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BACKGROUND: Vagus nerve stimulation is an investigational anti-inflammatory therapy targeting the nervous system to modulate immune activity. This study evaluated the efficacy and safety of transcutaneous auricular VNS (ta-VNS) in patients with pediatric-onset Crohn's disease (CD) or ulcerative colitis (UC). METHODS: Participants were 10-21 years of age with mild/moderate CD or UC and fecal calprotectin (FC) > 200 ug/g within 4 weeks of study entry. Subjects were randomized to receive either ta-VNS targeting the cymba conchae of the external left ear, or sham stimulation, of 5 min duration once daily for a 2-week period, followed by a cross over to the alternative stimulation for an additional 2 weeks. At week 4, all subjects received ta-VNS of 5 min duration twice daily until week 16. Primary study endpoints were clinical remission, and a ≥ 50% reduction in FC level from baseline to week 16. Heart rate variability measurements and patient-reported outcome questionnaires were completed during interval and week 16 assessments. RESULTS: Twenty-two subjects were enrolled and analyzed (10 CD, 12 UC). Six of 10 with CD had a wPCDAI > 12.5 and 6/12 with UC had a PUCAI > 10 at baseline, correlating to mild to moderate symptom activity. Among the 12 subjects with active symptomatic disease indices at baseline, clinical remission was achieved in 3/6 (50%) with CD and 2/6 (33%) with UC at week 16. Despite all subjects having FC levels ≥ 200 within 4 weeks of enrollment, five subjects (4 UC, 1 CD) had FC levels < 200 at the baseline visit and were excluded from the FC analysis. Of the remaining 17, median baseline FC was 907 µg/g (IQR 411-2,120). At week 16, 11/17 (64.7%) of those with baseline FC ≥ 200 had a ≥ 50% reduction in FC (95% CI 38.3-85.8). In the UC subjects, there was an 81% median reduction in FC vs baseline (833 µg/g; p = 0.03) while in the CD subjects, median reduction in FC at 16 weeks was 51% (357 µg/g; p = 0.09). There were no safety concerns. CONCLUSION: Noninvasive ta-VNS attenuated signs and symptoms in a pediatric cohort with mild to moderate inflammatory bowel disease. TRIAL REGISTRATION: NCT03863704-Date of registration 3/4/2019.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Head and Neck Neoplasms , Squamous Cell Carcinoma of Head and Neck , Humans , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carboplatin/administration & dosage , Carboplatin/adverse effects , Cetuximab/administration & dosage , Cetuximab/adverse effects , Cisplatin/administration & dosage , Cisplatin/adverse effects , Head and Neck Neoplasms/drug therapy , Head and Neck Neoplasms/pathology , Head and Neck Neoplasms/surgery , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/prevention & control , Paclitaxel/administration & dosage , Paclitaxel/adverse effects , Squamous Cell Carcinoma of Head and Neck/drug therapy , Squamous Cell Carcinoma of Head and Neck/pathology , Squamous Cell Carcinoma of Head and Neck/surgery , Treatment OutcomeSubject(s)
Cross Infection , Methicillin-Resistant Staphylococcus aureus , Staphylococcal Infections , Infant, Newborn , Humans , Intensive Care Units, Neonatal , Staphylococcus aureus , Staphylococcal Infections/drug therapy , Staphylococcal Infections/epidemiology , Staphylococcal Infections/prevention & control , Cross Infection/epidemiology , Cross Infection/prevention & control , MupirocinABSTRACT
BACKGROUND: Breast cancer (BC) is the most common noncutaneous malignancy in women and survivors are at an increased risk for secondary malignancy with lung cancer (LC) being the most common. There are few studies that have explored the clinicopathological specifics of LC in BC survivors. METHODS: In this single-institution, retrospective study, we identified BC survivors who subsequently developed LC, examined their breast and LC clinical and pathological characteristics and compared them to the general BC and LC population as published in the literature. RESULTS: In our study, we found the following associations that could be meaningful: an association between receiving radiation (RT) and LC (including a statistically significant P = .03 chance of ipsilateral LC after BC treatment with RT), a higher incidence and amount of smoking and LC, high BRCA positivity (78.9%) in the few patients who had germline testing, and a higher incidence of EGFR mutations in NSCLC after BC (60.9%) as well as an earlier stage of NSCLC disease. CONCLUSION: Treatments such as RT, genetic factors such as BRCA mutations, and tobacco use may increase the risk of developing LC amongst BC survivors. Exploring this further can potentially lead to better risk stratification through modified low-dose CT chest screening protocols to catch LCs earlier and ultimately improve outcomes. Past studies have shown that BC survivors who are subsequently diagnosed with NSCLC may have improved OS compared with primary NSCLC and our study showed a high incidence of EGFR mutated NSCLC, which also suggest both improved prognosis and a different molecular profile of NSCLC, which warrants further investigation. Lastly, BC survivors who subsequently are diagnosed with NSCLC had earlier stage disease in our study, perhaps a result of surveillance, highlighting the importance of close monitoring of BC survivors.
