3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
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3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
Carroll Ann Trotman, BDS, MA, MS
ICF version: 05/04/2021
TUFTS UNIVERSITY
Department of Orthodontics
ADULT INFORMED CONSENT TO PARTICIPATE IN RESEARCH
3D Dynamic and Patient-Centered Outcomes of Facial Reanimation
Surgery in Patients with Facial Paralysis
Principal Investigator: Carroll Ann Trotman, BDS, MA, MS
Co-Investigators: Tessa Hadlock, M.D.
Julian Faraway, Ph.D.
Ceib Phillips, Ph.D.
Study team telephone number: Laboratory Telephone: (617) 636-3591
24-hour Research Team Cell Phone: (617) 636-0347
Key Information: The following is a short summary of this study to help you decide whether
to be a part of this study. More detailed information is listed later on in this form.
Why am I being invited to take part in a research study?
We invite you to take part in a research study involving evaluation of facial paralysis because
you are a patient at the Facial Nerve Center (FNC) at Massachusetts Eye and Ear Infirmary
(MEEI) with Dr. Tessa Hadlock as your attending surgeon.
What should I know about a research study?
• Someone will explain this research study to you.
• Please also read all of the following information carefully.
• Whether or not you take part is up to you.
• You can choose not to take part.
• You can decide to take part and later change your mind.
• Your decision will not be held against you.
• You can ask all the questions you want before you decide. Do not sign unless you
understand the information in it and have had your questions answered to your
satisfaction.
• If you sign this form and decide to take part in this research study, keep a copy of the
signed form for your records. It has information, including important names and
telephone numbers that you may wish to refer to.
Why is this research being done?
Page 1 of 9
Tufts Institutional Review Boards
Submission ID:MOD-03-13412
Date Approved:5/8/20213D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
Carroll Ann Trotman, BDS, MA, MS
ICF version: 05/04/2021
Facial paralysis is the loss of facial movement due to a weakened or damaged facial nerve. The
resultant disfigurement and impairment in soft tissue movements not only impacts facial
esthetics and function, but also patients’ social and emotional quality of life. Treatments can
range from non-surgical interventions to facial reanimation surgery.
Surgeries for facial reanimation can have a tremendous impact on patients’ lives. For the surgery,
muscle may be transferred to the face and/or nerves may be modified. This study will focus on
different outcomes of the surgery.
How long will the research last and what will I need to do?
We expect that you will be in this research study for 3 visits over 18 months.
You will be asked to make a series of set facial movements that are designed to focus on the
areas of interest (such as mouth, nose, and eyebrow regions) in subjects with facial paralysis.
A 3D camera will be used to take photographs of your face. You will be seated comfortably in
front of the camera and the camera will be adjusted to focus on your face. Your face will be
photographed at rest and at the maximum position of different facial movements.
A set of video images will be recorded during each of the series of facial movements. Three
video cameras positioned at right angles to each other will record these images. The images will
be displayed on a split-screen color television and recorded using a standard video-recorder. The
images will be compiled and saved for later viewing.
In addition, you will be asked to complete a few different questionnaires (see below):
The Facial Clinimetric Evaluate Scale (FaCE): Features fifteen questions related to the negative
consequence of paralysis. This will take about 6 minutes.
Medical Outcomes Study Short Form (SF-36): Judges ability to perform normal daily activities
and well-being. 36 questions. This will take about 8 minutes to complete.
Recovery Perception questionnaire (PSP): Assesses symptom issues, social/self-issues, general
health issues and dentofacial issues. You will be rating the level of discomfort, difficulty or
dissatisfaction with each of the 25 items in terms of the extent of burden related to that item in
the past month. This will take about 6 minutes to complete.
More detailed information about the study procedures can be found under the “Procedures to be
Followed” section.
Is there any way being in this study could be bad for me?
You may get tired or restless during the session(s). You will be given breaks to rest, snack, and
use the restroom, etc. in order to minimize your discomfort. We will do nothing to hurt you.
More detailed information about the risks of this study can be found under the “Risks” section.
Page 2 of 9
Tufts Institutional Review Boards
Submission ID:MOD-03-13412
Date Approved:5/8/20213D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
Carroll Ann Trotman, BDS, MA, MS
ICF version: 05/04/2021
Will being in this study help me any way?
There are no benefits to you from your taking part in this research. We cannot promise any
benefits to others from your taking part in this research. However, possible benefits to others
include the information gained from this study will potentially enhance our understanding of
facial disability in patients with facial paralysis who undergo facial reanimation surgery. Because
the risks are minimal and the knowledge that can be gained from these studies is potentially of
considerable importance, the risk-benefit ratio is considered excellent.
