myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-12CGTLCKmyrwd-15Research ArticleИСХОДЫ СООБЩАЕМЫЕ ПАЦИЕНТАМИPATIENT REPORTED OUTCOMESИсходы, сообщаемые пациентами: обзор направлений примененияPatient-reported outcomes: an overview of applicationshttps://orcid.org/0000-0002-1089-8788МухинаС. М.MukhinaS. M.

Мухина Софья Михайловна — ординатор кафедры клинической фармакологии и доказательной медицины

Санкт-Петербург

St. Petersburg

sonicsmux@mail.ruhttps://orcid.org/0000-0002-3537-0998ОрловаЕ. В.OrlovaE. V.

Орлова Елена Владимировна — заведующая отделением клинической фармакологии; ассистент кафедры клинической фармакологии и доказательной медицины

Санкт-Петербург

St. Petersburg

ev-orlova@mail.ruФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет имени И. П. Павлова»РоссияFSBEI HE I. P. Pavlov SPbSMU MOH RussiaRussian Federation2022070620222217Copyright © Мухина С.М., Орлова Е.В., 20222022Мухина С.М., Орлова Е.В.Mukhina S.M., Orlova E.V.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/15

В статье описаны исходы, сообщаемые пациентами (PRO), и их роль в принятии решений в ориентированном на пациента здравоохранении. Рассмотрены направления использования PRO в клинических исследованиях, для оценки эффективности лечения; для подтверждения заявления на этикетке продукта регулирующими органами; в клинической практике для мониторинга состояний пациентов.

This article focuses on patient-reported outcomes (PROs) and their role in decision making in patient-centred healthcare. Let»s look at how PRO can be used in clinical trials, to evaluate the effectiveness of treatment, to validate a claim on a product label by regulatory authorities, and in clinical practice to monitor patient conditions.

исходысообщаемые пациентамипоказатели исходовсообщаемые пациентамикачество жизнисвязанное со здоровьеминструмент PROинформационная система оценки исходовсообщаемых пациентамиреальная клиническая практикамаркировка лекарственных препаратовэлектронная медицинская картаpatient-reported outcomespatient-reported outcome measureshealth-related quality of lifePRO instrumentPatient-Reported Outcomes Measurement Information Systemreal-world datalabelling of productelectronic medical recordReferencesU. S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U. S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U. S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006 Oct 11;4:79. doi: 10.1186 / 1477-7525-4-79U. S. 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The authors declare that there are no conflicts of interest present.