CRF English

University of Regensburg Tinnitus Research Initiative Tinnitus Subtyping Study

Center: 0 Principle Investigator:

Case Report Form Version: english August 2013

Patient ID: I 0 I I I - I I I I I I I

System ID: I 0 I 0 I I I I I - I 0 I I I

Database ID: I 0 I 0 I I I I I

Treatment Code I 0 I I I - I I I I 12 Wk w/ Follow-up

This study patient data is complete This study patient is a DROP OUT Æ Fill out end of study/drop-out-visit Fill out week 16 or follow-up A complete study patient data has the following visits documented:

Screening Baseline (V0) Week 2 (V1) Week 4 (V2) Week 8 (V3) Final visit (week 12) End of Study (Vend)/drop-out-visit Week 16 Study Follow-up (VFu)

Center version english: August 2013 2

Overview

Screening* Baseline* (V0)

Week 2 (V1)

Week 4 (V2)

Week 8 (V3)

Week 12 = End** (Vend)

Week 16 Follow up** (VFu)

TSCHQ A

Otological Examination A

Medical history (no CRF fomr) A

Audiometry A A B

Loudness match B B

Pitch match B B

Maskability B B

Residual Inhibition B B

THI A A A A A A A

TBF 12 B B B B B B B

Tinnitus Severity A A A A A A A

MDI B B B B B B B

WHOQOL B B B B B B B

CGI A A A A A

Concomittant medication A A A A A A A

Adverse Events A A A A A

Comorbidity A A A A A A A

Abbreviations: A Essential B Highly recommended TSCHQ Tinnitus Severity Case History Questionnaire THI Tinnitus Handicap Inventory (Newman et al 1996) TBF 12 Tinnitus Impairment Questionnaire CGI Clinical Global Impression MDI Major Depression Inventory WHOQOL World Health Organization – Quality of Life (Questionnaire) BREF Best available technique reference document

* = Screening and Baseline measurements can be performed the same day. In this case the questionnaires and the audiometry are only performed once. ** = If patients discontinues treatment, Week 12 = End Of Study as well as Week 16 = Follow-Up should be filled out.


Description of Intervention Protocol If the intervention is standardized and already in the coding list, please indicate the code: If the treatment is not standardized or not yet coded please desribe the therapy including all relevant treatment parameters; if available give published references for the protocol

If patient is a DROP-OUT record on page 83

Patient-ID I 0 I I I – I I I I I I I Date of the Visit: ________________________ (dd-mm-yyyy) SSccrreeeenniinngg


Screening Screening and Baseline measurements can be performed the same day. In this case the

questionnaires and the audiometry are only performed once.



Tinnitus Sample Case History Questionnaire (TSCHQ)

1.

Date of Birth: I I I.I I I.I I I I I (dd/mm/yyyy)

2.

Gender: Male Female

3.

Handedness Right Left Both Sides

4.

Family history of tinnitus complaints YES if YES: parents siblings children NO

5.

Initial onset: When did you first experience your tinnitus? I I I.I I I.I I I I I (dd/mm/yyyy)

6.

How did you perceive the beginning? Gradual Abrupt

7.

Was the initial onset of your tinnitus related to: loud blast of sound whiplash change in hearing stress head trauma other

8.

Does your tinnitus seem to PULSATE ? YES with heart beat YES, different from heart beat NO



9.

Where do you perceive your tinnitus right ear left ear both ears, worse in left both ears, worse in right both ears, equally inside the head elsewhere

10.

How does your tinnitus manifest itself over time? intermittent constant

11.

Does the LOUDNESS of the tinnitus vary from day to day? YES NO

12.

Describe the LOUDNESS of your tinnitus using a scale from 1-100. (1 = VERY FAINT; 100 = VERY LOUD) I I I I ( 1 – 100 )

13

Please describe in your own words what your tinnitus usually sounds like: The following list gives examples of some possible sensations, feel free to use other terms as well: hissing, ringing, pulsing, buzzing, clicking, cracking, tonal (like a dial tone or other kinds of tones), humming, popping, roaring, rushing, typewriter, whistling, whooshing.

14.

Does your tinnitus more sound like a tone or more like noise: tone noise crickets other



15.