Subject(s)
Breast Neoplasms , Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Neoplasms, Second Primary , Humans , Female , Retrospective Studies , Lung Neoplasms/epidemiology , Lung Neoplasms/etiology , Lung Neoplasms/pathology , Neoplasms, Second Primary/epidemiology , Neoplasms, Second Primary/etiology , Neoplasms, Second Primary/pathology , Carcinoma, Non-Small-Cell Lung/therapy , ErbB ReceptorsSubject(s)
Inflammatory Bowel Diseases , Venous Thromboembolism , Humans , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control , Anticoagulants/therapeutic use , Hospitalization , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/drug therapy , Blood Transfusion , Risk FactorsABSTRACT
Aim: Lung cancer (LC) is the leading cause of cancer-related deaths worldwide. The US Preventive Services Task Force and National Comprehensive Cancer Network recommend annual low-dose computed tomography (LDCT) for eligible adults. We conducted a study to assess physician LDCT referral patterns. Methods: The study was divided into a pre-, intervention, and post-intervention periods. The intervention was a LC screening educational series. We evaluated rates of LDCT screening referrals during pre- and post-intervention periods. Results: In the pre-intervention period, 75 patients fulfilled US Preventive Services Task Force and/or National Comprehensive Cancer Network criteria and 27% underwent LDCT. In the post-intervention period, 135 patients fulfilled either screening criteria of whom 61.5% underwent LDCT. Conclusion: In our study, educational lectures improved compliance significantly and should be used as tool for primary care providers to effectively increase LDCT screening referrals.
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INTRODUCTION: Curative intent treatment of head and neck cancer (HNC) is frequently radiation therapy over 7 weeks with concurrent chemotherapy. This regimen is effective but carries a burden of toxicity leading to severe pain and treatment breaks portending inferior outcomes. Conventional palliation methods include opioids, anticonvulsants and local anaesthetics. Breakthrough toxicities are nevertheless ubiquitous and present an urgent unmet need. Ketamine is an inexpensive drug with mechanisms of analgesia outside the opioid pathway including N-methyl-D-aspartate (NMDA) receptor antagonism and a pharmacologically unique property of opioid desensitisation. Systemic ketamine is validated in randomised controlled trials for efficacy in reducing pain and/or opioid burden in the oncologic setting. Literature supports peripherally administered ketamine for pain control without systemic toxicity. These data support our rationale of using ketamine mouthwash to decrease acute toxicity of curative treatment of HNC, the efficacy of which is our aim to elucidate. METHODS AND ANALYSIS: This is a phase II, Simon's two-stage trial. Patients have pathologically confirmed HNC and an intended regimen of 70 Gy of radiation with concurrent cisplatin. The protocol is initiated on diagnosis of grade 3 mucositis and consists of 2 weeks of 4 times daily (QID) ketamine mouthwash use. The primary endpoint is pain response defined as a combination of pain score and opioid use. 23 subjects will be enrolled in stage 1. If statistical criteria are met, 33 subjects will be enrolled in stage 2. Secondary endpoints include daily pain, daily opioid use, dysphagia at baseline and completion, nightly sleep quality, feeding tube placement and any unscheduled treatment breaks. ETHICS AND DISSEMINATION: All trial data will be stored in an Institutional Review Board (IRB) approved database. The protocol is registered under Northwell IRB registration number #22-0292 and U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) approval has been granted under IND number 161609. Results are intended to be published in an open-source journal and further data, statistics and source documents are available on request. TRIAL REGISTRATION NUMBER: NCT05331131.
