Osteoarthritis Pain Survey DRAFT

Hepatitis C Survey

Thank you for your interest in this health survey. In this survey, we will ask you about your experience with hepatitis C and your preferences for different possible hepatitis C medicines.

If you have any problems or concerns about this survey, please contact your help desk using the information you were provided when you were invited to the survey.

Please answer the following questions to confirm that you are eligible to participate in this survey.

[Screening Questions]

S1.Are you 18 years of age or older?

YES [CONTINUE]

NO [INELIGIBLE, END SURVEY]

S2.Have you ever been diagnosed with any of the following conditions by a doctor?

(Please select all that apply.)

Anxiety

Cancer

Depression

Diabetes

Gout

Heart Disease

Hepatitis C

Kidney Disease

Multiple Sclerosis

Osteoporosis

Psoriasis

Rheumatoid Arthritis

None of these

Eligible if answer yes to S1 and Hep C Selected in S2.

Ineligible, end survey.

Background Questions

B1.What is your gender?

Male

Female

B2.What is your marital status?

Married

Widowed

Divorced or separated

Single

Other

B3.What is your year of birth? ______

B4.What is the highest level of education you have completed? (Tick only one answer)

Less than secondary school education

Some secondary school education

Secondary school qualification

University first degree

Some postgraduate education but no higher degree obtained

Postgraduate or professional qualification

Other

B5.Which of the following best describes your current employment status?
(Tick only one answer)

Employed full-time

Employed part-time

Self-employed

Student

Retired

Unable to work due to disability or other health problem

Unemployed and looking for work

Unemployed and not looking for work

Other

[Consent Screen 1]

Study Purpose

You are one of about 200 people with hepatitis C in Europe who are being asked to take a survey to help us understand people’s preferences for different hepatitis C medicines. In this survey we will ask you about your experience with hepatitis C and your thoughts about possible hepatitis C medicines.

Study Duration

The survey will take about 45minutes to complete.

Study Details

This research study is being run by Research Triangle Institute (RTI) on behalf of a pharmaceutical company. RTI is a not-for-profit research organization in Research Triangle Park, North Carolina, United States. RTI has contracted with Knowledge Networks (KN) to collect data.

[Consent Screen 2]

Possible Risks or Discomforts

KN will protect your responses under its Privacy Policy. RTI and the pharmaceutical company will receive your survey responses, no personal identifiers. RTI also will make every effort to protect your responses. There is a potential risk of disclosure of the survey data, but the data could not be directly tied to you.

If you have concerns about your rights as a participant, you may e-mail the RTI Office of Research Protection at .

Benefits

There are no direct benefits to you from participating in this study. Your responses are very important because they will help researchers to understand people’s preferences for different hepatitis C medicines.

[Consent Screen 3]

Confidentiality

Many steps have been taken to protect your information. KN will report only your responses to RTI, not your names. If the results of this study are presented at scientific meetings or published in scientific journals, no information will be included that could identify you or your responses personally.

The Institutional Review Board (IRB) at RTI has reviewed this research. An IRB is a group of people who make sure that the rights of participants in research are protected. The IRB may check records of your activity in this research to see if proper procedures were followed.

Your Rights

Your decision to take part in this research study is completely voluntary. Your decision to participate in this study will not affect your usual medical care. You can refuse to answer any question or stop at any point after you begin the survey and still receive your KN points for participating in the survey.

[Consent Screen 4]

If you have read the previous screens andagree to participate, please click the Yes button, if not, click the No button.

Yes, Iagree to participate. [continue with next section]

No, I do not agree to participate. [go on to next question]

Are you sure you don't want to participate? Your opinions are important to us. Please select the Yes button to continue this survey; if not, select the No button to exit.

Yes, Iagree to participate. [continue with next section]

No, I do not agree to participate [end survey].

[If they do not agree to participate]

Thank you for your time. You have exited the survey.

Hepatitis C

Hepatitis C is a disease of the liver caused by the hepatitis C virus.Hepatitis C is spread by contact with the blood of an infected person. Most people infected with hepatitis C have no symptoms. Blood tests can detect if a person is infected with hepatitis C, but most people don’t find out that they have the infection until years later, after their liver has already been damaged.

There is no vaccine to prevent hepatitis C, but prescription medicines are available to treat the disease.

[NOTE: This definition and the section entitled “Your Experience with Hepatitis C” (Q1 to Q16) and Q30-Q31 was not shown to respondents from Spain.]

Your Experience with Hepatitis C

1.How long ago were you diagnosed with hepatitis C?

Less than 6 months

6 months to 1 year

2 to 5 years

6 to 10 years

More than 10 years

2.Different forms of hepatitis C are called genotypes. What genotype do you have?

Genotype 1

Genotype 2

Genotype 3

Genotype 4

Other genotype

Don’t know/not sure

3.Are you currently taking prescription hepatitis Cmedicines?

