Microsoft word - tpbrnonj patient questionnaire v050907

Study questionnaire for telephone survey (Patient Interview)
Before the start of the interview, ask patient if he/she has filled the sheets with the information on medications and contact of health professionals. If the answer is no, ensure that the patient has all his/her current medications handy at the time of the phone interview. Note to interviewer: Fill out prior to interview 1. Patient ID (Provided by center prior to start of interview) 2. Surrogate respondent? (A surrogate respondent should be used if the patient is unable to Date: ____/____/________ (mm/dd/yyyy) Date: ____/____/________ (mm/dd/yyyy) 8. Patient zip code of residence 9. Patient initials (First, Middle, Last) ____________ Note to interviewer: Before starting the interview, ensure that a signed consent form is on file. Then proceed with introduction (see the script). ONJ Case - Year of diagnosis (as indicated by doctor on screening form): _______________ Control Patient Section A. Oral Health Related to Quality of Life

I’ll begin asking you a few questions about how you feel about your teeth, mouth and gums.

1. How would you describe the health of your teeth and gums today? 2. During the last six weeks, have you had difficulty chewing any foods because of problems 3. During the last six weeks, have you had painful aching in your mouth? 4. During the last six weeks, have you felt uncomfortable about the appearance of your teeth, 5. During the last six weeks, have you felt that your food has been less flavorful due to any problems with your teeth, mouth or dentures? 6. During the last six weeks, have you had difficulty doing your usual jobs because of problems Section B. Oral Hygiene and Dental Service Utilization
The next set of questions refers to your personal oral hygiene before the year 2000.
1. In a typical year before the year 2000, how frequently did you BRUSH your teeth?
Once or more per day 4-6 times per week 2-3 times per week Once or less than once per week 2. In a typical year before the year 2000, how frequently did you FLOSS your teeth? Once or more per day 4-6 times per week 2-3 times per week Once or less than once per week 3. In a typical year before the year 2000, how frequently did you use an Oral Rinse? Once or more per day 4-6 times per week 2-3 times per week Once or less than once per week 4. Have you ever been diagnosed with gum disease that involved bone loss? Yes No Unknown If No, skip to 6 5. If yes, how old were you when you were first diagnosed? 6. In a typical year before the year 2000, how often did you visit the dentist? Once or more per year Every two years Less often than every two years Only when you have a problem 7. Did you visit any of the following health care providers after January 1st, 2000? Oral Surgeon, Periodontist (gum specialist), Orthodontist, Prosthodontist - Crown/Bridge Specialist, Denturist, Endodontist (root canal), Implant Specialist, Oral Medicine or Oral Pathologist, General Dentist, or other Medical Providers What was the date of your first visit? Could you give the name and telephone of the dental care providers you visited since January 1st, 2000? Section C. Osteonecrosis of the Jaw: Natural History
I am going to ask you a few questions regarding the condition we are studying in this research. The name of this condition is osteonecrosis of the jaw and information about it was mailed to you with the consent form you signed to agree to participate in this interview. (FOR CASES) Your dentist informed us that you have Osteonecrosis of the Jaw, but we need to confirm this information with you. (FOR CONTROLS) Your dentist informed us that you do not have Osteonecrosis of the Jaw. We need to confirm this information with you. 1. Do you currently or have you ever had an area of exposed bone in your mouth? This condition, where the bone becomes exposed and does not heal, is known as osteonecrosis of the jaw. This condition was described in the informational
brochure that was mailed to you and you may refer to this information if needed.
Now, we are going to ask questions relating to your mouth. The mouth is broken up into four sections: the upper right, upper left, lower right, and lower left. To locate these regions place your right index finger on the right-hand side of your face, the upper right section would be your upper jaw on the right-hand side of your face. The lower right section would be your lower jaw on the right-hand side of your face. You can use your left index finger to locate your upper left section and lower left section. Do you have any questions on how to locate the upper right, upper left, lower right and lower left regions of your mouth? Note to interviewer: Please, ask the following questions for each region with exposed bone and fill the box below. If there is a Yes to question 1, please complete questions 2 to 12 related to each region prior to progressing to the next region. 2. Which region of your mouth had an area of Upper Left 3. When was the first time you were told or you noticed that there was some exposed bone in this area? Prior to the bone becoming exposed, did you Did you ever take anything to improve the Systemic Antibiotics (pills) Systemic Antibiotics (pills) Chlorhexidine Oral Rinses Chlorhexidine Oral Rinses Is the area of exposed bone currently healed? (i.e., covered with skin, no exposed bone 10. If yes, when approximately did it heal? 11. Would you say that the area of exposed bone Dime or smaller at its worst was the size of a dime, a quarter Quarter Did you experience pain when the area of Section D. Concomitant Dental Factors
Now, I’d like to ask you about some dental procedures or events that may have occurred in the areas of your mouth after the year 2000. Please try to remember some important events in your life around the year 2000 to use as a reference. Note to interviewer: Please, when necessary repeat the questions for each region. Dental Treatment: The following questions relate to dental treatments that you may have undergone since the year 2000.