Subject(s)
Head and Neck Neoplasms , Ketamine , United States , Humans , Ketamine/therapeutic use , Analgesics, Opioid/therapeutic use , Mouthwashes/therapeutic use , Pain/drug therapy , Head and Neck Neoplasms/drug therapy , Chemoradiotherapy/methods , Clinical Trials, Phase II as TopicABSTRACT
INTRODUCTION: Osteoradionecrosis is a rare and debilitating risk of definitive chemoradiotherapy for head and neck squamous cell carcinoma. It is difficult to distinguish between osteoradionecrosis and recurrent or progressive disease, as clinical and radiologic features may be similar. Our aim was to compare the clinical presentation and radiologic features of osteonecrosis with those of recurrent or progressive cancer. METHODS: We conducted a single-center case series of 19 patients with head and neck squamous cell carcinoma diagnosed between 2011 and 2019 who subsequently developed clinical and/or radiological suspicion of osteoradionecrosis. The population was a referred sample from head and neck cancer physicians at Northwell Health Cancer Institute. Clinician notes and imaging reports were reviewed to assign a final diagnosis of either cancer, osteonecrosis, or indeterminate. RESULTS: No differences were found in the clinical presentation or radiologic features between groups. Median time between treatment and development of symptoms was longer in patients with a final diagnosis of osteoradionecrosis than recurrent or progressive disease (5 vs. 3 months), but this difference was not statistically significant. Radiation dose and type were not associated with diagnosis. Mean standard uptake value maximums on positron emission tomography/computed tomography were significantly higher in the cancer group (median 14.8 vs. 9.1, p < 0.0152). At 1 year after first suspicion of osteoradionecrosis, 100% of osteoradionecrosis patients were alive, versus 28.6% of cancer patients. DISCUSSION/CONCLUSION: There is significant overlap in clinical and radiologic features of osteoradionecrosis and cancer. Standard uptake maximums may be helpful in predicting diagnosis. Occurrence of symptoms within 6 months of completing chemoradiotherapy should raise the concern for malignancy.
Subject(s)
Head and Neck Neoplasms , Osteonecrosis , Osteoradionecrosis , Humans , Squamous Cell Carcinoma of Head and Neck/therapy , Osteoradionecrosis/diagnostic imaging , Osteoradionecrosis/etiology , Osteoradionecrosis/therapy , Head and Neck Neoplasms/therapy , Positron Emission Tomography Computed TomographyABSTRACT
INTRODUCTION: Retrospective studies have suggested that patients with poor performance status treated with immune checkpoint inhibitors have shorter overall survival and poorer response rates. This study was undertaken to investigate the possible relationships between inpatient immune checkpoint inhibitor use and clinical outcomes. METHODS: This was a retrospective chart review of cancer patients who received an immune checkpoint inhibitor while hospitalized from 1 January 2016 to 30 December 2020. The primary outcome was 90-day mortality or admission to hospice rate. Secondary outcomes included overall survival, time to death or discharge to hospice, and descriptive summarization of patient characteristics. RESULTS: A total of 52 patients were analyzed. At 90 days, 68.2% of subjects were expired or admitted to hospice (95% CI: 54.7-81%). 90-day overall survival was 47.1%; median survival time was 81 days (95% CI: 28-242 days). The median time to death or hospice was 35 days (95% CI: 24-72 days). The time to death or hospice was shorter for immune checkpoint inhibitor-naive patients compared to those who received immune checkpoint inhibitors prior to admission (29 days, 95% CI: 12-43 days vs. 242 days, 95% CI: 36-1288 days, respectively; HR: 2.74, 95% CI: 1.2-6.25; p = 0.0121). No differences were found when comparing other baseline characteristics. CONCLUSION: A majority of patients who received an immune checkpoint inhibitor while hospitalized were either discharged to hospice or expired by 90 days. An increased rate of death or discharge to hospice was observed for patients who were immune checkpoint inhibitor-naive prior to their admission.
