zdmeЗдоровье мегаполисаCity Healthcare2713-2617ГБУ «НИИОЗММ ДЗМ»10.47619/2713-2617.zm.2020.v1i1;96-107zdme-235Research ArticleОБЗОРЫREVIEWSРеформирование организационно-правовой составляющей системы донорства и трансплантации США с целью повышения ее эффективностиReforming the organizational and legal component of the United States of America donation and transplantation system to increase its effectivenesshttps://orcid.org/0000-0001-9019-9567ПинчукА. В.PinchukA. V.

Пинчук Алексей Валерьевич, д-р мед. наук, заведующий научным отделением трансплантации почки и поджелудочной железы.

 

Alexey V. Pinchuk, PhD, Head of the Scientific Department of Kidney and Pancreas Transplantation; Associate Professor of the Department of Transplantology and Artificial Organs; Head of the Organizational and Methodological Department for Transplantology

3, Bolshaya Sukharevskaya Sq., 129090, Мoscow;

9, Sharikopodshipnikovskaya str., 115088, Moscow;

20/1 Delegatskaya Str., 127473, Moscow.

PinchukAV@sklif.mos.ruhttps://orcid.org/0000-0001-9000-7078МухаметоваМ. С.MukhametovaM. S.

Мухаметова Мария Сергеевна, канд. экон. наук, руководитель отдела логистики

123100, Москва, Пресненская наб., д. 12.

 

Maria S. Mukhametova, candidate of economic sciences, Head of Logistics Department

12, Presnenskaya Naberezhnaya str., 123100, Moscow

Научно-исследовательский институт скорой помощи им. Н.В. Склифосовского Департамента здравоохранения города МосквыN. V. Sclifosovsky Research Institute of Emergency Medicine; Scientific Research Institute of Health Organization and Medical Management; Moscow State University of Medicine and DentistryООО «Гловис Рус»GLOVIS RUS LLC2020030320201196107Copyright © Пинчук А.В., Мухаметова М.С., 20202020Пинчук А.В., Мухаметова М.С.Pinchuk A.V., Mukhametova M.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.city-healthcare.com/jour/article/view/235

Обоснование. Востребованность трансплантаций ведет к росту спроса на донорские органы и, как следствие, к их дефициту во всем мире. США – один из мировых лидеров количеству доноров и трансплантаций органов. В статье представлены результаты анализа, ориентированного на поиск путей повышения эффективности деятельности американской системы донорства и трансплантации. Цель исследования – анализ организационно-правовой составляющей системы донорства и трансплантации органов в США и выявление возможных путей ее реформирования. Материалы и методы. В ходе исследования проводится информационно-логический анализ и оценка эффективности системы донорства и трансплантации США на основе имеющихся данных официальной статистики за период с 1991 по 2019 г., результатов симуляции применения презумпции согласия на посмертное донорство, нормативно-правовых актов, страховых программ и научных исследований зарубежных и российских ученых в области трансплантологии. Результаты. Сопоставление статистических данных показало, что, несмотря на значительные успехи США в развитии донорства и трансплантации, в стране, как и во всем мире, наблюдается растущая нехватка донорских органов. По результатам анализа определены перспективные направления реформирования системы донорства и трансплантации с целью повышения ее эффективности. Большим потенциалом для увеличения предложения донорских органов обладает возможный переход США от модели испрошенного согласия к презумпции согласия на посмертное донорство. В организационной модели донорства и трансплантации страны наименьшую эффективность имеет деятельность центров заготовки донорских органов, которым при этом отведена очень важная роль. Требует внимания финансовая уязвимость живых доноров и реципиентов донорских органов, т. к. очень часто применяемые страховые программы не покрывают их расходы, в т. ч. на иммуносупрессивные лекарства, по причине разрыва между стандартами медицинской помощи реципиентам донорских органов и политикой страховых компаний. Осуществляемые меры поддержки живого донорства явно недостаточны. Заключение. Определенные в ходе исследования направления реформирования системы донорства и трансплантации США требуют дальнейшей проработки и обсуждения в американском обществе, приятия новых нормативно-правовых актов, разработки новых правил работы участников системы, корректировки порядка оценки, финансирования и поддержки на государственном и международном уровне. Только комплекс организационно-правых, финансовых, стимулирующих мер будет способствовать увеличению числа донорских органов и количеству трансплантаций.

