scholarly journals Principles for the use of large-scale medical databases to generate real-world evidence

2020 ◽  
Vol 2 (1) ◽  
pp. 27-32
Author(s):  
Hiraku Kumamaru ◽  
Shingo Fukuma ◽  
Hiroki Matsui ◽  
Ryo Kawasaki ◽  
Hironobu Tokumasu ◽  
...  
Keyword(s):  
Real World ◽  
Large Scale ◽  
Medical Databases ◽  
Real World Evidence

scholarly journals Monoclonal Antibodies Targeting CGRP: From Clinical Studies to Real-World Evidence—What Do We Know So Far?

2021 ◽  
Vol 14 (7) ◽  
pp. 700
Author(s):  
Theodoros Mavridis ◽  
Christina I. Deligianni ◽  
Georgios Karagiorgis ◽  
Ariadne Daponte ◽  
Marianthi Breza ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Real World ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Clinical Investigation ◽  
Phase Iii ◽  
Real World Evidence ◽  
Symptomatic Management ◽  
Repurposed Drugs ◽  
Cephalic Pain

Now more than ever is the time of monoclonal antibody use in neurology. In headaches, disease-specific and mechanism-based treatments existed only for symptomatic management of migraines (i.e., triptans), while the standard prophylactic anti-migraine treatments consist of non-specific and repurposed drugs that share limited safety profiles and high risk for interactions with other medications, resulting in rundown adherence rates. Recent advances in headache science have increased our understanding of the role of calcitonin gene relate peptide (CGRP) and pituitary adenylate cyclase-activating polypeptide (PACAP) pathways in cephalic pain neurotransmission and peripheral or central sensitization, leading to the development of monoclonal antibodies (mAbs) or small molecules targeting these neuropeptides or their receptors. Large scale randomized clinical trials confirmed that inhibition of the CGRP system attenuates migraine, while the PACAP mediated nociception is still under scientific and clinical investigation. In this review, we provide the latest clinical evidence for the use of anti-CGRP in migraine prevention with emphasis on efficacy and safety outcomes from Phase III and real-world studies.

scholarly journals SHARP: Enabling generation of real-world evidence on a pan-European scale to improve the lives of individuals with severe asthma

2021 ◽  
pp. 00064-2021
Author(s):  
Job J.M.H. van Bragt ◽  
Susanne Hansen ◽  
Ratko Djukanovic ◽  
Elisabeth H.D. Bel ◽  
Anneke ten Brinke ◽  
...  
Keyword(s):  
Severe Asthma ◽  
Real World ◽  
Large Scale ◽  
Research Collaboration ◽  
Meta Analysis ◽  
National Registry ◽  
Patient Data ◽  
Local Analysis ◽  
Common Data Model ◽  
Real World Evidence

IntroductionReal world evidence is important to help unravel unanswered problems in severe asthma and is valuable to better understand the patient experience and common clinical practice.AimThe Severe Heterogeneous Asthma Registry, Patient-centred (SHARP) Clinical Research Collaboration (CRC) is created as a network of national registries and severe asthma centres that work together to perform registry based real world research and clinical studies on a pan-European scale.The CRCSuch collaboration requires a new, innovative design to overcome the many issues that arise with large-scale data collection across national borders. SHARP has developed a platform that offers a federated analysis approach where national registry data are transformed and integrated into a common data model (CDM). The CDM then allows a local analysis of de-identified patient data and subsequent aggregate (meta-)analysis. To facilitate an easily accessible way to set up new registries, SHARP enables new registries to take part in a central database, based on already proven technology. Next to being economical, this linkage ensures data from different SHARP central members to be comparable.The FutureTechnological advancements lead to an ever-expanding rate of patient data that will be collected; with the collective effort of the pan-European severe asthma research community SHARP hopes to ensure that they are well equipped to enter a new era of medical research, with the ultimate goal to positively impact the lives of patients with severe asthma.

