Patient-reported outcome
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1 Patient-reported outcome How does it compare to EORTC QOL assessment in EMBRACE? Pilot testing in Vienna Kathrin Kirchheiner, Elke Dörr
2 EORTC Answer categories not precise It remains unclear if frequency, intensity or interference is reported by patients No linear association with CTCAE Answer categories q not at all q a little q quite a bit q very much PRO-CTCAE Compatible with CTCAE v4, covers 78 symptoms Translations & validation in progress (GER, ENG, DAN, SPAN) 3-fold assessment, scores range from 0-4 Frequency q never q rarely q occasionally q frequently q almost constantly Severity of symptoms q none q mild q moderate q severe q very severe Interference with usual activities q not at all q a little q somewhat q quite a bit q very much
3 EORTC C30/Q09: During the past week, have you had pain? not at all a little quite a bit very much PRO-CTCAE a. frequency / b. severity / c. interference PRO 47a. In the last 7 days, how often did you have pain? never rarely occasionally frequently almost constantly PRO 47b. In the last 7 days, what was the severity of your pain at its worst? none mild moderate severe very severe PRO 47c. In the last 7 days, how much did pain interfere with your usual or daily activities? not at all a little bit somewhat quite a bit very much
4 EORTC C30/Q09: During the past week, have you had leaking of urine? not at all a little quite a bit very much PRO-CTCAE PRO 64a. In the last 7 days, how often did you have loss of control of urine (leakage)? never rarely occasionally frequently almost constantly PRO-CTCAE 64b. In the has last not 7 developed days, what an was item the for severity the assessment of your loss of of the control severityof urine (leakage) at its worst? none mild moderate severe very severe PRO 64c. In the last 7 days, how much did loss of control of urine (leakage) interfere with your usual or daily activities? not at all a little bit somewhat quite a bit very much
5 EORTC C30/Q09: During the past week, have you had leaking of urine? not at all a little quite a bit very much PRO-CTCAE PRO 64a. In the last 7 days, how often did you have loss of control of urine (leakage)? never rarely occasionally frequently almost constantly PRO 64b. In the last 7 days, what was the severity of your loss of control of urine (leakage) at its worst? none mild moderate severe very severe PRO 64c. In the last 7 days, how much did loss of control of urine (leakage) interfere with your usual or daily activities? not at all a little bit somewhat quite a bit very much
6 EORTC C30/Q17: During the past week, have you had diarrhea? not at all a little quite a bit very much PRO-CTCAE PRO 16a. In the last 7 days, how often did you have loose or watery stools (diarrhea)? never rarely occasionally frequently almost constantly PRO 16b. In the last 7 days, what was the severity of loose or watery stools (diarrhea) at its worst? PRO-CTCAE has not developed an item for the assessment of the none mild moderate severe very severe severity and the interference with ADL PRO 16c. In the last 7 days, how much did loose or watery stools (diarrhea) interfere with your usual or daily activities? not at all a little bit somewhat quite a bit very much
7 EORTC C30/Q17: During the past week, have you had diarrhea? not at all a little quite a bit very much PRO-CTCAE PRO 16a. In the last 7 days, how often did you have loose or watery stools (diarrhea)? never rarely occasionally frequently almost constantly PRO 16b. In the last 7 days, what was the severity of loose or watery stools (diarrhea) at its worst? none mild moderate severe very severe PRO 16c. In the last 7 days, how much did loose or watery stools (diarrhea) interfere with your usual or daily activities? not at all a little bit somewhat quite a bit very much
8 Pilot testing on feasibility 1. Work-up of all patient-reported symptoms that are assessed within EMBRACE II (EORTC C30 / CX24 / EN6) selection of corresponding items in PRO-CTCAE (28 symptoms) if not present, PRO-CTCAE items were complemented for the three-fold assessment structure (29 items added) 2. Cross sectional pilot assessment of EMBRACE I+II patients at different time points with both questionnaires 3. Adaptive assessment with research assistant: Only if symptom is present, it is explored further 4. Open feedback format for patients on the feasibility and acceptability of PRO-CTCAE
9 Endpoints not represented in PRO-CTCAE (but included in EORTC) bowel urgency, vaginal shortening and tightening, blood in stools, vaginal irritation / soreness, abnormal vaginal bleeding (PRO-CTCAE irregular menstrual bleeding ) Three-fold structure is applicable in the majority of symptoms (except urinary frequency, sexual symptoms no impact on ADL)
10 Sample size 31 VIE patients included in the pilot Cross-sectional from baseline up to 5 years in follow-up Sample size does not depend on the number of patients included but on the number of symptoms presented Descriptive statistics not applicable at the moment! The added PRO-CTCAE results represent a gain of information see examples
11 EORTC C30/17 PRO 16a. PRO 16b. PRO 16c. Have you had diarrhea? (N=8/31) In the last 7 days, how often did you have loose or watery stools (diarrhea)? In the last 7 days, what was the severity of loose or watery stools (diarrhea) at its worst? a little rarely moderate not at all a little frequently severe very much quite a bit occasionally moderate not at all quite a bit frequently very severe very much a little occasionally mild not at all In the last 7 days, how much did loose or watery stools (diarrhea) interfere with your usual or daily activities?
12 EORTC C30/17 PRO 16a. PRO 16b. PRO 16c. Have you had diarrhea? (N=8/31) In the last 7 days, how often did you have loose or watery stools (diarrhea)? In the last 7 days, what was the severity of loose or watery stools (diarrhea) at its worst? a little rarely moderate not at all a little frequently severe very much quite a bit occasionally moderate not at all quite a bit frequently very severe very much a little occasionally mild not at all In the last 7 days, how much did loose or watery stools (diarrhea) interfere with your usual or daily activities?
