Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery
Phase: NA
Conditions: Thyroid Cancer
Sponsor: Thomas Jefferson University

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THOMAS JEFFERSON UNIVERSITY 
Sidney Kimmel Cancer Center 
 
 
Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment 
Surgical Consent for Thyroid Surgery 
 
Principal Investigator: 
Elizabeth Cottrill MD  
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
(215) 955-6760 
Co-Investigator(s): 
Joseph Curry MD FACS 
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
David Cognetti MD FACS  
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Adam Luginbuhl MD FACS  
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Alexander Duffy MD 
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Katie Holland BS 
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Raphael Banoub MD  
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Michelle Schafer BS 
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
(607) 793-3670 
 
Kelley Yuan BS 
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Marisa Wu, BS 
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Sarah Sussman, BS   
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 

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Emily Sagalow, BS   
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Annie Moroco, MD 
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Kathryn Nunes, BS 
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Arielle Thal, MD 
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Hani Samarah BS 
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
(609) 668-4408 
Kalena Liu, BS 
Otolaryngology Head and Neck Surgery 
925 Chestnut St, Philadelphia, PA 19107 
 
Statistician: 
Scott Keith, PhD 
Pharmacology and Experimental Therapeutics 
1015 Chestnut Street, Suite 520, Philadelphia, PA 19107 
Funding Sponsor: 
Not applicable 
IND/IDE Holder: 
Not applicable 
IND/IDE Number: 
Not applicable 
Study Product: 
Not applicable 
Protocol IDs: 
IRB Control # 20E.663 
 
 
CONFIDENTIAL 
This document is confidential and the property of THOMAS JEFFERSON UNIVERSITY. 
No part of it may be transmitted, reproduced, published, or used by other persons without 
prior written authorization from the study sponsor. 
 

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Table of Contents (This will be based on the headers in the body of the document. To 
update the table, hit Ctrl+A, and then F9.)  
 
Signature Page ................................................................................................................................ 6 
Statement of Compliance ................................................................................................................ 6 
List of Abbreviations ...................................................................................................................... 7 
Study Summary ............................................................................................................................... 9 
1 
Introduction ............................................................................................................................ 11 
1.1 
Background Information ................................................................................................ 11 
1.2 
Rationale for the Proposed Study .................................... Error! Bookmark not defined. 
1.3 
Correlative Studies .......................................................... Error! Bookmark not defined. 
1.4 
Potential Risks and Benefits ........................................................................................... 12 
1.4.1 Potential Risks ............................................................................................................ 12 
1.4.2 Benefits ....................................................................................................................... 12 
2 
Study Objectives ..................................................................... Error! Bookmark not defined. 
2.1 
Objectives ........................................................................ Error! Bookmark not defined. 
2.1.1 Primary ........................................................................ Error! Bookmark not defined. 
2.1.2 Secondary .................................................................... Error! Bookmark not defined. 
2.1.3 Exploratory .................................................................. Error! Bookmark not defined. 
2.2 
Endpoints/Outcome Measures ........................................................................................ 13 
2.2.1 Primary ........................................................................ Error! Bookmark not defined. 
2.2.2 Secondary .................................................................... Error! Bookmark not defined. 
2.2.3 Exploratory .................................................................. Error! Bookmark not defined. 
3 
Study Design .......................................................................................................................... 13 
3.1 
Characteristics ................................................................. Error! Bookmark not defined. 
3.2 
Number of Subjects ........................................................................................................ 16 
3.3 
Duration of Therapy ....................................................................................................... 17 
3.4 
Duration of Follow Up ................................................................................................... 17 
3.5 
Treatment Assignment Procedures ................................................................................. 17 
3.5.1 Randomization Procedures (if applicable) ................................................................. 17 
3.5.2 Masking Procedures (if applicable) ............................................................................ 17 
3.6 
Study Timeline ............................................................................................................... 17 
3.6.1 Primary Completion ................................................................................................... 17 
3.6.2 Study Completion ....................................................................................................... 17 
3.7 
Substudies (if applicable) ................................................ Error! Bookmark not defined. 
4 
Study Enrollment and Withdrawal ......................................................................................... 17 
4.1 
Eligibility Criteria .......................................................................................................... 17 
4.1.1 Inclusion Criteria ........................................................................................................ 17 
4.1.2 Exclusion Criteria ....................................................................................................... 17 
4.2 
Gender/Minority/Pediatric Inclusion for Research ........................................................ 18 
4.3 
Strategies for Recruitment and Retention ...................................................................... 18 
4.4 
Subject Withdrawal ........................................................................................................ 18 
4.4.1 Reasons for Withdrawal ............................................................................................. 18 
4.4.2 Handling of Subject Withdrawals or Subject Discontinuation of Study Intervention 18 
4.5 
Premature Termination or Suspension of Study ............................................................ 19 
5 
Study Intervention .................................................................................................................. 19 
5.1 
Study Product ................................................................................................................. 19 

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5.2 
Study Product Description .............................................. Error! Bookmark not defined. 
5.2.1 Acquisition .................................................................................................................. 19 
5.2.2 Formulation, Packaging, and Labeling ........................ Error! Bookmark not defined. 
5.2.3 Product Storage and Stability ...................................... Error! Bookmark not defined. 
5.3 
Dosage, Preparation, and Administration ....................... Error! Bookmark not defined. 
5.4 
Dose Modifications and Dosing Delays .......................... Error! Bookmark not defined. 
5.5 
Study Product Accountability ......................................... Error! Bookmark not defined. 
5.6 
Assessing Subject Compliance with Study Product Administration ... Error! Bookmark 
not defined. 
5.7 
Co2,3ncomitant Medications/Treatments ......................... Error! Bookmark not defined. 
5.8 
Dietary Restrictions ......................................................... Error! Bookmark not defined. 
5.9 
Study Behavioral or Social Intervention(s) Description ................................................ 19 
5.10 
Study Procedural Intervention(s) Description ................................................................ 19 
5.11 
Administration of Procedural Intervention .................................................................... 20 
5.12 
Procedures for Training of Clinicians on Procedural Intervention Error! Bookmark not 
defined. 
5.13 
Assessment of Clinician and/or Subject Compliance with Study Procedural Intervention
 
Error! Bookmark not defined. 
6 
Study Schedule ....................................................................................................................... 21 
6.1 
Pretreatment Period/Screening ....................................................................................... 21 
6.2 
Enrollment/Baseline ....................................................................................................... 21 
6.3 
Treatment Period ............................................................. Error! Bookmark not defined. 
6.4 
End of Treatment Study Procedures ................................ Error! Bookmark not defined. 
6.5 
Post-treatment/Follow-Up ............................................... Error! Bookmark not defined. 
6.6 
Long Term/Survival Follow-up ..................................................................................... 21 
6.7 
Withdrawal Visit/Discontinuation of Therapy ............................................................... 21 
7 
Study Procedures and Evaluations ......................................................................................... 22 
7.1 
Study Procedures/Evaluations ........................................................................................ 22 
7.2 
Laboratory Procedures/Evaluations ............................................................................... 22 
7.2.1 Clinical Laboratory Evaluations ................................................................................. 22 
7.2.2 Special Assays or Procedures ..................................................................................... 22 
7.2.3 Specimen Preparation, Handling, and Storage ........................................................... 22 
7.2.4 Specimen Shipment .................................................................................................... 22 
8 
Evaluation of Safety ............................................................................................................... 22 
8.1 
Specification of Safety Parameters ................................................................................ 22 
8.1.1 Unanticipated Problems .............................................................................................. 22 
8.1.2 Adverse Events ........................................................................................................... 23 
8.1.3 Serious Adverse Events .............................................................................................. 23 
8.2 
Safety Assessment and Follow-Up ................................................................................ 23 
8.3 
Recording Adverse Events ............................................................................................. 23 
8.3.1 Relationship to Study Intervention ............................................................................. 24 
8.3.2 Expectedness .............................................................................................................. 24 
8.3.3 Severity of Event ........................................................................................................ 24 
8.4 
Safety Reporting ............................................................................................................. 24 
8.4.1 Unanticipated Problem Reporting to IRB .................................................................. 24 
8.4.1 Adverse Event Reporting to IRB ................................................................................ 25 
8.4.2 Serious Adverse Event Reporting to IRB ................................................................... 25 

