ih registry ptq final 2014

Intracranial Hypertension Registry Instructions

OHSU – CB723 3181 SW Sam Jackson Park Rd Portland, Oregon 97239 Telephone: (503) 418 – 2141 Fax: (503) 418 – 2139 Email: [email protected]

How to Join the Registry

What you will need before starting the paperwork: Names and addresses of physicians that you have seen for diagnosis or treatment of

intracranial hypertension (past and current doctors). If you do not know all the contact information for a doctor(s) please complete in as much as possible.

1. Complete, sign and date the following forms in your packet. Please use this checklist to be sure you have completed all the required forms.

18 and Older Age 7 – 18 Under age 7 Consent Form (1-6) Consent Form (1-6) Consent Form (1-6) HIPAA (8-10) Assent (7) HIPAA (8-10) Authorization (11) HIPAA (6-8) Authorization (11) Questionnaire (12-24) Authorization (11) Questionnaire (12-24) Questionnaire (12-24)

What do the forms in the enrollment packet mean? CONSENT FORM (pages 1-6). This form gives us permission to maintain a file about you. Your

signed consent must be witnessed - any adult individual can do this. If the patient is a child 7-18 years of age, a parent or legal guardian must sign.

CHILD ASSENT FORM (page 7). This form is required only if the patient is a child between the ages of 7-18 years. The child must sign this form.

HIPAA RESEARCH AUTHORIZATION (pages 8-10). This form explains how the Registry will handle your protected health information. If the patient is a child 7-18 years of age, a parent or legal representative must sign.

AUTHORIZATION TO DISCLOSE PROTECTED HEALTH INFORMATION (page 11). This form gives your doctor(s) permission to release your health information. If you have more than one doctor, leave the space under “I authorize:” blank. Complete the second area of the form under “to use and disclose a copy…” with your contact information (name & address). We recommend that you check next to the first three items in each column of the “consisting of:” section. Sign and Date this form. If the patient is a child 7-18 years of age, a parent or legal guardian must sign.

PATIENT QUESTIONNAIRE (pages 12-24). Complete as much of the form as you are able to.

2. Mail or fax the completed paperwork to us at the address listed below. Keep a copy for your records.

3. If you need assistance or have questions, please contact us at (503) 418 – 2141 or email: [email protected].

Thank you for your participation on behalf of all IH patients and their families!

OHSU – CB723, 3181 SW Sam Jackson Park Road, Portland, Oregon 97239 Telephone: (503) 418 – 2141 Fax: (503) 418 – 2139 Email: [email protected]

1. What is a registry? A registry is a central place for collecting, storing, and studying information about patients with a particular health problem. Our database includes extensive medical history information for each patient.

2. How is the IH Registry used? The IH Registry is accessed only by the IH Registry staff and OHSU specially-trained volunteers. Approved researchers may receive data files with information that has been de-identified (meaning your name, address, etc… has been removed from the data). If a researcher approaches us for clinical studies, the IH Registry’s staff will contact you if you qualify for a particular study. We will inform you of the study and you will be able to decide if you want to participate or not. We will never give your personal information to any outside party.

3. What good is a registry? The benefit of having a registry is to provide a significant amount of information to researchers about the long term medical circumstances of this condition. The mission of the Registry is to encourage IH research. The IH Registry is presently involved with a number of important research projects. Ultimately, research holds the answers to understanding, treating, and curing this devastating disorder.

4. Why is there so much paperwork for the Registry? The IH Registry operates under both federal regulation and the Oregon Health & Science University Institutional Review Board. All the consents are designed to insure that you understand enrollment with the Registry, your rights as a participant, and to ensure your confidentiality. The patient questionnaire provides us vital information about your personal experience with this condition.

5. What if I require accommodation? We are more than happy to accommodate your needs and perform a telephone interview for the medical questionnaire. If you would prefer this method of completing the questionnaire, contact our office by phone or email to schedule an appointment for a telephone interview. The completed forms will be forwarded to you for your review and signature.

6. What are the Steps to Enroll in the Registry? There are two easy steps to enroll in the Registry.

Step ONE: complete all the paperwork included with this letter. Step TWO: return the materials to the IH Registry.

We will then review your materials and request your medical records. After these two steps are completed, you are enrolled! Keep us updated on your address, email, and phone numbers because you will be receiving short annual follow-up questionnaires asking about your condition, as well as periodic newsletters about the Registry, and possibly contacts about clinical research programs!

