Online Surveys to Assess the Perception and Performance of Imaging Associated Aspects
Conditions: Perception of Imaging
Sponsor: University of Cincinnati

THE OHIO STATE UNIVERSITY 
Institutional Review Board 
 
 
 
 
Version 1: October 9, 2017 
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Protocol Title: 
Online Surveys to Assess the Perception and Performance of 
Imaging and Associated Aspects 
 
 
Protocol Project Number: 
 
RP0320_S02 
 
Protocol Date: 
October 9, 2017 
 
Principal Investigators: 
 
Michael V. Knopp, MD, PhD 
Professor and Novartis Chair of Imaging Research,  
Vice Chairman of Research 
Department of Radiology 
The Ohio State University Wexner Medical Center 
395 West 12th Avenue, Room 430 
Columbus, Ohio 43210 
Phone: (614) 293-9998 
Fax: 
(614) 293-9275 
E-Mail: knopp.16@osu.edu 
 

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Institutional Review Board 
 
 
 
 
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Study Team: 
Michael V Knopp 
principal investigator 
Chadwick L Wright 
Co-Investigator 
Katherine Binzel 
Co-Investigator 
Miriam Knopp 
Co-Investigator 
Michelle I. Knopp 
Co-Investigator 
Preethi Subramanian  
Key Personnel 
Michael Friel 
Key Personnel 
Melanie Hughes 
Key Personnel 
Sarah Spaulding 
Key Personnel 
Samantha Kisare 
 
 
Key Personnel 
Sarah Herald   
 
 
Key Personnel 
 
I. Overview  
In this exploratory, survey-based study, we will investigate the background, perception, current 
use practices, potential unmet needs and/or challenges in regard to imaging procedures, imaging 
technology, or any other aspect related to the broader field of imaging. To do this, we plan to 
recruit volunteer participants to complete online surveys. 
 
II. Objectives  
1.  We aim to understand the background, perception, current use practices, potential unmet needs 
and/or challenges in regards to imaging procedures, imaging technology, or any other aspect 
related to the broader field of imaging. 
 
2. We strive to increase information available in the topics of interest stated above. These findings 
will guide our research development, preparations for clinical trial design, and special interest 
groups. Additionally, these findings will serve as reference data for appropriate scientific 
publications. 
 
III. Background/Rationale 
Understanding the environment in which a business is operating is essential for business success. 
Taking this concept from the business world to the clinical research domain, clinical researchers 
must understand the environment in which and for which they are developing clinical trials and 
clinical innovations. Although commonly used in consumer assessments, survey tools are 
underutilized within the clinical research community, even though they aid in the understanding 
of clinical and scientific perceptions.  We have realized this as part of our online social media 
studies in the overall field of imaging. Using online survey tools can effectively and efficiently 
query true opinions or perceptions which might not be so objectively obtained in person to person 
or other interactions. 
 

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Understanding clinical perception and clinical practices outside of the local environment is also 
essential for assessing the feasibility for innovative and transformative changes in the imaging 
environment. 
 
IV. Procedures: Research Design  
A. Sample 
Volunteer population 
• Consists of volunteers agreeing to complete the survey tool 
• It is anticipated that the surveys will be completed by participants that can be considered 
stakeholders, such as physicians, technologist’s physicists, imaging scientists, administrative 
staff, or others with interest in the topic. 
• We do not exclude the participation of patients; however, they are not typically the target 
population.  
 
Inclusion Criteria 
• Male and female participants who have access to the online survey tool and can read and write 
in English 
•  We are not putting any age restriction on the participation of the survey as the age is not 
relevant in any way for the survey.  
 
Exclusion Criteria 
• None, as this is voluntary 
B. Measurement / Instrumentation 
Survey tools 
The survey will be administered via Survey Monkey or equivalent electronic web based tools. 
Participants will be recruited through professional contact, e-mail lists, webpages, electronic 
mailing, or social media posting. Participants will be completely anonymous, and no PHI will be 
accessed, used, or disclosed during the study.   
 
