Usability Aspects Reduce Design Complexity and Help Prevent Use-Related Errors in ICU Ventilators⋆

Abstract

The complexity of the user interface design of critical healthcare devices may lead to use-related errors. Involving users as co-creators to design simple user interfaces for critical healthcare systems helps reduce user-related errors and, ultimately, lowers the risk to life. The participation of co-creators is efective in reducing the design and process complexity while developing the experimental prototype, which may help reduce cognitive load. A usability evaluation was conducted to assess the users' perceptions and real experiences with the experimental prototype in actual settings. The participants involved in this study were requested to perform tasks on an experimental prototype and a questionnaire survey was used to gather the participants' feedback. The results reveal that the interface design increases the user perception of usability by minimizing complexities in design because a strong association between design aspects and system simplicity was observed. The findings provide valuable insight both practically and theoretically to improve the reliability and usability of critical healthcare devices.

Keywords

• eol>Critical healthcare devices
• Design complexity
• End User Development
• Participatory design
• Usability
• User interfaces

1. Introduction

Interface design is crucial in developing an efective interaction between systems and users. However, poor information organization and design complexity may lead to use-related errors. Besides errors, design complexity also increases the information processing time [ 1 ]. The cost of the errors may depend on the type of interaction, situation, and context of use. Most of the use-related errors are due to poor interaction and design quality. Coldewey et al. [ 2 ] observed that complex user interface design is a source of errors in critical healthcare devices. They further suggested that standardization in the design of interfaces can help to reduce the complexity and use-related errors. Likewise, Jorien et al. [ 3 ] state that most incidents while using the healthcare devices reported in the literature are use-related errors. It was also appeared that approximately 50 percent of adverse ventilator events were caused by human use errors [ 4 ]. Jiang et al. [ 4 ] argue that poor and complex user interface design of critical healthcare devices is the main cause of use-related errors. The World Health Organization (WHO) highlighted that the interface designs of healthcare devices are often complex, dificult to learn, and inappropriate for the situation in which it is adapted to be used [ 3 ]. Accordingly to IEC 62366-1 [ 3, 2 ] International Standard Organization (ISO) stresses to the manufacturers to ensure the health care devices should be easy and simple to use to minimize use-related errors because reducing the chance of risk increases patient safety. In the Intensive Care Unit (ICU), various healthcare devices (i.e., ventilator system, electrocardiogram

ECG, monitoring systems, and ventilator system) are utilized to observe the patient’s health conditions and statistics. These devices are operated through controls, dialogues, and buttons to facilitate patients in critical situations. It is necessary to pay more attention to cognitive ergonomics/human factors by improving the usability of functional and interaction processes while developing critical healthcare devices [ 5, 6, 3 ].

Appropriate design approaches, well-matured development methodologies, and robust Artificial Intelligence (AI) techniques are paramount in designing and developing healthcare devices to build usable, reliable, and trustworthy technologies [ 7, 8 ]. Therefore, the blend of user-centric design approaches in relation to "Participatory Design (PD) and End-User Development (EUD)", is considered cost-efective and suitable for developing reliable and customizable systems. [ 9, 10 ]. The PD emphasizes the participation and potential contribution of end users as co-creators in the design and development process, ensuring that the intended systems meet users’ requirements and expectations [ 9, 11, 12 ]. Like PD, EUD requires the involved user to support system customization in the design and development process [ 10 ]. The current study aims to employ the relevant design methodologies with modifications to develop usable software systems that meet user requirements and to assess the perceived usability or perception of the user interface developed using the proposed methodology for critical healthcare devices, focusing on ventilators, which are a necessary part of ICUs that provide respiratory support to unstable patients. Their crucial role makes the accuracy of ventilation functions and settings very critical using the adopted methodology (See Figure 1).