Intracranial Hypertension Registry Facts and Questions (FAQ)

Revised: 09/06/2012 1

IRB # e1010

OREGON HEALTH & SCIENCE UNIVERSITY RESEARCH REPOSITORY CONSENT FORM

INTRACRANIAL HYPERTENSION REGISTRY

Principal investigator: Emanuel Tanne, M.D. (503) 418-2141 Repository Guardians: Johnathan Au (503) 418-2141 Brenna Lobb (503) 418-2141 Co-Sponsors: Casey Eye Institute, Oregon Health & Science University

Intracranial Hypertension Research Foundation Purpose: The term “you” refers to people of all ages in this consent form. You have been

invited to take part in the Intracranial Hypertension Registry because you have been diagnosed as

having Intracranial Hypertension. The purpose of this Registry is to collect, store, and study

information about people who have Intracranial Hypertension (IH). This medical research is

being done to find causes of Intracranial Hypertension and new ways to treat it. Your identity

will not be shared with other researchers. Your information will stay in the Registry unless you

ask us to remove it. We do not know the number of people who will take part in the Registry, but

we expect the number to be several thousand or greater.

ABOUT RESEARCH REPOSITORIES Generally, a research repository collects, stores and distributes human tissue, specimens and/or data for use in future research projects. Research with blood, tissue or body fluids, and health data can help researchers understand how the human body works and other health related questions. Storing and gathering lots of specimens and data together can help to conduct future research and avoid re-collecting specimens and data over and over again. With this stored information and samples, researchers may develop new tests to find diseases, new ways to treat diseases, or develop new products, such as drugs. Sometimes researchers collect and store many specimens and data together and use them for different kinds of research in the future, or share them with other scientists and this is called a research repository.

Revised: 09/06/2012 2

Procedures: Before entrance into the Registry, we will ask you to fill out a medical

questionnaire designed specifically for those with IH. Please complete all questions on this

questionnaire, as well as read, sign, and date the Consent, HIPAA form, and Authorization to

Use and Disclose Protected Health Information forms included in the packet. Completion should

take approximately 20 minutes. The questionnaire includes, but is not limited to, questions about

demographics, past medical history (medications, surgeries), and current medications.

You will also receive additional questionnaires from the Registry from time to time. An annual

follow-up questionnaire will help us document any changes in your medical condition over time.

The Registry also requires another form about your medical history, findings, and treatment.

This is completed and sent to the Registry by your doctor(s). Once all forms are received, the

Registry will go over them and decide if there is enough information. If not, we will try to

contact you. If we are not able to get enough information from you or your doctor(s), it is

possible that your name and information will not be added to the Registry. If your doctor(s)

decline to complete the form, then medical records will be requested with your prior approval .

They will also be reviewed and information about your medications, surgeries, and other

diagnostic techniques such as imaging or lumbar punctures may be extracted to include in the

Registry database. No genetic information will be requested. If you have any questions

regarding this study now or in the future, contact Dr. Tanne or any of the Registry

representatives at (503) 418-2141.

Risks and Discomforts: Some of these questions may seem very personal or embarrassing and

may upset you. You may refuse to answer any of the questions that you do not wish to answer.

Revised: 09/06/2012 3

Although we have made every effort to protect your identity, there is a minimal risk of loss of

confidentiality.

Benefits: You will not directly benefit from taking part in this Registry. However, by taking part,

you may contribute new information, which may benefit patients in the future.

Alternatives: You may choose not to take part in this Registry. Taking part in the Registry does

not give you medical or surgical care for your intracranial hypertension. If a treatment becomes

available, the Registry will inform you about it, but will not take part in the treatment.

Confidentiality: Your name or your identity will not be used for publication or publicity

purposes. Within the Registry database at Oregon Health & Science University (OHSU), your

identity will be protected by a code. The design of the database ensures data security and

confidentiality. Access to the Registry’s information will be limited to the database manager,

members of the Registry steering committee, and OHSU-approved volunteers and staff. No

researchers or other individuals will have direct access to the Registry. Access to information

will be through requests given to the database manager, and reviewed and approved by a steering

committee, and a local or university IRB. Your name and identity will not be given in any

approved requests to any parties. Data will be stored indefinitely.