C. Detailed study procedures 
Subject enrollment 
Anyone with the link to the survey will be able to complete the survey.  
 
Administration of informed consent 
We are adding the following statement to the survey, which will be displayed prior to beginning 
the survey questions: “Your participation in this research is voluntary, and if you decide not to 
participate, you may withdraw any time without being penalized. This online survey will take 
approximately 5-10 minutes. Your responses are confidential, and we will not collect any 

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identifying information. If you have any questions about the survey, please contact Dr. Michael 
Knopp, MD, PhD at Knopp.16@osu.edu or survey@wcibmi.org. By clicking yes, you are agreeing 
to participate in the survey.” 
 
Withdrawal from the study 
The subject can withdraw at any time from the study by not completing the survey, and their 
information up to that point will not be recorded. 
 
Compensation for participation in the research 
There is no compensation for participation in the research. 
 
Enrollment and participation choices 
Enrollment will be limited to 5,000 participants; however, we anticipate a significantly lower 
number of participants for each survey.  
 
Survey tool  
The surveys access information that may be shared by special interest groups, such as working 
groups within specific societies. Information may also be made available on online social media, 
postings, or targeted emails. 
 
Subject participation choices 
Subjects are given the option to complete the survey. Therefore, completion of the survey is 
mandatory in order to be a participant in the research. 
 
Location of performance of research 
The research is done on online. Anyone with the link can complete the survey wherever internet 
access is available. 
 
Testing procedures and data recording 
We intend to develop many surveys similar to the two surveys attached, which serve as the initial 
surveys and also as samples for anticipated upcoming surveys in order to obtain information of 
specific topics. All the information obtained from each respondent is collected using 
SurveyMonkey, which saves the data into a secure database. Only authorized users can abstract 
from the database the responses for each of the survey questions. Hardcopies may only be created 
for temporary purposes as part of data analysis and will be subsequently disposed. 
 
Data analysis and analytics 
As this is an exploratory trial, we have no prior data available to develop a detailed analysis plan. 
Initially, analytics will be descriptive.  
 

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Data sharing 
Research findings may be presented at scientific meetings and may be included in scientific 
publications. Collected data will have no identifiable information. The data may be shared with 
collaborators as appropriate after defining data use agreement. 
 
D. Risk, Benefits, Safety, and Confidentiality  
Risks 
There are no apparent risks from participation in the survey tools. Theoretically, a data breach 
could occur; however, no identifying information will be used in this research.  
 
Benefits 
There are no apparent personal benefits of participation in the surveys tools. However, there is a 
benefit of contributing to the generation of knowledge to benefit society. Additionally, the local 
facility may be able to update future research based on findings of this study.  
 
Safety Monitoring 
There will be no specific safety monitoring. Data safety will be monitored according to 
institutional policies. 
 
Confidentiality of Records 
Collected data will have no identifiable information but may be shared with collaborators as 
appropriate after defining a data use agreement. 
 
E. Internal Validity 
Managing and verifying the internal validity is an important task in this exploratory research 
program in order to develop the appropriate methodology to be validated in prospective clinical 
trials. We will assess the different factors impacting internal validity of the data sets we generate. 
For the specific factors, we will address the following considerations. The following text uses 
material presented at https://en.wikipedia.org/wiki/Internal_validity and is hereby specifically 
acknowledged. 
 
Temporal precedence 
This describes the potential lack of clarity regarding how one experience may influence a 
subsequent experience as that might be a cause and effect relationship. 
 
Confounding 
A major threat to the validity of causal inferences is confounding. Observations in one variable 
may relate to another manipulated variable. Where spurious relationships cannot be ruled out, 
hypotheses would have to be appropriately developed. 
 

