scholarly journals The side effect profile of Clozapine in real world data of three large mental health hospitals

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0243437
Author(s):  
Ehtesham Iqbal ◽  
Risha Govind ◽  
Alvin Romero ◽  
Olubanke Dzahini ◽  
Matthew Broadbent ◽  
...  
Keyword(s):  
Mental Health ◽  
Side Effects ◽  
Adverse Effects ◽  
Hospital Admission ◽  
Real World ◽  
Smoking Status ◽  
Monthly Interval ◽  
Real World Data ◽  
Significance Level ◽  
The Real

Objective Mining the data contained within Electronic Health Records (EHRs) can potentially generate a greater understanding of medication effects in the real world, complementing what we know from Randomised control trials (RCTs). We Propose a text mining approach to detect adverse events and medication episodes from the clinical text to enhance our understanding of adverse effects related to Clozapine, the most effective antipsychotic drug for the management of treatment-resistant schizophrenia, but underutilised due to concerns over its side effects. Material and methods We used data from de-identified EHRs of three mental health trusts in the UK (>50 million documents, over 500,000 patients, 2835 of which were prescribed Clozapine). We explored the prevalence of 33 adverse effects by age, gender, ethnicity, smoking status and admission type three months before and after the patients started Clozapine treatment. Where possible, we compared the prevalence of adverse effects with those reported in the Side Effects Resource (SIDER). Results Sedation, fatigue, agitation, dizziness, hypersalivation, weight gain, tachycardia, headache, constipation and confusion were amongst the highest recorded Clozapine adverse effect in the three months following the start of treatment. Higher percentages of all adverse effects were found in the first month of Clozapine therapy. Using a significance level of (p< 0.05) our chi-square tests show a significant association between most of the ADRs and smoking status and hospital admission, and some in gender, ethnicity and age groups in all trusts hospitals. Later we combined the data from the three trusts hospitals to estimate the average effect of ADRs in each monthly interval. In gender and ethnicity, the results show significant association in 7 out of 33 ADRs, smoking status shows significant association in 21 out of 33 ADRs and hospital admission shows the significant association in 30 out of 33 ADRs. Conclusion A better understanding of how drugs work in the real world can complement clinical trials.

scholarly journals Parameter Optimization for Real-World ENSO Forecast in an Intermediate Coupled Model

2019 ◽  
Vol 147 (5) ◽  
pp. 1429-1445 ◽  
Author(s):  
Yuchu Zhao ◽  
Zhengyu Liu ◽  
Fei Zheng ◽  
Yishuai Jin
Keyword(s):  
Data Assimilation ◽  
Parameter Optimization ◽  
Real World ◽  
Climate Models ◽  
Coupled Model ◽  
Prediction Skill ◽  
Model Parameters ◽  
Real World Data ◽  
The Real ◽  
Advection Term

Abstract We performed parameter estimation in the Zebiak–Cane model for the real-world scenario using the approach of ensemble Kalman filter (EnKF) data assimilation and the observational data of sea surface temperature and wind stress analyses. With real-world data assimilation in the coupled model, our study shows that model parameters converge toward stable values. Furthermore, the new parameters improve the real-world ENSO prediction skill, with the skill improved most by the parameter of the highest climate sensitivity (gam2), which controls the strength of anomalous upwelling advection term in the SST equation. The improved prediction skill is found to be contributed mainly by the improvement in the model dynamics, and second by the improvement in the initial field. Finally, geographic-dependent parameter optimization further improves the prediction skill across all the regions. Our study suggests that parameter optimization using ensemble data assimilation may provide an effective strategy to improve climate models and their real-world climate predictions in the future.

scholarly journals Trastuzumab-based palliative chemotherapy for HER2-positive gastric cancer: a single-center real-world data

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tae-Hwan Kim ◽  
Hun Do Cho ◽  
Yong Won Choi ◽  
Hyun Woo Lee ◽  
Seok Yun Kang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Real World ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Conversion Surgery ◽  
Single Center ◽  
Her2 Positive ◽  
Real World Data ◽  
World Data ◽  
The Real

Abstract Background Since the results of the ToGA trial were published, trastuzumab-based chemotherapy has been used as the standard first-line treatment for HER2-positive recurrent or primary metastatic gastric cancer (RPMGC). However, the real-world data has been rarely reported. Therefore, we investigated the outcomes of trastuzumab-based chemotherapy in a single center. Methods This study analyzed the real-world data of 47 patients with HER2-positive RPMGC treated with trastuzumab-based chemotherapy in a single institution. Results With the median follow-up duration of 18.8 months in survivors, the median overall survival (OS) and progression-free survival were 12.8 and 6.9 months, respectively, and the overall response rate was 64%. Eastern Cooperative Oncology Group performance status 2 and massive amount of ascites were independent poor prognostic factors for OS, while surgical resection before or after chemotherapy was associated with favorable OS, in multivariate analysis. In addition, 5 patients who underwent conversion surgery after chemotherapy demonstrated an encouraging median OS of 30.8 months, all with R0 resection. Conclusions Trastuzumab-based chemotherapy in patients with HER2-positive RPMGC in the real world demonstrated outcomes almost comparable to those of the ToGA trial. Moreover, conversion surgery can be actively considered in fit patients with a favorable response after trastuzumab-based chemotherapy.

scholarly journals Reasoning with linguistic preferences using NPN logic

2010 ◽  
Vol 7 (3) ◽  
pp. 511-528 ◽  
Author(s):  
Goran Devedzic ◽  
Danijela Milosevic ◽  
Lozica Ivanovic ◽  
Dragan Adamovic ◽  
Miodrag Manic
Keyword(s):  
Side Effects ◽  
Decision Analysis ◽  
Decision Maker ◽  
Real World ◽  
Cognitive Maps ◽  
Fuzzy Cognitive Maps ◽  
Basic Notion ◽  
The Real ◽  
Alternative Framework ◽  
Linguistic Models

Negative-positive-neutral logic provides an alternative framework for fuzzy cognitive maps development and decision analysis. This paper reviews basic notion of NPN logic and NPN relations and proposes adaptive approach to causality weights assessment. It employs linguistic models of causality weights activated by measurement-based fuzzy cognitive maps? concepts values. These models allow for quasi-dynamical adaptation to the change of concepts values, providing deeper understanding of possible side effects. Since in the real-world environments almost every decision has its consequences, presenting very valuable portion of information upon which we also make our decisions, the knowledge about the side effects enables more reliable decision analysis and directs actions of decision maker.