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8.4.3 AE, SAE, and UAP Reporting to Funding Sponsor ................................................... 25 
8.4.4 Reporting of SAEs and AEs to FDA ........................... Error! Bookmark not defined. 
8.4.5 Events of Special Interest (if applicable) ..................... Error! Bookmark not defined. 
8.4.6 Reporting of Pregnancy .............................................................................................. 25 
8.5 
Halting Rules .................................................................................................................. 25 
9 
Study Oversight ...................................................................................................................... 25 
10 
Clinical Site Monitoring and Auditing .............................................................................. 25 
11 
Statistical Considerations ................................................................................................... 26 
11.1 
Study Hypotheses ........................................................................................................... 26 
11.2 
Analysis Plans ................................................................. Error! Bookmark not defined. 
11.3 
Interim Analyses and Stopping Rules ............................................................................ 26 
11.3.1 
Safety Review .......................................................... Error! Bookmark not defined. 
11.3.2 
Efficacy Review ....................................................... Error! Bookmark not defined. 
11.4 
Sample Size Considerations ........................................................................................... 26 
11.4.1 
Replacement Policy ................................................. Error! Bookmark not defined. 
11.4.2 
Accrual Estimates ................................................................................................... 26 
11.5 
Exploratory Analysis ....................................................... Error! Bookmark not defined. 
11.6 
Evaluation of Safety ........................................................ Error! Bookmark not defined. 
12 
Source Documents and Access to Source Data/Documents .............................................. 26 
13 
Quality Control and Quality Assurance ............................................................................. 27 
14 
Ethics/Protection of Human Subjects ................................................................................ 27 
14.1 
Ethical Standard ............................................................................................................. 27 
14.2 
Institutional Review Board ............................................................................................. 27 
14.3 
Informed Consent Process .............................................................................................. 27 
14.4 
Exclusion of Women, Minorities, and Children (Special Populations) ......................... 27 
14.5 
Subject Confidentiality ................................................................................................... 27 
14.6 
Future Use of Stored Specimens and Other Identifiable Data ....................................... 28 
15 
Data Handling and Record Keeping .................................................................................. 28 
15.1 
Data Management Responsibilities ................................................................................ 28 
15.2 
Data Capture Methods .................................................................................................... 28 
15.3 
Types of Data ................................................................................................................. 28 
15.4 
Study Records Retention ................................................................................................ 28 
15.5 
Protocol Deviations ........................................................................................................ 28 
16 
Study Finances ................................................................................................................... 28 
16.1 
Funding Source .............................................................................................................. 28 
16.2 
Conflict of Interest ......................................................................................................... 29 
16.3 
Subject Stipends or Payments ........................................................................................ 29 
17 
Publication and Data Sharing Policy ................................................................................. 29 
18 
Literature References ......................................................................................................... 29 
SUPPLEMENTAL MATERIALS ............................................................................................... 34 
Appendices .................................................................................................................................... 34 
APPENDIX A: SCHEDULE OF EVENTS .................................. Error! Bookmark not defined. 
 

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Signature Page 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable US federal regulations and ICH guidelines. 
Principal Investigator: 
Signed: 
 
Date: 
 
Name: 
Elizabeth Cottrill, MD 
Title:  
Assistant Professor, Head & Neck Endocrine and Oncologic Surgery 
Associate Residency Program Director 
Co-Director, Jefferson Thyroid & Parathyroid Center 
Dept. Otolaryngology Head & Neck Surgery 
Thomas Jefferson University Hospital 
925 Chestnut St. Philadelphia PA 19107 
Elizabeth.cottrill@jefferson.edu 
 
Statement of Compliance 
This study will be conducted in accordance with the International Conference on Harmonisation 
guidelines for Good Clinical Practice (ICH E6), the Code of Federal Regulations on the 
Protection of Human Subjects (45 CFR Part 46), and Thomas Jefferson University research 
policies 
 
 
 

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List of Abbreviations 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CIOMS 
Council for International Organizations of Medical Sciences 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CRO 
Clinical Research Organization 
CTCAE 
Common Terminology Criteria for Adverse Events 
DSMC 
Data and Safety Monitoring Committee 
DSMP 
Data and Safety Monitoring Plan 
FDA 
Food and Drug Administration 
FWA 
Federalwide Assurance 
GCP 
Good Clinical Practice 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PRC 
Protocol Review Committee 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SDS 
Safety Data Sheet (formerly MSDS; Material Safety Data Sheet) 
SKCC 
Sidney Kimmel Cancer Center 
SOP 
Standard Operating Procedure 

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TJU 
Thomas Jefferson University 
UAP 
Unanticipated Problem 
HNSA 
An Investigator-created Head and Neck-specific Surgical Assessment of 
Patient Comprehension (“Head and Neck Surgical Assessment”) 
TISCAV 
Thyroid Informed Surgical Consent Augmenting Video 
SC 
Standard Consent 
KA 
Knowledge Assessment 
DCS 
Decision Conflict Survey 
SDS 
Satisfaction with Decision Scale 
DRS 
Decision Regret Scale 
VAS-A 
Visual Analog Scale for Anxiety 
 
 
 
 
 
 

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Study Summary 
Title: 
Reimaging Consent: Comprehension and Decision-Making in Thyroid Surgery 
 
Précis: 
This study is a Jefferson multi-site, randomized controlled trial to address limited 
retention and high rates of decision regret in thyroid surgery utilizing a Thyroid 
Informed Surgical Consent Augmenting Video (TISCAV) in a cohort of patients 
undergoing thyroidectomy. We aim to: 1) Establish the current levels of 
comprehension following standard thyroidectomy consent discussion compared 
with the enhanced TISCAV consent; and 2) Measure conflict, satisfaction, regret, 
and anxiety surrounding decision-making following thyroidectomy consent 
discussion using TISCAV. Study participants with newly diagnosed thyroid 
nodules will be recruited from clinic. Participants will be administered a 
series of surveys at the preoperative and postoperative visits to assess 
comprehension, anxiety, decision conflict, satisfaction, and regret. Based on 
preliminary findings from our ongoing work, we have found TISCAV to be an 
educational, understandable, and accessible resource. As such, we hypothesize that 
TISCAV will improve comprehension and mitigate decision regret in 
thyroidectomy. Study results will modernize an aspect of surgery which has 
remained unevolved to empower and educate patients. 
 
 
Objectives: 
 
We aim to: 1) Establish the current levels of comprehension following standard 
thyroidectomy consent discussion compared with the enhanced TISCAV consent; 
and 2) Measure conflict, satisfaction, regret, and anxiety surrounding decision-
making following thyroidectomy consent discussion using TISCAV. 
 
Population: 
Patients > 18 years of age are eligible if they are opting to receive care at Jefferson 
Sidney Kimmel Cancer Center - City or at Jefferson Torresdale Hospital or at 
Yardley Otolaryngology involving thyroidectomy. They must agree to proceed 
with Head and Neck surgery from the Principal Investigator or the Co-
Investigators 
 
Number of Sites: 
Multicenter Center Study: TJUH Center City, Jefferson NE, Jefferson Yardley   
 
Description of 
Intervention: 
Participants who agree to participate will be randomized to either receive the 
intervention, the Jefferson-produced, evidence-based Thyroid Informed Consent 
Augmenting Video (TISCAV) or undergo standard consent (SC). The intervention 
is a multimedia presentation that explains in simple language the indications, risks, 
and benefits, steps, and otherwise expectations patients should have regarding 
their upcoming thyroid surgery while displaying animated visualization tools. 
 
Study Duration: 
12 months 
 
Participant 
Participation 
Duration: 
3 months 
 
Estimated Time to 
Complete 
Enrollment: 
 
12 months 
 
 

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Schematic of Study Design 
 
Schematic of Study Design 
 
Visit 1  
Enrollment 
(Day 0: 
0-30 min) 
 
 
 
  
 
 
 
 
 
 
Visit 1 (cont) 
Data Collection 
 (Day 0: 
30-60 min 
+/- 15) 
 
 
 
Visit 2  
Day of  
Surgery 
(Day ~14) 
 
 
Visit 3 
Post-Op  
Clinic 
(Day ~21) 
 
 
 
Visit 4 
Post-Op  
Clinic 
(Day ~100) 
 
 
 
 
 
