In an effort to integrate Human Practices into our project, we have conducted surveys in several ways to reach specific target groups and gain certain valuable insights. We have conducted three surveys in total, each designed with its own set of objectives to produce valuable insights:

Survey to reach the general public: A significant aspect of our project involves assessing its social impact. To achieve this, we've developed a comprehensive survey aimed at gathering diverse perspectives and feedback from the general public about GMO-based wearable biosensors. This survey is designed to ensure our project aligns with the broader community's needs and concerns.

Survey to reach food and metabolism students: With this survey, we collected experiences from students following a food and metabolism course for which they wore a continuous glucose monitor for three weeks. We used this opportunity to gauge the user-friendliness of the sensor among students with no prior sensor experience. This survey aims to gather insights on first-time wearable sensor users, mirroring potential experiences of Bye-O-Film users and will inform design considerations and improvements.

Survey to reach patients: We designed this survey with the specific goal of connecting with our target audience, individuals who have medical implants, particularly those who have encountered implant-related infections. By analyzing the survey responses, our objective was to obtain a deeper understanding of how these end-users perceive the issue we are addressing.

In the following section we discuss the results of our surveys and showcase our survey design process. At the end of this page, you can find details of our approach, as well as an example of our survey design process.

1. Awareness about medical implant infections
2. Use of GMOs in therapeutics
3. Comfort of wearable biosensors and considerations

Demographics

Out of the 37 participants, 33 provided information about their age. As can be seen in Figure 1, they are situated between 18 and 44 years old. 70.3% of our participants are female, while 21.6% are male, and 5,4% are non-binary. This demographic shows that the respondents are relatively young.

Figure 1: Answers regarding demographics.

Awareness and Biofilm Infections Knowledge

A limited number of participants expressed familiarity with infections associated with medical implants. Specifically, 43.2% acknowledged a complete lack of knowledge about these infections. In contrast, 29.7% of the participants were acquainted with the term 'biofilms,' while 45.9% were not, and 24.3% had some degree of familiarity with the term. These findings underscore the fact that a majority of respondents lack confidence in their understanding of medical implant-related infections and the concept of biofilms. This underscores the need for public education on biofilm infections.

Figure 2: Answers regarding awareness and knowledge of biofilm infections.

Concerns Regarding Infection

None of the participants reported personal experiences with implant-related infections. However, 29 out of the 37 participants expressed that they would be worried or extremely worried if they were to hypothetically experience an infection on their implant

Figure 3: Answers regarding concerns about infections.

Concerns Regarding GMOs

The majority of respondents (91.8%) expressed a high level of comfort with the idea of using diagnostic and therapeutic products based on GMOs, feeling very safe, safe, or neutral in this regard. However, some participants did raise concerns regarding GMO-based products. One participant pointed out the need for strict adherence to regulations in the production, handling, and disposal of GMO-based products, which might not always be followed by the average end-user. Another participant expressed the view that GMOs are potentially risky but not inherently dangerous, while someone else emphasized concerns about potential unforeseen effects on the microbiome.

These results underscore the importance of understanding the general public's concerns so that they can be addressed effectively. Participants also mentioned that they would feel more secure and confident about a GMO-based diagnostic product if there were comprehensive safety testing, transparent labeling, regulatory approvals, independent third-party verification, and detailed information about the product's benefits.

Figure 4: Answers regarding concerns about GMO-based products.

Wearable Biosensors Considerations

According to the respondents, the key considerations for wearable biosensors include comfort and fit, affordability, durability, long battery life, and measurement accuracy. The participants raised various concerns related to wearable biosensors, such as material allergies, water resistance, device longevity, size, the social stigma surrounding biosensors, infection risk, and user-friendliness. 

Figure 5: Answers concerning factors to consider regarding wearable biosensors.

Design

Most participants emphasized the significance of a discreet and minimalistic design when it comes to wearable biosensors. Only 6 out of the 37 respondents stated that aesthetics were not important to them. These findings provide valuable insights concerning the device's design and visual appeal, and imply how important this often overlooked aspect is.

Figure 6: Answers regarding design considerations concerning wearable biosensors.

