Japanese translation and linguistic validation of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Journal of Patient-reported Outcomes
Tempei MiyajiTakuhiro Yamaguchi

Abstract

The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients' self-reported symptomatic adverse events in cancer clinical trials. The aim of this study was to develop and linguistically validate a Japanese translation of PRO-CTCAE. Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. We then conducted cognitive interviews with 21 patients undergoing cancer treatment. Participants were asked to complete the PRO-CTCAE and were interviewed using semi-structured scripts and predetermined probes to investigate whether any items were difficult to understand or answer. The interviews were recorded and transcribed, and a thematic analysis was performed. The data were split into two categories: 1) remarks on the items and 2) remarks on the questionnaire in general. Twenty-one cancer patients undergoing chemotherapy or hormone therapy were interviewed at the University of Tokyo Hospital and the Kansai Medical University Hirakata Hospital during 2011 and 2012. Thirty-three PRO-CTCAE items were evaluated as "diffic...Continue Reading

References

Jul 19, 2002·Research in Nursing & Health·Jerry W LeeXinwei Esther Zhang
Apr 5, 2005·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Diane WildUNKNOWN ISPOR Task Force for Translation and Cultural Adaptation
Jan 9, 2008·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Catherine AcquadroUNKNOWN European Regulatory Issues and Quality of Life Assessment (ERIQA) Group
Mar 12, 2010·The New England Journal of Medicine·Ethan Basch
Jan 10, 2012·Biological & Pharmaceutical Bulletin·Takashi KawaguchiYoshinori Nagumo
Oct 17, 2012·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Ethan BaschSean Tunis
Jul 23, 2013·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Jennifer L HayUNKNOWN NCI PRO-CTCAE Study Group
Feb 4, 2016·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Benjamin ArnoldUNKNOWN PRO-CTCAE Spanish Translation and Linguistic Validation Study Group
May 27, 2017·Clinical Trials : Journal of the Society for Clinical Trials·Tito R MendozaEthan Basch

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Citations

May 23, 2019·Emergency Medicine Journal : EMJ·Gregory A DanielsJayne Viets-Upchurch
Jul 20, 2018·Journal of Gynecologic Oncology·Michelle K WilsonMichael Friedlander
Mar 29, 2021·Seminars in Oncology Nursing·Karen Eliana Pérez-Alfonso, Vanessa Sánchez-Martínez

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