Subject(s)
Hospice Care , Neoplasms , Humans , Immune Checkpoint Inhibitors/therapeutic use , Inpatients , Retrospective Studies , Neoplasms/drug therapyABSTRACT
BACKGROUND/OBJECTIVE: Coronavirus disease 2019 (COVID-19) is thought to contribute to diabetic ketoacidosis (DKA) and worse outcomes in patients with diabetes. This study compared the cumulative insulin dose required to achieve DKA resolution in the intensive care unit among patients with type 2 diabetes and COVID-19 infection versus without COVID-19 infection. METHODS: This retrospective cohort study evaluated 100 patients-50 patients with COVID-19 in cohort 1 and 50 patients without COVID-19 in cohort 2-treated with insulin infusions for DKA at a tertiary care teaching hospital. The primary outcome was to compare the cumulative insulin dose required to achieve DKA resolution in each cohort. The secondary outcomes included time to DKA resolution, mean insulin infusion rate, and mean weight-based cumulative insulin infusion dose required to achieve DKA resolution. All endpoints were adjusted for confounders. RESULTS: The mean cumulative insulin dose was 190.3 units in cohort 1 versus 116.4 units in cohort 2 (P = .0038). Patients receiving steroids had a mean time to DKA resolution of 35.9 hours in cohort 1 versus 15.6 hours in cohort 2 (P = .0014). In cohort 1 versus cohort 2, the mean insulin infusion rate was 7.1 units/hour versus 5.3 units/hour (P = .0025), whereas the mean weight-based cumulative insulin infusion dose was 2.1 units/kg versus 1.5 units/kg (P = .0437), respectively. CONCLUSION: COVID-19-infected patients required a significantly larger cumulative insulin dose, longer time to DKA resolution, higher insulin infusion rate, and higher weight-based insulin infusion dose to achieve DKA resolution versus non-COVID-19-infected patients with type 2 diabetes.
