<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">clinvest</journal-id><journal-title-group><journal-title xml:lang="ru">Качественная клиническая практика</journal-title><trans-title-group xml:lang="en"><trans-title>Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2588-0519</issn><issn pub-type="epub">2618-8473</issn><publisher><publisher-name>ООО «Издательство ОКИ</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">clinvest-14</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОЦЕНКА ТЕХНОЛОГИЙ ЗДРАВООХРАНЕНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>HEALTH TECHNOLOGY ASSESSMENT</subject></subj-group></article-categories><title-group><article-title>Принципы надлежащей практики для применения аналитического моделирования в оценке медицинских технологий: доклад Рабочей группы ISPOR по надлежащей практике исследований - исследования по моделированию</article-title><trans-title-group xml:lang="en"><trans-title>Principles of Good Practice for Decision Analytic Modeling in Health-Care Evaluation: Report of the ISPOR Task Force on Good Research Practices - Modeling Studies</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>C.Weinstein</surname><given-names>Milton</given-names></name><name name-style="western" xml:lang="en"><surname>Weinstein</surname><given-names>M. C.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>O’Brien</surname><given-names>Bernie</given-names></name><name name-style="western" xml:lang="en"><surname>O’Brien</surname><given-names>Bernie</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Hornberger</surname><given-names>John</given-names></name><name name-style="western" xml:lang="en"><surname>Hornberger</surname><given-names>John</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Jackson</surname><given-names>Joseph</given-names></name><name name-style="western" xml:lang="en"><surname>Jackson</surname><given-names>Joseph</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Johannesson</surname><given-names>Magnus</given-names></name><name name-style="western" xml:lang="en"><surname>Johannesson</surname><given-names>Magnus</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-5"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>McCabe</surname><given-names>Chris</given-names></name><name name-style="western" xml:lang="en"><surname>Mccabe</surname><given-names>Chris</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-6"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>R. Luce</surname><given-names>Bryan</given-names></name><name name-style="western" xml:lang="en"><surname>Luce</surname><given-names>Bryan R.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-7"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Павлыш</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Pavlysh</surname><given-names>A. V.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-8"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Колбин</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Kolbin</surname><given-names>A. S.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-9"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Center for Risk Analysis, Harvard School of Public Health, Boston, MA, USA, and Innovus Research,&#13;
Inc., Medford, MA</institution><country>Соединённые Штаты Америки</country></aff><aff xml:lang="en"><institution>Center for Risk Analysis, Harvard School of Public Health; Innovus Research, Inc</institution><country>United States</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario</institution><country>Канада</country></aff><aff xml:lang="en"><institution>McMaster University</institution><country>Canada</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Acumen, LLC, and Stanford University School of Medicine, Stanford, CA</institution><country>Соединённые Штаты Америки</country></aff><aff xml:lang="en"><institution>Acumen, LLC; Stanford University School of Medicine</institution><country>United States</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>Pharmaceutical Research Institute, Bristol-Myers Squibb, Princeton, NJ</institution><country>Соединённые Штаты Америки</country></aff><aff xml:lang="en"><institution>Pharmaceutical Research Institute</institution><country>United States</country></aff></aff-alternatives><aff-alternatives id="aff-5"><aff xml:lang="ru"><institution>Centre for Health Economics, Stockholm School of Economics, Stockholm</institution><country>Швеция</country></aff><aff xml:lang="en"><institution>Centre for Health Economics, Stockholm School of Economics</institution><country>Sweden</country></aff></aff-alternatives><aff-alternatives id="aff-6"><aff xml:lang="ru"><institution>Trent Institute for Health Services Research, University of Sheffield, Sheffield</institution><country>Великобритания</country></aff><aff xml:lang="en"><institution>Trent Institute for Health Services Research, University of Sheffield</institution><country>United Kingdom</country></aff></aff-alternatives><aff-alternatives id="aff-7"><aff xml:lang="ru"><institution>MEDTAP International, Bethesda, MD</institution><country>Соединённые Штаты Америки</country></aff><aff xml:lang="en"><institution>MEDTAP International</institution><country>United States</country></aff></aff-alternatives><aff-alternatives id="aff-8"><aff xml:lang="ru"><institution>Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова</institution><country>Россия</country></aff><aff xml:lang="en"><institution>First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-9"><aff xml:lang="ru"><institution>Первый Санкт-Петербургский государственный медицинcкий университет имени акад. И.П.Павлова; Санкт-Петербургский государственный университет</institution><country>Россия</country></aff><aff xml:lang="en"><institution>First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia; Saint Petersburg State University, Saint Petersburg, Russia</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2015</year></pub-date><pub-date pub-type="epub"><day>16</day><month>05</month><year>2018</year></pub-date><volume>0</volume><issue>2</issue><fpage>19</fpage><lpage>28</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; C.Weinstein M.C., O’Brien B., Hornberger J., Jackson J., Johannesson M., McCabe C., R. Luce B.R., Павлыш А.В., Колбин А.С., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">C.Weinstein M., O’Brien B., Hornberger J., Jackson J., Johannesson M., McCabe C., R. Luce B., Павлыш А.В., Колбин А.С.</copyright-holder><copyright-holder xml:lang="en">Weinstein M.C., O’Brien B., Hornberger J., Jackson J., Johannesson M., Mccabe C., Luce B.R., Pavlysh A.V., Kolbin A.S.