The IDDI System: Sociotechnical Plan

 

Coughs and Sneezes Spread Diseases. This catchy slogan, which according to Dhand and Li (2020) finds its origins in the 1918 flu pandemic, emphasizes the most common route of dissemination for respiratory pathogens. For example, Xie, Li, and Liu (2009) noted that a single sneeze has the power to expel as many as forty thousand droplets at speeds up to one hundred meters per second. Once expelled, Stadnytskyi et al. (2020) explained that these droplets initially remain airborne and will then, via Stokes’ law, fall downward and land on nearby surfaces. The following discussion introduces the Infectious Droplet Detection and Identification (IDDI) system that is designed to locate and classify contagious-particle-containing droplets circulating within the air and attached to various environmental surfaces. The unique features of the IDDI system are highlighted, clarifying current limitations, and after motivating its purpose, both the supportive and challenging forces surrounding its use will be articulated. The underlying methods, analytical plan, and anticipated results are also reviewed in addition to suggestions for future work. Concluding remarks summarize the main points of discussion and strengthen the overall mantra of the proposed system: Germs ain’t pretty; get your IDDI!

Scope

The IDDI system is composed of two complementary elements that are designed to be used in succession. The first IDDI component is a set of detection glasses that darken the user’s view and show contagious droplets as fluorescently lit material. For example, an uncontaminated doorknob will appear dark but a doorknob that has traces of contagious droplets will take on a fluorescent glow. Similarly, a non-infectious person who is sneezing, coughing, talking, or laughing will look like they are surrounded by darkened air. A contagious person, however, will look like they are ejecting fluorescently dyed particles.

The second IDDI component is a two-in-one identification device that is equipped with a scanner and breath-tester mechanism. After detecting the presence of a contagious droplet, the device can be used to either scan the contaminated surface or allow the affected individual to blow into its mouthpiece. The device then identifies the infectious particles, displaying the results on its touchscreen face, so that the exact form of the contagion is known. For example, the device might reveal that the droplets contain traces of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus known to cause coronavirus disease 2019 (COVID-19). It is important to clarify that for this identification to occur, the device must be connected to the internet. All droplet scans and collections are cross-referenced against a continuously updated repository of already classified contagions. As such, a newly detected contagion, e.g., a new viral strain, would not be immediately identified by the IDDI device. All previously unidentified contagions are passed along for further research so that a prompt identification can ensue and be available for subsequent scans/collections.

It is also necessary to explicitly state the fact that the IDDI device can only detect and identify contagious respiratory droplets. This means that it cannot be successfully applied for the detection and identification of other contagious diseases such as those that spread via blood-borne, fungal, or parasitic pathogens. While the IDDI display screen offers suggestions for effective cleaning solutions to target the classified droplet, the cleaning services themselves are not provided. All steps necessary to disinfect or eradicate the source of the contagion are solely the user’s responsibility.

Purpose

The IDDI system removes the elements of the unknown by solving the mystery of how contagions are spread. According to respiratory droplets can be carriers of a plethora of contagious pathogens such as the influenza virus, measles, and Mycobacterium tuberculosis. Xie et al. (2009) explained that such droplets are expelled into the environment when an infected individual sneezes, coughs, talks, laughs, breathes, or performs any other type of common expiratory activity. Post expulsion, Hammett (2020) continued to detail the potential pathways of the contagion and how the infectious pathogen can be transmitted. First, airborne particles can be inhaled by individuals within the range of the emission’s trajectory. Second, after the droplets land, a person can touch the contaminated surface and then internally transfer the contagion by touching their mouth, nose, or eyes. Zayas et al. (2012) summarized the respiratory transmission process by encapsulating it into a set of three necessary elements: (a) the infected transmissor, (b) the encompassing environment, and (c) the currently non-infected recipient. As shown in Figure 1, these elements form a cyclical pattern that iteratively continues when the originally non-infected recipient later becomes the infected transmissor.