Yes[Goto Q4]

No[Skip to Q6]

4.Which of the following hepatitis Cmedicines are you currently using (Tick only one answer)?

Interferon (Intron A) ONLY

Interferon (Intron A) PLUS ribavirin (Copegus or Rebetol)

Peginterferon alfa-2a (Pegasys) ONLY

Peginterferon alfa 2b (PegIntron) ONLY

Peginterferon alfa-2a (Pegasys) PLUS ribavirin (Copegus or Rebetol)

Peginterferon alfa 2b (PegIntron) PLUS ribavirin (Copegus or Rebetol)

Ribavirin ONLY

Other

Don’t know

5.For how long did your doctor tell you to take your current prescription hepatitis C medicines?

Less than 12 weeks (about 3 months)

12 weeks to 24 weeks (about 3 to 6 months)

25 weeks to 36 weeks (about 6 to 9 months)

37 weeks to 48 weeks (about 9 to 12 months)

More than 48 weeks (more than a year)

Not sure/can’t remember

6.Have you ever taken prescription hepatitis C medicines previously?

Yes[Go to Q7]

No[Go to Q10]

7.Which of the following hepatitis C medicines did you takepreviously(Tick only one answer)?

Interferon (Intron A) ONLY

Interferon (Intron A) PLUS ribavirin (Copegus or Rebetol)

Peginterferon alfa-2a (Pegasys) ONLY

Peginterferon alfa 2b (PegIntron) ONLY

Peginterferon alfa-2a (Pegasys) PLUS ribavirin (Copegus or Rebetol)

Peginterferon alfa 2b (PegIntron) PLUS ribavirin (Copegus or Rebetol)

Ribavirin ONLY

Other

Don’t know

8.How long did you take the hepatitis C medicine(s)?

Less than 12 weeks (about 3 months)

12 weeks to 24 weeks (about 3 to 6 months)

25 weeks to 36 weeks (about 6 to 9 months)

37 weeks to 48 weeks (about 9 to 12 months)

More than 48 weeks (more than a year)

Not sure/can’t remember

9. Why did you stop taking thehepatitis C medicine(s)?

I finished the treatment and am waiting for final results.

The medicine got rid of my hepatitis C infection.

My doctor told me the medicine was not working for me.

The medicine made me feel ill. [NOTE: For Germany, this comment was replaced with “I experienced side effects”.]

I didn’t think I needed the medicine.

The medicine was too expensive.

Other

Not sure

10.Besides hepatitis C, do you have any other chronic (lifetime) medical conditions that you take prescription medicines to treat?

Yes[Go to Q11]

No[Skip to next section]

11.Some prescription medicines contain two or more medicines in the same tablet or injection. Not counting any prescription medicines that you may be taking for your hepatitis C, how many different prescription medicines do you take each day? Please count all medicines individually, even if you take some as combinations.

0 [Skip to next section]

1 – 3[Go to Q12]

4 – 6[Skip to next section]

7 or more[Skip to next section]

12.Not counting any prescription medicines that you may be taking for your hepatitis C, do any of the other prescription medicines you are taking have special instructions, such as taking with meals or avoiding fatty foods?

Yes[Skip to next section]

No [Skip to next section]

FOR PATIENTS WHO INDICATED PRIOR/CURRENT TREATMENT ONLY («Yes» to Q3 or Q6)

13.How long after you were diagnosed with hepatitis C did you start[if Q3=yes and Q6=no: your current / if Q3=no and Q6=yes: your previous / if Q3=yes and Q6=yes: your first]treatment?

Almost immediately[Go to next section]

Within 6 months[Go to next section]

More than 6 months but less than 1 year[Go to Q14]

More than 1 year but less than 2 years[Go to Q14]

More than 2 years but less than 5 years[Go to Q14]

5 years or more [Go to Q14]

Not sure/can’t remember[Go to next section]

14.Why didn’t you start treatment for your hepatitis C straight away? (Tick all that apply)

I didn’t realise that hepatitis C was serious.

My doctor said I didn’t need treatment because my liver was okay.

I was worried about side effects.

I didn’t think the medicine would work for me.

I thought better treatments might be available in the future.

The medicines were too expensive.

I didn’t want my friends, loved ones, or co-workers to know I had hepatitis C.

I was afraid that the medicines for hepatitis C would interact with medicines I was taking for another condition.

My doctor said that treatments for hepatitis C were not a good idea for people like me.

I couldn’t fit the treatment into my life at the time.

Other

15.[Only if tick multiple boxes on Q14]Of all the reasons why you waited to start treatment for your hepatitis C, which one was the most important reason? (Tick only one answer)

I didn’t realise that hepatitis C was serious.

My doctor said I didn’t need treatment because my liver was okay.

I was worried about side effects.

I didn’t think the medicine would work for me.

I thought better treatments might be available in the future.

The medicines were too expensive.