1. A dental extraction is when a tooth is pulled from your jaw by a dentist. Sometimes a tooth can also be pulled by you when it is very loose. (FOR CONTROLS) Since the year 2000, have you had any teeth pulled or extracted until today? (FOR CASES) Since the year 2000, have you had any teeth pulled or extracted before the bone became exposed? 2. How many teeth were pulled? _________ Note to Interviewer: The following questions should be asked for each extracted tooth. Please use the table below to capture the appropriate answers. 3. What was the date when each tooth was extracted? 4. From which region of the mouth was the tooth extracted? 5. What was the reason? 1) Pain 2) Dental infection 3) Failing root canal 4) Gum disease 5) Cavity 6) Orthodontic Treatment 7) Do not know Date of Extraction
Extraction
Tooth Quadrant
Reason for Extaction (Check all that apply)
(MM/YYYY)
6. It sometimes occurs that an invasive dental surgery is needed. With dental surgery, the gums are reflected or pulled away from the tooth by the dentist and local anesthetic is used to make the area numb. A dental assistant is typically present to aspirate bleeding that may occur. (FOR CONTROLS) Since the year 2000, did you have a dental surgical procedure, other than extraction? (FOR CASES) Since the year 2000, did you have a dental surgical procedure, other than extraction, before the bone became exposed? Note to Interviewer: Please use the table below to capture questions (7-11) 7. What dental surgical procedure was performed?
8. In which region of your mouth was the procedure performed?
9. What was the date the procedure was performed?
10. If Dental Gum Surgery was performed, what was the reason for Dental Gum Surgery?
11. Were any of these procedures performed to reduce pain or discomfort or any funny or strange feelings?
Dental Procedure
If Dental Gum Surgery was
Date of Procedure
Were any of these procedures
Performed
Quadrant
performed, what was the reason performed to reduce pain or discomfort
(MM/YYYY)
for Dental Gum Surgery
or any funny or strange feelings?
12. (FOR CONTROLS) Since the year 2000, did you have removable dentures? (FOR CASES) Since the year 2000, did you have removable dentures before the bone became exposed? 13. What type of denture was it? Complete Upper Complete Lower Partial Upper Partial Lower 14. If partial, what side of your mouth is it located? Right Left 15. How often do you wear the denture? Frequent Infrequent (Frequent means that in any given week you would wear the denture 5 out of 7 days. On the days you wear the denture you would wear it for more than 6 hours. Infrequent means anything less than this). 16. Date you first received the denture?
Type of Denture
If partial, what side of your
Frequency of Denture Use
Date you first received the
mouth is it located?