 
Total N=40. Obtain research informed consent. Screen patient for inclusion criteria. 
Eligible patients are offered the opportunity to join the study. 
INTERVENTION GROUP 
Thyroidectomy Specific Knowledge Assessment 
TISCAV 
Thyroidectomy Specific Knowledge Assessment 
Decisional Conflict Survey (DCS) 
Satisfaction with Decision Scale (SDS) 
Visual Analog Scale of Anxiety (VAS-A) 
Thyroidectomy 
Statistical Analysis 
Randomize Patients 
Control: 
Standard Consent 
20 patients 
Intervention:  
TISCAV  
20 Patients 
CONTROL GROUP 
Thyroidectomy Specific Knowledge Assessment 
Standard Consent 
Thyroidectomy Specific Knowledge Assessment 
Decisional Conflict Survey (DCS) 
Satisfaction with Decision Scale (SDS) 
Visual Analog Scale of Anxiety (VAS-A) 
INTERVENTION GROUP 
Satisfaction with Decision Scale (SDS) 
Decision Regret Scale (DRS) 
Visual Analog Scale of Anxiety (VAS-A) 
CONTROL GROUP 
Satisfaction with Decision Scale (SDS) 
Decision Regret Scale (DRS) 
Visual Analog Scale of Anxiety (VAS-A) 
INTERVENTION GROUP 
Satisfaction with Decision Scale (SDS) 
Decision Regret Scale (DRS) 
Visual Analog Scale of Anxiety (VAS-A) 
CONTROL GROUP 
Satisfaction with Decision Scale (SDS) 
Decision Regret Scale (DRS) 
Visual Analog Scale of Anxiety (VAS-A) 

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1 Introduction 
1.1 Background Information 
 
Due to the improved detection of thyroid nodules, the number of patients presenting for thyroid surgery is 
on the rise, with a 300% increase over the past 3 decades. Surgeons are estimated to perform 150,000 
thyroidectomies annually in the United States. Patient education is an imperative component of surgical decision-
making, and both legally and ethically, patients deserve to know their clinical diagnosis and available therapeutic 
options, including their risks and benefits, in order to participate in informed consent. Patients with newly 
diagnosed thyroid nodules have unique options, including the consideration of active surveillance, in addition to 
surgical choices. Although thyroidectomy has known risks, there is no standardized script for consenting and the 
conversation may vary significantly both between and within institutions.  
The variation in informed consent practices commonly results in inadequate patient understanding. Medical 
information discussed during the clinical visit is poorly recalled, reportedly forgotten at a rate as high as 80%. 
The longer the time interval between discussion and intervention, the worse retention becomes. Poor 
preoperative understanding has been demonstrated in the field of otolaryngology. Although patients report 
satisfaction with the amount of information disclosed, at the time of the procedure half are unable to list a single 
potential surgical complication. Furthermore, patients with head and neck cancer often report poor understanding 
of anticipated surgical consequences, even when endorsing adequate understanding of the procedure. Endocrine 
surgery is not excluded from these challenges, half of patients with thyroid cancer report low satisfaction with 
the overall amount of information received about their diagnosis and treatment options.  
 
The discrepancy between physician teaching and patient education is critical to reconcile in order 
to attain quality patient education and shared decision-making. This inconsistency underscores patient 
factors, with those who are particularly vulnerable being those patients with language barriers, older age, low 
education levels, poor health literacy and anxiety during the clinical encounter. Utilization of technology for the 
delivery and augmentation of medical information is innovative. From a health system perspective, limited 
clinical time in busy surgical clinics in addition to the evolving complex diagnostic and treatment options makes 
adequate and quality surgical counselling a challenge. Many written tools such as pamphlets, information sheets, 
and websites have attempted to improve patient education, but have shown variable effect without obvious 
superiority. In patients undergoing thyroidectomy, the utilization of printed materials only demonstrated a 
recollection rate of 50%. One challenge with the adoption of printed materials is the elevated reading level at 
which they are commonly written, often exceeding that of the fourth to sixth grade reading level recommended 
by the NIH by multifold. In otolaryngology, it has been reported that 10% of patients have inadequate health 
literacy, and this, in combination with the complexity of anatomy and pathology in our specialty, can limit the 
accessibility of written resources.  
Multimedia educational resources have more consistently 
demonstrated improvement in patient comprehension. Within the field 
of otolaryngology where complex anatomy can contribute to poor patient 
understanding, multimedia has been found to be an effective and 
preferable tool to improve comprehension. Audiovisual content as an 
adjunct 
to 
routine 
informed 
consent 
discussion 
in 
various 
otolaryngology subspecialities, including rhinology and facial plastics, 
has been shown to improve retention. In head and neck oncologic 
patients, multimedia has been associated with improved education, 
satisfaction and lessened anxiety levels. As highlighted in Figure 1, 
improved patient understanding can have impact beyond recall to 
improve patient satisfaction and treatment adherence.  
As healthcare becomes increasingly patient-centered, patient education efforts have been targeted to 
improve decision-making and patient-centered care. Decision regret is defined as remorse or distress with 
regard to a treatment decision. High rates of decision regret have been shown in patients with cancer where 
active surveillance has been considered to be a reasonable treatment option. In otolaryngology, elevated rates of 
decision regret have been reported within the head and neck cancer patient population, and it has been shown 
that patients who are more informed experience less decision regret, even in the face of complication. 37–39 

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Preoperative anxiety is common and has been shown to influence patients to avoid a planned operation. 
Higher levels of anxiety have been reported prior to otolaryngology procedures compared to other surgical 
specialties, and elevated perioperative anxiety has been associated with low satisfaction. Anxiety has been shown 
to influence treatment decision in patients with cancer, where those patients with high levels of anxiety have 
been more likely to pursue surgical intervention over active surveillance. Historically, patient education efforts 
have been met with some resistance, driven largely by concern for heightening anxiety. However, many modern 
studies have demonstrated that information prior to medical procedures does not elevate anxiety levels. In fact, 
improving patient understanding prior to surgical intervention has been shown to decrease anxiety. The literature 
has demonstrated a beneficial role for video education in the reduction of patient anxiety.  
Though many studies have examined some aspects of decision-making in the perioperative period, there has 
been wide variability in methods and cohorts. There remains a paucity of work in patient education and decision-
making in the field of endocrine surgery. This study proposes the use of formative knowledge assessment, 
validated decision-making surveys to utilize a surgeon-designed Thyroid Informed Surgical Consent 
Augmenting Video (TISCAV). Through the proposed longitudinal randomized trial, this study seeks to improve 
patient education and shared decision-making in patients pursuing thyroid surgery.  
 
1.2 Rationale for Proposed Study 
 
Our proposal, based upon preliminary results, will test several hypotheses that are vital to 
modernizing the informed consent conversation prior to thyroidectomy. While previous studies have 
demonstrated poor understanding and retention in endocrine surgery patients prior to surgical intervention, 
literature has not demonstrated a superior intervention to improve comprehension. Therefore, our findings will 
provide insight into the role of a surgeon-designed TISCAV to improve comprehension and further appreciate 
decision-making in thyroid surgery. 
First, we will test the hypothesis that a surgeon-created patient education video improves baseline 
comprehension prior to thyroidectomy. Our preliminary findings suggest our video is a feasible and accessible 
intervention that is able to improve patient knowledge and confidence. Further analysis will allow us to identify 
superiority to traditional verbal patient consent. 
Second, we will test the hypothesis that informed patients are more confident in, more satisfied with, and 
experience less regret with their decision to pursue surgery. Utilizing several validated survey tools, this research 
will further examine decision-making for patients pursuing thyroid surgery, and further analysis will allow us to 
study the impact of state anxiety on this process. 
These proposed studies will be examined over the course of perioperative thyroid care though 3-month 
follow-up. This approach will assess multiple aspects of patient education and consideration during the 
perioperative period, and will inform interventions to improve comprehension and decision-making in patients 
undergoing thyroid surgery.  
 
1.3 Potential Risks and Benefits 
1.3.1 Potential Risks 
• 
Multimedia presentations: dizziness, confusion, loss of consciousness, seizures, palpitations, SOB, panic, 
anxiety.  
• 
Healthcare-information: Panic, Anxiety, Loss of Consciousness, Seizures, Palpitations, SOB, Dizziness, 
Confusion. 
1.3.2 Benefits 
• 
Knowledge of avenues for quality improvement in surgical care for thyroidectomy 
• 
By formative assessment, knowledge of current state of patient comprehension prior to thyroid 
surgery 
• 
Efficacy data of multimedia interventions for patient comprehension for thyroid surgery 

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• 
Confidence of Surgery-Specific Knowledge using validated survey, knowledge of current state of 
patient confidence of their thyroid surgery knowledge 
• 
Decisional conflict using validated survey related to decision to pursue thyroid surgery 
• 
Satisfaction with decision to pursue thyroid surgery using validated survey 
 
2 Study Objectives  
 
2.1 Primary Objectives 
 
AIM 1: Establish the current levels of comprehension following standard thyroidectomy consent 
discussion compared with the enhanced TISCAV consent.  
 