Figure 1. The Cycle of Respiratory Pathogen Transmission

An understanding of the three-pronged transmission pathway directly translates to the realization that controlling any one of the involved components will isolate the contagion from spreading. Unfortunately, however, this is not a straightforward task and to illustrate why this is so difficult, first consider the infected transmissor. If the contagious individual is feeling physical ailments and/or outwardly displaying signs of an illness (e.g., coughing), both the transmissor and potential recipients are given a tangible warning so that appropriate precautions can be taken.

Although safeguarding measures such as self-quarantine and disinfection processes can help, there are too many unknowns for the process to be foolproof. For example, Dhand and Li (2020) explained that droplet sizes are highly dependent upon their site of origin, as those produced in the oral cavity tend to be larger than those originating in the larynx and bronchioles. This is important because the size of the droplet dictates how quickly it will take for gravity to pull it down for surface landings. The specific expiratory action, as well as the force of the action, also needs to be considered because it influences the distance that the droplets can travel. Furthermore, Rabi et al. (2020) highlighted the role of surfaces, noting that the survivability of the infectious particles can vary significantly due to their type and structural composition. Given the myriad of involved variables, there is no existing universal model to describe how far the infectious droplets might spread, where they might land, and once landed, how long they might remain contagious.

While the previously described example demonstrates the intricacies of droplet spread in instances where there is awareness of the possible contagion, the complexity of this framework has the potential to greatly increase. For example, Asadi et al. (2020) emphasized that transmissors can produce contagious droplets while pre-symptomatic or asymptomatic. According to Kahler and Hain (2020), approximately 44% of SARS-CoV-2 infections have been traced to individuals who were not actively experiencing symptoms at the time the transmission occurred. Without being alarmed to take precaution, transmissors are more likely to pass their infectious droplets along to a larger set of potential recipients.

Although any rate of pathogen transmission can be problematic, Bedford et al. (2020) emphasized that when the levels of spread become significant and severe, a pandemic situation can arise. As such, the purpose of the IDDI system is to help contain the transmission of contagious respiratory illnesses and either prevent or drastically help temper the effects of a pandemic. The IDDI system achieves this goal by empowering both the potential recipient and potential transmissor to take control of their environment. By having knowledge of the exact location and specific type of infectious particles within their immediate surroundings, an individual can use this information to directly protect their own health as well as the health of those with whom they cross paths or share common surfaces.

The following examples breathe life to the purpose of the IDDI by representing various voices within the community. These testimonial-like narratives demonstrate an existing set of distinct needs and how the IDDI system can help.

Prospective Users' Needs (**Completely Fabricated**)

·       Prospective User 1: "My husband was just diagnosed with COVID-19. I have three small children and am doing my best to keep the germs in isolation by sanitizing and disinfecting. I would love to use the IDDI detection glasses to show exactly what surfaces I need to clean throughout the house. I would also love for it to show how long he is actively contagious because he really wants to see hug his family."

·       Prospective User 2: "I am currently immunocompromised because I am undergoing chemotherapy treatments. I would love to receive visits from friends and family but am concerned about catching germs that they may unknowingly carry. The IDDI system would allow me to screen all potential visitors so that I know whether I am putting myself at risk."

·       Prospective User 3: "My mental health has suffered from COVID-19 anxiety, and I am extremely nervous to leave my house. I think the IDDI system would help me overcome some of my fears because I would feel better about entering a church, grocery store, restaurant, or other public place if I could first scan the surroundings. I could also use the handheld device to tell me what kind of pathogen is present. For example, I might feel comfortable taking the risk of exposure to the common cold, as that is quite different than COVID-19."

·       Prospective User 4: "I am a small business owner and would love to use the IDDI system to show my potential customers that the inside of my establishment is free of respiratory contagions."

·       Prospective User 5: "I am an essential worker (e.g., healthcare worker, teacher, grocery store employee) and am while I am comfortable putting my own wellbeing at risk, I do not feel like I can pass along this risk to others. I would like to use the IDDI device to monitor my levels of contagion to be sure I am not serving as an active transmissor."

·       Prospective User 6: "I was exposed to COVID-19 and am not allowed to return to work until I have quarantined for 14 days. I am not able to bring in any income during this time and am worried about my bills. The IDDI device would help me to constantly monitor my condition and show my employer whether I am contagious. I would be able to come to work if I had proof that I was negative."