denture (MM/YYYY)
Partial Upper Denture Partial Lower Denture Complete Upper Denture Partial Upper Denture Partial Lower Denture Complete Upper Denture Partial Upper Denture Partial Lower Denture Complete Upper Denture Partial Upper Denture Partial Lower Denture 17. (FOR CONTROLS) Since the year 2000, did you have a root canal treatment? (FOR CASES) Since the year2000, did you have a root canal treatment before the bone became exposed? 18. In which region of your mouth was the root canal performed? What was the date the root canal was performed? Root Canal
Tooth Quadrant
Date of Root Canal (MM/YYYY)
19. (FOR CONTROLS) Since the year 2000, did you have any of your teeth straightened by orthodontic treatment? (FOR CASES) Since the year 2000, did you have any of your teeth straightened by orthodontic treatment before the bone became exposed? 20. What type of orthodontic treatment did you have? A) Fixed appliances, eg. Braces, B) Removable appliances, eg. Invisalign, or C) Both fixed and 21. In which region of your mouth was the procedure performed? What was the date the treatment started? What was the date the treatment finished? Orthodontic Treatment
Tooth Quadrant
Start Date
(MM/YYYY)
(MM/YYYY)
Both fixed and removable appliance Fixed appliances, eg. Braces Both fixed and removable appliance Fixed appliances, eg. Braces Dental Disease and Acute Trauma
We finished the section on dental procedures. The following questions are regarding dental problems such as dental diseases and traumatic injuries that you may have had that could affect your oral health. 22. (FOR CONTROLS) Since the year 2000, did your dental care provider ever tell you that you had deepened periodontal pockets and bone loss? (FOR CASES) Since the year 2000, did your dental care provider ever tell you that you had deepened periodontal pockets and bone loss before the bone became exposed? 23. Was it generalized (present throughout the mouth)? If Yes, skip to 25. 24. If No, in which region of your mouth was the 25. (FOR CONTROLS) Since the year 2000, did you have an injury, trauma, or accident to the lower part of your face or in your mouth? (FOR CASES) Since the year 2000, did you have an injury, trauma, or accident to the lower part of your face or in your mouth before the bone became exposed? 26. In which region of your mouth was the injury? What was the injury, trauma, or accident? Jaw (e.g. car accident) Jaw (e.g. car accident) Jaw (e.g. car accident) Jaw (e.g. car accident) ___________________ ___________________ ___________________ ___________________ Section E. Medical History

We finished the section of dental related questions. Now I would like to ask you some questions about your general health and your medical history. 1. Have you been treated for any of the following cancers? If yes, when were you diagnosed? a) Prostate Cancer (for men only) Unknown Date:____/________ (mm/yyyy) b) Breast Cancer (for men and women) Unknown Date:____/________ (mm/yyyy) Unknown Date:____/________ (mm/yyyy) Unknown Date:____/________ (mm/yyyy) If other, please specify: ___________________________ 2. Did your cancer spread to your bones or did you have a bone metastasis? 4. Did you receive cancer radiation therapy to the head and neck? 5. Have you ever been diagnosed by your doctor with the following: b) Lupus or any other auto-immune disease? g) Osteonecrosis in bones other than your jaws? j) Coagulopathy or blood clotting problems? 6. (for women only) Did you ever use Hormone Replacement Therapy? Section F. Occupational Exposures

Now I have some questions I would like to ask you regarding your occupational experiences. 1. Have you ever worked in the chemical industry? 2. Do you know some of the chemicals you were exposed to? ______________________________________________________________________________________ 3. To the best of your knowledge, have you ever been exposed to white phosphor either in the arms/gun manufacturing industry or in a phosphor plant? 4. Could you please describe how you were exposed to white phosphor? _____________________________________________________________________________________ 5. What was the length of employment, in years, during which you were exposed to white phosphor? _____________________________________________________________________________________ Section G. Education and Lifestyle Exposures
The following questions are related to your personal attributes, experiences, and lifestyle. Note to Interviewer: Please ask the patient what ethnicity they consider themselves to be. Note to Interviewer: Please ask the patient what race they consider themselves to be. 3. What is the highest grade or level of school you have completed or the highest degree you have c) More than high school (includes Associate, Bachelor’s, Master’s, Professional, or Doctoral degrees) The next question is about your combined family income in the last 12 months. Please remember that by combined family income, I mean your income plus the income of all family members living in the household before taxes. This would include income from sources such as wages, salaries, Social Security or retirement benefits, help from relatives and so forth. 4. Of the following income groups, can you tell me which best represents your total household income in 5. How many persons live in your household? Now, I’d like to ask some questions about your use of alcoholic beverages. Answer the questions as honestly and accurately as you can. Remember that one drink is defined as 12 ounces of beer, 5 ounces of wine, or one standard cocktail (1.5 ounces of 80-proof liquor). 6. In a typical year before the year 2000, how often did you have a drink containing alcohol? 7. In a typical year before the year 2000, how many drinks containing alcohol did you have on a typical Now, I’m going to ask questions about your smoking habits and use of other tobacco products. 8. Have you smoked 100 CIGARETTES or more in your entire life? 9. How old were you when you started smoking? 11. If No, how old were you when you quit smoking? 12. On average, how many cigarettes do/did you smoke per day? 13. Have you smoked at least 100 CIGARS in your entire life? 14. How old were you when you started smoking CIGARS? 16. If No, how old were you when you quit smoking CIGARS? Note to interviewer: If participant reports smoking cigars less frequently than daily, enter <1. 17. On average, how many CIGARS do/did you smoke? (choose one) _____________ per day 18. Have you EVER used CHEW TOBACCO regularly for a period of six weeks or more? 19. How old were you when you started using CHEW TOBACCO? 21. If No, how old were you when you quit using CHEW TOBACCO? 22. On average, how many times per day do/did you CHEW TOBACCO? 23. Have you EVER used MOIST OR DRY SNUFF regularly for a period of six weeks or more? 24. How old were you when you started using MOIST OR DRY SNUFF? 26. If No, how old were you when you quit using MOIST OR DRY SNUFF? 27. On average, how many times per day do/did you use MOIST OR DRY SNUFF? __________________
Section H. Medications
Now I would like to ask you about some of the medications that you have taken during your lifetime. This is the last section of the interview. It would
be helpful to use the sheets that we sent you in our last letter.