Surgery for metastases for esophageal-gastric cancer in the real world: Data from the AGAMENON national registry

2018 ◽  
Vol 44 (8) ◽  
pp. 1191-1198 ◽  
Author(s):  
Alberto Carmona-Bayonas ◽  
Paula Jiménez-Fonseca ◽  
Isabel Echavarria ◽  
Manuel Sánchez Cánovas ◽  
Gema Aguado ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Real World ◽  
National Registry ◽  
Real World Data ◽  
World Data ◽  
The Real

scholarly journals P232 Effectiveness of adalimumab biosimilar switching: real world data from a London rheumatology centre

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Shivanee Vigneswaran ◽  
Megan Galloway ◽  
Samuel Hanlon ◽  
Aoife Tynan ◽  
Animesh Singh
Keyword(s):  
Side Effects ◽  
Disease Activity ◽  
Real World ◽  
Biologic Therapy ◽  
Underlying Disease ◽  
Real World Data ◽  
Biologic Drugs ◽  
Control Activity ◽  
World Data ◽  
Long Term Treatment

Abstract Background Biologic drugs have revolutionised the management of many rheumatological diseases with remission or low disease activity now the realistic targets for treatment. However, given the chronic nature of most rheumatological disease and the need for long term treatment, there has been a significant increase in the cost associated with disease treatment. The advent of biosimilars offers an attractive target in reducing drug costs for payers. Biosimilar medications are thought to be equally efficacious as originator drugs. Real world data in adalimumab biosimilar switching is limited. In this audit we aim to examine the real-world outcomes from switching from originator Humira to biosimilar Amgevita in a London teaching hospital. Methods A list of all adult rheumatology patients on Amgevita was obtained through pharmacy records. All patients had been switched from Humira to Amgevita from February 2019. Using clinic letters and an in-house biologics database, data was collected on the underlying disease and the date of switch. Outcomes reviewed were disease activity scores pre and post switch, documented side effects and flare of disease activity following switch including decision to revert to originator Humira or change treatment. Results There was a total of 289 adult patients on Humira who switched to Amgevita. Of these patients, 28 in total discontinued treatment - 13 with rheumatoid arthritis, 10 with psoriatic arthritis and 5 with ankylosing spondylitis. 22 had to be switched back to Humira, with a further 4 patients approved to switchback and awaiting to restart. Two additional patients were switched to alternative biologic therapy due to inefficacy. A further 3 patients refused to switch onto Amgevita. Sixteen patients had documented flares, with one requiring admission and ten requiring local or systemic corticosteroid therapy to control activity. Seven patients had documented side effects which included chest pain, headache, rash and site reactions and one patient developed shingles post switch. Conclusion A total of 9.6% of patients switched to Amgevita had disease flare or side effects resulting in a switchback to Humira or alternative biologic therapy. For a biosimilar to be approved, efficacy and safety profiles needs to be comparable to the originator biological therapy and usually looks at two treatment naïve groups, rather than direct switch. Thereby, data on switches in therapy is limited. One systematic review looking at 11,053 patients with inflammatory arthritis treated with Etanercept and switched to Benepali, found 768 reverting to original therapy giving a lower total of 6.9%. We find that although no previous data of Amgevita, our figure of 9.6% appears high in the context of previously controlled inflammatory disease with Humira. Disclosures S. Vigneswaran None. M. Galloway None. S. Hanlon None. A. Tynan None. A. Singh None.

scholarly journals Validity of social media for assessing treatment patterns in oncology patients: a case study in melanoma

JAMIA Open ◽  
2019 ◽  
Vol 2 (4) ◽  
pp. 416-422
Author(s):  
Laura McDonald ◽  
Varun Behl ◽  
Vijayarakhavan Sundar ◽  
Faisal Mehmud ◽  
Bill Malcolm ◽  
...  
Keyword(s):  
Social Media ◽  
Confidence Intervals ◽  
Real World ◽  
Unmet Need ◽  
Data Access ◽  
Treatment Patterns ◽  
Patient Treatment ◽  
Real World Data ◽  
The Real ◽  
Third Line

Abstract There is a need to understand how patients are managed in the real world to better understand disease burden and unmet need. Traditional approaches to gather these data include the use of electronic medical record (EMR) or claims databases; however, in many cases data access policies prevent rapid insight gathering. Social media may provide a potential source of real-world data to assess treatment patterns, but the limitations and biases of doing so have not yet been evaluated. Here, we assessed whether patient treatment patterns extracted from publicly available patient forums compare to results from more traditional EMR and claims databases. We observed that the 95% confidence intervals of proportions of treatments received at first, second, and third line for advanced/metastatic melanoma generated from unstructured social media data overlapped with 95% confidence intervals from proportions obtained from 1 or more traditional EMR/Claims databases. Social media may offer a valid data option to understand treatment patterns in the real world.

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