2020 ◽  
Vol 41 (S1) ◽  
pp. s151-s152
Author(s):  
Lauren Epstein ◽  
Alicia Shugart ◽  
David Ham ◽  
Snigdha Vallabhaneni ◽  
Richard Brooks ◽  
...  
Keyword(s):  
Public Health ◽  
Acinetobacter Baumannii ◽  
Median Number ◽  
Skilled Nursing Facilities ◽  
Nursing Facilities ◽  
Skilled Nursing ◽  
Healthcare Facilities ◽  
Carbapenem Resistant ◽  
Number Of Patients ◽  
Single Facility

Background: Carbapenemase-producing carbapenem-resistant Acinetobacter baumannii (CP-CRAB) are a public health threat due to potential for widespread dissemination and limited treatment options. We describe CDC consultations for CP-CRAB to better understand transmission and identify prevention opportunities. Methods: We defined CP-CRAB as CRAB isolates with a molecular test detecting KPC, NDM, VIM, or IMP carbapenemases or a plasmid-mediated oxacillinase (OXA-23, OXA-24/40, OXA-48, OXA-58, OXA-235/237). We reviewed the CDC database of CP-CRAB consultations with health departments from January 1, 2017, through June 1, 2019. Consultations were grouped into 3 categories: multifacility clusters, single-facility clusters, and single cases. We reviewed the size, setting, environmental culturing results, and identified infection control gaps for each consultation. Results: We identified 29 consultations involving 294 patients across 19 states. Among 9 multifacility clusters, the median number of patients was 12 (range, 2–87) and the median number of facilities was 2 (range, 2–6). Among 9 single-facility clusters, the median number of patients was 5 (range, 2–50). The most common carbapenemase was OXA-23 (Table 1). Moreover, 16 consultations involved short-stay acute-care hospitals, and 6 clusters involved ICUs and/or burn units. Also, 8 consultations involved skilled nursing facilities. Environmental sampling was performed in 3 consultations; CP-CRAB was recovered from surfaces of portable, shared equipment (3 consultations), inside patient rooms (3 consultations) and nursing stations (2 consultations). Lapses in environmental cleaning and interfacility communication were common across consultations. Among 11 consultations for single CP-CRAB cases, contact screening was performed in 7 consultations and no additional CP-CRAB was identified. All 4 patients with NDM-producing CRAB reported recent international travel. Conclusions: Consultations for clusters of oxacillinase-producing CP-CRAB were most often requested in hospitals and skilled nursing facilities. Healthcare facilities and public health authorities should be vigilant for possible spread of CP-CRAB via shared equipment and the potential for CP-CRAB spread to connected healthcare facilities.Funding: NoneDisclosures: None

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):

Sign in / Sign up

Export Citation Format

Share Document