Research records may be reviewed and copied by the sponsors, other researchers approved by

the Intracranial Hypertension Registry, the OHSU Institutional Review Board, and the Office for

Human Research Protections (OHRP). The health-related information that we gather about you

in this study is personal. The researchers are required by law to protect the privacy of

information known as protected health information (PHI). All reasonable efforts will be made to

protect the confidentiality of your PHI, which may be shared with others to support this research,

Revised: 09/06/2012 4

for future research, to conduct public health reporting, and to comply with the law as required.

Despite these protections, there is a possibility that information about you could be used or

disclosed in a way that it will no longer be protected.

Costs: There will be no costs to you for taking part in the Registry.

Liability: If you believe you have been injured or harmed while participating in this research

and require immediate treatment, contact the Registry representatives (503 418-2141).

You have not waived your legal rights by signing this form. If you are harmed by the study

procedures, you will be treated. Oregon Health & Science University does not offer to pay for

the cost of the treatment. Any claim you make against Oregon Health & Science University may

be limited by the Oregon Tort Claims Act (ORS 30.260 through 30.300). If you have questions

on this subject, please call the OHSU Research Integrity Office at (503) 494-7887.

Participation: The Registry representatives (503 418-2141) have offered to answer any other

questions you may have about this study. If you have any questions regarding your rights as

registrant, you may contact the OHSU Research Integrity Office at (503) 494-7887.

You do not have to join this or any research study. If you do join, and later change your mind,

you may quit at any time. If you refuse to join or withdraw early from the study, there will be no

penalty or loss of any benefits to which you are otherwise entitled. If we receive incomplete or

insufficient medical information, your information may not be included in the Registry. The

Registry reserves this right in order to maintain the Registry at the highest quality, which

requires the most accurate and complete information possible. Information gathered during this

research study will not be placed into the Registry described in this form or used for future

Revised: 09/06/2012 5

research if you do not sign this form. You do not give up any of your legal rights by signing this

form.

If you wish to withdraw from the Registry at any time by providing a written notice, there will be

no costs or obligations to you. Once the Registry has received the written notice, you will receive

confirmation that your medical information has been removed from the Registry.

If you have any questions regarding this study now or in the future, contact Emanuel Tanne, MD,

or Research Coordinators, Johnathan Au and Brenna Lobb at (503) 418-2141.

Revised: 09/06/2012 6

Signatures: Your signature below indicates that you have read this entire form and that you

agree to store your specimens and data in this research repository for future research purposes.

Upon signing this consent, you will receive a copy.

OREGON HEALTH & SCIENCE UNIVERSITY INSTITUTIONAL REVIEW BOARD PHONE NUMBER (503) 494-7887

CONSENT/AUTHORIZATION FORM APPROVAL DATE

SEP 18, 2013

Do not sign this form after the expiration date of: 09/17/2014

Printed name of Research Subject

Signature of Subject Date

-OR-

Printed name of Subject’s Legally Authorized Representative

Signature of Subject’s Legally Authorized Representative Date

Printed name of Person Obtaining Consent

Signature of Person Obtaining Consent Date

IRB #:_e1010_ Approval Date: Sep 18, 2013

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OREGON HEALTH & SCIENCE UNIVERSITY Child Assent Form

(Use for children ages 7 through 17) TITLE: INTRACRANIAL HYPERTENSION REGISTRY

PRINCIPAL INVESTIGATOR: . Emanuel Tanne, M.D. (503) 418-2141

CO-SPONSORS: Casey Eye Institute, Oregon Health & Science University Intracranial Hypertension Research Foundation

Part I

One of the doctors listed above has explained this research study to me. I know how it may or may not help me. I also know that this study will help doctors know more about intracranial hypertension.

1. The study doctor will ask me to explain what I will do and what will happen in this study to be sure I understand the study.

2. The study doctor will ask me if I have any questions or want to know anything else about this study or intracranial hypertension.

3. The study doctor will ask me to explain some of the good and bad things that might happen if I enter this study.

Part II

I have thought about being a part of this study. I have asked and received answers to my questions. I agree to be in this study. I know that I don’t have to agree to be in the study. Even though I agree to be in it now, I know I may feel differently later on and can ask to stop being in the study. I know that I may talk with my parents and/or doctor about not being in this study at any time.