Subject(s)
COVID-19 Drug Treatment , COVID-19 , Diabetes Mellitus, Type 2 , Diabetic Ketoacidosis , COVID-19/complications , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Diabetic Ketoacidosis/chemically induced , Diabetic Ketoacidosis/drug therapy , Diabetic Ketoacidosis/epidemiology , Humans , Hypoglycemic Agents , Insulin , Insulin, Regular, Human/therapeutic use , Retrospective StudiesABSTRACT
BACKGROUND CONTEXT: In the U.S., medical malpractice litigation is associated with significant financial costs and often leads to the practice of defensive medicine. Among medical subspecialities, spine surgery is disproportionately impacted by malpractice claims. PURPOSE: To provide a comprehensive assessment of reported malpractice litigation claims involving elective lumbar spinal fusion (LSF) surgery during the modern era of spine surgery instrumentation in the U.S., to identify factors associated with verdict outcomes, and to compare malpractice claims characteristics between different approaches for LSF. STUDY DESIGN/SETTING: A retrospective review. PATIENT SAMPLE: Patients undergoing elective lumbar spinal fusion surgery. OUTCOME MEASURES: The primary outcome measure was verdict outcome (defendant vs. plaintiff verdict). Secondary outcome measures included alleged malpractice, injury/damage claimed, and award payouts. METHODS: The Westlaw legal database (Thomson Reuters, New York, NY, USA) was queried for verdict and settlement reports pertaining to elective LSF cases from 1970 to 2021. Data were collected regarding patient demographics, surgeon specialty, fellowship training, state/region, procedure, institutional setting (academic vs. community hospital), alleged malpractice, injury sustained, case outcomes, and monetary award. RESULTS: A total of 310 cases were identified, yielding 67% (n=181) defendant and 24% (n=65) plaintiff verdicts, with 9% (n=26) settlements. Neurosurgeons and orthopedic spine surgeons were equally named as the defendant (45% vs. 51% respectively, p=0.59). When adjusted for inflation, the median final award for plaintiff verdicts was $1,241,286 (95% CI: $884,850-$2,311,706) while the median settlement award was $925,000 (95% CI: $574,800-$1,787,130), with no stastistically significant differences between verdict and reported settlement payouts (p=0.49). The Northeast region displayed significantly higher award payouts compared to other U.S. regions (p=0.02). There were no associations in awards outcomes when comparing alleged malpractice, alleged injuries/damages, institutional setting, surgical procedures, and surgeon specialty or fellowship training. The most common claims were intraoperative error (28%, n=107) followed by failure to obtain informed consent (24%, n=94). In the analyzed cohort, the most common injuries leading to litigation were refractory pain and suffering (37%, n=149) followed by permanent neurological deficits (26%, n=106). There were no differences in alleged malpractice or injury sustained between cases in which the outcome was favorable to defendant versus plaintiff. Anterior lumbar interbody fusion (ALIF) cases were 2.75 times more likely to be cited for excessive or inappropriate surgery (OR: 2.75 [95% CI: 1.14, 6.86], p=0.02) when compared to posterior surgical approaches. CONCLUSION: The results of our analysis of reported claims suggest that medical malpractice litigation involving elective LSF is associated with jury verdicts over $1 million per case, with the most common alleged malpractice being intraoperative error and failure to obtain informed consent. Surgeon specialty, fellowship training, procedure type, and institution type were not associated with greater litigation risks; however, ALIF surgery had a significantly higher risk of involving claims of excessive or inappropriate surgery compared to posterior approaches for lumbar fusion. In addition, claims were significantly higher in the Northeast compared to other U.S. regions. Efforts to improve patient education through shared-decision making and proactive strategies to avoid, detect, and mitigate intra-operative procedural errors may decrease the risk of litigation in elective LSF.
Subject(s)
Malpractice , Spinal Fusion , Surgeons , Databases, Factual , Humans , Informed Consent , Neurosurgeons , Spinal Fusion/adverse effects , United StatesABSTRACT
Lung cancer (LC) is the leading cause of cancer-related deaths worldwide. The U.S. Preventive Services Task Force (USPSTF) and National Comprehensive Cancer Network (NCCN) recommend annual low-dose CT chest (LDCT) for LC screening in high-risk adults who meet appropriate criteria, which primarily focus on age and smoking history. Despite this, screening rates remain low and patients with LC are typically diagnosed at a later stage.We conducted a single-center retrospective analysis of patients with an established diagnosis of lung cancer to evaluate if screening guidelines were appropriately followed before the cancer diagnosis.Patients diagnosed with LC between 2016 and 2019 were included in the analysis. Charts were reviewed for demographics, detailed smoking history, as well as histology and stage of LC. Associations between categorical factors and screening were examined using the chi-square test. Associations between continuous and ordinal factors and screening were examined using the Mann-Whitney test.A total of 530 charts were reviewed, of which 52% met NCCN criteria and 35% met USPSTF criteria. Only 4.0% and 4.8% of patients who met NCCN and USPSTF criteria, respectively, underwent screening. There was a significant association between staging at diagnosis and screening with LDCT. All the patients who had screening CT scans were diagnosed at localized stages of lung cancer in both NCCN and USPSTF groups compared to 49.1% and 48% in eligible subjects that did not undergo screening, respectively.Our study showed that despite established guidelines for LC screening and insurance coverage, a vast majority of screening-eligible LC patients have never had LDCT. We found that patients who underwent screening as per guidelines were diagnosed at earlier stages of the disease. Ongoing efforts to increase awareness and adherence to LC screening guidelines are needed to improve early detection and reduce LC mortality.
