کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
6150455 1596428 2016 9 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Systematic collection of patient reported outcome research data: A checklist for clinical research professionals
ترجمه فارسی عنوان
جمع آوری سیستماتیک از بیمار گزارش داده شده نتایج تحقیق: یک چک لیست برای متخصصان تحقیقات بالینی
کلمات کلیدی
بیمار گزارش نتیجه، داده های خود گزارش شده، خاطرات بیمار، آزمایشات بالینی، راهنمایی، پرسشنامه،
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی پزشکی و دندانپزشکی (عمومی)
چکیده انگلیسی

Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries.Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contemporary Clinical Trials - Volume 48, May 2016, Pages 21-29
نویسندگان
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