In the foundation research, it is important to study the users’ experiences with the ventilators. How these experiences, technological fear, poor interaction, and design quality influence their adaptation. The findings helped define the problem and involve the appropriate procedures and relevant users while developing the prototype. The PD approach was adopted to create the design of the prototype of a ventilator. Because the PD empowered the user to participate actively and welcome their feedback during the design and development phase. Their participation as co-creators was important to reduce unnecessary content and be useful to simplify the functional and interaction process through continuous feedback or design iteration. Later, a tool was developed to assess the perceived usability and to explore the user experiences and perceptions about the experimental prototype in actual settings. The objective usability includes only limited measures (i.e., errors, clicks, and task time) to evaluate ventilators in artificial environments such as usability labs. Numerous studies have been conducted to investigate ways to minimize human errors. [ 4, 13, 14, 5, 15, 16 ]. However, only a few studies have discussed design strategies to minimize design complexity, cognitive load, errors, or other patient risks. The modified assessment (subjective/perceived usability) tool was observed to be more useful in gathering the users’ perceptions in an actual setting, providing more insight into the users’ experiences, and seeking important design strategies to ensure simplicity. Therefore, it is important to explore how PD improves the perception of usability by reducing design complexity, which may help clinicians prevent errors in critical situations.

The paper is structured as follows: Section 2 provides the literature review or background, Section 3 outlines the research methodology and experimental design, and Section 4 presents the results and analysis of the experimental data. Finally, the paper concludes with discussions, limitations, and potential directions for future research.

2. Related Work

Using careful design strategies and development methodologies along with consistent user participation during its development is crucial to building efective interfaces of healthcare devices to ensure reliability and eficiency. Feedback from domain experts and users to organize the features, functionality, and information is mandatory to deal with critical situations. The methodologies that discuss the active participation of users and stakeholders in designing and assessing critical healthcare devices may provide more insight into details about the system services, usage context, and situations in which the system should work eficiently. Because the design strategies that strictly follow guidelines related to the user’s empowerment reluctantly increase the system’s relevancy, innovativeness, and adoption. Human-centered design approaches that involve the user as a co-creator increase eficiency and satisfaction while decreasing the rate of medical errors [ 5 ]. This is because treating a serious and unstable patient with poor functional and performing healthcare devices may be dangerous and harmful to the patient [ 5 ]. Besides the bad performance and inadequate functionality, the poor usability of the ventilator interface design was discussed as the leading cause of human or use-related errors [ 5 ], implying that the precise arrangement of functional features and controls when using interactive screens is paramount to ensure usability and simplicity and to reduce the design complexity. Well-mature tools and designing techniques are important in the development of efective interfaces [ 17]. However, errors occurred due to incomplete and inappropriate interface design that failed to fulfill the users’ needs. Jiang et al. [18] studied the influence of ventilator design on user recognition and overall task eficiency. They argue that choosing the relevant design and ergonomic aspects and studying operator experiences and competency is crucial to avoid errors while operating the ventilators [16]. Moreover, humans cognitive capacity or processing memory is quite limited, so processing the excessive information on the screen also requires extensive cognitive load, which may lead to usability-related errors [ 5 ]. Therefore, a well-designed interface, interaction, and hardware quality significantly and positively influence the user perception of critical healthcare devices [ 15]. Likewise, Liu et al. [14] also identified the efect of information organization on the perceived usability (subjective perception) of the ventilator interface. Due to critical input from physicians, manufacturers should improve the interface design of ventilators to make them error-free and user-friendly [19]. Besides appropriate design strategies and choosing a relevant methodology, it also requires exploring the participation roles (e.g., patients, clinicians, doctors, & medical staf), caregivers, operating environment (e.g., temperature, light, noise, workload, & critical), device types, expectations, process complexity, user demographics, and usage urgency (e.g., convenience, safety, & eficiency) [ 9 ].

3. Research Methodology and Experimental Design

The prime objective of the study was to ensure simplicity in the interface design of critical healthcare devices by minimizing the complexity. It requires the selection of appropriate design and assessment approaches to improve the user experience. An experimental prototype was built for the current study (See Figure 2). The prototype was similar to the HAMILTON - C6 ventilator (smart and intelligent ventilators for ICU) [20] and considered a reliable and eficient ventilator in the technological studies [16, 15]. The interface design of the employed ventilator was altered with a little bit of design variations by involving the users as co-creators or designers. The PD empowers the user/ stakeholders (doctor,

The interface design use appropriate colors, animation, images, and layout.