Application Features

The majority of the respondents indicated that real-time health monitoring, alerts and notifications, and a user-friendly interface are the most important features of the application that is connected to the device. These results highlight important insights regarding the design and functionalities of the app.

Figure 7: Answers regarding important features of the application connected to the device.

In conclusion, this survey emphasizes the importance of public education and trust-building in emerging medical technologies, especially concerning implant-related infections and GMO-based products. Insights into wearable biosensors and application features offer valuable guidance for user-centered design. Overall, it underscores the significance of aligning healthcare innovations with public needs and preferences. We reflected upon these results and integrated the feedback and considerations in our design and engineering process. We accentuated focus on the design of the electronic device and the wearable biosensor, as can be seen on Product Design page.

Demographics

All six participants were female, and their ages ranged from 22 to 26 years old (Figure 8). This demographic information is important as it gives context to the responses, suggesting that the sample is relatively homogeneous in terms of gender and age.

Figure 8: Answers regarding demographics.

Experience with Monitoring Devices

Two participants had prior experience with monitoring devices, which could influence their perceptions and comfort levels with the new device. This prior experience may make them more familiar with the concept and more willing to tolerate any discomfort associated with wearing it.

Ease of Application

Participants generally found the device easy to apply, indicating that the initial setup process was user-friendly. This is a positive aspect as it reduces barriers to using the device effectively. Figure 9 shows how the participant's experience matched their expectations.

Figure 9: Answers regarding use-related expectations.

Comfort and Convenience

Two participants reported experiencing slight discomfort, mentioning a stinging sensation, especially during exercise, while three participants noted that the device was a minor inconvenience. This suggests that while the device is generally well-received for its ease of use and provision of valuable information, some users experienced discomfort and minor inconveniences (Figure 10). 

Figure 10: Answers regarding overall experience.

Usefulness of Information

Four participants found the device very useful for providing information and expressed satisfaction with how easily they could access the data through the accompanying application. This suggests that the device serves its intended purpose well and provides valuable information to the users. It also implies the interest of the users to contnously monitor their own health state.

Insights into Glucose Levels

Five participants claimed that wearing the device gave them insights into their glucose levels. This indicates that the device effectively fulfills its monitoring role and helps users become more aware of their glucose levels.

Awareness of Dietary Choices

Four participants reported being more aware of their dietary choices after wearing the device. This suggests that the device not only provides data but also has a positive impact on behavior by encouraging healthier choices.

Figure 11: Answers regarding awareness of dietary choices.

Impact on Daily Lives

One participant noted no noticeable impact on their daily life due to the monitor, while another mentioned inconvenience when wanting to go swimming. This indicates that for some users, the device may have a minimal impact on their routines, while for others, it may pose challenges in specific situations like swimming.

Course-Related Constraints

It's important to note that the participants had to adhere to certain constraints related to data collection for their course, such as fasting or eating at specific times. These constraints could have influenced their discomfort and overall experience. It's essential to consider these external factors when interpreting their feedback.

In conclusion, the survey results suggest that while the monitoring device was generally well-received for its ease of use and provision of valuable information, some users experienced discomfort and minor inconveniences, which may be related to the device itself or external constraints. Addressing these discomfort issues, particularly during physical activities, and finding solutions to minimize inconveniences in specific situations like swimming could improve the overall user experience.

Below we share the interview outline and preparation for our participant. The interview questions are based on the main goals and questions of the patients' survey, including instructions for the interviewer. We hope that this transparently shown information and workflow can help and inspire future iGEM teams on how they can conduct interviews and how they can organize their questions based on the other resources that they already have, like surveys. In the further section, we discuss the results of our interview.

Interview outline and directions

Introduction and Welcome:

• Greet the patient warmly and explain the purpose of the interview.
• Thank the patient for participating and ensure their comfort throughout the process.