 
AIM 2: Measure conflict, satisfaction, regret, and anxiety surrounding decision-making following 
thyroidectomy consent discussion using TISCAV. 
 
2.2 Endpoints/Outcome Measures 
 
We have demonstrated feasibility of the TISCAV to educate patients prior to thyroidectomy. However, 
the role of augmented consenting compared to standard discussion is unknown. To address this gap, we 
propose a prospective, randomized controlled trial recruiting 40 patients consenting for partial or total 
thyroidectomy. A survey will be administered to assess sociodemographic and clinical characteristics, as well 
as to measure comprehension using an investigator-created 10-item formative assessment. This will be 
administered at two time points: first at the onset of the clinic visit prior to consent, and again after consent at 
the conclusion of the preoperative clinic visit for both control and intervention arms. We expect that TISCAV 
will be associated with improved post-video comprehension compared to standard consent. Our findings will 
inform thyroid surgeons to better educate patients when deciding to pursue thyroidectomy.  
 
 
Our ongoing research suggests that TISCAV positively impacts confidence in the decision to pursue 
thyroidectomy. We propose a survey to assess decision-making during the consent process. At the initial 
preoperative visit, both groups will be administered the Decisional Conflict Survey (DCS) and Satisfaction 
with Decision Scale (SDS). The DCS is a 15-question validated survey and the SDS is a 6-question validated 
survey, and both are used to evaluate aspects of surgical decision-making. During the first (~1 week) and 
second (~3 months) postoperative visits, the SDS and the 5-question validated Decision Regret Scale (DRS) 
will be administered to assess patient response to their decision to pursue surgery. Additionally, at all 
timepoints, patients will be assessed using the Visual Analog Scale for Anxiety (VAS-A) to measure state 
anxiety. This aim seeks to assess patient reaction to their decision to pursue thyroidectomy after experiencing 
the consequences of this decision. We expect that TISCAV will be associated with lower rates of decision 
regret, higher rates of confidence and satisfaction, and comparable levels of anxiety. Assessing patient factors 
affecting decision-making will guide thyroid surgeons to better guide preoperative conversations 
3 Study Design 
 
 
 
The manner in which to improve perioperative patient understanding in the setting of informed consent 
remains unknown. To address this gap, this study proposes a prospective longitudinal investigation of the 
consent process in patients undergoing thyroidectomy. Survey research will examine the understanding, 

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confidence, anxiety, decision regret, and satisfaction associated with traditional and augmented informed 
consent for thyroidectomy. Participants will be assessed at 3-time points in order to assess knowledge and 
decision-making throughout the perioperative period: diagnosis, initial post-operative visit, and 3-month 
follow-up visit. 
 
 
3.1 Study Population.  
Eligible participants will include patients (1) with newly diagnosed thyroid nodule; (2) age ≥18 years; (3) 
who undergo thyroid lobectomy or total thyroidectomy. Participants will be excluded if they are unable to 
speak or read the English language. 
 
3.2 Recruitment, Accrual, and Feasibility 
 
The Thomas Jefferson University Hospital Jefferson Thyroid and Parathyroid Center evaluates more than 
1,000 new patients annually. Surgeons perform over 215 thyroid surgeries each year, which equates to 
approximately 18 thyroid surgeries per month. We will identify eligible patients using the electronic 
medical record to evaluate the outpatient appointment calendars of our involved surgeons and recruit using 
a clinic-based approach. We plan to enroll 40 patients during months 2 through 7. Data collection will 
continue throughout month 10. This sample size is reasonable based on the number of patients seen 
annually. Feasibility was previously defined at a threshold value of 80% based on prior unpublished work. 
In this preliminary study, feasibility was been measured at 93%. The study size of 40 participants will 
provide ample precision for the feasibility estimate. If we observe a similar proportion, then a Clopper-
Pearson Exact 95% confidence interval will be (86%, 98%). 
 
Our central hypothesis is that the utilization of TISCAV will be associated with improved surgery-
specific comprehension and decision-making during perioperative consent for thyroid surgery. Two 
specific aims are proposed to test the central hypothesis. 
 
Aim 1: Establish the current levels of comprehension following 
standard thyroidectomy consent discussion compared with the 
enhanced TISCAV consent. 
 
Preliminary Data. In a pilot study involving 30 patients, overall 
knowledge was significantly improved (+1.3) after viewing the TISCAV. 
Patients also reported increased confidence in understanding risks of 
surgery (+1.2) after watching the video.  
 
Methods. Eligible individuals will be approached to discuss study participation and, if interested, will 
undergo informed research consent. A survey including sociodemographic information, clinical 
characteristics, and an investigator-created 10-item formative assessment will be administered to study 
participants at initial visit prior to randomization, and again after consent at the conclusion of the 
preoperative clinic visit. 
 
Sociodemographic Information and Clinical Characteristics. Age, sex, marital status, race, ethnicity, 
education level, and employment status will be obtained from patients. The electronic medical record will 
be used to obtain medical history and endocrine data.  
 
Thyroid Informed Surgical Consent Augmenting Video (TISCAV). The TISCAV is an animated 8 
minute and 38 second video with surgeon voiceover. The video was scripted and recorded by the project 

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mentor with illustrations contributed by Sidney Kimmel Medical College students. It has been approved by 
Jefferson Creative Services for use of branding, and by the Department of Otolaryngology for content. 
Figure 2 depicts animations from the TISCAV, which describes surgical anatomy, indications, benefits, 
and possible risks to both thyroid lobectomy and total thyroidectomy.  
 
Formative Assessment. The assessment will be administered prior to patient education and again after 
consenting is finished to assess patient understanding. This 10-question multiple-choice survey has been 
reviewed by our endocrine surgery team for content. The assessment has been calculated at a Flesh-Kincaid 
Grade level 3.5, correlating to a 7th grade reading level.  
 
Aim 2: Measure conflict, satisfaction, regret, and anxiety surrounding decision-making following 
thyroidectomy consent discussion using TISCAV. 
 
Preliminary Data. In preliminary studies using a single question survey, patients report 98% satisfaction 
with the TISCAV. 
 
Methods. As described above, eligible individuals will be approached to discuss study participation and, if 
interested, will undergo informed research consent. A survey including sociodemographic information, 
clinical characteristics, and an investigator-created 10-item formative assessment will have been previously 
be administered to study participants. Following randomization at initial visit, patients will be administered 
a survey containing the decision-making tools. Following thyroid surgery, the patient will be administered 
a set of surveys at two subsequent timepoints: the first postoperative visit (1-2 weeks following surgery) 
and the 3-month postoperative visit. 
 
Sociodemographic Information and Clinical Characteristics. As previously described, age, sex, marital 
status, race, ethnicity, education level, and employment status will be obtained from patients, and the 
electronic medical record will be used to obtain medical history and endocrine data.  
 
Decision-Making Survey Instruments. Several validated survey instruments will be utilized in this study 
as shown in Table 2. The Decisional Conflict Survey (DCS) is a measurement of 5 dimensions of decision 
making using a 16-item question format. Measured on a 5-point scale, where each question is scored 0 to 
4. The total score is calculated out of 64, with five subcategories separated by question. These categories 
include uncertainty, informed, values clarity, support, and effect decision.60,61 The Satisfaction with 
Decision Scale (SDS) is a 6-item scale used to assess patient satisfaction with a healthcare decision. This 
is rated on a scale where each statement is scored 1 (not satisfied) to 5 (very satisfied). Total score is 
calculated out of 30, with higher scores indicating higher decision satisfaction.62 The Decision Regret Scale 
(DRS) is a 5-item statement scale used to evaluate regret after healthcare decision making. Each statement 
is measured 1 (strongly agree) to 5 (strongly disagree). Total score is calculated out of 25, with higher 
scores indicating high decisional regret.33 The Visual Analog Scale for Anxiety (VAS-A) is a simple and 
rapid assessment of anxiety using a single question, which has demonstrated adequate reliability, validity, 
and sensitivity.63 The VAS-A has been shown to be advantageous when multi-item inventories such as 
State-Trait Anxiety Inventory (STAI) may be burdensome, and it has been shown to correlate with the STAI 
in the perioperative setting.46 
 
Table 2. Decision-Making Survey Instruments 
Measure 
Domain 
Description 
Decisional Conflict 
Survey (DCS)60,61 
Conflict 
• 16-items (scored 0-64) to assess decisional conflict 
• Higher scores indicate higher decisional conflict 
• Five categories of subscores are calculated: uncertainty, 
informed, values clarity, support, and effective decision  

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Satisfaction with 
Decision Scale 
(SDS)62 
Satisfaction 
• 6-items (scored 6-30) to assess decision satisfaction 
• Higher scores indicate higher decision satisfaction 
Decision Regret 
Scale (DRS)33 
Regret 
• 5-items (scored 5-25) to assess decision regret 
• Higher scores indicate higher decisional regret 
Visual Analog Scale 
for Anxiety (VAS-
A)63 
Anxiety 
• Single question visual scale to assess state anxiety 
• Range from not at all anxious to extremely anxious 
 
 
3.3 Data Management and Statistical Analysis 
 
Surveys will be administered by a Research Associate via a tablet (or paper format if requested) using 
RedCap, a HIPAA-compliant survey data system. Data analysis will be performed using SPSS (27). 
Exploratory data analysis will be used to describe variables of interest and identify data anomalies that may 
invalidate the results. Data will be screened for outliers and will be assessed for their influence on results. 
Descriptive statistics will be utilized and a two-sided t-test will be constructed at α=0.05 to evaluate 
significance of the means.  
 