Please describe the PITCH of your tinnitus: very high frequency high frequency medium frequency low frequency

16.

What percent of your total awake time, over the last month, have you been aware of your tinnitus? For example, 100% would indicate that you were aware of your tinnitus all the time, and 25% would indicate that you were aware of your tinnitus ¼ of the time I I I I % (Please write in a single number between 1 and 100).

17.

What percent of your total awake time, over the last month, have you been annoyed, distressed, or irritated of your tinnitus ? I I I I % (Please write in a single number between 1 and 100).

18.

How many different treatments have you undergone because of your tinnitus ? none one 2 - 4 5 and more

19.

Is your tinnitus reduced by music or by certain types of environmental sounds such as the noise of a waterfall or the noise of running water when you are standing in the shower ? YES NO I don’t know

20.

Does the presence of loud noise make your tinnitus worse? YES NO I don’t know

21.

Does any head and neck movement (e.g. moving the jaw forward or clenching the teeth), or having your arms/hands or head touched, affect your tinnitus ? YES NO



22.

Does taking a nap during the day affect your tinnitus? worsens my tinnitus reduces my tinnitus has no effect

23.

Is there any relationship between sleep at night and your tinnitus during the day ? YES NO I don’t know

24.

Does stress influence your tinnitus? worsens my tinnitus reduces my tinnitus has no effect

25.

Does medication have an effect on your tinnitus? Medication Effect / Details

26.

Do you think you have a hearing problem? YES NO

27.

Do you wear hearing aids? Right Left Both None

28.

Do you have a problem tolerating sounds because they often seem much too loud? That is, do you often find too loud or hurtful sounds which other people around you find quite comfortable ? Never Rarely Sometimes Usually Always



29.

Do sounds cause you pain or physical discomfort ? YES NO I don’t know

30.

Do you suffer from headache? YES NO

31.

Do you suffer from vertigo or dizziness? YES NO

32.

Do you suffer from temporomandibular disorder? YES NO

33.

Do you suffer from neck pain ? YES NO

34.

Do you suffer from other pain syndromes? YES NO

35.

Are you currently under treatment for psychiatric problems ? YES NO



Tinnitus Handicap Inventory

Instructions: The purpose of this questionnaire is to identify difficulties that you may be experiencing because of your tinnitus. Please answer every question. Please do not skip any question. Please mark one answer with an _

1. Because of your tinnitus, is it difficult for you to concentrate?

yes sometimes no

2. Does the loudness of your tinnitus make it difficult for you to hear people?

yes sometimes no

3. Does your tinnitus make you angry?

yes sometimes no

4. Does your tinnitus make you feel confused?

yes sometimes no

5. Because of your tinnitus, do you feel desperate?

yes sometimes no

6. Do you complain a great deal about your tinnitus?

yes sometimes no

7. Because of your tinnitus, do you have trouble falling to sleep at night?

yes sometimes no

8. Do you feel as though you cannot escape your tinnitus?

yes sometimes no

9. Does your tinnitus interfere with your ability to enjoy your social activities (such as going out to dinner, to the movies)?

yes sometimes no

10. Because of your tinnitus, do you feel frustrated?

yes sometimes no

11. Because of your tinnitus, do you feel that you have a terrible disease?

yes sometimes no

12. Does your tinnitus make it difficult for you to enjoy life?

yes sometimes no

13. Does your tinnitus interfere with your job or household responsibilities?

yes sometimes no



14. Because of your tinnitus, do you find that your are often irritable?

yes sometimes no

15. Because of your tinnitus, is it difficult for you to read?

yes sometimes no

16. Does your tinnitus make you upset?

yes sometimes no

17. Do you feel that your tinnitus problem has placed stress on your relationships with members of your family and friends?

yes sometimes no

18. Do you find it difficult to focus your attention away from your tinnitus and on other things?

yes sometimes no

19. Do you feel that you have no control over your tinnitus?

yes sometimes no

20. Because of your tinnitus, do you often feel tired?

yes sometimes no

21. Because of your tinnitus, do you feel depressed?

yes sometimes no

22. Does your tinnitus make you feel anxious?

yes sometimes no

23. Do you feel that you can no longer cope with your tinnitus?

yes sometimes no

24. Does your tinnitus get worse when you are under stress?

yes sometimes no

25. Does your tinnitus make you feel insecure?

yes sometimes no



TBF 12 Tinnitus Impairment Questionnaire

Instructions: The purpose of this questionnaire is to identify problems your tinnitus is causing you. Please answer Never, Sometimes, or Often for each question. Check the answer that best applies. Do not skip any question. Please mark one answer with an _

