NCOG-15. THE EFFECTIVENESS OF ANTIEPILEPTIC DRUG DUOTHERAPIES IN GLIOMA PATIENTS: A MULTICENTER OBSERVATIONAL COHORT STUDY

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi155-vi155
Author(s):  
Pim van der Meer ◽  
Linda Dirven ◽  
Marta Fiocco ◽  
Maaike Vos ◽  
Mathilde Kouwenhoven ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adverse Effects ◽  
Treatment Failure ◽  
Antiepileptic Drug ◽  
Study Data ◽  
Observational Cohort Study ◽  
Cox Proportional Hazard ◽  
Cox Proportional Hazard Models ◽  
Observational Cohort

Abstract BACKGROUND Uncontrolled seizures on antiepileptic drug (AED) monotherapy are common in glioma patients and about a third of patients need an add-on AED. The aim of this study was to determine whether levetiracetam combined with valproic acid (LEV+VPA), a commonly prescribed duotherapy, was more effective than other duotherapy combinations, which included either LEV or VPA, in glioma patients. METHODS In this multicenter observational cohort study, data of patients with a diffuse grade 2-4 glioma and having uncontrolled seizures on their first-line monotherapy LEV or VPA, was retrospectively analyzed. Primary outcome was treatment failure (i.e. replacement by or addition of a new AED, or withdrawal of an AED) for any reason. Secondary outcomes included: 1) treatment failure due to uncontrolled seizures; and 2) treatment failure due to adverse effects. Time to treatment failure was estimated with multivariable Cox proportional hazard models, from moment of AED duotherapy treatment initiation. The maximum duration of follow-up was 36 months. RESULTS A total of 355 patients received AED duotherapy after they showed treatment failure due to uncontrolled seizures on monotherapy. LEV+VPA was prescribed in 66% (236/355) and other AED duotherapy combinations including LEV or VPA in 34% (119/355) of patients. Patients using other duotherapy versus LEV+VPA had higher risk of treatment failure for any reason (cause-specific hazard ratio [csHR]=1.50 [95%CI=1.07-2.12], p=0.020), due to uncontrolled seizures (csHR=1.73 [95%CI=1.10-2.73], p=0.018), but not due to adverse effects (csHR=0.88 [95%CI=0.47-1.67]), p=0.703). CONCLUSIONS This observational cohort study showed that LEV+VPA has better efficacy than other AED combinations with either LEV or VPA, but toxicity was similar in the two groups.

OS10.8.A The effectiveness of antiepileptic drug duotherapies in glioma patients: a multicenter observational cohort study

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii14-ii14
Author(s):  
P B van der Meer ◽  
L Dirven ◽  
M Fiocco ◽  
M Vos ◽  
M C M Kouwenhoven ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adverse Effects ◽  
Treatment Failure ◽  
Antiepileptic Drug ◽  
Observational Cohort Study ◽  
Proportional Hazard ◽  
Cox Proportional Hazard ◽  
Cox Proportional Hazard Models ◽  
Observational Cohort

Abstract BACKGROUND About 30% of glioma patients need an add-on antiepileptic drug (AED) due to uncontrolled seizures on AED monotherapy. This study aimed to determine whether levetiracetam combined with valproic acid (LEV+VPA), a commonly prescribed duotherapy, is more effective than other duotherapy combinations including either LEV or VPA in glioma patients. MATERIAL AND METHODS In this multicenter retrospective observational cohort study, treatment failure (i.e. replacement by or addition of a new AED, or withdrawal of an AED) for any reason was the primary outcome. Secondary outcomes included: 1) treatment failure due to uncontrolled seizures; and 2) treatment failure due to adverse effects. Time to treatment failure was defined as the time from the start of AED duotherapy until the time of treatment failure. Multivariable Cox proportional hazard models were estimated to study the association between risk factors and treatment failure. The maximum duration of follow-up was 36 months. RESULTS A total of 1435 patients were treated with first-line monotherapy LEV or VPA, of which 355 patients received AED duotherapy after they had treatment failure due to uncontrolled seizures on monotherapy. LEV+VPA was prescribed in 66% (236/355) and other AED duotherapy combinations including LEV or VPA in 34% (119/355) of patients. Patients using other duotherapy versus LEV+VPA had higher risk of treatment failure for any reason (cause-specific hazard ratio [csHR]=1.50 [95%CI=1.07–2.12], p=0.020), treatment failure due to uncontrolled seizures (csHR=1.73 [95%CI=1.10–2.73], p=0.018). There were no differences in failure due to adverse effects (csHR=0.88 [95%CI=0.47–1.67]), p=0.703) between the two groups. CONCLUSION This observational cohort study suggests that LEV+VPA has better efficacy than other AED combinations. Similar toxicities were experienced in the two groups.