OREGON HEALTH & SCIENCE UNIVERSITY INSTITUTIONAL REVIEW BOARD PHONE NUMBER (503) 494-7887


SEP 18, 2013


Name/signature:__________________________ Date:______________

8

(name of subject)

HIPAA RESEARCH AUTHORIZATION

IRB#1010

AUTHORIZATION FOR THE CREATION, USE, AND DISCLOSURE OF PROTECTED HEALTH INFORMATION FOR INSTITUTIONAL REVIEW BOARD APPROVED RESEARCH

This authorization is voluntary, and you may refuse to sign this authorization. If you refuse to

sign this authorization, your health care and relationship with OHSU will not be affected. However, you will not be able to enter this research study.

1. This form authorizes Oregon Health & Science University (OHSU) to use and disclose (release)

certain protected health information about that we will collect and store in this research repository.

2. The persons who are authorized to use and disclose your protected health information are: All investigators listed on page one of the Research Repository Consent Form and others at

OHSU who are participating in the oversight of this research repository. Others:

3. The persons who are authorized to access this information are:

The sponsor of this study: The OHSU Institutional Review Board Federal or other governmental agencies as required for their research oversight and public

health reporting in connection with this research study: OHRP FDA NIH Other:

Others: Researchers approved by the Intracranial Hypertension Registry as outlined in the Repository Protocol.

Comment: Any disclosures or uses for future research will require appropriate review and approval by the OHSU Institutional Review Board.

4. We may continue to use and disclose protected health information that we collect from you in this study until:

HIPAA Research Authorization expiration date -OR-

The repository is terminated Indefinitely Other:

5. You have the right to revoke this authorization and can withdraw your permission for us to use

your information and/or tissue or blood sample that identifies you for this research by sending a written request to the Principal Investigator listed on page one of the research consent form. If you do send a letter to the Principal Investigator, the use and disclosure of your protected health information and/or tissue or blood sample that identifies you for this research will stop as of the date he/she receives your request. However, the use and disclosure of information collected before the date of the letter or collected in good faith before your letter arrives is allowed to continue. If you withdraw permission for use of any tissue or blood samples that were collected from you for a genetic research study, they either will be destroyed or stored without any information that identifies you. Revoking this authorization will not affect your health care or your relationship with OHSU.

6. The information about you that is used or disclosed in this study may be re-disclosed and no longer protected under federal law. However, Oregon law restricts re-disclosure of HIV/AIDS

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information; mental health information; genetic information; and drug/alcohol diagnosis, treatment, or referral information.

HEALTH INFORMATION to be collected and stored for the purpose of maintaining a research repository.

Your complete existing health record ** Limited information from your existing health record** (specify):

____________________________________________________ ** If we are requesting existing health records that are located outside of OHSU, you will need to complete an additional authorization to release these records to OHSU.

History and physical examinations Reports: Laboratory Operative Discharge Progress

Photographs, videotapes, or digital or other images Diagnostic images/X-ray/MRI/CT Bioelectric Output (e.g., EEG, EKG) Questionnaires, interview results, focus group survey, psychology survey, behavioral performance

tests (e.g., memory & attention) Tissue and/or blood specimens Other:

7. If the information to be used or disclosed contains any of the types of records or information listed

just below, additional laws relating to use and disclosure of the information may apply. You understand and agree that this information will be used and disclosed only if you place your INITIALS in the applicable space next to the type of information.

N/A Acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)

infection information N/A Drug/alcohol diagnosis, treatment, or referral information N/A Mental or behavioral health or psychiatric care N/A Genetic testing information

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You will receive a copy of this authorization form after you sign it.

OREGON HEALTH & SCIENCE UNIVERSITY

INSTITUTIONAL REVIEW BOARD PHONE NUMBER (503) 494-7887


SEP 18, 2013


Printed name of Research Subject

Signature of Subject Date

-OR-

Printed name of Subject’s Legally Authorized Representative

Signature of Subject’s Legally Authorized Representative Date

Description of Relationship to Subject:

6/20/2003

Oregon Health & Science University

AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION ALL SECTIONS OF THE AUTHORIZATION MUST BE COMPLETED OR THE AUTHORIZATION WILL NOT BE ACCEPTED.