Never Sometimes Often

1. Because of your tinnitus is it difficult for you to concentrate?

2. Is it difficult for you to understand what people are saying because of the intensity of your tinnitus?

3. Do you get annoyed by your tinnitus?

4. Do you feel that you cannot escape your tinnitus?

5. Does your tinnitus interfere with your social activities (such as going out to dinner, to the movies)?

6. Do you feel frustrated because of your tinnitus?


8. Because of your tinnitus is it difficult for you to read?

9. Do you feel that your tinnitus has placed stress on your relationship with members of your family and friends?

10. Do you find it difficult to focus your attention on things other than your tinnitus?


12. Do you feel that you can’t cope with your tinnitus?



Tinnitus Severity In the questions below, please mark the number that best describes you: Please mark one answer with an _ 1. How much of a problem is your tinnitus at present?

not a problem a small problem a moderate problem

a big problem a very big problem

1

2

3

4

5

2. How STRONG or LOUD is your tinnitus at present? Not at all strong

or loud 0

1

2

3

4

5

6

7

8

9

10

extremely strong or loud

3. How UNCOMFORTABLE is your tinnitus at present, if everything around you is quiet?

Not at all uncomfortable

0

1

2

3

4

5

6

7

8

9

10

extremely uncomfortable

4. How ANNOYING is your tinnitus at present?

Not at all annoying

0

1

2

3

4

5

6

7

8

9

10

extremely annoying

5. How easy is it for you to IGNORE your tinnitus at present?

Very easy to ignore

0

1

2

3

4

5

6

7

8

9

10

Impossible to ignore

6. How UNPLEASANT is your tinnitus at present?

Not at all unpleasant

0

1

2

3

4

5

6

7

8

9

10

Extremely unpleasant



Major (ICD-10) Depression Inventory - MDI

The following questions ask about how you have been feeling over the last two weeks.

Please put a tick in the box which is closest to how you have been feeling.

How much of the time... All the time

Most of the time

Slightly more than

half the time

Slightly less than half the

time

Some of the time

At no time

1 Have you felt low in spirits or sad? □ □ □ □ □ □

2 Have you lost interest in your daily activities? □ □ □ □ □ □

3 Have you felt lacking in energy and strength? □ □ □ □ □ □

4 Have you felt less self-confident? □ □ □ □ □ □

5 Have you had a bad conscience or feelings of guilt? □ □ □ □ □ □

6 Have you felt that life wasn't worth living? □ □ □ □ □ □

7 Have you had difficulty in concentrating, e.g. when reading the newspaper of watching TV?

□ □ □ □ □ □

8a* Have you felt very restless? □ □ □ □ □ □

8b* Have you felt subdued or slowed down? □ □ □ □ □ □

9 Have you had trouble sleeping at night? □ □ □ □ □ □

10a* Have you suffered from reduced appetite? □ □ □ □ □ □

10b* Have you suffered from increased appetite? □ □ □ □ □ □

Psychiatric Research Unit, Clinimetrics Centre of Mental Health, Frederiksborg General Hospital, DK-4300 Hillerød WHO Collaborating Centre in Mental Health



WHOQOL-BREF

The following questions ask how you feel about your quality of life, health, or other areas of your life. I will read out each question to you, along with the response options. Please choose the answer that appears most appropriate. If you are unsure about which response to give to a question, the first response you think of is often the best one. Please keep in mind your standards, hopes, pleasures and concerns. We ask that you think about your life in the last four weeks. Please mark one answer with an _ Very poor Poor Neither poor

nor good Good Very good

1. How would you rate your quality of life?

1

2

3

4

5

Very

dissatisfied Dissatisfied Neither

satisfied nor dissatisfied

Satisfied Very satisfied

2. How satisfied are you with your health?

1

2

3

4

5

The following questions ask about how much you have experienced certain things in the last four weeks. Not at all A little A moderate

amount Very much An extreme

amount 3. To what extend do

you feel that physical pain prevents you

from doing what your need to do?