13 EORTC C30/17 PRO 16a. PRO 16b. PRO 16c. Have you had diarrhea? (N=8/31) In the last 7 days, how often did you have loose or watery stools (diarrhea)? In the last 7 days, what was the severity of loose or watery stools (diarrhea) at its worst? a little rarely moderate not at all a little frequently severe very much quite a bit occasionally moderate not at all quite a bit frequently very severe very much a little occasionally mild not at all In the last 7 days, how much did loose or watery stools (diarrhea) interfere with your usual or daily activities?
14 EORTC C30/17 PRO 16a. PRO 16b. PRO 16c. Have you had diarrhea? (N=8/31) In the last 7 days, how often did you have loose or watery stools (diarrhea)? In the last 7 days, what was the severity of loose or watery stools (diarrhea) at its worst? a little rarely moderate not at all a little frequently severe very much quite a bit occasionally moderate not at all quite a bit frequently very severe very much a little occasionally mild not at all In the last 7 days, how much did loose or watery stools (diarrhea) interfere with your usual or daily activities?
15 EORTC EN24/40 PRO 12a. PRO 12b. PRO 12c. Have you been troubled by In the last 7 days, how often In the last 7 days, what was In the last 7 days, how much did passing wind? (N=23/31) did you have increased passing of gas (flatulence)? the severity of your increased passing of gas (flatulence) at ist worst? increased passing of gas (flatulence) interfere with your usual or daily activities? a little occasionally moderate not at all a little occasionally moderate a little quite a bit occasionally moderate a little a little occasionally mild not at all quite a bit rarely moderate somewhat quite a bit frequently very severe very much quite a bit occasionally moderate not at all quite a bit rarely moderate not at all a little occasionally moderate not at all quite a bit occasionally severe not at all a little occasionally moderate not at all quite a bit occasionally moderate a little very much frequently severe somewhat a little rarely moderate very much quite a bit frequently very severe very much quite a bit occasionally severe very much
16 EORTC EN24/40 PRO 12a. PRO 12b. PRO 12c. Have you been troubled by In the last 7 days, how often In the last 7 days, what was In the last 7 days, how much did passing wind? (N=23/31) did you have increased passing of gas (flatulence)? the severity of your increased passing of gas (flatulence) at ist worst? increased passing of gas (flatulence) interfere with your usual or daily activities? a little occasionally moderate not at all a little occasionally moderate a little quite a bit occasionally moderate a little a little occasionally mild not at all quite a bit rarely moderate somewhat quite a bit frequently very severe very much quite a bit occasionally moderate not at all quite a bit rarely moderate not at all a little occasionally moderate not at all quite a bit occasionally severe not at all a little occasionally moderate not at all quite a bit occasionally moderate a little very much frequently severe somewhat a little rarely moderate very much quite a bit frequently very severe very much quite a bit occasionally severe very much
17 EORTC EN24/40 PRO 12a. PRO 12b. PRO 12c. Have you been troubled by In the last 7 days, how often In the last 7 days, what was In the last 7 days, how much did passing wind? (N=23/31) did you have increased passing of gas (flatulence)? the severity of your increased passing of gas (flatulence) at ist worst? increased passing of gas (flatulence) interfere with your usual or daily activities? a little occasionally moderate not at all a little occasionally moderate a little quite a bit occasionally moderate a little a little occasionally mild not at all quite a bit rarely moderate somewhat quite a bit frequently very severe very much quite a bit occasionally moderate not at all quite a bit rarely moderate not at all a little occasionally moderate not at all quite a bit occasionally severe not at all a little occasionally moderate not at all quite a bit occasionally moderate a little very much frequently severe somewhat a little rarely moderate very much quite a bit frequently very severe very much quite a bit occasionally severe very much
18 Patients feedback In summary, the majority of patients stated how detailed the assessment is 2 very positive comments 4 fairly negative comments and some clever questions on how to grade..
19 Patients feedback This is too detailed, the old questionnaire is sufficient Very detailed, I have to think a lot Very detailed Very detailed and very subjective Much better than yes or no, I have to think about it What is this for? Those questions only reflect the status at the very moment It is more detailed that s fine for me The questionnaire is very detailed and needs a lot of time Who is creating such absurd questions? Is the questionnaire funded by the European commission? Not bad, it is ok It is possible to give more detailed answers, it is not troublesome I don t like it. What is it for? Everything is assessed in more detail, maybe you will discover something relevant How do you compare my answers with other patients? Everyone feels different The questions are partly not precise enough, as the symptoms differ daily If this is all you want What do you want with this questionnaire? How does this help me? Questionnaire is fantastic. It s good that you are so interested in your patients It makes no problems to answer these questions You really want to know in detail. I never noticed it in such details It is fine because it is always the same structure The addition of details will not make the assessment more precise, you need to ask by free text field Some symptoms are not due to cancer or treatment-related side effects, how to indicate this? How do you define the answer category frequently? A definition would be helpful. The answer categories are not precise enough. What is the difference between a little / somewhat / quite a bit How to grade limb edema, if I wear compression tights? Regarding intensity of flatulence assessment, what do you mean? The noise or the smell?
20 Preliminary conclusion It can be summarized by now, that the added PRO-CTCAE results represent a substantial gain of information Patients do differentiate between frequency, intesity and interference in PRO-CTCAE to a high degree The assessment of PRO-CTCAE for all EMBRACE endpoints is quite a burden for patients (it might triple the questions) The majority of patients was nevertheless willing to test the PRO-CTCAE with our research assistent (personal approach) The feedback was mixed
21 Preliminary conclusion For solid conclusions, much more patients need to be included in order to re-assess more symptoms Multi-center approach necessary Approach needs either personal assistance or electronic assessment A sub-study might build a link between Europe and US PRO-CTCAE is the instrument of the future
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