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<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-45</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>КЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>CLINICAL TRIALS</subject></subj-group></article-categories><title-group><article-title>Оценка исходов пациентами в клинических исследованиях</article-title><trans-title-group xml:lang="en"><trans-title>Patient-reported outcomes in clinical 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>Леонова</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Leonova</surname><given-names>M. V.</given-names></name></name-alternatives><email xlink:type="simple">anti23@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ВП РНИМУ им. Н.И. Пирогова Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Russian National Research Medical University named after N.I. Pirogov</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2016</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>38</fpage><lpage>45</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Леонова М.В., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Леонова М.В.</copyright-holder><copyright-holder xml:lang="en">Leonova M.V.</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/45">https://www.clinvest.ru/jour/article/view/45</self-uri><abstract><p>Представлен обзор по использованию исходов лечения, оцениваемых пациентами patient-reported outcomes - PRO) в клинических исследованиях: концепция и содержание PRO, методология включения PRO в клинические исследования, этапы создания и разработки, основные виды и формы инструментов PRO, психометрические характеристики инструментов PRO (валидация, чувствительность, надёжность), техника проведения оценок PRO.</p></abstract><trans-abstract xml:lang="en"><p>A review on the use of patient-reported outcomes (PRO) in clinical studies: the concept and content of the PRO, methodology enable PRO in clinical studies, the stages of creation and development, basic types and forms of PRO instruments, psychometric characteristics of the instruments PRO (validation, sensitivity, reliability) of PRO assessment technique.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>исходы</kwd><kwd>оцениваемые пациентами</kwd><kwd>рatient-reported outcomes</kwd><kwd>инструменты PRO</kwd><kwd>клинические исследования</kwd><kwd>patient-reported outcomes</kwd><kwd>methodology</kwd><kwd>PRO instruments</kwd><kwd>clinical studies</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">Guidance for Industry. 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