Supporting Forces

The IDDI system represents a fusion of different technological innovations. The detection glasses incorporate a microscopic nanoscope that, according to Wang et al. (2011), relies on the fact that all infectious particles emit tiny evanescent waves. As such, the glasses use built-in microsphere glass beads to first collect the evanescent waves and then refocus them so that they can be directed for viewing in the lens of the glasses. Furthermore, refinements were made to the laser technology that Stadnytskyi et al. (2020) originally used to illuminate droplet bursts expelled from various modes of animated speech. As the waves are being refocused to the lens, they are hit with a fluorescent laser contained within the glasses frame. The microscopic nanoscope and tinting laser combination is the backbone of the detection glasses. The handheld scanner and mouthpiece device is also a product of blended innovation as it enables immediate identification and is not bound to the confines of a lab. Results are displayed in seconds and, perhaps even more importantly, provide a more accurate result than those obtained from the standard approaches that utilize polymerase chain reaction (PCR) or immunoassay testing techniques (Tahamtan & Ardebili, 2020). In short, novel technological advancements act as a fundamental beam of support for the IDDI system.

Economic factors also provide a means of support. Asadi et al. (2020) stressed the economic toll that the COVID-19 pandemic unleashed upon the world. Financial markets crashed due to the pandemic’s debilitating effects on travel and tourism, the restaurant and entertainment industries, and educational services, just to name a few. Barro, Ursua, and Weng (2020) noted that such negative outcomes are not new, citing a barrage of similar damages following the 1918-1920 Great Influenza. Stopping and/or curbing the effects of a pandemic will therefore prove economically fruitful. Additionally, the immediate and accurate pathogen identifications will also allow for funding efforts to be directed away from testing kits and put back into packages for economic relief and/or manufacturing of personal protective equipment. Finally, any lowered rate of disease transmission will translate into a lower likelihood of needed medical attention, hospitalizations, and time spent away from the workforce (Ambrosy et al., 2014).

Challenging Forces

Privacy violations are one of the formidable forces that need to be considered. According to Abouelmehdi et al. (2017), various policies around the world currently exist to protect the privacy of an individual’s health data. The Health Insurance Accountability Act (HIPAA) in the United States is one such example. Using the IDDI detection glasses to visibly see that a person is actively shedding a contagious respiratory pathogen is a clear infringement of their right to privacy. Furthermore, an IDDI system user not only possesses the ability to notice that someone is contagious, but they can also identify the exact type of the individual’s contagion. This identification can ensue without the transmissor even being aware, as it is possible that the user could scan some of the emitted droplets that landed on a nearby surface.

Ethical issues are also at play. Will a contagious individual be stigmatized? Will they be denied entry into a private establishment? It is unclear what kind of negative ramifications might ensue once people start to be labeled. Additionally, the cost of the IDDI affects the span of its user pool. Because only those able to afford the system will be able to apply it for taking personal precautions, a natural rift begins to occur. During any type of arising pandemic situation, Loayza (2020) explained that when compared to high-income countries, those of low- and middle-class must overcome a disproportional number of challenges because they have smaller reserves of resources to cushion the economic effects. It is possible that the IDDI system will increase the magnitude of this divide.

Methods

The Delphi Technique which, according to Goodman (1987), finds its roots in the Rand Corporation’s 1950s processes, will be applied. It will not necessarily be used for designing the scientific details of the IDDI system, but rather to help guide the recommendations surrounding its implementation. Following the guidelines of Green (2014), a panel of approximately 5-20 experts will be gathered. These experts will be pulled from a medley of domains so that the voices of various industries (e.g., educators, physicians, restaurateurs) can be represented. The anonymity of each contribution will be preserved by using un-named questionnaires, and exhaustive comprehension will be achieved through iterative rounds of data collection.

Model

The eight-dimensional sociotechnical model of Sittig and Singh (2010) will be used to guide decision-making with respect to designing, developing, implementing, and evaluating the IDDI system. Specifically created to overcome the challenges inherent to the health information domain, the model emphasizes a tightly coupled system of dependent and related modules not meant to proceed in any hierarchical nor sequential fashion. As such, it offers an intricate approach for rapidly paced and multifaceted health-centric applications. Table 1 explains each of the distinct components and Figure 2 presents a visual representation of their connectivity.