Background. The demand for transplants leads to an increase in the demand for donor organs and as the result to their shortage all over the world. The United States is one of the world leaders in the number of donors and organ transplants. The article presents the results of an analysis focused on finding ways to improve the efficiency of the American donation and transplantation system. Purpose. The aim of the study is to analyze the organizational and legal components of the United States organ donation and transplantation system and identify possible ways to reform it. Materials and methods. The study carries out informational analysis and assessment of the effectiveness of the US donation and transplantation system based on the available official statistics for the period from 1991 to 2019, the results of the simulation of the application of the presumption of consent to posthumous donation, regulatory legal acts, insurance programs and scientific research of foreign and Russian scientists in the transplantation field. Results. A statistical data comparison showed that, despite the significant success of the United States in the development of donation and transplantation, there is a growing shortage of donor organs in the country, as in the whole world. The results of the analysis identified promising directions for reforming the donation and transplantation system in order to increase its effectiveness. There is great potential for increasing the supply of donor organs by the possible transition of the United States from the model of requested consent to the presumption of consent for posthumous donation. Centers for the procurement of donor organs have the least efficiency in the US organizational model of donation and transplantation. The financial vulnerability of living donors and organ donor recipients requires attention, because insurance programs do not cover their expenses, incl. on immunosuppressive drugs, due to the gap between the standards of care for organ donor recipients and the policies of insurance companies. The ongoing support measures for living donation are clearly insufficient. Conclusion. The directions of the US donation and transplantation system reforming identified in the course of the study require further elaboration and discussion in American society, the adoption of new regulatory legal acts, the development of new rules for the work of the system participants, adjustments to the assessment procedure, funding and support at the state and international level. Only a set of organizational, legal, financial and stimulating measures will help to increase the number of donor organs and the number of transplants.