I authorize:

(Name of person / entity disclosing information)

(Address of person / entity)

(City, State, Zip Code)

to use and disclose a copy of the specific health information described below regarding:

(Name of individual) (Date of Birth)

(Address of Individual)

(City, State, Zip Code)

consisting of: History and physical examinations Consultation reports Laboratory reports Operative reports Discharge summary X-ray/Diagnostic images Bioelectric output (i.e., EKG, EEG) Tissue and/or blood specimens Other, specify

to: Intracranial Hypertension Registry (Name of recipient)

OHSU - CB723, 3181 SW Sam Jackson Park Road (Address of recipient)

Portland, OR 97239 (City, State, Zip Code)

for the purpose of: a research study at OHSU (IRB# e1010) (Describe each purpose of disclosure / Insert IRB#)

If the information to be disclosed contains any of the types of records or information listed below, additional laws relating to the use and disclosure of the information may apply. I understand and agree that this information will be disclosed only if I place my INITIALS in the applicable space next to the type of information.

_____ HIV/AIDS information _____ Mental health information _____ Genetic testing information _____ Drug/alcohol diagnosis, treatment, or referral information This authorization is voluntary, and you may refuse to sign this authorization. Refusal to sign the authorization will not adversely affect your ability to receive health care services or reimbursement for services; however, your refusal to sign this authorization may affect your ability to participate in the research study.

You may revoke this authorization in writing at any time. If you revoke your authorization, the information described above may no longer be used or disclosed for the purposes described in this written authorization. Any uses or disclosures already made with your permission cannot be undone. I understand that the information used or disclosed pursuant to this authorization may be subject to re-disclosure and no longer be protected under federal law. However, I also understand that federal or state law may restrict re-disclosure of HIV/AIDS information, mental health information, genetic information and drug/alcohol diagnosis, treatment or referral information. I have read this authorization and I understand it. Unless revoked, this authorization expires: no expiration date (insert applicable date or event)

(The statement “end of the research study” or “no expiration date” is sufficient for authorizations for use and disclosure of health information for research.)

By: _________________________________________________________ Date: ______________ (Signature of individual or Legally Authorized Representative)

Description of relationship to individual: __________________________________________________________

Intracranial Hypertension Registry CONFIDENTIAL Patient Enrollment Questionnaire

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Please answer all questions to the best of your ability. If you do not know the answer to a question, please check the “not sure” box. If you have any questions about the questionnaire, we prefer a phone call at (503) 418 – 2141 or email [email protected]. If you would like interview assistance, please contact our office. Throughout this questionnaire: Y = Yes N = No ? = NOT SURE THIS FORM IS BEING COMPLETED BY: The patient Someone else Name:___________________ Relationship to patient: _____________ Reason patient is not completing form:

Child (under 18) Non-English speaker Other (specify): ________________

PATIENT CONTACT INFORMATION Mr. ___________________ ____ ______________________ Male Mrs. First MI Last Female Ms. Miss _________________________________________________ Dr. Maiden Name (or other names used) ____________________________________________ __________________ Street Apt/Unit

____________________ _________ ____________ __________________ City State/Prov. Zip/Postal Code Country _______________ ______________ _____________ __________________ Home Phone Mobile Phone Work Phone Fax Phone _________________________________________________________________ Email Address(es)

SECONDARY CONTACT Please provide contact information for someone who is related or closely associated with you (e.g. family member, close friend). Your secondary contact’s information should be DIFFERENT than yours. This person is contacted only if we are unable to reach you through your primary contact information. _____________________________ ______________ __________________ Secondary Contact Name Relationship Phone

____________________________________________ ___________________ Street Apt/Unit

____________________ _________ ____________ ___________________ City State/Prov. Zip/Postal Code Country

________________________________________________________________ Email Address(es)


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PATIENT DEMOGRAPHIC INFORMATION DATE OF BIRTH: Month _________ Day ________ Year _______ NAME AS IT APPEARS ON YOUR BIRTH CERTIFICATE: First _________________ Middle__________________ Last__________________ CITY and STATE OF BIRTH: ______________________________________ COUNTRY OF BIRTH: _______________________________ Height Weight feet/inches inches cm lbs kgs stones

One year prior to diagnosis At diagnosis Current

RACE:

White Black/African American Asian More than one race

American Indian/Alaskan Native Native Hawaiian/Pacific Islander Other (specify): ______________

ETHNICITY: Hispanic/Latino Non-Hispanic/Latino

HIGHEST EDUCATIONAL LEVEL COMPLETED: In Elem/Junior High (grade _____ ) Trade/Technical/Vocational School Less than High School (grade _____ ) College High School Graduate School Some College Other (specify): ________________

OCCUPATION: Are you currently employed? (check all that apply) Full-time Retired Part-time Unemployed Full-time Student Disabled Part-time Student Other (specify): ________________ What is/was your occupation? ___________________________________________________


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MEDICATION HISTORY During the year prior to your diagnosis, did you take the following medications (questions 1-20)?

