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

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.

подростки, дети, ISPOR, маркировка медицинского продукта, сообщаемые пациентами исходы, педиатрия, PRO, исследовательская группа, adolescents, children, ISPOR, medical product labeling, patient-reported outcomes, pediatrics, PRO, task force

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