Doña Agustina Lassala y Doña Rafaela Larroy Lassala

You will be asked to send back a set of questionnaires, similar to those received upon enrollment into the study, in a stamped, self-addressed envelope, which will be provided to you and asked to mail it back within three weeks of receiving the questionnaires. If you have not returned a questionnaire package within the 3-week time period, you will be contacted up to three times and reminded to please return the questionnaire package. The questionnaire packages will take approximately 30-45 minutes to complete.

If additional information is needed, we would like your permission to review information about your previous medical history by examining your hospital chart.

4. POTENTIAL HARMS (INJURY, DISCOMFORTS OR INCONVENIENCE)

This is a minimal risk study. It is possible that you may find some questions in the questionnaires to be personal in nature, and you may choose to not answer these questions. In the unlikely event that you experience great distress as a result of a questionnaire, a psychologist on our research team will provide you with assistance in finding appropriate counseling resources should you ask for such assistance.

5. POTENTIAL BENEFITS

While you will not receive any medical benefit from participating in this study, your participation will help provide a further understanding of the quality of life and psychological well-being following a catheter ablation procedure. Information learned from this study may help improve patient care by enhancing the healthcare provider’s ability to determine the plan of care for these patients.

6. PROTECTING YOUR HEALTH INFORMATION

All St. Michael’s Hospital (SMH) study staff (study investigators, coordinators, nurses and delegates) are committed to respecting your privacy. No other persons will have access to your personal health information or identifying information without your consent, unless required by law. The study staff will make every effort to keep your personal health information private and confidential in accordance with all applicable laws, regulations, guidelines and privacy legislations, including the Personal Health Information Protection Act (PHIPA) of Ontario.

Any personal health information or personal information collected about you will be “de-identified” by replacing your personal identifying information with a “study number”. The SMH study staff is in control of the study code key, which is needed to connect your personal health information/personal information to you. The link between the study number and your personal identity will be safeguarded by the SMH study staff. Our guidelines include the following:

 All information that identifies you, both paper copy and electronic information, will be kept confidential and stored and locked in a secure place that only the study staff will be able to access.

 Electronic files will be stored securely on hospital or institutional networks or securely on any portable electronic devices.

 No information identifying you will be allowed off site in any form. Examples include your hospital or clinic charts, copies of any part of your charts, or notes made from your charts.  Questionnaires and data will be stored in a secure server at Toronto General Hospital. No

It is important to understand that despite these protections being in place, there continues to be the risk of unintentional release of information. The SMH study staff will protect your records and keep all the information in your study file confidential to the greatest extent possible. The chance that this information will be accidentally released is small.

Although all of your study data will be kept confidential, your medical records may be accessed by the study staff or the St. Michael’s Hospital Research Ethics Board. Such access will be used only for the purpose of verifying the authenticity and accuracy of the information collected for the study, without violating your confidentiality to the extent permitted by applicable laws and regulations. Federal and Provincial Data Protection regulations, including the Personal Information Protection and Electronic Documents Act (PIPEDA 2000) and the Personal Health Information Protection Act (PHIPA 2004) of Ontario, protect your personal information. They also give you the right to control the use of your personal information (including personal health information) and require your written permission for this personal information to be collected, used, or disclosed for the purposes of this study, as described in this consent form. You have the right to review and copy your personal information collected in this study. However, if you decide to be in this study or choose to withdraw from it, your right to look at or copy your personal information related to this study will be delayed until after the research is completed.

Study data will be retained for 10 years. 7. STUDY RESULTS

The results of this study may be presented at meetings or in publications. Your identity will not be disclosed in those presentations. At the end of the study, the study results, and conclusions may be disclosed to you, if you so wish.

8. POTENTIAL COSTS/REIMBURSEMENTS

There will be no charge to you for your participation in this study. 9. PARTICIPATION AND WITHDRAWAL

Participation in any research study is voluntary. At any time you may choose not to answer a given question. If you do decide to take part you will be asked to sign this consent form. If you choose not to participate, you and your family will continue to have access to customary care at St. Michael’s Hospital. If you decided to participate in this study and signed the consent form you can change your mind without giving a reason, and you may withdraw from the study at any time without affecting the care you and your family will receive at St. Michael’s Hospital. You should talk to your study doctor to determine how best to complete the withdrawal process.

10. NEW FINDINGS OR INFORMATION

We may learn new things during the study that you may need to know. You will be notified about any new information in a timely manner.

You will be kept informed, in a timely manner, of any information that may relate to your willingness to continue participation in the study. At the discretion of your doctor(s), you may be asked to sign a revised informed consent or consent addendum that provides this information.

You may ask questions at any time about this study. You should contact Research Coordinator, Zana Mariano at 416-864-6060 ext. 2696.

11. RESEARCH ETHICS BOARD CONTACT

If you have any questions regarding your rights as a research participant, you may contact Dr David Mazer, Chair, Research Ethics Board at 416-864-6060 ext 2557 during business hours. 12. STUDY CONTACTS

If you have any questions about this study, or if you feel you have experienced a research-related injury, contact the study doctor:

Dr. Paul Angaran, Cardiologist St. Michael’s Hospital

Room 6-050, Queen Wing 30 Bond Street, Toronto, Ontario

M5B 1W8

Tel: 416-864-5104

In case of emergency, please go to the nearest emergency department and let them know that you are in a study, and the principal investigators name.

Title: “Quality of Life and Psychosocial Well-Being Following VT Ablation” Consent Signature:

I acknowledge that the study described above has been explained to me and that any questions that I have asked have been answered to my satisfaction. I have been informed of the alternatives to participation in this study, including the right not to participate and the right to withdraw without compromising the quality of medical care at St. Michael’s Hospital for me and for other members of my family. As well, the potential harms have been explained to me and I also understand the benefits (if any) of participating in the research study.

I understand that I have not waived my legal rights nor released the investigators, sponsors, or involved institutions from their legal and professional responsibilities. I know that I may ask now, or in the future, any questions I have about the study. I have been told that records relating to me and my care will be kept confidential and that no information that will be disclosed without my permission unless required by law. I have been given sufficient time to read and understand the above information.

I hereby voluntarily consent to participate in the research study described above. I will receive two copies of the consent form - one signed copy which I will keep and the other which will be returned to the study team.

I understand that my family physician and/or specialist and pharmacist will be informed of my participation in this study.

_______________________________ ________________

Participant’s Signature Date

_______________________________

Participant’s Printed Name

Participant’s telephone number: ________________________________ STUDY PERSONNEL STATEMENT

The person signing this consent form has had the study fully and carefully explained and has been given an opportunity to ask any questions regarding the nature, risks and benefits of the subject’s participation in this research study.

_______________________________ ________________

Signature of Person Obtaining Consent Date

_______________________________

Participant #: _______________ Date: _______________

Appendix D – Baseline Questionnaire

STUDY QUESTIONNAIRE