Section 1: Awareness of Biofilm Infections: Main Open Questions:

• Are you familiar with the concept of biofilm infections related to medical implants?
  • Follow-up Questions:
  • Please share any information or knowledge you have about biofilm infections.
• Have you received any information from your healthcare provider about the risk of biofilm infections related to your implant?
• Are you aware of the different treatment options available for biofilm infections related to medical implants?
  • Follow-up Questions:
  • Can you describe any specific treatments you are aware of?
• How confident are you in your knowledge of how biofilm infections are treated?
• Have you ever experienced a biofilm infection related to your medical implant?
  • Follow-up Questions:
  • If yes, please describe the circumstances and symptoms of the infection.
  • How was it diagnosed, and what treatment did you receive?

Section 2: Impact of Biofilm Infections: Main Open Questions:

• How do you think a biofilm infection could affect your overall health and quality of life?
  • Follow-up Questions:
  • Could you expand on your answer to the previous question and elaborate on your choice?
• How confident are you in managing potential biofilm infections with your current medical implant?

Section 3: Bacterial Biosensor for Biofilm Tracking: Main Open Questions:

• Are you familiar with bacterial biosensors and their potential application in tracking biofilms?
  • Follow-up Questions:
  • Please share any knowledge or thoughts you have about bacterial biosensors.
• How open are you to using a bacterial biosensor to monitor biofilm formation on your medical implant?
• What concerns, if any, do you have about using a bacterial biosensor for this purpose?
  • Follow-up Questions:
  • Can you elaborate on any specific concerns you may have?
• Would you prefer alternative methods to monitor biofilm formation over using a bacterial biosensor?
  • Follow-up Questions:
  • If yes, what alternative methods would you consider?

Section 4: Sharing Experiences and Patient Support: Main Open Questions:

• Do you believe sharing your experiences with biofilm infections could help improve healthcare for other patients?
  • Follow-up Questions:
  • In what ways do you think sharing your experiences can contribute to improvements?
• How important do you think it is for patients to communicate their experiences to healthcare providers and researchers?
• Based on your experiences, what types of support or resources do you believe would benefit patients dealing with biofilm infections?
  • Follow-up Questions:
  • Can you provide specific examples of support or resources that you think would be valuable?

Document the patient's insights on the potential impact of sharing experiences and their suggestions for enhancing patient support.

Closing:

• Thank the patient for their valuable input and participation.
• Ensure the patient has an opportunity to ask questions or provide additional information.
• Confirm the patient's consent for using their input in research.

End of Interview.

We embarked on the task of survey development, drawing inspiration and valuable insights from the experiences shared by iGEM Team Groningen 2022. While we retained and integrated many of their recommendations, we also expanded upon their guidance, adapting it to our unique project needs. In addition to implementing their advice, our team introduced several new elements to enhance the survey design. Below we explore these key points and discuss the evolution of our survey development process.Points from iGEM Team Groningen 2022.

1. Ethical Considerations, Informed Consent, Data Collection

iGEM Team Groningen 2022 emphasized the importance of obtaining informed consent, and we followed suit by adapting it to our survey. We maintained a strong commitment to ethical considerations, ensuring our informed consent process complied with EU legislation. This foundation of ethical conduct remained pivotal in our survey development. We have made sure to use the correct documentation, transparently inform our participants, and ensure that the rules of the institution through which we are distributing the survey are in line with our process and execution.

2. Research Goal and Hypothesis

Defining the research goal and hypothesis was essential to the 2022 team, and we embraced this principle wholeheartedly, aligning our survey's objectives accordingly. We have also designed our survey questions with a specific focus and relevance and hence made three different surveys to focus on different questions that arose during our design and human practices integration process. For each survey, we have started with general lists of questions that are relevant to our target demographic, and we have reviewed them within the team and with experts, as mentioned on the [Human Practices] and [Collaborations] pages.

3. Target Group

Recognizing the need for a concise and comprehensible survey, iGEM Team Groningen 2022 identified the general public as their target group. Our team shared this perspective and targeted the general public, acknowledging the diversity of potential participants. In addition, we had two more narrow focus groups that were case-specific: the students and the patients, for we created separate surveys. Ensuring accessibility to a broad demographic remained a core principle for data representativeness. We have also ensured that the patient survey is also available in Dutch, to make the experience more comfortable and inviting for Dutch native speakers.