scholarly journals Association Rule Analysis for Validating Interrelationships of Combined Medication of Compound Kushen Injection in Treating Colon Carcinoma: A Hospital Information System-Based Real-World Study

2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Huisheng Yang ◽  
Yanming Xie ◽  
Jisheng Ni ◽  
Yue Liu ◽  
Rui Song ◽  
...  
Keyword(s):  
Information System ◽  
Colon Carcinoma ◽  
Real World ◽  
Association Rule ◽  
Hospital Information System ◽  
Large Scale ◽  
Treatment Guidelines ◽  
Real World Evidence ◽  
Combined Medication ◽  
Compound Kushen Injection

Background. Real world evidence is important for informing healthcare practice and developing medical products and has gained broad interest in healthcare. Compound Kushen Injection (CKI) has been widely applied into treatment of colon carcinoma (CC) in China. Postapproval drug assessment related retrospective studies using electrical medical record (EMR) collected from hospital information system (HIS) is one of the most important categories of real-world study (RWS). Based on HIS EMR, interrelationships of combined medication of CKI in treating CC can be validated in real world settings. Methods. This study was conducted based on a large-scale integrated database of EMR derived from HIS. EMR of 3328 patients initially diagnosed with CC among 49,597 patients treated with CKI were included in the study. Descriptive statistical analyses and apriori algorithm based association rule analyses were performed, respectively, to validate frequency distribution and interrelationships of combined medication of CKI in treating CC. Results. The pharmacological mechanisms of TCMs that have been commonly used in conjunction with CKI include heat-clearing and detoxifying, qi-reinforcing, blood circulation-promoting and stasis-removing, blood-stanching, and qi-regulating. For modern medicines, antibiotics, antineoplastic chemotherapeutic drugs, immunomodulator, 5-HT receptor antagonist drugs, and corticosteroids are most often combined with CKI. The association rules of medication combinations of CKI in treating CC in real world manifest certain laws for both TCMs and modern medicines. They are generally in line with CC treatment guidelines. Conclusions. It is a common practice for CKI to be integrated with both modern medicines and TCMs when treating CC in China. The associations of medication combinations of CKI in treating CC manifest certain laws for both TCMs and modern medicines. The RWS for validating interrelationships of combined medication may provide evidence for rational use of CKI. Further explorations are needed to verify and expand the conclusions.

1243-P: Novel Use of Natural Language Processing to Identify Reasons for Insulin Discontinuation in Patients with T2DM: A Real-World Evidence Study

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1243-P
Author(s):  
JIANMIN WU ◽  
FRITHA J. MORRISON ◽  
ZHENXIANG ZHAO ◽  
XUANYAO HE ◽  
MARIA SHUBINA ◽  
...  
Keyword(s):  
Natural Language Processing ◽  
Natural Language ◽  
Language Processing ◽  
Real World ◽  
Real World Evidence

381-P: Real-World Evidence that Impaired Awareness of Hypoglycemia Increases Severe Hypoglycemia Rates in T2DM (InHypo-DM Study)

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 381-P
Author(s):  
ALEXANDRIA RATZKI-LEEWING ◽  
STEWART B. HARRIS ◽  
NATALIE H. AU ◽  
SUSAN WEBSTER-BOGAERT ◽  
JUDITH B. BROWN ◽  
...  
Keyword(s):  
Real World ◽  
Severe Hypoglycemia ◽  
Real World Evidence ◽  
Impaired Awareness

1607-P: Real-World Evidence of the Impact of Obesity on Residual Teeth in the Japanese Population

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 1607-P
Author(s):  
MAYU HAYASHI ◽  
KATSUTARO MORINO ◽  
KAYO HARADA ◽  
MIKI ISHIKAWA ◽  
ITSUKO MIYAZAWA ◽  
...  
Keyword(s):  
Real World ◽  
Japanese Population ◽  
Real World Evidence ◽  
The Impact
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