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Selection bias 
Researchers and participants bring to the experiment a myriad of characteristics, some learned and 
others inherent, for example, sex, weight, hair, eye, and skin color, personality, mental capabilities, 
and physical abilities, and also attitudes like motivation or willingness to participate. Since the 
survey will be sent out via invite through working groups, societies, shared links etc., there is 
potential for selection bias based on shared characteristics of these groups. Selection bias refers to 
the problem that, at pre-test, differences between groups exist that may interact with the 
independent variable and thus be 'responsible' for the observed outcome.  
 
During the selection step of the research study, if an unequal number of test subjects have similar 
subject-related variables, there is a threat to the internal validity. If subjects in two groups to be 
compared are dissimilar with regard to the independent variable but are alike in one or more of the 
subject-related variables, it may jeopardize the internal validity. 
 
Self-selection to participate in this research can have a negative effect on the interpretive power of 
the dependent variable; this is especially known for online surveys where individuals of specific 
demographics opt into the test at higher rates than other demographics. 
 
History 
Events outside of the study/experiment or between repeated measures of the dependent variable 
may affect participants' responses to experimental experiences. Often, these are large scale events 
(natural disaster, political change, etc.) that affect participants' attitudes and behaviors such that it 
becomes impossible to determine whether any change in the dependent measures is due to the 
independent variable or the historical event. 
 
Maturation 
Subjects may change during the course of the experiment or even between measurements. Both 
permanent changes, such as physical growth, and temporary changes, like fatigue, provide 
"natural" alternative explanations; thus, they may change the way a subject would react to the 
independent variable. So, upon completion of the study, the researcher may not be able to 
determine if the cause of the discrepancy is due to time or the independent variable. 
 
Repeated testing 
Repeatedly measuring participants may lead to bias. Participants may remember the answers, or 
they may be conditioned to know that they are being tested. Repeatedly taking (the same or similar) 
tests usually leads to score gains. 
 
Instrument change 
The instrument used during the testing process can change the experiment, an aspect that we will 
manage via device quality control to the greatest extent possible. This also refers to observers 

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being more concentrated or primed, or having unconsciously changed the criteria they use to make 
judgments. This can also be an issue with self-report measures, such as facility perceptions given 
at different times. In this case, the impact may be mitigated through the use of retrospective 
pretesting. If any instrumentation changes occur, the internal validity of the main conclusion is 
affected. 
 
Differential attrition 
This error occurs if inferences are made on the basis of only those participants that have 
participated from the start to the end. Participants may have dropped out of the study before 
completion, possibly even due to the study or experiment itself. If this attrition is systematically 
related to any feature of the study, such as the administration of the independent variable or the 
instrumentation, or, if dropping out leads to relevant bias between groups, a whole class of 
alternative explanations may be possible that account for the observed differences. 
 
Selection-maturation interaction 
This occurs when the subject-related variables, color of hair, skin color, etc., and the time-related 
variables, age, physical size, etc., interact. If a discrepancy between the two groups occurs between 
the testing, the discrepancy may be due to the age differences in the age categories. 
 
Experimenter bias 
Experimenter bias occurs when the individuals who are conducting an experiment inadvertently 
affect the outcome by non-consciously behaving in different ways to members of control and 
experimental groups. It is possible to eliminate the possibility of experimenter bias through the use 
of double blind study designs, in which the experimenter is not aware of the condition to which a 
participant belongs. 
 
F. Data Analysis 
Data will be abstracted from excel worksheets. Descriptive statistical methods will be 
predominately used. 
 
Funding support 
Wright Center of Innovation Development fund 
 
 
Bibliography 
(1) Online Social Media Practices in Nuclear Medicine and Molecular Imaging: A Concept to 
Incentivize Creation of Digital and Web-Based Content. 
Wright CL, Niederkohr RD, Knopp MU, Knopp MV. 
J Nucl Med. 2017 Jun;58(6):12N-14N. PMID: 2857229 

THE OHIO STATE UNIVERSITY 
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