4. Delivery

The 2022 team's choice of exclusively online survey distribution minimized bias, and we adopted a similar approach, utilizing various online and offline channels to reach a diverse audience. We mirrored this approach, leveraging online survey platforms, social media, flyers, and other channels to broaden our reach. In addition, we have created a poster for the patients' survey, as we did not have direct access to contact with patients. We would have had to rely on a more passive method, so we chose to design an eye-catching and inviting poster containing essential information about the survey and a QR code to the survey. We made the posters in both English and Dutch, to ensure accessibility for most of the demographics. Our adaptability in delivery methods maintained a focus on inclusivity.

5. Questions

Designing clear, unambiguous questions was a fundamental aspect of survey development for the 2022 team. We continued this practice and included additional survey design considerations. For example, we made sure that the survey questions were organized in separate sections that share a common theme. In addition, each section included a short description describing what the questions were about and why the participants' input is important. The purpose of this feature is to guide the participant through the survey and ensure a more comprehensive and less intense experience when faced with a large amount of questions. We also made sure to include a variety of questions and answer formats. It is important for a specific type of question to have an appropriate answer format: multiple choice, check boxes, scales, long and short paragraph answers. For us it ensures easier data collection and allows us to indirectly clarify what kind of information is required form the participant. On the other hand, the participant also finds it easier to comprehend questions and also keep the interest and attention fixed on the survey, if the questions are engaging and the question style is not identical throughout the whole survey.

6. Peer Review and Focus Group

The 2022 team recognized the importance of rigorous review processes, involving peer reviews and focus groups. We, too, conducted peer reviews to refine grammar, structure, and clarity. A focus group provided valuable insights into participants' interpretations of questions, ensuring their accuracy and preventing misinterpretations.

New Additions and Expansions by iGEM Team Groningen 2023

7. Enhancing Comprehensibility

Our team took additional steps to enhance survey comprehensibility. We incorporated eye-catching visuals, clear section divisions, comprehensive introductions for each section, progress bars, and estimated time consumption. These elements aimed to encourage participants to complete the survey in its entirety. In addition, we paid attention to the design of the survey itself, recognizing how the aesthetic features of such documents affect the responses and outreach of the survey. For example, we used relevant images for survey and section heathers to engage the participants and create an inspiring and thoughtful atmosphere. We also included a progress bar to inform the participants about the length and extent of the survey, which could motivate the participants to fully complete it. We also used more extensive features of Google Forms to make the progress through the survey easier: depending on the answers to certain questions, the participants would be directed to the next relevant sections, instead of having to go through all of them. In addition, we clarified the informed consent form shown in the first section of the survey, by organizing the information under question subtitles. Here we put ourselves in the shoes of the survey participants, wondering what the main questions one would ask before participating in the survey. This is another feature that makes the information more comprehensive and the experience more enjoyable for the participants.

8. Organic Approach

Seeking more personalized end-user insights, we designed posters with survey links in both English and Dutch. Our initial plan was to display these posters in medical facilities, collaborating with stakeholders to support our approach. We put thought and effort into the visual design, recognising the importance it has in reaching the target group.

9. Challenges and Alternative Distribution

Our team faced challenges with putting up the patient surveys in hospitals, experiencing delays in the ethical review process. This highlighted the importance of initiating ethical review processes early to avoid project timeline setbacks. To overcome setbacks with hospitals, we adapted by placing posters in physiotherapy practitioner offices, university bulletin boards, and city bulletin boards, and sharing survey links online. This flexibility demonstrated our resourcefulness in survey dissemination, ensuring the continued collection of data effectively.

These new elements introduced by our team, such as enhanced comprehensibility, an organic approach to engagement, and flexibility in distribution methods, add depth and adaptability to our survey development process. While we built upon the foundation laid by the 2022 team, these additions were crucial in making our survey more effective, inclusive, and resilient in the face of challenges. Through this collaborative effort, we aimed to contribute to the evolving landscape of responsible survey design within the scientific community.

Informed participation consent

Who is researching?