scholarly journals Prevalence and Course of IgA and IgG Antibodies against SARS-CoV-2 in Healthcare Workers during the First Wave of the COVID-19 Outbreak in Germany: Interim Results from an Ongoing Observational Cohort Study

Healthcare ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 498
Author(s):  
Mark Reinwald ◽  
Peter Markus Deckert ◽  
Oliver Ritter ◽  
Henrike Andresen ◽  
Andreas G. Schreyer ◽  
...  
Keyword(s):  
Cohort Study ◽  
Healthcare Workers ◽  
Significant Proportion ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Observational Cohort Study ◽  
Igg Antibodies ◽  
University Hospitals ◽  
Observational Cohort

(1) Background: Healthcare workers (HCWs) are prone to intensified exposure to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in the ongoing pandemic. We prospectively analyzed the prevalence of antibodies against SARS-CoV-2 in HCWs at baseline and follow up with regard to clinical signs and symptoms in two university hospitals in Brandenburg, Germany. (2) Methods: Screening for anti-SARS-CoV-2 IgA and IgG antibodies was offered to HCWs at baseline and follow up two months thereafter in two hospitals of Brandenburg Medical School during the first wave of the COVID-19 pandemic in Germany in an ongoing observational cohort study. Medical history and signs and symptoms were recorded by questionnaires and analyzed. (3) Results: Baseline seroprevalence of anti-SARS-CoV-2 IgA was 11.7% and increased to 15% at follow up, whereas IgG seropositivity was 2.1% at baseline and 2.2% at follow up. The rate of asymptomatic seropositive cases was 39.5%. Symptoms were not associated with general seropositivity for anti-SARS-CoV-2; however, class switch from IgA to IgG was associated with increased symptom burden. (4) Conclusions: The seroprevalence of antibodies against SARS-CoV-2 was low in HCWs but higher compared to population data and increased over time. Screening for antibodies detected a significant proportion of seropositive participants cases without symptoms.

scholarly journals Antidepressant dose and the risk of deliberate self-harm

2014 ◽  
Vol 23 (4) ◽  
pp. 329-331 ◽  
Author(s):  
C. Barbui ◽  
S.B. Patten
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
Propensity Score ◽  
Adverse Effects ◽  
Suicidal Behaviour ◽  
Research Question ◽  
Observational Cohort Study ◽  
Panic Attacks ◽  
Observational Cohort ◽  
Self Harm

Although the mechanism by which antidepressants (ADs) may increase the risk of suicide-related outcomes is unknown, it has been hypothesised that some adverse effects, including akathisia, insomnia and panic attacks, as well as an early energising effect that might allow patients with depression to act on suicidal impulses, may have a key role. Considering that these adverse effects are dose-related, it might be hypothesised that the risk of suicidal behaviour is similarly related to the AD dose. This research question has recently been addressed by a propensity score-matched observational cohort study that involved 162 625 patients aged 10–64 years with a depression diagnosis who initiated therapy with citalopram, sertraline or fluoxetine. In this commentary, we discuss the main findings of this study in view of its methodological strengths and limitations, and we suggest possible implications for day-to-day clinical practice.

scholarly journals Neonatal Severe Hyperbilirubinemia Online Registry in Jiangsu Province: protocol for a multicentre, prospective, open, observational cohort study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040797
Author(s):  
Qianqian Li ◽  
Xiaoyi Deng ◽  
Junmei Yan ◽  
Xiaofan Sun ◽  
Xiaoyue Dong ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Observational Cohort Study ◽  
Jiangsu Province ◽  
Survival Status ◽  
Bilirubin Encephalopathy ◽  
Brainstem Response ◽  
Observational Cohort ◽  
Severe Hyperbilirubinemia

