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1Academic Journal
Authors: V. M. Perepukhov, B. Ya. Alekseev, K. M. Nyushko, В. М. Перепухов, Б. Я. Алексеев, К. М. Нюшко
Source: Cancer Urology; Том 20, № 4 (2024); 132-138 ; Онкоурология; Том 20, № 4 (2024); 132-138 ; 1996-1812 ; 1726-9776
Subject Terms: исследования реальной клинической практики, prostate cancer, Radium-223 dichloride, Radium-223, radiopharmaceutical, androgen deprivation therapy, median overall survival, median progression-free survival, real-world clinical practice studies, рак предстательной железы, дихлорид радия-223, Радий-223, радиофармацевтический препарат, андрогенная депривационная терапия, медиана общей выживаемости, медиана выживаемости без прогрессирования
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Relation: https://oncourology.abvpress.ru/oncur/article/view/1903/1576; Шахзадова А.О., Старинский В.В., Лисичникова И.В. Состояние онкологической помощи населению России в 2022 году. Сибирский онкологический журнал 2023;22(5):5–13.; Freedland S.J., Humphreys E.B., Mangold L.A. et al. Risk of prostate cancer-specific mortality following biochemical recurrence after radical prostatectomy. JAMA 2005;294(4):433–9. DOI:10.1001/jama.294.4.433; Kupelian P.A., Buchsbaum J.C., Elshaikh M. et al. Factors affecting recurrence rates after prostatectomy or radiotherapy in localized prostate carcinoma patients with biopsy Gleason score 8 or above. Cancer 2002;95(11):2302–7. DOI:10.1002/cncr.10977; Рак предстательной железы. Клинические рекомендации. Минздрав России, 2021.; Gallaher J., Cook L.M., Gupta S. et al. Improving treatment strategies for patients with metastatic castrate resistant prostate cancer through personalized computational modeling. Clin Exp Metastasis 2014;31:991–9. DOI:10.1007/s10585-014-9674-1; Kirby M., Hirst C., Crawford E.D. Characterising the castration-resistant prostate cancer population: a systematic review. Int J Clin Pract 2011;65(11):1180–92. DOI:10.1111/j.1742-1241.2011.02799.x; Bubendorf L., Schöpfer A., Wagner U. et al. Metastatic patterns of prostate cancer: an autopsy study of 1,589 patients. Hum Pathol 2000;31(5):578–83. DOI:10.1053/hp.2000.6698; Smith M., Parker C., Saad F. et al. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2019;20(3):408–19. DOI:10.1016/S1470-2045(18)30860-X; Parker C., Nilsson S., Heinrich D. et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 2013;369(3):213–23. DOI:10.1056/NEJMoa1213755; Алексеев Б.Я., Томбаль Б., Кельн А.А. Рак предстательной железы в условиях ограниченных возможностей. Онкоурология 2021;17(4):112–4. DOI:10.17650/1726-9776-2021-17-4-112-114; Gillessen S. Presented at: European Society for Medical Oncology Congress; September 13–17, 2024; Barcelona, Spain. Abstract LBA1.; Maughan B.L., Kessel A., McFarland T.R. et al. Radium-223 plus enzalutamide versus enzalutamide in metastatic castration-refractory prostate cancer: final safety and efficacy results. Oncologist 2021;26(12):1006–e2129. DOI:10.1002/onco.13949; Morris M.J., De Wit R., Vogelzang N.J. et al. A phase III trial of docetaxel versus docetaxel and radium-223 (Ra-223) in patients with metastatic castration-resistant prostate cancer (mCRPC): DORA. J Clin Oncol 2021;39:TPS5091.; Bruland Ø.S., Nilsson S., Fisher D.R., Larsen R.H. et al. High-linear energy transfer irradiation targeted to skeletal metastases by the α-emitter 223Ra: adjuvant or alternative to conventional modalities? Clin Cancer Res 2006;12(20):6250s–7s. DOI:10.1158/1078-0432.CCR-06-0841; Kerr C. (223)Ra targets skeletal metastases and spares normal tissue. Lancet Oncol 2002;3(8):453. DOI:10.1016/s1470-2045(02)00835-5; Hyväkkä A., Kääriäinen O.S., Utriainen T. et al. Radium-223 dichloride treatment in metastatic castration-resistant prostate cancer in Finland: A real-world evidence multicenter study. Cancer Med 2023;12(4):4064–76. DOI:10.1002/cam4.5262; Matsumoto T. Effectiveness and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases in real-world practice: a multi-institutional study. Int J Urol 2023;30(2):139–46.; Zhang H. Survival and fracture risk with radium-223 therapy in metastatic castrate-resistant prostate cancer (mCRPC): a real-world analysis. J Clin Oncol 2024;42:50.; Юрмазов З.