What happens if I do not want to be in this research?
Participation in research is completely voluntary. You can decide to participate or not to stop
taking part in it at any time for any reason. Your alternative to participating in this research study
is to not participate.
If you refuse to participate in the study or stop being this study, it will not affect your care or
treatment outside this study, payment for your health care, or your health care benefits.
Detailed Information: The following is more detailed information about this study in
addition to the information listed above.
PURPOSE OF STUDY
The study is being conducted in order to generate a database of 3D measures to analyze the
outcomes of different gracilis muscle transplants or modifications for mid-facial reanimation and
to potentially provide patients with a list of possible procedures that may improve the outcomes
from treatments.
Because there have been no tools developed to evaluate the facial disability and the outcomes of
treatments in patients with facial paralysis, the benefits of the different treatment approaches is
unknown. This study will help create tools to evaluate the outcomes of reanimation surgery in
patients with facial paralysis using measures of facial soft tissue. The tools will be used to
generate future hypotheses to help surgeons’ with surgical interventions and outcomes.
Study visits will be conducted in the Facial Animation Laboratory run by Dr. Trotman in the
Department of Orthodontics at Tufts University School of Dental Medicine.
This study is sponsored by the National Institutes of Health (NIH).
We expect up to 125 subjects to be screened in order to have 96 subjects complete the study.
PROCEDURES TO BE FOLLOWED
Visit 1: Baseline (Before surgery); about 1 hour and 45 minutes
You will be instructed by the study staff to read this informed consent form (ICF) and given time
to have any questions answered. Then you will be instructed to sign the ICF and will be given a
copy. You will be asked to complete a medical history and provide demographic information.
You will provide us with your contact information, as well as the contact information of
Page 3 of 9
Tufts Institutional Review Boards
Submission ID:MOD-03-13412
Date Approved:5/8/20213D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
Carroll Ann Trotman, BDS, MA, MS
ICF version: 05/04/2021
someone else you know, so that we can reach you to schedule or re-schedule appointments
during the course of the study. You then will be screened according to inclusion/exclusion
criteria.
You will be asked to complete the Facial Clinimetric Evaluate Scale (FaCE), which will take
about 6 minutes. Next, you will be asked to complete the Medical Outcomes Study Short Form
(SF-36), which will take about 8 minutes. And lastly you will be asked to complete a Recovery
Perception questionnaire (PSP), which will take about 6 minutes.
Facial movements will be measured using the motion capture system. Photographs of your face
will be taken with the 3D camera. Video images will be recorded during each series of facial
movements.
Visit 2: 5 Months after Surgery; about 1 hour and 45 minutes
Medical history will be reviewed and any changes will be noted. Eligibility/withdrawal criteria
will be reviewed.
Facial movements will be measured using the motion capture system. Photographs of your face
will be taken with the 3D camera. Video images will be recorded during each series of facial
movements.
Visit 3:18 Months after Surgery; about 1 hour and 45 minutes
Medical history will be reviewed and any changes will be noted. Eligibility/withdrawal criteria
will be reviewed.
You will be asked to complete the Facial Clinimetric Evaluate Scale (FaCE), which will take
about 6 minutes. Next, you will be asked to complete the Medical Outcomes Study Short Form
(SF-36), which will take about 8 minutes. And lastly you will be asked to complete a Recovery
Perception questionnaire (PSP), which will take about 6 minutes.
Facial movements will be measured using the motion capture system. Photographs of your face
will be taken with the 3D camera. Video images will be recorded during each series of facial
movements.
Your demographic information that is collected as part of this research will not be used or
distributed for future research studies, even if all your identifiers are removed.
WITHDRAWAL
If you are eligible to participate and decide to be in the study, the Principal Investigator may still
choose to stop your participation in this study if she thinks it is in your best medical interest.
You can also leave the research at any time it will not be held against you. If you refuse to
Page 4 of 9
Tufts Institutional Review Boards
Submission ID:MOD-03-13412
Date Approved:5/8/20213D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
Carroll Ann Trotman, BDS, MA, MS
ICF version: 05/04/2021
participate in the study or stop being in this study, it will not affect your care or treatment outside
this study, payment for your health care, or your health care benefits.
We will tell you about any new information that may affect your health, welfare, or choice to
stay in the research.
If you withdraw or are withdrawn from the study, any data collected from you before your
withdrawal will still be used for the study.