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.clinvest.ru/jour/article/view/14">https://www.clinvest.ru/jour/article/view/14</self-uri><abstract/><trans-abstract xml:lang="en"><p>Principles of Good Practice for Decision Analytic Modeling in Health-Care Evaluation: Report of the ISPOR Task Force on Good Research Practices - Modeling Studies Abstract. Objectives: Mathematical modeling is used widely in economic evaluations of pharmaceuticals and other healthcare technologies. Users of models in government and the private sector need to be able to evaluate the quality of models according to scientific criteria of good practice. This report describes the consensus of a task force convened to provide modelers with guidelines for conducting and reporting modeling studies. Methods: The task force was appointed with the advice and consent of the Board of Directors of ISPOR. Members were experienced developers or users of models, worked in academia and industry, and came from several countries in North America and Europe. The task force met on three occasions, conducted frequent correspondence and exchanges of drafts by electronic mail, and solicited comments on three drafts from a core group of external reviewers and more broadly from the membership of ISPOR. Results: Criteria for assessing the quality of models fell into three areas: model structure, data used as inputs to models, and model validation. Several major themes cut across these areas. Models and their results should be represented as aids to decision making, not as statements of scientific fact; therefore, it is inappropriate to demand that models be validated prospectively before use. However, model assumptions regarding causal structure and parameter estimates should be continually assessed against data, and models should be revised accordingly. Structural assumptions and parameter estimates should be reported clearly and explicitly, and opportunities for users to appreciate the conditional relationship between inputs and outputs should be provided through sensitivity analyses. Conclusions: Model-based evaluations are a valuable resource for health-care decision makers. It is the responsibility of model developers to conduct modeling studies according to the best practicable standards of quality and to communicate results with adequate disclosure of assumptions and with the caveat that conclusions are conditional upon the assumptions and data on which the model is built.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>математическое моделирование</kwd><kwd>оценка технологий здравоохранения</kwd><kwd>принятие решений</kwd><kwd>валидация моделей</kwd><kwd>анализ чувствительности</kwd><kwd>mathematical modeling</kwd><kwd>health technology assessment</kwd><kwd>decision-making</kwd><kwd>model validation</kwd><kwd>sensitivity analysis</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">National Research Council. Improving Information for Social Policy Decisions: The Uses of Microsimulation Modeling, Vol. 1, Review and Recommendations. Washington: National Academy Press; 1991.</mixed-citation><mixed-citation xml:lang="en">National Research Council. Improving Information for Social Policy Decisions: The Uses of Microsimulation Modeling, Vol. 1, Review and Recommendations. Washington: National Academy Press; 1991.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Weinstein MC, Toy EL, Sandberg EA, et al. Modeling for health care and other policy decisions: uses, roles, and validity. Value Health 2001; 4: 348-61.</mixed-citation><mixed-citation xml:lang="en">Weinstein MC, Toy EL, Sandberg EA, et al. Modeling for health care and other policy decisions: uses, roles, and validity. Value Health 2001; 4: 348-61.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Sculpher M., Fenwick E., Claxton K. Assessing quality in decision analytic cost-effectiveness models: a suggested framework and example of application. Pharmacoeconomics 2000; 17:461-77.</mixed-citation><mixed-citation xml:lang="en">Sculpher M., Fenwick E., Claxton K. Assessing quality in decision analytic cost-effectiveness models: a suggested framework and example of application. Pharmacoeconomics 2000; 17:461-77.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Hay J., Jackson J., Luce B., et al. Methodological issues in conducting pharmacoeconomic evaluations-modeling studies. Value Health 1999; 2:78-81.</mixed-citation><mixed-citation xml:lang="en">Hay J., Jackson J., Luce B., et al. Methodological issues in conducting pharmacoeconomic evaluations-modeling studies. Value Health 1999; 2:78-81.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Akehurst R., Anderson P., Brazier J., et al. Decision analytic modeling in the economic evaluation of health technologies. Pharmacoeconomics 200.0;17: 443-4.</mixed-citation><mixed-citation xml:lang="en">Akehurst R., Anderson P., Brazier J., et al. Decision analytic modeling in the economic evaluation of health technologies. Pharmacoeconomics 200.0;17: 443-4.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Gold MR, Siegel JE, Russell LB, Weinstein MC, editors. Cost-Effectiveness in Health and Medicine. Report of the Panel on Cost-Effectiveness in Health and Medicine. New York: Oxford University Press; 1996.</mixed-citation><mixed-citation xml:lang="en">Gold MR, Siegel JE, Russell LB, Weinstein MC, editors. Cost-Effectiveness in Health and Medicine. Report of the Panel on Cost-Effectiveness in Health and Medicine. New York: Oxford University Press; 1996.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Hunink M., Glasziou P., Siegel J., et al. Decision Making in Health and Medicine: Integrating Evidence and Values. Cambridge: Cambridge University Press; 2001.</mixed-citation><mixed-citation xml:lang="en">Hunink M., Glasziou P., Siegel J., et al. Decision Making in Health and Medicine: Integrating Evidence and Values. Cambridge: Cambridge University Press; 2001.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Kuntz K., Weinstein M. Modelling in economic evaluation. In: Drummond M, McGuire A, editors. Economic Evaluation in Health Care: Merging Theory with Practice. Oxford: Oxford University Press; 2001.</mixed-citation><mixed-citation xml:lang="en">Kuntz K., Weinstein M. Modelling in economic evaluation. In: Drummond M, McGuire A, editors. Economic Evaluation in Health Care: Merging Theory with Practice. Oxford: Oxford University Press; 2001.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Briggs A. Handling uncertainty in economic evaluation and presenting the results. In: Drummond M, McGuire A, editors. Economic Evaluation in Health Care: Merging Theory with Practice. Oxford: Oxford University Press; 2001.</mixed-citation><mixed-citation xml:lang="en">Briggs A. Handling uncertainty in economic evaluation and presenting the results. In: Drummond M, McGuire A, editors. Economic Evaluation in Health Care: Merging Theory with Practice. Oxford: Oxford University Press; 2001.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
