Part A
Drug Safety
Development and initial validation of a patient-reported adverse drug event questionnaire
de Vries ST, et al.
Supplemental Digital Content
This Supplemental Digital Content contains the appendix referred to in the full version of this article, which can be found at http://adisonline.com/drugsafety
© 2013 Adis Data Information BV. All rights reserved.
Page 21.
Part A
This questionnaire contains questions about the drugs that you take and any side effects (adverse effects) that you experience from these drugs. The questionnaire is made up of two parts:
Part A: general information, your drug use and the symptoms you experience
Part B: side effects that you have experienced during the past four weeks
Your details will remain confidential at all times.
Instructions
Most of the questions can be answered by checking the box next to the most applicable answer. There are no right or wrong answers and there will generally only be one possible answer, unless stated otherwise. There are also a number of questions that ask you to provide additional information on the dotted lines.
If you check the box next to the wrong answer, you can color that box black and then check the box next to the right answer. For example:
Are you married?
¢ No
T Yes
The intended answer in this example was ‘Yes’.
Most respondents take between 20 and 40 minutes to complete the questionnaire. You may need more time or less time to complete it yourself.
Please feel free to take a break during the questionnaire, but we do ask that you complete it at a later time, as incomplete questionnaires cannot be used for this research.
Thank you very much for your cooperation
1. What is your gender?
o Male
o Female
2. How old are you?
years
3. What town/city do you live in?
4. What is your highest level of completed education?
o No education completed
o Elementary school, special education
o Junior secondary vocational education, pre-vocational education
(for example VMBO, LTS, LEAO)
o Junior general secondary education
(for example MAVO, MULO, ULO, VMBO-t)
o Senior secondary vocational education, other vocational education
(for example MBO, MEAO, MTS, BBL)
o Senior general secondary education
(for example HAVO, VWO, Athenaeum, HBS)
o Higher professional education
(for example HBO, HTS, HEAO)
o University education (research university)
o Other (please specify)
5. What is your country of birth?
o The Netherlands
o Other (please specify)
6. What is your father’s country of birth?
o The Netherlands
o Other (please specify)
o Don’t know
7. What is your mother’s country of birth?
o The Netherlands
o Other (please specify)
o Don’t know
8. How would you describe your general health?
o Excellent
o Very good
o Good
o Fair
o Poor
Drug use9. Which prescription drugs did you take during the past 4 weeks?
Example: I took metformin 500mg for diabetes.Example
name + strength
metformin 500mg / Example
disease/disorder
diabetes
Please enter all prescription drugs that you took during the past 4 weeks below:
Name + strength of the drug / For which disorder/disease /ailment did or do you take this drug?Question 9. Drug use, continued
Name + strength of the drug / For which disorder/disease /ailment did or do you take this drug?10. Do you suffer from other disorders or diseases besides those mentioned above?
o No
o Yes (please specify)
11. Did you use drugs during the past 4 weeks for which you did not require a prescription (for example self-help drugs, incidental drugs or alternative, homeopathic or natural drugs)?
o No
o Yes (please specify)
Symptoms12. Did you experience symptoms during the past 4 weeks?
· If yes, you can find lists of symptoms per body part on the following pages. You should first consider in which part of your body you experienced the symptoms. You can then go to the page mentioned for each of the body parts. There you can check the box next to the applicable symptom.
o Yes, I experienced symptoms in the following parts of my body:
13. Which symptoms involving your ‘eyes and/or eyelids’ did you experience during the past 4 weeks (you may give more than one answer)?