3.4 Potential Pitfalls and Alternative Strategies 
 
We acknowledge volunteer bias as a potential limitation to our study, as patients interested in participating 
in this survey may be those who are more interested or eager to be involved in their health and surgical 
decision-making. Although such bias would be expected to be present across both treatment arms. 
Furthermore, the study is performed at a single tertiary care academic center with a predominantly White 
and non-Hispanic population, which may yield limited generalizability. We acknowledge a potential pitfall 
of insufficient accrual within the study time frame. If that occurs, we will address by extending our 
recruitment time if necessary.  
 
 
3.5 Future Directions 
 
Utilization of novel surgeon-created multimedia technologies for perioperative information delivery is a 
feasible, accessible, and effective intervention to address current limitations in the preoperative healthcare 
setting. The findings from this project can be further extrapolated to specifically study those most 
vulnerable populations previously identified. Beyond written information or clinical encounters, 
audiovisual materials may be uniquely applied to address health literacy barriers. We look to adapt this 
multimedia presentation to languages beyond English, including Spanish and Mandarin, both of which are 
commonly spoken by patients in our clinic. The data collected from these proposed studies will inform 
patient education and decision-making in thyroid surgery, and seek to empower and educate patients, 
including those with low health literacy who are most vulnerable in standard consenting. Through insight 
into patient comprehension and decision-making factors, we can advance an aspect of surgery which has 
remained unevolved.  
 
 
  
3.6 Number of Participants 

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40 participants 
3.7 Duration of Therapy 
N/A 
3.8 Duration of Follow Up 
N/A 
3.9 Treatment Assignment Procedures 
3.9.1 Randomization Procedures 
Subjects that consent to the study will be randomized into the intervention or control group. 
Subjects will be randomized using a coin flip program.  
3.9.2 Masking Procedures 
N/A 
3.10 Study Timeline 
3.10.1 Primary Completion 
12 months 
3.10.2 Study Completion 
12 months 
4 Study Enrollment and Withdrawal 
4.1 Eligibility Criteria 
4.1.1 Inclusion Criteria 
 
Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:  
• 
Patients who opt to receive care at Jefferson Sidney Kimmel Cancer Center or at Jefferson Torresdale 
Hospital or at Yardley Otolaryngology from the Principal Investigator or the Co-Investigators.  
• 
Patients ≥ 18 years of age   
• 
Patients diagnosed with thyroid disease for which thyroidectomy is indicated.   
• 
Patients who provide verbal informed consent for the clinical trial.   
• 
Patients who are willing to comply with all study procedures and be available for the duration of the 
study   
• 
Patients who read and speak fluent English 
• 
Patients who do not meet any of the exclusion criterion.   
4.1.2 Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this study: 
Patients opting to review the TISCAV but otherwise unwilling to comply with all study procedures for the 
duration of the study  
• 
Patients who cannot read or speak English fluently  

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• 
Patients with a known history of adverse reactions to multimedia presentations or videos of potentially 
emotionally distressing nature 
• 
Patients < 18 years of age 
• 
Patients who, for any other reason, are suspected to be unable to complete assessment and survey-
based materials in the context of this study.  
4.2 Gender/Minority/Pediatric Inclusion for Research  
We will not exclude potential subjects from participating in this study based on ethnic origin or socioeconomic 
status.  Every attempt will be made to enter all eligible patients in this protocol and therefore address the study 
objectives in a patient population representative of the disease population at Jefferson Sidney Kimmel Cancer 
Center, Jefferson Hospital Torresdale, and Yardley Otolaryngology. Thyroid cancer has a predominance of 
females to males. Thus, we expect to an enrollment pattern that reflects these epidemiologic facts for Thyroid-
related studies. 
4.3 Strategies for Recruitment and Retention 
Eligible patients are identified and recruited at the three participating institutions: Jefferson SKCC, Jefferson 
Torresdale Hospital, Yardley Otolaryngology. Subjects from Center City will have an ID number. To aid the 
Principal and Co-Investigators in identifying eligible participants, the clinic-designated research assistant will 
review the weekly clinic roster to identify patients who may be eligible for study participation. Eligible 
patients will be preliminarily identified based on clinical factors suggesting a high-likelihood of thyroid 
surgery recommendation. The clinic-designated research assistant will meet face-to-face with the Principal and 
Co-Investigators to discuss potential eligibility. Identified patients will be approached with an eligibility 
interview addressing inclusion and exclusion criteria. Eligible patients who meet inclusion criteria will be 
randomized into the intervention protocol arm or the control arm. Patients will complete surveys and either 
TISCAV or SC followed by open discussion with the surgeon. Patients will then be contacted by phone for 
postoperative survey timepoints. 
4.4 Participant Withdrawal 
4.4.1 Reasons for Withdrawal 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may terminate a study participant’s participation in the study if: 
• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
participant. 
• 
The participant meets an exclusion criterion (either newly developed or not previously recognized) 
that precludes further study participation. 
4.4.2 Handling of Participant Withdrawals and Participant Discontinuation of 
Study Intervention 
 Patients can withdraw at any time during the study if they no longer want to participate in the trial.  If a 
subject withdraws consent to participate in the study, permission will be sought to use data pertaining to the 
subject in the analysis as far as they participate, and they will be removed from subsequent analyses.   
Specific reasons for discontinuing a subject from this study are: 
1. Voluntary discontinuation by the subject who is at any time free to discontinue their participation in 
the study, without prejudice to further treatment. 
2. Safety reasons as judged by the investigator. 
3. Patient inability to participate in the counselling component of the intervention 
4. Subject lost to follow-up 
5. Death 

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4.5 Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable cause. Written 
notification, documenting the reason for study suspension or termination, will be provided by the suspending 
or terminating party to the principal investigator. If the study is prematurely terminated or suspended, the 
principal investigator will promptly inform the IRB and will provide the reason(s) for the termination or 
suspension.  
Circumstances that may warrant termination include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants. 
• 
Insufficient adherence to protocol requirements. 
• 
Data that is not sufficiently complete and/or evaluable.  
• 
Determination of futility. 
5 Study Intervention 
5.1 Study Product  
The investigational product in this study is an educational intervention. TISCAV will be used to teach patients 
about the indication, risks, benefits of Thyroid Surgery and provide details about the surgical procedure as 
well. The TISCAV was scripted and recorded by the Principal Investigator and illustrations were created by 
Sidney Kimmel Medical College students. The TISCAV is roughly 10 minutes in duration and is approved by 
Jefferson Creative Services for use of Logo/Brand, Fonts, and Color Schemes. After initially viewing the 
TISCAV in clinic, patients also can review at their convenience on YouTube. 
5.1.1 Acquisition 
  
Product is an electronic video and is available with unlimited use at zero cost. The TISCAV is 
approved by Jefferson for use of Logo/Brands/Fonts/Patients at their convenience on YouTube at the following 
location: 
https://www.youtube.com/watch?v=52lpC4YTSC0  
5.1.2 Study Behavioral or Social Intervention(s) Description 
N/A  
5.2 
Study Procedural Intervention(s) Description 
 
See 6.2 
 
 
 
 
 
 
 
 
 
 
 
 
 

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5.3 
Administration of Procedural Intervention 
Schematic of Study Design 
 
Visit 1  
Enrollment 
(Day 0: 
0-30 min) 
 
 
 
  
 
 
 
 
 
 
Visit 1 (cont) 
Data Collection 
 (Day 0: 
30-60 min 
+/- 15) 
 
 
 
Visit 2  
Day of  
Surgery 
(Day ~14) 
 
