Duke Study

Central Oregon Ear, Nose & Throat is partnering with Duke University’s CHEER network to conduct a research study on the association of migraine and other headaches in patients seen by ENT specialists.

We would appreciate your cooperation in participating in this research study. If you would like to participate, the only thing you need to do is complete a questionnaire.

You do not need to have a history of migraine headache to participate. Any patient can fill out the questionnaire regardless of their headache history.

THANK YOU!

Consent for Participation in Research Activities

Title of Project: Assessment of Migraine (and other Headache Types) in Otolaryngology IRB Number: Pro0006135

You are being asked to take part in a research study on headaches and migraine. Please read this consent form carefully and take your time making your decision. The nature of the study, risks, inconveniences, discomforts, and other important information about the study are listed below.

Dr. John P. Renton will conduct the study and it is funded by the Association of Migraine Disorders, and coordinated by Duke University and the Duke Clinical Research Institute (DCRI). The sponsor of this study, The Association of Migraine Disorders, will pay Central Oregon ENT, LLC to perform this research, and these funds may reimburse part of Dr. Renton’s salary. Central Oregon ENT, LLC is one of about twenty different Ear Nose and Throat (ENT) clinics across the country participating in this project.

WHY IS THIS STUDY BEING DONE?

The purpose of this study is to explore the prevalence of migraine and other headaches in patients seen by ENT specialists.

HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?

Approximately 2000 people will take part in this study at about twenty different hospitals and medical facilities, and approximately 300 people will take part at Central Oregon ENT, LLC.

WHAT IS INVOLVED IN THE STUDY?

If you are between the ages of 18 and 88 and agree to be in this study, you will be given a questionnaire packet to complete. The packet includes a demographic form, which asks for information about your age, race and gender. We will also ask you questions about your history with headaches and migraines. We anticipate it will take you approximately 5 minutes to complete this information. Based on your answers about headaches, you may be asked to complete additional questionnaires, which will be color coded in yellow. Please follow the instructions on the forms about how to continue. If you are asked to complete the additional questionnaires, it will take approximately 10-15 minutes of your time to complete. You may notice that some questions seem to be asked more than once; however they do focus on slightly different issues and help to capture your overall feedback.

Part of the questionnaire packet will be completed by the clinical provider you are seeing in the clinic today. The provider questionnaire is color coded in blue. Please be sure to give the blue questionnaire pages to your provider. The provider will document the reason for your visit, as well as results from any ENT related tests or procedures recently performed. In case your clinical provider is unable to complete his/her section on the form while you are being seen, your name will be temporarily written on a cover sheet. This will allow the provider to go back and look the information up after your visit. Once the provider questionnaire is complete, your name will be removed from the questionnaire and destroyed. The packets are pre-numbered to match your questionnaire with the provider’s. You will not be identified after your name is removed from the cover page of the provider’s questionnaire.

When you have completed your section of the questionnaire, please give it to your provider. If you need additional time to complete the questionnaire, please return it to the front desk staff in the clinic after you are done. They will temporarily store it in a secure, designated box for the study staff to retrieve at the end of the day.

Your participation is voluntary. You may choose not to participate or decide to withdraw from the study at any time by contacting the study contact listed below. You will not be penalized in any way if you choose not to participate or if you withdraw, and your care will not be affected. However, if you decide to withdraw from the study after you leave the clinic, we will not be able to discard your survey or remove the data from the database. Your survey will be stored without your name or any other identifying information, leaving no way for us to link it back to you.

HOW LONG WILL I BE IN THIS STUDY?

Your participation in this study will last approximately 20 minutes, the amount of time it should take to complete the questionnaire during your visit today. Again, you can choose not to participate at any time without penalty or loss of any benefits to which you are entitled.

WHAT ARE THE RISKS OF THE STUDY?

There are no physical risks associated with the study. There is, however, the potential risk of loss of confidentiality. Every effort will be made to keep your information confidential; however, this cannot be guaranteed. Some of the questions we will ask you as part of this study may make you feel uncomfortable. You may refuse to answer any of the questions and you may take a break at any time during the study. You may stop your participation in this study at any time.

ARE THERE ANY BENEFITS TO TAKING PART IN THE STUDY?

If you agree to take part in this study, there is no direct medical benefit to you. However, the information you provide may help others in the future.

WILL MY INFORMATION BE KEPT CONFIDENTIAL?

Study records that identify you will be kept confidential as required by law. Federal Privacy Regulations provide safeguards for privacy, security, and authorized access. Except when required by law, you will not be identified by name, social security number, address, telephone number, or any other direct personal identifier in study records disclosed outside of Central Oregon ENT, LLC. For records disclosed outside of Central Oregon ENT, LLC you will be assigned a unique code number. The information from your survey will be entered in an on-line database that is shared with Duke University and DCRI for analysis. However, it does not include any identifying information that could potentially link the survey back to you.

Your name or any other identifying information will not be entered into the study database. We will temporarily document your name on the cover page of the provider’s questionnaire. The purpose of this is to allow the provider to go back and look up information about today’s visit, such as the diagnosis and treatment plan. Once the provider questionnaire is complete, your name will be removed and destroyed, with no way to link the questionnaire packet back to you. In the event that there is a delay in removing your name right away, the paper surveys will be kept in a locked drawer in the research team’s office. Please do not write your name or any other identifying information, such as your medical record number or date of birth on any of the pages.

While the information and data resulting from this study may be presented at scientific meetings or published in a scientific journal, your identity will not be revealed.

WHAT ARE THE COSTS?

There will be no additional costs to you as a result of being in this study.

WHAT ABOUT COMPENSATION?

There will be no compensation for participation in this research study.

WHAT ABOUT RESEARCH-RELATED INJURIES?

Immediate necessary medical care is available at Central Oregon ENT, LLC in the event that you are injured as a result of your participation in this research study. However, there is no commitment by Central Oregon ENT, LLC to provide monetary compensation or free medical care to you in the event of a study-related injury.

For questions about the study or research-related injury, contact Dr. John Renton at (541) 382-3100 during regular business hours, after hours and on weekends and holidays.

WHAT ABOUT MY RIGHTS TO DECLINE PARTICIPATION OR WITHDRAW FROM THE STUDY?

You may choose not to be in the study, or, if you agree to be in the study, you may withdraw from the study at any time. If you withdraw from the study, no new data about you will be collected for study purposes other than data needed to keep track of your withdrawal.

Your decision not to participate or to withdraw from the study will not involve any penalty or loss of benefits to which you are entitled, and will not affect your access to health care at Central Oregon ENT, LLC.

WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?

For questions about the study or a research-related injury, or if you have problems, concerns, questions or suggestions about the research, contact Dr. John Renton at (206) 523-5584 during regular business hours, after hours and on weekends and holidays.

For questions about your rights as a research participant, or to discuss problems, concerns or suggestions related to the research, or to obtain information or offer input about the research, contact the Duke Institutional Review Board (IRB) Office at (919) 668-5111.

In addition, you may also contact the study coordinator, Evelyn Webber, at (541) 312-6787.

IRB approved 8/5/15