Table 1. Eight Components of the IDDI Support Model, Adapted from Sittig and Singh (2010)

One of the most important aspects of this eight-pronged implementation model is its interwoven nature. This means that any one component should not be isolated for independent study, but rather, recognizing its dynamic interaction with the other parts, be dependently considered as part of the larger ecosystem. For example, addressing HIPPA concerns would require that the computing infrastructure, delivered content, team of developers, and workflow processes are all in alignment to support the objective. As such, the full picture must always serve as the overall guide so that the effects of any changes made to one of the components can be traced through to the others.

Figure 2. Visual Representation of the Interaction of Components for IDDI Implementation

Analytical Plan

The analytical plan will be rolled out in waves to reflect the tiers of IDDI system development, refinement, and implementation. The first two to three years will concentrate on small focus groups to settle on the details of the overall design, process flow, and included features. The focus groups will be interactive so that the participants can wear the glasses, operate the identification scanner, and blow into the mouthpiece of the device. Questionnaires will be administered to collect constructive feedback about potential tweaks. The IDDI system will be updated as needed to maximize user satisfaction.

The second stage of implementation will focus on the IDDI system’s ability to contain the spread of contagious droplets. Following the approaches of Cowling et al. (2009) and Simmerman et al. (2011), a cluster randomized, controlled trial will be conducted. In this design, certain clinics will be identified throughout five major cities (Philadelphia, Boston, San Diego, New Orleans, and Austin) in the United States. Patients with a confirmed case of either the influenza virus or the COVID-19 virus will be eligible for participation. After granting consent, the positively tested participant as well as all their household contacts will be randomized in a 1:1:1 ratio to one of three study arms: (a) control group; (b) hygiene and facemask group; or (c) IDDI system group. As described in Table 2, the study arms will be cumulatively designed. Home visits will then be conducted by study nurses within 24 hours of enrollment, and again on days 3, 7, 10, and 14. These visits will be used to collect a variety of datapoints from all participants such as signs and symptoms, nasal/throat swab specimen collections, and swab-based evaluation of high-touch surfaces throughout the house. Additionally, participants will also be asked to keep a daily journal to record both their physical and mental symptoms and any arising issues with the IDDI system devices.

The third IDDI implementation phase will involve an assessment of real-world practicality and perceived usefulness. Participants across the United States will be recruited and randomized into a perspective study of two arms: (a) control and (b) IDDI system. Those in both arms will receive educational training about the transmission of contagious droplets, but those in the IDDI arm will also receive the IDDI system device. Participants will be followed for approximately three months and asked to complete weekly questionnaires about their physical health as well as mental anxieties about potential contagion exposures. Those in the IDDI group will also be asked to respond to questions about the functionality of using each of the devices. Ideally, this study will be conducted during the peak cold and flu season.

Table 2. Intervention Arms of the Cluster-Randomized Trial

Anticipated Results

The results of the cluster randomized trial are expected to reveal significant differences with respect to the three intervention arms. First, like the trends depicted in Figure 3, the percent of infected household contacts will be lowered as the intensity of the intervention increases. Households randomized to the IDDI system arm will show the smallest number of additional household contacts becoming infected. The data will be statistically evaluated with 95% confidence intervals (CIs) generated via a cluster bootstrap with a resampling factor of one thousand and a multivariate logistic regression to control for any within-household effects (Cowling et al., 2009; Simmerman et al., 2011). It is anticipated that the differences will be statistically significant.

 Figure 3. Expected Results of Transmission Spread

It is also anticipated that the results of the cluster randomized trial will reveal significant differences with respect to the number of contaminated surfaces within each household. The households associated with the IDDI system will show none or very few traces of contagion, the control group of households will show a high number of contaminated surfaces, and the hygiene and facemask group will fall somewhere between these two extremes. High levels of IDDI user satisfaction are also expected, as well as lowered results of anxiety associated with spreading germs and becoming sick.

