Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Phase: NA
Conditions: Thyroid Nodules, Thyroid Cancer
Sponsor: University of Florida

AIM1: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a 
Shared Decision Making Conversation Aid 
NCT04472026 
5/23/23

Aim 1. Adequate selection of patients for thyroid biopsy: evaluation of a shared decision making 
conversation aid 
Abstract: 
Thyroid nodules are commonly discovered and their evaluation and diagnosis precedes the epidemic of 
thyroid cancer that is harmful to patients and overwhelms the medical system. We hypothesize that the 
use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate 
when deciding between performing a thyroid biopsy or following thyroid nodules with serial ultrasound. 
As a result, the use of this tool can lead to a more careful selection of patients that should undergo 
thyroid biopsy. 
The proposed research seeks to: AIM1. Update a conversation aid prototype that was developed to 
support shared decision making in the diagnosis of thyroid cancer through evaluation of clinical practice 
and feedback from end users. 
Background  
We are living in an epidemic of thyroid cancer diagnoses that directly harms patients. The incidence of 
thyroid cancer in the United States has tripled during the last three decades, with >50, 000 patients 
diagnosed annually, mostly due to identification of small indolent cancers that would not be harmful if 
left undiagnosed and untreated. These patients receive risky treatment and suffer emotional and 
economic burden. For example: 1) the quality of life of patients with thyroid cancer is decreased when 
compared with patients with worse prognosis, 2) a diagnosis of thyroid cancer is associated with the 
highest incidence of bankruptcy and 3) the cost of caring for patients with thyroid cancer is expected to 
rise to $21 billion. This diagnostic and treatment journey leaves most patients with a diagnosis of thyroid 
cancer that only led to harm without improving the duration or the quality of their life. This reality of 
over-diagnosis and over-treatment affects 7 out of 10 women and 5 out of 10 men diagnosed with 
thyroid cancer in the United States. 
This detrimental epidemic is partially attributed to the inadequate selection of patients who would 
benefit from a thyroid biopsy and thyroid cancer diagnosis. Six out of 10 people have thyroid nodules 
that can be detected by imaging. The diagnostic cascade that leads to the over-diagnosis of thyroid 
cancer begins most commonly with the incidental discovery of these nodules. Patient selection for 
thyroid nodule biopsy and thyroid cancer diagnosis is inadequate and leads to harm. To address this 
quality gap, recent practice guidelines recommend for careful selection of patients for thyroid biopsy 
and against biopsy of small thyroid nodules with low risk for thyroid cancer. However, the 
implementation of these recommendations, can be hindered by challenging clinical conversations with 
patients who are anxious about a potential cancer diagnosis and assume that more investigation is 
always better. Counseling about complex topics such as thyroid cancer risk and over-diagnosis can be 
difficult. In fact, most patients after a thyroid biopsy know little about these topics and are not routinely 
engaged in making the decision to further investigate thyroid nodules. 
Shared decision-making (SDM) is a communication process in which patients and clinicians work 
together to decide the next best step. The use of conversation aids that support SDM helps patients 
make medical decisions that are consistent with their informed values, be more knowledgeable and 
active in the decision-making process and better understand concepts such as risk. In oncology, the use 

of conversation aids can help overcome barriers for patient-centered care. To support SDM, promote 
patient centered care and help clinicians identify patients who would benefit from a thyroid nodule 
biopsy according to guideline recommendations, we have developed an electronic conversation aid for 
patients diagnosed with a thyroid nodule. This conversation aid includes a summary of the clinical 
evidence guiding patient selection for thyroid biopsy, the values of each diagnostic alternative (biopsy vs 
observation) and allows clinicians to incorporate the patients preferences and situation into the decision 
making process. We hypothesize that use of this conversation aid will support SDM, improve patient 
selection for thyroid biopsy and reduce the unnecessary diagnosis of thyroid cancer.   
Specific Aims 
AIM 1. Field-test and update the conversation aid prototype. We will enroll patients (30-75) and 
clinicians (10-15) who have used the conversation aid at the University of Florida (UF) and Mayo Clinic 
(MC) to evaluate the acceptability of its use and barriers to implementation. Post visit semi structured 
interviews and recordings of the clinical visits will be qualitatively analyzed after transcription. We 
hypothesize the conversation aid will be accepted and facilitate the decision making process.  
Research Plan 
We hypothesize that the use of a conversation aid in patients with thyroid nodules will enhance the 
collaboration between patients and clinicians, supporting SDM and lead to adequate and careful 
selection of patients that should undergo thyroid biopsy in accordance with current clinical practice 
recommendations. If successful, this innovative intervention will help close the gap between practice 
recommendations and adequate selection of patients for thyroid biopsy.  
AIM 1. Field-test and update the conversation aid prototype  
Setting. The Endocrinology, Ear, Nose and Throat (ENT) and Surgery Clinics at the University of Florida, 
FL and the Division of Endocrinology at Mayo Clinic, MN.  
Participants and identification procedures.  
1. Patients: Eligible patients would be identified by review of the upcoming clinic schedule of 
participating clinicians.  We will include 30-75 English-speaking adults > 18 years old who present for 
evaluation of a thyroid nodule and discuss the need for thyroid biopsy. UF students and staff, will be 
included in the study, although not targeted. We will exclude patients with hyperthyroidism, 
pregnant patients and those in which the nodule of interest has already been biopsied or who have 
received counseling by a local specialist in the year before their visit.  
 