ANTIBIOTICS BIRTH CONTROL Y N ? Y N ? Cipro (ciprofloxacin) Birth control pills (specify):__________ Vibramycin (doxycycline) Norplant (levonorgestrel implant) Minocycline Other (specify): __________________ Tetracycline Other drugs for an infection OTHER

(specify): _________________ Accutane (isotretinoin) Prednisone/Decadron (corticosteriod drugs)

PSYCHOTROPICS Cardurone (amiodarone) Lithane (lithium) Danazol Other drugs for depression/anxiety Stanozol

(specify): _________________ Perhexiline maleate Human growth hormone

VITAMINS Lupron (luprolide acetate) Units of Vitamin A daily: _________ Other (specify): __________________ DIAGNOSIS The following questions pertain to your condition during the time you were being diagnosed with intracranial hypertension, sometimes called “pseudotumor cerebri” (PTC), “idiopathic intracranial hypertension” (IIH), “primary intracranial hypertension”, “benign intracranial hypertension” (BIH), or “secondary intracranial hypertension” (SIH). 21. When were you diagnosed with intracranial hypertension? Month: _____ Year: _____ 22. What is the doctor’s name who told you that you had intracranial hypertension?

__________________________________________________________________________

23. Were you told by a physician that your condition was caused by a medication (drug)?

Y N Not Sure

23a. What drug were you told caused your condition? __________________________

23b. When did you start taking the drug? Month__________ Year ________ Y N ?

23c. When you stopped taking the drug, did you get better? 23d. Did you try the drug again? 23e. Did your symptoms come back when you tried the drug again?

24. Were you told by a physician that your IH was caused by another medical condition?

Y N Not Sure

24a. What medical condition were you told caused your IH? ______________________


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SIGNS AND SYMPTOMS Please indicate if you experienced any of the following symptoms during the time of your diagnosis with intracranial hypertension (questions 25 – 35). Y N ? 25. Headache from elevated intracranial pressure 26. Flashing lights, spots, or floaters 27. Double vision 28. Blurred vision 29. Black-/white-/grey- outs in your central vision (visual obscurations) 30. Swollen optic nerves (Papilledema) 31. Neck pain or stiffness 32. Pain in the shoulder, spine, or extremities 33. Ringing, rushing, or swooshing sounds in time with your pulse, (Pulse Synchronous Tinnitus [PST]) 34. Other (specify): ____________________________________________________ 35. Please indicate when each of the following began: Headache from elevated intracranial pressure Month _____ Year ____

Tinnitus (PST) Month _____ Year ____ Neck pain or stiffness Month _____ Year ____

SYMPTOM SEVERITY Please indicate the severity of your general health and the listed symptoms for each specified time point (questions 36 – 50). One Year Prior to Diagnosis 36. General Health?

0 1 2 3 4 5 6 7 8 9 10

Excellent Very Good Good Fair Poor

37. How severe were your Headaches? 0 1 2 3 4 5 6 7 8 9 10

No Pain Moderate The Worst Pain Ever

38. How severe was your Tinnitus (PST)? 0 1 2 3 4 5 6 7 8 9 10

None Annoying Incapacitating

39. Impaired Peripheral Vision (side vision)? 0 1 2 3 4 5 6 7 8 9 10

Normal Diminished Severely Decreased

40. Impaired Visual Acuity (central vision)? 0 1 2 3 4 5 6 7 8 9 10

Normal Decreased Severe Loss


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At Diagnosis 41. General Health?

0 1 2 3 4 5 6 7 8 9 10

Excellent Very Good Good Fair Poor

42. How severe were your Headaches? 0 1 2 3 4 5 6 7 8 9 10


43. How severe was your Tinnitus (PST)? 0 1 2 3 4 5 6 7 8 9 10






Currently 46. General Health?