5

4

3

2

1

4. How much do you need any medical

treatment to function in your daily life?

5

4

3

2

1

5. How much do you enjoy life?

1

2

3

4

5

6. To what extend do you feel your life to be

meaningful?

1

2

3

4

5

Not at all A little A moderate

amount Very much Extremely

7. How well are you able to concentrate?

1

2

3

4

5

8. How safe do you feel in your daily life?

1

2

3

4

5

9. How healthy is your physical environment?

1

2

3

4

5



The following questions ask about how competely you experience or were able to do certain things in the last four weeks.

Not at all A little Moderately Mostly Completely 10. Do you have enough

energy for everyday life?

1

2

3

4

5

11. Are you able to accept your bodily

appearance?

1

2

3

4

5

12. Have you enough money to meet your

needs?

1

2

3

4

5

13. How available to you ist he information that you need in your day-

to-day life?

1

2

3

4

5

14. To what extend do you have the

opportunity for leisure activities?

1

2

3

4

5

Very poor Poor Neither poor


15. How well are you able to get around?

1

2

3

4

5

Very




16. How satisfied are you with your sleep?

1

2

3

4

5

17. How satisfied are you with your ability to perform your daily living activities?

1

2

3

4

5

18. How satisfied are your with your capacity for

work?

1

2

3

4

5

19. How satisfied are you with yourself?

1

2

3

4

5

20. How satisfied are you with your personal

relationships?

1

2

3

4

5

21. How satisfied are you with your sex life?

1

2

3

4

5

22. How satisfied are you with the support you

get from your friends?

1

2

3

4

5

23. How satsified are you with the conditions of

your living place?

1

2

3

4

5

24. How satisfied are you with your access to

health services?

1

2

3

4

5

25. How satisfied are you with your transport?

1

2

3

4

5



The following question refers to how often you have felt or experienced certain things in the last four weeks

Never Seldom Quite often Very often Always 26. How often do you

have negative feelings such as blue

mood, despair, anxiety, depression?

5

4

3

2

1

© World Health Organization 2004



Comorbidity

If the patient is suffering from any clinically relevant comorbity at study enrollment (Screening), please document these in the Comorbidity Form (page 101).

Concomittant Medication If the patient is taking any kind of medication at study enrollment or 3 months before, please document these in the Concomittant Medication Form (page 97 - 98).

For non-pharmacological interventions please document these in the Non-pharmacological Intervention Form (page 102).



Otological Examination Did the Otological Examination reveal any clinically relevant pathological findings?

No Yes, please specify:



Audiological Examination

Audiometry Date of Exam ____.____.______ (dd. mm.yyyy) Right Ear Frequency 125

Hz 250 Hz

500 Hz

1 kHz

2 kHz

3 kHz

4 kHz

6 kHz

8 kHz

Hearing loss [dB HL]

Frequency 10

kHz 11,2 kHz

12,5 kHz

14 kHz

16 kHz


normal (0-20 dB HL) AHZ (21-60 dB HL) IHZ (61-x dB HL)

Left Ear Frequency 125

Hz 250 Hz

500 Hz

1 kHz

2 kHz

3 kHz

4 kHz

6 kHz

8 kHz


Frequency 10

kHz 11,2 kHz

12,5 kHz

14 kHz

16 kHz



Tinnitusmatching Tinnitus: Right Left both sides Right I I I I I I - I I I I I I Hz

pure tone narrow band broad band not defineable Left I I I I I I - I I I I I I Hz

pure tone narrow band broad band not defineable Minimal Masking Level Right I I I I I dB Left I I I I I dB Objective Tinnitus or other excluding criteria? NO YES Residual inhibition:

No Partial Complete Duration [sec.]:



I certify that the patient has correctly filled out the CRF pages 5–17 (Screening) to the best of his/her knowledge. I I I.I I I.I I I I I ________________________ Date (dd/mm/yy Doctor’s signature

Patient-ID I 0 I I I – I I I I I I I Date of the Visit: ________________________ (dd-mm-yyyy) BBaasseelliinnee ((VV00))


Baseline (V0) Screening and Baseline measurements can be performed the same day. In this case the

questionnaires and the audiometry are only performed once.