2. Clinicians: We will enroll clinicians that counsel patients with thyroid nodules from the 
endocrinology, ENT and surgery divisions at UF and from the endocrinology division at MC. 
Intervention. We have developed a conversation aid for patients with thyroid nodules and aim to field 
test this prototype. This conversation aid was developed using person-centered design procedures 
including direct observation of clinical encounters and integration of the best available evidence guiding 
the selection of patients for thyroid biopsy. We would use information from 1) direct evaluation of 
recorded clinical visits and 2) semi-structured interviews to identify areas that would need to be 
modified on this conversation aid and to explore barriers and facilitators to the use of this tool in clinical 

practice.  We will collect information related to past medical history and thyroid disease from electronic 
medical record review and clinicians will complete a post visit survey after each visit (pen and paper 
survey). 
We will ask clinicians to use the prototype during clinical encounters in which they are counseling 
patients with thyroid nodules regarding the diagnostic alternatives of thyroid biopsy or surveillance with 
periodic thyroid ultrasound. Before clinicians use the tool, study personnel will review the conversation 
aid with participating clinicians and do a demonstration so that they are familiarized with the tool. These 
visits will be recorded and analyzed using qualitative research methods, after they have been 
transcribed.  
In addition, patients and clinicians will be interviewed after their visit following an interview guide and 
clinicians will fill out a small questionnaire after each visit (pen and paper). 
Enrollment 
1) Patients.  Patients would be invited to participate in the study once they have been roomed and are 
waiting to see their clinician. The study coordinator will verify eligibility with the patient. The consent 
process will take care in a private room. We will seek written informed consent, consent for video/audio 
recording and authorization for review of electronic medial records to obtain information related to 
their medical history and thyroid nodule features. 
The study coordinator will quickly setup and start recording before leaving the room. The participants 
can stop this recording (video, aimed at the desk, or audio when the video camera is aimed at the 
ceiling) at any time. 
2) Clinicians.  Eligible clinicians are those who counsel patients with thyroid nodules.  We will approach 
eligible clinicians at their convenience to discuss the goals of the study and their potential participation. 
We will obtain written informed consent and consent for audio/video recording. 
3) Guest. If an eligible patient has a caregiver/guest with them we will seek the consent for participation 
given that their participation during the medical visit would be recorded and they may wish to 
participate in the post visit interview.  If a guest does not want to participate, the patient would not be 
included in the study as we don’t want to disrupt their visit dynamic. Informed consent and consent for 
audio/video recording will be obtained. 
4) Other.  Commonly, clinicians would work with scribes, students, and other ancillary staff.  We will 
obtain consent for audio/video recording during the medical visit. 
Measurements and Outcomes. The main outcome is an updated prototype based on qualitative 
assessment of feedback from patients and clinicians and evaluation of their clinical visits. We will 
conduct semi-structured interviews of patients and clinicians after using the conversation aid to identify 
barriers to implementation of the tool following the Consolidated Framework for Implementation 
Research Construct. We have focused on characteristics related to the intervention, outer setting and 
individuals.  
Patients will be interviewed after their clinical visit and physicians will be interviewed after they have 
used the tool in 3-5 clinical encounters; we will also ask clinicians to fill a post-visit questionnaire (pen 

