How do patients interpret and respond to a single-item global indicator of cancer treatment tolerability?

Author:

Peipert John Devin,Shaunfield Sara,Kaiser Karen,Moreno Patricia I.,Fox Rina S.,Kircher Sheetal,Mohindra Nisha,Ip Edward,Zhao Fengmin,Wagner Lynne,Cella David

Funder

National Cancer Institute

Publisher

Springer Science and Business Media LLC

Subject

Oncology

Reference34 articles.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human. Statistical principles for clinical trials. February 5th 1998. https://database.ich.org/sites/default/files/E9_Guideline.pdf. Accessed 25 Apr 2022

2. Atkinson TM, Ryan SJ, Bennett AV et al (2016) The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review. Support Care Cancer 24(8):3669–3676

3. Basch E, Jia X, Heller G et al (2009) Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst 101(23):1624–1632

4. Basch E, Campbell A, Hudgens S et al (2020) Broadening the definition of tolerability in cancer clinical trials to capture the patient experience. Friends of Cancer, Washington, DC

5. Kim J, Singh H, Ayalew K et al (2018) Use of PRO measures to inform tolerability in oncology trials: implications for clinical review, IND safety reporting, and clinical site inspections. Clin Cancer Res 24(8):1780–1784

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