This research is carried out by a team of students from the University of Groningen and Hanzehogeschool Groningen, as part of the international Genetically Engineered Machine (iGEM) competition. We are a multidisciplinary team of 14 graduate and undergraduate students from various backgrounds, such as Biomolecular Sciences, Biomedical Sciences, Chemistry, Chemical Engineering, Computer Sciences, Physics, Graphics, and Product Design, motivated to use all of our expertise to tackle a world problem. iGEM is set up to give students the opportunity to work on an interdisciplinary synthetic biology project. Synthetic biology involves the design and construction of novel artificial biological pathways, organisms, and devices or the redesign of existing natural biological systems.

What is the project about and what are biofilms?

This year our team has set out to tackle the increasingly alarming issue of biofilm infection related to medically implanted devices, such as prosthetic joints and implantable devices. These infections are difficult to detect and treat through conventional methods such as antibiotic treatments. Biofilm infections on medical implants and devices are a global concern given the difficulty of their detection and treatment, as well as the increasing number of orthopedic surgeries. Biofilm infections are one of the major causes of failure of orthopedic surgeries and causes of post-operational complications. Biofilm infections not only pose a threat to medical complications, but also may increase medical costs to the hospitals, insurance companies, and the patient, and also cause mental stress to the patient who is fearing having these infections.

We propose a synthetic biology-based solution to this challenge, which involves developing a tunable, modular, contained, bacterial biosensor to detect the infection in its early stages. In addition, we intend to develop our biosensor to provide phage treatment to help disrupt the further formation of the biofilm. Finally, we will attempt to develop an electronic device with a user-friendly interface that senses and reports the presence of the infection. Our goal is to develop a user-friendly, biology-based alternative solution to biofilm sensing and treatment that would relieve both patients and medical professionals from the stresses of biofilm-caused complications.

The purpose of this survey

A big part of our project is evaluating how our work may affect society. Our project aims to develop a tool that, in the future, may help people with medical implants, especially the ones who have already experienced biofilm infections. Hence, it is important for us to understand this problem from the perspective of people with medical implants and include their opinions in our design process. We have created this survey with the purpose of reaching our end-users, which are people with medical implants, including people who have experienced implant-related infections. This survey will be used for the integrated human practices part of our project. Based on the answers to the survey, we will be able to conclude how the end-user perceives the problem that we are trying to solve. We also aim to improve our design with the input from this survey. Finally, we hope to find participants who would be willing to contact us for interviews.

Information about participation

Participation in this survey is completely voluntary and you can withdraw at any time without giving a reason by emailing igemteam@rug.nl. The survey is anonymous unless the participant decides they want to contact us for further conversation. Personally identifiable data will never be published. Raw data will be secured on a password-protected server with multi-factor authentication available only to the team and its supervisors. Non-personally identifiable data resulting from the survey will be summarized in figures and published on the webpage of iGEM Groningen 2023. After publication of non-personally identifiable data (no later than October 1st, 2023) it is no longer possible to remove and/or change data points of specific participants. Raw data resulting from the survey will be deleted from our internal servers on January 1, 2024.

To participate in the survey, you must be 18 years of age or older and reside in a member state of the European Union. For questions regarding the above, or to retrospectively withdraw from the survey, please email igemteam@rug.nl. For further questions or comments about the handling of your personal data, you may also address the Data Protection Officer of the University of Groningen (privacy@rug.nl).

It takes about 15 minutes to complete this survey. It consists of 7 mandatory and 1 optional section, containing around 35 questions. There are both required and non-required questions in this survey. There is no right or wrong answer. Please fill in the first thing that comes to mind once you have understood the question correctly. If you have any questions you can contact us via igemteam@rug.nl.

By answering 'YES', you confirm that you have read and understand the information above and agree to participate in this survey.

• Yes / No

Participant Information

Understanding the diverse educational, age, and gender backgrounds of participants is key to capturing a comprehensive range of perspectives. Your answers in this section will help us contextualize the survey responses and analyze patterns across different groups.

• Education:
  • Primary education
  • Secondary education
  • Post-secondary education
  • University
  • Not applicable
• Age:
  • 18-80
• Gender:
  • Male
  • Female
  • Other

Implant Information

Your medical implant experience is a vital aspect of this survey. In this section, we'll gather some fundamental details about the type of implant you have, its duration, and whether you've faced any complications or infections. An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure.

