Best practices and pragmatic approaches for patient-reported outcomes and quality of life measures in cancer clinical trials.

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Tác giả: Hanna Bandos, Reena S Cecchini, Eva Culakova, Fenghai Duan, Amylou C Dueck, Heather J Gunn, Minji K Lee, Jon A Steingrimsson, Pedro A Torres-Saavedra, Joseph M Unger

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: United States : Journal of the National Cancer Institute. Monographs , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 657511

Patient-reported outcomes (PROs) are often collected in cancer clinical trials. Data obtained from trials with PROs are essential in evaluating participant experiences relating to symptoms, financial toxicity, or health-related quality of life. Although most features of clinical trial design, implementation, and analyses apply to trials with PROs, several considerations are unique. In this paper, we focus on specific issues such as selection of the tool, timing and frequency of assessments, and data collection methods. We discuss how the estimand framework can be used in connection with PROs, properties of common estimation methods, and handling of missing outcomes. With a plethora of literature available, we aim to summarize best practices and pragmatic approaches to the design and analysis of the studies incorporating PROs.
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