Subject(s)
Early Detection of Cancer , Lung Neoplasms , Adult , Humans , Lung Neoplasms/diagnosis , Mass Screening , Retrospective Studies , Tomography, X-Ray ComputedABSTRACT
BACKGROUND: An optimal approach for providing sufficient antenatal surveillance for fetal growth restriction (FGR) has yet to be elucidated. Moreover, there is scant literature on the fetal response to betamethasone and its effect on fetal Dopplers. OBJECTIVE: To compare persistence of umbilical artery Doppler abnormalities after corticosteroid administration and adverse perinatal outcome in growth restricted fetuses. METHODS: Retrospective cohort study (2008-2018) of singleton gestations with FGR (EFW <10th percentile) and umbilical artery Doppler abnormalities (absent or reversed end diastolic velocity) between 24 and 34 weeks of gestation at two institutions. Included patients had Dopplers performed before betamethasone administration and again within 1 week. Excluded were multiple gestations, chromosomal abnormalities, fetal anomalies, or missing outcome information. Pregnancies with persistently abnormal Dopplers were compared with those in which an improvement of Dopplers was noted. The primary outcome was a composite that consisted of indicated preterm birth <32 weeks, 1 or 5 min APGAR score <7, intrauterine fetal demise, and neonatal demise. Secondary outcomes included length of NICU stay, ventilator support, gestational age at delivery, interval between steroids and delivery, and birth weight. RESULTS: Fifty-three FGR pregnancies met inclusion criteria. Umbilical artery Dopplers improved after steroids in 32% (n = 17). No difference in the frequency of the primary outcome was observed between the persistently abnormal Doppler and improved Doppler groups (72.2% vs. 70.6%, respectively), and there was no difference in any of the secondary outcomes. CONCLUSIONS: Perinatal outcomes in FGR pregnancies were not affected by improved versus persistently abnormal umbilical artery Dopplers after betamethasone administration.
Subject(s)
Premature Birth , Umbilical Arteries , Betamethasone/therapeutic use , Female , Fetal Growth Retardation/diagnostic imaging , Fetal Growth Retardation/drug therapy , Fetus/blood supply , Gestational Age , Humans , Infant, Newborn , Pregnancy , Retrospective Studies , Ultrasonography, Doppler , Ultrasonography, Prenatal , Umbilical Arteries/diagnostic imagingABSTRACT
INTRODUCTION: The recently published FLAURA trial demonstrated that osimertinib has remarkable efficacy in front-line setting for non-small cell lung cancer (NSCLC). While this has transformed current practice, there are no effective treatments following progression on osimertinib. The aim of our study was to compare progression-free survival (PFS) and overall survival (OS) between patients initiated on osimertinib to those started on other EGFR TKIs. METHODS: This was a multicenter, retrospective study conducted at two large academic centers. Adult patients with EGFR-mutated non-small cell lung cancer (NSCLC) who received EGFR therapy between 2014 and 2019 were included. Patients were dichotomized based on front-line TKI (osimertinib vs. other). PFS, OS, and time-to-discontinuation were evaluated. RESULTS: One-hundred seventy-two patients were included in the final analysis. Fifty-two (30.2%) patients received osimertinib and 120 (69.8%) patients received another EGFR TKI. The PFS rates at 6, 12, and 18 months were 86.3%, 79.5%, 69.8% in the osimertinib group and 86.6%, 64.2%, 39.3% in the other EGFR TKI group, respectively (p < 0.0036).Estimated OS at 6, 12, and 18 months was similar for both groups: 94.2%, 94.2%, 80.2% and 95.7%, 93.9%, 84.1%, respectively [Adjusted HR = 0.95 (95% CI, 0.37-2.44; p < 0.9128]. CONCLUSION: Osimertinib demonstrated greater 12 and 18 month PFS compared to other EGFR TKIs. This finding is consistent with results of the FLAURA trial. However, unlike FLAURA, there were no differences in estimated OS between the two groups in our study. Further research to evaluate optimal sequencing strategies in the real world of first, second and third generation TKIs is needed.
