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 |