The research setting was a tertiary health care institution in South Korea equipped with 1335 beds. Patient care areas in the hospital are stratified into general wards (GWs), comprehensive nursing care wards (CNCWs), and intensive care units (ICUs), depending on the level of nursing care and patient severity. Typically, a nurse in a GW is responsible for overseeing 16 patients with an IQR between 12 and 24 years. Basic nursing tasks in GWs, including EC, bathing, and feeding, are facilitated predominantly by family members or caregivers. Regarding EC, nursing duties primarily involve changing diapers and documenting intake and output quantities. The national introduction of CNCWs in 2016 was intended to reduce the financial burden of public nursing care and enhance the quality of inpatient services [26]. CNCWs deliver 24-hour comprehensive patient care administered by professionally trained nurses without the support of informal caregivers, a model also employed in ICUs. All essential nursing care in both CNCWs and ICUs, including EC, is provided by trained nurses. However, the patient-to-nurse ratio in CNCWs, usually 5 or 6 to 1, is higher than in ICUs, where it is typically 2 or 3 to 1.

Using a mixed methods approach, we conducted both qualitative and quantitative analyses to capture a comprehensive understanding of the participants’ perspectives on the Smart Excretion Care System.

The quantitative analysis aimed to gather scaled feedback on potential enhancements and additions to the functions and features of the Smart Excretion Care System. In addition, this analysis identified patterns and tendencies in user preferences and expectations. An introductory survey was conducted to ensure that all the participants were adequately informed and ready to provide insights during the focus group interviews (Table S1 of Multimedia Appendix 1). The questionnaire was separated into 4 distinct categories: the nurses’ role in managing patient elimination, applicable indications, needs, and evaluation.

For the qualitative analysis, we implemented an exploratory content analysis of the transcribed interviews to comprehend the participants’ perspectives on the Smart Excretion Care System. The transcripts were rigorously examined and verified by the research team. The coauthors collaboratively generated, compared, reviewed, and validated codes and subthemes to ensure the reliability of the data. The study followed the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines [27].

We enrolled registered nurses from Seoul National University Bundang Hospital (SNUBH) who had a minimum of 1 year of professional experience. We engaged nurses from all departments at SNUBH without exclusion, except for career experience, and garnered diverse opinions and insights regarding their work environments. However, priority was given to applicants from ICU wards given their greater involvement in EC. SNUBH’s extensive history since its inception in 2003 of adopting various smart patient care technologies, such as smart bedside stations and a patient guide system, made its nursing staff an ideal cohort for this study [10,28-31]. For participant recruitment, we utilized purposive and snowball sampling, 2 nonprobability sampling methods that allow for strategic participant selection and expansion of potential study subjects through existing participant referrals, respectively [32,33]. Consistent with a previous study, our interview design included at least 5 participants per group [27].

To ascertain participants’ needs concerning medical devices that could assist them in managing patients’ EC, we introduced the nurses to the Smart Excretion Care System.

This prototype device was primarily developed to replace conventional diaper usage and to effectively manage patients’ excretions (Figure 1).

It also facilitates the acquisition of digestive health data and prevents patients who are bedridden from developing skin complications resulting from urinary and fecal waste, such as pressure ulcers and incontinence-associated dermatitis (IAD). The prototype was engineered for individuals with mobility restrictions, such as individuals who are bedridden, disabled, or those who are older adults. The system employs advanced sensing technology to detect and remove urine and feces while simultaneously offering washing and air-drying features for enhanced hygiene and comfort, thus presenting an efficient substitute for traditional paper diapers. It ensures comprehensive washing, both anteriorly and posteriorly, accompanied by a warm air-drying mechanism and a deodorization feature, promising a hygienic user experience. It also includes a movable nozzle and sex-specific diaper cup, permitting 30-degree positional adjustments to boost cleaning efficiency and user comfort. The Smart Excretion Care System was also designed to seamlessly integrate patient data into electronic medical records (EMRs) (Figure 2).

The system communicates with a local server that collects and processes data from the care apparatus. The local server is linked to a central server capable of amalgamating and managing data from multiple local servers. The central server can also be integrated with an EMR system. This setup enables health care providers to monitor and track the health and hygiene status of individual users by incorporating crucial data into their comprehensive medical records. Moreover, this integration facilitates remote patient monitoring and personalized care.