Comorbidity

If the patient is suffering from any NEW (compared to Screening) clinically relevant comorbity, please document these in the Comorbidity Form (page 101).

Concomittant Medication If the patient is taking any kind of NEW (compared to Screening) medication, please document these in the Concomittant Medication Form (page 97 - 98). Please also document tinnitus specific drugs if this is a pharmacological intervention.




Otological Examination

(only to be filled in if not performed during screening!) Did the Otological Examination reveal any clinically relevant pathological findings?

No Yes, please specify:



Audiological Examination (only to be filled in if not performed during screening!)


Hz 250 Hz

500 Hz

1 kHz

2 kHz

3 kHz

4 kHz

6 kHz

8 kHz


Frequency 10

kHz 11,2 kHz

12,5 kHz

14 kHz

16 kHz




Hz 250 Hz

500 Hz

1 kHz

2 kHz

3 kHz

4 kHz

6 kHz

8 kHz


Frequency 10

kHz 11,2 kHz

12,5 kHz

14 kHz

16 kHz






No Partial Complete Duration [sec]:





1. Because of your tinnitus, is it difficult for you to Concentrate?

yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no

6. Do you complain a great deal about you tinnitus?

yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no




yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no






1

2

3

4

5


or loud 0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10



Not at all annoying

0

1

2

3

4

5

6

7

8

9

10

extremely annoying


Very easy to ignore

0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10








Most of the time

Slightly more than

half the time


time

Some of the time

At no time








□ □ □ □ □ □









WHOQOL-BREF




1

2

3

4

5

Very





1

2

3

4

5






5

4

3

2

1



5

4

3

2

1


1

2

3

4

5


meaningful?

1

2

3

4

5




1

2

3

4

5


1

2

3

4

5


1

2

3

4

5






1

2

3

4

5


appearance?

1

2

3

4

5


needs?

1

2

3

4

5


to-day life?

1

2

3

4

5



1

2

3

4

5




1

2

3

4

5

Very





1

2

3

4

5


1

2

3

4

5


work?

1

2

3

4

5


1

2

3

4

5


relationships?

1

2

3

4

5


1

2

3

4

5



1

2

3

4

5


your living place?

1

2

3

4

5


health services?

1

2

3

4

5


1

2

3

4

5







5

4

3

2

1




I certify that the patient has correctly filled out the CRF pages 26–33 (Baseline) to the best of his /her knowledge. I I I.I I I.I I I I I ________________________ Date (dd/mm/yy) Doctor’s Signature

Patient-ID I 0 I I I – I I I I I I I Date of the Visit: ________________________ (dd-mm-yyyy) WWeeeekk 22 ((VV11))


Week 2 (V1)



Adverse Events

If the patient is suffering from any Adverse Event, please document these in the Adverse Event Report Form (page 100).

Concomittant Medication If the patient is taking any kind of NEW or modified (compared to Baseline) medication, please document these in the Concomittant Medication Form (page 97 - 98). Please also document tinnitus specific drugs if this is a pharmacological intervention.







yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no




yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no

22. Does your tinnitus make your feel anxious?

yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no






1

2

3

4

5


or loud 0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10



Not at all annoying

0

1

2

3

4

5

6

7

8

9

10

extremely annoying


Very easy to ignore

0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10








Most of the time

Slightly more than

half the time


time

Some of the time

At no time








□ □ □ □ □ □









WHOQOL-BREF




1

2

3

4

5

Very





1

2

3

4

5






5

4

3

2

1



5

4

3

2

1


1

2

3

4

5


meaningful?

1

2

3

4

5




1

2

3

4

5


1

2

3

4

5


1

2

3

4

5






1

2

3

4

5


appearance?

1

2

3

4

5


needs?

1

2

3

4

5


to-day life?

1

2

3

4

5



1

2

3

4

5




1

2

3

4

5

Very





1

2

3

4

5


1

2

3

4

5


work?

1

2

3

4

5


1

2

3

4

5


relationships?

1

2

3

4

5


1

2

3

4

5



1

2

3

4

5


your living place?

1

2

3

4

5


health services?