А., Усынин Е.А., Медведева А.А. и др. Клинический опыт применения радия-223 у больных с костными метастазами при кастрационно-резистентном раке предстательной железы. Онкоурология 2022;18(1):70–6. DOI:10.17650/1726-9776-2022-18-1-70-76.; Van der Doelen M.J., Oving I.M., Wyndaele D.N.J. et al. Health-related quality of life, psychological distress, and fatigue in metastatic castration-resistant prostate cancer patients treated with radium-223 therapy. Prostate Cancer Prostatic Dis 2023;26(1):142–50. DOI:10.1038/s41391-022-00569-8; Кит О.И., Максимова Н.А., Гусарева М.А. и др. Применение внутривенной радионуклидной терапии радия хлоридом [223Ra] у пациентов с костными метастазами кастрационно-резистентного рака предстательной железы. Южно-Российский онкологический журнал 2024;5(4):6–13. DOI:10.37748/2686-9039-2024-5-4-1; Матвеев В.Б., Маркова А.С. Эффективность и безопасность радия-223 в исследованиях реальной клинической практики. Онкоурология 2020;16(4):129–35. DOI:10.17650/1726-9776-2020-16-4-129-135; https://www.pharmjournal.ru/jour/announcement/view/1527; https://prostorpharma.ru/preparaty/rflp-radiya-xlorid-223ra/; https://oncourology.abvpress.ru/oncur/article/view/1903
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2Academic Journal
Authors: M. A. Borzova, А. S. Kolbin
Source: Качественная клиническая практика, Vol 0, Iss 1, Pp 64-69 (2021)
Subject Terms: RS1-441, Pharmacy and materia medica, пострегистрационное клиническое исследование, Medical technology, неинтервенционное клиническое исследование, R855-855.5, 16. Peace & justice, исследования реальной клинической практики
Access URL: https://www.clinvest.ru/jour/article/download/564/576
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https://www.clinvest.ru/jour/article/view/564/576
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3Academic Journal
Authors: T. A. Goldina, A. S. Kolbin, D. Yu. Belousov, V. G. Borovskaya
Source: Качественная клиническая практика, Vol 0, Iss 1, Pp 56-63 (2021)
Subject Terms: пострегистрационные исследования безопасности, 4. Education, исследования сравнительной эффективности исследований, неинтервенционные исследования, исследования реальной клинической практики, 3. Good health, рандомизированные контролируемые исследования, RS1-441, пострегистрационные исследования эффективности, 03 medical and health sciences, Pharmacy and materia medica, 0302 clinical medicine, интервенционные исследования, рутинная медицинская практика, данные реальной клинической практики, Medical technology, R855-855.5, прагматические клинические исследования, 0305 other medical science, доказательства из реальной клинической практики
Access URL: https://www.clinvest.ru/jour/article/download/563/575
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https://www.clinvest.ru/jour/article/view/563
https://www.clinvest.ru/jour/article/download/563/575
https://cyberleninka.ru/article/n/obzor-issledovaniy-realnoy-klinicheskoy-praktiki -
4Academic Journal
Authors: V. V. Sikachev, V. V. Gorin, A. S. Kolbin, D. Yu. Belousov
Source: Качественная клиническая практика, Vol 0, Iss 5, Pp 64-69 (2021)
Subject Terms: RS1-441, 2. Zero hunger, Pharmacy and materia medica, пострегистрационное клиническое исследование, Medical technology, неинтервенционное клиническое исследование, R855-855.5, 16. Peace & justice, исследования реальной клинической практики
Access URL: https://www.clinvest.ru/jour/article/download/552/560
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https://cyberleninka.ru/article/n/pravovye-aspekty-provedeniya-issledovaniy-realnoy-klinicheskoy-praktiki -
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6Academic Journal
Authors: S. Gilyarevsky R., С. Гиляревский Р.