IntroductionSevere hyperbilirubinaemia in newborns can be easily complicated by acute bilirubin encephalopathy or even kernicterus, which could lead to neurological sequelae or death. However, there is no systematic study of the management of severe hyperbilirubinaemia in China. The Neonatal Severe Hyperbilirubinemia Online Registry study aims to investigate the management of jaundice before admission, risk factors and outcomes of severe hyperbilirubinaemia in a real-world setting in China.Methods and analysisThis is a prospective, multicentre, open, observational cohort study. From May 2020 to April 2023, more than 2000 patients with neonatal severe hyperbilirubinaemia from 13 tertiary hospitals in Jiangsu Province will join the study. Demographic data and treatment information will be collected from their clinical data. Management measures for jaundice before admission will be collected by the WeChat applet (called ‘Follow-up of jaundice’) after being provided by the patient’s guardian using a mobile phone. Follow-up data will include cranial MRI examination results, brainstem auditory-evoked potential or automatic auditory brainstem response, physical examination results and Griffiths Development Scales-Chinese at the corrected ages of 3–6 months and 1 and 2 years. Results and conclusions will be recorded using ‘Follow-up of jaundice.’ In-hospital outcomes, including severity of hyperbilirubinaemia (severe, extreme, hazardous), acute bilirubin encephalopathy (mild, moderate, severe) and survival status (death or survival), will be collected at discharge. Follow-up outcomes will include loss to follow-up, survival status and kernicterus (yes or no) at 2 years. The research will enhance our comprehensive knowledge of jaundice management before admission, risk factors and outcomes of severe hyperbilirubinaemia in China, which will ultimately help to reduce the incidence of neonatal severe hyperbilirubinaemia.Ethics and disseminationOur protocol has been approved by the Medical Ethics Committee of Nanjing Maternity and Child Health Care Hospital. We will present our findings at national conferences and peer-reviewed paediatrics journals.Trial registration numberNCT04251286.

scholarly journals Treatment Duration for Uncomplicated Staphylococcus aureus Bacteremia To Prevent Relapse: Analysis of a Prospective Observational Cohort Study

2012 ◽  
Vol 57 (3) ◽  
pp. 1150-1156 ◽  
Author(s):  
Yong Pil Chong ◽  
Song Mi Moon ◽  
Kyung-Mi Bang ◽  
Hyun Jung Park ◽  
So-Youn Park ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Cohort Study ◽  
Antibiotic Therapy ◽  
Treatment Failure ◽  
Practice Guidelines ◽  
Observational Cohort Study ◽  
Care Hospital ◽  
Prospective Observational Cohort Study ◽  
Short Course ◽  
Observational Cohort

ABSTRACTPractice guidelines recommend at least 14 days of antibiotic therapy for uncomplicatedStaphylococcus aureusbacteremia (SAB). However, these recommendations have not been formally evaluated in clinical studies. To evaluate the duration of therapy for uncomplicated SAB, we analyzed data from our prospective cohort of patients with SAB. A prospective observational cohort study was performed in patients with SAB at a tertiary-care hospital in Korea between August 2008 and September 2010. All adult patients with SAB were prospectively enrolled and observed over a 12-week period. Uncomplicated SAB was defined as follows: negative results of follow-up blood cultures at 2 to 4 days, defervescence within 72 h of therapy, no evidence of metastatic infection, and catheter-related bloodstream infection or primary bacteremia without evidence of endocarditis on echocardiography. Of 483 patients with SAB, 111 met the study criteria for uncomplicated SAB. Fifty-three (47.7%) had methicillin-resistant SAB. When short-course therapy (<14 days) and intermediate-course therapy (≥14 days) were compared, the treatment failure rates (10/38 [26.3%] versus 16/73 [21.9%]) and crude mortality (7/38 [18.4%] versus 16/73 [21.9%]) did not differ significantly between the two groups. However, short-course therapy was significantly associated with relapse (3/38 [7.9%] versus 0/73;P= 0.036). In multivariate analysis, primary bacteremia was associated with a trend toward increased treatment failure (P= 0.06). Therefore, in the treatment of uncomplicated SAB, it seems reasonable to consider at least 14 days of antibiotic therapy to prevent relapse, as practice guidelines recommend. Because of its poor prognosis, primary bacteremia, even with a low risk of complication, should not be treated with short-course therapy.