1

2

3

4

5


1

2

3

4

5







5

4

3

2

1




CGI (Clinical Global Impression) Global Improvement Please rate the total improvement of your tinnitus complaints compared to before beginning of treatment Please mark one answer with an _ 1:Very much better 2: Much better 3: Minimally better 4: No change 5: Minimally worse 6: Much worse 7: Very much worse



I certify that the patient has correctly filled out the CRF pages 37 – 45 (Week 2) to the best of his /her knowledge. I I I.I I I.I I I I I ________________________ Date (dd/mm/yy) Doctor’s Signature



Week 4 (V2)



Adverse Events


Concomittant Medication If the patient is taking any kind of NEW or modified (compared to Baseline) medication, please document these in the Concomittant Medication Form (page 97 - 98) Please also document tinnitus specific drugs if this is a pharmacological intervention.







yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no




yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no






1

2

3

4

5


or loud 0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10



Not at all annoying

0

1

2

3

4

5

6

7

8

9

10

extremely annoying


Very easy to ignore

0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10








Most of the time

Slightly more than

half the time


time

Some of the time

At no time








□ □ □ □ □ □









WHOQOL-BREF




1

2

3

4

5

Very





1

2

3

4

5






5

4

3

2

1



5

4

3

2

1


1

2

3

4

5


meaningful?

1

2

3

4

5




1

2

3

4

5


1

2

3

4

5


1

2

3

4

5






1

2

3

4

5


appearance?

1

2

3

4

5


needs?

1

2

3

4

5


to-day life?

1

2

3

4

5



1

2

3

4

5




1

2

3

4

5

Very





1

2

3

4

5


1

2

3

4

5


work?

1

2

3

4

5


1

2

3

4

5


relationships?

1

2

3

4

5


1

2

3

4

5



1

2

3

4

5


your living place?

1

2

3

4

5


health services?

1

2

3

4

5


1

2

3

4

5







5

4

3

2

1




Week 8 (V3)



Adverse Events









yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no




yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no






1

2

3

4

5


or loud 0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10



Not at all annoying

0

1

2

3

4

5

6

7

8

9

10

extremely annoying


Very easy to ignore

0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10








Most of the time

Slightly more than

half the time


time

Some of the time

At no time








□ □ □ □ □ □









WHOQOL-BREF




1

2

3

4

5

Very





1

2

3

4

5






5

4

3

2

1



5

4

3

2

1


1

2

3

4

5


meaningful?

1

2

3

4

5




1

2

3

4

5


1

2

3

4

5


1

2

3

4

5






1

2

3

4

5


appearance?

1

2

3

4

5


needs?

1

2

3

4

5


to-day life?

1

2

3

4

5



1

2

3

4

5




1

2

3

4

5

Very





1

2

3

4

5


1

2

3

4

5


work?

1

2

3

4

5


1

2

3

4

5


relationships?

1

2

3

4

5


1

2

3

4

5



1

2

3

4

5


your living place?

1

2

3

4

5


health services?

1

2

3

4

5


1

2

3

4

5







5

4

3

2

1


Patient-ID I 0 I I I – I I I I I I I Date of the Visit: ________________________ (dd-mm-yyyy) Final Visit (week 12) - End of Study / Drop-out-visit


final visit (week 12) – end of study drop-out-visit



Adverse Events






Audiological Examination


Hz 250 Hz

500 Hz

1 kHz

2 kHz

3 kHz

4 kHz

6 kHz

8 kHz


Frequency 10

kHz 11,2 kHz

12,5 kHz

14 kHz

16 kHz




Hz 250 Hz

500 Hz

1 kHz

2 kHz

3 kHz

4 kHz

6 kHz

8 kHz


Frequency 10

kHz 11,2 kHz

12,5 kHz

14 kHz

16 kHz






No Partial Complete Duration [sec.]:



Tinnitus Handicap Inventory Instructions: The purpose of this questionnaire is to identify difficulties that you may be experiencing because of your tinnitus. Please answer every question. Please do not skip any question. Please mark one answer with an _


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no




yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no






1

2

3

4

5


or loud 0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10



Not at all annoying

0

1

2

3

4

5

6

7

8

9

10

extremely annoying


Very easy to ignore

0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10








Most of the time

Slightly more than

half the time


time

Some of the time

At no time








□ □ □ □ □ □









WHOQOL-BREF




1

2

3

4

5

Very





1

2

3

4

5






5

4

3

2

1



5

4

3

2

1


1

2

3

4

5


meaningful?