Subject(s)
Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Adult , Humans , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/genetics , Lung Neoplasms/drug therapy , Lung Neoplasms/genetics , Retrospective Studies , ErbB Receptors/genetics , MutationABSTRACT
ABSTRACT: The Centers for Disease Control and Prevention estimates that half of the antibiotic prescriptions for acute respiratory tract infections (ARTIs) in ambulatory care settings are unnecessary. To better understand the quality-of-care implications of prescription patterns for ARTIs, we conducted a retrospective chart review of outpatient ARTI visits, across a large integrated health system, and examined the association of patient characteristics with receiving antimicrobials, as well as the association between receiving antimicrobials and healthcare utilization (outpatient and emergency department visits). We found that 55.4% of all ARTI outpatients were treated with antimicrobials. There was no association between patient demographics and antimicrobial prescriptions on either the first (p < .0771) or follow-up (p < .6316) visits. A lower comorbidity score was significantly associated with receiving antimicrobials (p < .0022). Patients who received antimicrobials at the first visit had significantly higher number of follow-up visits (p < .005) and more follow-up antimicrobial prescriptions (p < .0066) as compared with patients who did not receive antimicrobials at the first visit. Our results highlight the potential for clinicians to improve quality of care in ARTI management.
Subject(s)
Anti-Infective Agents , Respiratory Tract Infections , Anti-Bacterial Agents/therapeutic use , Anti-Infective Agents/therapeutic use , Humans , Practice Patterns, Physicians' , Prescriptions , Respiratory Tract Infections/drug therapy , Retrospective StudiesABSTRACT
There is a need to discriminate which COVID-19 inpatients are at higher risk for venous thromboembolism (VTE) to inform prophylaxis strategies. The IMPROVE-DD VTE risk assessment model (RAM) has previously demonstrated good discrimination in non-COVID populations. We aimed to externally validate the IMPROVE-DD VTE RAM in medical patients hospitalized with COVID-19. This retrospective cohort study evaluated the IMPROVE-DD VTE RAM in adult patients with COVID-19 admitted to one of thirteen Northwell Health hospitals in the New York metropolitan area between March 1, 2020 and April 27, 2020. VTE was defined as new-onset symptomatic deep venous thrombosis or pulmonary embolism. To assess the predictive value of the RAM, the receiver operating characteristic (ROC) curve was plotted and the area under the curve (AUC) was calculated. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. Of 9407 patients who met study criteria, 274 patients developed VTE with a prevalence of 2.91%. The VTE rate was 0.41% for IMPROVE-DD score 0-1 (low risk), 1.21% for score 2-3 (moderate risk), and 5.30% for score ≥ 4 (high risk). Approximately 45.7% of patients were classified as high VTE risk, 33.3% moderate risk, and 21.0% low risk. Discrimination of low versus moderate-high VTE risk demonstrated sensitivity 0.971, specificity 0.215, PPV 0.036, and NPV 0.996. ROC AUC was 0.703. In this external validation study, the IMPROVE-DD VTE RAM demonstrated very good discrimination to identify hospitalized COVID-19 patients at low, moderate, and high VTE risk.