донорство органовтрансплантацияСШАЦентры заготовки донорских органов (OPO)Medicareиммуносупрессивные препаратыстраховое покрытиеorgan donationtransplantationUSAOrgan Procurement Centers (OPO)Medicareimmunosuppressive drugsinsurance coverageReferencesAxelrod D.A., Schnitzler M.A., Xiao H., Irish W., Tuttle Newhall E., Chang S. H., Kasiske B.L., Alhamad T., Lentine K.L. An economic assessment of contemporary kidney transplant practice// American Journal of Translplantation. 2018. Vol. 18. Iss. 5. P. 1168-1176. Available at: https://doi.org/10.1111/ajt.14702 [Accessed July 3, 2020].Axelrod D.A., Schnitzler M.A., Xiao H., Irish W., Tuttle Newhall E., Chang S. H., Kasiske B.L., Alhamad T., Lentine K.L. An economic assessment of contemporary kidney transplant practice// American Journal of Translplantation. 2018. Vol. 18. Iss. 5. P. 1168-1176. Available at: https://doi.org/10.1111/ajt.14702 [Accessed July 3, 2020].Global observatory on donation and transplantation. Charts. Available at: http://www.transplantobservatory.org/data-charts-andtables/chart/ [Accessed July 3, 2020].Global observatory on donation and transplantation. Charts. Available at: http://www.transplantobservatory.org/data-charts-andtables/chart/ [Accessed July 3, 2020].Global observatory on donation and transplantation. Statistics by country and year. Available at: http://www.transplant-observatory. org/summary/ [Accessed July 3, 2020].Global observatory on donation and transplantation. Statistics by country and year. Available at: http://www.transplant-observatory. org/summary/ [Accessed July 3, 2020].International registry in organ donation and transplantation. USA 2019 statistics. Available at: https://www.irodat.org/p=database&c=US&year=2019#data [Accessed July 3, 2020].International registry in organ donation and transplantation. USA 2019 statistics. Available at: https://www.irodat.org/p=database&c=US&year=2019#data [Accessed July 3, 2020].International registry in organ donation and transplantation. USA 2000 statistics. Available at: https://www.irodat.org/p=database&c=US&year=2000#data [Accessed July 3, 2020].International registry in organ donation and transplantation. USA 2000 statistics. Available at: https://www.irodat.org/p=database&c=US&year=2000#data [Accessed July 3, 2020].International registry in organ donation and transplantation. 2019 Donation activity charts. Available at: https://www.irodat.org/?p=database#data [Accessed July 3, 2020].International registry in organ donation and transplantation. 2019 Donation activity charts. Available at: https://www.irodat.org/?p=database#data [Accessed July 3, 2020].1991-2019 USA Organ Donation and Transplantation Statistics: Graph Data. U.S. Government Information on Organ Donation and Transplantation. Available at: https://www.organdonor.gov/statistics-stories/statistics/data. html [Accessed July 3, 2020].1991-2019 USA Organ Donation and Transplantation Statistics: Graph Data. U.S. Government Information on Organ Donation and Transplantation. Available at: https://www.organdonor.gov/statistics-stories/statistics/data. html [Accessed July 3, 2020].Verheijde J.L., Rady M.Y., McGregor J.L. The United States Revised Uniform Anatomical Gift Act (2006): New challenges to balancing patient rights and physician responsibilities//Philos Ethics Humanit Med. 2007; 2: 19. Available at: doi: 10.1186/1747-5341-2-19 [Accessed July 3, 2020].Verheijde J.L., Rady M.Y., McGregor J.L. The United States Revised Uniform Anatomical Gift Act (2006): New challenges to balancing patient rights and physician responsibilities//Philos Ethics Humanit Med. 2007; 2: 19. Available at: doi: 10.1186/1747-5341-2-19 [Accessed July 3, 2020].Organ Donation FAQs. U.S. Government Information on Organ Donation and Transplantation. Available at: https://www.organdonor.gov/about/factsterms/donation-faqs.html [Accessed July 3, 2020].Organ Donation FAQs. U.S. Government Information on Organ Donation and Transplantation. Available at: https://www.organdonor.gov/about/factsterms/donation-faqs.html [Accessed July 3, 2020].Organ Donation Statistics. U.S. Government Information on Organ Donation and Transplantation. Available at: https://www.organdonor.gov/statistics-stories/statistics.html [Accessed July 3, 2020].Organ Donation Statistics. U.S. Government Information on Organ Donation and Transplantation. Available