1

2

3

4

5




1

2

3

4

5


1

2

3

4

5


1

2

3

4

5






1

2

3

4

5


appearance?

1

2

3

4

5


needs?

1

2

3

4

5


to-day life?

1

2

3

4

5



1

2

3

4

5




1

2

3

4

5

Very





1

2

3

4

5


1

2

3

4

5


work?

1

2

3

4

5


1

2

3

4

5


relationships?

1

2

3

4

5


1

2

3

4

5



1

2

3

4

5


your living place?

1

2

3

4

5


health services?

1

2

3

4

5


1

2

3

4

5







5

4

3

2

1




1. Is the patient interested in continuing the treatment? Yes No If no, please give reasons:

no beneficial effect

side effects due to treatment Others In case of yes in question 1: 2. Will the treatment be continued? Yes No If no, please give reasons:

treatment not available

treatment too expensive Others

If patient is a DROP-OUT record date: I I I.I I I.I I I I I (dd/mm/yyyy) not specified

DROP-OUT Reasons

No beneficial effect

psychopathological deterioration

adverse events

consent withdrawn

meets the exclusion criteria

lost to follow-up without known reason

other reasons – please specify:


Patient-ID I 0 I I I – I I I I I I I Date of the Visit: ________________________ (dd-mm-yyyy) WWeeeekk 1166 == FFoollllooww--UUpp ((VVFFuu))


Week 16 = Follow-Up (VFu)



Adverse Events








1. Because of your tinnitus, is it difficult for you to Concentrate?

yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no




yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no

19. Do you feel that your have no control over your tinnitus?

yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no


yes sometimes no






1

2

3

4

5


or loud 0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10



Not at all annoying

0

1

2

3

4

5

6

7

8

9

10

extremely annoying


Very easy to ignore

0

1

2

3

4

5

6

7

8

9

10




0

1

2

3

4

5

6

7

8

9

10








Most of the time

Slightly more than

half the time


time

Some of the time

At no time








□ □ □ □ □ □









WHOQOL-BREF




1

2

3

4

5

Very





1

2

3

4

5






5

4

3

2

1



5

4

3

2

1


1

2

3

4

5


meaningful?

1

2

3

4

5




1

2

3

4

5


1

2

3

4

5


1

2

3

4

5






1

2

3

4

5


appearance?

1

2

3

4

5


needs?

1

2

3

4

5


to-day life?

1

2

3

4

5



1

2

3

4

5




1

2

3

4

5

Very





1

2

3

4

5


1

2

3

4

5


work?

1

2

3

4

5


1

2

3

4

5


relationships?

1

2

3

4

5


1

2

3

4

5



1

2

3

4

5


your living place?

1

2

3

4

5


health services?

1

2

3

4

5


1

2

3

4

5







5

4

3

2

1




CGI (Clinical Global Impression) Global Improvement Please rate the total improvement of your tinnitus complaints compared to before beginning of treatment Please mark one answer with an _

1:Very much better

2: Much better

3: Minimally better

4: No change

5: Minimally worse

6: Much worse

7: Very much worse

Patient-ID I 0 I I I – I I I I I I I DDooccuummeennttaattiioonn ooff mmeeddiiccaattiioonn iinncclluuddiinngg ssttuuddyy mmeeddiiccaattiioonn iinn ccaassee ooff pphhaarrmmaa wwoorrkkggrroouupp ssttuuddyy


Instruction Concomittant Medication General Information: Please record here all drugs (even over-the-counter drugs) including the Study Medication, which have been ingested within the last three months before screening respectively up to the time of study starting and which will be ingested during the study. Please use a new line for every new drug!

Active Ingredient Please mention the active ingredients of each used drug including the Study Medication. See that the spelling of the drug’s name is correct and do not use any abbreviations!

Unit For example gram (g), milligram (mg), milliliter (ml), etc. For compound preparation please mention the pharmaceutical form „cap“ (capsule), „tab“ (tablet), etc. instead of the unit!

