myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-069CVSRRDmyrwd-92Research ArticleНАБЛЮДАТЕЛЬНЫЕ ИССЛЕДОВАНИЯOBSERVATIONAL STUDYМетаданные в медицинеMetadata in medicinehttps://orcid.org/0009-0001-2228-8565ВалееваА. Х-М.ValeevaA. Kh-M.

Валеева Алтынай Хаджи-Муратовна — ординатор кафедры клинической фармакологии и доказательной медицины

Санкт-Петербург

Altynai H.‑M. Valeeva — Resident of the department of Clinical Pharmacology and Evidence-Based Medicine

St. Petersburg

sovoglazka2000@yandex.ruhttps://orcid.org/0000-0001-7704-9900ГомонЮ. М.GomonYu. M.

Гомон Юлия Михайловна — д. м. н., профессор кафедры клинической фармакологии и доказательной медицины

Санкт-Петербург

Yulia M. Gomon — Dr. Sci. (Med.), professor of the department of Clinical Pharmacology and Evidence- Based Medicine

St. Petersburg

gomonmd@yandex.ruhttps://orcid.org/0009-0000-2215-5861БелявскаяН. М.BelyavskayaN. M.

Белявская Надежда Максимовна — врач-терапевт

д. Кальтино, Ленинградская область

Nadezhda M. Belyavskaya — Belyavskaya Nadezhda — local doctor therapist

village of Kaltino, Leningrad Region

belnad08@gmail.comФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова»РоссияFirst St. Petersburg State Medical University named after I. P. PavlovRussian FederationФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова»; СПбГБУЗ «Больница Святого Великомученика Георгия»РоссияFirst St. Petersburg State Medical University named after I. P. Pavlov; Hospital of the Holy Great Martyr GeorgeRussian FederationГБУЗ ЛО «Всеволожская клиническая межрайонная больница» врачебная амбулаторияРоссияVsevolozhsk Clinical Interdistrict Hospital, medical outpatient clinicRussian Federation202525042025515964Copyright © Валеева А.Х., Гомон Ю.М., Белявская Н.М., 20252025Валеева А.Х., Гомон Ю.М., Белявская Н.М.Valeeva A.K., Gomon Y.M., Belyavskaya N.M.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.myrwd.ru/jour/article/view/92

Наблюдательные исследования, имеющие решающее значение для понимания сложных явлений реального мира, часто страдают от плохой обнаруживаемости и воспроизводимости данных. Проект MINERVA (Метаданные для обнаружения данных и воспроизводимости исследований в наблюдательных исследованиях) в Европе был направлен на решение этих проблем путём разработки и внедрения надёжных стандартов и практик метаданных.

Observational study, crucial for understanding complex real-world phenomena, often suffers from poor data detectability and reproducibility. The MINERVA (Metadata for Data Discovery and Research Reproducibility in Observational Studies) project in Europe aimed to address these issues by developing and implementing reliable metadata standards and practices.