at: https://www.organdonor.gov/statistics-stories/statistics.html [Accessed July 3, 2020].DeRoos L.J., Marrero W.J., Tapper E. B., Sonnenday Ch. J., Lavieri M.S., Hutton D.W., Parikh N.D.. Estimated Association Between Organ Availability and Presumed Consent in Solid Organ Transplant. JAMA Network Open, 2019; 2 (10): e1912431 Available at: DOI: 10.1001/jamanetworkopen.2019.12431 [Accessed July 3, 2020].DeRoos L.J., Marrero W.J., Tapper E. B., Sonnenday Ch. J., Lavieri M.S., Hutton D.W., Parikh N.D.. Estimated Association Between Organ Availability and Presumed Consent in Solid Organ Transplant. JAMA Network Open, 2019; 2 (10): e1912431 Available at: DOI: 10.1001/jamanetworkopen.2019.12431 [Accessed July 3, 2020].Organ Procurement and Transplantation Network. Available at: https://optn.transplant.hrsa.gov/members/ [Accessed July 3, 2020].Organ Procurement and Transplantation Network. Available at: https://optn.transplant.hrsa.gov/members/ [Accessed July 3, 2020].Aubert O., Reese P.P., Audry B. Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance// JAMA Intern Med. 2019;179(10):1365-1374. Available at: doi: 10.1001/jamainternmed.2019.2322 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2748452 [Accessed July 3, 2020].Aubert O., Reese P.P., Audry B. Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance// JAMA Intern Med. 2019;179(10):1365-1374. Available at: doi: 10.1001/jamainternmed.2019.2322 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2748452 [Accessed July 3, 2020].Sparks H. US throws away thousands of kidneys despite donor shortage: study// New York Post. August 27, 2019. Available at: https://nypost.com/2019/08/27/us-throws-away-thousands-ofkidneys-despite-donor-shortage-study [Accessed July 3, 2020].Sparks H. US throws away thousands of kidneys despite donor shortage: study// New York Post. August 27, 2019. Available at: https://nypost.com/2019/08/27/us-throws-away-thousands-ofkidneys-despite-donor-shortage-study [Accessed July 3, 2020].Organ Procurement and Transplantation Network (OPTN) Policies. Available at: https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf [Accessed July 3, 2020].Organ Procurement and Transplantation Network (OPTN) Policies. Available at: https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf [Accessed July 3, 2020].Executive Order on Advancing American Kidney Health. THE WHITE HOUSE, July 10, 2019. Available at: https://www.whitehouse.gov/presidential-actions/executive-order-advancingamerican-kidney-health/ [Accessed July 3, 2020].Executive Order on Advancing American Kidney Health. THE WHITE HOUSE, July 10, 2019. Available at: https://www.whitehouse.gov/presidential-actions/executive-order-advancingamerican-kidney-health/ [Accessed July 3, 2020].Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization. A Proposed Rule by the Centers for Medicare & Medicaid Services on 12/23/2019. Available at: https://www.federalregister.gov/documents/2019/12/23/2019-27418/medicareand-medicaidprograms-organ-procurementorganizations-conditions-for-coverage-revisionsto#print [Accessed July 3, 2020].Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization. A Proposed Rule by the Centers for Medicare & Medicaid Services on 12/23/2019. Available at: https://www.federalregister.gov/documents/2019/12/23/2019-27418/medicareand-medicaidprograms-organ-procurementorganizations-conditions-for-coverage-revisionsto#print [Accessed July 3, 2020].Kunwar D. Increasing Organ Donation in the United States // The Regulatory Review. University of Pennsylvania. February 19, 2020. Available at: https://www.theregreview.org/2020/02/19/kunwarincreasing-organdonation-united-states/ [Accessed July 3, 2020].Kunwar D. Increasing Organ Donation in the United States // The Regulatory Review. University of Pennsylvania. February 19, 2020. Available at: https://www.theregreview.org/2020/02/19/kunwarincreasing-organdonation-united-states/ [Accessed July 3, 2020].Geilfuss C. F.II., King O.R.Organ Procurement Organizations: CMS Proposes Revisions to Conditions For Coverage Designed To Increase Donated Organs// The National Law Review. July 3, 2020.Volume X, Number 185. Available at: https://www.natlawreview.com/article/organ-procurement-organizations-cms-proposesrevisions-to-conditions-coverage [Accessed July 3, 2020].Geilfuss C. F.II., King O.R.Organ Procurement