Problems in terminology are typical for any developing area of knowledge including Real World Evidence. In particular, we deal with variability of terms (use of different terms and their meanings for the same definition) and questions of their motivation (use of various motivating factors leading to variability). Moreover, the terms «data», «study» and «Real World Evidence» in Russia are polysemantic and used in different meanings. Indeed, study is both data processing and source of routine practice data in the same time. Analysis of legislative documents of the Eurasian Economic Union (EAEU) shows that today they contain 2 phrases: routine clinical practice (term with certain definition) and real clinical practice (part of other terms without definition). We found similar problems in terminology at the global level analyzing www.clinicaltrials.gov. Understanding the development of terminology is significant regarding development and evaluation of classification of Real World Evidence studies. Real World Evidence was historically formed from pharmacoepidemiology and currently goes beyond this scientific discipline. The term «RWE studies» is complex and systemic. Its use in legislation may lead to conflicts between current legislation regulating a part of RWE study designs and new legislation that will regulate the RWE studies. That is, there may potentially be a situation of double regulation for some RWE designs. Therefore, the issues of classification of RWE studies and the use of this classification in legislation, especially in pharmacovigilance, registration and decision-making in healthcare, are extremely important. In this regard, there are new needs for further development, including the need for classification of RWE studies. Analyzing regulatory documents, guidelines and scientific publications, we formulated criteria to classify any RWE studies from traditional interventional to innovative hybrid researches. This approach makes it possible to indicate various study designs corresponding to RWE studies. Finally, structuring and systematization of knowledge in real world data and RWE studies are necessary for development of clear criteria in decision-making and application of RWE in healthcare.

01 Jan 2022·Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova

What worries people with multiple sclerosis in Russia? Semantic analysis of patient messages using artificial intelligence tools

Article

Author: Efimenko, I V ; Pliskunova, Yu V ; Khoroshevsky, V F ; Boyko, A N ; Paleeva, A G ; Taraskin, O V

OBJECTIVETo study the needs of patients suffering from multiple sclerosis (MS) in Russia.MATERIAL AND METHODSThe technologies of Big Data analysis and intelligent processing of unstructured information (semantic analysis of natural language texts), developed by Semantic Hub were used. Semantic Hub platform scans digital environment to connect to the sources of interest and to collect data of potential interest (i.e. texts generated by patients and their caregivers, in anonymized form). As the next step, each text is analyzed using natural language understanding technologies to build the knowledge base with aggregated data.RESULTSThe semantic analysis of natural language texts made it possible to describe virtual population of Russian patients with MS and their caregivers on the Web: age, gender, regions of residence, movements, key Web resources for getting information and communicating with each other, insights about medical care and the quality of life of patients with MS.CONCLUSIONSIn addition to doctors' recommendations, today the patient can get information from various sources, including other patients with MS. This trend requires attention of medical community: it is necessary to help patients get reliable information about the disease, and methods of therapy. Doctor-to-patient communication on the Web should be widely discussed to develop effective and ethical approaches.

01 Jan 2022·Advances in Dermatology and Allergology

Treating chronic urticaria refractory to H1-antihistamines in Russia: data from the AWARE study

Article

Author: Abdrakhmanov, Azat ; Ukhanova, Olga ; Emelyanov, Alexander ; Meshkova, Raisa ; Litvin, Loliana ; Danilycheva, Inna

IntroductionData on burden and treatment outcomes of chronic spontaneous urticaria (CSU) in Russia are limited. Poor adherence to recommended treatments can lead to suboptimal management of CSU patients.AimTo understand disease burden, treatment algorithms, and outcomes of CSU in the Russian cohort of the AWARE study.Material and methodsAWARE was a global prospective, non-interventional study of chronic urticaria in the real-world setting. Adult patients with H1-antihistamines (H1AH)-refractory CSU for ≥ 2 months were included. Disease characteristics, quality of life (QoL), healthcare resource utilisation (HRU), and pharmacological treatments were observed during the 2-year study period.ResultsOf the 135 patients enrolled from Russia, 121 completed the study. Pre-baseline, ~37% of patients were managed with non-recommended treatments (33% treated with sedative H1AH; 4% with other non-recommended treatments) and 28.2% of patients were not treated for CSU. There was a reduction in the use of sedative H1AH during the study (0.9% of patients treated with sedative H1AHs at Year 2). Decreased disease activity was seen as early as 3 months and continued to improve over 2 years (Urticaria Activity Score over 7 days (UAS7): 20.2 at baseline (n = 124) to 10.1, 7.1, and 3.2 at month 3 (n = 118), 12 (n = 109), and 24 (n = 109), respectively). This corresponded with QoL improvements (dermatology life quality index (DLQI) score: 10.3 at baseline to 5.4, 3.6, and 2.3 at Month 3 (n = 75), 12 (n = 98), and 24 (n = 92), respectively), and reduced angioedema and hives throughout the study.ConclusionsThe burden of CSU in Russia is high, contributing to increased HRU. Guideline-recommended treatments and systematic escalation of therapy to achieve complete symptom control can improve management of patients with CSU.

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