Data were collected through face-to-face interviews that began with structured questions but were designed to allow flexibility for open discussions. Conducted in groups of 6 (9%) to 8 (12%) participants grouped by ward, these sessions aimed to foster a candid exchange of views. While the interviews started with predetermined questions, the interviewer also posed additional, spontaneous questions based on the participants’ responses, making the process akin to a semistructured interview. Each session, lasting between 30 and 40 minutes, was recorded and transcribed with the participants’ consent.

The study was approved by the Institutional Review Board of Human Research of the SNUBH, Republic of Korea (B-2102-667-308). All participants were informed of their rights, including the option to withdraw from the study at any time.

This study enrolled 67 participants, with no subsequent dropouts (Table 1). A significant majority of participants were female, and the predominant age group was between 20 and 39 years, with an equal number of participants in their 20s and 30s. Among the participants, 30 (45%) were drawn from GWs, 16 (24%) from CNCWs, 12 (18%) from ICUs, and 8 (12%) from the infection control team. In terms of career experience, 33 (49%) of the participants had between 3 and 5 years of experience, while 9 (14%) had 1 to 2 years of experience. Data saturation was achieved after interviewing approximately 45 (67%) of the participants.

This study aimed to identify the anticipated benefits and barriers to the development of the Smart Excretion Care System for clinical facilities. Focus group interviews were conducted to assess the burden of EC for nurses, the adaptation of the Smart Excretion Care System, the functions they wished to add, and the evaluation of pilot devices.

Building on the existing literature, our study underscores the critical gap in addressing the usability of Smart Excretion Care Systems. Previous research has predominantly focused on various domains of nursing care, such as safety, nutrition, counseling, and education [5-7]. However, despite the evident significance of EC, particularly in the context of an aging population and the associated challenges [1-4], studies focusing on the practical application and usability of smart systems for EC remain conspicuously absent. Most prior studies have either conducted exploratory investigations or worked toward standardizing nursing practices [8,9]. The development of numerous smart devices, such as smart mattresses and patient transport robots [17-23], is a progressive step. However, when it comes to EC, the emphasis has mainly been on biological signal collection and fecal analysis [24,25]. Therefore, our study is a pioneering endeavor to evaluate the usability of a comprehensive Smart Excretion Care System aimed at holistically addressing patients’ urinary and bowel elimination needs.

The focus group interview results revealed that the burden of EC was well understood. According to this study, the percentage of EC work during working hours and the number of delays in other work due to EC were highest in CNCWs. The biggest problems related to EC were irregular excretion and diarrhea, with 94% of patients needing fecal care in the highest ICU. This result may be because nurses in CNCWs are fully in charge of EC, like those in ICUs, but there are more patients per nurse in these wards than in ICUs. Regarding the burden on nurses, a previous study on intensive care nurses found the highest incidence of musculoskeletal pain was due to nursing tasks [34]. Other studies have analyzed the prevalence of musculoskeletal disorders and the physical burden on nurses, including urinary and bowel elimination care, position changes, and transfers, but there have been no studies on the burden of urinary and bowel EC [11-13].

The Smart Excretion Care System was investigated in terms of department, disease, and patients’ physical characteristics. There was a common opinion that ICUs are most in need of the Smart Excretion Care System. In terms of patient indicators, those with stroke or dementia were seen as most in need of such a system. Regarding patients’ physical characteristics, those who were unconscious or conscious but unable to move were thought to require EC the most. The findings here show that the burden of EC is related more to the physical characteristics of the patient than to the severity of the patient’s disease condition.

To define the method of disinfection or cleaning of the device, a group interview with the infection control team was conducted. The results suggested that the disinfection method should differ depending on the concerned part, such as the part of the cup, the hose, the main body, or the bucket. The consensus was that the cup part should be cleaned with a disinfectant and replaced when applied to other patients; the hose should be used for disinfection of the existing product itself; and the waste basket should be deposited with disinfectant. Immunocompromised patients and those with acupuncture wounds could be at a high risk of infection; therefore, medical staff should use their judgment when using the device. C. difficile infections induce apoptosis, so the device cannot be used even at a low level of disinfection. However, it would be available for patients with hepatitis A and polycystic-resistant bacteria, such as Methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci [35-37].