Organizations: CMS Proposes Revisions to Conditions For Coverage Designed To Increase Donated Organs// The National Law Review. July 3, 2020.Volume X, Number 185. Available at: https://www.natlawreview.com/article/organ-procurement-organizations-cms-proposesrevisions-to-conditions-coverage [Accessed July 3, 2020].Organ Procurement Organization (OPO) Conditions for Coverage Proposed Rule: Revisions to Outcome Measures for OPOs. Dec 17, 2019. Centers for Medicare & Medicaid Services. Available at: https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organization-opoconditions-coverage-proposed-rule-revisionsoutcome-measures-opos [Accessed July 3, 2020].Organ Procurement Organization (OPO) Conditions for Coverage Proposed Rule: Revisions to Outcome Measures for OPOs. Dec 17, 2019. Centers for Medicare & Medicaid Services. Available at: https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organization-opoconditions-coverage-proposed-rule-revisionsoutcome-measures-opos [Accessed July 3, 2020].Baxter A. HHS proposals aim to boost organ donation supply//HealthExec. December 17, 2019. Available at: https://www.healthexec.com/topics/policy/hhs-proposals-aim-boost-organ-donationsupply [Accessed July 3, 2020].Baxter A. HHS proposals aim to boost organ donation supply//HealthExec. December 17, 2019. Available at: https://www.healthexec.com/topics/policy/hhs-proposals-aim-boost-organ-donationsupply [Accessed July 3, 2020].Removing Financial Disincentives to Living Organ Donation. A Proposed Rule by the Health and Human Services Department on 12/20/2019. Federal register. The Daily Journal of the United States Government Available at: https://www.federalregister.gov/documents/2019/12/20/201927532/removingfinancial-disincentives-to-living-organ-donation [Accessed July 3, 2020].Removing Financial Disincentives to Living Organ Donation. A Proposed Rule by the Health and Human Services Department on 12/20/2019. Federal register. The Daily Journal of the United States Government Available at: https://www.federalregister.gov/documents/2019/12/20/201927532/removingfinancial-disincentives-to-living-organ-donation [Accessed July 3, 2020].Eligibility Guidelines. National Living Donor Assistance Center. Available at: https://www.livingdonorassistance.org/How-to-Apply/Eligibility-Guidelines [Accessed July 3, 2020].Eligibility Guidelines. National Living Donor Assistance Center. Available at: https://www.livingdonorassistance.org/How-to-Apply/Eligibility-Guidelines [Accessed July 3, 2020].Organ transplants. The official U.S. Government Site of Medicare. https://www.medicare.gov/coverage/organ-transplants [Accessed July 3, 2020].Organ transplants. The official U.S. Government Site of Medicare. https://www.medicare.gov/coverage/organ-transplants [Accessed July 3, 2020].Coverage of immunosuppressant drugs and vitamins for people with ESRD. Medicare Interactive. Available at: https://www.medicareinteractive.org/get-answers/medicare-health-coverage-options/medicareand-end-stage-renal-disease-esrd/coverage-ofimmunosuppressant-drugs-and-vitamins-forpeople-with-esrd [Accessed July 3, 2020].Coverage of immunosuppressant drugs and vitamins for people with ESRD. Medicare Interactive. Available at: https://www.medicareinteractive.org/get-answers/medicare-health-coverage-options/medicareand-end-stage-renal-disease-esrd/coverage-ofimmunosuppressant-drugs-and-vitamins-forpeople-with-esrd [Accessed July 3, 2020].Aleccia J.A ‘No-Brainer’? Calls Grow For Medicare To Cover Anti-Rejection Drugs After Kidney Transplant//Kaiser Health News. July 17, 2019. Available at: https://khn.org/news/kidney-transplant-anti-rejection-drugs-medicarecoverage/[Accessed July 3, 2020].Aleccia J.A ‘No-Brainer’? Calls Grow For Medicare To Cover Anti-Rejection Drugs After Kidney Transplant//Kaiser Health News. July 17, 2019. Available at: https://khn.org/news/kidney-transplant-anti-rejection-drugs-medicarecoverage/[Accessed July 3, 2020].Potter L.M., Maldonado A.Q., Lentine K.L., Schnitzler M.A., Zhang Z., Hess G.P., Garrity E., Kasiske B.L., Axelrod D.A. Transplant recipients are vulnerable to coverage denial under Medicare Part D. American Journal of Transplantation. The American Society of Transplantation and the American Society of Transplant Surgeons. 