метаданные в медицинемедицинские информационные системыMINERVAнаблюдательные исследованияmetadata in medicinemedical information systemsMINERVAobservational studyReferencesГОСТ Р 7.0.10-2010 Набор элементов метаданных «Дублинсĸое ядро»(ISO 15836:2003 Information and documentation – The Dublin Core Metadata Element Set) [GOST R 7.0.10-2010 The Dublin Core Metadata Element Set (ISO 15836:2003 Information and documentation – The Dublin Core Metadata Element Set)Приĸаз Минздрава РФ от 24.12.2018 № 911Н «Об утверждении требований ĸ государственным информационным системам в сфере здравоохранения субъеĸтов Российсĸой Федерации, медицинсĸим информационным системам медицинсĸих организаций и информационным системам фармацевтичесĸих организаций»Order of the Ministry of Health of the Russian Federation dated December 24, 2018 No. 911n "On Approval of Requirements for State Information systems in the field of healthcare of the Subjects of the Russian Federation, medical information systems of medical organizations and information systems of pharmaceutical organizations"Свердлов Ф. Ю. Проблема информатизации лечебно-профилактических учреждений РФ (на примере ЛПУ г. Москвы). Врач и информационные технологии. 2014;4:52-58.Sverdlov F. Yu. The problem of informatization of medical and preventive institutions of the Russian Federation (on the example of a medical and preventive institution in Moscow). Doctor and information technology. 2014;4:52-58. (In Russ.)Good Practice Guide for the use of the Metadata: Catalogue of Real-World Data Sources V 1.0, European Medicines Agency, EMA/787647/2022, September 2022. Доступно по: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/good-practice-guide-use-metadata-catalogue-real-world-data-sources_en.pdf.Good Practice Guide for the use of the Metadata: Catalogue of Real-World Data Sources V 1.0, European Medicines Agency, EMA/787647/2022, September 2022. Доступно по: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/good-practice-guide-use-metadata-catalogue-real-world-data-sources_en.pdf.Gini R, Sturkenboom MCJ, Sultana J, Cave A, Landi A, Pacurariu A, Roberto G, Schink T, Candore G, Slattery J, Trifirò G; Working Group 3 of ENCePP (Inventory of EU data sources and methodological approaches for multisource studies). Different Strategies to Execute Multi-Database Studies for Medicines Surveillance in Real-World Setting: A Reflection on the European Model. Clin Pharmacol Ther. 2020 Aug;108(2):228-235. doi: 10.1002/cpt.1833.Gini R, Sturkenboom MCJ, Sultana J, Cave A, Landi A, Pacurariu A, Roberto G, Schink T, Candore G, Slattery J, Trifirò G; Working Group 3 of ENCePP (Inventory of EU data sources and methodological approaches for multisource studies). Different Strategies to Execute Multi-Database Studies for Medicines Surveillance in Real-World Setting: A Reflection on the European Model. Clin Pharmacol Ther. 2020 Aug;108(2):228-235. doi: 10.1002/cpt.1833.Pajouheshnia R, Gini R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Maciá MA, Schäfer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfélix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pírez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Žerovnik Š, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe. Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871.Pajouheshnia R, Gini R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Maciá MA, Schäfer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfélix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pírez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Žerovnik Š, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe. Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871.Kurz X, Perez-Gutthann S; ENCePP Steering Group. Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):245-252. doi: 10.1002/pds.4381.Kurz X, Perez-Gutthann S; ENCePP Steering Group. Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):245-252. doi: 10.1002/pds.4381.Wilkinson MD, Dumontier M, Aalbersberg IJ, Appleton G, Axton M, Baak A, Blomberg N, Boiten JW, da Silva Santos LB, Bourne PE, Bouwman J, Brookes AJ, Clark T, Crosas M, Dillo I, Dumon O, Edmunds S, Evelo CT, Finkers R, Gonzalez-Beltran A, Gray AJ, Groth P, Goble C, Grethe JS, Heringa J, 't Hoen PA, Hooft R, Kuhn T, Kok R, Kok J, Lusher SJ, Martone ME, Mons A, Packer AL, Persson B, Rocca-Serra P, Roos M, van Schaik R, Sansone SA, Schultes E, Sengstag T, Slater T, Strawn G, Swertz MA, Thompson M, van der Lei J, van Mulligen E, Velterop J, Waagmeester A, Wittenburg P, Wolstencroft K, Zhao J, Mons B. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data. 2016 Mar 15;3:160018. doi: 10.1038/sdata.2016.18. Erratum in: Sci Data. 2019 Mar 19;6(1):6. doi: 10.1038/s41597-019-0009-6.Wilkinson MD, Dumontier M, Aalbersberg IJ, Appleton G, Axton M, Baak A, Blomberg N, Boiten JW, da Silva Santos LB, Bourne PE, Bouwman J, Brookes AJ, Clark T, Crosas M, Dillo I, Dumon O, Edmunds S, Evelo CT, Finkers R, Gonzalez-Beltran A, Gray AJ, Groth P, Goble C, Grethe JS, Heringa J, 't Hoen PA, Hooft R, Kuhn T, Kok R, Kok J, Lusher SJ, Martone ME, Mons A, Packer AL, Persson B, Rocca-Serra P, Roos M, van Schaik R, Sansone SA, Schultes E, Sengstag T, Slater T, Strawn G, Swertz MA, Thompson M, van der Lei J, van Mulligen E, Velterop J, Waagmeester A, Wittenburg P, Wolstencroft K, Zhao J, Mons B. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data. 2016 Mar 15;3:160018. doi: 10.1038/sdata.2016.18. Erratum in: Sci Data. 2019 Mar 19;6(1):6. doi: 10.1038/s41597-019-0009-6.HMA–EMA, “Priority Recommendations of the HMA-EMA Joint big Data Task Force,” HMA EMA Big Data Steering Committee Group. Доступно по: https://www.ema.europa.eu/en/documents/other/priority-recommendations-hma-ema-joint-big-data-task-force_en.pdf.HMA–EMA, “Priority Recommendations of the HMA-EMA Joint big Data Task Force,” HMA EMA Big Data Steering Committee Group. Доступно по: https://www.ema.europa.eu/en/documents/other/priority-recommendations-hma-ema-joint-big-data-task-force_en.pdf.HMA/EMA joint Big Data Steering Group. Big Data Workplan 2023-2025. Доступно по: https://www.ema.europa.eu/en/documents/work-programme/workplan-2023-2025-hma-ema-joint-big-data-steering-group_en.pdf.HMA/EMA joint Big Data Steering Group. Big Data Workplan 2023-2025. Доступно по: https://www.ema.europa.eu/en/documents/work-programme/workplan-2023-2025-hma-ema-joint-big-data-steering-group_en.pdf.Pajouheshnia R, Gini R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Maciá MA, Schäfer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfélix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pírez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Žerovnik Š, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe. Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871.Pajouheshnia R, Gini R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Maciá MA, Schäfer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfélix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pírez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Žerovnik Š, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe. Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871.European Medicines Agency. Good Practice Guide for the Use of the Metadata Catalogue of Real-World Data Sources V 1.0. Доступно по: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/good-practice-guide-use-metadata-catalogue-real-world-data-sources_en.pdf.European Medicines Agency. Good Practice Guide for the Use of the Metadata Catalogue of Real-World Data Sources V 1.0. Доступно по: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/good-practice-guide-use-metadata-catalogue-real-world-data-sources_en.pdf.Swertz MA, Dijkstra M, Adamusiak T, van der Velde JK, Kanterakis A, Roos ET, Lops J, Thorisson GA, Arends D, Byelas G, Muilu J, Brookes AJ, de Brock EO, Jansen RC, Parkinson H. The MOLGENIS toolkit: rapid prototyping of biosoftware at the push of a button. BMC Bioinformatics. 2010 Dec 21;11 Suppl 12(Suppl 12):S12. doi: 10.1186/1471-2105-11-S12-S12.Swertz MA, Dijkstra M, Adamusiak T, van der Velde JK, Kanterakis A, Roos ET, Lops J, Thorisson GA, Arends D, Byelas G, Muilu J, Brookes AJ, de Brock EO, Jansen RC, Parkinson H. The MOLGENIS toolkit: rapid prototyping of biosoftware at the push of a button. BMC Bioinformatics. 2010 Dec 21;11 Suppl 12(Suppl 12):S12. doi: 10.1186/1471-2105-11-S12-S12.European Medicines Agency. “RWD Catalogues: Support. FAQ No. 57”. Режим доступа: https://catalogues.ema.europa.eu/support.European Medicines Agency. “RWD Catalogues: Support. FAQ No. 57”. Режим доступа: https://catalogues.ema.europa.eu/support.Gini R, Pajouheshnia R, Gardarsdottir H, Bennett D, Li L, Gulea C, Wientzek-Fleischmann A, Bazelier MT, Burcu M, Dodd C, Durán CE, Kaplan S, Lanes S, Marinier K, Roberto G, Soman K, Zhou X, Platt R, Setoguchi S, Hall GC. Describing diversity of real world data sources in pharmacoepidemiologic studies: The DIVERSE scoping review. Pharmacoepidemiol Drug Saf. 2024 May;33(5):e5787. doi: 10.1002/pds.5787.Gini R, Pajouheshnia R, Gardarsdottir H, Bennett D, Li L, Gulea C, Wientzek-Fleischmann A, Bazelier MT, Burcu M, Dodd C, Durán CE, Kaplan S, Lanes S, Marinier K, Roberto G, Soman K, Zhou X, Platt R, Setoguchi S, Hall GC. Describing diversity of real world data sources in pharmacoepidemiologic studies: The DIVERSE scoping review. Pharmacoepidemiol Drug Saf. 2024 May;33(5):e5787. doi: 10.1002/pds.5787.Pajouheshnia R, Gini R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Maciá MA, Schäfer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfélix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pírez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Žerovnik Š, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe. Pharmaco-epidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871.Pajouheshnia R, Gini R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Maciá MA, Schäfer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfélix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pírez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Žerovnik Š, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe. Pharmaco-epidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871.Swertz M, van Enckevort E, Oliveira JL, Fortier I, Bergeron J, Thurin NH, Hyde E, Kellmann A, Pahoueshnja R, Sturkenboom M, Cunnington M, Nybo Andersen AM, Marcon Y, Gonçalves G, Gini R. Towards an Interoperable Ecosystem of Research Cohort and Real-world Data Catalogues Enabling Multi-center Studies. Yearb Med Inform. 2022 Aug;31(1):262-272. doi: 10.1055/s-0042-1742522.Swertz M, van Enckevort E, Oliveira JL, Fortier I, Bergeron J, Thurin NH, Hyde E, Kellmann A, Pahoueshnja R, Sturkenboom M, Cunnington M, Nybo Andersen AM, Marcon Y, Gonçalves G, Gini R. Towards an Interoperable Ecosystem of Research Cohort and Real-world Data Catalogues Enabling Multi-center Studies. Yearb Med Inform. 2022 Aug;31(1):262-272. doi: 10.1055/s-0042-1742522.

The authors declare that there are no conflicts of interest present.