Information:
Fel:
ID
23875
Beskrivning
Patient-Reported Adverse Drug Event Questionnaire for the evaluation of drug safety, Part B. Publication granted by Sieta de Vries. Publishing results based on the questionnaire should include the following reference: de Vries, S.T., Mol, P.G.M., de Zeeuw, D. et al. Drug Saf (2013) 36: 765. doi:10.1007/s40264-013-0036-8
Nyckelord
Versioner (1)
- 2017-07-16 2017-07-16 -
Rättsinnehavare
Sieta de Vries
Uppladdad den
16 juli 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Drug Safety Patient-Reported Adverse Drug Event Questionnaire Part B
Drug Safety Patient-Reported Adverse Drug Event Questionnaire Part B
Similar models
Drug Safety Patient-Reported Adverse Drug Event Questionnaire Part B
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Side effect
Item
29. Can you describe the side effect in your own words?
text
C0041755 (UMLS CUI [1])
Item
30. When did you first experience this side effect of your drugs?
text
C1510608 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Code List
30. When did you first experience this side effect of your drugs?
CL Item
Today (Today)
CL Item
Yesterday (Yesterday)
CL Item
2-7 days ago (2-7 days ago)
CL Item
Between 1 week and 1 month ago (Between 1 week and 1 month ago)
CL Item
Between 1 and 6 months ago (Between 1 and 6 months ago)
CL Item
Between 6 and 12 months ago (Between 6 and 12 months ago)
CL Item
More than 12 months ago (More than 12 months ago)
Item
31. Has this side effect gone away by now or improved?
text
C0041755 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
CL Item
No, the side effect has not gone away yet (No, the side effect has not gone away yet)
CL Item
No, but the side effect has clearly improved (No, but the side effect has clearly improved)
CL Item
No, but the side effect was treated and has now improved (No, but the side effect was treated and has now improved)
CL Item
Yes, the side effect went away by itself (Yes, the side effect went away by itself)
CL Item
Yes, the side effect went away after I stopped taking the drug (Yes, the side effect went away after I stopped taking the drug)
CL Item
Yes, the side effect went away after treatment (Yes, the side effect went away after treatment)
CL Item
Yes, the side effect other (please specify (Yes, the side effect other (please specify)
other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
frequency Side effect
Item
32. How often did you experience this side effect during the past 4 weeks (on how many or which days)?
text
C0439603 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Item
33. On the days that you experienced this side effect, how much did it bother you (how bad or intense was it)?
text
C0522510 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Code List
33. On the days that you experienced this side effect, how much did it bother you (how bad or intense was it)?
CL Item
Not at all (Not at all)
CL Item
Only a bit (Only a bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a lot (Quite a lot)
CL Item
Very much (Very much)
Item
34. On the days that you experienced this side effect, how much influence did it have on your daily functioning?
text
C4062591 (UMLS CUI [1])
Code List
34. On the days that you experienced this side effect, how much influence did it have on your daily functioning?
CL Item
Not at all (Not at all)
CL Item
Only a bit (Only a bit)
CL Item
Somewhat (Somewhat)
CL Item
Quite a lot (Quite a lot)
CL Item
Very much (Very much)
SAE
Item
35. Did this side effect result in serious medical situations for yourself during the past 4 weeks?
boolean
C1519255 (UMLS CUI [1])
SAE hospitalization
Item
35. Did this side effect result in serious medical situations for yourself during the past 4 weeks?- Yes, Admitted to hospital.
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
SAE unable to work
Item
35. Did this side effect result in serious medical situations for yourself during the past 4 weeks?- Yes, permanent incapacity to work
boolean
C1519255 (UMLS CUI [1,1])
C0849751 (UMLS CUI [1,2])
C0849751 (UMLS CUI [1,2])
SAE Life-threatening situation
Item
35. Did this side effect result in serious medical situations for yourself during the past 4 weeks? - Yes, Life-threatening situation
boolean
C1519255 (UMLS CUI [1,1])
C1517874 (UMLS CUI [1,2])
C1517874 (UMLS CUI [1,2])
SAE other
Item
35. Did this side effect result in serious medical situations for yourself during the past 4 weeks?- If Other, please specify
text
C1519255 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item
36. What action did you take in relation to this side effect during the past 4 weeks?
text
C2826626 (UMLS CUI [1])
