Patients' consent preferences for research uses of information in electronic medical records: interview and survey data

Appendix 1. [As supplied by authors] Interview Guide – one-on-one interviews

Background

The use of personal health information for research purposes is an important issue for patients, health care workers and researchers. Canada has rules to protect privacy and confidentiality in health research, but we have become increasingly sensitive to the importance of consulting more with patients about their views. There are a number of projects being conducted at the Centre for Evaluation of Medicines that involve the use of computers in health care. This study aims to find out what patients think about the use of their health information for research.

¨ Self – Role (RA conducting interviews)

¨ Summary of Patient Involvement: We will be asking a standard set of open-ended questions. We want to hear your honest thoughts and feelings.

¨ Consent: Hand out consent form and go over with participant

¨ Stress confidentiality: Inform participant that what they share in the interview will not be shared with anyone else and that data will be analyzed in a group format with identifying information deleted from transcripts

¨ Any questions before we begin?

A. Introduction

In the COMPETE study, a team is working with family doctors in the Hamilton area to look at ways of using computers to improve prescribing for a number of common medical conditions. It is an example of a study that uses health information for research purposes. Once identifiers such as name and address are removed, information such as medications and diagnoses is collected from charts. It is then put into a computer database with information from other patients. This information cannot be traced back to the individual patient by the researchers. All research findings are reported in aggregate form (i.e. combined with others). The research is conducted at an academic setting, the Centre for Evaluation of Medicines which is in the Father Sean O’Sullivan Research Centre at St. Joseph’s Hospital.

1. How long have you been a patient with Dr. ____________?

2. Dr. ___________’s office was recently computerized. How did you learn that your doctor’s office was computerized?

3. How many times have you been to see Dr _____ since the office was computerized?

4. Can you share with me your feelings about this recent change?

ID#: _____________ Date: _________________

Core Areas of Focus

1. How to be Approached about Research Using Health Information

As you know, information from patient files will be used to learn about the diagnosis and treatment of medical conditions as mentioned above. There are a number of different ways that your physician could tell you about this study.

A) If you were being consulted for the first time, do you have any thoughts about how you would like to be approached about information from your family doctor’s chart being used for research purposes?

Prompt: Verbal vs. Written

B) How much detail would you want to know about the study?

C) Would you want to know about every study that your physician is taking part in?

D) When would you like to be informed about research that your physician is taking part in (before going to the office or when you go to the office).

1. Consent Options

There are a number of ways that your physician could tell you about his or her participation in research. Let’s talk about these different possibilities:

a) Advised only (sign/letter/brochure/booklet) of his/her participation in research-no consent is required

-give patient letter/brochure/booklet to look at

b) Advise you AND you may inform receptionist/doctor if you do NOT want to participate (negative consent)

ASSUME: If nothing is said, your physician assumes you agree to use of your information

c) Ask for your consent AND you sign a consent form, which explains the research (positive consent)

ASSUME: Lack of signed agreement means no consent

d) Proxy decision

Option 1. Your physician consents to having his/her records in the study and you are neither advised nor consulted

Option 2. Gather together a panel of people with the same medical condition, discuss with them and follow their advice.

ID#: _____________ Date: _________________

1. a) Which of the above options most reflects what you would prefer to do?

b) If you were to give consent, would you want to do this verbally or in written form?

2. Are there particular types or topics of research that you feel would change your mind about providing consent?

3. Duration of Consent

If you were to agree to the use of your health information for a research study, I’m wondering about your thoughts about how long your consent for a study should be in effect. What do you think of the following options? In each case, you would have the option to withdraw at any point in time with no effect on the quality of care provided to you.

1. Indefinitely

2. Reviewed annually

3. For the duration of the study with the time period specified

4. Future/New Uses

What comes to mind when you think of the following scenario?

Suppose a study included information about your heart problems and treatments with your consent. Next year, the research team decides that it would like to conduct research on a different condition (e.g. asthma) using information from the database that your health information is part of.

1. What are your thoughts about the new use of your health information?

2. Would you feel comfortable with this?

3. Are there any concerns that you have?

4. How would you like to see this situation handled?

5. Is there a need for consent for this new use? If so, in what way(s) would this be different than the initial consent?

Other Issues

1) It’s common now that funding agencies require private sector funding as well. How do you feel about different companies and groups helping to sponsor research?

¨ Software Companies

¨ Pharmaceutical Industry

¨ Insurance Companies

¨ Government

2) Another issue related to sponsorship is the potential commercialization of health data gathered from research. What are your thoughts about the following two scenarios?

a) Sponsorship with no input into data collection and reporting (was funded by the pharmaceutical industry even though they had no influence on the study and only received the final combined results)

b) Possibility to sell health data to other organizations for further analyses (the results might lead to changes in government funding of drugs to only those that provide improvements in health)

ID#: _____________ Date: _________________

Demographics

1. Age

2. Gender

3. Occupation

4. Number of times you see your physician each year

I have asked you many questions today. Do you have any questions for me?

Appendix 2. Phase 3 survey

SITE: ______________ DATE: ___________________

Health Information and Research Survey

Your family doctor has agreed to take part in some research that will analyze information from patients’ charts. All of the information collected will be put together into a database to see how family doctors are taking care of patients. This information will go directly from your doctor’s computer to the research computer. No one will actually read your chart and no personal information such as your name, address or health card number will ever be put into the database.

Researchers at St. Joseph’s Hospital in Hamilton are interested in what you think about using health information for research. Please check the box below that best describes your answer.

1. If your doctor is taking part in a research study, how much detail do you want to know about the research? Check the one answer you like best.

q A. I only want to know that my health information is being used for a research study.

q B. I want to know that a research study is being done using my information and that I can ask for more details if I want to.

q C. I only want to know the general type of research being done and do not want to know any details.

q D. I want to know the following. Check all that apply:

q the name of the study

q the goals of the study

q how I or others will benefit from this study

q who is paying for the study

q what happens to the information after it is collected

q other: ________________________

2. There are 3 ways to give consent to a research study. Check the one way you like best.

q I would like to be told about the study (e.g. through a sign in the office) and it is up to me to say ‘no’.

q I would like to be able to verbally say ‘yes’ or ‘no’ to the study before I am enrolled.

q I would like to sign a written consent form stating I agree to the study.

PLEASE TURN OVER Þ

3. I think the length of time my consent should be given for is:

q No time limit

q The time of the study only

q One year and reviewed each year

q Other: ______________________

4. Some people have concerns about who pays for research studies.

Circle the number that best describes your level of concern if any of the following is paying for research your doctor takes part in.

5. About You:

Your Age: q 18 to 24 years q 55 to 64 years

q 25 to 34 years q 65 to 74 years

q 35 to 44 years q 75 to 84 years

q 45 to 54 years q over 85 years

Gender: q Male q Female

About how many times do you see your doctor each year?

q < 1 q 1 q 2 to 5 q 6 to 10 q Over 10

Have you ever taken part in a research study before?

q Yes q No q I am not sure

THANK-YOU FOR YOUR HELP!