and paper) addressing the topics of interest. This interviews would be recorded and transcribed for 
analysis. 
The interview for patients will be conducted in person in a private room immediately after their visit, 
when feasible and acceptable by patients. However, we will offer the opportunity to set up a visit time 
for the interview up to 7 days after their initial visit as they might have other appointments. We will also 
offer the opportunity to complete the conversation remotely (e.g. UF zoom account) to facilitate 
enrollment. 
The interview for clinicians will be conducted in person or remotely at a convenient time after the 
clinicians have used the tool in 3-8 clinical encounters. 
We will evaluate the recordings of the clinical visit to complement the findings of the interviews as they 
relate to the use of the tool in clinical practice.  We plan to use a grounded theory approach for our 
qualitative analysis, an inductive method in which a theory is developed entirely based on analysis of the 
data. In addition, we will review the recordings of the clinical encounters to verify fidelity (extent to 
which the tool was used during the visit) to the use of the tool during practice.   
Sample size and Statistical Analysis. Qualitative research methods allow researchers to obtain an in 
depth understanding of a particular phenomenon by focusing on individual experiences. Sample size is 
usually determined by reaching a saturation point, where new themes are no longer identified; a priori 
sample size is not specified. However, in the field of SDM in oncology, thyroid cancer and thyroid 
nodules, previous qualitative studies have included 6-25 participants. As such, we anticipate evaluating 
3-8 clinical encounters per clinician following a purpose sampling strategy to allow similar numbers of 
encounters from each clinician and including patients with different characteristics that would make the 
encounters more informative. In addition, we will obtain descriptive statistics about the patients’ and 
clinicians’ characteristics. 
Data management 
Patients approached by study staff that agree to participate will be captured in the remote data capture 
system (REDCap).  Potential eligible patients found to be ineligible or eligible but who decline 
participation will be captured as well.  The reason for ineligibility or reason for decline will be captured 
along with patients’ age, sex, and race/ethnicity.   
Data from the medical record will be obtained for all enrolled patients that agree to capture 
demographic and clinical data.   
All video recording will be stored in a secure drive to which only the study personnel will have access.   
Clinical information and survey data would be stored into REDCAP and available only to study personnel. 
The transcription of recordings required for qualitative analysis will be completed by a third party 
company.  Audio recordings will be send electronically (https://thelai.com/ , Landmark Transcription) 
Possible Discomforts and Risks 
The participants in the study will not be expose to any significant risks.    

This study does not involve any procedures, medications or tests. However, we will be recording the 
medical encounters during routine care, which might make participants uncomfortable. We will offer 
the option of audio recording only if preferred and underline with participants that the recording can be 
stopped at any time. 
We will approach patients for enrollment once they are roomed and this could result in a minimal delay 
in the clinic schedule.  To avoid interruption, we will discuss with clinicians before approaching patients 
during clinic time and if they are running behind, we will not approach the patient. We have completed 
a study following this approach in our outpatient clinics, and have had no issues related to timing.   
In addition, in  the case of the patients in AIM1, they will be asked to participant in a post visit interview. 
This might represent burden in terms of time. The interview focuses on questions related to their clinical 
visit and no sensitive topics would be evaluated. This interview will be completed in a private room.  
Similarly, clinicians on Aim1, will be asked to participate in an interview to provide feedback on the 
conversation aid and complete a short questionnaire after each visit, that might represent a burden in 
terms of time. 
Possible Benefits 
The participants of the study would not receive any direct benefit.  However, the information obtained 
from this study will help us refine and test a tool that aims to improve the quality of the conversation 
between patients and clinicians when discussing the need of thyroid biopsy.  This tool will be beneficial 
for patients diagnosed with thyroid nodules in the future. 
Conflict of Interest 
None of the investigators has any conflict of interest in regards to patents, owning stock or serving as 
consultant 
 
 

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in a large VA outpatient population. J Gen Intern Med. 2008;23(5):561-566. 
83. 
Zikmund-Fisher BJ, Smith DM, Ubel PA, Fagerlin A. Validation of the Subjective Numeracy Scale: 
effects of low numeracy on comprehension of risk communications and utility elicitations. Med 
Decis Making. 2007;27(5):663-671. 
84. 
Cunny KA, Perri M, 3rd. Single-item vs multiple-item measures of health-related quality of life. 
Psychol Rep. 1991;69(1):127-130. 
85. 
Dhand NK, & Khatkar, M. S. Statulator: An online statistical calculator. Sample Size Calculator for 
Estimating a Single Proportion. 2014; http://statulator.com/SampleSize/ss1P.html. Accessed 17 
April 2019  
86. 
Pencille LJ, Campbell ME, Van Houten HK, et al. Protocol for the Osteoporosis Choice trial. A 
pilot randomized trial of a decision aid in primary care practice. Trials. 2009;10:113. 
87. 
Hemming K, Lilford R, Girling AJ. Stepped-wedge cluster randomised controlled trials: a generic 
framework including parallel and multiple-level designs. Stat Med. 2015;34(2):181-196. 
 
