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Table 2 PRO-CTCAE symptom terms presenting comprehension difficulties across 2 rounds of cognitive interviews

From: Dutch translation and linguistic validation of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™)

Source of Difficulty

Proportions with difficulty Round1

n (%)

PRO-CTCAE Symptom term

Examples of difficulties experienced by participants in Round 1

Decisions after Round 1

Decisions after Round 2

Comprehension

3/24(12.5)

Hives

Netelroos

Participant was not sure he understood what was meant by ‘hives’

No suitable alternative term; no revision

Not applicable

3/24 (12.5)

Stretch marks

Striemen

Participant comments suggested that the Dutch terminology chosen for ‘stretch marks’ was not well understood

Revised to include parenthetical phrasing and retested

Well comprehended; revised phrasing retained

2/21 (10)

Nail ridging

Geribbelde nagels

Participant was confused with the description of bumps and ridges; they did not understand that this could occur with finger or toenails

No suitable alternative term; no revision

Not applicable

1/24 (4)

Gas

Winderigheid

Participant did not understand the specific phrasing for ‘flatulence’, although they were able to comprehend the meaning of the item overall

No revision

Not applicable

6/90 (6.6)

Mouth and throat sores

Zweertjes in de mond/keel (aften)

Participant stated that it was not clear whether this question was also about blisters in the mouth.

No suitable alternative term; no revision

Not applicable

1/21 (4.8)

Ringing in ears

Oorsuizen

One participant did not understand the phrasing chosen for ´ringing in ears’.

Most participants comprehended this item well; no suitable alternative; no revision

Not applicable

Clarity of phrasing (intent or meaning of item unclear)

1/24 (4.2)

Visual floaters

Zwevende vlekjes of sliertjes die voor uw ogen bewegen

One participant misinterpreted ‘visual floaters’ as ‘blurred vision’

Most participants were clear about the meaning of this item; no revision

Not applicable

1/21 (4.8)

Urinary urgency

Urinaire aandrang

One participant thought that the phrasing ‘all of a sudden’ implied that urinary urgency was unexpected; this participant was experiencing chronic urinary urgency

Most participants were clear about the meaning of this item; no revision.

Not applicable

2/24 (8.3)

Decreased libido

Verminderd libido

Participant had a decreased sexual interest, but attributed this to his age

Most participants were clear about the meaning of this item; no revision

Not applicable

2/24 (8.3)

Unable to achieve orgasm

Uitgesteld orgasme

The Dutch phrasing of ‘unable’, combined with the response choice “no’, resulted in misinterpretation due to double negative

Item revised to improve clarity: In the last 7 days, was it IMPOSSIBLE TO HAVE AN ORGASM OR CLIMAX?

Not applicable

4/21(19)

Increased sweating

Toegenomen transpiratie

Participant found it difficult to differentiate when sweating is due to hot flushes and when not

No suitable alternative; no revision

Not applicable

7/90 (7.8)

Anxious

Angst

Participant was not sure whether the items about anxiety refer to general anxiety or cancer- related anxiety

No suitable alternative; no revision

Not applicable

3/70 (4.2)

Rash

Huiduitslag

Participant comments indicated confusion about what types of rash were included in this item

Item revised to improve clarity: In the last 7 days, did you have any form of RASH?

Not applicable

3/19 (15.8)

Achieve and maintain erection

Erectie krijgen en behouden

Phrasing of this item in the source language made phrasing in Dutch confusing and unclear (i.e., “severity of your difficulty” could not be well translated).

Revised item: In the last 7 days, how SERIOUS were your PROBLEMS WITH GETTING OR KEEPING AN ERECTION at their WORST?

Not applicable

Ease of judgement, recall and response

1/21(5.)

Pain and swelling at injection site

Pijn en zwelling bij injectieplek

Participant stated that this question asks about two things, and is therefore difficult to answer

Item generally well comprehended; no revision.

Not applicable

1/21 (4.7)

Body odor

Lichaamsgeur

Participant stated that this is difficult to judge about yourself

Item generally well comprehended; no revision

Not applicable

2/39 (9.5)

Vaginal dryness

Vaginale droogheid

Participant found this difficult to judge because she was not sexually active

Item generally well comprehended; no revision

Not applicable