The system switches from one screen to the next smoothly.

I found the various functions in this system were well integrated.

Is the system consistent? The system uses controls that are immediately obvious.

It was easy to learn to use the system.

I found that the system is simple. (Dependent variable) Mean 4.82 4.81 4.87 4.80 4.91 3.99 4.92

SD 1.765 1.752 1.842 1.893 1.790 2.215 1.721 medical staf, and caregivers) to participate actively so the designers can understand their actual needs during the design process. An experiment was conducted to evaluate the perceived usability of experimental ventilators in the intensive care units of hospitals. Usability is a quality factor that precisely describes the users’ experiences with technologies and software systems with respect to their needs, expectations, values, abilities, and context of use [21, 22]. The experimental prototype was deployed online using web-based services. A 19-inch touchscreen system (16 GM RAM with NVIDIA graphic card) was used for experimentation and data collection, whereas the originally targeted ventilator was 17 inches. Written instructions and guidelines for the chosen task were provided to the participants before the experiment. The tasks include starting ventilation, changing the setting, and changing the model only. In 13 months, 167 people participated in the experimentation with complete feedback. Several reliable system usability assessment tools (e.g., system usability scale) are available in the literature to evaluate perceived usability. The survey tools employed in this study include ten survey items using a Likert-scaled incurring rating from "strongly disagree, disagree, neutral agree, and strongly agree". It specifies the degree to which users perceived the technology as complex, easy to use, cumbersome, consistent, integrated functions, supportive, requires significant learning, and confident or other experiences (see Table 1). The measurement items to gather the user perception for the experimental prototype were adopted from the literature [23, 24, 25, 26, 27, 28, 29, 30]. The used items were modified to achieve the required assessment goals by gathering the participants’ experience and true perception of the developed prototype.

4. Results and Discussion

Linear regression (LR) was used to explore the significance of usability and design aspects that are important to minimize the complexity of interface design. The SPSS software was used to perform the LR. LR is a statistical approach to assess the strength of the relationship or association between independent and dependent variables [31]. It intends to model the relationship between the variables by appropriate fitting a linear equation (linear expression) to the observed (experimental) data [31]. This method is extensively used for forecasting and prediction in technological studies [31]. The computed results revealed that the adopted methodologies show significant outcomes (see Tables 2, 3, 4). The design strategies used to develop the interface design and organize the features improve the user interaction with the developed prototype of the employed ventilator. In continuation, several other studies [16, 15] also emphasized the need to improve the user experiences and initial perception of ventilators by minimizing the design and process complexities. The results also provided suficient grounds for the employed design approaches and development methodologies (PD). It was observed that the developed user interface for the selected ventilator improves user perception by ensuring simplicity in design, process, and information organization. In a study, Lee et al. [ 1 ] also observed simplicity as the principal component of perceived usability, significantly improving users’ initial perceptions and positive experiences with technologies. Simplicity is a crucial component of a highly usable interface. A simple and well-structured interface design to support task performance, layout, hierarchical organization, animations, and visual elements improves the user perception of usability and learning to use. The easy-to-learn and easy-to-use supports the users in task performance and prevents them from input errors. Moreover, safe input values, instantaneous information, and quick settings to control the ventilator provide the ideal usability experience. Likewise, simplicity means a layout that includes a framework having well-structured processes and information, interface organization, proper arrangement functionality and features to ensure smooth workflow [ 1, 32, 33 ].