Source: Rational Pharmacotherapy in Cardiology; Vol 17, No 4 (2021); 584-593 ; Рациональная Фармакотерапия в Кардиологии; Vol 17, No 4 (2021); 584-593 ; 2225-3653 ; 1819-6446
Subject Terms: clinical practice studies, big data, pharmacoepidemiological studies, direct oral anticoagulants, исследования реальной клинической практики, «большие данные», фармакоэпидемиологические исследования, прямые пероральные антикоагулянты
File Description: application/pdf
Relation: https://www.rpcardio.com/jour/article/view/2541/2210; U.S. Food and Drug Administration. Framework for FDA’s realworld evidence programa (2018) [cited by Jun 30, 2021. Available from: https://www.fda.gov/media/120060/download.; Berger ML, Doban V. Big data, advanced analytics and the future of comparative effectiveness research. J Comp Eff Res. 2014;3(2):167-76. DOI:10.2217/cer.14.2.; Okada M. Big data and real-world data-based medicine in the management of hypertension. Hypertens Res. 2021;44(2):147-53. DOI:10.1038/s41440-020-00580-3.; Hay SI, George DB, Moyes CL, Brownstein JS. Big data opportunities for global infectious disease surveillance. PLoS Med. 2013;10(4):e1001413. DOI:10.1371/journal.pmed.1001413.; Ola O, Sedig K. The challenge of big data in public health: an opportunity for visual analytics. Online J Public Health Inform. 2014;5(3):223. DOI:10.5210/ojphi.v5i3.4933.; Fanaroff AC, Califf RM, Lopes RD. New Approaches to Conducting Randomized Controlled Trials. J Am Coll Cardiol 2020;75:556-9. DOI:10.1016/j.jacc.2019.11.043.; Murray KW, Duggan A. Understanding Confounding in Research Pediatr Rev. 2010;31(3):124-6. DOI:10.1542/pir.31-3-124.; Meuli L, Dick F. Understanding Confounding in Observational Studies. Eur J Vasc Endovasc Surg. 2018;55(5):737. DOI:10.1016/j.ejvs.2018.02.028.; Fanaroff AC, Califf RM, Windecker S, et al. Levels of Evidence Supporting American College of Cardiology/American Heart Association and European Society of Cardiology Guidelines, 2008-2018. JAMA. 2019;321:1069-80. DOI:10.1001/jama.2019.1122.; Гиляревский С.Р., Гаврилов Д.В., Гусев А.В. Результаты ретроспективного анализа записей электронных амбулаторных медицинских карт пациентов с хронической сердечной недостаточностью: первый российский опыт. Российский Кардиологический Журнал. 2021;26(5):4502. DOI:10.15829/1560-4071-2021-4502.; Althubaiti A. Information bias in health research: definition, pitfalls, and adjustment methods. J Multidiscip Healthc. 2016;9:211-7. DOI:10.2147/JMDH.S104807.; Matsumoto S, Fukui M, Hamaguchi M, et al. Is home blood pressure reporting in patients with type 2 diabetes reliable? Hypertens Res. 2014;37(8):741-5. DOI:10.1038/hr.2014.66.; Schneeweiss S, Rassen JA, Glynn RJ, et al. High-dimensional propensity score adjustment in studies of treatment effects using health care claims data. Epidemiology. 2009;20(4):512-22. DOI:10.1097/EDE.0b013e3181a663cc.; Cox DR, Kartsonaki C, Keogh RH. Big data: Some statistical issues. Stat Probab Lett. 2018;136:1115. DOI:10.1016/j.spl.2018.02.015.; Beaulieu-Jones BK, Finlayson SG, Yuan W, et al. Examining the Use of Real-World Evidence in the Regulatory Process. Clin Pharmacol Ther. 2020;107(4):843-52. DOI:10.1002/cpt.1658.; Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ. 2018;363:k3532. DOI:10.1136/bmj.k3532.; Benchimol EI, Smeeth L, Guttmann A, et al.; RECORD Working Committee. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med. 2015;12(10):e1001885. DOI:10.1371/journal.pmed.1001885.; von Elm E, Altman DG, Egger M, et al.; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007;370(9596):1453-7. DOI:10.1016/S0140-6736(07)61602-X.; Hemkens LG, Benchimol EI, Langan SM, et al. The reporting of studies using routinely collected health data was often insufficient. J Clin Epidemiol. 2016;79:104-11. DOI:10.1016/j.jclinepi.2016.06.005.; Dreyer NA, Schneeweiss S, McNeil BJ, et al.; GRACE Initiative. GRACE principles: recognizing highquality observational studies of comparative effectiveness. Am J Manag Care. 2010;16(6):467-71.; European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Guide on methodological standards in pharmacoepidemiology (2011) [cited by Jun 30, 2021. Available from: www.encepp.eu/standards_and_guidances/methodologicalGuide.shtml.; Blake KV, Devries CS, Arlett P, et al.; for the European Network of Centres for Pharmacoepidemiology Pharmacovigilance. Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Pharmacoepidemiol Drug Saf. 2012;21(7):690-6. DOI:10.1002/pds.3281.; Franklin JM, Schneeweiss S. When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials? Clin Pharmacol Ther. 2017;102(6):924-33. DOI:10.1002/cpt.857.; Schneeweiss S. Improving therapeutic effectiveness and safety through big healthcare data. Clin Pharmacol Ther. 2016;99(3):262-5. DOI:10.1002/cpt.316; Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-World Evidence What Is It and What Can It Tell Us? N Engl J Med. 2016;375(23):2293-7. DOI:10.1056/NEJMsb1609216.; Guimarães PO, Krishnamoorthy A, Kaltenbach LA, et al. Accuracy of Medical Claims for Identifying Cardiovascular and Bleeding Events After Myocardial Infarction: A Secondary Analysis of the TRANSLATE-ACS Study. JAMA Cardiol. 2017;2(7):750-7. DOI:10.1001/jamacardio.2017.1460.; Anglemyer A, Horvath HT, Bero L. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. In: The Cochrane Collaboration, ed. Cochrane Database of Systematic Reviews. Chichester, UK: John Wiley & Sons, Ltd; 2014 [cited by Jun 30, 2021. Available from: http://doi.wiley.com/10.1002/14651858.MR000034.pub2. Accessed May 12, 2016.; Hemkens LG, Contopoulos-Ioannidis DG, Ioannidis JPA. Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey. BMJ. 2016;352:i493. DOI:10.1136/bmj.i493.; Dahabreh IJ, Sheldrick RC, Paulus JK, et al. Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes. Eur Heart J. 2012;33(15):1893-901. DOI:10.1093/eurheartj/ehs114.; Stampfer MJ, Colditz GA, Willett WC, et al. Postmenopausal estrogen therapy and cardiovascular disease. Ten-year follow-up from the nurses' health study. N Engl J Med. 1991;325(11):756-62. DOI:10.1056/NEJM199109123251102.; Rossouw JE, Anderson GL, Prentice RL, et al.; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002;288(3):32133. DOI:10.1001/jama.288.3.321.; Grodstein F, Manson JE, Stampfer MJ. Postmenopausal hormone use and secondary prevention of coronary events in the nurses' health study. a prospective, observational study. Ann Intern Med. 2001;135(1):1-8. DOI:10.7326/0003-4819-135-1-200107030-00003.; Hernán MA, Alonso A, Logan R, et al. Observational studies analyzed like randomized experiments: an application to postmenopausal hormone therapy and coronary heart disease. Epidemiology. 2008;19(6):766-79. DOI:10.1097/EDE.0b013e3181875e61.; Goodman SN, Schneeweiss S, Baiocchi M. Using Design Thinking to Differentiate Useful From Misleading Evidence in Observational Research. JAMA. 2017;317(7):705-7. DOI:10.1001/jama.2016.19970.; Schneeweiss S, Seeger JD, Landon J, Walker AM. Aprotinin during coronary-artery bypass grafting and risk of death. N Engl J Med. 2008;358(8):771-83. DOI:10.1056/NEJMoa0707571.; Fergusson DA, Hébert PC, Mazer CD, et al.; BART Investigators. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med. 2008;358(22):2319-31. DOI:10.1056/NEJMoa0802395.; Agoritsas T, Merglen A, Shah ND, et al. Adjusted Analyses in Studies Addressing Therapy and Harm: Users' Guides to the Medical Literature. JAMA. 2017;317(7):748-59. DOI:10.1001/jama.2016.20029.; ISPOR Membership profile [cited by May 12, 2021. Available from: URL: https://www.ispor.org.; Proietti M, Romanazzi I, Romiti GF, et al. Real-World Use of Apixaban for Stroke Prevention in Atrial Fibrillation: A Systematic Review and Meta-Analysis. Stroke. 2018;49(1):98-106. DOI:10.1161/STROKEAHA.117.018395.; Escobar C, MartÍ-Almor J, Pérez Cabeza A, MartÍnez-Zapata MJ. Direct Oral Anticoagulants Versus Vitamin K Antagonists in Real-life Patients With Atrial Fibrillation. A Systematic Review and Meta-analysis. Rev Esp Cardiol (Engl Ed). 2019;72(4):305-16. DOI:10.1016/j.rec.2018.03.009.; https://www.rpcardio.com/jour/article/view/2541
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7Report
Прямые оральные антикоагулянты при неклапанной фибрилляции предсердий: реальная клиническая практика
Subject Terms: тромбоэмболические осложнения, неклапанная фибрилляция предсердий, апиксабан, nonvalvular atrial fibrillation, apixaban, прямые оральные антикоагулянты, real-life clinical trials, thromboembolic complications, исследования реальной клинической практики, direct oral anticoagulants, 3. Good health
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8Academic Journal
Authors: Беленков Ю.Н., Арутюнов Г.П., Барбараш О.Л., Бондарева И.Б., Виллевальде С.В., Галявич А.С., Гиляревский С.Р., Дупляков Д.В., Козиолова Н.А., Лопатин Ю.М., Мареев Ю.В., Марцевич С.Ю., Панченко Е.П., Фомин И.В., Явелов И.С., Яхонтов Д.А.
Source: Kardiologiia
Subject Terms: Rct, real-life clinical practice study, pseudo-randomization, oral anticoagulants, рки, исследования реальной клинической практики, псевдорандомизация, пероральные антикоагулянты, propensity match score
Availability: https://repository.rudn.ru/records/article/record/79629/