I didn’t want my friends, loved ones, or co-workers to know I had hepatitis C.

I was afraid that the medicines for hepatitis C would interact with medicines I was taking for another condition.

My doctor said that treatments for hepatitis C were not a good idea for people like me.

I couldn’t fit the treatment into my life at the time.

Other

16.Why did you decide to go ahead and start [if Q3=yes and Q6=no: your current / if Q3=no and Q6=yes: your previous / if Q3=yes and Q6=yes: your first]treatment? (Tick all that apply)

Now is a good time for me to start treatment.

My doctor said the hepatitis C was starting to hurt my liver.

The medicines seemed to be better than they were when I was first diagnosed with hepatitis C.

I got insurance to pay for the medicines.

I stopped taking other medicines that would interact with the hepatitis C medicines.

My overall health improved, so I could concentrate on dealing with my hepatitis C.

My overall health declined, and I thought I needed to get rid of the hepatitis C.

My doctor, family member, or friend encouraged me to start treatment.

Other

Features of Hepatitis CTreatments

The goal of hepatitis C treatment is to get rid of the virus completely.

Most people who are treated for hepatitis C take 2 medicines. The standard of care is an injection with a pen once a week, or a tablet twice a day.

In the future, treatments for hepatitis C might work better than they do now. Future treatments may include a third medicine. This third medicine would be taken by mouth as a tablet. Now we will describe features of different hepatitis C treatments that might exist now or sometime in the future.

Later in the survey, we will ask you to think about hepatitis C treatments with these features:

• Total number of weeks on treatment,
• Chance that the treatment will get rid of the virus completely,
• Number of weeks the third medicine is taken,
• Chance of getting a severe rash that requires stopping the third medicine,
• Chance of getting severe anaemiathat requires additional injections of a fourth medicine while taking the third medicine, and
• Number of times a day the third medicine is taken.

Please read the following descriptions of each of these features. If you need to, you can refer back to this information as you take the survey.

Treatment Feature: Total number of weeks of treatment

Treatment for hepatitis C is usually counted in weeks. With current hepatitis C treatments, most people need to take their hepatitis C medicines for 24 – 48 weeks (about 6 months to 1 year). If a third medicine is added, the total length of treatment might be shorter.

In this survey, we will describe various hepatitis C treatments that take different numbers of weeks to complete. The total number of weeks of treatment we will ask you to consider are:

• 24 weeks (about 6 months),
• 28 weeks (about 7 months), and
• 48 weeks (about 1 year).

17.How important is the total number of weeks of treatment for hepatitis C to you?

Not important at all

A little important

Moderately important

Quite important

Extremely important

Treatment Feature: Chance that the treatment will get rid of the virus completely

The goal of hepatitis C treatment is to get rid of the virus completely after taking the medicines for 24 to48 weeks.

We will ask you to think about hepatitis C treatments that have different chances of getting rid of the virus completely. The following pictures may help you think about these chances.

Each person in the boxes below represents one person who takes a hepatitis C medicine. There are 100 people in each box. The people marked by colourwill have a successful treatment, meaning that the treatment will get rid of the virus completely. The people shaded greywill not have a successful treatment. The number of people who will have a successful treatment tells you how big your own chance of getting rid of the virus completely is.

1. Each person in this box represents one person who takes hepatitis C medicines. How many of these people will not get rid of the virus completely?

15 out of 100 (15%)

25 out of 100 (25%)

60 out of 100 (60%)

85 out of 100 (85%)

Treatment Choices

[If answer “Yes” to Q3 or Q6, they see the following sentence first].

Imagine that you were just diagnosed with hepatitis C and have never taken any hepatitis C treatment before.

Suppose that you go to see the doctor and he or she tells you that you need to start hepatitis Ctreatment today.

Suppose that there are only two treatments, Treatment A and Treatment B. The treatments vary depending on how long you take the medicines and the chance that they get rid of the virus completely from your body.

1. Which treatment would you choose if these were the only treatments available?

Treatment Feature: Number of weeks the third medicine is taken

Adding a third medicine to your hepatitis C treatment may increase the chance that the treatment will be successful. The third medicine is only taken part of the time. Sometimes people start all 3 medicines at the beginning. Other times, people start with the standard treatment (i.e.Peginterferon and ribavirin) and then begin the third medicine later. If there is no third medicine, then you would take the standard treatment for the whole time you are on treatment.

In this survey, we will ask you to think about different hepatitis C treatments that might include the third medicine. The number of weeks on the third medicine you will be asked to consider are:

• 0 weeks (no third medicine is taken with the treatment)
• 12 weeks (from the start to week 12)
• 24 weeks (from week 5 to week 28); standard treatment from week 1 to week 4
• 44 weeks (from week 5 to week 48); standard treatment from week 1 to week 4

1. Which treatment would you choose if these were the only treatments available?

Treatment Feature: Chance of getting a severe rash that requires stopping the third medicine