/ Yes, I experienced this symptom and ...I don’t think the drug caused it or I’m not sure / I do think that it is, or could be, a side effect of my drug
/
Blurred vision / o / o
Double vision / o / o
Seeing less or poorer vision / o / o
Seeing (black) spots / o / o
Night blindness / o / o
Flashes of light / o / o
Painful eyes / o / o
Teary, watery eyes / o / o
Dry eyes / o / o
Burning, itchy or irritated eyes / o / o
Inflamed eyes / o / o
Itchy or irritated eyelids / o / o
Inflamed eyelids / o / o
Puffy or swollen eyes or eyelids / o / o
Enlarged pupils / o / o
Pressure on the eyes / o / o
Burst eye vessels / o / o
Inability to move eyes / o / o
Unusual eye movements / o / o
Other (please specify) ...... / o / o
14. Which symptoms involving your ‘throat, nose, ears (hearing) and/or swallowing’ did you experience during the past 4 weeks (you may give more than one answer)?
/ Yes, I experienced this symptom and ...I don’t think the drug caused it or I’m not sure / I do think that it is, or could be, a side effect of my drug
/
Painful throat, throat-ache / o / o
Inflamed throat / o / o
Dry throat / o / o
Difficulty swallowing, food sticks in the throat / o / o
Choking / o / o
Changed sense of smell (for example sensitivity to odors) / o / o
Bloody nose, nosebleed / o / o
Dry nostrils / o / o
Blocked nose / o / o
Runny nose / o / o
Ear infection / o / o
Earache / o / o
Buzzing or ringing in the ear or ears / o / o
Impaired hearing, difficulty hearing or deafness / o / o
Other (please specify) ...... / o / o
15. Which symptoms involving ‘sweating, blushing, temperature, colds and/or the flu’ did you experience during the past 4 weeks (you may give more than one answer)?
/ Yes, I experienced this symptom and ...I don’t think the drug caused it or I’m not sure / I do think that it is, or could be, a side effect of my drug
/
Shivering, shivery / o / o
Goose bumps / o / o
Cold limbs (for example cold feet and/or hands) / o / o
Often cold / o / o
Lower body temperature / o / o
Higher body temperature (not fever) / o / o
Fever (temperature above 38 degrees Celsius) / o / o
Insufficient sweating/transpiration / o / o
Excessive sweating/transpiration / o / o
Blushing / o / o
Cold / o / o
Flu-like symptoms / o / o
Coughing, barking, hawking / o / o
Sneezing / o / o
Swollen glands / o / o
Other (please specify) ...... / o / o
16. Which symptoms involving your ‘mouth, lips, speech and/or voice’ did you experience during the past 4 weeks (you may give more than one answer)?
/ Yes, I experienced this symptom and ...I don’t think the drug caused it or I’m not sure / I do think that it is, or could be, a side effect of my drug
/
Ulcers or bumps in the mouth and/or on the roof of the mouth / o / o
Increased saliva in the mouth / o / o
Dry mouth, less saliva in the mouth / o / o
Painful or sensitive mouth / o / o
Lockjaw / o / o
Bad breath / o / o
Inflamed lips / o / o
Painful or sensitive lips / o / o
Dry lips de woorden kunnen komen / o / o
Swollen lips / o / o
Voice change (for example hoarseness, huskiness) ------/ o / o
Unclear speech, mumbling, speech difficulties / o / o
Word-finding problems, stumbling speech / o / o
Other (please specify) ...... / o / o
17. Which symptoms involving your ‘tongue, teeth, gums and/or taste did you experience during the past 4 weeks (you may give more than one answer)?
/ Yes, I experienced this symptom and ...I don’t think the drug caused it or I’m not sure / I do think that it is, or could be, a side effect of my drug
/
Tooth discoloration / o / o
Plaque / o / o
Caries, tooth decay / o / o
Toothache / o / o
Teeth grinding / o / o
Inflamed or irritated gums / o / o
Bleeding gums / o / o
Sensitive gums / o / o
Painful or sensitive tongue / o / o
Swollen tongue / o / o
Tingling tongue / o / o
Changed sense of taste / o / o
Tongue blistering / o / o
Dry tongue / o / o
Tongue discoloration / o / o
Other (please specify) ...... / o / o
18. Which symptoms involving your ‘lungs, heart, chest, breathing and/or blood’ did you experience during the past 4 weeks (you may give more than one answer)?