 

AIM1: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a 
Shared Decision Making Conversation Aid 
NCT04472026 
5/23/23

IRB Project #: IRB202000837
Page 1 of 4
IRB Version: 10/01/2018
PI Version: 8/07/2020
INFORMED CONSENT FORM
to Participate in Research, and
Title of this study: Adequate selection of patients for thyroid biopsy: evaluation of a shared 
decision making conversation aid
Researchers:    
Principal Investigator: Naykky Singh Ospina, MD, MSc
Phone number – 352-273-8656
You are being asked to participate in a research study.
Before you agree to take part in this study, Dr. Singh Ospina or her representative will 
tell you:

Why the study is being done and what will happen to you if you take part in the 
study: 
The goal of this research project is to obtain feedback for educational materials 
that have been developed for patients and clinicians to discuss the management of 
thyroid nodules.  
If you were to participate in this research study we will like to: 1) audio or video 
record clinical visits in which you counsel patients with thyroid nodules using our 
thyroid nodule conversation aid, 2) interview you after you have used the thyroid 
nodule conversation aid in 3-5 encounters and 3) have you complete a post visit 
questionnaire after each visit in which you use the thyroid nodule conversation aid.

How long you will be in the study:  You will be involved in this research project 
until you counsel 8-10 patients using our conversation aid and complete an 
interview to provide us with feedback.

How many people will be in the study: We plan to enroll up to 17 clinicians, 260 
patients and 520 guest (assuming an average of 2 per patient).

The possible foreseeable risks, discomforts, and benefits of this research:  
Having your clinical visit recorded can be uncomfortable or feel strange.  You can 
turn off the recording at any time.  We anticipate the post visit interview will take 
15-20 minutes of your time. These recordings will be send electronically to a third 
party for professional transcription, in order to conduct analysis. Lastly, your 
recordings and feedback would be securely stored in the University of Florida 
restricted servers, however, there is always a potential risk of a data breach.
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 2 of 4
IRB Version: 10/01/2018
PI Version: 8/07/2020
There is no direct benefit to you for participating in this study, however, you might 
benefit from learning the information presented in the educational materials. In 
addition, we will use your feedback to modify and update our educational 
materials, to help patients and clinicians discuss the management of thyroid 
nodules.

Alternatives to being in the study:  You can decide not to participate in this study 
and routinely counsel your thyroid nodule patients.

How your study records will be maintained and who will have access:  
Information collected about you will be stored in locked filing cabinets or in 
computers with security passwords.  Only certain people have the legal right to 
review these research records, and they will protect the secrecy (confidentiality) of 
these records as much as the law allows.  These people include the researchers 
for this study, certain University of Florida officials, the hospital or clinic (if any) 
involved in this research, and the Institutional Review Board (IRB; an IRB is a 
group of people who are responsible for looking after the rights and welfare of 
people taking part in research).   Otherwise your research records will not be 
released without your permission unless required by law or a court order.
Researchers will take appropriate steps to protect any information they collect 
about you.  However, there is a slight risk that information about you could be 
revealed inappropriately or accidentally.  Depending on the nature of the 
information such a release could upset or embarrass you, or possibly even affect 
your insurability or employability.  
If the results of this research are published or presented at scientific meetings, 
your identity will not be disclosed.

If it will cost you anything to take part in this study: There would be no cost to you 
if you participate in this study.

