You are invited to participate in a research study conducted by Matthew Nicholson, a student researcher at McMaster University and the student principal investigator of this study and Sarrah Lal, assistant professor at McMaster and the local principal investigator. You are invited to participate because you are a member of the general public who may access patient-available medical reports online, at this time or in the future.

To decide if you are interested in participating in this study, you should understand the research involved, as well as potential risks and benefits of participating. This form provides detailed information about the randomized control study.

WHY IS THIS RESEARCH BEING DONE?

We are conducting a randomized control trial assessing the usefulness of widely available artificial intelligence in helping patients understand medical reports with plain-language translations. Patients may have access, through online portals, to their medical reports written by clinicians. Typically, these reports are explained to patients by the primary care provider. However, accessing these reports can still lead to confusion due to medical jargon, leading to anxiety. Generally, this would result in a follow up with the primary care provider, but these additional interactions can be costly, time consuming, and stressful for both clinicians and patients.

With artificial intelligence programs like ChatGPT, patients may be able to enter the information from their medical reports into the chatbot for a patient-friendly, plain-language translation of the report. This study will evaluate how accurate and reliable these translated reports are by comparing understanding to an untranslated report, as well as a report translated by a clinician. The data from this study will help us decide on the effectiveness of AI to act as a virtual clinician for these specific clinical follow-up interactions.

WHAT IS THE PURPOSE OF THIS STUDY?

The purpose of this study is to establish the ability of freely available artificial intelligence (AI) models like ChatGPT to translate medical jargon into inclusive, plain English. This is necessary research due to the significant knowledge gap between clinicians and patients which can cause confusion and worsened health outcomes among patients. This is coupled with an increase in access to online medical records for patients, with limited increased in access to support and tools for easing this transition. With proper tools to bridge this knowledge gap between patients and clinicians, patients can gain a better understanding of their health and maintain an involved role in their own healthcare. ChatGPT is becoming a go-to tool for many people who use it for a variety of applications, including understanding clinical terms. The question then becomes, can large language models like ChatGPT effectively translate medical jargon? Providing evidence that this intervention is effective could lead to a reduction in costly, stressful, and time-consuming interactions for both healthcare professionals and patients. For this reason, this study is being conducted as a survey to establish a baseline for the effectiveness of AI as a virtual clinician.

WHAT WILL MY RESPONSIBILITIES BE IF I TAKE PART IN THE STUDY?

We are recruiting individuals who are above the age of 18 and are fluent in the English language. If you volunteer to participate in the study, we will ask you to do the following things:

This survey will ask you questions about yourself including your approximate age, gender, birth month, and highest level of education, after which you will read a short piece of text that replicates a medical report, followed by questions about the content of the report and your thoughts on the report, as well a question about AI. Lime Survey is secure and compliant with privacy regulations. By accessing the survey through this link, you are consenting to being a participant in this research study based on the information provided in this consent document. In electing to take part in this survey, it is your responsibility to respond to each question. Surveys that are incomplete will not be considered in the study.

WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS?

There are no foreseeable discomforts for participants of this study. Some participants may feel overwhelmed by the medical jargon in the piece of text they read, but there is no pressure or expectation to understand this language. Participants are only asked questions about the content to gauge the clarity of the report, not their individual abilities to understand medical terms. There may be an inconvenience with regards to the time needed to complete the survey, which is expected to be around 10 minutes.

HOW MANY PEOPLE WILL BE IN THIS STUDY?

We hope to involve 200 participants in the study, with a diverse sample of varied age, gender, level of education, and area of study in education.

WHAT ARE THE POSSIBLE BENEFITS FOR ME AND/OR FOR SOCIETY?

Possible benefits for you as a result of your involvement include helping to establish the usefulness of AI as a virtual clinician. Benefits for society include the improvement of health equity by increasing the evidence for patient-driven health tools, and by bridging the gap between clinicians and patients. The results of this study will be made available to participants in the form of an inclusive summary, with a graphical representation such as an infographic.

IF I DO NOT WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES?

You do not have to participate in this study. There are no consequences if you choose not to complete the survey. Participation is completely voluntary.

WHAT INFORMATION WILL BE KEPT PRIVATE?

All email address information will be kept private, and this information will be stored on a secure drive. Study participant names will not be collected, and all study participants will be given a coded study ID. For the purposes of ensuring proper monitoring of the research study, it is possible that representatives of Hamilton Integrated REB (HiREB), this institution, and affiliated sites or regulatory authorities may consult your original (identifiable) data to check that the information collected for the study is correct and follows proper laws and guidelines. By participating in this study, you authorize such access. To the extent permitted by applicable laws and regulations, records identifying participants will not be made publicly available. After the survey closes in June, 2024, the data collected will be analyzed. During the study period, all data will be stored on a secure drive hosted by McMaster University. Following the close of the study, all survey data collected will be destroyed.

CAN PARTICIPATION IN THE STUDY END EARLY?

You may withdraw from this study at any time by not answering the survey questions and by exiting the survey. As the responses are de-identified after submission, it is not possible to withdraw responses once the survey has been submitted. Participating in this study does not exclude you from participating in any other studies/research.

CAN I RECEIVE THE RESULTS FROM THIS STUDY AFTER PARTICIPATING?

Participants can elect, at the end of the survey, to provide their email in order to receive the results of the study after participating. The expected close date of the study is in June, 2024, and results will be available after this date.

WILL THERE BE ANY COSTS?

There are no foreseeable costs to participation in this study.

WHAT HAPPENS IF I HAVE A RESEARCH-RELATED INJURY?

If you consent to participate, it does not mean that you waive any legal rights you may have under the law, nor does it mean that you are releasing the investigator(s), institution(s) and/or sponsor(s) from their legal and professional responsibilities, with regards to a data breach.

WHO CAN I CONTACT?

If you have any questions or concerns about the research now or later, please contact the student principal investigator Matthew Nicholson (nichom18@mcmaster.ca).