 
Visit 3 
Post-Op  
Clinic 
(Day ~21) 
 
 
 
Visit 4 
Post-Op  
Clinic 
(Day ~100) 
 
 
 
 
 
 
Total N=40. Obtain research informed consent. Screen patient for inclusion criteria. 
Eligible patients are offered the opportunity to join the study. 
INTERVENTION GROUP 
Thyroidectomy Specific Knowledge Assessment 
TISCAV 
Thyroidectomy Specific Knowledge Assessment 
Decisional Conflict Survey (DCS) 
Satisfaction with Decision Scale (SDS) 
Visual Analog Scale of Anxiety (VAS-A) 
Thyroidectomy 
Statistical Analysis 
Randomize Patients 
Control: 
Standard Consent 
20 patients 
Intervention:  
TISCAV  
20 Patients 
CONTROL GROUP 
Thyroidectomy Specific Knowledge Assessment 
Standard Consent 
Thyroidectomy Specific Knowledge Assessment 
Decisional Conflict Survey (DCS) 
Satisfaction with Decision Scale (SDS) 
Visual Analog Scale of Anxiety (VAS-A) 
INTERVENTION GROUP 
Satisfaction with Decision Scale (SDS) 
Decision Regret Scale (DRS) 
Visual Analog Scale of Anxiety (VAS-A) 
CONTROL GROUP 
Satisfaction with Decision Scale (SDS) 
Decision Regret Scale (DRS) 
Visual Analog Scale of Anxiety (VAS-A) 
INTERVENTION GROUP 
Satisfaction with Decision Scale (SDS) 
Decision Regret Scale (DRS) 
Visual Analog Scale of Anxiety (VAS-A) 
CONTROL GROUP 
Satisfaction with Decision Scale (SDS) 
Decision Regret Scale (DRS) 
Visual Analog Scale of Anxiety (VAS-A) 

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6 Study Schedule  
6.1 Pretreatment Period/Screening 
 
• 
Visit 1, Day 0, 0 – 30 minutes 
o 
Eligible patients are identified by a clinical-designated research assistant. 
o 
Clinic-designated research assistant meets face-to-face with the PI and Co-I to potentially 
eligible subjects 
o 
Patients who consent for thyroid surgery are approached with eligibility interview questions 
of inclusion and exclusion criteria 
o 
Patients are randomized 
6.2 Enrollment/Baseline 
• 
Visit 1, Day 0, 30-60 minutes +/- 15 minutes 
o 
INTERVENTION ARM:  
§ 
Patients complete the initial KA 
§ 
** Patients review the TISCAV** 
§ 
Patients complete the post-intervention KA 
§ 
Patients complete the DCS, SDS, VAS-A 
o 
CONTROL ARM: 
§ 
Patients complete the initial KA 
§ 
** Patients undergo SC** 
§ 
Patients complete the post-intervention KA 
§ 
Patients complete the DCS, SDS, VAS-A 
6.3 End of Treatment Study Procedures  
• 
Visit 2, Day ~21 – Postop Visit 1 
o 
INTERVENTION ARM:  
§ 
Patients are phoned around the time of their initial postoperative visit 
§ 
Patients complete the SDS, DRS, and VAS-A 
o 
CONTROL ARM: 
§ 
Patients are phoned around the time of their initial postoperative visit 
§ 
Patients complete the SDS, DRS, and VAS-A 
• 
Visit 3, Day ~100 – Postop Visit 2 
o 
INTERVENTION ARM:  
§ 
Patients are phoned around the time of their 3 month postoperative visit 
§ 
Patients complete the SDS, DRS, and VAS-A 
o 
CONTROL ARM: 
§ 
Patients are phoned around the time of their 3 month postoperative visit 
§ 
Patients complete the SDS, DRS, and VAS-A 
6.4 Long Term/Survival Follow-up  
N/A 
6.5 Withdrawal Visit/Discontinuation of Therapy 
If a subject withdraws consent to participate in the study, permission will be sought to use data pertaining 
to the subject in the analysis as far as they participate, and they will be removed from subsequent 

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analyses. Subjects will be called by phone at least on three occasions, phone calls at least twice will be 
carried out to the next-of-kin and certified letters will be sent twice. If follow-up is not obtained after the 
previously listed attempts have been carried out the subject will be considered lost to follow-up. 
7 Study Procedures and Evaluations 
7.1 Study Procedures/Evaluations 
 
Decision-Making Survey Instruments. Several validated survey instruments will be utilized in this study. The 
Decisional Conflict Survey (DCS) is a measurement of 5 dimensions of decision making using a 16-item 
question format. Measured on a 5-point scale, where each question is scored 0 to 4. The total score is calculated 
out of 64, with five subcategories separated by question. These categories include uncertainty, informed, values 
clarity, support, and effect decision. The Satisfaction with Decision Scale (SDS) is a 6-item scale used to assess 
patient satisfaction with a healthcare decision. This is rated on a scale where each statement is scored 1 (not 
satisfied) to 5 (very satisfied). Total score is calculated out of 30, with higher scores indicating higher decision 
satisfaction. The Decision Regret Scale (DRS) is a 5-item statement scale used to evaluate regret after healthcare 
decision making. Each statement is measured 1 (strongly agree) to 5 (strongly disagree). Total score is calculated 
out of 25, with higher scores indicating high decisional regret.33 The Visual Analog Scale for Anxiety (VAS-A) 
is a simple and rapid assessment of anxiety using a single question, which has demonstrated adequate reliability, 
validity, and sensitivity. The VAS-A has been shown to be advantageous when multi-item inventories such as 
State-Trait Anxiety Inventory (STAI) may be burdensome, and it has been shown to correlate with the STAI in 
the perioperative setting.  
7.2 Laboratory Procedures/Evaluations 
7.2.1 Clinical Laboratory Evaluations 
N/A 
7.2.2 Special Assays or Procedures 
N/A 
7.2.3 Specimen Preparation, Handling, and Storage 
N/A 
7.2.4 Specimen Shipment 
N/A 
8 Evaluation of Safety 
8.1 Specification of Safety Parameters 
8.1.1 Unanticipated Problems 
Unanticipated problems (UAPs) include, in general, any incident, experience, or outcome that meets the 
following criteria: 

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• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and 
informed consent document; and (b) the characteristics of the participant population being studied; 
UAPs are considered to pose risk to participants or others when they suggest that the research places 
participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) 
than was previously known or recognized. 
8.1.2 Adverse Events 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during 
the study. That is considered related to the study-specific treatment.  Intercurrent illnesses or injuries should be 
regarded as adverse events. Abnormal results of diagnostic procedures are adverse events if the abnormality: 
• 
Results in study withdrawal 
• 
Is associated with a serious adverse event 
• 
Is associated with clinical signs or symptoms 
• 
Leads to additional treatment or to further diagnostic tests 
• 
Is considered by the investigator to be of clinical significance 
8.1.3 Serious Adverse Events 
Adverse events are classified as serious or non-serious.   
A serious adverse event is any AE that is:  
• 
fatal 
• 
life-threatening 
• 
requires or prolongs hospital stay 
• 
results in persistent or significant disability or incapacity 
• 
a congenital anomaly or birth defect 
• 
an important medical event 
 
Important medical events are those that may not be immediately life threatening but are clearly of major 
clinical significance. They may jeopardize the subject and may require intervention to prevent one of the other 
serious outcomes noted above.  For example, drug overdose or abuse, a seizure that did not result in in-patient 
hospitalization or intensive treatment of bronchospasm in an emergency department would typically be 
considered serious. All adverse events that do not meet any of the criteria for serious should be regarded as 
non-serious adverse events 
8.2 Safety Assessment and Follow-Up 
The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 
(for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study visit, the 
investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be 
followed for outcome information until resolution or stabilization. 
8.3 Recording Adverse Events 
At each contact with the subject, the investigator will seek information on adverse events by specific 
questioning and, as appropriate, by examination. Information on all adverse events related to the intervention 
arm of this study will be recorded immediately in the source document, and in the appropriate adverse event 
module of the case report form (CRF). All clearly related signs, symptoms, and abnormal diagnostic 
procedures results should be recorded in the source document, though should be grouped under one diagnosis. 
 
All adverse events related to the intervention occurring during the study period will be recorded. Adverse 
events will be reported from both study sites using the online reporting system. 