Subject(s)
COVID-19 , Risk Assessment , Venous Thromboembolism , COVID-19/complications , Humans , Inpatients , New York City , Retrospective Studies , Risk Factors , Venous Thromboembolism/diagnosis , Venous Thromboembolism/epidemiologyABSTRACT
BACKGROUND: For people with advanced stage cystic fibrosis (CF), tailored survival estimates could facilitate preparation for decision-making in the event of acutely deteriorating respiratory function. METHODS: We used the US CF Foundation national database (2008-2013) to identify adult people with incident advanced stage CF (forced expiratory volume in 1 s (FEV1) ≤45% predicted). Using the lasso method for variable selection, we divided the dataset into training and validation samples (2:1), and developed two multivariable Cox proportional hazards models to calculate probabilities of survival from baseline (T0 model), and from 1 year after (T12 model). We also performed Kaplan-Meier survival analyses. RESULTS: 4752 people were included. For the T0 model, FEV1; insurance; non-invasive ventilation; supplemental oxygen; Burkholderia colonisation; cirrhosis; depression; dialysis; current smoking; unclassifiable mutation class and cumulative CF exacerbations predicted increased mortality. Baseline transplant evaluation status of 'accepted, on waiting list' predicted decreased mortality. For the T12 model, interim decrease in FEV1 >10%, and pulmonary exacerbations additionally increased predicted mortality. Lung transplantation was associated with lower mortality. Of the 4752, 93.5%, 86.4%, 79.7% and 73.9% survived to 1, 2, 3 and 4 years, respectively, without considering any confounding variables. The models had moderate predictive ability indicated by the area under the time-dependent receiver operating characteristic curve (0.787, 95% CI 0.769 to 0.794 for T0 model; and 0.779, 95% CI 0.767 to 0.797 for T12 model). CONCLUSION: We have developed models predicting survival in people with incident advanced stage CF, which can be reapplied over time to support shared decision-making about end-of-life treatment choices and lung transplantation. These estimates must be updated as data become available regarding long-term outcomes for people treated with CF transmembrane conductance regulator modulators.
Subject(s)
Advance Care Planning , Cystic Fibrosis , Lung Transplantation , Cystic Fibrosis/therapy , Forced Expiratory Volume , Humans , LungABSTRACT
AIM: To determine risk factors for MRSA colonization in a Level IV Neonatal Intensive Care Unit (NICU) independent of length of stay and gestational age in the context of a persistently circulating MRSA clone. DESIGN: Retrospective matched case-control study. SETTING: Level IV NICU PATIENTS: Infants admitted between April 4,2017- March 31,2018. METHODS: Based on weekly surveillance cultures, infants who acquired MRSA were matched 1:1 with MRSA-negative control infants by duration of exposure (length of stay) and gestational age to determine risk factors for acquisition. RESULTS: Fifty case infants were matched with controls. Isolates from 45 of the 50 cases were mupirocin-resistant and related by pulse-field gel electrophoresis. On matched univariable analysis, the following were significantly associated with a risk for MRSA acquisition: 1.Bed location in the acute area(Pâ¯=â¯0.03), 2.Requirement of any level of respiratory support during the week prior to MRSA detection(Pâ¯=â¯0.04), 3.Higher ATP pass rate (a measure of effectiveness of cleaning) during the week of and week prior(Pâ¯=â¯0.01), 4.Higher MRSA colonization pressure during the week of and week prior(P< 0.0001), 5.Not having a hearing test during the time between the previous negative culture and MRSA acquisition(Pâ¯=â¯0.01). A multivariable conditional logistic regression model (that excluded ATP pass rate) found that only colonization pressure was associated with acquisition of MRSA colonization. CONCLUSIONS: In an outbreak setting, MRSA colonization pressure is significantly associated with MRSA acquisition in the NICU independent of length of stay and gestational age.