scholarly journals The Relationship between AKI and CKD in Patients with Type 2 Diabetes: An Observational Cohort Study

2020 ◽  
Vol 32 (1) ◽  
pp. 138-150 ◽  
Author(s):  
Simona Hapca ◽  
Moneeza K. Siddiqui ◽  
Ryan S.Y. Kwan ◽  
Michelle Lim ◽  
Shona Matthew ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cohort Study ◽  
Observational Studies ◽  
Observational Cohort Study ◽  
Patients With Diabetes ◽  
Observational Cohort ◽  
The Relationship ◽  
Egfr Slope

BackgroundThere are few observational studies evaluating the risk of AKI in people with type 2 diabetes, and even fewer simultaneously investigating AKI and CKD in this population. This limits understanding of the interplay between AKI and CKD in people with type 2 diabetes compared with the nondiabetic population.MethodsIn this retrospective, cohort study of participants with or without type 2 diabetes, we used electronic healthcare records to evaluate rates of AKI and various statistical methods to determine their relationship to CKD status and further renal function decline.ResultsWe followed the cohort of 16,700 participants (9417 with type 2 diabetes and 7283 controls without diabetes) for a median of 8.2 years. Those with diabetes were more likely than controls to develop AKI (48.6% versus 17.2%, respectively) and have preexisting CKD or CKD that developed during follow-up (46.3% versus 17.2%, respectively). In the absence of CKD, the AKI rate among people with diabetes was nearly five times that of controls (121.5 versus 24.6 per 1000 person-years). Among participants with CKD, AKI rate in people with diabetes was more than twice that of controls (384.8 versus 180.0 per 1000 person-years after CKD diagnostic date, and 109.3 versus 47.4 per 1000 person-years before CKD onset in those developing CKD after recruitment). Decline in eGFR slope before AKI episodes was steeper in people with diabetes versus controls. After AKI episodes, decline in eGFR slope became steeper in people without diabetes, but not among those with diabetes and preexisting CKD.ConclusionsPatients with diabetes have significantly higher rates of AKI compared with patients without diabetes, and this remains true for individuals with preexisting CKD.

scholarly journals Observational cohort study to investigate the unmet need and time waiting for referral for specialist opinion in adult asthma in England (UNTWIST asthma)

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e031740
Author(s):  
John D Blakey ◽  
Alicia Gayle ◽  
Mariel G Slater ◽  
Gareth H Jones ◽  
Michael Baldwin
Keyword(s):  
Cohort Study ◽  
Waiting Time ◽  
Unmet Need ◽  
Observational Cohort Study ◽  
Clinical Practice Research Datalink ◽  
High Dose ◽  
Specialist Referral ◽  
Number Of Patients ◽  
Observational Cohort

ObjectivesThis study aimed to estimate how many patients with asthma in England met the referral eligibility criteria using national asthma guidelines, identify what proportion were referred and determine the average waiting time to referral.DesignThis is an observational cohort study.Setting/Data sourcesRoutinely collected healthcare data were provided by Clinical Practice Research Datalink records and Hospital Episode Statistics records from January 2007 to December 2015.ParticipantsPatients with asthma aged 18–80 years participated in this study.Main outcome measuresEligibility for referral by the British Thoracic Society/Scottish Intercollegiate Guidelines Network (BTS/SIGN) 2016 guidelines, determined after a 3-month pharmacological therapy exposure assessment, was classed by either ‘high-dose therapies’, ‘continuous or frequent use of oral steroids’ or ‘incident eligibility’ during follow-up (continuous oral corticosteroids for more than 3 months, or ≥800 µg/day inhaled corticosteroids/long-acting β2-agonist (or three controllers) and ≥2 asthma attacks/year).ResultsFrom the final cohort (n=23293), 19837 patients were eligible for specialist referral during follow-up based on the BTS/SIGN guideline recommendations. Among eligible patients without any previously recorded referral, 4% were referred during follow-up, with a median waiting time of 880 days (IQR=1428 days) between eligibility and referral.ConclusionsA large number of patients with asthma were eligible for specialist referral, of which a small proportion were referred, and many experienced a long waiting time before referral. The results indicate a major unmet need in asthma referral, which is a potential source of preventable harm and are likely to have implications regarding how services are organised to address this unmet need.

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