When or if you may be told about new findings which may affect your willingness 
to keep taking part in this study:  as soon as the research team is aware of them.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, 
as required by U.S. Law.  This Web site will not include information that can 
identify you.  At most, the Web site will include a summary of the results. You can 
search this Web site at any time. 
If you agree to participate in this study, you will be given a signed copy of this 
document.
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 3 of 4
IRB Version: 10/01/2018
PI Version: 8/07/2020
You may contact Dr. Naykky Singh Ospina, MD, MSc at (352) -273-8656 at any time 
if you have questions about the research or if you think that you have been hurt by the 
research.
You may contact the Institutional Review Board at the University of Florida Health 
Science Center at (352) 273-9600 if you have questions about your rights as a research 
subject or what to do if you are injured.
You may choose not to be in this study or you may quit being in the study at any time 
and there will be no penalty and no loss of any benefits you are entitled to.
Once this research study is completed, any information that could identify you might be 
removed from any identifiable private information collected and that, after such removal, 
the information could be used for future research studies or distributed to another 
investigator for future research studies without additional informed consent from you or 
your legally authorized representative.
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 4 of 4
IRB Version: 10/01/2018
PI Version: 8/07/2020
Signing this document means that the research study, including the above information, 
has been described to you orally and/or that you have read this document, and you 
voluntarily agree to take part.
________________________________
______________
Signature of Person Obtaining Consent
Date
________________________________
______________
Consent and Authorization of Patient
Date
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 1 of 4
IRB Version: 10/01/2018
PI Version: 10/16/2020
INFORMED CONSENT FORM
to Participate in Research, and
Title of this study: Adequate selection of patients for thyroid biopsy: evaluation of a shared 
decision making conversation aid
Researchers:    
Principal Investigator: Naykky Singh Ospina, MD, MSc
Phone number – 352-273-8656
You are being asked to participate in a research study.
Before you agree to take part in this study, Dr. Singh Ospina or her representative will 
tell you:

Why the study is being done and what will happen to you if you take part in the 
study: 
The goal of this research project is to improve our educational materials for thyroid 
nodules based on your opinion of which parts worked well and which ones need 
improvement.  
If you were to participate in this research study we will like to: 1) audio or video 
record the clinical visit you are attending as a guest and 2) ask you to participate in 
an interview after this visit.

How long you will be in the study:  You will be involved until we complete your 
post visit interview.


How many people will be in the study: We plan to enroll up to 17 clinicians, 260 
patients and 520 guests (assuming an average of 2 per patient).

The possible foreseeable risks, discomforts, and benefits of this research:  
Having your clinical visit recorded can be uncomfortable or feel strange.  You can 
turn off the recording at any time.  We anticipate the post visit interview will take 
15-20 minutes of your time. These recordings will be send electronically to a third 
party for professional transcription, in order to conduct analysis. Lastly, your 
recordings and feedback would be securely stored in the University of Florida 
restricted servers, however, there is always a potential risk of a data breach.
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 2 of 4
IRB Version: 10/01/2018
PI Version: 10/16/2020
There is no direct benefit to you for participating in this study, however, we will use 
your feedback to modify and update our educational materials, to help patients and 
clinicians discuss the management of thyroid nodules.   

Alternatives to being in the study:  You can decide not to participate in this study 
and attend the clinical visit as a guest today.

How your study records will be maintained and who will have access:  
Information collected about you will be stored in locked filing cabinets or in 
computers with security passwords.  Only certain people have the legal right to 
review these research records, and they will protect the secrecy (confidentiality) of 
these records as much as the law allows.  These people include the researchers 
for this study, certain University of Florida officials, the hospital or clinic (if any) 
involved in this research, and the Institutional Review Board (IRB; an IRB is a 
group of people who are responsible for looking after the rights and welfare of 
people taking part in research).   Otherwise your research records will not be 
released without your permission unless required by law or a court order.
Researchers will take appropriate steps to protect any information they collect 
about you.  However, there is a slight risk that information about you could be 
revealed inappropriately or accidentally.  Depending on the nature of the 
information such a release could upset or embarrass you, or possibly even affect 
your insurability or employability.  
If the results of this research are published or presented at scientific meetings, 
your identity will not be disclosed.

If it will cost you anything to take part in this study: There would be no cost to you 
if you participate in this study.