With regard to the possible improvements, most study participants wanted a notification sign that would be visible whenever the device detected abnormalities in the excrement. Size-related requirements were also important so that the machine could be placed at the foot of the patient’s bed. The participants hoped that a function would be developed to automatically spray creams or ointments to prevent pressure ulcers and IAD. In addition, the development of functions to measure the amount of excrement, such as hourly urine output, was seen as more important than measuring its frequency.

This study found that the position of the patients should be considered when using the Smart Excretion Care System. The proposed system can be used by patients in the supine position. However, almost all the participants said that the machine should be available to patients in the semi-Fowler position. These findings are in line with the results of prior studies suggesting that the semi-Fowler position is effective in several disease conditions [38-40]. This indicates the importance of developing the Smart Excretion Care System for use in the semi-Fowler position.

Seamless integration with EMRs is paramount to the broader landscape of health care informatics. This study evaluates the capabilities of the proposed Smart Excretion Care System in this context. The high ratings for automated urine and stool output checks, combined with the system’s ability to perform urinalysis and bowel classification, suggest the promising potential of this technology. This integration would not only enhance patient care by offering real-time, accurate data but also help health care professionals in making informed decisions, reducing manual entry errors, and improving the overall workflow. The slightly lower rating for user identification may indicate concerns regarding privacy and data security, underscoring the importance of robust encryption and security protocols in future iterations of the system.

This study has several limitations. First, the data were derived from a single tertiary hospital. For a more comprehensive understanding and generalization of our findings, future research involving multiple centers will be invaluable. Second, the qualitative research process, especially with semistructured interviews, carries inherent biases. While we did not explicitly introduce assumptions, the framing and phrasing of the questions, especially after prediscussions with nurses, might have led the participants in certain directions or limited the scope of their responses. Questions like “What are the expected benefits of using the Smart Excretion Care System device?” can inadvertently emphasize the positive aspects, whereas other questions may emphasize the challenges. Despite this, it is important to note that the questions were crafted with the genuine aim of understanding nurses’ perspectives on a novel medical device without any predetermined agenda. Third, although every effort was made to maintain objectivity, the interpretation of qualitative data was inevitably influenced by the researchers’ personal perspectives. To mitigate this, we adhered to the COREQ guidelines. We also cross-validated the deduced themes with multiple researchers to curtail potential biases.

Fourth, the nursing environments surrounding EC can differ significantly across hospitals and countries. Since our study provides insights from a specific setting, these findings may not be universally applicable. That said, the core challenges related to EC are likely consistent across many settings, offering valuable lessons for researchers and professionals elsewhere. Fifth, the metrics provided by the nurses, such as the percentage of EC work per shift, delays due to EC, and the estimated time for EC, were based on nurses’ perceptions rather than on precise measurements using scientific tools or time-motion studies. Future research should aim to quantify these aspects more accurately, possibly through detailed time-motion studies or analyses of nursing records. Sixth, a significant limitation is the study’s reliance on participants’ perceptions of a theoretical design without the experience of the actual functioning of the technology. This approach inherently required the participants to visualize and understand the proposed technology based on descriptions and potential demonstrations. Consequently, their perspectives may have been limited or even flawed because they did not have hands-on experience with the system in a real-world setting. Engaging participants in discussions about conceptual design may not capture the intricacies, challenges, and benefits they might encounter when using the technology in their daily routines. In future studies, beta testing the technology in a qualitative format could offer deeper and more accurate insights.

This was a formative research study using focus group interviews to collect basic data for the development of the Smart Excretion Care System for clinical and community care settings. The required improvements to the pilot devices are meaningful for identifying the expected benefits, barriers, and consequent demands of the hospital’s Smart Excretion Care System and the burden of nurses’ EC. Furthermore, while our focus was primarily on alleviating the burden on nurses, we recognize the intrinsic value of the patient’s perspective, especially given the potentially invasive nature of this technology. Their voices and comfort are paramount because the aim of any health care technology is to enhance patient care. In future studies, it would be beneficial to incorporate patient feedback to ensure that the developed system is both efficient for caregivers and respectful of the patients’ dignity and privacy.