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The clinical course of each event will be followed until resolution, stabilization, or until it has been determined 
that the study treatment or participation is not the cause. Serious adverse events that are still ongoing at the end 
of the study period will be followed up to determine the outcome. Any serious adverse event that occurs after 
the study period and is possibly related to the study treatment or study participation will be recorded and 
reported immediately. 
8.3.1 Relationship to Study Intervention 
The relationship to study intervention or study participation must be assessed and documented for all adverse 
events. Evaluation of relatedness must consider etiologies such as natural history of the underlying disease, 
concurrent illness, concomitant therapy, study-related procedures, accidents, and other external factors.  
The following guidelines are used to assess relationship of an event to study intervention: 
1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and event onset. 
c. The event abates when the intervention is discontinued. 
d. The event reappears upon a re-challenge with the intervention. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event onset. 
b. An alternate etiology has been established. 
8.3.2 Expectedness 
The PI is responsible for determining whether an AE is expected or unexpected. An AE will be considered 
unexpected if the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the intervention. Risk information to assess expectedness can be obtained from 
preclinical studies, the investigator’s brochure, published medical literature, the protocol, or the informed 
consent document. 
8.3.3 Severity of Event 
Adverse events will be graded for severity according to the Common Terminology Criteria for 
Adverse Events (CTCAE) version 5.0.  
8.3.4 Intervention 
Any intervention implemented to treat the adverse event must be documented for all adverse events. 
8.4 Safety Reporting  
8.4.1 Reporting to IRB 
8.4.1.1 Unanticipated Problems 
All incidents or events that meet criteria for unanticipated problems (UAPs) as defined in Section 8.1.1 
Unanticipated Problems require the creation and completion of an unanticipated problem report form (OHR-
20).  
UAPs that pose risk to participants or others, and that are not AEs, will be submitted to the IRB on an OHR-20 
form via the eazUP system within 10 working days of the investigator becoming aware of the event.  
UAPs that do not pose risk to participants or others will be submitted to the IRB at the next continuing review.  

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8.4.1.2 Adverse Events  
Grade 1 AEs will be reported to the IRB at continuing review.  
Grade 2 AEs will be reported to the IRB at the time of continuing review.  
8.4.1.3 Serious Adverse Events  
SAEs will be reported to the IRB on OHR-10 forms via the electronic reporting system (eSAEy) according to 
the required time frames described below. 
Grade 3-4 AEs that are unexpected and deemed to be at least possibly related to the study will be reported to 
the IRB within 2 working days of knowledge of the event. 
Grade 3-4 AEs that are deemed unrelated to the study will be reported to the IRB within 5 working days.  
Grade 5 AEs will be reported to the IRB within one working day of knowledge of the event. 
All SAEs will be submitted to the IRB at continuing review, including those that were reported previously. 
8.4.2 Reporting to SKCC DSMC 
All AEs and SAEs, safety and toxicity data, and any corrective actions will be submitted to the DSMC per the 
frequency described in the SKCC DSMP. The report to the SKCC DSMC will also include any unanticipated 
problems that in the opinion of the PI should be reported to the DSMC. 
For expedited reporting requirements, see table below: DSMC AE/SAE Reporting Requirements 
 
8.4.3 Reporting of Pregnancy 
8.5 Halting Rules 
9 Study Oversight 
In addition to the PI’s responsibility for oversight, study oversight will be under the direction of the SKCC’s 
Data and Safety Monitoring Committee (DSMC). The SKCC DSMC operates in compliance with a Data and 
Safety Monitoring Plan (DSMP) that is approved by the NCI.  
10 Clinical Site Monitoring and Auditing 
Clinical site monitoring and auditing is conducted to ensure that the rights of human participants are protected, 
that the study is implemented in accordance with the protocol and/or other operating procedures, and that the 
quality and integrity of study data and data collection methods are maintained. Monitoring and auditing for this 
study will be performed in accordance with the SKCC’s Data and Safety Monitoring Plan (DSMP) developed 
by the SKCC Data and Safety Monitoring Committee (DSMC). The DSMP specifies the frequency of 
monitoring, monitoring procedures, the level of clinical site monitoring activities (e.g., the percentage of 
participant data to be reviewed), and the distribution of monitoring reports. Some monitoring activities may be 
performed remotely, while others will take place at the study site(s). Appropriate staff will conduct monitoring 
activities and provide reports of the findings and associated action items in accordance with the details 
described in the SKCC DSMP. 

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11 Statistical Considerations  
11.1 Study Hypotheses and Analysis Plans 
 
 
To estimate the efficacy of TISCAV for increasing surgery-specific comprehension. Patient surgery-specific 
comprehension will be measured by formatively using KA. Means and standard deviations of KA scores will 
be computed. A two-sided paired t-test will be constructed at the α=0.05 level to evaluate the statistical 
significance of mean changes in KA scores between timing of tests. A two-sided two-sample t-test will be 
constructed at the α=0.05 level to evaluate the statistical significance of the difference in mean HNSA scores 
between the groups. This will be further applied to the DCS, SDS, DRS, and VAS-A across timepoints and 
between groups 
 
  
11.2 Interim Analyses and Stopping Rules 
There are no interim analyses planned for this pilot study. 
11.3 Sample Size Considerations 
 
Feasibility was previously defined at a threshold value of 80% based on prior unpublished work. In this 
preliminary study, feasibility was measured at 93%. The study size of 40 participants will provide ample 
precision for the feasibility estimate. If we observe a similar proportion, then a Clopper-Pearson Exact 
95% confidence interval will be (86%, 98%).  
 
11.3.1 Accrual Estimates 
We will aim to recruit 3-4 patients per month over the course of 12 months for a total of 40 study 
participants. 
12 Source Documents and Access to Source Data/Documents 
Study staff will maintain appropriate medical and research records for this study, in compliance with ICH E6, 
and regulatory and institutional requirements for the protection of confidentiality of participant information. 
Study staff will permit authorized representatives of SKCC and regulatory agencies to examine (and when 
required by applicable law, to copy) research records for the purposes of quality assurance reviews, audits, and 
evaluation of the study safety, progress and data validity. 

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13 Quality Control and Quality Assurance 
The investigator will allocate adequate time for monitoring activities. The Investigator will also ensure 
that compliance or quality assurance reviewers are given access to all the above noted study-related 
documents and study related facilities (e.g., pharmacy, diagnostic laboratory, etc.), and has adequate 
space to conduct the monitoring visit. 
14 Ethics/Protection of Human Participants  
14.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the principles set forth in The 
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, as 
drafted by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral 
Research (April 18, 1979) and codified in 45 CFR Part 46 and/or the ICH E6.  
14.2 Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted 
to the IRB for review and approval. Approval of both the protocol and the consent form must be obtained 
before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB 
before the changes are implemented in the study.  
14.3 Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to participate in the study and 
continues throughout study participation. Extensive discussion of risks and possible benefits of study 
participation will be provided to participants and their families, if applicable. A consent form describing in 
detail the study procedures and risks will be given to the participant. Consent forms will be IRB-approved, and 
the participant is required to read and review the document or have the document read to him or her. The 
investigator or designee will explain the research study to the participant and answer any questions that may 
arise. The participant will sign the informed consent document prior to any study-related assessments or 
procedures. Participants will be given the opportunity to discuss the study with their surrogates or think about 
it prior to agreeing to participate. They may withdraw consent at any time throughout the course of the study. 
A copy of the signed informed consent document will be given to participants for their records. The rights and 
welfare of the participants will be protected by emphasizing to them that the quality of their clinical care will 
not be adversely affected if they decline to participate in this study. The consent process will be documented in 
the clinical or research record.  
14.4 Exclusion of Women, Minorities, and Children (Special Populations) 
Women and minorities will be included in this study. Children will be excluded from this study as pediatric 
populations less than 18 years of age are legally not allowed to purchase nicotine products and they are not 
included in the study population.  
14.5 Participant Confidentiality 
Information about study subjects will be kept confidential and managed according to the requirements of the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations require a signed 
subject authorization informing the subject of the following:  
 
• 
What protected health information (PHI) will be collected from subjects in this study. 
• 
Who will have access to that information and why. 

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• 
Who will use or disclose that information. 
• 
The rights of a research subject to revoke their authorization for use of their PHI.  
 