5. Conclusion

Simplicity reduces complexity as complex user interface design (touch screen and physical e.g., LEDs, knobs, and touch buttons) of critical healthcare devices may lead to use-related errors. Involving users as co-craters to design simple user interfaces for critical healthcare systems helps reduce user-related errors and, ultimately, lowers the risk to life. The participation of co-creators is also efective in reducing the design and process complexity while developing the experimental prototype, which may help reduce cognitive load. Likewise, Katre et al. [19] argue that due to critical input from physicians, manufacturers should improve the interface design of ventilators to make them error-free and user-friendly. A usability evaluation was conducted to assess the users’ perceptions and real experiences with the experimental prototype in actual settings. The test and questionnaire concerning the experimental prototype revealed a strong association between design aspects and the simplicity of the system. This implies that a well-integrated, and organized design presenting only essential information, and supporting the user in performing the relevant tasks and operations is very important to deal with the patient in critical situations to foster the safety and reliability of critical healthcare devices. [11] A. Dearden, H. Rizvi, Participatory design and participatory development: a comparative review, Proceedings of the Tenth Anniversary Conference on Participatory Design 2008 Indiana Un (2008) 81–91. URL: http://www.mendeley.com/catalog/ participatory-design-participatory-development-comparative-review/. [12] R. C. Smith, C. Bossen, A. M. Kanstrup, Participatory design in an era of participation, CoDesign 13 (2017) 65–69. URL: http://dx.doi.org/10.1080/15710882.2017.1310466. doi:10.1080/15710882. 2017.1310466. [13] G. Bhutkar, D. Katre, G. G. Ray, S. Deshmukh, Usability model for medical user interface of ventilator system in intensive care unit, IFIP Advances in Information and Communication Technology 407 (2013) 46–64. doi:10.1007/978-3-642-41145-8_5. [14] Y. Liu, L. Tech, A.-l. Osvalder, Usability Evaluation of a Gui Prototype For a Ventilator Machine,

Journal of Clinical Monitoring and Computing 18 (2004) 365–372. [15] P. P. Morita, P. B. Weinstein, C. J. Flewwelling, C. A. Bañez, T. A. Chiu, M. Iannuzzi, A. H. Patel, A. P. Shier, J. A. Cafazzo, The usability of ventilators: A comparative evaluation of use safety and user experience, Critical Care 20 (2016) 1–9. doi:10.1186/s13054-016-1431-1. [16] S. Jeon, H. K. Kim, D. Lee, J. Kim, E. J. Park, User experience of MV2000-MT (SU:M2) as a Mechanical Ventilator: A Comparative Clinical Study on Usability, Safety, and Medical Staf Satisfaction, Journal of Biomedical Engineering Research 40 (2019) 260–267. URL: http://dx.doi. org/10.9718/JBER.2019.40.6.260. [17] J. R. Ward, P. J. Clarkson, An analysis of medical device-related errors: Prevalence and possible solutions, Journal of Medical Engineering and Technology 28 (2004) 2–21. doi:10.1080/ 0309190031000123747. [18] M. Jiang, S. Liu, Q. Feng, J. Gao, Q. Zhang, Usability study of the user-interface of intensive care ventilators based on user test and eye-tracking signals, Medical Science Monitor 24 (2018) 6617–6629. doi:10.12659/MSM.909933. [19] D. Katre, G. Bhutkar, S. Karmarkar, Usability Heuristics and Qualitative Indicators for the Usability Evaluation of Touch Screen Ventilator Systems, in: IFIP Advances in Information and Communication Technology, Springer Berlin Heidelberg, USA, 2009, pp. 83–97. doi:10.1007/ 978-3-642-36137-1. [20] Hamilton, Hamilton-C6, 2024. URL: https://www.hamilton-medical.com/Products/HAMILTON-C6.

html. [21] C. Faisal, M. Shakeel Faridi, Z. Javed, Usability evaluation of in-housed developed ERP system, in: Proceedings of SPIE - The International Society for Optical Engineering, volume 8285, 2011. doi:10.1117/12.913212. [22] C. M. N. C. Faisal, S. Tariq, T. Ahtram, M. M. S. Abbasi, S. Sarwer, A. Selamat, A Novel Usability Matrix for ERP Systems Using Heuristic Approach, 2012 International Conference on Management of e-Commerce and e-Government (2012) 291–296. URL: http://ieeexplore.ieee.org/lpdocs/epic03/ wrapper.htm?arnumber=6374927. doi:10.1109/ICMeCG.2012.34. [23] J. Brooke, SUS: A ’Quick and Dirty’ Usability Scale, Usability Evaluation In Industry 189 (1996) 207–212. doi:10.1201/9781498710411-35. [24] H. Hoehle, R. Aljafari, V. Venkatesh, Leveraging Microsoft’s mobile usability guidelines: Conceptualizing and developing scales for mobile application usability, International Journal of Human Computer Studies 89 (2016) 35–53. URL: http://dx.doi.org/10.1016/j.ijhcs.2016.02.001. doi:10.1016/j.ijhcs.2016.02.001. [25] D. Cyr, Website design, trust and culture: An eight country investigation, Electronic Commerce