Dose Please specifiy the concentration per unit during the mentioned time intervall. For compound preparation please specify the number of capsules, tablets etc.! If the daily dosage of the drug has been changed, this should be documented with a stop date. In a new line, the changed (new) dosage will be documented with a start date of first intake of the new dosage.

Dose Regime Please use the following abbreviations: qd 1 x daily 6xd 6 x daily qw 1 x a week bid 2 x daily prn if required biw 2 x a week tid 3 x daily qod every second day tiw 3 x a week qid 4 x daily qow every second week qm 1 x a month 5xd 5 x daily

Route Please use one of the following abbreviations: po oral sl sublingual top topical iv intravenous td transdermal pr rectal im intramuscular inh by inhalation pv vaginal sc subcutaneous nas nasal son others

Start / Stop date or ongoing Please fill in the date when the drug was ingested first / last (start / stop date). If you do not know the exact date please mention the year at least. At every visit and at the end of the study it has to be checked, if any single drug has been discontinued in the meantime (by indicating the finish date) respectively if it will be further ingested after the end of the study. In this case please make a check mark where applicable. The End Date cannot be before the Begin Date.



No concomittant medication No. Active Ingredient Dose Unit Dose

regimen Route Begin

(dd/mm/yyyy) Stop date (dd/mm/yyyy)

Ongoing? ;

01 I I I.I I I.I I I I I I I I.I I I.I I I I I








Date (end of study): I I I.I I I.I I I I I Name: Signature:



No concomittant medication No. Active Ingredient Dose Unit Dose

regimen Route Begin

(dd/mm/yyyy) Stop date (dd/mm/yyyy)

Ongoing? ;










Patient-ID I 0 I I I – I I I I I I I AAddvveerrssee EEvveennttss


Instruction Adverse Event Adverse Event Please fill in every adverse event during the study treatments.

Start date / finish date or ongoing after the end of study

Please fill in the date when the adverse events appeared the first / the last time. Please check all the adverse events documented during the visits and at the end of the study with regard to its finish date and list it in the column. In case of ongoing up to the time of the follow-up periord (adverse event is not decayed yet) please make a check mark where applicable. The END date cannot be before the BEGIN date.

Intensity Please describe the intensity of the adverse event. 1 = light 2 = medium 3 = serious

Relation to drug treatment

Please describe the relationship between adverse event and the study treatment. 0 = no relationship 1 = doubtful 2 = possible 3 = probably 4 = certain

Consequences for drug treatment

Please describe the consequences for study treatment. 0 = unchanged dose rate 3 = temporarily interrupted 1 = increased dose rate 4 = study treatment terminated 2 = reduced dose rate

Other action taken Other action taken? 0 = none 1 = drug treatment (please mention) 2 = other medical treatment 3 = (extended) hospitalization 4 = diagnostic and clinical tests 5 = others

Outcome At the end of the study, please check all adverse events documented during all visits regarding the outcome and fill in the corresponding code. 1 = already recovered 4 = not recovered 2 = still recovering 5 = death (Indication as SAE necessary) 3 = recovered with deficits 6 = unknown

Patient-ID I 0 I I I – I I I I I I I AAddvveerrssee EEvveennttss


No adverse event

No. Adverse Event Begin (dd/mm/yyyy)

Stop date or ongoing at study end? ;

Intensity relation to drug treatment

consequences for drug treatment

other action taken

outcome

01

I I I.I I I.I I I I I I I I.I I I.I I I I I I I I I I I I I I I

02


03


04


05


06


07


08



Patient-ID I 0 I I I – I I I I I I I CCoommoorrbbiiddiittyy


No Comorbidity

No. Disease Begin

(dd/mm/yyyy) Stop date or ongoing? ;

Treatment 1 – No treatment 2. – Drug treatment

01 I I I.I I I.I I I I I I I I.I I I.I I I I I I I I I









Patient-ID I 0 I I I – I I I I I I I NNoonn--pphhaarrmmaaccoollooggiiccaall IInntteerrvveennttiioonn


No. Type of Intervention Frequency per week Begin (dd/mm/yyyy)

Stop date (dd/mm/yyyy)

Ongoing? ;










CRF English

Documents

Transcript of CRF English