/ Yes, I experienced this symptom and ...I don’t think the drug caused it or I’m not sure / I do think that it is, or could be, a side effect of my drug
/
Hiccups / o / o
Lung disorder / o / o
Pneumonia / o / o
Pneumothorax / o / o
Respiratory infection / o / o
Hyperventilation / o / o
Apnea (gap between breaths longer than 10 seconds) / o / o
Sleep apnea (gaps or pauses between breaths while sleeping) / o / o
Slow breathing / o / o
Rapid breathing / o / o
Shortness of breath, wheeziness, difficulty breathing, quickly out of breath / o / o
Panting, puffing, wheezing, whistling (heavy breath) / o / o
Palpitations / o / o
Rapid heartbeat / o / o
Slow heartbeat / o / o
Irregular heartbeat, arrhythmia / o / o
Chest pain or pressure / o / o
Blood poisoning / o / o
Hemorrhage / o / o
High blood pressure / o / o
Low blood pressure / o / o
Anemia / o / o
Thrombosis / o / o
Other (please specify) ...... / o / o
19. Which symptoms involving your ‘bladder and/or urination’ did you experience during the past 4 weeks (you may give more than one answer)?
/ Yes, I experienced this symptom and ...I don’t think the drug caused it or I’m not sure / I do think that it is, or could be, a side effect of my drug
/
Blood in urine / o / o
Urine discoloration / o / o
Pain when urinating / o / o
Burning sensation when urinating / o / o
Less frequent and/or difficulty urinating / o / o
More frequent need to urinate / o / o
Less urine per toilet visit / o / o
Urine incontinence (involuntary urine loss) / o / o
Pressure on the bladder / o / o
Bladder infection / o / o
Other (please specify) ...... / o / o
20. Which symptoms involving your ‘intestines, stomach, vomiting, feces and/or bowel movements’ did you experience during the past 4 weeks (you may give more than one answer)?
/ Yes, I experienced this symptom and ...I don’t think the drug caused it or I’m not sure / I do think that it is, or could be, a side effect of my drug
/
(Excessive) burping, belching / o / o
Nauseous, sick / o / o
Acid indigestion, stomach acid, heartburn / o / o
Vomiting reflex / o / o
Vomiting / o / o
Vomiting blood / o / o
Bloated feeling / o / o
Bloated stomach / o / o
Intestinal, stomach, abdominal cramps and/or pain / o / o
Gurgling or rumbling in the intestines and/or stomach / o / o
Flatulence (gas) / o / o
Hemorrhoids / o / o
Fecal incontinence (involuntary loss of feces) / o / o
Diarrhea / o / o
Runnier, softer feces (not diarrhea) / o / o
Mucus in feces / o / o
Blood with feces / o / o
Blood in feces / o / o
Blockage, constipation, hard feces / o / o
Black feces / o / o
More frequent bowel movements / o / o
Other (please specify) ...... / o / o
21. Which symptoms involving your ‘skin, hair and/or nails’ did you experience during the past 4 weeks (you may give more than one answer)?
/ Yes, I experienced this symptom and ...I don’t think the drug caused it or I’m not sure / I do think that it is, or could be, a side effect of my drug
/
Greasy skin / o / o
Warm/burning skin / o / o
Dry, rough skin / o / o
Painful skin / o / o
Itchiness / o / o
Flaking / o / o
Acne / o / o
Blisters / o / o
Rashes (for example red patches, pimples) / o / o
Spot (painful), ulcer, wound / o / o
Skin discoloration (for example yellow or pale skin) / o / o
Pigment stains / o / o
Patches of little or no skin pigment (pale patches of skin) / o / o
Bruises, contusions / o / o
Increased sensitivity of the skin to light / o / o
Weak hair / o / o
Loss of hair / o / o
Increased hair growth / o / o
Nail discoloration / o / o
Wrinkled nails / o / o
Brittle, fragile nails / o / o
Other (please specify) ...... / o / o