RISKS
As with any research study there is the potential risk of loss of confidentiality. Every effort will
be made to keep your information confidential; however, this cannot be guaranteed. You may
stop your participation in this study at any time.
There are no known risks associated with the collection of clinical treatment details, 3D
photographs, video images, or questionnaires. Small dots will be put on your face and will be
held in place of special removable glue. Although the glue does not contain latex, some people
may be allergic to it. We will test this by placing a small amount of the glue on the back of your
hand and wait for 15 minutes to see if you have a reaction. If you do have a reaction, we will
treat the affected area with 1% hydrocortisone cream. We will then use something else to help
put the dots to your face.
RESEARCH RELATED INJURY
Emergency medical treatment will be given to you if you are hurt or get sick as a direct result of
being in this research study. You or your insurance carrier are to pay for any such medical care.
Any needed medical care is available at the usual cost. All needed facilities, emergency
treatment, and professional services are available to you, just as they are to the general public.
There are no plans to pay for your treatment if you get hurt or sick as part of this study. This
institution has not set aside any money to pay for a research-related injury or illness.
COSTS
There are no costs to you associated with participation in this study. You and/or your insurance
plan will need to pay for the costs of your regular medical care.
PAYMENT
You will receive a payment of $500 at the completion of each study visit. There will be 3 study
visits for a total of $1500 payment for your participation.
Payment will be made using a debit gift card. It works like a bank debit card. We will give you
a new debit card after every completed visit.
You may use this card at any store that accepts credit cards. All cards will be activated before we
give them to you. The debit cards are available for use immediately once you receive them.
Page 5 of 9
Tufts Institutional Review Boards
Submission ID:MOD-03-13412
Date Approved:5/8/20213D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
Carroll Ann Trotman, BDS, MA, MS
ICF version: 05/04/2021
Due to federal tax law, you are required to provide us your social security number in order to
process your payments. If you receive over $600 from Tufts University Health Sciences in a
single calendar year (either in a single study or multiple studies), you will be issued an IRS 1099
form. This may affect your taxes. Only payments for being in research studies will be used to
decide if you should receive the IRS form.
PRIVACY AND CONFIDENTIALITY
Confidentiality and privacy are maintained in several ways. If you are eligible for participation
based on the inclusion/exclusion criteria, you will be identified by research staff from the records
at MEEI. You will be contacted by the research staff from either MEEI or TUSDM who will ask
if he/she can discuss a research project with you. If you want to learn more, you will be
contacted by research staff and the proposed study will be described in detail. You are free to
decline participation and not participating will have no effect your patient status at MEEI.
Data collection will be performed in a dedicated room at TUSDM. Telephone contact will be
made from a research associate’s office. No reference to the study is included on envelopes used
in any mailings to you. You will be identified by a study ID number, different from your clinical
(medical record) identifier. You will not be identifiable in any presentation. Individual
identification will be removed from any photographs or other materials that are presented as
examples of individual treatment responses. Photographs and images of your faces will be sent to
consulting surgeons.
Before sending photographs and images of your face to consultants, personal identifiers (such as
name, birthdate, and medical record number) will be removed. We will not utilize photographs
or images of your face for publications or presentations without your written consent to do so.
De-identified data (which is information collected from you and the identifiers listed above are
removed) will be shared with consultants Dr. Ceib Phillips at the University of North Carolina
and Dr. Julian Faraway at the University of Bath, UK. Dr. Phillips will look at the psycho-social
tests linked to the surgeons’ evaluations. Dr. Faraway will help with analyzing the information
collected from you and help make animated models of facial movement data.
We will make every effort to keep your information private, but it cannot be completely
guaranteed. Certain government agencies Office for Human Research Protections, Department of
Health and Human Services and the Institutional Review Board of Tufts Medical Center and
Tufts University Health Sciences, may check records that identify you. This might include your
medical or research records and the informed consent form you signed. The records of this study
might also be reviewed to make sure all rules and guidelines were followed.
We may publish the results of this research. However, we will keep your name and other
identifying information confidential.
This research is covered by a Certificate of Confidentiality from the National Institutes of
Health. The researchers with this Certificate may not disclose or use information, documents, or
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative,
Page 6 of 9
Tufts Institutional Review Boards
Submission ID:MOD-03-13412
Date Approved:5/8/20213D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
Carroll Ann Trotman, BDS, MA, MS
ICF version: 05/04/2021
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a
court subpoena, unless you have consented for this use. Information, documents, or
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not
connected with the research except, if there is a federal, state, or local law that requires
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have
consented to the disclosure, including for your medical treatment; or if it is used for other
scientific research, as allowed by federal regulations protecting research subjects.
AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE HEALTH
INFORMATION
If you sign this document, you give permission to the Principal Investigator named above and
research staff at Tufts University School of Dental Medicine as well as other individuals at
TUSDM who may need to access your information to do their jobs (such as for treatment,
payment (billing) or health care operations) to use or disclose (release) your health information
that identifies you for the research study described above.
The parties listed in the preceding paragraph may disclose the health information described
below to the following persons and organizations for their use in connection with the research
study:
• Individuals or organizations working under the direction of the Principal Investigator(s)
for the study,
• Outside individuals or entities that have a need to access this information to perform
activities relating to the conduct of this research, such as analysis by outside laboratories
on behalf of Tufts University School of Dental Medicine
• Other researchers and institutions that are conducting or participating in this study,
• The study sponsor Tufts University funded by the National Institute of Health and any
companies that they use to oversee, manage, or conduct the research,
• The Office for Human Research Protections in the U.S. Department of Health and
Human Services, the United States Food and Drug Administration (FDA) and other
federal and state agencies that have the right to use the information as required by law,
and
• The members and staff of any Institutional Review Board (IRB) monitoring the study
The health information that we may use or disclose (release) for this research study includes all
information in your medical record related to the diagnosis and management of your reanimation
surgery, including the record of your care, as well as any information collected or created during
the course of this study.
Tufts University School of Dental Medicine is required by law to protect your health
information. By signing this document, you authorize Tufts University School of Dental
Medicine to use and/or disclose (release) your health information for this research. Those
persons who receive your health information may not be required by Federal privacy laws (such
as the Privacy Rule) to protect it and may share your information with others without your
Page 7 of 9
Tufts Institutional Review Boards
Submission ID:MOD-03-13412
Date Approved:5/8/20213D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
Carroll Ann Trotman, BDS, MA, MS
ICF version: 05/04/2021
permission, if permitted by laws governing them. You may not be allowed to see or copy the
information described on this form as long as the research is in progress, but you have a right to
see and copy the information upon completion of the research in accordance with hospital
policies.
Tufts University School of Dental Medicine may not withhold or refuse to provide you with
clinical care based on whether or not you sign this form.
This authorization does not have an expiration date. You may change your mind and revoke
(take back) this authorization at any time. Even if you revoke this authorization, this site’s
clinical, administrative and research staff may still use or disclose health information they
already have obtained about you as necessary to maintain the integrity or reliability of the current
research. To revoke this authorization, you must write to: HIPAA Privacy Officer for Research at
One Kneeland Street, Room 334, Boston, MA 02111. If you revoke this authorization, you may
no longer be allowed to participate in the research described in this form.
WHOM TO CONTACT
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the
Principal Investigator Dr. Carroll Ann Trotman at (617) 636-0846 during daytime hours and
(410) 948-1615 in the evenings and on weekends. You may also call the research team directly,
24 hours a day, at (617) 636-0347.
If you have question about your rights as a research study subject, call the Tufts Medical Center
and Tufts University Health Sciences Institutional Review Board (IRB) at (617) 636-7512. The
IRB is a group of doctors, nurses, and non-medical people who review human research studies
for safety and protection of people who take part in the studies. Federal law requires the IRB to
review and approve any research study involving humans. This must be done before the study
can begin. The study is also reviewed on a regular basis while it is in progress. This research
study has been reviewed and approved by the IRB of Tufts Medical Center and Tufts University
Health Sciences.
Page 8 of 9
Tufts Institutional Review Boards
Submission ID:MOD-03-13412
Date Approved:5/8/20213D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients with Facial Paralysis
Carroll Ann Trotman, BDS, MA, MS
ICF version: 05/04/2021
Documentation of Consent
I have been given a copy of this form. I have read it, or it has been read to me. I understand the
information and have had my questions answered to my satisfaction. I agree to take part in this
study.
I understand that I will be informed of any new findings developed during the course of this
research study that may affect my willingness to stay in this research study.
_________________________________________ _____________
Participant’s Signature Date
I have fully explained to ________________________________ the nature and purpose of the
above-described study and the risks that are involved in its performance. I have answered all
questions to the best of my ability.
_____________ ____________________________________________
Date Principal Investigator or Representative’s Signature
Page 9 of 9
Tufts Institutional Review Boards
Submission ID:MOD-03-13412
Date Approved:5/8/2021You can also read
