Asking the right questions to get the right answers: using cognitive interviews to review the acceptability, comprehension and clinical meaningfulness of patient self-report adverse event items in oncology patients

Figures & data

Table 1. Example of the rewording of the CTCAE grading into a PRAE item (nausea).

CTCAE Version 4.0	PRAE item
Nausea	Have you felt sick (nauseous)?
	0. No
1. Loss of appetite without alteration in eating habits	1. I felt a bit sick but I was able to eat and drink as usual
2. Oral intake decreased without significant weight loss, dehydration or malnutrition	2. I felt quite sick and I ate or drank less than usual
3. Inadequate oral caloric or fluid intake, tube feeding, TPN, or hospitalization indicated	3. I felt very sick and was not able to eat or drink

Figure 1. Examples of cognitive probes used to explore patient understanding of PRAE item (nausea).

Table 2. The Tracking matrix for PRAE pain item, CTCAE grading V 4.0, cognitive probes, supporting quotes and changes made by round.

CTCAE V 4.0 (pain)	PRAE original litem	Changes made to item and supporting quotes			Item post-cognitive interview
		Round 1 (n = 20)	Round 2 (n = 20)	Round 3 (n = 20)
	Q. Have you had pain?	Comprehension	Comprehension	No changes made	Q. Have you had pain or discomfort anywhere on your body?
	0. No	Patients x6 thought they only had to report cancer-related pain	Patients x2 could not endorse the term pain but labeled it discomfort		0. No
1. Mild pain 2. Moderate pain, limiting  instrumental ADL 3. Severe pain, limiting  self-care ADL	1. I had mild pain 2. I had moderate pain and I was not able to do some of the things I normally do (e.g., household chores) 3. I had severe pain and I was not able to carry out daily activities	Examples of quotes ‘Is it pain because of the treatment or just normal pain like backache or…?’ p5 ‘Yes, you see my answer to that has nothing to do with chemo, it’s the aftermath of the DVT. ….Well actually if we're still talking about the chemo, then that should be none, shouldn't it? So we should change that’ p2 what tumor group and age?	Examples of quotes ‘Ok that word pain and my expression of discomfort’ R: Do you prefer to call it discomfort? ‘I do when they ask me things yes. How often do you have pain around your body? It’ll have to be rarely because I can’t define what pain is. I mean erm drilling your teeth is painful isn’t it? But you can have a needle that’s very quickly painful but they’re two different intensities.’ R: So if we said it was discomfort what would you say to that? ‘Yes, yes’ p39		1. I had mild pain or discomfort 2. I had moderate pain or discomfort and I was not able to do some of the things I normally do (e.g., household chores/shopping*) 3. I had severe pain or discomfort and I was not able to take care of myself (getting out of bed, bathing, dressing†)
		Added Anywhere on your body	Added Discomfort

ADL: activities of daily living; R: researcher.

* denotes addition of shopping general change to clarify instrumental ADL; †descriptors to clarify self-care ADL.

Table 3. Patient characteristics for overall sample (N = 60) and by round (n = 20).

Overall sample (N = 60)		Round 1	Round 2	Round 3
Age
Mean 59.6, (SD 12)		59.05 (11.5)	61.35 (13.6)	58.25 (11.5)
Range 35–84		39–76	41–84	35–77
Gender (n)
Female: 33, Male: 27		F: 15, M: 5	F: 13, M: 7	F: 5, M: 15
Months since diagnosis
Mean 24.6 (SD: 36)		31.91 (48)	21.65 (30)	20.35 (28)
Range 3–164		0–164	2–84	1–111
Days since last treatment
Mean 10.1 (SD: 13)		7.45 (10)	14.35 (17)	8.40 (11)
Range 0–62		0–34	0–62	0–38
Tumor group (n)
Breast	12	7	3	2
Gynecological	12	3	6	3
Renal	11	1	4	6
Lung	12	6	4	2
Colorectal	13	3	3	7
Recruitment site (n)
Acute	14	5	8	1
Daycase/OPD	46	15	12	19
Treatment (n)
Chemotherapy	49	19	16	14
Biological therapy	11	1	4	6
Metastases (n)
None	28	7	9	12
In 1 area	21	10	4	7
>1 area	11	3	7	1
Education
Basic compulsory school   education only	20	10	8	2
Beyond basic school   (e.g., vocational qualifications)	17	3	7	7
University degree or equivalent	23	7	5	11
Employment (n)	9	3	2	4
Full time	8	4	4	0
Part time	10	0	4	6
Illness/disability	31	13	9	9
Retired	1	0	0	1
Unemployed	1	0	1	0
Other
Social support (n)
Married	32	7	11	14
Cohabiting	6	2	1	3
Separated	13	7	5	1
Widowed	6	2	3	1
Single	3	2	0	1