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Качественная клиническая практика

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Инструменты для сбора данных сообщений об исходах от медицинского вмешательства от пациентов (PRO) применяемые в педиатрии и предназначенные для инструкции для медицинского продукта: Отчёт Исследовательской группы ISPOR по разработке Надлежащих Исследовательских Практик о сообщаемых пациентами исходах

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Аннотация

Общие сведения: Инструменты для сбора данных сообщений об исходах от медицинского вмешательства от пациентов (PRO) у детей и подростков часто включают в клинические исследования с целью сбора данных, подтверждающие сведения, изложенные в инструкции по применению медицинского продукта. Цель: Целью настоящего отчёта исследовательской группы было создание рекомендаций по надлежащей практики для исследований PRO в педиатрии, организованных с целью предоставления данных для принятия управленческих решений и подтверждающих сведений, изложенных в инструкции по применению медицинского продукта. Рекомендации основываются на консенсусе междисциплинарной группы исследователей, объединённых в исследовательскую группу, ассоциированную с Международным Обществом Фармакоэкономики и Исследования Исходов (International Society for Pharmacoeconomics and Outcomes Research (ISPOR)). В тех случаях, когда был недостаток доступных сведений или, когда общие принципы неприменимы ко всем ситуациям, настоящая исследовательская группа указывает факторы, которые следует рассмотреть при принятии решений касательно дизайна и использования педиатрических инструментов PRO, при этом обозначая проблемы, требующие дальнейших исследований. Надлежащие Исследовательские Практики: Обсуждены пять надлежащих исследовательских практик: 1). Рассмотреть особенности развития и определить критерии для введения PRO, основанные на возрасте пациента: опираясь на предыдущие исследования, проанализированы четыре возрастные группы (<5 лет, 5-7 лет, 8-11 лети 12-18 лет). Эти возрастные группы рекомендуют в качестве отправной точки при принятии решений. Конкретные возрастные рамки следует определять отдельно для каждой популяции и инструмента PRO; 2). Установить содержательную валидность педиатрических инструментов PRO: в данном разделе обсуждают преимущества привлечения детей в качестве экспертов, а также стратегии выявления концепций и когнитивных интервью с детьми; 3). Определить, необходим ли инструмент PRO: обсуждают отличия между двумя типами (доверительный и обсервационный) опросников, заполняемых опрашиваемыми, и даны рекомендации; 4). Убедиться, что инструмент создан и оформлен соответственно целевой возрастной группе. К рассмотренным факторам относят лексикон, связанный со здоровьем, уровень чтения, шкалы ответов, память, длительность, наглядность, оформление, организационные подходы и электронный сбор данных; 5). Рассмотреть кросс культурные аспекты. Выводы: Для формирования методического руководства для будущих исследований, особенно включающих детей младшего возраста и сообщения от родителей, требуются дополнительные данные. Поскольку, данные PRO всё чаще используются для подтверждения и улучшению информации в инструкции к медицинским продуктам в педиатрии, стоит ожидать новую информацию, касающуюся стандартов, этих инструментов. Использование инструментов PRO в клинических исследованиях и при оформлении заявки на регистрацию медицинского продукта помогут убедиться в том, что переживание ребёнком болезни и процесса лечения адекватным образом отображены и проанализированы при принятии административных решений.

Об авторах

Louis Matza
Outcomes Research, United BioSource Corporation
Россия


Donald Patrick
University of Washington
Россия


Anne Riley
Johns Hopkins Bloomberg School of Public Health
Россия


John Alexander
Division of Anti-Infective Products, FDA
Россия


Luis Rajmil
IMIM-Hospital del Mar Medical Research Institute, and Catalan Agency for Health Information, Assessment and Quality
Россия


Andreas Pleil
Pfizer Global Pharmaceuticals, Pfizer, Inc
Россия


Monika Bullinger
University Medical Centre Hamburg-Eppendorf
Россия


Р. А. Гапешин
Санкт-Петербургский государственный университет
Россия


С. М. Малышев
Санкт-Петербургский государственный университет
Россия


А. С. Колбин
Первый Санкт-Петербургский государственный медицинcкий университет имени акад. И.П.Павлова; Санкт-Петербургский государственный университет
Россия


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Для цитирования:


., ., ., ., ., ., ., Гапешин Р.А., Малышев С.М., Колбин А.С. Инструменты для сбора данных сообщений об исходах от медицинского вмешательства от пациентов (PRO) применяемые в педиатрии и предназначенные для инструкции для медицинского продукта: Отчёт Исследовательской группы ISPOR по разработке Надлежащих Исследовательских Практик о сообщаемых пациентами исходах. Качественная клиническая практика. 2015;(2):44-69.

For citation:


Matza L.S., Patrick D.L., Riley A.W., Alexander J.J., Rajmil L., Pleil A.M., Bullinger M., ., ., . Pediatric Patient-Reported Outcome Instruments for Research to Support Medical Product Labeling: Report of the ISPOR Good Research Practices for the Assessment of Patient-Reported Outcomes in Children and Adolescents Task Force. Kachestvennaya klinicheskaya praktika. 2015;(2):44-69. (In Russ.)

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