Table 2 Symptom terms and attributes presenting difficulties with comprehension, clarity or ease of response and the decisions about item phrasing that were made based on the data from two rounds of cognitive debriefing interviews (Round 1, n = 81 including 68 females 13 males; Round 2 n = 15 including 12 females 3 males)
PRO-CTCAE Symptom Terms | |||||
Source of Difficulty | Proportion with Difficulties in Round 1 (n = 81) | PRO-CTCAE Symptom Term % (f/n) | Examples of Difficulties Experienced by Participants in Round 1 | Decisions based on data from Round 1 | Decisions based on data from Round 2 |
Comprehension | ≥ 20% with difficulties | None | |||
≥ 10% and < 20% with difficulties | Bed sores 17.3% (14/81) | Participants (14/81) did not understand what was meant by ‘bed sore’. | Rephrased to include an elaboration and retested | Well comprehended (15/15) and phrasing retained | |
Difficulty getting or keeping an erection 15.4% (2/13 males) | Participants (2/13) did not understand what was meant by ‘erection’. | No suitable alternative term; retested | Well comprehended (3/3 males) and phrasing retained | ||
Ejaculation problem 15.4% (2/13 males) | Participants (2/13) did not understand what was meant by ‘ejaculation’. | No suitable alternative term; retested | Well comprehended (3/3 males) and phrasing retained | ||
Increased passing of gas 16% (13/81) | Participants (9/81) did not understand what was meant by ‘passing of gas’. | Rephrased and retested | Well comprehended (15/15) and phrasing retained | ||
< 10% with difficulties | Abdominal pain 1.2% (1/81) | Participant (1/81) did not understand what was meant by ‘abdominal pain’. Some participants suggested other plain language Chinese phrasing (synonyms) that would be more culturally acceptable to the Chinese-speaking population from southern region. | Included synonyms and retested | Well comprehended (15/15) and phrasing retained | |
Bloating 1.2% (1/81) | Participant (1/81) did not understand what was meant by ‘bloating’. Some participants suggested alternate plain Chinese language phrasing (synonyms) that would be more culturally acceptable to the Chinese-speaking population from southern region. | Included synonyms and retested | Well comprehended (15/15) and phrasing retained | ||
Flashing lights in front of your eyes 1.2% (1/81) | Participant (1/81) did not understand what was meant by ‘flashing lights’. Some participants’ (3/81) facial expressions suggested uncertainty about the intended meaning of this symptom term. | Rephrased and retested | Well comprehended (15/15) and phrasing retained | ||
Frequent urination 6.2% (5/81) | Participants (4/81) did not understand what was meant by ‘frequent urination’. Some participants suggested alternate simple Chinese language phrases (synonyms) that would be more culturally acceptable to the Chinese-speaking population from southern region. | Included synonyms and retested | Well comprehended (15/15) and phrasing retained | ||
Numbness or tingling in your hands or feet 1.2% (1/81) | Participant (1/81) did not understand what was meant by ‘numbness or tingling’. Some participants’ (3/81) facial expressions suggested uncertainty about the intended meaning of this symptom term. | Rephrased and retested | Well comprehended (15/15) and phrasing retained | ||
Wheezing 2.5% (2/81) | Participant (1/81) did not understand what was meant by ‘wheezing’. Participants recommended an elaboration to improve comprehension and clarity. | Rephrased, included an elaboration, and retested | Well comprehended (15/15) and phrasing retained | ||
Ease of recall, judgment and response | ≥ 20% with difficulties | Stretch marks 22.2% (18/81) | Participants (18/81) were uncertain if it related to pregnancy. | Rephrased and retested | Well comprehended (15/15) and phrasing retained |
≥ 10% and < 20% with difficulties | None | ||||
< 10% with difficulties | Hot flashes 6.2% (5/81) | Participants (3/81) were uncertain if it related to fever or feeling hot. Some participants recommended an elaboration to improve comprehension and clarity. | Item rephrased to include an elaboration and retested | Well comprehended (15/15) and phrasing retained | |
General pain 4.9% (4/81) | Participants (3/81) were uncertain about the type/ location of pain. Some participants recommended an elaboration to improve comprehension and clarity. | Item rephrased to include an elaboration and retested | Well comprehended (15/15) and phrasing retained | ||
Nausea 4.9% (4/81) | Participants (4/81) confused this terminology as ‘vomiting’. Some participants suggested to include some elaborations. | Rephrased, added an elaboration, and retested | Well comprehended (15/15) and phrasing retained | ||
Vaginal dryness 4.4.% (3/68 females) | Participants (2/68) were uncertain about the context of condition. Some participants (5/68) showed hesitation with responses | Rephrased and retested | Well comprehended (12/12 females) and phrasing retained | ||
Nothing could cheer you up 3.7% (3/81) | Participants (3/81) had difficulty choosing a response. Some participants (2/81) showed hesitation with responses | Rephrased and retested | Well comprehended (15/15) and phrasing retained | ||
Pain during vaginal sex 2.9% (2/68 females) | Participants (2/68) had difficulty choosing a response. Some participants (5/68) showed hesitation with responses | Rephrased and retested | Well comprehended (12/12) and phrasing retained | ||
Pounding or racing heartbeat 2.5% (2/81) | Participants (2/81) did not understand to what extend to be considered as pounding. Some participants (2/81) showed hesitation with responses | Rephrased and retested | Well comprehended (15/15) and phrasing retained | ||
Sad or unhappy feelings 1.2% (1/81) | Participant (1/81) had difficulty choosing a response. Some participants (3/81) showed hesitation with responses. | Rephrased and retested | Well comprehended (15/15) and phrasing retained | ||
Urinary urgency 1.2% (1/81) | Participant (1/81) did not understand to what extend to be considered as urge. Some participants suggested alternate simple Chinese language phrases (synonyms) that would be more culturally acceptable to the Chinese-speaking population from southern region. | Included synonyms and retested | Well comprehended (15/15) and phrasing retained | ||
PRO-CTCAE Attributes | |||||
Source of Difficulty | Proportion with difficulties in Round 1 (n = 81) | PRO-CTCAE Attribute % (n/N) | Examples of Difficulties Experienced by Participants in Round 1 | Decisions based on data from Round 1 | Decisions based on data from Round 2 |
Comprehension | ≥ 20% with difficulties | None | |||
≥ 10% and < 20% with difficulties | None | ||||
< 10% with difficulties | Interfere 8.6% (7/81) | Participants (4/81) did not understand what was meant by ‘interfere’. | No suitable alternative term; retested | Well comprehended (15/15) and phrasing retained | |
Ease of recall, judgement and response | ≥ 20% with difficulties | Severity at its Worst 23.5% (19/81) | Participants (11/81) commented this was a double barrelled phrasing, making it difficult to choose a response. | Rephrased and retested | Well comprehended (15/15) and phrasing retained |
≥ 10% and < 20% with difficulties | How Often 11.1% (9/81) | Participants (9/81) were unclear if this question was asking for them to provide precise count of the number of times something occurred, thus making it difficult to select from the response choices. | Rephrased and retested | Well comprehended (15/15) and phrasing retained | |
< 10% with difficulties | None | ||||