15 February 2018. Available at: https://doi.org/10.1111/ajt.14703 [Accessed July 3, 2020].Potter L.M., Maldonado A.Q., Lentine K.L., Schnitzler M.A., Zhang Z., Hess G.P., Garrity E., Kasiske B.L., Axelrod D.A. Transplant recipients are vulnerable to coverage denial under Medicare Part D. American Journal of Transplantation. The American Society of Transplantation and the American Society of Transplant Surgeons. 15 February 2018. Available at: https://doi.org/10.1111/ajt.14703 [Accessed July 3, 2020].Immunosuppressant Drug Coverage under Medicare Part D Benefit. American Society of Transplantation. Available at: https://www.myast.org/public-policy/key-position-statements/immunosuppressant-drug-coverage-undermedicare-part-d-benefit [Accessed July 3, 2020].Immunosuppressant Drug Coverage under Medicare Part D Benefit. American Society of Transplantation. Available at: https://www.myast.org/public-policy/key-position-statements/immunosuppressant-drug-coverage-undermedicare-part-d-benefit [Accessed July 3, 2020].Боенко Н. А., Минина М. Г. К вопросу о сотрудничестве государств в области донорства органов и трансплантологии. Вестник трансплантологии и искусственных органов. 2018;20(4):107-111. https://doi.org/10.15825/1995-1191-2018-4-107-111Боенко Н. А., Минина М. Г. К вопросу о сотрудничестве государств в области донорства органов и трансплантологии. Вестник трансплантологии и искусственных органов. 2018;20(4):107-111. https://doi.org/10.15825/1995-1191-2018-4-107-111Виноградов В. Л. Актуальные вопросы органного донорства. Введение. Лекция. Трансплантология. 2013;(4):15-23.Виноградов В. Л. Актуальные вопросы органного донорства. Введение. Лекция. Трансплантология. 2013;(4):15-23.Минина М. Г. Комплексный подход в обеспечении эффективного донорства органов для трансплантации: диссертация кандидата медицинских наук: 14.00.41 / Минина Марина Геннадьевна; [Место защиты: ГУ «Российский научный центр хирургии РАМН»]. – Москва, 2008. – 169 с.Минина М. Г. Комплексный подход в обеспечении эффективного донорства органов для трансплантации: диссертация кандидата медицинских наук: 14.00.41 / Минина Марина Геннадьевна; [Место защиты: ГУ «Российский научный центр хирургии РАМН»]. – Москва, 2008. – 169 с.Минина М. Г. Причины неэффективного развития органного донорства. Трансплантология. 2011;(1):71-74. https://doi.org/10.23873/2074-0506-2011-0-1-71-74Минина М. Г. Причины неэффективного развития органного донорства. Трансплантология. 2011;(1):71-74. https://doi.org/10.23873/2074-0506-2011-0-1-71-74Резник О. Н., Михель Д. В. Глобальный дефицит донорских органов: анализ национальных стратегий самообеспечения. Вестник трансплантологии и искусственных органов. 2020;22(1):174-183. https://doi.org/10.15825/1995-1191-2020-1-174-183Резник О. Н., Михель Д. В. Глобальный дефицит донорских органов: анализ национальных стратегий самообеспечения. Вестник трансплантологии и искусственных органов. 2020;22(1):174-183. https://doi.org/10.15825/1995-1191-2020-1-174-183Резник О. Н., Резник А. О. Популяризация идеи посмертного донорства органов: практика, проблемы, перспективы. Вестник трансплантологии и искусственных органов. 2018;20(4):112-120. https://doi.org/10.15825/1995-1191-2018-4-112-120Резник О. Н., Резник А. О. Популяризация идеи посмертного донорства органов: практика, проблемы, перспективы. Вестник трансплантологии и искусственных органов. 2018;20(4):112-120. https://doi.org/10.15825/1995-1191-2018-4-112-120Хубутия М. Ш., Минина М. Г. Комментарий к статье «Анализ причин дефицита доноров органов и основные направления его преодоления». Трансплантология. 2011;(2-3):22-23. https://doi.org/10.23873/2074-0506-2011-0-2-3-22-23Хубутия М. Ш., Минина М. Г. Комментарий к статье «Анализ причин дефицита доноров органов и основные направления его преодоления». Трансплантология. 2011;(2-3):22-23. https://doi.org/10.23873/2074-0506-2011-0-2-3-22-23Шмарина Н. В., Дмитриев И. В., Хубутия Б. З., Пинчук А. В. Трансплантации почек от доноров c расширенными критериями пожилым реципиентам в НИИ СП им. Н. В. Склифосовского. Трансплантология. 2018;10(3):175-184. https://doi.org/10.23873/2074-0506-2018-10-3-175-184Шмарина Н. В., Дмитриев И. В., Хубутия Б. З., Пинчук А. В. Трансплантации почек от доноров c расширенными критериями пожилым реципиентам в НИИ СП им. Н. В. Склифосовского. Трансплантология. 2018;10(3):175-184. https://doi.org/10.23873/2074-0506-2018-10-3-175-184

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