Study Information Sheet

University of California, Irvine · POLYPedia: Performance and Learning in a Gamified Colorectal Polyp Detection Training Platform · UCI IRB STUDY00002384

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Lead Researcher: Tevan Luong, MD, Resident Physician, Department of Medicine.
Faculty Advisor: William Karnes, MD, Health Sciences Professor of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine.
Contact: the POLYPedia team
Study location: Online (POLYPedia website), University of California, Irvine.
Study sponsor: Department of Medicine, UCI.

Summary of key information

Participation is voluntary. You are being asked to take part in a research study. Taking part is completely voluntary. You can use POLYPedia without joining the study. Please read the information below and ask the researchers about anything you do not understand.

Study purpose. The purpose of this study is to learn whether POLYPedia, a web-based training game, measures and improves skill at finding colorectal polyps on colonoscopy images, and how performance differs by level of training.

Study procedures. You will create a POLYPedia account and play up to eight modules of 200 colonoscopy images, with a new module opening every 3 days. For each image you tap the polyp or tap “No Polyp,” then see the correct answer.

Expected duration. Each module takes about 10–15 minutes, for a total of up to about 2 hours over 3 or more weeks. There are no study visits.

Risks. The main risk is that someone could learn how you scored. Researchers analyze your data under a code, never share individual results with anyone who evaluates you, and report only group results.

Benefits to you. You may improve your polyp-detection skill through practice with instant feedback, but this is not guaranteed.

Benefits to others. The results may improve how colonoscopy, and finding polyps in particular, is taught.

Alternatives. You can use POLYPedia for practice without joining the study, or choose not to use it.

Am I eligible to participate in this study?

You can take part if you are 18 or older and a UCI medical student, internal medicine resident, GI fellow, or attending gastroenterologist or endoscopist.

What procedures are involved with this study and how long will they take?

1. Sign up (about 5 minutes). Open https://www.polypedia.net on your phone, tablet or computer. Create an account with your email, a password, your level of training and your institution. POLYPedia gives you a random player name (for example, “Plucky Narwhal 42”), which is shown with your scores on the leaderboard that other players can see, instead of your name. To join the study, check the research box shown with this sheet.
2. Tutorial (optional, about 2 minutes). Practice on 10 images. The tutorial is not used for research.
3. Modules (about 10–15 minutes each). Play up to eight modules of 200 colonoscopy images. For each image, tap the center of the polyp or tap “No Polyp.” A timer runs for each image, and after each answer the game shows where the polyp was and where you tapped. A new module opens 3 days after you finish the previous one. The last module also shows 20 images from Module 1 again, to check how much you remember. You can pause a module and continue later.
4. Review (optional, a few minutes). After each module you see your score summary, can review every image and can flag any image that looks mislabeled.

Participation includes no visits and takes a total of about 2 hours over 3 or more weeks.

What is recorded: your email (only for signing in), your random player name, level of training and institution, and for each image where you tapped or whether you chose “No Polyp,” whether you were correct, how long you took, your scores and any images you flag. The colonoscopy images are de-identified and contain no patient information.

What are the possible discomforts or risks related to the study?

This study involves no known risks beyond those of everyday life. Possible risks and discomforts:

• Loss of confidentiality: someone could learn how you performed (unlikely; mild to moderate).
• Pressure: you might feel pressure to take part or to score well because the invitation came through your program (less common; mild). Taking part, and how well you score, will not affect your grades, evaluations, rotations or fellowship applications.
• Frustration with timed tasks or low scores (less common; mild).
• Time: about 2 hours in total (mild).

Will I be paid for taking part in this study?

You will not be paid for taking part in this study. You will not be reimbursed for any out-of-pocket expenses.

What are the costs of taking part in this study?

There is no cost to you. You use your own device and internet connection.

What happens if I want to stop taking part in this study?

You are free to stop at any time. To withdraw from the study, email the Lead Researcher; your data will be removed from the study analysis. You can keep using POLYPedia after withdrawing.

How will my personal information be kept?

Identifiable data: your email and player name are replaced with a code in all research data. Researchers analyze only the coded data. Your email stays only in POLYPedia's sign-in system so that you can log in.

Data storage: game data are stored in a secure Google Firebase database. Only you can see your own data, and only the research team can access the research data. Coded analysis files are stored on UCI's secure OneDrive.

Data retention: in accordance with UC Office of the President policy, research information will be kept for 10 years after the end of the calendar year in which the research is completed.

Who will have access to my study data?

The research team, authorized UCI personnel and regulatory entities such as the Office for Human Research Protections (OHRP) may have access to your study records to protect your safety and welfare. Your individual results will not be shared with program directors or anyone who evaluates you. Presentations and publications will report group results only.

While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.

Future research use: your information will be used only for this study. It will not be shared with other researchers.

Are there other issues to consider in deciding whether to participate in this study?

Investigator financial conflict of interest: No one on the study team has a disclosable financial interest related to this research project.

Who can answer my questions about the study?

If you have any comments, concerns or questions about this research, contact the research team listed at the top of this sheet.

Please contact the UCI Institutional Review Board by phone at (949) 824-8170, by email at IRB@research.uci.edu, or by mail at University of California, Irvine, Office of Research, Irvine, CA 92697-7600 if you cannot reach the researchers, have concerns or complaints about the research, have questions about your rights as a research subject, or have general comments or suggestions.

What is an IRB? An Institutional Review Board (IRB) is a committee of scientists and non-scientists that protects the rights and welfare of people who take part in research and makes sure research follows the rules.

How do I agree to participate in this study?

Participation in this study is voluntary. You may stop at any time without penalty or loss of benefits to which you are otherwise entitled. Your decision will not affect your relationship with UCI, your grades, evaluations, rotations or fellowship applications.

To join, check the research box below (“I have read this information and agree that my de-identified POLYPedia data may be used for this research study”). No signature is required. You can still use POLYPedia without checking the box. You may print or save a copy of this sheet.

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