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

Table 3 PRO-CTCAE items evaluated as “difficult to understand” or “difficult to answer” by more than 20% of patients and their remarks

Item	Attribute	Patients with difficulty (%)	No. of remarks coded^a	Comprehension	Clarity	Knowledge/recall	Ease of judgment	Examples of patient remarks
Evaluated as “difficult to understand” by >20% of patients
Anxiety	Severity	3/11 (27%)	6	–	2	3	2	Cannot apprehend severity of worst anxiety
Evaluated as “difficult to answer” by >20% of patients
Anxiety	Severity	3/11 (27%)	6	–	2	3	2	To know my anxiety at its worst is difficult due to ambiguous and constant nature of symptom
Blurry vision^b	Severity	3/10 (30%)	0	.	.	.	.	–
Body odor	Severity	3/11 (27%)	5	.	.	5	.	I am not sure if I should give my own evaluation or third-person’s evaluation
Decreased appetite	Interference	3/11 (27%)	2	–	.	2	.	Hard to imagine a situation where decreased appetite interferes with daily activities
Decreased sexual interest	Severity	5/10 (50%)	4	.	.	1	3	Unsure if decreased sexual interest resulting from the aging process should be included
Skin burns from radiation^b	Severity	4/10 (40%)	0	.	.	.	.	–
Unable to orgasm/climax	Presence	4/10 (40%)	1	.	.	.	1	This is a question for patients on lower stages, not for those on 4th stage
Took too long to climax^b	Presence	4/10 (40%)	0	.	.	.	.	–

^aMultiple remarks could be coded from a single patient
^bSeveral items elicited no remarks in interviews even though they were evaluated as difficult to understand or answer in the initial investigation