The results of the second study are expected to align with these findings. Namely, it is anticipated that participants randomized to the IDDI system arm will report less instances of contracting illnesses that are spread via respiratory droplets, higher levels of comfort with attending public events and entering brick and mortar establishments, and higher levels of feeling empowered about their health status. Any reported problems with the use and/or operation of the IDDI system will guide discussions for potential design updates or decisions about how it should be integrated into everyday life.

The results of both randomized trials will be used to lay the foundation for rolling the IDDI system out on a much grander scale. The demonstrated efficacy will be essential to IDDI acceptance, and the momentum will be strengthened as more and more people begin to use it and experience its benefits. Ideally, with a widespread IDDI system saturation, any future pandemics fueled by respiratory droplet transmissions will be prevented altogether. At a minimum, however, the effects of a future pandemic should be curbed. For example, mandatory statewide lockdowns are not likely to be needed, hospitalizations should decrease, and the economy will not experience such drastic financial burdens.

Conclusion

The main objective of the IDDI system is to contain the spread of respiratory contagions. At a societal level, it will bring economic benefits by preventing business closures, lowering hospitalizations, and reducing the number of workplace absences. At an individual level, it will primarily bring empowerment. Every IDDI system user will be equipped with a tool for taking control of their own well-being. Armed with a device for detecting and identifying pathogens, all IDDI users will be able to solve the mystery of how respiratory contagions are spread. The IDDI system removes the element of the unknown and puts power back into the hands of the people.

Transforming the IDDI system from an innovative idea into a mature device with demonstrated efficacy only represents the first step of the process. The next step, which involves diffusing it into society, is necessary for the objectives of the IDDI system to be fully realized. Such an integration will be guided by the ideas of Owen, Macnaghten, and Stilgoe (2012) and the concept of responsible research and innovation (RRI). As Macnaghten et al. (2014) so eloquently discussed, RRI is a framework that provides interpretive flexibility against a backdrop that is culturally framed and politically entangled. Given the intricate details of the IDDI system in the way of its supporting and challenging forces as well as the interactively dependent nature of the components surrounding its implementation, the RRI approach is fitting.

According to Owen et al. (2012), the RRI framework consists of three essential ingredients. First, there is the need to democratize the innovation and emphasize its well intentions and “for good” orientation. Responsiveness is second, and the purpose of this component is to stress the importance of diffusing the innovation alongside already existing mechanisms for anticipating, reflecting, and deliberating the potential directions of influence and needed policies. The third dimension involves molding the responsibilities for handling the unforeseen consequences that might ensure. Working together, these three components will help take the IDDI system from a device simply present within a society to a device that is perceived as for the society and part of the society.

The full success of the IDDI system is also dependent upon the collaboration of multiple parties and their continued diligence to upholding the IDDI objectives. Scientists must continually work on classifying new viral strains so that the IDDI can keep up with the identification of additional developments and mutations. The technology team must continue to support the workflow processes and make updates for things such as security fixes and feature improvements. The pools of users must also work together to do their part in containing the spread of droplet transmissions. The future of pandemics will not change with just one user, but it might when everyone comes together to do their part.

Areas of Future Research

The first extension to the IDDI system focuses on overcoming its current limitations. In addition to detecting and identifying contagious droplets, the IDDI could also incorporate a similar mechanism for handling other pathogens such as those that spread via aerosols or in a blood-borne manner. Keeping with this line of thought, it is also possible that the IDDI system could be engineered to detect active viruses that can be transmitted from animals and insects. Known as vector-borne diseases, this includes malaria, dengue hemorrhagic fever, and the Zika virus (Denes et al., 2019; Gratz, 1999). Furthermore, if the IDDI is eventually extended to illuminate internal activities (e.g., active Zika within the body of a mosquito), it is not too far-fetched to envision a future where an IDDI-like device could detect the start of cancerous cell activity, a forming blood clot, or any other kind of otherwise hidden danger. Other unknown and invisible threats could also be targeted, such as black mold spores and carbon monoxide gas.

The IDDI system could also be extended to incorporate a mechanism for disinfecting and cleaning so that the contagion could be eliminated on the spot. A zapper-type laser could be built into the handheld device so that any expelled droplets could be immediately eradicated. This would bring more power to the IDDI, by removing the requirement that users do the cleaning on their own.

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