Code List
36. What action did you take in relation to this side effect during the past 4 weeks?
CL Item
Nothing (Nothing)
CL Item
In consultation with a healthcare professional, the drug dosage was reduced (In consultation with a healthcare professional, the drug dosage was reduced)
CL Item
I reduced the dosage of the drug by myself (I reduced the dosage of the drug by myself)
CL Item
In consultation with a healthcare professional, I stopped taking the drug temporarily (In consultation with a healthcare professional, I stopped taking the drug temporarily)
CL Item
I stopped taking the drug temporarily by myself (I stopped taking the drug temporarily by myself)
CL Item
In consultation with a healthcare professional, I stopped taking the drug permanently (In consultation with a healthcare professional, I stopped taking the drug permanently)
CL Item
I stopped taking the drug by myself (I stopped taking the drug by myself)
CL Item
A drug and/or remedy has been prescribed to reduce/relieve the side effect, please specify (A drug and/or remedy has been prescribed to reduce/relieve the side effect, please specify)
CL Item
I started using other drugs and/or remedy by myself to reduce/relieve the side effect, please specify (I started using other drugs and/or remedy by myself to reduce/relieve the side effect, please specify)
CL Item
Other, please specify (Other, please specify)
other drugs
Item
36. If other drugs and/or remedy used, please specify
text
C0205394 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
other
Item
36. If other, please specify
text
C0205394 (UMLS CUI [1])
Symptoms Adverse reaction to drug
Item
37. Why do you think this symptom was caused by your drug? -I did not experience this symptom before I started taking the drug
boolean
C1457887 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Symptoms Adverse reaction to drug
Item
37. Why do you think this symptom was caused by your drug? - The symptom started soon after I started taking the drug
boolean
C1457887 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Symptoms Adverse reaction to drug
Item
37. Why do you think this symptom was caused by your drug? - I experienced this symptom less often before I started taking the drug
boolean
C1457887 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Symptoms Adverse reaction to drug
Item
37. Why do you think this symptom was caused by your drug? - The symptom was less serious before I started taking the drug
boolean
C1457887 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Symptoms Adverse reaction to drug
Item
37. Why do you think this symptom was caused by your drug? - The symptom went away when I stopped taking the drug and came back when I started taking it again
boolean
C1457887 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Symptoms Adverse reaction to drug
Item
37. Why do you think this symptom was caused by your drug? - The symptom went away when I stopped taking the drug
boolean
C1457887 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Symptoms Adverse reaction to drug
Item
37. Why do you think this symptom was caused by your drug? - The symptom started or grew worse when the drug dosage was increased
boolean
C1457887 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Symptoms Adverse reaction to drug
Item
37. Why do you think this symptom was caused by your drug? - The symptom decreased or went away when the drug dosage was decreased
boolean
C1457887 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Symptoms Adverse reaction to drug
Item
37. Why do you think this symptom was caused by your drug? - A healthcare professional (for example a doctor or pharmacist) confirmed this
boolean
C1457887 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Symptoms Adverse reaction to drug
Item
37. Why do you think this symptom was caused by your drug? - The symptom is described in the patient leaflet
boolean
C1457887 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
other
Item
37. If other, please specify
text
C0205394 (UMLS CUI [1])
Adverse reaction to drug
Item
38. Which drug or drugs do you think caused this side effect? One drug that I use (please specify):
text
C0041755 (UMLS CUI [1])
Adverse reaction to drug
Item
38. Which drug or drugs do you think caused this side effect? More than one drug that I use (please specify):
text
C0041755 (UMLS CUI [1])
Adverse reaction to drug
Item
38. Which drug or drugs do you think caused this side effect? I don’t know, please go to question 42
boolean
C0041755 (UMLS CUI [1])
Item
39. How sure are you that this side effect is caused by this drug or these drugs?
text
C1704787 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
Code List
39. How sure are you that this side effect is caused by this drug or these drugs?
CL Item
Very sure (Very sure)
CL Item
Quite sure (Quite sure)
CL Item
Not very sure (Not very sure)
CL Item
Very unsure (Very unsure)
duration drug usage
Item
40. How long had you been using this drug or these drugs before this side effect started occurring?
text
C0449238 (UMLS CUI [1,1])
C0242510 (UMLS CUI [1,2])
C0242510 (UMLS CUI [1,2])
Item
41. How satisfied are you with the drug (or drugs) described in question 38 when you consider both this particular side effect and the effect of the drug or drugs?
text
C0242428 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Code List
41. How satisfied are you with the drug (or drugs) described in question 38 when you consider both this particular side effect and the effect of the drug or drugs?
CL Item
Very satisfied (Very satisfied)
CL Item
Satisfied (Satisfied)
CL Item
Neither satisfied or dissatisfied (Neither satisfied or dissatisfied)
CL Item
Dissatisfied (Dissatisfied)
CL Item
Very dissatisfied (Very dissatisfied)
other reason side effect
Item
42. Do you think there are other reasons for your experiencing this side effect (other than your drugs)?
boolean
C0205394 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0879626 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0879626 (UMLS CUI [1,3])
specify
Item
42. If yes, pleaase specify
text
C1521902 (UMLS CUI [1])
concomitant medication
Item
43. Have you experienced this side effect in the past in combination with other drugs?
boolean
C2347852 (UMLS CUI [1])
specify
Item
43. If yes, pleaase specify
text
C1521902 (UMLS CUI [1])
remarks
Item
You may make any further remarks below:
text
C0947611 (UMLS CUI [1])