0 1 2 3 4 5 6 7 8 9 10 Excellent Very Good Good Fair Poor

47. How severe are your Headaches? 0 1 2 3 4 5 6 7 8 9 10


48. How severe is your Tinnitus (PST)? 0 1 2 3 4 5 6 7 8 9 10







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LUMBAR PUNCTURE 51. Did you have a spinal tap to make your diagnosis? Yes No (if no, go to # 58) 51a. When? Month_______Year_______

51b. What was the opening pressure measurement? _______ 51c. Who was the physician performing the spinal tap? __________________________ 51d. In what position were you when the spinal tap was done?

Lying on side Lying on stomach Sitting 52. How many spinal taps have you had? ______ 52a. What was the highest opening pressure measurement of any of your taps? ______ Please indicate the effect of the spinal tap on the following symptoms. If the symptom was better, indicate for how long.

Better Worse None How Long? Hours Days Months Years 53. Headache (from IH) ________ 54. Tinnitus (PST) ________ 55. Neck pain/stiffness ________ 56. Central Vision ________ 57. Side Vision ________

CURRENTLY The following questions ask about how you feel right now. Compared to one year ago, how are the following: Much Somewhat About the Somewhat Much Not

Better Better Same Worse Worse Applicable 58. General Health: 59. Headache: 60. Tinnitus (PST): 61. Central Vision: 62. Side Vision: Compared to the time of your diagnosis, how are the following: Much Somewhat About the Somewhat Much Not

Better Better Same Worse Worse Applicable 63. General Health: 64. Headache: 65. Tinnitus (PST): 66. Central Vision: 67. Side Vision:


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TREATMENTS FOR IH The following questions are about treatment of your intracranial hypertension.

Y N ? 68. Have you lost weight since your diagnosis?

68a. How much weight did you lose? _________ lbs kgs stones

68b. Did losing the weight reduce your symptoms of IH? (if no, got to #69)

68c. Did losing the weight eliminate your symptoms of IH?

69. Have you had any type of weight loss surgery?

69a. What type of surgery did you have?

Gastric banding

Roux-en-Y gastric bypass

Biliopancreatic diversion

Other (specify): ____________

Sleeve gastrectomy Not sure

69b. Date of surgery? Month_________ Year_________

69b.i. Weight at time of weight loss surgery? _______ lbs kgs stones

69b.ii. Weight loss one-year after surgery? _______ lbs kgs stones

69c. Did the surgery reduce your symptoms of IH? (if no, got to #70)

69d. Did the surgery eliminate your symptoms of IH?

70. Have you had a shunt placed for IH?

70a. Date of first shunt surgery? Month_________ Year_________

70b. How many shunt procedures have you had (including revisions)? ______

70c. What type of shunt procedure(s) did you have?

Lumboperitoneal Other (specify): _________________ Ventriculoperitoneal Not sure Ventriculoatrial

71. Have you had subtemporal decompression?

72. Have you had cranial vault expansion?

73. Have you had optic nerve sheath fenestration (an optic nerve operation)?

73a. On which side did you have optic nerve fenestration?

Right Left Both Not sure

73b. How many times have you had this type of operation?

Right _______ Left _______ Both _______ Not sure


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74. Were you told that you have/had a narrowing (stenosis) or a blood clot (thrombosis) in the veins (sinuses) of your head or brain?

74a. Did you have a stent for this stenosis or thrombosis?

74b. Did you have other treatment for this stenosis or thrombosis?

If yes, please specify:__________________________________________

Y N ?

75. Have you taken medications for intracranial hypertension (if none, go to # 76) Taken? Relief? Y N Taken? Relief? Y N

Diamox (Acetazolamide) Topamax (Topiramate)

Lasix (Furosemide) Neptazane (Methazolamide)

Other (specify) _____________________________________________

76. Currently, what medications are you taking? Please list.

Medication Name(s) Medication Name(s) Medication Name(s)

REPRODUCTIVE Females (males go to # 84, Medical History)

Y N ?

77. Have you been diagnosed with PCOS (Polycystic Ovarian Syndrome)?

78. How many times have you been pregnant? _______ (If 0, go to #84, Medical History)

79. How many live births have you had? _______

80. Did you develop intracranial hypertension during a pregnancy?

81. Were you pregnant at the time of diagnosis?

82. Have you been pregnant since your diagnosis?

83. Did you take Diamox during any of your pregnancies?

83a. During how many pregnancies did you take Diamox? _______

83b. Did you take Diamox during the first or second trimester in any of your pregnancies?

