Item Reduction For Vision Related Quality of Life Questionnaire

Principal Investigator: Dr. Michael Cusimano, MD, MHPE, FRCSC, PhD, FACS
Division of Neurosurgery, St. Michael’s Hospital
Professor of Neurosurgery, Education, and Public Health, University of Toronto
Purpose of Questionnaire
The following questions are part of a research study to create a questionnaire that can reliably assess the vision-related quality of life in patients with a pituitary tumor. We are interested in your opinion regarding the importance and relevance of the following statements regarding the condition of your vision.

Description of the Research
The study will ask you to answer some questions about your vision-related quality of life. The questionnaire will display specific questions related to your diagnosis and current treatment you are on, your activities of daily living, and about any vision problems you may be experiencing. By examining the responses you make, we will determine what vision-related factors are the most important and relevant to you. You do not have to answer any question that you do not feel like answering. You do not have to give a reason for not answering if you do not want to. You can also stop the questionnaire at any time.

The entire questionnaire will take about 30-45 minutes to complete. 

Confidentiality and Privacy
All responses and information pertaining to the identity of any person who completed this survey will remain strictly confidential. Such information will only be accessible to the research team. All data provided will be used only for the purposes of this study and will not be released for any other purpose without prior consent.
If you are interested in participating in further phases of the study and completing subsequent versions of the questionnaire, you will be given the option to provide your e-mail address so that the research team can get in contact with you at a later time. Please note that email is not a secure form of communication. If you do choose to provide your e-mail address, it will be stored separately from your survey responses in our databases.  

The questionnaire will ask you to create and enter a self-generated identification code. Data collected using SurveyMonkey resides on the SurveyMonkey servers which are located outside of Canada, and may be subject to privacy laws and legislation which differ from those in Canada (such as the USA PATRIOT Act of 2001, which entitles US government bodies to access information held in the US, for governmental security and other purposes). It will only be used for research purposes.

If the results of the study are published, your identity will remain confidential. It is expected that the information collected during this study will be used in analyses and will be published/presented to the scientific community at meetings and journals. Direct quotes from your responses may be used in reports or publications, but the quotes will not be attributed to you or contain any information that could be used to identify you.The study investigators will keep your study records securely stored for 5 years following the publication of the study, or 10 years after the completion of the study – whichever comes first.

We do not want to identify your answers as belonging to you. We have not asked for your name or any other piece of information that identifies you. If you do not want your answers to be linked to you, please do not enter your name or any other piece of information that identifies you into any of your answers below.

There will be approximately 300 people enrolled in the study.

Publication of Results
We may present this study at a scientific conference and we intend to write an article about this study for a scientific journal.  You can ask us to send you a copy of the article when it is published by contacting Dr. Michael Cusimano, the principal investigator.  

Potential Risks or Discomforts
The risks or harms of participating in this study are minimal. You may refuse to answer questions or stop the questionnaire at any time if you experie
Potential Benefit
You will receive no direct benefit or credit for participating in this questionnaire; however, your participation may benefit future patients with pituitary tumors.

Participation and Withdrawal
You can choose to end your participation in this research at any time without having to provide a reason, and will not impact your relationship with any of the groups involved with this research project. If you choose to withdraw from the study, you are encouraged to contact the research team.

All participants will be asked to create a self-generated identification code, which will only be used by the research team in the event that you wish to withdraw your data from the study.

You may withdraw your permission to use information that was collected about you for this study at any time by letting the research team know. However, this would also mean that you withdraw from the study.

If you don’t complete the survey, we will still retain the data that we collected from you unless you inform us that you would like your data to be withdrawn from the study.

Who do participants contact for questions?
If you have questions about taking part in this study, please contact the research team at 416-864-5312, or by email at Participants may keep a copy of this covering letter for their records.

If you have any questions regarding your rights as a research participant, you may contact the Unity Health Toronto Research Ethics Board (REB), at 416-864-6060 ext. 2557 during regular business hours.

By clicking the “next” button below, I confirm that I have read this form and decided that I will participate in the project as described above. Its general purposes, the particulars of involvement, and possible risks and inconveniences have been explained to my satisfaction. I understand that I can discontinue participation at any time.