When or if you may be told about new findings which may affect your willingness 
to keep taking part in this study:  as soon as the research team is aware of them.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, 
as required by U.S. Law.  This Web site will not include information that can 
identify you.  At most, the Web site will include a summary of the results. You can 
search this Web site at any time.
If you agree to participate in this study, you will be given a signed copy of this 
document.
You may contact Dr. Naykky Singh Ospina, MD, MSc at (352) -273-8656 at any time if 
you have questions about the research or if you think that you have been hurt by the 
research.
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 3 of 4
IRB Version: 10/01/2018
PI Version: 10/16/2020
You may contact the Institutional Review Board at the University of Florida Health 
Science Center at (352) 273-9600 if you have questions about your rights as a research 
subject or what to do if you are injured.
You may choose not to be in this study or you may quit being in the study at any time 
and there will be no penalty and no loss of any benefits you are entitled to.
Once this research study is completed, any information that could identify you might be 
removed from any identifiable private information collected and that, after such removal, 
the information could be used for future research studies or distributed to another 
investigator for future research studies without additional informed consent from you or 
your legally authorized representative.
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 4 of 4
IRB Version: 10/01/2018
PI Version: 10/16/2020
Signing this document means that the research study, including the above information, 
has been described to you orally and/or that you have read this document, and you 
voluntarily agree to take part.
________________________________
______________
Signature of Person Obtaining Consent
Date
________________________________
______________
Consent and Authorization of Patient
Date
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 1 of 7
IRB Version: 10/01/2018
PI Version: 10/16/2020 
INFORMED CONSENT FORM
to Participate in Research, and
AUTHORIZATION 
to Collect, Use, and Disclose Protected Health Information (PHI)
INTRODUCTION
Name of person seeking your consent:
Place of employment & position: 
GENERAL INFORMATION ABOUT THIS STUDY
1. Name of Participant ("Study Subject")
___________________________________________________________________ 
2. What is the Title of this research study (this “Research Study”)?
Adequate selection of patients for thyroid biopsy: evaluation of a shared decision 
making conversation aid
3. Whom do you call if you have questions about this Research Study (the “Study 
Team”)?
Principal Investigator: Naykky Singh Ospina, MD, MSc
Phone number – 352-273-8656
4.  Who is paying for this Research Study?
 
The sponsor of this study is National Cancer Institute.
5. In general, what do you need to know about this Research Study?
Agreeing to become involved in any research is always voluntary.  By signing this 
form, you are not waiving any of your legal rights.  If you decide not to participate in 
this research, you will not be penalized in any way and you will not lose any benefits 
to which you are entitled. If you have questions about your rights as a research 
subject, please call the University of Florida Institutional Review Board (IRB) office at 
(352) 273-9600.    
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 2 of 7
IRB Version: 10/01/2018
PI Version: 10/16/2020 
a) In general, what is the purpose of the research, how long will you be 
involved?  
The goal of this research project is improving our educational materials for thyroid 
nodules based on your opinion of which parts worked well and which ones need 
improvement.  You will be involved until you complete the post visit interview.
b) What is involved with your participation, and what are the procedures to be 
followed in the research? 
If you were to participate in this research study we will like to : 1) audio or video 
record your clinical visit, 2) interview you after your visit to obtain your opinion on 
our educational materials and 3) review your medical records to obtain information 
related to your medical history and thyroid nodule.
c) What are the likely risks or discomforts to you? 
Having your clinical visit recorded can be uncomfortable or feel strange.  You can 
turn off the recording at any time.  We anticipate the post visit interview will take 
15-20 minutes of your time. These recordings will be send electronically to a third 
party for professional transcription, in order to conduct analysis. Lastly, your 
recordings and clinical information would be securely stored in the University of 
Florida restricted servers, however, there is always a potential risk of data breach.
d) What are the likely benefits to you or to others from the research? 
There is no direct benefit to you for participating in this study, however, we will use 
your opinion to modify and update our educational materials, to help patients and 
clinicians discuss the management of thyroid nodules.   
e) What are the appropriate alternative procedures or courses of treatment, if 
any, that might be helpful to you?  
You can decide not to participate in this study and meet with your clinician to 
discuss how to manage your thyroid nodule.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law.  This Web site will not include information that can identify you.  
At most, the Web site will include a summary of the results. You can search this Web 
site at any time.
Additional and more detailed information is provided within the remainder of 
this Informed Consent form, please read before deciding if you wish to 
participate in this study
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 3 of 7
IRB Version: 10/01/2018
PI Version: 10/16/2020 
WHAT CAN YOU EXPECT IF YOU PARTICIPATE IN THIS STUDY?
6. What will be done as part of your normal clinical care (even if you did not 
participate in this Research Study)? 
You will receive counseling for your thyroid nodule.
7.  What will be done only because you are in this Research Study? 
If you agree to participate: 
1.We will record (audio or video) your clinical visit using a small camera. You, your 
clinician, and any visitors can turn off the recorder at any time. 
2. Your clinician will use the educational materials we have developed with you in 
your visit. 
3. We will interview you after your visit to obtain feedback. This interview can happen 
immediately after the visit and up to 7 days from today. We will record this interview.
4. We will review your electronic medical record, to obtain information related to your 
past medical history and thyroid history.
Once this research study is completed, any information that could identify you might 
be removed from any identifiable private information or identifiable biospecimens 
collected and that, after such removal, the information or biospecimens could be used 
for future research studies or distributed to another investigator for future research 
studies without additional informed consent from you or your legally authorized 
representative.
If you have any questions now or at any time during this Research Study, please 
contact one of the Research Team members listed in question 3 of this form.
8. What identifiable health information will be collected about you and how will it be 
used?
The Research Team will collect demographic information, past medical history and 
thyroid disease information from review of your medical record.
The Research Team may collect this information from other healthcare providers, 
such as laboratories, which are a part of this research, as well as healthcare providers 
that are not part of this research (other doctors, hospitals or clinics). Other 
professionals at the University of Florida or Shands Hospital who provide study-related 
care, and the University of Florida Institutional Review Board (IRB), may also collect 
your health information. 
The Research Team listed in question 3 above will use or share your health 
information as described below to carry out this research study. 
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 4 of 7
IRB Version: 10/01/2018
PI Version: 10/16/2020 
9. With whom will this health information be shared?
This health information may be shared with:

the study sponsor (listed in Question 4 of this form);

United States governmental agencies which are responsible for overseeing 
research, such as the Food and Drug Administration, the Department of Health 
and Human Services, and the Office of Human Research Protections;

Government agencies which are responsible for overseeing public health 
concerns such as the Centers for Disease Control and federal, state and local 
health departments.

The IRB that reviewed this Research Study and ensures your rights as a Study 
Subject are protected 
Otherwise, your identifiable health information will not be shared without your 
permission unless required by law or a court order. Once your health information is 
shared with those listed above, it is possible that they could share it without your 
permission because it would no longer be protected by the federal privacy law. 
 
10. How long will you be in this Research Study?
Your active participation will last until you complete the post visit survey in the next 7 
days.
This Authorization to use and share your health information expires at the end of the 
study, unless you revoke it (take it back) sooner.
11.How many people are expected to take part in this Research Study?
We expect to enroll up to 260 patients and their guests (520, on average 2 per patient) 
and 17 clinicians.
WHAT ARE THE RISKS AND BENEFITS OF THIS STUDY AND 
WHAT ARE YOUR OPTIONS?
12.What are the possible discomforts and risks from taking part in this Research 
Study?
Your participation requires recording of your medical visit, a post visit interview and 
review of your medical record. Participating the post visit interview will require 15-20 
minutes of your time.  Additionally, unauthorized review of the data generated in this 
study could occur.
This Research Study may also include risks that are unknown at this time.
Please note, participating in more than one research study or project may further 
increase the risks to you.  If you are already enrolled in a research study, please inform 
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 5 of 7
IRB Version: 10/01/2018
PI Version: 10/16/2020 
one of the Research Team members listed in question 3 of this form or the person 
reviewing this consent with you before enrolling in this or any other research study or 
project.
During the study, the Research Team will notify you of new information that may 
become available and might affect your decision to remain in the study. 
The University of Florida is required by law to protect your health information. Your 
health information will be stored in locked filing cabinets or on computer servers with 
secure passwords, or encrypted electronic storage devices, as required by University 
policy. However, there is a slight risk that information about you could be released 
inappropriately or accidentally. Depending on the type of information, a release could 
upset or embarrass you, or possibly affect your ability to get insurance or a job. 
If you wish to discuss the information above or any discomforts you may experience, 
please ask questions now or call one of the Research Team members listed in question 
3 in this form.
13a. What are the potential benefits to you for taking part in this Research Study?
Although you may not directly benefit from participating in this research study, there is 
potential benefit to people in the future as a result of the information gathered in this 
study.
13b. How could others possibly benefit from this Research Study?
In this study, we aim to obtain feedback to update educational material that can help 
patients and clinicians discuss the management of thyroid nodules, allowing both 
parties to be engaged in the decision-making process.
13c. How could the Research Team members benefit from this Research Study?
In general, presenting research results helps the career of a researcher. Therefore, the 
Research Team listed in question 3 of this form may benefit if the results of this 
Research Study are presented at scientific meetings or in scientific journals.
14.What other choices do you have if you do not want to be in this study? 
You can decide not to participate in this study and discuss the management of your 
thyroid nodule with your doctor.
You may also refuse to authorize the use of your health information, but if you refuse, 
you may not be allowed to be in this research study or receive any research-related 
treatment that is only available in this research study. However, your decision not to 
sign this Authorization will not affect any other treatment you may be eligible to receive.
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 6 of 7
IRB Version: 10/01/2018
PI Version: 10/16/2020 
15a. Can you withdraw from this study?
You may withdraw your consent and stop participating in this Research Study at any 
time.  If you do withdraw your consent, there will be no penalty to you, and you will not 
lose any benefits to which you are otherwise entitled. If you decide to withdraw your 
consent to participate in this Research Study for any reason, please contact the 
Research Team listed in question 3 of this form. They will tell you how to safely stop 
your participation.
You can also change your mind and take back this Authorization at any time by sending 
a written notice to the Research Team listed in question 3 of this form to let them know 
your decision. If you take back this Authorization, the Research Team may only use and 
disclose your health information already collected for this research study. No additional 
health information about you will be collected or disclosed to the Research Team. 
However, if you take back this Authorization, you may not be able to continue in this 
study. Please discuss this with a member of the Research Team listed in question #3.
15b.Can the Principal Investigator withdraw you from this Research Study? 
You may be withdrawn from this Research Study without your consent for the following 
reasons:

None.
WHAT ARE THE FINANCIAL ISSUES IF YOU PARTICIPATE?
16. If you choose to take part in this Research Study, will it cost you anything?
There would be no cost to you if you participate in this study.
17.Will you be paid for taking part in this Research Study?
There is no compensation for participating in this study
.
18.What if you are injured while in this Research Study?
  
Please contact one of the Research Team members listed in question 3 of this form if 
you experience an injury or have questions about any discomforts that you experience 
while participating in this Research Study.
 
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
Page 7 of 7
IRB Version: 10/01/2018
PI Version: 10/16/2020 
SIGNATURES
As an investigator or the investigator’s representative, I have explained to the participant 
the purpose, the procedures, the possible benefits, and the risks of this Research Study; 
the alternative to being in the study; and how the participant’s protected health information 
will be collected, used, and shared with others: 
Signature of Person Obtaining Consent and 
Authorization
Date
You have been informed about this study’s purpose, procedures, possible benefits, and 
risks; the alternatives to being in the study; and how your protected health information will 
be collected, used and shared with others. You have received a copy of this Form. You 
have been given the opportunity to ask questions before you sign, and you have been 
told that you can ask questions at any time.  You voluntarily agree to participate in this 
study. You hereby authorize the collection, use and sharing of your protected health 
information as described above. By signing this form, you are not waiving any of your 
legal rights.
Signature of Person Consenting and Authorizing
Date
 
Study ID:IRB202000837   Date Approved: 10/16/2020

IRB Project #: IRB202000837
IRB Version: 10/01/2018
PI Version: 4/16/2020
Consent to be Photographed, Video and/or Audio Recorded
With your permission, you will have the following done during this research (check all that 
apply):
 photographed
 video recorded
 audio recorded
Your name or personal information will not be identified on the photograph(s), video or audio 
recordings, and confidentiality will be strictly maintained.  However, when these photograph(s), 
video and/ or audio recordings are shown or heard, others may be able to identify you.
The Principal Investigator (PI) of this study, Singh Ospina, or [his/her] successor, will keep the 
photograph(s), video and/or audio recordings in a locked cabinet, in a folder on a password 
protected computer server drive, or as an encrypted electronic file.  These photograph(s), 
video and/or audio recordings will be shown under [his/her] direction to students, researchers, 
doctors, or other professionals and persons.
Please indicate under what conditions Dr. Singh Ospina has your permission to use the 
photograph(s), video and/or audio recordings, and sign and date below.
  The following will be destroyed once the study is closed (initial next to all that apply):   
  ____ photograph(s)      _____ video recording(s)        _____ audio recording(s)
  As described in the Informed Consent Form, and for the purposes of education at the 
University of Florida Health Science Center.  The PI may keep the following for an 
indefinite period of time in a locked file, in a password protected computer server drive, 
or as an encrypted electronic file (initial next to all that apply):      
  ____ photograph(s)      _____ video recording(s)        _____ audio recording(s)
  As described in the Informed Consent Form; for the purposes of education at the 
University of Florida Health Science Center; and for presentations at scientific 
meetings outside the University.  The PI may keep the following for an indefinite 
period of time in a locked file, in a password protected computer server drive, or as an 
encrypted electronic file (initial next to all that apply):
  ____ photograph(s)      _____ video recording(s)        _____ audio recording(s)
Signature
Date
                                                                                                                          
Study ID:IRB202000837   Date Approved: 4/16/2020