Yes No Not Sure


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MEDICAL HISTORY Please indicate if you have and have had any of the following conditions (questions 84 – 113): Y N ? Y N ? Intracranial bleeding: aneurysm Systemic lupus erythematosis Migraine headache (headache not from IH) Anemia Clotting of veins in head (thrombosis) Under-active thyroid (hypo-) Blood clotting disorders Over-active thyroid (hyper-) High blood pressure Pituitary tumor Cushing’s disease Hydrocephalus Addison’s disease Aqueductal stenosis Chronic sinusitis Leukemia Kidney failure Arnold-Chiari malformation Dialysis Lymphoma Kidney transplant Viral meningitis Liver failure Acute lymphocytic meningitis Liver transplant Guillian-Barré syndrome Lyme disease Mono (mononucleosis) Sleep Apnea Polio Head trauma (Specify): ___________________________ Date(s):______________ Brain tumor (Specify): _________________________________________________ Spinal cord tumor (Specify): ____________________________________________

114. Please list any other significant medical conditions (e.g, diabetes):

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________ FAMILIAL HISTORY Please indicate if any of your family members have or have had intracranial hypertension.

Y N ? 115. Father 116. Mother 117. Brother Was it a twin brother? Y N ? 118. Sister Was it a twin sister? Y N ? 119. Other (e.g., aunt, 2nd cousin; specify): _________________________________


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OTHER Please use this space to tell us anything else you consider important about your medical history or your experience with IH: ____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

PHYSICIANS Please list any and all physicians you have seen for your intracranial hypertension. We will obtain records from the doctors that you list below. If you are unable to find the addresses for your physicians, please fill in the name, state, and specialty of the physician. Please list the physician that knows the most about your condition first.

Physician 1

Made Diagnosis Present Doctor Performed Surgery

Name: _____________________________________Specialty: _________________________________

Hospital/Institution: ____________________________________________________________________

Address: _____________________________________________________________________________

City: ____________________________ State: _______ Zip: _____ Country: ____________

Phone: _______________ Fax: _________________ Email: _________________________

First Visit: Month ______ Year ______ Are you still seeing this physician? Y

Last Visit: Month ______ Year ______ N


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Physician 2


Name: _____________________________________Specialty: _________________________________


Address: _____________________________________________________________________________


Phone: _______________ Fax: _________________ Email: _________________________



Physician 3


Name: _____________________________________Specialty: _________________________________


Address: _____________________________________________________________________________


Phone: _______________ Fax: _________________ Email: _________________________



Physician 4


Name: _____________________________________Specialty: _________________________________


Address: _____________________________________________________________________________


Phone: _______________ Fax: _________________ Email: _________________________




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Physician 5


Name: _____________________________________Specialty: _________________________________


Address: _____________________________________________________________________________


Phone: _______________ Fax: _________________ Email: _________________________



IMAGING STUDIES Please list all hospitals/facilities where you have had imaging studies of the head, neck, or spine performed. Sometimes imaging studies are done at hospitals, an outside center, or a mobile van.

Some types of imaging studies that you may have undergone are:

MRI, MRV, MRA Shunt studies Venogram CT X-Rays (Skull, Spinal, Sinus, etc.) Arteriogram PET Contrast Studies Ultrasounds (eyes)

Imaging Study 1

Type(s) of Study ______________________________ Date(s) of Study: _______________________

Referring Physician(s): __________________________________________________________________

Hospital/facility Name: __________________________________________________________________

Address: _____________________________________________________________________________


Imaging Study 2




Address: _____________________________________________________________________________



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Imaging Study 3




Address: _____________________________________________________________________________


Imaging Study 4




Address: _____________________________________________________________________________


120. How did you hear about the Intracranial Hypertension Registry? IHRF website Doctor/Doctor’s Office (specify): _____________________ IHRF announcement Support Group (specify): ___________________________ Friend/Relative Other (specify): __________________________________

You are finished! Thank you for completing the questionnaire!

______________________ _____________________________ ________________ Printed Name Signature Date

Relationship to patient: ___________________________________

Please return to: Intracranial Hypertension Registry

OHSU – CB723 3181 SW Sam Jackson Park Road

Portland, Oregon 97239

OR fax to: (503) 418 – 2139

ih registry ptq final 2014

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