1. Have you EVER taken any of the following drugs orally or BY MOUTH? b) Actonel and Calcium® or Risedronate + Calcium Carbonate f) Fosamax Plus D® or Alendronate + Vitamin D h) An oral bisphosphonate of which you don’t remember the name A Note to interviewer: Complete the A box before proceeding to the B box Please, ask the
questions 2-5 for each drug marked above and fill the box below. B Note to interviewer: Please, after
completing the section A, ask the questions below for each drug/dosage combination. 6. When did you start taking _____ (name 3. For what condition(s) were you taking _____ (name of the drug)? 4. What is the dosage, number of units and frequency that you take ___________(name of the 5. Did you ever change this prescription? Either the drug itself, the dose, the units or the If yes, enter changed prescription in a new line If answer to question is ‘Unknown’, enter UNK If year not known, ask for best guess or 9999 enter current date, if still
Note to interviewer: Possible indications of oral bisphosphonates are Osteoporosis, Paget's disease, and Heterotopic ossification. TPBRNONJ Patient Questionnaire 8. Have you EVER received any of the following drugs intravenously (IV)? b) Bonefos® and Ostac® or Clodronate (not available in the US) f) An intravenous bisphosphonate of which you don’t remember the name A Note to interviewer: Complete the A box before proceeding to the B box Please, ask the
questions 2-5 for each drug marked above and fill the box below. B Note to interviewer: Please, after
completing the section A, ask the questions below for each drug/dosage combination. 13. When did you start taking _____ (name 10. For what condition(s) were you taking _____ (name of the drug)? 11. What is the dosage, number of units and frequency that you take ___________(name of the 12. Did you ever change this prescription? Either the drug itself, the dose, the units or the If yes, enter changed prescription in a new line If answer to question is ‘Unknown’, enter UNK If year not known, ask for best guess or 9999 enter current date, if still
Note to interviewer: Possible indications of IV bisphosphonates are Metastatic bone lesions, Hypercalcemia, Multiple myeloma, Osteolytic bone lesions with metastatic breast cancer, and Paget's disease. 15. Do you remember EVER taking one of these steroid drugs? (Mark all that apply.) a) Prednisone (e.g. Deltasone®, Meticorten®, Orasone®) b) Dexamethasone (e.g. Decadron®, Dexone®, Hexadrol®) If other, please specify: ________________________ If No to all drugs, skip to question 22. A Note to interviewer: Complete the A box before proceeding to the B box Please, ask the
questions for each drug marked above and fill the box below. B Note to interviewer: Please, after
completing the section A, ask the questions below for each drug/dosage combination. 20. When did you start taking _____ (name 17. For what condition(s) were you taking _____ (name of the drug)? 18. What is the dosage, number of units and frequency that you take ___________(name of the 19. Did you ever change this prescription? Either the drug itself, the dose, the units or the If yes, enter changed prescription in a new line If answer to question is ‘Unknown’, enter UNK If year not known, ask for best guess or 9999 enter current date, if still
22. Since the year 2000, have you taken any other medication regularly or for 6 months or more? 23. What are the names of the medications? A Note to interviewer: Complete the A box before proceeding to the B box Please, ask the
questions for each drug cited above and fill the box below. B Note to interviewer: Please, after
completing the section A, ask the questions below for each drug/dosage combination. 24. For what condition(s) were you taking _____ (name of the drug)? 27. When did you start taking _____ (name 25. What is the dosage, number of units and frequency that you take ___________(name of the 26. Did you ever change this prescription? Either the drug itself, the dose, the units or the If yes, enter changed prescription in a new line If answer to question is ‘Unknown’, enter UNK If year not known, ask for best guess or 9999 enter current date, if still

Source: http://www.nationaldentalpbrn.org/pdf/TPBRNONJ%20Patient%20Questionnaire%20v050907.pdf