If a subject revokes authorization to collect or use PHI, the investigator, by regulation, retains the ability to use 
all information collected prior to the revocation of subject authorization.  For subjects that have revoked 
authorization to collect or use PHI, attempts should be made to obtain permission to collect at least vital status 
(i.e. that the subject is alive) at the end of their scheduled study period. 
14.6 Future Use of Stored Specimens and Other Identifiable Data  
N/A 
15 Data Handling and Record Keeping 
The investigators are responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data 
reported. All source documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data. The investigators will maintain adequate case histories of study participants, including accurate case 
report forms (CRFs), and source documentation. 
15.1 Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff under the supervision of 
the investigator. All source documents and laboratory reports will be reviewed by the study team and data 
entry staff, who will ensure that they are accurate and complete. Unanticipated problems and adverse events 
must be reviewed by the investigator or designee. 
15.2 Data Capture Methods 
Electronic surveys and questionnaires will be distributed to all patients at each study visit. Survey responses 
will be populated into REDCap by the research coordinator. Documents will be collected and stored for all 
patients in a secure area. 
15.3 Types of Data* 
Clinical data regarding patient medical history, social history and history of disease will be de-identified 
and collected in a dual-factor authentication protected password encrypted database. Outcomes measures 
collected in the form of surveys will be collected on paper assessments which will be evaluated and stored 
in a locked cabinet in 925 Chestnut St. 6th floor.  
15.4 Study Records Retention 
All study essential documents will be retained by the investigator for 2 years after the completion of the study. 
15.5 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol, Good Clinical Practice, or Manual 
of Procedures requirements. The noncompliance may be on the part of the participant, the investigator, or 
study staff. As a result of deviations, corrective actions are to be developed by the study staff and implemented 
promptly.  All deviations from the protocol must be addressed in study participant source documents and 
promptly reported to the IRB and other regulatory bodies according to their requirements.  
16 Study Finances 
16.1 Funding Source 

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This study will be financed through a grant if available. 
16.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by a properly 
constituted Conflict of Interest Committee with a Committee-sanctioned conflict management plan that has 
been reviewed and approved by the study sponsor prior to participation in this study. All Jefferson University 
Investigators will follow the TJU Conflicts of Interest Policy for Employees (107.03). 
16.3 Participant Stipends or Payments 
N/A 
17 Publication and Data Sharing Policy 
An Executive Committee consisting of all investigators will be responsible for developing publication 
procedures and resolving authorship issues. The Principal Investigator will hold the primary responsibility for 
publication of the any results of the study. Approval will be obtained from the primary responsible party before 
any information can be used or passed on to a third party. Costs associated with data sharing and publication 
will be paid for by the Sidney Kimmel Cancer Center.  This study will comply with the NIH Public Access 
Policy, which ensures that the public has access to the published results of NIH funded research. It requires 
scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive 
PubMed Central upon acceptance for publication. 
 
 
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SUPPLEMENTAL MATERIALS 
Appendices 
 
 
 
FIGURE 1: Thyroid Cancer GENDER: Recent Trends in SEER Age-Adjusted Incidence Rates, 
2000-2017 
 
 
 

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FIGURE 2: Thyroid Cancer GENDER: Recent Trends in SEER Age-Adjusted Incidence Rates, 
2000-2017 
 
 
 
 
 
 
TABLE 1: Thyroid Cancer: Recent Trends in SEER Age-Adjusted Incidence Rates, 2000-2017 
 
 

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FIGURE 3: Thyroid Cancer RACE: Recent Trends in SEER Age-Adjusted Incidence Rates, 
2000-2017 
 
 
 
 
 
 
FIGURE 4: Thyroid Cancer AGE: Recent Trends in SEER Age-Adjusted Incidence Rates, 2000-
2017 

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FIGURE 5: Thyroid Cancer AGE: Recent Trends in SEER Age-Adjusted Incidence Rates, 2000-
2017 
 
 
 

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FIGURE 6: Knowledge Assessment 
 
 
 
 
 
 
 
Understanding Your Upcoming Thyroid Surgery 
Formative Assessment 
 
 
 
 
1. Which of the following is a reason to have 
thyroid surgery? 
a. Suspicious thyroid nodule 
b. Overactive thyroid gland 
c. Very enlarged thyroid gland 
d. Cancer in a thyroid nodule 
e. All of the above 
 
2. Steps of thyroid surgery include all of the 
following EXCEPT: 
a. Incision in the skin 
b. Removing the parathyroid 
c. Opening the muscles in the neck 
d. Sealing the blood vessels that supply the 
thyroid gland 
 
3. Which of the following is a risk of thyroid 
surgery? 
a. Injury to the parathyroid glands 
b. Injury to the nerves to the vocal cords 
c. Bleeding 
d. Pain 
e. All of the above 
 
4. Pain after thyroid surgery most commonly 
includes all of the following EXCEPT: 
a. Sore throat 
b. Sore muscles in neck and back 
c. A small amount of pain at the incision 
d. Severe pain at the incision 
 
5. The _________ is in charge of balancing 
calcium levels in the body: 
a. Thyroid 
b. Parathyroid 
c. Pancreas 
d. Liver 
 
 
6. The risk of having low blood calcium levels 
is greatest after which of the following 
surgeries: 
a. Hemithyroidectomy (half of the 
thyroid) 
b. Isthmusectomy (middle part of the 
thyroid) 
c. Total thyroidectomy (all of the 
thyroid) 
d. Same for all of the above 
 
7. Significant bleeding after surgery occurs 
in____. 
a. More than half of patients (>50%) 
b. About half of patients (50%) 
c. 1 in 4 patients (25%) 
d. Less than 1 in 100 patients (<1%) 
 
8. True or False: In the rare event of having 
bleeding after surgery, a second surgery may 
be needed to remove the collection of blood. 
a. True 
b. False 
 
9. True or False: Most patients will require 
antibiotics after surgery. 
a. True 
b. False 
 
10. The risk of permanent damage to the nerve 
to the vocal cord after thyroid surgery is: 
a. More than half of patients (>50%) 
b. About half of patients (50%) 
c. 1 in 4 patients (25%) 
d. Less than 1 in 100 patients (<1%) 
 
 

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FIGURE 7: Decisional Conflict Survey  
 
 
 
FIGURE 8: Decisional Regret Scale 
 
 
 
 
 
Decisional Conflict Survey (DCS) 
 
 
 
 
Yes 
Probably 
Yes 
Unsure 
Probably 
No 
No 
Do you know which options are available to you? 
0 
1 
2 
3 
4 
Do you know the benefits of each option? 
0 
1 
2 
3 
4 
Do you know the risks and side effects of each 
option? 
0 
1 
2 
3 
4 
Are you clear about which benefits matter most to 
you? 
0 
1 
2 
3 
4 
Are you clear about which is more important to you 
(the benefits or the risks and side effects)? 
0 
1 
2 
3 
4 
Do you have enough support from others to make a 
choice? 
0 
1 
2 
3 
4 
Are you choosing without pressure from others? 
0 
1 
2 
3 
4 
Do you have enough advice to make a choice? 
0 
1 
2 
3 
4 
Are you clear about the best choice for you? 
0 
1 
2 
3 
4 
Do you feel sure about what to choose? 
0 
1 
2 
3 
4 
Is this decision easy for you to make? 
0 
1 
2 
3 
4 
Do you feel you have made an informed choice? 
0 
1 
2 
3 
4 
Does your decision show what is important to you? 
0 
1 
2 
3 
4 
Do you expect to stick with your decision? 
0 
1 
2 
3 
4 
Are you satisfied with your decision? 
0 
1 
2 
3 
4 
 
 
 
 
 
Decision Regret Scale (DRS) 
 
 
 
Please think about the decision you made about 
your thyroid surgery after talking to your 
surgeon. Please show how you feel about these 
statements. 
Strongly 
Agree 
Agree 
Neither 
Disagree 
Strongly 
Disagree 
It was the right decision. 
1 
2 
3 
4 
5 
I regret the choice that was made. 
1 
2 
3 
4 
5 
I would go for the same choice if I had to do it over 
again. 
1 
2 
3 
4 
5 
The choice did me a lot of harm. 
1 
2 
3 
4 
5 
The decision was a wise one. 
1 
2 
3 
4 
5 
 

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FIGURE 9: Satisfaction with Decision Scale 
 
 
 
 
 
 
Satisfaction with Decision Scale (SDS) 
 
 
 
 
Not 
Satisfied 
 
 
 
Very 
Satisfied 
I am satisfied that I was adequately informed about 
the issues important to my decision. 
1 
2 
3 
4 
5 
The decision I made was the best decision possible 
for me personally. 
1 
2 
3 
4 
5 
I am satisfied that my decision was consistent with 
my personal values. 
1 
2 
3 
4 
5 
I expect to successfully carry out (or continue to 
carry out) the decision that I made. 
1 
2 
3 
4 
5 
I am satisfied that this was my decision to make. 
1 
2 
3 
4 
5 
I am satisfied with my decision. 
1 
2 
3 
4 
5