Research and Applications 12 (2013) 373–385. doi:10.1016/j.elerap.2013.03.007. [26] C. M. N. Faisal, M. Gonzalez-Rodriguez, D. Fernandez-Lanvin, J. D. Andres-Suarez, Web Design Attributes in Building User Trust, Satisfaction, and Loyalty for a High Uncertainty Avoidance Culture, IEEE Transactions on Human-Machine Systems 47 (2017) 847–859. doi:10.1109/THMS. 2016.2620901. [27] F. Chaudhry Muhammad Nadeem, F.-L. Daniel, D. A. Javier, G.-R. Martin, Design quality in building behavioral intention through afective and cognitive involvement for e-learning on smartphones,

References

[1] D. Lee , J. Moon , Y. Jin , M. Y. Yi , Antecedents and consequences of mobile phone usability; Linking simplicity and interactivity to satisfaction , trust , and brand loyalty , Information and Management 52 ( 2015 ) 295 - 304 .

[2] B. Coldewey , A. Diruf , R. Röhrig , M. Lipprandt , Causes of use errors in ventilation devices - Systematic review , Applied Ergonomics 98 ( 2022 ). doi: 10 .1016/j.apergo. 2021 . 103544 .

[3] J. van der Peijl , J. Klein, C. Grass , A. Freudenthal , Design for risk control: The role of usability engineering in the management of use-related risks , Journal of Biomedical Informatics 45 ( 2012 ) 795 - 812 . URL: http://dx.doi.org/10.1016/j.jbi. 2012 . 03 .006. doi: 10 .1016/j.jbi. 2012 . 03 .006.

[4] M. Jiang , D. Sun , Q. Li , D. Wang , The usability of ventilator maintenance user interface: A comparative evaluation of user task performance, workload, and user experience , Science Progress 103 ( 2020 ) 1 - 18 . doi: 10 .1177/0036850420962885.

[5] N. S. Marjanovic , A. De Simone , G. Jegou , E. L'Her, A new global and comprehensive model for ICU ventilator performances evaluation , Annals of Intensive Care 7 ( 2017 ). doi:10.1186/ s13613-017-0285-2.

[6] M. Jiang , D. Sun , Q. Li , D. Wang , The usability of ventilator maintenance user interface: A comparative evaluation of user task performance, workload, and user experience , Science Progress 103 ( 2020 ) 1 - 18 . doi: 10 .1177/0036850420962885.

[7] V. S. Barletta , F. Cassano , A. Pagano , A. Piccinno , A collaborative AI dataset creation for speech therapies , in: CEUR Workshop Proceedings , volume 3136 , 2022 , pp. 81 - 85 .

[8] H. Hussain , C. M. Faisal , M. A. Habib , M. Gonzalez-Rodriguez , D. Fernandez-Lanvin , J. De Andres, ARLexic game: an augmented reality-based serious game for training of dyslexic and dysgraphic children , Virtual Reality 27 ( 2023 ) 3649 - 3663 . URL: https://doi.org/10.1007/s10055-023-00862-4. doi: 10 .1007/s10055-023-00862-4.

[9] S. Hussain , E. B. Sanders , M. Steinert , Participatory design with marginalized people in developing countries: Challenges and opportunities experienced in a field study in Cambodia , International Journal of Design 6 ( 2012 ) 91 - 109 .

[10] A. Esposito , M. Calvano , A. Curci , G. Desolda, R. Lanzilotti , C. Lorusso , A. Piccinno , End-User Development for Artificial Intelligence: A Systematic Literature Review, Lecture Notes in Computer Science (including subseries Lecture Notes in Artificial Intelligence and Lecture Notes in Bioinformatics) 13917 LNCS ( 2023 ) 19 - 34 . doi: 10 .1007/978-3- 031 -34433- 6 _ 2 .