1. What type of medical implant do you currently have?
2. How long have you had the medical implant?
3. Have you experienced any complications or infections related to the implant?
4. Have you experienced any complications or infections related to the implant?
5. If you are comfortable sharing, what implant-related complications have you experienced?
6. Taking into account your experiences, how satisfied are you with your medical implant overall?
7. What factors contribute to your level of satisfaction or dissatisfaction?

Awareness of Biofilm Infections

Your familiarity with biofilm infections related to medical implants is significant. By assessing your awareness, we gain insights into the level of information provided by healthcare providers and the general public's understanding of this issue. Understanding your awareness of different treatment options for biofilm infections aids us in evaluating the dissemination of information and identifying potential gaps in knowledge.

1. Are you familiar with the concept of biofilm infections related to medical implants?
2. Have you received any information from your healthcare provider about the risk of biofilm infections related to your implant?
3. Are you aware of the different treatment options available for biofilm infections related to medical implants?
4. How confident are you in your knowledge of how biofilm infections are treated?
5. Have you ever experienced a biofilm infection related to your medical implant?
6. If yes, please describe the circumstances and symptoms of the infection.

Your Experience with Infections

We're interested in the duration and frequency of biofilm infections you've experienced. Your responses provide insights into the variability and persistence of these infections. Complications arising from biofilm infections can have a significant impact on health. Sharing your experiences in this section helps us understand the broader implications of these infections on individuals. Your thoughts on managing biofilm infections are highly valued. Feel free to share your satisfaction with existing treatments and your ideas for improving how we address these challenges.

1. How long did the biofilm infection last before it was successfully treated?
2. If you've had more than one infection, how many times have you experienced a biofilm infection?
3. Did you encounter any complications or adverse effects due to the biofilm infection(s)?
4. If yes, please specify the nature of the complications and their impact on your health.
5. How satisfied are you with the treatment and management of your biofilm infection(s)?
6. What improvements, if any, do you suggest for managing such infections?

Impact of Biofilm Infections

In this section, we explore the potential ways biofilm infections might influence your overall well-being and quality of life. We're curious about your confidence in handling these situations with your current medical implant.

1. How do you think a biofilm infection could affect your overall health and quality of life?
2. Could you expand on your answer to the previous question and elaborate your choice?
3. How confident are you in managing potential biofilm infections with your current medical implant?

Bacterial Biosensor for Biofilm Tracking

Have you come across the fascinating world of bacterial biosensors for tracking biofilm formation? We're keen to hear about your familiarity with them, your openness to incorporating such technology, and any concerns you might have.

1. Are you familiar with bacterial biosensors and their potential application in tracking biofilms?
2. How open are you to using a bacterial biosensor to monitor biofilm formation on your medical implant?
3. What concerns, if any, do you have about using a bacterial biosensor for this purpose?
4. Would you prefer alternative methods to monitor biofilm formation over using a bacterial biosensor?
5. If yes, what alternative methods would you consider?

Interest in Being Contacted for an Interview

If you're up for a deeper conversation, we'd love to hear from you. Let us know if you're open to participating in an interview to further explore your experiences. If you're willing, kindly provide your preferred contact information for follow-up.

1. Would you be willing to participate in an interview or conversation to discuss your experiences further?
2. If yes, please provide your preferred contact information (email or phone number) for follow-up.
3. If you agree to be contacted for an interview, what interview format would you prefer? (e.g., in-person, phone, video call)

Sharing Experiences and Patient Support

Your insights hold the potential to make a difference. Reflect on how sharing your biofilm infection experiences might contribute to better healthcare for all. We're also interested in your perspective on the importance of patient-provider communication. Your unique experiences shed light on ways to enhance patient support. Take a moment to consider what kinds of resources or assistance could be more beneficial for individuals facing biofilm infections. Your suggestions can truly shape positive change.

1. Do you believe sharing your experiences with biofilm infections could help improve healthcare for other patients?
2. How important do you think it is for patients to communicate their experiences to healthcare providers and researchers?
3. Based on your experiences, what types of support or resources do you believe would benefit patients dealing with biofilm infections?

Figure 12: Poster explaining the project and description of the purpose of the survey for collecting patients' experiences with biofilm infections on medical implants.